[Federal Register: November 29, 1999 (Volume 64, Number 228)]
[Rules and Regulations]
[Page 66541-66547]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr29no99-1]
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Rules and Regulations
Federal Register
________________________________________________________________________
This section of the FEDERAL REGISTER contains regulatory documents
having general applicability and legal effect, most of which are keyed
to and codified in the Code of Federal Regulations, which is published
under 50 titles pursuant to 44 U.S.C. 1510.
The Code of Federal Regulations is sold by the Superintendent of Documents.
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DEPARTMENT OF AGRICULTURE
Food Safety and Inspection Service
9 CFR Parts 304, 305, 327, 335, 381, and 500
[Docket No. 95-025F]
RIN 0583-AC34
Rules of Practice
AGENCY: Food Safety and Inspection Service, USDA.
ACTION: Final rule.
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SUMMARY: The Food Safety and Inspection Service (FSIS) is amending its
rules of practice that apply to Agency enforcement actions. FSIS is
defining each type of enforcement action that it may take, the
conditions under which it is likely to take each of these actions, and
the procedures that it will follow in doing so. This rule is part of
FSIS's ongoing effort to consolidate, streamline, and clarify the meat
and poultry product inspection regulations.
EFFECTIVE DATE: This rule is effective January 25, 2000.
FOR FURTHER INFORMATION CONTACT: Daniel Engeljohn Ph.D., Director,
Regulations Development and Analysis Division, Office of Policy,
Program Development and Evaluation, FSIS, Room 112, Cotton Annex
Building, 300 12th Street, SW, Washington, DC 20250-3700; (202) 720-
5627.
SUPPLEMENTARY INFORMATION:
Background
Under the Federal Meat Inspection Act (FMIA) and the Poultry
Products Inspection Act (PPIA), the Secretary of Agriculture is charged
with the responsibility of protecting the public health by assuring
that meat and poultry products distributed in commerce are wholesome,
not adulterated, and properly marked, labeled, and packaged. To
accomplish this objective, the statutes require the Secretary to
administer a comprehensive inspection program which includes examining
live animals prior to slaughter, inspecting all carcasses to be used
for human food, and inspecting facilities where meat and poultry
products are produced or stored. FSIS has broad authority to issue
regulations to carry out the provisions of the FMIA and PPIA, including
authority to prescribe the terms and conditions under which inspection
will be provided and maintained and pursuant to which the marks of
inspection will be applied.
An establishment's failure to comply with regulatory requirements
can result in the Agency's inability to determine that products are not
adulterated as required by the inspection statutes. Accordingly, FSIS
may find it necessary to take action to prevent the production and
shipment of product until the Agency is assured that there is
compliance with the statutes and their implementing regulations. For
example, FSIS can refuse to grant an application for inspection. It can
take regulatory control actions to retain product, to reject equipment
or facilities, to slow or stop lines, or to refuse to allow the
processing of specifically identified product. The Agency may refuse to
allow the marks of inspection to be applied to products or suspend
inspection by interrupting the assignment of program employees to all
or part of an establishment. FSIS also can withdraw inspection or
rescind or refuse to approve markings, labels, or containers.
FSIS takes these types of actions when an establishment fails to:
(1) develop and implement a HACCP plan or operate in accordance with 9
CFR Part 417; (2) develop, implement, and maintain Sanitation Standard
Operating Procedures (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); (4) comply with the Salmonella performance
standard requirements prescribed in sections 9 CFR 310.25(b) or
381.94(b); (5) maintain sanitary conditions; (6) humanely slaughter
livestock; or (7) destroy condemned product. FSIS also takes these
actions when an applicant for inspection, a recipient of inspection, or
anyone responsibly connected with the applicant or recipient is unfit
to engage in business because of prior criminal convictions, or when
establishment personnel assault, intimidate, or interfere with Federal
inspection service.
When FSIS refuses to grant an application for inspection, seeks to
withdraw inspection, or refuses 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 FSIS's own ``Rules of
Practice,'' which have been set out in 9 CFR part 335 for meat or part
381, subpart W, for poultry and are now replaced by 9 CFR part 500.
FSIS's supplemental rules of practice also provide for the withholding
of the marks of inspection and the suspension of inspection.
When public health is a concern, FSIS immediately suspends
inspection until the problem is corrected. FSIS refuses to mark product
as ``inspected and passed'' or retains an establishment's meat or
poultry products if the Agency determines that meat or poultry products
are adulterated or cannot determine, as required by the statutes, that
those products are not adulterated. Such actions typically are
discontinued when the adulterated products have been destroyed or
properly controlled, or when the deficiencies or noncompliances are
corrected satisfactorily. The current supplemental rules also provide
for an opportunity to address and correct problems before the Agency
files a formal administrative complaint to suspend or withdraw an
establishment's grant of inspection.
On January 12, 1998, FSIS issued a proposed rule (63 FR 1797) to
reorganize and revise its supplemental rules of practice to better
ensure that its enforcement procedures are fair; to eliminate
redundancy; to identify the situations that may lead FSIS to take
enforcement action which may include refusing to grant or withholding
the marks of inspection and suspending or withdrawing inspection; and
to establish the procedures FSIS would follow in taking such actions.
Comments
FSIS received 64 comments in response to the proposed rule.
Although the commenters supported the consolidation and streamlining of
the
[[Page 66542]]
rules of practice, they raised concerns about the actual proposed
revisions to the regulations. The following is a discussion of the
commenters' issues.
1. FSIS Authority
Several commenters asserted that an establishment's failure to meet
the Salmonella performance standards, to carry out and meet generic E.
coli testing requirements, or to prevent a HACCP system failure would
not provide an adequate basis to suspend or seek withdrawal of
inspection. They contend that the FMIA and PPIA authorize FSIS to
remove inspectors only when an establishment fails to follow sanitary
practices, refuses to destroy condemned carcasses, fails to comply with
the Humane Slaughter Act, or is convicted in a criminal proceeding.
FSIS disagrees with this assessment of the Agency's authority.
Under the FMIA and the PPIA, FSIS is charged with the duty and the
responsibility to protect the public health by developing and
implementing an effective, comprehensive, and scientifically valid
inspection system that will ensure that meat and poultry products are
wholesome, not adulterated, and properly marked, labeled, and packaged.
FSIS is required by these statutes to carry out continuous inspection
of slaughter and processing operations at Federal establishments and to
make the affirmative determination that the meat and poultry products
produced at those establishments are wholesome and not adulterated
prior to marking the products as ``inspected and passed.''
FSIS has specified, through regulations, the conditions under which
meat and poultry products must be produced [the HACCP/Pathogen
Reduction regulations]. These regulations are essential, integral
components of the FMIA and PPIA inspection system, and the failure,
inability, or unwillingness of an establishment to comply with these
food safety regulations effectively precludes FSIS from making the
statutorily-mandated determination that meat and poultry products are
wholesome, not adulterated, and entitled to bear the legend ``inspected
and passed.'' The inspection system provided for in the FMIA and PPIA
is a continuous and real-time inspection program that, by its very
nature, requires real-time and continuous inspection determinations. It
is clear that the FMIA and the PPIA contemplate and authorize the
Agency to take prompt and, if necessary, immediate action to carry out
its public health responsibility to ensure that only products that are
marked ``inspected and passed'' are shipped in commerce. It is the
Agency view, therefore, that compliance with FSIS's food safety
regulations, including the HACCP/Pathogen Reduction regulations, is a
necessary predicate for inspection services and for the application of
the marks of inspection under the FMIA and the PPIA, and that FSIS has
inherent authority to withhold the marks, to suspend inspection
services, and to withdraw inspection when these requirements are not
satisfied.
In addition, FSIS is required to prescribe the rules and
regulations for sanitation, with which slaughter and processing
establishments must comply. The term ``sanitation'' is comprehensive
and encompasses the array of procedures, practices, and controls
employed by establishments to ensure that the products they produce are
wholesome and not adulterated. Sanitation obviously includes procedures
for the cleaning of equipment and facilities; proper sanitation also
encompasses practices for ensuring the acceptability of incoming
products and ingredients, proper product handling and preparation
practices, controlling condemned product, and properly storing product.
It is also FSIS's view that the SSOP requirements, the HACCP
regulations, the Salmonella performance standards, and the generic E.
coli testing requirements are material components of an effective
sanitation program that is sufficient to meet the requirements of the
FMIA and PPIA. For example, E. coli testing is prescribed in the HACCP/
Pathogen Reduction regulations to verify that the establishment is
employing sanitary dressing procedures to prevent the fecal
contamination of carcasses. Also, the Salmonella performance standards
were adopted to ensure that an establishment's procedures, practices,
and controls, as embodied in its HACCP plans, are working properly. The
Agency has ample statutory authority to withhold, suspend, or seek
withdrawal, in accord with the facts of any particular case, when the
Agency's sanitation requirements are not satisfied.
2. Due Process: Notice and Opportunity To Achieve Compliance
Commenters also raised concerns that the proposed rules did not
provide adequate due process protections for establishments. The
commenters argued, for example, that the taking of withholding actions
by inspectors, and the resulting interruption of plant operations,
without providing the establishment with notice of the deficiencies and
an opportunity to demonstrate or achieve compliance is unreasonable and
contrary to applicable law. Commenters underscored this point with
particular focus on HACCP regulation noncompliances, contending that
notice and opportunity to establish compliance were essential in such
cases before taking withholding or suspension actions.
Some commenters believed that the proposed rules of practice were
inconsistent with other FSIS regulations and policies related to the
suspension of inspection. They cited, for example, the Quality Control
(QC) regulations and the Progressive Enforcement Action program. Under
these regulations and policies, in situations not involving the
preparation and distribution of adulterated product, establishments
were provided an opportunity to achieve compliance before FSIS
terminated a QC program or imposed progressive sanctions.
FSIS is mindful that withholding the marks of inspection and
suspending inspection services are significant enforcement actions to
be taken only after careful evaluation of the facts and circumstances.
At the same time, as discussed above, it is FSIS's statutory
responsibility and duty to protect public health by maintaining an
inspection system that will ensure that meat and poultry products
produced and shipped in commerce are wholesome and not adulterated.
FSIS agrees that fundamental fairness requires that appropriate due
process be accorded establishments in connection with enforcement
actions under the FMIA and PPIA. FSIS believes that the proposed rules
of practice, as modified and specified in this document will, in fact,
protect the due process rights of all establishments.
As we make clear in this final rule, FSIS will continue to provide
notice and an opportunity to demonstrate or achieve compliance in
situations where the violations and deficiencies disclosed by
inspection or investigation do not, in the Agency's view, present a
public health concern that requires immediate action. Where, however,
noncompliance with the requirements of the acts and regulations
indicates that continued production and shipment of product do pose, in
the Agency's view, an imminent threat to public health, FSIS will take
immediate action. Accordingly, section 500.3 of the rules of practice
sets out the conditions under which FSIS may withhold the marks of
inspection or suspend inspection without prior written notification and
section 500.4 sets out the conditions under which FSIS may withhold the
marks of inspection or suspend
[[Page 66543]]
inspection after providing prior written notification.
Commenters also argued that FSIS's noncompliance records (NRs)
should not be deemed adequate to notify an establishment of the
Agency's determination that there has been a ``system failure.''
It is FSIS's view that NRs do constitute valid and effective notice
to an establishment that the establishment has not maintained
regulatory compliance. An NR informs the establishment of the specific
deficiency involved and on its face invites the establishment to
respond to the finding and to present in writing its immediate and
further planned corrective actions. The NR also specifically notes the
right to appeal the inspector's finding and potential regulatory
consequences of the NR.
When an NR is issued, it is incumbent upon the establishment to
evaluate the NR carefully and to act upon and respond to it promptly
and effectively. In particular, it is important that establishments
address the NRs related to a HACCP plan noncompliance because such NRs
may indicate that the plan is not working properly and should be
reassessed. Accordingly, FSIS believes that should the Agency determine
that it is necessary to withhold the marks of inspection or to suspend
inspection because of multiple or recurring noncompliances, evidenced
by NRs, the establishment will have been given appropriate notice as
well as ample opportunity to demonstrate or achieve compliance.
Nonetheless, in cases where FSIS has determined that multiple or
recurring noncompliances warrant the withholding of the marks of
inspection or suspension of inspection, this final rule provides for
written notification to the establishment before withholding or
suspending inspection when the circumstances do not pose an imminent
threat to public health.
Therefore, in response to the comments, FSIS is revising the
regulatory language used in the proposed rule. This final rule lists
the types of enforcement actions that the Agency may take and
identifies the circumstances under which each action may be taken. This
final rule also clarifies the procedures FSIS will follow to provide,
when appropriate, prior notification to establishments.
Section 500.1 defines a ``regulatory control action,''
``withholding action,'' and ``suspension.'' A regulatory control action
is the retention of product, rejection of equipment or facilities,
slowing or stopping of lines, or refusal to allow the processing of
specifically identified product. A withholding action is the refusal to
allow the marks of inspection to be applied to products. A withholding
action may affect all products in the establishment or product produced
by a particular process. A suspension is an interruption of the
assignment of program employees to all or part of an establishment.
Section 500.2 states that FSIS may take a regulatory control action
because of insanitary conditions or practices, product adulteration or
misbranding, conditions that preclude FSIS from determining that
product is not adulterated or misbranded, or inhumane handling or
slaughtering of livestock. These control actions are necessary, indeed
essential, in-plant enforcement tools for inspectors to use in cases
where the noncompliance is willful or involves public health, interest,
or safety. Typically, regulatory control actions involve specific
amounts of product or generally well-defined deficiencies such as
crushed and open cartons or malfunctioning equipment. If FSIS takes a
regulatory control action, it will immediately notify the establishment
orally or in writing of the action and of the basis for the action. An
establishment may appeal a regulatory control action, as provided in 9
CFR 306.5 and 381.35.
Withholding actions are generally more significant than regulatory
control actions and affect a larger part of an establishment or the
establishment's processes. In most cases, in-plant inspection personnel
take these actions because of systemic problems, such as HACCP plan
inadequacies. Typically, the actions necessary to correct the problem
that resulted in a withholding action are more complex than those
necessary to resolve a problem that resulted in a regulatory control
action and are likely to require an establishment to accomplish a HACCP
plan reassessment and make any necessary plan modification or to revise
its Sanitation SOP.
A suspension of inspection is likely to have an even more
significant impact on an establishment than a withholding action.
Typically, an FSIS District Manager or Agency official at a higher
level suspends inspection after an establishment fails to correct a
situation involving a withholding action, or when the nature of the
noncompliances are such that the corrective action, such as HACCP plan
reassessment or changes in the establishment's operation, may take a
significant amount of time to implement.
Section 500.3 states that FSIS may take a withholding or suspension
action without providing the establishment prior notification because
the establishment produced and shipped adulterated or misbranded
product as defined in 21 U.S.C. 453 or 21 U.S.C. 602; the establishment
does not have a HACCP plan as specified in section 417.2 of the
regulations; the establishment does not have Sanitation SOPs as
specified in sections 416.11-416.12 of the regulations; sanitary
conditions are such that any products in the establishment are or would
be rendered adulterated; an establishment operator, officer, employee,
or agent assaulted, threatened to assault, intimidated, or interfered
with an FSIS employee; the establishment violated the terms of a
regulatory control action; or the establishment did not destroy a
condemned meat or poultry carcass, or part or product thereof, in
accordance with 9 CFR part 314 or part 381, subpart L, within three
days of notification. FSIS also may impose a suspension without
providing the establishment prior notification because the
establishment is handling or slaughtering animals inhumanely.
Section 500.4 states that FSIS may take a withholding action or
impose a suspension after the Agency provides an establishment prior
notification and the opportunity to demonstrate or achieve compliance
because the HACCP system is inadequate, as specified in 9 CFR 417.6,
due to multiple or recurring noncompliances; the Sanitation SOPs have
not been properly implemented or maintained as specified in 9 CFR
416.13-16; the establishment has not maintained sanitary conditions as
prescribed in 9 CFR 416.2-416.8 due to multiple or recurring
noncompliances; the establishment did not collect and analyze samples
for Escherichia coli Biotype I and record results in accordance with 9
CFR 310.25(a) or 381.94(a); or the establishment did not comply with
the Salmonella performance standard requirements prescribed in 9 CFR
310.25(b) or 381.94(b).
Section 500.5 states that if FSIS takes a withholding action or
imposes a suspension without prior written notification, the Agency
will notify the establishment orally and, as promptly as circumstances
permit, in writing. The written notification will provide the effective
date of the action, reasons for the action, products or processes
affected by the action, opportunity for the establishment to present
immediate corrective action and further planned preventive action, and
the appeals procedures. This section also addresses the prior
notification provided for in section 500.4. This prior notification
will state the type of action that may be
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taken; describe the reason for the proposed action; identify the
products or processes affected by the proposed action; advise the
establishment of its right to contact FSIS to contest the basis for the
proposed action or to explain how compliance has been or will be
achieved; and advise the establishment that it will have three business
days from receipt of the written notification to respond to FSIS unless
the time period is extended by FSIS.
The provisions in section 500.5 also reiterate that an
establishment may appeal the withholding action or suspension, as
provided in section 9 CFR 306.5 and 381.35. Also, this section provides
that if FSIS suspends inspection and does not hold the suspension
action in abeyance, the establishment may request a hearing pursuant to
the Uniform Rules of Practice, 7 CFR Subtitle A, part 1, subpart H.
Upon such request, the Administrator will file a complaint that will
include a request for an expedited hearing.
Section 500.6 addresses withdrawal of inspection, and section 500.7
addresses refusal of inspection. These provisions are substantially
unchanged from the January 1998 proposal. When FSIS withdraws or
refuses inspection, 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). Also, FSIS made no significant changes, other than
renumbering the sections, to the provisions that relate to rescinding
or refusing approval of marks, labels, and containers, (section 500.8)
and refusing or withdrawing inspection for applicants or recipients
unfit to engage in business (sections 500.6 and 500.7).
3. Appropriateness of Other Aspects of the Regulations
Some commenters suggested that FSIS should better explain the
Agency's practice of allowing an establishment to operate while under a
suspension if the establishment presents adequate written assurances
that corrective actions are being implemented.
It has been FSIS's experience that some establishments, upon being
notified that the Agency intends to suspend inspection, offer a plan to
address the circumstances that caused FSIS to issue the notification.
In these cases, FSIS has concluded that, even though the basis for a
suspension existed, it was appropriate to hold the suspension in
abeyance and to allow the establishment to continue to operate under
its proposed corrective and preventive actions.
Section 500.5(e) states that FSIS may hold a suspension in abeyance
and allow the establishment to operate under the conditions agreed to
by FSIS and the establishment.
Some commenters suggested that there should be a third-party review
of an establishment's response to the notification of the Agency's
intent to take an enforcement action, and that this third party should
make the decision on whether the enforcement action is warranted.
FSIS concluded that such third-party review is not appropriate
under the meat and poultry inspection statutes. The Agency is required
to make the determination that the statutes and regulations have been
complied with, and that the products produced meet the statutory
requirements. The suggested procedure is clearly inconsistent with the
statutory authority and plan embodied in the FMIA and PPIA and would be
impractical and contrary to the public interest.
A number of commenters raised concerns about FSIS's appeal policy.
Some recommended provisions for alternative dispute resolution instead
of an administrative hearing before an Administrative Law Judge in
cases where there is a scientific dispute. Under the provisions
submitted by the commenters, the Agency would create a standing panel
of expert advisors to be called upon on an as needed basis. The
establishment and the Agency would be permitted to call witnesses and
present relevant evidence, especially scientific evidence, to the
panel. The panel's decision along with any dissenting views would be
written and shared with the establishment and the Agency. The
Administrator, as the ultimate decisionmaker for the government, would
give the panel's decision due consideration. Other commenters suggested
that FSIS establish a special appeals resolution team in the Technical
Service Center to which all appeals from inspection decisions would
automatically be sent. Some commenters urged FSIS to specify how long
it will take to resolve appeals, to allow establishments to continue
operating while an appeal of an FSIS decision to suspend or withdraw
inspection is pending, except in the event of an ``imminent hazard to
health,'' and to reimburse regulated establishments for losses during
``down time'' when they win an appeal from an inspection decision.
As stated in the proposed rule, FSIS is committed to providing
establishments with appropriate notice and an effective opportunity to
appeal withholding actions and suspensions of inspection. It recognizes
the need for timely resolution of all such appeals. The Agency intends
to develop regulations to address how appeals are handled. However,
since there were no proposed regulations on appeals included in the
proposed rules of practice, establishing such rules in this document is
outside the scope of this rulemaking. FSIS plans to issue a proposed
rulemaking related to the appeals process at a later date.
Until new regulations on appeals are in place, appeals will
continue to be heard through the ``chain-of-command'' process, which is
incorporated into FSIS's existing regulations (9 CFR 306.5 and 381.35).
In an attempt to ensure the timely review of appeals, FSIS issued FSIS
Notice 14-98 on April 20, 1998. This notice explains FSIS's policy
regarding the appeal of inspection findings and decisions. It also
established the Inspection Appeals Tracking System (IATS) report which
the Agency uses to help ensure a timely response to appeals.
Some commenters stated that FSIS should not delete the provisions
in section 335.13. In this regulation, FSIS stated that it will notify
an establishment of what actions are necessary to correct an insanitary
condition and of the time within which corrections must be made.
It is an establishment's responsibility to identify problems and to
determine how best to correct them. Section 335.13 appeared by its
terms to place the burden for devising and correcting insanitary
conditions on the Agency. Such regulations are not consistent with the
Pathogen Reduction/HACCP approach. The Agency will identify problems
when an establishment fails to do so, but it is the establishment's
responsibility to identify problems on a continuing basis and to
identify, select, and implement effective action to correct
noncompliances. FSIS will verify that establishments have taken the
necessary corrective actions. Accordingly, FSIS is removing section
335.13.
Commenters also questioned the elimination of section 335.40,
``Present Your Views (PYV)'' provisions, which allow establishments
believed to have violated the FMIA an opportunity to present their
views to the Agency regarding an alleged criminal violation before FSIS
refers the violation to the Department of Justice for prosecution. The
commenters pointed out that the PYV provisions are a statutory
entitlement for poultry processors, and that by rescinding the
regulations, the
[[Page 66545]]
Agency is backing away from equity between meat and poultry.
After consideration of these comments, FSIS has reconsidered its
proposal and will not remove Part 335, Subpart E.
Executive Order 12866 and Regulatory Flexibility Act
This final 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 a determination that this final rule
will 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 final
rule. Costs and benefits are related to the regulatory actions, not the
proceedings. At the present time, there is no way to predict whether
industry ``down time'' will increase or decrease under these revised
rules of practice. To the extent that resolution of disputes in a
timely and efficient manner will be facilitated by these rules, there
are potential benefits to consumers, industry, and the government. When
disputes are related to public health issues, FSIS may reduce health
risks to consumers by stopping an establishment's operations until the
problem has been resolved.
There are also costs to industry associated with actions that
suspend production operations.
Executive Order 12988
This final rule has been reviewed under Executive Order 12988,
Civil Justice Reform. When this 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 final rule does not include any new paperwork requirements.
Additional Public Notification
In an effort to better ensure that minorities, women, and persons
with disabilities are made aware of this final rule, FSIS will announce
it and provide copies of this Federal Register publication in the FSIS
Constituent Update.
FSIS provides a weekly FSIS Constituent Update, which is
communicated via fax to over 300 organizations and individuals. In
addition, the update is available on line through the FSIS web page
located at http://www.fsis.usda.gov. The update is used to provide
information regarding FSIS policies, procedures, regulations, Federal
Register Notices, FSIS public meetings, recalls, and any other types of
information that could affect or would be of interest to our
constituents/stakeholders. The constituent fax list consists of
industry, trade, and farm groups, consumer interest groups, allied
health professionals, scientific professionals and other individuals
that have requested to be included. Through these various channels,
FSIS is able to provide information with a much broader, more diverse
audience. For more information and to be added to the constituent fax
list, fax your request to the Office of Congressional and Public
Affairs, at (202) 720-5704.
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
Rules of practice.
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 continues to read as
follows:
Authority: 21 U.S.C. 601-695; 7 CFR 2.18, 2.53.
2. Part 304 is amended by revising the heading to read as set forth
above, and amending Sec. 304.2 by removing paragraphs (c) and (e),
redesignating paragraph (d) as paragraph (c), and revising the last
sentence of paragraph (b) to read as follows:
* * * * *
Sec. 304.2 Information to be provided.
* * * * *
(b) * * * Any application for inspection 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 continues to read as
follows:
Authority: 21 U.S.C. 601-695; 7 CFR 2.18, 2.53.
Sec. 305.5 [Removed]
4. Part 305 is amended by removing Sec. 305.5.
PART 327--IMPORTED PRODUCTS
5. The authority citation for part 327 continues to read as
follows:
Authority: 21 U.S.C. 601-695; 7 CFR 2.18, 2.53.
6. Section 327.6 is amended by removing the last four sentences in
paragraph (f) and adding in their place 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 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
Secs. 335.1-335.32 (Subparts A--D [Removed]
7. Part 335 Subparts A through D (Secs. 335.1-335.32) are removed.
Subpart E--Criminal Violations is redesignated as Subpart A.
PART 381--POULTRY PRODUCTS INSPECTION REGULATIONS
8. The authority citation for part 381 continues 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 is amended by removing paragraphs (a), (b), and
(c); redesignating paragraph (d) as (b); and adding a new paragraph (a)
to read as follows:
Sec. 381.21 Refusal of inspection.
(a) Any application for inspection in accordance with this part may
be denied or refused in accordance with the rules of practice in part
500 of this chapter.
* * * * *
[[Page 66546]]
Sec. 381.29 [Removed]
10. Part 381 is amended by removing Sec. 381.29.
Secs. 381.230-381.236 (Subparts VI) [Removed]
11. Part 381 is amended by removing Subpart W (Secs. 381.230--
381.236).
SUBCHAPTER E--REGULATORY REQUIREMENTS UNDER THE FEDERAL MEAT INSPECTION
ACT AND THE POULTRY PRODUCTS INSPECTION ACT
12. Subchapter E is amended by adding a new Part 500 to read as
follows:
PART 500--RULES OF PRACTICE
Sec.
500.1 Definitions.
500.2 Regulatory control action.
500.3 Withholding or suspension of inspection without prior
notification.
500.4 Withholding action or suspension of inspection with prior
notification.
500.5 Notification, appeals, and actions held in abeyance.
500.6 Withdrawal of inspection.
500.7 Refusal to grant inspection.
500.8 Procedures for rescinding or refusing approval of marks,
labels, sizes, and containers.
Authority: 21 U.S.C. 451-470, 601-695; 7 U.S.C. 450, 1901-1906;
7 CFR 2.18, 2.53.
Sec. 500.1 Definitions.
(a) A ``regulatory control action'' is the retention of product,
rejection of equipment or facilities, slowing or stopping of lines, or
refusal to allow the processing of specifically identified product.
(b) A ``withholding action'' is the refusal to allow the marks of
inspection to be applied to products. A withholding action may affect
all product in the establishment or product produced by a particular
process.
(c) A ``suspension'' is an interruption in the assignment of
program employees to all or part of an establishment.
Sec. 500.2 Regulatory control action.
(a) FSIS may take a regulatory control action because of:
(1) Insanitary conditions or practices;
(2) Product adulteration or misbranding;
(3) Conditions that preclude FSIS from determining that product is
not adulterated or misbranded; or
(4) Inhumane handling or slaughtering of livestock.
(b) If a regulatory control action is taken, the program employee
will immediately notify the establishment orally or in writing of the
action and the basis for the action.
(c) An establishment may appeal a regulatory control action, as
provided in sections 306.5 and 381.35 of this chapter.
Sec. 500.3 Withholding action or suspension without prior
notification.
(a) FSIS may take a withholding action or impose a suspension
without providing the establishment prior notification because:
(1) The establishment produced and shipped adulterated or
misbranded product as defined in 21 U.S.C. 453 or 21 U.S.C. 602;
(2) The establishment does not have a HACCP plan as specified in
Sec. 417.2 of this chapter;
(3) The establishment does not have Sanitation Standard Operating
Procedures as specified in Secs. 416.11-416.12 of this chapter;
(4) Sanitary conditions are such that products in the establishment
are or would be rendered adulterated;
(5) The establishment violated the terms of a regulatory control
action;
(6) An establishment operator, officer, employee, or agent
assaulted, threatened to assault, intimidated, or interfered with an
FSIS employee; or
(7) The establishment did not 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.
(b) FSIS also may impose a suspension without providing the
establishment prior notification because the establishment is handling
or slaughtering animals inhumanely.
Sec. 500.4 Withholding action or suspension with prior notification.
FSIS may take a withholding action or impose a suspension after an
establishment is provided prior notification and the opportunity to
demonstrate or achieve compliance because:
(a) The HACCP system is inadequate, as specified in Sec. 417.6 of
this chapter, due to multiple or recurring noncompliances;
(b) The Sanitation Standard Operating Procedures have not been
properly implemented or maintained as specified in Secs. 416.13 through
416.16 of this chapter;
(c) The establishment has not maintained sanitary conditions as
prescribed in Sec. Sec. 416.2 through 416.8 of this chapter due to
multiple or recurring noncompliances;
(d) The establishment did not 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;
(e) The establishment did not meet the Salmonella performance
standard requirements prescribed in Secs. 310.25(b) or 381.94(b) of
this chapter.
Sec. 500.5 Notification, appeals, and actions held in abeyance
(a) If FSIS takes a withholding action or imposes a suspension, the
establishment will be notified orally and, as promptly as circumstances
permit, in writing. The written notification will:
(1) State the effective date of the action(s),
(2) Describe the reasons for the action(s),
(3) Identify the products or processes affected by the action(s),
(4) Provide the establishment an opportunity to present immediate
and corrective action and further planned preventive action; and
(5) Advise the establishment that it may appeal the action as
provided in Secs. 306.5 and 381.35 of this chapter.
(b) The prior notification provided for in Sec. 500.4 of this part
will:
(1) State the type of action that FSIS may take;
(2) Describe the reason for the proposed action;
(3) Identify the products or processes affected by the proposed
action;
(4) Advise the establishment of its right to contact FSIS to
contest the basis for the proposed action or to explain how compliance
has been or will be achieved; and
(5) Advise the establishment that it will have three business days
from receipt of the written notification to respond to FSIS unless the
time period is extended by FSIS.
(c) An establishment may appeal the withholding action or
suspension, as provided in Secs. 306.5 and 381.35 of this chapter.
(d) If FSIS suspends inspection and does not hold the suspension
action in abeyance as provided in paragraph (e) of this section, the
establishment may request a hearing pursuant to the Uniform Rules of
Practice, 7 CFR Subtitle A, part 1, subpart H. Upon such request, the
Administrator will file a complaint that will include a request for an
expedited hearing.
(e) FSIS may hold a suspension in abeyance and allow the
establishment to operate under the conditions agreed to by FSIS and the
establishment.
Sec. 500.6 Withdrawal of inspection.
The FSIS Administrator may file a complaint to withdraw a grant of
Federal inspection in accordance with the Uniform Rules of Practice, 7
CFR Subtitle A, part 1, subpart H because:
(a) An establishment produced and shipped adulterated product;
(b) An establishment did not have or maintain a HACCP plan in
accordance with part 417 of this chapter;
[[Page 66547]]
(c) An establishment did not have or maintain Sanitation Standard
Operating Procedures in accordance with part 416 of this chapter;
(d) An establishment did not maintain sanitary conditions;
(e) An establishment did not collect and analyze samples for
Escherichia coli Biotype I and record results as prescribed in
Secs. 310.25(a) or 381.94(a) of this chapter;
(f) An establishment did not comply with the Salmonella performance
standard requirements as prescribed in Secs. 310.25(b) and 381.94(b) of
this chapter;
(g) An establishment did not slaughter or handle livestock
humanely;
(h) An establishment operator, officer, employee, or agent
assaulted, threatened to assault, intimidated, or interfered with an
FSIS program employee; or
(i) A recipient of inspection or anyone responsibly connected to
the recipient is unfit to engage in any business requiring inspection
as specified in section 401 of the FMIA or section 18(a) of the PPIA.
Sec. 500.7 Refusal to grant inspection.
(a) The FSIS Administrator may refuse to grant Federal inspection
because an applicant:
(1) Does not have a HACCP plan as required by part 417 of this
chapter;
(2) Does not have Sanitation Standard Operating Procedures as
required by part 416 of this chapter;
(3) Has not demonstrated that adequate sanitary conditions exist in
the establishment as required by part 308 or part 381, subpart H, and
part 416 of this chapter;
(4) Has not demonstrated that livestock will be handled and
slaughtered humanely; or
(5) Is unfit to engage in any business requiring inspection as
specified in section 401 of the FMIA or section 18(a) of the PPIA.
(b) If the Administrator refuses to grant inspection, the applicant
will be provided the opportunity for a hearing in accordance with the
Uniform Rules of Practice, 7 CFR Subtitle A, part 1, subpart H.
Sec. 500.8 Procedures for rescinding or refusing approval of marks,
labels, and containers.
(a) FSIS may 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.
(b) FSIS will provide written notification that:
(1) Explains the reason for rescinding or refusing the approval;
(2) Provides an opportunity for the establishment to modify the
marking, labeling, or container so that it will no longer be false or
misleading; and
(3) Advises the establishment of its opportunity to submit a
written statement to respond to the notification and to request a
hearing.
(c) If FSIS rescinds or refuses approval of false or misleading
marks, labels, or sizes or forms of any container for use with any meat
or poultry product, an opportunity for a hearing will be provided in
accordance with the Uniform Rules of Practice, 7 CFR Subtitle A, part
1, subpart H.
Done at Washington, DC on: November 17, 1999.
Thomas J. Billy,
Administrator.
[FR Doc. 99-30603 Filed 11-26-99; 8:45 am]
BILLING CODE 3410-DM-P