[Federal Register Volume 61, Number 89 (Tuesday, May 7, 1996)]
[Notices]
[Pages 20509-20513]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 96-11456]
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DEPARTMENT OF AGRICULTURE
Food Safety and Inspection Service
[Docket No. 96-012N]
Interstate Shipment of State-inspected Meat and Poultry Products
AGENCY: Food Safety and Inspection Service, USDA.
ACTION: Notice; request for public comments.
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SUMMARY: The 1996 Farm Bill requires the Secretary of Agriculture to
submit to Congress, by July 3, 1996, recommendations concerning the
steps necessary to achieve interstate shipment of State-inspected meat
and poultry products. Under the Federal Meat Inspection Act (FMIA) and
the Poultry Products Inspection Act (PPIA), products inspected under
State programs ``at least equal to'' the Federal inspection program may
be distributed only within State boundaries. FSIS is requesting comment
from the public on which issues need to be addressed in responding to
the Congressional directive to make recommendations concerning the
interstate shipment of State-inspected products. Possible issues
include, but are not limited to: the safety, wholesomeness, and
labeling of State-inspected products; recall responsibilities; the
administration of State programs; the funding of Federal oversight of
State inspection programs; the funding of Federal assistance to State
inspection programs; jurisdictional complications; eligibility of such
products for export; and economic effects. The Agency plans to use
these comments in formulating its recommendations to Congress
concerning State-inspected meat and poultry products.
DATES: Comments must be received on or before June 6, 1996.
ADDRESSES: Please send an original and two copies of written comments
to Policy, Evaluation and Planning Staff, Attn: FSIS Docket Clerk,
DOCKET No. 96-012N, Room 4352 South Building, Food Safety and
Inspection Service, U.S. Department of Agriculture, Washington, DC
20250.
FOR FURTHER INFORMATION CONTACT: Mr. Patrick Clerkin, Office of the
Administrator, Food Safety and Inspection Service, U.S. Department of
Agriculture, Washington, DC 20250; Code (202) 205-0700.
SUPPLEMENTARY INFORMATION:
1996 Farm Bill Provision
Section 918(b) of the Federal Agriculture Improvement and Reform
Act of 1996 (PL 104-127; known as the 1996 Farm Bill), which was signed
into law April 4, 1996, requires that, not later than 90 days after
enactment of the Farm Bill, or by July 3, 1996, the Secretary of
Agriculture submit a report to Congress concerning the steps necessary
to achieve interstate shipment of meat and poultry products inspected
under State programs that are ``at least equal to'' the Federal
inspection programs. Under the current Federal meat and poultry
inspection laws, such products may be distributed solely within the
States in which they are prepared.
Background
Under the Federal Meat Inspection Act (FMIA; 21 U.S.C. 601 et seq.)
and the Poultry Products Inspection Act (PPIA; 21 U.S.C. 451 et seq.),
FSIS is responsible for ensuring that meat, meat food, and poultry
products distributed in interstate and foreign commerce are safe,
wholesome, not adulterated, and properly marked, labeled, and packaged.
FSIS currently conducts antemortem and postmortem inspection of
livestock and poultry at slaughtering establishments, inspects further-
processed meat and poultry products, inspects the sanitary conditions
of facilities where meat and poultry products are produced, and
certifies U.S. products for export to foreign countries. FSIS
investigates violations of the inspection laws and violative products
are controlled through detentions, civil seizures and voluntary
recalls.
FSIS inspection is supported by laboratory services in the fields
of chemistry, microbiology, serology, and pathology. An important
laboratory-supported function is the National Residue Program, which is
designed to help prevent the distribution in commerce of products
containing illegal concentrations of drugs, pesticides, and other
chemicals. FSIS also carries out microbiological surveys to determine
pathogen levels in raw meat and poultry and special microbiological
studies and surveillance of raw and processed products. An example of
this is the testing of raw ground beef for the presence of E. coli
O157:H7.
FSIS operates a compliance program aimed at ensuring that meat and
poultry products in commerce are not adulterated or misbranded. Through
this program, the Agency exercises regulatory authority over businesses
that transport, store, or distribute meat and poultry products in
interstate commerce after those products leave federally inspected
establishments. The Agency also registers meat or poultry brokers,
renderers, manufacturers, or wholesalers, or others dealing in meat or
poultry products that are not intended for human consumption.
FSIS also maintains a comprehensive import inspection system. That
system involves two major activities, the first being oversight to
ensure that exporting countries have in place appropriate controls over
their meat and poultry inspection systems. Such countries (1) must
undergo a rigorous review process before they can become eligible to
export meat and poultry to the United States and (2) must receive
periodic reviews by FSIS to maintain such eligibility. Only plants
operating under FSIS approved national inspection programs may qualify
to export meat and poultry products into the United States. Meat and
poultry products inspected under regional or provincial (i.e., state)
inspection programs in foreign countries are not eligible for export to
the United States.
The second part of our import control program is reinspection at
the port of entry, on a sample basis, of meat and poultry products as
they enter the United States. Reinspection is a check to make sure that
the foreign country's inspection system is working. Seventy-four import
inspection personnel carry out import reinspection at approximately 160
official import establishments.
The program for determining the eligibility of a foreign country to
export to the United States is based on a systems approach. FSIS
focuses on a country's overall inspection system as a means of ensuring
consumer protection. For instance, the Agency examines whether the
country has the legal authority to impose requirements equivalent to
those of the United States in areas such as sanitation and antemortem
and postmortem inspection. We examine the organizational structure and
staffing of its inspection program. We also conduct on-site reviews of
the country's inspection operations to evaluate the effectiveness of
all aspects of the country's program.
Once a country becomes eligible, FSIS conducts on-site reviews of
its inspection system--usually one or more times a year. The frequency
of the reviews is determined by a country's performance history,
including previous plant reviews as well as product reinspection at
United States ports-of-entry. If a country does not continue to operate
an inspection system that
[[Page 20510]]
complies with all FSIS requirements, it is removed from the list of
countries eligible to export to the United States.
FSIS port-of-entry inspection is a further check on the
effectiveness of the foreign country's inspection system. It should be
emphasized that reinspection is carried out on products that have
already passed the foreign country's inspection and been certified as
meeting all U.S. requirements by the exporting country.
USDA import inspectors, using an automated system, examine each lot
of product for general condition, proper labeling, and proper
certification that the products comply with all U.S. regulatory
requirements. In addition, based on a plant's history of compliance
with inspection requirements, the nature of the product, and the size
of the shipment, the automated system generates an inspection plan for
each shipment that may identify additional inspection tasks. The system
applies a statistical sampling plan to each lot of product presented
for reinspection. Selected reinspection tasks could include detailed
product examination; net weight verification; container condition
review; product label examination; species testing; and laboratory
analyses for food chemistry, residues, and microbial contamination. In
addition, import inspectors can take additional samples whenever they
suspect a problem. Daily reinspection results from all ports-of-entry
are entered and stored in the system, continuously updating the
compliance histories for every foreign establishment exporting to the
United States.
The FMIA (at 7 U.S.C. 661) and the PPIA (at 7 U.S.C. 454) authorize
the Secretary of Agriculture to cooperate with the States in their
development and administration of meat and poultry inspection programs
that impose requirements for mandatory antemortem and postmortem
inspection and establishment sanitation, and requirements governing the
preparation of further-processed products, that are ``at least equal
to'' the corresponding Federal requirements. Products produced for
human food and inspected under ``equal-to'' State programs are limited
by Federal law to intrastate distribution. The Acts further authorize
the Secretary to cooperate with the States in administering compliance
programs under authorities that are ``at least equal to'' those
provided by Title II of the FMIA (21 U.S.C. 641-645) or Section 11 of
the PPIA (21 U.S.C. 460).
FSIS has signed State-Federal cooperative agreements with States
that have chosen to operate their own inspection programs; with
separate agreements on compliance-related matters. Under these
agreements, FSIS provides advice and technical assistance to the States
and funds up to 50 percent of the cost of operating the State programs.
Technical assistance activities include providing routine training of
State inspection personnel at the FSIS training center, providing
special training when new inspection systems are introduced, and
helping State laboratories with problems requiring specialized
expertise. Federal and State compliance personnel are trained together
at the Federal Law Enforcement Training Center.
If, for any reason, a State fails to develop or maintain and
enforce effective inspection requirements that are ``at least equal
to'' those of the Federal program, USDA is required to designate the
State for Federal inspection. In designated States, all establishments
wishing to engage in commercial activities requiring inspection must
apply to, and be approved by, FSIS for Federal inspection. Designation
may also be applied to individual establishments, the meat portion of a
State program, the poultry portion, or the entire program.
The FMIA and PPIA provisions for ``equal-to'' State inspection
programs were introduced by the 1967 Wholesome Meat Act (WMA) and the
1968 Wholesome Poultry Products Act (WPPA), which provided numerous
amendments to the Meat Inspection Act of 1906 and the Poultry Products
Inspection Act of 1957. The amendments relating to State programs were
prompted mainly by concern over the potential for distribution to the
consumer of unwholesome or adulterated meat and poultry products
because of the absence of mandatory inspection for products produced
and sold within States and localities. The original inspection laws had
provided for mandatory Federal inspection of products in interstate
commerce but not of products distributed solely within a State. At the
time the WMA and WPPA were passed, up to 25 percent of meat food
products and 13 percent of poultry products were produced without
Federal inspection coverage and, if inspected at all, were subject to
widely varying State and local standards.
The WMA and WPPA extended inspection coverage to thousands of
establishments that had not been previously subject to Federal
standards or ``equal-to'' State standards. Many of the establishments
affected were smaller facilities, some located in remote areas, which
produced small quantities of meat, meat food, or poultry products. In
presenting the WMA to the Senate, the Senate Committee on Agriculture
and Forestry (Senate Report No. 799, Nov. 21, 1967) expressed the view
that some of the Federal standards for plant construction were
unrealistic for some small facilities, and encouraged USDA to consider
basing the eligibility of an establishment for inspection on a combined
evaluation of the operating procedures used by the establishment and
the building construction and physical facilities rather than upon a
separate evaluation of these factors. If the operating procedures were
patterned so as to ensure the sanitary handling of products within the
establishment and result in wholesome food, the establishment could be
declared eligible for Federal inspection. However, the Senate report
emphasized that State requirements concerning wholesomeness, additives,
labeling, and other regulations were not to be compromised and had to
be at least equal to Federal standards. The WPPA accommodated small
establishments by authorizing USDA to exempt from inspection
establishments handling 20,000 or fewer birds per year to be
distributed solely within a State and by providing other exemptions.
Growth and Development of the State-Federal Cooperative Inspection
Program
Following the enactment of the WMA and the WPPA, many States opted
for designation rather than fund the necessary improvements to meet the
``equal-to'' provisions of the Acts. From 1971 to 1981, 23 States and
four Territories were designated, primarily because of an inability to
fund the programs. Four States chose to designate the poultry
inspection branches of their programs, but retained the meat inspection
branches. USDA monitored and reviewed the remaining 27 meat or meat and
poultry inspection programs, and issued annual certifications that the
programs were meeting the ``equal-to'' requirements, as provided in the
Acts. At present, 26 States have active programs, 24 covering both meat
and poultry inspection and 2 covering meat only.
During the 1970's and 1980's, the Federal approach to oversight of
State programs changed. Initially, FSIS provided training and guidance
to assist the States in applying the national standards. Once the
various State programs were able to demonstrate their ability to
administer and maintain ``equal-to'' programs without Federal guidance,
FSIS changed its oversight approach to one of monitoring and
verification.
[[Page 20511]]
In exercising its oversight function, FSIS conducts a system review
of each State's program. A system review involves a combined evaluation
of the State's requirements, operations, and enforcement of its meat
and poultry inspection laws. Each State maintaining an inspection
program must keep on file with USDA an up-to-date State Performance
Plan (SPP) 1. The SPP, which is required by an FSIS directive and
not by regulation, documents the existence of State laws, regulations,
funding, workforce, laboratories, and other resources necessary for the
State to operate an ``equal-to'' program. The SPP also describes
operations and enforcement and how the State's program works in the
particular environment of the State to ensure the integrity of meat and
poultry products intended for intrastate sale, transportation, and use.
The head of each State program must certify annually, in writing, that
the program meets ``equal-to'' requirements.
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\1\ Members of the public who are interested in reviewing a
State's SPP may contact Dr. Robert Fetzner, Director, Federal-State
Relations Staff, at (202) 720-6313, to arrange an appointment.
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Teams of subject matter experts from FSIS conduct comprehensive
reviews of each State program every three-to-five years to verify
adherence to SPP's. These reviews include random sampling of in-plant
records and conditions. On a continuing basis, FSIS field officials
work directly with State officials providing advice and assistance.
When information from Federal officials in the field or from other
sources leads FSIS to suspect deficiencies in State programs, FSIS
conducts special reviews.
FSIS also exercises oversight of State compliance programs covering
intrastate commerce in meat and poultry products intended for human
food or other purposes to ensure that these programs are ``at least
equal to'' the Federal compliance program. FSIS verifies that the laws
and regulations covering compliance-related matters provide the State
with authorities ``at least equal to'' those provided FSIS under the
FMIA and PPIA. FSIS also ensures that State agencies have resources
adequate to carry out effective compliance programs, including
qualified personnel and adequate funding. State compliance programs
must be effective in controlling products that are suspected of being
adulterated or misbranded; in enforcing recordkeeping requirements and
providing for necessary access to establishment facilities, records,
and inventory; and in ensuring proper registration of meat or poultry
brokers, renderers, manufacturers, wholesalers, or others dealing in
meat or poultry products not intended for human consumption.
In addition, FSIS reviews State procedures for reporting violations
of State meat and poultry inspection laws, initiating civil or criminal
proceedings, documenting breakdowns in the State inspection system, and
ensuring that the requirements for products not to be used for human
food are observed.
External Reviews of FSIS Oversight of State Programs
The efficacy of FSIS reviews of State ``equal-to'' status has been
questioned periodically by external reviewers. In 1983, the General
Accounting Office (GAO) audited USDA's State oversight procedures to
determine whether FSIS certification of State ``equal-to'' status
conformed to the authorizing legislation. At the time, FSIS was basing
its certification on a quarterly review and rating of individual State-
inspected establishments. GAO reported that USDA's procedures were
reasonable, but that the certification process lacked uniformity across
regions.2 GAO also noted that FSIS's internal reviews did not
include regular assessments of State program oversight.
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\2\ A copy of the GAO report is on file in the FSIS Docket Room,
Room 4352 South Agriculture Building, Washington DC 20250.
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In response to the GAO Report, FSIS adopted a systems approach to
reviewing and evaluating State inspection programs. This change
resulted in the SPP requirement and the comprehensive reviews described
above. FSIS chose this approach because it provided for long-range
improvement, allowed States to assume more responsibility for program
controls, broadened the scope of Federal oversight, and reduced Federal
costs.
In January 1994, the Department's Office of Inspector General (OIG)
reported, among other findings, that the Agency's comprehensive reviews
did not address State program weaknesses in a number of areas,
including establishment sanitation, inspection scheduling, and
procedures for obtaining and handling laboratory samples.3 OIG
also questioned the consistency of FSIS reviews from region to region
and the adequacy of follow-ups to verify that State corrective action
plans resulting from FSIS comprehensive reviews were carried out. FSIS
has taken some steps to address the deficiencies noted in the OIG
report and continues to work on improvements.
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\3\ A copy of the OIG report is on file in the FSIS Docket Room,
Room 4352 South Agriculture Building, Washington, DC 20250.
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The Interstate Shipment Issue
As stated above, the FMIA and PPIA, as amended by the WMA and the
WPPA, permit State-inspected products to be shipped only in intrastate
commerce. The Acts would have to be amended before State-inspected
products could be distributed in interstate commerce.
In 1968, when Congress was deliberating on the WPPA, the issue of
interstate shipment of State poultry products was debated at length.
Congress rejected the proposal at that time. One reason was that
allowing interstate shipment of State inspected poultry but not of red
meat would create an unacceptable disparity between the red meat and
poultry inspection programs. Congress left open the possibility of
future consideration of the interstate shipment issue after State meat
and poultry inspection programs had been firmly established. Congress
has considered amending the Acts to allow the interstate shipment of
State-inspected products on a number of occasions since that time.
Issues to be Addressed
FSIS is requesting comments to be used in preparing its report to
Congress on the interstate shipment issue as required by the 1996 Farm
Bill. FSIS is, regrettably, setting a short time limit for submitting
comments on this issue. However, the Farm Bill has set a 90-day
timeframe within which the Agency must submit its recommendations to
Congress.
In the view of FSIS, reporting on ``the steps necessary to achieve
interstate shipment'' of State-inspected meat and poultry products,
means, in part, addressing any issues arising from the States'
Performance Plans. Concerning these issues, commenters should identify
the factors that might weigh for or against permitting State-inspected
products into interstate commerce and what steps would be necessary to
address those factors. Commenters should specify whether such factors
are generic to all establishment types or specific to slaughter
establishments or to processing establishments. Some specific aspects
of the current SPP's that may warrant focus include:
Food safety
Laboratory services and sampling
Facility and equipment requirements
Labeling
Recall procedures
[[Page 20512]]
Food Safety Issues: Current Inspection System
What additional steps, if any, should be taken to provide
full assurance to the Nation's consumers that State-inspected products
produced under the current system of inspection meet the same standards
of food safety and wholesomeness as Federal or foreign-inspected
products?
What modifications to the SPP's would be necessary to
provide for the monitoring of each State's product in interstate
commerce and for feedback to the State program?
Laboratory Services
What improvements, if any, need to be made in State
laboratory standards, sampling programs, or performance?
Establishment facility and equipment requirements
What issues relating to establishments' facilities,
equipment, and sanitation need to be considered, and how?
Marking and Labeling; Product Identification
How should State-inspected product be identified in
commerce? Should special marking or labeling requirements be imposed?
What effect would permitting interstate shipment of State-
inspected product have on the consumer's ability to determine whether a
product or its ingredients had been inspected and would consumer
confidence in the safety and quality of meat and poultry products be in
any way affected?
Recall Procedures
Which agency or agencies should exercise jurisdiction in
cases involving the recall of a State-inspected product that may have
been distributed to several other States?
Could confusion over jurisdiction arise that could impede
timely action to prevent the consumption of unsafe, adulterated
products?
In addition to the issues arising from the SPP's, FSIS welcomes
comments on other issues that could have a bearing on interstate
shipment of State-inspected products. These issues include State
implementation of HACCP-based inspection, interstate relations
(including the refusal of one State to accept the products of another
State), acceptance of product inspected under equivalent systems, the
export of State-inspected product, economic effects, and the
availability of resources for Federal assistance and oversight.
Administration of State Programs; HACCP
Commenters are invited to consider what additional challenges might
arise with the adoption and implementation of ``Pathogen Reduction;
HACCP'' regulations proposed by the Agency.
Should interstate shipment of State-inspected products be
authorized prior to the States' implementation of the HACCP and
pathogen reduction regulations?
Should interstate shipment of State-inspected products be
authorized prior to FSIS's evaluation of States' operations under these
adopted regulations?
Is implementation of HACCP by the States a factor that
should even be considered?
Interstate Relations
What potential exists for States with conflicting
standards to bring actions in Federal courts against firms located in
other States or against the States in which such firms are located?
If interstate shipment of State-inspected meat and
poultry products is allowed, should there be some provision for all
consumers in the States and Territories to participate in the
rulemaking proceedings in any one of the States concerning such
products?
Should a State be able to refuse acceptance of another
State's products? If so, under what conditions? What avenues of
recourse are available to the State whose products are refused? What
should be the FSIS role in such matters?
Acceptance of Product Inspected Under Equivalent Systems
Meat and poultry products prepared under foreign inspection systems
that are equivalent to the Federal inspection system are allowed in
interstate commerce. Foreign products that are shipped to the United
States have been inspected and passed by a national inspection program
that meets standards equivalent to those of this country's Federal
program. These programs are subject to regular systems reviews by FSIS
officials and, in addition, products imported to this country are
subject to FSIS reinspection at points of entry before they are shipped
in interstate commerce. Reinspection is a performance-based system;
foreign establishments with better compliance histories have their
products reinspected less frequently.
Should the FSIS reinspection system for imported products
be considered to provide the same level of assurance to the public that
foreign-inspected products receive?
If State-inspected products are allowed in interstate
commerce without reinspection, should any other measures be considered?
What resources would be necessary to carry out this
inspection and from what source or sources should they be obtained?
Export of State-inspected Product
Should State-inspected product be considered eligible for
export? Why or why not? Under what conditions should export of State-
inspected product be permitted?
How would technical problems and trade issues be
addressed? By whom would these problems and issues be addressed?
How would costs be addressed?
How would permitting the interstate shipment of State-
inspected product affect the acceptability to foreign countries and
importers of U.S.-export products generally?
What agency or agencies would be responsible for
certifying exports?
Economic Effects
The number of meat and poultry establishments under State
inspection has been declining steadily in recent years. For example, in
1986, 3,707 meat or poultry establishments were operating under State
inspection in 27 States, but by 1994 there were 2,904 such
establishments in the same number of States.
Permitting interstate sale and distribution of State-inspected
products could eliminate the incentives for holding a Federal grant of
inspection rather than a State grant. This change could affect the
economies of the Federal and State programs if it resulted in
significant shifts of establishments between the Federal and State
systems.
Should the ability of an establishment to choose between
Federal and State inspection be restricted in any way? Why?
Would States be induced to compete with one another by
marketing their inspection programs so as to influence company
decisions on where to locate new or relocate existing meat and poultry
establishments? If so, what would be the consequences for the States,
for workers, for consumers?
What would be the implications or consequences of
allowing sales of State-inspected product to Federal establishments for
further processing? Would this affect decisions by domestic or foreign
buyers?
What effect should permitting the interstate shipment of
State-inspected product have on establishments where Federal inspection
is performed by State
[[Page 20513]]
employees under Federal-State cooperative agreements, pursuant to the
Talmadge-Aiken Act (7 U.S.C. 450)?
Availability of Resources for Federal Oversight of and Assistance to
State Programs
A perennial question to be addressed is the availability of
resources for appropriate Federal oversight of State programs to ensure
that they are ``at least equal to'' the Federal program. The resource
question is sometimes highlighted when the Agency's oversight of State
programs undergoes external evaluation by GAO or OIG, as discussed
above. Nevertheless, the ability of the Agency to meet the need for
oversight of State programs will continue to be challenged by a
scarcity of resources. This challenge is likely to be far greater than
it is at present if State-inspected products are permitted to be
shipped in interstate commerce, for the volume and geographical
distribution of State-inspected products could be greater than they are
now, and the handling of the products more complicated.
What is the best way to ensure the continued provision of
resources necessary for Federal oversight of State programs?
What would be the effect on State resources of allowing
interstate shipment of State-inspected product, especially if large
numbers of establishments switch from Federal to State inspection?
In addition, how should the financing of State programs
be accomplished? Should USDA continue to pay up to half the cost of
operating a State program?
If a wider market were opened to State-inspected
products, would sales volumes rise and would State economies be better
able to support a larger share of program operations?
The foregoing list of issues is not intended to be inclusive; FSIS
recognizes that commenters may suggest other issues and provide
comments regarding them. FSIS welcomes comments on other issues related
to interstate shipment of meat and poultry from State-inspected
establishments.
Done, at Washington, D.C., on: May 3, 1996.
Michael R. Taylor,
Acting Under Secretary for Food Safety.
[FR Doc. 96-11456 Filed 5-3-96; 1:40 pm]
BILLING CODE 3510-12-M