83030 Federal Register / Vol. 85, No. 245 / Monday, December 21, 2020 / Notices 

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). 

Done in Washington, DC. 

Paul Kiecker, 

Administrator. 

[FR Doc. 2020–28082 Filed 12–18–20; 8:45 am] 

BILLING CODE 3410–DM–P 

DEPARTMENT OF AGRICULTURE 

Food Safety and Inspection Service 

[Docket No. FSIS–2018–0034] 

Availability of FSIS Guideline for 

Industry Response to Customer 

Complaints 

AGENCY: Food Safety and Inspection 

Service, USDA. 

ACTION: Notice of availability. 

SUMMARY: The Food Safety and 

Inspection Service (FSIS) is announcing 

the availability of an updated version of 

the guideline for industry on how to 

respond to customer complaints of meat 

and poultry products contaminated with 

foreign materials. FSIS originally 

published the guideline in March 2019. 

Additionally, FSIS is responding to 

comments received on the March 2019 

guideline. 

ADDRESSES: A downloadable version of 

the guideline is available to view and 

print at https://www.fsis.usda.gov/wps/ 

portal/fsis/topics/regulatorycompliance/compliance-guides-index. 

No hard copies of the guideline have 

been published. 

FOR FURTHER INFORMATION CONTACT: 

Rachel Edelstein, Assistant 

Administrator, Office of Policy and 

Program Development; Telephone: (202) 

205–0495. 

SUPPLEMENTARY INFORMATION: 

Background 

The Food Safety and Inspection 

Service (FSIS) administers a regulatory 

program under the Federal Meat 

Inspection Act (FMIA) (21 U.S.C. 601 et 

seq.), the Poultry Products Inspection 

Act (PPIA) (21 U.S.C. 451 et seq.), and 

the Egg Products Inspection Act (EPIA) 

(21 U.S.C. 1031 et seq.) to protect the 

health and welfare of consumers. The 

Agency is responsible for ensuring that 

meat, poultry, and egg products are safe, 

wholesome, and correctly labeled and 

packaged. 

Updated Guideline 

On March 11, 2019, FSIS announced 

the availability of a guideline to assist 

all FSIS-regulated establishments that 

slaughter, or further process inspected 

meat and poultry products to develop 

and implement procedures for 

responding to customer complaints of 

adulterated and misbranded meat and 

poultry products (84 FR 8662). 

FSIS has updated the guideline based 

on comments received. Specifically, 

FSIS revised and reorganized the 

guideline to improve readability; further 

clarified that a customer complaint 

program is not required; included 

methods for establishments to 

demonstrate control of products; added 

information on when establishments 

must notify FSIS that adulterated or 

misbranded products have entered 

commerce; added and clarified when 

establishments are required to address 

foreign material contamination in their 

Hazard Analysis and Critical Control 

Point (HACCP) plan; and clarified 

applicable regulatory requirements for 

corrective actions, reassessments, and 

recall procedures. 

While FSIS specifically developed 

this document to address foreign 

material customer complaints, 

establishments can apply the 

information to other customer 

complaints of adulterated or 

misbranded products in commerce. 

FSIS encourages establishments that 

may receive customer complaints 

regarding adulterated or misbranded 

meat and poultry products to follow this 

guideline. This document does not 

present or describe any new regulatory 

requirements. This guideline represents 

current FSIS thinking, and FSIS will 

update it as necessary to reflect 

comments received and any additional 

information that becomes available. 

Comments and Responses 

FSIS received public comments from 

six trade associations, a poultry 

products producer, a pork products 

producer, a consumer advocacy 

organization, a HACCP consulting 

group, and an equipment manufacturer. 

A summary of the comments and the 

Agency’s responses follows: 

Foreign Material Adulteration 

Comment: Several trade associations 

stated that the guidelines applied an 

overreaching and overly broad concept 

of the term ‘‘adulteration’’ by suggesting 

that any amount of foreign material, 

regardless of size or nature, adulterates 

meat and poultry products. The 

comments asserted that not all 

contaminants are food safety hazards 

and that the guidelines should reflect a 

risk-based approach to foreign material 

adulteration, taking into account 

whether the foreign material would 

present a health hazard. 

Response: The FMIA and the PPIA (21 

U.S.C. 601 and 453) and FSIS 

regulations (9 CFR 301.2, 381.1, and 

531.1) state that the term ‘‘adulterated’’ 

applies, among other circumstances, to 

meat or poultry products: 

—If it bears or contains any poisonous 

or deleterious substance which may 

render it injurious to health; 

—if it consists in whole or in part of 

any filthy, putrid, or decomposed 

substance or is for any other reason 

unsound, unhealthful, unwholesome, or 

otherwise unfit for human food; 

—if it has been prepared, packed, or 

held under insanitary conditions 

whereby it may have become 

contaminated with filth, or whereby it 

may have been rendered injurious to 

health. 

Thus, under the FMIA and PPIA and 

the regulations, the presence of foreign 

materials adulterates meat and poultry 

products. Examples of foreign materials 

found in meat and poultry products 

include: Glass or metal fragments, 

which are deleterious substances that 

may injure health; machinery pieces, 

such as rubber or plastic, which are 

filthy, or unwholesome, or unfit for 

food; or sand or rocks, which typically 

contaminate food products because of 

preparation under insanitary conditions. 

FSIS disagrees that the Agency’s 

interpretation of ‘‘adulteration’’ is 

overly broad. 

FSIS assesses the public health 

concern or hazard presented when a 

recall action is initiated for products 

adulterated with foreign materials. FSIS 

categorizes the recall as Class I 

(reasonable probability that the use of 

the products will cause serious, adverse 

Federal Register / Vol. 85, No. 245 / Monday, December 21, 2020 / Notices 83031 

health consequences or death), Class II 

(remote probability of adverse health 

consequences from the use of the 

products), or Class III (products will not 

cause adverse health consequences). 

FSIS Directive 8080.1, Recall of Meat 

and Poultry Products, provides further 

information on recall classifications: 

FSIS Directive 8080.1. 

In response to these comments and 

related concerns raised, FSIS intends to 

revise and update the recall directive to 

clarify recall classification issues and 

instructions to FSIS personnel 

concerning recalls as necessary. In 

addition, FSIS intends to review recalls 

of meat and poultry products associated 

with foreign materials over the past 

several years to determine whether the 

Agency should make additional changes 

to this guidance or instructions to 

inspection program personnel to 

prevent or reduce related recalls. 

Comment: One FSIS-regulated 

company comment agreed that the 

presence of any foreign object meets the 

definition of adulteration and requested 

that the Agency clarify that objects 

inherent to the product, such as bones 

and feathers, would not render the 

product adulterated. 

Response: Objects inherent to a 

product are not ‘‘foreign material,’’ 

however, the presence of these objects 

can render meat or poultry products 

adulterated. The FMIA and PPIA 

definition of ‘‘adulterated,’’ states that, 

‘‘. . . in case the substance is not an 

added substance, such article shall not 

be considered adulterated under this 

clause if the quantity of such substance 

in or on such article does not ordinarily 

render it injurious to health’’ (21 U.S.C. 

601(m)(1) and 453(g)(1)). Thus, for 

example, if the size and amount of bone 

in a product would present a health 

hazard, the product is adulterated. 

When bone or other materials inherent 

to products, such as feathers or hair, do 

not present a health hazard, they may 

make the products unwholesome or 

unfit for human food, and therefore, 

adulterated, depending on the amount 

of these materials and the nature of the 

products. For example, boneless 

skinless chicken breast with noticeable 

amounts of bone or feathers may be 

unwholesome and unfit for consumers. 

Hazard Analysis and Critical Control 

Point (HACCP) Systems and Food Safety 

Hazards 

Comment: Several trade associations 

and the consulting group commented 

that not all foreign materials are food 

safety hazards, and therefore, do not 

have to be addressed in an 

establishment’s HACCP system. 

Response: An establishment may not 

find in its hazard analysis that foreign 

material contamination is reasonably 

likely to occur in its meat or poultry 

products. Further, some foreign material 

contamination may not cause meat or 

poultry to be unsafe for human 

consumption. If establishments can 

support that foreign material 

contamination is not reasonably likely 

to occur, or if it has occurred, the 

contamination has not caused the 

products to be unsafe for human 

consumption, establishments would not 

need to address foreign material 

contamination in its HACCP plan. 

However, if direct product 

contamination or product adulteration 

has occurred, the establishment must 

address the event in the HACCP system 

(e.g., the HACCP plan, Sanitation 

Standard Operating Procedures (SOPs), 

and prerequisite programs) and take 

applicable corrective actions. If the 

presence of foreign material is a 

deviation from a critical limit, the 

establishment is required to take the 

corrective actions in the establishment’s 

HACCP plan. If foreign material 

contamination has occurred, has caused 

products to become unsafe, and the 

establishment has not addressed the 

hazard in its HACCP plan, the 

establishment would be required to take 

corrective actions in 9 CFR 417.3(b), 

which would include reassessing its 

HACCP plan to determine whether the 

establishment needs to address foreign 

materials in its HACCP plan. If the 

establishment has found that foreign 

material contamination has occurred but 

does not constitute a food safety hazard, 

the establishment would need to assess 

whether it needs to make changes to its 

Sanitation SOP (9 CFR 416.14 and 

416.15). An establishment should 

address any foreign material 

contamination issues related to 

sanitation in its Sanitation SOP. FSIS 

recognizes there may be foreign material 

contamination not related to sanitation 

issues or public health hazards. 

Establishments may be able to support 

addressing those foreign material 

contamination issues in other 

prerequisite programs under the HACCP 

system. 

HACCP Preshipment Review 

Comment: Many of the trade 

associations stated that the guideline 

expands the definition of a HACCP 

System to include any programs 

associated with a production lot, and 

that the expanded definition would 

impact the documents included in the 

preshipment review. The comments also 

stated that the preshipment review 

should only encompass corrective 

actions and documents related to 

monitoring and verification of critical 

control points (CCPs). 

Response: The HACCP system 

includes the HACCP plan and all 

prerequisite programs associated with 

the HACCP plan (78 FR 32184). The 

HACCP regulations (9 CFR 417.5(c)) 

state that, ‘‘Prior to shipping product, 

the establishment shall review the 

records associated with the production 

of that product, documented in 

accordance with this section.’’ This 

regulation encompasses all records and 

does not limit the preshipment review 

to only CCP and corrective action 

records. When an establishment 

completes a preshipment review, it 

indicates that the establishment takes 

full and final responsibility for applying 

its HACCP controls to the products that 

it has produced. 

HACCP Reassessment 

Comment: Many trade associations 

requested clarification on when a 

HACCP plan reassessment is required. 

The consumer advocacy group 

commented that establishments should 

be compelled to reassess their HACCP 

plans to identify those points in 

production where there is a possibility 

of extraneous material contamination. 

One trade association commented that 

HACCP reassessment is only required 

and appropriate when the adulterant 

results from an unforeseen food safety 

hazard. 

Response: An establishment is 

required to reassess the HACCP plan 

whenever changes occur that could 

affect the hazard analysis or alter the 

HACCP plan (9 CFR 417.4(a)(3)(i)). For 

example, if there is an equipment 

change that could result in 

contaminated products if the equipment 

is not properly maintained. In addition, 

as is noted above, whenever an 

establishment determines an unforeseen 

hazard has occurred, it must perform a 

reassessment as part of the corrective 

actions to determine if the hazard 

should be incorporated into the HACCP 

plan 9 CFR 417.3(b)(4)). Establishments 

are not required to reassess the HACCP 

plan after every customer complaint. 

For example, an establishment is not 

required to reassess its HACCP plan 

after receiving a customer complaint if: 

• The establishment determines that 

the complaint is not valid or the 

complaint is unsubstantiated; 

• The complaint concerns a hazard 

already addressed in the establishment’s 

HACCP plan; 

• The complaint does not describe 

contamination that posed a risk to 

human health; or 

83032 Federal Register / Vol. 85, No. 245 / Monday, December 21, 2020 / Notices 

• The complaint does not concern a 

problem with the hazard analysis or 

HACCP plan, e.g., misbranding 

unrelated to allergens. 

When the establishment addresses 

foreign material contamination in its 

HACCP plan and a customer complaint 

represents a deviation from an existing 

critical limit, the establishment must 

perform corrective actions (9 CFR 

417.3(a)) but is not required to perform 

a reassessment. 

FSIS does not agree that an additional 

requirement that establishments 

reassess their HACCP plans specifically 

for extraneous material is necessary. 

Sanitation Standard Operating 

Procedures (SOPs) Corrective Actions 

Comment: One trade association 

requested more information on the 

regulatory requirements for Sanitation 

SOP corrective actions (9 CFR 416.15) 

and recordkeeping requirements (9 CFR 

416.16) if no food safety hazard exists. 

Response: The Sanitation SOP 

regulations (9 CFR 416.11–416.17) 

require that an establishment identify 

the procedures sufficient to prevent the 

direct contamination or adulteration of 

products (9 CFR 416.12(a)). When an 

establishment’s Sanitation SOPs fail to 

prevent adulteration of products, 

including contamination by foreign 

materials, it must take appropriate 

corrective actions, including 

appropriate reevaluation and 

modification of the Sanitation SOPs (9 

CFR 416.15) and document those 

actions (9 CFR 416.16). An 

establishment must address the 

Sanitation SOP corrective actions and 

recordkeeping requirements, even when 

a food safety hazard does not exist in 

that product. FSIS Sanitation SOP 

regulations do not provide for an 

‘‘allowance’’ of direct contamination 

that is acceptable, the establishment 

must identify the procedures to prevent 

direct contamination or adulteration of 

products. 

‘‘In-Commerce’’ Clarification 

Comment: Many comments requested 

clarification on when adulterated 

products are considered ‘‘in commerce’’ 

and whether products on premises 

owned by the producing establishment, 

such as warehouses or other facilities, 

demonstrates that there is control of the 

products. 

Response: FSIS stated in the guideline 

that, in general, products are considered 

to be ‘‘in commerce,’’ or having 

‘‘entered commerce,’’ when they have 

left the direct control of the producing 

establishment and are in distribution, 

freely moving to consignees and 

customers. FSIS does not want to limit 

an establishment’s flexibility and 

innovation for moving products by 

providing a strict definition of ‘‘direct 

control.’’ Common methods that 

establishments use to demonstrate that 

they are maintaining direct control 

include written procedures, programs, 

or agreements that describe their 

process for maintaining control. For 

example, an establishment may have 

physical control over products, through 

a company seal on a trailer or tamper 

evident tape on containers. Products 

may move between two establishments 

or facilities owned by the same 

corporation under direct control, 

provided the control is sufficiently 

documented and HACCP system 

decisions are consistent with the 

expressed control. The guideline was 

revised to include questions 

establishments can consider in 

determining if they have direct control 

and methods they can use to 

demonstrate control. 

Reporting Adulterated Product in 

Commerce 

Comment: Several trade associations 

requested clarification of the timeframe 

for establishments to notify the FSIS 

District Office when learning or 

determining that adulterated products 

have entered commerce. Commenters 

questioned whether an establishment is 

required to notify the District Office as 

soon as it has learned or has reason to 

believe adulterated products have 

entered commerce or instead when the 

establishment has completed its 

investigation and has determined that 

adulterated products have entered 

commerce. One industry comment 

suggested that the District Office be 

required to respond to the establishment 

within a specific time limit and provide 

the establishment information 

concerning whether the issue has been 

resolved, is pending review, or has been 

passed to an FSIS recall committee. The 

commenter also suggested that the 

District Office be required to provide 

guidance on whether the establishment 

would be required to take corrective 

actions or reassess their HACCP plan 

under the HACCP regulations. 

Response: The notification regulation 

(9 CFR 418.2) requires an establishment 

to notify the District Office within 24 

hours of learning or determining that an 

adulterated or misbranded meat or 

poultry product received by or 

originating from the establishment has 

entered commerce, if the establishment 

believes or has reason to believe this has 

happened. FSIS is not able to pinpoint 

a ‘‘start time’’ of the 24-hours, since 

every case is different. In many cases, 

the establishment will learn of a 

complaint and need to investigate the 

validity. During the investigation, the 

point at which the establishment 

‘‘believes, or has reason to believe’’ 

adulterated product has entered 

commerce is when the establishment 

must report the event within 24 hours. 

The investigation does not have to be 

completed before the establishment 

believes, or has reason to believe, that 

adulterated product entered commerce. 

The District Office will work with the 

establishment, but FSIS does not believe 

that providing detailed information will 

be necessary in all cases. District Offices 

will determine what information is 

appropriate and possible to provide to 

an establishment on a case-by-case 

basis. Official establishments should be 

familiar enough with the regulatory 

requirements in 9 CFR parts 416 and 

417 to determine when corrective 

actions are required, what actions will 

meet the regulatory requirements, when 

a reassessment is required, how a 

reassessment is documented, and when 

the establishment should implement 

recall procedures. FSIS has clarified 

reassessment, notification, and 

corrective action regulatory 

requirements in the updated guidance. 

Establishments can contact FSIS field 

personnel or headquarters personnel if 

they have additional questions about a 

specific situation. The Agency 

recognizes that establishments need 

timely communication with the District 

Office and will ensure this 

communication continues. 

Comment: A member of industry 

requested that FSIS clarify in the 

guideline what action domestic 

establishments should take if they 

shipped product adulterated by foreign 

material to a foreign country. The same 

commenter asked for clarification about 

what an establishment should do if they 

receive adulterated product from a 

foreign country. 

Response: Official establishments are 

required to notify the District Office if 

they ship or receive adulterated 

products (9 CFR 418.2 and U.S.C. 612 

and 459(b)). The notification 

requirement applies to domestic 

establishments that ship products to 

another country (i.e., export). FSIS has 

added language in the guideline in the 

‘‘Responsibilities at the Producing 

Establishment’’ section to clarify this 

requirement. 

Isolated Events Versus Systemic Foreign 

Material Contamination 

Comment: Several trade associations 

stated that the guideline failed to 

address the difference between an 

isolated foreign material contamination 

event and systemic foreign material 

Federal Register / Vol. 85, No. 245 / Monday, December 21, 2020 / Notices 83033 

contaminations. One commenter stated 

that reporting an isolated event, with no 

evidence of other product in commerce, 

is premature and serves little purpose. 

Another commenter proposed 

notification only when an isolated event 

posed a public health risk, or when 

there were two or more foreign 

contamination issues of a similar nature 

or on-going findings of the same root 

cause. 

Response: The notification 

requirement allows the Agency to 

quickly determine whether a recall 

action is necessary. If an establishment 

has evidence that the event is isolated, 

the establishment is still required to 

report the event to the District Office 

and should present this evidence to the 

District Office. 

Recall Notification (9 CFR 418.2) and 

Notice of Receipt of Adulterated or 

Misbranded Product (FSIS Form 8140– 

1) 

Comment: Many commenters 

questioned whether Form 8140–1 was 

necessary, given the regulatory 

requirement of 9 CFR 418.2. Many 

comments also suggested that the 

notification process needed to be 

consolidated, streamlined, and 

standardized among District Offices. 

Many comments suggested that all 

District Offices have a designated email 

account posted on the FSIS web page so 

that establishments can report shipment 

or receipt of adulterated or misbranded 

products. A separate comment was 

submitted recommending that 

establishments utilize the Agency’s 

Public Health Information System 

(PHIS)to report incidents. 

Response: FSIS is in the process of 

modernizing inspector reporting 

methods and replacing the paper-based 

reporting with electronic reporting in 

PHIS. FSIS is also developing an 

optional industry interface in PHIS that 

will provide a centralized location for 

establishments to report to the 

applicable District Office that they have 

shipped or received adulterated or 

misbranded products. Establishments 

may continue to notify the District 

Offices through traditional methods, 

such as phone calls, and each District 

Office lists a 24-hour phone number that 

is available for reporting listed at 

https://www.fsis.usda.gov/wps/portal/ 

informational/districtoffices. 

Consumer Complaint Program 

Requirement 

Comment: Many trade associations 

requested that the guideline clarify that 

there is no requirement that an 

establishment develop or implement a 

consumer complaint program and no 

requirement that a complaint handling 

program, if one exists, be incorporated 

into the HACCP plan or Sanitation 

SOPs. The consumer advocacy group 

commented that there should be a 

requirement for a consumer complaint 

program for all establishments. 

Response: The guideline has been 

revised to further clarify that a customer 

complaint program is not required and, 

if one is developed, there is no 

requirement to incorporate the program 

into the HACCP system. 

FSIS’s regulatory requirements for 

HACCP (9 CFR part 417) and Sanitation 

SOPs (9 CFR part 416) address the 

requirements to prevent adulteration. As 

noted above, if changes occur that affect 

the hazard analysis or HACCP plan, 

including consumer complaints, or if 

hazardous foreign materials are found in 

the products and the HACCP plan does 

not address the hazard, the 

establishment is required to reassess the 

HACCP plan (9 CFR 417.4(a)(3)(i) and 

417.4(b)) and make necessary changes to 

address the hazard. Based on the 

reassessment, the establishment may 

incorporate a new CCP into its HACCP 

plan to address foreign materials, or it 

may develop a prerequisite program 

(including the Sanitation SOP, as 

discussed below) to prevent the hazard 

that would be part of the HACCP 

system. 

FSIS regulations require that an 

establishment’s Sanitation SOPs 

describe all procedures sufficient to 

prevent adulteration of products (9 CFR 

416.12(a)). When Sanitation SOPs, 

which are prerequisite to the HACCP 

plan, fail to prevent adulteration of 

products through contamination with 

foreign materials, the establishment is 

required to take corrective actions (9 

CFR 416.15). Corrective actions include 

ensuring appropriate disposition of 

products, restoring sanitary conditions, 

preventing the recurrence of direct 

contamination or adulteration of 

products, and evaluating and making 

necessary modification of the Sanitation 

SOPs to prevent future adulteration 

with foreign materials. 

Pet Food 

Comment: One trade association 

stated that adulterated meat and poultry 

products may be diverted to the pet food 

industry, specifically dog and cat food. 

The commenter requested that the 

guideline state that FSIS does not allow 

or condone downgraded human food 

material that presents a health or safety 

risk be diverted to a by-product stream 

for use in pet food. The comment also 

requests a statement that any human 

food by-products, including adulterated 

human food processed at these facilities, 

is subject to FDA regulation under the 

Food Safety Modernization Act (FSMA) 

once it leaves the facility. 

Response: These comments are 

generally outside the scope of this 

guideline. Except for the fee-for-service 

program for certifying products for dog 

and cat food in 9 CFR part 355.29, FSIS 

does not inspect pet food or products 

intended for pet food. However, FSIS 

revised the guideline to include 

language recommending that FSISinspected establishments communicate 

with pet food manufacturers before 

sending products to a pet food facility 

to ensure that the products are eligible 

under FDA requirements and is 

acceptable to the pet food manufacturer. 

Rail Dust 

Comment: A comment from the 

equipment manufacturer stated rail dust 

and black specks are the most frequent 

causes of foreign material contamination 

and that the industry should switch to 

an oil-free contamination-free system. 

Response: FSIS regulations (9 CFR 

part 416) require an establishment’s 

sanitation procedures to prevent direct 

contamination of products and for nonfood contact surfaces to be cleaned as 

often as necessary to prevent insanitary 

conditions or the adulteration of 

products. The regulations provide 

inspected establishments flexibility to 

meet these regulatory requirements and 

most establishments do. Therefore, FSIS 

disagrees with the need to establish 

prescriptive, new requirements 

concerning sanitation systems. 

Providing Flexibility 

Comment: Many trade associations 

expressed concern that the inflexible 

approach in the guideline could deter 

the implementation of new foreign 

material detection methods and 

encouraged FSIS to adopt policies that 

encourage establishments to identify 

and address non-hazardous foreign 

material before an actual health risk is 

posed. 

Response: The guideline does not set 

up any new requirements or limit 

flexibility. The Agency agrees that 

establishments should be encouraged to 

identify and address non-hazardous 

foreign material before an actual health 

risk is posed. The changes and 

clarifications the Agency has made to 

the guidance should encourage 

establishments to develop policies and 

procedures to better address foreign 

material hazards. 

Formatting and Editorial Comments 

Comment: Several comments made 

recommendations and suggestions for 

reorganizing, reformatting, and 

83034 Federal Register / Vol. 85, No. 245 / Monday, December 21, 2020 / Notices 

clarifying the graphics and text in the 

guideline. 

Response: FSIS appreciates these 

recommendations and made the 

recommended changes when the 

suggestions did not conflict with FSIS 

policy. 

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 Constituent Update is available on 

the FSIS web page. Through the web 

page, FSIS provides 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: 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). 

Done in Washington, DC. 

Paul Kiecker, 

Administrator. 

[FR Doc. 2020–28112 Filed 12–18–20; 8:45 am] 

BILLING CODE 3410–DM–P 

DEPARTMENT OF AGRICULTURE 

Food Safety and Inspection Service 

[Docket No. FSIS–2020–0035] 

Notice of Request for Renewal of an 

Approved Information Collection 

(Common or Usual Name for Raw Meat 

and Poultry Products Containing 

Added Solutions) 

AGENCY: Food Safety and Inspection 

Service, USDA. 

ACTION: Notice and request for 

comments. 

SUMMARY: In accordance with the 

Paperwork Reduction Act of 1995 and 

the Office of Management and Budget 

(OMB) regulations, the Food Safety and 

Inspection Service (FSIS) is announcing 

its intention to request renewal of the 

approved information collection 

regarding labeling requirements for raw 

meat and poultry products that do not 

meet the standard of identity regulations 

and to which solutions have been 

added. There are no changes to the 

existing information collection. The 

approval for this information collection 

will expire on June 30, 2021. 

DATES: Submit comments on or before 

February 19, 2021. 

ADDRESSES: FSIS invites interested 

persons to submit comments on this 

Federal Register notice. Comments may 

be submitted by one of the following 

methods: 

• Federal eRulemaking Portal: This 

website provides commenters the ability 

to type short comments directly into the 

comment field on the web page or to 

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, 

Washington, DC 20250–3700. 

• Hand- or courier-delivered 

submittals: Deliver to 1400 

Independence Avenue SW, Washington, 

DC 20250–3700. 

Instructions: All items submitted by 

mail or electronic mail must include the 

Agency name and docket number FSIS– 

2020–0035. 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)205–0495 to schedule a time to 

visit the FSIS Docket Room at 1400 

Independence Avenue SW, Washington, 

DC 20250–3700. 

FOR FURTHER INFORMATION CONTACT: Gina 

Kouba, Office of Policy and Program 

Development, Food Safety and 

Inspection Service, USDA, 1400 

Independence Avenue SW, Mailstop 

3758, South Building, Washington, DC 

20250–3700; (202) 720–5627. 

SUPPLEMENTARY INFORMATION: 

Title: Common or Usual Name for 

Raw Meat and Poultry Products 

Containing Added Solutions. 

OMB Number: 0583–0152. 

Expiration Date of Approval: 6/30/ 

2021. 

Type of Request: Renewal of an 

approved information collection. 

Abstract: FSIS has been delegated the 

authority to exercise the functions of the 

Secretary (7 CFR 2.18, 2.53), as specified 

in the Federal Meat Inspection Act 

(FMIA) (21 U.S.C. 601, et seq.), and the 

Poultry Products Inspection Act (PPIA) 

(21 U.S.C. 451, et seq.). These statutes 

mandate that FSIS protect the public by 

verifying that meat and poultry products 

are safe, wholesome, unadulterated, and 

properly labeled and packaged. 

FSIS is requesting renewal of an 

approved information collection 

regarding labeling requirements for raw 

meat and poultry products that do not 

meet the standard of identity regulations 

(9 CFR part 317 and part 381) and to 

which solutions have been added. There 

are no changes to the existing 

information collection. The approval for 

this information collection will expire 

on June 30, 2021. 

FSIS requires establishments that 

manufacture products containing added 

solutions to label the products with a 

descriptive designation that provides an 

accurate description of the raw meat or 

poultry component, the percentage of 

added solution incorporated into the 

raw meat or poultry product, and the 

individual ingredients or multiVerDate Sep<11>2014 22:33 Dec 18, 2020 Jkt 253001 PO 00000 Frm 00008 Fmt 4703 Sfmt 4703 E:\FR\FM\21DEN1.SGM 21DEN1