Procedures for Appealing Product Retentions

Federal RegisterFeb 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.

* * * * *

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.

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