[Federal Register Volume 63, Number 7 (Monday, January 12, 1998)]
[Proposed Rules]
[Pages 1797-1800]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 98-573]
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DEPARTMENT OF AGRICULTURE
Food Safety and Inspection Service
9 CFR Parts 304, 305, 327, 335, 381, and 500
[Docket No. 95-025P]
RIN 0583-AC34
Rules of Practice
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
consolidate and amend its regulations concerning the rules of practice
that apply to refusal, suspension, or withdrawal of inspection
services. FSIS also is proposing to add specific language regarding the
refusal, suspension, or withdrawal of inspection services when the
Agency determines that an establishment's Hazard Analysis and Critical
Control Point (HACCP) system is inadequate, an establishment is not
meeting the Salmonella pathogen reduction performance standards, an
establishment's Sanitation Standard Operating Procedures (Sanitation
SOP's) are inadequate or ineffective, or an establishment is not
complying with generic E. coli testing requirements. This proposal is
part of FSIS's ongoing efforts to consolidate, streamline, and clarify
the meat and poultry product inspection regulations.
DATES: Comments on the proposed regulations must be received on or
before March 13, 1998.
ADDRESSES: Please send an original and two copies of comments to: FSIS
Docket Clerk, Docket No. 95-025P, Room 102, Cotton Annex, 300 12th
Street, SW, Washington, DC 20250-3700.
FOR FURTHER INFORMATION CONTACT: Ms. Patricia Stolfa, Assistant Deputy
Administrator, Office of Policy, Program Development and Evaluation,
FSIS, Room 402, Cotton Annex Building, 300 12th Street, SW, Washington,
DC 20250-3700; (202) 205-0699.
SUPPLEMENTARY INFORMATION:
Background
Under the authority of the Federal Meat Inspection Act (FMIA) and
the Poultry Products Inspection Act (PPIA), FSIS can refuse to grant
inspection, suspend inspection, or withdraw inspection services from
establishments based on unsanitary conditions (9 CFR 335.13 and
381.234), inhumane livestock slaughtering (9 CFR 335.30-.32), or
unfitness to engage in business because of prior criminal convictions
(9 CFR 335.10 and 381.231). Inspection services also can be suspended
or withdrawn if establishments fail to destroy condemned product (9 CFR
335.11 and 9 CFR 381.232), or if establishment personnel assault,
intimidate, or interfere with inspection service employees (9 CFR
335.20-.21 and 381.235-.236). Additionally, FSIS can rescind approval
of any marking, labeling, or container that is false or misleading (9
CFR 335.12 and 381.233).
As discussed in the ``Pathogen Reduction; Hazard Analysis and
Critical Control Point (HACCP) System'' final rule (61 FR 38806), FSIS
also can refuse to grant, suspend, or withdraw the grant of inspection
if an establishment has failed to: (1) Develop and implement a HACCP
plan or operate in accordance with 9 CFR Part 417; (2) develop,
implement, and maintain Sanitation SOP's in accordance with 9 CFR part
416; (3) conduct generic E. coli testing in accordance with 9 CFR
310.25(a) or 381.45(a); or (4) meet the pathogen reduction performance
standard for Salmonella or, after failing two sample sets, reassess its
HACCP plan in accordance with 9 CFR 310.25(b) or 381.94(b).
When FSIS determines to refuse to grant an application for
inspection, to withdraw a grant of inspection, or to rescind or refuse
to approve markings, labels or containers, the Agency initiates an
administrative action under USDA's Rules of Practice Governing Formal
Adjudicatory Proceedings Instituted by the Secretary Under Various
Statutes (7 CFR subtitle A, part 1, subpart H), as supplemented by its
own ``Rules of Practice,'' which are set out in 9 CFR part 335 or part
381, subpart W. The Department's uniform Rules of Practice contain the
procedures applicable to formal adjudicatory proceedings under various
USDA implemented statutes, including specified sections of the FMIA and
PPIA. The Department's Rules of Practice contain procedures that FSIS
follows when filing a complaint with the Department's Hearing Clerk and
requesting a hearing before an Administrative Law Judge. FSIS's current
supplemental Rules of Practice regulations provide establishments an
opportunity to correct problems before the Agency files a complaint to
withdraw the establishment's grant of inspection. However, FSIS may
suspend inspection services until the problem is corrected.
Generally, FSIS initially uses ``withholding actions'' to withhold
the mark of inspection from an establishment's products that are
deficient. A U.S. Retain Tag is placed on deficient product or a U.S.
Rejected Tag is attached to deficient equipment. The withholding action
is discontinued when the deficiencies are corrected.
In most cases, FSIS suspends inspection services only after
repeated violations. A suspension may affect an entire establishment or
may be limited to a specific process or production line within the
establishment. A suspension will last until the establishment achieves
compliance with the applicable laws and regulations. If the suspension
involves an entire establishment, FSIS removes inspection personnel
unless there is reason to believe that corrective action can be
completed in a timeframe that is
[[Page 1798]]
consistent with the efficient assignment of program personnel. FSIS may
allow the establishment to operate while under a suspension if the
establishment presents adequate written assurances that corrective
actions are being implemented. If establishments fail to take
appropriate corrective actions, FSIS may proceed to file a complaint to
withdraw inspection services, as discussed above.
FSIS is committed to providing establishments with appropriate
notice and an opportunity to appeal withholding actions and suspensions
of inspection. It recognizes the need for timely resolution of all such
appeals. Withholding actions taken by FSIS inspectors can be appealed
to the next level of supervision. The decision to suspend inspection
services is made by the District Manager. Traditionally, appeal from
this decision has been to the Assistant Deputy Administrator for Field
Enforcement Operations. FSIS intends to continue handling appeals
through the ``chain-of-command'' process, which is incorporated into
FSIS's existing regulations (9 CFR 306.5 and 381.35). However, the
Agency has received comments raising concerns about the timeliness of
this process, especially when operations have been shut down.
FSIS welcomes comments on the adequacy of its approach. One
possible alternative to the Agency's traditional approach would be for
it to include specific appeal procedures in the supplemental Rules of
Practice regulations concerning the procedures that the Agency will
follow in providing notice and an opportunity to contest a suspension.
For example, the appeal procedures could be modeled after the Food and
Drug Administration's procedures for supervisory review (21 CFR 10.75)
. FSIS also requests comments on how it should provide notice of a
suspension action and on whether additional procedures are necessary
and appropriate if an establishment wishes to appeal a suspension. FSIS
will consider the comments it receives on these issues and intends to
provide the most appropriate review mechanisms in any final rule that
it issues.
Proposed Rule
For the most part, FSIS's supplemental Rules of Practice duplicate
each other and the Department's uniform Rules of Practice regulations.
FSIS's regulations do, however, establish procedures for the suspension
of inspection services. However, these regulations are difficult to
read and do not clearly outline the process. Therefore, as part of
FSIS's ongoing efforts to consolidate, streamline, and clarify the meat
and poultry products inspection regulations, FSIS is proposing to
reorganize and revise these regulations to eliminate redundancy and to
clearly identify the processes and situations involved when FSIS
suspends inspection services.
FSIS is proposing to revise and consolidate the existing
regulations into a new part, CFR Part 500, ``Rules of Practice.''
Section 500.11 in this proposed new part is titled, ``Refusal to Grant
Inspection'' and sets out the following different bases on which FSIS
may refuse to grant inspection services to an applicant: (1) Failure to
develop a HACCP plan as required by Secs. 417.2 and 417.4; (2) failure
to develop Sanitation SOP's as required by part 416; (3) failure to
demonstrate that adequate sanitary conditions exist in accordance with
part 416, and part 308 or part 381, subpart H; or (4) failure to
demonstrate that livestock will be handled and slaughtered humanely
(proposed Sec. 500.11(a)). Proposed Sec. 500.11(b) states that, if FSIS
refuses to grant inspection, the applicant will be notified and have an
opportunity for a hearing in accordance with the uniform Rules of
Practice, 7 CFR Subtitle A, part 1, subpart H.
Section 500.12 in the proposed new part is titled ``Conditions for
the Suspension or Withdrawal of Inspection.'' This section lists the
following as the different bases on which FSIS may suspend or withdraw
inspection: (a) Failure to implement HACCP or operate in accordance
with part 417; (b) failure to implement or maintain Sanitation SOP's in
accordance with part 416; (c) failure to collect and analyze samples
for E. coli Biotype I and record results in accordance with
Secs. 310.25(a) or 381.94(a); (d) failure to meet the Salmonella
performance standard requirements or reassess a HACCP plan in
accordance with Secs. 310.25(b) or 381.45(b); (e) failure to maintain
sanitary conditions in accordance with part 308 or part 381, subpart H;
(f) failure to destroy a condemned meat or poultry carcass, or part or
product thereof, in accordance with part 314 or part 381, subpart L,
within three days of notification; (g) assault, threat of assault,
intimidation or other interference with an inspection service
employee's performance of official duties; or (h) inhumane slaughtering
or handling of livestock.
Section 500.13 of the proposed new part is titled ``Suspension of
Inspection.'' It states that inspection services may be suspended at an
establishment that has a condition described in Sec. 500.12, and that
if inspection is suspended, an establishment will receive a written
``Notice of Suspension of Inspection.'' Under proposed Sec. 500.13(b),
the notice will include the following: (1) The effective date of the
suspension; (2) the reasons for the suspension; and (3) the name and
address where an appeal may be sent. Proposed Sec. 500.13(c) states
that a suspension of inspection will remain in effect until an
establishment brings itself into compliance with the regulations.
Section 500.14 of the proposed new part is ``Withdrawal of
Inspection.'' It states that inspection services may be withdrawn at an
establishment that fails to correct conditions in Sec. 500.12 (proposed
Sec. 500.14(a)) and that FSIS will initiate a complaint to withdraw
inspection in accordance with the Uniform Rules of Practice, 7 CFR
Subtitle A, part 1, subpart H (proposed Sec. 500.14(b)).
Section 500.15 of the proposed new part is titled ``Rescinding the
Approval of Marks, Labels, or Containers'' and states that FSIS will
rescind or refuse approval of false or misleading marks or labels or
container sizes or forms for use with any meat or poultry product under
section 7 of the FMIA, or under section 8 of the PPIA, in accordance
with the Uniform Rules of Practice, 7 CFR Subtitle A, part 1, subpart
H. Proposed Sec. 500.15(b) states that the Agency will provide
notification that explains the basis for any such action, grants an
opportunity to modify the marking, labeling, or container so that it is
no longer false or misleading, and advises the firm of its opportunity
for a hearing with respect to the merits or validity of the Agency's
determination about the product's labeling.
Section 500.16 of the proposed new part is titled ``Refusing or
Withdrawing Inspection Service for Unfitness to Engage in Business
Requiring Federal Inspection'' and states that applicants for
inspection services or recipients of inspection services unfit to
engage in business requiring inspection as specified in section 401 of
the FMIA or section 18(a) of the PPIA will be refused or have their
inspection services withdrawn in accordance with the Uniform Rules of
Practice, 7 CFR Subtitle A, part 1, subpart H.
There is one provision in the current regulations that FSIS has not
incorporated into the proposed regulations. Under the current
regulations in section 335.13, establishments operating under
insanitary conditions are notified by FSIS as to what action is
necessary to
[[Page 1799]]
correct the violations and of the time period within which corrections
must be made. FSIS has decided not to incorporate this provision in
these proposed regulations because, as discussed in the Pathogen
Reduction/HACCP final rule, it is the establishment's responsibility to
identify problems that exist and to determine how best to correct them.
FSIS also is proposing to delete some of its other regulations that
are duplicative. First, this proposal would eliminate Sec. 305.5, (9
CFR 305.5) ``Withdrawal of Inspection; Statement of Policy.'' The
subject that this statement of policy addresses is dealt with fully in
proposed Part 500. Similarly, the Agency is proposing to eliminate
Sec. 381.29, which is duplicative for the same reason.
The Agency is also proposing to eliminate all portions of
Secs. 304.2, 327.6 and 381.21 that refer to denying or refusing an
application for inspection or import reinspection services and to
replace those portions with a statement indicating that any application
for inspection services can be denied in accordance with the rules of
practice in Part 500.
Lastly, FSIS is proposing to remove part 335, subpart E. This
subpart, also referred to as the ``present your views'' (PYV)
provision, was added in 1988 under the Processed Products Inspection
Improvement Act of 1986 (Pub. L. 99-641, Title VI), which was not
reauthorized by Congress in 1992.
The PYV provision allows suspected violators of the FMIA an
opportunity to present their views regarding the alleged criminal
violation to the Secretary of Agriculture before FSIS refers the
violation to the Department of Justice for prosecution. Because the PYV
provision can be a useful administrative procedure, FSIS will continue
to use the PYV process, as a matter of administrative discretion, in
appropriate situations. However, FSIS has determined that it is
unnecessary to continue to include the provision in its regulations.
Executive Order 12866 and Regulatory Flexibility Act
This proposed rule has been determined to be not significant, and
therefore, has not been reviewed by the Office of Management and
Budget.
The Administrator has made an initial determination that this
proposed rule would not have a significant economic impact on a
substantial number of small entities, as defined by the Regulatory
Flexibility Act (5 U.S.C. 601).
There are no direct costs or benefits associated with this
proposal. Costs and benefits are related to the regulatory actions, not
the proceedings. At the present time, there is no way to predict
whether ``down time'' will increase or decrease under these proposed
rules of practice. To the extent that disputes can be resolved in a
timely and more efficient manner, there are potential benefits to both
industry and the government. To the extent that clear rules of practice
promote timely and effective regulatory action, there would also be
consumer protection benefits.
When disputes are related to public health issues, there is a risk
reduction component to having operations suspended during the period of
resolution. There are also costs associated with actions that suspend
production operations.
Executive Order 12988
This proposed rule has been reviewed under Executive Order 12988,
Civil Justice Reform. If the proposed rule becomes final: (1) All state
and local laws and regulations that are inconsistent with this rule
would be preempted; (2) no retroactive effect would be given to this
rule; and (3) administrative proceedings would not be required before
parties may file suit in court challenging this rule.
Paperwork Requirements
This proposed rule does not include any new paperwork requirements.
List of Subjects
9 CFR Part 304
Meat inspection.
9 CFR Part 305
Meat inspection.
9 CFR Part 327
Imports, Meat inspection.
9 CFR Part 381
Poultry and poultry products.
9 CFR Part 500
Administrative practice and procedure, Crime, Government employees,
Meat inspection.
For the reasons set forth in this preamble, 9 CFR chapter III would
be amended as follows:
PART 304--APPLICATION FOR INSPECTION; GRANT OF INSPECTION
1. The authority citation for part 304 would continue to read as
follows:
Authority: 21 U.S.C. 601-695; 7 CFR 2.18, 2.53.
2. Part 304 would be amended by revising the title to read as set
forth above, amending Sec. 304.2 to remove paragraphs (c) and (e),
redesignating paragraph (d) as paragraph (c), and removing the last
sentence of paragraph (b) and replacing it with a sentence to read as
follows:
Sec. 304.2 Information to be furnished; grant or refusal of
inspection.
* * * * *
(b) * * * Any application for inspection services may be refused in
accordance with the rules of practice in part 500 of this chapter.
* * * * *
PART 305--OFFICIAL NUMBERS; INAUGURATION OF INSPECTION; WITHDRAWAL
OF INSPECTION; REPORTS OF VIOLATION
3. The authority citation for part 305 would continue to read as
follows:
Authority: 21 U.S.C. 601-695; 7 CFR 2.18, 2.53.
4. Part 305 would be amended by removing section 305.5.
PART 327--IMPORTED PRODUCTS
5. The authority citation for part 327 would continue to read as
follows:
Authority: 21 U.S.C. 601-695; 7 CFR 2.18, 2.53.
6. Section 327.6 would be amended by removing the last four
sentences in paragraph (f) and replacing them with one sentence to read
as follows:
Sec. 327.6 Products for importation; program inspection, time and
place; application for approval of facilities as official import
inspection establishment; refusal or withdrawal of approval; official
numbers
* * * * *
(f) * * * Any application for inspection services under this
section may be denied or refused in accordance with the rules of
practice in part 500 of this chapter.
* * * * *
PART 335--RULES OF PRACTICE GOVERNING PROCEEDINGS UNDER THE FEDERAL
MEAT INSPECTION ACT
7. Part 335 would be removed.
PART 381--POULTRY PRODUCTS INSPECTION REGULATIONS
8. The authority citation for part 381 would continue to read as
follows:
Authority: 7 U.S.C. 138f; 7 U.S.C. 450, 21 U.S.C. 451-470; 7 CFR
2.18, 2.53.
9. Section 381.21 would be revised to read as follows:
[[Page 1800]]
Sec. 381.21 Refusal of inspection.
Any application for inspection services in accordance with this
part may be denied or refused in accordance with the rules of practice
in part 500 of this chapter.
10. Part 381 would be amended by removing section 381.29.
11. Part 381 would be amended by removing Subpart W.
SUBCHAPTER E--REGULATORY REQUIREMENTS UNDER THE FEDERAL MEAT
INSPECTION ACT AND THE POULTRY PRODUCTS INSPECTION ACT
12. Subchapter E would be amended by adding a new Part 500 to read
as follows:
PART 500--RULES OF PRACTICE
Sec.
500.11 Refusal to grant inspection.
500.12 Conditions for the suspension or withdrawal of inspection.
500.13 Suspension of inspection.
500.14 Withdrawal of inspection.
500.15 Rescinding or refusing approval of marks, labels, and
containers.
500.16 Refusing or withdrawing inspection for applicants or
recipients unfit to engage in business.
Authority: 7 U.S.C. 450, 1901-1906; 21 U.S.C. 451-470, 601-695;
7 CFR 2.18, 2.53.
Sec. 500.11 Refusal to grant inspection.
(a) Inspection services may be refused to be granted at an
establishment for any of the following reasons:
(1) Failing to develop a HACCP plan as required by Secs. 417.2 and
417.4 of this chapter; or
(2) Failing to develop Sanitation SOP's as required by part 416 of
this chapter; or
(3) Failing to demonstrate that adequate sanitary conditions exist
as required by part 308 or part 381, subpart H, and part 416 of this
chapter; or
(4) Failing to demonstrate that livestock will be handled and
slaughtered humanely.
(b) If FSIS refuses to grant inspection services, the applicant
will be notified and given an opportunity for a hearing in accordance
with the Uniform Rules of Practice, 7 CFR, subtitle A, part 1, subpart
H.
Sec. 500.12 Conditions for the suspension or withdrawal of inspection.
Inspection services may be suspended or withdrawn at an
establishment for any of the following reasons:
(a) Failing to implement HACCP or operate in accordance with part
417 of this chapter; or
(b) Failing to implement or maintain Sanitation SOP's in accordance
with part 416 of this chapter; or
(c) Failing to maintain sanitary conditions in accordance with part
308 or part 381, subpart H, and part 416 of this chapter; or
(d) Failing to collect and analyze samples for Escherichia coli
Biotype I and record results in accordance with Secs. 310.25(a) or
381.94(a) of this chapter; or
(e) Failing to meet the Salmonella performance standard
requirements in accordance with Secs. 310.25(b)(3)(iii) and
381.94(b)(3)(ii) of this chapter; or
(f) Failing to destroy a condemned meat or poultry carcass, or part
or product thereof, in accordance with part 314 or part 381, subpart L,
of this chapter within three days of notification; or
(g) Impairing inspection because of assaults, threats of assault,
intimidation or other interference that prevents a program official
from conducting official duties; or
(h) Slaughtering or handling livestock inhumanely.
Sec. 500.13 Suspension of inspection.
(a) Inspection services may be suspended at an establishment for
any of the conditions described in Sec. 500.12 of this part.
(b) If inspection services are suspended, an establishment will
receive a written ``Notice of Suspension of Inspection.'' The notice
will provide the following:
(1) The effective date of the suspension.
(2) The reasons for the suspension.
(3) The name and address where an appeal may be sent.
(c) A suspension of inspection services will remain in effect until
an establishment is found to be in compliance with the regulations in
this chapter.
Sec. 500.14 Withdrawal of inspection.
(a) A grant of inspection services may be withdrawn at an
establishment that fails to correct any of the conditions described in
Sec. 500.12 of this part.
(b) FSIS will initiate a complaint to withdraw inspection services
in accordance with the Uniform Rules of Practice, 7 CFR, subtitle A,
part 1, subpart H.
Sec. 500.15 Rescinding or refusing approval of marks, labels, and
containers
(a) FSIS will rescind or refuse approval of false or misleading
marks, labels, or sizes or forms of any container for use with any meat
or poultry product under section 7 of the FMIA, or under section 8 of
the PPIA, in accordance with the Uniform Rules of Practice, 7 CFR,
subtitle A, part 1, subpart H.
(b) FSIS will provide written notification that:
(1) Explains the reason for rescinding or refusing the approval,
(2) Provides an opportunity to modify the marking, labeling, or
container so that it will no longer be false or misleading, and
(3) Advises the firm of its opportunity to submit a written
statement to answer the notification and to request a hearing with
respect to the merits or validity of FSIS's determination.
(c) Effective upon service of the notification in accordance with
Sec. 1.147 of the Uniform Rules of Practice (7 CFR 1.147), the use of
the marking, labeling, or container shall cease.
(d) If a hearing is requested, FSIS will initiate a complaint in
accordance with the Uniform Rules of Practice, 7 CFR, subtitle A, part
1, subpart H.
Sec. 500.16 Refusing or withdrawing inspection for applicants or
recipients unfit to engage in business.
If the Administrator has reason to believe that an applicant for
inspection services or recipient of inspection services is unfit to
engage in any business requiring inspection because of any of the
reasons specified in section 401 of the FMIA or section 18(a) of the
PPIA, inspection services will be refused or withdrawn in accordance
with the Uniform Rules of Practice, 7 CFR, subtitle A, part 1, subpart
H.
Done at Washington, DC on: January 5, 1998.
Thomas J. Billy,
Administrator.
[FR Doc. 98-573 Filed 1-9-98; 8:45 am]
BILLING CODE 3410-DM-P