Mr. Chairman,
Thank you for the opportunity to participate in today's hearing on
"Protecting the U.S. Consumer from Food Borne Illnesses." My name is Dr .
Michael Friedman. I am the Deputy Commissioner for Operations at the Food and
Drug Administration (FDA). With me today are Dr. Stephen Sundlof, Director,
Center for Veterinary Medicine and Dr. Fred Shank, Director, Center for Food
Safety and Applied Nutrition.
As you are aware, the United States food supply is one of the safest, most
abundant, and most affordable in the world. This has been accomplished through
a program that relies on science, cooperative efforts with government agencies
at all levels, increased cooperation with our international counterparts, as
well as interaction with academia, industry, and consumers. FDA is committed to
ensuring safety, and working to protect the American consumer from unsafe,
adulterated, or misbranded food. The agency strives to improve its existing
monitoring programs, research, product approval processes, and enforcement
efforts. To these ends, we welcome your ongoing interest in this subject. My
discussion of food safety will center on foodborne pathogens in food derived
from animals, which you have indicated is the focus of this hearing. I plan to
describe what FDA is doing to protect the food supply from these pathogens; the
roles of FDA's Center for Veterinary Medicine (CVM) and Center for Food Safety
and Applied Nutrition (CFSAN) in developing policies to control foodborne
pathogens; and how we work collaboratively with our federal and state
counterparts to protect the public health by safeguarding the food supply.
FOOD SAFETY
Virtually all food available to the U.S. public is wholesome and unlikely to
cause illness to the consumer. However, as with most things, health risks do
exist. Foodborne illness originates from a variety of sources. -Pathogenic
organisms, such as viruses, bacteria, and parasites, represent the most widely
recognized causative agents and are the focus of my remarks as you have
requested in your letter of invitation. Other foodborne risks such as naturally
occurring toxicants, animal drug residues, pesticides, and environmental
contaminants also have the potential, individually or in combination, to be the
cause of illness. Moreover, food production practices, processing, storage,
distribution, handling and home preparation techniques either individually or in
combination have the potential to increase the risk of microbiological or
chemical caused illness. However, risks caused by chemical contaminants and
food production practices are not the focus of my remarks for today's hearing.
Foodborne illness is not a new form of disease, nor is it one- dimensional.
Foodborne illnesses have been with us as long as man has walked the earth. In
the United States, foodborne microbial illness is a major cause of personal
distress, preventable death, and avoidable financial loss. Several studies
conducted over the past 10 years have indicated that an estimated 6.5 million to
81 million people become ill from pathogens in food every year, resulting in an
estimated 9,000 deaths.
It is worth noting that the majority of the illnesses that occur are mild
and of short duration and frequently are not even diagnosed. However, a small
fraction can produce immediate, acute effects, sometimes involving many people
in a single episode, with reactions ranging from gastrointestinal upset to
death. There is also the potential for chronic, or long term risks, but these
are not as clearly quantifiable.
Examples of some foodborne pathogens originating in animals include
Salmonella spp., i.e., Salmonella enteritidis, Campylobacter jejuni, and
Escherichia coli 0157:H7.
Salmonella spp. are bacteria that cause gastrointestinal disease (nausea,
vomiting, abdominal pain, diarrhea, fever, and headache), that is sometimes
fatal. The illness has been associated with consumption of many different
foods, including raw meats, poultry, eggs, milk and dairy products, fish,
shrimp, frog legs, yeast, coconut, sauces and salad dressings, cake mixes,
cream-filled desserts and topping, dried gelatin, peanut butter, cocoa,
chocolate, and melons. The infectious dose may be very small. Infections with
Salmonella may be followed by chronic arthritis symptoms three to four weeks
after onset of acute symptoms. Salmonella enteritidis bacteria cause
gastrointestinal disease (abdominal pain, nausea, diarrhea, vomiting, and fever)
which has often been associated with consumption of undercooked or raw eggs. As
with other Salmonella spp., the infectious dose may be very small, and infection
may be followed by enteric fever, septicemia, or chronic arthritis symptoms.
Campylobacter jejuni bacteria cause campylobacteriosis, a gastroenteritis
(watery diarrhea, malaise, fever, abdominal pain) associated with consumption of
foods of animal origin, especially poultry and raw milk. A chronic symptom
which may follow infection includes Guillain-Barr6 syndrome.
Escherichia coli 0157:H7 is a verotoxin-forming bacterium that causes
hemorrhagic colitis and may, in the very young and the elderly, cause the
sometimes fatal hemolytic uremic syndrome. Hemolytic uremic syndrome is
characterized by renal failure. The infectious dose may be very low.
Undercooked or raw ground beef, salami, mayonnaise-based salad dressings, raw
milk, yogurt, and apple cider have been implicated in outbreaks and sporadic
cases.
As you can see from the list above, the most likely animalderived foods
which present risks of food-borne disease are meat, poultry, milk, seafood and
eggs. Food derived from animals can be exposed to these pathogens on the farm,
at slaughter, or through mishandling anywhere from the farm to the table.
REGULATING FOOD SAFFTY
FDA is responsible for regulating the safety of a great many foods,
including eggs, seafood, and dairy products. The U.S. Department of
Agriculture (USDA) has the primary authority for regulating meat and poultry.
FDA also is responsible for the safety of animal feeds. A significant part of
FDA's responsibility is to keep both human foods and animal feeds free of
microorganisms such as fungi or bacteria, and their toxins (mycotoxins and
bacterial toxins), illegal residues of drugs, pesticides, and environmental
contaminants that are harmful to public health. our agency carries out these
responsibilities in cooperation or partnership with other federal or state
organizations by: working with the animal health industry to ensure that safe
and effective drugs are available to treat animal diseases, particularly those
that may impact human health; conducting and facilitating research in the area
of food safety; inspecting firms; sampling and analyzing products to determine
if the producers of these goods have complied with the provisions of the FDC
Act; taking appropriate enforcement actions when the agency finds that firms are
not complying with the law; and providing guidance, training, and technical
assistance. But, the law places the burden of ensuring that animal drugs are
used safely and appropriately and that contaminants are controlled as much as
possible in the production of food through observance of good manufacturing
practice (GMP), on food manufacturers, producers, and distributors.
FDA's food safety programs have evolved over many years to become both broad
reaching and highly specialized. This evolution occurred due to a number of
factors that, together, make the regulation of food an unusually complex
undertaking.
Our program has three fundamental safety objectives: (1) targeting our
efforts toward controlling known "acute,, type pathogens (e.g., salmonella),
through the use of safe and effective animal drugs and feed additives to treat
infected animals, and other prevention programs; (2) monitoring the food supply
in coordination with other agencies in order to prevent the consumption of
unsafe food and to gather information on the known or emerging pathogens (i.e.
transmissible spongiform encephalopathies); and (3) learning more about
potential long term problems and taking steps to lower long term risk.
I would now like to describe some things that we are doing to meet these
objectives with regard to foodborne pathogens.
CENTER FOR VETERINARY MEDICINE (CVM)
Prevention of human illness from foodborne pathogens may begin with control
of the pathoaen in its animal host. Cvm is responsible for evaluating and
approving drugs to prevent, control, and treat diseases in animals. This
includes foodproducing animals, as well as companion pets and exotic animals.
FDA requires drug sponsors to show that each new animal drug, including those
intended for use in animal feeds, is safe and effective for its intended use
before it can be approved for marketing. When a drug is used in food producing
animals, CVM's charge is to assure that any food derived from the animals (meat,
eggs, seafood, or dairy products) is free from potentially harmful drug
residues. Evidence substantiating safety and effectiveness in the target
animals, and safety of any food derived from treated animals must be submitted
by the drug sponsor to CVM for evaluation by its scientific review experts.
Once a drug is approved, CVM monitors the drug's continued safety and
effectiveness through post-marketing surveillance programs. An estimated 80
percent of U.S. livestock and poultry are treated with an animal drug during
their lifetime. The availability of safe and effective drugs for use in
food-producing animals has benefited the consuming public by increasing
production at reduced cost, and improving the quality of these food items, while
ensuring the safety of these foods.
The challenges faced by CVM in the area of food safety have become more
complex over the last several years as the technology of food production has
advanced. Animals are now grown in high density production facilities which
have increased the efficiency of food production, but which also have put
additional stress on the animals and made the control of diseases critical.
Furthermore, recent changes in drug manufacturing production technology have
created new and more sophisticated types of animal drugs for CVM to evaluate.
Each of these advances presents a unique situation that must be evaluated before
the drug can be approved. And, because of the newness of the technology
associated with some of these drugs, the CVM has also had to respond to concerns
about the public's perceived threat from the use of these new technologies.
Such was the case in recombinant Bovine Somatotropin.
Aside from new safety issues in food production, technological advancements
in recent years have also had a significant effect on the number of requests by
drug sponsors to CVM for review. During the last six fiscal years, CVM has
experienced a 29% increase in the number of submissions for review (from 5880 in
1990 to over 7595 in 1995). At the same time, the CVM,s resources have
decreased in terms of budget and manpower. In the face of increasing workloads
and decreasing resources we have searched for innovative ways to lessen the
impact of these trends. Reinventing the New Animal Drug Approval Process
Recently, CVM has undertaken a major initiative to reengineer the review and
approval process for new animal drug applications (NADAs). This initiative has
already proven to be a more speedy and effective process, which will serve to
make more animal drugs available to treat animal disease.
The traditional animal drug approval process was very segmented. The drug
sponsor decided what information would prove that a drug was safe and effective,
and then the information was collected, compiled and submitted to the CVM for
review. The CVM evaluated all the data and informed the sponsor of its
assessment. if there were any deficiencies, the firm would collect more data,
compile and submit it, and wait for CVM,s decision. This process resulted in
numerous iterations before the drug was finally approved. It was also very
resource and time intensive.
Our new approach focuses on encouraging sponsors to involve CVM in their
drug development process as early as possible, and encourages an interactive
approach throughout the planning, research, and review of the drug. In this
way, CVM and the drug sponsor can agree on requirements for the approval of a
drug used for the specific indication, and identify any data needed. This
approach helps the sponsor reach an understanding with CVM before development is
started so that any project undertaken has an increased probability of resulting
in the approval of the product. It also allows for modifications to the drug
development plan to address any unexpected results as information becomes
available.
The response from the participating sponsors has been very positive. They
believe this new approach has proven itself to be beneficial in increasing the
efficiency of the drug approval process. It also benefits them by assisting in
management and coordination of their limited resources during drug development.
Some specific initiatives that are part of this reengineered drug approval
process are:
- Pre-Submission Conferences - CVM is encouraging sponsors of new animal drugs
to participate in pre-submission conferences where the sponsor's objectives and
CVM's requirements are discussed in detail. The result of these conferences is
agreement on the information necessary to support approval for the desired use
of the drug. These conferences help the sponsors to focus their efforts toward
conducting studies which are pivotal in determining whether the drug is safe and
effective, and help to decrease complaints about unexpected new requirements.
- Review of Study Protocols - Although not required by regulation or statute,
CVM is strongly encouraging sponsors to submit protocols for any pivotal studies
for CVM's input and concurrence. Using this procedure to assure that the design
of a study will result in adequate information to evaluate the drug, any
subsequent shift in review personnel is seamless to the process. Although
resource intensive to FDA, CVM believes this initiative will ultimately save
time and make the drug approval process much more efficient, and has committed
itself to a 50 day review time for protocols. The review of protocols enable
reviewers to evaluate studies in a more timely manner, and the sponsors to
embark on a development plan with more comfortable understanding and agreement
with FDA on the requirements.
- Phased Review of Data Submissions - Instead of waiting until all the
supporting information is collected and compiled, the sponsors are now
encouraged to submit critical studies during their drug development in the form
of an Investigational New Animal Drug Application (INADA). CVM will then review
the results of these studies so that any new concerns can be addressed prior to
submitting a full NADA. It is advantageous to both the drug sponsor and CVM in
identifying unexpected problems in the research, and facilitating any necessary
modifications to the drug development. For example, early review of a dose
determination study will ensure that clinical trials for efficacy and target
animal safety are conducted with the effective formulation and dose of the drug.
- Direct Review of Submission - Another innovation to increase the efficiency
of the review process is the distribution of administrative processing
responsibilities to those areas responsible for the scientific evaluation of the
data submitted for review. Previously, CVM endorsed the concept of a project
manager for each drug product. This added a point of quality control with one
CVM employee responsible for the drug product and its current status, but it was
extremely resource intensive. This direct review process, linked with the
phased review policy, has encouraged a more interactive and efficient review
process. This distribution is only possible because the Center has a tracking
system that can be used as a "Virtual Project Manager" that monitors the current
status of the drug development. Although the tracking system and this policy is
relatively new, both the sponsors and the scientific review staff believe this
level of interaction has benefited the drug approval process tremendously.
- Sponsor-Monitored Method Trials - We have shifted the primary responsibility
for validation of regulatory methods to the sponsor. Instead of relying on
government laboratories (with other competing priorities) to schedule and
complete a method trial, the sponsor may now contract with non-government
laboratories to conduct method trials. This ensures prompt conduct of the
necessary trials, and although both USDA and FDA laboratories may still
participate in the method trial, this change assures that there is an adequate
number of laboratories available for timely completion of this phase of drug
approval.
CVM has implemented several other initiatives to improve drug availability,
reduce regulations, increase food safety, and support the reengineered drug
approval process. These initiatives include:
- Expedited-Review Status for New Animal Drugs - New and innovative products,
such as a new chemical entity not yet approved for use in animals, or a drug
targeted for a disease condition that has no approved therapy are important
advances that may significantly impact on food safety. If a drug qualifies for
CVM,s expedited review program, target times for review of data are reduced from
the statutory 180 days to 90 days. Since 1982, the center has granted expedited
review status to 32 documents (3 NADAS, 1 Public Master File, and 28 INADAs for
expedited data review).
Updated Guidance Document-E - CVM has also focused on updating several
guidance documents. These serve as aids to industry for various portions of
drug development. Over the last several years, documents have been finalized to
provide guidance for development of study protocols, clarification of
responsibilities of clinical investigators, evaluation of food additives for
fish, and submission of manufacturing chemistry master files. Several other
documents are in various stages of preparation or revision, including efficacy
and/or animal safety requirements for carcass quality, anticoccidial,
anthelmentic and mastitis drugs.
Data Integrity - Improvements in the regulated industry's data collection
and quality assurance is increasing the efficiency of the data review process
within the CVM. This has been accomplished through use of guidance documents,
workshops, and other educational initiatives. With the drug sponsors assuming
more responsibility for the type and quality of data submitted for review, we
can focus our resources on the evaluation of the studies with regard to the
effect of the drug.
Treatment INADs for Minor Species - Approval of drugs for minor animal
species (i.e., many pets, aquaculture species, exotic animals) provide limited
incentive for traditional pharmaceutical sponsor drug development, and these
voids in availability of therapy can impact on food safety. CVM has developed a
system of "treatment INAD'S" and "public master files" that allow clinical data
to be gathered by those that need the drugs. The collected data are placed in
public master files for future reference by pharmaceutical sponsors in support
of NADAS. Public funds from USDA's National Research Supported Project No. 7
(NRSP-7) are also directed to this effort. NRSP-7 is a federally funded program
established to assist animal producers and veterinarians obtain FDA approval of
drugs for minor uses.
Environmental Requirement Changes - Based upon ten years of reviewing
environmental assessments for animal drugs, CVM has found that many of the
applications and requests that currently require assessments have no significant
impact on the environment. Therefore, the agency is proposing to exclude these
uses from preparing an environmental assessment. In most cases, elimination of
these environmental assessments will result in no additional risk to the
environment and will provide a substantial savings to the regulated industry and
CVM. However, we will be coordinating this policy with EPA in case there are
situations that do not have the potential for environmental impact. This
focuses the agency's environmental review resources on those areas that have
potential for significant environmental impacts.
STARS - CVM implemented a new Submission Tracking and Reporting System
(STARS) in November 1992. This database plays a critical function in monitoring
the status of CVM,s pending applications and files. It assists in coordinating
scientific reviews and CVM's responses to the industry's requests. With this
new system, prioritized time frames are assigned to submissions based on the
type of request and the amount and complexity of the data the firm submits.
STARS has helped CVM focus to assure a complete and coordinated response to
sponsors, applications. This database has also enabled the implementation of
phased review and direct review of drugs, by providing a tool to help manage the
complex process associated with drug approval.
CVM's Food Safety Programs
CVM has initiated several programs and research projects that are designed
to help prevent harmful pathogens from being transmitted to humans through the
food supply and/or the environment. These include CVM's:
Bacterial Susceptibility Monitoring Program - CVM has initiated a
collaborative bacterial susceptibility monitoring program with other FDA
Centers, USDA, and the Center for Disease Control and Prevention (CDC), in
response to the recommendations of an FDA Advisory Committee on fluoroquinolone
antibiotics and a 1995 American Society of Microbiology Task Force on Antibiotic
Resistance. This program grew out of concerns by FDA and other scientific
experts about how to best maintain antibiotic effectiveness, ensure safety, and
increase the availability of new products to veterinary practitioners and the
food animal industry. Because the development of bacterial resistance to
existing drugs or to future approved products would negatively impact both
efficacy and safety, FDA has made the susceptibility monitoring a priority
program.
The national surveillance program will monitor changes in bacterial
susceptibilities of zoonotic pathogens from human and animal clinical specimens,
from healthy farm animals, and from carcasses of food-producing animals at
slaughter plants. Prior to this program, there was no comprehensive national or
global surveillance system for monitoring antimicrobial resistance of enteric
pathogens in humans or animals and none at all which combined the two
populations.
Through this new program, baseline susceptibility patterns of Salmonella
isolates from animals and Salmonella and E. coli 0157:H7 isolates from humans
already have been determined. The susceptibility profiles of these isolates
form a baseline to which future changes in susceptibility and emergence of new
resistance can be compared. on- going monitoring is underway at USDA's
Agricultural Research Service's National Animal Disease center in Ames, Iowa and
at CDC's Foodborne Disease Laboratory in Atlanta.
The problem of antimicrobial resistance is complex and requires
collaborative efforts by several agencies; the establishment of FDA's monitoring
program is a significant milestone to its solution.
Salmonella Control Program in Feed and Feed Ingredients - In September 1990,
C'04 announced a program for attaining Salmonella negative feed ingredients and
finished feeds. Since then, CVM has held numerous meetings with representatives
of industry, academia, and other Federal and State agencies to coordinate the
work of achieving Salmonella negative feed.
CVM initiated the formation of a Federal-State Steering Committee in July
1991. The Committee requested that the United States Animal Health Association
(USAHA) serve as a scientific forum for debate on the means to best eliminate
harmful microbial contamination from feed. in October 1991, USAHA established
the Feed Safety Committee to serve as a venue for the forum. The work of this
committee was divided among four subcommittees. The subcommittees are live
production (poultry, beef, pork, dairy, and aquaculture); microbiology (sampling
and techniques); feed manufacturing (to include ingredients, equipment, and
additives); and feed transportation. The membership of the Feed Safety
Committee and the Subcommittees consists of members of government industry and
academia.
We believe that the best way to reduce Salmonella contamination in feed is
through a quality assurance program and to achieve this we are focusing on the
Hazard Analysis Critical Control Points (HACCP) approach. The Salmonella
contamination which occurs during the production, and during storage and
transportation, is largely preventable. Major segments of the feed industry
have developed HACCP plans. To further reduce Salmonella contamination of feed
requires that each manufacturer tailor a HACCP plan to each feed manufacturing
facility. Currently, several firms in the feed and feed ingredients industries
are working on developing generic HACCP plans. CVM encourages the feed industry
to actively seek industry wide acceptance of HACCP-based plans. CVM is prepared
to offer comments on specific plans if requested.
CVM also has reveiwed five Food Additive Petitions (FAP) for chemicals or
processes to control Salmonella in feed have been accepted for review. Two have
been approved, one is under review, and two are inactive because of the lack of
adequate information from the sponsor.
On September 28, 1995, the regulations were amended to permit the
irradiation of complete poultry feeds and poultry feed ingredients to achieve
Salmonella negative feed. Based on the scientific information, we believe that
this irradiation will also be effective against E. coli.
On April 9, 1996, the regulations were amended to permit the use of
formaldehyde as an antimicrobial food additive for maintaining poultry feeds
Salmonella negative for up to 14 days. Again, while the specific approval is
for Salmonella control, the scientific literature suggests that the formaldehyde
will also be effective against other common microbes in feed.
The approval of FAPs with antimicrobial activity is an important step toward
the goal of Salmonella negative feed and of improving the safety of feed for
animals and ultimately, increasing the safety of food products of animal origin.
Research - Research in CVM has as its mission the application of current
scientific procedures to the solution of CVM regulatory issues. The primary
focus of CVM's research is food safety. While CMV's food safety responsibilities
encompass foodborne diseases, its resources address this particular aspect of
human health primarily through the need to ensure that safe and effective animal
drugs are available to treat these diseases.
Particular importance is placed on the priority for research in CVM. Recent
Congressional interest in CVM has focused on the potential for drug residues in
animal derived food and the availability of residue detection methods for
monitoring. Drug residues in milk have been of particular interest to Congress
and the subject of GAO reports.
The food safety focus of CVM research also has included the development and
evaluation of procedures necessary to detect unsafe residues of unapproved
animal drugs, metabolism studies in domestic animals as well as fish, evaluation
and approval of drug residue screening tests for milk, and current issues on
zoonotic disease of importance in domestic animals. All these programs are
directed to food safety by ensuring that there are no unsafe drug residues in
animal derived food; and by minimizing the human risk from animal disease by
ensuring the health of domestic animals. Through a Federal/State/industry
cooperative program, involving the National Conference on Interstate Milk
Shipments and the milk industry, all Grade A milk is now screened with evaluated
screening tests for beta- lactam drugs prior to introduction into the food
chain.
Under the umbrella of food safety, CVM has supported studies on zoonotic
disease in animals which could be transferred to humans. Animal feeds are
considered a source of Salmonella spp. in animals and therefore, a source of
this disease in humans. CVM research has been directed to the evaluation of
procedures to detect Salmonella spp. in feeds.
CVM has previously conducted studies on the human health issue of the
transfer of resistance organisms from animals to humans.
Earlier studies were designed to develop data on comparison of Salmonella
spp and Campylobacter jejuni in foods of animal origin and the occurrence of
human illness caused by those two organisms. Other CVM research on the area of
zoonotic disease has been to quantify the extent of drug resistance in select
pathogenic bacteria isolated from food-producing animals. These studies were a
primary reason for the current regulation requiring the development of data for
new antibiotics on the shedding of resistant organisms from the use of the
antibiotic in food producing animals.
Animal Drug Availability Leaislation
FDA also recognizes that statutory changes also may be appropriate to make
more animal drugs available to treat sick animals. FDA has worked very closely
with the animal health industry to develop language that will provide adequate
flexibility in the approval process while maintaining public and animal health
safeguards. Although the agency still has several significant concerns with
language proposed in bills before Congress, the agency has been actively
involved in discussions with the animal health industry coalition to address our
concerns. Our discussions have also included the possibility of an important
new category of animal drugs for use in feed, "Veterinary Feed Directive Drugs."
We are encouraged by the way these discussions are moving and hope that they may
result in a bill that both the industry and Agency can support.
MONITORING THE FOOD SUPPLY
In the United States, the protection of the public from unsafe microbes in
food is a shared responsibility between FDA, CDC, and USDA at the federal level,
and state and local government agencies at their respective levels. CFSAN and
FDA's Office of Regulatory Affairs (ORA) have the primary responsibility in this
area for the Agency.
CDC Surveillance Program
Effective surveillance is key to tracking foodborne pathogens. Such
surveillance provides policy makers and health professionals with the basis for
developing, implementing, and evaluating control policies that will lead to a
healthier United States population in the new millennium. Science is providing
the regulatory community with new information, often through the use of
sophisticated genetic techniques, which help us identify weaknesses in our
system and points where preventive intervention strategies may be applied. From
current epidemiologic data, we can conclude that our most important foodborne
hazards are microbial, primarily Salmonella spp., Campylobacter jejuni, and
Escherichia coli (E. coli) 0157:H7. The Public Health Service has included
foodborne disease risk reduction in the national health promotion and disease
prevention objectives of Healthy People 2000. These objectives include
reductions in the numbers of foodborne infections with Salmonella spp.,
Campylobacter jejuni, and E. coli 0157:H7, and reductions in the number of
outbreaks of Salmonella enteritidis infections.
CDC's experience with newly emerging foodborne pathogens, well- recognized
pathogens appearing in new foods, and foodborne illnesses in immunocompromised
consumers, suggests that foodborne disease is an ever changing public health
challenge--a problem of emerging infectious disease. In partnership with
representatives from state health departments, other federal agencies, medical
and public health professional associations, and international organizations,
CDC has developed a strategic plan entitled "Addressing Emerging Infectious
Disease Threats: A Prevention Strategy for the United States."
To assure close coordination and adequate support for this program, CFSAN
has assigned one of its employees to CDC as a full-time liaison. FDA and USDA
have also transferred funds to CDC to help support this program.
FDA's Role in Monitoring the Food Supply
One important aspect of FDA's food safety program is its inspectional
strategy. Inspections can determine the adequacy of conditions in a food plant
at the time of the inspection, but not whether the company is operating reliably
and consistently, over the long term, to produce safe food. Furthermore, the
current system of regulatory controls is reactive, not preventive. That is, the
system generally relies on detecting and correcting problems after they occur,
rather than preventing them in the first place. only in certain limited areas,
such as low-acid canned foods, are mandated preventive controls currently in
place. FDA believes that it is time to consider improvements in the system and
adopt a Hazard Analysis Critical Control Point (HACCP) approach to food safety,
particularly for seafood. Such a change has been endorsed by such authoritative
organizations as the National Academy of Sciences (NAS), the Codex Alimentarius
Commission and the National Advisory Committee on the Microbiological Criteria
for Foods (NACMCF).
As described by the NACMCF, HACCP has seven basic steps. it begins with an
in depth analysis of potential hazards, followed by identification of points in
the processing operation (critical control points) where the failure to control
the hazard is likely to result in illness or injury to the consumer. Steps
three and four are the establishment of critical limits associated with each
identified critical control point and delineation of procedures to monitor the
limits. The firm identifies corrective action procedures to be taken when
monitoring indicates that a critical limit has been exceeded. Then, an
effective recordkeeping system must be in place to document the HACCP system.
Finally, the HACCP system should be verified to assure that it is functioning
properly.
Actually, HACCP is not new. The FDA's low acid canned food program,
established in 1973, uses HACCP principles. This program has been very
effective in assuring the safety of canned foods.
In December of 1995, FDA issued a final rule for mandatory HACCP for the
seafood industry, to become effective on December 18, 1997. Because we believe
the future of food safety lies with the HACCP approach, FDA announced, in an
August 1994 advance notice of proposed rulemaking, that it is considering the
development of HACCP regulations for other segments of the U.S. food supply,
including domestic and imported foods. FDA also initiated a program to help the
agency obtain additional information and experience on whether, and how, to
design HACCP systems for foods other than seafood. Seven major food companies
are participating in FDA's HACCP pilot program, and the products involved
represent a wide range of foods, manufacturing processes, and hazards.
HACCP takes on even more importance with globalization of the food supply
and the need for a consistent system for assuring trading partners of the safety
of imported products. The U.S. is importing more food, often in processed form
rather than raw, 31 than ever before. In the early 1970's, all imported
products regulated by FDA numbered approximately 500,000 formal entries (i.e.,
those valued at $1250 or more). In 1995, 1,300,000 food products alone entered
the U.S. Likewise, U.S. exports are increasing yearly. The U.S. must be
prepared to demonstrate that American products introduced into international
commerce meet high standards of quality and safety. Industry use of HACCP
procedures is one way of accomplishing this. In fact, the European Union has
incorporated the HACCP system into food safety standards and directives.
FDA's model Food Code also incorporated a framework for the application of
HACCP at retail. The Food Code provides a set of food handling recommendations
that can be used as models for retail establishments such as restaurants,
grocery stores, vending operations and.nurs.ing homes. Its primary focus is the
prevention of foodborne illness. The Food Code includes input from many
sources, including the Conference for Food Protection, Association for Food and
Drug Officials, industry, other federal agencies and academia.
Cooperation with Other Organizations
One of the most important and cost-effective ways in which FDA works to
assure the safety of the nation's food supply is through cooperative efforts
with other federal, state, and private organizations. While FDA has
traditionally collaborated with USDA and CDC, the intensity of our cooperation
has increased significantly in the last several years. FDA and USDA have placed
full-time liaisons at CDC to ensure that all foodborne illness activities are
fully coordinated.
The federal agencies have also increased collaboration and cooperation with
state and local agencies that have primary responsibility for regulating the
activities of the retail segment of the food industry. We also have increased
collaboration with trade associations, such as the National Food Processors
Association and the Grocery Manufacturer's Association, to gain their support
and cooperation in implementing food safety programs, and with training
organizations, such as the Food Marketing Institute and the Educational
Foundation of the National Restaurant Association, which conduct training
programs and disseminate information on food safety to their members.
The agencies participate in numerous forums to discuss foodborne disease.
These forums include:
- Healthy People 2000: National Health Promotion and Disease Prevention
Objectives, a prevention initiative to improve the health of the American people
during the decade of the 1990s. One of the 22 priority areas is food and drug
safety. FDA is the lead agency for this priority area, working closely with CDC
and USDA and through the states and non-government organizations. Healthy
People 2000 tracks yearly progress in food safety improvement through four
objectives, including tracking the incidence of five foodborne bacterial
diseases.
- The National Advisory Committee on Microbioloaical Criteria for Foods
(NACMEC), an advisory committee formed in 1987 by USDA and coordinated by FSIS,
FDA, National Marine Fisheries Service, and the Department of Defense. The
Committee provides impartial scientific advice to federal food regulatory
agencies for use in the development of an integrated food safety system approach
to ensure the safety of domestic, imported, and exported foods. NACMCF has
provided the agencies with outstanding advice, including development of HACCP
principles, which are now incorporated in the HACCP programs mentioned above.
- The Conference for Food Protection, comprises representatives from
regulatory agencies at all levels of government, the food industry, academia,
and consumer organizations. Its goal is to promote food safety at retail by
identifying and addressing problems, providing uniform procedures, and promoting
mutual respect and trust by establishing a working liaison among all parties
concerned with food safety.
- The Food Safety and Nutrition Education Task Force, co-chaired by FDA and an
industry trade group, comprises food and nutrition consumer affairs and
education representatives from industry, trade, consumer and public health
organizations, government agencies, and public affairs firms. This group
focuses on education strategies and initiatives.
- The National Center for Food Safety and Technolocry (NCFSIL, a cooperative
government/academia/industry research endeavor that includes the Illinois
Institute of Technology (IIT), the IIT Research Institute, the University of
Illinois Food Science Department, FDA/CFSAN, and food-related industries.
Cooperative research endeavors at the NCFST provides FDA scientists access to
highly technical expertise and provides the opportunity to conduct critical food
safety research, which could not have been attained by FDA alone.
- The Columbus CFSAN seafood and molecular biology researchers will soon be
located at the Columbus Center in Baltimore's Inner Harbor. They will focus on
applying new technologies to enhance the safety of the food supply for the
American consumer. In this state of the art facility, CFSAN scientists will
combine their expertise conducting research in molecular biology and seafood
safety. Their research will be used to develop and evaluate new scientific
approaches which aid the FDA in accomplishing its mission.
- The University of Maryland On April 15, 1996, FDA entered into a partnership
with the University of Maryland. Under this partnership, internationally
recognized scientists from both organizations will share their expertise on
significant issues pertaining to food safety, nutrition, and food science. We
believe that pooling resources will enhance our ability to acquire and maintain
state-of-the-art science facilities and equipment. Four areas of emphasis
include: 1) the development of enhanced methods for detecting foodborne
pathogens, contaminants, and toxins; 2) the designing of nutrition and clinical
studies to better assess nutrient quality, safety, and proper labeling; 3) the
evaluation of technological innovations that will assist in the review of food
ingredients, risk assessment, international standards, and educational research;
and 4) the ability to better anticipate and respond to technological
developments that affect consumers, their behavior and the food industry.
- Seafood HACCP Alliance and the Meat and Poultry HACCP Alliance, an
affiliation of federal, state, industry, and academic organizations that,
working together, have developed curricula to conduct training programs to
facilitate the implementation of HACCP. These training programs will formally
begin in the summer of 1996.
- The Salmonella enteritidis Interagency Working Group, an integrated
coordinated approach to the control of S. enteritidis in eggs. The group
comprised representatives from USDA (FSIS, APHIS, Agriculture Marketing Service,
Agriculture Research Service); CDC; FDA (Center for Food Safety and Applied
Nutrition); the U.S. Animal Health Association; representatives from the egg
industry; state animal health departments; and state departments of public
health. The working group has considered issues like quality assurance programs
as an alternative to the USDA S. enteritidis traceback regulation and
requirements for the refrigeration of eggs during transportation and storage.
- Implementation Group on Pmeraina Infectious T)iseases, an interagency
working group of the Committee on International Science, Engineering and
Technology (CISET), formed in December, 1994. It published a report on emerging
and re-emerging infectious diseases, including foodborne diseases, in September,
1995. Five sub-working groups, chaired by representatives from CDC, FDA, the
National Institutes of Health (NIH), U.S. Agency for International Development,
the Department of Defense (DOD) and the State Department, and including outside
experts from academia, industry, and non-profit organizations are now working on
implementation of recommendations from that report.
Resarch FDA cooperates with other agencies in research on a wide variety of
topics including food safety. Research is joint, collaborative, or funded by
other agencies. CFSAN cooperates with the CDC, USDA, NIH and DOD(NAVY), the
National Aeronautics and Space Administration, the Department of Veterans
Affairs, the National Institute for Standards and Technology and other agencies.
The research function and ability to collaborate is essential to solving food
safety, food technology and epidemiology questions.
Other Cooperative Endeavors
We would like to highlight several special scientific collaborations that
have resulted in successful outcomes. Two examples are illustrative:
- FDA is providing CDC with $190,800 in FY-96 to continue active
surveillance of listeriosis in 5 geographic areas with a total population of
15,000,000. The active surveillance project found a decline in incidence of
listeriosis between 1986 and 1992 which coincided with: (1) efforts by FDA, CDC,
and USDA to increase publicity about how foodborne listeriosis is transmitted;
(2) increased regulatory activity; and (3) publication of recommendations for
prevention of foodborne listeriosis This low level of disease has continued
through 1994. It is unclear at present whether the decline is permanent, and as
such, continued surveillance in at least a part of the current surveillance area
is crucial.
- FDA and CDC using DNA fingerprinting technology to analyze Salmonella
Tennessee isolates from numerous dry soy- and milkbased infant formulas and
other products, the environment, and two ill Canadian infants were able to link
the plant environment and products contained within the facility to illness
among consumers. This resulted in the recall of powdered infant formulas,
medical foods, whole milk powder, nonfat dry milk, ice cream mixes, powdered
drink for meal replacement and a powdered supplement for use by lactating or
pregnant women, wh:lch were dried and/or packaged at the food processing plant.
ADDITIONAL ISSUES
Mr. Chairman, in your letter of invitation you requested that I speak today
about FDA's regulatory actions related to the Transmissible Spongiform
Encephalopathies (TSEs), and the relationship between Campylobacter jejuni and
Guillain-Barr6 Syndrome. While FDA shares responsibility in these areas with
other federal and state agencies, we also have important information to provide.
Camplyobacter jejuni and Guillain-Barre Syndrome
Campylobacter jejuni is the most common cause of bacterial gastroenteritis
in the U.S., causing an estimated 125,000 culture- confirmed and perhaps three
million total cases of diarrhea annually. The predominant source of C. jejuni
infections is raw or undercooked chicken. Poultry is'regulated by the United
States Department of Agriculture. Among the commodities which FDA regulates, C.
jejuni outbreaks in the U.S. are primarily associated with the consumption of
raw milk. Other foods regulated by FDA demonstrated to serve as vectors
(rarely) for the dissemination of C. jejuni include mushrooms, raw or poorly
cooked fish, and raw shellfish (mussels and oysters).
Guillain-Barre syndrome can appear as a late developing illness following a
C. jejuni infection. It may also follow illness caused by other bacterial
pathogens, viral infections, immunizations, ma3or surgery, and other (unknown)
causes. The syndrome is characterized by acute neuromuscular paralysis in both
adults and children. It develops one to three weeks after an acute respiratory
or gastrointestinal infection. It is rare (only about four to five thousand
cases per year) and most patients fully recover.
Research/Analysis - FDA conducts applied research on methods to quickly and
accurately recover and identify C. jejuni in commodities under our-jurisdiction.
The FDA Bacteriological Analytical Manual contains a chapter on the "Isolation
of Camp.ylobacter Species from Food and Water." FDA Field Laboratories perform
analytical tests for the presence of Camp.ylobacter spp. in food commodities
regulated by the FDA. To date, we have detected C. jejuni in only one sample of
shellfish collected from a shellfish growing area that had been closed to
harvesting.
Consumer Education - In a 1991 issue of FDA Consumer, FDA outlined ways to
prevent foodborne illness in the home, including prevention tips on safe storage
of food items, the importance of cleanliness, the need to keep hot foods hot and
cold foods cold, and organisms that can cause disease and their likely source.
Other information on C. jejuni and its relationship to seafood is available
through the FDA Seafood Hotline. The Hotline is available 24 hours a day, seven
days a week.
Retail Practices--Guidance - The 1995 Food Code published by the Food and
Drug Administration serves as guidance to local, state, territorial, and tribal
authorities, and to federal agencies in enforcement of their food safety laws
covering, restaurants, food stores, institutional feeding, and vending
operations. The 1995 Food Code includes specific poultry and seafood cooking
advice and a consumer advisory regarding the risk associated with the
consumption of raw or undercooked animal foods.
Prevention - The prevention of campylobacteriosis relies upon the avoidance
of cross contamination in food-handling, maintenance of good kitchen hygiene,
adequate cooking of meat and poultry, and the avoidance of those foods known to
be vectors. Pasteurization is an effective way to eliminate Campylobacter
jejuni in milk because the organism is sensitive to heat.
On May 2, 1990, FDA approved the irradiation of poultry up to a dose of 3
kGy for pathogen reduction. Treatment of poultry with radiation had been shown
to be effective in significantly reducing the load of several pathogenic
microorganisms on poultry products, among them, species of Salmonella, Yersinia
and Campylobacter.
Other Activities - CDC, USDA, and FDA have initiated a pilot diarrheal
disease reporting system. Working in cooperation with state health departments,
CDC will collect and analyz6 illness data from five "Sentinel Sites" around the
country (California, Connecticut, Georgia, Minnesota and Oregon). Data
collected will provide a framework for identifying current and emerging trends
in foodborne illness. The survey will collect data on diarrheal diseases
(including campylobacteriosis) associated with dairy products, fruits,
vegetables ' and seafood, which are regulated by FDA, and with meat and poultry,
which are regulated by USDA.
Food safety goals are part of the PHS program, Healthy People 2000: National
Health Promotion and Disease Prevention Objectives. One of the goals is the
reduction of infections caused by key foodborne pathogens including
Campvlobacter jejuni.
Transmissible Spongiform Encephalopathy (TSES) are a group of transmissible,
slowly progressive, degenerative diseases of the central nervous systems that
are invariably fatal. Scrapie in sheep and goats, bovine spongiform
encephalopathy (BSE), transmissible mink encephalopathy, chronic wasting disease
of deer and elk, and Creutzfeldt-Jakob Disease (CJD) in humans are examples of
TSES. The agents believed to be responsible for transmitting TSEs are highly
resistant to procedures that modify or destroy nucleic acids of living
infectious organisms.
FDA has been active in the trying to understand TSES. Since 1988 when UK
scientists discovered an epidemiological link between rendered ruminant products
in cattle feed and ESE, FDA has participated in ESE discussions nationally and
world-wide to understand the agent and epidemic. Collaborations with such
organizations as CDC, USDA and NIH have helped the Agency focus on appropriate
actions.
USDA has confirmed that no cases of ESE have been diagnosed in the United
States. However, as a means of helping to prevent the occurrence of ESE in the
US, FDA issued a proposed rule (PR) on August 29, 1994. The PR declared
specified offal from adult (more than 12 months of age) sheep and goats as not
generally recognized as safe (GRAS) for use in ruminant feed. Since the PR
issued, the Agency has evaluated the comments submitted on the proposal and
monitored the scientific advances made in understanding the interrelationships
among the animal TSES.
Epidemiological evidence from the United Kingdom (UK)'suggests that an
outbreak of ESE may be linked to feeding of ruminant proteins to cattle. ESE
has been diagnosed in over 155,000 head of cattle from almost 33,000 herds in
the UK. A UK ban on the feeding of ruminant protein to ruminants is believed to
have resulted in a steady decline in the number of cases of ESE.
Ten cases of CJD with a new neuropathological profile have been identified
recently in the UK. Although sporadic cases of CJD occur world-wide at a rate
of 1-2 cases per million population per year, these 10 cases appear to represent
a new variant of CJD (v-CJD), which might be unique to the UK. The appearance
of these 10 cases of v-CJD raises the possibility that they could be causally
linked to BSE. However, a link with BSE cannot be confirmed on the basis of
this epidemiological evidence alone.
Because of this potential association, an advanced notice of proposed
rulemaking (ANPRM) will publish imminently in the Federal Register announcing
that FDA is soliciting comments on the issue of using protein-derived from
ruminants in ruminant feed. The Agency believes that this action will better
protect the health of animals and minimize any risk which might be faced by
humans. FDA will be soliciting comments on all aspects of the ANPRM, including,
among other things: 1.) the occurrence in the United States of TSEs in animals,
including ESE; 2.) how TSEs occur and are spread among animals, and among humans
and what vectors might be involved; 3.) scientific information on the ecology of
TSES; 4.)scientific information supporting the exclusion of any ruminant-derived
proteins from the proposed prohibition; 5.) establishment of Hazard Analysis
Critical Control Points (HACCP) for the rearing of ruminants, and the rendering
or other processing of ruminant derived feed ingredients, that could reduce the
need to prohibit the feeding of ruminant protein to ruminants; and 6.) details
of rendering or processing practices that may inactivate the TSE agents, and
information and evidence of the effectiveness of rendering in the inactivation
of TSE agents.
In addition to TSEs and Campylobacter, you have asked that I speak about the
effect that regulatory delay may have on food safety. The agency currently
faces a greater number of challenges and stresses than ever before. New food
processing and packaging technologies, new food distribution and consumption
patterns, increasing public health concerns about low levels of certain chemical
contaminants, and new microbial pathogens all contribute to today's food safety
challenges. The size, diversity, and international character of the food
industry add to the stress on FDA's food safety assurance program as well, with
FDA's current inventory listing over 49,400 food establishments. The number of
foreign food products shipped to food products to the United States is
continuing to increase. In 1995 alone, there were well over 1.3 million food
import entries.
Given the current constraints on government resources, it is unlikely that
FDA will ever have sufficient resources to inspect, sample, and analyze more
than a small percentage of all food products, domestic as well as imported.
Thus, it is FDA's goal to use our resources in the most effective way to
minimize consumer exposure to unsafe products. The Agency is developing and
implementing new and innovative strategies to meet these goals, through
partnerships, improved product review and approval processes, HACCP, reduced
number of regulations and environmental assessments.
FOOD ADDITIVE PETITION PROCESS
Mr. Chairman, we would like to take this opportunity to highlight some of
the activities that have taken place with regard to the agency's food additive
petition process since we last testified before the Subcommittee on this issue
and to announce several changes to be made to this process. As you know, on
June 22, 1995, the Interim Deputy Commissioner for operations, Ms. Linda
Suydam, testified before this Subcommittee on the subject of food additive
regulation. Ms. Suydam described the changes being made to speed up the food
additive review process and additional planned reforms. Since then, we have
made some important strides in reducing the petition inventory. I'd like to
briefly describe these efforts for you:
At the time of the June 1995 hearing, there were a total of 295 petitions in
the inventory. Program staff have made a commitment to have reached a final
decision on at least 100 of these petitions by the end of FY 1996, and I am
pleased to be able to report that as of April 30, 1996, 2Z of that cohort of
petitions have been acted on. (Of course, petitions continue to be received; for
example, for the 12 months following May 1, 1995, 56 new petitions were
received, and final actions were taken on a total of la petitions; of these U
were approvals. Both of these latter two numbers are.higher than for any
calendar year since 1986). These gains were achieved because of steps we took
during the last year, including:
-
reassignment of 23 laboratory scientists to the petition review effort;
- use of the Threshold of Regulation policy, finalized in July, 1995, to
exempt from the requirement for a regulation certain low-risk substances used in
food packaging;
- increased use of outside scientific experts in resolving novel questions
in food additive petitions;
- use of a Special Project Team to expedite review of certain petitions for
food packaging materials;
- the dropping or withdrawal of petitions that are incomplete or inadequate.
- establishing objective criteria for judging each employee's performance.
We have also initiated actions that will result in new efficiencies in the
process, and further reductions in the petition inventory, including the
following: 0 We have allocated approximately $1.5 M for the upgrading of
information management capabilities to allow modern petition indexing,
information retrieval, and document tracking; 0 On April 3, we issued a
proposal, under the Reinventing Government Initiative, to exempt many petitions
from the requirement to prepare an environmental assessment, saving both
petitioner and reviewer effort;
- In another REGO initiative, we are Preparing a proposal to replace the
current lengthy and burdensome GRAS affirmation petition process with a
simplified and streamlined notification process;
*
- We are exploring new ways to improve the quality of submitted petitions,
for example, by holding workshops for petitioners, and by making guidance for
petitioners more readily available through the World Wide Web;
- Finally, on April 19, we issued requests for proposals for two contracts
for review of certain petition data, that will materially assist us in clearing
the inventory of unreviewed studies; we anticipate that this action will
ultimately have the greatest single impact on inventory reduction of any of our
initiatives.
I am convinced that by following through on these initiatives, we will
substantially reduce the pending petition inventory to the point where a newly
submitted petition can receive the prompt attention of reviewers in all
necessary disciplines; only then can we make real progress in improving
timeliness and predictability of action on all new incoming petitions. To that
end, I am personally following closely the progress being made in reducing the
inventory: weekly, I am receiving regular reports, and will, in the next few
weeks, be working with the CFSAN to establish more ambitious performance goals
and measures for inventory reduction, and will be looking at any opportunities
to provide additional resources for this effort.
At the June 1995 hearing, Chairman Shays noted that the statutory timeframe
for review was 180 days, and that any review period in excess of that was in
violation of the statute. Mr. Shays urged FDA to deal forcefully with the
overdue petitions and requested FDA to suggest a new statutory timeframe that
was achievable in practice.
In response to that request, FDA began a comprehensive review of its food
additive review program. The results of this review were summarized in a
concept paper that was submitted to the Department of Health and Human Services
on October 2, 1995. The reform ideas outlined in the concept paper have been
discussed with Subcommittee staff, and have, in addition, been the springboard
for numerous discussions with representatives of interested food-industry and
consumer groups.
v FDA proposes a number of substantive changes that would significantly
improve its food additive petition review performance, thereby achieving
predictable and significantly faster petition reviews. A number of these
changes would require amendments to the FD&C Act, and several others would
require that new regulations be promulgated or that existing regulations be
amended. Today I will describe in detail only the suggestions for statutory
changes.
The primary recommended statutory change is that the present 90- day
statutory time frame for petition approval (extendable for an additional 90
days) be changed to a:
-
6-month statutory time frame for conducting complete reviews (extendable for
an additional 6 months) for food contact material (so- called "indirect
additive,,) petitions; and
-
12-month statutory time frame for conducting complete reviews (extendable
for an additional 12 months) for so-called direct food additive petitions.
These deadlines will be phased in and become effective over a five-year
period. FDA's ability to achieve these statutory requirements and meet these
timeframes will depend on reasonable flexibility to reallocate existing
resources or development of new external resources, in conjunction with our
initiatives to increase efficiency of the process.
By "complete reviews' FDA means that at the end of the specified time
period, the agency will have completed the technical and scientific review and
will have either made a decision that the petition is approvable and published a
regulation, or has informed the petitioner that the petition is not approvable
and the reasons that it is not. The petitioner would have the right to appeal
a decision to deny a petition. These deadlines could be extended at the
petitioner's request (if, for example, the petitioner prefers an extension to a
denial).
These suggested statutory timeframes recognize the fact that some petitions
are scientifically more complex than others and, therefore, require longer
review. This fact was also recognized in the December 21, 1995, report of the
Committee on Government
Reform and oversight on the food additive petition review process.
I should add an important note: There is currently no distinction between
direct additives and food contact materials in the statute. This distinction
would need to be established by regulation.
Phased implementation of performance goals
As noted earlier, FDA proposes to phase in its accomplishment of these
deadlines over the next 5 years. FDA has already begun to act to reduce the
backlog, and will continue to work toward its goal to eliminate the backlog
within two to three years. once the backlog is significantly reduced, FDA's
goals are as follows:
For food contact material petitions, FDA's goal is to act on 60% of new
petitions within 6 months in the first year of implementation of the new
program; 75% of new petitions within 6 months in the second year; and 90% of new
petitions within 6 months in the third and subsequent years.
For direct food additive petitions, FDA's goal is to act on 50% of new
petitions within 12 months in the first year of implementation of the new
program; 65% of new petitions within 12 months in the second year; and 80% of
new petitions within 12 months in the third and subsequent years.
Additional recommended statutory changes
FDA recommends that additional statutory changes be made to direct the
establishment of new appeal procedures, to streamline rulemaking procedures, to
exempt food additive petition review from certain provisions of the Federal
Advisory committee Act and to amend section 721 of the Act to provide for
parallel changes for color additive petition review.
Necessary administrative changes
Several other reforms will be needed in order for FDA's overall goals to be
met. Perhaps most important among them is the promulgation of regulations to
raise the threshold for filing petitions. Such regulations will improve the
completeness and overall quality of petitions, which in turn will increase the
likelihood that petitions, once accepted by the agency for review, will be
approvable. In addition to the REGO proposals, mentioned earlier, other reforms
are also contemplated, among them a requirement that petitioners certify that
the data contained in a petition have been properly and correctly recorded,
analyzed, and reported.
Likely outcomes of reform in the absence of additional resources
In FDA's June 1995 testimony, the agency committed to improve its food
additive review performance without the benefit of additional resources. The
reforms identified in the testimony and those discussed above will strengthen
FDA's ability to speed petition reviews, and will go some distance toward
structuring a workable program of food additive review. However, FDA
anticipates that, unless the quality of the petition's receives is significantly
improved, many petitions will not be considered sufficient for filing, and many
filed petitions will be denied because they contain unresolved safety questions.
This is an outcome that both FDA and the food industry wish to avoid.
These points deserve amplification. With current resources, FDA is unable
to devote sufficient resources for consulting with prospective petitioners
before filing, because to do so would divert resources needed to review pending
petitions. Without pre-filing consultation, and with a new filing threshold
that sets higher standards for the information that petitions must contain, many
submitted petitions are likely to be found insufficient for filing. For
petitions that are filed, the situation is similar. With current resources, FDA
is not able to devote the level of effort required to complete all scientific
reviews and resolve all safety questions for filed petitions within a time
period satisfactory to industry or to FDA. While this cooperative process has
added significantly to the likelihood that petitions ultimately will be
approved, it has also added significantly to the time required to approve
petitions, contributed significantly to development of the present overly long
average review times, and has therefore ultimately worked to the detriment of
the goal of timely reviews. Were FDA to commit to new statutory deadlines to
reach a decision within 12 to 24 months for direct food additive petitions, FDA
scientists would be unable to continue their current practice of working
substantively with petitioners to resolve the scientific issues and safety
questions that arise during review. if required to reach a decision by the
statutory deadline, it is likely, therefore, that FDA would deny many petitions
as containing insufficient data to support approval.
CONCLUSION
The American food supply is among the safest if not the safest in the world.
This has been achieved by incorporating the best science available in our
regulatory research, by monitoring, and by education. Changing technologies,
rapidly emerging and virulent pathogens, as well as globalization of the food
supply present new and unique challenges to maintaining a safe food supply and
protecting the consumer. FDA cannot do this alone and indeed has not - but in
this time of decreasing resources, as outlined above, we are forming new
partnerships, as well as strengthening others with our federal, state, and local
counterparts as well as academia and industry to leverage our resources and
capitalize on the needs and expertise of our counterparts and customers. These
cooperative efforts also include a review of how we currently do business and
how best to carry out our mission. As mentioned above, we have made changes
such as in our new animal drug review process and will make changes in other
areas to improve the way we function.
Thank you.