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