[Federal Register Volume 65, Number 53 (Friday, March 17, 2000)]
[Proposed Rules]
[Pages 14489-14491]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 00-6641]


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DEPARTMENT OF AGRICULTURE

Food Safety and Inspection Service

9 CFR Parts 318, 319, and 327

[Docket No. 97-012P]


Elimination of Requirements for the Compliance Monitoring System 
for Cured Pork Products

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 meat inspection regulations by removing the regulations that 
prescribe the Agency's compliance monitoring system for cured pork 
products. Removing these regulations will not affect the regulatory 
requirements that industry is responsible for meeting. The proposal 
will remove requirements that specify the frequency with which FSIS 
samples these products and the enforcement actions that the Agency will 
take in response to specific laboratory findings from analysis of 
product samples. FSIS is proposing to remove these prescriptive 
controls on itself because the Agency intends to institute a new 
approach to sampling and testing meat and poultry products to verify 
that the products meet regulatory requirements

[[Page 14490]]

for consumer protections other than food safety (i.e., misbranding and 
economic adulteration). If the Agency takes this action, it will be 
able to reallocate some of its in-plant and laboratory resources to 
give greater emphasis to food safety concerns.

DATES: Comments must be received on or before May 16, 2000.

ADDRESSES: Submit one original and two copies of written comments to 
Docket Clerk, DOCKET #97-012P, U.S. Department of Agriculture, Food 
Safety and Inspection Service, Room 102 Cotton Annex Building, 300 
Twelfth Street, SW., Washington, DC 20250-3700.

FOR FURTHER INFORMATION CONTACT: Daniel Engeljohn, PhD., Director, 
Regulations Development and Analysis Division, Food Safety and 
Inspection Service, Washington, DC 20250-3700, (202) 720-5627.

SUPPLEMENTARY INFORMATION:  

Background

    FSIS' mission is to ensure that meat, poultry, and processed egg 
products are safe, wholesome, and properly marked, labeled, and 
packaged. FSIS has carried out its food safety responsibilities 
primarily by managing an inspection program within meat and poultry 
slaughter and processing establishments. This program has relied 
heavily on FSIS inspection personnel to detect and correct 
establishments' noncompliance.
    FSIS is in the process of reforming its regulatory and 
administrative approach to achieving its mission. The Agency's 
``Pathogen Reduction; Hazard Analysis and Critical Control Point 
(HACCP) Systems'' final rule (61 FR 38806, 7/26/96) announced and 
provided the framework for modernization of FSIS' inspection system, 
particularly with respect to its food safety goals. This rule 
established requirements applicable to all meat and poultry 
establishments that were designed to reduce the occurrence and numbers 
of pathogenic microorganisms on meat and poultry products. As part of 
FSIS' modernization of its food safety strategy, the Agency stresses 
the need to clarify and strengthen the responsibilities of 
establishments in meeting the requirements of FSIS' regulations, plus 
the concomitant responsibility of the Agency to hold establishments 
accountable for meeting those requirements.
    As FSIS shifts its emphasis from telling the regulated industry how 
to comply with regulatory requirements to oversight of industry-
developed HACCP systems and other related process control procedures, 
the Agency must reevaluate its regulatory approach to consumer 
protection issues other than food safety. In an advanced notice of 
proposed rulemaking (ANPR) published elsewhere in this issue of the 
Federal Register, FSIS is presenting its plans for a new approach to 
verifying compliance with these other consumer protection requirements. 
FSIS is referring to these verification activities as its other 
consumer protection (OCP) activities. Among these activities are the 
Agency's efforts to ensure that products that are subject to food 
standards comply with those standards.
    Cured pork products, such as hams, shoulders, picnics, and butts, 
must comply with food standards that specify a minimum percentage of 
meat protein after all fat has been removed from the product. These 
food standards are referred to as ``minimum meat Protein Fat Free (PFF) 
percentage requirements'' or simply as ``PFF requirements.'' The PFF 
requirements that establishments must meet are codified at 9 CFR 
319.104 and 319.105. In 9 CFR 318.19 and 327.23, FSIS has established a 
monitoring system that details the sampling frequencies and enforcement 
procedures FSIS uses to ensure that domestic and imported cured 
products meet the PFF requirements.
    FSIS' compliance procedures for cured pork products are not 
consistent with the Agency's planned approach to economic sampling. The 
Agency plans to consider economic risk factors, such as an 
establishment's compliance history, and apparent consumer protection 
needs in determining which products to sample and test. The PFF system 
generates from 6,000 to 7,000 samples annually and thus represents an 
impediment to efficient and effective resource allocation. This number 
of samples did not stand out in the mid-l980's when FSIS was analyzing 
approximately 100,000 food chemistry samples annually. Today, with 
overall food chemistry samples in the 15,000 to 25,000 range, the 
Agency cannot afford to devote such a large portion of its overall food 
chemistry activity to one issue.
    The existing compliance procedures for cured pork products have 
contributed to confusion concerning the respective roles and 
responsibilities of FSIS and industry. Industry has responsibility for 
complying with regulatory requirements. FSIS has responsibility for 
verifying compliance with regulatory requirements and taking 
enforcement actions when it finds noncompliance. The ANPR makes clear 
that this basic division of responsibilities applies to other consumer 
protection activities in the same way that it applies to food safety. 
However, when FSIS established the PFF compliance monitoring system, 
the Agency's approach was to assume responsibility for ensuring 
compliance. The system has thus effectively been a government run 
quality control system. The regulations implementing the system go so 
far as to provide an exemption for establishments that take 
responsibility and institute their own quality control procedures. The 
centrally directed PFF sampling system has been applied to only those 
establishments that have not implemented their own control systems.
    The compliance procedures for cured pork products are an anomaly 
within the regulatory framework for enforcing food standards. FSIS is 
responsible for verifying compliance with 60 different food standards. 
The PFF requirements for cured pork products is the only standard of 
identity or composition where regulations direct FSIS sampling 
frequencies in response to specific laboratory findings. For other 
products, e.g., cooked sausage, FSIS directives state that Agency 
sampling frequencies are to be based on cumulative laboratory results. 
In still other cases, such as enforcement of the 30 percent fat limit 
for ground beef, there are no written instructions concerning Agency 
responses to findings that product exceeds the limit.
    Because the compliance procedures for cured pork products in 
Secs. 318.19 and 327.23 are not consistent with the Agency's planned 
approach to economic sampling, require too great an expenditure of 
Agency resources, and are not consistent with what the Agency considers 
to be the appropriate division of responsibilities between itself and 
industry, FSIS is proposing to remove these compliance procedures from 
its regulations. However, as noted above, eliminating the PFF 
compliance monitoring system would not affect the PFF content 
performance standards that establishments are required to meet.

Executive Order 12988

    This proposed rule has been reviewed under Executive Order 12988, 
Civil Justice Reform. When the rule is adopted (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 proceeding would not be required before parties may 
file suit in court challenging this rule.

[[Page 14491]]

Executive Order 12866 and Regulatory Flexibility Act

    This proposed rule has been reviewed under Executive Order 12866. 
The Administrator has determined that this proposed rule would not have 
a significant economic impact on a substantial number of small 
entities. However, this proposed rule is part of FSIS' new approach to 
OCP as discussed in the ANPR published elsewhere in this issue of the 
Federal Register. Because the Office of Management and Budget 
designated the OCP ANPR as significant, FSIS submitted this rule to OMB 
for review.
    Establishments producing cured pork products must comply with the 
food standards that specify a minimum percentage of meat protein after 
all fat has been removed from the product (9 CFR 319.104 and 319.105). 
This proposed rule only removes the requirements that specify the 
frequency at which FSIS samples such products.
    This regulatory action would enable FSIS to better allocate its 
resources to address matters involving food safety. Because some 
establishments depend on FSIS' testing as a substitute for their own 
quality control responsibilities, such establishments may bear higher 
costs. Conversely, FSIS' new approach to economic sampling will focus 
enforcement actions on establishments that violate the requirements of 
the regulations. Sample collection will be less random and arbitrary. 
Therefore, some sample collection activities would be reduced in some 
establishments.

Additional Public Notification

    FSIS has considered the potential civil rights impact of this 
public meeting on minorities, women, and persons with disabilities. 
FSIS anticipates that this proposed rule will not have a negative or 
disportionate impact on minorities, women, or persons with 
disabilities. Proposed rules generally are designed to provide 
information and receive public comments on substantive issues that may 
lead to new or revised agency regulations or instructions. Public 
involvement in all segments of rulemaking and policy development is 
important. Consequently, in an effort to better ensure that minorities, 
women, and persons with disabilities are made aware of this proposed 
rule and are informed about the mechanism for providing their comments, 
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.

Paperwork Requirements

    There are no paperwork or recordkeeping requirements associated 
with this proposed rule.

List of Subjects

9 CFR Part 318

    Compliance.

9 CFR Part 319

    Standards.

    For the reasons set forth in the preamble, FSIS proposes to amend 9 
CFR Parts 318, 319, and 327, as follows:

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

    1. The authority citation for Part 318 would continue to read as 
follows:

    Authority: 7 U.S.C. 138f; 7 U.S.C. 450, 1901-1906; 21 U.S.C. 
601-695; 7 CFR 2.18, 2.53

PART 318--[REMOVED]

    2. Part 318 would be amended by removing section 318.19.

PART 319--DEFINITIONS AND STANDARDS OF IDENTITY AND STANDARDS OF 
IDENTITY OR COMPOSITION

    3. The authority citation for Part 319 would continue to read as 
follows:

    Authority: 7 U.S.C. 450, 1901-1906; 21 U.S.C. 601-695; 7 CFR 
2.18, 2.53


Sec. 319.104  [Amended]

    4. Section 319.104 would be amended by revising footnote 1 of 
paragraph (a), by removing the phrase at the end of the sentence, ``and 
compliance shall be determined under Sec. 318.19 of this subchapter for 
domestic cured pork products and Sec. 327.23 of this subchapter for 
imported pork product.'', by removing paragraph (c), and by 
redesignating paragraph (d) as paragraph (c).


Sec. 319.105  [Amended]

    5. Section 319.105 would be amended by revising footnote 1 of 
paragraph (a), by removing the phrase at the end of the sentence, ``and 
compliance shall be determined under section 318.19 of this 
subchapter.'', by removing paragraph (c), and by re-designating 
paragraph (d) as paragraph (c).

PART 327--IMPORTED PRODUCTS

    6. 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


Sec. 327.23  [Removed]

    7. Part 327 would be amended by removing section 327.23.

    Done at Washington, D.C. on: March 13, 2000.
Thomas J. Billy,
Administrator.
[FR Doc. 00-6641 Filed 3-16-00; 8:45 am]
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