[Federal Register Volume 71, Number 149 (Thursday, August 3, 2006)]
[Rules and Regulations]
[Pages 43958-43961]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E6-12565]


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DEPARTMENT OF AGRICULTURE

Food Safety and Inspection Service

9 CFR Parts 327 and 381

[Docket No. 03-033F; FDMS Docket Number FSIS-2005-0026]
RIN 0583-AD08


Frequency of Foreign Inspection System Supervisory Visits to 
Certified Foreign Establishments

AGENCY: Food Safety and Inspection Service, USDA.

ACTION: Final rule.

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SUMMARY: The Food Safety and Inspection Service (FSIS) FSIS is amending 
9 CFR parts 327 and 381 to bring the frequency with which foreign 
inspection systems are required to make supervisory visits to certified 
establishments into agreement with the frequency with which the Agency 
makes supervisory visits to domestic establishments. This final rule 
does not affect in-plant inspection requirements. FSIS is deleting the 
requirement that supervisory visits take place ``not less frequent[ly] 
than one such visit per month.'' Instead, FSIS will require foreign 
inspection systems to make ``periodic supervisory visits'' to certified 
establishments to ensure that establishments meet FSIS requirements for 
certification to export meat and poultry to the United States.

DATES: Effective Date: September 5, 2006.

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

SUPPLEMENTARY INFORMATION:

Background

    On August 18, 2004, FSIS published a proposal in the Federal 
Register (69 FR 51194-51196) to amend 9 CFR 327.2(a)(2)(iv)(A) and 9 
CFR 381.196(a)(2)(iv)(A) to provide that supervisory visits by a 
representative of the foreign inspection system are to occur at 
periodic intervals to ensure that establishments and products meet the 
requirements for certification to the United States on an ongoing 
basis. This change would make the Agency's requirements for foreign 
inspection programs as consistent as possible with the FSIS domestic 
inspection program. It would also allow foreign countries flexibility 
in structuring their programs.
    Upon the effective date of this final rule, FSIS will send an 
official letter to each eligible country announcing: The change from 
the monthly requirement and requesting, in writing, formal notice of 
the eligible country's projected frequency of supervisory visits; an 
explanation of why the proposed frequency will ensure that the eligible 
country's system produces safe, wholesome, unadulterated, and properly 
labeled and packaged product on an ongoing basis; and an explanation of 
how the system will ensure that any immediate need for supervisory 
intervention will be recognized and met. The frequency of periodic 
supervisory visits will be evaluated for adequacy by FSIS through its 
annual audit process, in which the ongoing eligibility of an exporting 
country is reviewed.

Comments

    FSIS received four comments on the proposed rule. One comment 
supported the proposal. Three comments raised concerns, with one 
calling for the proposal to be withdrawn. The concerns expressed in 
these three comments are summarized and answered below.

Equivalence With U.S. Domestic Inspection System Culture

    Two comments noted that FSIS has stated that there are continual 
contacts between its inspectors in domestic plants and supervisors 
through means other than personal visits and questioned whether such 
intensive interaction exists within exporting countries that would no 
longer be held to monthly supervisory visits.

FSIS Response

    The Agency notes that the inspection system of a country requesting 
eligibility to export meat and poultry products to the United States is 
thoroughly investigated during the equivalence evaluation process 
described at length in the proposal to this final rule. A key part of 
the evaluation is an assessment of in-plant implementation of 
inspection system procedures, which includes an examination of the 
appropriate level of supervisory oversight for certified 
establishments. An applying country must demonstrate that its 
inspection system, as implemented, includes features equivalent to 
those of the U.S. system before the country can be found equivalent.
    As stated above, upon the effective date of this final rule, FSIS 
will send an official letter to each eligible country announcing the 
change from the monthly requirement. FSIS will request formal notice in 
writing of the eligible country's projected frequency of supervisory 
visits and an explanation of why the proposed frequency will ensure 
that the eligible country's system produces safe and wholesome product 
on an ongoing basis. Each eligible country will also be asked to 
describe, in writing, how its system will ensure that any immediate 
need for supervisory intervention will be recognized and met. The 
frequency of periodic supervisory visits will be evaluated for adequacy 
by FSIS in its annual audits reviewing the ongoing eligibility of an 
exporting country.

Equivalence With Domestic State Inspection Systems

    Another comment noted that the 28 State inspection systems are 
required to be ``at least equal to'' the Federal inspection system, and 
that many federally-inspected plants have reported supervisory visits 
more frequently than the monthly requirement that will be eliminated 
for eligible exporting countries by the final rule.

[[Page 43959]]

FSIS Response

    The Agency notes that, as it does not set a mandatory frequency for 
itself, it does not require a set frequency of supervisory visits from 
the ``equal to'' State inspection systems. Thus, there is no compelling 
reason for the Agency to require exporting countries to meet a specific 
frequency that is not mandatory for any domestic program. Supervisory 
visits in domestic establishments under Federal inspection occur at the 
frequency required by local conditions and by Agency concerns regarding 
the situation at a given plant. Thus the frequency of visits varies 
from plant to plant, but overall such visits occur less frequently than 
once a month.

Definition of ``Periodic''

    One comment asked if the Agency will define ``periodic'' and 
require uniformity among countries eligible to export meat and poultry 
products to the United States.

FSIS Response

    As there is no domestic requirement for a specific frequency of 
supervisory visits to plants, ``periodic'' will mean a frequency 
determined by exporting countries as adequate to ensure that certified 
establishments continually meet FSIS equivalency requirements, as 
evaluated and verified by the Agency. As stated above, upon the 
effective date of this final rule, FSIS will send an official letter to 
each eligible country announcing the change from the monthly 
requirement and will request formal notice, in writing, of the eligible 
country's projected frequency of supervisory visits.

Timely Information

    One comment asked whether the Agency has a mechanism for staying 
current with regulatory or procedural changes in exporting countries.

FSIS Response

    The Agency has long maintained a system of exchanging official 
letters with trading partners to provide notice of any relevant changes 
in both regulations and inspection procedures. FSIS, furthermore, 
conducts an ongoing system of equivalence verification to update the 
original equivalence evaluation. One key element of this verification 
system is a recurring document analysis of the laws, regulations, and 
implementing policies of the foreign food regulatory system to ensure 
that an equivalent infrastructure is in place, and that timely 
notification of any relevant changes has been made through the system 
of official letters. As stated above, upon the effective date of this 
final rule, FSIS will send official letters to all eligible countries 
informing them of the change from the monthly requirement and 
requesting formal notice of their projected frequency of supervisory 
visits.
    The second key element of the equivalence verification process is 
the annual on-site food regulatory system audit conducted by FSIS 
technical specialists in every country that exports meat or poultry 
products to the United States. During these annual system audits, FSIS 
seeks evidence that the exporting country has instituted sanitary 
measures adequate to provide the same level of protection that is 
ensured by our domestic system. The system audit focuses on two 
essential components of safe food production, industry process control 
and government regulatory control. The frequency of periodic 
supervisory visits would be evaluated for adequacy by FSIS in the 
annual audits.
    The third component of equivalence verification is port-of-entry 
reinspection, where FSIS randomly samples meat and poultry products as 
they enter the United States to ensure that exporting country 
certificates are authentic and accurate, and that products meet all 
U.S. standards pertaining to safe, wholesome, unadulterated, and 
properly labeled and packaged product. Although records are maintained 
on each certified establishment, reinspection is designed to verify 
effectiveness of the foreign inspection system. Port-of-entry 
reinspection is directed by the Automated Import Information System 
(AIIS), a centralized computer database that stores daily reinspection 
results from all ports of entry for each country and for each 
establishment. When a shipment is presented for reinspection, the AIIS 
scans its existing records to determine whether the foreign country, 
the establishment, and the product are eligible for export to the 
United States. The shipment is refused entry if any component of 
eligibility is absent.
    Given these well-established mechanisms, and the additional FSIS 
request for notice of an exporting country's projected frequency of 
periodic supervisory visits, the Agency is confident that it will 
quickly become aware of any changes in an exporting country's 
regulatory system and practice.

Terrorism

    One comment stated that eliminating the requirement for monthly 
supervisory visits could undercut the war on terrorism by loosening 
control of products destined for export to the United States.

FSIS Response

    As described above, the inspection system of a country requesting 
eligibility to export meat and poultry products to the United States is 
analyzed intensively during the equivalence evaluation process, which 
includes a review of in-plant implementation of inspection system 
procedures. A country applying for eligibility must demonstrate that 
its inspection system, as implemented, includes features equivalent to 
those of the U.S. system before the country can be found equivalent.
    As stated above, upon the effective date of this final rule, FSIS 
will send an official letter to each eligible country announcing the 
change from the monthly requirement and requesting formal notice in 
writing of the eligible country's projected frequency of supervisory 
visits. FSIS will also request that each country explain why the 
proposed frequency will ensure that its system produces safe and 
wholesome product on an ongoing basis, and describe how the system will 
ensure that any immediate need for supervisory intervention will be 
recognized and met.
    To verify the continuing equivalence of an eligible exporting 
country, FSIS maintains a comprehensive system of import inspection 
controls as described above, which includes recurring document analysis 
of a foreign country's inspection system, annual on-site audits, and 
port-of-entry reinspection. During the Agency's annual audits of those 
foreign countries exporting meat, poultry, and egg products to the 
United States, information is provided to the exporting countries on 
the FSIS security guidelines for food processors and for the 
transportation and distribution of meat, poultry, and egg products. 
FSIS auditors also report to the appropriate inspection officials any 
potential threats that they observe during the audit. In these annual 
equivalence/verification audits, FSIS will evaluate the frequency of 
periodic supervisory visits for adequacy.
    FSIS has also developed strong internal resources for food defense 
that provide an extra margin of protection against potential terrorism 
involving the food supply. These resources include the Office of Food 
Defense and Emergency Response (OFDER), a dedicated, full-time staff 
whose sole responsibility is food security, and Import Surveillance 
Liaison Officers who are stationed around the country to augment the 
efforts of traditional FSIS inspectors assigned to import houses.

[[Page 43960]]

The Agency, furthermore, participates in the Federal International 
Trade Data System (ITDS), a multi-department, multi-agency initiative 
establishing a single, automated system for sharing data on the 
inspection and certification of products moving in foreign commerce.
    With these notification and auditing mechanisms and other 
initiatives in place, FSIS believes it can verify that countries 
eligible to export meat and poultry products to the United States 
maintain, among other things, food defense procedures and practices 
that are equivalent to those of the United States.

Executive Order 12866 and Regulatory Flexibility Act

    This rule has been reviewed under Executive Order 12866. It has 
been determined to be not significant for purposes of E.O. 12866 by the 
Office of Management and Budget (OMB).
    The main effect of this action is to give eligible countries the 
flexibility to structure their own supervisory programs as they deem 
necessary so as to ensure that establishments continue to meet the 
requirements for certification to export to the United States. This 
action will enable the United States to meet its obligation as a 
signatory to the World Trade Organization (WTO) ``Agreement on the 
Application of Sanitary and Phytosanitary Measures'' not to impose 
import requirements on inspection systems or establishments in an 
exporting country that are more stringent than those applied 
domestically. No costs should ensue from this final action.

Executive Order 12988

    This final rule has been reviewed under Executive Order 12988, 
Civil Justice Reform. When 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.

Effect on Small Entities

    This action affects only how foreign countries perform inspection 
and will not have any effect on domestic establishments. Therefore, the 
Administrator, FSIS, has made a determination that 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).

Expected Effect on FSIS, Other Federal Agencies, State and Local 
Governments and Foreign Countries

    This final action is expected to have no effect upon FSIS or other 
Federal agencies. It is likely to have only minimal effects on foreign 
countries. The action will not affect State and local governments.

Expected Environmental Effects

    Amending 9 CFR parts 327 and 381 to bring the frequency with which 
foreign inspection systems are required to make supervisory visits to 
certified establishments into agreement with the frequency with which 
the Agency makes supervisory visits to domestic establishments is an 
activity that will not have a significant individual or cumulative 
effect on the human environment. Therefore, this action is 
appropriately subject to the categorical exclusion from the preparation 
of an environmental assessment or environmental impact statement 
provided under 7 CFR 1b.4(6) of the U.S. Department of Agriculture 
regulations.

Paperwork Requirements

    No new paperwork requirements are associated with this final 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. This information 
collection was approved under OMB number 0583-0094. The final rule 
contains no other paperwork requirements.

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_Interim_&_Final_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 e-mail subscription service which 
provides automatic and customized access to selected food safety news 
and information. This service is available at http://www.fsis.usda.gov/news_and_events/email_subscription/. 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 account.

List of Subjects

9 CFR Part 327

    Imported products.

9 CFR Part 381

    Imported poultry products, poultry inspection.


0
For the reasons discussed in the preamble, FSIS is amending 9 CFR parts 
327 and 381, as follows:

PART 327--IMPORTED PRODUCTS

0
1. The authority for part 327 continues to read as follows:

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


0
2. Section 327.2(a)(2)(iv)(A) is revised to read as follows:

[[Page 43961]]

Sec.  327.2  Eligibility of foreign countries for importation of 
products into the United States.

    (a) * * *
    (2) * * *
    (iv) * * *
    (A) Periodic supervisory visits by a representative of the foreign 
inspection system to each establishment certified in accordance with 
paragraph (a)(3) of this section to ensure that requirements referred 
to in paragraphs (a)(2)(ii)(A) through (H) of this section are being 
met: Provided, That such visits are not required with respect to any 
establishment during a period when the establishment is not operating 
or is not engaged in producing products for exportation to the United 
States;
* * * * *

PART 381--POULTRY PRODUCTS INSPECTION REGULATIONS

0
3. The authority 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.

Subpart T--Imported Poultry Products

0
4. Section 381.196(a)(2)(iv)(A) is revised to read as follows:


Sec.  381.196  Eligibility of foreign countries for importation of 
products into the United States.

    (a) * * *
    (2) * * *
    (iv) * * *
    (A) Periodic supervisory visits by a representative of the foreign 
inspection system to each establishment certified in accordance with 
paragraph (a)(3) of this section to ensure that requirements referred 
to in paragraphs (a)(2)(ii)(A) through (H) of this section are being 
met: Provided, That such visits are not required with respect to any 
establishment during a period when the establishment is not operating 
or is not engaged in producing products for exportation to the United 
States;
* * * * *

    Done at Washington, DC, on July 31, 2006.
Barbara J. Masters,
Administrator.
[FR Doc. E6-12565 Filed 8-2-06; 8:45 am]
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