og96031.txt

Office of the General Counsel
B-272531.1
July 29, 1996
The Honorable Richard G. Lugar Chairman The Honorable Patrick J.
Leahy Ranking Minority Member Committee on Agriculture, Nutrition,
and Forestry United States Senate
The Honorable Pat Roberts Chairman The Honorable E (Kika) de la
Garza Ranking Minority Member Committee on Agriculture House of
Representatives
Subject: Pathogen Reduction: Hazard Analysis and Critical
Control Point (HACCP) Systems
Pursuant to section 801(a)(2)(A) of title 5, United States Code,
this is our report on a major rule promulgated by Department of
Agriculture, Food Safety and Inspection Service, entitled "Pathogen
Reduction: Hazard Analysis and Critical Control Point (HACCP)
Systems" (RIN: 0583-AB69). We received the rule on July 10, 1996.
It was published in the Federal Register as a final rule on July
25, 1996. 61 Fed. Reg. 38805.
The rule establishes requirements applicable to meat and poultry
establishments designed to reduce the occurrence and numbers of
pathogenic microorganisms on meat and poultry products, reduce the
incidence of foodborne illness associated with the consumption of
those products and provide a new framework for modernization of the
current system of meat and poultry inspection.
Enclosed is our assessment of the Food Safety and Inspection
Service's compliance with the procedural steps required by sections
801(a)(1)(B)(i) through (iv) of title 5 with respect to the rule.
Our review indicates that the Food Safety and Inspection Service
complied with the applicable requirements.
GAO/OGC-96-31
If you have any questions about this report, please contact
James W. Vickers, Senior Attorney, at [phone]. The official
responsible for GAO evaluation work relating to the Department of
Agriculture, Food Safety and Inspection Service is Robert A.
Robinson, Director of Food and Agriculture Issues. Our Office has
issued Food Safety and Quality-Uniform, Risk-based Inspection
System Needed to Ensure Safe Food Supply (GAO/RCED-92-152) and Food
Safety-Risk-based Inspections and Microbial Monitoring Needed for
Meat and Poultry (GAO/RCED-94-110) concerning the subject of this
rule. Mr. Robinson can be reached at [phone].
Robert P. Murphy General Counsel
Enclosure
cc: Michael R. Taylor Administrator Food Safety and Inspection
Service
Page 2 GAO/OGC-96-31
ENCLOSURE
ANALYSIS UNDER 5 U.S.C. § 801(a)(1)(B)(i)-(iv) OF A MAJOR RULE
ISSUED BY THE DEPARTMENT OF AGRICULTURE, FOOD SAFETY AND INSPECTION
SERVICE ENTITLED "PATHOGEN REDUCTION: HAZARD ANALYSIS AND CRITICAL
CONTROL POINT (HACCP) SYSTEMS" (RIN: 0583-AB69)
(i) Cost-benefit analysis
The Food Safety and Inspection Service (FSIS) prepared a
cost-benefit analysis which concludes that the costs associated
with the rule are far outweighed by the public health benefits to
be derived.
The analysis concludes that the 20-year industry costs are
estimated to be $969 to $1,156 million and the 20-year cost to the
government to be $56.5 million. The analysis considers data for
average wages, the cost of specific processing equipment and the
cost of conducting specific laboratory analyses.
The potential health benefits resulting from the elimination of
the four pathogens is estimated to be $7.13 to $26.59 billion over
20 years. The range of benefits occurs because of the current
uncertainty in the estimates of the number of cases of foodborne
illness and death attributable to the pathogens that enter the meat
and poultry supply at the manufacturing stage.
(ii) Agency actions relevant to the Regulatory Flexibility Act,
5 U.S.C. §§ 603-605, 607 and 609
The Administrator of FSIS has concluded that the rule will have
a significant economic impact on a substantial number of small
entities and an initial regulatory flexibility analysis and final
regulatory flexibility analysis has been prepared and included in
the notice of proposed rulemaking and the final rule notice,
respectively, as required by sections 603 and 604. The analyses
comply with the informational requirements of the sections
including the classes of small entities subject to the requirement
and alternatives considered to reduce to the burden on the small
entities.
The final regulatory flexibility analysis discusses the comments
received from both the industry and the Office of Advocacy, Small
Business Administration and the changes made to the proposed rule
to grant regulatory relief to the small entities including the
sequencing of implementation by establishment size.
GAO/OGC-96-31
The analyses use both quantifiable and general descriptions of
the effects of the rule on small entities as required by section
607 and small entities, in addition to the actions required by 5
U.S.C. § 553, participated in the numerous meetings, forums and
conferences held in connection with the preparation of the final
rule as required by section 609.
(iii) Agency actions relevant to sections 202-205 of the
Unfunded Mandates Reform Act of 1995, 2 U.S.C. §§ 1532-1535
Based on the cost-benefit analysis performed by FSIS, the rule
will impose an unfunded mandate on the private sector of $99.6 to
$119.8 million annually and therefore the rule is subject to the
requirements of the Act.
As required by section 205, FSIS considered several regulatory
alternatives to the imposition of the mandatory HACCP but
determined that the requirements expressed in the final rule
constituted the most cost-effective and least burdensome
alternative that would meet the objective of the rule.
To fulfill the requirements of section 204 regarding providing
an opportunity for input from State, local and tribal governments,
a "Federal-State-Relations Conference" was held and the numerous
comments received from these entities were considered and are
discussed in the preamble and the final Regulatory Impact
Analysis.
Finally, FSIS considered the comments of several state
government officials that the rule imposed an unfunded mandate on
State inspection programs because of the need for these programs to
remain "at least equal to" the Federal inspection program. FSIS
concluded that because of the necessary restructuring and
reprogramming of the State inspection programs, FSIS assistance and
the flexibility provided under the "equal to" provisions, most
states should be able to complete the modifications to their
programs with minimal additional cost. Moreover, any additional
costs would be eligible to receive up to 50 percent Federal
matching funds.
(iv) Other relevant information or requirements under Acts and
Executive orders
Administrative Procedure Act, 5 U.S.C. §§ 551 et seq.
The rule was promulgated using the notice and comment procedures
of 5 U.S.C. § 553. A notice of proposed rulemaking was published on
February 3, 1995. 60 Fed. Reg. 6774. The initial comment period of
120 days was extended for an additional 30 days and later reopened
for an additional 95 days. Also, FSIS held seven informational
briefings, three scientific and technical conferences, a 2-day
Page 2 GAO/OGC-96-31
public hearing, a scoping session, six issue-focused public
meetings, a Federal-State conference, and a Food Safety Forum. In
addition to the information gained through these meetings and
conferences, 6,800 comments were received in response to the
Federal Register notice.
The preamble to the final rule contains an extensive discussion
of the comments received and the changes to the proposed rule which
were made was a result.
Paperwork Reduction Act, 44 U.S.C. §§ 3501-3520
The rule requires establishments to document their compliance
with the Hazard Analysis and Critical Control Points (HACCP)
Systems, first in the development of a plan and thereafter in a
continuous record of process performance. The information
collection requirements were discussed in the preamble to the
proposed rule making published on February 3, 1995. (60 Fed. Reg.
6832). At the same time, public comments to both FSIS and the
Office of Management and Budget were requested.
In the preamble to the final rule, FSIS notes that the Office of
Management and Budget has approved its information collection
requirements system under OMB No. 0583-0103 with an annual burden
of 14,371,901 hours. However, in view of comments received and a
reevaluation of the requirements by agency subject matter experts
and private consultants, FSIS has reduced the annual burden to
8,053,319 hours, a 6,318,582-hour reduction. This reduction was
obtained through more accurate burden estimates and the elimination
of certain requirements including time and temperature reports and
personnel resumes of establishment employees.
FSIS has submitted these changes in the information collection
requirements to OMB for its approval and certified to OMB that the
information collection complied with each of the objectives
identified in 44 U.S.C. § 3506(c)(3).
Statutory authorization for the rule
This rule is promulgated under the authorities of 21 U.S.C. §§
451-470 (Poultry Products Inspection Act), 21 U.S.C. §§ 601-695
(Federal Meat Inspection Act) and 7
U.S.C. §§ 1901-1906 (Humane Methods of Slaughter Act of
1978).
Executive Order No. 12866
The rule has been determined to be economically significant
under Executive Order No. 12866 requiring review by the Office of
Information and Regulatory Affairs, OMB. Both the proposed rule and
the final rule were reviewed and approved as complying with the
requirements of the Order based on the information supplied by
FSIS, including the initial and final Regulatory Impact
Analyses.
Page 3 GAO/OGC-96-31
Executive Order No. 12988
According to the preamble, the final rule was reviewed pursuant
to Executive Order No. 12778, Civil Justice Reform. However, that
Executive Order has been replaced by Executive Order 12988, Civil
Justice Reform, effective May 5, 1996. The prior Executive Order
contained a similar requirement now found at Section 3(b)(2)(A) of
the newly effective Order requiring that the preemptive effect of
the rule be specified. FSIS states that under the Poultry Products
Inspection Act (PPIA) and the Federal Meat Inspection Act (FMIA),
cited above, state and local jurisdictions are preempted from
imposing any requirements with respect to federally inspected
premises and facilities that are in addition to, or different from,
those imposed under PPIA or FMIA.
FSIS did not identify any other statute or executive order
imposing procedural requirements relevant to the rule.
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