[Federal Register: May 1, 2001 (Volume 66, Number 84)]
[Rules and Regulations]
[Page 21631-21639]
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Rules and Regulations
Federal Register
DEPARTMENT OF AGRICULTURE
Food Safety and Inspection Service
9 CFR Parts 362 and 381
[Docket No.01-045IF]
RIN 0583-AC84
Mandatory Inspection of Ratites and Squabs
AGENCY: Food Safety and Inspection Service, USDA.
ACTION: Interim final rule.
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SUMMARY: The Food Safety and Inspection Service (FSIS) is amending the
Poultry Products Inspection Regulations (Part 381) and the Voluntary
Poultry Inspection Regulations (Part 362) to include ratites and squabs
under the mandatory poultry products inspection regulations. The Agency
is responding to the FY 2001 Agriculture, Rural Development, Food and
Drug Administration and Related Agencies Appropriations Act (the
Appropriations Act), signed by the President on October 28, 2000, which
provides that 180 days after the date of its enactment, U.S.
establishments slaughtering or processing ratites or squabs for
distribution into commerce as human food will be subject to the
requirements of the Poultry Products Inspection Act (PPIA), rather than
the voluntary poultry inspection program under section 203 of the
Agricultural Marketing Act of 1946 (AMA). The provision of the
Appropriations Act specifying that ratites and squabs come under the
Agency's mandatory inspection requirements is effective on April 26,
2001. Interested parties may comment on this interim final rule.
DATES: This interim final rule will be effective April 26, 2001.
Comments must be received on this interim final rule by July 2, 2001.
ADDRESSES: Submit one original and two copies of written comments
within the scope of the rulemaking to FSIS Docket Clerk, Docket #01-
045IF, U.S. Department of Agriculture, Food Safety and Inspection
Service, Room 102, Cotton Annex, 300 12th Street, SW., Washington, DC
20250-3700. All comments submitted in response to this proposal will be
available for public inspection in the Docket Clerk's Office between
8:30 a.m. and 4:30 p.m., Monday through Friday.
FOR FURTHER INFORMATION CONTACT: For information about the interim
final rule, contact Dr. Arshad Hussain, Director, Inspection and
Enforcement Standards Development Staff, Office of Policy, Program
Development, and Evaluation, FSIS, U.S. Department of Agriculture, Room
202, Cotton Annex, 300 12th Street, SW, Washington, DC 20250-3700,
(202) 720-3219.
SUPPLEMENTARY INFORMATION:
Background
On October 28, 2000, the President signed the Appropriations Act,
which provides that 180 days after the date of its enactment, U.S.
establishments that slaughter or process ratites (such as ostriches,
emus, and rheas) or squabs for distribution into commerce as human food
will be subject to the requirements of the PPIA (21 U.S.C. 451, et
seq.), rather than the voluntary poultry inspection program under
section 203 of the AMA (7 U.S.C. 1622). This provision of the
Appropriation Act is effective on April 26, 2001.
Ratites are members of a superorder (Ratitae) of flightless birds
that have small or rudimentary wings and flat breastplates, e.g.,
ostriches, emus, and rheas. Squabs are young pigeons that have not yet
flown.
Ratites are currently inspected under the Voluntary Poultry
Inspection Regulations as an experimental program. Operators who wish
to continue to slaughter or process ratites or squabs after April 26,
2001, for transport or sale in commerce must apply to FSIS for a grant
of inspection for mandatory inspection service (Secs. 381.6 and
381.16). As of April 26, 2001, grants of voluntary inspection for
ratites and squabs will no longer be valid. Fees for ratite and squab
inspection services will no longer be charged, except for overtime and
holiday inspection services. Applications for mandatory inspection must
be submitted on an FSIS application form available from any FSIS
District Office or from FSIS Headquarters, Washington, DC 20250. FSIS
will give notice in writing to each applicant granted (or denied)
inspection.
Under the regulations that implement the PPIA, before being granted
Federal inspection, an establishment must have written Sanitation
Standard Operating Procedures (SOPs) (Sec. 381.22(a)) and a Hazard
Analysis and Critical Control Point (HACCP) plan that the establishment
has validated (Sec. 381.22 (b) and (c)). Establishments can receive
conditional grants of inspection for a period of not more than 90 days
while they validate their HACCP plans (Sec. 381.22(b)).
Import Inspection
This interim final rule will be effective on April 26, 2001. Within
18 months of that date, imported ratite or squab products will have to
originate in countries that are eligible to export poultry to the
United States and will have to be processed in establishments certified
by the government of the foreign country as eligible to export to the
United States. Currently, these countries include Canada, France, Great
Britain, and Israel. Hong Kong and Mexico have not yet been approved by
the United States to slaughter poultry; therefore, they are only
eligible to export to the United States processed poultry products that
originate from Canada, France, Great Britain, Israel, or the United
States (Sec. 381.196).
All countries exporting or wanting to export ratite and squabs
products to the United States, regardless of their current eligibility
status regarding meat and poultry product exports to the United States,
may do so for the next 18 months subject to the following. Countries
already eligible to export poultry to the United States will be able to
export ratites and squabs as soon as they certify to FSIS those
establishments eligible to export to the United States. These countries
are Canada, Israel, Great Britain, and France. Animal health
restrictions continue to apply so there is no change with regard to the
eligibility of specific products based on APHIS regulations.
Countries eligible to export meat to the United States will be
permitted to export ratites to the United States
[[Page 21632]]
provided the animals are slaughtered in an establishment certified to
export to the Unites States and provided the countries submit a request
for establishing equivalency. Certified establishments are required to
meet FSIS HACCP and Pathogen Reduction requirements. At this point,
Australia and New Zealand, which are both eligible to export meat to
the United States, have indicated that they want to export ratites.
Countries not eligible to export meat or poultry to the United
States will need to submit a request for equivalency and FSIS will need
to make an equivalency determination according to 9 CFR Part 327.
As indicated above, however, each country desiring to begin or
continue exporting such products to the United States will have to
apply for an equivalence determination of its ratite and squab
inspection system. Countries' ratite and squab export inspection
systems must be found to be equivalent with the U.S. domestic
inspection system within 18 months of the effective date of the
Agency's new mandatory ratite and squab inspection requirements (April
26, 2001).
After the 18 month period has ended, all shipments of ratites and
squabs from eligible countries must be accompanied with the appropriate
veterinary health certificate (Sec. 381.197) and must be presented to
FSIS for import reinspection prior to entry (Sec. 381.199).
Countries wanting to export ratites and squab to the United States
should make a written request to export poultry to FSIS through the
United States Embassy located in the country. FSIS will conduct both a
document review and an on-site audit to determine if the country
operates an equivalent poultry inspection system.
During the review, FSIS will work cooperatively with the Animal and
Plant Health Inspection Service, which approves the entry of poultry
products according to the disease status of the exporting country.
If the country's export inspection system is found to be equivalent
with the U.S. domestic inspection system, FSIS will publish a proposal
in the Federal Register to list the country as eligible to export
poultry products to the United States. After the public has had 60 days
to comment on this proposed rule, FSIS will review all of the public
comments and make a final determination of equivalence. The
determination to list a country as equivalent, and, therefore, eligible
to export poultry products to the United States, is published as a
final rule in the Federal Register, along with FSIS's responses to the
public comments. At that time, the country's inspection service may
certify establishments for export of poultry products, including
ratites and squabs, to the United States.
Summary of Interim Final Rule
FSIS is making a number of technical changes in its regulations,
which it believes are noncontroversial, to provide for the inspection
of ratites and squabs. The Agency is amending 9 CFR 362.1(d) to remove
squab from the definition of ``Poultry'' in the Voluntary Poultry
Inspection Regulations. FSIS is also amending Sec. 362.1(e) to include
ratites and squabs with chickens, turkeys, ducks, geese, and guineas in
the definition of ``Poultry Product.'' The Agency is also amending
Sec. 381.1(b) to include ratites and squabs within the definition of
``Poultry'' in the Poultry Products Inspection Regulations.
FSIS is amending Sec. 381.36(b) to require a pen for the ante
mortem inspection of ratites. It is necessary to specify that a pen be
available for ratites because ante mortem inspection of ratites is done
on an individual bird basis, rather than a lot basis as is done for
other amenable poultry.
The Agency is amending Sec. 381.66 to exempt ratites from the
chilling requirements of Sec. 381.66 paragraphs (b), (c), and all of
(d), except for (d)(1). Ratites are air-chilled rather than water-
chilled, as is the case with most amenable poultry.
FSIS is amending Sec. 381.67 to include squabs with young chickens
under traditional inspection procedures. The two types of birds are of
similar size and weight and thus can be inspected in a similar manner.
The Agency is amending Sec. 381.70 to permit an exception to
examining and inspecting ratites on the day of slaughter for humane
reasons or, for low volume establishments, under certain conditions.
This amendment allows the humane handling of ratites to be the same as
that for livestock.
FSIS is amending Sec. 381.71 to provide information on how suspect
and condemned ratites are to be handled. This amendment is necessary
because the treatment of suspect and condemned ratites is different
than the treatment of suspect and condemned birds of other amenable
species.
FSIS is amending Sec. 381.72 to reflect the fact that ratites
showing disease symptoms at ante mortem will be handled differently
than other diseased poultry.
The Agency is amending Sec. 381.76 to add Ratite Inspection as the
fifth post mortem poultry inspection system. This amendment is
necessary because inspection of ratites must be done in a different
manner than inspection of other amenable poultry species. Thus,
inspection of ratites cannot be done under the existing four inspection
systems.
FSIS is amending Sec. 381.96 to provide that ratite carcasses and
parts that are shipped unpacked must bear the official brand. This
addition is necessary because ratites are the only species of amenable
species that are likely to be shipped unpacked.
Finally, FSIS is proposing to make some editorial changes to
Sec. 362.1 to correct inaccuracies and to provide for greater clarity.
Regulatory Impact Analysis
Basis for Regulatory Action
Currently, ratites and squabs are inspected on a voluntary, fee-
for-service basis under section 203 of the AMA. The interim final rule
will amend Sec. 362.1(d) to remove squab from the definition of poultry
in the Voluntary Poultry Inspection Regulations and will amend
Sec. 381.1 to include ratites and squabs under the Agency's mandatory
poultry inspection requirements.
Congress mandated, in the FY 2001 Agriculture Appropriation Act,
that 180 days from the date of enactment (April 26, 2001) U.S.
establishments that slaughter or process ratites or squabs will come
under mandatory inspection by FSIS.
Baseline
Ratites and squabs are considered non-amenable species and are
currently inspected by the Agency on a voluntary, fee-for-service
basis.\1\ These species are also inspected on a mandatory or voluntary
basis under State programs. Ratites are an order of flightless birds
that includes ostriches, emus, rheas, cassowaries, and kiwis. The most
economically important species of ratites are the ostrich and the emu.
Squabs are young domesticated pigeons that have never flown. Ratite and
squab meat is valued for its flavor and nutritional characteristics.
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\1\ The FMIA and PPIA do not mandate the inspection of ratites
and squabs. FSIS provides, on a fee-for-service basis, voluntary
inspection services under the Argicultural Marketing Act of 1946 for
these species and others such as reindeer, elk, deer, antelope,
water buffalo, bison, migratory water fowl, game birds, and rabbits.
The Food and Drug Administration has primary statutory authority
over all food animals and birds not covered by the FMIA and the
PPIA.
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Since 1992, when FSIS first granted a request for voluntary
inspection for ostriches, approximately 166 establishments have been
issued a grant of inspection for ratite operations.
[[Page 21633]]
Currently 99 establishments possess a grant of inspection. In 1999,
there were a total of 48,286 (76%) ratites inspected in Federal
establishments and 14,427 (24%) ratites inspected in State
establishments, or a total of 62,713 ratites inspected (Table 1).
Ostriches made up the largest share (69%) of the ratites inspected
under the Federal program, whereas emus made up the largest share (56%)
of the ratites inspected under State programs.
Table 1.--Ratites and Squab Inspection Volume and Establishments, FY 1999
----------------------------------------------------------------------------------------------------------------
Federal State establishments
establishments ----------------------
Species ---------------------- Total
Number % of Number % of inspected
inspected total inspected total
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Ratites
Ostrich............................................ 33,521 86 5,254 14 38,775
Emu................................................ 14,745 64 8,068 36 22,813
Other.............................................. 20 2 1,105 98 1,125
--------------------------------------------------------
Ratites Total.................................... 48,286 76 14,427 24 62,713
Squabs................................................. 175,496 14 1,122,131 86 1,297,627
--------------------------------------------------------
Totals............................................. 223,782 16 1,136,558 84 1,360,240
========================================================
Ests. Number Number
------------- -------------
Squabs............................................. 2 2
Ratites............................................ 99 95
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In 1999, states with a large share of ratites inspected under the
Federal program were California, Georgia, Illinois, Louisiana,
Oklahoma, and Texas. Alabama, California, Mississippi, North Carolina,
Ohio, and Texas inspected a large share of ratites under State
programs. There were almost an equal number of establishments involved
in slaughter of ratites under the Federal (99) and State (95)
inspection programs.
Ostriches
Ostrich is the largest bird in the world, standing about seven to
eight feet tall and weighing 300-400 pounds when fully grown. Industry
representatives indicate that there were about 600 ostrich growers
1998, down from 1000 growers in 1996. There is significant uncertainty
about the annual production of ostriches and other ratites at this
time. The Agency requests reliable information on the annual number of
ratites and squab produced and the number of producers.
Ostriches are slaughtered at an average age of 12 months. The
average weight at slaughter is 350 pounds. Ostrich meat is sold as
steaks, fillets, medallions, roasts, and ground meat. Currently,
ostriches are processed in establishments that are equipped to process
other red meat species such as cattle, sheep, goats, and swine.
Emus
A mature emu reaches a height of 5 to 6 feet tall, weighing 90 to
120 pounds. In 1999, 22,813 emus were inspected under Federal and State
programs (Table 1). There are a number of valuable products derived
from emus in addition to their meat.
There is also significant uncertainty about the annual production
of emus. Some source indicate that there may be as many as 500,000
birds on 5,000 to 6,000 farms in the U.S., with the majority of them in
Texas, Oklahoma, and elsewhere in the Southwest.
Squabs
Squabs are young domesticated pigeons that have never flown. Squabs
usually weigh 1 pound or less at the time of slaughter (about 4 weeks
old). In 1999, California and Oregon were the only two states that
inspected squabs under the Federal voluntary inspection program. In
that year, 175,496 squabs were inspected (Table 1). During that same
period 1,122,131 squabs were inspected under the inspection programs of
California and South Carolina.
Regulatory Alternatives
FSIS considered two options in developing its interim final rule.
The first option the Agency considered was to only change the
definition of poultry in the Poultry Products Inspection Regulations to
include ratites and squabs. This approach may have caused confusion in
the industry because it would be difficult to apply some of the current
poultry regulations to ratites and squabs, e.g., chilling and certain
handling requirements.
The Agency's second option was to make the changes required by
statute and other changes as noted above. FSIS selected this option
because it will provide a more orderly transition from voluntary
inspection to mandatory inspection of ratites and squabs than the first
option at little or no additional cost.
Benefits
There are three primary benefits that may result from extending
mandatory inspection services to ratites and squabs: industry growth,
public health, and industry cost savings.
Having the inspection mark on the ratite and squab products could
lead to greater consumer confidence and acceptability of the products.
Demand could be expected to increase as a result. Establishments that
are able to capitalize on the change in consumer preference may realize
increased sales of these products. To the extent that inspection
promotes growth in the ratite and squab industry, society could benefit
also from the increased employment and earnings of workers in these
establishments. Studies are not available to identify the potential
growth in the industry that may occur.
The public health benefits of inspection are related to the
reduction in risk associated with consumption of all ratite and squab
meat that must be inspected using the same procedures employed in the
meat and poultry industries. HACCP systems, Sanitation SOPs, and
process control practices have been shown to reduce contamination by
harmful foodborne pathogens.
A shift to the mandatory inspection system will eliminate the
payment of
[[Page 21634]]
fees for inspection services. This is not a benefit from an economic
perspective as the costs of inspection are transferred elsewhere in the
economy. Since FSIS will recover these costs through appropriated
funds, the change to a mandatory inspection system results in an income
transfer from the public to the ratite and squab industry. The total
cost savings to the industry would be about $2 million in 2001, with
the possibility of increasing over time with the expansion of the
industry.
Industry Costs
The compliance cost of extending mandatory inspection to ratite and
squab species will be negligible. All establishments involved in
slaughtering amenable species, as of January 25, 2000, must be in
compliance with the provisions of Pathogen Reduction/Hazard Analysis
Critical Control Point (PR/HACCP) final rule. Under the provisions of
the rule, all slaughter establishments under mandatory inspection are
required to have HACCP plans and meet process control requirements.
Nearly all establishments that slaughter and process ratites and squabs
because they also slaughter other species under mandatory inspection
have already implemented HACCP, Sanitation SOPs, and other measures
consistent with the requirements of this rule. These establishments
will still be required to make changes to their HACCP or sanitation
procedures to include ratites and squabs. Establishments that have not
included ratites and squabs in their HACCP plans \2\ would incur
minimal costs associated with HACCP plan modification.
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\2\ HACCP plans are not required to cover non-amenable species.
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As poultry is subject to mandatory Federal inspection, ratites and
squabs will be subject to E. coli testing requirements. Establishments
that slaughter more than one kind of poultry and livestock are required
to test the kind of species slaughtered in the greatest number. The
number of establishments where ratites and squabs will be the species
being slaughtered in the greatest number is very low. Consequently,
very few establishments will be required to perform additional E. coli
testing for process control verification. The costs per establishment
for E. coli testing are shown in Table 2. The Agency is requesting
information on the number of establishments where ratites or squabs
are, or would become, the major species for slaughter.
For those establishments slaughtering and processing ratites and
squabs under voluntary inspection, the transition to mandatory
inspection will not require changes in equipment and processing
methods. Ratites are currently being slaughtered and processed in
establishments that are equipped to process cattle, sheep, goats, and
swine. Squabs are processed using the same equipment and procedures as
those used for young chickens.
The Agency estimates that 50% of the Federal establishments (50
establishments) and 25% of the State establishments (24 establishments)
may be required to make minor changes in their HACCP plan to
accommodate mandatory inspection requirements for ratites.
Table 2.--Potential Costs for Mandatory Federal Inspection
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Per est. Industry
Costs (dollars) ($thousand)
------------------------------------------------------------------------
Start up Cost:
HACCP Plan Modification............. 500 37.0
SSOP Modification................... 100 7.4
Recurring Cost: E. coli Sampling (26 520 38.5
samples@$20 per sample per
establishment).........................
Recordkeeping........................... 300 22.2
-------------------------------
Total............................. 1,420 105.1
------------------------------------------------------------------------
The Agency seeks comment or further information pertaining to its
cost figures for mandatory inspection.
Other additional costs that would apply to all establishments
applying for Federal mandatory inspection will be the application cost.
This cost will be negligible, as it is limited to a one-time cost for
filling out an application, about $10. The total compliance cost to the
establishments identified above are estimated to be $105,100.
FSIS is aware that some State inspected ratite product may contain
sodium nitrite and/or sodium nitrate even though the Food and Drug
Administration (FDA) regulations do not authorize such use of these
substances for ratite products. However, once ratites are officially
defined as poultry under PPIA regulations, such use will not be allowed
in FSIS inspected products. FSIS does not have information on the types
or amounts of product affected by this change, but is seeking
information.
FSIS Costs
The Agency anticipates the need to conduct baseline microbiological
and chemical residue studies. These studies constitute the major costs
to the Agency totaling $600,000.
Microbiological Testing
The microbiological studies would help the Agency determine the
prevalence of harmful bacteria or pathogens in ratites and squabs.
These studies can also be used to develop performance standards for
pathogen reduction. The costs of a microbiological baseline testing for
ratites are $110,000 and for squabs, $95,000 (Tables 3 and 4).
Chemical Residue Testing
Chemical residue studies would help the Agency determine the
presence of violative chemical and drug residues in ratites and squabs.
Chemical residue testing would be necessary to determine how these
additional species would be incorporated in the Agency's annual residue
testing program. FSIS' one-time costs for chemical residue studies for
ratites and squabs are $210,000 and $185,000, respectively (Tables 3
and 4).
[[Page 21635]]
Table 3.--Cost to FSIS of a Mandatory Ratite Inspection Program
------------------------------------------------------------------------
Inspection Thousands of
One-time costs hours dollars
------------------------------------------------------------------------
Chemical Residue Study.................. .............. 210.0
Microbiological Baseline................ .............. 110.0
-------------------------------
Total............................... .............. 320.0
Transfer Payment:\1\ Federally-Inspected 38,524 1,959.0
Ests...................................
------------------------------------------------------------------------
\1\ The hourly rate for Federal inspection in FY 2000 is estimated to be
$38.44 per hour.
Table 4.--FSIS Mandatory Squab Inspection Program Costs
------------------------------------------------------------------------
Inspection Thousands of
One-time costs hours dollars
------------------------------------------------------------------------
Chemical Residue Study.................. .............. 185.0
Microbiological Baseline................ .............. 95.0
-------------------------------
Total............................... .............. 280.0
Transfer Payment:\1\ Federally-Inspected 322 16.4
Ests...................................
------------------------------------------------------------------------
\1\ The hourly rate for Federal inspection in FY 2000 is estimated to be
$38.44 per hour.
Transfer Payments
Under voluntary inspection, establishments pay for inspection
services. The funds for mandatory inspection activities are
appropriated from Federal tax revenues. The transition from voluntary
to mandatory inspection changes the source of inspection program
funding. The Agency estimates that the industry cost of inspection of
ratites and squabs for 1999 in Federal establishments was $1,975,000,
of which ratites accounted for $1,959,000 and squabs, $16,400,
including overhead (Tables 3 and 4).
When ratite and squab inspection becomes mandatory, it is possible
that the volume of ratites and squabs inspected at Federally inspected
establishments will increase beyond what is currently being inspected.
First, there may be significant volumes of ratites and squabs that are
currently slaughtered and consumed without inspection that would be
brought under inspection. Second, an establishment currently under a
State inspection program that is shipping ratites and squabs in
interstate commerce would have to shift to Federal inspection to
maintain its markets. It is expected that 25% of the establishments
under State voluntary inspection would migrate to the Federal mandatory
program. The analysis does not take into account the potential increase
in the demand for inspection services. Both species currently account
for an extremely small share of meat and poultry inspection. Changes in
the required level of inspection program personnel are not expected to
be significant in the near-term.
The estimated total cost of inspection in State establishments is
$554,400 for 14,427 ratites and 1,122,131 squabs for FY 1999. Under the
current agreement the Agency has with state having a voluntary
inspection program, the Agency pays half of the inspection program
costs, or $277,191 (Table 5).
Under a mandatory program, states would no longer be able to
collect fees for inspection services. States may decide to terminate
their ratite and squab inspection program. If this occurs, FSIS will
take over inspection at the facilities operating under a State program
and thereby absorb the total costs of inspection at these
establishments. For those states that do not have a State voluntary
program for ratites and squabs, the impact of a Federal mandatory
inspection program will be minimal. The payment of these costs at
previously State inspected establishments is an income transfer similar
to that occurring for Federally inspected establishments.
The total transfer payment to Federal and State establishments is
$2,252,000 (1,975,000 plus 277,000).
Table 5.--Ratites and Squabs Inspection Cost at State Establishments--FY 1999
----------------------------------------------------------------------------------------------------------------
Total
Number inspection Total cost of
Species inspected hours inspections
required \1\
----------------------------------------------------------------------------------------------------($thousand)-
Ratites......................................................... 14,427 11,510 442.4
Squabs.......................................................... 1,122,131 2,912 111.9
-----------------------------------------------
Total....................................................... 1,136,558 14,422 554.4
----------------------------------------------------------------------------------------------------------------
\1\ FSIS hourly base rate of $38.44 times inspection hours required.
Consumer Cost
In large part, the costs of ratite and squab inspection are
transferred from producers to taxpayers. As the burden of paying for
inspection service is eliminated, establishments may transfer these
cost savings to consumers through lower prices.
Economic Impact on International Trade Assessment
Countries that previously had little interest in export
certification may petition FSIS if additional species come under
mandatory inspection. Foreign
[[Page 21636]]
establishments that specialize in exotic species may seek to broaden
their markets by exporting to the United States. The Agency may need to
evaluate the equivalence of a greater number of foreign food regulatory
inspection systems.
Executive Order 12866 and Regulatory Flexibility Act
Because this interim final rule has been determined to be
significant, the Office of Management and Budget (OMB) has reviewed it
under Executive Order 12866.
The Administrator, FSIS, has determined that this interim final
rule would not have a significant economic impact, as defined by the
Regulatory Flexibility Act (5 U.S.C. 601), on a substantial number of
small entities.
Small establishments will not be adversely affected by this interim
final rule. Few establishments slaughter and process ratites or squabs
exclusively. They usually slaughter and process both amenable and non-
amenable species. For small slaughtering establishments as well as
large ones, ratites and squabs do not comprise all or even most of
their business. Of the 100 establishments that slaughter or process
ratites and squabs, only two slaughter over 90% of the squabs consumed
in the market. There are no establishments that dominate the
slaughtering of ratites. Small entities will benefit along with the
rest of the industry with the increased marketability of their product
and the cost savings realized because they will no longer have to pay
fees to either FSIS or the state for voluntary inspection service.
Executive Order 12988
This interim final rule has been reviewed under Executive Order
12988, Civil Justice Reform. This interim final rule: (1) Preempts
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. However, the administrative procedures specified
in 9 CFR 306.5, 381.35, and 590.320 through 590.370, respectively, must
be exhausted before any judicial challenge of the application of the
provisions of this proposed rule, if the challenge involves any
decision of an FSIS employee relating to inspection services provided
under the PPIA.
Executive Order 13132
Executive Order 13132, ``Federalism,'' requires that Agencies
assess the federalism implications of their policy statements and
actions, i.e., the effects of those statements and actions on the
States, on the relationship between the national government and the
States, or on the distribution of power and responsibilities among the
various levels of government. The Federal Meat Inspection Act (FMIA)
and the Poultry Products Inspection Act (PPIA) preempt State and local
laws in regard to the manufacture and distribution of meat and poultry
products. Therefore, FSIS policy statements and actions impact
federalism within the context of these statutory preemptions.
States and local jurisdictions are preempted by the FMIA and PPIA
from imposing any marking, labeling, packaging, or ingredient
requirements on federally inspected meat and poultry products that are
in addition to, or different than, those imposed under the FMIA and the
PPIA. States and local jurisdictions may, however, exercise concurrent
jurisdiction over meat and poultry products that are within their
jurisdiction and outside official establishments for the purpose of
preventing the distribution of meat and poultry products that are
misbranded or adulterated under the FMIA and PPIA, or, in the case of
imported articles, that are not at such an establishment, after their
entry into the United States.
Specifically, under section 301 of the FMIA and section 5 of the
PPIA, a State may administer State meat and poultry inspection programs
provided that it has developed and is effectively enforcing State meat
and poultry inspection requirements at least equal to those imposed
under titles I and IV of the FMIA and sections 1-4, 6-10, and 12-22 of
the PPIA. These titles contemplate continuous ongoing programs. When
States can no longer effectively enforce meat and poultry inspection
requirements at least equal to Federal requirements, they must be
``designated'' by the Secretary to receive Federal inspection.
When FSIS revises its meat and poultry inspection requirements,
States that administer their own inspection programs may be impacted,
since they must continue to enforce requirements equal to those of
FSIS. To minimize any additional costs States must incur to modify
their inspection programs, FSIS grants the States significant
flexibility under the ``equal to'' provisions of the FMIA and PPIA.
Further, States are eligible to receive up to 50 percent Federal
matching funds to cover the costs of their inspection programs.
Paperwork Reduction Act Requirements
Title: Mandatory Inspection of Ratites and Squabs.
Type of Collection: New.
The paperwork and recordkeeping requirements in this final rule
will be approved on an emergency basis by OMB under control number
0583-01120. FSIS is seeking comments on the paperwork and recordkeeping
requirements in this interim final rule so that the Agency may receive
a three-year approval for these requirements.
Abstract: FSIS has reviewed the paperwork and record keeping
requirements in this interim final rule in accordance with the
Paperwork Reduction Act. Under this proposed rule, FSIS is requiring
several information collection and record keeping activities. FSIS is
requiring that establishments slaughtering and processing ratites and
squabs apply for Federal Inspection. Also, these establishments will
need to develop and maintain Sanitation SOPs, HACCP plans, and perform
testing for E. coli.
Estimate of Burden: FSIS estimates that the time to apply for
inspection would be two hours. The time to develop a Sanitation SOP
will be two days (16 hours) and five minutes to file. FSIS estimates
that an establishment will spend about 5 minutes a day developing an
average of eight monitoring records, per Sanitation SOP, and two
minutes a day filing each record. The time to develop a HACCP plan or
process schedule would take an average of two days (16 hours) and five
minutes to file. FSIS estimates that an establishment will spend about
five minutes a day developing an average of eight monitoring records,
per HACCP plan or process schedule, and two minutes a day filing each
record. The time to record E. coli testing results would be five
minutes a day.
Respondents: Meat and poultry product establishments and
irradiation facilities.
Estimated Number of Respondents: 105 (100 ratite and 5 squab
establishments).
Estimated Number of Responses per Respondent: 8,252.
Estimated Total Annual Burden on Respondents: 54,758 hours.
Copies of this information collection assessment can be obtained
from Lee Puricelli, Paperwork Specialist, Food Safety and Inspection
Service, USDA, 112 Annex, 300 12th SW., Washington, DC 20250.
Comments are invited on: (a) Whether the collection of information
is necessary for the proper performance of the functions of the Agency,
including whether the information will have practical utility; (b) the
accuracy of the Agency's estimate of the burden of the collection of
information including the validity of the methodology and
[[Page 21637]]
assumptions used: (c) ways to enhance the quality, utility, and clarity
of the information to be collected; and (d) ways to minimize the burden
of the collection of information on those who are to respond, including
through the use of appropriate automated, electronic, mechanical, or
other technological collection techniques or other forms of information
technology.
Comments are requested by July 2, 2001. To be most effective,
comments should be sent to OMB within 30 days of the publication date.
List of Subjects
9 CFR Part 362
Poultry and poultry products.
9 CFR Part 381
Poultry and poultry products.
PART 362--VOLUNTARY POULTRY INSPECTION REGULATIONS
For the reasons stated in the preamble, FSIS is amending 9 CFR
chapter III as follows:
1. The authority citation for part 362 is revised to read as
follows:
Authority: 7 U.S.C. 1622; 7 CFR 2.18 (g) and (i) and 2.53.
2. Sections 362.1 and 362.2 are revised to read as follows:
Sec. 362.1 Definitions.
The definitions in Sec. 381.1 are incorporated in this part except
for the definitions excluded in Sec. 362.2(a). In addition to those
definitions, the following definitions will be applicable to the
regulations in this part.
(a) Act. ``Act'' means the Agricultural Marketing Act of 1946, as
amended (60 Stat. 1087, as amended; 7 U.S.C. 1621 et seq.).
(b) Inspector. ``Inspector'' means any officer or employee of the
Department authorized to perform any duties under the regulations in
this part.
(c) Person. ``Person'' means any individual, corporation, company,
association, firm, partnership, society, or joint stock company, or
other organized business unit.
(d) Poultry. ``Poultry'' means any migratory water fowl or game
bird, whether dead or alive.
(e) Poultry Product. ``Poultry product'' means any poultry carcass
or part thereof; or any human food product which is made wholly or in
part from the carcass of any domesticated bird (as defined in
Sec. 381.1(b) of this chapter) and is excepted from the inspection
requirements of the Poultry Products Inspection Act (21 U.S.C. 451 et
seq.).
Sec. 362.2 Types and availability of service.
Upon application, in accordance with Sec. 362.3, the following
types of service may be furnished under the regulations in this part:
(a) Inspection service. An inspection and certification service for
wholesomeness relating to the slaughter and processing of poultry and
the processing of poultry products. All provisions of Part 381 and
Secs. 416.1 through 416.6 of this chapter shall apply to the slaughter
of poultry, and the preparation, labeling, and certification of the
poultry and poultry products processed under this poultry inspection
service except for the following provisions: the definitions of
``Act,'' ``animal food manufacturer,'' ``Inspection Service,''
``inspector,'' ``Inspector in Charge,'' ``poultry,'' ``poultry
product,'' ``poultry food product,'' ``poultry products broker,''
``renderer,'' and ``U.S. Refused Entry'' in Secs. 381.1 (b), 381.3 (a),
381.6, 381.10, 381.13-381.17, 381.21, 381.29, 381.39-381.42, 381.175
(a)(2), 381.175 (a)(3), 381.179, 381.185-381.187, 381.192, and 381.195-
381.225.
(b) Export certification service. At the request of any person
intending to export any slaughtered poultry or poultry product,
inspectors may make certification regarding products for human food
purposes, to be exported, as meeting conditions or standards that are
not imposed or are in addition to those imposed by the regulations in
this chapter and the laws under which such regulations were issued.
(c) Identification Service. (1) Poultry or other product that is
federally inspected and passed at an official establishment, or upon
importation, under the Poultry Products Inspection Act, is officially
marked to identify it as federally inspected and passed. In order to
facilitate the division of such poultry or other product into smaller
portions or its combination into larger units and still maintain its
identify as product which has been federally inspected and passed and
so marked, inspectors may supervise the handling and weighing of the
product and mark such portions and units with the official mark of
inspection when they determine that identify has been maintained.
(2) At the time service is furnished, product must be sound,
wholesome, and fit for human food. The service will be available only
on premises other than those of an official establishment. The
sanitation of the place or area where service is furnished must comply
with provisions of Secs. 416.1 through 416.6 of this chapter.
(3) The mark of inspection shall be applied only under the
immediate supervision of an inspector.
(4) This service does not cover further cutting and processing of
products. These activities must take place at an official
establishment.
(5) The registration and recordkeeping requirements enumerated in
Part 381, subpart Q, of this chapter shall apply to persons requesting
voluntary identification service under this paragraph (c).
PART 381--POULTRY PRODUCTS INSPECTION REGULATIONS
3. The authority citation for Part 381 continues to read as
follows:
Authority: 7 U.S.C. 138f, 450; 21 USC 451-470; 7 CFR 2.18, 2.53.
4. Section 381.1 (b) is amended by revising the definition of
poultry to read as follows:
Poultry. ``Poultry'' means any domesticated bird (chickens,
turkeys, ducks, geese, guineas, ratites, or squabs, also termed young
flightless pigeons), whether live or dead.
* * * * *
5. Amend Sec. 381.36 by revising the first sentence of paragraph
(b) to read as follows:
Sec. 381.36 Facilities required.
(b) Facilities for ante mortem inspection. A suspect pen is
required for adequate ratite inspection. * * *
* * * * *
6. Amend Sec. 381.66 by revising the headings of paragraphs (b) and
(c), and by revising paragraph (d)(1) to read as follows:
Sec. 381.66 Temperatures and chilling and freezing procedures.
* * * * *
(b) General chilling requirements, except for ratites. * * *
(c) Ice and water chilling requirements, except for ratites. * * *
(d) (1) Moisture absorption and retention limits.
(1) Poultry washing, chilling, and draining practices and
procedures shall be such as will minimize moisture absorption and
retention at time of packaging. Ratites must meet the requirements of
this paragraph but are exempt from the rest of Sec. 381.66(d).
* * * * *
7. Amend Sec. 381.67, by revising the text preceding the table and
the heading of the table, to read as follows:
[[Page 21638]]
Sec. 381.67 Young chicken and squab slaughter inspection rate maximums
under traditional inspection procedure under traditional inspection
procedure.
The maximum number of birds to be inspected by each inspector per
minute under the traditional inspection procedure for the different
young chicken and squab slaughter line configurations are specified in
the following table. These maximum rates will not be exceeded. The
inspector in charge will be responsible for reducing production line
rates where in the inspector's judgment the prescribed inspection
procedure cannot be adequately performed within the time available,
either because the birds are not presented by the official
establishment in such a manner that the carcasses, including both
internal and external surfaces and all organs, are readily accessible
for inspection, or because the health conditions of a particular flock
dictate a need for a more extended inspection procedure. The standards
in 381.170(a) of this part specify which classes of birds constitute
young chickens and squabs. Section 381.76(b) specifies when either the
traditional inspection procedure or the modified traditional inspection
procedure can or must be used.
Maximum Production Line Rates--Chickens and Squabs-Traditional
Inspection Procedures
* * * * *
8. Amend Sec. 381.70 by designating the text as paragraph (a) and
by adding paragraph (b) to read as follows:
Sec. 381.70 Ante mortem inspection; when required; extent.
* * * * *
(b) The examination and inspection of ratites will be on the day of
slaughter, except:
(1) When it is necessary for humane reasons to slaughter an injured
animal at night or on a Sunday or holiday, and the FSIS veterinary
medical officer cannot be obtained; or
(2) In low volume establishments, when ante mortem inspection
cannot be done on the day of slaughter, and the birds to be slaughtered
have received ante mortem inspection in the last 24 hours, provided the
establishment has an identification and control system over birds that
have received ante mortem inspection.
9. Amend Sec. 381.71 by designating the text as paragraph (a) and
by adding paragraphs (b), (c), (d), (e), and (f) to read as follows:
Sec. 381.71 Condemnation on ante mortem inspection.
* * * * *
(b) Dead-on-arrival ratite carcasses and ratites condemned on ante
mortem inspection will be tagged ``U.S. Condemned'' by an establishment
employee under FSIS supervision and disposed of by one of the methods
prescribed in Sec. 381.95.
(c) All seriously crippled ratites and non-ambulatory ratites,
commonly termed ``downers,'' shall be identified as ``U.S. Suspects.''
(d) Ratites exhibiting signs of drug or chemical poisoning shall be
withheld from slaughter.
(e) Ratites identified as ``U.S. Suspects'' or ``U.S. Condemned''
may be set aside for treatment. The ``U.S. Suspect'' or ``U.S.
Condemned'' identification device will be removed by an establishment
employee under FSIS supervision following treatment if the bird is
found to be free of disease. Such a bird found to have recovered from
the condition for which it was treated may be released for slaughter or
for purposes other than slaughter, provided that in the latter instance
permission is first obtained from the local, State, or Federal sanitary
official having jurisdiction over movement of such birds.
(f) When it is necessary for humane reasons to slaughter an injured
ratite at night or Sunday or a holiday, and the Agency veterinary
medical officer cannot be obtained, the carcass and all parts shall be
kept for inspection, with the head and all viscera except the
gastrointestinal tract held by the natural attachment. If all parts are
not so kept for inspection, the carcass shall be condemned. If on
inspection of a carcass slaughtered in the absence of an inspector, any
lesion or other evidence is found indicating that the bird was sick or
diseased, or affected with any other condition requiring condemnation
of the animal on ante mortem inspection, or if there is lacking
evidence of the condition that rendered emergency slaughter necessary,
the carcass shall be condemned. Ratites that are sick, dying, or that
have been treated with a drug or chemical and presented for slaughter
before the required withdrawal period, are not covered by emergency
slaughter provisions.
10. Revise Sec. 381.72 to read as follows:
Sec. 381.72 Segregation of suspects on ante mortem inspection.
(a) All birds, except ratites, that on ante mortem inspection do
not plainly show, but are suspected of being affected with, any disease
or condition that under Secs. 381.80 to 381.93 of this Part may cause
condemnation in whole or in part on post mortem inspection, shall be
segregated from the other poultry and held for separate slaughter,
evisceration, and post mortem inspection. The inspector shall be
notified when such segregated lots are presented for post mortem
inspection, and inspection of such birds shall be conducted separately.
Such procedure for the correlation of ante mortem and post mortem
findings by the inspector, as may be prescribed or approved by the
Administrator, shall be carried out.
(b) All ratites showing symptoms of disease will be segregated,
individually tagged as ``U.S. Suspects'' by establishment personnel
under FSIS supervision with a serially numbered metal or plastic leg
band or tag bearing the term ``U.S. Suspect,'' and held for further
examination by an FSIS veterinarian. Depending upon the findings of the
veterinarian's examination, these birds will either be passed for
regular slaughter, slaughtered as suspects, withheld from slaughter, or
condemned on ante mortem. Those ratites affected with conditions that
would be readily detected on post mortem inspection need not be
individually tagged on ante mortem inspection with the ``U.S. Suspect''
tag provided that such ratites are segregated and otherwise handled as
``U.S. Suspects.'' All ratites identified as ``U.S. Condemned'' shall
be tagged by establishment personnel, under FSIS supervision, with a
serially numbered metal or plastic leg band or tag bearing the term
``U.S. Condemned.''
11. Amend Sec. 381.76 by revising the introductory text of
paragraph (b) (1) to read as follows:
Sec. 381.76 Post-mortem inspection, when required; extent;
traditional, Streamlined Inspection System (SIS), New Line Speed (NELS)
Inspection System and the New Turkey Inspection (NTI) System; rate of
inspection.
* * * * *
(b)(1) There are five systems of post-mortem inspection:
Streamlined Inspection System (SIS) and the New Line Speed (NELS)
Inspection System, both of which shall be used only for broilers and
cornish game hens; the New Turkey Inspection (NTI) System, which shall
be used only for turkeys; Traditional Inspection; and Ratite
Inspection.
* * * * *
12. Revise Sec. 381.96 to read as follows:
Sec. 381.96 Wording and form of the official inspection legend.
Except as otherwise provided in this subpart, the official
inspection legend required to be used with respect to inspected and
passed poultry products
[[Page 21639]]
shall include wording as follows: ``Inspected for wholesomeness by U.S.
Department of Agriculture.'' This wording shall be contained within a
circle. The form and arrangement of such wording shall be exactly as
indicated in the example in Figure 1, except that the appropriate
official establishment number shall be shown, and if the establishment
number appears elsewhere on the labeling material in the manner
prescribed in Sec. 381.123(b), it may be omitted from the inspection
mark. The administrator may approve the use of abbreviations of such
inspection mark; and such approved abbreviations shall have the same
force and effect as the inspection mark. The official inspection
legend, or the approved abbreviation thereof, shall be printed on
consumer packages and other immediate containers of inspected and
passed poultry products, or on labels to be securely affixed to such
containers of such products and may be printed or stenciled thereon,
but shall not be applied by rubber stamping. When applied by a stencil,
the legend shall not be less than 4 inches in diameter. An official
brand must be applied to inspected and passed carcasses and parts of
ratites that are shipped unpacked.
Done at Washington, DC, on: April 25, 2001.
Thomas J. Billy,
Administrator.
[FR Doc. 01-10679 Filed 4-26-01; 1:36 pm]
BILLING CODE 3410-DM-P
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