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FSIS Docket Clerk
Docket #98-066N
Room 102 Cotton Annex Building
300 12th Street, SW
Washington, DC 20250-3700
Re: Comments on In-Distribution Pilot Test Project Report (Docket
No. 98-066N)
Dear Sir or Madam:
The Food Marketing Institute (FMI) appreciates the opportunity
to submit the following comments in response to the Federal
Register notice issued by the Food Safety and Inspection Service
(FSIS) of the U.S. Department of Agriculture (USDA) announcing
the availability of the document entitled, "Report on the
In-Distribution Inspection Pilot Test Project" (hereinafter
In-Distribution Report). 64 Fed. Reg. 3678 (Jan. 25, 1999). FMI
is strongly opposed to the In-Distribution Project and urges FSIS
to abandon it.
FMI is a non-profit association that conducts programs in research,
education, industry relations and public affairs on behalf of
its 1,500 members and their subsidiaries. Our membership includes
food retailers and wholesalers, as well as their customers, in
the United States and around the world. FMI's domestic member
companies operate approximately 21,000 retail food stores with
a combined annual sales volume of $220 billion, which accounts
for more than half of all grocery store sales in the United States.
FMI's retail membership is composed of large multi-store chains,
small regional firms, and independent supermarkets. Our international
membership includes 200 members from 60 countries.
The In-Distribution Report reflects USDA's recommendation for
the disposition of the inspection resources that are realized
as a result of the shift to a Hazard Analysis Critical Control
Point (HACCP) program in meat and poultry processing plants. However,
we respectfully submit that the Agency's decision to allocate
these resources in the manner described oversteps the Agency's
statutory authority and unnecessarily duplicates existing state
and local inspection programs. Moreover, increasing the retail
testing programs in scope and frequency will not enhance food
safety. We recommend that USDA allocate the inspection resource
savings realized from the shift to a HACCP program to areas in
the food safety system found by an independent governmental body,
such as the General Accounting Office, to need improvement, e.g.,
the safety of imported foods. Our comments on the proposal and
our recommendations with respect to the reallocation of resources
are explained more fully below.
The Federal Meat Inspection Act (FMIA) and the Poultry Products
Inspection Act (PPIA) generally authorize USDA to inspect facilities
engaging in the production of meat and meat food products and
poultry and poultry products. 21 U.S.C. §§ 451, et
seq.; 21 U.S.C. §§ 601, et seq. However,
retail stores and restaurants that conduct meat and poultry processing
operations of the type that are "traditionally and usually
conducted at retail stores and restaurants" are exempt from
USDA's inspection jurisdiction. 21 U.S.C. § 661(c)(2).
Among the activities that USDA intends for in-plant inspectors
who have been moved to the distribution chain to perform, the
In-Distribution Report vaguely describes an activity entitled
"Reviews of Food-Related Businesses and Allied Industries."
The entire description the Agency provides of this activity follows:
In the United States there are hundreds of thousands of food-related
businesses, such as warehouses, transportation companies, distributors,
retail stores, restaurants and caterers. A small percentage of
these food-related businesses and a small percentage of businesses
that handle animal byproducts, such as renderers, are reviewed
each year. These reviews of food-related businesses and allied
industries have been identified as inspection tasks to be performed
by ID inspectors. A greater number of reviews will be performed
when FSIS has ID inspectors available to perform this function.
In-Distribution Report at 5. The description provided by the report
does not impart adequate information regarding the scope of the
"reviews" or the activities that would be conducted
for us to provide meaningful comment on this aspect of the proposal.
Nor does it provide sufficient notice to the regulated community.
However, regardless of the Agency's intention, USDA is clearly
prohibited by the FMIA and PPIA from instituting an overall inspection
program of retail stores that are engaged in meat and poultry
processing activities of the type traditionally and usually conducted
at retail stores.
The current system employs an efficient "division of labor"
to ensure the safety of the food supply. In general, federal inspectors
execute their responsibility for ensuring the safety of meat and
poultry products by performing the majority of their inspection
duties in processing plants. Concurrent state and local inspection
programs, which are based on the Food and Drug Administration's
(FDA's) model Food Code, provide comprehensive regulation of retailers
(including restaurants and supermarkets) and the full range of
food products that retailers supply to consumers, including meat
and poultry. As FSIS Administrator Thomas J. Billy notes in the
introduction to the Food Code, "It is also important in this
era of shrinking government resources for government agencies
to work together to ensure efficient as well as effective
regulatory oversight of food safety." FDA, Food Code (1997)
(emphasis added). Duplication of state and local inspection activities
wastes limited resources.
Along these lines, Secretary of Agriculture Dan Glickman was recently
quoted as follows:
…[W]e at USDA are in daily collaboration with state, local
and federal agencies…
One thing I've learned from the breadth of questions I field is
that people don't care if it's USDA or FDA, they don't care if it's a federal meat inspector or a state public health inspector; they just want their government to do its job and do it well.
Food Regulation Weekly at 11-12 (March 1, 1999).
This sentiment was echoed by Janice Oliver, FDA's Deputy Director
for Systems & Support, at a briefing on January 29, 1999.
In particular, Ms. Oliver stated that federal regulators are working
with the states to develop an integrated food safety system (FINE)
to "stop duplication" and because inspectors "…don't
need to be tripping all over each other." At the same meeting,
FDA's Lou Carson said that FDA and USDA are committed to developing
a "more efficient and effective food safety system, in accordance
with the Food Safety Initiative."
The In-Distribution Inspection Pilot Test Project is contrary
to the opinions expressed by Secretary Glickman and the goals
of FINE, and it raises serious questions about FSIS's commitment
to a more efficient and less duplicative regulatory system.
Moreover, FSIS has not presented any evidence to suggest that
increased inspection oversight is needed in the distribution chain.1
We understand that the ostensible purpose of the proposed program
is to focus inspections to make food safer and, thereby, reduce
illnesses.2 However, before inspections can be focused to improve
food safety, FSIS must determine the areas in which a need for
inspection oversight exists. Under the aegis of the current state
and local inspection systems, foodborne illnesses traced to retail
stores represent a small fraction of such cases. For example,
New York state officials concluded that foodborne illnesses attributable
to retail establishments account for well below two percent (2%)
of all such illnesses.3 Thus, the proportion of foodborne illnesses
allocable to the retail sector does not justify the substantial
increase of federal inspection resources that FSIS proposes.
Testing food at retail is analogous to the maxim, "Closing
the barn door after the horse is gone." That is, under the
existing retail testing program, inspectors enter retail stores
to purchase food products that are then tested for the presence
of microbial contamination. Definitive results of microbiological
tests take several days to obtain. By that time, the food that
had been on the shelf with the test product has usually been sold
to and ingested by the consumer. Thus, testing food that is being
sold to consumers does not prevent foodborne illness and does
not protect consumers.
In this regard, the federal retail testing program currently in
place to determine E. coli O157:H7 adulteration in ground
meat has not proven effective in enhancing food safety. Specifically,
as of January, 1999, more than 26,000 samples of ground beef had
been collected. Of the nearly 16,000 samples that were collected
from retail facilities, only 7 positive results were found. No
positive results have been connected to an outbreak or illness.
Rather than testing food products that are being sold to consumers
in stores, FSIS should expend its resources to ensure that the
federal mark placed on meat and poultry products under the Federal
Meat Inspection Act and the Poultry Products Inspection Act is
not applied to contaminated or misbranded products before they
leave the federal plant, thereby providing the highest level of
assurance that the food that enters retail stores is free from
microbial contamination.
As part of the In-Distribution Pilot Test Project, FSIS intends
to determine whether some of the adulteration and misbranding
inspections that are currently conducted at processing plants
can be performed in the distribution chain, instead. The Agency
notes that many meat and poultry products are prepared by regulated
establishments in consumer-ready packages and suggests that samples
of these products might be collected in the marketplace rather
than at processing plants. As an example, FSIS states that samples
of pre-packaged ham might be taken at retail to determine
"adherence to accurate labeling and restricted ingredient
requirements." 62 Fed. Reg. 31553, 31561 (June 10, 1997).
This proposal defies logic.
"Economic adulteration," such as excessive moisture
in meat or poultry products, or "misbranding" for failure
to identify all additives in a product are problems that can only
be rectified by the processor. Retailers cannot cause or correct
economic adulteration or misbranding of pre-packaged food. Accordingly,
testing at retail does not serve any function except to eliminate
an activity that is efficiently (and properly) conducted in processing
plants.
Moreover, since the results of retail testing aimed at economic
adulteration and misbranding will primarily be obtained only after
consumers have purchased the products despite any economic or
labeling defects, the harm will occur before it will be found
or remedied if inspectors wait to look for it until the food is
already for sale to consumers at the store. In some cases, costly
investigative and traceback procedures will be required, which
would not have been necessary if the problem had been ameliorated
at the plant. Restitution to consumers for harm caused by economic
adulteration or misbranding would then necessitate product recall
or reimbursement procedures: both extremely costly, labor-intensive
actions that would profoundly diminish consumer confidence in
the food supply and erode consumer confidence in the efficacy
of the regulatory bodies that are charged with its protection.
FMI strongly opposes an inspection program that would lead to
these unnecessary and counterproductive actions. Meaningful remediation
of economic adulteration or misbranding problems can only occur
at the establishment level by testing products before they are
shipped to retail stores.
According to an April, 1998 Government Accounting Office (GAO)
report, current efforts of the federal government to ensure the
safety of imported foods are inconsistent and unreliable. (GAO/RCED-98-103,
April 30, 1998). A subsequent GAO report specifically recommends
redirecting some of the resources FSIS currently appropriates
to carcass-by-carcass slaughter inspections to "food safety
activities that better reduce the threat of foodborne illness,"
such as improving FDA's oversight of imported foods by assisting
foreign countries in developing equivalent food safety systems
or improving oversight of imported foods at ports of entry. "Food
Safety: Opportunities to Redirect Federal Resources and Funds
Can Enhance Effectiveness" at 8 (GAO/RCED-92-224, August
1998).
However, despite the clear recommendation of the GAO, the In-Distribution
Report proposes to allocate these valuable resources to an area
that is already fully regulated and that has not been determined
to need any further federal oversight. In accordance with the
federal government's own assessment of the appropriate means for
improving food safety, we recommend that resources conserved from
the shift to HACCP programs in federally inspected meat and poultry
plants be used to fortify an area that has been identified as
needing improvement, such as improving oversight of imported foods.
FSIS states that the Agency intends to augment "reviews"
of food-related businesses and to expand the testing program to
include "other microbes, undeclared species, preservatives,
binders, and extenders." In-Distribution Report at 6. Retail
supermarkets outside the selected areas will not be subject to
this level of federal regulation. Accordingly, retailers who will
be encompassed by the new program will be placed at an unfair
competitive disadvantage.
The potential ramifications for the retail supermarkets that will
be subjected to the pilot project without consultation or consent
are significant and have not been adequately explained or addressed
by the Agency. For example, no apparent thought has been extended
to the disposition or meaning of the results of the additional
testing that will be performed under the pilot program; that is,
will the results be released to the public? Will testing under
the pilot program trigger fines or other penalties assessed against
the retailers in the study to which non-participating retailers
would not be subject?
The justifications and goals stated for the program are variously
described throughout the draft document, and include helping "the
Agency demonstrate the feasibility of significantly increasing
the frequency of certain tasks that are now performed outside
of federally inspected plants." In-Distribution Report at
4 (emphasis added). However, before addressing whether it is feasible,
or possible, to increase the performance of certain tasks, we
submit that the Agency should first determine the intrinsic value
of doing these tasks.
Moreover, although ostensibly a pilot project, FSIS baldly states
that "eventually, ID inspection in the test locations will
evolve into a permanent system nationwide." In-Distribution
Report at 13. This statement reveals that the Agency has reached
its ultimate conclusion before the value of the destination has
been established by the very pilot program that is purported to
do so. In that case, no pilot project is necessary and the Agency
should use the appropriate notice and comment rulemaking procedures,
including the statutory safeguards available for small businesses
under the Regulatory Flexibility Act as amended by the Small Business
Regulatory Enforcement Fairness Act. 5 U.S.C. § 601, et
seq. Given the substantial impact on small businesses that
the In-Distribution Project will have, the Agency must certainly
use the proper rulemaking procedures together with the full panoply
of protections for small businesses before adopting the In-Distribution
Project on a national basis.
Finally, the activities identified in the draft project for the
In-Distribution inspection personnel to conduct appear to have
been selected based on the activities inspectors have been trained
to conduct in plants, rather than based upon a fresh assessment
of activities that might improve food safety in the distribution
channels. Indeed, FSIS states that the models should "result
from an assessment of all in-plant regulatory work to determine
whether some tasks can be performed effectively and efficiently
in-distribution and, where more appropriate, supplement some in-plant
regulatory work with in-distribution oversight." 62 Fed.
Reg. at 31559. FSIS appears to be trying to move inspectors and
inspection activities out to the distribution channels simply
to accomplish a reduction of inspectors in the plants without
an adequate analysis of the appropriate mechanisms for improving
food safety. See, e.g., discussion of economic adulteration
supra.
We appreciate the opportunity to provide you with our comments
on this matter of great interest to our members, and we look forward
to working with you. If we may provide you with any further information
regarding our recommendations, please do not hesitate to let us
know.
Sincerely,
Tim Hammonds
President and CEO
1 See Motor Vehicle Manufacturers Ass’n v. State Farm Mutual Automobile Insurance Co., 463 U.S. 29 (1983) (agency must examine relevant data and articulate satisfactory explanation for its action, including a rational connection between facts found and choice made); Burlington Truck Lines v. U.S., 371 U.S. 156 (1962) (agency findings must be supported by substantial evidence).
2 See, e.g., 62 Fed. Reg. 31553, 31557 (June 10, 1997) (inspections should be performed to "improve food safety through a reduction in foodborne illness caused by pathogenic bacteria on meat and poultry products").
3Of the 1,895 reported cases of confirmed or suspected foodborne disease, only 13 (or 0.7%) had been confirmed to have arisen from retail food stores; an additional 11 cases of foodborne contamination weresuspected to have arisen at retail food stores. Table IV, "Confirmed, Suspected & Unknown Etiology of Foodborne Disease Outbreaks Cumulative: 01/01/80 through 12/31/95," as reported in New York State Department of Health, A Summary of Foodborne Disease Outbreaks in New York State (date unknown).