[Federal Register: March 13, 2000 (Volume 65, Number 49)]
[Proposed Rules]
[Page 13511-13560]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr13mr00-21]
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Part III
Department of Agriculture
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Agricultural Marketing Service
7 CFR Part 205
National Organic Program; Proposed Rule
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DEPARTMENT OF AGRICULTURE
Agricultural Marketing Service
7 CFR Part 205
[Docket Number: TMD-00-02-PR2]
RIN 0581-AA40
National Organic Program
AGENCY: Agricultural Marketing Service, USDA.
ACTION: Proposed rule.
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SUMMARY: This proposed rule would establish a National Organic Program
(NOP or program) under the direction of the Agricultural Marketing
Service (AMS), an arm of the United States Department of Agriculture
(USDA). This national program is intended to facilitate interstate
commerce and marketing of fresh and processed food that is organically
produced and to assure consumers that such products meet consistent,
uniform standards. This program will establish national standards for
the production and handling of organically produced products, including
a National List of substances approved and prohibited for use in
organic production and handling. This proposal will establish a
national-level accreditation program to be administered by AMS for
State officials and private persons who want to be accredited as
certifying agents. Under the program, certifying agents will certify
production and handling operations in compliance with the requirements
of this regulation and initiate compliance actions to enforce program
requirements. The proposal includes requirements for labeling products
as organic and containing organic ingredients. The rule also provides
for importation of organic agricultural products from foreign programs
determined to have equivalent organic program requirements. The program
is proposed under the Organic Foods Production Act of 1990, as amended.
DATES: Comments must be submitted on or before June 12, 2000.
ADDRESSES: Interested persons are invited to submit written comments on
this proposal to: Keith Jones, Program Manager, National Organic
Program, USDA-AMS-TMP-NOP, Room 2945-So., Ag Stop 0275, PO Box 96456,
Washington, DC 20090-6456. Comments also may be sent by fax to (703)
365-0760 or filed via the Internet through the National Organic
Program's homepage at: http://www.ams.usda.gov/nop. Written comments to
this proposed rule submitted by regular mail and faxed comments should
be identified with docket number TMD-00-02-PR. To facilitate the timely
scanning and posting of comments to the NOP homepage, multiple page
comments submitted by regular mail should not be stapled or clipped.
Commenters should identify the topic and section number of this
proposal to which the comment refers.
It is our intention to have all comments to this proposal, whether
mailed, faxed, or submitted via the Internet, available for viewing on
the NOP homepage at http://www.ams.usda.gov/nop in a timely manner.
Comments submitted in response to this proposal will be available for
viewing at USDA-AMS, Transportation and Marketing, Room 2945-South
Building, 14th and Independence Ave., SW, Washington, DC, from 9:00
a.m. to 12:00 p.m. and from 1:00 p.m. to 4:00 p.m., Monday through
Friday (except official Federal holidays). Persons wanting to visit the
USDA South Building to view comments received in response to this
proposal are requested to make an appointment in advance by calling
(202) 720-3252.
FOR FURTHER INFORMATION CONTACT: Richard Mathews, Senior Agricultural
Marketing Specialist, USDA-AMS-TM-NOP, Room 2510-So., PO Box 96456,
Washington, DC 20090-6456; Telephone: (202) 205-7806; Fax: (202) 205-
7808.
SUPPLEMENTARY INFORMATION:
Background of the National Organic Program
To address problems created by inconsistent organic standards, the
organic industry attempted to establish a national voluntary organic
certification program in the late 1980's. However, that effort failed
to develop a consensus on needed organic standards. Congress was then
petitioned by an organic industry trade association to establish a
mandatory national organic program, resulting in the Organic Foods
Production Act of 1990 (the Act). Congress passed the Act to: (1)
Establish national standards governing the marketing of certain
agricultural products as organically produced products; (2) assure
consumers that organically produced products meet a consistent
standard; and (3) facilitate commerce in fresh and processed food that
is organically produced. This proposal is designed to implement the
Act.
To help readers better understand this proposal, we have provided
answers to some frequently asked questions about the proposed rule,
including some of the issues most commonly raised in public comments.
Is this the final word on National organic standards?
No. This is only a proposed rule. It is important that you take the
time to read it carefully and write to USDA to give us your
recommendations, being as specific as you can. Your comments are due by
June 12, 2000.
Your comments do matter. On December 16, 1997, the first proposed
rule was published in the Federal Register, and 275,603 people wrote to
us to explain why and how the rule should be rewritten, the largest
public response to a proposed rule in USDA history. Then, in the
October 24, 1998 Federal Register, we asked for public comment on
issues concerning livestock confinement, medications, and the authority
of certifying agents, and 10,817 people wrote to us. As you read
through this document, you will get a sense of what these comments said
because in each section we briefly summarize the relevant comments and
provide our response to them.
We expect to publish a final rule later this year, once we know
what you think about this proposal. The final rule will have, as
proposed here, an implementation phase-in period so farmers and
processors won't have to change overnight.
Has there been citizen input on this proposal beyond public comments?
Yes. The National Organic Standards Board (NOSB) is a 15-member
citizen board that advises the Secretary on all aspects of the National
Organic Program and has special responsibility for development of the
National List. Established by law in 1990, the NOSB includes 3
environmental representatives, 3 consumer representatives, 4 organic
farmers/ranchers, 2 organic processors, 1 retailer, 1 scientist, and 1
certifying agent. Currently, the NOSB comprises 14 members. The 15th
member, an accredited certifying agent, would be appointed after
certifying agents are accredited by the Secretary. Since the first NOSB
was appointed in 1993, the Board has held 19 public meetings, including
one public teleconference, crisscrossing the country to hear from the
public before making recommendations to the Secretary on national
standards. The vast majority of commenters on the first proposed rule
urged the Secretary to rewrite the proposal in line with NOSB
recommendations--and this is what we have done. More information on
NOSB
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members, meeting minutes, and a side-by-side comparison of this
proposal with NOSB recommendations can be found at www.ams.nop/gov.
In addition, to be consistent with OMB Circular No, A-119, which
directs agencies to use voluntary consensus standards, USDA considered
adoption of the American Organic Standards, Guidelines for the Organic
Industry as a voluntary consensus standard for use in the National
Organic Program. In October 1999, the Organic Trade Association
published the American Organic Standards (AOS). The AOS standards were
developed over several months with two opportunities for comment from
interested parties. The introduction states that the standards are
written as an up-to-date compilation and codification of organic
standards and certification procedures, as they are understood and
applies in the United States. Organic Trade Association members are
expected to follow the guidelines.
USDA has determined that it would be impractical to use the
American Organic Standards in lieu of USDA developed standards for the
following reasons: (1) Not all participants in the organic industry
elected to participate in developing the AOS; (2) the AOS are new to
the industry so there has not been sufficient time for the industry to
assess their effectiveness, and (3) some certifying agents disagree
with portions of the AOS.
Why do we need national standards for organic food?
National standards for organic food production are designed to
bring about greater uniformity in the production, manufacture, and
marketing of organic products. In the absence of a national standard,
49 State and private organizations have established individual programs
and standards for certifying organic agricultural products. The lack of
consistency between these standards has created problems for farmers
and handlers of organic products, particularly if they want to sell
their products in multiple States with different standards. Lack of a
nationwide standard has also created confusion for consumers, who may
be uncertain what it really means when a food product is called
``organic.''
With a national standard, consumers across the country can go into
any store and have full confidence that any food product labeled
``organic'' meets a strict, consistent standard no matter where it was
made. Use of the word, ``organic,'' on the label of any product that
does not meet the standard is strictly prohibited.
Consumers will have that confidence, because this proposal requires
for the first time that all organic operations be certified by USDA-
approved certifying agents. Up to now, certification has been optional;
some farmers choose not to be certified at all, and others are
certified by State or private certifiers using different standards. It
can be hard for consumers to know if a product has been certified, or,
if it has, to what standard. Under this proposal, all organic
operations, except for the very smallest, would be certified to the
same standard. And all products labeled as ``organic'' would have to
comply with the production and handling standards in this rule.
Consumers can also look for the USDA organic seal, which can only
be used on products that have been certified by USDA-approved
certifying agents. This seal assures consumers that the maker of the
product is part of a rigorous certification program and has been
thoroughly reviewed by professional inspectors trained in organic
agriculture.
National standards will also bring greater predictability for
producers of organic foods. There will be no confusion about whether a
product satisfies the particular standard of any State, for example,
because all organic foods will meet the same standards.
Finally, a national standard for organic food will help our farmers
and manufacturers sell organic products in other countries. The lack of
a consistent national organic program has limited access to important
markets in other countries because of the confusion created by
multiple, independent standards. A strong national standard will help
to ensure buyers in other countries that all U.S. organic products meet
the same standards.
How can I tell how much organic food is in a product?
This proposal sets strict labeling standards based on the
percentage of organic content. If a product is 100 percent organic, it
can, of course, be labeled as such. A product that is at least 95
percent organic can be described as, for example, ``organic cereal.''
If a cereal, for example, contains between 50 and 95 percent organic
content, it can be described as ``cereal made with organic
ingredients,'' and up to three organic ingredients can be listed.
Finally, if the food contains less than 50 percent organic content, the
term, ``organic,'' may only appear on the ingredient information panel.
These four new labeling categories will provide consumers with much
greater information than they have today. [Labeling is covered in
subpart D.]
What is the National List?
The National List of Allowed and Prohibited Substances (known as
the National List) identifies specific substances that may or may not
be used in organic production and handling operations. The National
List is developed by the NOSB, through consultation with outside
experts, and forwarded to the Secretary for approval. The list
identifies those synthetic substances, which would otherwise be
prohibited, that may be used in organic production based on the
recommendations of the NOSB. Only those synthetic substances found on
the National List may be used. The National List also identifies those
natural substances that may not be used in organic production, as
determined by the Secretary based on the NOSB recommendations.
The first proposal included some substances on the National List
that were not recommended by the NOSB. This proposal contains no
substances on the approved list that were not found in the NOSB
recommendations.
This proposal also includes restrictions or other conditions on the
use of allowed substances, also known as ``annotations,'' as
recommended by the NOSB. Such annotations have been used by existing
State and private certification programs to further ensure that allowed
substances are used in a manner that is consistent with organic
production. (The National List is covered in subpart G, Secs. 205.600
through 205.607.)
Does this proposal prohibit use of genetic engineering in organic
production?
Yes. This proposal prohibits the use of genetic engineering
(included in the broad definition of ``excluded methods'' in this
proposal, based on the definition recommended by the National Organic
Standards Board) in the production of all foods and ingredients that
carry the organic label.
275,603 commenters on the first proposal nearly universally opposed
the use of this technology in organic production systems. Based on this
overwhelming public opposition, this proposal prohibits its use in the
production of all organic foods even though there is no current
scientific evidence that use of excluded methods presents unacceptable
risks to the environment or human health. While these methods have been
approved for use in general agricultural production and may offer
certain benefits for the
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environment and human health, consumers have made clear their strong
opposition to their use in organically grown food. Since the use of
excluded methods in the production of organic foods runs counter to
consumer expectations, foods produced with these methods will not be
permitted to carry the organic label. (Excluded methods are defined in
subpart A and discussed further under Production and Handling (subpart
C), Labeling (subpart D), and the National List (subpart G).)
Will genetic engineering be allowed in the production of foods that
contain both organic and nonorganic ingredients?
No. For products with mostly organic content--those products where
more than half of the ingredients are organic and that have the word,
``organic,'' on the main product label-- excluded methods must not be
used in the production of any ingredients. Only those products, in
which fewer than half of the ingredients are organic and in which the
organic ingredients are only identified on the ingredient panel, could
contain nonorganic ingredients produced through excluded methods.
We believe consumers have expressed a clear expectation that these
methods should not be used in the production of any ingredients
contained in mostly organic products. Because prominent use of the
word, ``organic,'' on the label of such products reinforces that
expectation, we have chosen to prohibit use of excluded methods in
production of both the organic and nonorganic ingredients.
We recognize that this policy will place additional burdens on
organic food processors and certifying agents because the ability to
meet these requirements will depend largely on practices used in
conventional agricultural markets. For organic food processors, it may
be harder to find sources of nonorganic ingredients that are produced
without use of excluded methods. Similarly, certifying agents may face
greater difficulty because they will be required to ensure that
handlers have complied with this requirement. However, we believe that
the need to meet strong consumer expectations outweighs these concerns.
Furthermore, we anticipate that as marketplace practices or standards
evolve, these practices will be the basis for implementing this
provision, providing handlers and certifying agents recognize criteria
with which to evaluate sources of nonorganic ingredients in products
containing both organic and nonorganic ingredients.
Does this proposal prohibit use of irradiation in organic production?
Yes. This proposal prohibits the use of irradiation in the
production of all foods and ingredients that carry the organic label.
275,603 commenters on the first proposal almost universally opposed the
use of this technology in organic production systems. Based on this
overwhelming public opposition, this proposal prohibits its use in the
production of all organic foods even though there is no current
scientific evidence that use of irradiation presents unacceptable risks
to the environment or human health and may, in fact, offer certain
benefits. Because this rule is a marketing standard and consumers have
expressed a clear expectation that irradiation should not be used in
the production of organic foods, foods produced with this technology
will not be permitted to carry the organic label.
The prohibition on irradiation extends to nonorganic ingredients
used in mostly organic ingredients--those products where more than half
of the ingredients are organic and that have the word, ``organic,'' on
the main product label. Only those products, in which fewer than half
of the ingredients are organic and in which the organic ingredients are
only identified on the ingredient panel, could contain irradiated
nonorganic ingredients. We do not believe that this prohibition on
irradiation in nonorganic ingredients will place undue burden on either
handlers or certifiers because of current labeling requirements for
irradiated products.
Does this proposal prohibit use of sewage sludge in organic production?
Yes. This proposal prohibits the use of sewage sludge in the
production of all foods and ingredients that carry the organic label.
This prohibition extends to nonorganic ingredients used in the
production of mostly organic foods--those products in which more than
half of the ingredients are organic and that have the word,
``organic,'' on the main product label. Only those products, in which
fewer than half of the ingredients are organic and which the organic
ingredients are only identified on the ingredient panel, could contain
nonorganic ingredients produced using sewage sludge.
275,603 commenters on the first proposal almost universally opposed
the use of this technology in organic production systems. Based on this
overwhelming public opposition, this proposal prohibits its use in the
production of all organic foods, even though there is no current
scientific evidence that use of sewage sludge in the production of
foods presents unacceptable risks to the environment or human health.
We believe consumers have expressed a clear expectation that sewage
sludge should not be used in the production of any ingredients
contained in mostly organic products. Because prominent use of the
word, ``organic,'' on the label of such products reinforces that
expectation, we have chosen to prohibit use of sewage sludge in
production of both the organic and nonorganic ingredients. We recognize
that this policy may place additional burdens on organic food
processors and certifying agents. However, we believe that the need to
meet strong consumer expectations outweighs these concerns.
Does this proposal set standards for livestock production?
Yes. The proposal sets the first comprehensive standards for
production of organic animals and meat products. Under this proposal,
use of antibiotics would be prohibited in organic livestock production.
The standards also prohibit the routine confinement of animals and
require that ruminant animals have access to outdoor land and pasture,
although temporary confinement would be allowed under certain, limited
circumstances. Animals under organic management must also receive 100-
percent organically grown feed. (Organic livestock management issues
are discussed in greater detail under subpart C, 205.236 through
205.239.)
Does this proposal prohibit ``ecolabeling''?
No. This proposal only regulates use of the term, ``organic,'' on
product labels. Other labels would be allowed as long as they are
truthful and not misleading and meet general food labeling
requirements. The labeling requirements of this proposal are intended
to assure that the term, ``organic,'' and other similar terms or
phrases are not used in a way that misleads consumers. Should we find
that terms or phrases are being used to represent ``organic'' when the
products are not produced to the requirements of this regulation, we
would proceed to restrict their use. (Labeling is covered in subpart
D.)
Are organic foods pesticide-free?
No. Organic farmers can use natural pesticides to control weeds and
insects and maintain the high quality of organic products that
consumers have come to expect. Use of synthetic chemical pesticides,
however, is prohibited unless specifically allowed on the National List
as recommended by the
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National Organic Standards Board and approved by the Secretary. (The
National List is covered in subpart G, sections 205.600 through
205.607.)
Who needs to be certified?
As a general rule, all organic production and handling operations
must be certified. The Act and this proposal, however, do provide for
some exceptions. For example, organic operations with less than $5,000
in annual sales of organic products do not require certification.
Similarly, organic operations that handle only those products with less
than 50 percent organic content or that restrict labeling of organic
ingredients to the ingredient information panel do not require
certification. Finally, we are not requiring certification of most
grocery stores and restaurants (referred to in this proposal as
``retail food establishments'') at this time.
Even where operations do not require certification, however, all
organic food products must meet the national standards as described in
this proposal. In that way, consumers can be confident that all
products labeled as ``organic'' meet the national standards, even if
they did not require certification under the NOP. (Certification is
covered in subpart E; the exceptions from certification are found in
subpart B.)
Will organic farmers have to pay fees?
Organic farmers and other organic operations will have to pay fees
for organic certification but will not be charged any fees by USDA.
Fees for certification services will be set by the private or State
certifying agents. The proposal also requires that certifying agents
make their schedule of fees publicly available so that organic
operations can plan appropriately and so that they can make informed
choices where multiple certifying agents are available. USDA will also
review fees charged by certifying agents to ensure that they are
reasonable and that they are being applied fairly to all organic
operations. Under this proposal, USDA would only charge fees for
reviewing (``accrediting'') certifying agents. These fees will
primarily be based on the actual costs of the accreditation work done
by USDA staff so that certifying agents with smaller and less complex
programs will pay lower fees. The proposal also provides for a
reduction in the accreditation fees during the first 18 months of the
program to provide an incentive for certifying agents to become
accredited under the new national program as soon as possible. (Fees
are covered in subpart G, Secs. 205.640 through 205.642.)
How do I become an accredited certifying agent?
All certifying agents must be accredited by USDA. Certifying agents
may apply for accreditation effective with publication of the final
rule and are encouraged to apply as soon after publication of the final
rule as possible. USDA will provide additional information on applying
for accreditation on or about the date of publication of the final
rule. This information will be available on the NOP website and by mail
upon request.
Applications for accreditation will be handled on a first-come-
first-served basis. Those that apply within the first 6 months
following publication of the final rule and are determined by the
Administrator to meet the requirements for accreditation will be
notified of their status in writing on or about 12 months after
publication of the final rule. This approach is being taken because of
the market advantage that could be realized by accredited certifying
agents if USDA did not announce the accreditations simultaneously.
(Accreditation is covered in subpart F.)
What are the roles and responsibilities of certifying agents in the
National Organic Program?
Certifying agents are the ``front line'' representatives of USDA
and play a critical role in the oversight and enforcement of the
national organic standards program. Once accredited by USDA, certifying
agents are empowered to make key decisions regarding the status of
organic operations. Certifying agents review the organic plans of
organic operations and are authorized to grant certification to those
operations that meet the strict national organic standards. Certifying
agents are also responsible for the continuing oversight of organic
operations-- reviewing annual updates of organic plans, conducting
residue analyses, and conducting other monitoring activities.
In cases in which a certifying agent finds that an organic
operation does not meet the national standards, the agent is empowered
to issue notices of noncompliance and to initiate suspension or
revocation of certification. Organic operations can appeal such
decisions to USDA but unless the organic operation appeals the
certifying agent's decision or can correct the problems identified by
the certifying agent, the agent's decision will stand. (Accreditation
is covered in subpart F; Compliance is covered in subpart G,
Secs. 205.660 through 205.668; and Appeals are covered in subpart G,
Secs. 205.680 through 205.681.]
How will USDA ensure that the National standards are applied fairly and
consistently by all certifying agents?
Because this proposal gives certifying agents such an important
role in enforcing the national standards, USDA oversight of those
certifying agents is particularly important. Under this proposal, all
certifying agents, both private and in State organic programs, would
have to be accredited by USDA before they could begin to certify
organic operations. It is this accreditation process, in which USDA
reviews all certifying agents to make sure they understand and can
accurately apply the national organic standards, that is USDA's main
tool to ensure that the standards are applied fairly and consistently
by all certifying agents.
The accreditation process is really one of ongoing oversight by
USDA. Accreditation must be renewed every 5 years so that we can be
sure certifying agents continue to meet the program standards. USDA
will conduct one or more site visits of certifying agents during the
period of accreditation as another mechanism of monitoring their
compliance. Finally, certified operations may file complaints with USDA
if they believe they have been treated unfairly or if a certifying
agent is otherwise not following the program requirements. We will
investigate these complaints for possible enforcement action.
Can States have organic standards that are more strict than the
National standard?
Yes. Some States may have unique environmental or other concerns
that they believe require extra conditions above the national standard.
In those cases, States would apply to USDA to have their special State
program approved by the Secretary.
However, no State would be allowed to set up a program that does
not at least meet the national standard. And States would not be
allowed to use their programs to keep out or otherwise discriminate
against organic products made in another State. (State Programs are
covered in subpart G, Secs. 205.620 through 205.622.)
What is the timeframe for implementation?
The final rule in this rulemaking process will establish a
procedure and a timeframe for implementing the NOP. We expect that the
interim period between publication of the final rule in this rulemaking
process and the effective date of the program (actual implementation of
regulations) will be 18 months. The following is a
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preliminary list of several administrative and program issues that must
be implemented during that period. Certifying agent applications will
be evaluated and accreditation granted. Certifying agents will, in
turn, certify production and handling operations to the requirements of
these regulations. Equivalency discussions will be held with foreign
governments and foreign certifying agents. Guidelines and practice
standards on production and handling practices must be finalized and
distributed by the NOP. A petition process for recommending amendments
to the National List must be developed and distributed. The NOSB will
continue to review materials for the National List. State programs may
have to make adjustments in their organic certification programs for
consistency with the standards of this program. Producers should use
the interim period to prepare their production operations to comply
with the relevant requirements of this program. Handlers should use the
interim period to prepare for necessary changes in the labeling of
their products.
Prior Documents in This Proceeding
This proposed rule is issued pursuant to the Organic Food
Production Act of 1990 (Act or OFPA), as amended (7 U.S.C. 6501 et
seq.). This proposal replaces the proposed rule published in the
Federal Register December 16, 1997. Comments to the first proposal were
considered in the preparation of this proposed rule.
The following notices related to the NOSB and the development of
this proposed regulation have been published in the Federal Register.
Five notices of nominations for membership on the NOSB were published
between April 1991 and June 1999 (56 FR 15323, 59 FR 43807, 60 FR
40153, 61 FR 33897, 64 FR 33240). Two notices of extension of time for
submitting nominations were published on September 22, 1995, and
September 23, 1996 (60 FR 49246, 61 FR 49725). Seventeen notices of
meetings of the NOSB were published between March 1992 and October 1999
(57 FR 7094, 57 FR 27017, 57 FR 36974, 58 FR 85, 58 FR 105, 58 FR 171,
59 FR 58, 59 FR 26186, 59 FR 49385, 60 FR 51980, 60 FR 15532, 61 FR
43520, 63 FR 7389, 63 FR 64451, 64 FR 3675, 64 FR 28154, 64 FR 54858).
One notice of public hearings on organic livestock and livestock
products was published on December 30, 1993 (58 FR 69315). One notice
specifying a procedure for submitting names of substances for inclusion
on the National List was published on March 27, 1995 (60 FR 15744). A
rule proposing the NOP was published on December 16, 1997 (62 FR
65850). An extension of the time period for submitting comments to the
proposed rule was published on February 9, 1998 (63 FR 6498). One
request for comments on Issue Papers was published on October 28, 1998
(63 FR 57624). A notice of a program to assess organic certifying
agencies was published on June 9, 1999 (64 FR 30861).
This preamble includes a discussion of the proposed rule and
supplementary information, including the Regulatory Impact Assessment,
Regulatory Flexibility Act Analysis, Federalism Impact Statement, and
Paperwork Reduction Act Analysis. The Civil Rights Impact Analysis is
not included as an attachment but may be obtained by writing at the
address provided above or via the Internet through the National Organic
Program's homepage at: http://www.ams.usda.gov/nop.
National Organic Program Overview
Subpart A--Definitions
Proposal Description
This subpart defines various terms used in this part. These
definitions are intended to enhance conformance with the regulatory
requirements through a clear understanding of the meaning of key terms.
We have amended terms and definitions carried over from the first
proposal where necessary to make their wording consistent with the
language used in this proposal. We have removed the definition for the
following terms because the terms are not used in this proposal or have
been determined to be unnecessary: Active ingredient in any input other
than pesticide formulations, active ingredient in pesticide
formulations, agroecosystem, botanical pesticides, breeding, chapter,
cation balancing agent, certification activities, certification
applicant, certified facility, chapter, confirmation of accreditation,
contaminant, critical control point, cytotoxic mode of action,
degradation, detectable residue level, extract, farm, foliar nutrient,
formulated product, fungicide, generic name, incidental additive, inert
ingredient in any input other than pesticide formulations,
intentionally applied, made with certain organic ingredients, mating
disrupter, micronutrient, nonactive residues, nonorganic agricultural
ingredient or product, petition, preliminary evaluation, processing
methods, production aid, production input, proper manuring,
putrefaction, site evaluation, soil amendment, split operation,
subtherapeutic, suspension of accreditation, synergist, synthetic
volatile solvent, treated, untreated seeds, USDA seal, and weed. We
received comments on some of the definitions that have been deleted. We
have not addressed these comments here because the relevant definitions
have been deleted.
Definitions--Changes Based On Comments
This subpart differs from our first proposal in several respects as
follows:
(1) We have amended the term, ``audit trail,'' by replacing the
category, ``organic'' or ``made with certain organic ingredients,''
with ``100 percent organic,'' ``organic,'' or ``made with organic
(specified ingredients),'' or agricultural product containing less than
50 percent organic ingredients identified as organic in an ingredients
statement. We have taken this action to clarify the definition as
requested by several commenters.
(2) We have amended the term, ``buffer area,'' to ``buffer zone''
and amended the term by replacing ``a certified farm or portion of a
farm'' with ``a certified production operation or portion of a
production operation.'' A few commenters suggested including a minimum
size for the buffer zone and specifying that buffer zones must be
uncropped vegetated areas. The appropriate size and type of a buffer
zone is highly site-specific and cannot be rigidly specified for all
locations without placing unreasonable burdens on some producers.
Several commenters supported determination of the appropriate buffer
zone size and type by the producer in consultation with the certifying
agent. Additional information on this issue can be found at subpart C,
Crop Production, Changes Requested But Not Made, item 1.
(3) We have amended the definition of the term, ``certification or
certified,'' to make the language in the definition consistent with the
language of this proposal. We have also removed the language concerning
the information to be found on a certificate. Commenters suggested
amending the definition by adding the words, ``annual'' and ``based on
an on-site inspection and comprehensive review of the operation.''
Other commenters recommended deleting the reference to products on a
certificate because it is the operation, not the product, that is
certified. We have not made the suggested additions because the issues
are adequately addressed in the regulations. We have removed the
language concerning information found on a certificate because this
information
[[Page 13517]]
is adequately addressed in the regulations.
(4) We have amended the definition of ``certifying agent'' to
clarify that the term only applies to State-entity and private-entity
certifying agents. We have taken this action because there was some
confusion among commenters over whether the original definition
included a State program's governing State official.
(5) We have amended the definition of ``commercially available'' by
removing the phrase, ``to be feasibly and economically used.'' We have
taken this action because we agree with commenters that use of the
phrase provides an opportunity for producers and handlers to avoid use
of preferred inputs. We have also clarified that ``commercially
available'' applies to processors by including the words, ``or
processing ingredient.'' Additional information on this issue can be
found at subpart C, Production and Handling (General), Changes
Requested But Not Made, item 2.
(6) We have amended the definition of ``compost'' by referring to
compost as ``the product of a carefully managed process through which
microorganisms break down plant and animal materials into more
available forms suitable for application to the soil.'' We also state
that ``composting'' must use methods to raise the temperature of raw
materials to the levels needed to stabilize nutrients and kill
pathogens. Specific instructions on the production of compost for use
in organic production has been referenced to the National Resources
Conservation Service's (NRCS) practice standard for a composting
facility (Code 317). The NRCS practice Standard provides a field tested
and verifiable procedure for producing compost. We have made these
changes because commenters suggested that we clarify the meaning of
compost. Several commenters stated that the definition should include
rules about what kinds of materials are acceptable for use in compost.
Additional information on this issue can be found at subpart C,
Production and Handling (General), Changes Based On Comments, item 4.
(7) We have amended the definition of ``crop rotation'' by adding a
statement about the relationship of crop rotation to perennial crops as
suggested by an industry association.
Several commenters suggested inserting references to the use of
legumes and sod as essential to crop rotation. The benefits achieved
through the use of legumes and sod could be fulfilled through many
types of rotation plans, which could only be developed according to the
site-specific climate, soil type, and type of crops or livestock
produced on a given operation. In the interest of flexibility this
proposal does not specify what specific crops have to be included in a
crop rotation. The issue addressed in this suggestion is addressed in
the crop rotation practice standard at Sec. 205.205. Additional
information on crop rotation can be found at subpart C, Production,
Changes Based On Comments, item 5.
(8) We have amended the definition of ``disease vectors'' by adding
that disease vectors include plants and animals that transmit disease
organisms or pathogens which may attack crops or livestock. A few
commenters pointed out that the definition as originally proposed was
technically inaccurate because it did not address the transmission of
disease organisms to crops or livestock.
(9) We have rewritten the definition of ``employee'' to provide
that an employee is any person providing paid or volunteer services for
a certifying agent. A few States requested that the definition clearly
reference volunteers. A trade association recommended expanding the
definition to include any person who works for a certifying agent. We
have included volunteers in this proposal because of their substantial
use by some certifying agents. Other States suggest changing
``certification decisions'' to ``certification activities'' to include
any person who is involved in the certification process. We have
addressed the commenters' concern by referring to services provided by
the employee for the certifying agent. A few States stated that the
definition needs to clarify who is the employer of an independent
inspector. An independent inspector would not be included in the
definition of employee. Such persons are considered to be contractors.
Some States expressed concern regarding the use of volunteers from
certified production and handling operations. Section 205.501(a)(11)
requires that a certifying agent prevent conflicts of interest by not
permitting any employee, inspector, contractor, or other personnel to
accept payment, gifts, or favors of any kind, other than prescribed
fees, from any business inspected, except that a certifying agent that
is a not-for-profit organization with an Internal Revenue Code tax
exemption may accept voluntary labor from certified operations. Under
this exception all volunteers would be excluded from work, discussions,
and decisions in all stages of the certification process and the
monitoring of certified production or handling operations for all
entities in which such person has or has held a commercial interest,
including an immediate family interest or the provision of consulting
services, within the prior 12-month period. Additional information on
conflicts of interest can be found at subpart F, Changes Based On
Comments, items 4 and 5, and subpart F, Changes Requested But Not Made,
items 5, 6, 7, and 8; subpart F, Additional Provisions, item 2.
(10) We have rewritten the definition of ``fertilizer'' to provide
for the inclusion of minor nutrients and trace elements with the three
primary nutrients (nitrogen, phosphorus, potassium) contained in a
substance or a blended substance utilized in a soil fertility program.
This is a generic definition of fertilizer. Issues concerning what
substances may be present in a fertilizer for organic production are
addressed in subpart C of this proposal.
(11) We have amended the definition of ``handle'' by providing that
the term shall not include the sale, transportation, or delivery of
crops or livestock by the producer thereof to a handler. This change
was made because we found merit in a certifying agent's concern that
farmers were turned into handlers by definition. This was not our
intent.
(12) We have amended the definition of ``inspector'' to make terms
used in the definition consistent with terms used in this proposal and
to remove the phrase, ``who is qualified.'' A State certifying agent
suggested deleting the phrase, ``who is qualified,'' because the issue
of inspector qualification is more appropriately addressed in the
regulations. We concur that the definition of ``inspector'' does not
need to address the issue of qualifications, especially in light of the
fact that certifying agents are required by these regulations to use
qualified inspectors.
(13) We have amended the definition of ``livestock'' by adding
reference to the production of fiber, feed, and other agricultural-
based consumer products and by providing that ``livestock'' shall not
include fish or bees for the production of food, fiber, feed, or other
agricultural-based consumer products. A trade association and several
States recommended adding fibers to the definition. We have added
fiber, feed, and other agricultural-based consumer products to the
definition to capture all types of consumer products that would be
produced from livestock. We have excluded aquatic animals from the
definition of livestock pending future development of detailed practice
standards for specific aquatic animals. We have also excluded bees from
the definition of livestock pending future National Organic Standards
Board (NOSB or Board) review and recommendations on apiculture.
[[Page 13518]]
Additional information on this issue can be found at subpart C,
Livestock Production, Changes Based On Comments, items 3 and 4.
(14) We have amended the definition of ``market information.'' A
commenter suggested that the definitions of the terms, ``labeling'' and
``market information,'' were difficult to distinguish from one another
and needed clarification. We have added language to make a distinction
between the two terms. ``Market information'' now includes the phrase,
``distributed, broadcasted, or made available outside of retail
outlets.'' This phrase indicates that any information distributed,
broadcasted, or made available outside of retail outlets to assist in
the sale or promotion of a product falls under the ``market
information'' category. ``Labeling'' includes any information displayed
or made available in retail outlets on or about the product.
(15) We have amended the definition of ``organic'' to clarify that
the term, ``organic,'' is used as a labeling term. Commenters,
including several States, stated that the definition repeated the
proposed requirements for allowing the use of ``organic'' on a product
label. They suggested amending the definition to clarify that the term,
``organic,'' is used as a labeling term. We made the suggested change
because we agree that the definition unnecessarily repeated regulatory
information and that use of the term, ``organic,'' is intended as a
labeling term.
(16) We have amended the definition of ``producer'' to clarify that
the term includes the production of fiber and other agricultural-based
consumer products. Several States suggested that the definition of
``producer'' be amended to clarify that a producer could also be
growing or producing a fiber product. We agree that this clarification
is needed and have also added reference to ``other agricultural-based
consumer products'' to further clarify that the term includes all
agricultural-based consumer products produced by a producer.
(17) We have changed the definition of ``routine use of
parasiticide'' to the definition recommended by the NOSB. Commenters
suggested removing ``without cause'' from the definition in the first
proposal and adding such phrases as ``without an indication of illness
from parasites,'' ``administration with need based on the presence of a
diagnosed problem with parasites,'' and ``with or without cause.'' The
NOSB's definition solves the problems caused by the use of the phrase,
``without cause.'' Additional information on this issue can be found at
subpart C, Livestock Production, Changes Based On Comments, item 9.
(18) We have amended the definition of ``slaughter stock'' by
changing ``human consumption'' to ``consumption by humans and other
animals.'' A few commenters recommended deleting the word, ``human,''
to indicate that organic livestock may also be used to produce pet
food. We agree that slaughter stock may be used in the production of
products for consumption by humans and other animals.
(19) We have amended the term, ``soil quality,'' and its definition
by referencing ``water'' in the term and the definition. This change
was made because of the reference to ``soil and water quality'' in
Sec. 205.200 of this proposal. Several State commenters stated that the
definition of ``soil quality'' was too vague and would pose problems in
enforcing a requirement that addressed the effect of various practices
on soil quality. Other commenters requested expansion of the definition
to include a discussion of why soil quality is important and what
functions healthy soil serves in an organic production system. Another
State suggested expanding the definition to include water quality,
since there were several references in the regulations to effects on
soil or water quality. The importance of soil quality has been
addressed under subpart C of this proposal. We acknowledge that the
phrase, ``soil and water quality,'' is used in subpart C and have,
therefore, expanded the term, ``soil quality,'' to ``soil and water
quality'' and amended the definition accordingly. We have also added a
new phrase to the previous definition to acknowledge that one important
criterion of soil and water quality is the control of environmental
contaminants. The determination of which observable indicators to
monitor and how to interpret the observations will be subject to
documentation in the organic system plan and consultation between the
producer and the certifying agent. Guidance will be provided to
certifying agents through program manuals. Additional information on
this issue can be found at subpart C, Production and Handling
(General), Changes Based On Comments, item 2.
(20) We have amended the term, ``governing State official,'' to
``State program's governing State official'' and retained the
definition to clarify the difference between a State certifying agent
and a governing State official. We have used the term, ``State
program's governing State official,'' throughout this proposal. A trade
association and a State recommended removing the word,
``certification,'' from the definition. We have not made this change
because the term is meant to identify the person responsible for
administering the State's organic certification program. By ``State
organic certification program,'' we mean the law, regulations, and any
policies and procedures established by the State to govern the organic
certification of producers or handlers by State or private certifying
agents.
(21) We have amended the definition of ``unavoidable residual
environmental contamination.'' Commenters stated that USDA should set
levels rather than make case-by-case decisions regarding residual
environmental contamination. They suggested that background levels
could be used to determine whether land exceeds the level. Another
commenter requested a clear statement of ``unavoidable'' and
``contamination'' to facilitate enforcement. Some States stated that
there should be a level that is unacceptable for organic agriculture. A
commenter suggested that the definition read, ``The presence of a
material prohibited in organic production, processing, or handling in
soil, crop, or food that occurs as a result of factors beyond the
control of the producer, processor, or handler.'' Another commenter
suggested that the definition read, ``Background levels of prohibited
substances at a site which are clearly beyond the control of a
certified organic farm operator through notices to neighbors, careful
avoidance of abnormally precontaminated sites, and establishment of
buffer zones.'' In this proposal, we have defined ``unavoidable
residual environmental contamination'' as ``background levels of
naturally occurring or synthetic chemicals that are persistent in the
soil or present in organically produced agricultural products that are
below established tolerances.''
Definitions--Changes Requested But Not Made
This subpart retains from our first proposal terms and their
definitions on which we received comments as follows:
(1) A few commenters requested that the definition of
``Administrator'' be revised to provide that authority to administer
the National Organic Program may be delegated to a State official. We
have not made the recommended change because the definition of
``Administrator'' merely addresses the top official of the Agricultural
Marketing Service (AMS) and any AMS official to whom the Administrator
may delegate authority. The definition is not meant to address working
relationships established
[[Page 13519]]
between AMS and a State or State entity.
(2) An environmental group requested that we delete the phrase,
``other than during the manufacture of a multiingredient product
containing both types of ingredients,'' from the definition of
``commingling.'' This proposal requires that a handler prevent the
commingling of organic and nonorganic products but permits use of the
word, ``organic,'' in labeling a product made with organic and
nonorganic ingredients in accordance with these regulations. Therefore,
it is necessary to indicate that the term, ``commingling,'' does not
apply to the manufacture of multiingredient products produced in
accordance with these regulations.
(3) A farmers' association recommended that the Secretary delegate
authority for determining crop year to certifying agents because crop
year will vary from region to region. We have found no compelling
reason to make certifying agents responsible for determining crop year
and have not made the recommended change.
(4) A few commenters requested that the definition of ``handling
operation'' be amended to exclude retailers of prepackaged agricultural
products. This change is unnecessary because such retailers are
excluded by the definition of ``handling operation'' through the
phrase, ``except final retailers of agricultural products that do not
process agricultural products.''
(5) Several commenters, including a State department of
agriculture, recommended elimination of the exception for weight labels
in the definition of ``label.'' We have not made the recommended change
to the definition of ``label'' because, as used in this proposal,
``label'' is intended to represent the organic nature of the product. A
weight label that does not refer to the organic nature of the product
would not constitute a label for the purposes of this proposal.
(6) A commenter requested that the definitions for ``labeling'' and
``market information'' be amended to refer only to products produced by
the seller. We have not made this requested change because changing the
definitions to only include products produced by the seller would
severely restrict the application of the terms, ``labeling'' and
``market information.'' As defined, ``labeling'' and ``market
information'' correctly include any information that may be presented
to consumers concerning all products sold whether produced by the
seller, most likely a retail outlet, or produced by a production or
handling operation from which the seller acquired the products.
(7) A commenter requested that we include definitions for
``manure'' and ``aged or rotted manure.'' Under this proposal it is not
necessary to define either term.
(8) An environmental organization requested that a phrase be added
to the definition of ``mulch'' to indicate that acceptable mulch
materials leave no chemical or toxic residues. This proposal allows the
use of composted plant and animal wastes obtained from nonorganic
sources, such as commercial compost products. Uncomposted plant or
animal waste material which has been treated with a substance can be as
utilized as a mulch provided the substance appears on the National List
or complies with the OFPA. Off-farm plant and animal wastes from food
processing, municipal yard waste facilities, and other sources are used
extensively in existing organic operations and generally permitted by
organic certification programs. Using such organic wastes is consistent
with a system of organic production and handling, which calls for
recycling organic wastes to return nutrients to the land. We believe
that concerns about potential contaminants in plant and animal waste
materials can be addressed by the requirement in this proposal that
these materials be managed in a manner that prevents such
contamination. Accordingly, this change has not been made. Additional
information on this issue can be found at subpart C, Crop Production,
Changes Requested But Not Made, items 2 and 3.
(9) Several commenters suggested adding information to the
definition of ``National Organic Standards Board'' to address the role
of the NOSB with regard to the National List. This change is
unnecessary because the role of the NOSB is adequately covered in
section 6517, National List, of the Act.
(10) Numerous comments were received from consumers, environmental
groups, and organic producers concerning the definition of the term,
``nonagricultural ingredient.'' Commenters expressed the view that this
term represented an attempt by USDA to circumvent the intent of the Act
that synthetic ingredients not be permitted in organic processed
products. We disagree with the position that the Act prohibits the use
of synthetic ingredients in organic processed products. The use of
synthetic ingredients in organic processed products is discussed in the
preamble to the National List found in subpart G. We have changed the
term, ``nonagricultural ingredient,'' to ``nonagricultural substance''
to be consistent with the language used in this proposal. The
definition remains the same.
(11) Commenters stated their objection to the use of the term,
``nonsynthetic (natural),'' and its definition. A commenter mistakenly
stated that the term, ``natural,'' was defined in the Act. Other
commenters felt that use of any term that was not included in the Act
was a violation of the Act. Because the term, ``natural,'' is so
ambiguous and subject to differing interpretations, the term,
``nonsynthetic,'' as used throughout this regulation, represents an
important clarification of the intent of the Act, and we have,
therefore, retained it in this proposal.
(12) A few commenters requested that the definition of ``petition''
be amended by adding the phrase, ``to the National Organic Standards
Board,'' immediately following the word, ``submitted.'' We have not
made the requested change for two reasons. First, the change is
unnecessary. Second, petitions, whether addressed to the NOSB or
National Organic Program (NOP) Staff, will be received by the NOP
because the administrative functions of the NOSB are performed at the
NOP office. Petitions received will be distributed by the NOP to the
NOSB and appropriate technical reviewers.
(13) A producers association stated that the definition for
``processing'' was confusing with regard to the difference between a
handler and a processor. A handling operation that performs any of the
activities listed in the definition of processing becomes a processor.
We have found no compelling reason to revise this comprehensive
definition for processing, which comes directly from the Act. A
commenter suggested that this definition be changed to include
repackaging for weight. In addition to the definition being stipulated
by the Act, affixing a weight label to a product is a normal retail
activity that does not warrant the expense and effort necessary to
certify all retailers who routinely affix weight labels to organic
product.
(14) A few commenters requested that the definition of ``State
organic certification program'' be amended by adding a statement
indicating that a State program could have additional requirements.
This issue is addressed in subpart G, State Organic Certification
Programs, Proposal Description.
(15) A technical institute recommended including genetically
engineered organisms and their products in the definition of
``synthetic,'' and an environmental
[[Page 13520]]
group wanted the definition to include the combustion of minerals. We
have not amended the definition as given in the Act because it already
includes the combustion of minerals, which are chemically changed by
the process of combustion. We also do not consider it necessary to
classify genetically engineered organisms as either synthetic or
nonsynthetic for the purposes of this regulation, since these organisms
and their products are prohibited for use in organic production or
handling regardless of whether or not they are synthetic.
(16) A commenter recommended adding the word, ``synthetic,''
immediately preceding the word, ``substances,'' in the second sentence
of the definition of ``system of organic farming and handling.'' We
disagree with this suggestion because ``substances'' as used in this
definition could be synthetic or nonsynthetic. A few commenters
requested deletion of the word, ``extraneous,'' as a modifier of
``synthetic additives'' in the definition of ``system of organic
farming and handling.'' The commenters stated that use of the word,
``extraneous,'' implied that synthetic additives can be used in organic
processed products. Synthetics may be used in processed products if the
substance is included on the National List. Additionally, the word,
``extraneous,'' modifies the word, ``processing,'' in the definition,
and we consider use of extraneous processing to be inconsistent with
organic handling. For these reasons, we have not removed the word,
``extraneous,'' from the definition. We have, however, amended the
term, ``system of organic farming and handling,'' by deleting
``farming'' and inserting ``production.'' The definition for the term,
``system of organic production and handling,'' is unchanged. We have
taken this action to make the term consistent with the language of this
proposal. Additional information on this issue can be found at subpart
C, Production and Handling (General), Changes Requested But Not Made,
item 1.
(17) Several commenters, including a State Department of
Agriculture and a fishery association, requested that wild game and
aquatic animals be included in the definition of ``wild crop.''
Regarding aquatic animals, we intend to develop detailed practice
standards for specific aquatic species, which will be published for
comment and finalized prior to the implementation of the NOP. Given the
virtual absence of recognized certification programs for aquatic
operations, including aquaculture, there are no U.S. models on which to
base national standards. Additional information on this issue can be
found at subpart B, Changes Requested But Not Made, item 11 and subpart
C, Crop Production, Changes Requested But Not Made, item 7.
Accordingly, we have not made the requested changes to the definition
of ``wild crop.''
Definitions--Additional Provisions
Upon further review of the definitions in the first proposal, we
have decided to propose the following additions and changes.
Amended Definitions
(1) We have amended the definition of ``accreditation'' to include
foreign entities as now provided for in subpart F, Accreditation.
Additional information on including foreign entities in accreditation
can be found at subpart B, Additional Provisions, item 1, and subpart
F, Changes Based On Comments, item 1.
(2) We have amended the definition of ``allowed synthetic'' by
replacing ``for use in organic farming'' with ``for use in organic
production, or handling.'' This correction was necessary because the
National List includes synthetic substances used in organic production
and handling.
(3) We have amended the terms, ``certified organic farm,''
``certified organic handling operation,'' and ``certified organic wild-
crop harvesting operation,'' with the term, ``certified operation.''
The term, ``certified operation,'' is used throughout this proposal to
refer to a crop or livestock production, wild-crop harvesting, or
handling operation or portion of an operation that is certified by an
accredited certifying agent as utilizing a system of organic production
or handling as described by the Act and regulations in this part. We
have taken this action to simplify the regulatory language.
(4) We have amended the term, ``cultural,'' to ``cultural methods''
and amended the definition by removing all references to livestock. We
have taken this action because this proposal does not refer to cultural
methods with reference to livestock health care.
(5) We have amended the definition of ``field'' by replacing
``farm'' with ``production operation.'' This action was taken because
``farm'' has been replaced by ``production operation'' throughout this
proposal.
(6) We have amended the definition of ``handler'' by adding the
phrase, ``including producers who handle crops or livestock of their
own production.'' We have made this change to clarify that producers
who handle their own production become handlers under the regulations.
Such producer/handlers must be certified as a handler.
(7) We have amended the term, ``inert ingredient in pesticide
formulations,'' to ``inert ingredient.'' We have also amended the
definition by specifying that the pesticide product is used in organic
crop or livestock production and handling. These changes have been made
to make the term and its definition consistent with the language used
in the National List. This proposal takes a different position on inert
ingredients, as explained in subpart G, National List, Changes Based on
Comments, item 6, than was taken in the first proposal. Because of the
increased importance of inert ingredients in this proposal, we have
rejected the position of the few commenters who recommended removal of
this definition.
(8) We have amended the term, ``organic plan,'' to ``organic system
plan'' and made editorial changes to the definition to make the term
and language of the definition consistent with the language in this
proposal.
(9) We have amended the definition of ``peer review panel'' by
removing ``to assist in evaluating the performance of a certifying
agent'' and inserting ``to assist in evaluating applicants for
accreditation as certifying agents.'' This change clarifies that the
role of the peer review panel is to evaluate applicants for
accreditation. Additional information on ``peer review panel'' can be
found at subpart C, Proposal Description, Production and Handling
(General).
(10) We have amended the definition of ``person'' by adding
``contractor'' to clarify that, when the regulations use ``person,''
the meaning includes ``contractors.''
(11) We have amended the definition of ``records'' by removing the
record examples. A trade association and several States recommend
adding ``process flow charts'' to the examples of records. Another
commenter, who does not want to give USDA unlimited access to personnel
files, suggested the creation of a specific list of records to be
maintained. We have rewritten the recordkeeping provisions, removing
all references to specific records or types of records which must be
maintained. We have taken this action because we believe that it is
impracticable to specify in detail every class of records which may be
found essential in demonstrating compliance with the Act and
regulations. Different types of certified production and handling
operations will, by the very nature of their business, be required to
maintain different records to establish their
[[Page 13521]]
compliance with the Act and regulations. Additional information on the
issue of listing every class of records which may be found essential in
demonstrating compliance with the Act and regulations can be found at
subpart B, Changes Based On Comments, item 6.
(12) We have amended the definition of ``State.'' Addition of the
term, ``State entity,'' necessitated our amendment of the definition of
``State'' to clarify that State means the States of the United States
of America.
(13) We have amended the term, ``system of organic farming and
handling,'' to ``system of organic production and handling'' and
retained the original definition in this proposal. The original
definition was crafted to be consistent with the requirements of the
Act. We have changed ``farming'' to ``production'' to provide a more
encompassing term, which may come to include such diverse activities as
hydroponics, green house production, and harvesting of aquatic animals.
The purpose of the original definition was to describe practices and
substances consistent with systems of organic farming and organic
handling as required by the Act and to provide an explicit reference
point for determining which practices and substances are most
consistent with these systems. Several commenters suggested that the
definition include the concepts, ``agroecosystem health,'' ``ecological
harmony,'' and ``biological diversity.'' Commenters also suggested
including definitions for ``organic agriculture,'' ``organic farming,''
and ``transition to organic.'' This definition is intended to clarify
regulatory provisions in this proposal and is not intended as a broad
philosophical statement. The terms, ``organic agriculture,'' ``organic
farming,'' and ``transition to organic,'' are not used in this proposal
and, therefore, are not defined.
(14) We amended the definition of transplant to prevent confusion
with a related term, ``seedling.'' While the terms, ``transplant'' and
``seedling'' are often used interchangeably, the Act treats them as
distinct and establishes separate regulatory requirements. We have
determined that the physical process of moving and replanting a
seedling results in that seedling becoming a transplant. We have
created this distinction to be able to enforce the full requirements of
the Act. Additional information on ``transplant'' can be found at
subpart C, Crop Production, Changes Based On Comments, item 4.
New Definitions
(1) We have defined ``accredited laboratory.'' Information
concerning ``accredited laboratory'' can be found at subpart G,
Inspection and Testing, Reporting, and Exclusion from Sale, Proposal
Description.
(2) We have defined ``action level.'' Information concerning
``action level'' can be found at subpart G, Inspection and Testing,
Reporting, and Exclusion from Sale, Changes Based On Comments, item 2.
(3) We have defined ``agricultural inputs.'' Information concerning
``agricultural inputs'' can be found at subpart G, Inspection and
Testing, Reporting, and Exclusion from Sale, Changes Based On Comments,
item 1.
(4) We have defined ``Agricultural Marketing Service (AMS) ``
because the term is used throughout this proposal.
(5) We have defined ``breeder stock.'' We have added this
definition because this proposal establishes conditions for the
administration of an allowed synthetic parasiticide to livestock
producing offspring for incorporation into an organic operation. We
have also proposed conditions under which dairy stock, whose milk or
milk products are to be sold, labeled, or represented as organically
produced, may be treated with allowed synthetic parasiticides.
Additional information on this issue can be found at subpart C,
Livestock Production, Changes Based On Comments, item 9.
(6) We have defined ``bulk.'' Information concerning ``bulk'' can
be found at subpart D, Additional Provisions, item 7.
(7) We have defined ``claims.'' Information concerning ``claims''
can be found at subpart D, Changes Based On Comments, item 1.
(8) We have defined ``detectable residue.'' Information concerning
``detectable residue'' can be found at subpart G, Inspection and
Testing, Reporting, and Exclusion from Sale, Proposal Description and
at Changes Based On Comments, item 2.
(9) We have defined ``drift.'' Information concerning ``drift'' can
be found in subpart G, Residue Testing, changes based on comments, item
2.
(10) We have defined ``estimated national mean.'' Information
concerning ``estimated national mean'' can be found at subpart G,
Inspection and Testing, Reporting, and Exclusion from Sale, Proposal
Description and at Changes Based On Comments, item 2.
(11) We have defined ``excluded methods.'' As a result of extensive
public comment, we have revised the definition of certain methods to be
excluded from organic production systems. Many commenters suggested
that we use the definition for certain methods to be excluded from
organic production systems proposed by the NOSB. This proposal
essentially adopts that definition. ``Excluded methods'' refers to a
variety of methods used to genetically modify organisms or influence
their growth and development by means that are not possible under
natural conditions or processes and are not considered compatible with
organic production. Such methods would include recombinant DNA, cell
fusion, and micro-and macroencapsulation. Such methods would not
include the use of traditional breeding, conjugation, fermentation,
hybridization, in vitro fertilization, or tissue culture.
We recognize that the phrases, ``natural conditions or processes''
and ``not considered compatible with organic production,'' may be
subject to interpretation. We have proposed to use these phrases for
two reasons. First, ``natural conditions or processes'' is used in the
NOSB and American Organic Standards definitions, both of which were the
result of consultation with organic industry and consumer stakeholders
and, thus, accurately reflect current industry practices as well as
consumer preferences. Second, we recognize that industry and consumer
expectations regarding the products of these techniques in organic
production systems may evolve. We believe that, taken together, these
phrases allow for a degree of flexibility to ensure that our
regulations continue to accurately reflect industry practices and
consumer preferences. In cases where questions may arise regarding a
specific technique, we anticipate that such questions would be resolved
by the Administrator based on recommendations from the NOSB.
(12) We have defined ``feed additive.'' Information concerning
``feed additive'' can be found at subpart C, Livestock Production,
Changes Based On Comments, item 7.
(13) We have defined ``feed supplement'' Information concerning
feed supplement'' can be found at subpart C, Livestock Production,
Changes Based On Comments, item 7.
(14) We have defined ``forage.'' Information concerning ``forage''
can be found at subpart C, Livestock Production, Changes Based On
Comments, item 4.
(15) We have defined ``immediate family.'' Information concerning
``immediate family'' can be found at subpart F, Changes Based On
Comments, items 14 and 15; Changes Requested But Not Made, item 18; and
Additional Provisions, item 2.
(16) We have defined ``ingredient'' because the term is used
throughout subpart D.
[[Page 13522]]
(17) We have defined ``inspection'' because the term is used
throughout subparts E and F.
(18) We have defined ``lot.'' Information concerning ``lot'' can be
found at subpart D, Proposal Description and at Additional Provisions,
item 6.
(19) We have defined ``natural resources of the operation.'' This
definition has been added to provide greater context for evaluating the
``maintain or improve'' requirement for a system of organic production
and handling. Information concerning ``natural resources of the
operation'' can be found at subpart C, Production and Handling
(General), Changes Based On Comments, item 2.
(20) We have defined ``nonretail container.'' Information
concerning ``nonretail container'' can be found at subpart D, Proposal
Description and at Additional Provisions, item 6.
(21) We have defined ``practice standard.'' Practice standards have
been added to this proposal in response to commenter requests for more
specific guidelines for measuring the performance of an organic system
of production and handling. A practice standard is a series of specific
guidelines, requirements, and operating procedures through which a
production or handling operation implements a required component of its
organic system plan. For example, this proposal contains a practice
standard for soil fertility and crop nutrient management which
describes the tillage practices, sources and handling restrictions for
nutrients, and prohibited activities that a production operation must
comply with. There are specific practice standards applicable to crop,
livestock, and wild-crop production, and handling operations. We are
also proposing to incorporate the terms of the NRCS practice standard
for a composting facility into the requirements of this proposal.
Additional information on ``practice standards'' can be found at
subpart C, Production and Handling (General), Changes Based On
Comments, item 4.
(22) We have defined ``private entity'' because the term is used
throughout subpart F to differentiate between governmental (State
entity) and nongovernmental (private entity) organizations providing
certification services.
(23) We have defined ``production lot number.'' Information
concerning ``production lot number'' can be found at subpart D,
Proposal Description and at Additional Provisions, item 6.
(24) We have defined ``residue testing'' because the term is used
throughout the inspection and Testing, Reporting, and Exclusion from
Sale portion of subpart G.
(25) We have defined ``retail food establishment.'' Information on
``retail food establishment'' can be found in subpart B, Applicability,
Proposal Description and Additional Provisions, item 2.
(26) We have defined ``sewage sludge.'' This term has been added
and defined as synonymous with ``biosolids'' to incorporate the
Environmental Protection Agency's regulatory language for this category
of materials. Information concerning ``sewage sludge'' can be found at
subpart C, Crop Production, Changes Based On Comments, item 1.
(27) We have defined ``State entity.'' This proposal provides for
the accreditation of domestic, tribal government, and foreign
governmental subdivisions that provide certification services. We refer
to such an entity in this proposal as a ``State entity.'' Additional
information on ``State entity'' can be found at subpart F, Changes
Based On Comments, item 1.
(28) We have defined ``tolerance.'' Information concerning
``tolerance'' can be found at subpart G, Inspection and Testing,
Reporting, and Exclusion from Sale, Proposal Description and at Changes
Based On Comments, item 2.
Subpart B--Applicability
This subpart provides an overview of what has to be certified under
the National Organic Program (NOP), describes exemptions and exclusions
from certification, addresses use of the term, ``organic,'' and
addresses recordkeeping by certified production and handling
operations.
Proposal Description
Except for exempt and excluded operations, each production or
handling operation or specified portion of a production or handling
operation that produces or handles crops, livestock, livestock
products, or other agricultural products that are intended to be sold,
labeled, or represented as ``100 percent organic,'' ``organic,'' or
``made with organic (specified ingredients)'' must be certified.
Certified operations must meet all applicable requirements of these
regulations.
Certifying agents will begin the process of certifying organic
production and handling operations to the national standards upon
receipt of their accreditation from the Administrator. All production
and handling operations certified by an accredited certifying agent
will be considered certified to the national standards until the
certified operation's anniversary date of certification. We are
providing this phase-in procedure for production and handling
operations certified by newly accredited certifying agents because we
believe that such certifying agents will, upon publication of the final
rule, demonstrate their eligibility for accreditation by applying the
national standards to the certification and renewal of certification of
their clients. We are also providing this phase-in procedure to provide
relief to certified operations which would otherwise have to be
certified twice within a 12-month period (prior to their certifying
agent's accreditation and again following their certifying agent's
accreditation). This relief will only be available to those certified
operations certified by a certifying agent that receives its
accreditation within 18 months from the date of publication of the
final rule. We anticipate that certifying agents and production and
handling operations will move as quickly as possible to begin operating
under the national organic standards. We are providing this substantial
phase-in period because accredited certifying agents will have to
schedule on-site inspections around varying growing seasons and because
certifying agents and production and handling operations will need time
to adapt to the new national organic standards.
Exempt and Excluded Operations. This regulation establishes several
categories of exempt or excluded operations. Exempt operations derive
their exemption from the Act while excluded operations are excluded as
a result of a Departmental policy decision. An exempt or excluded
operation does not need to be certified. However, operations that
qualify as exempt or excluded operations may elect to apply for
certification. A production or handling operation that is exempt or
excluded from obtaining certification still must meet other regulatory
requirements contained in this rule as explained below.
Exempt Operations. (1) A production or handling operation that has
$5,000 or less in gross agricultural income from organic sales annually
is exempt from certification and does not need to submit an the organic
system plan to anyone for acceptance or approval. However, an exempt
producer or handler must comply with the labeling requirements of
Sec. 205.309 and the organic production and handling requirements
applicable to its type of operation. For example a producer of organic
vegetables, that performs no handling functions, would have to comply
with the labeling requirements
[[Page 13523]]
of Sec. 205.309 and the applicable production requirements in
Secs. 205.202 through 205.207. The labeling and production and handling
requirements protect the integrity of organically produced products.
(2) A retail food establishment or portion of a retail food
establishment that handles organically produced agricultural products
but does not process them is exempt from all of the requirements in
these regulations.
(3) A handling operation or portion of a handling operation that
handles agricultural products containing less than 50 percent organic
ingredients by total weight of the finished product (excluding water
and salt) is exempt from the requirements in these regulations, except
the recordkeeping provisions of Sec. 205.101(c); the provisions for
prevention of contact of organic products with prohibited substances in
Sec. 205.272; and the labeling regulations in Sec. 205.309. The
recordkeeping provisions maintain an audit trail for organic products.
The prevention of contact with prohibited substances and the labeling
requirements protect the integrity of organically produced products.
(4) If a handling operation or portion of a handling operation that
handles agricultural products containing at least 50 percent organic
ingredients by weight (excluding water and salt) does not use the word,
``organic,'' on any package panel other than the information panel, it
is exempt from the requirements in these regulations, except the
recordkeeping provisions of Sec. 205.101(c); the provisions for
prevention of contact of organic products with prohibited substances as
provided in Sec. 205.272; and the labeling regulations in Sec. 205.309.
The recordkeeping provisions maintain an audit trail for organic
products. The prevention of contact with prohibited substances and
labeling requirements protect the integrity of organically produced
products.
As noted above, exempt handling operations producing
multiingredient products must maintain records as required by
Sec. 205.101(c). This would include records sufficient to: (1) prove
that ingredients identified as organic were organically produced and
handled, and (2) verify quantities produced from such ingredients. Such
records must be maintained for no less than 3 years and the operation
must allow representatives of the Secretary and the applicable State
program's governing State official access to the records during normal
business hours for inspection and copying to determine compliance with
the applicable regulations.
Excluded Operations. (1) A handling operation or portion of a
handling operation that sells organic agricultural products labeled as
``100 percent organic,'' ``organic,'' or ``made with organic (specified
ingredients)'' that are packaged or otherwise enclosed in a container
prior to being received or acquired by the operation, remain in the
same package or container, and are not otherwise processed while in the
control of the handling operation is excluded from the requirements in
these regulations, except for the provisions for prevention of
commingling and contact of organic products with prohibited substances
in Sec. 205.272. The requirements for the prevention of commingling and
contact with prohibited substances protect the integrity of organically
produced products.
This exclusion will avoid creating an unnecessary barrier for
handlers who distribute nonorganic products and who want to offer a
selection of organic products.
(2) A retail food establishment or portion of a retail food
establishment that processes or prepares, on the premises of the retail
food establishment, raw and ready-to-eat food from certified
agricultural products labeled as ``100 percent organic,'' ``organic,''
or ``made with organic (specified ingredients)'' is excluded from the
requirements in these regulations, except for the provisions for
prevention of contact of organic products with prohibited substances as
provided in Sec. 205.272; and the labeling regulations in Sec. 205.309.
The prevention of commingling and contact with prohibited substances
and labeling requirements protect the integrity of organically produced
products.
Excluded retail food establishments include restaurants;
delicatessens; bakeries; grocery stores; or any retail outlet with an
in-store restaurant, delicatessen, bakery, salad bar, or other eat-in
or carry-out service of processed or prepared raw and ready-to-eat
food.
We have excluded such retail food establishments because comments
to the first proposal concerning the issue of certification of retail
food establishments were completely divergent. Comments ranged from the
certification of all retail food establishments to exclusion of all
retail food establishments. There is clearly a great deal of public
concern regarding the handling of organic products by retail food
establishments. Someday retail food establishments may be subject to
regulation under this NOP. Any such regulation would be preceded by
rulemaking with an opportunity for public comment. Our exclusion of
retail food establishments from this proposal does not prevent a State
from developing an organic retail food establishment certification
program or otherwise regulating retail food establishments that
prepare, package, or process organic agricultural products.
No retailer, regardless of this exclusion and the exceptions found
in the definitions for ``handler'' or ``handling operation,'' may sell,
label, or provide market information on a product unless such product
has been produced and handled in accordance with the Act and these
regulations. Any retailer who knowingly sells or labels a product as
organic, except in accordance with the Act and these regulations, will
be subject to a civil penalty of not more than $10,000 under this
program. Such retailer may also be subject to enforcement actions and
penalties under Federal statutes and their implementing regulations
administered by other agencies of the Federal government.
Recordkeeping Requirements for Certified Operations. A certified
operation must maintain records concerning the production and handling
of agricultural products that are sold, labeled, or represented as
``100 percent organic,'' ``organic,'' or ``made with organic (specified
ingredients)'' sufficient to demonstrate compliance with the Act and
regulations. Such records must be adapted to the particular business
that the certified operation is conducting, fully disclose all
activities and transactions of the certified operation in sufficient
detail to be readily understood and audited, be maintained for not less
than 5 years beyond their creation, and be sufficient to demonstrate
compliance with the Act and regulations. Certified operations must make
the records required by this regulation available for inspection and
copying by authorized representatives of the Secretary, the applicable
State program's governing State official, and the certifying agent.
Access to such records must be provided during normal business hours.
Examples of Records. Each exempt, excluded, and certified operation
should maintain the records which demonstrate compliance with the Act
and the regulations applicable to it and which it believes establish an
audit trail sufficient to prove to the Secretary, the applicable State
program's governing State official, and the certifying agent that the
exempt, excluded, or certified operation is and has been in compliance
with the Act and regulations.
[[Page 13524]]
Examples of records include: Application and supporting documents
for certification; organic system plan and supporting documents;
purchased inputs, including seeds, transplants, livestock, and
substances (fertilizers, pesticides, and veterinary biologics
consistent with the livestock provisions of subpart C), cash purchase
receipts, receiving manifests (bills of lading), receiving tickets, and
purchase invoices; field records (planting, inputs, cultivation, and
harvest); storage records (bin register, cooler log); livestock
records, including feed (cash purchase receipts, receiving manifests
(bills of lading), receiving tickets, purchase invoices, copies of
grower certificates), breeding records (calendar, chart, notebook,
veterinary documents), purchased animals documentation (cash purchase
receipts, receiving manifests (bills of lading), receiving tickets,
purchase invoices, copies of grower certificates), herd health records
(calendar, notebook, card file, veterinary records), and input records
(cash purchase receipts, written records, labels); producer invoice;
producer contract; receiving manifests (bills of lading); transaction
certificate; producer certificate; handler certificate; weigh tickets,
receipts, and tags; receiving tickets; cash purchase receipts; raw
product inventory reports and records; finished product inventory
reports and records; daily inventories by lot; records as to
reconditioning, shrinkage, and dumping; production reports and records;
shipping reports; shipping manifests (bills of lading); paid freight
and other bills; car manifests; broker's contracts; broker's
statements; warehouse receipts; inspection certificates; residue
testing reports; soil and water testing reports; cash receipt journals;
general ledgers and supporting documents; sales journals; accounts
payable journals; accounts receivable journals; cash disbursement
journals; purchase invoices; purchase journals; receiving tickets;
producer and handler contracts; cash sales receipts; cash purchase
journals; sales invoices, statements, journals, tickets, and receipts;
account sales invoices; ledgers; financial statements; bank statements;
records of deposit; canceled checks; check stubs; cash receipts; tax
returns; accountant's or other work papers; agreements; contracts;
purchase orders; confirmations and memorandums of sales; computer data;
computer printouts; and compilations of data from the foregoing.
Request for Comment. This proposal provides that all ingredients in
a multiingredient product identified as organic must have been produced
by a production or handling operation certified by an accredited
certifying agent. We are seeking comment on the following question.
Should handlers be allowed to identify organically produced products
produced by exempt production operations as organic ingredients? Such
identification would be restricted to the ingredients list on the
information panel. This may provide a wholesale outlet for organically
produced agricultural products produced by producers exempted from
certification because their gross agricultural income from organic
sales totals $5,000 or less annually.
Compliance with Federal Statutes and Regulations. Any agricultural
product that is sold, labeled, or represented as ``100 percent
organic,'' ``organic,'' or ``made with organic (specified
ingredients)'' must be produced and handled in accordance with the
requirements in these regulations. Organic agricultural products must
be produced and handled in compliance with the Federal Meat Inspection
Act, the Poultry Products Inspection Act, and the Egg Products
Inspection Act, concerning meat, poultry, and egg products; the Federal
Food, Drug, and Cosmetic Act; the Federal Insecticide, Fungicide, and
Rodenticide Act; and any other applicable Federal statute and its
implementing regulations.
Foreign Applicants. The regulations in this part, as applicable,
apply equally to domestic and foreign applicants for accreditation,
accredited certifying agents, domestic and foreign applicants for
certification as organic production or handling operations, and
certified production and handling operations unless otherwise
specified.
Applicability--Changes Based on Comments
This subpart differs from our first proposal in several respects as
follows:
(1) Exception for Handlers Serving Three or Fewer Certified
Operations. We have removed the provision that would have allowed
handlers providing services to fewer than three certified organic
producers to operate without separate certification under the NOP
(Sec. 205.201). Such handlers will now have to be certified unless
otherwise exempted or excluded from certification under Sec. 205.101 of
these regulations. We have taken this action because we believe that
the first proposal invites problems, such as making certain that the
contracted handler maintains compliance with the Act and regulations,
taking enforcement actions against persons violating the Act and
regulations, and being equitable to all handlers since large-volume
handling operations may qualify for inclusion under the provision on
the basis of few clients while small-volume handlers would be
disqualified because they have three or more clients.
More than 100 comments were received, most from consumers, in
opposition to the provision. Many of the commenters erroneously
interpreted the provision as an exemption for handlers of product for
less than three certified operations. Most of these commenters
expressed the belief that it is a violation of the Act to allow
handlers to operate through inclusion under another certified
operation's certification rather than through separate certification
under the Act and regulations. Several commenters stated that it is
unacceptable to exempt handling operations providing services to fewer
than three certified entities from separate certification. Several
commenters stated that operations that process products from a
certified producer should always be certified. Several State
departments of agriculture and others stated that the exemption for
handlers servicing fewer than three certified operations does not make
sense. They emphasized that certified operations could produce very
large quantities of organic product and a large-scale handler may
contract with only a few certified producer operations. Therefore, they
called for elimination of the exemption. A few commenters questioned
the certified operation's ability to ensure that the contracted handler
maintains compliance with the Act and regulations. They expressed their
belief that the certified operation would have no authority to maintain
compliance with the Act within a facility it neither owns nor manages.
We never intended to exempt handlers of fewer than three certified
operations from certification. Rather, we proposed a means by which
handlers of fewer than three certified operations could be covered
under the certification of a certified operation for which it provides
handling services.
Several of the commenters favored the provision that any handling
operation that provides handling services to fewer than three certified
entities that produce or handle agricultural products that are or that
are intended to be sold, labeled, or represented as organic or made
with certain organic ingredients would not be required to be separately
certified apart from the operations for which it provides such
services. However, supporters of the concept differed in their position
on the proposal. Most stated that the provision would work
[[Page 13525]]
only if it is made clear that a handler can provide services to only
one or two separate entities and qualify for the exemption and only if
included in the certifications of and inspected along with the entities
for which the handler will provide the services. They further
emphasized that all applicable standards must be met. A few supporters
recommended that there be a contract between the handler and the
certified operation and that the certified operation be responsible for
any failure of the handler to adhere to these regulations. Another
commenter stated that, if handlers are to be exempt from certification,
the qualifying parameter for exemption should be based upon economic
value similar to that for production operations.
Two commenters supported the proposal but wanted the fewer-than-
three-certified-operations limitation removed. One of the commenters, a
nonprofit agricultural organization, expressed the belief that the
limitation needlessly restricts commercial activity, invites an
excessive amount of paperwork related to certification applications,
and provides no greater assurances for quality control. This commenter,
referring to the definition of handling operation at section 6502(10)
of the Act, interpreted ``to receive or otherwise acquire'' as
synonymous with taking legal title to the product. This commenter
stated that this interpretation creates a distinct, verifiable
threshold which clearly identifies those operations needing to be
certified and those that do not need to be certified. Under the
commenter's suggested system, handlers who take legal title to organic
products assume responsibility for their subsequent handling and are
required to have their operations certified. Any handler who works on
organic products without taking legal title would have his or her
activities approved and monitored by the certifying agent responsible
for the product when it arrived at the handler's door. The commenter
believes that noncertified handlers who wanted to serve organic
customers would quickly learn to provide the quality control and
accountability requirements which certifying agents expect to see.
We disagree with the commenters who recommended removal of the
fewer-than-three-certified-operations restriction on the grounds that
the proposal to limit exemptions to handlers contracting with fewer
than three certified operations needlessly restricts commercial
activity, invites an excessive amount of paperwork related to
certification applications, and provides no greater assurances for
quality control. The primary justification given for removal of the
fewer-than-three-certified-operations restriction is the belief that
any handler who works on organic products without taking legal title
would have his or her activities approved and monitored by the
certifying agent responsible for the product when it arrived at the
handler's door. First, it is unreasonable to expect the certifying
agent to be responsible for monitoring noncertified handlers even if
they are providing services to an operation certified by the certifying
agent. Second, we disagree with the commenter's interpretation that
``to receive or otherwise acquire'' is synonymous with taking legal
title to the product. ``To receive or otherwise acquire'' involves the
possession, control, or custody of a product. Such possession, control,
or custody of a product may or may not involve the transfer of title to
the product. In other words, a handler may have possession, control, or
custody of the product under a right derived from a certified operation
but not under a claim of the handler's title to the product.
(2) Certification for a Portion of a Production or Handling
Operation. We have clarified that a portion of a production or handling
operation can be certified. We have taken this action because we agree
with the association commenter who suggested that the Department
clarify for potential applicants for certification that a portion of
their production or handling operation can be certified. The Act at
section 6506(b) authorizes the certification of specific fields of a
production operation or parts of a handling operation when: (1) In the
case of a production operation or field, the area to be certified has
distinct, defined boundaries and buffer zones separating the land being
operated through the use of organic methods from land that is not being
operated through the use of such methods; (2) the operators of such
production or handling operation maintain records of all organic
operations separate from records relating to other operations and make
such records available at all times for inspection by the Secretary,
the certifying agent, and the State program's governing State official;
and (3) appropriate physical facilities, machinery, and management
practices are established to prevent the possibility of a mixing of
organic and nonorganic products or a penetration of prohibited
chemicals or other substances on the certified area. This clarification
is found at Sec. 205.100 of this proposal.
(3) Exemption for Operations with $5000 or Less in Income. We have
clarified at Sec. 205.101(a)(1) that the producer and handler exemption
from certification applies to production and handling operations that
sell agricultural products as organic but whose gross agricultural
income from organic sales totals $5,000 or less annually. We have taken
this action because of commenter confusion over whether the $5,000
level applied to all sales of agricultural products or just sales of
organic agricultural products. This action is consistent with the
position of a State department of agriculture, which stated that the
$5,000 exemption should apply to organic sales, not sales of all
agricultural products. The commenter believes that, as originally
proposed, the regulation would limit opportunities for organic industry
development, especially for small producers and other small
agribusinesses.
(4) Applicability of Regulation to Exempt Operations. We have
revised the producer and handler exemption, provided to producers and
handlers with gross agricultural income from organic sales totaling
$5,000 or less annually, to provide that such operations are exempt
from certification and do not need to submit an organic system plan to
anyone for acceptance or approval but must comply with the requirements
for organic production and handling and the labeling requirements for
agricultural products produced on an exempt or excluded operation. We
have taken this action because the first proposal too narrowly
addressed the regulatory requirements that exempt producers must meet.
Our purpose is to exempt such production and handling operations from
the regulatory and financial burdens of certification but not to exempt
them from the standards for organic production and handling. A
fundamental concept of this regulation is to establish a label for
organic. To the extent that these entities will be using the term,
``organic,'' to describe their product, they must be truthful. If they
don't comply with the other requirements of this part, they cannot
truthfully describe their product as organic.
Several State commenters expressed the belief that the producer
exemption would be too difficult to enforce. Some expressed the belief
that exempt production operations would still require monitoring to
verify compliance with organic standards. A State department of
agriculture commented that some monitoring of uncertified operations
would still be needed to verify compliance with standards; otherwise
there would be no guarantee that standards would be met for
[[Page 13526]]
products being sold as organic. Another State, which expressed strong
disagreement with the producer exemption, asked how complaints against
such producers would be reconciled if they are exempt from the NOP and
do not have to maintain records over a multiple-year period. This
commenter stated its intent, under its State program, to require
certification of organic production operations producing less than
$5,000 in agricultural product yearly. This same commenter acknowledged
the Federal program's obligation to provide the exemption as required
by section 6505(d) of the Act.
A producer raised the issue of having exempt operations provide
affidavits of compliance with the Act and regulations except for
certification. A certifying agent made the observation that the rule as
first proposed would not permit exempt producers, whether operating
under an affidavit or not, to sell any of their products to a certified
operation for further processing unless they were fully certified. This
certifying agent stated that it did not believe excluding exempt
producers from selling any of their products to a certified operation
for further processing unless they were fully certified was consistent
with the intent of the Act.
We disagree with both commenters. First, we believe that an
affidavit program for exempt producers, opting to exercise their right
to the exemption, would impose unnecessary regulation upon entities
that the Act clearly intended not to impose such regulation upon.
Second, an affidavit program would create a regulatory burden on the
Department and certifying agents that would not be justified by the
size of such operations. We recognize, as pointed out by commenters,
that some State programs currently require organic production
operations that would be exempt under this national program to register
with the State and to comply with requirements such as filing financial
records and maintaining records of production methods and substances
used.
While we believe that an affidavit program is not appropriate at
the national level, we do believe that States would be authorized to
regulate organic operations exempted under the NOP's $5,000-or-less
organic sales exemption under an approved State program. Under this
proposal, producers and handlers exempted under the NOP's $5,000-or-
less organic sales exemption will be exempt from the certification
regulations and will not have to submit an organic system plan to
anyone for acceptance or approval but will be required to comply with
the requirements for organic production and handling and for labeling.
States may implement a program for monitoring the activities of exempt
production and handling operations and enforcing compliance with the
NOP. States will be permitted to require certification of federally
exempted producers and handlers under an approved State organic
certification program. The Department will consider any complaint of
noncompliance with these regulations by an exempt production or
handling operation and take appropriate action.
(5) Applicability of Federal Statutes. We have added at
Sec. 205.102(c) reference to a production or handling operation's
responsibility for complying with all applicable Federal statutes and
their implementing regulations as those statutes may apply to the
production and handling of agricultural products. We have made this
addition as a means of advising producers, handlers, and the public
that these regulations do not supersede or alter a producer's or
handler's responsibilities under other Federal statutes and their
implementing regulations.
A processors association urged the Department to advise the public
in this rule that food products produced and processed under the
organic standard must comply with applicable provisions of the Federal
Food, Drug, and Cosmetic Act; the Federal Meat Inspection Act; the
Poultry Products Inspection Act; and all other relevant statutes and
their implementing regulations, in all respects, especially related to
adulteration and misbranding.
(6) Recordkeeping Provisions. We have rewritten the recordkeeping
provisions removing all references to specific records or types of
records which must be maintained. In their place, we are requiring that
certified operations maintain records adapted to the particular
business that the certified operation is conducting. Such records must
disclose all activities and transactions of the certified operation in
sufficient detail as to be readily understood and audited and must be
sufficient to demonstrate compliance with the Act and regulations. We
have taken this action because we believe that it is impracticable to
specify in detail every class of records which may be found essential
in demonstrating compliance with the Act and regulations. Different
types of certified production and handling operations will, by the very
nature of their business, be required to maintain different records to
establish their compliance with the Act and regulations.
A certifying agent and a beekeepers association expressed support
for the recordkeeping requirements in the first proposal. The
beekeeping association emphasized the value of such recordkeeping in
monitoring the use of substances. A marketing association and a State
commented that the recordkeeping period for a list of substances
applied to a certified operation should be changed from 3 to 5 years to
be consistent with the requirements of section 6511(d) of the Act. A
research foundation suggested removal of the requirement for
identifying the name and address of the person who applies and who has
applied any substance to any part of the farm and any livestock or
other agricultural product. A trade association recommended the
addition of a new paragraph addressing the records required to be
maintained by crop production operations to establish an audit trail.
Specifically, the commenter recommended that the new paragraph require
that an audit trail be maintained by all organic crop production
operations, which records: (1) All sources and amounts of all off-farm
inputs; (2) the dates, rate, method of application, location, reason
for use, and name and address of applicator for all off-farm inputs;
(3) the dates, projected and actual yield, and harvest location of all
crops produced by the operation, both organic and nonorganic; (4) the
dates, quantities, and locations of all crops stored; (5) the transport
system(s) used to distribute organic crops; and (6) the product name,
date, quantity, and buyer of all products sold, both organic and
nonorganic. A State commenter stated that the maintenance of records on
a certified operation is important, but there must be restraint in
requiring redundant or irrelevant information. Approximately 50 retail
commenters, speaking on behalf of a producer handler, stated that the
recordkeeping requirements were burdensome and overly complicated.
Comments indicated that there was some concern regarding what
records had to be maintained by certified operations. Commenters were
concerned about requiring the maintenance of the correct records for
establishing an audit trail, avoiding the retention of redundant or
irrelevant records, and minimizing the burden and complexity of the
recordkeeping.
We agree with the commenters who stated that the recordkeeping
period for a list of substances applied should be consistent with the
5-year recordkeeping requirements of the Act.
[[Page 13527]]
Accordingly, this proposal at Sec. 205.103(b)(3) requires that
certified operations maintain all records applicable to their organic
operations for not less than 5 years beyond their creation. We disagree
with those commenters who called for more specifics relative to what
records need to be maintained and agree with those commenters who
expressed concern regarding the magnitude of records required to be
maintained. This proposal provides each production and handling
operation with the opportunity to decide for itself what records are
necessary to demonstrate its compliance with the Act and regulations.
(7) Exemption from Prevention of Commingling. We have removed the
requirement that a handling operation or portion of a handling
operation that handles only agricultural products that contain less
than 50 percent organic ingredients by total weight of the finished
product (excluding water and salt) that is exempt from the requirements
in this part comply with the provision for the prevention of
commingling. As noted in item 8 below, exempt handlers of agricultural
products that contain at least 50 percent organic ingredients by weight
will also be exempt from complying with the provision for the
prevention of commingling. We have taken this action because the
commingling of agricultural products is often a part of the processing
activity. Such operations must, however, comply with all of the
applicable labeling provisions of subpart D including the prohibition
on the combining of organic and nonorganic forms of the same
agricultural product. In other words, the handler must not, for
example, combine organic and nonorganic corn if corn is to be shown on
the information panel as ``organic corn.''
A commenter called for the removal of the requirement that an
exempt handler comply with the provisions for the prevention of
commingling and contact of organic products with prohibited substances.
The commenter claimed that requiring exempt handlers to prevent
commingling of organic and nonorganic products and contact of organic
products with prohibited substances is inconsistent with the Act. We do
not agree. As noted above, we have removed the prevention of
commingling requirement because the commingling of agricultural
products is often a part of the processing activity. We have not,
however, removed the requirement for the prevention of contact of
organic products with prohibited substances because the requirement is
necessary to safeguard the integrity of organic ingredients used in the
products being handled.
(8) Exemption for Handlers that Handle Product Containing at Least
50 Percent Organic Ingredients. We have provided at Sec. 205.101(a)(4)
that any handling operation or portion of a handling operation that
handles agricultural products that contain at least 50 percent organic
ingredients by weight (excluding water and salt) that chooses to not
use the word, ``organic,'' on any panel other than the information
panel is exempt from the requirements in these regulations, except the
provisions for prevention of contact of organic products with
prohibited substances as set forth in Sec. 205.272, the labeling
provisions of Sec. 205.309, and the recordkeeping provisions of
Sec. 205.101(c).
A commenter stated that the Department is required under the Act to
exempt any handling operation or portion of a handling operation that
processes agricultural products that contain at least 50 percent
organically produced ingredients by weight (excluding water and salt).
We disagree with the commenter. Section 6505(c)(1) of the Act ties the
exemption from certification to use of the word, ``organic,'' on the
principal display panel. The Secretary, in consultation with the
National Organic Standards Board (NOSB) and the Secretary of Health and
Human Services, may require certification of any operation that chooses
to use the word, ``organic,'' on the principal display panel. This
proposal provides that handlers, processing agricultural products that
contain at least 50 percent organically produced ingredients by weight
(excluding water and salt), who choose to only use the word,
``organic,'' on the information panel are exempt from certification.
Handlers processing agricultural products that contain at least 50
percent organically produced ingredients by weight (excluding water and
salt) who choose to use the word, ``organic,'' on any other panel,
including the principal display panel, must be certified. Use of the
word, ``organic,'' on the principal display panel carries with it
connotations in the minds of consumers regarding the organic nature of
the product which necessitate certification of handlers of such
products. Further, requiring certification of handlers of such products
is consistent with current industry practice.
Applicability--Changes Requested But Not Made
This subpart retains from our first proposal regulations on which
we received comments as follows:
(1) Exemptions for Handlers. Commenters stated that under no
circumstances should organic handling operations be exempt from
certification. A few environmental organizations, a certifying agent,
and an industry association commented that the first proposal exceeded
statutory authority by broadening the producer exemption in section
6505(d) of the Act to apply to handlers. An agriculture research and
education organization stated that, while the Act does not specifically
identify handling operations under the producer exemption, including
them is a reasonable and workable interpretation of the Act. The
commenter stated that the Act provides an exemption to persons who sell
no more than $5,000 annually in value of agricultural products and it
sees no reason why the exemption should not include handlers. This
commenter also recommended that the NOP develop a new category of
exemption of up to $10,000 for on-farm processing. The commenter's
recommended exemption would apply to value-added, made-on-site
products, such as maple syrup, jams, and relishes, and would allow
individuals to combine their production and handling exemptions.
We do not agree with those commenters who stated that the first
proposal exceeded statutory authority. The title of the exemption in
the Act (section 6505(d)) specifically refers to small farmers.
However, the text to the exemption provides, in full, that ``subpart
(a)(1) shall not apply to persons who sell no more than $5,000 annually
in value of agricultural products.'' ``Person'' is defined in the Act
as ``an individual, group of individuals, corporation, association,
organization, cooperative, or other entity.'' The Act defines
``agricultural product'' as ``any agricultural commodity or product,
whether raw or processed, including any commodity or product derived
from livestock, that is marketed in the United States for human or
livestock consumption. Handlers are covered by the definition of
``person'' and ``agricultural product'' and are thereby eligible for
exemption.
The financial burden of certification is no less for handlers with
sales of no more than $5,000 annually than it is for producers with
sales of no more than $5,000 annually. Therefore, since the cost of
certification is the primary reason for exempting production
[[Page 13528]]
operations with sales of no more than $5,000 annually, it is reasonable
to also exempt handling operations with sales of no more than $5,000
annually.
This proposal exempts production and handling operations that sell
agricultural products as ``organic'' but whose gross agricultural
income from organic sales totals $5,000 or less annually. Production
and handling operations exempted on the basis of organic sales of
$5,000 or less annually are exempt from certification under Subpart E
and do not need to submit an organic system plan under Sec. 205.201 but
must comply with the applicable organic production and handling
requirements of subpart C and the labeling requirements of
Sec. 205.309.
Exemptions for production operations and handling operations are
separate exemptions. Therefore, a production operation that is also a
handling operation, due to its production and sale of processed
products, must qualify for each exemption separately. The balance of
this paragraph lists exemption eligibility examples. A production
operation with gross agricultural income from organic sales totaling
$5,000 or less annually will be exempt from certification as an organic
production operation. A handling operation with gross agricultural
income from organic sales totaling $5,000 or less annually will be
exempt from certification as an organic handling operation. A
production and handling operation with gross agricultural income from
organic production sales totaling $5,000 or less annually and organic
handling sales totaling $5,000 or less annually will be exempt from
certification as an organic production operation and from certification
as an organic handling operation. A production and handling operation
with gross agricultural income from organic production sales totaling
$5,000 or less annually and organic handling sales totaling more than
$5,000 annually will be exempt from certification as an organic
production operation only. A production and handling operation with
gross agricultural income from organic production sales totaling more
than $5,000 annually and organic handling sales totaling $5,000 or less
annually will be exempt from certification as an organic handling
operation only.
Products marketed by exempt production operations and handling
operations cannot be represented as certified organic or display the
U.S. Department of Agriculture (USDA) organic seal. Products from
exempt operations may not be included as organic ingredients in a
multiingredient product produced or processed in a certified operation.
We anticipate that this exemption will be used primarily by small
market gardeners, hobbyists, and other small producers who sell produce
and other agricultural products at farmers markets and roadside stands
to consumers within their communities.
(2) Exceeding $5000 Limit for Exemption. A few commenters,
including a State, raised the concern that an organic operation might
not anticipate sales over $5,000 but could exceed its exemption due to
a bumper crop or market price increases, putting the operation in
violation. The Department believes that once an exempted operation
reaches the $5,000 maximum exemption level, it is compelled to seek
certification, which it would have to obtain and maintain if it is to
continue to sell organic products. A certified organic operation,
including one which previously lost its exempt status, could switch
from certified to exempt if its size or operations were changed such
that it no longer sold more than $5,000 annually in value of
agricultural products.
(3) Certification of Exempt Operations. A producer interpreted
``exempt'' as meaning that operations exempted from certification could
not be certified as an organic operation. This interpretation is not
correct. Any production or handling operation, including an exempt
operation, which makes application for certification as an organic
operation and meets the requirements for organic certification may be
certified.
(4) Increasing the Statutory Limitation of $5000 for Exemption. In
the first proposal, we asked for comments as to whether the $5,000
level for exemption from certification should be raised to $10,000 or
to another amount and why an increased amount would be appropriate.
Suggested levels ranged from $2,000 to $50,000. The suggested levels
and justifications for such levels are not sufficiently consistent for
us to recommend that Congress change the $5,000 level.
In addition, we requested data as to the number of operations that
may be exempt under the current $5,000 limitation for exemption and the
number of operations that may be exempt under any new monetary amount
suggested. Comments from the few States responding to the request for
data as to the number of operations that may be exempt under the
current $5,000 limitation revealed that from one-third to one-half of
organic producers in the commenting States would be exempt under the
statutorily authorized $5,000 exemption limitation.
(5) Certification of Retail Operations. A commenter said the first
proposal ignored retail operations which contract with an organic farm
to produce organic products with the store's brand on the label. The
commenter said the retail operation should be certified because it is
responsible if violation occurs in the organic production or handling
of the branded product. The commenter is incorrect in suggesting that
the retailer would be held responsible for a violation if the violation
occurred at the production or handling facility. When a retail
operation contracts for the production, packaging, or labeling of
organic product, it is the certified production or handling operation
that is responsible for meeting the applicable organic production or
handling requirements under the Act and these regulations. If a
violation occurs in the organic production or handling of the product,
the certified production or handling operation retains responsibility
for the violation even if the retailer's name is on the label.
(6) Exemption for Products Containing Less than 50 Percent Organic
Ingredients. Several commenters representing States and organic
organizations opposed the exemption of a handling operation or portion
of a handling operation that handles only agricultural product
containing less than 50 percent organic ingredients. They stated that
handling operations creating products with organic ingredients should
be certified regardless of the percentage of organic ingredients found
in the products they produce. These commenters stated that exemptions
from certification undermine audit trails and consumer confidence. Each
of these commenters called for removal of the proposed exemption.
Another commenter stated that, if a product is less than 50 percent
organic, then it is not organic and should not be labeled or sold as
such.
We disagree with the comments. Because such products consist of
less than 50 percent organic ingredients, handlers may only use the
word, ``organic,'' on the information panel of such products to
truthfully represent the organic nature of the ingredients. Such
handlers must also comply with the recordkeeping provisions of
Sec. 205.101(c), the prevention of contact of organic products with
prohibited substances provisions of Sec. 205.272, and the labeling
provisions of Sec. 205.309.
(7) Ensuring Organic Ingredients are Not Contaminated. A commenter
asked how the Department would ensure that organic ingredients are not
contaminated without certification of the handling operation creating
the final
[[Page 13529]]
product. Handling operations that handle agricultural products
containing less than 50 percent organic ingredients and at least 50
percent organic ingredients that are exempt from certification must
maintain records sufficient to: (1) Prove that ingredients identified
as organic were organically produced and handled, and (2) verify
quantities produced for such ingredients. Such operations are required
at Sec. 205.101(c) of this proposal to allow representatives of the
Secretary and the applicable State program's governing State official
access to these records for inspection and copying during normal
business hours to determine compliance with the applicable regulations.
(8) Exclusion for Handlers that Receive and Distribute Prepackaged
Product. Commenters raised several issues regarding the exclusion of
handlers who receive and distribute prepackaged organic products. At
least three certifying agents commented that all retailers should be
certified unless they handle only organic product in a ``final, sealed
retail container,'' or ``final impermeable containers.'' The commenters
are apparently seeking further assurance that nothing is added to the
organic product while under control of a distributor or retail
operation. Because of the wide variety of organic products and the
special needs of some of those products, establishing restrictions on
the kind of containers used for transportation could unfairly treat
some products and commodity industries. For example, some organic
products may require containers which ``breathe'' or allow the exchange
of air and outside temperatures. Nonpermeable containers could hasten
spoilage of some fresh and processed organic products.
A few certifying agents proposed that distributors and trucking
companies which transport agricultural products also should be
certified under this part. However, such transportation operations do
not carry out the functions specified in the definitions for handler
and handling operations. Distributors and trucking companies have
traditionally been excluded from requirements of agricultural
production regulations. The Act cannot be used to regulate activities
or entities beyond its regulatory authorities. In this case, it is the
responsibility of producers, handlers, interim handlers, and retailers
to meet the requirements of this regulation by ensuring that their
contracted shippers and distributors understand, respect, and protect
the integrity of the organic products they are transporting.
An organic association requested that proper notification of ``good
organic handling practices'' be made to the transportation, trucking,
and public warehousing sectors to inform them of their
responsibilities. The commenter stated that the notification should
include requirements for audit trail records, measures needed to
prevent commingling and contamination by prohibited substances. This
commenter expressed the belief that excluded handlers should
preregister and provide a signed statement of acknowledgment of the
requirements. Regarding enforcement of the suggested requirements, this
commenter stated that enforcement of the requirements should be funded
and administered by existing State and Federal inspection services.
We acknowledge the need for education regarding the requirements of
this rule as well as such issues as the handling of organic products.
The NOP, in cooperation with the NOSB, will provide educational
material to the public regarding the requirements of this rule. Such
educational material will include good organic handling practices made
available to the transportation, trucking, and public warehousing
sectors. However, we disagree with the suggestions calling for
preregistration of exempt and excluded handlers and enforcement of the
requirements by existing State and Federal inspection services. We
believe the suggestions create a burden, on exempt and excluded
handlers, the Department, and certifying agents, not justified by the
nature of the handling performed.
(9) Seafood Products. A marketing institute recommended that the
first proposal be revised to address seafood products in a separate
seafood section and to include provisions that apply to seafood
harvested in the wild. This commenter stated that wild-caught seafood
should be allowed to be labeled as organic. A processors association
also called for the labeling of wild-caught seafood as organic.
While the first proposal contained no standards solely for aquatic
animals in an organic operation, it did contain provisions applicable
to their production. The first proposal allowed fish and crustaceans,
among other livestock types, to be sold, labeled, or represented as
organic if such livestock had been brought into an organic operation no
later than the earliest commercially available stage of life. Several
commenters suggested that the management of aquatic animals differs
sufficiently from mammals and poultry to require separate regulatory
provisions. We concur and intend to develop detailed practice standards
for specific aquatic animals as discussed further under the production
and handling subpart.
Applicability--Additional Provisions
Upon further review of the applicability provisions in the first
proposal, we have decided to propose the following additions and
changes.
(1) Foreign Applicants. We have added a new provision at
Sec. 205.104 addressing applicability of these regulations to foreign
applicants. We have made this addition to clarify our intent that the
regulations in this part apply equally to domestic and foreign
applicants for accreditation, accredited certifying agents, domestic
and foreign applicants for certification as organic production or
handling operations, and certified organic production and handling
operations unless otherwise specified in these regulations.
(2) New Exclusions. We have excluded retail food establishments
that process or prepare raw and ready-to-eat food from most of the
requirements in these regulations. An excluded retail food
establishments must comply with the requirements for the prevention of
contact with prohibited substances provisions of Sec. 205.272 and the
labeling provisions of Sec. 205.309. We have excluded such retail food
establishments because comments to the first proposal concerning the
issue of certification of retail food establishments (restaurant,
delicatessen, bakery, grocery store, or other retail outlet) preparing,
packaging, or processing raw and ready-to-eat organic agricultural
products that are previously labeled as ``100 percent organic,''
``organic,'' or ``made with organic (specified ingredients)'' were
completely divergent. The first proposal also contained an
inconsistency which would have required a supermarket delicatessen to
be certified but would have excluded from certification a restaurant
with carry-out delicatessen products.
As the comments discussed below show, there is clearly a great deal
of public concern regarding the handling of organic products by retail
food establishments. Should we decide to regulate retail food
establishments under the NOP, we will proceed with rulemaking and
provide an opportunity for public comment.
Our exclusion of retail food establishments from this proposal does
not prevent a State from developing an organic retail food
establishment certification program or otherwise regulating retail food
establishments that prepare, package, or process organic
[[Page 13530]]
agricultural products. Texas and Maryland currently have retailer
certification programs.
No retailer, regardless of this exclusion and the exceptions found
in the definitions for ``handler'' or ``handling operation,'' may sell
or label a product as organically produced and handled or fix a label
to or provide other market information concerning an agricultural
product if such label or information implies that such product is
produced and handled using organic methods unless such product has been
produced and handled in accordance with the Act and these regulations.
Any retailer who knowingly sells or labels a product as organic, except
in accordance with the Act and these regulations, will be subject to a
civil penalty of not more than $10,000 under this program. Such
retailer may also be subject to enforcement actions and penalties under
Federal statutes and their implementing regulations administered by
other agencies of the Federal Government.
More than 90 commenters, including an organic association, stated
that the retailer exclusion in the first proposal violates the
requirement to certify all handling operations. The organic association
believes that processing, as defined in the Act, includes all the
normal culinary arts, food manufacturing, and packaging. All of these
commenters, including some States, recommended removal of the
exclusion. Several commenters, including a few States, expressed
concern that exclusions from certification eliminate effective audit
trails and undermine consumer confidence in organic products. One State
commented that it believed retail food establishments should be
certified because they are the last handler link from producer to
consumer.
Several commenters stated that retailers who receive organic
product have a high potential for loss of integrity of the organic
product due to accidental misuse of pesticides and sanitizers during
shipping or storage and to inadvertent commingling with nonorganic
product. The commenters believe that, even though a retailer may only
display and sell organic product, such retailer should be certified and
monitored for compliance to ensure proper treatment of the product in
shipment and storage. A State agency, however, cautioned against
establishing another burden on the organic industry. The commenter said
that if sorting from bulk and repackaging into smaller packages
requires certification, then many small ``natural food'' retail outlets
would find certification more costly than the economic benefits of
marketing organic products. The commenter said many small, natural food
retail food establishments would likely stop carrying organic items.
A few commenters stated there is a high potential for fraud among
retailers who have the opportunity to repackage, mislabel, and sell
nonorganic product as organic. Therefore, they believe that all
retailers must be subject to certification or some form of oversight to
assure that they are not mislabeling product.
A commenter representing a large retail grocery store operation
said that good identification procedures enable retail stores to keep
organic product separated from nonorganic product during
transportation, storage, and in-store displays. The commenter continued
that unduly rigid requirements would be burdensome on retailers. The
commenter indicated that the costs of certification and compliance may
outweigh the benefits of carrying organic product.
Another commenter from a major retail food establishment suggested
that retailers that wash and sort fresh organic produce for display
should be required to follow ``good organic handling practices'' that
would establish recordkeeping responsibilities and prevent commingling
with nonorganic products and contamination by prohibited materials. The
commenter suggested that conformance could be maintained by existing
State or local health inspectors or Federal inspectors with special
training in organic handling systems. However, there is no authority in
the Act to require the services of State or local inspectors.
Another retailer stated that retailers will comply with regulations
because consumers will hold retailers responsible for deficiencies or
illegal actions through the entire production and processing chain for
agricultural products.
A commenter stated that, if a restaurant serves organic foods, it
should be allowed to so state. The commenter went on to say that
restaurants and grocery stores have a right to state that they used
organic ingredients in preparing a given dish. This commenter believes
that restaurants and grocery stores selling organic products, even if
they prepare them, should not have to be certified. A few commenters
claimed that processing, as defined in the Act, includes all culinary
arts and food manufacturing. They stated that restaurants must be
certified or, at the very least, be required to keep records of organic
foods prepared. A State commenter who stated that exemptions undermine
audit trails and consumer confidence suggested that restaurants serving
organic foods be required to maintain records showing the origin and
certification status of raw agricultural ingredients used in the
restaurant's food products.
The Department routinely monitors compliance of various food
producers, handlers, distributors, and retailers which are regulated
under a variety of Departmental programs. The Department responds to
consumer complaints and often conducts unannounced compliance
investigations and audits of agricultural industry businesses. The
Department understands the need for and commits Departmental resources
to this organic program. In addition, oversight of these operations can
be conducted by State agencies.
Subpart C--Organic Crop, Wild Crop, Livestock, and Handling
Requirements
Proposal Description
This subpart sets forth the requirements with which production and
handling operations must comply in order to sell, label, or represent
agricultural products as ``100 percent organic,'' ``organic,'' or
``made with organic (specified ingredients).'' The producer or handler
of an organic production or handling operation must comply with all
applicable provisions of subpart C. Any practice implemented in
accordance with this subpart must maintain or improve the natural
resources, including soil and water quality, of the operation.
Production and handling operations which sell, label, or represent
agricultural products as organic in any manner and which are exempt or
excluded from certification must comply with the requirements of this
subpart, except for the development of an organic system plan.
Production and Handling (General). The Organic Food Production Act
of 1990 (OFPA or Act) requires that all crop, wild crop, livestock, and
handling operations requiring certification submit an organic system
plan to their certifying agent and, where applicable, the State organic
program. The organic system plan is a detailed description of how an
operation will achieve, document, and sustain compliance with all
applicable provisions in the OFPA and these regulations. The certifying
agent must concur that the proposed organic system plan fulfills the
requirements of Subpart C, and any subsequent modification of the
organic plan by the producer or handler must receive the approval of
the certifying agent.
[[Page 13531]]
The organic system plan is the forum through which the producer or
handler and certifying agent collaborate to define, on a site-specific
basis, how to achieve and document compliance with the requirements of
certification. The organic system plan commits the producer or handler
to a sequence of practices and procedures resulting in an operation
that complies with every applicable provision in the regulations.
Accreditation qualifies the certifying agent to attest to whether an
organic system plan comports with the organic standard. The organic
system plan must be negotiated, enacted, and amended through an
informed dialogue between certifying agent and producer or handler, and
it must be responsive to the unique characteristics of each operation.
An organic system plan contains six components. First, the organic
system plan must describe the practices and procedures used, including
the frequency with which they will be used, in the certified operation.
Second, it must list and characterize each substance used as a
production or handling input. Third, it must identify the monitoring
techniques which will be used to verify that the organic plan is being
implemented in a manner which complies with all applicable
requirements. Fourth, it must explain the recordkeeping system used to
preserve the identity of organic products from the point of
certification through delivery to the customer who assumes legal title
to the goods. Fifth, the organic system plan must describe the measures
to be taken to avoid contact between certified production and handling
operations and prohibited substances and document how the operation
will prevent commingling of organic and nonorganic products. Finally,
the organic system plan must contain the additional information deemed
necessary by the certifying agent to evaluate site-specific conditions
relevant to compliance with these or applicable State program
regulations. Producers or handlers may submit a plan developed to
comply with other Federal, State, or local regulatory programs if it
fulfills the requirements of an organic system plan.
The first element of the organic system plan requires a narrative
or other descriptive format that identifies the practices and
procedures to be performed and maintained, including the frequency with
which they will be performed. Practices are tangible production and
handling techniques such as the method for applying manure, the
mechanical and biological methods used to prepare and combine
ingredients and package finished products, and the measures taken to
exclude pests from a facility. Procedures are the protocols established
for selecting appropriate practices and materials for use in the
organic system plan, such as a procedure for locating commercially
available organically produced seed. Procedures reflect the decision-
making process used to implement the organic system plan.
By requiring information on the frequency with which production and
handling practices and procedures will be performed, this proposal
calls for the organic system plan to include an implementation
schedule, including information on the timing and sequence of all
relevant production and handling activities. The plan will include, for
example, information about planned crop rotation sequences, the timing
of any applications of organic materials, and the timing and location
of soil tests. Livestock management practices might describe
development of a rotational grazing plan or addition of mineral
supplements to the feed supply. A handling operation might identify
steps involved in locating and contracting with farmers who could
produce organic ingredients that were in short supply.
The second element that must be included in an organic system plan
is information on the application of substances to land, facilities, or
agricultural products. This requirement encompasses both natural and
synthetic materials allowed for use in production and handling
operations. For natural materials which may be used in organic
operations under specific restrictions, the organic plan must detail
how the application of the materials will comply with those
restrictions. For example, farmers who apply manure to their fields
must document in their organic system plans how they will prevent that
application from contributing to water contamination.
The third element of the organic system plan is a description of
the methods used to evaluate its effectiveness. Producers and handlers
are responsible for identifying measurable indicators that can be used
to evaluate how well they are achieving the objectives of the
operation. For example, production objectives could be measured through
regular tallies of bushels or pounds of product sold from the farm or
in numbers of cases sold from a handling operation. Indicators that can
identify changes in quality or effectiveness of management practices
could be relatively simple, such as the information contained in a
standard soil test. The specific indicators used to evaluate a given
organic system plan will be determined by the producer or handler in
consultation with the certifying agent. Thus, if the organic system
plan calls for improvements in soil organic matter content in a
particular field, it would include provisions for analyzing soil
organic matter levels at periodic intervals. If herd health improvement
is an objective, factors such as somatic cell count or observations
about changes in reproductive patterns might be used as indicators.
The fourth element of the organic system plan is a description of
the recordkeeping system used to verify and document an audit trail, as
appropriate to the operation. For each crop or wild-crop harvested, the
audit trail must trace the product from the field, farm parcel, or area
where it is harvested through the transfer of legal title. A livestock
operation must trace each animal from its entrance into through removal
from the organic operation. A handling operation must trace each
product that is handled and sold, labeled, or represented as organic
from the receipt of its constituent ingredients to the sale of the
processed product. In response to several comments received, this
proposal provides information, found in subpart B, Sec. 205.103, on the
records needed to establish a verifiable audit trail.
The fifth element which must be included in an organic system plan
pertains to split production or handling operations. This provision
requires an operation that produces both organic and nonorganic
products to describe the measures used to prevent commingling of
organic and nonorganic products. This requirement addresses contact of
organic products, including livestock, organic field units, storage
areas, and packaging to be used for organic products, with prohibited
substances. Requirements in the first proposal for information about
the nonorganic portion of the operation have been removed.
We do not propose to list the specific requirements to be included
in an organic system plan. We expect to publish a program manual to
provide guidance on appropriate documentation for the certification
process. In the meantime, the accreditation process provides an
assurance that certifying agents are competent to determine the
specific documentation they require to review and evaluate an
operation's organic system plan. Section 205.200(a)(6) allows a
certifying agent to request additional information needed to determine
that an organic system plan meets the requirements of this
[[Page 13532]]
subpart. The site-specific nature of organic production and handling
necessitates that certifying agents have the authority to determine
whether specific information is needed to carry out their function.
Crop Production. Any field or farm parcel used to produce an
organic crop must have been managed in accordance with the requirements
in Secs. 205.203 through 205.206 and have had no prohibited substances
applied to it for at least 3 years prior to harvest of the crop. Such
fields and farm parcels must also have distinct, defined boundaries and
buffer zones to prevent contact with the land or crop by prohibited
substances applied to adjoining land.
A producer of an organic crop must manage soil fertility, including
tillage and cultivation practices, in a manner that maintains or
improves the physical, chemical, and biological condition of the soil
and minimizes soil erosion. Crop nutrients must be budgeted and
supplied through proper use of manure or other animal and plant
materials, mined mineral substances, and other substances approved for
use under these regulations. The producer must manage animal and plant
waste materials to maintain or improve soil organic matter content in a
manner that does not contribute to contamination of crops, soil, or
water by plant nutrients, pathogenic organisms, heavy metals, or
residues of prohibited substances. Raw animal manure must either be
composted, applied to land used for a crop not intended for human
consumption, or incorporated into the soil at least 90 days before
harvesting an edible product that does not come into contact with the
soil or soil particles and at least 120 days before harvesting an
edible product that does come into contact with the soil or soil
particles. Composted plant or animal waste materials used for soil
fertility must be produced in compliance with the Natural Resources
Conservation Service's (NRCS) Conservation Practice Standard for a
Composting Facility (Code 317). Uncomposted plant and animal waste
materials may be used to amend soil fertility. A plant or animal waste
material that has been chemically altered by a manufacturing process
may be used only if it is included on the National List of synthetic
substances allowed for use in organic production. Mined substances of
low solubility may be used as sources of crop nutrients, as may mined
substances of high solubility, when justified by soil or crop tissue
analysis. Ashes of untreated plant or animal materials which have not
been combined with a prohibited substance and which are not included on
the National List of nonsynthetic substances prohibited for use in
organic crop production may be used to produce an organic crop.
Synthetic crop nutrient supplements that appear on the National List of
allowed synthetic substances may be used as a source of crop nutrients
when justified by soil or crop tissue analysis. The producer may not
use any fertilizer that contains a synthetic substance not allowed for
crop production on the National List or use sewage sludge. Burning crop
residues as a means of disposal, except for trimmings of perennial
crops burned to suppress the spread of disease, is prohibited.
The producer must use organically grown seeds, annual seedlings,
and planting stock, except that untreated nonorganic seeds and planting
stock may be used when equivalent organic varieties are not
commercially available. Seed and planting stock treated with substances
that appear on the National List of synthetic substances allowed for
use in organic production may be used when an organically produced or
untreated variety is not commercially available. Nonorganically
produced annual seedlings may be used when a temporary variance has
been established due to damage caused by unavoidable business
interruption, such as fire, flood, or frost. Planting stock used to
produce a perennial crop may be sold as organically produced planting
stock after it has been maintained under a system of organic management
for at least 1 year. Seeds, annual seedlings, and planting stock
treated with prohibited substances may be used to produce an organic
crop when the application of the substance is a requirement of Federal
or State phytosanitary regulations. Seeds, annual seedlings, or
planting stock produced through an excluded method may not be used for
organic production.
The producer is required to implement a crop rotation, including
but not limited to sod, cover crops, green manure crops, and catch
crops. The crop rotation must maintain or improve soil organic matter
content, provide for effective pest management in perennial crops,
manage deficient or excess plant nutrients, and control erosion to the
extent that these functions are applicable to the operation.
The producer must use preventive practices to manage crop pests,
weeds, and diseases, including but not limited to crop rotation, soil
and crop nutrient management, sanitation measures, and cultural
practices that enhance crop health. Such cultural practices include the
selection of plant species and varieties with regard to suitability to
site-specific conditions and resistance to prevalent pests, weeds, and
diseases. Mechanical and biological methods that do not entail
application of synthetic substances may be used as needed to control
pest, weed, and disease problems that may occur. Pest control practices
include augmentation or introduction of pest predators or parasites;
development of habitat for natural enemies; and nonsynthetic, nontoxic
controls such as lures, traps, and repellents. Weed management
practices include mulching with fully biodegradable materials; mowing;
livestock grazing; hand weeding and mechanical cultivation; flame,
heat, or electrical techniques; and plastic or other synthetic mulches,
provided that they are removed from the field at the end of the growing
or harvest season. Disease problems may be controlled through
management practices which suppress the spread of disease organisms and
the application of nonsynthetic biological, botanical, or mineral
inputs. When these practices are insufficient to prevent or control
crop pests, weeds, and diseases, a biological or botanical substance,
or a synthetic substance that is allowed on the National List may be
used provided that the producer evaluates and mitigates the effects of
repetitive use of the same or similar materials on resistance and
shifts in pest, weed, or disease types. The producer must use a pest,
weed, or disease control substance in compliance with the Federal
Insecticide, Fungicide, and Rodenticide Act. Pest control substances
produced through excluded methods are prohibited.
Any wild crop that is to be sold, labeled, or represented as ``100
percent organic,'' ``organic,'' or ``made with organic (specified
ingredients)'' must be harvested from land to which no prohibited
substances have been applied for at least 3 years prior to harvest. The
wild crop must also be harvested in a manner that ensures such
harvesting or gathering will not be destructive to the environment and
will sustain the growth and production of the wild crop.
Livestock Production. We propose that any livestock or edible
livestock product to be sold, labeled, or represented as organic must
be maintained under continuous organic management from birth or
hatching, with four exceptions. Poultry or edible poultry products must
be from animals that have been under continuous organic management
beginning no later than the second day of life. Milk or milk products
must be from animals that
[[Page 13533]]
have been under continuous organic management beginning no later than 1
year prior to the production of such products. A nonedible livestock
product must be derived from an animal that has been under continuous
organic management beginning no later than 1 year prior to the harvest
of the nonedible product. Livestock used as breeder stock may be
brought from a nonorganic operation into an organic operation at any
time, provided that, if such livestock are gestating and the offspring
are to be organically raised from birth, the breeder stock must be
brought into the organic operation prior to the last third of
pregnancy.
We also propose that, should an animal be brought into an organic
operation pursuant to this section and subsequently moved to a
nonorganic operation, neither the animal nor any products derived from
it may be sold, labeled, or represented as organic. Breeder or dairy
stock that has not been under continuous organic management from birth
may not be sold, labeled, or represented as organic slaughter stock. No
organism produced with excluded methods may be used for breeding
purposes or for the production of livestock products intended to be
sold, labeled, or represented as organic. The producer of an organic
livestock operation must maintain records sufficient to preserve the
identity of all organically managed livestock and all edible and
nonedible organic livestock products produced on his or her operation.
We are proposing that, except for feed additives and supplements
included on the National List of synthetic substances allowed for use
in organic livestock production, the total feed ration for livestock
managed in an organic operation must be composed of agricultural
products, including pasture and forage, that are organically produced.
Any portion of the feed ration that is handled must comply with organic
handling requirements. The producer must not use animal drugs,
including hormones, to promote growth in an animal or provide feed
supplements or additives in amounts above those needed for adequate
growth and health maintenance for the species at its specific stage of
life. The producer must not feed animals under organic management
plastic pellets for roughage or formulas containing urea or manure. The
feeding of mammalian and poultry slaughter by-products to mammals or
poultry is prohibited. The producer must not supply animal feed, feed
additives, or feed supplements in violation of the Federal Food, Drug,
and Cosmetic Act.
The producer of an organic livestock operation must establish and
maintain preventive animal health care practices. The producer must
select species and types of livestock with regard to suitability for
site-specific conditions and resistance to prevalent diseases and
parasites. The producer must provide organic feedstuffs, as well as
vitamins, minerals, and other supplements, sufficient to meet the
animals' nutritional requirements. The producer must establish
appropriate housing, pasture conditions, and sanitation practices to
minimize the occurrence and spread of diseases and parasites. Animals
in an organic livestock operation must be maintained under conditions
which provide for exercise, freedom of movement, and reduction of
stress appropriate to the species. Additionally, all physical
alterations performed on animals in an organic livestock operation must
be conducted to promote the animals' welfare and in a manner that
minimizes stress and pain.
The producer of an organic livestock operation must administer
vaccines and other veterinary biologics as needed to protect the well-
being of animals in his or her care. When preventive practices and
veterinary biologics are inadequate to prevent sickness, the producer
may administer medications included on the National List of synthetic
substances allowed for use in livestock operations. The producer may
not administer synthetic parasiticides to breeder stock during the last
third of gestation if the progeny is to be sold, labeled, or
represented as organically produced. After administering synthetic
parasiticides to dairy stock, the producer must observe a 90-day
withdrawal period before selling the milk or milk products produced
from the treated animal as organically produced. Every use of a
synthetic medication or parasiticide must be incorporated into the
livestock operation's organic system plan subject to approval by the
certifying agent.
We propose that the producer of an organic livestock operation must
not treat an animal in that operation with antibiotics, any synthetic
substance not included on the National List of synthetic substances
allowed for use in livestock production, or any substance that contains
a nonsynthetic substance included on the National List of nonsynthetic
substances prohibited for use in organic livestock production. The
producer must not administer any animal drug, other than vaccinations,
in the absence of illness. The use of hormones is prohibited in organic
livestock production, as is the use of synthetic parasiticides on a
routine basis. The producer must not administer synthetic parasiticides
to slaughter stock or administer any animal drug in violation of the
Federal Food, Drug, and Cosmetic Act. The producer must not withhold
medical treatment from a sick animal to maintain its organic status.
All appropriate medications and treatments must be used to restore an
animal to health when methods acceptable to organic production
standards fail. Livestock that are treated with prohibited materials
must be clearly identified and shall not be sold, labeled, or
represented as organic.
Under this proposal, a livestock producer must document in his or
her organic system plan the preventative measures he or she has in
place to deter illness, the allowed practices he or she will employ if
illness occurs, and his or her protocol for determining when a sick
animal must receive a prohibited animal drug. The standards we are
proposing will not allow an organic system plan that envisions an
acceptable level of chronic illness or proposes to deal with disease by
sending infected animals to slaughter. Neither situation can be
considered consistent with the principles of organic management. The
organic system plan must reflect a proactive approach to health
management, drawing upon allowable practices and materials. Animals
with conditions that do not respond to this approach must be treated
appropriately and diverted to nonorganic markets.
The producer of an organic livestock operation must establish and
maintain livestock living conditions for the animals under his or her
care which accommodate the health and natural behavior of the
livestock. The producer must provide access to shade, shelter, exercise
areas, fresh air, and direct sunlight suitable to the species, its
stage of production, the climate, and the environment. This requirement
includes access to pasture for ruminant animals. The producer must also
provide appropriate clean, dry bedding, and, if the bedding is
typically consumed by the species, it must comply with applicable
organic feed requirements. The producer must provide shelter designed
to allow for the natural maintenance, comfort level, and opportunity to
exercise appropriate to the species. The shelter must also provide the
temperature level, ventilation, and air circulation suitable to the
species and reduce the potential for livestock injury. The producer may
provide temporary confinement of an animal because of inclement
weather; the animal's stage of production;
[[Page 13534]]
conditions under which the health, safety, or well-being of the animal
could be jeopardized; or risk to soil or water quality. The producer of
an organic livestock operation is required to manage manure in a manner
that does not contribute to contamination of crops, soil, or water by
plant nutrients, heavy metals, or pathogenic organisms and optimizes
nutrient recycling.
Handling. This proposal permits mechanical or biological methods to
be used to process an agricultural product intended to be sold,
labeled, or represented as ``100 percent organic,'' ``organic,'' or
``made with organic (specified ingredients)'' for the purpose of
retarding spoilage or otherwise preparing the agricultural product for
market. It permits the use of nonagricultural substances and
nonorganically produced agricultural products that are included on the
National List in or on a processed agricultural product intended to be
sold, labeled, or represented as ``organic'' or ``made with organic
(specified ingredients).'' This proposal prohibits a handler from using
ionizing radiation for any purpose, an ingredient produced with
excluded methods, or a volatile synthetic solvent in or on a processed
agricultural product intended to be sold, labeled, or represented as
``100 percent organic,'' ``organic,'' or ``made with organic (specified
ingredients).''
The practice standard for facility pest management requires the
producer or handler operating a facility to use management practices to
prevent pests, including removing pest habitat, food sources, and
breeding areas; preventing access to handling facilities; and
controlling environmental factors, such as temperature, light,
humidity, atmosphere, and air circulation to prevent pest reproduction.
Permitted pest control methods include augmentation or introduction of
predators or parasites for the pest species; mechanical or physical
controls, including traps, light, or sound; and nontoxic, nonsynthetic
controls, such as lures and repellents.
This proposal permits the use of a nonsynthetic biological or
botanical substance or any synthetic substance to control facility
pests if the permitted prevention and control practices are not
effective. Any substance applied must be used in accordance with the
label provisions as approved by the appropriate authority, such as the
Environmental Protection Agency (EPA) or the Food and Drug
Administration (FDA). We propose that the handler of an organic
handling operation who uses any biological, botanical, or synthetic
substance to control facility pests must specify in the organic system
plan all measures taken or intended to be taken to prevent contact
between the substance and any ingredient or finished product intended
to be sold, labeled, or represented as organic or made with organic
ingredients. In addition to these restrictions, the handler must
include in the organic handling plan an evaluation of the effects of
repetitive use of the same or similar materials on pest resistance and
shifts in pest types.
This proposal delineates practice standards that must be followed
by an organic handling operation to prevent the commingling of organic
and nonorganic products and protect organic products from contact with
prohibited substances. An organic handling operation must not use
packaging materials and storage containers or bins that contain a
synthetic fungicide, preservative, or fumigant in handling an organic
product. The operation also must not use or reuse any storage bin or
container that was previously in contact with any prohibited substance
unless the reusable bin or container has been thoroughly cleaned and
poses no risk of prohibited materials contacting the organic product.
Temporary Variances. This subpart establishes conditions under
which operations may receive temporary variances from the provisions
contained in Secs. 205.203 through 205.207, 205.336 through 205.239,
and 205.270 through 205.272. The Administrator may establish temporary
variances due to natural disasters declared by the Secretary;
unavoidable business interruption caused by catastrophe such as wind,
fire, hail, flooding, excessive moisture, earthquake, or drought; or to
conduct research on organic production and handling techniques or
inputs. A certifying agent may recommend that the Administrator
establish a temporary variance for unavoidable business interruption.
The Administrator will determine how long a temporary variance will be
in effect at the time it is established, subject to extension as the
Administrator deems necessary. Upon notification by the Administrator
that a temporary variance has been established due to a natural
disaster, a certifying agent must inform each production and handling
operation it certifies within the affected geographical region or each
individual production and handling operation affected by the temporary
variance. Temporary variances may not be issued for any practice,
material, or procedure which is otherwise prohibited by these
regulations.
A request for issuance of a temporary variance, the justification
for it, and measures to evaluate the impact of the practice on the
operation's natural resources must be documented in the organic plan
and approved by the certifying agent. For example, if a drought
resulted in a severe shortage of organically produced hay, a dairy
operation might be permitted to substitute some nonorganic hay for a
portion of the herd's diet to prevent liquidation of the herd. The
producer must keep records showing the source and amount of the hay and
update the organic plan to describe the justification for the practice
and a timeframe for restoring the total feed ration to organic sources.
The certifying agent might also request that the plan include
contingency measures to avoid the need to resort to nonorganic feed in
case of a future shortage. A variance for experimental purposes might
be issued to permit a crop producer to undertake on-farm trials of
small quantities of a new (but not produced with excluded methods) crop
variety that was not available as organic seed.
Production and Handling (General)--Changes Based on Comments
The subpart differs from our first proposal in several respects as
follows:
(1) Genetically Engineered Organisms. In the first proposal, we
invited public comment on the use of genetically engineered organisms
(GEO's) or their products in a system of organic production and
handling. Specifically, we asked whether the use of GEO's or their
products should be permitted, prohibited, or allowed on a case-by-case
basis in organic production or handling operations. Hundreds of
thousands of public comments opposed the use of GEO's or their products
in organic production or processing. In response to these comments,
this proposal prohibits use of genetic engineering (included in the
broad definition of ``excluded methods'' in this proposal, based on the
definition recommended by the National Organic Standards Board (NOSB))
in all stages of organic production and handling. This proposal
contains a specific prohibition on the use of seeds, annual seedlings
and planting stock (Sec. 205.204(b)), pest control substances
(Sec. 205.206(f)), organisms (Sec. 205.236 (b)(3)), and ingredients
(Sec. 205.270(c)(2)) produced with excluded methods.
Products created with modern biotechnology techniques have been
tested, approved by the appropriate regulatory agencies, and can be
used safely in general agricultural production. At the same time,
[[Page 13535]]
consumers have made clear their opposition to use of these techniques
in organic food production. This rule is a marketing standard, not a
safety standard. Since use of genetic engineering in the production of
organic foods runs counter to consumer expectations, foods produced
through excluded methods will not be permitted to carry the organic
label.
We acknowledge that the broad prohibition on use of excluded
methods in organic production and handling systems may create
compliance obstacles for organic operations and certifying agents. For
example, many current certification programs allow vaccination of
animals with synthetic compounds when such treatment is mandatory.
However, while many FDA-approved vaccines are now produced using
excluded methods, we are unaware of any certification program which has
an enforcement mechanism to ensure that such substances are not used in
organic production. We do not know to what extent, if any, organic
livestock producers are currently using vaccines produced with excluded
methods or how a prohibition on the use of such substances would affect
development of the industry.
Similarly, the prohibition on the use of excluded methods in the
production of organic foods may also present challenges to organic
handlers and certifying agents. This may pose a particular problem with
respect to the nonorganic ingredients of multiingredient products with
50-95 percent organic content, to which the prohibition on use of
excluded methods also applies. For example, it may be harder for
organic food processors, who may struggle to find sources of nonorganic
ingredients that are produced without use of excluded methods and for
certifying agents, who must ensure that handlers have complied with
this requirement.
As with most elements of this program, compliance monitoring and
enforcement will rely on the ongoing oversight of organic operations by
USDA-accredited certifying agents, rather than on product testing.
Certifying agents must approve organic plans that detail procedures and
practices to be followed by organic operations and will review
extensive records maintained by organic operations to ensure that they
are complying with the approved organic plans and the regulations.
This system of compliance assurance will be particularly important
with respect to the prohibition on use of excluded methods. Producers
and handlers must be vigilant in the acquisition of materials and
products. Certifying agents should be aware of agricultural products
produced through excluded methods and must carefully review material
and product origin documentation. It will be the responsibility of
certifying agents to review the sourcing specifications and other
provisions of producer and handler organic plans to ensure the
integrity of organic and multiingredient products. We anticipate that
this system of carefully reviewed and documented organic plans, which
establishes documented procedures demonstrating good faith efforts to
diligently pursue and maintain the integrity of ingredients produced
without use of excluded methods, could satisfy the requirements in this
regulation.
With respect to the prohibition on the use of excluded methods in
production of the nonorganic ingredients in multiingredient products,
we recognize that the ability to meet these requirements depends
primarily on practices used in conventional agricultural markets. We
also recognize that practices for preserving product identity,
including segregating genetically engineered and nongenetically
engineered products, are evolving in some conventional markets.
Currently there are no consensus industry standards for product
segregation, rather contractual agreements are used to the extent
possible. As the marketplace evolves toward recognized best practices
or standards for product testing and segregation, we anticipate that
these methods and systems will become the standards for implementing
the prohibition on use of excluded methods in production of nonorganic
ingredients in multiingredient products. Linking the requirements
pertaining to nonorganic ingredients in this proposal to the evolving
practices within the marketplace will provide certifying agents with a
verifiable criterion against which to evaluate production and handling
processes, as well as providing greater certainty to handlers and
processors as they seek to identify acceptable sources of nonorganic
ingredients.
As with other prohibited substances, a positive detection of a
product of excluded methods would trigger an investigation by the
certifying agent to determine if a violation of organic production or
handling standards occurred and would not necessarily represent a
violation on its own. The presence of a detectable residue alone does
not necessarily indicate use of a product of excluded methods that
would constitute a violation of the standards.
We anticipate that these issues will be of particular interest to
commenters on the proposal, and that comments may help to shed light on
industry capabilities and expectations. We recognize that this policy
will place additional burdens on certified operations and certifying
agents, but we believe that the necessity to meet strong consumer
expectations outweighs these concerns.
(2) Measurable Degradation Standard. We are proposing that any
practice implemented in accordance with the requirements for organic
production and handling must maintain or improve the soil and water
quality of the operation. This provision is a modification of the
requirement in the first proposal that the use or application of a
practice not result in measurable degradation of soil or water quality.
Some commenters stated that the concept of measurable degradation was
too limiting and reduced the holistic principles behind organic
production to an exercise in risk assessment. In introducing the
concept of measurable degradation, we stated that its purpose was to
``clarify that all methods and substances used in an organic operation
shall be consistent with a system of organic farming and handling and
the purposes of the OFPA.'' As such, measurable degradation and the
specific indicators of soil and water quality used to monitor it were
designed as tools to evaluate compliance with the OFPA and not as ends
in themselves.
The new provision requiring that an organic operation maintain or
improve its soil and water quality retains the linkage between
production and handling practices and the natural resources of the
operation, which is a fundamental tenet of both organic production and
the OFPA. We have introduced the ``maintain or improve'' provision to
allow for consideration of a variety of environmental indicators that
contribute to the overall performance of the operation. Both the
objective of certification--establishing an organic system of
production and handling--and the standard by which it is achieved--the
requirements in this proposal--remain constant for all operations. The
environmental indicators used to establish and monitor compliance with
an approved organic system plan will depend upon the site-specific
conditions of the individual operation. For example, a producer and
certifying agent would consider the soil types, hydrology, other
environmental conditions and the specific nature of the crops and
livestock being produced to
[[Page 13536]]
determine which indicators would best reflect the performance of the
organic system plan. Site-specific conditions--high water table, soils
that are prone to erosion--combined with the operation's production
practices--the use of persistent inputs such as copper or sulfur
compounds, the type of tillage practices used--will dictate the
selection of environmental indicators. While individual indicators,
especially when signaling that significant change has occurred, remain
important, the ``maintain or improve'' provision allows a producer or
handler and his or her certifying agent to assume a broader perspective
in monitoring compliance with the OFPA.
Many commenters objected to the requirement in the first proposal
that certain production practices ``not result in a measurable
degradation of the soil.'' The purpose of the ``measurable
degradation'' requirement was solely to provide producers and their
certifying agents with quantifiable, verifiable tools with which to
evaluate compliance with the applicable regulations. While the current
proposal does not refer to ``measurable degradation'' in the practice
standards, producers and handlers must identify and incorporate into
their organic system plans specific testing and evaluation techniques
to measure the environmental impact of their production practices. In
many cases, this requirement could be filled with a standard soil
analysis, which would indicate trends in soil organic content, nutrient
composition, and physical properties. In other cases, chemical or
biological analysis of stream water entering and leaving a crop or
livestock operation could suffice to monitor compliance with the
practice standards. There is no way to substantiate the effectiveness
of the practices and materials used in an organic production system
without some form of measurable verification. Analytical procedures to
monitor the condition, over time, of an operation's resource base are a
standard feature of efficient resource management, whether or not the
operation is organically managed.
(3) Function and Content Requirements of the Organic System Plan.
We propose significant changes in the function and content requirements
of the organic system plan to solidify its role in the relationship
between producer or handler and certifying agent. Public comment on the
first proposal identified numerous perceived deficiencies in the
provisions for an organic system plan. Some commenters, including
organic certifying agents and industry associations, stated that the
proposed content requirements were a ``shadow'' of the plan intended by
the OFPA because the regulatory text did not include the words,
``management,'' ``rotation,'' or ``manure.'' Some commenters
characterized the organic system plan in the first proposal as a simple
list of materials to be used and practices to be followed and thought
that it would not adequately address why the producer or handler made
specific production choices. Echoing the recommendation adopted by the
NOSB at its June 1994 meeting in Santa Fe, NM, other commenters
suggested that each organic system plan should be required to include
key elements of organic production, such as soil and crop management,
resource conservation, crop protection, and maintenance of organic
integrity through growing, harvesting, and postharvest operations. We
fully agree with the principle that a comprehensive organic system plan
is an integral component of a certified operation and that it provides
the foundation for the working relationship between the certifying
agent and the producer or handler. This proposal contains a standard
that defines and characterizes an organic system of production and
handling and establishes the organic system plan as the centerpiece of
the relationship between producer or handler and certifying agent.
Some commenters expressed concern that the first proposal did not
link the organic system plan to specific regulatory requirements such
as proper tillage, crop rotation, and manuring. The first proposal did,
however, require operations to document compliance with all applicable
standards. The obligation to document compliance with all applicable
standards was implicit in the requirement that an organic system plan
contain a description of the practices to be performed and maintained
to establish a system of organic farming and handling. A producer or
handler intending to engage in a practice must comply with the
corresponding standards and include his or her intentions for doing so
in the organic system plan. This proposal contains a similar provision,
found in Sec. 205.200(a)(1), which requires a description of the
practices and procedures used in the certified operation, again,
without stating the specific standards with which the operation must
comply.
We acknowledge that, by providing the regulatory guidance necessary
to implement the OFPA, the Secretary is further empowering accredited
certifying agents to determine whether an operation's organic system
plan meets the requirements of the statute. The provisions for an
organic system plan in Sec. 205.200(a)(1)-(6) outline the prerequisites
for certification. Combined with the production and handling standards
in Secs. 205.201 through 205.207, 205.236 through 205.239, and 205.270
through 205.272, these requirements provide the criteria necessary for
certifying agents to determine whether to grant certification.
For similar reasons, we propose not to include in this proposal a
list of the specific requirements to be included in a particular type
of organic system plan. For example, while the first proposal required
that a farm operation submit the total acreage under organic management
as part of its organic system plan, there is no similar requirement in
this proposal. We believe that accredited certifying agents are capable
of determining the specific documentation they require to review an
application for certification. Certifying agents are granted authority
to request the information they deem essential to the performance of
their duties. Many resources are available to certifying agents for
determining the information needed to make certification decisions. The
Federal-State Marketing Improvement Program of the Agricultural
Marketing Service (AMS) helped fund a project (#12-25-G-0202) which
created an organic inspection manual and developed a whole set of
organic certification form templates. Among these templates are
detailed forms for organic farm, livestock, and handling system plans.
AMS worked with the Independent Organic Inspectors Association and the
Organic Certifiers Council on this project and supports continued
movement toward standardized certification documentation. The NOSB
provided recommendations, including sample questionnaires, for the
information it deems necessary for inclusion in an organic system plan.
Additionally, the Organic Trade Association recently released the
American Organic Standards that drew upon broad industry involvement to
create a detailed description of organic system plan requirements.
The organic system plan in the first proposal included requirements
for split farming operations--meaning farms that engage in both organic
and nonorganic production--that some commenters stated were excessive.
These commenters pointed out that the OFPA does not provide for the
organic system plan to include any production or handling practice not
consistent with the OFPA, and that the practices on the nonorganic
portion of the split-farm
[[Page 13537]]
would not be consistent with the Act. Based on these comments, this
proposed organic production system plan will not require information
about a split-farm's nonorganic operations. However, this proposal
requires that a split operation, whether a production or a handling
operation, describe the measures it is taking or will take to prevent
commingling of organic and nonorganic product and to prevent contact of
organic products, fields, or facilities with prohibited substances.
(4) Regulatory Enforcement. The National Organic Program (NOP) will
require consistent and effective enforcement of the regulations across
diverse crop, wild crop, livestock, and handling operations which are
differentiated by site-specific conditions within dissimilar geographic
regions. The resources and objectives of each certified operation are
unique, and the OFPA, accordingly, provides certifying agents with
criteria, not formulas, to determine whether the practices, procedures,
and inputs described in an organic system plan constitute compliance
with the OFPA. The flexibility implicit in this approach allows
producers and handlers to choose from a variety of production and
handling options. In addition to being flexible, a regulatory mechanism
must be clear, consistent, and enforceable. For this reason, producers
and handlers must document the choices they make in an organic system
plan and demonstrate a good-faith effort to implement the plan. For
example, the decision to use an allowed synthetic pest control
substance must be based on evidence that prevention and nonsynthetic
pest control measures are not adequate.
Public comment indicated that the regulatory mechanisms that were
introduced in the first proposal, including orders of preference,
performance standards, and provision for allowance of certain practices
``if necessary,'' provided producers and handlers too much discretion
in selecting materials and practices. These comments indicated that
insufficient oversight by certifying agents could dilute the meaning of
organic certification. Therefore, we are proposing significant changes
in the regulatory mechanisms which govern producers, handlers, and
their certifying agents in determining the materials, practices, and
procedures used in an organic operation.
One regulatory mechanism used in the first proposal was an ``order
of preference'' scheme for selecting organic practices or materials
employed in production and handling. This scheme was proposed for a
number of areas: Crop rotation; manuring practices; soil fertility and
nutrient management; seeds and planting stock selection; crop pest,
weed, and disease prevention and management; livestock health care;
selection of handling ingredients; and prevention and facility pest
management. There was also a general order of preference requirement
that mandated the use of nonsynthetic substances in preference to
synthetic substances.
Comments from at least one industry association supported using
orders of preference to assure that choices made by producers and
handlers will be as consistent as possible with organic farming and
handling principles. Others, including several organic certifying
agents, felt that the conditions for choosing a lower order of
preference were not specified clearly enough and could result in
inconsistent enforcement of the standards. Some commenters thought that
certifying agents would be overly burdened by having to review and
approve the justification in the organic plan for choosing less
preferable practices, although some stated that if the criteria for
choosing a lower order of preference were clarified and documentation
of the reasoning behind the choice was explicitly required, then this
scheme would be workable. Some noted that ranking practices and inputs
according to their suitability is analogous to the ``approved,
restricted, prohibited'' scheme which many State and private
certification programs employ. A few commenters expressed the belief
that establishing provisions to issue variances would address their
concerns and provide for adequate oversight and enforcement concerning
practices, procedures, and inputs that are considered to be acceptable
but less desirable for organic production and handling.
However, several commenters, including consumers and organic
certifying agents, asserted that ``preference'' could be interpreted as
purely based on the personal choice or convenience of the producer or
handler. Some certifying agents indicated that the soil fertility order
of preference was too complex and difficult to enforce. A number of
consumers disliked this concept because it permitted some deviation
from the most desirable standards, such as use of organically produced
seeds. Another commenter speculated that this scheme could be
interpreted as establishing different levels of ``organicness.''
Although these interpretations do not reflect the intent of the first
proposal, in the interest of clarity, we have removed references to
orders of preference in the current regulatory text. We also removed
the general requirement for orders of preference and to simplify the
scheme so that it will be less burdensome for certifying agents to
enforce. Several provisions in this proposal, including the seeds and
planting stock practice standard (Sec. 205.204) and the crop pest,
weed, and disease management practice standard (Sec. 205.206) will
allow less desirable practices or substances to be used only if the
preferred alternative is either ineffective or not commercially
available. As was true of the first proposal, justification for
choosing a less desirable alternative, such as nonorganic seeds or
planting stock, must be documented in the relevant organic system plan
and approved by the certifying agent.
Several commenters, including industry and environmental
associations, also took issue with the use in the first proposal of
performance standards, which specify the required outcome but not the
practices that must be used to achieve it. The general provision that
any practice or substance used in an organic operation not contribute
to measurable degradation of soil or water quality is an example of
such a performance standard. Objections to the use of performance
standards referred to the nature of organic production standards, which
focus on the production process and not quantifiable outcomes such as
pesticide residue levels. Some of these commenters asserted that such a
mechanism would relegate organic standards to a risk assessment model,
which is not appropriate for evaluating a system of organic management.
We agree that standards for an organic management system cannot be
reduced to measurable outcomes, and this was not the intent of the
proposed performance standards in the first proposal. The evaluation of
measurable indicators as benchmarks of the proper functioning of a
management system is compatible with the overall requirement that
practices be implemented that are consistent with a system of organic
farming and handling. Such indicators help to determine whether a given
operation is in compliance with the regulations. For example, the crop
rotation provisions in this proposal list a series of functions,
including weed management, that should be provided by an appropriate
rotation. While the possible types of rotation that could achieve this
objective are virtually limitless and could not be specifically
prescribed, recording changes in weed populations could document the
[[Page 13538]]
effectiveness of the rotation being implemented.
Another type of regulatory provision employed in the first proposal
permitted the use of certain practices or substances only ``if
necessary.'' This was proposed for the introduction of nonorganic
animals into an organic operation, for using up to 20 percent
nonorganic livestock feed, for permitting restrictions on access by
livestock to space for movement and access to outdoors, and for use of
synthetic processing aids in producing an organic processed product. A
producer or handler was required to establish his or her need to use a
particular practice or substance based on site-specific circumstances.
The basis for each such decision was to be stated in the organic system
plan and evaluated by the certifying agent. Many commenters indicated
that this provision was not appropriate because, for example, the
allowance for the use of 20 percent nonorganic livestock feed, ``if
necessary,'' left a loophole that could permit an unscrupulous producer
to use nonorganic feed without a valid reason that was consistent with
the regulations. We concur that this allowance for practices ``if
necessary'' is overly vague and have removed the provision from this
proposal. It has been replaced by more specific regulatory
restrictions, referred to as practice standards, which better reflect
the recommendations of the NOSB.
We have addressed comments that requested more specific guidelines
for acceptable organic practices by introducing the concept of practice
standards. Practice standards are a series of specific guidelines,
requirements, and operating procedures for common agricultural
practices such as crop rotation, pest management, and crop nutrient
management. The NOSB reviewed portions of the current NRCS practice
standards for crop rotation, nutrient management, pest management,
composting facilities, and cover or green manure crops at its
Washington, DC, meeting in June 1999. NRCS practice standards, while
not public health standards, contain rigorous, field-tested provisions
which provide specific benchmarks for monitoring the performance of
many required organic production techniques. A practice standard can
also serve as the foundation for an even more detailed program manual.
For example, we are proposing that composted animal and plant waste
materials which are used for soil fertility and crop nutrient
management must be produced at a facility in compliance with the NRCS
practice standard for a Composting Facility (Code 317). This document
establishes minimum acceptable requirements for the design,
construction, and operation of a composting facility. A copy of this
practice standard may be obtained from any NRCS field office. A copy of
this practice standard may be viewed at USDA-AMS-TMD-NOP, Room 2510--
South Building; 1400 Independence Ave., SW, Washington, DC 20250-0248.
The NOP intends to publish additional practice standards for public
comment in the Federal Register. We are also holding discussions with
NRCS to determine whether farming operations which comply with the
certification requirements of the NOP will have the added benefit of
being able to participate simultaneously with NRCS cost-share programs.
Incorporating NRCS practice standards into the requirements for
organic certification introduces a significantly greater degree of
specificity than most organic standards have previously contained. For
example, the Composting Facility practice standard includes
specifications for facility size, moisture content of the compost pile,
carbon-nitrogen ratio, and the interval which certain temperatures must
be sustained to achieve a finished product. The practice standard also
contains restrictions on source materials which may make it difficult
to utilize certain categories of materials which have traditionally
been allowed in organic compost production. Enforcing these additional
requirements will require far greater oversight from the certifying
agent, and expertise in this area will become another factor in
accreditation. NRCS uses its practice standards for voluntary cost-
share programs, and organic producers may find the requirements
burdensome as an added, mandatory expense. Despite the many comments we
received criticizing the provisions for performance standards in the
first proposal, organic certification schemes have traditionally
prescribed outcomes and allowed producers and handlers flexibility in
selecting practices used to achieve them. However, we received many
other comments stating that more rigorous, clearly defined regulatory
mechanisms were needed to protect the integrity of organic
certification. We have considered the use of NRCS practice standards to
provide clear, consistent, and verifiable guidelines for conducting
essential organic production practices. We are particularly interested
in receiving specific comment on the feasibility of using NRCS practice
standards for compost production and how such practice standards may
generally be used to establish organic standards.
(5) Temporary Variances. Section 205.201(b) of this proposal
provides procedures for establishing a temporary variance from certain
requirements of subpart C. The temporary variance is a mechanism for
providing regulatory flexibility that did not appear in the first
proposal. This mechanism is proposed in response to comments from an
industry association and several certifying agents who expressed the
need, in certain circumstances, to use practices that would otherwise
not comply with the applicable practice standard. Similar mechanisms
are used by most existing certifying agents to make exceptions in cases
of compelling need, when there is minimal concern for compromising the
integrity of an organic system. Temporary variances are established
from specific requirements and not, unless specified, from all
production standards. They are established for a determined period of
time, subject to extension as deemed necessary by the Administrator.
For example, the Administrator could, under appropriate circumstances,
waive the requirement that a producer must provide livestock with a
ration composed of 100 percent organically produced feed.
Temporary variances are created under very specific circumstances
and are subject to strong oversight by the Department to prevent
potential abuse. This proposal contains three situations in which the
Administrator could establish a temporary variance. These situations
are: natural disasters as declared by the Secretary in a specific
geographical area; business interruption caused by wind, flood, fire,
or other catastrophic event; or for the purpose of conducting research
or trials of techniques, varieties, or ingredients used in organic
production or handling. In the case of natural disaster declared by the
Secretary, the Administrator will establish a temporary variance
available to all organic operations within the area designated as
affected. For local catastrophic events in which the Secretary does not
declare a disaster, the certifying agent is responsible for making
recommendations to the Administrator for establishing temporary
variances. Catastrophic events must be of a sufficient magnitude and
have a direct, immediate impact such that the operation could not
continue to function without the temporary variance. Certifying agents
are responsible for making a recommendation for a temporary variance in
situations prompted by
[[Page 13539]]
research needs. Producers and handlers cannot appeal directly to the
Administrator for a temporary variance but must make such a request
through their certifying agent.
Temporary variances, as proposed here, will not extend to any
practice or substance that is expressly prohibited by any provision of
the OFPA, the applicable standards, these regulations, or any other
Federal, State, or local laws or regulations. For example, a variance
cannot be granted for use of an organism produced through excluded
methods, for use of sewage sludge as a fertilizer, or for use of
irradiation to process an organic product or ingredient. We expect to
provide additional guidelines in a program manual to assist certifying
agents in evaluating how much of an allowance is appropriate, such as
how much of the ration for which animals could come from nonorganic
sources under a variance.
Production and Handling (General)--Changes Requested But Not Made
This subpart retains from our first proposal regulations on which
we received comments as follows:
(1) Definition of ``System of Organic Farming and Handling''. The
first proposal contained a definition of a ``system of organic farming
and handling'' to provide an explicit reference point for determining
which practices and substances were consistent with such a system.
Several industry associations and certifying agents commented that the
definition was helpful but lacking in key concepts, such as
``ecological balance,'' ``agroecosystem health,'' and ``biological
diversity.'' Several thought the definition should receive greater
emphasis in the regulations as a reference point for the underlying
principles of organic production and handling and that the NOSB's
definition should be used. Although we considered many of the concepts
discussed by commenters, only the scope and not the meaning of the
original definition has been changed. The definition in this proposal
is based on the one we developed in consultation with the NOSB but is
limited to concepts that are incorporated into the OFPA. Measuring
compliance with the component-based mandates of the OFPA, such as
fostering soil fertility and preventing water contamination by manure,
does not require criteria as far-reaching as ``agroecosystem health''
or ``biological diversity.'' We also took into consideration the costs
to comply with such open-ended requirements and determined that this
could be excessively burdensome. Synergistic benefits may be associated
with organic production and handling systems, but the OFPA requires
only that individual components of the system--soil, water, wild crop
environment--be protected. Adherence to the conservation practices
found in the individual practice standards will result in cumulative
benefits to the agroecosystem, but producers and handlers would have
difficulty measuring compliance at this scale. Establishing standards
that address individual components of an organic farming system, such
as tillage practices and manure management, will directly and
beneficially impact the entire ecosystem. For the purpose of
enforcement, however, we propose retaining the component-based criteria
for evaluating a system of organic farming and handling.
(2) Commercial Availability Standard. The first proposal allowed
certain materials and practices, such as nonorganic seeds and
nonorganic minor ingredients in a product labeled organic, to be chosen
if preferable alternatives were not ``commercially available.'' We have
retained the commercial availability principle in this proposal but
have limited its use to the provisions addressing the selection of
organic or untreated seeds and planting stock. A number of producers,
consumers, and certifying agents expressed concern that producers or
handlers not be permitted to base claims of commercial unavailability
on any price difference between organic and nonorganic inputs. They
argued that the term, ``feasibly and economically,'' in the proposed
definition of ``commercially available'' were too vague to be
enforceable. Comments from an industry association supported the use of
this concept but requested a more specific definition that could be
used to assess the economic dimension of commercial availability. The
NOSB has also cited commercial availability as a valid criterion for
allowing some flexibility in the choice of inputs and stated that the
term is applicable to the quantity and quality of available product as
well as its cost.
Although commercial availability is not defined in the OFPA, the
concept is well established within current certification programs and
the commercial world in general. To be considered commercially
available, a preferred input must be known and readily available in the
sense that a producer or handler can locate and acquire the quantity
and quality of product needed to sustain his or her operation. The
producer or handler must make a good faith effort to procure the
preferred input but should not be expected to rely on an inconsistent
supply of a necessary commodity. We do not provide a formula for
determining when price difference alone is enough to justify purchase
of the less desirable input because of the multiple factors which could
affect such a decision.
By limiting the application of the commercial availability standard
to the selection of organic or untreated seeds and planting stock, we
are limiting its use to relatively narrow and well defined markets. A
producer must justify a choice based on commercial availability when
submitting an organic plan to the certifying agent, and it must be
supported by evidence of a good-faith effort to obtain the preferred
input. The attempt to source an input from known suppliers and an
investigation to discover potential new suppliers constitute the
producer's good-faith effort. Certifying agent approval of the organic
plan provides sufficient protection against abuse of this provision.
Although comments reflected concern that too many allowances for
nonorganic inputs could dilute the integrity of certification, the
organic industry has built its reputation while using the commercial
availability exemption for sourcing certain materials. Certifying agent
oversight can ensure that it works in the NOP as well.
Production and Handling (General)--Additional Provisions
Upon further review of the provisions in the first proposal, we
have decided to propose the following additions and changes.
(1) Dual Use of an Organic System Plan. Section 205.201(b) allows a
producer or handler to submit an organic production system plan
developed to meet the requirements of another Federal, State, or local
regulatory program if the plan fulfills the applicable requirements of
this section. Government agencies may have programs in place that
require participating agricultural producers or handlers to develop and
follow a management plan. For example, the NRCS Environmental Quality
Incentives Program (EQIP) requires a conservation plan. An organic
production system plan could be incorporated into such a conservation
plan and fully comply with the requirements proposed in Sec. 205.201 of
this proposal. This new provision could reduce the paperwork burden for
an operation that participates in more than one program requiring a
farm conservation plan.
[[Page 13540]]
Crop Production--Changes Based on Comments
This subpart differs from our first proposal in several respects as
follows:
(1) Biosolids. The first proposal requested public comment on the
possible use of biosolids as a means of enhancing soil fertility on an
organic agricultural operation. Our interpretation of the term,
``biosolids,'' is synonymous with the definition of sewage sludge
contained in 40 CFR part 503. In response to the comments we received,
this proposal adds biosolids to the list in Sec. 205.203(e)(2) of
substances that are specifically prohibited for use in organic
production.
The first proposal reviewed some historical information about the
Federal enforcement of biosolids use and the steps taken by EPA, FDA,
and the U.S. Department of Agriculture (USDA) to ensure that biosolids
are safe to use on crops for human consumption. Comments were solicited
as to whether biosolids should be permitted or prohibited in organic
production. The first proposal noted that the NOSB recommended that
biosolids should be classified as synthetic and were not appropriate
for use in organic crop production. The NOSB took this position at its
1996 meeting in Indianapolis, IN, and reaffirmed it at its 1998 meeting
in Ontario, CA.
We received hundreds of thousands of comments, virtually all of
which strongly opposed the use of biosolids in organic agriculture. The
vast majority of the commenters stated that biosolids can contain
synthetic substances prohibited in organic agriculture, such as
industrial waste, street runoff containing petroleum products, and
household waste contaminated with cleaning products, polychlorinated
biphenyls (PCB's) and dioxins. Commenters indicated that sewage sludge
should not be allowable because it may contain synthetic materials
prohibited in organic production which are not restricted under EPA
regulations. Many commenters stated that biosolids are not currently
allowed in organic production and that permitting their use would run
contrary to consumer expectations. Such an allowance would place
producers at a competitive disadvantage in domestic and international
markets. While sewage sludge may be safely used in conventional
agriculture, allowing its use under these standards would be
inconsistent with the historical understanding of organic fertility
management shared by producers and consumers. Therefore, this proposal
prohibits the use of sewage sludge in organic production.
(2) Tillage and Conservation Practices. While no comments objected
to the inclusion of tillage and cultivation practices in the first
proposal, a few took issue with the requirement that these practices
result in ``no measurable degradation'' of soil quality. In this
proposal, the concept of `` no measurable degradation'' has been
replaced with the requirement to ``maintain or improve'' soil quality.
We agree with commenters who suggest that prevention of soil erosion is
an important consideration for the selection of tillage and cultivation
methods and have included a requirement that tillage and cultivation
practices maintain or improve the physical, chemical, and biological
condition of soil and minimize soil erosion. We have removed other
references to preventing measurable degradation when using plant or
animal wastes in the first proposal and replaced them with a
requirement, in Sec. 205.203(c), that the producer manage these
materials to maintain or improve soil organic matter content in a
manner that does not contribute to contamination of crops, soil, or
water by plant nutrients, pathogenic organisms, heavy metals, or
residues of prohibited substances. In accordance with several comments
received, this provision frames the requirement in terms of achieving a
positive outcome rather than avoiding a negative one. This proposal
specifies the types of measurable degradation that could result from
improper or excessive application of plant or animal waste materials,
and producers, in consultation with the certifying agent, will identify
potential problems and address them in the organic system plan. The
organic system plan must also identify appropriate monitoring
activities to ensure that the ``maintain or improve'' requirement is
being met. For example, a producer who manages an on-farm composting
facility might make regular observations of the pile to check for
leaking and periodically sample a nearby stream for nitrate content.
(3) Application of Raw Manure. The first proposal requested public
comment on appropriate guidelines to ensure that use of raw animal
manure would not cause contamination of food products by pathogens that
cause foodborne illness. The OFPA restricts the use of raw manure by
requiring that a reasonable period of time elapse between its
application to a crop intended for human consumption and the harvest of
that crop. This period of time must be approved by the certifying
agent, but in no event may it be less than 60 days. The OFPA stipulates
that the certifying agent determine the interval between the last
application of raw manure and harvest of the crop to ensure the safety
of the crop. Furthermore, the OFPA prohibits raw manure from being
applied to any crop in a way that significantly contributes to water
contamination by nitrates or bacteria. The first proposal contained an
order of preference which favored the use of composted materials,
including manure, as inputs for soil fertility but allowed raw manure
applications subject to the 60-day minimum preharvest interval
contained in the OFPA.
Many public comments addressed the issue of raw manure use, and
some industry, producer, consumer, and environmental groups submitted
substantial technical information. Many of these commenters addressed
the human health risk associated with the use of manure in organic crop
production. Most of these comments suggested that a determination of
sufficient time to ensure the safety of a crop depends on soil and
climate conditions, but that the 60-day period specified in the OFPA
was not sufficient. Some commenters cited various amounts of time that
might be considered safe. Other commenters stated that no interval
between application and harvest could be considered safe and
recommended prohibiting the application of raw manure to any crop. The
NOSB had extensive deliberations on the use of raw manure in organic
crop production at its June 1999 meeting in Washington, DC.
The OFPA's requirement that raw manure be applied in a manner that
ensures the safety of the crop presents a unique regulatory challenge.
We have consistently maintained that the NOP is for marketing, not food
safety, purposes. Organic production and handling standards, which are
not based on risk assessment of public health consequences, may differ
from the requirements established by agencies that are responsible for
food safety regulations. The OFPA's requirement that the application of
raw manure ensures the safety of the food to which it has been applied
requires the NOP to move toward establishing a public health standard.
This requirement is especially challenging given that there is no
Federal oversight of the application of raw manure to any kind of crop
nor any public health standards to establish what constitutes safe use
of raw manure. Applications of raw manure are a hazardous, threatening
[[Page 13541]]
pathogenic contamination of food products, notwithstanding the use of
composted manure, which can carry similar hazards.
We have responded to the concerns regarding the application of raw
manure to organically produced crops by proposing the standards
contained in Sec. 205.203(c)(1). We propose that raw animal manure must
be composted, unless it is applied to land used for a crop not intended
for human consumption, incorporated into the soil not less than 120
days prior to the harvest of a product in direct contact with the soil
surface or particles, or incorporated into the soil not less than 90
days prior to the harvest of a product the edible portion of which does
not have contact with the soil surface or particles. However, many
site-specific variables affect the viability of pathogens in raw
manure, and we cannot determine whether this standard will be
sufficient under all conditions to fulfill the safe food requirement
contained in the OFPA. We are requesting comment on the development of
more comprehensive standards that certifying agents are capable of
enforcing. We are also requesting comment on how to regulate the
authority to determine the ``reasonable period of time'' between the
last application of raw manure and harvest of a crop which the OFPA
delegates to the certifying agent. Given the need for far greater
scientific understanding of the spread of pathogens in raw manure, we
do not consider that certifying agents should be expected to make the
determination of safety.
Several comments were received which suggest that any use of raw
animal manure could jeopardize human health and that the use of raw
animal manure by organic farmers thereby increases the risk that
organic foods may not be as safe as conventionally produced foods. We
recognize that our knowledge of the risks from foodborne pathogens has
advanced since the OFPA was passed a decade ago, and that safety
precautions have been strengthened accordingly. Therefore, we are
seeking further guidance for developing regulations that minimize the
potential for contamination of crops grown for human consumption by
pathogens from raw animal manure. This approach is consistent with the
traditional organic certification procedures which have restricted the
use of raw manure for environmental as well as health concerns. Other
Federal and State regulatory programs may impose additional
requirements on the use of raw manure in crop production which could be
applicable to organic operations.
The first proposal required that management practices for the
application and storage of raw manure be implemented in a manner that
does not significantly contribute to contamination of water by nitrates
and bacteria, including human pathogens. The use of the word,
``significantly,'' in this provision is a direct reference to the
authorizing language in the OFPA (Section 2114(b)(2) (C)). However,
commenters suggested that this language implies that ``insignificant''
contamination would be acceptable. This proposal requires that soil
management practices aim at preventing, to the extent possible, any
contamination of water by nitrates and pathogenic bacteria.
(4) Use of Treated Seed. The first proposal permitted the use of
treated seeds if the same variety was not commercially available in
untreated form or if unanticipated or emergency circumstances made it
infeasible to obtain untreated seeds. In this context, ``treated seed''
refers to the application of a pesticide to a seed prior to planting
and does not include the use of a disinfection treatment for a seed
that is intended for sprouting and food use. A number of comments from
producer and industry groups suggested that this was appropriate but
that a producer should have to choose an ``equivalent'' untreated seed
variety that was commercially available. The term, ``equivalent,''
indicates that two seed varieties have similar performance attributes,
such as resistance to drought and insects, and production traits,
including yield, size, and shape of the commodity. We agree with this
provision because it favors a nonsynthetic input over a synthetic one
and have, therefore, included it in this proposal. We are also
requiring that, when selecting a nonorganically produced seed, a
producer select an untreated equivalent variety in preference to one
which has been treated with an allowed synthetic treatment.
Some comments objected to any allowance for the use of treated
seeds or planting stock, citing the prohibition in 2109(c)(3) of the
OFPA (7 U.S.C. 6508(c)(3)) on the use of transplants that are treated
with any synthetic or prohibited material. We recognize that the use of
synthetic seed treatments, some of which are acutely toxic, may seem
inconsistent with a system of organic production and handling, but it
is an established practice in State and private certification programs
and is supported by provisions of the OFPA. We believe that retention
of the commercial availability requirement, a preference for untreated,
nonorganically produced seed over treated, nonorganically produced
seed, and the use of temporary variances in this proposal provide an
appropriate context for regulating the use of synthetic seed
treatments.
The requirement from the first proposal that all seeds, annual
seedlings, and planting stock be organically produced is retained in
this proposal. Similarly, this proposal contains a comparable exception
to the requirement so that nonorganically produced seeds and planting
stock could be used to produce an organic crop when an equivalent
organically produced variety is not commercially available. A
producer's decision to use nonorganically produced seeds and planting
stock for reasons of commercial nonavailability of equivalent organic
varieties must be included in his or her organic plan and agreed to by
the certifying agent. We decided to retain these provisions from the
first proposal after receiving comments from producer and industry
groups that acknowledged that the supplies of organic farm inputs will
not be sufficient to provide for the seed and planting stock needs of
all organic operations in the near future. We have added the
requirement that producers select equivalent untreated seed over
treated seed when commercial availability allows them to use a
nonorganically produced variety. We recognize that these provisions
could lead to certifying agents facing numerous decisions regarding
commercial availability and equivalency in the organic system plans
they review. This degree of oversight is warranted, however, to ensure
that the use of synthetic materials in organic production is kept to a
minimum. We are not extending the commercial availability exception to
the requirement for organically produced annual seedlings because the
comments indicated that the organic input suppliers are effectively
meeting this demand.
In contrast to the first proposal, we propose that any synthetic
seed treatment used in organic production must be included on the
National List of synthetic substances allowed for use in organic
production. We base this requirement on the OFPA, which identifies
``treated seed'' as a category of synthetic substances eligible for
inclusion on the National List. We believe that including specific seed
treatments on the National List will satisfy the requirement in the
OFPA that a farmer shall not apply a material to or
[[Page 13542]]
engage in a practice on seeds or seedlings that is contrary to or
inconsistent with the applicable certification program. The approach we
are proposing is also consistent with current practice in the organic
industry. The NOSB endorsed this approach at its 1994 meeting in Santa
Fe, NM, by recommending that seed treated with synthetic fungicides
appearing on the National List be allowed when nontreated varieties are
commercially unavailable.
We propose that producers or handlers may request a temporary
variance due to unavoidable natural disaster in order to use
nonorganically produced annual seedlings. The temporary variance will
be appropriate in instances in which an unexpected event such as a
frost, flooding, fire, or other catastrophic event destroyed the
producer's nontreated planting materials and no organically produced
replacements are commercially available. This provision cannot be used
to compensate for mismanagement by the producer. For example, a
producer who planted seedlings prior to the recognized frost date and
lost his or her crop to a freeze could not claim that this disaster was
unavoidable. This provision requires that the producer make all
reasonable efforts to protect his or her seeds, annual seedlings, and
planting stock before being allowed to substitute with treated
replacements.
Some commenters cited the prohibition in section 2109(c)(3) of the
OFPA against using transplants that are treated with any synthetic or
prohibited material as justification for prohibiting the use of
synthetic seed treatments. However, the statute permits the use of
seeds and seedlings treated with substances included on the National
List of allowed synthetic substances. The seemingly inconsistent
requirements for seedlings and transplants, functionally equivalent
terms, have made this a difficult issue to resolve. The first proposal
attempted to reconcile these differences by defining transplant as an
annual seedling produced on an organic farm and transplanted to a field
on the same farm operation to raise an organically produced crop. Many
commenters felt that distinguishing between annual seedlings which
originated on and off the operation was not a valid approach. We
concur, and have removed this definition, and interpret the term,''
transplant,'' as applying to any seedling which is transported and
replanted, regardless of whether it originated on the operation or not.
We interpret the prohibition on using a transplant treated with any
synthetic or prohibited material as taking effect after the seedling
has been physically transplanted. Therefore, the prohibition only
applies to materials applied after transplanting and not to the
synthetic treatment included on the National List, which may have been
applied to the seed that produced the seedling.
The application of disinfectants to seeds used for sprouting
represents a unique dimension of the seed treatment issue. Raw sprouts
pose a potential food safety risk because the conditions under which
they are produced--growing time, temperature, water activity, pH and
nutrient content--can foster the rapid growth of bacteria. In 1999, FDA
issued guidance advising sprout producers and seed suppliers of
measures to reduce microbial hazards common to sprout production. These
measures include treating seeds with one or more approved methods such
as presprout soaking with 20,000 ppm calcium hypochlorite. Based on the
recommendation of the NOSB, the Secretary has included on the National
List in this proposal three chlorine materials to disinfect and
sanitize food contact surfaces. However, these materials carry the
annotation that residual chlorine levels in water shall not exceed the
maximum residual disinfectant limit under the Safe Drinking Water Act,
which is well below the 20,000 ppm level that FDA currently advises
sprout producers to follow.
Existing State and private certification programs have diverged in
their response to the FDA guidance on chlorine treatments. While
treating food products with high concentrations of chlorine has
traditionally been prohibited, some certifying agents currently allow
sprout treatment at the 20,000 ppm level. Producers of organic sprouts
are finding it increasingly difficult to balance the FDA guidance, the
expectations of consumers, and the requirements of their certifying
agents. This proposal contains no specific guidance on the use of
chlorine treatments on seeds used in sprout production. As synthetic
compounds, chlorine materials would have to be added to the National
List at specified concentrations to be used for disinfecting sprouts.
Without a specific National List exemption, operations that treat
sprouts at the level established in the FDA guidance could not be
organically managed.
(5) Crop Rotation. The OFPA requires an organic crop production
plan to foster soil fertility through practices that include a crop
rotation. The first proposal required the establishment of a crop
rotation or other ``means'' of ensuring soil fertility and effective
pest management but did not provide explicit restrictions concerning
situations in which those means could be substituted. Producers and
producer groups sent many comments stressing the importance of a proper
crop rotation for successful organic crop production and objecting to
the vague allowance for other methods to be used in its place. Although
we have not changed the definition of crop rotation from the first
proposal, the new practice standard eliminates the possibility that an
organic producer will substitute some other practice for a crop
rotation. This proposal does, however, allow for variances from an
approved crop rotation plan due to natural disasters, including
weather.
A few commenters made the point that, although the OFPA includes a
provision for a crop rotation as a means of improving soil fertility, a
crop rotation serves other critical functions as well. We reviewed the
NRCS practice standard for crop rotation (Code 328) which addresses
many of the concerns raised in public comment. Accordingly,
Sec. 205.205 of this proposal requires the producer to implement a crop
rotation, including, but not limited to, cover crops, sod, green manure
crops, alley crops, and catch crops. These techniques serve the
following functions as applicable to the operation: maintain or improve
soil organic matter content; provide for effective pest management in
annual and perennial crops; manage deficient or excess plant nutrients;
provide erosion control to minimize soil loss; and manage subsurface
water to prevent transport of dissolved materials.
A few comments suggested requiring that rotation plans include sod
or legumes, which serve to improve soil organic matter content and
increase soil nitrogen supplies to meet the demands of a following
crop. However, all of these functions could be fulfilled through many
different types of rotation plans, which could only be developed
according to the site-specific climate, soil type, and type of crops or
livestock produced on a given operation. In the interest of
flexibility, therefore, this proposal does not specify what crops have
to be included in a crop rotation. An organic plan that meets the
criteria specified in this proposal must be developed by a producer and
approved by the certifying agent.
Proposed Sec. 205.205(b) specifically applies to perennial crops.
Under this provision, an orchard plan might include establishment of
hedgerow areas that provide habitat for beneficial insects to assist in
effective pest management. This provision was added
[[Page 13543]]
in response to comments stating that an organic farm plan should
address the functions provided by crop rotations even in the case of
perennial crops such as orchards and sod. We expect to develop program
manuals containing more detailed information on different types of
rotations, including methods to fulfill the prescribed functions for
perennial crops, that are suitable to a wide range of types of
operations and geographic conditions.
(6) Prohibition on Cytotoxic Pest Control Substances. In response
to several comments, we have deleted the provision in the first
proposal to prohibit use of a synthetic carbon-based substance having a
cytotoxic mode of action for any use as a pest control substance. Some
commenters interpreted this provision to mean that this single
criterion would substitute for those specified in the OFPA for
evaluating substances proposed for inclusion on the National List.
Other commenters, including industry groups, objected to this provision
because it has not previously been part of certification standards and
its meaning was too ambiguous. Some substances that have historically
been accepted for organic production could have cytotoxic effects when
used in inappropriate concentrations. Although this provision added to
and did not replace the evaluation criteria contained in the OFPA and
eliminated the need for the NOSB to review clearly inappropriate
substances, it has been removed from this proposal in the interest of
clarity.
Crop Production--Changes Requested But Not Made
This subpart retains from our first proposal regulations on which
we received comments as follows:
(1) Buffer Zones. Section 205.202(a)(3) of this proposal requires
that any land on which organic crops are produced have distinct,
defined boundaries and buffer zones, such as runoff diversions, to
prevent the unintended exposure of the crop to prohibited substances
from adjoining land. Several commenters suggested that the regulations
should specify a minimum size for buffer zones, as is currently
required by some organic certifying agents. Although specifying a size
for these zones would establish a more definable requirement, it could
also impose unnecessary burdens on some organic producers without
offering greater protection of organic fields and crops from unintended
contact with prohibited substances. Another commenter argued that
buffer zones should not be required for unmanaged lands such as
wilderness areas or abandoned farms. There might be no need for a
buffer zone if an organic farm were completely surrounded by wilderness
or abandoned farms, which is one reason why a the size of a buffer zone
should not be specified. This proposal leaves the determination of an
adequate buffer zone to the organic producer and the certifying agent
on a case-by-case basis. Buffer zone provisions are an important part
of each organic production system plan, and we will provide guidelines
for buffer zones in program manuals.
(2) Nonorganic Plant and Animal Waste Materials. The first proposal
permitted the use of any uncomposted plant or animal wastes. It also
allowed use of composted plant or animal wastes obtained from
nonorganic sources, such as commercial compost products. Several
consumer and environmental groups objected to permitting the use of
plant or animal wastes from nonorganic sources. Such materials, they
argued, could potentially contain residues of prohibited substances
that could compromise the integrity of the organic farm system.
However, off-farm plant and animal wastes from food processing,
municipal yard waste facilities, and other sources are used extensively
in existing organic operations and are generally permitted by organic
certification programs. Bone meal, fish meal, and seaweed meal are also
commonly used as organic farm inputs. Commercial fertilizer products
that contain mixtures of such plant and animal by-products are commonly
permitted for use in existing organic certification programs, subject
to certifying agent review. Using such organic wastes is consistent
with a system of organic production and handling, which calls for
recycling organic wastes to return nutrients to the land. We believe
that concerns about potential contaminants in plant and animal waste
materials can be addressed by the requirement in this proposal that
these materials be managed in a manner that prevents such
contamination. For example, cotton gin trash that had been treated with
a prohibited substance could only be used if the organic system plan
specified composting the material before adding it to the soil.
Composting has been shown to effectively biodegrade synthetic organic
compounds, and the organic system plan could also call for the compost
or soil to be monitored regularly for specific residues.
Finally, the first proposal and this proposal prohibit the use of
any commercially blended fertilizer product that contains a prohibited
substance, as required by the OFPA. Although a number of commenters
worried that a product containing toxic synthetic substances as inert
ingredients could be used for organic production, this prohibition
prevents such products from being used. For this reason, the use of any
composted or uncomposted plant or animal wastes to supply soil or crop
nutrient is permitted without further limitation other than preventing
contamination of soil or water by pathogenic organisms, heavy metals,
or residues of prohibited substances. The certifying agent will be
expected to have the expertise to recognize materials that might be of
concern and ensure that they are properly addressed in the organic
system plan. We expect to provide additional guidelines in program
manuals to help evaluate whether animal manure is fully decomposed, as
well as guidelines for other types of materials to address potential
soil or water quality concerns. We acknowledge the need to examine
carefully commercial blended fertilizers and soil amendments to ensure
that such products do not contain prohibited substances.
(3) Chemically Altered Plant or Animal Waste Materials. The first
proposal allowed the use of a composted or uncomposted plant or animal
waste material that had been chemically altered by a manufacturing
process--such as leather meal, newspaper, and biosolids--if the
material was included on the National List of allowed synthetics. Only
newspaper was proposed for inclusion on the National List. A few
commenters objected to this allowance, although newspaper is commonly
permitted as a mulch material or as an ingredient in compost in
existing organic certification programs and was recommended for this
use by the NOSB. The National List review process offers an adequate
safeguard to ensure that other waste materials that may be permitted in
the future will be consistent with a system of organic production and
handling, and we propose to retain this provision in Sec. 205.203(c)(5)
of this proposal.
(4) Soil and Crop Mineral Nutrients. This proposal includes
provisions for supplying soil and crop mineral nutrients that are
similar to those in the first proposal. While use of a proper crop
rotation and recycled plant and animal wastes can often provide all the
mineral nutrients required by crops, supplemental sources of these
nutrients are sometimes needed. Section 205.203(d) of this proposal
permits a producer to supply soil and crop nutrients through use of
mined minerals and other nonsynthetic sources. Synthetic micronutrients
are also allowed if they are included on the
[[Page 13544]]
National List. Ash from plant or animal materials can be used, as long
as the burned material was not treated or combined with a prohibited
substance and was not included on the National List of prohibited
nonsynthetic substances. For example, ashes from treated wood or
incinerator ash are not permitted, nor is ash from manure, which is on
the National List of prohibited nonsynthetics. The prohibition of
burning crop residues on the farm in the first proposal has been
retained, but an exception for burning trimmings of perennial crops to
control diseases has been added in response to an NOSB recommendation.
Commenters raised no objection to the proposed allowance for
mineral substances of low solubility, including lime, greensand
(glauconite), and rock phosphate, which have traditionally been
permitted in organic certification programs. However, numerous
producers and certifying agents expressed concern about the allowance
for use of mined mineral substances of high solubility or salinity.
These include substances such as sodium (Chilean) nitrate or potassium
nitrate (niter), potassium chloride (muriate of potash), langbeinite
(sulfate of potash magnesia), and potassium sulfate. Because of their
potential to degrade soil quality by contributing to soil salinization,
these substances, along with the synthetic micronutrients that are on
the National List of allowed synthetics, were allowed only when used in
cases of known nutrient deficiency. Many commenters objected to the use
of sodium nitrate and potassium nitrate in organic production, and some
contested the determination that nonsynthetic, mined sources of
potassium nitrate are available. Some also objected to allowing
potassium chloride, which has traditionally been prohibited in most
organic certification programs. Several commenters argued that no
highly soluble source of nitrogen, synthetic or not, should be
permitted for application to soil in an organic management system. They
indicated that these materials are not permitted in international
organic standards, and approval could potentially harm exports of
organic products. The NOSB reviewed Chilean nitrate in 1995 and
recommended certain restrictions on the use of this material, which is
allowed with restrictions in some existing organic certification
programs and prohibited in others. In accordance with the NOSB's
recommendation, this proposal permits these materials to be used
according to justifications in the organic system plan. More detailed
guidance will be provided in program manuals on the appropriate
justifications for the use of highly soluble nutrient sources,
including plans for discontinuing their use. Soil or tissue testing
will be an important aspect of justifying the need for any such
supplementation. Producers concerned about requirements for export
markets can request certification to the standards required by
individual contracts.
(5) Nonorganically Produced Planting Stock. The first proposal
allowed nonorganically produced planting stock used to produce a
perennial crop to be sold, labeled, or represented as organically
produced after the planting stock had been managed on an organic
operation for a period of no less than 1 crop year. This provision is
authorized by section 2107(a)(11) of the OFPA (7 U.S.C. 6506(a)(11)).
Some commenters thought this provision provided a loophole for
indiscriminate use of treated planting stock on an organic operation.
They argued that a producer could purchase treated nursery stock and
list it as organic planting stock in the organic plan after only 1
year. However, producer and industry groups supported this provision as
an important stimulus to the organic input suppliers, since it allows a
nursery operation to purchase planting stock from a nonorganic
operation and later resell this stock as organically produced. The
first proposal described an organic nursery operation which could
purchase nonorganic dwarf apple rootstock and graft it with locally
adapted varieties and then sell the resulting planting stock as
organically produced after raising it organically for at least 1 year.
We agree that the potential benefits of this provision outweigh its
possible abuses, and Sec. 205.204(d) of this proposal permits
nonorganically produced planting stock to be used as planting stock to
produce a perennial crop to be sold, labeled, or represented as
organically produced after the planting stock has been under a system
of organic management for no less than 1 crop year.
(6) Pest, Weed, and Disease Control Practice Standard. The OFPA
sets forth practices such as the use of natural poisons that persist in
the environment or plastic mulches that are prohibited or restricted in
the control of pests, weeds, and diseases in organic crops. It also
lists the following categories of active synthetic pest, weed, and
disease control substances that may be considered for exemption if they
are included on the National List: Copper and sulfur compounds; toxins
derived from bacteria; pheromones; soaps; horticultural oils; fish
emulsions; treated seed; vitamins and minerals; livestock parasiticides
and medications, and production aids, including netting, tree wraps and
seals, insect traps, sticky barriers, row covers, and equipment
cleansers. Section 205.206 of this proposal contains the practice
standard to implement the provisions of the OFPA for synthetic pest
control substances.
We have made a minor modification by eliminating one element of the
order of preference which commenters considered too difficult to
enforce. There is no distinction made in this proposal between pest
prevention and control practices in terms of preferability. However, a
provision in the first proposal that permitted application of a
botanical or allowed synthetic pest control substance only if
previously delineated methods were ineffective has been retained. This
provision is supported by public comments from producers, certifying
agents, and many consumers who emphasized that such substances, while
sometimes necessary, should only be permitted as a last resort. This
provision requires a producer to document the need for copper and
sulfur fungicides, dormant oils, or similar materials in their organic
system plan.
(7) Wild-crop Harvesting. We received few comments on the provision
in the first proposal concerning wild-crop harvesting, and, therefore,
this proposal retains similar requirements. Changing the term for the
location from which wild crops may be harvested from ``land'' to
``area'' is the only substantive difference between the first proposal
and this one. We made this change to be consistent with the language in
the OFPA. One commenter stated that maps should be required as part of
the certification process. A certifying agent could reasonably require
such maps to assist in evaluating the organic system plan, but we have
not made their inclusion a requirement.
The provisions of this section apply only to the management of wild
crops. The OFPA includes ``fish used for food, wild or domesticated
game, or other nonplant life'' in the definition of livestock, and we
are considering additional standards for animals and animal products
harvested from the wild. We received substantial public comment on the
opportunities for developing standards for marine and freshwater
aquatic animals (encompassing finfish and shellfish) and apiculture
operations. Additional comments addressed the feasibility of developing
production standards for harvesting wild terrestrial animals.
[[Page 13545]]
The certification of aquatic animals has very limited precedent
among existing certifying agents and will require additional dialogue
before credible standards can be developed. The FY 2000 Agriculture,
Rural Development, Food and Drug Administration, and Related Agencies
Appropriations Act provides funds for the NOP to convene national
meetings to consider the development of organic standards for aquatic
animals. Meetings will be held in Alaska, Alabama, and Rhode Island.
Simultaneously, the NOP will be working with stakeholders from the
aquaculture community to consider standards for the production of farm-
raised aquatic animals.
The certification of apiculture operations has some precedent among
certifying agents. However, due to many unique production
considerations, organic certification for apiculture operations has
been very limited. Public comment on the first proposal indicated that
consensus on critical apiculture issues including forage area and pest
management will require considerable additional dialogue. The NOSB has
expressed interest in leading the discussion of the key issues
pertinent to certification of apiculture operations. We will
incorporate public participation and the NOSB's recommendations into
future production standards for apiculture as well as for other wild
harvested livestock operations as needed.
(8) Practice Standards for Specialty Crop Operations. Several
organic certifying agents and producer associations commented that the
proposed rule did not sufficiently detail prescribed practices for many
specialized aspects of organic production and handling, such as
mushrooms, greenhouses, and aquaculture. We concur that such details
are lacking, and to a certain extent, this proposal addresses that gap
through the introduction of more detailed practice standards. In some
cases, more specific regulations appropriate for such specialized
operations, including aquaculture, mushroom production, and greenhouse
operations, will be filled in as recommendations are developed by the
NOSB. Beyond this, the Department expects to address the need for
greater specificity through program manuals, which will provide more
detailed guidance about site-specific decisions. For example, program
manuals could include examples of crop rotation plans suited to
different geographic regions, soil conditions, and types of
enterprises. Program manuals could also be used to provide guidance
about how indicators of the condition of the natural resource base can
be qualitatively assessed using simple field observations so that the
impact of site-specific practices on soil and water quality can be
documented in the organic plan.
Crop Production--Additional Provisions
Upon further review of the provisions in the first proposal, we
have decided to propose the following additions and changes.
(1) Mandatory Phytosanitary Treatment of Seeds, Seedlings, and
Planting Stock. Section 205.204(e) of this proposal contains a new
provision that permits the use of treated seeds, seedlings, or planting
stock in cases in which Federal or State phytosanitary regulations
require treatment. For example, some States require seed potatoes or
strawberry crowns to be treated to prevent the spread of plant
diseases. The OFPA authorizes reasonable exemptions from specific
requirements for compliance with Federal or State emergency pest or
disease treatment programs. This provision is also consistent with the
NOSB's recommendation on the use of treated planting stock.
(2) Restriction on the Use of a Synthetic Pest Control Substance.
The first proposal included a provision that any use of biological or
botanical pest control substances or synthetic pest control substances
approved for use on the National List had to be used in a manner that
did not result in measurable degradation of soil or water quality. This
provision has been removed, and Sec. 205.207(e) of this proposal
includes a new provision that further restricts use of these substances
by requiring the producer to implement measures to evaluate and
mitigate the effects of repetitive use of the same or similar materials
on pest resistance and shifts in pest types. This requirement can be
met by reviewing available research on pest resistance to the substance
being used and observing changes in pest populations following repeated
application of the substance. Public comments pointed out evidence that
nonsynthetic biological and botanical pest control substances, if
overused, pose concerns for inducing accelerated resistance in pest
populations.
Livestock Production--Changes Based on Comments
This subpart differs from our first proposal in several respects as
follows:
(1) Minimum Period of Organic Management--Nonedible Products. The
first proposal established a 90-day minimum period of organic
management for animals from which nonedible products, such as wool,
were to be harvested. Many consumers and producers said that a 90-day
period was too short and that an animal should be under organic
management for at least 1 year before a nonedible organic product could
be obtained from it. This requirement is consistent with the provision
that dairy animals receive a minimum of 1 year of continuous organic
management prior to the production of the milk or milk products to be
sold, labeled, or represented as organic. Therefore, this proposal has
been revised to state that an animal brought into an organic operation
must be under continuous organic management for 1 year prior to the
harvest of nonedible products that are sold, labeled, or represented as
organic.
(2) Origin of Mammalian Slaughter Stock. The first proposal allowed
mammalian livestock from a nonorganic source for the production of
organic meat if the livestock was brought into an organic operation no
later than the 15th day of life, if necessary. Public comment was
sought as to the specific conditions, such as commercial unavailability
of organic livestock or an emergency situation, that should be a
prerequisite for allowing mammalian livestock of nonorganic origin to
be designated as organic slaughter stock. Thousands of commenters,
along with the NOSB, strongly opposed allowing the use of cows, sheep,
or other mammals as organic slaughter stock if they were not organic
from birth. Most of them also rejected allowing such practices on an
``if necessary'' basis. Accordingly, Sec. 205.236 requires that
mammalian slaughter stock be organically raised from birth.
(3) Standard for Aquatic Animal Production. While the first
proposal contained no standards solely for aquatic animals in an
organic operation, it did contain provisions applicable to their
production. The first proposal allowed fish and crustaceans, among
other livestock types, to be sold, labeled, or represented as organic
if such livestock had been brought into an organic operation no later
than the earliest commercially available stage of life. Several
commenters suggested that the management of aquatic species differs
significantly from mammals and poultry and would require separate
regulatory provisions. We concur and intend to develop detailed
practice standards for specific aquatic species that will be published
for comment and finalized prior to the implementation of the NOP. Given
the virtual absence of recognized certification programs for
[[Page 13546]]
aquatic operations, including aquaculture, there are limited models on
which to base national standards. Therefore, we must create
opportunities for producers, consumers, certifying agents, and other
interested parties to participate in the development of practice
standards. We will hold public meetings in Alaska, Alabama, and Rhode
Island to receive comment and anticipate that the NOSB will also
provide recommendations.
(4) Apiculture Standard. The first proposal allowed bees to be
brought into an organic operation at any stage of life and required
that the predominant portion of their forage be organically produced.
Several commenters, including producer and industry groups, pointed out
that bees differ significantly from other livestock types and that the
first proposal lacked sufficient details to guide honey producers. Many
consumers stated that the provisions proposed for bee forage, which
required only that a predominant portion of the bees' forage be
organic, were too vague and lenient. Recognizing that the provisions in
the first proposal for certifying beekeeping operations were
inadequate, we removed them entirely from this proposal. We will review
the detailed production and handling standards for beekeeping
operations that several certifying agents have developed and assess the
feasibility of developing a practice standard. The NOSB has agreed to
review and recommend an apiculture practice standard for organic honey
production and hive care, including the origin of organic bees.
(5) Organic Feed Requirement. The first proposal allowed a producer
to feed livestock up to 20 percent of the total feed ration in a given
year that was not organically produced. Furthermore, in an emergency
situation, the first proposal allowed the Administrator to increase the
amount of nonorganic feed that could be provided. Thousands of comments
were received opposing any allowance for nonorganic livestock feed, and
many thought that no conditions justified providing any nonorganic feed
to organic animals. Most producer groups, organic certifying agents,
and industry groups, however, recognized that eliminating all
flexibility in this regard could seriously inhibit growth of the
organic livestock industry and reduce the availability organic
livestock products. Several existing certification programs allow some
use of nonorganic feed in emergencies, in one case specifying that up
to 10 percent of the livestock ration may be nonorganic. Commenters
made it clear that the commercial availability of certified organic
livestock feed has increased enough to eliminate exemptions based on
availability, even in regions such as the Northeast where supplies were
previously difficult to obtain. The NOSB also recommended providing an
allowance for livestock to receive nonorganic feed in emergency
situations, with strict requirements for documentation in the organic
system plan.
Based on the public comment received and the recommendations of the
NOSB, we agree that allowances for providing nonorganic feed to
organically managed livestock should be limited to emergencies, such as
fire, drought, flood, and other natural disasters. Accordingly, we have
removed the provision from the first proposal that a producer may
provide up to 20 percent nonorganically raised feed ``as necessary.''
Exemptions for emergency use of nonorganic feed must be authorized by
the Administrator through the procedures for establishing a temporary
variance. Producers will work with their certifying agents to determine
the minimum percentage of nonorganic feed needed to supply the
nutritional requirements of the livestock until the 100 percent organic
ration can be restored.
(6) New Dairy Herd exemption. The first proposal included an
exemption to allow an entire, distinct dairy herd--converted to organic
management for the first time--to be fed nonorganic feed up to 90 days
prior to the production of milk or milk products labeled as organic. A
few producer groups supported this allowance for a one-time, whole-herd
exemption to make it feasible for existing conventional dairy farmers
to convert to organic management without incurring the costs of 100
percent organic feed for 12 months prior to certification. However, in
light of the strong opposition to any nonorganic feed allowance by
consumers and its inconsistency with NOSB recommendations, we have
eliminated this provision.
(7) Synthetic Feed Additives. The first proposal prohibited the
feeding of substances containing synthetic amino acid additives and
synthetic trace elements to stimulate the growth or production of
livestock. In Sec. 205.237(c)(2), the term, ``synthetic amino acids,''
is replaced with the term, ``additives,'' which includes nutritional
substances other than amino acids. Some commenters stated that the
term, ``additives,'' more precisely reflects the intent of the OFPA,
which prohibits the use of growth stimulants. The provision in the
first proposal to permit use of synthetic amino acid additives to
fulfill the normal nutritional needs of livestock is retained in
Sec. 205.237(a).
(8) Prohibition on Antibiotics. The OFPA prohibits producers from
using subtherapeutic doses of antibiotics. While this suggests that
treatment with antibiotics at therapeutic levels is allowed, the OFPA
does not contain affirmative conditions for their use. In developing
provisions in the first proposal for treating livestock with
antibiotics, we reviewed the NOSB recommendations, public input
received at NOSB meetings, testimony presented at livestock hearings,
and existing State and private standards. We found that innovative
production practices and consumer expectations had increasingly
diminished the use of antibiotics in organic livestock since passage of
the OFPA. At its 1994 meeting in Santa Fe, NM, the NOSB recommended
prohibiting the use of antibiotics in the production of organic
slaughter stock but allowing their use with extended withdrawal
intervals for dairy and breeder stock. By its Ontario, CA, meeting in
1998, the NOSB recommended prohibiting all antibiotic use after animals
were brought into an organic operation. Other comments we reviewed
favored allowing the use of antibiotics because organic livestock might
benefit from receiving such treatments. Other commenters requested that
organic producers be prohibited from withholding treatment from sick
animals for economic reasons.
The first proposal permitted mammals raised as organic slaughter
stock to receive antibiotics in the first 21 days of life and other
species to be given antibiotics in the first 7 days of life. The
rationale for allowing antibiotic use was based on concerns about the
vulnerability of newly born or hatched livestock brought into an
organic operation from a nonorganic source. The first proposal
permitted organic slaughter stock to originate from nonorganic sources
if it was brought under organic management at an early stage of life.
Allowing the use of animal drugs could be an appropriate safety net for
young organic livestock during their first week of organic management.
We requested public comment on the use of animal drugs in the
production of organic livestock, including organic slaughter stock. We
also published an issue paper in October 1998 entitled ``The Use of
Antibiotics and Parasiticides in Organic Livestock Production,''
requesting additional public comment on this subject.
We received thousands of comments from consumers, producers, and
industry groups objecting to any allowance for antibiotic use in
[[Page 13547]]
organically produced livestock. Many of these comments supported a
comprehensive prohibition on the use of antibiotics, regardless of the
animal's age or the type of products produced from it. Based on these
public comments and the availability of alternative production
practices, this proposal prohibits selling, labeling, or representing
as organic any animal that has been treated with an antibiotic at any
dosage.
(9) Parasiticide Use. The first proposal permitted livestock in an
organic operation to receive parasiticides topically at any time of
life, provided that the producer complied with the prohibition against
routine use of a synthetic internal parasiticide. We concluded that,
while some earlier public comment favored prohibiting the use of
internal parasiticides and the NOSB recommended restricting their use,
many producers had indicated that parasiticides were essential to their
operations. These producers stated that parasites can threaten animal
health at any stage of life and that the use of parasiticides is
unavoidable in certain regions of the country. Even under highly
controlled situations, some parasites endemic to certain regions can be
carried by wild birds, water, or feed. Concerns for the overall health
of an animal warranted that parasiticides be used as soon as possible
after determining the presence of parasites at a level affecting the
health of the infected livestock.
In responding to the first proposal, a large number of commenters
stated that synthetic parasiticides should be prohibited in organic
production, especially for slaughter stock. The NOSB also recommended
prohibiting the use of parasiticides in slaughter animals. For other
livestock, the Board recommended that, in certain climates, in certain
stages of production, and for certain animals, the use of synthetic
parasiticides might be necessary. The Board stated that breeding stock,
for example, could receive parasiticides up to certain stages of
gestation specific to the type of livestock. Such use of synthetic
parasiticides would be highly restricted and include a lengthy period
of elapsed time before the animal's offspring would be eligible for use
in a certified operation. The Board proposed developing practice
standards to address specific instances in which parasiticides could be
allowed.
This proposal allows the use of synthetic parasiticides included on
the National List for use in organic production on breeder and dairy
stock provided that preventative practices and veterinary biologics are
inadequate to prevent infestation. This proposal prohibits
administering synthetic parasiticides to livestock sold for slaughter.
These provisions reflect an attempt to balance the conflicting
positions taken by consumers and producers in response to the first
proposal and the subsequent issue paper on livestock medications. We
recognize that the goal of organic production is to use management
practices and natural substances to eliminate, when possible, reliance
on synthetic materials. However, we do not believe that a comprehensive
prohibition on synthetic parasiticides is feasible for all species and
for all regions of the country at this time. Additionally, the new
requirements for access to the outdoors for organically managed
livestock contained in this proposal may exacerbate exposure to
parasites for animals in systems which previously used greater degrees
of confinement. These provisions are also consistent with the position
of the NOSB, which recommended at its October 1999 meeting to allow a
synthetic parasiticide for use on organically raised breeder and dairy
stock with the same restrictions incorporated in this proposal.
The OFPA prohibits the use of synthetic internal parasiticides on a
routine basis. In the first proposal, the word, ``routine,'' was
defined as administering an animal drug ``without cause.'' Many
commenters objected to that definition, pointing out that producers
would not administer a parasiticide unless they perceived a justifiable
cause. Commenters fear that this might lead to dependence on
parasiticides rather than a management system to reduce the number of
parasites. Therefore, this proposal adopts the NOSB-recommended
definition for ``routine'' as use of a synthetic parasiticide on a
regular, planned, or periodic basis. The prohibition on using synthetic
treatments on a routine basis is retained in Sec. 205.238(c)(4).
(10) Temporary Confinement. The first proposal provided that, if
necessary, animals could be maintained under conditions that restrict
the available space for movement or access to outdoors if other living
conditions were adequate to maintain the animals' health without the
use of permitted animal drugs. This provision considered the effects of
climate, geographical location, and physical surroundings on the
ability of animals to have access to the outdoors. We explained that a
system of organic production is soil based and that animals should be
allowed, as appropriate, access to the soil. This understanding was
considered in balance with animal health issues, such as the need to
keep animals indoors during extended periods of inclement weather. The
determination of necessity was to be based on site-specific conditions
described by the producer in an organic system plan or updates to an
organic plan, which required approval from the certifying agent. We
requested public comment as to the conditions under which animals may
be maintained to restrict the available space for movement or access to
the outdoors. We also released an issue paper in October 1998 entitled
``Livestock Confinement in Organic Production Systems'' to solicit
further public participation in preparing this proposal.
Many commenters stated that, while confinement is appropriate under
certain conditions, access to the outdoors is a fundamental tenet of
organic livestock production. Commenters cited the widespread
prohibition on confinement systems, such as raising poultry in battery
cages, contained in domestic and international standards. Producers of
organic livestock have incorporated access to the outdoors into viable
production systems for all major commercial species, and consumers
clearly identify these practices as a distinguishing characteristic of
organic products. Some commenters stated that production standards
containing broad allowances for confinement would weaken their
incentive for purchasing organic products. Some producers pointed out
that providing animals access to the outdoors can reduce stress and
diminish the risk of transmitting disease. The vast majority of
commenters strongly indicated that protection of an animal's welfare or
the soil and water resources of the operation were the only appropriate
conditions for restricting access to the outdoors. Furthermore, many
commenters stated that the condition and properties of the outdoor area
to which an animal receives access, such as the nutritional content of
pasture, must be important considerations in developing livestock
production standards.
Section 205.239(b) of this proposal specifies the circumstances
under which animals may be temporarily confined. This new requirement
proposes temporary confinement during periods of inclement weather;
certain stages of production such as when dairy animals are very young;
when the animal's health, safety, or well-being are jeopardized; or
when there is risk to soil and water quality. The NOSB specified that
the stage of an animal's production
[[Page 13548]]
is not intended to include the lactation cycle of dairy animals in
which only dry cows would be allowed access to the outside and pasture.
The NOSB recommended and we propose that when there is a risk to soil
or water quality, livestock should be temporarily confined. Practice
standards addressing when and how individual species may be temporarily
confined will be developed and published in program manuals. We are
also incorporating the NOSB recommendation that ruminants receive
access to pasture during the periods they are not temporarily confined.
(11) Physical Alterations. This proposal contains a requirement in
Sec. 205.238(a)(5) that the producer of an organic livestock operation
must perform, as needed, physical alterations on livestock to promote
the animal's welfare and in a manner that minimizes pain and stress.
Physical alterations include castration and other practices, such as
wing clipping, intended to modify or affect the animal's behavior in
confinement. We received comments on the first proposal which stated
that the performance of physical alterations is integral to a system of
organic livestock production which must be addressed in the standards.
Subsequently, some commenters on the confinement issue paper drew a
connection between certain physical alterations, such as debeaking in
poultry, and the conditions for space and mobility under which
livestock are raised We anticipate that this subject will be a
significant consideration when the NOP engages in equivalency
discussions under the Codex Alimentarius guidelines.
While many certification programs have production standards for
conducting physical alterations on animals, we cannot identify general
consensus on which practices should be approved or prohibited. Many
production variables, including breed, the number and concentration of
animals raised, and the available natural resource base, influence the
selection of production practices. Operations which raise the same
species of livestock could, due to differences in production practices,
require different approaches to whether and how to conduct physical
alterations. We do not have sufficient information at this time to
propose species-specific guidelines but anticipate working with
producers, consumers, and certifying agents to develop a better
understanding on which to act. By including the requirement for
conducting physical alterations in a manner which promotes an animal's
welfare and minimizes pain and stress in this proposal, we are
acknowledging two points. One, physical alterations have an appropriate
and at times necessary role in livestock production, and, two,
consideration for animal welfare and comfort is an integral component
of organic livestock production.
In order to use an animal's welfare and comfort as a condition for
establishing standards, we are requesting comment on techniques to
measure animal stress. Certifying agents will need objective,
verifiable methods to determine whether a producer is fulfilling the
livestock management conditions established in the organic system plan.
Such methods may include physiological or behavioral approaches to
measuring stress and may be directed at individual animals or larger
groups such as herds or flocks. The many comments addressing the well-
being of animals under organic management indicate that this issue is
central to the differentiation of organic production standards from
nonorganic practices. We need consistent, verifiable enforcement
techniques to ensure that organic producers are capable of attaining
and documenting such standards.
(12) Treatment of Sick or Injured Animals. In this proposal, any
animal that is to be sold, labeled, or represented as organic may not
be treated with a prohibited animal drug, including antibiotics,
synthetic substances that are not allowed, or nonsynthetic substances
that are prohibited. Any substance used as an animal drug in organic
livestock production must be approved by FDA or registered by EPA and
must be administered in compliance with the Federal Food, Drug, and
Cosmetic Act. This proposal simultaneously requires that sick or
injured animals must be treated with the appropriate animal medicine
regardless of whether organic status is lost as a result of doing so.
This requirement has been added in response to an NOSB recommendation.
Thousands of comments expressed concern that organic livestock would
suffer unduly if producers were not required to provide treatment,
especially to save the life of a critically ill animal, rather than
risk the suffering or death of the animal simply to maintain its
organic status. If the treatment required under this proposal includes
the use of a prohibited substance, the animal and any product derived
from it must be diverted to the nonorganic market.
(13) Feeding of Animal By-Products. Although we received thousands
of comments supporting a ban on the feeding of any animal by-products
to livestock under organic management, a broad prohibition would
prevent certain essential practices, such as feeding milk to young
mammals. This prohibition is also inappropriate in the case of
carnivorous livestock, such as many aquatic species. We believe that
the comments we received were not intended to prohibit such practices
but were, rather, motivated by concerns for food safety and the humane
treatment of animals. This proposal prohibits the feeding of poultry
and mammalian slaughter by-products to organically raised poultry or
mammals. This change is based on the thousands of comments that
expressed strong consumer preference against adding animal by-products
into feed for the same species. There was concern that this practice
could expose ruminant animals to Bovine Spongiform Encephalopathy
(BSE). FDA regulates animal feed additives and uses its authority to
address the human health considerations of animal refeeding. FDA
continually revises its regulations to ensure the highest level of
protection against known and emerging human health risks. The
prohibition on feeding poultry and mammalian slaughter by-products to
organically raised poultry or mammals contained in this proposal is
based solely on the consumer preference expressed in public comment and
is not a food safety standard. Future changes that are made to FDA
regulations will be reflected in NOP standards.
(14) Withdrawal Intervals. The first proposal required that a
producer determine that an animal was fully recovered from the
condition for which an animal drug was administered before a product
obtained from that animal could be sold, labeled, or represented as
organic. In compliance with FDA regulations, this could not have been
less than the withdrawal time specified on the label of the animal drug
administered. We received comments from producer groups that favored
extending the withdrawal times specified on animal drug labels. Many
private certification programs applied the principle of extended
withdrawal periods to the use of antibiotics in dairy and breeder stock
before innovations in production led to such substances being
prohibited. The NOSB has continued to include extended withdrawal
period annotations with its recommendations for the use of
parasiticides.
Based on consumer preference and the recommendations of the NOSB,
we are proposing an extended withdrawal interval for three animal drugs
(Ivermectin, Lidocaine, and Procaine) included on the National List in
this proposal. FDA exercises full responsibility for determining and
[[Page 13549]]
enforcing the withdrawal intervals for animal drugs. No food safety
arguments are used or implied to support the use of extended withdrawal
periods. Rather, we determined that extended withdrawal periods are
more compatible with consumer expectations of organically raised
animals. In emergency situations where the need for a synthetic
parasiticide or medicine is unavoidable, an extended withdrawal period
would indicate that such use was neither routine nor normal. This
approach is consistent with the manner in which organic certification
agencies addressed antibiotic use in livestock production. Before the
current prohibition on antibiotics became the industry norm, certifying
agents allowed their use under restricted conditions, including
extended withdrawal intervals, to demonstrate to consumers that such
use was genuinely essential.
Livestock Production--Changes Requested But Not Made
This subpart retains from our first proposal regulations on which
we received comments as follows:
(1) Feed Requirements. The first proposal required the use of
preventive health care practices, including diverse feedstuffs,
appropriate housing, well maintained pasture, and good sanitation
practices, and this proposal contains similar provisions. It also
included provisions for administering appropriate veterinary biologics,
vitamins, and minerals, and on selecting species and types of livestock
with regard to suitability for site-specific conditions and resistance
to prevalent diseases and parasites. Preventive health care practices
were generally supported by comments as being consistent with a system
of organic livestock production.
Many commenters requested an explanation of the term, ``diverse
feedstuffs,'' and some expressed concern that this provision could
permit use of feed supplements which might be prohibited by other
Federal, State, or local laws. All provisions proposed in this subpart
must be in compliance with applicable laws and regulations, including
the Federal Food, Drug, and Cosmetic Act; the OFPA; and our definition
of a system of organic production and handling. Vitamins, minerals, and
other synthetic or nonagricultural supplements, which appear on the
National List of allowed synthetic livestock products in the first
proposal are similarly permitted here, and provide a means to diversify
an animal's diet. Soybean meal and other organically produced feed
concentrates also serve this purpose. We encourage the NOSB to develop
and recommend practice standards to provide additional guidance
regarding the appropriate variety of feed for specific livestock
species. Both the first proposal and this one defer to publications of
the National Research Council's Committee on Animal Nutrition to
establish nutrient requirements for livestock. Producers and certifying
agents will use these publications to ensure that animal nutrient
requirements are met.
Handling--Changes Based on Comments
This subpart differs from our first proposal in several respects as
follows:
(1) Irradiation. In the first proposal, we requested public comment
on the compatibility of ionizing radiation (irradiation) with a system
of organic production and handling. We also asked if there are
effective alternatives to ionizing radiation, such as sanitary
practices, heat pasteurization, and incidental additives, that are
compatible with a system of organic production and handling, and, if
so, how they are compatible. We further asked whether the use of
ionizing radiation was considered an essential standard industry
practice or good manufacturing practice. Although the NOSB recommended
prohibiting the use of ionizing radiation for organic products, we
requested this information because of increasing concern about
foodborne illness and growing interest in FDA-approved ionizing
radiation as a sanitation or preservation treatment for a wide range of
agricultural products.
We received hundreds of thousands of comments from every segment of
the organic community--producers, processors, certifying agents,
consumers, environmental groups, and retailers--opposing the use of
ionizing radiation. These comments indicated that ionizing radiation
has been expressly prohibited in all existing organic certification
standards, international as well as domestic. Allowing this practice
could put domestic producers and handlers at a trade disadvantage,
disrupt international markets, and undermine consumer faith in the
integrity of the domestic organic label.
Comments suggested alternatives to ionizing radiation for
preventing contamination by human pathogens. Alternatives include heat
disinfection, refrigeration, moisture and oxygen reduction, packaging,
hygienic handling, and appropriate use of disinfectant substances.
Although no one suggested that any products might be unavailable if
irradiation were prohibited, many commenters expressed the willingness
to do without any product that required irradiation. In response to the
overwhelming consensus of public comment, this proposal prohibits any
use of ionizing radiation for the handling of any organic product in
Sec. 205.270(c).
(2) Incidental Additives. The first proposal included a provision
that permitted the use of incidental additives in processing, except
those extracted with a volatile synthetic solvent, if it was necessary
for the production of the product. As with previous provisions for
practices that could be used only ``if necessary,'' the preamble to the
first proposal explained that a determination of necessity was based on
site-specific conditions that were described by a producer or handler
in an organic system plan or updates to an organic system plan and
reviewed by the certifying agent. We requested comments as to the
conditions under which an incidental additive might be considered
necessary and requested comment as to whether handlers who handle only
products sold, labeled, or represented as ``made with certain organic
ingredients'' should be exempted from the restriction of using
incidental additives only if necessary. An incidental additive was
defined as an additive that is present in an agricultural product at an
insignificant level, does not have any technical or functional effect
in the product, and is not considered an active ingredient. This
definition is consistent with 21 CFR 101.100(a)(3)(ii) and is the basis
for the definition of an incidental additive in this proposal.
Although thousands of consumers objected to the use of synthetic
substances in processed organic products, many others specified that an
incidental additive that had been reviewed and approved by the NOSB
would be acceptable. Few respondents supported exempting products
labeled as ``made with organic ingredients'' from restrictions on the
use of incidental additives. The NOSB recommended that documentation be
required for use of synthetic incidental additives and that handlers
demonstrate progress over time in finding replacements. Organic
industry groups also commented that hundreds of incidental additives
are currently being used to process organic products and that
prohibiting the use of such substances would severely restrict the
choices available to consumers and limit the growth of the organic
sector. The NOSB recommended several synthetic incidental additives for
the National List, recognizing that a wide range of organic products
could not be feasiblely manufactured without the use
[[Page 13550]]
of incidental additives such as defoaming agents, adjuvants,
clarifiers, filtering agents, and equipment cleansers. Therefore, this
proposal requires that any incidental additive used to process
agricultural products that are intended to be sold, labeled, or
represented as ``organic'' or ``made with organic (specified
ingredients)'' must be included on the National List of allowed
nonagricultural (nonorganic) substances in Sec. 205.605. A product
labeled as ``100 percent organic'' could not be produced through the
use of any synthetic processing aid.
(3) Prevention and Control of Facility Pests. The first proposal
addressed the prevention and control of facility pests and authorized
the NOP to require such terms and conditions as are determined
necessary. These provisions were based on existing organic
certification programs and NOSB recommendations. The first proposal
included a three-step order of preference, which commenters found to be
overly complex and difficult to enforce. This proposal retains similar
provisions but simplifies the scheme so that there are only two levels
of distinction between preferable and less preferable practices. In
this proposal, pest prevention and control methods that do not entail
use of biological, botanical, or synthetic substances are equally
acceptable, and the producer or handler may only use biological,
botanical, or synthetic substances if other approved methods are not
effective. Paragraph (c) of Sec. 205.271 parallels the provision
proposed in Sec. 205.206(d) addressing crop pest, weed, and disease
management. Accordingly, it requires an operator of an organic handling
operation who applies any biological, botanical, or synthetic substance
for the prevention or control of pests to implement measures to
evaluate the effects of repetitive use of the same or similar materials
on pest resistance and shifts in pest types.
(4) Storage Containers. Sections 205.272 (b)(1) and (b)(2) of this
proposal contain provisions similar to the first proposal which
prohibit the use of storage containers or bins, including packages and
packaging materials, that contain synthetic fungicides, preservatives,
or fumigants. These requirements also prohibit the use or reuse of any
bag or container that was previously in contact with any substance that
could compromise the organic integrity of its contents. This proposal
adds a provision to permit the reuse of a bag or container originally
used for conventional products if the reusable bin or container has
been thoroughly cleaned and poses no risk of prohibited materials
contacting organic products. Producers and handlers commented that it
is possible and desirable to reuse some kinds of containers if
precautions are taken. This modification is consistent with the OFPA,
which requires that the organic quality of a product not be
compromised.
(5) Agricultural Fibers. Some commenters stated that the labeling
provisions in the first proposal for processed commodities containing
organically produced cotton fibers were excessively restrictive. The
OFPA provides the Secretary with the authority to implement standards
for organically produced agricultural fibers, including cotton, used
for nonfood purposes. This authority includes standards for the
production of the agricultural fiber as well as handling standards to
regulate the practices and materials that are used in the manufacture
of the nonfood commodity. State and private certification agents have
made substantial progress in developing and implementing handling
standards for organically produced agricultural fibers that are gaining
acceptance in the marketplace. We are reviewing the existing
certification guidelines and industry practices and anticipate
developing standards for processing organically produced agricultural
fibers.
Handling--Changes Requested But Not Made
This subpart retains from our first proposal regulations on which
we received comments as follows:
(1) Facility Pest Control Substances. The first proposal permitted
the use of any substance to control facility pests, as long as the
intended use was approved by the appropriate regulatory authority and
the substance was applied in a manner that prevents it from coming into
contact with any organic product. Many consumers objected to this
provision and suggested that prohibited substances should never be
allowed to be used in any organic operation. However, comments from a
number of organic handlers and one industry association stated that,
because handling operations must comply with health regulations that
require elimination of any pests that may invade food handling
facilities, prohibited substances must sometimes be used. The NOSB also
acknowledged this possibility in its recommendations, and most organic
certification programs similarly allow for such an occurrence, with
strict provisions for safeguarding the integrity of organic products.
In agreement with these comments, we have proposed a similar allowance
in Sec. 205.271(c). The handler must fully document in his or her
organic plan the evidence that such a measure was necessary and the
measures taken to protect organic products or ingredients from coming
into contact with any pest control substance.
(2) Waxes. We propose to retain the definition of packaging
included in the first proposal, which encompasses waxes used in contact
with an edible surface of an agricultural product. A number of
commenters disagreed with the inclusion of waxes in the definition of
packaging, arguing that waxes should be considered nonagricultural
ingredients and, therefore, should be required to appear on the
National List of nonagricultural (nonorganic) substances allowed as
ingredients in or on processed products labeled as ``organic'' or
``made with organic (specified ingredients).'' However, the first
proposal did require carnauba and other waxes to be on the National
List of nonagricultural ingredients allowed for use in organic
processed products, and this proposal contains a similar provision.
These provisions adequately address the concerns expressed by the
commenters that only waxes meeting the criteria for ingredients in
organic processed products be permitted. It is appropriate to include
waxes in the definition of packaging to ensure that prohibited
substances are not added to approved waxes that may be applied to the
edible surface of organic products, in accordance with the OFPA, which
prohibits use of any packaging materials that contain synthetic
fungicides, preservatives, or fumigants.
Subpart D--Labels, Labeling, and Market Information
The Act provides that a person may sell or label an agricultural
product as organically produced only if the product has been produced
and handled in accordance with provisions of the Act and these
regulations. This subpart sets forth labeling requirements for organic
agricultural products and products with organic ingredients based on
their percentage of organic composition. For each labeling category,
this subpart establishes what ``organic'' terms and references can and
cannot be displayed on a product package's principal display panel,
information panel, ingredient statement, and on other package panels.
Labeling is proposed for containers used in shipping and storing
organic product and for denoting organic bulk products in market
information which is displayed or disseminated at the point of retail
sale. Restrictions on labeling organic product produced by exempt
operations are described. Finally, this
[[Page 13551]]
subpart proposes a new USDA organic seal or shield (hereafter referred
to as the USDA Seal) and regulations for display of the USDA seal and
display of the seals, logos, or other identifying marks of certifying
agents.
The intent of these sections is to ensure that organically produced
agricultural products are consistently labeled to aid consumers in
selection of organic products and to prevent labeling abuses. These
provisions cover the labeling of a product as ``organic'' and are not
intended to supersede other labeling requirements specified in various
Federal labeling regulations. For instance, we propose that the percent
of organic ingredients and the name of the certifying agent be
displayed on the information panel of packaged products and that the
organic ingredients be identified as ``organic'' in the ingredient
statement. The Food and Drug Administration (FDA) has authority to
regulate the placement of information on package information panels
and, thus, FDA labeling requirements in 21 CFR parts 100 through 169
must be complied with by handler when affixing organic labels to
product packages. Display of the USDA Seal and certifying agent seals,
logos, or other identifying marks also must be in accordance with those
regulations. The requirements of FDA's Fair Packaging and Labeling Act
(FLPA) and the Federal Food, Drug, and Cosmetic Act (FFDCA) must be
followed. Likewise, the Federal Trade Commission has authority over
product advertising and the extent to which a handler or retail food
establishment engages in advertising as part of its market information
activities. The Federal Trade Commission (FTC) regulations in 16 CFR
must be followed. USDA's Food Safety and Inspection Service's (FSIS)
Federal Meat Inspection Act, Poultry Products Inspection Act, and Egg
Products Inspection Act also have implementing regulations in 9 CFR
which must be followed. The labeling requirements specified in this
subpart must not be applied in a manner so that they would conflict
with the labeling requirements of these and other Federal and State
programs.
While this regulation does not require labeling of an organic
product as organic, we assume that producers and handlers will choose
to label their organic products and display the USDA Seal to the extent
allowed in these regulations. They will do this to improve the
marketability of their organic product.
In this proposal, assembly, packaging, and labeling of a
multiingredient organic product are considered handling activities. The
certification of handling operations is covered in subpart C of this
regulation. No claims, statements, or marks using the term,
``organic,'' or display of certification seals, other than as provided
in this regulation, may be used. A handler which chooses not to use
these required and prohibited labeling provisions may not otherwise
label or represent a product as organic.
Once a handler makes a decision to market a product as organic or
containing organic ingredients, the handler is required to follow the
provisions in this subpart regarding use, display, and location of
organic claims and certification seals. Handlers who may produce
organic ingredients and/or assemble multiingredient products composed
of more than 50 percent organic ingredients must be certified as an
organic handling operation. Handlers of products of less-than-50-
percent organic ingredients do not have to be certified unless the
handler actually produces one or more of the ingredients used in the
less-than-50-percent product. Repackers who purchase certified organic
product from other entities for repackaging and labeling must be
certified as an organic operation. Entities which simply relabel a
product package would be subject to recordkeeping requirements to show
proof that the product purchased prior to relabeling was, indeed,
organically produced. Distributors which receive and transport labeled
product to market are not subject to certification or any handling
requirements of this regulation.
Proposal Description
The general labeling principle employed in this proposal, and to
which we think most commenters would subscribe, is that labeling or
identification of the organic nature of a product should increase as
the organic content of the product increases. In other words, the
higher the organic content of a product, the more prominently its
organic nature can be displayed. This is consistent with provisions of
the Act which establishes the three percentage categories for organic
content and basic labeling requirements in two of those categories.
Section 205.300 specifies the general use of the term, ``organic,''
on product labels. Paragraph (a) establishes that the term,
``organic,'' may be used only on labels and in market information of
agricultural products and ingredients that have been certified as
produced and handled in accordance with these regulations. The term,
``organic,'' cannot be used on a product label for any purpose other
than to modify or identify the product or ingredient in the product
that is organically produced and handled. Products not organically
produced and handled will not be able to use the term, ``organic,'' on
any package panel or in market information in any way that implies the
product is organically produced.
Categories of Organic Content. The type of labeling and market
information that can be used and its placement on different panels of
consumer packages will be based on the percentage of organic
ingredients in the product. The percentage will reflect the actual
weight or fluid volume (excluding water and salt) of the organic
ingredients in the product. Four categories of organic content are
proposed: 100 percent organic; 95 percent or more organic content; 50
to 95 percent organic content; and less than 50 percent organic
content.
100 Percent Organic
For labeling and market information purposes, this proposal allows
a ``100 percent organic'' label for an agricultural product that is
composed of a single ingredient such as raw, organically produced
fruits and vegetables. The product also may be composed of two or more
organically produced ingredients, provided that the individual
ingredients are organically produced and handled consistent with
provisions in subpart C of this regulation. No processing aids may be
used in the production of 100 percent organic products. This proposal
provides that labeling provisions for ``100 percent organic'' products
be the same as provisions for the 95 percent ``organic'' products
specified below.
Organic
Products labeled or represented as ``organic'' will contain, by
weight (excluding water and salt), at least 95 percent organically
produced raw or processed agricultural product. The organic ingredients
must be produced using production and handling practices pursuant to
subpart C of this regulation. The nonorganic (5 percent or less)
ingredients may be composed of nonorganic or nonagricultural
substances. The difference between 100 percent organic products and 95
percent-plus products is that the latter may contain up to 5 percent
nonorganic or nonagricultural products.
Multiingredient Product: 50-95 Percent Organic Ingredients
For labeling and market information purposes, the third category of
agricultural products are multiingredient products containing by weight
or fluid volume (excluding water
[[Page 13552]]
and salt) between 50 and 95 percent organic agricultural ingredients
produced pursuant to these regulations. Such products may be labeled or
represented as ``made with organic (specified ingredients).'' By
``specified,'' we mean the name of the agricultural product forming the
organic ingredient. The organic ingredients must be produced using
substances on the approved National List in subpart G and employing
organic production and handling practices consistent with subpart C of
this regulation. For instance, breakfast cereal made with 75 percent
organically produced and processed wheat and 25 percent other,
nonorganically produced grains, raisins, and nuts can be labeled as
``made with organic wheat'' on the principal display panel. To qualify
for this organic labeling, the nonorganic ingredients (grains, raisins,
and nuts) must be produced and handled without use of the first three
prohibited practices specified in paragraph (e) (excluded methods,
sewage sludge, or ionizing radiation). However, those nonorganic
ingredients may be produced or handled using practices prohibited in
paragraphs (e)(4) through (e)(7) (using substances not on the National
List; containing added sulfites, nitrates, or nitrites; using
nonorganic ingredients when organic ingredients are available; and
using organic and nonorganic forms of the same ingredient).
Multiingredient Product: Less Than 50 Percent Organic Ingredients
The final labeling category covers multiingredient products with
less than 50 percent organic ingredients (by weight or fluid volume,
excluding water and salt). The organic ingredients must be produced
using substances on the approved National List in subpart G and
employing organic production and handling practices consistent with
subpart C of this part. The remaining nonorganic ingredients (50
percent or more of the product) may be produced, handled, and assembled
without regard to these regulations (using prohibited substances and
prohibited production and handling practices). Organic labeling of
these products is limited to the information panel only as provided in
Sec. 205.305.
Prohibited Practices. This proposal prohibits labeling of whole
products or ingredients as ``organic'' if those products or ingredients
are produced using any of the following production or handling
practices: (1) Ingredients or processing aids containing or created
using excluded methods (genetically modified organisms (GMO)) or the
products of excluded methods; (2) ingredients that have been produced
using applications of sewage sludge (biosolids) as fertilizer; (3)
ingredients that have been processed with ionizing radiation; (4)
processing aids not approved on the National List; (5) sulfites,
nitrates, or nitrites added to or used in processing of an organic
product in addition to those substances occurring naturally in a
commodity; (6) use of the phrase, ``organic when available,'' or
similar statement on labels or in market information when referring to
products composed of nonorganic ingredients used in place of specified
organic ingredients; and (7) labeling as ``organic'' any product
containing both organic and nonorganic forms of an ingredient specified
as ``organic'' on the label. The prohibitions on the use of excluded
methods, sewage sludge, irradiated products, and prohibited processing
aids are included here to be consistent with the revised National List
of Approved and Prohibited Substances in subpart G.
These seven prohibitions apply to the four labeling categories of
products and are not individually repeated as prohibited practices in
the following sections. Table 1, Prohibited Production and Handling
Practices for Organic Labeling, is a summary reference of how the seven
prohibited practices must be applied in the production and handling of
organic and nonorganic ingredients of products in the four labeling
categories.
Table 1.--Prohibited Production and Handling Practices for Labeling Categories
--------------------------------------------------------------------------------------------------------------------------------------------------------
Use both
Use processing Contain added Use organic organic &
Labeling category Use excluded Use sewage Use irradiation aids not on sulfites, ingredients nonorganic
methods sludge national list nitrates, when available forms of same
nitrites ingredient
--------------------------------------------------------------------------------------------------------------------------------------------------------
``100 percent Organic''
Single/multiingredients NO.............. NO.............. NO.............. Use NO NO............. NO............. NO.
completely organic. Processing Aids.
``Organic''
Organic Ingredients (95% NO.............. NO.............. NO.............. NO.............. NO............. NO............. NO.
or more).
Nonorganic Ingredients NO.............. NO.............. NO.............. NO.............. NO............. NO............. NO.
(5% or less).
``Made with Organic
(specified ingredients)''
Organic Ingredients (50- NO.............. NO.............. NO.............. NO.............. NO............. NO............. NO.
95%).
Nonorganic Ingredients NO.............. NO.............. NO.............. OK.............. OK............. NA*............ NA*.
(49% or less).
Less-than 50% Organic
Ingredients
Organic Ingredients (49% NO.............. NO.............. NO.............. NO.............. NO............. NO............. NO.
or less).
Nonorganic Ingredients OK.............. OK.............. OK.............. OK.............. OK............. NA<SUP>*</SUP>............ NA<SUP>*</SUP>
(50% or more).
--------------------------------------------------------------------------------------------------------------------------------------------------------
<SUP>*</SUP> Not applicable.
Calculating the Percentage of Organic Ingredients. This proposal
specifies procedures for calculating the percentage, by weight or fluid
volume, of organically produced ingredients in an agricultural product
labeled or represented as ``organic.''
The organic percentage of liquid products and liquid ingredients
will be determined based on the fluid volume of the product and
ingredients (excluding water and salt). When a product is identified on
the principal display panel or the information panel as being
reconstituted with water from a concentrate, the organic content will
be calculated on the basis of a single-strength concentration.
Some products may contain both dry and liquid ingredients that are
produced organically. In such cases, this proposal provides that the
percentage of total organic ingredients will be based on the
[[Page 13553]]
combined weight of the dry organic ingredient(s) and the weight of the
liquid organic ingredient(s), excluding water and salt. For example, a
product may be made using organically produced vegetable oils or grain
oils or contain organic liquid flavoring extracts in addition to other
organic and nonorganic ingredients. In these cases, the weight of the
liquid organic oils or flavoring extracts, less any added water and
salt, would be added to other solid organic ingredients in the product,
and their combined weight would be the basis for calculating the
percentage of organic ingredients. We believe this process provides the
most appropriate and least burdensome method for calculating the
organic percentage of such multiingredient products.
Only one figure providing the total percentage of all organic
ingredients will be shown on the information panel. The total
percentage will be displayed on the information panel of the consumer
package above or below the ingredient statement with the words,
``contains X percent organic ingredients,'' or a similar phrase. If the
total percentage is a fraction, it will be rounded down to the nearest
whole number. The percentage of each organic ingredient will not be
required to be displayed.
Labeling ``100 Percent Organic'' and ``Organic'' Products. This
proposal includes optional, required, and prohibited practices for
labeling packages of agricultural products that are ``100 percent
organic'' or ``organic'' (at least 95 percent organic). Only products
that are composed of a wholly organic single ingredient or entirely of
certified organic ingredients may be identified with a percentage
number (100 percent) on the principal display panel. Products between
95 and 100 percent organic composition, when identified as ``organic''
on the principal display panel, will be required to state on the
information panel the percentage of organic ingredients in the finished
product and identify each organic ingredient in the ingredient
statement.
The handler may display the following information on the principal
display panel, the information panel, and any other part of the package
and in market information representing the product: (1) The term, ``100
percent organic'' or ``organic,'' as applicable, to the content of the
product; (2) the USDA Seal; and (3) the seal, logo, or other
identifying mark of the certifying agent (hereafter referred to as
``seal or logo'') which certified the handler of the finished product.
The seals or logos of other certifying agents which certified organic
raw materials or organic ingredients used in the product also may be
displayed, at the discretion of the handler. If multiple organic
ingredients are identified on the ingredient statement, the handler of
the finished product that combined the various organic ingredients must
maintain documentation, pursuant to subpart B of this regulation,
certifying the organic content of the added ingredients.
While certifying agent identifications can appear on the package
with the USDA Seal, they may not appear larger than the USDA Seal on
the package. There is no restriction on the size of the USDA Seal as it
may appear on any panel of a packaged product, provided that display of
the Seal conforms with the labeling requirements of FDA and FSIS.
This proposal specifies three labeling practices that will be
required if a handler labels a product ``100 percent organic'' or
``organic'' on the principal display panel. If a product is labeled as
``100 percent organic'' the ingredients may also be modified with the
term, ``organic,'' but would not have to be so labeled because it is
assumed from the 100 percent label that all ingredients are organic.
For 95 percent-plus products that contain more than one ingredient,
each organic ingredient listed in the ingredient statement must be
modified with the term, ``organic.'' Water and salt in the ingredient
will not be identified as ``organic.'' Secondly, the total percentage
of organic ingredients in the product must be shown on the information
panel. The percentage statement should be placed in a manner that it
can be viewed in relation to the ingredient statement.
The handler also must display on the information panel the name of
the certifying agent which certified the handler producing the finished
product. The handler has the option to include the business address or
telephone number of the certifying agent. This information must be
placed below or otherwise near the manufacturer or distributor's name.
Labeling Products ``Made with Organic (Specified Ingredients)''.
With regard to agricultural products ``made with organic (specified
ingredients)''--those products containing between 50 and 95 percent
organic ingredients--this proposal establishes the following optional,
required, and prohibited labeling practices.
Under optional practices, the statement, ``made with organic
(specified ingredients),'' may be placed on the principal display panel
and other panels of the package. The same statement can also be used in
market information representing the product. However, the following
restrictions will be placed on the statement, ``made with organic
(specified ingredients),'' when it appears on the principal display
panel: (1) The statement cannot list more than three organic
ingredients in the product; (2) the statement cannot appear in print
that is larger than one half (50 percent) of the size of the largest
print or type appearing on the principal display panel; and (3) the
statement must appear in its entirety in the same type size, style, and
color without highlighting. Display of the statement, ``made with
organic (specified ingredients),'' on other panels must be similarly
consistent with the size of print used on those panels. These
restrictions are consistent with FDA regulations and similar to the
recommendations of the National Organic Standards Board (NOSB). This
provision will help assure that the statement, ``made with organic
(specified ingredients),'' is not displayed in such a manner as to
misrepresent the actual organic composition of the product.
We also propose that, at the handler's option, the certifying
agent's seal or logo may be displayed on the principal display panel or
other package panel.
Packages of products labeled as ``made with organic (specified
ingredients)'' will be required to display on the information panel the
total percentage of organic ingredients in the product and modify each
organic ingredient listed in the ingredient statement with the term,
``organic.'' The percentage of organic ingredients must be displayed so
that it can be viewed in relation to the ingredient statement.
The name of the certifying agent which certified the handler of the
finished product must be displayed below or otherwise near the
manufacturer or distributor's name. The statement may include the
phrase, ``Certified organic by * * *'' or ``Ingredients certified as
organically produced by * * *'' to help distinguish the certifying
agent from the manufacturer or distributor. At the handler's option,
this label may include the business address or telephone number of the
certifying agent which certified the handler of the finished product.
Labeling Products with Less Than 50 Percent Organic Ingredients.
The final labeling category covers packaged multiingredient
agricultural product containing less than 50 percent organic
ingredients.
Handlers of ``less than 50 percent'' multiingredient products, who
choose to declare the organic nature of the
[[Page 13554]]
product, may do so only on the information panel by declaring the total
percentage of organic ingredients in the product and, in the ingredient
statement, modifying the organic ingredients with the term,
``organic.'' The percentage statement must be displayed so that it can
be viewed in relation to the ingredient statement.
Products composed of less than 50 percent organic content cannot
display the USDA Seal or any certifying agent's seal or logo anywhere
on the product package or in market information.
Handlers of such products will be subject to this regulation in the
following ways. Those handlers who only purchase organic and nonorganic
ingredients and assemble a finished product of less than 50 percent
organic content do not have to be certified as organic handlers. They
will be responsible for appropriate handling and storage of the organic
ingredients prior to product assembly and for maintaining records
verifying the organic certification of the ingredients used in the
product. To the extent that the packaging process includes affixing the
label to finished product package, those handlers will be responsible
for meeting the labeling requirements of this subpart. Handlers who
produce an organic ingredient prior to assembly into a finished
product, even though the finished product contains less than 50 percent
organic content, and must be certified as to the source of the organic
ingredient(s). The nonorganic ingredients may be produced, handled, and
assembled without regard to the requirements of this part.
The handler who affixes the label to the product package will be
responsible for calculating the percentage of organic ingredients in an
organic product. As part of the certifying agent'' annual certification
of the handler, the certifier will verify the calculation and labeling
of packages.
Table 2, Labeling Consumer Product Packages, provides a summary of
the required and prohibited labeling practices for the four labeling
categories.
Table 2.--Labeling Consumer Product Packages
----------------------------------------------------------------------------------------------------------------
Principal display Ingredient Other package
Labeling category panel Information panel statement panels
----------------------------------------------------------------------------------------------------------------
``100 percent Organic'' ``100 percent ``100% Organic''.. If multiingredient ``100 percent
(Entirely organic; whole, raw organic''. product, identify Organic''.
or processed product). each ingredient
as ``organic''.
USDA Seal and Certifying agent .................. USDA Seal and
Certifying agent name (required); Certifying agent
sets(s). business address, seal(s).
tele. #
(optional).
``Organic`` (95% or more organic ``Organic''....... ``X% Organic Identify organic ``Organic''.
ingredients). Ingredients''. ingredients as
``organic''.
USDA Seal and Certifying agent .................. USDA Seal and
Certifying agent name (required); Certifying agent
seals(s). business address, seal(s).
tele. #
(optional).
``Made with Organic (specified ``Made with ``X% Organic Identify organic ``Made with
ingredients)'' (50 to 95% organic Ingredients''. ingredients as organic
organic ingredients). (specified ``organic''. (specified
ingredients)''. ingredients)''.
Certifying agent Certifying agent Identify organic ``Made with
seal of final name (required; ingredients as organic
product handler. business address, ``organic''. (specified
tele. # ingredients)''.
(optional).
Prohibited: USDA Prohibited: USDA .................. Prohibited: USDA
Seal. Seal. Seal.
Less-than 50% Organic Prohibited: Any ``X% Organic Identify organic Prohibited: Any
Ingredients (49% or less reference to Ingredients''. ingredients as reference to
organic ingredients). organic content ``organic''. organic content
of product. of product.
Prohibited: USDA Prohibited: USDA .................. Prohibited: USDA
Seal & Certifying Seal & Certifying Seal & Certifying
agent seal. agent seal. agent seal.
----------------------------------------------------------------------------------------------------------------
Misrepresentation in Labeling of Organic Products. The labeling
requirements of this proposal are intended to assure that the term,
``organic,'' and other similar terms or phrases are not used on a
product package or in marketing information in a way that misleads
consumers as to the contents of the package. Thus, we intend to monitor
the use of the term, ``organic,'' and other similar terms and phrases.
Should we find that terms or phrases are being used on product packages
to represent ``organic'' when the products are not produced to the
requirements of this regulation, we will proceed to restrict their use.
After consideration of alternative labeling terms that handlers
might wish to use to qualify or modify the term, ``organic,'' we have
determined that handlers may not qualify or modify the term,
``organic,'' using adjectives such as, ``pure'' or ``healthy,'' e.g.,
``pure organic beef'' or ``healthy organic celery.'' The term,
``organic,'' is used in labeling to indicate a certified system of
agricultural production and handling. Terms such as ``pure,''
``healthy,'' and other similar adjectives attribute hygienic,
compositional, or nutritional characteristics to products. Use of such
adjectives misrepresents products produced under the organic system of
agriculture as having special qualities as a result of being produced
under the organic system. Furthermore, use of such adjectives would
incorrectly imply that products labeled in this manner are different
from other ``organic'' products that are not so
Moreover, ``pure,'' ``healthy,'' and other similar terms are
regulated by FSIS and FDA. These terms may be used only in accordance
with the labeling requirements of FDA and FSIS. For example, the
regulations implemented by FSIS, 9 CFR 317.363, define the terms,
``healthy,'' ``health,'' and similar derivations and the conditions of
use as a nutritional claim. Also, according to FSIS regulations, 9 CFR
317.8(b)(34), the term, ``pure,'' as well as the terms, ``all,'' ``100
percent,'' and similar terms, may only be used to indicate that a
single ingredient product is composed of 100 percent of the product
ingredient and contains no other ingredients. The term, ``healthy,'' is
regulated by FDA (21 CFR
[[Page 13555]]
101.14) and can be used, with documentation, only to indicate or
characterize a relationship of the product to a disease or health-
related condition. The prohibition on use of these terms to modify
``organic'' does not otherwise preclude their use in other labeling
claims.
We also intend to monitor the use of the term, ``organic,'' in
corporate or company names and seek additional guidance from the FTC.
We do not believe that the term, ``organic,'' in a brand name context
inherently implies an organic production or handling claim or
inherently constitutes a false or misleading statement.
The determination as to whether the use of the term, ``organic,''
in a brand name conveys a message about the product's attributes must
be made by the Secretary. We will monitor use of the term, ``organic,''
in product and company names at this time. However, if we find that the
term is being used in a false or misleading way to misrepresent the
organic nature of the product, we have the authority under section
6519(b) of the Act to take action against such use. Such determinations
and actions will be taken on a case-by-case basis.
Labeling of Products Shipped in International Markets. Domestically
produced organic products intended for export may be labeled to meet
the requirements of the country of destination or any labeling
requirements specified by a particular foreign buyer. For instance, a
product label may require a statement that the product has been
certified to, or meets, certain European Union organic standards. Such
factual statements regarding the organic nature of the product will be
permitted. However, those packages must be exported and cannot be sold
in the United States with such a statement on the label because the
statement indicates certification to standards other than are required
under this program. As a safeguard for this requirement, we require
that shipping containers and bills of lading for such exported products
display the statement, ``for export only,'' in bold letters. Handlers
also will be expected to maintain records, such as bills of lading and
U.S. Customs Service documentation, showing export of the products.
Only products which have been certified and labeled consistent with the
requirements of the National Organic Program (NOP) may be shipped to
international markets without marking the shipping containers ``for
export only.''
Organic product produced under a foreign country's or international
association's organic standards deemed equivalent to these standards
and certified by a certifying agent accredited by the Secretary may be
imported into the United States provided that the product labels are
consistent with the requirements of this subpart. Any labeling on the
product package or in market representation cannot imply that the
product is also certified to other organic standards or requirements
that are more restrictive than this national program. These provisions
are consistent with international standards and will facilitate
international trade of organically produced products and, thus, benefit
the global organic industry.
Labeling Nonretail Containers. Section 205.306 provides for
labeling nonretail containers used to ship or store raw or processed
organic agricultural products that are labeled ``100 percent organic,''
``organic,'' and ``made with organic (specified ingredients).'' These
labeling provisions are not intended for shipping or storage containers
that also will be used in displays at the point of retail sale. They
would be used for easy identification of the product to help prevent
commingling with nonorganic product or handling of the product which
would destroy the organic nature of the product (fumigation, etc.).
Retail containers will have to meet labeling provisions specified in
Sec. 205.307.
Containers used only for shipping and storage of any product
labeled as containing 50 percent or more organic content may, at the
handler's discretion, display the following information: (1) The name
and contact information of the certifying agent which certified the
handler of the finished product; (2) the term, ``organic,'' modifying
the product name; (3) any special handling instructions that must be
followed to maintain the organic integrity of the product; and (4) the
USDA Seal and the appropriate certifying agent seal. This information
is optional if handlers believe display of the information helps ensure
special handling or storage practices which are consistent with organic
practices.
Containers used for shipping and storage of organic product must
display a production lot number if such a number is used in the
processing and handling of the organic product being shipped or stored.
The lot number must be included for inventory control and quality
assurance purposes. To help assure export of organic product produced
and labeled to foreign specifications, the shipping containers and
shipping documents (bills of lading) must be marked with the phrase,
``for export only,'' in bold letters. The handler also must maintain
records showing export of the product to a foreign country.
Much of the required information may overlap information that the
handler normally affixes to shipping and storage containers or
information that is required under other Federal labeling regulations.
Provisions in this proposal do not take precedence over food safety or
quality control provisions which may be required for specified products
or types of products covered by such Federal regulations. There are no
restrictions on size or display of the term, ``organic product,'' or
the certifying agent seal unless otherwise required by other Federal or
State statutes.
Labeling Products at the Point of Retail Sale Section 205.101(b)(2)
of subpart B on Applicability provides regulations regarding the
certification of retail food establishments under this program. Those
operations are subject to labeling and market information requirements
concerning products offered to consumers at the point of retail sale.
Such labeling and market information must truthfully represent the
organic nature and handling of the product.
Section 205.307 applies to organically produced products that are
not prepackaged prior to sale and are presented in a manner which
allows the consumer to select the quantity of the product purchased.
To be labeled as ``100 percent organic'' or ``organic'' at the
point of retail sale, the processing and assembly of such products must
be carried out by a certified manufacturing facility for distribution
to a retail food establishment. For instance, a tossed salad may be
labeled as ``100 percent organic tossed salad'' or ``organic tossed
salad'' (consistent with the percentage of organic ingredients in the
salad) provided the salad and ingredients have been produced and
assembled under organic certification. If the multiingredient product
is identified as ``organic'' at the point of retail sale, any
ingredient statement displayed at retail sale must identify the organic
ingredients as ``organic.'' The retail materials may also display the
USDA Seal and the seal or logo of the certifying agent. If shown, the
certifying agent seal must not be larger than the USDA Seal.
Using the same example, a product made with 95 percent or more
certified organic salad components but which is assembled at an
uncertified operation may be labeled ``tossed salad made with organic
(specified ingredients).'' The retail food establishment may not
[[Page 13556]]
display the USDA Seal or the seal or seals of cerftifying agents
involved in ingredient certifications because the final assembly of the
product was not certified pursuant to the handling requirements of this
regulation.
Our position on the applicability of these regulations to different
business entities is more completely explained in subpart B,
Applicability, of this regulation.
``Section 205.308 addresses processed products ``made with organic
(specified ingredients)'' that are not prepackaged prior to sale and
are presented in a manner which allows the consumer to select the
quantity of the product purchased. These products will include, but
will not be limited to, multiingredient products containing between 50
and 95 percent organic ingredients. Retail displays, display
containers, and market information for such products may display the
phrase, ``made with organic (specified ingredients)'' provided that the
product has been assembled by a manufacturing facility certified
pursuant to this regulation. Up to three organic ingredients may be
identified in the statement. If such statement is declared in market
information at the point of retail sale, the ingredient statement must
identify the organic ingredients as ``organic.'' Retail display and
market information of such bulk products cannot use the USDA Seal but
may display the seal or logo of the certifying agent which certified
the finished product, provided that assembly of the product was carried
out at a certified manufacturing facility. The certifying agent's seal
or logo may be displayed at the option of the retail food
establishment. If such a product has not been assembled at a certified
manufacturing facility, the retail display and market information may
not identify the product as ``made with organic (specified
ingredients).''
Prepared food products containing less than 50 percent organic
ingredients at retail sale may not be identified as organic or
containing organic ingredients. The USDA Seal and any certifying agent
seal or logo may not be displayed.
Labeling Products Produced on Exempt or Excluded Operations. This
proposal provides limited organic labeling provisions for organic
product produced or handled on exempt and excluded operations. Such
operations would include retail food establishments, certain
manufacturing facilities, and production and handling operations with
annual organic sales of less the $5,000. They are discussed more
thoroughly in subpart B, Applicability.
Under this proposal, any such operation that is exempt or excluded
from certification, or which chooses not to be certified, may not label
its products in a way which indicates that the operation has been
certified as organic. Primarily, this means that the exempt or excluded
operation may not display the USDA Seal or any seal or logo of a
certifying agent. Any packaged organic product from an exempt or
excluded operation may not use the labeling terms ``100 percent
organic,'' or ``organic,'' or ``made with organic (specified
ingredients),'' on the principal display panel. Those labeling terms
are reserved for products produced by certified operations. The organic
representation of exempt or excluded operation products may only be
made on the information panel where the organic percentage can be
displayed and the organic ingredients identified as ``organic.''
Retail displays and market representation of such products may not
indicate that the product has been certified as organic. For instance,
a whole, raw, organic product marketed directly to consumers at a
farmers market or roadside stand as ``organic apples'' or ``organic
tomatoes.'' However, no terms may be used which indicate ``certified''
organic apples, etc. No organic seal or logo may be displayed with the
product at the point of retail sale.
We propose these restrictions simply as truth in labeling
provisions because use of terms or phrases reserved for certified
operations and products and display a certification seal will indicate
that the product has been certified. We believe this requirement will
help differentiate between certified and not certified products and
help maintain the integrity of certified products while providing
limited organic labeling opportunities for exempt and excluded
operations.
Finally, this rule proposes that exempt organic producers cannot
sell their product to a handler for use as an ingredient or for
processing into an ingredient that will be labeled as ``organic'' on
the information panel. However, this restriction is raised for public
comment in subpart B, Applicability, of this part.
Small producers or handlers who qualify for exemption but who
choose to be certified pursuant to these regulations can label their
product as certified organic and can sell that product to certified
handlers for further processing as an organic ingredient.
USDA Seal. This proposal introduces a new, redesigned, USDA Seal,
that can be placed on consumer packages, displayed at retail food
establishments, and used in market information to show that products
have been produced and handled in accordance with these regulations.
The Seal can only be used to identify raw and processed products that
are labeled as ``100 percent organic'' or ``organic.'' It cannot be
used for products labeled as ``made with organic (specified
ingredients)'' (50 to 95 percent organic ingredients) or on
multiingredient products with less than 50 percent organic ingredients.
The USDA Seal presented in this proposal will consist of the
phrase, ``USDA Certified Organic,'' on a shield or badge design. When
used, the seal must be the same form and design as shown in figure 1 of
Sec. 205.310 of this proposal. The seal must be printed legibly and
conspicuously. On consumer packages, retail displays, and labeling and
market information, the Seal may be printed on a white, light colored,
or transparent background with contrasting dark colored words and
shield outline or on a dark colored background with contrasting words
and shield outline in one or two light colors. The Seal also may be
printed in the colors red, white, and blue as follows: a white
background, with dark blue shield outline, and red words. The choice of
color scheme is left to the discretion of the producer, handler, or
retail food establishment based on other colors on the product package
and other considerations.
Labeling--Changes Based On Comments
This subpart differs from our first proposal in several respects as
follows:
(1) Use of terms other than ``organic.'' The first proposal stated
that informational statements which imply ``organic'' production and
handling should be used only on products that are produced and handled
in accordance with these regulations. The proposal identified several
informational statements commonly referred to as ``eco-label'' or
``green'' terms and phrases such as: ``produced without synthetic
fertilizers,'' ``pesticide free farm,'' ``no drugs or growth hormones
used,'' ``raised without antibiotics,'' ``ecologically produced,''
``sustainably harvested,'' etc. We asked for comments on these and
other terms or phrases which directly or indirectly imply that a
product was organically produced and handled.
Commenters favored use of ``eco-label'' and ``green'' terms and
phrases on any product labels. The general consensus expressed in the
comments is
[[Page 13557]]
that producers and handlers should be able to make claims about their
product provided the claims are truthful.
While commenters did not oppose the use of eco-label terms or
phrases on nonorganic products, they made it clear that the term,
``organic,'' should only be used on products produced and handled in
accordance with these regulations. Several commented that consumers
respond favorably to the term, ``organic,'' when used on a product
label, and, therefore, proper use of the term must be closely
protected.
We also received several comments regarding use of the terms,
``biological'' and ``ecological,'' on product labels. A few comments
indicated that the terms should be allowed on nonorganic products to
truthfully describe an alternative agricultural system under which the
product was produced or processed. However, most commenters opposed use
of the terms as substitutes for the term ``organic'' on product labels.
We agree with the majority of comments received on this subject,
and we, therefore, propose to regulate the term, ``organic,'' and no
other terms. We propose that the term, ``organic,'' may only be used on
labeling and market information of products that are produced and
handled in accordance with these regulations. We understand that the
terms, ``ecological'' and ``biological,'' are a special case in that
they are used synonymously with the term, ``organic,'' in other
countries. However, they cannot be used interchangeably with the term,
``organic,'' in this country. These terms may be used as eco-labels at
this time. However, we will proceed to restrict use of these or any
other terms if we find that they are used on product packages in the
United States to represent ``organic'' when the products are not
produced to the requirements of this regulation.
(2) 100 percent organic category. Our first proposal did not
provide for a ``100 percent organic'' category because that level of
organic composition is not specifically provided for in the Act. While
the Act and the first proposal provide for a labeling category of 95
percent or higher organic content, commenters appealed for a labeling
category for product that is 100 percent organic. Many suggested that
being able to use the term, ``100 percent,'' will give handlers added
incentive to use only certified ingredients in multiingredient
products. Some commenters suggested that if a product is composed only
of organic ingredients, with no additives or other substances, it
should be allowed to be labeled and represented in market information
as 100 percent.
We agree that a ``100 percent organic'' labeling category may
increase the effectiveness of marketing efforts and may provide
incentives for handlers to use more certified organic ingredients in
their multiingredient products. Therefore, this proposal will allow the
term, ``100 percent organic,'' to be used on labels affixed to or
market information representing raw or processed organic products that
are composed entirely of organically produced agricultural product.
(3) Identification of private certifying agents. Under the first
proposal, identification of private certifying agents was not permitted
on the principal display panel with the USDA Seal and the State organic
seal. While a few commenters suggested that only the USDA Seal should
be displayed on the principal display panel, the majority of those
commenting on this topic requested that private certifying agent seals
be displayed on an equal basis with a seal of the appropriate State's
organic program. Although the number of State certifying agents is
relatively small, private certifying agents believe that State organic
programs and State certifying agents may implement measures in States
that work against the interests of private certifying agents. The
Department believes those concerns to be unfounded. Under the NOP, the
Secretary will approve all State organic programs and accredit all
State certifying agents. However, any of those programs or agents that
might discriminate or work against the interests of private certifying
agents in the State would not be approved by the Secretary.
Some commenters suggested that many private certifying agent seals
are widely recognized and respected and their seals influence consumer
choices in product purchases. It is appropriate that private certifying
agents be afforded the same treatment with regard to labeling as the
State certifying agent. We agree with commenters' requests for equal
treatment of certifying agents and that certifier seals may have
marketing potential in some areas. Therefore, we specify in this
proposal that a private certifying agent's seal or logo can be
displayed to the same extent as the seal of a State certifying agent.
This change is reflected throughout this subpart.
(4) Use of a certifying agent's seal or logo. Many commenters
believe that the certifying agent's seal, logo, or identifying mark
shown on ``100 percent organic'' and ``organic'' products should be the
seal or mark of the certifying agent that certifies the handler of
finished product. Commenters also stated that labels should not be used
to misrepresent one product as being more organic than another product,
which might happen if multiple seals are displayed on one product
package and only two are displayed on a competing product package.
While we understand the commenters' points, we believe that display of
certifying agent seals on products labeled ``100 percent organic,''
``organic,'' and ``made with organic (specified ingredients)'' should
remain optional for handlers. If two or more certifying agents are
involved in certifying raw organic agricultural product and organic
ingredients used in a finished product, the seals or marks of those
certifying agents may be displayed, at the discretion of the handler.
There should be only two restrictions to using multiple certifying
agent seals: (1) The seal of the certifier of the handling operation
producing the finished product should be displayed; and (2) only the
seals of those certifying agents actually involved with certification
of the product or ingredients may be displayed. For instance, a private
certifying agent may certify a product assembled using organic
ingredients produced in Texas and certified by the Texas State
certifying agent. The product package may, at the handler's option,
display the Texas State agent's seal in addition to the seal of the
private certifying agent which certified the operation creating other
organic ingredients and creating the finished product. Likewise,
display of a seal of a foreign country's organic program or foreign
certifying agent will be permitted only if the foreign agent certified
the finished product or a product ingredient.
Some commenters say that display of two State agent seals may
confuse consumers. However, we do not believe it is likely that
handlers will choose to display multiple certifying agent seals to
misrepresent a product. We also do not believe that possible consumer
confusion from display of multiple seals should take precedence over
the handler's right to provide product information. If multiple
certifying agent seals or marks are displayed on a product package or
in market information, the handler or retail food establishment must
maintain appropriate records showing proof of all organic
certifications.
(5) Display of certifying agent name and business address.
Commenters also suggested that the certifying agent's name and business
address be displayed adjacent to identification of the handler or
distributor of products labeled ``organic'' and ``made with organic
[[Page 13558]]
(specified ingredients).'' The commenters stated that such information
should be available for consumers who may have questions about the
organic nature of a product or product ingredients. We agree that the
name of the certifying agent should be included on a product package
but believe that display of the business address or telephone number
should be optional to the handler who assembles the finished product
and affixes the label on the package. If a consumer wants to inquire
about the organic nature of a purchased product, the consumer can
obtain contact information through the certifying agent database listed
on the NOP homepage. Finally, to clearly identify the information
provided, the statement, ``Certified organic by * * *'' or
``Ingredients certified as organically produced by * * *,'' may be used
to distinguish the certifying agent from the manufacturer or
distributor of the product.
The statement and agent identification is intended for information
purposes only and is not to promote the organic nature of the product.
The certifying agent identification may be placed below the
manufacturer or distributor information and must not interfere with
display of that information.
(6) Size of certifying agent seal. There was a general consensus
among commenters that the seals of State and private certification
agents should not be larger than the USDA Seal. To emphasize the market
value of such a national organic seal and maintain some consistency of
treatment with regard to the different organic content categories, we
propose that State and private certifying agent seals can be the same
size as but must not exceed the size of the USDA Seal on any package
label or in market information. The size of the USDA Seal on a package
is left to the discretion of the handler.
(7) Displaying the percentage of organic ingredients. The first
proposal permitted use of the word, ``organic,'' in the ingredient
statements to modify those ingredients that were produced and handled
pursuant to these regulations, but did not require the percentage of
organic ingredients to be displayed on the label. Most all commenters
responding to this labeling issue stated that identification of organic
ingredients as ``organic'' will encourage handlers to increase the
organic composition of multiingredient products. However, some
commenters did not favor any use of the word, ``organic,'' on packages
of multiingredient products containing less than 50 percent organic
ingredients. Some commenters also suggested that including the total
percentage of organic content adjacent to the ingredient statement (in
which the organic ingredients are identified) would give relevance to
the ingredient statement. We concur with commenters' recommendations
about the display of the total percentage of organic content and
propose that the percentage of organic ingredients be placed on the
information panel. The percentage statement and the ingredient
statement should be shown in a way that indicates the relationship of
the information. If a product is labeled ``100 percent organic,'' all
ingredients (except water and salt), by definition, would have to be
certified organic ingredients, and each ingredient may be but would not
have to be identified as ``organic.'' Identification of organic
ingredients would be required for products labeled ``organic'' and
``made with organic (specified ingredients),'' and for products
containing less than 50 percent organic ingredients. We did not change
the identification of organic ingredients for products containing less
than 50 percent organic ingredients because we believe the uses of the
term on the information panel and ingredient statement of such product
packages do not imply that the product is organic.
(8) Labeling of products containing 50-95 percent organic
ingredients. The first proposal specified that products with 50-95
percent organic content could use ``made with certain organic
ingredients'' on the label. Many commenters suggested that the word,
``certain,'' may appear confusing to consumers and that a stronger
statement is needed to identify the organic nature of the product. One
commenter sought clarification of whether the term, ``certain,'' is a
substitute for the name of the ingredient in a single-ingredient
product. Many requested that the statement be changed to allow specific
identification of the organic ingredients on the principal display
panel. Because that is the panel first and most often observed by
consumers, the commenters indicated that the information presented on
the principal display panel should be clear and accurate to assist
consumers in making their purchasing decisions.
After review of the comments, we believe that, if the statement is
going to be displayed on the principal display panel, it should state
the specified organic ingredient in the product; e.g., ``made with
organic (specified ingredients).'' Replacing the word, ``certain,''
with the actual organic commodity name or organic ingredient will add
the specificity sought by commenters and assist consumers in making
more informed choices. Under this proposal, the statement, ``made with
organic (specified ingredients),'' must be used on the principal
display panel and on other package panels of a product containing
between 50 and 95 percent organic ingredients.
Several commenters suggested that the size of the letters in the
phrase be limited to a fraction of the size of the product name as it
appears on the principal display panel. They stated that limiting the
size of the letters will keep the statement from making the product
appear more organic than products with 95 percent organic ingredients.
For instance, if a product contains 55 percent organic ingredients and
the statement, ``made with organic (specified ingredients),'' is
displayed on the principal display panel in large, bold letters, the
product may appear more organic than a 97-percent product simply
labeled ``organic.'' Commenters recommended letter sizes from one-half
to three-fourths the size of the product name as it appears on the
principal display panel.
We also believe that the labeling for these products should not use
typeface or letter sizes which would mislead consumers. FDA labeling
requirements in 21 CFR 101.3(d) specify that required statement of
identity of the product shall be in a size most reasonably related to
the largest printed matter on a panel. FDA enforces ``reasonably
related'' as being one half the size of the largest printed matter,
which is usually the product name. Therefore, to be consistent with FDA
labeling requirements, we have established the print size of the
statement, ``made with organic (specified ingredients),'' to be not
more than 50 percent, or one half, of the largest print size appearing
on the principal display panel. This print size is consistent with the
recommendation of many commenters but is smaller than the 75 percent
recommended by the NOSB. We propose that the statement, ``made with
organic (specified ingredients),'' appear in only one print style and
color, without highlighting.
We believe that these additional restrictions on display of the
statement will enable the message to be delivered and yet provide some
structure and consistency to display of the statement. It is our
intention that the statement not be used to disproportionately dominate
the principal display panel or other panels and not be used to
misrepresent the organic nature of the product.
(9) Limiting the number of organic ingredients listed. Some
commenters suggested limiting the number of organic ingredients that
could be
[[Page 13559]]
included in the statement ``made with organic ingredients.'' This topic
was the subject of much NOSB deliberation and public discussion.
Commenters reasoned that if the list of organic ingredients became too
long, the product could appear to be more organic than ``95 percent''
products. For instance, a product could have 10 organic ingredients,
but those 10 ingredients may comprise only 51 percent of the product.
The consensus of comments suggested that the statement should be
limited to three organic ingredients, which is the industry standard.
We believe their recommendation has merit and, therefore, propose that
up to three organic ingredients can be shown in the statement. We
encourage additional comments on the maximum number of ingredients that
should be allowed to appear in the statement on the principal display
panel. Commenters should provide reasons for the number they recommend.
(10) Qualifications for display of the USDA Seal. In the first
proposal, we permitted the display of the USDA seal on products with 50
percent or more organic ingredients. Commenters objected. They
overwhelmingly endorsed a high organic content standard for a product
to be labeled as ``organic.'' They believe products containing less
than 95 percent organic ingredients do not have sufficient organic
content to justify an ``organic'' label on the principal display panel,
and should not be so labeled under the NOP regulations. Commenters also
stated that display of the USDA Seal will be very desirable. Many
stated that a prohibition on display of the USDA Seal on 50-to-95-
percent products would encourage handlers who assemble multiingredient
products to use more organically produced ingredients and fewer
nonorganic ingredients. They suggested that the USDA Seal and the
certifying agent's seal or logo not be displayed on any package panel
of products ``made with organic (specified ingredients)'' or on
products with less than 50 percent organic ingredients.
We agree that some distinction should be made between 95 percent-
plus organic products and the 50-95 percent organic products. Handlers
of 95 percent-plus organic products may display both the USDA Seal and
the certifying agent seal or logo on the principal display panel of the
product. The commenters propose that handlers of 50-95 percent organic
products not be allowed to display either seal on the principal display
panel. However, we believe that, because handlers of 50-95 percent
organic product are required to be certified under this program, it is
appropriate that they should be allowed to display some evidence of
that certification. We propose, therefore, that handlers of 50-95
percent organic product may display the seal or logo of the certifying
agent which certified the finished product. Display of the USDA Seal
will still be restricted to only 100 percent organic products and to 95
percent-plus products. We believe this provision will provide more
equitable treatment for handlers of 50-95 percent products who are
required under this regulation to obtain and maintain organic
certification in order to label their organic product. It will also
maintain a distinction between the two product levels by continuing the
restriction on display of the USDA Seal. We believe that, while display
of the USDA Seal is less likely to be an incentive for handlers of
products at the lower end of the 50 to 95 percent range of organic
content, handlers of products at the higher end of the 50 to 95 percent
organic content range may be encouraged to increase the organic content
in order to display the USDA Seal.
An organic product produced or handled by an exempt or excluded
operation, including those with less than $5,000 annual organic sales,
may not display the USDA Seal or the seal of a certified agent because
the operation has not been certified. Even if the organic content of
the product is 95 percent or higher, the product still cannot be
labeled as ``certified'' organic or marketed using an organic seal or
logo.
(11) Design of the USDA Seal. The final change prompted by comments
is redesign of the USDA Seal. The Seal in the first proposal was a
triangular shape behind a circle of recycling arrows around a globe
figure with the word, ``organic,'' printed diagonally across the globe.
That proposed seal was opposed by hundreds of commenters. Comments
included: The triangle resembles a radioactive warning symbol or
fallout shelter sign; the diagonal line across the circle appears to be
the universal ``no'' sign (such as ``no walking,'' ``no smoking''); the
globe design doesn't show up; the globe design implies an international
program; the design is too busy; simplify the design; use the words,
``certified organic''; use a text logo; the seal will be too costly to
produce; and the triangle points will puncture or tear plastic when
printed.
Given the overwhelming negative response to the first seal, we
propose a simplified design composed of the words, ``USDA CERTIFIED
ORGANIC,'' inside a shield or badge design. This design is consistent
with comments requesting simplicity and use of the words, ``certified
organic.'' At the request of commenters, this proposal provides for
labeling on transparent material. We believe the proposed basic dark on
light or light on dark requirement is broad enough to allow handlers
the flexibility needed to match color schemes compatible with their
product packages. The alternative red, white, and blue color scheme
offers handlers what consumers may identify as a more official or
patriotic display of the Seal. We believe it is important that the Seal
be displayed in a consistent manner, within general light/dark
guidelines so that the Seal becomes easily recognizable to consumers.
Labeling--Changes Requested But Not Made
Comments reflecting different opinions on the same topic are
covered above (e.g., the number of organic ingredients listed on the
principal display panel, the size of ``organic'' letters on the
principal display panel, a recommended redesign of the USDA Seal,
etc.). Obviously, not all such conflicting recommendations can be
accepted. Two comments were received which are not accepted but which
we believe warrant further consideration by the public and the organic
community. We request additional comments regarding the following two
recommendations. Commenters should specify their recommendation
regarding each topic and provide reasons for their recommendation.
(1) Changing the ``organic'' threshold for multiingredient
products. At least one commenter suggested that the 50-95 percent
labeling category sets too low a threshold for organic labeling of
multiingredient products. The commenter suggested that, for increased
international acceptance of USDA standards, the lowest acceptable
percentage for receiving an organic label should be 70 percent organic
ingredients, based on the European Union (EU) standard which now
requires a minimum of 70 percent organic ingredients for the product to
be labeled as ``organic'' (or, ``biological'' or ``ecological'').
The EU standard allows products with a 70 percent organic content
to be labeled as ``organic,'' where our proposal will require at least
95 percent organic content before a product could be labled as
``organic.'' This 95 percent standard is in the Act. Where the two
standards differ is that the EU standard doe not have a ``made with
organic (specified ingredients)'' category proposed in this rule.
[[Page 13560]]
While the Act establishes a 50-percent minimum ingredient content,
that percentage can be adjusted upward if doing so would further the
purposes of the Act. To do so, however, the Secretary must have good
cause and justification for establishing a higher minimum organic
ingredient content. In other words, we could raise the minimum organic
ingredient content threshold to 70 percent, redefining two of our four
categories. The four categories would be: less than 70 percent, 70-95
percent, greater than 95 percent, and 100 percent. Under this scenario,
the prohibitions on excluded methods, irradiation, and sewage sludge
would not apply to the nonorganic ingredients of products with less
than 70 percent organic content. At the same time, these products would
only be able to list the organic ingredients on the information panel.
The ``made with organic ingredients'' category, to which the
prohibition would apply, would be 70-95 percent organic content. The
only products that would get the ``organic'' designation would still be
those with at least 95 percent organic content.
Because we find no compelling reason to raise the 50-percent
minimum ingredient content threshold established in the Act, we have
not accepted the commentor's recommendation in this proposal. However,
if comments on this proposal suggest an appropriate justification, the
minimum ingredient content threshold could be raised in the final rule.
(2) Minimum content requirements for organic ingredients. One
commenter suggested that a minimum percentage of the entire product
weight be established to qualify for a single ingredient to be included
in the statement, ``made with organic (specified ingredients).'' The
commenter suggested that this would help prevent misrepresentation of
the organic nature of a product. The commenter suggested that the
minimum content for any ingredient should be 15 percent. The commenter
did not justify the 15-percent minimum (as opposed to another minimum
percentage). Because such a recommendation could prevent important
ingredients from being specified on a product label, we have not
incorporated the comment in this proposal. However, we believe the
comment may have merit. One factor in establishing a minimum percentage
for any individual ingredient listed on the principal display panel
would be the established minimum percentage for all organic ingredients
in a product, the question raised in the paragraph above. For instance,
if the minimum percentage of all ingredients is established at 70
percent to conform to EU standards, should there be a minimum
percentage for any individual organic ingredient that could be listed
on the principal display panel as one of three organic ingredients in
the product? Would such a labeling restriction prevent identification
of an important organic ingredient from being displayed on the
principal display panel?
Commenters on questions (1) and (2) should state whether they think
the recommendations would further the marketing of organic products
and, if so, clearly state the recommended percentage for each question
and the reasons for their opinions regarding each issue.
(3) Labeling requirements for small operations. A majority of those
who commented on the exemption for small operations (less than $5,000
organic sales) in the first proposal stated that such operations are
not exempt from labeling requirements under the Act. In this proposal,
we provide limited labeling provisions which prohibit exempt and
excluded operations, including those with less than $5,000 in annual
organic sales, from labeling their products in a way that indicates the
operations or the products have been certified as organic. These
provisions will not allow such operations to use labeling terms and
organic seals and logos specified for certified operations. We believe
those terms, logos and seals should be reserved for operations and
products that are certified under these regulations.
Labeling--Additional Provisions
Upon further review of the label and market information provisions
in the first proposal, we propose the following additions and changes.
(1) Display of a State organic seal. Under the first proposal, each
State organic certification program would have been allowed to display
a seal or logo of its State organic program. The first preamble stated
that it was appropriate for a State to have a seal representing its
organic program, thus allowing product produced under that program to
bear the State's seal.
Currently, 13 State departments of agriculture (or other State
agency) and approximately 40 private agents certify to a variety of
private and State organic requirements. After establishing a policy
which more clearly defines the criteria for approval of a State organic
program, we believe that, in the interest of consistent and uniform
national standards, product packages should not display the seal of a
State organic program if the seal is different from the seal or mark
used by the State's organic certifying agent.
This determination is based on a proposed change in State programs.
A State organic program will be approved by the Secretary for specific,
need-based reasons particular to that State (see State Programs under
subpart G). To establish and maintain uniform national standards,
States will not be authorized to implement more restrictive organic
standards simply to promote State products that are ``more organic''
than products produced and handled in other States or under NOP
requirements. Rather, the Secretary will approve only those State
programs that need more restrictive requirements to protect or preserve
unique environmental conditions or to accommodate product and handling
practices unique to a State or portion of a State. In the absence of
such environmental conditions or production practice needs, a State's
organic program must have the same requirements as this NOP. If this is
the case and if a relatively few State programs are approved to have
more restrictive requirements, then no real purpose is served by
permitting State organic programs to display a separate and distinct
seal on a product label. Such a seal would not represent a ``more
organic'' product.
In the place of a State organic program seal, this proposal
provides for the seal or logo of a State certifying agent to be
displayed on packages, if that certifying agent certifies the organic
operation producing the product. Selection of a State or private
certifying agent is the choice of the organic producer or handler being
certified. A State's department of agriculture (or other equivalent
State agency) may establish one or more State certifying agent offices
as part of its governmental operations, or the State may license a
private certifying agent to certify organic operations on behalf of the
State. In either case, the certifying agent would certify these
national requirements and not the particular requirements of a State
organic program unless those requirements were approved by the
Secretary. Therefore, the only organic seal or mark representing a
State will be the seal or mark of a State's certifying agent or
licensed certifying agent. Any certifying agent licensed by the State
must be accredited by the Secretary pursuant to subpart F of this
proposal.
(2) Labeling for international markets. We have added two
paragraphs under section 205.300 to provide for labeling of products
intended for international markets. Domestically produced organic
products intended for export may be labeled to meet the requirements of
the country of destination or any labeling
[[Continued on page 13561]]
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