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 the 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)
- General Standards for Tolerances
- Resolution of the "Delaney Paradox"
- Special Provisions for Infants and Children
- Consideration of Pesticide Benefits
- Endocrine Disruptors (Estrogenic Substances)
- Other Factors to be Considered in Setting Tolerances
- Consumer "Right to Know" Provisions
- Re-evaluation of Existing Tolerances
- International Standards for Pesticide Residue
Levels
- National Uniformity of Tolerances
- Residue Monitoring and Civil Penalties
FEDERAL INSECTICIDE, FUNGICIDE, AND RODENTICIDE ACT PROVISIONS (FIFRA)
- Periodic Review of Pesticide Registrations
- Emergency Suspension Authority
- Extension of Reregistration Fee Authority
- Minor Use Pesticides (including Public Health
Uses)
- Review of Antimicrobial Pesticides
- Expediting Review of Safer Pesticides
- Maintenance Applicator and Service Technician Training
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
- provide an
opportunity for participants to inform EPA of issues regarding the new
statute;
- identify several
priority issues to pursue through discussion and possible consensus building;
and,
- discuss aspects of the Agency's implementation plan presented to the Advisory Committee for review.
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:
- What priorities should
EPA establish for implementation of the FQPA (e.g., within all of the
new provisions)?
- Given the new provisions
and associated requirements, are there current regulatory activities in
EPA's Pesticide Program that should be eliminated or given lower priority
as EPA begins implementation of the FQPA?
- How can EPA most effectively
balance its mandate to protect human health with its mandate for protecting
the environment?
- What are the roles
for growers, other federal agencies, states, registrants, the public,
etc. in implementation of FQPA?
- What are the communication
activities that should be undertaken as a part of implementation?
- How should environmental
justice concerns be considered as a part of implementation?
- How can the concept of community-based environmental protection be incorporated into implementation of FQPA?
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:
- Section 18s
- Worker Concerns
- Infant and
Children Provisions
- Minor Uses
-
Communication
and Right to Know
-
Impacts on
IPM
- Resources for
Implementation
- Transition
Issues - Both Short and Long Term
- Aggregate Exposure
- Common Mechanism
of Toxicity
- 10-fold Uncertainty
Factor
- Reduced Risk Pesticides
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:
- Recognition
of the tremendous size of the task before EPA to implement the FQPA (e.g.,
currently making 300 tolerance decisions a year; under FQPA, EPA will
need to make about 900 per year.) and the amount of resources that will
be needed.
- Congress has appropriated an additional $30 million for implementation of FQPA and the Safe Drinking Water Act. Many members urged EPA to allocate much of it to FQPA activities.
Communication and Right-to-Know
The following reflects many of the concerns raised by members during the discussion:
- Brochure for
distribution in grocery stores is required by FQPA. Many members felt
that development of it should be the Agency's priority.
- A number of
members stressed the need to test the message to be used in the brochure
to determine the best message to use (i.e., communicates the message in
an understandable manner.)
- Several members
suggested that EPA needs to identify the audience for the brochure and
write the materials towards that group.
- Many members
suggested that the audience should include low income consumers; it was
observed that this is a different audience than that being reached by
the EPA hotline. (Resource problems associated with the hotline were raised
and discussed.)
- Some members urged the use of partnerships to leverage resources as well as to provide additional credibility.
Risk: Aggregate Exposure and Common Mechanism of Toxicity
The following reflects many of the concerns raised by members during the discussion:
- Some members
raised concerns about data gaps and how they would be addressed.
- Most members
seemed to support the idea of using defaults when data are not available;
they did not, however, agree on how defaults would be determined.
- Concern was
expressed by a number of members about the quality of data to be used
in decision-making.
- Many members
identified the need for a transparent process so that growers and others
would understand how decisions are made.
- Members considered
the three approaches outlined by EPA in the background paper (requiring
data that demonstrate common mode of action, using structure activity
relationships to group chemicals, and grouping chemicals with common endpoints)
to determine common mode of toxicity. Many of them felt that all three
should be considered and the appropriate one used for each case.
- Some members
suggested that EPA should consider the use of time limited tolerances
when they use defaults.
- Issues around lack of data on aggregate exposure were raised.
Minor Uses
The following reflects many of the concerns raised by members during the discussion:
- Communication
to growers about products at risk.
- Discussion
of uses retained tends to include only registrants and EPA; a number of
members urged greater and earlier involvement of growers.
- It was observed
by several members that the need for additional data under FQPA places
an increased burden on growers to gather and provide data. It was also
noted several times that growers can provide data on actual usage.
- The idea of
reserving a portion of the risk cup for minor uses was raised. It received
mixed reviews.
- Concern was
raised by a number of members about the impact of FQPA on the adoption
of IPM.
- Some members
suggested that the loss of minor use products may drive fruit and vegetable
production offshore.
- A number of members urged that USDA and EPA look proactively for alternatives to chemicals that are likely to be canceled.
Reduced Risk Pesticides
The following reflects many of the concerns raised by members during the discussion:
- Many members
pointed to the current lack of resources in this program. The background
paper had noted that more than two applications will overwhelm the program's
capabilities.
- Discussion
by the members reflected confusion over whether the goal of this program
was to address absolutely safe products or those that are relatively safer.
- Members acknowledged
that if the scope is defined too broadly, too many applications will qualify
and the program will be overwhelmed.
- Possible measures for success of a reduced risk pesticides program were identified.
Benefits
The following reflects many of the concerns raised by members during the discussion:
- Members discussed
what kind of benefits are to be considered under FQPA and which under
FIFRA.
- FQPA allows
the consideration of benefits only if there is a "significant disruption
of the food supply." Members questioned how that would be defined.
- It was observed that decisions have rarely been driven by economic considerations in the past; it is unclear how benefits will be used in the future.
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:
- EPA presented
its proposed strategy for reassessing tolerances. It was noted that FQPA
will change the Agency's priorities for the reregistration process.
- Several members
raised concerns about the lack of adequate data on aggregate exposure.
- This discussion
resulted in members identifying concerns about the process to be used
for categorizing chemicals under the common mode of toxicity requirement.
That such grouping will draw in other chemicals was addressed and members
explored with EPA staff how this would be handled.
- Problems with data on exposure and on common mode led to the restatement of concerns about defaults, data gaps and the magnitude of resources needed to accomplish this task.
Worker Risk
- EPA staff presented
their current activities to address risk to workers: the worker protection
standard, certification, decontamination procedures, etc.
- Some members
detailed their experiences which suggest that workers have safety problems
due to increased exposure and increased risk of injury and disease.
- Several members
urged EPA to consider worker exposure when they are calculating aggregate
exposure.
- Concerns about
the quality of information on worker exposure was raised by some members.
- Some members noted that worker training and education are successful in protecting workers.
Human Health Risk Assessment
- In utero testing
and the 10-fold uncertainty factor were presented to the Scientific Advisory
Panel (SAP) at its' October meeting. Dr. McConnell, chair of the SAP,
explained the SAP process and its preliminary findings. Based on the studies
reviewed, the SAP agreed with the Agency that there is not convincing
data that pre-natal exposure does increase the incidence of cancer. Thus,
in utero testing would not be required in all circumstances.
- On the 10-fold uncertainty factor, the SAP agreed that there is a need for an additional uncertainty factor on a case-by-case basis and that the Agency should use a weight-of-evidence approach.
Section 18's
- EPA explained
the Section 18 process and how decisions are made, especially that EPA
now has to establish a time limited tolerance when it grants a Section
18.
- Some members
expressed concern about the potential for Section 18's to utilize all
available resources.
- A number of
members pointed to the amount of information that will now be required
and questioned whether Section 18's will be viable since emergencies cannot
be planned.
- Concern was
also raised about the potential that the Agency may not be able to respond
in a timely manner.
- Some members
suggested that one way to address some of the anticipated problems with
Section 18's is to give more responsibility to the states.
- Some members urged that there be a special process for deciduous, perennial crops that allows them to submit Section 18's months in advance.
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.
- Many members
asked clarifying questions. Many of the members preferred the option that
provided the most detail. EPA staff noted that the tradeoff is between
the amount of data needed for that option versus the need to make decisions
in a timely manner.
- Some members suggested that EPA use a phased approach - start with the option that requires the least data and move through the others if the product would not qualify and if additional information is available.
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:
- EPA addressed
three major issues addressed by the science assessment: protecting sensitive
populations, including children; aggregate exposure; and common mode of
action. They noted that a fourth major issue, endocrine disruptors, would
be addressed in another forum.
- Several participants
wanted EPA to explain their choice to use common mode of action versus
mechanism of action and expressed concern that the choice be consistent
with the meaning of the law. EPA is currently trying to determine how
to pragmatically comply with the "common mechanism" provision;
this issue was taken up at the March SAP meeting. In the meantime, EPA
felt that describing the "common mechanism" provision using
the term "common mode" was a compromise.
- Other participants
requested that EPA clarify how they interpreted the additional uncertainty
factor (up to 10-fold); starting with 10-fold uncertainty factor unless
data showed otherwise, or basing it on the weight-of-evidence? EPA explained
that additional information about the uncertainty factor will be available
soon after the Agency considers the SAP review of the issue.
- Many members wanted reassurance that there would be additional opportunities to evaluate and comment on the issues presented. EPA assured members that there would be additional opportunities.
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:
- EPA presented
an updated proposal for the reregistration and registration decision process
and summarized the interim decision logic, stressing that it was conditional
and time-limited.
- EPA explained
the three revised risk cup options to determine the percent of risk to
reserve in the risk cup. EPA identified Option 2, which allows categorization
of active ingredients based upon the level of risk (high and low), as
their preferred option.
- Several members
raised concerns about the use of defaults to determine the percent of
the risk cup to reserve, particularly for lawn and residential exposure.
EPA explained that they would use defaults only when data were not available.
They welcomed other sources of data and requested that members provide
guidance on how to allocate the risk cup fairly.
- Some members
wanted clarification on how this process would apply to non-food uses.
EPA explained that they would consider non-food uses when characterizing
aggregate exposure and when sensitive populations could be affected.
- Many members
were concerned about what and how subpopulations would be addressed. EPA
noted that there were 22 subpopulations identified in the food consumption
surveys and that subpopulations are generally the driving force when allocating
risk.
- After some
discussion, many members supported the use of Option 2.
- At the close of the discussion, EPA reiterated that members were invited to take part in the information-sharing meeting on interim decision logic on December 12, 1996 at EPA.
Tolerance Reassessment Program
After EPA presented a summary of the proposed tolerance reassessment program, the following key points were made:
- Several members
were concerned about whether EPA had sufficient resources to devote to
the proposed program. EPA noted that they were evaluating the demand for
resources.
- Other members
wanted EPA to explain what happens to pesticides for which reregistration
is close to completion. EPA explained that they will be scheduled for
consideration in 1997 and 1998.
- Some members questioned the efficacy of time-limited decisions. EPA acknowledged the concern and suggested that the group consider and propose more effective alternative strategies using coalitions in the user community.
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:
- EPA addressed
the overall implementation plan of the minor use program, the results
of the Section 18 Workshop, the status of Section 18 activities, and current
Section 18 decisions facing EPA.
- Several members
wanted to know how EPA planned to involve the grower community to address
concerns which included crop size, expediting reduced risk pesticides,
the safety of using weight-of-evidence to address worker safety, and criteria
for risk allocation. In addition, suggesting that the grower community
could become more involved by providing EPA with additional data, some
members proposed that EPA arrange to hold structured meetings with the
minor use community and work closely with other affected agencies.
- EPA supported
this suggestion and requested that USDA lead the effort to bring the registrant
community, grower groups, and the agencies together to recommend to EPA
what criteria should be used to allocate risk.
- EPA also presented
an example of a pending Section 18 decision on two unregistered fungicides
on seed corn. EPA indicated that it was concerned about whether these
could be granted based on its interpretation of the new requirements.
[Note: Since the meeting, these two Section 18's were granted.]
- Many members felt that the example was not a good one because seed corn is not a food. They urged EPA to use common sense when assessing risk.
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.