[Federal Register Volume 80, Number 181 (Friday, September 18, 2015)]
[Proposed Rules]
[Pages 56401-56405]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2015-23455]


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DEPARTMENT OF AGRICULTURE

Food Safety and Inspection Service

9 CFR Part 327

[Docket No. FSIS-2012-0028]
RIN 0583-AD51


Eligibility of Namibia To Export 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 Namibia to the list of countries whose meat inspection system is 
equivalent to the system that the United States has established under 
the Federal Meat Inspect Act (FMIA) and its implementing regulations. 
FSIS's review of Namibia's laws, regulations, and inspection 
implementation show this to be the case.
    At this time, because Namibia advised FSIS that it intends to 
export only boneless (not ground) raw beef products, such as primal 
cuts, chuck, blade, and beef trimmings to the United States, FSIS has 
only assessed Namibia's inspection system with respect to beef. Thus, 
should this rule become final, Namibia would need to submit additional 
information for FSIS to review before FSIS would allow Namibia to 
export product from other types of livestock to the U.S. All products 
that Namibia exports to the U.S. will be subject to re-inspection at 
United States ports of entry by FSIS inspectors.

DATES: Comments must be received on or before November 17, 2015.

ADDRESSES: FSIS invites interested persons to submit comments on this 
notice. Comments may be submitted by one of the following methods:
     Federal eRulemaking Portal: This Web site provides the 
ability to type short comments directly into the comment field or 
attach a file for lengthier comments. Go to http://www.regulations.gov. 
Follow the on-line instructions at that site for submitting comments.
     Mail, including CD-ROMs, etc.: Send to Docket Clerk, U.S. 
Department of Agriculture, Food Safety and Inspection Service, Patriots 
Plaza 3, 1400 Independence Avenue SW., Mailstop 3782, Room 8-163A, 
Washington, DC 20250-3700.
     Hand- or courier-delivered submittals: Deliver to Patriots 
Plaza 3, 355 E Street SW., Room 8-163A, Washington, DC 20250-3700.
    Instructions: All items submitted by mail or electronic mail must 
include the Agency name and docket number FSIS-2012-0028. Comments 
received in response to this docket will be made available for public 
inspection and posted without change, including any personal 
information, to http://www.regulations.gov.
    Docket: For access to background documents or comments received, go 
to the FSIS Docket Room at Patriots Plaza 3, 355 E Street SW., Room 8-
164, Washington, DC 20250-3700 between 8:00 a.m. and 4:30 p.m., Monday 
through Friday.

FOR FURTHER INFORMATION CONTACT: Dr. Daniel Engeljohn, Assistant 
Administrator, Office of Policy and Program Development; Telephone: 
(202) 205-0495.

SUPPLEMENTARY INFORMATION:

Background

    FSIS is proposing to amend its meat products inspection regulations 
to add Namibia to the list of countries eligible to export meat 
products to the United States (9 CFR 327.2(b)). Namibia is not 
currently listed as eligible to export such products to the United 
States.

Statutory Basis for Proposed Action

    Under the FMIA and the regulations that implement it, meat and meat 
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 (21 U.S.C. 620). The FMIA also 
requires that the livestock from which such imports are produced be 
slaughtered and handled in connection with slaughter in a manner that 
is consistent

[[Page 56402]]

with the Humane Methods of Slaughter Act (7 U.S.C. 1901-1906). Section 
327.2 of Title 9 of the Code of Federal Regulations (CFR) sets out the 
procedures by which foreign countries may become eligible to export 
meat and meat products to the United States.
    Paragraph 327.2(a) of 9 CFR requires that a foreign country's meat 
inspection system provide standards equivalent to those of the United 
States and provide legal authority for the inspection system and its 
implementing regulations that is equivalent to that of the United 
States. Specifically, a country's legal authority and regulations must 
impose requirements equivalent to those of the United States with 
respect to: (1) Ante-mortem inspection, humane methods of slaughter and 
handling, and post-mortem inspection by, or under the direct 
supervision of, a veterinarian; (2) official controls by the national 
government over establishment construction, facilities, and equipment; 
(3) direct and continuous official supervision of slaughtering and 
preparation of product by inspectors to ensure that product is not 
adulterated or misbranded; (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 and for sanitary 
handling of product at establishments certified to export; (7) official 
controls over condemned product; (8) a Hazard Analysis and Critical 
Control Point (HACCP) system; and (9) any other requirements found in 
the FMIA and its implementing regulations (9 CFR 327.2(a)(2)(ii)).
    The country's inspection system must also impose requirements 
equivalent to those of the United States with respect to: (1) 
Organizational structure and staffing to ensure uniform enforcement of 
the requisite laws and regulations in all certified establishments; (2) 
national government control and supervision over the official 
activities of employees or licensees; (3) qualified inspectors; (4) 
enforcement and certification authority; (5) administrative and 
technical support; (6) inspection, sanitation, quality, species 
verification, and residue standards; and (7) any other inspection 
requirements (9 CFR 327.2(a)(2)(i)).
    A foreign country's inspection system must be evaluated by FSIS 
before eligibility to export meat and meat 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. FSIS requests that 
countries provide information about their inspection systems through 
its self-reporting tool (SRT). The SRT is a standardized questionnaire 
that FSIS provides to foreign governments to gather information that 
characterizes foreign inspection systems. Through the SRT, FSIS 
collects information on practices and procedures in six areas, known as 
equivalence components: (1) Government Oversight, (2) Statutory 
Authority and Food Safety Regulations, (3) Sanitation, (4) HACCP 
Systems, (5) Chemical Residue Testing Programs, and (6) Microbiological 
Testing Programs. FSIS evaluates the information submitted to verify 
that the critical points in the six equivalence components are 
addressed satisfactorily with respect to standards, activities, 
resources, and enforcement. If the document review is satisfactory, an 
onsite review is scheduled using a multidisciplinary team to evaluate 
all aspects of the country's inspection program. This comprehensive 
process is described more fully on the FSIS Web site at: http://www.fsis.usda.gov/wps/portal/fsis/topics/international-affairs/importing-products/equivalence/equivalence-process-overview.
    The FMIA and implementing regulations require that foreign 
countries be listed in the CFR as eligible to export meat and meat 
products to the United States. FSIS must engage in rulemaking to list a 
country as eligible. Countries found eligible to export meat or meat 
products to the United States are listed in the meat inspection 
regulations at 9 CFR 327.2(b). Once listed, the government of an 
eligible country must certify to FSIS that establishments that wish to 
export meat products to the United States are operating under 
requirements equivalent to those of the United States (9 CFR 
327.2(a)(3)). Countries must renew certifications of establishments 
annually (9 CFR 327.2(a)(3)).
    Section 20 of the FMIA (21 U.S.C. 620) prohibits the importation 
into the United States of adulterated or misbranded carcasses, parts of 
carcasses, meat, or meat products of amenable species that are capable 
of use as human food. To verify that products imported into the United 
States are not adulterated or misbranded, FSIS reinspects and randomly 
samples those products at ports of entry, before they enter U.S. 
commerce.

Evaluation of the Namibian Meat Inspection System

    In 2002 and again in 2005, the government of Namibia requested 
approval to export meat (beef) products to the United States. Namibia 
stated that, if approved, its immediate intent was to export boneless 
(not ground) raw beef products such as primal cuts, chuck, blade, and 
beef trimmings to the United States.
    In 2006, FSIS conducted a document review of Namibia's meat 
(slaughter and processing) inspection system to determine whether that 
system is equivalent to the United States' meat inspection system. FSIS 
concluded, on the basis of that review, that Namibia's laws, 
regulations, control programs, and procedures were sufficient to 
achieve the level of public health protection required by FSIS.
    Accordingly, FSIS proceeded with an on-site audit of Namibia's meat 
inspection system from September 25 to October 11, 2006, to verify 
whether Namibia's central competent authority (CCA) in charge of food 
inspection effectively implemented a meat inspection system equivalent 
to that of the United States. FSIS concluded that Namibia's meat 
inspection system did not meet the equivalence components for 
government oversight, statutory authority and food safety regulations, 
sanitation, HACCP, and chemical residue and microbiological testing 
programs. For example, FSIS found that the CCA did not have adequate 
administrative controls over the inspection system and lacked a 
training program to maintain the competency of the inspection personnel 
and laboratory analysts. Namibia did not provide direct and continuous 
inspection by the assigned government inspectors. Additionally, the 
sanitation programs at the establishments visited by the audit team 
lacked measures to prevent recurring deficiencies that could result in 
direct product contamination or adulteration, and inspectors did not 
identify the problems.
    Following the 2006 on-site audit, Namibia provided a corrective 
action plan that addressed FSIS's findings. Namibia also implemented 
comprehensive inspection training programs on requirements consistent 
with FSIS requirements for all its inspection and laboratory personnel.
    From September 2 to 9, 2009, FSIS conducted a follow-up on-site 
audit to determine whether the outstanding issues identified during the 
previous on-site audit had been resolved. The 2009 audit identified new 
systemic deficiencies within the equivalence components for government 
oversight, sanitation, HACCP, chemical residue, and microbiological 
testing programs. Specifically, the 2009 audit found that Namibia did 
not have a plan to

[[Page 56403]]

continuously analyze and implement staffing requirements in order to 
provide relief staff assignments during planned and unplanned field 
inspection personnel absences. In addition, Namibia did not effectively 
require that establishments maintain sanitation programs to prevent 
insanitary conditions and product contamination. Namibia also did not 
provide effective verification to ensure HACCP plans were effectively 
implemented and did not provide adequate control over laboratory 
quality systems.
    Following the 2009 on-site audit, Namibia again provided a 
comprehensive corrective action plan that addressed the findings 
identified. FSIS reviewed the corrective action plan and concluded that 
Namibia had satisfactorily addressed all the 2009 audit findings. In 
addition, FSIS concluded that Namibia's corrective action plan 
satisfactorily addressed all the previous 2006 audit findings.
    In 2013, FSIS conducted an initial equivalence follow-up on-site 
audit of Namibia's meat inspection system and verified that Namibia had 
satisfactorily implemented the corrective action plans proffered in 
response to the 2009 on-site audit. In 2013, the FSIS audit identified 
new findings within the equivalence components of government oversight, 
statutory authority and food safety regulations, sanitation, and 
chemical residue testing programs. The audit found that although the 
CCA had implemented all corrective action plans related to government 
oversight, it was unable to provide any record to demonstrate that the 
inspection personnel at the local establishments were properly 
implementing and documenting inspection procedures. Additionally, 
inspection personnel were including non-compliance findings on the 
Inspection Verification Activities Sheet instead of using a separate 
non-compliance record (NR) form to document non-compliance findings. 
Regarding statutory authority and food safety regulations, Namibia had 
implemented all related corrective action plans but could not 
demonstrate that it had adequate records to verify that establishments 
met Specified Risk Materials (SRM) requirements, to enforce SRM 
requirements, and to prevent potential SRM contamination from cattle 30 
months of age or older. The CCA also had not effectively implemented 
its verification procedures for sanitation performance standards and 
was unable to demonstrate how it assessed its residue plan results. 
Namibia's National Residue Program did not have sampling plan 
procedures or strategies for dealing with residue violators.
    In response to the 2013 audit findings, Namibia implemented 
immediate corrective actions and submitted another corrective action 
plan that addressed the findings identified during the audit of its 
food safety system. FSIS reviewed Namibia's corrective action plan and 
concluded that Namibia had satisfactorily addressed 2013 audit 
findings. FSIS conducted another audit in 2014 to verify that Namibia 
had effectively implemented those corrective actions.
    On the basis of the 2014 follow-up on-site audit, FSIS has 
concluded that Namibia has fully implemented the corrective action plan 
that it had submitted in response to the 2013 audit. FSIS did not find 
any significant problems during the audit. Furthermore, through the 
audit, FSIS found that Namibia has implemented a sampling and testing 
program for Shiga toxin-producing Escherichia coli (STEC) that is 
equivalent to FSIS's program. Therefore, FSIS has determined that the 
CCA has adequately addressed all previous audit findings and met FSIS 
equivalence criteria related to all six components.
    In summary, FSIS has completed the document review, on-site audits, 
and verification of corrective actions as part of the equivalence 
process, and all outstanding issues have been resolved. FSIS has 
determined that, as implemented, Namibia's inspection system (slaughter 
and processing) with respect to beef is equivalent to the United 
States' meat inspection system. The final 2009, 2013, and 2014 audit 
reports on Namibia's meat inspection system (slaughter and processing) 
can all be found on the FSIS Web site at: http://www.fsis.usda.gov/wps/portal/fsis/topics/international-affairs/importing-products/eligible-countries-products-foreign-establishments/foreign-audit-reports.
    Should this rule become final, Namibia will be eligible to export 
to the U.S. boneless (not ground) beef raw products such as primal 
cuts, chucks, blade, and beef trimmings. The government of Namibia will 
need to certify to FSIS that those establishments that wish to export 
beef or beef products to the United States are operating in accordance 
with requirements equivalent to those of the United States. FSIS will 
verify that the establishments certified by Namibia's government meet 
the United States requirements through periodic and regularly scheduled 
audits of Namibia's meat inspection system.
    If this proposed rule is adopted, the beef products that Namibia 
exports to the United States will be subject to re-inspection at the 
U.S. ports-of-entry for, but not limited to, transportation damage, 
product and container defects, labeling, proper certification, general 
condition, and accurate count. Moreover, even though a foreign country 
may be listed in FSIS regulations as eligible to export to the United 
States, the exporting country's products must also comply with all 
other applicable requirements of the United States. These requirements 
include restrictions under 9 CFR part 94 of APHIS' regulations, which 
also regulate the export of meat products from foreign countries to the 
United States.
    In the future, if Namibia wants to export other meat products to 
the U.S. (e.g., pork products), it will need to notify FSIS and submit 
information about its requirements and inspection program for these 
products. FSIS would then review the information and determine whether 
the Agency needs to audit the operations in Namibia producing these 
products to determine whether the requirements and inspection program 
for these products is equivalent to those in the U.S. Namibia would not 
be allowed to export additional products to the U.S. until FSIS 
determines that the country's requirements and inspection program for 
the products are equivalent to FSIS's system.
    In addition, FSIS will conduct other types of re-inspection 
activities, such as incubation of canned products to ensure product 
safety and taking product samples for laboratory analysis for the 
detections of drug and chemical residues, pathogens, species, and 
product composition. Products that pass re-inspection will be stamped 
with the official United States mark of inspection and allowed to enter 
United States commerce. If they do not meet United States requirements, 
they will be refused entry and within 45 days must be exported to the 
country of origin, destroyed, or converted to animal food (subject to 
approval of the U.S. Food and Drug Administration (FDA), depending on 
the violation. The import re-inspection activities can be found on the 
FSIS Web site at http://www.fsis.usda.gov/wps/portal/fsis/topics/international-affairs/importing-products/phis-import-component/phis-implementation-letter-to-importers/ct_index.

Executive Order 12866 and Regulatory Flexibility Act

    This proposed rule has been designated a ``non-significant'' 
regulatory action under section 3(f) of

[[Page 56404]]

Executive Order (E.O.) 12866. Accordingly, the rule has not been 
reviewed by the Office of Management and Budget (OMB) under E.O. 12866.

Economic Impact Analysis for Namibia Export Equivalence

    This proposed rule would add Namibia to the list of countries 
eligible to export meat products into the United States. The government 
of Namibia intends to certify only one Namibian establishment as 
eligible to export boneless raw beef products to the United States. 
Given this establishment's beef production capacity and the projected 
export volume, FSIS projects that this rule, if implemented, will not 
have an impact on the United States economy. The annual boneless beef 
production of this establishment averaged 21.4 million pounds from 2008 
to 2014. The projected volume of export to the United States is about 
1.9 million pounds in 2015, increasing to about 12.5 million pounds in 
2019.\1\ The average annual United States domestic beef production in 
2012-2014 was 25.3 billion pounds, projected to be 24.2 billion pounds 
in 2015.\2\ The total United States import of beef averages 2.47 
billion pounds per year for 2012-2014, projected to be 2.91 billion 
pounds in 2015.\3\ Therefore, the projected Namibia beef imports in 
2015 would only be about 0.007% of total U.S. production and 0.07% of 
total U.S. imports. If Namibia achieves the projected export goal in 
2019 and assuming that United States beef production and import volume 
stay about the same, the projected beef imports from Namibia would 
still only be about 0.05% of total U.S. production, and 0.5% of total 
U.S. imports.
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    \1\ According to Namibia, this is the ``optimistic'' projection 
they wish to achieve. Market conditions will affect actual results.
    \2\ http://www.ers.usda.gov/media/1823699/rmpfore_apr-2015_r.xls, accessed on May 8, 2015; part of Livestock, Dairy, & 
Poultry Outlook at Economic Research Service, USDA.
    \3\ Ibid.
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    Although Namibia indicates that, for now, it is seeking to export 
boneless beef products only, this would not preclude it from exporting 
other meat products in the future, provided that the products meet all 
FSIS and APHIS requirements and any additional requirements that FSIS 
might have in place with regard to the products. Therefore, the long-
term economic impact could be larger than what we can assess right now.

Effect on Small Entities

    The FSIS Administrator has made a preliminary 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). As mentioned above, the expected trade volume is very 
small. Therefore, the proposed action should have no significant impact 
on small entities that produce beef products domestically.

Executive Order 12988, Civil Justice Reform

    This proposed rule has been reviewed under Executive Order 12988, 
Civil Justice Reform. Under this rule: (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) no 
administrative proceedings will be required before parties may file 
suit in court challenging this rule.

Paperwork Reduction Act

    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 system provides standards equivalent to those of 
the United States, and that the legal authority for the system and 
their implementing regulations are equivalent to those of the United 
States. FSIS provided Namibia with 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 proposed rule 
contains no other paperwork requirements.

E-Government Act

    FSIS and USDA are committed to achieving the purposes of the E-
Government Act (44 U.S.C. 3601, et seq.) by, among other things, 
promoting the use of the Internet and other information technologies 
and providing increased opportunities for citizen access to Government 
information and services, and for other purposes.

Additional Public Notification

    FSIS will officially notify the World Trade Organization's 
Committee on Sanitary and Phytosanitary Measures (WTO/SPS Committee) in 
Geneva, Switzerland, of this proposal and will announce it on-line 
through the FSIS Web page located at: http://www.fsis.usda.gov/regulations_&_policies/Proposed_Rules/index.asp.
    FSIS also will make copies of this publication available through 
the FSIS Constituent Update, which is used to provide information 
regarding FSIS policies, procedures, regulations, Federal Register 
notices, FSIS public meetings, and other types of information that 
could affect or would be of interest to our constituents and 
stakeholders. The Update is available on the FSIS Web page. Through 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 automatic and customized access to selected food 
safety news and information. This service is available at: http://www.fsis.usda.gov/subscribe. Options range from recalls to export 
information, regulations, directives, and notices. Customers can add or 
delete subscriptions themselves, and have the option to password 
protect their accounts.

USDA Non-Discrimination Statement

    No agency, officer, or employee of the USDA shall, on the grounds 
of race, color, national origin, religion, sex, gender identity, sexual 
orientation, disability, age, marital status, family/parental status, 
income derived from a public assistance program, or political beliefs, 
exclude from participation in, deny the benefits of, or subject to 
discrimination any person in the United States under any program or 
activity conducted by the USDA.

How To File a Complaint of Discrimination

    To file a complaint of discrimination, complete the USDA Program 
Discrimination Complaint Form, which may be accessed online at http://www.ocio.usda.gov/sites/default/files/docs/2012/Complain_combined_6_8_12.pdf, or write a letter signed by you or your 
authorized representative.
    Send your completed complaint form or letter to USDA by mail, fax, 
or email: Mail: U.S. Department of Agriculture, Director, Office of 
Adjudication, 1400 Independence Avenue SW., Washington, DC 20250-9410. 
Fax: (202) 690-7442. Email: program.intake@usda.gov.
    Persons with disabilities who require alternative means for 
communication (Braille, large print, audiotape, etc.), should contact 
USDA's TARGET Center at (202) 720-2600 (voice and TDD).

List of Subjects in 9 CFR Part 327

    Imports, Meat Inspection.

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

[[Page 56405]]

PART 327--IMPORTED PRODUCTS

0
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]

0
2. Amend Sec.  327.2 by adding Namibia in alphabetical order to the 
list of countries in paragraph (b).

    Done at Washington, DC, on September 14, 2015.
Alfred V. Almanza,
Acting Administrator.
[FR Doc. 2015-23455 Filed 9-17-15; 8:45 am]
BILLING CODE 3410-DM-P