36794 Federal Register / Vol. 83, No. 147 / Tuesday, July 31, 2018 / Proposed Rules 

DEPARTMENT OF AGRICULTURE 

Food Safety and Inspection Service 

9 CFR Part 316 

[Docket No. FSIS 2018–0019] 

RIN 0583–AD69 

Elimination of the Requirement That 

Livestock Carcasses Be Marked ‘‘U.S. 

Inspected and Passed’’ at the Time of 

Inspection Within a Slaughter 

Establishment for Carcasses to be 

Further Processed Within the Same 

Establishment 

AGENCY: Food Safety and Inspection 

Service, USDA. 

ACTION: Proposed rule. 

SUMMARY: FSIS is proposing to amend 

the Federal meat inspection regulations 

to eliminate the requirement that 

livestock carcasses be marked with the 

official inspection legend at the time of 

inspection in a slaughter establishment, 

if the carcasses are to be further 

processed in the same establishment. 

DATES: Comments must be received on 

or before October 1, 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: 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, Food Safety and 

Inspection Service, U.S. Department of 

Agriculture; Telephone: (202) 205–0495. 

SUPPLEMENTARY INFORMATION: 

Background 

In the past, slaughter establishments 

often would ship carcasses to other 

establishments for further processing 

into primal, subprimal, and other meat 

cuts and products. Today however, most 

establishments that slaughter swine, 

cattle, or sheep also fabricate the 

carcasses into various primal and 

subprimal parts, as well as other meat 

products. After a carcass has passed 

inspection, the slaughter establishment 

typically moves it, under control, to 

another department in the same 

establishment for further processing. 

The establishment then typically ships 

the resulting meat food products, rather 

than marked carcasses, in fully labeled 

containers either for further processing 

at other establishments or into 

commerce. 

The Federal Meat Inspection Act 

(FMIA) requires the inspection of all 

livestock carcasses and parts of 

livestock carcasses prepared in 

slaughter establishments as articles of 

commerce capable of use as human food 

(21 U.S.C. 604). In this same provision, 

the FMIA requires that such carcasses 

and parts of carcasses found to be not 

adulterated be stamped as ‘‘inspected 

and passed’’ before they enter 

commerce. The FMIA also gives FSIS 

broad authority to promulgate rules and 

regulations necessary to carry out its 

provisions (21 U.S.C. 621). 

The regulations at 9 CFR 316.9 set 

forth more prescriptive, and partially 

outdated, requirements for the marking 

of inspected carcasses. Specifically, the 

regulation at 9 CFR 316.9(a) requires 

each carcass at an official establishment 

to be marked at the time of inspection 

with the official inspection legend. This 

requirement is intended to prevent 

uninspected carcasses from being 

shipped in commerce from slaughter 

establishments to processing 

establishments or elsewhere. However, 

given contemporary practices at 

slaughter establishments, marking the 

carcass on the slaughter floor is often 

unnecessary, as the carcass will be 

moved elsewhere in the same 

establishment for further processing. 

Requests To Move Carcasses and Parts 

of Carcasses To Processing Without 

Marking the Carcass 

Numerous slaughter establishments 

have requested waivers from the 

requirement in 9 CFR 316.9(a), i.e., that 

the carcasses they further process inhouse not be required to be marked at 

the time of inspection. The information 

presented with these requests has 

described the steps that establishments 

would take to ensure that uninspected, 

unmarked, or adulterated product does 

not enter commerce. These steps 

typically include: (1) Ensuring that all 

carcasses inspected and passed by 

USDA, but not marked on the slaughter 

floor, are stored and processed in the 

establishment; (2) ensuring that all 

products shipped from the 

establishment bear the mark of 

inspection or are shipped in fully 

labeled containers that bear the mark of 

inspection; and (3) ensuring that FSIS 

still maintains control over any 

carcasses that do not pass inspection. 

FSIS has granted many of these 

waivers, per the regulations at 9 CFR 

303.1, thereby allowing inspected and 

passed carcasses to move, without the 

mark of inspection, from the slaughter 

floor to processing departments in the 

same establishment. At one point, 

because of the high number of waivers 

granted, FSIS issued an administrative 

notice to inspectors (FSIS Notice 17–16) 

with instructions for verification 

activities at establishments that had 

received a waiver from these 

requirements. FSIS has allowed this 

notice to expire, in anticipation of this 

rulemaking. Further, based on 

discussions with FSIS District Offices, 

while a significant number of 

establishments are currently operating 

under such waivers, there are no reports 

of unmarked carcasses being shipped 

into commerce. 

FSIS has carefully considered the 

available information on allowing 

establishments to move carcasses and 

parts of carcasses to processing without 

marking the carcass with the inspection 

legend. From its experience with 

establishments to which it has provided 

waivers, the Agency has concluded that 

controls that establishments have put in 

place and Agency procedures to address 

inspection of unmarked carcasses have 

been successful in preventing unmarked 

carcasses from leaving the establishment 

for processing in an outside facility. 

FSIS is thus proposing that 

establishments not be required to mark 

carcasses with the inspection legend 

when the carcasses leave the slaughter 

floor to be further processed within the 

same establishment. However, all 

primals, subprimals, parts and other 

meat food products will have to be 

properly labeled and bear the mark of 

inspection before entering commerce. 

Under the proposed rule, FSIS 

inspection personnel will continue to 


daltland on DSKBBV9HB2PROD with PROPOSALS
Federal Register / Vol. 83, No. 147 / Tuesday, July 31, 2018 / Proposed Rules 36795 

1 Data source: Public Health Inspection System as 

of June 2017, provided by FSIS’s Office of Data 

Integration and Food Protection. 

2Livestock Slaughter 2016 Summary (April 

2017). USDA, National Agricultural Statistics. 

http://usda.mannlib.cornell.edu/usda/current/ 

LiveSlauSu/LiveSlauSu-04-19-2017.pdf, p.15. 

accessed 06/01/2017. 

3 Data source: Bureau of Labor Statistics (BLS) 

most recent report of average wage of meat 

slaughterers and packers. https://www.bls.gov/oes/ 

current/oes513023.htm/, accessed 06/2017. 

4 Data from Ketchum Manufacturing Inc., a 

manufacturer of meat stamps, through telephone 

interview on 4/17/2017. 

verify that the establishment has in 

place in its Hazard Analysis and Critical 

Control Point (HACCP) plan, Sanitation 

Standard Operating Procedures (SOPs), 

or other prerequisite programs, controls 

to ensure that unmarked carcasses are 

further processed in the establishment 

and that carcasses that are not further 

processed in the establishment do not 

leave the establishment unmarked. 

Additionally, should this rule become 

final, inspectors would verify through 

records review or direct observation that 

the establishment’s procedures ensure 

that: (1) The establishment properly 

identifies and handles carcasses or parts 

eligible for the mark of inspection 

through edible channels, so that only 

edible, inspected and passed product 

proceeds to fabrication; (2) the 

establishment can account for the 

number of carcasses it slaughters and 

moves through its establishment and 

that it correctly identifies the species 

slaughtered on the final label; (3) 

retained carcasses or parts remain under 

FSIS control until the establishment 

makes corrections that render the 

carcass or part eligible to bear the mark 

of inspection (e.g., carcasses retained for 

residue sample or pending pathology 

disposition are held in FSIS controlled 

retained cages in the cooler); and (4) 

whole carcasses transported to another 

establishment bear the mark of 

inspection. 

Executive Orders 12866 and 13563, and 

the Regulatory Flexibility Act 

Executive Orders 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 

benefits, distributive impacts, and 

equity). Executive Order (E.O.) 13563 

emphasizes the importance of 

quantifying both costs and benefits, of 

reducing costs, of harmonizing rules, 

and of promoting flexibility. This 

proposed 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 (OMB) under E.O. 12866. 

Economic Impact Analysis 

FSIS is proposing to remove the 

requirement for carcasses slaughtered in 

an establishment to bear the mark of 

inspection after being inspected and 

passed on the slaughter floor if the 

carcasses are to be further processed in 

the same establishment. Since this 

requirement is no longer necessary to 

prevent adulterated food product from 

entering commerce (see explanation in 

the Background section above), 

removing it will have no negative public 

health impact. Nor will it impose costs 

on the industry or the Agency. 

In regard to benefits from the 

rulemaking, removing an unnecessary 

requirement will allow establishments 

the flexibility to be innovative and to 

operate in the most efficient manner. In 

addition, it will also allow FSIS to 

utilize its resources more appropriately 

by relieving inspectors of unnecessary 

tasks. The expected benefits from this 

proposed rule would accrue from time 

and resource savings. Inspected and 

passed carcasses meant for further 

processing would not have to wait for 

the mark of inspection but could move 

directly to further processing. Thus, 

establishments that slaughter livestock 

and process livestock carcasses in the 

same facility would benefit from fewer 

delays in their operations and greater 

flexibility to conduct processing 

operations on inspected and passed 

carcasses. 

Agency data show that there are 

approximately 797 meat slaughtering 

establishments, and approximately 676 

of them (∼85 percent) do both 

slaughtering and processing.1 FSIS 

estimates that approximately 644 of 

these 676 establishments (∼95 percent) 

further process the carcasses they 

slaughter. Given that the annual 

production of meat by Federal inspected 

establishments is approximately 150 

million heads,2 roughly 120.9 million 

carcasses are subject to the requirements 

in 9 CFR 316.9 (150 million × 85 percent 

× 95 percent). Assuming that it takes 

establishment labor, on average, 3 

seconds to stamp each carcass, and that 

approximately half of the 

establishments already have waivers 

from the requirement, approximately 

50,417 additional hours would be saved. 

Most establishments use hired workers 

to do the stamping. If we assume the 

average hourly pay (salary plus benefits) 

is $20,3 then the time saved is 

equivalent to approximately $1.01 

million annually. 

In addition, such establishments 

would no longer need to replace the 

broken or worn out stamps previously 

used for marking carcasses on the 

slaughter floor. Typically, a stamp 

(usually made of bronze) costs $225 and 

lasts 5 years.4 The annualized cost of 

the stamp is $55 (if the interest rate is 

7 percent) or $50 (if the interest rate is 

3 percent). Assuming each 

establishment (that does not already 

have a waiver from the requirement) 

uses one stamp per year, the annual 

savings on these stamps would be 

between $16,700 and $18,600. 

Additionally, establishments would 

no longer need to make written requests 

for waivers from the requirement to 

stamp carcasses further processed 

within the same establishment and 

would no longer need to wait to have 

such requests approved. Further, 

because FSIS inspectors would no 

longer need to ensure that inspected and 

passed carcasses bear the mark of 

inspection before they are sent for 

further processing, FSIS inspectors 

would have greater flexibility to focus 

on activities that are more important in 

ensuring food safety, such as verifying 

that establishments meet HACCP 

regulations and collecting product 

samples. However, the time needed for 

submitting a written waiver request and 

waiting for approval is minimal, and the 

saving of that time would be offset by 

the increase in time needed for 

establishments to amend their HACCP 

plans, Sanitation SOPs, or prerequisite 

programs to add controls for the 

movement of these unmarked carcasses 

under this proposed rule. Similarly, the 

time saved for FSIS inspectors to ensure 

that inspected carcasses bear the mark 

of inspection would be offset by the 

increase in time to verify that 

establishments meet HACCP 

regulations. 

There are no expected costs 

associated with this proposed rule. 

Establishments already operating under 

a waiver will have procedures in their 

HACCP plans, Sanitation SOPs, or 

prerequisite programs that ensure that 

carcasses that are not further processed 

in the establishment do not leave the 

establishment unmarked. Other 

establishments will need to revise these 

procedures. However, FSIS expects that 

any costs associated with revising the 

procedures would be offset by increased 

flexibility allowed to those 

establishments as discussed in the 

foregoing section. 

Regulatory Flexibility Act Assessment 

The FSIS Administrator has made a 

preliminary determination that this 


daltland on DSKBBV9HB2PROD with PROPOSALS
36796 Federal Register / Vol. 83, No. 147 / Tuesday, July 31, 2018 / Proposed Rules 

proposed rule will not have a significant 

economic impact on a substantial 

number of small entities, as defined by 

the Regulatory Flexibility Act (5 U.S.C. 

601). The proposed 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 proposed rule would 

yield cost savings. Therefore, if finalized 

as proposed, this rule is expected to be 

an E.O. 13771 deregulatory action. 

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 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. 

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 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, 

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. 

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. 

Constituent updates are 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 in 9 CFR Part 316 

Food labeling, Food packaging, Meat 

inspection. 

For the reasons set forth in the 

preamble, FSIS is proposing to amend 9 

CFR part 316 as follows: 

PART 316—MARKING PRODUCTS 

AND THEIR CONTAINERS 

■ 1. The authority citation for part 316 

is revised to read as follows: 

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

2.55. 

■ 2. In § 316.9, revise paragraph (a), 

redesignate paragraphs (b) through (d) 

as paragraphs (c) through (e), 

respectively, and add a new paragraph 

(b) to read as follows: 

§ 316.9 Products to be marked with official 

marks. 

(a) Each carcass that has been 

inspected and passed in an official 

establishment must be marked at the 

time of inspection with the official 

inspection legend containing the 

number of the official establishment, if 

the carcass is to be shipped into 

commerce from the establishment 

without further processing. 

(b) A passed and inspected carcass 

that is to be further processed in the 

slaughtering establishment need not be 

marked with the official inspection 

legend at the time of inspection, 

provided the establishment develops 

and implements, as part of a HACCP 

plan, Sanitation SOPs, or other 

prerequisite program, procedures to 

ensure that: 

(1) Unmarked carcasses are further 

processed only in the slaughtering 

establishment; 

(2) Unmarked carcasses that, for any 

reason, are not further processed in the 

establishment do not leave the 

establishment unmarked; and 

(3) Unmarked and retained carcasses 

or parts remain under FSIS control until 

the establishment makes any corrections 

that are necessary to render the carcass 

or part eligible to bear the mark of 

inspection. 

* * * * * 


daltland on DSKBBV9HB2PROD with PROPOSALS
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 


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