[Federal Register Volume 68, Number 120 (Monday, June 23, 2003)]
[Rules and Regulations]
[Pages 37069-37071]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 03-15740]


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DEPARTMENT OF AGRICULTURE

Food Safety and Inspection Service

9 CFR Part 381

[Docket No. 02-015DF]
RIN 0583-AC97


Addition of Australia and New Zealand to the List of Foreign 
Countries Eligible to Import Poultry Products (Ratite Only) Into the 
United States

AGENCY: Food Safety and Inspection Service, USDA.

ACTION: Direct final rule.

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SUMMARY: The Food Safety and Inspection Service (FSIS) is announcing 
that it will add Australia and New Zealand to the list of countries 
eligible to import poultry products (ratite only) into the United 
States (U.S.). Reviews by FSIS of Australia's and New Zealand's laws, 
regulations, and other written materials, as well as the findings of an 
on-site review of each country's system, show that their regulatory 
systems that apply to ratite slaughter and processing include 
requirements that are equivalent to that of the United States under the 
Poultry Products Inspection Act (PPIA) and its implementing 
regulations.
    Under this direct final rule, ratites slaughtered and processed in 
certified establishments in Australia and in New Zealand will be 
permitted to be imported into the U.S. All ratite products imported 
into the U.S. from Australia and New Zealand will be subject to 
reinspection at U.S. ports-of-entry by FSIS inspectors.

DATES: This rule will be effective August 22, 2003, unless written 
adverse comments within the scope of this rulemaking or written notice 
of intent to submit adverse comments within the scope of this 
rulemaking are received on or before July 23, 2003. If FSIS receives 
adverse comments, a timely withdrawal will be published in the Federal 
Register informing the public that the rule will not take effect.

ADDRESSES: Submit adverse comments or notice of intent to submit 
adverse comments within the scope of this rulemaking to: FSIS Docket 
Clerk, Docket 02-015DF, Room 102, Cotton Annex, 300 C Street, 
SW., Washington, DC 20250-3700. Reference materials cited in this 
document and any comments received will be available for public 
inspection in the FSIS Docket Room from 8:30 a.m. to 4:30 p.m., Monday 
through Friday.

FOR FURTHER INFORMATION CONTACT: Mr. Clark Danford, Acting Director, 
Import-Export Programs Staff, Office of International Affairs; (202) 
720-6400.

SUPPLEMENTARY INFORMATION:

Background

    Effective April 2001, ratites were officially classified as poultry 
and subject to mandatory inspection under the PPIA (56 FR 22899). Prior 
to that time, imported ratites were regulated by the Food and Drug 
Administration (FDA).
    FSIS will amend the Federal poultry products inspection regulations 
to add Australia and New Zealand to the list of countries eligible to 
import ratite and ratite products into the U.S. These countries have 
consistently maintained their eligibility to certify meat slaughter and 
processing operations.
    Section 17 (21 U.S.C. 466(d)) of the PPIA states (1) 
notwithstanding any other provision of law, all poultry, or parts or 
products of poultry capable of use as human food offered for 
importation into the U.S. shall--(A) be subject to inspection, 
sanitary, quality, species verification, and residue standards that 
achieve a level of sanitary protection equivalent to that achieved 
under the U.S. standards; and (B) have been processed in facilities and 
under conditions that achieve a level of sanitary protection equivalent 
to that achieved under U.S. standards. (2)(A) The Secretary may treat 
as equivalent to a U.S. standard a standard of an exporting country 
described in paragraph (1) if the exporting country provides the 
Secretary with scientific evidence or other information, in accordance 
with risk assessment methodologies determined appropriate by the 
Secretary, to demonstrate that the standard of the exporting country 
achieves the level of sanitary protection achieved under the U.S. 
standard. For the purposes of this subsection, the term ``sanitary 
protection'' means protection to safeguard public health. (B) The 
Secretary may (i) determine, on a scientific basis, that the standard 
of the exporting country does not achieve the level of protection that 
the Secretary considers appropriate; and (ii) provide the basis for the 
determination in writing to the exporting country on request. (3) Any 
such imported poultry article that does not meet such standards shall 
not be permitted entry into the U.S. (4) The Secretary shall enforce 
this subsection through (A) random inspections for such species 
verification and for residues; and (B) random sampling and testing of 
internal organs and fat of carcasses for residues at the point of 
slaughter by the exporting country, in accordance with methods approved 
by the Secretary. Section 17 (21 U.S.C. 466(a)) of the PPIA also 
prohibits the importation of any slaughtered poultry, or parts or 
products thereof, of any kind into the U.S. unless they are healthful, 
wholesome, fit for human food, not adulterated, and contain no dye, 
chemical, preservative, or ingredient which renders them unhealthful, 
unwholesome, adulterated, or unfit for human food and unless they also 
comply with the rules and regulations made by the Secretary of 
Agriculture to assure that imported poultry or poultry products comply 
with the standards provided for in this Act.
    The importation of ratite products must be in compliance with the 
Federal poultry products inspection regulations to ensure that they 
meet the standards provided in the PPIA. 9 CFR 381.196 establishes the 
procedures by which foreign countries that want to import ratite or 
ratite products into the U.S. may become eligible to do so.
    Section 381.196 requires that authorities in a foreign countries'' 
poultry inspection system certify that (1) the system provides 
standards equivalent to those of the U.S. and (2) the legal authority 
for the system and its implementing regulations are equivalent to those 
of the U.S. Specifically, a country's regulations must impose 
requirements that are equivalent to those of the U.S. in the following 
areas: (1) Ante-mortem and post-mortem inspection; (2) official 
controls by the national government over plant construction, 
facilities, and equipment; (3) direct and continuous supervision of 
slaughter activities, where applicable, and product preparation by 
official inspection personnel; (4) complete separation of 
establishments certified to export from those not certified; (5) 
maintenance of a single standard of inspection and sanitation 
throughout certified establishments; (6) requirements for sanitation at 
certified establishments and for sanitary handling of poultry products; 
(7) official controls over condemned material until destroyed or 
removed and, thereafter, excluded from the establishment; (8) a Hazard 
Analysis and Critical Control Point system as set out in 9 CFR part 
417; and (9) other matters for which requirements are contained in the 
Act or the regulations of this part.

[[Page 37070]]

    Section 381.196 also requires that a poultry inspection system 
maintained by a foreign country, with respect to establishments that 
prepare products in that country for export to the U.S., ensure that 
those establishments and their products comply with requirements that 
are equivalent to the provisions of the PPIA and the poultry products 
inspection regulations. Besides relying on its initial determination of 
a country's eligibility, coupled with ongoing system audits to ensure 
that products shipped to the U.S. are safe, wholesome, and properly 
labeled and packaged, FSIS reinspects imported ratite and ratite 
products by randomly sampling the products as they enter the U.S.
    In addition to meeting the certification requirements under 9 CFR 
part 381, a foreign country's inspection system must be evaluated by 
FSIS before it will be granted eligibility to import ratite products 
into the U.S. This evaluation consists of two processes: a document 
review and an on-site review.
    The document review is an evaluation of the laws, regulations, and 
other written materials used by the country to operate its inspection 
program. To help the country organize its materials, FSIS gives the 
country questionnaires that ask for detailed information about the 
country's inspection practices and procedures in five risk areas. These 
five risk areas, which are the focus of the evaluation, are sanitation, 
animal disease, slaughter/processing, residues, and enforcement. FSIS 
evaluates the information to verify that the critical points in the 
five risk areas are addressed satisfactorily with respect to standards, 
activities, resources, and enforcement.
    If the document review is satisfactory, an on-site review is 
conducted by an experienced and trained auditor or a multi-disciplinary 
team that evaluates all aspects of the country's inspection program, 
including laboratories and individual establishments within the 
country.

Evaluation of the Australian and the New Zealand Inspection Systems

    In response to requests from Australia and from New Zealand for 
approval to import ratite and ratite products into the U.S., FSIS 
conducted a review of the Australian and New Zealand ratite inspection 
systems to determine whether they are equivalent to the U.S. ratite 
inspection system. First, FSIS compared each country's ratite 
inspection laws and regulations with U.S. requirements. The study 
concluded that the requirements contained in both countries'' ratite 
inspection laws and regulations are equivalent to those mandated by the 
PPIA and its implementing regulations. FSIS then conducted an on-site 
review of the Australian and New Zealand ratite inspection system in 
operation. Both countries inspect ratites under the same program that 
FSIS has found equivalent for other species. Both countries were found 
to be implementing the slaughter and inspection procedures that FSIS 
found to be equivalent during the document analysis. Therefore, the 
FSIS review team concluded that the implementation of ratite processing 
standards and procedures in both countries is equivalent to that of the 
U.S.
    Under this direct final rule, ratite products imported into the 
U.S. from Australia and from New Zealand will be subject to 
reinspection at the ports-of-entry for transportation damage, labeling, 
proper certification, general condition, and accurate count. Other 
types of inspection will also be conducted, including examining the 
product to detect organoleptic food safety or quality defects and 
performing microbiological or chemical analyses to detect pathogens or 
drug residues.
    Products that pass reinspection will be stamped with the official 
mark of inspection and allowed to enter into U.S. commerce. If they do 
not meet U.S. requirements, they will be stamped ``U.S. Refused Entry'' 
and re-exported, destroyed, or converted to animal food.
    Accordingly, FSIS intends to amend section 381.196(b) of the 
poultry products inspection regulations to add Australia and New 
Zealand as countries from which ratite and ratite products are eligible 
for importation into the U.S. As a country eligible to import ratite 
and ratite products into the U.S., the governments of Australia and of 
New Zealand will certify to FSIS those establishments that intend to 
import such products into the U.S. and that operate according to U.S. 
requirements. FSIS will verify that establishments certified by the 
Australia or the New Zealand government are meeting the U.S. 
requirements. This verification will be done through annual on-site 
audits of the establishments while they are in operation.
    Although a foreign country may be listed as eligible to import 
ratite and ratite products into the U.S., products from that country 
must also comply with other U.S. requirements, including the 
restrictions under title 9, part 94 of the Animal and Plant Health 
Inspection Service's regulations that relate to the importation of 
ratite and ratite products from foreign countries into the U.S.

Executive Order 12988

    This direct final rule has been reviewed under Executive Order 
12988, Civil Justice Reform. States and local jurisdictions are pre-
empted by the PPIA from imposing any marking, labeling, packaging, or 
ingredient requirements on federally inspected ratite or ratite 
products that are in addition to, or different than, those imposed 
under the PPIA. States and local jurisdictions may, however, exercise 
concurrent jurisdiction over ratite and ratite products that are 
outside official establishments for the purpose of preventing the 
distribution of ratite and ratite products that are misbranded or 
adulterated under the PPIA, or, in the case of imported articles, that 
are not at such an establishment, after their entry into the U.S.
    This direct final rule is not intended to have a retroactive 
effect. After this rule is adopted, administrative proceedings will not 
be required before parties may file suit in court challenging this 
rule. However, the administrative procedures specified in 9 CFR 381.35 
must be exhausted prior to any judicial challenge of the application of 
the provisions of this direct final rule, if the challenge involves any 
decision of an FSIS employee relating to inspection services provided 
under the PPIA.

Executive Order 12866 and Regulatory Flexibility Act

    This direct final rule has been reviewed under Executive Order 
12866. It has been determined to be not significant for purposes of 
E.O. 12866 and therefore, has not been reviewed by the Office of 
Management and Budget (OMB).
    Currently, there are three establishments in Australia and one in 
New Zealand that import ratite products into the U.S. These 
establishments would continue to import approximately 160,000 pounds of 
fresh or frozen whole, cut-up, or deboned ratite meat per year.
    If the volume and types of ratite products that are imported 
increases, as well as competition for the available market, it is 
expected that benefits from this direct final rule would generally 
accrue to consumers in the form of lower prices. However, the volume 
and other changes in trade stimulated by this rule is likely to be so 
small as to have little effect on supply and farm-level prices for 
poultry or livestock. Apart from any change in prices, U.S. consumers 
may still benefit from an increased choice of poultry products in the 
marketplace.

[[Page 37071]]

    The costs of this direct final rule will accrue primarily to 
producers in the form of greater competition from Australia and New 
Zealand. However, as mentioned in the preceding paragraph, the volume 
of trade stimulated by this rule would be very small, is unlikely to 
increase, and is likely to have no effect on supply and farm-level 
prices. Since Australia and New Zealand already import ratite products 
into the U.S. under FDA regulations, it is unlikely that U.S. firms 
that produce products that would compete with Australian and New 
Zealand's imports of ratite products would face short-run difficulties. 
In the long run, it is expected that even if certain adjustments need 
to be made because of changes in the volume or product-type imported, 
such firms would adjust their product mix in order to compete 
effectively.

Effect on Small Entities

    The Administrator, FSIS, has made an initial determination that 
this direct final rule will not have a significant impact on a 
substantial number of small entities, as defined by the Regulatory 
Flexibility Act (5 U.S.C. 601 et seq). This direct final rule will add 
Australia and New Zealand to the list of countries eligible to import 
poultry products (ratites only) into the U.S. As stated above, three 
establishments in Australia and one in New Zealand have applied to 
their respective governments for certification to import ratite 
products into the U.S. These establishments would continue to import 
approximately 160,000 pounds of fresh or frozen whole, cut-up, or 
deboned ratite meat per year. The change in volume of trade stimulated 
by this rule would be very small, if any, and not likely to have much 
of an effect on supply and prices. Therefore, this rule is not expected 
to have an impact on small domestic entities that produce these types 
of products. Even if product quantities and varieties increase, it is 
expected that the volume increase will be minimal and no significant 
impact will be realized.

Paperwork Requirements

    The paperwork requirements associated with the development of this 
direct final rule are approved under OMB number 0583-0094.

Additional Public Notification

    Public awareness of all segments of rulemaking and policy 
development is important. Consequently, in an effort to better ensure 
that minorities, women, and persons with disabilities are aware of this 
direct final rule, FSIS will announce it and make copies of this 
Federal Register publication available through the FSIS Constituent 
Update. FSIS provides a weekly Constituent Update, which is 
communicated via Listserv, a free e-mail subscription service. In 
addition, the update is available on-line through the FSIS Web page 
located at http://www.fsis.usda.gov. The update is used to provide 
information regarding FSIS policies, procedures, regulations, Federal 
Register notices, FSIS public meetings, recalls, and any other types of 
information that could affect or would be of interest to our 
constituents/stakeholders. The constituent Listserv consists of 
industry, trade, and farm groups, consumer interest groups, allied 
health professionals, scientific professionals, and other individuals 
that have requested to be included. Through the Listserv and web page, 
FSIS is able to provide information to a much broader, more diverse 
audience.
    For more information contact the Congressional and Public Affairs 
Office, at (202) 720-9113. To be added to the free e-mail subscription 
service (Listserv) go to the ``Constituent Update'' page on the FSIS 
Web site at http://www.fsis.usda.gov/oa/update/update.htm. Click on the 
``Subscribe to the Constituent Update Listserv'' link, then fill out 
and submit the form.

List of Subjects 9 CFR Part 381

    Imported poultry products, Ratite and ratite products.


0
For the reasons set out in the preamble, FSIS is amending 9 CFR part 
381 as follows:

PART 381--POULTRY PRODUCTS INSPECTION REGULATIONS

0
1. The authority citation for part 381 continues to read as follows:

    Authority: 7 U.S.C. 138f; 450; 21 U.S.C. 451-470; 7 CFR 2.18, 
2.53

0
2. Section 381.196 is amended by adding ``Australia (ratites only)'' 
and ``New Zealand (ratites only)'' in alphabetical order to the list of 
countries in paragraph (b).

    Done in Washington, DC, on: June 17, 2003.
Dr. Garry L. McKee,
Administrator.
[FR Doc. 03-15740 Filed 6-20-03; 8:45 am]
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