[Federal Register Volume 84, Number 229 (Wednesday, November 27, 2019)]
[Rules and Regulations]
[Pages 65265-65269]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2019-25750]
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DEPARTMENT OF AGRICULTURE
Food Safety and Inspection Service
9 CFR Parts 310, 327, 381, 424, 557, and 590
[Docket No. FSIS-2018-0027]
RIN 0583-AD72
Publication Method for Lists of Foreign Countries Eligible To
Export Meat, Poultry, or Egg 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 its
regulations to remove lists of foreign countries eligible to export
meat, poultry, and egg products to the United States. FSIS will
maintain a single list of eligible foreign countries on its website.
The criteria FSIS uses to evaluate whether a foreign country is
eligible to export meat, poultry, or egg products has not changed. This
rule will allow FSIS to more efficiently and clearly communicate
equivalence determinations by maintaining a single list of exporting
countries on its website, rather than maintaining one list on the
website and outdated lists in the codified regulations. In addition,
the Agency is amending it regulations to remove references to the
lists.
DATES: Effective December 27, 2019.
FOR FURTHER INFORMATION CONTACT: Terri Nintemann, Assistant
Administrator, Office of Policy and Program Development; Telephone:
(202) 720-0089.
SUPPLEMENTARY INFORMATION:
Background
On April 12, 2019, FSIS proposed to amend its regulations to remove
lists of foreign countries eligible to export meat, poultry, or
processed egg products to the United States and, instead, maintain such
lists on its website (84 FR 14894). The proposal noted that it did not
include any changes to the criteria FSIS uses to evaluate whether a
foreign country is eligible. The proposal also described how removing
the lists from the regulations would affect FSIS's process for
implementing equivalence determinations. Instead of publishing proposed
and final rules in the Federal Register, FSIS will now implement
equivalence determinations through Federal Register notices with
requests for public comment. FSIS will respond to public comments in
any Federal Register notice that finalizes an equivalence
determination. FSIS will also use this process when it is necessary to
terminate the eligibility of a foreign country. This final rule will
allow FSIS to convey more clearly information on countries' equivalence
status. Once the rule is in place, the list posted on the website will
not conflict with any outdated information in the Federal Register. In
addition to removing the lists from the regulations, the Agency
proposed to amend six parts of 9 CFR Chapter III (310, 327, 381, 424,
557, 590) to remove references to the lists.
After reviewing comments on the proposed rule, FSIS is finalizing
it without changes, except for non-substantive changes, for clarity, to
the regulatory language proposed for 9 CFR 327.2(b).
Responses to Comments
FSIS received 15 comments, from 13 individuals, an industry
association representing egg processors, and a consumer advocacy
organization. The issues raised in the comments and the Agency
responses are summarized below.
Comments: FSIS received comments relating to the use of online
lists. One individual questioned the use of online lists as potentially
confusing or difficult to locate by stakeholders. Another recommended
that FSIS ensure that the online lists are updated soon after
determinations are finalized. The consumer advocacy organization
believed that keeping equivalence determinations on FSIS's website
could invite hacking or mistakes and expressed concern that some
individuals do not have access to the internet.
Response: FSIS does not believe these concerns warrant
reconsideration of the use of online lists. This rule's amendments to
the Code of Federal Regulations (CFR) direct readers to the web address
where FSIS maintains the list, www.fsis.usda.gov/importlibrary. FSIS
will additionally publish notice of equivalence determinations in the
Federal Register and include links to these determinations in its
Constituent Update, which is posted weekly on FSIS's website. FSIS will
ensure that its web content managers update the online lists shortly
after any final determination is published in the Federal Register.
FSIS's website is protected to ensure that only authorized users may
gain access or make changes. The system keeps track of past versions,
which may be restored if needed. Therefore, no hacking event could
permanently alter the entries on the lists.
Comments: The industry group supported the proposed rule, but urged
FSIS not to weaken its equivalence standards, reduce opportunities for
public participation, or make any currently public aspects of the
equivalence process non-public. It also urged FSIS to be more
transparent in its investigations, audits, and determinations and
ensure that the offices of the Under Secretary for Food Safety and the
Secretary of Agriculture provide oversight for equivalence
determinations. The consumer advocacy organization opposed the proposed
rule as undermining the importance of equivalence determinations.
Response: Under this final rule, FSIS is not changing its
equivalence standards or opportunities for public comment. FSIS will
continue to maintain the same level of transparency in these
determinations by publishing its on-site audit reports and allowing for
public comment on preliminary equivalence determinations. The offices
of the Under Secretary for Food Safety and the Secretary of Agriculture
currently review every preliminary and final equivalence determination
made by FSIS and will continue to do so under this final rule.
Comments: The industry group also recommended that FSIS create
specific regulatory requirements establishing a comment period for
Federal Register notices of equivalence determinations and a provision
mandating that the Agency will respond to comments in the Federal
Register. The consumer advocacy organization advocated for a 60-day
comment period for all
[[Page 65266]]
equivalence determinations, and a minimum 30-day period for any
rulemaking that removes a country's equivalence.
Response: Consistent with other Federal agencies, FSIS regulations
do not establish length of comment periods for any proposal rules. The
Agency will retain flexibility to set and extend comment periods as
needed to adequately receive and consider public feedback. Also,
consistent with other Federal agencies, FSIS regulations do not state
that FSIS will respond to public comments in a second Federal Register
notice. That being said, after a preliminary equivalence determination,
FSIS will publish a Federal Register notice, including the response to
public comments, to finalize (or decline to finalize) any equivalence
determination.
Comment: The industry group sought clarification with regard to the
FSIS's proposal to amend the current version of the regulations at 9
CFR 590.910 to remove the list of foreign countries eligible to export
processed egg products to the United States and instead refer to the
list of countries eligible to export on the FSIS website. As FSIS
explained in Footnote 2 of the proposed rule, FSIS already had proposed
to revise Sec. 590.910 of the regulations in an earlier proposed rule
concerning egg products (83 FR 6314, February 13, 2018), but only for
more consistency with the existing regulations for meat and poultry.
Response: FSIS proposed to amend the version of Sec. 590.910 in
effect at the time. Because the February 2018 proposed rule regarding
egg products has not been made final, those regulations are still in
effect. FSIS is thus amending those regulations, as proposed. If the
February 2018 rulemaking is made final, its version of Sec. 590.910
will incorporate the changes made by this final rule regarding the
listing of foreign countries with equivalent egg products inspection
systems.
Comment: The consumer advocacy organization sought clarification on
the time period before a country would be listed as inactive on FSIS's
website.
Response: FSIS states on its website and in instructions to Agency
personnel that, after three or more years without shipping, a country
will be considered ``inactive'' and must apply for a reinstatement of
equivalence. See FSIS Directive 9770.1, Determining Initial and
Reinstating the Equivalence of Foreign Food Safety Inspection Systems.
Therefore, consistent with current practice, if a country does not ship
for three years, FSIS will move the country to the ``inactive'' chart
on the FSIS website.
Comment: An individual commenter asked how the rule would promote
efficiency and if there were other costs to FSIS.
Response: As FSIS explained in the economic analysis, the change in
publication method will not create additional costs to FSIS, which will
continue to implement equivalence determinations through the Federal
Register. Similarly, there will not be additional costs for industry or
foreign countries seeking to export to the United States. This final
rule will allow FSIS to more efficiently propose and finalize
equivalence determinations without changing the substantive criteria or
level of evaluation of foreign food safety systems. This will save
staff time and allow FSIS's list of exporting countries to more quickly
reflect changes in foreign counties' equivalence status. FSIS will also
gain efficiency by maintaining a single list of exporting countries on
its website, rather than maintaining one list on the website and a
separate list in the codified regulations.
Comments: The industry group urged FSIS to apply stricter scrutiny
to foreign food safety systems. It also expressed concern about whether
the processed egg products system in the Netherlands is genuinely
equivalent to the U.S. system. An individual commenter suggested that
imported meat and poultry products be monitored and tested for safety
by the FDA.
Response: These comments are outside the scope of this rulemaking,
which focuses solely on the publication method of lists of foreign
countries eligible to export meat, poultry, and egg products to the
United States.
Executive Orders 12866 and 13563
Executive Orders (E.O.s) 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 has been designated as a ``non-significant'' regulatory
action under section 3(f) of E.O. 12866. Accordingly, the rule has not
been reviewed by the Office of Management and Budget under E.O. 12866.
Expected Costs of the Final Rule
This final rule doesn't change the requirements for importing meat,
poultry, and egg products to the United States. FSIS will continue to
determine whether a foreign country's food safety inspection system for
meat, poultry, or egg products is equivalent to FSIS's inspection
system. FSIS will announce the results of equivalence determinations
through a notice with a request for comments in the Federal Register,
rather than a proposed rule. In addition, FSIS will continue to assess
the costs and benefits of new countries becoming eligible to ship
product to the United States. This change in procedure will not alter
U.S. production, imports, or consumption; therefore, FSIS does not
expect a change in U.S. consumer price due to this final rule. The
change in procedure is also not expected to add any additional cost to
the countries applying for eligibility to import meat, poultry, and egg
products to the United States, nor does it add costs to FSIS, or the
U.S. meat, poultry, or egg products industries.
Expected Cost Savings and Benefits of the Final Rule
While there are no additional costs associated with this final
rule, the benefit from the final rule is an increase in the efficient
use of FSIS resources. FSIS will continue to use the Federal Register
to receive and respond to public comments on equivalence
determinations, but the notice process will allow FSIS to more
efficiently propose and finalize equivalence determinations. FSIS
expects that the notice process will take less time than the current
rulemaking process. FSIS will also gain efficiency by maintaining a
single list of exporting countries on its website, rather than
maintaining one list on the website and separate lists in the codified
regulations.
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 economic impact on a substantial number of small
entities in the United States. Under this final rule, the requirements
for importing meat, poultry, and egg products to the United States will
not change. Thus, no market effect is expected from this final rule.
Small entities, therefore, will not bear additional costs, as market
factors remain unchanged.
Executive Order 13771
Consistent with E.O. 13771 (82 FR 9339, February 3, 2017), FSIS has
[[Page 65267]]
estimated that this final rule will yield cost savings. Therefore, this
final rule is an E.O. 13771 deregulatory action.
Paperwork Reduction Act
FSIS has reviewed the paperwork and recordkeeping requirements in
this final rule in accordance with the Paperwork Reduction Act (44
U.S.C. 3501, et seq.). Foreign countries seeking to export meat,
poultry, or egg 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. FSIS provides countries with
questionnaires asking for detailed information about the country's
inspection practices and procedures to assist that country in
organizing its materials. This information collection was approved
under OMB control number 0583-0094. This final rule only affects FSIS's
methods of proposing and finalizing equivalence determination after the
Agency has made a preliminary determination. It contains no new or
expanded paperwork requirements.
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.
Congressional Review Act
Pursuant to the Congressional Review Act (5 U.S.C. 801 et seq.),
the Office of Information and Regulatory Affairs designated this rule
as not a ``major rule,'' as defined by 5 U.S.C. 804(2).
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.
Executive Order 13175
This rule has been reviewed in accordance with the requirements of
Executive Order 13175, ``Consultation and Coordination with Indian
Tribal Governments.'' E.O. 13175 requires Federal agencies to consult
and coordinate with tribes on a government-to-government basis on
policies that have tribal implications, including regulations,
legislative comments or proposed legislation, and other policy
statements or actions that have substantial direct effects on one or
more Indian tribes, on the relationship between the Federal Government
and Indian tribes or on the distribution of power and responsibilities
between the Federal Government and Indian tribes.
FSIS has assessed the impact of this rule on Indian tribes and
determined that this rule does not, to our knowledge, have tribal
implications that require tribal consultation under E.O. 13175. If a
Tribe requests consultation, the Food Safety and Inspection Service
will work with the Office of Tribal Relations to ensure meaningful
consultation is provided where changes, additions and modifications
identified herein are not expressly mandated by Congress.
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).
Additional Public Notification
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 will also announce and provide a link to it 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
Constituent 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.
List of Subjects
9 CFR Part 310
Animal diseases, Meat inspection.
9 CFR Part 327
Food labeling, Food packaging, Imports, Meat inspection.
9 CFR Part 381
Administrative practice and procedure, Animal diseases, Crime,
Exports, Food grades and standards, Food labeling, Food packaging,
Government employees, Grant programs-agriculture, Intergovernmental
relations, Laboratories, Meat inspection, Nutrition, Polychlorinated
biphenyls (PCB's), Poultry and poultry products, Reporting and
recordkeeping requirements, Seizures and forfeitures, Signs and
symbols, Technical assistance, Transportation.
9 CFR Part 424
Food additives, Food packaging, Meat inspection, Poultry and
poultry products.
9 CFR Part 557
Fish, Food grades and standards, Food labeling, Food packaging,
Imports, Seafood.
9 CFR Part 590
Eggs and egg products, Exports, Food grades and standards, Food
labeling, Imports, Reporting and recordkeeping requirements.
[[Page 65268]]
For the reasons set forth in the preamble, FSIS is amending 9 CFR
Chapter III as follows:
PART 310--POST-MORTEM INSPECTION
0
1. The authority citation for part 310 continues read as follows:
Authority: 21 U.S.C. 601-695; 7 CFR 2.18, 2.53.
0
2. In Sec. 310.22, revise paragraph (d)(1)(i) to read as follows:
Sec. 310.22 Specified risk materials from cattle and their handling
and disposition.
* * * * *
(d) * * *
(1) * * *
(i) It is derived from cattle that were inspected and passed in an
official establishment in the United States or in a certified foreign
establishment in a country eligible to export meat and meat products to
the United States under 9 CFR 327.2(b) and it is otherwise eligible for
importation under 9 CFR 327.1(b), and
* * * * *
PART 327--IMPORTED PRODUCTS
0
3. 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
4. In Sec. 327.2:
0
a. Remove the phrase ``by including the name of such foreign country
in'' and add in its place ``in accordance with'' in paragraph (a)(1);
0
b. Revise paragraphs (a)(4) and (b); and
0
c. Remove paragraph (c).
The revisions read as follows:
Sec. 327.2 Eligibility of foreign countries for importation of
products into the United States.
(a) * * *
(4) Meat and meat food products from foreign countries not deemed
eligible in accordance with paragraph (b) of this section are not
eligible for importation into the United States, except as provided by
Sec. 327.16 or Sec. 327.17. Eligibility of any foreign country under
this section may be withdrawn whenever the Administrator determines
that the system of meat inspection maintained by such foreign country
does not assure compliance with requirements equivalent to all the
inspection, building construction standards, and other requirements of
the Act and the regulations in this subchapter as applied to official
establishments in the United States; or that reliance cannot be placed
upon certificates required under this part from authorities of such
foreign country; or that, for lack of current information concerning
the system of meat inspection being maintained by such foreign country,
such foreign country should be required to reestablish its eligibility.
(b) A list of countries eligible to export specific process
categories of meat and meat food products is maintained at http://www.fsis.usda.gov/importlibrary. Meat and meat food products from
listed countries must be accompanied by foreign inspection certificates
of the country of origin, as required by Sec. 327.4, and are eligible
under the regulations in this subchapter for entry into the United
States after inspection and marking as required by the applicable
provisions of this part. Fresh, chilled, or frozen or other product
from countries in which rinderpest, foot-and-mouth disease or African
swine fever exist, as provided in part 94 of this title, are ineligible
for importation into the United States.
PART 381--POULTRY PRODUCTS INSPECTION REGULATIONS
0
5. The authority citation for part 381 continues to read as follows:
Authority: 7 U.S.C. 138f, 450; 21 U.S.C. 451-470; 7 CFR 2.7,
2.18, 2.53.
Sec. 381.145 [Amended]
0
6. In Sec. 381.145, amend paragraph (a) by removing the phrase
``listed in Sec. 381.196(b),'' and adding in its place ``eligible to
export such poultry and poultry products to the United States under
Sec. 381.196(b),''.
0
7. In Sec. 381.195, revise paragraph (c) to read as follows:
Sec. 381.195 Definitions; requirements for importation into the
United States.
* * * * *
(c) Except as provided in Sec. 381.207, slaughtered poultry and
other poultry products may be imported only if they were processed
solely in countries found eligible to export poultry products to the
United States under Sec. 381.196(b). Slaughtered poultry may be
imported only if it qualifies as ready-to-cook poultry.
Sec. 381.196 [Amended]
0
8. Amend Sec. 381.196 as follows:
0
a. In paragraph (a)(1), remove the phrase ``by including the name of
such foreign country in'' and add in its place ``in accordance with'';
and
0
b. Revise paragraphs (a)(4) and (b).
The revisions read as follows:
Sec. 381.196 Eligibility of foreign countries for importation of
poultry products into the United States.
(a) * * *
(4) Poultry products from foreign countries not deemed eligible in
accordance with paragraph (b) of this section may not be imported into
the United States, except as provided by Sec. Sec. 381.207 and
381.209. Eligibility of any foreign country under this section may be
withdrawn whenever the Administrator determines that the system of
poultry inspection maintained by such foreign country does not assure
compliance with requirements equivalent to all the requirements of the
Act and the regulations as applied to official establishments in the
United States; or that reliance cannot be placed upon certificates
required under this subpart from authorities of such foreign country;
or that, for lack of current information concerning the system of
poultry inspection being maintained by such foreign country, such
foreign country should be required to reestablish its eligibility.
(b) A list of countries eligible to export specific process
categories of poultry products to the United States is maintained at
http://www.fsis.usda.gov/importlibrary. Such products from listed
countries must be accompanied by inspection certificates of the country
of origin, as required by Sec. 381.197, and are eligible under the
regulations in this subpart for entry into the United States, after
inspection and marking as required by the applicable provisions of this
subpart.
PART 424--PREPARATION AND PROCESSING OPERATIONS
0
9. The authority citation for part 424 continues to read as follows:
Authority: 7 U.S.C. 138f, 450; 21 U.S.C. 451-470; 7 CFR 2.7,
2.18, 2.53.
Sec. 424.21 [Amended]
0
10. Amend Sec. 424.21 as follows:
0
a. In paragraph (a)(2)(i), remove the phrase ``listed in'' and add in
its place ``determined to be eligible to export such products to the
United States under''; and
0
b. In paragraph (a)(3), remove the phrase ``listed in'' and add in its
place ``determined to be eligible to export such products to the United
States under''.
PART 557--IMPORTATION
0
11. The authority citation for part 557 continues to read as follows:
[[Page 65269]]
Authority: 21 U.S.C. 601-602, 606-622, 624-695; 7 CFR 2.7,
2.18, 2.53.
0
12. In Sec. 557.2, revise paragraph (b) to read as follows:
Sec. 557.2 Eligibility of foreign countries for importation of fish
and fish products into the United States.
* * * * *
(b) The countries eligible to export specific process categories of
fish and fish products are listed at http://www.fsis.usda.gov/importlibrary. Such products must be covered by foreign inspection
certificates of the country of origin as required by Sec. 557.4.
Products from such countries are eligible under the regulations in this
subchapter for entry into the United States after inspection and
marking as required by the applicable provisions of this part.
PART 590--INSPECTION OF EGGS AND EGG PRODUCTS (EGG PRODUCTS
INSPECTION ACT)
0
13. The authority citation for part 590 continues to read as follows:
Authority: 21 U.S.C. 1031-1056.
0
14. Revise Sec. 590.910 to read as follows:
Sec. 590.910 Eligibility of foreign countries for importation of egg
products into the United States.
(a) Whenever it is determined by the Administrator that the system
of egg products inspection maintained by any foreign country is such
that the egg products produced in such country are processed, labeled,
and packaged in accordance with, and otherwise comply with, the
standards of the Act and these regulations including, but not limited
to the same sanitary, processing, facility requirements, and continuous
Government inspection as required in Sec. Sec. 590.500 through 590.580
applicable to inspected articles produced within the United States,
notice of that fact will be given according to paragraph (b) of this
section. Thereafter, egg products from such countries shall be eligible
for importation into the United States, subject to the provisions of
this part and other applicable laws and regulations. Such products must
meet, to the extent applicable, the same standards and requirements
that apply to comparable domestic products as set forth in these
regulations. Egg products from foreign countries not deemed eligible in
accordance with paragraph (b) of this section are not eligible for
importation into the United States, except as provided by Sec.
590.960. In determining if the inspection system of a foreign country
is the equivalent of the system maintained by the United States, the
Administrator shall review the *COM007*inspection regulations of the
foreign country and make a survey to determine the manner in which the
inspection system is administered within the foreign country. The
survey of the foreign inspection system may be expedited by payment by
the interested Government agency in the foreign country of the travel
expenses incurred in making the survey. After approval of the
inspection system of a foreign country, the Administrator may, as often
and to the extent deemed necessary, authorize representatives of the
Department to review the system to determine that it is maintained in
such a manner as to be the equivalent of the system maintained by the
United States.
(b) A list of countries eligible to export egg products to the
United States is maintained at http://www.fsis.usda.gov/importlibrary.
Done at Washington, DC.
Carmen M. Rottenberg,
Administrator.
[FR Doc. 2019-25750 Filed 11-26-19; 8:45 am]
BILLING CODE 3410-DM-P