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Summary Report of Food Safety Advisory Committee

Note: EPA no longer updates this information, but it may be useful as a reference or resource.

Background on the Food Safety Advisory Committee

The Food Safety Advisory Committee (FSAC) was established to provide stakeholders an opportunity to exchange information and ideas on regulatory, policy, and implementation issues with EPA. The committee met four times from September to December 1996. Additional information on the committee membership, agendas and papers presented, and meeting summaries is available in th Office of Pesticide Programs Public Regulatory Docket under docket number "OPP-00450."

On August 3, 1996, President Clinton signed into law the Food Quality Protection Act of 1996 (FQPA) (P.L. 104-170). After years of debate in Congress over food safety and the inconsistencies between the two major pieces of legislation addressing pesticide usage, FQPA was passed unanimously by the 104th Congress with support from the Administration and a broad coalition of environmental, public health, agricultural, and industry groups. FQPA amends the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) and the Federal Food, Drug, and Cosmetic Act (FFDCA). FIFRA gives EPA authority to register pesticides for use in the United States and prescribes labeling and other regulatory requirements to prevent unreasonable adverse effects on human health and the environment. Under FFDCA, EPA establishes tolerances (maximum legally permissible levels) for pesticide residues in food. Tolerances are enforced by the Department of Health and Human Services/Food and Drug Administration (HHS/FDA) for most foods, and by the U.S. Department of Agriculture/Food Safety Inspection Service (USDA/FSIS) for meat, poultry, and some egg products.

The new law is a comprehensive overhaul of the nation's food safety system that regulates pesticides on foods. The FQPA replaces the current tolerance-setting system with a single, stringent health-based standard for all pesticides in all foods to assure protection from unacceptable pesticide exposure ("a reasonable certainty of no harm"), provides new health protections for infants and children from pesticide risks, expedites approval of safer pesticides, creates incentives for the development and maintenance of effective crop protection tools for farmers, and requires periodic re-evaluation of pesticide registrations and tolerances to ensure that scientific data supporting pesticide registrations will remain up-to-date in the future, and contains new measures to expand consumers' right-to-know about pesticide health risks. Specific provisions include:

FEDERAL FOOD, DRUG, AND COSMETIC ACT PROVISIONS (FFDCA)

FEDERAL INSECTICIDE, FUNGICIDE, AND RODENTICIDE ACT PROVISIONS (FIFRA)

Most of FQPA took effect immediately upon the President's signature. Thus, the U.S. Environmental Protection Agency was immediately faced with having to implement new standards and requirements. Most of the pending decisions were put on hold until the Agency could determine how to implement the new requirements. To assist them as the Agency began implementation efforts, the Agency established an advisory committee, the Food Safety Advisory Committee (FSAC), as a subcommittee of EPA's National Advisory Council for Environmental Policy and Technology to assist them in soliciting input from stakeholders, including industry, environmental and health groups, scientists, pesticide user groups, farmers, state and federal agencies, public health community, Congressional staff, and American consumers. (A list of members and their alternates is contained in Appendix A.) The purpose of the Advisory Committee was to provide input to EPA on some of the broad policy choices facing the Agency and on strategic direction for the Pesticides Program.

The Food Safety Advisory Committee was chaired by Deputy Administrator Fred Hansen with Assistant Administrator for Prevention, Pesticides and Toxic Substances Lynn Goldman serving as Vice-Chair. Keystone Center staff facilitated the meetings. As a subcommittee of a federally chartered advisory committee, FSAC operated under the provisions of the Federal Advisory Committee Act (FACA). Thus, the meetings were open to the public, notice of meetings were placed in the Federal Register, at each meeting there was opportunity for public comment, and a docket was kept. All materials related to the FSAC are maintained as a public record in the docket, number 00450.

The objectives of the Food Safety Advisory Committee (FSAC) were to

Given the Agency's desire to have the Office of Pesticide Programs making decisions under the new law as soon as possible, it was decided that the FSAC should meet four times between September and December. The short duration of the Advisory Committee reflected the need and desire of the Agency to have the Committee address strategic, policy-level questions, not the details of implementation. It was explained that the Agency's goal was to publish a detailed implementation plan early in 1997. The first meeting of FSAC was held on September 26, 1996. Subsequent meetings were held October 14-15, November 21-22, and December 5, 1996.

An important point that was reiterated frequently throughout the four meetings is that the goal of the FSAC discussions was NOT consensus; it was to get input from the members. If consensus developed, it would be documented.

Questions posed to the FSAC initially to guide discussions included:

Topics Addressed by FSAC:

During the FSAC meetings, input was given to EPA on which provisions should be given priority during the implementation process. As a part of these meetings, FSAC members also identified and discussed concerns related to the interpretation of specific provisions. Following are brief summaries of the topics and concerns raised at each of the FSAC meetings. More detailed meeting summaries, for each meeting, are attached as appendices to this report.

First Meeting - September 26, 1996

This was an organizational meeting. EPA outlined the objectives of the Committee which are to provide input on implementation of the FQPA; it was noted that consensus would not be sought. EPA provided a review of the major provisions of the FQPA and indicated the major changes from previous law. The Committee agreed to groundrules. The remainder of the meeting was spent identifying issues to be covered at the subsequent three meetings including:

Second Meeting, October 22-23, 1996

Prior to the second meeting, conference calls were held for participants to discuss questions raised by EPA in a series of prepared background papers. Written summaries of the conference calls were distributed to FSAC members and a brief verbal summary was used to initiate discussion of each topic. The topics addressed were communication, risk, minor uses, reduced risk pesticides, and benefits. The main points made in the plenary discussion for each topic are outlined below.

Resources

The following reflects many of the concerns raised by members during the discussion:

Communication and Right-to-Know

The following reflects many of the concerns raised by members during the discussion:

Risk: Aggregate Exposure and Common Mechanism of Toxicity

The following reflects many of the concerns raised by members during the discussion:

Minor Uses

The following reflects many of the concerns raised by members during the discussion:

Reduced Risk Pesticides

The following reflects many of the concerns raised by members during the discussion:

Benefits

The following reflects many of the concerns raised by members during the discussion:

Proposed Interim Decision Logic

EPA staff presented a proposed interim decision logic that outlined how an application for a chemical may be handled under FQPA. Many of the members stated that at first glance the logic seemed to make sense. Several noted that the devil is in the details, but it at least gave them something to consider. The proposed logic or process was refined further between the October and November meetings.

Third Meeting, November 14-15, 1996

The third plenary session addressed the topics originally identified at the first meeting as well as some that had arisen during the October meeting. Topics included workers' issues, human health risk assessment (in utero, 10-fold uncertainty factor, and aggregate exposure), tolerance reassessment, Section 18's, and the proposed interim decision process. At the meeting, USDA staff provided brief overviews of their programs that address pest management and information collection.

Tolerance Reassessment

The following reflects many of the concerns raised by members during the discussion:

Worker Risk

Human Health Risk Assessment

Section 18's

Proposed Interim Decision Process (Revised)

EPA presented a flow chart of the revised process to further reflect the comments received. Subsequent discussion addressed issues raised such as aggregate exposure and different ways to handle defaults as presented in the handout illustrating possible options.

Fourth Meeting, December 5, 1996

At the fourth and final plenary meeting, the FSAC was asked to comment on the Draft Implementation Plan Outline and to continue discussions on minor uses and the Section 18 program. The discussion of the Draft Implementation Plan included their consideration of the approach to science assessment, interim decision logic for screening risks, and the tolerance reassessment program. Following the group's discussion of these topics, EPA expressed appreciation for the time and commitment of Committee members throughout the process and invited them to take part in future fora which would provide additional opportunities for public comment.

Draft Implementation Plan Outline

EPA presented an overview of the Draft Implementation Plan Outline. They explained that, in addition to providing context and background on the FQPA, the plan includes guidance on the approach to risk assessment, requirements for minor uses, description of other regulatory requirements, plans for public outreach, and additional sources of information.

Approach to Science Assessment

Following is a summary of key discussion points made by members:

Interim Decision Logic for Screening Risks

Key aspects of EPA's presentation and subsequent discussion on the interim decision logic for screening risks are summarized below:

Tolerance Reassessment Program

After EPA presented a summary of the proposed tolerance reassessment program, the following key points were made:

Minor Uses and Section 18 Program

Some of the key elements of the discussion on minor uses and the Section 18 program are summarized below:

Next Steps for Implementation of the Food Quality Protection Act of 1996

At the conclusion of the last meeting on December 5, both Fred Hansen and Lynn Goldman thanked Committee members for the time they spent participating in the FSAC and their input. From their perspective, the Committee's discussions had met the objectives laid out for the Committee. As a result, EPA had a clear sense of stakeholders' concerns and had received valuable feedback on initial policy directions. (e.g., the decision process and the risk cup).

Even though the FSAC will no longer exist, Committee members and others were encouraged to continue to provide EPA staff with input as implementation of the FQPA proceeds. They were reminded that a number of other fora exist for providing input including the Pesticide Program Dialogue Committee, the Endocrine Disruptors Screening and Testing Advisory Committee, the Scientific Advisory Panel, etc.

Building on these discussions and efforts underway within the Agency, the Office of Pesticide Programs noted that they hoped to receive comments on the draft implementation plan outline from Advisory Committee members by December 20, 1996.

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