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FRED R. SHANK, Ph.D. - SUBCOMMITTEE ON HEALTH AND THE ENVIRONMENT

STATEMENT BY
FRED R. SHANK, Ph.D.
DIRECTOR
CENTER FOR FOOD SAFETY AND APPLIED NUTRITION

FOOD AND DRUG ADMINISTRATION
PUBLIC HEALTH SERVICE
DEPARTMENT OF HEALTH AND HUMAN SERVICES

BEFORE THE SUBCOMMITTEE ON HEALTH AND THE ENVIRONMENT
COMMITTEE ON ENERGY AND COMMERCE
U.S. HOUSE OF REPRESENTATIVES

JUNE 19, 1991

FOR RELEASE ONLY UPON DELIVERY

Mr. Chairman:
I appreciate the opportunity to testify today on H.R. 2342, the
"Safety of Pesticides in Food Act of 1991." This legislation would revise
the authority of the Environmental Protection Agency (EPA) under the Federal
Food, Drug, and Cosmetic Act (FDC Act) to regulate pesticide residues in
food. The bill would also have both a direct and an indirect impact on the
programs of the Food and Drug Administration (FDA).

EPA, FDA, and USDA share responsibility for the Federal regulation of
pesticides used on food or feed. EPA registers pesticides for use and
establishes tolerances, which are the maximum amounts of residues that may
legally remain in or on a food when a pesticide chemical is used according to
label directions. FDA enforces compliance with EPA's tolerances by sampling
and analyzing both domestic and imported food to determine whether any
pesticide residues remaining in or on the food conform with established
limits. USDA carries out this function for meat and poultry products.

FDA has watched closely and participated in the debate on regulation of
pesticides that has occurred over the past several years in Congress as well
as in the public arena. Moreover, FDA has long been involved in the broader
issues of food safety. Indeed, although we agree that food safety law reform
with respect to pesticides is warranted, we caution that this effort not
divert attention from other food safety problems, such as microbiological
hazards, which equal or exceed the risks posed by pesticide residues.

This debate over regulation of pesticides has generated a wide range of
proposed revisions to food safety law, but also has highlighted some areas of
general agreement. For example, there is agreement about the need to
streamline the process for taking regulatory action against pesticide
registrations and associated tolerances for pesticides about which serious
safety considerations have arisen, and for harmonization of discrepancies in
current law.

As you may recall, in October 1989, President Bush urged that changes to food
safety law include improvements to enhance EPA's authority to suspend
pesticide use; streamline cancellation procedures; establish periodic review
of pesticide registrations; increase consultation among the agencies having
responsibility for regulating pesticides; strengthen EPA's enforcement
authorities; eliminate inconsistent standards for pesticide residues in raw
and processed foods through implementation of a "negligible risk standard;"
and establish prospectively, national uniformity for pesticide tolerances.
H.R. 2342 also addresses several of these points.

FDA is keenly aware that absolute safety can never be guaranteed.The role of
Federal agencies must be to assure that agricultural pesticides pose no
unreasonable risks, to set protective limits for pesticide residues, and to
enforce these limits. Through proper risk assessment and risk management,
risks can be reduced to insignificant or "negligible" levels.

We, therefore, believe that any changes to the existing statutory framework
for pesticide regulation should be consistent with current scientific
principles and public health goals, be flexible enough to allow regulatory
decisions to reflect advances in scientific understanding, and be
enforceable. The latter can be accomplished only if Federal regulatory
agencies are provided with adequate tools to do the job.

We have serious concerns about the impact of the legislation generally, as
well as several concerns specific to FDA's programs.

NEGLIGIBLE RISK
As you know, under the current law, pesticides which are applied to or
concentrate in processed foods are subject to the Delaney clause in section
409 of the FDC Act, while pesticide residues in raw agricultural commodities
are subject to a risk/benefit determination under section 408. The Delaney
clause, read literally, requires absolute safety and would prevent the
establishment of any tolerance for a residue in a processed food of any
pesticide that is a human or animal carcinogen.

At the time the Food Additive Amendments were enacted (1958), the Delaney
clause, literally interpreted, was consistent with the scientific knowledge
and technology of the day: the number of known or postulated carcinogens was
fairly small, and the then state-of-the-art capability to detect a substance
at a level of a few parts per million was considered ultrasensitive. As
testing methods have become more sophisticated, however, it has become
abundantly clear that a new approach for addressing risk is needed.
Increasingly sensitive analytical methods allow detection of substances at
the level of parts per trillion.

An appropriate negligible risk approach allows these scientific advances to
be taken into account. FDA is quite familiar with this type of approach, as
we use or have proposed its use in a number of cases. For instance,
advances in risk assessment enable scientists to conclude that some
substances shown to be carcinogens in high-dose animal studies represent no
risk to human health when present in minute quantities in the food supply
under specified conditions of use of the substances. This conclusion was
also reached by the National Academy of Sciences in its 1987 report,
Regulating Pesticides in Foods: the Delaney Paradox.

H.R. 2342 defines "negligible risk" as a reasonable certainty that "no harm
to human health" will be caused by exposure to a pesticide chemical residue,
thus recognizing the need to update the statutory safety standard applicable
to carcinogens by applying this concept to pesticide residues. The bill also
addresses the need for aconsistent standard for regulating pesticide residues
in both raw agricultural commodities and processed foods by applying
negligible risk to all pesticide residues. While we support the use of this
concept as the basis for establishment of pesticide residue tolerances, we
believe there are serious drawbacks to the bill's highly prescriptive
definitions of "negligible risk."

The bill differentiates between pesticide residues for which EPA can identify
a level at which the pesticide will not cause or contribute to any known or
anticipated harm to human health ("threshold" pesticides), and
"non-threshold" substances, for which such a level cannot be identified. All
carcinogens are placed into the latter category regardless of their mechanism
of action. We believe that this wholesale treatment of all carcinogens as
non-threshold substances is contrary to the evolving scientific knowledge
about carcinogens. We believe that for some carcinogenic pesticide residues,
a threshold may be identified, and that such threshold carcinogens should be
regulated like all other threshold chemicals.

Another issue that we would raise as a point of general concern is found in
Section 408(m)(2)(C), which would require EPA to have the burden of proof in
any judicial proceeding pertaining to tolerances, including revocation or
denial of a tolerance. Currently, the FDC Act requires the proponent of a
food additive petition or the sponsor of a new drug to show that a food
additive or drug is safe for its intended use. FDA's regulations for
administrative hearings reflect this, in that the proponent of safety is
required to bear the burden of proof in any administrative proceeding. We
suggest that the provision be deleted.

BACKGROUND ON FDA'S PESTICIDE PROGRAM
Before discussing the rest of our concerns about the bill with respect to
FDA's existing program, some general background on FDA's pesticide residue
monitoring program and strategy might be helpful.

Over 300 pesticides have tolerances for use on food crops in the United
States, and an additional 200-300 pesticides may be used in foreign
countries. Over 100 countries export foods to the United States annually,
and crops are produced in all 50 states and in U.S. territories each year.
The challenge for FDA is to select from this universe of literally hundreds
of thousands of possible pesticide/commodity/location combinations those
which should be given priority.

The agency has developed a sampling strategy to focus its resources as
efficiently, comprehensively and cost-effectively as possible. In general,
the agency emphasizes commodities that have relatively high dietary
importance, for example, potatoes rather than artichokes because potatoes are
consumed in much greater amounts. FDA also considers factors such as the
toxicity of a pesticide and its metabolites and degradation products, volume
of usage, the types of crops likely to be treated, prior residue findings
andviolations, and state monitoring programs.

FDA routinely cooperates with EPA and includes in its sampling program
chemicals identified by EPA as being of special interest. For example, FDA
provides EPA with monitoring data for pesticides undergoing "Special Review,"
initiated when new evidence suggests that use of the pesticide may present a
previously unrecognized risk.

While we are certainly aware of the need and desirability of continuing
cooperation with EPA, we stress that FDA needs regulatory flexibility to
determine the most appropriate sampling strategies, direct our pesticide
monitoring resources in the most cost-effective, efficient manner possible,
and still be able to respond in a timely fashion to specific concerns or
issues that arise. The basis for sampling as set forth by H.R. 2342 could
preclude this.

Section 408(k) of H.R. 2342 would require FDA to give priority to foods
containing residues identified by EPA as either above the negligible risk
standard, or "which may under certain circumstances reach or exceed such
standard."

We are concerned with the potentially significant impact this might have on
the agency's monitoring resources. Strict FDA compliance with the wording of
the bill could have FDA concentrating the bulk of its monitoring effort and
existing resources on relatively few chemicals.

This provision also seems to suggest that certain pesticides for which
tolerances have been established pose the greatest public health risk, and
thus warrant the greatest monitoring effort. Our monitoring data over the
years have shown that tolerances are rarely exceeded. The vast majority of
the illegal pesticide residues we detect each year involve pesticide
residue/food combinations for which no tolerance has been established. We
are concerned that this provision appears to give lower priority to
monitoring for residues resulting from misuse and monitoring for pesticides
that are used in other countries but not in the U.S. We therefore question
whether the monitoring priorities in the proposed bill will enhance consumer
protection. We also respectfully note that Congress, the General Accounting
Office, and others have repeatedly urged FDA to expand its sampling of
imported foods. The bill's monitoring provisions appear to contradict this
goal.

EXPOSURE DATA
Several sections of H.R. 2342 refer to "statistically significant data" with
regard to estimating dietary exposure to pesticide residues. Section
408(b)(2)(E) identifies nine population groups (primarily children) for which
such data are expected to be available and used by EPA in evaluating risk.
While we support the intent of the bill to prevent children from bearing a
disproportionate risk from exposure to residues, we question thecodification
of the divisions in the groups identified in the bill. Agencies need
flexibility to define food consumption groupings based on valid scientific
criteria.

We further question whether data regarding the food consumption patterns of
groups with "special consumption patterns" are available. Given the wide
range of potential diets for extant ethnic populations, vegetarians, etc.,
the task of evaluating dietary exposure for all these potential populations,
even if the data were available, takes on monumental proportions.

METHODS OF ANALYSIS
FDA supports the concept of formal consultation with EPA to assure that an
analytical method suitable for enforcement exists before a pesticide
tolerance is established or allowed to remain in effect. FDA and EPA have
for many years consulted on analytical methods and maintain an interagency
task group, which includes representatives from USDA, for the regular
exchange of information about analytical methodology. FDA agrees with the
bill's proposal that analytical methods be considered early on in the
tolerance setting process, and that multiresidue methods be emphasized.

We note, however, that the bill does not require EPA consultation with FDA
when a method is identified under the "Special Rule" or when an analytical
method is reevaluated. We see no reason for absence of consultation in the
"Special Rule" situation and during the reevaluation of a method. We believe
that the same level of consultation is necessary in any situation involving
an analytical method that FDA may use in its enforcement program.

We are also concerned that the "Special Rule" could potentially force upon
the agency an inappropriate, albeit the most sensitive, analytical method,
regardless of that method's cost, complexity, or validity. The
acceptability of a method should not be based solely on its sensitivity per
se. Moreover, the "Special Rule" provision, as written, requires only that a
method detect a residue. FDA needs analytical methods capable of both
detection and measurement to enforce tolerances and monitor the incidence and
levels of pesticide residues.

We are also concerned that the consultation contemplated in the bill will
compel FDA to conduct laboratory trials of methods.

FEES
The bill authorizes EPA to impose and collect fees related to registering and
establishing tolerances for pesticides. We believe this authorization should
be expanded to include the costs of the additional activities required of FDA
under this bill. For example, as mentioned previously, H.R. 2342 would
require FDA to perform monitoring over and above the Agency's regulatory
program to determine if residues are in compliance, and also to evaluate the
suitability of analytical methods. To carry out additionalsampling and
analyses and evaluate analytical methods without affecting the current
program would require additional resources. We believe the costs of these
additional activities should be covered by user fees.

CONCLUSION
In sum, we believe that H.R. 2342's incorporation of the concept of
negligible risk to be a significant first step toward updating the law to
reflect changes in scientific knowledge and methodologies. Rational food
safety law reform is warranted in light of what we now know about chronic
exposure to chemicals and the progress science has made since the Delaney
clause was first enacted.

As currently written, however, we oppose enactment of H.R. 2342 because of
the concerns outlined by the Administration at this hearing. Nevertheless,
the Administration is ready to work with Committee staff to discuss ways in
which our concerns might be resolved.

Mr. Chairman, we commend the Committee for opening the discussion on these
vital issues, and thank you for affording us this opportunity to testify. I
would be pleased to answer any questions that you or members of the committee
have.