[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
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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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