[Federal Register: May 10, 2005 (Volume 70, Number 89)]
[Proposed Rules]               
[Page 24485-24488]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr10my05-7]                         

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Proposed Rules
                                                Federal Register
________________________________________________________________________

This section of the FEDERAL REGISTER contains notices to the public of 
the proposed issuance of rules and regulations. The purpose of these 
notices is to give interested persons an opportunity to participate in 
the rule making prior to the adoption of the final rules.

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[[Page 24485]]



DEPARTMENT OF AGRICULTURE

Food Safety and Inspection Service

9 CFR Part 327

[Docket No. 02-019P]
RIN 0583-AD16

 
Addition of Chile to the List of Countries Eligible To Export 
Meat and Meat Products to the United States

AGENCY: Food Safety and Inspection Service, USDA.

ACTION: Proposed rule.

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SUMMARY: The Food Safety and Inspection Service (FSIS) is proposing to 
add Chile to the list of countries eligible to export meat and meat 
products to the United States. Reviews by FSIS of Chile's laws, 
regulations, and other materials show that its meat inspection system 
includes requirements equivalent to all provisions in the Federal Meat 
Inspection Act (FMIA) and its implementing regulations.
    Although a foreign country may be listed as eligible to export meat 
and meat products, products from that country must also comply with all 
other U.S. requirements, including those of the U.S. Customs Service 
and the restrictions under Title 9, part 94 of the Animal and Plant 
Health Inspection Service (APHIS) regulations that relate to the 
importation of meat and meat products from foreign countries into the 
United States. FSIS and APHIS work closely together to ensure that meat 
and meat products imported into the United States comply with the 
regulatory requirements of both agencies.
    Under this proposal, meat and meat products processed in certified 
Chilean establishments may be exported to the United States. All such 
products will be subject to re-inspection at United States ports-of-
entry by FSIS inspectors.

DATES: Comments must be received on or before July 11, 2005.

ADDRESSES: FSIS invites interested persons to submit comments on this 
proposed rule. Comments may be submitted by any of the following 
methods:
     Mail, including floppy disks or CD-ROM's, and hand-or 
courier-delivered items: Send to Docket Clerk, U.S. Department of 
Agriculture, Food Safety and Inspection Service, 300 12th Street, SW., 
Room 102 Cotton Annex, Washington, DC 20250.
     Federal eRulemaking Portal: Go to http://www.regulations.gov.
 Follow the online instructions at that site for 

submitting comments.
    All submissions received must include the Agency name and docket 
number 02-019P.
    All comments submitted in response to this proposal, as well as 
research and background information used by FSIS in developing this 
document, will be available for public inspection in the FSIS Docket 
Room at the address listed above between 8:30 a.m. and 4:30 p.m., 
Monday through Friday. The comments also will be posted on the Agency's 
Web site http://www.fsis.usda.gov/regulations_&_policies/2005_Proposed_Rules_Index/index.asp
.


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

SUPPLEMENTARY INFORMATION:

Background

    FSIS is proposing to amend the Federal meat inspection regulations 
to add Chile to the list of countries eligible to export meat and meat 
products to the United States (9 CFR 327(b)), as was requested by the 
Chilean government. Chile is not currently listed as eligible to export 
such products to the United States.
    Listing Chile as eligible to export meat products to the United 
States would expand international markets and enhance the free flow of 
trade with Chile as required under World Trade Organization (WTO) 
provisions. This proposed action would support U.S. trade initiatives 
and USDA's policy of liberalizing agricultural trade with Chile, and 
would honor U.S. obligations to WTO. Under the Uruguay Round Agreement, 
FSIS is obligated to make equivalence determinations of the inspection 
systems of foreign countries requesting to import meat, poultry, or egg 
products into the United States.
    Section 20 of the FMIA (21 U.S.C. 620) prohibits the importation 
into the United States of carcasses, parts of carcasses, meat, or meat 
food products of cattle, sheep, swine, goats, horses, mules, or other 
equines that are capable of use as human food that are adulterated or 
misbranded. The FMIA also requires that livestock from which imported 
meat products are produced be slaughtered and handled in connection 
with slaughter in accordance with the Humane Slaughter Act (7 U.S.C. 
1901-1906). Imported meat products must be in compliance with part 327 
of title 9, Code of Federal Regulations (9 CFR part 327), to ensure 
that they meet the standards provided in the FMIA. Section 327.2 
establishes the procedures by which foreign countries that want to 
export meat and meat products to the United States may become eligible 
to do so.
    Section 327.2(a) requires authorities in a foreign country's meat 
inspection system to certify that (1) the system provides standards 
equivalent to those of the United States, and (2) the legal authority 
for the system and its implementing regulations are equivalent to those 
of the United States. Specifically, a country's regulations must impose 
requirements equivalent to those of the United States 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) separation of establishments 
certified to export from those not certified; (5) maintenance of a 
single standard of inspection and sanitation throughout certified 
establishments; (6) official controls over condemned product; and (7) 
requirements of a Hazard Analysis and Critical Control Point (HACCP) 
system within certified establishments.
    Section 327.2 also requires a meat inspection system maintained by 
a foreign country, with respect to establishments preparing products in 
that country for export to the United States, to ensure that those 
establishments and their meat products comply with requirements 
equivalent to the provisions of the FMIA and the meat product 
inspection regulations. Foreign

[[Page 24486]]

country authorities must be able to ensure that all certifications 
required under Part 327 of the meat product inspection regulations 
(Imported Products) can be relied upon before USDA-FSIS will grant 
approval to export meat products to 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 meat products 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 operate its meat 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, which 
are the focus of the evaluation. These five risk areas 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/OPPDE/IPS/EQ/EQProcess.htm. 

Besides relying on its initial determination of a country's 
eligibility, coupled with ongoing reviews to ensure that products 
shipped to the United States are safe, wholesome, and properly labeled 
and packaged, FSIS randomly reinspects meat and poultry products as 
they are offered for entry into the United States.

Evaluation of the Chilean Meat Inspection System

    FSIS conducted a thorough review of the Chile meat inspection 
system to determine if it is equivalent to the U.S. meat inspection 
system. First, FSIS compared Chile's meat inspection laws and 
regulations with U.S. requirements. The study concluded that the 
requirements contained in Chile's meat inspection laws and regulations 
are equivalent to those mandated by the FMIA and implementing 
regulations. FSIS then conducted an on-site review of the Chile meat 
inspection system in operation. The FSIS review team concluded that 
Chile's implementation of meat slaughter and processing standards and 
procedures was equivalent to those of the United States. The audit 
reports on Chile can be found on the FSIS Web site at http://www.fsis.usda.gov/OPPDE/Far/index.htm
.

    The FSIS process to determine the equivalence of a country's meat 
or poultry inspection system is independent from any APHIS animal 
health status determination that may be made for the same given 
country. 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 meat products to the U.S., those meat products must 
also comply with all other U.S. requirements before entry. Before a 
shipment of meat or meat products may be presented for re-inspection at 
the port-of entry by FSIS, it must have first met the requirements of 
both the U.S. Customs Service 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, meat 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 meat and meat 
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 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. Certain animal diseases can be highly 
communicable and could have a devastating economic impact on the U.S. 
meat industry were they to enter the United States. For example, bovine 
Foot and Mouth Disease (FMD) is not currently present in Chile but does 
occur in nearby Argentina. Due to the proximity of Argentina, APHIS and 
Chilean officials closely monitor this animal disease and have found no 
cause for concern.
    For these reasons, FSIS believes that sufficient controls are in 
place to ensure that meat and meat products processed in Chile will not 
pose a risk in the U.S.
    Accordingly, FSIS is proposing to amend Part 327 of the Federal 
meat inspection regulations to add Chile as a country from which meat 
and meat products may be eligible for import into the United States. As 
a country eligible to export meat products to the United States, the 
government of Chile would certify to FSIS those establishments wishing 
to export such products to the U.S. and operating according to U.S. 
requirements. FSIS would retain the right to verify that establishments 
certified by the Chile government are meeting the U.S. requirements. 
This verification would be done through annual on-site reviews of the 
establishments while they are in operation.
    All meat products exported to the United States from Chile would be 
subject to reinspection at the ports-of-entry for transportation 
damage, labeling, proper certification, general condition, and accurate 
count. Other types of inspection would also be conducted, including 
examining product for defects and performing laboratory analyses to 
detect chemical residues or microbial contamination.
    Products that pass reinspection will be stamped with the official 
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 allowed entry for the purpose of converting to 
animal food.

[[Page 24487]]

Economic Impact Analysis

    The United States annually imports about 14 million metric tons 
(MT) of meat products, worth about $4.2 billion. These amounts are 
projected to increase by 2011 to about 17 million MT, worth $5.1 
billion.
    Current information indicates that several establishments in Chile 
would be able to ship meat and, potentially, meat products to the 
United States--largely beef, pork, and lamb. The exports would consist 
of an estimated 600 MT of bone-in and boneless beef valued at $1.8 
million; an estimated 500 MT of bone-in pork cuts (ribs) valued at 
$2.65 million; and about 500 MT of lamb carcasses, carcass halves, and 
quarters, valued at $1.5 million. Listing Chile as eligible to export 
meat to the United States would therefore add a very small portion to 
total U.S. meat imports.
    The additional 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.
    Benefits would include increased trade with Chile and the 
availability to U.S. consumers of a greater quantity of meat of the 
kinds mentioned. Wholesale prices of all grades of these products have 
been moving upward during the last several years. Importing beef, pork, 
and lamb from Chile would not affect this trend or would do so only 
very slightly. Both nations would benefit from an expansion of trade in 
meat as part of a wide range of commodities.
    Constraints on the expansion of trade in meat 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 current updates of the animal disease 
status of regions in Chile where establishments likely to export 
product to the United States are located.
    Estimates of benefits and costs of increased trade in meat with 
Chile are based on data supplied by FSIS Office of International 
Affairs and Field Operations staffs; Foreign Agricultural Service (FAS) 
databases and trade reports; Economic Research Service (ERS) databases, 
reports, and analyses; and Census Bureau databases and reports. 
Standard economic analytical techniques were used in estimating effects 
of the proposed rulemakings.
    The major source of uncertainty in estimating the effects of the 
proposed rulemaking is in forecasting the number of establishments 
likely to be certified for importation of products into the United 
States. Other, less important, sources of uncertainty include 
imprecision in the economic data to be consulted, e.g., estimates of 
demand elasticities and probable errors in multi-year forecasts of 
prices for the commodities to be regulated under the proposed 
rulemakings.

Effect on Small Entities

    The Administrator, FSIS, has made an initial determination that 
this proposed 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 proposed rule would add Chile to the list of 
countries eligible to export meat and meat products to the United 
States. The volume of trade stimulated by this rule would be very small 
and would have relatively little effect on supply and prices. 
Therefore, this proposed rule is not expected to have a significant 
impact on small entities that produce these types of products 
domestically.

Paperwork Requirements

    No new paperwork requirements are associated with this proposed 
rule. Foreign countries wanting to export meat and meat products to the 
United States are required to provide information to FSIS certifying 
that their inspection systems provide 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, before they may start exporting such product to 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 the country in organizing 
its materials. This information collection was approved under OMB 
number 0583-0094. The proposed rule contains no other paperwork 
requirements.

Executive Order 12866 and Regulatory Flexibility Act

    This proposed 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).

Executive Order 12988

    This proposed rule has been reviewed under Executive Order 12988, 
Civil Justice Reform. If this proposed 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.

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 final rule, FSIS will announce it on-
line through the FSIS Web page located at http://www.fsis.usda.gov/regulations_&_policies/2005_Proposed_Rules_Index/index.asp.
 The 

Regulations.gov Web site is the central online rulemaking portal of the 
United States government. It is being 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 also will make copies of this Federal Register publication 
available through the FSIS Constituent Update, which is used to provide 
information regarding FSIS policies, procedures, regulations, Federal 
Register notices, FSIS 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 also is 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 email subscription service which 
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,

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directives and notices. Customers can add or delete subscriptions 
themselves and have the option to password protect their account.

List of Subjects in 9 CFR Part 327

    Imported products.

    For the reasons set out in the preamble, FSIS is proposing to amend 
9 CFR part 327 as follows:

PART 327--IMPORTED PRODUCTS

    1. The authority citation for part 327 continues to read as 
follows:

    Authority: 21 U.S.C. 601-695; 7 CFR 2.18, 2.53.


Sec.  327.2  [Amended]

    2. Section 327.2 is amended by adding Chile in alphabetical order 
to the list of countries in paragraph (b).

    Done at Washington, DC, on May 4, 2005.
Barbara J. Masters,
Acting Administrator.
[FR Doc. 05-9279 Filed 5-9-05; 8:45 am]