81_FR_45359 81 FR 45225 - Eligibility of Namibia To Export Meat Products to the United States

81 FR 45225 - Eligibility of Namibia To Export Meat Products to the United States

DEPARTMENT OF AGRICULTURE
Food Safety and Inspection Service

Federal Register Volume 81, Issue 134 (July 13, 2016)

Page Range45225-45229
FR Document2016-16546

The Food Safety and Inspection Service (FSIS) is amending the Federal meat inspection regulations to add Namibia to the list of countries eligible to export meat and meat products to the United States. FSIS has reviewed Namibia's laws, regulations, and inspection system as implemented, and has determined that they are equivalent to the Federal Meat Inspection Act (FMIA), the regulations implementing this statute, and the United States food safety system for meat and meat products. Under this final rule, Namibia will only be able to export to the United States boneless (not ground) raw beef products, such as primal cuts, chuck, blade, and beef trimmings, processed in certified Namibian establishments, because FSIS only assessed Namibia's meat inspection system with respect to these products. Namibia would need to submit additional information for FSIS to review before FSIS would allow Namibia to export other beef product or product from other types of livestock to the United States. All products that Namibia exports to the United States will be subject to reinspection at United States ports-of-entry by FSIS inspectors.

Federal Register, Volume 81 Issue 134 (Wednesday, July 13, 2016)
[Federal Register Volume 81, Number 134 (Wednesday, July 13, 2016)]
[Rules and Regulations]
[Pages 45225-45229]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2016-16546]



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Federal Register / Vol. 81, No. 134 / Wednesday, July 13, 2016 / 
Rules and Regulations

[[Page 45225]]



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: Final rule.

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SUMMARY: The Food Safety and Inspection Service (FSIS) is amending the 
Federal meat inspection regulations to add Namibia to the list of 
countries eligible to export meat and meat products to the United 
States. FSIS has reviewed Namibia's laws, regulations, and inspection 
system as implemented, and has determined that they are equivalent to 
the Federal Meat Inspection Act (FMIA), the regulations implementing 
this statute, and the United States food safety system for meat and 
meat products.
    Under this final rule, Namibia will only be able to export to the 
United States boneless (not ground) raw beef products, such as primal 
cuts, chuck, blade, and beef trimmings, processed in certified Namibian 
establishments, because FSIS only assessed Namibia's meat inspection 
system with respect to these products. Namibia would need to submit 
additional information for FSIS to review before FSIS would allow 
Namibia to export other beef product or product from other types of 
livestock to the United States. All products that Namibia exports to 
the United States will be subject to reinspection at United States 
ports-of-entry by FSIS inspectors.

DATES: Effective Date: September 12, 2016.

FOR FURTHER INFORMATION CONTACT: Dr. Daniel L. Engeljohn, Assistant 
Administrator, Office of Policy and Program Development, Food Safety 
and Inspection Service, U.S. Department of Agriculture; Telephone: 
(202) 205-0495.

SUPPLEMENTARY INFORMATION: 

Background

    On September 18, 2015, FSIS published a proposed rule in the 
Federal Register (80 FR 56401) to add Namibia to the list of countries 
eligible to export meat products to the United States (9 CFR 327.2(b)). 
This final rule is consistent with the proposed rule.
    As is explained in the proposed rule, under the FMIA and 
implementing regulations, meat and meat products imported into the 
United States must be produced under standards for safety, 
wholesomeness, and labeling 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 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) requires that a foreign country's meat inspection system 
provide standards equivalent to those of the United States and to 
provide legal authority for the inspection system and its implementing 
regulations that is equivalent to that of the United States. 
Specifically, a country's laws 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)).

Evaluation of the Namibian Meat Inspection System

    As explained in the proposed rule, 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 to evaluate the laws, 
regulations, and other documentation used by Namibia to execute its 
meat inspection program. FSIS examined the information submitted by 
Namibia to verify that the following equivalence components were 
addressed satisfactorily with respect to standards, activities, 
resources, and enforcement: (1) Government Oversight; (2) Statutory 
Authority and Food Safety Regulations; (3) Sanitation; (4) Hazard 
Analysis and Critical Control Point Systems; (5) Chemical Residue 
Testing Programs; and (6) Microbiological Testing Programs. The 
document review was satisfactory to FSIS, and FSIS scheduled an on-site 
review to evaluate all aspects of Namibia's meat inspection program.
    In 2006, FSIS conducted an on-site audit of Namibia's meat 
inspection system and identified systemic deficiencies within the six 
equivalence components. In response to this audit, Namibia submitted a 
corrective action plan that addressed FSIS's findings. In

[[Page 45226]]

2009, FSIS conducted a follow-up on-site audit to verify that all 
outstanding issues identified during the previous audit had been 
resolved and that Namibia had satisfactorily implemented all the laws, 
regulations, and instructions to the field that FSIS found to be 
equivalent during the document review and previous audit. Nonetheless, 
the new audit identified new systemic deficiencies within the 
equivalence components of government oversight, sanitation, HACCP, 
chemical residue, and microbiological testing programs.
    Following the 2009 on-site audit, Namibia again provided a 
comprehensive corrective action plan that addressed the findings 
identified. In 2013, FSIS proceeded with a follow-up on-site audit of 
Namibia's meat inspection system and verified that Namibia had 
satisfactorily implemented the corrective actions taken in response to 
the 2009 on-site audit. The 2013 audit identified new findings within 
the equivalence components of government oversight, statutory authority 
and food safety regulations, sanitation, and chemical residue testing 
programs.
    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 conducted another on-site audit in 2014 to 
verify that Namibia had effectively implemented those corrective 
actions.
    FSIS concluded, on the basis of the 2014 audit, that Namibia had 
fully implemented the corrective action plan that it submitted in 
response to the 2013 audit. FSIS did not find any significant problems 
during the 2014 on-site audit. Furthermore, through the audit, FSIS 
found that Namibia had implemented a sampling and testing program for 
Shiga toxin-producing Escherichia coli (STEC) that is equivalent to 
FSIS's program. Industry in Namibia is required to control for or 
address STEC so that it is at a non-detectable level, and government 
testing in Namibia verifies that industry has the necessary controls in 
place.
    For more detailed information on FSIS's evaluation of the Namibian 
meat inspection system, see the proposed rule (80 FR 56401) and for the 
full audit reports, go to: http://www.fsis.usda.gov/wps/portal/fsis/topics/international-affairs/importing-products/eligible-countries-products-foreign-establishments/foreign-audit-reports.

Final Rule

    After considering the comments received on the proposed rule, 
discussed below, FSIS concludes that Namibia's meat inspection system 
is equivalent to the United States' inspection system for meat and meat 
products. Therefore, FSIS is amending its meat inspection regulations 
to add Namibia to the list of countries eligible to export meat and 
meat products to the United States (9 CFR 327.2(b)). Under FSIS's 
import regulations, the government of Namibia must certify to FSIS that 
those establishments that wish to export meat and meat products to the 
United States are operating under requirements equivalent to those of 
the United States (9 CFR 327.2(a)).
    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. In the 
future, if Namibia wants to export other beef products (e.g., ground 
beef) or other meat products to this country (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 United States. Namibia would not be allowed to export 
additional products to the United States until FSIS determines that the 
country's requirements and inspection program for the products are 
equivalent to FSIS's system.
    Although a foreign country may be listed in FSIS's regulations as 
eligible to export meat and meat products to the United States, the 
exporting country's products must also comply with all other applicable 
requirements of the United States, including those of the Animal and 
Plant Health Inspection Service (APHIS). These requirements include 
restrictions under 9 CFR part 94 of the APHIS regulations, which 
regulate the importation of meat and meat products from countries into 
the United States to control the spread of specific animal diseases. 
According to 9 CFR 94.1, APHIS listed Namibia as a country free of 
rinderpest and foot-and-mouth disease (excluding the region north of 
the Veterinary Cordon Fence).
    Also, under this final rule, all meat and meat products exported to 
the United States from Namibia will be subject to reinspection by FSIS 
at United States ports of entry for, but not limited to, transportation 
damage, product and container defects, labeling, proper certification, 
general condition, and accurate count.
    FSIS will conduct other types of reinspection activities, such as 
incubation of canned products to ensure product safety and taking 
product samples for laboratory analysis to detect any drug or chemical 
residues or pathogens that may render the product unsafe or any species 
or product composition violations that would render the product 
economically adulterated. Products that pass reinspection will be 
stamped with the official mark of inspection and allowed to enter 
United States commerce. If they do not meet this country's 
requirements, they will be refused entry and within 45 days will have 
to be returned to the country of origin, destroyed, or converted to 
animal food (subject to approval of the Food and Drug Administration 
(FDA)), depending on the violation. The import reinspection activities 
can be found on the FSIS Web site at: http://www.fsis.usda.gov/wps/portal/fsis/topics/international-affairs/importing-products/port-of-entry-procedures.
    In addition, Namibian meat and meat products will be eligible for 
importation into the United States only if they are from animals 
slaughtered on or after the effective date of this final rule.

Summary of Comments and Responses

    FSIS received 92 comments on the proposed rule. Eighty-one of the 
comments were received from individuals; 10 of the comments were 
received from trade associations representing American cattlemen and 
the beef industry, pork producers, milk producers, and farmers; and one 
comment was from a consumer advocacy group. Of the 92 comments, 87 were 
against the proposed rule, including those from all of the trade 
associations. Four individuals and one advocate on the behalf of the 
Namibian Meat Board were in support of the proposed rule.
    The following is a discussion of the relevant issues raised in the 
comments.
    Comments: Almost all of the comments expressed concern about the 
recent outbreaks of foot and mouth disease (FMD) in the areas north of 
the Veterinary Cordon Fence (VCF), a fence separating Northern Namibia 
and neighboring countries from the central and southern parts of 
Namibia that is designed to contain FMD outbreaks north of the fence. 
The majority of the individuals and various trade associations stated 
that the prevalence of FMD in the region presents a threat to the 
security of U.S. cattle and food safety. The commenters stated that 
Namibia cannot guarantee that FMD-infected animals will stay out of the

[[Page 45227]]

region in Namibia south of the VCF. Several trade associations also 
expressed concern about deficiencies found in a 2013 European 
Commission audit of Namibia's animal health control system.\1\ One 
trade association concluded that these deficiencies would result in 
commingling of contaminated cattle with cattle from the FMD-free zone 
south of the VCF. A few commenters were also concerned that the 
proposed rule did not address what steps FSIS would take to ensure that 
such commingling does not occur.
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    \1\ Final Report of an audit, carried out in Namibia, from 19 
February to 01 March 2013, in order to evaluate the animal health 
control system in place, in particular relation to controls on foot-
and-mouth disease. The audit found insufficient implementation and 
documentation of actions following the incursion of FMD positive 
buffalo in the disease-free zone. An Audit conducted by the European 
Commission, Health and Consumers Directorate--General, September 7, 
2013.
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    Several trade associations also expressed concern in their comments 
about the future of the VCF. Commenters cited recent statements made by 
the Namibian Agricultural Minister who, according to the commenters, 
has expressed a desire to have the fence removed. Additional commenters 
pointed to the lack of structural integrity of the VCF. Those 
commenters stated that the VCF is frequently breached by the country's 
elephant and buffalo population, which raises the possibility of other 
wildlife traveling through carrying FMD.
    Furthermore, one trade association expressed concern over a 30-
kilometer section of the VCF dismantled by the authorities. The trade 
association argued that this places southern Namibia at risk of 
becoming re-infected with FMD, because it allows buffaloes and 
elephants to re-enter the FMD-free zone. Additionally, some commenters 
expressed concern about the lack of a recent APHIS audit, and requested 
that FSIS delay any further action on the proposed rule until APHIS 
conducts an audit and publishes a formal risk assessment.
    Response: Although Namibia may be listed in FSIS's regulations as 
eligible to export poultry products to the United States, the products 
must also comply with all other applicable requirements of the United 
States, including those of USDA's APHIS, before any products can enter 
the United States.
    APHIS is responsible for preventing the entry of foreign animal 
diseases into the livestock population of the United States. APHIS 
determines the animal health status of foreign countries or regions for 
certain diseases, and this process is outlined in Title 9 CFR part 92. 
These animal health status determinations help establish the import 
requirements for livestock and products derived from them.
    In 2006, APHIS recognized the region of Namibia south of the VCF as 
free of FMD and rinderpest (71 FR 62198). This regulation relieved 
certain restrictions due to FMD and rinderpest on the importation into 
the United States of certain live animals and animal products from all 
regions of Namibia except the region north of the VCF. APHIS is 
developing a prioritization process for conducting reviews of countries 
or regions that have received animal health status recognition, such as 
the FMD freedom recognition granted to a region of Namibia. FSIS has 
provided the concerns identified in the comments on the proposed rule 
to APHIS, and APHIS will consider these as they finalize and implement 
their prioritization process. Therefore, at this time, APHIS rules 
allow beef from the region of Namibia south of the VCF to be exported 
to the United States.
    FSIS and APHIS work closely together to ensure that all 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 matters of 
importance to both agencies. The MOU was last updated November 20, 
2014. 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.
    Comments: A majority of the trade associations and the consumer 
advocacy group comments expressed concern about the deficiencies found 
in the 2006, 2009, and 2013 FSIS audits, particularly with respect to 
problems FSIS found in the Namibian food-safety system, the lack of 
collaboration FSIS found between the Namibian ministries, and staffing 
problems FSIS identified in the ministries.
    Response: FSIS assesses a country's food regulatory system in terms 
of six equivalence components and uses its findings from the assessment 
in deciding whether or not to grant eligibility to the country for the 
importation of its meat or meat food products into the United States. 
On the basis of the 2014 follow-up on-site audit, FSIS determined that 
Namibia fully met the criteria within those six equivalence components, 
in accordance with 9 CFR 327.2. Specifically, FSIS found that Namibia 
had a system in place to verify and enforce HACCP requirements. FSIS 
also found that Namibia had an effective strategy for implementing 
sample collection for chemical residue monitoring. Regarding staffing 
problems found during the 2009 on-site audit within the government 
oversight component, Namibia implemented corrective action plans for 
relief inspection personnel. FSIS concluded that Namibia had 
satisfactorily addressed the findings in this component. FSIS found 
Namibia to have remedied all deficiencies regarding the components that 
the Agency had uncovered in past audits, and determined that, as 
implemented, Namibia's inspection system (slaughter and processing) for 
beef is equivalent to the United States' meat inspection system. The 
details of Namibia's compliance with those components 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.
    Additionally, regarding deficiencies noted during past FSIS audits 
of the Namibian food-safety system, the history, background and 
verification of corrective actions are documented in the 2009, 2013, 
and 2014 final audit reports.
    Namibia has established its equivalence and when this final rule is 
effective, Namibia will be eligible to export certain beef products to 
the United States. FSIS ensures that countries maintain equivalence 
through a three-part process, involving: (1) Recurring equivalence 
reviews (e.g., through use of the country Self Reporting Tool or other 
documentation from the Central Competent Authority) of the exporting 
country's applicable laws and regulations; (2) periodic on-site 
equivalence verification audits in the exporting country; and (3) 
ongoing point-of-entry (POE) re-inspection of shipments received from 
the exporting country. These POE activities include examination of 
products for defects,

[[Page 45228]]

container examinations, and laboratory analysis of product samples.
    For all these reasons, therefore, concerns about deficiencies found 
in past FSIS audits are unwarranted. The deficiencies have been 
remedied and the Namibian inspection system will be subject to ongoing 
verification to ensure that it continues to maintain standards 
equivalent to those of the United States.
    Comments: Some comments from individuals and trade associations 
expressed concern over the economic effect that the rule would have on 
American ranchers. These commenters stated that the importation of 
Namibian beef would lower the price of beef overall and cause a decline 
in sales and job loss for the American beef industry. Two individuals 
supported the proposed rule and agreed with FSIS's economic analysis.
    Response: FSIS estimates that the expected amount of imported 
Namibian beef is only 0.008 \2\ to 0.05 percent of the United States 
beef production; therefore, there will be no significant impact on 
sales and the United States economy.
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    \2\ In the proposed rule, FSIS used 2012-2014 U.S. beef 
production data to estimate the expected amount of imported Namibian 
beef would be .007 to .05 percent of the United States beef 
production. In the final rule, FSIS used U.S. beef production data 
from 2012-2015 to update the estimated expected amount of imported 
Namibian beef to be .008 to .05 percent of the United States beef 
production.
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    Comment: The one trade association that disputed FSIS's economic 
analysis specifically stated that applying multipliers from a paper by 
VanSickle,\3\ Namibia's beef import of 1.9 million pound in the first 
year (after the rule is finalized) and 12.5 million pounds in the 5th 
year will likely result in a negative impact on the United States 
economy of $14.9 million and $96 million, respectively; and the United 
States will suffer 127 job losses in the first year and 837.5 job 
losses in the 5th year.
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    \3\ The VanSickle paper is a comment paper submitted to APHIS in 
2004 by John VanSickle on the economic analysis in the APHIS 
proposed rule for Bovine Spongiform Encephalopathy: Minimal Risk 
Regions and Importation of Commodities. The commenter attached a 
copy of the paper.
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    Response: The multipliers the commenter used, i.e. $3.87 impact on 
total United States economic output per $1 decline in sales for the 
cattle ranching and farming sector and 67 United States job losses per 
1 million pounds of additional beef imports, are from a paper that has 
not been peer-reviewed. The multipliers in the VanSickle paper were 
results from an input-output model (I-O model) named IMPLAN. However, 
the paper did not describe the model or the input data, nor specify the 
assumptions of the model. Therefore, there is no way to validate the 
model's accuracy in depicting the linkage from beef imports to total 
economic output and job loss. As a consequence, the credibility of the 
multipliers lacks support. All economic projection models and 
estimations are based on assumptions. To properly interpret a model's 
projections, it is important to understand and evaluate the accuracy of 
its assumptions every step of the way. Neither the VanSickle paper nor 
the commenter ever addressed any of these issues.
    In fact, the use of an I-O model such as IMPLAN has been considered 
problematic in economic research. In addition to the lack of 
transparency inherent in the software-generated calculations, peer-
reviewed journal articles have also suggested that inaccurate 
production functions are one of IMPLAN's weakest links, and that an I-O 
model has the potential to over-calculate impact.\4\ In addition, in a 
review of several studies that used methodology similar to IMPLAN, 
Kinnaman (2011) found the studies to be based on questionable 
assumptions that likely overstate the economic impact.\5\ Furthermore, 
Brown and Munasib & Rickman (2014) also found studies using I-O models 
over-estimated actual economic impact of natural gas extraction. 
Because of the difficulty in using the I-O model appropriately and 
correctly, there are hardly any relevant studies based on such models 
for agriculture imports that have gone through the peer review process 
of an economic journal.\6\
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    \4\ Lazarus, W.F., D.E. Platas, and G.W. Morse, 2002. IMPLAN's 
Weakest Link: Production Functions or Regional Purchase 
Coefficients? Journal of Regional Analysis and Policy, 32 (2002): 
33-48.; Brown, J.P., Goetz, S.J., Ahearn, M.C., & Liang, C. (2014) 
Linkages between Community-Focused Agriculture, Farm Sales, and 
Regional Growth. Economic Development Quarterly, 28(1), 5-16.
    \5\ Kinnaman, T.C., 2011. The Economic Impact of Shale Gas 
Extraction: A Review of Existing Studies. Ecol. Econ. 70: 1243-1249.
    \6\ Brown, J.P., Goetz, S.J., Ahearn, M.C., & Liang, C. (2014) 
Linkages between Community-Focused Agriculture, Farm Sales, and 
Regional Growth. Economic Development Quarterly, 28(1), 5-16; 
Munasib, A. and D.S. Rickman, 2015. Regional Economic Impacts of the 
Shale Gas and Tight Oil Boom: A Synthetic Control Analysis. Regional 
Science and Urban Economics, 50:1-17.
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    There are other economic impact models that are more comprehensive 
and more robust than I-O models, such as econometric simulation models 
(ESMs) or computable general equilibrium (CGE) models. It is quite an 
undertaking to use these models, for modelers have to collect data and 
adjust assumptions in the models before running estimations. It is only 
sensible to use these models when the size of expected imports is 
significant. Because the projected amount of beef imports from Namibia 
is very small, only 0.07 to 0.44 percent of total United States 
imports, FSIS believes it does not need a model to tell that it is very 
unlikely to have a noticeable impact on beef prices and other economic 
measures.

Executive Order 12866 and 13563, and the Regulatory Flexibility Act

    Executive Orders (E.O.) 12866 and 13563 direct agencies to assess 
all costs and benefits of available regulatory alternatives and, if 
regulation is necessary, to select regulatory approaches that maximize 
net benefits (including potential economic, environmental, public 
health and safety effects, distributive impacts, and equity). E.O. 
13563 emphasizes the importance of quantifying both costs and benefits, 
of reducing costs, of harmonizing rules, and of promoting flexibility. 
This final rule was designated a ``non-significant'' regulatory action 
under section 3(f) of E.O. 12866. Accordingly, this rule was not 
reviewed by the Office of Management and Budget (OMB) under E.O. 12866.

Economic Impact Analysis for Namibia Export Equivalence

    This final rule adds 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 final rule will not have a significant 
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 exports to the United States is about 
1.9 million pounds in the first year, increasing to about 12.5 million 
pounds in five years.\7\ The average annual United States domestic beef 
production in 2012-2015 was 24.9 billion pounds, projected to be 24.6 
billion pounds in 2016.\8\ The total United States import of beef 
averages 2.70 billion pounds per year for 2012-2015, projected to be 
2.85

[[Page 45229]]

billion pounds in 2016.\9\ Therefore, the projected Namibian beef 
imports in the first year would only be about 0.008 percent of total 
United States production, and 0.07 percent of total United States 
imports. If Namibia achieves the projected export goal in five years, 
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 percent of total United States production, and 0.44 
percent of total United States imports.
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    \7\ According to Namibia, this is the ``optimistic'' projection 
they wish to achieve. Market conditions will affect actual results.
    \8\ http://www.ers.usda.gov/media/2009937/ldp-m-260.pdf, 
accessed on April 7, 2016; part of Livestock, Dairy, & Poultry 
Outlook by Economic Research Service, USDA.
    \9\ Ibid.
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    Although Namibia indicates that, for now, it is seeking to export 
boneless beef products only, this final rule would not preclude their 
exporting other meat products in the future, if the products meet all 
other applicable requirements of the United States, including those of 
USDA's APHIS, 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 FSIS can assess right now.

Regulatory Flexibility Act Assessment

    The FSIS Administrator certifies that, for the purposes of the 
Regulatory Flexibility Act (5 U.S.C. 601-602), this final rule will not 
have a significant impact on a substantial number of small entities in 
the United States. As mentioned above, the expected trade volume is 
very small. Therefore, the action should have no significant impact on 
small entities that produce beef products domestically.

Executive Order 12988, Civil Justice Reform

    This final 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 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 system and 
their implementing regulations are equivalent to those of the United 
States. This information collection was approved under OMB number 0583-
0153. The 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 rule and will announce it online through 
the FSIS Web page located at: http://www.fsis.usda.gov/wps/portal/fsis/topics/regulations/federal-register/interim-and-final-rules.
    Public awareness of all segments of rulemaking and policy 
development is important. Consequently, FSIS will announce this Federal 
Register publication on-line through the FSIS Web page located at: 
http://www.fsis.usda.gov/federal-register.
    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: [email protected].
    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

    Food labeling, Food packaging, Imports, Meat inspection.

    For the reasons set out in the preamble, FSIS amends 9 CFR part 327 
as follows:

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(b) by adding ``Namibia'' in alphabetical order to 
the list of countries.

    Done at Washington, DC, on July 1, 2016.
Alfred V. Almanza,
Acting Administrator.
[FR Doc. 2016-16546 Filed 7-12-16; 8:45 am]
BILLING CODE 3410-DM-P



                                                                                                                                                                                                  45225

                                                Rules and Regulations                                                                                          Federal Register
                                                                                                                                                               Vol. 81, No. 134

                                                                                                                                                               Wednesday, July 13, 2016



                                                This section of the FEDERAL REGISTER                     Administrator, Office of Policy and                   product at establishments certified to
                                                contains regulatory documents having general             Program Development, Food Safety and                  export; (7) official controls over
                                                applicability and legal effect, most of which            Inspection Service, U.S. Department of                condemned product; (8) a Hazard
                                                are keyed to and codified in the Code of                 Agriculture; Telephone: (202) 205–0495.               Analysis and Critical Control Point
                                                Federal Regulations, which is published under                                                                  (HACCP) system; and (9) any other
                                                50 titles pursuant to 44 U.S.C. 1510.                    SUPPLEMENTARY INFORMATION:
                                                                                                                                                               requirements found in the FMIA and its
                                                                                                         Background                                            implementing regulations (9 CFR
                                                The Code of Federal Regulations is sold by
                                                the Superintendent of Documents. Prices of                  On September 18, 2015, FSIS                        327.2(a)(2)(ii)).
                                                new books are listed in the first FEDERAL                published a proposed rule in the                         The country’s inspection system must
                                                REGISTER issue of each week.                             Federal Register (80 FR 56401) to add                 also impose requirements equivalent to
                                                                                                         Namibia to the list of countries eligible             those of the United States with respect
                                                                                                         to export meat products to the United                 to: (1) Organizational structure and
                                                DEPARTMENT OF AGRICULTURE                                States (9 CFR 327.2(b)). This final rule              staffing to ensure uniform enforcement
                                                                                                         is consistent with the proposed rule.                 of the requisite laws and regulations in
                                                Food Safety and Inspection Service                          As is explained in the proposed rule,              all certified establishments; (2) national
                                                                                                         under the FMIA and implementing                       government control and supervision
                                                9 CFR Part 327                                           regulations, meat and meat products                   over the official activities of employees
                                                [Docket No. FSIS–2012–0028]                              imported into the United States must be               or licensees; (3) qualified inspectors; (4)
                                                                                                         produced under standards for safety,                  enforcement and certification authority;
                                                RIN 0583–AD51                                                                                                  (5) administrative and technical
                                                                                                         wholesomeness, and labeling that are
                                                                                                         equivalent to those of the United States              support; (6) inspection, sanitation,
                                                Eligibility of Namibia To Export Meat                                                                          quality, species verification and residue
                                                Products to the United States                            (21 U.S.C. 620). The FMIA also requires
                                                                                                         that the livestock from which such                    standards; and (7) any other inspection
                                                AGENCY:  Food Safety and Inspection                      imports are produced be slaughtered                   requirements (9 CFR 327.2(a)(2)(i)).
                                                Service, USDA.                                           and handled in connection with                        Evaluation of the Namibian Meat
                                                ACTION: Final rule.                                      slaughter in a manner that is consistent              Inspection System
                                                                                                         with the Humane Methods of Slaughter
                                                SUMMARY:    The Food Safety and                                                                                   As explained in the proposed rule, in
                                                                                                         Act (7 U.S.C. 1901–1906).
                                                Inspection Service (FSIS) is amending                                                                          2002 and again in 2005, the government
                                                                                                            Section 327.2 of Title 9 of the Code
                                                the Federal meat inspection regulations                                                                        of Namibia requested approval to export
                                                                                                         of Federal Regulations (CFR) sets out the
                                                to add Namibia to the list of countries                                                                        meat (beef) products to the United
                                                                                                         procedures by which foreign countries                 States. Namibia stated that, if approved,
                                                eligible to export meat and meat                         may become eligible to export meat and
                                                products to the United States. FSIS has                                                                        its immediate intent was to export
                                                                                                         meat products to the United States.                   boneless (not ground) raw beef products
                                                reviewed Namibia’s laws, regulations,                    Paragraph 327.2(a) requires that a
                                                and inspection system as implemented,                                                                          such as primal cuts, chuck, blade, and
                                                                                                         foreign country’s meat inspection                     beef trimmings to the United States.
                                                and has determined that they are                         system provide standards equivalent to
                                                equivalent to the Federal Meat                                                                                    In 2006, FSIS conducted a document
                                                                                                         those of the United States and to                     review to evaluate the laws, regulations,
                                                Inspection Act (FMIA), the regulations                   provide legal authority for the
                                                implementing this statute, and the                                                                             and other documentation used by
                                                                                                         inspection system and its implementing                Namibia to execute its meat inspection
                                                United States food safety system for                     regulations that is equivalent to that of
                                                meat and meat products.                                                                                        program. FSIS examined the
                                                                                                         the United States. Specifically, a                    information submitted by Namibia to
                                                   Under this final rule, Namibia will
                                                                                                         country’s laws and regulations must                   verify that the following equivalence
                                                only be able to export to the United
                                                                                                         impose requirements equivalent to those               components were addressed
                                                States boneless (not ground) raw beef
                                                                                                         of the United States with respect to: (1)             satisfactorily with respect to standards,
                                                products, such as primal cuts, chuck,
                                                                                                         Ante-mortem inspection, humane                        activities, resources, and enforcement:
                                                blade, and beef trimmings, processed in
                                                                                                         methods of slaughter and handling, and                (1) Government Oversight; (2) Statutory
                                                certified Namibian establishments,
                                                                                                         post-mortem inspection by, or under the               Authority and Food Safety Regulations;
                                                because FSIS only assessed Namibia’s
                                                                                                         direct supervision of, a veterinarian; (2)            (3) Sanitation; (4) Hazard Analysis and
                                                meat inspection system with respect to
                                                                                                         official controls by the national                     Critical Control Point Systems; (5)
                                                these products. Namibia would need to
                                                                                                         government over establishment                         Chemical Residue Testing Programs;
                                                submit additional information for FSIS
                                                                                                         construction, facilities, and equipment;              and (6) Microbiological Testing
                                                to review before FSIS would allow
                                                                                                         (3) direct and continuous official                    Programs. The document review was
                                                Namibia to export other beef product or
                                                                                                         supervision of slaughtering and                       satisfactory to FSIS, and FSIS scheduled
                                                product from other types of livestock to
                                                                                                         preparation of product by inspectors to               an on-site review to evaluate all aspects
                                                the United States. All products that
                                                                                                         ensure that product is not adulterated or             of Namibia’s meat inspection program.
                                                Namibia exports to the United States
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                                                                                                         misbranded; (4) complete separation of                   In 2006, FSIS conducted an on-site
                                                will be subject to reinspection at United
                                                                                                         establishments certified to export from               audit of Namibia’s meat inspection
                                                States ports-of-entry by FSIS inspectors.
                                                                                                         those not certified; (5) maintenance of a             system and identified systemic
                                                DATES: Effective Date: September 12,                     single standard of inspection and                     deficiencies within the six equivalence
                                                2016.                                                    sanitation throughout certified                       components. In response to this audit,
                                                FOR FURTHER INFORMATION CONTACT: Dr.                     establishments; (6) requirements for                  Namibia submitted a corrective action
                                                Daniel L. Engeljohn, Assistant                           sanitation and for sanitary handling of               plan that addressed FSIS’s findings. In


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                                                45226             Federal Register / Vol. 81, No. 134 / Wednesday, July 13, 2016 / Rules and Regulations

                                                2009, FSIS conducted a follow-up on-                     Namibia’s meat inspection system is                      FSIS will conduct other types of
                                                site audit to verify that all outstanding                equivalent to the United States’                      reinspection activities, such as
                                                issues identified during the previous                    inspection system for meat and meat                   incubation of canned products to ensure
                                                audit had been resolved and that                         products. Therefore, FSIS is amending                 product safety and taking product
                                                Namibia had satisfactorily implemented                   its meat inspection regulations to add                samples for laboratory analysis to detect
                                                all the laws, regulations, and                           Namibia to the list of countries eligible             any drug or chemical residues or
                                                instructions to the field that FSIS found                to export meat and meat products to the               pathogens that may render the product
                                                to be equivalent during the document                     United States (9 CFR 327.2(b)). Under                 unsafe or any species or product
                                                review and previous audit. Nonetheless,                  FSIS’s import regulations, the                        composition violations that would
                                                the new audit identified new systemic                    government of Namibia must certify to                 render the product economically
                                                deficiencies within the equivalence                      FSIS that those establishments that wish              adulterated. Products that pass
                                                components of government oversight,                      to export meat and meat products to the               reinspection will be stamped with the
                                                sanitation, HACCP, chemical residue,                     United States are operating under                     official mark of inspection and allowed
                                                and microbiological testing programs.                    requirements equivalent to those of the               to enter United States commerce. If they
                                                   Following the 2009 on-site audit,                     United States (9 CFR 327.2(a)).                       do not meet this country’s requirements,
                                                Namibia again provided a                                    FSIS will verify that the                          they will be refused entry and within 45
                                                comprehensive corrective action plan                     establishments certified by Namibia’s                 days will have to be returned to the
                                                that addressed the findings identified.                  government meet the United States                     country of origin, destroyed, or
                                                In 2013, FSIS proceeded with a follow-                   requirements through periodic and                     converted to animal food (subject to
                                                up on-site audit of Namibia’s meat                       regularly scheduled audits of Namibia’s               approval of the Food and Drug
                                                inspection system and verified that                      meat inspection system. In the future, if             Administration (FDA)), depending on
                                                Namibia had satisfactorily implemented                   Namibia wants to export other beef                    the violation. The import reinspection
                                                the corrective actions taken in response                 products (e.g., ground beef) or other                 activities can be found on the FSIS Web
                                                to the 2009 on-site audit. The 2013 audit                meat products to this country (e.g., pork             site at: http://www.fsis.usda.gov/wps/
                                                identified new findings within the                       products), it will need to notify FSIS                portal/fsis/topics/international-affairs/
                                                equivalence components of government                     and submit information about its                      importing-products/port-of-entry-
                                                oversight, statutory authority and food                  requirements and inspection program                   procedures.
                                                safety regulations, sanitation, and                      for these products. FSIS would then                      In addition, Namibian meat and meat
                                                chemical residue testing programs.                       review the information and determine                  products will be eligible for importation
                                                   In response to the 2013 audit findings,               whether the Agency needs to audit the                 into the United States only if they are
                                                Namibia implemented immediate                            operations in Namibia producing these                 from animals slaughtered on or after the
                                                corrective actions and submitted                         products to determine whether the                     effective date of this final rule.
                                                another corrective action plan that                      requirements and inspection program
                                                                                                                                                               Summary of Comments and Responses
                                                addressed the findings identified during                 for these products is equivalent to those
                                                the audit of its food safety system. FSIS                in the United States. Namibia would not                 FSIS received 92 comments on the
                                                conducted another on-site audit in 2014                  be allowed to export additional                       proposed rule. Eighty-one of the
                                                to verify that Namibia had effectively                   products to the United States until FSIS              comments were received from
                                                implemented those corrective actions.                    determines that the country’s                         individuals; 10 of the comments were
                                                   FSIS concluded, on the basis of the                   requirements and inspection program                   received from trade associations
                                                2014 audit, that Namibia had fully                       for the products are equivalent to FSIS’s             representing American cattlemen and
                                                implemented the corrective action plan                   system.                                               the beef industry, pork producers, milk
                                                that it submitted in response to the 2013                   Although a foreign country may be                  producers, and farmers; and one
                                                audit. FSIS did not find any significant                 listed in FSIS’s regulations as eligible to           comment was from a consumer
                                                problems during the 2014 on-site audit.                  export meat and meat products to the                  advocacy group. Of the 92 comments, 87
                                                Furthermore, through the audit, FSIS                     United States, the exporting country’s                were against the proposed rule,
                                                found that Namibia had implemented a                     products must also comply with all                    including those from all of the trade
                                                sampling and testing program for Shiga                   other applicable requirements of the                  associations. Four individuals and one
                                                toxin-producing Escherichia coli (STEC)                  United States, including those of the                 advocate on the behalf of the Namibian
                                                that is equivalent to FSIS’s program.                    Animal and Plant Health Inspection                    Meat Board were in support of the
                                                Industry in Namibia is required to                       Service (APHIS). These requirements                   proposed rule.
                                                control for or address STEC so that it is                include restrictions under 9 CFR part 94                The following is a discussion of the
                                                at a non-detectable level, and                           of the APHIS regulations, which                       relevant issues raised in the comments.
                                                government testing in Namibia verifies                   regulate the importation of meat and                    Comments: Almost all of the
                                                that industry has the necessary controls                 meat products from countries into the                 comments expressed concern about the
                                                in place.                                                United States to control the spread of                recent outbreaks of foot and mouth
                                                   For more detailed information on                      specific animal diseases. According to 9              disease (FMD) in the areas north of the
                                                FSIS’s evaluation of the Namibian meat                   CFR 94.1, APHIS listed Namibia as a                   Veterinary Cordon Fence (VCF), a fence
                                                inspection system, see the proposed rule                 country free of rinderpest and foot-and-              separating Northern Namibia and
                                                (80 FR 56401) and for the full audit                     mouth disease (excluding the region                   neighboring countries from the central
                                                reports, go to: http://www.fsis.usda.gov/                north of the Veterinary Cordon Fence).                and southern parts of Namibia that is
                                                wps/portal/fsis/topics/international-                       Also, under this final rule, all meat              designed to contain FMD outbreaks
                                                affairs/importing-products/eligible-                     and meat products exported to the                     north of the fence. The majority of the
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                                                countries-products-foreign-                              United States from Namibia will be                    individuals and various trade
                                                establishments/foreign-audit-reports.                    subject to reinspection by FSIS at                    associations stated that the prevalence
                                                                                                         United States ports of entry for, but not             of FMD in the region presents a threat
                                                Final Rule                                               limited to, transportation damage,                    to the security of U.S. cattle and food
                                                  After considering the comments                         product and container defects, labeling,              safety. The commenters stated that
                                                received on the proposed rule,                           proper certification, general condition,              Namibia cannot guarantee that FMD-
                                                discussed below, FSIS concludes that                     and accurate count.                                   infected animals will stay out of the


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                                                                  Federal Register / Vol. 81, No. 134 / Wednesday, July 13, 2016 / Rules and Regulations                                        45227

                                                region in Namibia south of the VCF.                      determinations help establish the                        Response: FSIS assesses a country’s
                                                Several trade associations also                          import requirements for livestock and                 food regulatory system in terms of six
                                                expressed concern about deficiencies                     products derived from them.                           equivalence components and uses its
                                                found in a 2013 European Commission                        In 2006, APHIS recognized the region                findings from the assessment in
                                                audit of Namibia’s animal health control                 of Namibia south of the VCF as free of                deciding whether or not to grant
                                                system.1 One trade association                           FMD and rinderpest (71 FR 62198). This                eligibility to the country for the
                                                concluded that these deficiencies would                  regulation relieved certain restrictions              importation of its meat or meat food
                                                result in commingling of contaminated                    due to FMD and rinderpest on the                      products into the United States. On the
                                                cattle with cattle from the FMD-free                     importation into the United States of                 basis of the 2014 follow-up on-site
                                                zone south of the VCF. A few                             certain live animals and animal                       audit, FSIS determined that Namibia
                                                commenters were also concerned that                      products from all regions of Namibia                  fully met the criteria within those six
                                                the proposed rule did not address what                   except the region north of the VCF.                   equivalence components, in accordance
                                                steps FSIS would take to ensure that                     APHIS is developing a prioritization                  with 9 CFR 327.2. Specifically, FSIS
                                                such commingling does not occur.                         process for conducting reviews of                     found that Namibia had a system in
                                                   Several trade associations also                       countries or regions that have received               place to verify and enforce HACCP
                                                expressed concern in their comments                      animal health status recognition, such                requirements. FSIS also found that
                                                about the future of the VCF.                             as the FMD freedom recognition granted                Namibia had an effective strategy for
                                                Commenters cited recent statements                       to a region of Namibia. FSIS has                      implementing sample collection for
                                                made by the Namibian Agricultural                        provided the concerns identified in the               chemical residue monitoring. Regarding
                                                Minister who, according to the                           comments on the proposed rule to                      staffing problems found during the 2009
                                                commenters, has expressed a desire to                    APHIS, and APHIS will consider these                  on-site audit within the government
                                                have the fence removed. Additional                       as they finalize and implement their                  oversight component, Namibia
                                                commenters pointed to the lack of                        prioritization process. Therefore, at this            implemented corrective action plans for
                                                structural integrity of the VCF. Those                   time, APHIS rules allow beef from the                 relief inspection personnel. FSIS
                                                commenters stated that the VCF is                        region of Namibia south of the VCF to                 concluded that Namibia had
                                                frequently breached by the country’s                     be exported to the United States.                     satisfactorily addressed the findings in
                                                elephant and buffalo population, which                                                                         this component. FSIS found Namibia to
                                                                                                           FSIS and APHIS work closely together
                                                raises the possibility of other wildlife                                                                       have remedied all deficiencies regarding
                                                                                                         to ensure that all meat and meat
                                                traveling through carrying FMD.                                                                                the components that the Agency had
                                                   Furthermore, one trade association                    products imported into the United
                                                                                                         States comply with the regulatory                     uncovered in past audits, and
                                                expressed concern over a 30-kilometer                                                                          determined that, as implemented,
                                                section of the VCF dismantled by the                     requirements of both agencies. In 1985,
                                                                                                         FSIS and APHIS signed a memorandum                    Namibia’s inspection system (slaughter
                                                authorities. The trade association argued                                                                      and processing) for beef is equivalent to
                                                that this places southern Namibia at risk                of understanding (MOU) in which both
                                                                                                         agencies agreed to cooperate in meeting               the United States’ meat inspection
                                                of becoming re-infected with FMD,
                                                                                                         their respective needs relative to                    system. The details of Namibia’s
                                                because it allows buffaloes and
                                                                                                         information exchange of disease                       compliance with those components can
                                                elephants to re-enter the FMD-free zone.
                                                                                                         surveillance, diagnostic testing,                     all be found on the FSIS Web site at:
                                                Additionally, some commenters
                                                                                                         investigations, trace backs, and animal               http://www.fsis.usda.gov/wps/portal/
                                                expressed concern about the lack of a
                                                                                                         and public health emergencies to                      fsis/topics/international-affairs/
                                                recent APHIS audit, and requested that
                                                                                                         achieve their related objectives of                   importing-products/eligible-countries-
                                                FSIS delay any further action on the
                                                                                                         reducing the spread of animal diseases,               products-foreign-establishments/
                                                proposed rule until APHIS conducts an
                                                                                                         and of providing a wholesome and                      foreign-audit-reports.
                                                audit and publishes a formal risk
                                                assessment.                                              economical food supply. The MOU is                       Additionally, regarding deficiencies
                                                   Response: Although Namibia may be                     updated periodically to ensure that it                noted during past FSIS audits of the
                                                listed in FSIS’s regulations as eligible to              addresses matters of importance to both               Namibian food-safety system, the
                                                export poultry products to the United                    agencies. The MOU was last updated                    history, background and verification of
                                                States, the products must also comply                    November 20, 2014. In accord with this                corrective actions are documented in
                                                with all other applicable requirements                   MOU, FSIS and APHIS established                       the 2009, 2013, and 2014 final audit
                                                of the United States, including those of                 procedures for communication between                  reports.
                                                USDA’s APHIS, before any products can                    the two agencies regarding the                           Namibia has established its
                                                enter the United States.                                 inspection, handling, and disposition of              equivalence and when this final rule is
                                                   APHIS is responsible for preventing                   imported meat products. APHIS and                     effective, Namibia will be eligible to
                                                the entry of foreign animal diseases into                FSIS communicate regularly to ensure                  export certain beef products to the
                                                the livestock population of the United                   that products APHIS has restricted from               United States. FSIS ensures that
                                                States. APHIS determines the animal                      entering the United States because of                 countries maintain equivalence through
                                                health status of foreign countries or                    animal disease concerns are not                       a three-part process, involving: (1)
                                                regions for certain diseases, and this                   imported into the United States.                      Recurring equivalence reviews (e.g.,
                                                process is outlined in Title 9 CFR part                    Comments: A majority of the trade                   through use of the country Self
                                                92. These animal health status                           associations and the consumer advocacy                Reporting Tool or other documentation
                                                                                                         group comments expressed concern                      from the Central Competent Authority)
                                                  1 Final Report of an audit, carried out in Namibia,
                                                                                                         about the deficiencies found in the                   of the exporting country’s applicable
jstallworth on DSK7TPTVN1PROD with RULES




                                                from 19 February to 01 March 2013, in order to           2006, 2009, and 2013 FSIS audits,                     laws and regulations; (2) periodic on-
                                                evaluate the animal health control system in place,
                                                in particular relation to controls on foot-and-mouth     particularly with respect to problems                 site equivalence verification audits in
                                                disease. The audit found insufficient                    FSIS found in the Namibian food-safety                the exporting country; and (3) ongoing
                                                implementation and documentation of actions              system, the lack of collaboration FSIS                point-of-entry (POE) re-inspection of
                                                following the incursion of FMD positive buffalo in
                                                the disease-free zone. An Audit conducted by the
                                                                                                         found between the Namibian ministries,                shipments received from the exporting
                                                European Commission, Health and Consumers                and staffing problems FSIS identified in              country. These POE activities include
                                                Directorate—General, September 7, 2013.                  the ministries.                                       examination of products for defects,


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                                                45228             Federal Register / Vol. 81, No. 134 / Wednesday, July 13, 2016 / Rules and Regulations

                                                container examinations, and laboratory                   nor specify the assumptions of the                     running estimations. It is only sensible
                                                analysis of product samples.                             model. Therefore, there is no way to                   to use these models when the size of
                                                   For all these reasons, therefore,                     validate the model’s accuracy in                       expected imports is significant. Because
                                                concerns about deficiencies found in                     depicting the linkage from beef imports                the projected amount of beef imports
                                                past FSIS audits are unwarranted. The                    to total economic output and job loss.                 from Namibia is very small, only 0.07 to
                                                deficiencies have been remedied and                      As a consequence, the credibility of the               0.44 percent of total United States
                                                the Namibian inspection system will be                   multipliers lacks support. All economic                imports, FSIS believes it does not need
                                                subject to ongoing verification to ensure                projection models and estimations are                  a model to tell that it is very unlikely
                                                that it continues to maintain standards                  based on assumptions. To properly                      to have a noticeable impact on beef
                                                equivalent to those of the United States.                interpret a model’s projections, it is                 prices and other economic measures.
                                                   Comments: Some comments from                          important to understand and evaluate                   Executive Order 12866 and 13563, and
                                                individuals and trade associations                       the accuracy of its assumptions every                  the Regulatory Flexibility Act
                                                expressed concern over the economic                      step of the way. Neither the VanSickle
                                                effect that the rule would have on                       paper nor the commenter ever                              Executive Orders (E.O.) 12866 and
                                                American ranchers. These commenters                      addressed any of these issues.                         13563 direct agencies to assess all costs
                                                stated that the importation of Namibian                    In fact, the use of an I–O model such                and benefits of available regulatory
                                                beef would lower the price of beef                       as IMPLAN has been considered                          alternatives and, if regulation is
                                                overall and cause a decline in sales and                 problematic in economic research. In                   necessary, to select regulatory
                                                job loss for the American beef industry.                 addition to the lack of transparency                   approaches that maximize net benefits
                                                Two individuals supported the                            inherent in the software-generated                     (including potential economic,
                                                proposed rule and agreed with FSIS’s                     calculations, peer-reviewed journal                    environmental, public health and safety
                                                economic analysis.                                       articles have also suggested that                      effects, distributive impacts, and
                                                   Response: FSIS estimates that the                     inaccurate production functions are one                equity). E.O. 13563 emphasizes the
                                                expected amount of imported Namibian                     of IMPLAN’s weakest links, and that an                 importance of quantifying both costs
                                                beef is only 0.008 2 to 0.05 percent of the              I–O model has the potential to over-                   and benefits, of reducing costs, of
                                                United States beef production; therefore,                calculate impact.4 In addition, in a                   harmonizing rules, and of promoting
                                                there will be no significant impact on                   review of several studies that used                    flexibility. This final rule was
                                                sales and the United States economy.                     methodology similar to IMPLAN,                         designated a ‘‘non-significant’’
                                                                                                         Kinnaman (2011) found the studies to                   regulatory action under section 3(f) of
                                                   Comment: The one trade association
                                                                                                         be based on questionable assumptions                   E.O. 12866. Accordingly, this rule was
                                                that disputed FSIS’s economic analysis
                                                                                                         that likely overstate the economic                     not reviewed by the Office of
                                                specifically stated that applying
                                                                                                         impact.5 Furthermore, Brown and                        Management and Budget (OMB) under
                                                multipliers from a paper by VanSickle,3
                                                                                                         Munasib & Rickman (2014) also found                    E.O. 12866.
                                                Namibia’s beef import of 1.9 million
                                                pound in the first year (after the rule is               studies using I–O models over-estimated                Economic Impact Analysis for Namibia
                                                finalized) and 12.5 million pounds in                    actual economic impact of natural gas                  Export Equivalence
                                                the 5th year will likely result in a                     extraction. Because of the difficulty in                  This final rule adds Namibia to the
                                                negative impact on the United States                     using the I–O model appropriately and                  list of countries eligible to export meat
                                                economy of $14.9 million and $96                         correctly, there are hardly any relevant               products into the United States. The
                                                million, respectively; and the United                    studies based on such models for                       government of Namibia intends to
                                                States will suffer 127 job losses in the                 agriculture imports that have gone                     certify only one Namibian establishment
                                                first year and 837.5 job losses in the 5th               through the peer review process of an                  as eligible to export boneless raw beef
                                                year.                                                    economic journal.6                                     products to the United States. Given this
                                                   Response: The multipliers the                           There are other economic impact
                                                                                                                                                                establishment’s beef production
                                                commenter used, i.e. $3.87 impact on                     models that are more comprehensive
                                                                                                                                                                capacity and the projected export
                                                total United States economic output per                  and more robust than I–O models, such
                                                                                                                                                                volume, FSIS projects that this final rule
                                                $1 decline in sales for the cattle                       as econometric simulation models
                                                                                                                                                                will not have a significant impact on the
                                                ranching and farming sector and 67                       (ESMs) or computable general
                                                                                                                                                                United States economy. The annual
                                                United States job losses per 1 million                   equilibrium (CGE) models. It is quite an
                                                                                                                                                                boneless beef production of this
                                                pounds of additional beef imports, are                   undertaking to use these models, for
                                                                                                                                                                establishment averaged 21.4 million
                                                from a paper that has not been peer-                     modelers have to collect data and adjust
                                                                                                                                                                pounds from 2008 to 2014. The
                                                reviewed. The multipliers in the                         assumptions in the models before
                                                                                                                                                                projected volume of exports to the
                                                VanSickle paper were results from an                                                                            United States is about 1.9 million
                                                                                                           4 Lazarus, W.F., D.E. Platas, and G.W. Morse,
                                                input-output model (I–O model) named                                                                            pounds in the first year, increasing to
                                                                                                         2002. IMPLAN’s Weakest Link: Production
                                                IMPLAN. However, the paper did not                       Functions or Regional Purchase Coefficients?           about 12.5 million pounds in five
                                                describe the model or the input data,                    Journal of Regional Analysis and Policy, 32 (2002):    years.7 The average annual United
                                                                                                         33–48.; Brown, J.P., Goetz, S.J., Ahearn, M.C., &
                                                  2 In the proposed rule, FSIS used 2012–2014 U.S.       Liang, C. (2014) Linkages between Community-
                                                                                                                                                                States domestic beef production in
                                                beef production data to estimate the expected            Focused Agriculture, Farm Sales, and Regional          2012–2015 was 24.9 billion pounds,
                                                amount of imported Namibian beef would be .007           Growth. Economic Development Quarterly, 28(1),         projected to be 24.6 billion pounds in
                                                to .05 percent of the United States beef production.     5–16.                                                  2016.8 The total United States import of
                                                In the final rule, FSIS used U.S. beef production          5 Kinnaman, T.C., 2011. The Economic Impact of
                                                                                                                                                                beef averages 2.70 billion pounds per
                                                data from 2012–2015 to update the estimated              Shale Gas Extraction: A Review of Existing Studies.
                                                                                                                                                                year for 2012–2015, projected to be 2.85
jstallworth on DSK7TPTVN1PROD with RULES




                                                expected amount of imported Namibian beef to be          Ecol. Econ. 70: 1243–1249.
                                                .008 to .05 percent of the United States beef              6 Brown, J.P., Goetz, S.J., Ahearn, M.C., & Liang,
                                                production.                                              C. (2014) Linkages between Community-Focused             7 According to Namibia, this is the ‘‘optimistic’’
                                                  3 The VanSickle paper is a comment paper               Agriculture, Farm Sales, and Regional Growth.          projection they wish to achieve. Market conditions
                                                submitted to APHIS in 2004 by John VanSickle on          Economic Development Quarterly, 28(1), 5–16;           will affect actual results.
                                                the economic analysis in the APHIS proposed rule         Munasib, A. and D.S. Rickman, 2015. Regional             8 http://www.ers.usda.gov/media/2009937/ldp-m-

                                                for Bovine Spongiform Encephalopathy: Minimal            Economic Impacts of the Shale Gas and Tight Oil        260.pdf, accessed on April 7, 2016; part of
                                                Risk Regions and Importation of Commodities. The         Boom: A Synthetic Control Analysis. Regional           Livestock, Dairy, & Poultry Outlook by Economic
                                                commenter attached a copy of the paper.                  Science and Urban Economics, 50:1–17.                  Research Service, USDA.



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                                                                  Federal Register / Vol. 81, No. 134 / Wednesday, July 13, 2016 / Rules and Regulations                                               45229

                                                billion pounds in 2016.9 Therefore, the                  information collection was approved                   deny the benefits of, or subject to
                                                projected Namibian beef imports in the                   under OMB number 0583–0153. The                       discrimination any person in the United
                                                first year would only be about 0.008                     rule contains no other paperwork                      States under any program or activity
                                                percent of total United States                           requirements.                                         conducted by the USDA.
                                                production, and 0.07 percent of total
                                                                                                         E-Government Act                                      How To File a Complaint of
                                                United States imports. If Namibia
                                                                                                           FSIS and USDA are committed to                      Discrimination
                                                achieves the projected export goal in
                                                five years, and assuming that United                     achieving the purposes of the E-                         To file a complaint of discrimination,
                                                States beef production and import                        Government Act (44 U.S.C. 3601, et                    complete the USDA Program
                                                volume stay about the same, the                          seq.) by, among other things, promoting               Discrimination Complaint Form, which
                                                projected beef imports from Namibia                      the use of the Internet and other                     may be accessed online at http://
                                                would still only be about 0.05 percent                   information technologies and providing                www.ocio.usda.gov/sites/default/files/
                                                of total United States production, and                   increased opportunities for citizen                   docs/2012/Complain_combined_6_8_
                                                0.44 percent of total United States                      access to Government information and                  12.pdf, or write a letter signed by you
                                                imports.                                                 services, and for other purposes.                     or your authorized representative.
                                                   Although Namibia indicates that, for                                                                           Send your completed complaint form
                                                                                                         Additional Public Notification
                                                now, it is seeking to export boneless                                                                          or letter to USDA by mail, fax, or email:
                                                beef products only, this final rule would                   FSIS will officially notify the World                 Mail: U.S. Department of Agriculture,
                                                not preclude their exporting other meat                  Trade Organization’s Committee on                     Director, Office of Adjudication, 1400
                                                products in the future, if the products                  Sanitary and Phytosanitary Measures                   Independence Avenue SW.,
                                                meet all other applicable requirements                   (WTO/SPS Committee) in Geneva,                        Washington, DC 20250–9410.
                                                of the United States, including those of                 Switzerland, of this rule and will                       Fax: (202) 690–7442.
                                                USDA’s APHIS, and any additional                         announce it online through the FSIS                      Email: program.intake@usda.gov.
                                                                                                         Web page located at: http://                             Persons with disabilities who require
                                                requirements that FSIS might have in
                                                                                                         www.fsis.usda.gov/wps/portal/fsis/                    alternative means for communication
                                                place with regard to the products.
                                                                                                         topics/regulations/federal-register/                  (Braille, large print, audiotape, etc.),
                                                Therefore, the long-term economic
                                                                                                         interim-and-final-rules.                              should contact USDA’s TARGET Center
                                                impact could be larger than what FSIS
                                                                                                            Public awareness of all segments of                at (202) 720–2600 (voice and TDD).
                                                can assess right now.
                                                                                                         rulemaking and policy development is                  List of Subjects in 9 CFR Part 327
                                                Regulatory Flexibility Act Assessment                    important. Consequently, FSIS will
                                                                                                         announce this Federal Register                          Food labeling, Food packaging,
                                                   The FSIS Administrator certifies that,
                                                                                                         publication on-line through the FSIS                  Imports, Meat inspection.
                                                for the purposes of the Regulatory
                                                Flexibility Act (5 U.S.C. 601–602), this                 Web page located at: http://                            For the reasons set out in the
                                                final rule will not have a significant                   www.fsis.usda.gov/federal-register.                   preamble, FSIS amends 9 CFR part 327
                                                impact on a substantial number of small                     FSIS also will make copies of this                 as follows:
                                                entities in the United States. As                        publication available through the FSIS
                                                                                                         Constituent Update, which is used to                  PART 327—IMPORTED PRODUCTS
                                                mentioned above, the expected trade
                                                volume is very small. Therefore, the                     provide information regarding FSIS                    ■ 1. The authority citation for part 327
                                                action should have no significant                        policies, procedures, regulations,                    continues to read as follows:
                                                impact on small entities that produce                    Federal Register notices, FSIS public
                                                                                                         meetings, and other types of information                Authority: 21 U.S.C. 601–695; 7 CFR 2.18,
                                                beef products domestically.                                                                                    2.53.
                                                                                                         that could affect or would be of interest
                                                Executive Order 12988, Civil Justice                     to our constituents and stakeholders.                 § 327.2   [Amended]
                                                Reform                                                   The Update is available on the FSIS
                                                                                                                                                               ■  2. Amend § 327.2(b) by adding
                                                  This final rule has been reviewed                      Web page. Through the Web page, FSIS
                                                                                                                                                               ‘‘Namibia’’ in alphabetical order to the
                                                under Executive Order 12988, Civil                       is able to provide information to a much
                                                                                                                                                               list of countries.
                                                Justice Reform. Under this rule: (1) All                 broader, more diverse audience. In
                                                State and local laws and regulations that                addition, FSIS offers an email                          Done at Washington, DC, on July 1, 2016.
                                                are inconsistent with this rule will be                  subscription service which provides                   Alfred V. Almanza,
                                                preempted; (2) no retroactive effect will                automatic and customized access to                    Acting Administrator.
                                                be given to this rule; and (3) no                        selected food safety news and                         [FR Doc. 2016–16546 Filed 7–12–16; 8:45 am]
                                                administrative proceedings will be                       information. This service is available at:            BILLING CODE 3410–DM–P
                                                required before parties may file suit in                 http://www.fsis.usda.gov/subscribe.
                                                court challenging this rule.                             Options range from recalls to export
                                                                                                         information, regulations, directives, and             DEPARTMENT OF HEALTH AND
                                                Paperwork Reduction Act
                                                                                                         notices. Customers can add or delete                  HUMAN SERVICES
                                                  No new paperwork requirements are                      subscriptions themselves, and have the
                                                associated with this rule. Foreign                       option to password protect their                      Food and Drug Administration
                                                countries wanting to export meat and                     accounts.
                                                meat products to the United States are                                                                         21 CFR Part 876
                                                required to provide information to FSIS                  USDA Non-Discrimination Statement
                                                certifying that their inspection systems                   No agency, officer, or employee of the              [Docket No. FDA–2016–N–1813]
jstallworth on DSK7TPTVN1PROD with RULES




                                                provide standards equivalent to those of                 USDA shall, on the grounds of race,
                                                                                                                                                               Medical Devices; Gastroenterology-
                                                the United States, and that the legal                    color, national origin, religion, sex,
                                                                                                                                                               Urology Devices; Classification of the
                                                authority for the system and their                       gender identity, sexual orientation,
                                                                                                                                                               Metallic Biliary Stent System for
                                                implementing regulations are equivalent                  disability, age, marital status, family/
                                                                                                                                                               Benign Strictures
                                                to those of the United States. This                      parental status, income derived from a
                                                                                                         public assistance program, or political               AGENCY:    Food and Drug Administration,
                                                  9 Ibid.                                                beliefs, exclude from participation in,               HHS.


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Document Created: 2016-07-13 01:44:11
Document Modified: 2016-07-13 01:44:11
CategoryRegulatory Information
CollectionFederal Register
sudoc ClassAE 2.7:
GS 4.107:
AE 2.106:
PublisherOffice of the Federal Register, National Archives and Records Administration
SectionRules and Regulations
ActionFinal rule.
ContactDr. Daniel L. Engeljohn, Assistant Administrator, Office of Policy and Program Development, Food Safety and Inspection Service, U.S. Department of Agriculture; Telephone: (202) 205-0495.
FR Citation81 FR 45225 
RIN Number0583-AD51
CFR AssociatedFood Labeling; Food Packaging; Imports and Meat Inspection

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