[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
