[Federal Register: August 13, 2004 (Volume 69, Number 156)]
[Proposed Rules]               
[Page 50086-50088]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr13au04-14]                         

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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 50086]]



DEPARTMENT OF AGRICULTURE

Food Safety and Inspection Service

9 CFR Part 327

[Docket No. 01-029P]
RIN 0583-AC91

 
Addition of San Marino 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 San Marino to the list of countries eligible to export meat and 
meat products to the United States. Reviews of San Marino's laws, 
regulations, and other written materials show that its meat processing 
system meets 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.
    Establishments that would be certified under this proposed 
regulation would only be exporting pork products to the United States. 
Pork products from San Marino may be imported into the United States 
only if these products are from swine slaughtered in certified 
slaughter establishments located in other countries eligible to export 
meat to the United States and are processed in certified establishments 
in San Marino. All meat products exported from San Marino to the United 
States would be subject to reinspection at the U.S. ports-of-entry by 
FSIS inspectors as required by law.

DATES: Comments must be received on or before October 12, 2004.

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 01-029P.
    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 at http://www.fsis.usda.gov/OPPDE/rdad/FRDockets.htm.


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

SUPPLEMENTARY INFORMATION: 

Background

    FSIS is proposing to amend the Federal meat inspection regulations 
to add San Marino to the list of countries eligible to export meat and 
meat products to 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 which 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. 9 CFR 327.2 establishes 
the procedures by which foreign countries wanting 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 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

[[Page 50087]]

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 comprise 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 samples imported meat and poultry products 
for reinspection as they enter the United States.

Evaluation of the San Marino Inspection System

    In response to a request from San Marino in 1997 for approval to 
export meat and meat products to the United States, FSIS conducted a 
thorough review of the San Marino meat inspection system to determine 
if it was equivalent to the U.S. meat inspection system. First, FSIS 
compared San Marino's meat inspection laws and regulations with U.S. 
requirements. The study concluded that the requirements contained in 
San Marino'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 San Marino meat inspection system in 
operation. The FSIS review team concluded that San Marino's 
implementation of meat processing standards and procedures was 
equivalent to those of the United States.
    All meat products exported to the United States from San Marino 
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 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.
    Accordingly, FSIS is proposing to amend Sec.  327 of the Federal 
meat inspection regulations to add San Marino 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 San Marino 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 San Marino government 
are meeting the U.S. requirements. This would be done through annual 
on-site reviews of the establishments while they are in operation.
    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. The Agency notes that APHIS has classified San Marino as 
having a substantial risk associated with Bovine Spongiform 
Encephalopathy (BSE). Although pork is the specific product proposed 
for import into the United States from San Marino, FSIS considered BSE 
risk in its evaluation process. APHIS is responsible for keeping 
foreign animal diseases out of the United States. 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. Those products that APHIS has restricted from 
entering the United States will be refused entry.
    FSIS and APHIS work closely together and communicate regularly to 
ensure that meat and meat products imported into the United States 
comply with the regulatory requirements of both agencies.
    The full report on San Marino can be found on the FSIS Web site at 
http://www.fsis.usda.gov/OPPDE/Far/index.htm.


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.

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).
    There is only one establishment in San Marino that has applied to 
export meat products to the United States. This establishment would 
export non-shelf stable cooked meat products. U.S. imports from this 
establishment are expected to total approximately 500,000 pounds per 
year.
    U.S. firms export small amounts of pork and poultry products to San 
Marino. Table A reports the most current information, from 1996-2000, 
on U.S. exports of poultry and pork products to San Marino. Poultry 
exports were highest in 1994, before declining and eventually falling 
to zero. Poultry exports reappeared again in 1998, but again at 
relatively low levels. Between 1994 and 2000, U.S. firms exported pork 
products to San Marino only once, in 1994. Since then, there have been 
no further exports of pork products.
    Adoption of this proposed rule would continue to open trade between 
the U.S. and San Marino. This proposed rule would also increase the 
U.S. food supply.
    The impact of this proposed rule on U.S. consumers is voluntary in 
that consumers will not be required to purchase meat products produced 
and processed in San Marino, although they may choose to do so. 
Expected benefits from this type of proposed rule would accrue 
primarily to consumers in the form of competitive prices due to a 
larger market variety of meat products. The volume of trade stimulated 
by this proposed rule, however, will likely be so small as to have 
little effect on supply and prices. Consumers, apart from any change in 
prices, would

[[Page 50088]]

benefit from increased choices in the marketplace.
    The costs of this rule will accrue primarily to producers in the 
form of greater competition from San Marino. Again, it must be noted 
that the volume of trade stimulated by this rule would be very small, 
likely having little effect on supply and prices. Nonetheless, it is 
possible that U.S. firms that produce products that would compete with 
San Marino imports could face short-term difficulty. However, in the 
long run, such firms could adjust their product mix in order to compete 
effectively.

 Table A.--U.S. Exports of Poultry and Pork Products to San Marino 1996-
                                  2000
------------------------------------------------------------------------
                                                                Average
             Calendar year                Quantity    Value    price per
                                           (tons)    ($1,000)     ton
------------------------------------------------------------------------
Poultry:
    1996...............................          0      $0.00         NA
    1997...............................          0       0.00         NA
    1998...............................         68         68      $1.00
    1999...............................         24         14       0.58
    2000...............................         69         55       0.80
Pork:
    1996...............................          0      $0.00         NA
    1997...............................          0       0.00         NA
    1998...............................          0       0.00         NA
    1999...............................          0       0.00         NA
    2000...............................          0       0.00         NA
------------------------------------------------------------------------

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 San Marino to the list of 
countries eligible to export meat products into the United States. 
Currently, only one San Marino establishment has applied to export 
product to the United States. This establishment is planning to export 
approximately 500,000 pounds of non-shelf stable cooked meat products 
to the United States per year. The volume of trade stimulated by this 
rule would be very small, likely having 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 livestock products to the 
United States are required to provide information to FSIS certifying 
that its inspection system provides standards equivalent to those of 
the United States and that the legal authority for the system and its 
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 San Marino 
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.

Additional Public Notification

    Public awareness of all segments of rulemaking and policy 
development is important. In an effort to ensure that this notice comes 
to the attention of the public--including minorities, women, and 
persons with disabilities--FSIS will announce it on-line through the 
FSIS Web page located at http://www.fsis.usda.gov. 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 
broader and more diverse audience.

List of Subjects in 9 CFR Part 327

    Imports, Meat and meat products.

    For the reasons set out in the preamble, 9 CFR part 327 would be 
amended as follows:

PART 327--IMPORTED PRODUCTS

    1. The authority citation for part 327 would continue 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 would be amended by adding ``San Marino'' in 
alphabetical order to the list of countries in paragraph (b).

    Done in Washington, DC, on August 1, 2004.
Barbara J. Masters,
Acting Administrator.
[FR Doc. 04-18567 Filed 8-12-04; 8:45 am]
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