Thursday, March 01, 2007

From: Richard S. Silverman
Joseph A. Levitt
Ryan D. Shadrick Wilson
Date: February 23, 2007
Re: Safe Food Act of 2007
Last week, legislation was introduced in both houses of Congress that would create a
Single Food Agency and dramatically expand the scope of existing food safety laws. Senator
Richard Durbin (D-IL) and Congresswoman Rosa DeLauro (D-CT) introduced companion bills
entitled the “Safe Food Act of 2007.” 1/ If enacted, this legislation would create the Food Safety
Administration and consolidate within this agency all responsibilities regarding food safety,
labeling, inspection, and enforcement currently divided among several federal agencies,
primarily responsibilities of the Food and Drug Administration (FDA) and the Food Safety and
Inspection Service (FSIS). Additionally, the bill would impose more stringent requirements
related to the registration of food establishments, process controls, performance standards,
inspections, imports, mandatory recalls, and recordkeeping, as well as provide for increased
penalties and citizen lawsuits.
Throughout the past decade, both Sen. Durbin and Rep. DeLauro have sought to
consolidate food regulatory efforts in this country, introducing similar legislation at least five
times in the past ten years. Each previous effort garnered little momentum. This year, however,
with the Democratic control of the Congress, and Sen. Durbin as Senate Majority Whip, and Rep.
DeLauro as Chair of the House Agriculture Appropriations Subcommittee, the bill is likely to
garner increased attention and visibility, as evidenced by a Congressional oversight hearing on
this very subject chaired recently by Rep. DeLauro (see summary of hearing below). This
legislative effort will be considered within the broader context of a series of highly publicized
recent outbreaks, including the E. coli outbreaks related to spinach and lettuce and the finding of
Salmonella in peanut butter. Finally, a recent report from the U.S. Government Accountability
1/ S. 654 and H.R. 1148.
Hogan & Hartson LLP
- 2 -
\\\DC - 075177/000300 - 2438973 v1
Office (GAO) designated, for the first time, federal oversight of food safety as a “high-risk” area,
citing “the need to integrate the fragmented federal food safety system.” 2/
The proposed Safe Food Act of 2007 is nearly identical to the proposed Safe Food Act of
2005. Because of the heightened attention likely to be given to this most recent incarnation, we
believe that it is important for the food industry to be aware of some of the Act’s key provisions.
This memorandum is intended to briefly summarize these provisions. This memorandum will
also summarize key points from the recent Congressional hearing on this subject.
The Single Food Agency
The Act would establish within the Executive Branch an agency called the Food Safety
Administration (FSA). The head of this branch would be the Administrator of Food Safety and
would be charged with administering and enforcing all food safety laws, overseeing the
implementation of all federal food safety inspections and enforcement efforts, and coordinating
the federal response to food-borne illness outbreaks. All provisions of existing laws under which
the Food and Drug Administration (FDA), U.S. Department of Agriculture (USDA),
Environmental Protection Agency (EPA), and the Department of Commerce (DOC) currently
regulate food would be transferred to and administered by the FSA. The primary agencies that
would be affected would be: FDA’s Center for Food Safety and Applied Nutrition and Center
for Veterinary Medicine; USDA’s Food Safety and Inspection Service, Agricultural Marketing
Service, and Animal and Plant Health Inspection Service; DOC’s National Marine Fisheries
Service; and, certain divisions with the EPA that control and regulate pesticide residues.
Registration and Category Designations for All Food Establishments
The Act would mandate that any domestic food establishment, or foreign food
establishment engaged in processing food in the United States, register with the Administrator. 3/
Upon receipt and review of registrations, the Administrator would then provide a registration
number for each establishment and designate each establishment as a Category 1, 2, 3, 4, or 5
establishment. Pursuant to the Act, the categories are defined as follows:
• A “Category 1 food establishment” slaughters animals for food.
2/ GAO, “Federal Oversight of Food Safety: High Risk Designation Can Bring Needed
Attention to Fragmented System,” Testimony before the Subcommittee on Agriculture, Rural
Development, FDA, and Related Agencies, Committee on Appropriations, House of
Representatives, Feb. 8, 2007, GAO-07-449T. GAO has been a long-time advocate of a Single
Food Agency, dating back more than a decade.
3/ Pursuant to the Act, the term “food establishment” means “a slaughterhouse, factory
warehouse, or facility” that “processes food or a facility that holds, stores, or transports food of
food ingredients.” The term does not include entities such as farms, restaurants, or other retail
food establishments.
Hogan & Hartson LLP
- 3 -
\\\DC - 075177/000300 - 2438973 v1
• A “Category 2 food establishment” processes raw meat, poultry, or seafood products
regardless of whether the establishment also has a kill step, or animal feed and other
products deemed by the Administrator to be at high risk for contamination and the
process for which does not include a step validated to destroy contaminants.
• A “Category 3 food establishment” processes meat, poultry, seafood products, and
other products that the Administrator determines to be at high risk of contamination
and whose processes include a step validated to destroy contaminants.
• “A Category 4 food establishment” processes all other categories of food products not
covered in the above categories.
• “A Category 5 food establishment” stores, holds, or transports food products prior to
delivery for retail sale (e.g., warehouses).
As explained below, these designations would determine the type and frequency of
inspection faced by the establishment.
Suspension of Registration
The Act would permit the Administrator to suspend the registration of an establishment
for “violation of a food safety law.” No distinction is made among the types of violations that
might trigger suspension, but there is a requirement for notice and an opportunity for a hearing
within three days of the suspension. It would be considered a “prohibited act” for an
establishment to operate without a valid registration.
Preventative Process Controls
Pursuant to the Act, within a year of enactment, the Administrator would be tasked with
promulgating far-reaching regulations aimed at “ensuring that food establishments carry out their
responsibilities” related to food safety. These regulations would accomplish the following:
require all food establishments to adopt preventative process controls, set standards for sanitation,
mandate sampling and testing, and require recordkeeping and records access to monitor
Performance Standards for Contaminants
The Act also would task the Administrator with establishing and enforcing performance
standards with respect to food-borne contaminants. The Act defines “contaminant” broadly to
include “bacterium, chemical, natural or manufactured toxin, virus, parasite, prion, physical
hazard, or other human pathogen that when found on or in food can cause human illness injury or
death.” The Act also would expand the definition of the term “adulterated” to cover food
“bearing or containing a contaminant that causes illness or death among sensitive populations.”
Within six months of enactment, the Administrator would be required to identify the
contaminants and foods that contribute significantly to food-borne illness. Then, it would
Hogan & Hartson LLP
- 4 -
\\\DC - 075177/000300 - 2438973 v1
establish appropriate performance standards to protect against these contaminants. These
standards would set the level of contaminant that can safely be present in food and include zero
tolerances for fecal matter and any other contaminants already subject to zero tolerances. For the
five contaminants that contribute to the greatest number of illnesses and deaths associated with
meat, poultry, and seafood, these performance standards would be expected within three years of
enactment and would be revised at least every three years thereafter. When there is an absence
of data to support a performance standard, regulations would define performance in terms of
“best reasonably achievable performance.” All current performance standards, tolerances, action
levels, and similar standards would remain in effect pending action by the Administrator.
To monitor compliance with performance standards, the Act would mandate a sampling
program with requirements “at least as stringent” as the Hazard Analysis and Critical Control
Point (HACCP) system requirements that already apply to meat and poultry establishments.
Regulations promulgated within a year of enactment would outline the program. If, following a
finding that an establishment fails to meet a performance standard, the establishment fails to take
corrective action, the Act gives the FSA authority to increase inspection frequency, withdraw the
mark of inspection, or detain, seize, or condemn food. As noted below, the Act also gives the
FSA the authority to order a recall.
Inspection Frequency
The Act would increase the frequency of inspections for many food establishments. The
following frequencies are established for each of the five categories defined above:
• Category 1—continuous inspection
• Category 2—random inspections at least daily
• Category 3—random inspections at least monthly and ongoing verification that
processes are controlled
• Category 4—random inspections at least quarterly
• Category 5—random inspections at least annually
Based on calculated risk assessments and “to foster risk-based allocation of resources,” the Act
would allow the Administrator to determine increasing or decreasing frequencies for
subcategories of food establishments or individual establishments. The Act also outlines how the
Administrator should handle the transition to the new inspection system. Before the completion
of the transition process, the Administrator would be required to develop an official mark to be
affixed to products produced in Category 1, 2, and 3 establishments. Pursuant to certain
requirements, Category 4 and 5 establishments would be permitted to voluntarily use the official
Hogan & Hartson LLP
- 5 -
\\\DC - 075177/000300 - 2438973 v1
Recordkeeping and Records Access
The Act would expand both the recordkeeping obligations of establishments and the
federal government’s authority to inspect records. The Administrator would have broad
authority to require that a range of records related to food safety be maintained, including records
describing results of tests and sampling. In addition to those records currently required to be
provided to federal inspectors upon request, the Act would grant broad access to all records
deemed necessary to determine whether food is in compliance with all food safety laws and to
track the food in commerce, excluding any “sensitive information,” such as trade secrets.
Lack of Preemption and Federal/State Cooperation
The Act would require that the Administrator coordinate food safety efforts with the
states and maintain current agreements with the states until they are reviewed. Notably, the Act
has an explicit provision that says: “Nothing in this Act shall be construed to preempt the
enforcement of State food safety laws and standards that are at least as stringent as those under
this Act.” This provision could have a significant impact, opening the door for states to enact
more stringent food safety requirements.
The Act would require that the Administrator routinely inspect “food and food animals”
before entry to the United States. Such inspections would ensure compliance with all food safety
and labeling requirements. The Act would give the Administrator authority to deny entry, detain,
seize, or condemn product.
Within two years of its enactment, the Act would also require that the Administrator
establish a system for certifying foreign governments or foreign establishments seeking to import
food to the United States. At least every five years after a certification, the FSA would conduct
an audit of the importer to ensure continued compliance. And, the Administrator would have
authority to withdraw certification if imported food is linked to an outbreak of a human illness, if
certification requirements are not met, or if there is a refusal to allow U.S. officials to conduct
necessary audits.
Pursuant to the Act, the Administrator must promulgate regulations establishing “a
national system for tracing food and food producing animals from point of origin to retail sale.”
The Act provides little guidance as to how such a system should be developed or implemented,
but it is explicit that a tracing system should not interfere with the implementation of country of
origin labeling requirements included in the 2002 Farm Bill.
Public Health Assessment
The Act would require that the Administrator conduct a detailed public health assessment.
To do this, the Administrator would build upon the resources at the Centers for Disease Control
Hogan & Hartson LLP
- 6 -
\\\DC - 075177/000300 - 2438973 v1
and Prevention and conduct a large sampling program. Following this surveillance and sampling,
the Administrator would be tasked with ranking food categories based on hazards, identifying
appropriate approaches to minimize the hazards, and assessing the public health environment for
emerging diseases.
Enforcement Authority
If enacted, the Act would expand the authority of the federal government to take several
enforcement actions. Most significantly, the Act would grant the FSA mandatory recall
authority, and its inspectors would be permitted to order the administrative detention of food if a
food safety or misbranding concern arises during an inspection.
The Act provides for both civil penalties and criminal sanctions for violations, and it
provides explicit “whistleblower” protection for government or company employees that provide
information concerning violations.
Citizen Civil Actions
Pursuant to the Act, any person may commence a civil action against any person or
establishment that violates a regulation or “other action of the Administrator to ensure the safety
of food.” The Act would mandate that such actions be brought in federal court, and it permits
courts to consider, in addition to actual damages, the award to plaintiffs of court costs and
reasonable attorneys’ fees.
Introduction of the Safe Food Act of 2007 was preceded by a February 8 Congressional
hearing (“Food Safety: Shedding Light on a Broken System”) on the federal framework for
regulating food safety. Chaired by Rep. DeLauro of the House Agriculture Appropriations
Subcommittee, the hearing featured testimony addressing agency resources, jurisdiction,
coordination, and oversight. Several speakers expressed concern that the current system is
ineffective because it is “fragmented” and features a “patchwork” of programs administered
across several regulatory agencies. The following testimony, in particular, may be of interest:
• The U.S. Comptroller General, David M. Walker, reviewed the General
Accountability Office’s (GAO) recent decision to designate federal oversight of food
safety as a “high risk” area. In its 2007 list of high risk programs, GAO called for a
“fundamental reexamination” of the federal food safety system, including
comprehensive reform legislation and an analysis of alternative food safety systems.
• Michael Taylor, a Professor at the University of Maryland School of Medicine, and
former senior official at both FDA and FSIS, supported GAO’s call for
transformation of the food safety system. Expressing concern that “no one is in
charge” of food safety, Mr. Taylor recommended that Congress modernize the
Hogan & Hartson LLP
- 7 -
\\\DC - 075177/000300 - 2438973 v1
relevant laws and provide clear lines of authority, designating one agency and one
official as ultimately responsible for food safety. Mr. Taylor also urged Congress to
provide adequate funding for any statutory changes.
• Carole Tucker Foreman of the Consumer Federation of America criticized USDA’s
claims of continuing improvement in fighting Listeria, citing the fact that the federal
goal of reducing Listeria-related illnesses to 2.5 cases per million by 2005 had not
been met (the illness rate in 2005 was 3 cases per million, down from a baseline of 5
cases per million).
• Mark Dopp of the American Meat Institute commended USDA’s food safety program
and described a downward trend in the incidence of foodborne illnesses. In particular,
Mr. Dopp pointed out that the incidence of E. coli O157:H7 in ground beef products
is down 80% over the past five years.
• Thomas E. Stenzel of the United Fresh Produce Association expressed his view that
FDA currently has adequate statutory authority to set fresh produce standards that
protect public health. He recommended that FDA use that authority to adopt new
food safety requirements for fresh produce. Although Mr. Stenzel believed that FDA
has adequate authority to ensure produce safety, he also stated that he did not
conceptually oppose a single food safety agency.
If enacted, the Safe Food Act of 2007 would result in substantial changes to the food
safety system and would impose significant new requirements on the food industry. It would be
an enormous challenge for the government to implement, given the many new regulations,
development of risk-based categories and inspection frequencies, and establishment of a
certification program for imported food. The bill’s implementation would also require
government resource levels far above current budgets.
The recent Congressional hearing reflects the environment in which this bill will be
considered. Even though this hearing was conducted by the Appropriations Subcommittee, it is
noteworthy that most of the testimony addressed organizational, statutory, and program
effectiveness issues. Additional Congressional interest in food safety should be expected to
continue throughout this legislative session.
* * *
We will monitor the progress of the legislation and keep you apprised of significant
developments. If you should have any questions, please do not hesitate to contact us.

No comments: