[Federal Register: July 18, 2001 (Volume 66, Number 138)]
[Rules and Regulations]
[Page 37397-37401]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr18jy01-1]
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[[Page 37397]]
DEPARTMENT OF AGRICULTURE
Animal and Plant Health Inspection Service
7 CFR Parts 300 and 353
[Docket No. 99-030-2]
Accreditation Standards for Laboratory Seed Health Testing and
Seed Crop Phytosanitary Inspection
AGENCY: Animal and Plant Health Inspection Service, USDA.
ACTION: Final rule.
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SUMMARY: We are amending the export certification regulations to
provide specific standards under which non-government facilities may be
accredited to perform laboratory seed testing and seed crop field
inspection services to serve as the basis for the issuance of a Federal
phytosanitary certificate, export certificate for processed plant
products, or phytosanitary certificate for reexport. The accreditation
standards for these laboratory testing and field inspection services
were developed to provide the basis for non-government facilities to
become accredited to perform the testing or inspection services that
may be used as supporting documentation for the issuance of
certificates for certain plants or plant products.
EFFECTIVE DATE: August 17, 2001. The incorporation by reference
provided for by this rule is approved by the Director of the Federal
Register as of August 17, 2001.
FOR FURTHER INFORMATION CONTACT: Mr. Narcy G. Klag, Program Manager,
Phytosanitary Issues Management, Operational Support, PPQ, APHIS, 4700
River Road Unit 140, Riverdale, MD 20737-1236; (301) 734-8262.
SUPPLEMENTARY INFORMATION:
Background
The export certification regulations contained in 7 CFR part 353
(referred to below as the regulations) set forth the procedures for
obtaining certification for plants and plant products offered for
export or reexport. Export certification is not required by the
regulations; rather, it is provided by the Animal and Plant Health
Inspection Service (APHIS) as a service to exporters who are shipping
plants or plant products to countries that require phytosanitary
certification as a condition of entry. After assessing the condition of
the plants or plant products intended for export relative to the
receiving country's regulations, an inspector will issue an
internationally recognized phytosanitary certificate (PPQ Form 577), a
phytosanitary certificate for reexport (PPQ Form 579), or an export
certificate for processed plant products (PPQ Form 578), if warranted.
Since 1975, APHIS has participated with State governments in the
Cooperative Phytosanitary Export Certification Program, which allows
certain State and county officials, as well as APHIS officials, to
issue phytosanitary certificates, phytosanitary certificates for
reexport, or export certificates for processed plant products. Because
the number of Federal inspectors is limited, the use of State and
county inspectors is a considerable benefit to exporters of plants and
plant products in terms of both time and convenience.
On June 20, 2000, we published in the Federal Register (65 FR
38218-38223, Docket No. 99-030-1) a proposal describing standards to be
used to evaluate facilities for accreditation to perform laboratory
seed testing and seed crop field inspection in accordance with 7 CFR
part 353.
We solicited comments concerning our proposal for 60 days ending
August 21, 2000. We received 28 comments by that date. They were from
seed companies, seed industry associations, plant health associations,
and individuals. All the commenters generally supported the proposed
rule, although three commenters suggested certain specific changes to
it. All issues raised by the commenters are discussed below.
Two commenters suggested that we should replace references to seed
crop field inspection in the rule with the term seed crop phytosanitary
inspection or a similar term, and clarify that this activity includes
inspection of greenhouses or growth chambers where plants are grown for
seed production as well as visual inspection of seed crops. The same
commenters suggested that we replace references to laboratory seed
testing with the term laboratory seed health testing. They stated that
in both cases, the terms in the proposal did not unambiguously identify
the purpose of the inspection and testing.
We agree, and have made the requested changes. We have also
clarified in the discussion of the procedures for seed crop
phytosanitary inspection in Sec. 353.9(b)(2)(i) that this activity
includes inspection of greenhouses or growth chambers where plants are
grown for seed production, as well as visual inspection of seed crops.
One commenter suggested that the rule should specify that the
activities performed by approved facilities include seed sampling for
the purpose of laboratory seed health testing and visual inspection of
seed just prior to export. We believe it is fairly clear in the rule
that facilities that perform seed crop phytosanitary inspection and
laboratory seed health testing may perform these activities as part of
accomplishing the purpose of their inspection and testing. For example,
the rule directs facilities to Reference Manual B for detailed
procedures on seed sampling. However, we have added these two
activities to Sec. 353.9(b)(2)(i) as examples of functions facilities
may perform.
Two commenters suggested, regarding the proposal's discussion of
physical plant and equipment requirements for facilities, that a
laboratory may need all the required equipment for full seed health
testing but not for diagnostic activities in support of phytosanitary
inspection, which often only requires a hand lens. They suggested that
we change the rule to state that the accredited facility must ``have
access'' to this equipment should it be necessary; i.e., make the
equipment required test-dependent.
The intent of the proposed rule was to require facilities to have
specified equipment only if it is needed to perform the tests for which
the facility is accredited. Proposed Sec. 353.9(b)(2) stated that a
facility ``must use the equipment required to conduct the laboratory
testing or seed crop phytosanitary inspections for which it is
accredited.'' To clarify this point, we are
[[Page 37398]]
changing that sentence in this final rule to read that a facility
``must have access to all equipment required to conduct the laboratory
testing or seed crop phytosanitary inspections for which it is
accredited.''
One commenter noted, regarding the proposal's discussion of
serological testing, that some laboratories may use ``field ready test
kits'' that do not require all the equipment listed in
Sec. 353.9(b)(2)(v).
We agree. Proposed Sec. 353.9(b)(2)(v) stated regarding serological
tests that ``These tests require grinding, extraction, and sample
purification equipment; fluorescent microscopes; plate readers;
spectrophotometers; and the appropriate assay materials.'' We are
adding to the end of that sentence the phrase ``or appropriate
equipment to use field ready test kits.''
The same commenter also asked whether APHIS intended to prohibit
field determinations, or to require field determinations to be
confirmed by laboratory diagnostics. If laboratory confirmation is
required, the commenter asked whether APHIS must accredit the
laboratory providing the diagnostic confirmation.
APHIS intends to allow field determinations that are conducted in
accordance with the procedures authorized by Reference Manual B. In the
normal practice of field inspection, samples are routinely sent to a
laboratory for identification or confirmation of a visual
identification. It is not APHIS' intention to accredit these
laboratories. However, the procedures to provide this laboratory
support, including the identity and qualifications of the laboratory,
must be detailed in the accredited facility's quality manual. A
facility's procedures for confirming field inspections may be reviewed
during the initial approval and periodic audits of the accredited
facility.
Two comments addressed the proposed requirement in
Sec. 353.9(b)(4)(i) that ``Evaluation of plant or tissue samples must
be undertaken by a plant pathologist or by laboratory technicians under
the supervision of a plant pathologist.'' These commenters noted that
by using modern communications and computer technology, technicians may
work ``under the supervision of a plant pathologist'' even if the
pathologist is at a different location.
We agree, and have added the following phrase at the end of the
sentence in Sec. 353.9(b)(4)(i): ``who may provide such supervision
either on-site, or from a remote location.''
One commenter suggested that the Association of Official Seed
Analysts should be added to the National Seed Health System (NSHS)
Working Group identified in Reference Manual A.
Membership in the NSHS Working Group is outside the scope of this
rulemaking. This commenter should contact the current chair of the NSHS
Seed Technical Working Group to address this issue.
One commenter addressed a sentence in the economic analysis section
of the proposed rule that read: ``It is expected that, like any
business, seed testing laboratories will recoup these expenses by
appropriate structuring of the fees they set for their services.'' This
commenter noted that, in addition to laboratories, this is also true
for non-laboratory accredited entities providing other phytosanitary
inspection services.
We agree, and have modified the language in this final rule's
economic analysis accordingly.
One commenter asked for APHIS to clarify whether only non-
government entities are eligible to apply for accreditation under the
rule. In particular, this commenter asked about the eligibility of
public universities that administer seed certification units.
Even though most of the examples discussed in the proposed rule
were private, non-government entities, the rule does not preclude
accreditation of governmental agencies or other public institutions,
including public universities. These agencies may apply for
accreditation and, if eligible, will be accredited.
One commenter asked how APHIS will accept and protect confidential
business information submitted by applicants for accreditation.
The regulations already in place at Sec. 353.8(b)(5) state that
``All information gathered during the course of a non-government
facility's assessment and during the term of its accreditation will be
treated by APHIS with the appropriate level of confidentiality, as set
forth in the U.S. Department of Agriculture's administrative
regulations in Sec. 1.11 of this title.'' APHIS will protect the
confidentiality of such information. To make sure that such information
is clearly identified by the applicant, we are adding the following
sentence to paragraph Sec. 353.9(a) in the rule, which describes how to
submit application material: ``If there are portions of the application
deemed to contain trade secret or confidential business information
(CBI), each page of the application containing such information should
be marked `CBI Copy.' ''
One commenter asked whether specific test methodologies and
materials will be in Reference Manual B, or in a facility's quality
manuals. As stated in the proposal, Reference Manual B will contain
specific methodologies to conduct tests, field inspections, sampling,
and related procedures. The facility's quality manual will document the
quality system designed to ensure that the methodologies in Reference
Manual B are followed, and will address matters such as purity of
materials, and calibration of equipment, and so forth. Quality manuals
may summarize or quote methodologies from Reference Manual B to the
extent that facilities find it useful to do so.
One commenter asked whether APHIS accepts liability for incorrect
diagnostics or field inspections carried out by accredited entities.
APHIS does not accept liability for inaccurate results. Once
accredited, individual facilities retain the same liability for
conducting tests that are inaccurate or fraudulent that they bore
before becoming accredited. Facilities should be protected against
liability if they follow the methodologies required by APHIS and report
test and inspection results accordingly. If evidence accumulates that a
particular methodology does not yield reliable results, APHIS may have
to revise that methodology, but accredited facilities are only
responsible for properly conducting and reporting the required
procedures.
One commenter asked for details regarding how often Reference
Manuals A and B will be revised, and when they will be incorporated by
reference. These manuals are currently posted on the APHIS website
(http://www.aphis.usda.gov/ppq/pim/accreditation) in the form in which
they have been incorporated by reference by this final rule. We expect
that the manuals, especially Reference Manual B, will require updating
as new tests are added or as improved test and inspection methodologies
are validated. APHIS intends to update the copies of the Reference
Manuals on the website, and the copies incorporated by reference with
the Office of the Federal Register, as needed, perhaps about twice per
year.
One commenter noted that APHIS has stated that the Iowa State Seed
Science Center will be used on the assessment team to evaluate and
audit facilities applying for accreditation. This commenter stated that
APHIS would need additional help to meet its evaluation workload in
order to process all the applications from interested facilities, and
stated that State governmental agencies could also be used to meet this
need.
[[Page 37399]]
We agree that APHIS will likely need additional assistance to meet
the workload involved in evaluating and auditing facilities. Since
APHIS does not have the capability or expertise to provide the
necessary testing and auditing, we will utilize selected public
facilities to conduct these activities. The Iowa State Seed Science
Center will be used as the initial ``accreditation unit'' under this
system; however, it is anticipated that APHIS may need to utilize other
organizations, including State agencies, to properly evaluate all the
private facilities that wish to be accredited.
Therefore, for the reasons given in the proposed rule and in this
document, we are adopting the proposed rule as a final rule, with the
changes discussed in this document.
Executive Order 12866 and Regulatory Flexibility Act
This rule has been reviewed under Executive Order 12866. The rule
has been determined to be not significant for the purposes of Executive
Order 12866 and, therefore, has not been reviewed by the Office of
Management and Budget.
This rule will amend the export certification regulations to
provide standards under which facilities may become accredited to
perform laboratory seed health testing or inspection services that can
serve as the basis for the issuance of Federal phytosanitary
certificates for export, phytosanitary certificates for reexport, or
export certificates for processed plant products. Accrediting such
facilities is currently allowed under 7 CFR 353.8. The existing
regulations provide a framework upon which accreditation programs could
be established, but they do not, in and of themselves, entail any costs
to APHIS or any facility. However, when facilities are accredited under
the accreditation criteria contained in this rule for seed laboratories
and field inspection facilities, that action will entail costs to both
the entities being accredited and the accrediting body (i.e., APHIS).
Those costs, and the benefits expected from the accreditation program,
are summarized below and were fully evaluated in the economic analysis
section of the previous final rule that established a program for
accrediting facilities, published in the Federal Register on January 8,
1999 (64 FR 1098-1106, Docket No. 95-071-2).
The accreditation program is expected to be self-supporting, and
any costs to APHIS should be recouped through accreditation fees. Costs
for establishing each accredited facility will vary, depending on the
range of activities for which a facility seeks accreditation, the
initial cost of the APHIS preaccreditation assessment, the type and
number of any proficiency tests that will have to be conducted, and the
frequency with which post-accreditation evaluation activities such as
check tests and site visits will have to be conducted. It is expected
that, like any business, seed testing laboratories and other accredited
facilities will recoup these expenses by appropriate structuring of the
fees they set for their services.
The seed industry is expected to benefit from this action because
domestic seed exporters routinely require the services of inspectors
and agents in order to obtain the phytosanitary certification required
by most, if not all, importing countries; benefits can be realized in
terms of more timely certifications, which in turn can lead to reduced
costs as well as increased U.S. exports.
The value of seed exported from the United States to other
countries continues to grow rapidly, from $665 million in 1994-95 (July
to June), to $705 million in 1995-96, to more than $800 million in
1996-97. There has been a concomitant rise in demand for laboratory
testing and inspection services to meet other countries import
requirements. The ability of Federal, State, and county testing and
inspection services to meet this growing demand will be increasingly
strained. Already there are instances in which the availability of
accredited facilities would have prevented the loss of export sales.
For example, some seed export opportunities have been forfeited
because the results of preharvest field inspections are usually not
known until after harvest, due to the limited number and heavy workload
of government laboratories available to perform seed testing. It is
common for seed from several fields to be blended after harvest and
before shipment. If the sample from one field is subsequently reported
to contain an actionable pest, then none of the blended seed--which may
have been harvested from as many as eight or nine fields--could be
exported. In one case in which this occurred, the affected seed company
lost foreign sales worth $250,000. Such losses are much less likely to
occur if there is more timely reporting of preharvest inspections;
accredited inspection facilities may be able to make such timely
reports. In general, we expect that adding a number of non-government
facilities providing testing and inspection services will allow the
future demand for these services to be distributed among facilities in
a manner that will readily adjust to fluctuations in the demand for
these services, and will allow both government and non-government
facilities to report results in a timely manner.
Overall, the economic benefits that should result from the
availability of accredited non-governmental seed laboratories and field
inspection facilities greatly exceed the costs. By providing access to
services by accredited non-government facilities to support the
issuance of phytosanitary certificates that many trading partners
require as a condition of entry for U.S. goods, this action should
greatly enhance export opportunities for U.S. producers. While this
rule does not directly create or open any new markets for U.S. seed
exports, it makes it easier for exporters to obtain necessary
certification in a timely manner. This should result in U.S. companies
obtaining more contracts in which delivery time is of the essence.
While we do not have data to exactly estimate the value of such
potential contracts, comments from seed companies suggest that their
value may be on the order of $10 million per year.
We do not have detailed information on the number of small
businesses engaged in exporting seeds or in testing seeds. Seed and
bulb producers are combined in Standard Industrial Classification (SIC)
0181 with several other types of businesses, and seed testing
laboratories are combined with other types of testing laboratories
under SIC 8734. From the data available, there appear to be several
hundred seed producers that may be small businesses, but very few of
these engage directly in export. Instead, they sell seed to wholesale
seed brokers who sell to export markets. None of these wholesale seed
brokers appear to be small businesses. Several very large seed
production companies are known to sell their products directly to
export markets. With regard to seed testing laboratories, we estimate
that a dozen or so laboratories, some of which are small businesses,
will become accredited in accordance with this rule and will increase
their revenue from inspection and testing services.
Under these circumstances, the Administrator of the Animal and
Plant Health Inspection Service has determined that this action will
not have a significant economic impact on a substantial number of small
entities.
Executive Order 12372
This program/activity is listed in the Catalog of Federal Domestic
Assistance under No. 10.025 and is subject to Executive Order 12372,
which requires
[[Page 37400]]
intergovernmental consultation with State and local officials. (See 7
CFR part 3015, subpart V.)
Executive Order 12988
This rule has been reviewed under Executive Order 12988, Civil
Justice Reform. This rule: (1) Preempts all State and local laws and
regulations that are inconsistent with this rule; (2) has no
retroactive effect; and (3) does not require administrative proceedings
before parties may file suit in court challenging this rule.
Paperwork Reduction Act
This rule contains no new information collection or recordkeeping
requirements under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501
et seq.)
List of Subjects
7 CFR Part 300
Incorporation by reference, Plant diseases and pests, Quarantine.
7 CFR Part 353
Exports, Incorporation by reference, Plant diseases and pests,
Reporting and recordkeeping requirements.
Accordingly, 7 CFR parts 300 and 353 are amended as follows:
PART 300--INCORPORATION BY REFERENCE
1. The authority citation for part 300 continues to read as
follows:
Authority: 7 U.S.C. 7701-7772; 7 CFR 2.22, 2.80, and 371.3.
2. In Sec. 300.1, new paragraphs (c) and (d) are added to read as
follows:
Sec. 300.1 Materials incorporated by reference.
* * * * *
(c) Reference Manual A. The Reference Manual for Administration,
Procedures, and Policies of the National Seed Health System, which was
published on February 25, 2000, by the National Seed Health System
(NSHS), has been approved for incorporation by reference in 7 CFR
chapter III by the Director of the Office of the Federal Register in
accordance with 5 U.S.C. 552(a) and 1 CFR part 51. Copies of Reference
Manual A:
(1) Are available for inspection at the Office of the Federal
Register Library, 800 North Capitol Street NW, Suite 700, Washington,
DC, and the APHIS Library, U.S. Department of Agriculture, 4700 River
Road, Riverdale, MD 20737; or
(2) May be obtained by writing to Phytosanitary Issues Management,
Operational Support, PPQ, APHIS, 4700 River Road Unit 140, Riverdale,
MD 20737-1236, and on the APHIS Web site at http://www.aphis.usda.gov/
ppq/pim/accreditation.
(d) Reference Manual B. The Reference Manual for Seed Health
Testing and Phytosanitary Field Inspection Methods, which was published
on February 27, 2001, by the National Seed Health System (NSHS), has
been approved for incorporation by reference in 7 CFR chapter III by
the Director of the Office of the Federal Register in accordance with 5
U.S.C. 552(a) and 1 CFR part 51. Copies of Reference Manual B:
(1) Are available for inspection at the Office of the Federal
Register Library, 800 North Capitol Street NW, Suite 700, Washington,
DC, and the APHIS Library, U.S. Department of Agriculture, 4700 River
Road, Riverdale, MD 20737; or
(2) May be obtained by writing to Phytosanitary Issues Management,
Operational Support, PPQ, APHIS, 4700 River Road Unit 140, Riverdale,
MD 20737-1236, and on the A APHIS Web site at http://
www.aphis.usda.gov/ppq/pim/accreditation.
PART 353--EXPORT CERTIFICATION
3. The authority citation for part 353 continues to read as
follows:
Authority: 7 U.S.C. 7711, 7712, 7718, 7751, and 7754; 21 U.S.C.
136 and 136a; 7 CFR 2.22, 2.80, and 371.3.
4. In Sec. 353.1, definitions of Reference Manual A and Reference
Manual B are added, in alphabetical order, to read as follows:
Sec. 353.1 Definitions.
* * * * *
Reference Manual A. The Reference Manual for Administration,
Procedures, and Policies of the National Seed Health System, published
by the National Seed Health System (NSHS). Reference Manual A describes
the structure, administration, procedures, policies, and working
practices of the NSHS and also contains relevant documentation, forms,
and references for the NSHS. Reference Manual A is incorporated by
reference at Sec. 300.1 of this chapter, and is available by writing to
Phytosanitary Issues Management, Operational Support, PPQ, APHIS, 4700
River Road Unit 140, Riverdale, MD 20737-1236, and on the APHIS Web
site at http://www.aphis.usda.gov/ppq/pim/accreditation.
Reference Manual B. The Reference Manual for Seed Health Testing
and Phytosanitary Field Inspection Methods, published by the National
Seed Health System (NSHS). Reference Manual B contains the detailed
seed health testing, seed sampling, and inspection procedures for the
NSHS. Reference Manual B is incorporated by reference at Sec. 300.1 of
this chapter, and is available by writing to Phytosanitary Issues
Management, Operational Support, PPQ, APHIS, 4700 River Road Unit 140,
Riverdale, MD 20737-1236, and on the APHIS Web site at http://
www.aphis.usda.gov/ppq/pim/accreditation.
* * * * *
Sec. 353.8 [Amended]
5. Section 353.8 is amended by adding a new sentence at the end of
the section to read as follows: ``(Approved by the Office of Management
and Budget under control number 0579-0130)''.
6. A new Sec. 353.9 is added to read as follows:
Sec. 353.9 Standards for accreditation of non-government facilities to
perform laboratory seed health testing and seed crop phytosanitary
inspection.
(a) Application for accreditation, certification of accreditation,
and monitoring of accredited facilities. A facility may apply to be
accredited to perform laboratory seed health testing or seed crop
phytosanitary inspection, or to renew such accreditation, by submitting
an application in accordance with Sec. 353.8(b)(2) of this part. If
there are portions of the application deemed to contain trade secret or
confidential business information (CBI), each page of the application
containing such information should be marked ``CBI Copy.'' The
application must be accompanied by a copy of the facility's quality
manual and a nonrefundable application fee of $1,000. The applicant
must make additional deposits to cover the costs of gaining and
maintaining accreditation into a trust fund established in accordance
with Sec. 353.8(c) of this part upon request by the Administrator.
(1) Upon determining that a facility is eligible for accreditation,
the Administrator will issue the facility a certificate of
accreditation. Accreditation will be for a period of 3 years from the
date of issuance of the certificate of accreditation and may be renewed
by submitting a new application and application fee in accordance with
this paragraph.
(2) The Administrator may deny or withdraw accreditation in
accordance with Sec. 353.8(a)(2) of this part. A facility may appeal
denial of accreditation in accordance with Sec. 353.8(a)(2)(i) of this
part, and may appeal withdrawal of
[[Page 37401]]
accreditation in accordance with Sec. 353.8(a)(2)(ii) of this part.
(3) A facility that has been denied accreditation or had its
accreditation withdrawn may not reapply within 60 days of the date the
facility was notified in writing that accreditation was denied or
withdrawn.
(4) After a facility is accredited, the facility must allow APHIS
access to the facility and all of its equipment and records for the
purpose of conducting unannounced audits to determine the facility's
continuing eligibility for accreditation. Such audits will occur at
least once a year and may be performed more frequently at the
discretion of the Administrator.
(b) Standards for accreditation. A facility that, in accordance
with Sec. 353.8(b)(2) of this part, applies to be accredited to perform
laboratory seed health testing or seed crop phytosanitary inspection
will be evaluated for accreditation against these standards:
(1) Physical plant. The facility's physical plant (e.g., laboratory
space, office space, greenhouses, vehicles, etc.) must:
(i) Have laboratory and office spaces enclosed by walls and locking
doors to prevent unauthorized access;
(ii) Conform to all State and local zoning and other ordinances;
and
(iii) Provide a work area that is dedicated to laboratory functions
and has sufficient space to conduct the required tests and store the
materials and samples required for the tests in a manner that prevents
contamination by other samples in the laboratory and from other
sources.
(2) The facility must have access to all equipment required to
conduct the laboratory testing or seed crop phytosanitary inspections
for which it is accredited. Specific test methodologies, materials, and
the calibration and monitoring of the equipment must conform to
Reference Manual B, which is incorporated by reference at Sec. 300.1 of
this chapter. The general requirements for each test category are as
follows:
(i) Seed crop phytosanitary inspections. Seed crop phytosanitary
inspection may also include related activities such as collection of
seed samples for later laboratory testing, visual inspection of seed
just prior to export, and inspection of greenhouses or growth chambers
where plants are grown for seed production, as well as visual
inspection of seed crops. In the field, inspectors must use accurate
field maps, hand lenses, and secure containers for the collection,
storage, and transportation of samples. Inspectors must have direct
access to a laboratory that is fully equipped to carry out any
necessary diagnostic tests needed for field samples.
(ii) Direct visual examination. Visual examination of seed requires
a stereo microscope. Visual examination of tissue requires a compound
light microscope. Visual examination of loosely attached or
accompanying material requires a centrifuge and shaker.
(iii) Incubation. Required equipment includes incubation chambers,
laminar flow hoods, media preparation equipment, scales, pH meters,
distilled and sterile water, gas burners, an autoclave, and the
appropriate media for the specified tests.
(iv) Grow-out tests. Grow-out tests require a greenhouse, growth
chamber, or an outdoor quarantine location, and access to a laboratory
that is fully equipped to carry out any required diagnostic tests.
(v) Serological tests. These tests require grinding, extraction,
and sample purification equipment; fluorescent microscopes; plate
readers; spectrophotometers; and the appropriate assay materials; or
the appropriate equipment to use field ready test kits.
(vi) DNA probes. To conduct these tests, a laboratory must be
equipped with polymerase chain reaction (PCR) equipment, including
thermal cyclers, electrophoresis and gel blotting equipment, and the
reagents and DNA polymerases necessary to conduct the PCR.
(3) Methods of testing and inspection. The facility must conduct
its laboratory seed health testing and seed crop phytosanitary
inspection procedures in accordance with Reference Manual B. The
facility must have a quality manual documenting its quality system for
laboratory seed health testing and seed crop phytosanitary inspection
procedures. The quality system must follow the general guidelines
described in ANSI/ASQC Q9001-1994, American National Standard: Quality
Systems-Model for Quality Assurance in Design, Development, Production,
Installation and Servicing. Acceptable models for quality systems for
accredited facilities are also described in detail in Reference Manual
A, which is incorporated by reference at Sec. 300.1 of this chapter.
The personnel who perform the testing and inspection services must
comply with the quality manual, and management must enforce this
compliance. The facility must maintain documented procedures for
identification, collection, indexing, access, filing, storage,
maintenance, and disposition of quality system records. The facility
must maintain quality system records to demonstrate conformance to the
quality manual and the effective operation of the quality system.
(4) Personnel. There must be a selection procedure and a training
system to ensure technical competence of all staff members. The
education, technical knowledge, and experience required to perform
assigned test and inspection functions must be documented and clearly
defined. In addition:
(i) Evaluation of plant or tissue samples must be undertaken by a
plant pathologist or by laboratory technicians under the supervision of
a plant pathologist, who may provide such supervision either on-site,
or from a remote location. Where personnel are required to be trained
at a facility to evaluate the particular types of plants or tissue
samples handled by the facility, the training program must be evaluated
by APHIS and determined to be effective.
(ii) All staff must have access to and be familiar with the
reference materials, guides, and manuals required for the routine
performance of the tests and inspections they conduct.
(Approved by the Office of Management and Budget under control
number 0579-0130.)
Done in Washington, DC, this 11th day of July 2001.
Craig A. Reed,
Administrator, Animal and Plant Health Inspection Service.
[FR Doc. 01-17839 Filed 7-17-01; 8:45 am]
BILLING CODE 3410-34-U
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