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Testimony on Regulation of Food Additives by Linda Suydam
Interim Deputy Commissioner for Operations
Food and Drug Administration
Public Health Service
U.S. Department of Health and Human Services
Before the House Committee on Government Reform and Oversight, Subcommittee on Human Resources and Intergovernmental Relations
June 22, 1996
I am pleased to be here today to provide information about
the Food and Drug Administration's (FDA) regulation of food
additives. Under the Federal Food, Drug, and Cosmetic Act (the
Act), FDA is responsible for evaluating the safety and approving
the use of food additives and color additives. In addition, FDA
currently reviews petitions to affirm that substances used in
food are generally recognized as safe (GRAS).
This statement addresses why the Agency reviews the safety of
chemicals added to the food supply in the manner it does and
identifies concerns that have been raised regarding the existing
review process. It then outlines the comprehensive plan that FDA
has devised to improve management of the overall program, reduce
the inventory of pending petitions, and improve the timeliness
and predictability of Agency decisions.
FDA's primary mission is to ensure that the food supply is
safe for 280 million American consumers. Clearly, we have
achieved this goal: the American food supply is one of the safest
and most abundant in the world. The American public fully
expects its food--including any substances added to food--to be
safe, regardless of who consumes the food, the quantity consumed,
or the period of time over which it is consumed. The requirement
that chemical substances used as food additives be shown to be
safe before they can be introduced into the food supply is a
critical link in the food safety chain.
Approval of a food additive poses unique safety
considerations for the Agency. Unlike drugs which are ingested
for the significant therapeutic benefit they are intended to
confer on the patient, food additives are eaten by everyone and,
by definition, are not supposed to produce any pharmacological
effect. They do not provide direct benefits that justify exposing
consumers to risk. This is true even for food additives, such as
artificial sweeteners, that may have a beneficial effect on the
American diet. Even in the case of an artificial sweetener, for
example, there are already safe and effective alternatives
available to reduce caloric intake for anyone motivated to do so.
Other factors also contribute to the unique safety concerns
related to food additives. A food additive potentially will be
consumed by everyone in the population, including pregnant women,
children, and the elderly. In addition, food additives are going
to be consumed by healthy individuals and may be consumed for an
Finally, when FDA approves use of a food additive, that
approval is generic--it permits anyone to manufacture or use the
additive (consistent with any existing patent protection), in
conformance with the substance's identity, specifications, and
conditions of use. unlike drugs or medical devices, a food
additive regulation is not a product license limited to a single
sponsor or manufacturer. Therefore, a food additive petition
must contain information adequate to demonstrate that the
additive is safe under each and every condition of use to be
permitted and to identify issues that would require restrictions
to ensure safety.
Food ingredients can be classified into four groups: 1) food
additives; 2) color additives; 3) ingredients for which either
FDA or the U.S. Department of Agriculture specifically authorized
use prior to 1958, the so-called, "Prior Sanctioned Substances;"
and 4) GRAS substances, that is, substances that are agreed upon
as safe by the general scientific community on the basis of
scientific evidence or that were marketed prior to 1958 and are
considered GRAS because of a long history of safe use. Only food
and color additives require premarket approval. Our focus today
is on food additives, 1 of which there are two types: those
intentionally added to foods (direct additives) and those that
can be expected to become components of food unintentionally
because of their use (indirect additives). This latter category
includes components of food packaging materials which may migrate
into the food. Food additives vary greatly in composition and
may be consumed, in the aggregate, in amounts exceeding millions
of pounds per year. 1 Unless otherwise noted, the term "food
additive" in this statement applies to color additives also.
The Food Additives Amendment of 1958 and the Color Additive
Amendments of 1960 require that chemicals that are going to be
used in food are safe. The 1958 law was a milestone in that it
required safety testing for chemicals used in foods prior to
their use, and placed the burden for conducting that testing
squarely on the industry. It was the clear intent of Congress in
its drafting of the Food Additives Amendment to the Act that
safety was to be the only consideration in the decision whether
to authorize use of a food additive. The legislative history of
the 1958 amendments defined the standard by which FDA is to
measure the safety of additives. Congress stated that:
Safety requires proof of a reasonable certainty that no harm
will result from the proposed use of an additive. It does
not--and cannot--require proof beyond any possible doubt that no
harm will result under any conceivable circumstance.
The Color Additive Amendments contain the identical safety
FDA's review of an additive is not an attempt to determine
the absolute harmlessness of any chemical substance, nor an
attempt to establish that no harm will result under any
conceivable circumstance. Rather, it is a scientific inquiry to
determine, with reasonable certainty, that no harm will result
from the proposed use of an additive. The statute requires that
the Agency perform a thorough, careful review that will allow us
credibly to support and defend our evaluation that the use of an
additive will be safe.
The credibility of FDA's review is very valuable for food
manufacturers. They can be secure in the knowledge that FDA
evaluated ingredients in their products and in the packages in
which they are sold, and determined that these materials will not
be harmful to the public. FDA stands behind these manufacturers
and supports the safety of their products. Furthermore, the
credibility of the safety of the U.S. food supply and the safety
of FDA permitted food ingredients is a boon to domestic food
producers who engage in global trade.
As we stated at the outset, FDA's primary mission is to
ensure the safety of the food supply. With that mission comes
the very important obligation to review and render decisions on
proposed new food additives expeditiously, and we acknowledge
that we need to improve our performance in this regard. The U.S.
food industry is entitled to timely and predictable decisions on
food additive petitions. We are committed to improving the
review process in order to provide those decisions, and to do
this in a way that will not jeopardize food safety or the
independence, integrity and credibility of the review process.
We have taken, therefore, a close look at our process for
reviewing petitions and have developed a comprehensive plan to
improve the efficiency and overall functioning of the food
additive review program. We will describe the plan in greater
detail later in the testimony, but in essence, it addresses
improvements to the management of the program and new approaches
for the review of petitions that we believe will reduce the
numbers of pending petitions and ensure timely review of new
The major elements of the plan include:
- reorganization of FDA's Center for Food Safety and Applied
Nutrition (CFSAN) to place petition review resources under one
- development and issuance of a "Threshold of Regulation"
approach for indirect additives that meet specific criteria;
- performance goals to review petitions within defined time
- reform of the GRAS regulatory process;
- additional Agency resources to reduce the inventory of
pending petitions; and
- use of external scientific expertise to expedite the review
of pending petitions;
- elimination or reduction of requirements for environmental
assessments for many petitions; and
- expanded programs to help petitioners submit complete,
This plan represents our thoughtful--but practical--attempt
to reach a goal of timely, predictable decisions on food additive
petitions. We believe that implementation of this comprehensive
plan as a whole will, in the long run, result in significant,
long-term improvement. We have begun implementation of several
components and already have seen positive results.
For the plan to be fully successful, however, we will need
the cooperation and assistance of the food industry. Presently,
many petitions, when submitted, have shortcomings in the data
needed to support a decision to approve the additive. Similarly,
during FDA's review, the data in a petition too often are found
to be of poor quality or inadequate. An example of this is when
the data do not answer the particular questions that a study was
designed to address.
In the past, because of the competitive nature of the
marketplace, the industry has been reluctant to have the Agency
formally deny product petitions. Consistent with industry's
preference, FDA's traditional policy for food additives has been
to work very closely with each petitioner to develop data,
including additional scientific studies if necessary, to resolve
safety questions that arise. we do this instead of simply denying
those petitions that lack adequate supporting data. The point is
that while this cooperative process to correct deficiencies in a
petition added to the review time, it also added significantly to
the likelihood that an additive ultimately would be approved.
In short, we acknowledge that FDA can improve the process for
reviewing petitions for food ingredients, and we affirm our
commitment to providing industry with timely decisions.
Nevertheless, we also must call upon the industry to ensure that
the petitions submitted to the Agency are of adequate quality so
as not to impede the timeliness of a final decision.
I would like to add one final note regarding resources in the
Agency as a whole. Part of the difficulty of addressing program
needs in a time of limited and dwindling resources has meant that
the Agency had to make some hard choices regarding its internal
priorities. Historically, FDA has committed significant
resources to review the safety and effectiveness of drugs and
medical devices. Although such products have some associated
risks, they confer clear benefits to the health of the public.
With management changes and additional resources in both the
drugs and device programs, we have been able to improve our
performance markedly. By applying some of the lessons we have
learned in those two programs to the food additive process, we
believe that we can achieve similar results.
II. THE AGENCY'S PLAN
FDA is committed to decreasing the time to a decision, and to
reducing the pending inventory of active petitions, every bit as
much as petitioners are. Our efforts to do so, however, must not
compromise the safety of products entering the marketplace and
must be fair to all petitioners. Indeed, FDA already has
implemented changes to speed and improve the petition review
process. A brief description of our comprehensive plan follows:
A. MANAGEMENT REFORMS
- CFSAN Reorganization
In November 1992, CFSAN was reorganized, placing most
petition review resources under one central line management.
Prior to this time, the former Division of Food and Color
Additives had to coordinate review of chemistry and toxicology
data with other offices under different directors. These other
directors were responsible for programs other than petition
review. Under the reorganized structure, the direct line
authority of the Director of the Office of Premarket Approval
over most personnel reviewing petitions provides for more
effective and efficient oversight of the process and allows for
more uniform alignment of priorities.
- Special Focus Team for Complex Scientific Issues
To assist in the review of petitions that present complex
scientific or regulatory issues, FDA organized a Regulatory and
Science Policy Board, composed of the senior management of the
Office of Premarket Approval and other senior scientists from
CFSAN or other parts of the Agency as needed. The board acts to
resolve difficult scientific issues and to set policy for
non-routine petitions and other food ingredient-related issues.
- Increased Use of Other Scientists
CFSAN is increasing its direct use in the petition review
process of both non-federal scientists and research scientists
from other Centers and agencies when CFSAN scientists lack
specific expertise. Such scientists provide in-depth reviews and
reports for the development of regulations and serve as
consultants for the pre-market review process in CFSAN. For
example, to resolve novel questions raised in the review of
petitions to evaluate the use of fat substitutes, CFSAN requested
assistance from clinical nutritionists at the U. S. Department of
Agriculture (Beltsville), and from reviewers from FDA's Center
for Veterinary Medicine to evaluate special animal studies in
The Agency also intends to increase significantly
consultation with the Food Advisory Committee, especially for
help in resolving complex scientific issues, such as those posed
by novel food ingredients. For example, the Agency sought advice
from the Committee regarding FDA's approach to regulating
products developed using biotechnology.
- Contract with the Federation of American Societies for
Experimental Biology (FASEB)
FDA has been criticized as being too conservative in making
safety determinations and as requiring more testing than is
necessary or appropriate. FDA has asked FASEB, under an existing
contract, to consider these issues.
A vexing issue for the Agency today is deciding how to reach
a safety decision for food ingredients for which tests using
traditional animal models may not be appropriate. For example,
consumer interest in nutritionally modified diets has led to new
food ingredients used in high amounts that replace or supplement
common food components, principally, sugar or fat. In such
situations, FDA has made safety judgments on a case-by-case
basis, using criteria that it believed would be accepted by the
community of food safety experts. FDA believes that some of its
decisions have been delayed because of a lack of general
agreement on the testing that is appropriate when traditional
approaches may not resolve safety questions definitively. To
address this, FDA also has asked FASEB to institute a study to
make recommendations on, among other things, criteria that the
scientific community would agree justify the use of alternative
models to ensure the safety of food ingredients.
B. REDUCING THE PENDING INVENTORY OF PETITIONS
Increase Petition Review Staff
A problem that contributes significantly to FDA's lengthy
review time is the sizable inventory of pending petitions.
Indeed, because of the queue of assignments on a particular
reviewer's desk, it may take a long time before work on a newly
submitted petition can begin. Studies from petitions submitted
previously are "ahead" of the new petition and fairness to
petitioners dictates that they be reviewed first.
To reduce the backlog of pending petitions, the Agency is
committing resources for the food additive process from other
offices in CFSAN and other Centers, such as, the National Center
for Toxicological Research. For example, research scientists may
perform technical reviews of studies in pending petitions. We
will make available no fewer than 22 FTE's from other programs
over the next 6- 12 months for this effort.
Almost 150 of the approximately 290 pending petitions are for
indirect additives (components of food packaging or other
articles that come in contact with food). Generally, the testing
requirements for many of these substances are standard and
straightforward for which the Agency has well developed
guidelines for the industry. Therefore, we expect to award a
contract for independent third-party scientific review of some
indirect additive petitions. Upon receipt of the results of the
review, FDA will render the final safety decision and prepare the
documents to approve the petition or, in the case that the
petition is not approvable, to inform the petitioner of the
Similarly, for many direct food ingredients, there are often
thousands of pages of data from studies carried out to assess the
toxicity of the compound in animals. In order to expedite
completion of the review of the pending direct food additive
petitions and of the more complex pending indirect additive
petitions, FDA will award a contract for review of specific types
of studies--such as classical, standard toxicity studies,
routinely submitted in support of both direct and indirect
additive petitions. We believe that this will greatly speed our
notification to a petitioner that the data in the petition
support approval, or why the data do not support such a finding.
These programs should assist us in reducing substantially the
number of pending petitions. This, in turn, will improve our
timeliness in reaching decisions on petitions of all types.
C. NEW APPROACHES TO PETITION REVIEW
The Agency believes that the expenditure of resources for
review of a particular petition should be commensurate with the
risk posed by the substance. To address petitions for low-risk
situations, we have done the following:
- "Threshold of Regulation" Policy
Because of their low dietary exposure, many indirect
additives are likely to pose relatively little risk to consumers.
Because of the large number of petitions submitted for indirect
food additives, however, FDA has had to expend a large amount of
resources reviewing these petitions.
FDA has implemented a "Threshold of Regulation" approach for
indirect additives. In October 1993, FDA proposed this policy,
which establishes a process for determining when the likelihood
or extent of migration to food of a noncarcinogenic substance
used in packaging is so trivial as not to require regulation of
the substance as a food additive. Under this process,
information about the proposed use of a noncarcinogenic substance
that results in a dietary concentration that does not exceed the
threshold would undergo an abbreviated review by FDA, as opposed
to the extensive review and formal issuance of a regulation
normally required for food additives.
We have been implementing this policy on a limited basis, and
in FY 1994, we issued 46 letters for substances that might
otherwise have been the subject of food additive petitions. The
final regulations implementing the Threshold of Regulation policy
will be completed and published in the Federal Register soon.
- Reinvention of GRAS Regulatory Process
Unlike a food additive, a substance that is "generally
recognized as safe" by qualified experts may be used lawfully in
the absence of any FDA action. In part because of this
distinction, and as part of President Clinton's and Vice
President Gore's National Performance Review, FDA is proposing to
replace the current regulatory process for reviewing the GRAS
status of ingredients with a simple notification procedure.
Under this process, FDA will have a brief period of time-- 60 to
90 days--to object to an independent GRAS determination reflected
in a notification.
- Expanding Criteria for Exclusion from a Requirement to
Prepare are Environmental Assessments
Under the National Performance Review, we also are proposing
to eliminate or reduce requirements for environmental assessments
for many routine petitions.
- Policy for Food Biotechnology Products
We created a process whereby the developer of a food product
utilizing biotechnology (many such products present low risk)
consults the Agency early on to discuss the product and identify
potential safety and regulatory issues. This process allows the
Agency to use its resources effectively to remain abreast of
developments in the food biotechnology field and identify those
cases in which premarket review and approval may be warranted.
To date, the Agency has concluded the consultation process on
approximately a dozen products.
D. PERFORMANCE GOALS
One of the industry's greatest concerns is that the Agency
takes too long to inform petitioners that the information in a
petition supports approval, or that the data are inadequate and
clarification or more data are needed. A key lesson of the
prescription drug user fee program has been the utility of
establishing performance goals in managing the product review
process. we believe the establishment of such goals for the food
additive petition review process will serve to fulfill the
Agency's commitment to timely and predictable decisionmaking over
the long term. We are announcing that we will be establishing
performance goals for the review of food additive petitions.
Such goals can only become operative, however, once the backlog
of pending petitions is reduced substantially and the other
management review process improvements are implemented fully.
In considering the performance goals that we might set, we
have classified petitions into one of three "tiers" based on
length, complexity, or novelty of issues presented. These
proposed response time goals will apply to new petitions received
following full implementation of the comprehensive plan.
- TIER I petitions would include "routine" petitions of
several classes: e.g., many indirect additive petitions, or
subsequent approvals for an already approved additive where new
issues do not arise. For these petitions, our goal is to issue
an Agency response-- that the submission is adequate, or provide
a complete description of why it is not adequate--within 90 days
of receipt of the submission.
- TIER II includes petitions that do not pose novel
scientific or regulatory issues, but which contain more data than
a petition that would meet the criteria for Tier I. For these
petitions, our goal is to issue an Agency response within 180
days of receipt of submission.
- TIER III includes petitions for additives that present
difficult or novel scientific or regulatory and policy issues or
either have wide exposure (such as an artificial sweetener) or
high exposure (such as an additive used as a macro-ingredient).
Petitions for such additives generally contain very numerous
and/or very complex safety studies. For these petitions, our goal
is to issue an Agency response within 360 days of submission.
We propose to phase in our accomplishment of these goals over
three years, beginning one year after initiation of the contracts
to reduce the backlog. For example, our goal is to act on 70
percent of new Tier I petitions within 90 days in the first year,
60 percent of new Tier II petitions within 180 days in the first
year, and likewise, 50 percent of new Tier III petitions within
the 360 day goal. A complete list of our goals is as follows:
TIER I 70%; year 1; 80% year 2; 90% year 3
TIER II 60% year 1; 75% year 2; 90% year 3
TIER III 50% year 1; 65% year 2; 80% year 3
We believe that full implementation of this program will
respond to industry's major concern about the process: Decisions
will be reached in a more timely manner, and with much greater
predictability for petitioners.
There is still much to be done, but once our plan has been
completely phased in, we believe we will see additional speed and
efficiency in our review process, while simultaneously preserving
the integrity, credibility, and science base of that review, and,
importantly, continuing to protect the public health.
E. WORKING WITH INDUSTRY
- PETITIONERS WORKSHOPS
FDA has well-established guidelines for petitioners, for
example, preparing chemistry data to measure migration of
packaging materials, or information needed to determine exposure
scenarios, etc. We also are exploring other ways to educate
petitioners regarding development of petitions that are complete
and sufficient. For example, we are planning a "Food Additive
Petition Workshop" in conjunction with CFSAN's National Center
for Food Safety and Technology in Chicago to be held in the fall;
if successful, we will hold additional workshops.
- INDUSTRY PROPOSALS
FDA is interested also in the "Industry Initiative for Food
Additive Petitions," which has been proposed by Pfizer, Inc.,
together with a group of other food and food ingredient
companies. The proposal aims to improve the quality of the data
submitted to the Agency, thereby facilitating and potentially
reducing FDA's review time. We believe elements of this proposal
could be helpful both for FDA and for industry. We look forward
to working with the industry to identify elements that will
improve the process and simultaneously preserve the credibility
and integrity of that process in keeping with the existing safety
standard upon which the American public and the industry rely.
Mr. Chairman, the Agency is keenly aware that the food
additive, color additive, and GRAS affirmation petition processes
take too long. We have outlined and already begun to implement
our comprehensive plan to remedy the situation. We are willing
to work with the Committee and to consider other approaches that
might further improve the efficiency of this program.
We strongly urge, however, that the zeal to speed up the
process not be allowed to override the credibility and integrity
of that process, nor to undermine consumers, confidence in the
safety of the American food supply. American consumers and the
food industry would be ill served if food safety is sacrificed
simply because of a desire for a speedy review of petitions.
Consumers expect safety and industry relies upon FDA's careful
scientific decisions regarding the safety of food ingredients.
We do not want either of those to be compromised.
I would be happy to answer any questions you or other members
of the Committee may have.
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