[Federal Register Volume 85, Number 245 (Monday, December 21, 2020)]
[Notices]
[Pages 83030-83034]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2020-28112]
-----------------------------------------------------------------------
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/regulatory-compliance/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
[[Page 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
[[Page 83032]]
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
[[Page 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 FSIS-
inspected 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 non-food 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
[[Page 83034]]
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: [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).
Done in Washington, DC.
Paul Kiecker,
Administrator.
[FR Doc. 2020-28112 Filed 12-18-20; 8:45 am]
BILLING CODE 3410-DM-P