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 Once the rule is in place, the list posted on the website will not conflict with any outdated information in the Federal Register .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 ( printed 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 § 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 § 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 § 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 ( printed 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: program.intake@usda.gov

Persons with disabilities who require alternative means for communication (Braille, large print, audiotape, etc.), should contact USDA's TARGET Center at (202) 720-2600 (voice and TDD).

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.

( printed page 65268)

For the reasons set forth in the preamble, FSIS is amending 9 CFR Chapter III as follows:

1. The authority citation for part 310 continues read as follows:

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

2. In § 310.22, revise paragraph (d)(1)(i) to read as follows:

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.

4. In § 327.2:

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);

b. Revise paragraphs (a)(4) and (b); and

c. Remove paragraph (c).

The revisions read as follows:

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.

6. In § 381.145, amend paragraph (a) by removing the phrase “listed in § 381.196(b),” and adding in its place “eligible to export such poultry and poultry products to the United States under § 381.196(b),”.

7. In § 381.195, revise paragraph (c) to read as follows:

8. Amend § 381.196 as follows:

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

b. Revise paragraphs (a)(4) and (b).

The revisions read as follows:

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.

10. Amend § 424.21 as follows:

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

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”.

11. The authority citation for part 557 continues to read as follows:

( printed page 65269) Authority: 21 U.S.C. 601-602, 606-622, 624-695; 7 CFR 2.7, 2.18, 2.53.

12. In § 557.2, revise paragraph (b) to read as follows:

13. The authority citation for part 590 continues to read as follows:

Authority: 21 U.S.C. 1031-1056.

14. Revise § 590.910 to read as follows:

Done at Washington, DC.