[Federal Register Volume 66, Number 88 (Monday, May 7, 2001)]
[Rules and Regulations]
[Pages 22899-22907]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: R1-10679]



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  Federal Register / Vol. 66, No. 88 / Monday, May 7, 2001 / Rules and 
Regulations  

[[Page 22899]]



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

    Editorial Note: Federal Register rule document 01-10679 
originally appeared in the issue of Tuesday, May 1, 2001 at 66 FR 
21631-21639. Due to several errors (repeated text and missing text 
on page 21635) the document is being reprinted in its entirety.

AGENCY: Food Safety and Inspection Service, USDA.

ACTION: Interim final rule.

-----------------------------------------------------------------------

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

[[Page 22900]]

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 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

[[Page 22901]]

meat is valued for its flavor and nutritional characteristics.
---------------------------------------------------------------------------

    \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.
---------------------------------------------------------------------------

    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. 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
----------------------------------------------------------------------------------------------------------------
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
----------------------------------------------------------------------------------------------------------------

    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

[[Page 22902]]

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 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.
    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
------------------------------------------------------------------------
                                             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.
---------------------------------------------------------------------------

    \2\ HACCP plans are not required to cover non-amenable species.
---------------------------------------------------------------------------

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 22903]]



     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 22904]]

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 22905]]

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 22906]]

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 22907]]

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

    Editorial Note: Federal Register rule document 01-10679 
originally appeared in the issue of Tuesday, May 1, 2001 at 66 FR 
21631-21639. Due to several errors (repeated text and missing text 
on page 21635) the document is being reprinted in its entirety.
[FR Doc. R1-10679 Filed 5-4-01; 8:45 am]
BILLING CODE 1505-01-D