[Federal Register Volume 59, Number 30 (Monday, February 14, 1994)]
[Unknown Section]
[Page 0]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 94-3367]


[[Page Unknown]]

[Federal Register: February 14, 1994]


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DEPARTMENT OF AGRICULTURE
Food Safety and Inspection Service

9 CFR Parts 306, 318 and 381

[Docket No. 92-022P]
RIN 0583-AB62

 

Procedures for Appealing Product Retentions

AGENCY: Food Safety and Inspection Service, USDA.

ACTION: Proposed rule.

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SUMMARY: The Food Safety and Inspection Service (FSIS) is proposing to 
amend the Federal meat and poultry products inspection regulations to 
require appeals above the circuit supervisor level that are related to 
disposition of retained meat and poultry product to be made in writing; 
provide that an establishment has 20 calendar days to appeal a 
retention, recondition or rework product, or properly dispose of the 
product; and establish procedures to ensure appropriate disposition of 
product immediately after a decision has been reached on an appeal. The 
proposal also would allow establishments to accumulate retained product 
for the purpose of re-examination with specialized detecting equipment 
provided written procedures for such activity are approved by the 
Regional Director. This proposal rule responds to recommendations from 
USDA's Office of Inspector General.

DATES: Comments must be received on or before March 16, 1994.

ADDRESSES: Written comments to Policy Office, Attn: Diane Moore, FSIS 
Hearing Clerk, room 3171, South Building, Food Safety and Inspection 
Service, U.S. Department of Agriculture, Washington, DC 20250. (See 
also COMMENTS under SUPPLEMENTARY INFORMATION.)

FOR FURTHER INFORMATION CONTACT:
Robert D. Murphy, Director, Processing Operations Staff, Inspection 
Management Program, Inspection Operations, Food Safety and Inspection 
Service, U.S. Department of Agriculture, Washington, DC 20250, (202) 
720-3491.

SUPPLEMENTARY INFORMATION:

Comments

    Interested persons are invited to submit comments concerning this 
action. Written comments should be sent to the Policy Office at the 
address shown above and should refer to Docket No. 92-022P. Any person 
desiring opportunity for oral presentation of views, as provided under 
the Poultry Products Inspection Act, must make such request to Mr. 
Murphy so that arrangements may be made for such views to be orally 
presented. A record will be made of all views orally presented. All 
comments submitted in response to this notice will be available for 
public inspection in the Policy Office from 9 a.m. to 12:30 p.m. and 
from 1:30 p.m. to 4 p.m., Monday through Friday.

Executive Order 12866

    This proposed rule is in conformance with Executive Order 12866. 
This proposed rule: (1) Would have an effect on the economy of less 
than $100 million; (2) would not adversely affect in a material way the 
economy, a sector of the economy, productivity, competition, jobs, the 
environment, public health or safety, or State, local, or tribal 
governments or communities; (3) would not create a serious 
inconsistency or otherwise interfere with an action taken or planned by 
another agency; (4) would not alter the budgetary impact of 
entitlements, grants, user fees, or loan programs or rights and 
obligations of recipients thereof; and (5) would not raise novel legal 
or policy issues arising out of legal mandates, the President's 
priorities, or principles set forth in Executive Order 12866.

Executive Order 12778

    This proposed rule has been reviewed under Executive Order 12778, 
Civil Justice Reform. States and local jurisdictions are preempted 
under the Federal Meat Inspection Act (FMIA) and the Poultry Products 
Inspection Act (PPIA) from imposing any marking or packaging 
requirements on federally inspected meat or poultry products that are 
in addition to, or different than, those imposed under the FMIA and 
PPIA. States and local jurisdictions may, however, exercise concurrent 
jurisdiction over meat and poultry products that are outside official 
establishments for the purpose of preventing the distribution of meat 
and poultry products that are misbranded or adulterated under the FMIA 
or PPIA, or, in the case of imported articles, which are not at such an 
establishment, after their entry into the United States. Under the FMIA 
and PPIA, States that maintain meat or poultry inspection programs must 
impose requirements on State inspected products and establishments that 
are at least equal to those required under the FMIA and PPIA. These 
States may, however, impose more stringent requirements on such State 
inspected products and establishments.
    This proposed rule is not intended to have retroactive effect. 
There are no applicable administrative procedures that must be 
exhausted prior to any judicial challenge to the provisions of this 
rule. However, the administrative procedures specified in Part 335 of 
Federal meat inspection regulations and Part 381, Subpart W of the 
poultry products inspection regulations, must be exhausted prior to any 
judicial challenge to the provisions of this rule, if the challenge 
involves any decision of an inspector relating to inspection services 
provided under the FMIA and PPIA.

Effects on Small Entities

    The Administrator, FSIS, has made an initial determination that 
this proposed rule would not have a significant economic impact on a 
substantial number of small entities. The proposal provides a time 
limit of 20 calendar days to appeal a decision to retain meat or 
poultry products that was made by the in-plant inspector and concurred 
in by the circuit supervisor, recondition or rework product, or 
properly dispose of the product. FSIS has determined that a 20-day time 
period provides ample time for the establishment to research and 
evaluate the situation and make a decision on whether to recondition or 
rework the product or request that the product be condemned by the 
inspector. In addition, the proposal would require that establishment 
management make such appeals in writing. The proposal would exempt 
establishments from the 20-day time limit for reconditioning and 
reworking product when establishments intend to accumulate product for 
re-examination by mechanical detecting devices. Because of the expense 
to establishments of renting mechanical detecting equipment and 
employing technicians to operate the equipment, some establishments may 
elect to store product suspected of being adulterated until a 
sufficient amount is accumulated to justify the cost of the detection 
equipment and technicians. However, the Agency would allow the 
accumulation of suspect product beyond the 20 days only if the 
establishment has written procedures on file that provide information 
to assure that the identity, location and security of suspect product 
is maintained.
    The Agency has determined that the additional paperwork burden 
associated with this proposed rule is necessary to maintain control of 
and assure proper disposition of product that may be adulterated. The 
Agency has reviewed the recordkeeping requirements and has determined 
that they do not impose a significant burden on small entities.

Paperwork Requirements

    This proposal would require that establishments electing to 
accumulate product for re-examination with mechanical detection devices 
submit written procedures to the Regional Director for prior approval. 
Approval of the written procedure will be based on the establishment's 
ability to provide the physical space to store the accumulated product 
and its ability to assure that the identity and security of the product 
is maintained. These procedures would describe how the establishment 
will maintain the identity of the suspect product, where the suspect 
product will be stored, how long the product will be stored, and what 
measures will be taken to secure the product. The proposal would also 
require that appeals above the circuit supervisor's level be made in 
writing. These paperwork requirements will be submitted to the Office 
of Management and Budget under the Paperwork Reduction Act (44 U.S.C. 
3501 et seq.).

Background

    The Federal Meat Inspection Act (21 U.S.C. 601 et seq.) and the 
Poultry Products Inspection Act (21 U.S.C. 451 et seq.) require the 
Secretary of Agriculture to administer an inspection program that 
assures consumers that meat and poultry products distributed in 
commerce are wholesome, not adulterated, and properly marked, labeled, 
and packaged.
    During processing, there are a number of ways that meat and poultry 
products may become adulterated or misbranded. When product is 
suspected of being adulterated or misbranded, FSIS inspectors place a 
``U.S. Retain'' tag on the suspect product at the time of reinspection 
at the official establishment and the product is held for further 
inspection. Upon further inspection, if the product is found to be 
adulterated, it is subject to condemnation. However, the inspector may 
permit product to be reconditioned or reworked so it will not be 
misbranded or adulterated under certain conditions (9 CFR 318.2 and 
381.99).
    Once product is retained, an establishment must recondition or 
rework the retained product, properly dispose of the product, or appeal 
the inspector's/circuit supervisor's decision to his/her immediate 
supervisor.
    Currently, there is no time limit on actions to be taken by the 
establishment when product is retained by FSIS. At times, retained 
product is accumulated from different lots and held in storage for 
several months or more with no action taken or planned by the 
establishment.
    The proposed regulations are intended to prevent incidents such as 
one recently investigated by USDA's Office of Inspector General 
involving the release of beef trimmings containing plastic shavings 
from plastic cutting boards. The investigation disclosed that about 
160,000 pounds of beef trimmings containing plastic shavings had been 
produced at different times at two different establishments of the same 
corporation.
    Suspect product was retained by FSIS in April and September 1991. 
FSIS allowed the release of all of the trimmings in December 1991 after 
examining a sample of product produced at one of the establishments.
    The Office of Inspector General (OIG) provided a report\1\ of the 
investigation to the Secretary of Agriculture on July 30, 1992. 
Although the investigation disclosed that FSIS's inspection process 
ensures a safe and wholesome product, the report recommended, among 
other things, that FSIS strengthen its regulations with regard to 
documenting appeals, providing procedures for reconsidering retention 
decisions, and handling and disposition of retained product.
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    \1\A copy of the report is available from the FSIS Hearing 
Clerk, Room 3171, South Building, Food Safety and Inspection 
Service, U.S. Department of Agriculture, Washington, DC 20250.
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    FSIS is proposing to amend the Federal meat and poultry products 
inspection regulations to: (1) Require establishments to submit written 
appeals above the circuit supervisor's level when the appeal relates to 
disposition of retained meat or poultry product, (2) provide that an 
establishment has 20 calendar days to: (a) Appeal a retention, (b) 
recondition or rework product, or (c) properly dispose of the product, 
and (3) establish procedures to ensure appropriate disposition of 
product immediately after a decision has been reached on an appeal.
    FSIS has determined that a 20-day time period provides ample time 
for the establishment to research and evaluate the situation and make a 
decision on whether to recondition or rework the product or request 
that the product be condemned by the inspector. The time limit would 
not apply, however, for retained product that is accumulated for re-
examination using mechanical detecting devices. Frequently, when 
contamination (plastic, metal or other foreign material capable of 
detection with approved specialized detection equipment) occurs during 
processing, it is difficult to visually determine the precise amount of 
product affected. Therefore, FSIS permits the use of approved 
mechanical detection devices, such as X-ray equipment, to be used by 
establishments to detect such contamination and to salvage the portions 
of the product that are not contaminated. The mechanical detection 
equipment must be approved as prescribed in Secs. 308.5 and 381.53 of 
the meat and poultry inspection regulations. Because of the expense to 
establishments of renting mechanical detection equipment and employing 
technicians to operate the equipment, some establishments may elect to 
store product suspected of being contaminated until a sufficient amount 
is accumulated to justify the cost of the detection equipment and 
technicians.
    Under the proposed regulations, FSIS would allow the accumulation 
of suspect product beyond 20 calendar days only if the product is 
intended for further examination by mechanical detection equipment and 
only when the establishment has written procedures on file that provide 
information to assure that the identity, location and security of 
suspect product are maintained.
    However, if the Administrator or his/her designee determines that 
the establishment's written procedures for accumulating product are 
unacceptable, FSIS would not permit the establishment to accumulate 
suspect product beyond 20 calendar days and would formally notify the 
establishment in writing of the basis for this decision. The 
establishment would then be afforded an opportunity to modify the 
procedure in accordance with the formal notification by submitting a 
written statement in response to the denial notification. The 
establishment would also be afforded a right to request a hearing with 
respect to the merits or validity of the denial. If the establishment 
requests a hearing and the Administrator or his/her designee, after 
review of the answer, determines the initial determination to be 
correct, he/she would file the notification, answer and the request for 
hearing, which shall constitute the complaint and answer in the 
proceeding, with the Hearing Clerk of the Department. The proceeding 
would be conducted in accordance with Rules of Practice which shall be 
adopted for this proceeding.
    In addition, the footnotes in Secs. 318.2 and 381.145 of the 
Federal meat and poultry products inspection regulation would be 
revised to reflect that the Agency is authorizing field office 
personnel to develop sampling plans for specific products.

List of Subjects

9 CFR Part 306

    Appeals, Meat inspections, Retentions.

9 CFR Part 318

    Appeals, Meat inspection, Retentions.

9 CFR Part 381

    Appeals, Poultry products inspection, Retentions.

    For the reasons discussed in the preamble, FSIS is proposing to 
amend 9 CFR parts 306, 318 and 381 of the Federal meat and poultry 
products inspection regulations to read as follows:

PART 306--ASSIGNMENT AND AUTHORITIES OF PROGRAM EMPLOYEES

    1. The authority citation for part 306 would continue to read as 
follows:

    Authority: 21 U.S.C. 601-695; 7 CFR 2.17, 2.55.

    2. Section 306.5 would be revised as follows:


Sec. 306.5  Appeals.

    Any person receiving inspection service, may if dissatisfied with 
any decision of an inspector relating to any inspection, file an appeal 
from such decision: Provided, That such appeal is filed within 48 hours 
from the time the decision was made. Any such appeal from a decision of 
an inspector shall be made to his/her immediate supervisor having 
jurisdiction over the subject matter of the appeal, and such superior 
shall determine whether the inspector's decision was correct. Review of 
such appeal determination, when requested, shall be made by the 
immediate superior of the employee of the Department making the appeal 
determination. Appeals above the circuit supervisor level of decisions 
related to product retentions shall be made in writing by the 
establishment within a period of twenty (20) calendar days from the 
date of the retention. Denial of a labeling application by the 
inspector-in-charge shall not constitute a basis for an appeal under 
this section.

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

    3. The authority citation for part 318 would continue to read as 
follows:

    Authority: 7 U.S.C. 450, 1901-1906; 21 U.S.C. 601-695; 7 CFR 
2.17, 2.55.

    4. Section 318.2 (c), footnote 1, and (d) would be revised as 
follows:


Sec. 318.2  Reinspection, retention, and disposal of meat and poultry 
products at official establishments.

* * * * *
    (c) Reinspection may be accomplished through use of statistically 
sound sampling plans that assure a high level of confidence. The 
circuit supervisor shall designate the type of plan and the program 
employee shall select the specific plan to be used in accordance with 
instructions issued by the Administrator.\1\
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    \1\Further information concerning sampling plans which have been 
adopted for specific products may be obtained from the circuit 
supervisors of program circuits. These sampling plans are developed 
for individual products and will be distributed for field use as 
they are developed. The type of plan applicable depends on factors 
such as whether the product is in containers, stage of preparation, 
and procedure followed by the establishment operator. The specific 
plan applicable depends on the kind of product involved, such as 
liver, oxtail, etc.
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    (d) A U.S. retained tag shall be placed by a Program employee at 
the time of reinspection at any official establishment on all products 
which are suspected on such reinspection of being adulterated or 
misbranded, and such products shall be held for further inspection. 
Such tag shall be removed only authorized Program employees.
    (1) Reinspection determinations regarding adulteration may be 
deferred:
    (i) For up to twenty (20) calendar days, if a product has become 
soiled or unclean by falling on the floor or in any other accidental 
way, an the inspector determines the condition can be corrected, in 
which case the product shall be cleaned (including trimming if 
necessary) or otherwise handled in a manner approved by the inspector 
to assure that it will not be adulterated or misbranded and shall then 
be presented for final reinspection and disposal in accordance with 
this section within a period of twenty (20) calendar days, or
    (ii) When the Regional Director grants prior approval of an 
establishment's written procedures for storing at the official 
establishment product suspected of adulteration with metal, plastic, or 
other material capable of detection by the use of approved specialized 
mechanical detection devices prior to final reinspection. These written 
procedures shall describe how the establishment will maintain the 
identity of the suspect product, where the suspect product will be 
stored, how long the product will be stored, and what measures will be 
taken to secure the product.
    (A) Approval of an establishment's written procedures for 
accumulating product will be based on the establishment's ability to 
provide the physical space to store the accumulated product and its 
ability to assure that the identity and security of the product is 
maintained.
    (B) In any situation where the establishment's written procedure 
for accumulating product is found by the Administrator or his/her 
designee to be unacceptable, formal written notification shall be given 
to the establishment of the basis for the denial. The establishment 
will be afforded an opportunity to modify the procedure in accordance 
with the notification. The establishment shall be afforded an 
opportunity to submit a written statement in response to this 
notification of denial and a right to request a hearing with respect to 
the merits or validity of the denial. If the establishment requests a 
hearing and the Administrator or his/her designee, after review of the 
answer, determines the initial determination to be correct, he/she 
shall file with the Hearing Clerk of the Department the notification, 
answer and the request for hearing, which shall constitute the 
complaint and answer in the proceeding, which shall hereafter be 
conducted in accordance with Rules of Practice which shall be adopted 
for this proceeding.
    (C) Specialized mechanical detection devices shall be approved in 
accordance with the provisions of Sec. 308.5 of this subchapter.
    (2) Upon final reinspection, the product shall be disposed of as 
follows:
    (i) If the inspector determines that the product is not adulterated 
or misbranded, the inspector shall remove the U.S. retained tag;
    (ii) If the inspector determines that the product is adulterated, 
it shall be condemned as prescribed in Sec. 310.5 of this subchapter;
    (iii) If the inspector determines that the product is misbranded, 
it shall be held under a U.S. retained tag, or a U.S. detention tag as 
provided in part 329 of this subchapter, pending correction of the 
misbranding or issuance of an order under section 7 of the Act to 
withhold from use the labeling or container of the product, or the 
institution of a judicial seizure action under section 403 of the Act 
or other appropriate action.
    (iv) The inspector shall make a record of each transaction under 
paragraph (d)(2) of this section and shall report actions taken by the 
inspector to the area supervisor.
    (3) Immediately after an establishment is notified of a final 
Agency decision denying an appeal regarding retained product, all such 
retained product shall be condemned and destroyed under the inspector's 
supervision.

PART 381--POULTRY PRODUCTS INSPECTION REGULATIONS

    5. The authority citation for part 381 would continue to read as 
follows:

    Authority: 7 U.S.C. 450, 21 U.S.C. 451-470, 7 CFR 2.17, 2.55.

    6. Section 381.35 would be amended by adding a new sentence after 
the third sentence to read as follows:


Sec. 381.35  Appeal inspections; how made.

    * * * Appeals above the circuit supervisor level of decisions 
related to product retentions shall be made in writing by the 
establishment within a period of twenty (20) calendar days from the 
date of the retention. * * *
    7. Section 381.145(b) would be revised and the undesignated 
paragraph following paragraph (b) would be removed as follows:


Sec. 381.145  Poultry products and other articles entering or at office 
establishments; examination and other requirements.

* * * * *
    (b)(1) All poultry products and all carcasses, parts thereof, meat 
and meat products of cattle, sheep, swine, goats, or equines which 
enter any official establishment shall be identified by the operator of 
the official establishment at the time of receipt at the official 
establishment. All poultry products, and all carcasses, parts thereof, 
meat and meat food products of such animals, which are processed or 
otherwise handled at any official establishment shall be subject to 
examination by an inspector at the official establishment in such 
manner and at such times as may be deemed necessary by the inspector-
in-charge to assure compliance with the regulations. Such examination 
may be accomplished through use of statistically sound sampling plans 
that assure a high level of confidence. The circuit supervisor shall 
designate the type of plan and the Program employee shall select the 
specific plan to be used in accordance with instructions issued by the 
Administrator.\1\ Upon such examination, if any such article or portion 
thereof is found to be adulterated by the inspector, such article or 
portion shall, in the case of poultry products, be condemned and 
disposed of as prescribed in Sec. 381.95, except that a determination 
regarding adulteration may be deferred by the inspector and such 
product retained as prescribed in Sec. 381.77 and Sec. 381.99 of this 
subchapter if:
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    \1\Further information concerning sampling plans which have been 
adopted for specific products may be obtained from the circuit 
supervisor of program circuits. These sampling plans are developed 
for individual products and will be distributed for field use as 
they are developed. The type of plan applicable depends on factors 
such as whether the product is in containers, state of preparation, 
and procedures followed by the establishment operator. The specific 
plan applicable depends on the kind of product involved, such as 
whole birds, parts, etc.
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    (i) By reprocessing, the product may be made not adulterated, and 
shall, in the case of such articles be presented for reinspection and 
disposal in accordance with this section within a period of twenty (20) 
calendar days. In this case, the procedures in Sec. 381.77 and 
Sec. 381.99 regarding retained product shall apply.
    (ii) Prior approval is granted by the Regional Director of an 
establishment's written procedures for storing at the official 
establishment product suspected of adulteration with metal, plastic, or 
other material capable of detection by the use of approved specialized 
mechanical detection devices prior to final reinspection. These written 
procedures shall describe how the establishment will maintain the 
identity of the suspect product, where the suspect product will be 
stored, how long the product will be stored, and what measures will be 
taken to secure the product.
    (A) Approval of an establishment's written procedures for 
accumulating product will be based on the establishment's ability to 
provide the physical space to store the accumulated product and its 
ability to assure that the identity and security of the product is 
maintained.
    (B) In any situation where the establishment's written procedure 
for accumulating product is found by the Administrator or his/her 
designee to be unacceptable, formal written notification shall be given 
to the establishment of the basis for the denial. The establishment 
will be afforded an opportunity to modify the procedure in accordance 
with the notification. The establishment shall be afforded an 
opportunity to submit a written statement in response to this 
notification of denial and a right to request a hearing with respect to 
the merits or validity of the denial. If the establishment requests a 
hearing and the Administrator or his/her designee, after review of the 
answer, determines the initial determination to be correct, he/she 
shall file with the Hearing Clerk of the Department the notification, 
answer and the request for hearing, which shall constitute the 
complaint and answer in the proceeding, which shall hereafter be 
conducted in accordance with Rules of Practice which shall be adopted 
for this proceeding.
    (C) Specialized mechanical detection devices shall be approved in 
accordance with the provisions of Sec. 381.53 of this subchapter.
    (2) If upon final inspection, the product is found by the inspector 
to be not adulterated or misbranded, the inspector shall remove the 
U.S. Retained tag. If the product is found to be adulterated by the 
inspector, it shall be condemned as prescribed in Sec. 381.95 of this 
subchapter. If a product is found upon reinspection to be misbranded, 
it shall be held under a U.S. Retained tag, or a U.S. detention tag as 
provided in Sec. 381.210 and Sec. 381.211 of this subchapter, pending 
correction of the misbranding or issuance of an order under section 8 
of the Poultry Products Inspection Act to withhold from use the 
labeling or container of the product, or the institution of a judicial 
seizure action under section 20 of the Act or other appropriate action. 
The inspector shall make a record of each transaction under this 
paragraph and shall report actions taken by the inspector to the area 
supervisor.
    (3) Immediately after an establishment is notified of a final 
Agency decision denying an appeal regarding retained product all such 
product shall be disposed of, in accordance with Sec. 381.95, under the 
inspector's supervision.
* * * * *
    Done at Washington, DC, on: February 7, 1994.
Patricia Jensen,
Acting Assistant Secretary, Marketing and Inspection Services.
[FR Doc. 94-3367 Filed 2-11-94; 8:45 am]
BILLING CODE 3410-DM-M