Federal Register / Vol. 83, No. 147 / Tuesday, July 31, 2018 / Proposed Rules 36797 

Done in Washington, DC. 

Paul Kiecker, 

Acting Administrator. 

[FR Doc. 2018–16345 Filed 7–30–18; 8:45 am] 

BILLING CODE 3410–DM–P 

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: Proposed rule. 

SUMMARY: FSIS is proposing to amend 

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. 

DATES: To receive full consideration, 

comments should be received by August 

30, 2018. 

ADDRESSES: FSIS invites interested 

persons to submit comments on this 

proposed rule. Comments may be 

submitted by one of the following 

methods: 

• Federal eRulemaking Portal: This 

website provides the ability to type 

short comments directly into the 

comment field on this web page or 

attach a file for lengthier comments. Go 

to http://www.regulations.gov. Follow 

the on-line instructions at that site for 

submitting comments. 

• Mail, including CD–ROMs, etc.: 

Send to Docket Clerk, U.S. Department 

of Agriculture, Food Safety and 

Inspection Service, 1400 Independence 

Avenue SW, Mailstop 3758, Room 6065, 

Washington, DC 20250–3700. 

• Hand- or courier-delivered 

submittals: Deliver to 1400 

Independence Avenue SW, Room 6065, 

Washington, DC 20250–3700. 

Instructions: All items submitted by 

mail or electronic mail must include the 

Agency name and docket number FSIS– 

2018–0005. Comments received in 

response to this docket will be made 

available for public inspection and 

posted without change, including any 

personal information, to http://

www.regulations.gov. 

Docket: For access to background 

documents or comments received, call 

(202) 720–5627 to schedule a time to 

visit the FSIS Docket Room at 1400 

Independence Avenue SW, Room 6065, 

Washington, DC 20250–3700. 

FOR FURTHER INFORMATION CONTACT: 

Roberta Wagner, Assistant 

Administrator, Office of Policy and 

Program Development; Telephone: (202) 

205–0495. 

SUPPLEMENTARY INFORMATION: 

Background 

FSIS regulations at 9 CFR 318.12 and 

381.152 govern the manufacture of pet 

food and other uninspected, inedible 

products in official meat and poultry 

establishments. These regulations set 

forth prescriptive requirements 

intended to prevent the creation of 

insanitary conditions in official 

establishments, the commingling of 

inedible and edible meat and poultry 

products, and the movement of inedible 

meat and poultry products into 

commerce as human food. They also 

require that pet food and other inedible 

products be manufactured in official 

establishments only when an FSIS 

inspector is on premises. 

These prescriptive requirements for 

the production of pet food and other 

inedible products (e.g., inedible 

rendered fats, lungs, lung lobes, and 

experimental products) are 

incompatible with the Hazard Analysis 

and Critical Control Point (HACCP) 

regulations at 9 CFR part 417 and the 

related sanitation regulations at 9 CFR 

part 416. Under the HACCP regulations, 

establishments are responsible for 

developing and implementing HACCP 

plans incorporating the controls 

determined by the establishment to be 

necessary and appropriate to produce 

safe, unadulterated products. 

Specifically under HACCP, official 

establishments must determine the food 

safety hazards reasonably likely to occur 

in the production process; institute 

controls necessary to prevent those 

hazards from occurring or keeping them 

within acceptable limits; monitor the 

performance of controls and verify the 

HACCP system is working as intended; 

and maintain required HACCP records. 

HACCP is a flexible system that 

appropriately places the responsibility 

for food safety on establishments and 

enables them to tailor their control 

systems to the needs of specific 

processes and operating conditions. 

Similarly, the Sanitation Performance 

Standards (SPS) and requirements for 

Sanitation Standard Operating 

Procedures (SOPs) at 9 CFR part 416 set 

forth sanitation objectives to be 

achieved, while allowing establishments 

to develop and employ innovative and 

effective sanitation procedures 

customized to the nature of their 

operations. Under the Sanitation SOP 

regulations, FSIS requires that all 

inspected establishments develop and 

implement written Sanitation SOPs to 

prevent direct contamination or 

adulteration of product before and 

during operations. An establishment’s 

Sanitation SOP typically covers the 

scheduled, daily pre-operational and 

operational cleaning and sanitation of 

equipment and surfaces that may 

contact product directly. Under the SPS 

regulations, establishments must 

address all of the other aspects of 

establishment sanitation that can affect 

food safety, e.g., pest control, adequate 

ventilation, lighting, and plumbing 

systems. 

Under the 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 the 

movement of inedible products into 

commerce as human food. FSIS 

inspectors verify the implementation 

and effectiveness of these controls 

through inspection, records review and, 

as necessary, product sampling. Thus, 

FSIS inspectors do not need to be 

present in an official establishment 

when it manufactures inedible products 

in order to verify that edible products 

are not adulterated as a result. 

Proposed Changes 

FSIS is proposing to eliminate the 

prescriptive regulatory requirements at 

9 CFR 318.12 and 381.152 governing the 

manufacture of uninspected, inedible 

products, such as pet food, and 

restricting the hours during which such 

products may be prepared in an official 

establishment. Specifically, these 

regulations set forth specific 

requirements regarding the sanitary 

handling of inedible products and their 

separation from edible products, as well 

as the placement, movement and 

cleaning of equipment in areas where 

inedible product is manufactured. They 

also require that the manufacture of 

uninspected, inedible products be 

conducted only during those hours in 

which the establishment operates under 

inspectional supervision. These 

regulations were issued before FSIS 

published its HACCP and Sanitation 

SOP regulations, when prescriptive 

regulatory requirements were deemed 

necessary to prevent the adulteration of 

meat and poultry products by the 


daltland on DSKBBV9HB2PROD with PROPOSALS
36798 Federal Register / Vol. 83, No. 147 / Tuesday, July 31, 2018 / Proposed Rules 

preparation of inedible products in the 

same establishment. 

FSIS is proposing to replace the 

prescriptive requirements in 9 CFR 

318.12 and 381.152 with general 

standards governing the manufacture of 

uninspected, inedible products in 

official establishments. The proposed 

standards require that the manufacture 

of uninspected products in official 

establishments must not result in the 

adulteration of meat and poultry 

products, create insanitary conditions 

whereby meat and poultry products may 

be adulterated, or prevent or otherwise 

interfere with inspection or other 

program tasks performed by FSIS 

personnel. Establishments that 

manufacture pet food and other inedible 

products should be meeting these 

proposed standards already, through the 

implementation of their HACCP plans, 

Sanitation SOPs or other prerequisite 

programs. 

Executive Order 12866 and the 

Regulatory Flexibility Act 

This proposed rule has been 

designated as a ‘‘non-significant’’ 

regulatory action under section 3(f) of 

Executive Order (E.O.) 12866. 

Accordingly, the proposed rule has not 

been reviewed by the Office of 

Management and Budget under E.O. 

12866. 

Economic Impact Analysis 

As stated above, the HACCP and the 

sanitation regulations provide a 

framework or food safety system for 

establishments to produce safe, 

unadulterated product. Compliance 

with these requirements makes the 

prescriptive requirements in 9 CFR 

318.12 and 381.151 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 manner. Similarly, the rule 

should also allow FSIS to use its 

resources more appropriately by 

relieving inspectors of unnecessary 

tasks. 

Regulatory Flexibility Act (RFA) 

FSIS has examined the economic 

implications of the proposed rule as 

required by the RFA (5 U.S.C 601–612). 

If a rule has a significant economic 

impact on a substantial number of small 

entities, the RFA requires that 

regulatory options that would lessen the 

economic effect of the rule on small 

entities be analyzed. FSIS has 

determined that, should it become final, 

the proposed rule would not have a 

significant impact on a substantial 

number of small entities. 

Executive Order 13771 

This proposed rule, if finalized as 

proposed, is expected to be a 

deregulatory action under E.O. 13771. 

Assessment of the costs and cost savings 

may be found in the preceding 

economic analysis. 

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 EGovernment 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 12988, Civil Justice 

Reform 

This proposed rule has been reviewed 

under Executive Order 12988, Civil 

Justice Reform. Under this rule: (1) All 

State and local laws and regulations that 

are inconsistent with this rule will be 

preempted; (2) no retroactive effect will 

be given to this rule; and (3) no 

administrative proceedings will be 

required before parties may file suit in 

court challenging this rule. 

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 governmentto-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 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 


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Federal Register / Vol. 83, No. 147 / Tuesday, July 31, 2018 / Proposed Rules 36799 

1All Commission regulations referred to herein 

are found in chapter I of title 17 of the Code of 

Federal Regulations. Commission regulations are 

accessible on the Commission’s website, http://

www.cftc.gov. 

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 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. 

For the reasons set forth in the 

preamble, FSIS is proposing to amend 9 

CFR parts 318 and 381 as follows: 

PART 318—ENTRY INTO OFFICIAL 

ESTABLISHMENTS; REINSPECTION 

AND PREPARATION OF PRODUCTS 

■ 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. 

■ 2. Section 318.12 is revised to read as 

follows: 

§ 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 § 325.11(d) of this 

subchapter. 

PART 381—POULTRY PRODUCTS 

INSPECTIONS REGULATIONS 

■ 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. 

■ 4. Section 381.152 is revised to read 

as follows: 

§ 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. 

Done in Washington, DC. 

Paul Kiecker, 

Acting Administrator. 

[FR Doc. 2018–16339 Filed 7–30–18; 8:45 am] 

BILLING CODE 3410–DM–P 

COMMODITY FUTURES TRADING 

COMMISSION 

17 CFR Part 41 

RIN 3038–AE61 

Position Limits and Position 

Accountability for Security Futures 

Products 

AGENCY: Commodity Futures Trading 

Commission. 

ACTION: Proposed rule. 

SUMMARY: The Commodity Futures 

Trading Commission (‘‘CFTC’’ or 

‘‘Commission’’) is proposing to amend 

its position limits rules for security 

futures products (‘‘SFPs’’) by: Increasing 

the default level of equity SFP position 

limits, and modifying the criteria for 

setting a higher level of position limits 

and position accountability levels. In 

addition, the proposed amended 

position limit regulation would provide 

discretion to a designated contract 

market (‘‘DCM’’) to apply limits to either 

a person’s net position or a person’s 

position on the same side of the market. 

The Commission also proposes criteria 

for setting position limits on an SFP on 

other than an equity security, generally 

based on an estimate of deliverable 

supply. 

DATES: Comments must be received on 

or before October 1, 2018. 

ADDRESSES: You may submit comments, 

identified by RIN 3038–AE61 and 

‘‘Position Limits and Position 

Accountability for Security Futures 

Products,’’ by any of the following 

methods: 

• CFTC website: http://

comments.cftc.gov. Follow the 

instructions for submitting comments 

through the Comments Online process 

on the website. 

• Mail: Christopher Kirkpatrick, 

Secretary of the Commission, 

Commodity Futures Trading 

Commission, Three Lafayette Centre, 

1155 21st Street NW, Washington, DC 

20581. 

• Hand delivery/courier: Same as 

Mail above. 

Please submit your comments using 

only one method. 

All comments must be submitted in 

English, or if not, accompanied by an 

English translation. Comments will be 

posted as received to http://

www.cftc.gov. You should submit only 

information that you wish to make 

available publicly. If you wish the 

Commission to consider information 

that is exempt from disclosure under the 

Freedom of Information Act, a petition 

for confidential treatment of the exempt 

information may be submitted according 

to the procedures set forth in section 

145.9 of the Commission’s regulations.1

The Commission reserves the right, 

but shall have no obligation, to review, 

pre-screen, filter, redact, refuse or 

remove any or all of your submission 

from http://www.cftc.gov that it may 

deem to be inappropriate for 

publication, such as obscene language. 

All submissions that have been redacted 

or removed that contain comments on 

the merits of the rulemaking will be 

retained in the public comment file and 

will be considered as required under the 

Administrative Procedure Act and other 


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