[Federal Register Volume 84, Number 157 (Wednesday, August 14, 2019)]
[Rules and Regulations]
[Pages 40225-40227]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2019-17344]



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 Rules and Regulations
                                                 Federal Register
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 This section of the FEDERAL REGISTER contains regulatory documents 
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  Federal Register / Vol. 84, No. 157 / Wednesday, August 14, 2019 / 
Rules and Regulations  

[[Page 40225]]



DEPARTMENT OF AGRICULTURE

Food Safety and Inspection Service

9 CFR Parts 318 and 381

[Docket No. FSIS 2016-0032]
RIN 0583-AD66


Preparation of Uninspected Products Outside of the Hours of 
Inspectional Supervision

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 and poultry products inspection regulations to eliminate 
prescriptive requirements governing the manufacture of uninspected 
products, such as pet food, in edible product areas of official 
establishments and to allow official establishments to manufacture such 
products outside the hours of inspection. These prescriptive 
regulations are no longer necessary and are inconsistent with the 
Hazard Analysis and Critical Control Point (HACCP) and sanitation 
regulations. Removal of these unnecessary provisions will provide 
establishments the flexibility to be innovative and operate in the most 
efficient, cost effective manner.

DATES: Effective October 15, 2019.

FOR FURTHER INFORMATION CONTACT: Roberta Wagner, Assistant 
Administrator, Office of Policy and Program Development, FSIS; 
Telephone: (202) 205-0495.

SUPPLEMENTARY INFORMATION:

Background

    On, July 31, 2018 (83 FR 36797), FSIS proposed to eliminate the 
prescriptive regulatory requirements at 9 CFR 318.12 and 381.152 that 
govern the manufacture of uninspected, inedible products, such as pet 
food, and restrict the hours during which such products may be prepared 
in an official establishment. These prescriptive regulations were 
issued before FSIS published its regulations requiring HACCP, 
Sanitation Standard Operating Procedures (sanitation SOPs), and 
compliance with the Sanitation Performance Standards. Under HACCP and 
sanitation requirements, an establishment that produces both edible and 
inedible meat and poultry products must develop and implement the 
controls and procedures necessary to prevent the adulteration of edible 
products by insanitary conditions and product commingling, as well as 
to prevent the movement of inedible products into commerce as human 
food.
    FSIS is finalizing the proposed rule with one non-substantive 
technical correction. Specifically, FSIS is adding a reference to the 
revised regulations in 9 CFR 381.193, which govern the labeling of 
uninspected, inedible poultry products. This citation was inadvertently 
left out of the proposal to revise the regulations at 9 CFR 381.152, 
but an analogous citation was proposed for meat regulations at 9 CFR 
318.12(b).

Responses to Comments

    FSIS received eight comments on the proposed rule submitted by a 
trade association representing the pet food industry, a trade 
organization representing the meat and poultry industry, five 
individuals, and a commenter purporting to be an airline. The meat and 
poultry trade organization and one individual supported the proposal. A 
summary of issues raised by other commenters follows:
    Comment: The trade association representing the pet food industry 
urged FSIS to work with the U.S. Food and Drug Administration (FDA) to 
ensure that all establishments under FSIS regulatory oversight are 
aware that FDA regulations implementing the Food Safety Modernization 
Act (FSMA) require certain firms that produce animal food to perform a 
hazard analysis and establish and implement risk-based preventive 
controls (see 80 FR 56169).
    Response: FSIS will continue to work with FDA regarding official 
FSIS establishments that may need to comply with FDA's good 
manufacturing practice and/or preventive controls for animal food 
regulations.
    Comment: Two individuals opposed the rule, expressing concerns that 
it would result in there being no regulatory oversight of pet food 
production.
    Response: Pet food products will continue to be regulated at both 
the Federal and State levels. At the Federal level, FDA regulates 
animal feed and companion animal food. The Federal Food, Drug, and 
Cosmetic Act (FFDCA) requires that all animal foods, like human foods, 
be safe to eat, produced under sanitary conditions, contain no harmful 
substances, and be truthfully labeled. Most states also have laws that 
require registration or licensing to sell animal food.
    Comment: An individual asked for clarification on how the proposed 
change affects or applies to retail exempt facilities.
    Response: This final rule removes requirements in 9 CFR 318.12 and 
381.152, which only apply to official establishments producing meat and 
poultry products under Federal inspection. This final rule does not 
address the preparation or processing of animal food at retail firms, 
including those that operate under FSIS's retail exemption.
    Comment: One comment from a former inspector expressed concerns 
that the proposal would lessen the ability of FSIS inspectors to ensure 
that inedible products are not put into commerce as human food.
    Response: This rule does not affect the authority or ability of 
FSIS inspectors to verify that official establishments manufacturing 
inedible product are keeping it separate from meat and poultry products 
and not otherwise creating insanitary conditions through its 
manufacture. Nor does this rule affect the authority or ability of FSIS 
inspectors to take enforcement actions to prevent inedible product from 
entering commerce as human food.

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

[[Page 40226]]

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.

Economic Impact Analysis

    As stated above, compliance with HACCP and sanitation regulations 
facilitates the production of safe, unadulterated product by 
establishments and makes the prescriptive requirements in 9 CFR 318.12 
and 381.152 unnecessary. Because these prescriptive requirements are no 
longer necessary to ensure the production of safe, unadulterated food, 
removing them will have no negative public health impact. In addition, 
this rule will not impose costs on the industry or the Agency.
    Further, removing the unnecessary, prescriptive requirements should 
allow establishments additional flexibility to be innovative and to 
operate in the most efficient, cost effective manner. Similarly, the 
rule should also allow FSIS to use its resources more appropriately. 
However, FSIS cannot quantify these savings.

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. The final rule will not increase costs 
to the industry.

Executive Order 13771

    Consistent with E.O. 13771 (82 FR 9339, February 3, 2017), FSIS has 
estimated that this final rule will yield cost savings. Therefore, this 
final rule is an E.O. 13771 deregulatory action.

Executive Order 12988, Civil Justice Reform

    This final rule has been reviewed under E.O. 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

    There are no paperwork or recordkeeping requirements associated 
with this proposed rule under the Paperwork Reduction Act of 1995 (44 
U.S.C. 3501-3520).

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 
E.O. 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, FSIS 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.

Additional Public Notification

    Public awareness of all segments of rulemaking and policy 
development is important. Consequently, FSIS will announce this Federal 
Register publication online 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.

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

9 CFR Part 318

    Food additives, Food packaging, Laboratories, Meat inspection, 
Reporting and recordkeeping requirements, Signs and symbols.

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, Poultry and poultry products, Reporting and recordkeeping 
requirements, Seizures and forfeitures, Signs and symbols, Technical 
Assistance, Transportation.


[[Page 40227]]


    For the reasons set forth in the preamble, FSIS amends 9 CFR parts 
318 and 381 as follows:

PART 318--ENTRY INTO OFFICIAL ESTABLISHMENTS; REINSPECTION AND 
PREPARATION OF PRODUCTS

0
1. The authority citation for part 318 continues to read as follows:

    Authority:  7 U.S.C. 138f, 450, 1901-1906; 21 U.S.C. 601 695; 7 
CFR 2.18, 2.53.


0
2. Section 318.12 is revised to read as follows:


Sec.  318.12  Manufacture of uninspected, inedible products at official 
establishments.

    (a) Official establishments may manufacture pet food or similar 
uninspected, inedible products in areas where edible products also are 
produced, provided that the manufacture of uninspected, inedible 
products does not:
    (1) Adulterate edible products;
    (2) Create insanitary conditions in the official establishment 
whereby edible products may be adulterated; or
    (3) Prevent or interfere with inspection or other program tasks 
performed by FSIS personnel in the official establishment.
    (b) Pet food and similar uninspected, inedible products must be 
distinguished from edible products so as to avoid their distribution as 
human food. Pet food or similar uninspected, inedible products must be 
labeled or otherwise identified in accordance with Sec.  325.11(d) of 
this subchapter.

PART 381--POULTRY PRODUCTS INSPECTIONS REGULATIONS

0
3. The authority citation for part 381 continues to read as follows:

     Authority:  7 U.S.C. 138f; 7 U.S.C. 450; 21 U.S.C. 451-470; 7 
CFR 2.18, 2.53.


0
 4. Section 381.152 is revised to read as follows:


Sec.  381.152  Manufacture of uninspected, inedible products at 
official establishments.

    (a) Official establishments may manufacture pet food or similar 
uninspected, inedible products in areas where edible products also are 
produced, provided that the manufacture of uninspected, inedible 
products does not:
    (1) Adulterate edible products;
    (2) Create insanitary conditions in the official establishment 
whereby edible products may be adulterated; or
    (3) Prevent or interfere with inspection or other program tasks 
performed by FSIS personnel in the official establishment.
    (b) The immediate container of uninspected, inedible products 
manufactured in an official establishment shall be conspicuously 
labeled so as to distinguish them from human food in accordance with 
Sec.  381.193 of this subchapter.

    Done in Washington, DC.
Carmen M. Rottenberg,
Administrator.
[FR Doc. 2019-17344 Filed 8-13-19; 8:45 am]
 BILLING CODE 3410-DM-P