[Federal Register Volume 72, Number 211 (Thursday, November 1, 2007)]
[Rules and Regulations]
[Pages 61793-61796]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E7-21511]


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DEPARTMENT OF AGRICULTURE

Food Safety and Inspection Service

9 CFR Part 381

[Docket No. FSIS-2007-0024]
RIN 0583-AD25


Eligibility of Chile to Export Poultry and Poultry Products to 
the United States

AGENCY: Food Safety and Inspection Service, USDA.

ACTION: Final rule.

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SUMMARY: The Food Safety and Inspection Service (FSIS) is adding Chile 
to the list of countries eligible to export poultry and poultry 
products to the United States. Reviews by FSIS of Chile's laws, 
regulations, and inspection implementation show that its poultry 
inspection system requirements are equivalent to the relevant 
provisions of the Poultry Products Inspection Act (PPIA) and its 
implementing regulations.
    With this final rule, poultry and poultry products processed in 
certified Chilean establishments may be exported to the United States. 
All such products will be subject to reinspection at United States 
ports-of-entry by FSIS inspectors.

DATES: Effective Dates: December 3, 2007.

FOR FURTHER INFORMATION CONTACT: Ms. Sally White, Director, 
International Equivalence Staff, Office of International Affairs; (202) 
720-6400.

SUPPLEMENTARY INFORMATION: 

Background

    The Food Safety and Inspection Service (FSIS) is amending its 
poultry products inspection regulations to add Chile to the list of 
countries eligible to export poultry and poultry products to the United 
States (9 CFR 381.196).

Statutory Basis for Proposed Action

    Section 17 of the PPIA (21 U.S.C. 466) prohibits importation into 
the United States of slaughtered poultry, or parts or products thereof, 
of any kind unless they are healthful, wholesome, fit for human food, 
not adulterated, and contain no dye, chemical, preservative, or 
ingredient that renders them unhealthful, unwholesome, adulterated, or 
unfit for human food. Under the PPIA and the regulations that implement 
it, poultry products imported into the United States must be produced 
under standards for safety, wholesomeness, and labeling accuracy that 
are equivalent to those of the United States. Section 381.196 of Title 
9 of the CFR sets out the procedures by which foreign countries wanting 
to export poultry and poultry products to the United States may become 
eligible to do so.
    Section 381.196(a) provides that a foreign country's poultry 
inspection system must include standards equivalent to those of the 
United States, and that the legal authority for the inspection system 
and its implementing regulations must also be equivalent to those of 
the United States. Specifically, a country's regulations must impose 
requirements equivalent to those of the United States with respect to: 
(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) separation of establishments certified to 
export from those not certified; (5) maintenance of a single standard 
of inspection and sanitation throughout certified establishments; and 
(6) official controls over condemned product.
    The foreign country's inspection system must ensure that 
establishments preparing poultry or poultry products for export to the 
United States, and their products, comply with requirements equivalent 
to those of the PPIA and the regulations promulgated by FSIS under the 
authority of that statute. The foreign country certifies the 
appropriate establishments as having met the required standards. The 
country must satisfy FSIS that the certifications it issues are 
reliable before FSIS will grant approval to the country to export 
poultry or poultry products to the United States (9 CFR 381.196). To 
assess the reliability of the foreign country's certifications, FSIS 
evaluates the country's inspection system and performs ongoing reviews 
of that system. To ensure that products imported into the United States 
are safe, wholesome, and properly labeled and packaged, FSIS randomly 
re-inspects and samples those products before they enter the United 
States.
    In addition to meeting the certification requirements, a foreign 
country's inspection system must be evaluated by FSIS before 
eligibility to export poultry or poultry products to the United States 
can be granted. 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 effect its inspection program. To help the country in organizing its 
material, FSIS gives the country questionnaires asking 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 scheduled using a multi-disciplinary team to evaluate all aspects of 
the country's inspection program, including laboratories and individual 
establishments within the country. The process of determining 
equivalence is described fully on the FSIS Web site at http://www.fsis.usda.gov/regulations_&_policies/equivalence_process/index.asp.
    The PPIA and the regulations that implement it require that foreign 
countries be listed as eligible in the Code of Federal Regulations. 
FSIS must do rulemaking to list a country as eligible. Countries found 
eligible to export poultry or poultry products into the United States 
are listed in the poultry inspection regulations at 9 CFR 381.196(b). 
Once listed, it is the responsibility of the eligible country to 
certify that establishments meet the requirements to export poultry or 
poultry products to the United States, and to ensure that products from 
these establishments are safe, wholesome, and not misbranded.

Evaluation of the Chilean Inspection System for Poultry and Poultry 
Products

    In response to a request from Chile for approval to export poultry 
and poultry products to the United States, FSIS conducted a review of 
Chile's poultry slaughter inspection system to determine whether it is 
equivalent to the U.S. poultry inspection system. First, FSIS compared 
Chile's poultry inspection laws and regulations with U.S. requirements. 
The Agency concluded that the requirements contained in Chile's poultry 
slaughter inspection laws and regulations are equivalent to the PPIA 
and to the regulations that FSIS has adopted under the PPIA to effect 
that statute.

[[Page 61794]]

    FSIS then conducted an on-site review of Chile's poultry slaughter 
inspection system in operation from August 9 through 18, 2005. The FSIS 
review team concluded that, as implemented, Chile's poultry slaughter 
standards and procedures are equivalent to those of the United States. 
As a result, FSIS published a proposed rule (FSIS-2006-0030) in the 
Federal Register of February 26, 2007 (72 FR 8293-8296), that would add 
Chile to the list of countries eligible to export poultry and poultry 
products to the United States.
    One comment to the proposed rule noted a deficiency that FSIS had 
found in its 2005 onsite audit of Chile's inspection system--that Chile 
was not conducting species verification testing as required--and 
questioned how, given that deficiency, FSIS could find Chile's system 
equivalent. On May 10, 2007, FSIS replied to this question through a 
Federal Register document (FSIS-2007-0016) providing SUPPLEMENTARY 
INFORMATION and re-opening the comment period for the proposed rule (72 
FR 26567) so that the public could comment on the new information made 
available, with comments to be received by May 25, 2007. In this 
Federal Register document, FSIS noted that Chile had immediately 
committed to remedying the deficiency and had documented the steps that 
it had taken to implement species verification testing. FSIS evaluated 
the documentation provided by Chile and became confident that Chile has 
sufficient controls in place to ensure that species verification 
testing is being performed. FSIS documentation of the materials 
submitted by Chile to satisfy the species verification requirement for 
poultry can be found online as an addendum to the 2005 FSIS audit 
report on Chile's poultry inspection system at http://www.fsis.usda.gov/regulations_&_policies/Foreign_Audit_Reports/index.asp.

Comments on the Proposal

    The Agency received a total of 13 comments on the proposed rule. 
All comments received were in response to the proposed rule published 
February 26, 2007. FSIS did not receive any additional comments to the 
May 10, 2007, Federal Register document that re-opened the comment 
period on the proposal.
    All comments supported the proposal except one that questioned 
whether FSIS import reinspection would be adequate to prevent public 
health threats from entering the United States from Chile.
    With this final rule in effect, any poultry and poultry products 
exported to the United States from Chile will be subject to 
reinspection by FSIS at the ports-of-entry for transportation damage, 
labeling, proper certification, general condition, and accurate count. 
FSIS will also conduct other types of inspection, including examination 
of products for defects and sampling and laboratory analysis of 
products for chemical residues or for microbiological contamination. 
Products that pass reinspection will be stamped with the official U.S. 
mark of inspection and allowed to enter U.S. commerce. If they do not 
meet U.S. requirements, they will be refused entry and must be re-
exported, destroyed, or converted to animal food. Thus, FSIS import 
reinspection is more than adequate to prevent products that present a 
public health threat from entering the U.S.
    Furthermore, the FSIS process to determine the equivalence of a 
country's meat or poultry inspection system is independent from any 
animal health status determination that may be made for the same 
country by USDA's Animal and Plant Health Inspection Service (APHIS). 
The APHIS declaration regarding animal health or disease status, 
however, also determines whether a country can export product to the 
U.S., as well as the types of products that would be eligible. Even 
though a foreign country is listed in FSIS regulations as eligible to 
export poultry and poultry products to the U.S., those poultry products 
must also comply with all other U.S. requirements before entry. Before 
a shipment of poultry or poultry products may be presented for 
reinspection at the port-of entry by FSIS, it must have first met the 
requirements of both U.S. Customs and Border Protection and APHIS.
    APHIS is responsible for keeping foreign animal diseases out of the 
United States. Under Title 9, Part 94 of the Code of Federal 
Regulations (9 CFR Part 94), APHIS sets forth restrictions on the 
importation of any fresh, frozen, and chilled meat and meat products, 
poultry and poultry products, and edible products from countries in 
which certain animal diseases exist. APHIS can independently restrict 
an eligibility listing through a ``regionalization'' process (9 CFR 
Part 92--Importation of Animals and Animal Products: Procedures for 
Requesting Recognition of Regions). Those products that APHIS has 
restricted from entering the United States because of animal disease 
conditions in the country of origin will be refused entry before 
reaching an FSIS import inspection facility.
    FSIS and APHIS work closely together to ensure that all poultry and 
poultry products imported into the United States comply with the 
regulatory requirements of both agencies. In 1985, FSIS and APHIS 
signed a memorandum of understanding (MOU) in which both agencies 
agreed to cooperate in meeting their respective needs relative to 
information exchange of disease surveillance, diagnostic testing, 
investigations, trace backs, and animal and public health emergencies 
to achieve their related objectives of reducing the spread of animal 
diseases, and of providing a wholesome and economical food supply. The 
MOU is updated periodically to ensure that it addresses areas of 
importance to both agencies. In accord with this MOU, FSIS and APHIS 
established procedures for communication between the two agencies 
regarding the inspection, handling, and disposition of imported meat 
and poultry products. APHIS and FSIS communicate regularly to ensure 
that products APHIS has restricted from entering the United States 
because of animal disease concerns are not imported into the United 
States.
    FSIS notes that APHIS has found no current evidence of animal 
disease of consequence in Chile. For all these reasons, FSIS believes 
that sufficient controls are in place to ensure that poultry and 
poultry products processed in Chile will not pose a risk in the U.S.
    As a country eligible to export poultry and poultry products to the 
United States, the government of Chile must certify to FSIS those 
establishments that wish to export such products to the United States 
and that operate in accordance with these requirements. FSIS will 
retain the right to verify that the establishments certified by Chile's 
government are meeting the U.S. requirements and will verify that 
Chile's inspection system meets U.S. requirements through annual 
audits. Therefore, based on its review of the Chilean system and its 
consideration of the comments on the proposal, FSIS concludes that 
Chile's poultry inspection system is equivalent to that of the U.S., 
and therefore, Chilean poultry establishments that have been certified 
by the Chilean government are eligible to begin exporting product to 
the U.S.

Executive Order 12866 and Regulatory Flexibility Act

    This final rule has been reviewed under Executive Order 12866 by 
the Office of Management and Budget (OMB) and has been determined to be 
not significant for purposes of E.O. 12866. This rulemaking will add 
Chile to the list of countries eligible to export poultry and poultry 
products to the United States.

[[Page 61795]]

Economic Impact Analysis

    This rule was designated as non-significant. It is expected that 
approximately five establishments in Chile will be exporting poultry 
and poultry products to the U.S. Chile expects to export raw young 
chicken breast (deboned) products, starting in 2007 with 5,000 Metric 
Tons (MT) and reaching an estimated 12,000 MT in 2010. These estimates 
are based on Chile's actual and future production capacity and its 
decision to maintain an increasing presence in the export market. For 
comparison, FSIS estimated, based on data from the USDA Agricultural 
Marketing Service (AMS) and the National Agricultural Statistics 
Service (NASS), that in 2005 the U.S. produced about 1,444,000 MT of 
raw young chicken breast (deboned) products. Chile's estimated initial 
exports to the U.S. in 2007 should represent about three-tenths of one 
percent (5,000 MT/1,444,000 MT) of the U.S. domestic production of raw 
young chicken breast (deboned) products, in 2005. Further, if Chile's 
exports to the U.S. reach, in 2010, the estimate of 12,000 MT of raw 
young chicken breast (deboned) products, these imports will represent 
about eight-tenths of one percent (12,000 MT/1,444,000 MT) of the U.S. 
domestic production of raw young chicken breast (deboned) products in 
2005.
    Expected benefits from this type of final rule will accrue 
primarily to consumers in the form of lower prices. The small volume of 
trade stimulated by this final rule, however, will likely have little 
effect on supply and prices. Consumers, apart from any change in 
prices, would benefit in principle from increased choices at 
competitive price points in the marketplace.
    The costs of this rule will accrue primarily to U.S. producers in 
the form of greater competition from Chile. Again, it must be noted 
that the volume of trade stimulated by this rule will be very small, 
likely having little discernible effect on supply and prices.
    General benefits will include increased trade with Chile and the 
availability to U.S. consumers of a greater quantity of poultry and 
poultry products. Both nations will benefit from an expansion of trade 
in poultry and poultry products as part of a wide range of commodities.
    Constraints on the expansion of trade in poultry and poultry 
products between the United States and Chile are expected to occur 
mainly in the form of restrictions imposed under U.S. animal health 
laws. APHIS has agreed to supply FSIS with evaluations and updates of 
the animal disease status of regions in Chile where establishments 
likely to export poultry and poultry product to the United States are 
located.
    The additional poultry and poultry product shipments are likely to 
have only a slight effect on the Agency's assignment of import 
inspection resources at points of entry on the East and West coasts. It 
is unlikely, on the basis of current information, that any additional 
import inspection personnel would need to be hired.
    Estimates of benefits and costs of increased trade in poultry and 
poultry products with Chile are based on data supplied by the FSIS 
Office of International Affairs and Office of Field Operations; Foreign 
Agricultural Service (FAS) databases and trade reports; Economic 
Research Service (ERS) databases, reports, and analyses; Agricultural 
Marketing Service (AMS) databases, reports, and analyses; National 
Agricultural Statistics Service (NASS) databases, reports, and 
analyses; and Census Bureau databases and reports. Standard economic 
analytical techniques were used in estimating effects of this 
rulemaking.
    The major source of uncertainty in estimating the effects of this 
final rule is in forecasting the number of establishments likely to be 
certified by Chile to export poultry and poultry products to the United 
States. Other, less important, sources of uncertainty include 
imprecision in the economic data consulted, e.g. estimates of demand 
and supply elasticities and probable errors in multi-year forecasts of 
prices for the poultry and poultry product commodities that would be 
regulated under the final rule.

Effect on Small Entities

    This 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). This final rule will add Chile to the list of countries 
eligible to export poultry and poultry products to the United States. 
The volume of trade stimulated by this rule will be very small and will 
have minimal effect on poultry and poultry products supplies and 
prices.

Executive Order 12988

    This final rule has been reviewed under Executive Order 12988, 
Civil Justice Reform. If this final rule is adopted:
    (1) All State and local laws and regulations that are inconsistent 
with this rule will be preempted;
    (2) No retroactive effect will be given to this rule; and
    (3) Administrative proceedings will not be required before parties 
may file suit in court challenging this rule.

Paperwork Requirements

    No new paperwork requirements are associated with this final rule. 
Foreign countries wanting to export poultry and poultry products to the 
United States are required to provide information to FSIS certifying 
that their inspection systems effect standards equivalent to those of 
the United States, and that the legal authority for the systems and 
their implementing regulations are equivalent to those of the United 
States. FSIS collects this information one time only. FSIS gave Chile 
questionnaires asking for detailed information about the country's 
inspection practices and procedures to assist that country in 
organizing its materials. This information collection was approved 
under OMB number 0583-0094. The final rule contains no other paperwork 
requirements.

E-Government Act Compliance

    The Food Safety and Inspection Service is committed to complying 
with the E-Government Act, to promote the use of the Internet and other 
information technologies to provide increased opportunities for citizen 
access to Government information and services, and for other purposes.

Additional Public Notification

    Public awareness of all segments of rulemaking and policy 
development is important. Consequently, in an effort to ensure that the 
public and in particular minorities, women, and persons with 
disabilities, are aware of this proposed rule, FSIS will announce it 
online through the FSIS Web page located at http://www.fsis.usda.gov/regulations_&_policies/2007_Interim_&_Final_Rules_Index/index.asp.
    The Regulations.gov Web site is the central online rulemaking 
portal of the United States Government. It is offered as a public 
service to increase participation in the Federal Government's 
regulatory activities. FSIS participates in Regulations.gov and will 
accept comments on documents published on the site. The site allows 
visitors to search by keyword or Department or Agency for rulemakings 
that allow for public comment. Each entry provides a quick link to a 
comment form so that visitors can type in their comments and submit 
them to FSIS. The Web site is located at http://www.regulations.gov/.
    FSIS will also make copies of this Federal Register publication 
available

[[Page 61796]]

through the FSIS Constituent Update, which is used to provide 
information regarding FSIS policies, procedures, regulations, Federal 
Register notices, public meetings, recalls, and other types of 
information that could affect or would be of interest to our 
constituents and stakeholders. The Update is communicated via Listserv, 
a free e-mail subscription service consisting of industry, trade, and 
farm groups, consumer interest groups, allied health professionals, 
scientific professionals, and other individuals who have requested to 
be included. The Update is also available on the FSIS Web page. Through 
Listserv and the Web page, FSIS is able to provide information to a 
much broader, more diverse audience.
    In addition, FSIS offers an e-mail subscription service that 
provides an automatic and customized notification when popular pages 
are updated, including Federal Register publications and related 
documents. This service is available at http://www.fsis.usda.gov/news_and_events/email_subscription/ and allows FSIS customers to sign up 
for subscription options across eight categories. Options range from 
recalls to export information to regulations, directives and notices. 
Customers can add or delete subscriptions themselves and have the 
option to password protect their accounts.

List of Subjects in 9 CFR Part 381

    Imported 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 2.7, 
2.18, 2.53.


Sec.  381.196(b)  [Amended]

0
2. Section 381.196(b) is amended by adding Chile in alphabetical order 
to the list of countries in paragraph (b).

    Done at Washington, DC, on October 29, 2007.
Alfred V. Alamanza,
Administrator.
 [FR Doc. E7-21511 Filed 10-31-07; 8:45 am]
BILLING CODE 3410-DM-P