Copyright 1999 Federal News Service, Inc.
Federal News Service
APRIL 22, 1999, THURSDAY
SECTION: IN THE NEWS
LENGTH:
4081 words
HEADLINE: PREPARED TESTIMONY OF
JAMES V.
AIDALA
ASSOCIATE ASSISTANT ADMINISTRATOR
OFFICE OF PREVENTION,
PESTICIDES, AND TOXIC SUBSTANCES
U.S. ENVIRONMENTAL PROTECTION AGENCY
AND KEITH PITTS
SPECIAL ASSISTANT TO THE DEPUTY SECRETARY
U.S.
DEPARTMENT OF AGRICULTURE
BEFORE THE
HOUSE COMMITTEE ON
AGRICULTURE
SUBCOMMITTEE ON DEPARTMENT OPERATIONS, OVERSIGHT, NUTRITION AND
FORESTRY
BODY: INTRODUCTION
Good morning Mr. Chairman and members of the subcommittee. We are pleased to
appear before you today to discuss the Environmental Protection Agency s (EPA)
and the U.S. Department of Agriculture's (USDA) implementation of the
Food Quality Protection Act (FQPA). Since last June, when
former EPA Deputy Administrator Fred Hansen and USDA Deputy Secretary Rominger
appeared before you, we have made many important decisions. Mr. Peter Robertson
has joined us as Acting Deputy Administrator to work side-by-side with Deputy
Secretary Rominger. In our follow-up remarks this morning, we hope to provide
you and your subcommittee with a brief summary of where we stand at the moment
in implementing FQPA, and our future plans. Since the passage of FQPA, and
especially in the past ten months, significant progress has been made in
strengthening public health protections.
Today is Earth Day. While
communities around the country are planting trees, collecting roadside trash,
and learning the importance of recycling, we are reminded of the significance of
this piece of legislation. FQPA was enacted to provide greater food safety,
especially for infants and children, and all of us are fully committed to
achieving the protections embodied in FQPA.
Earth Day also allows us to
recognize that farmers play a significant role in our economy and in
environmental protection. The Administration realizes that we need to meet the
mandates of FQPA in a manner that provides assurance to our farmers that they
will continue to have the critical tools they need to grow our food. Mr.
Chairman, both EPA and USDA are committed to the principle that safer food does
not need to come at the expense of American agriculture. We believe we can
strengthen environmental protection while maintaining agricultural growth. This
is essential for the successful implementation of FQPA.
One year ago this
month, Vice President Gore asked both EPA and USDA to employ four guiding
principles to serve as the cornerstones of our efforts to implement FQPA. First,
we should ensure that our pesticide and food safety regulatory decisions are
grounded in the best available science. Second, our regulatory process must be
transparent and predictable, so that consumers can continue to have full
confidence in the safety of our food supply, and pesticide producers and users
can depend on a consistent process. Third, the Agency and the Department must
work together to provide a reasonable transition for growers to newer, reduced
risk pesticides and pest control practices. And fourth, we must continue to
reach out and open the process for participation by all interested parties whose
opinions and experiences are proving to be exceedingly valuable. Since FQPA's
enactment, EPA and USDA have developed new policies, created new programs, and
established new procedures-- all firmly rooted in these fundamental principles.
In August 1996, EPA was presented with a new food safety law. We knew we
would have to work more closely with industry, growers and the environmental
community to meet the challenges outlined in FQPA. We are indebted to the
members of the Food Safety Advisory Committee and the Tolerance Reassessment
Advisory Committee (TRAC) who helped us devise a process for developing complex
science policies, and design an effective pilot program for refining risk
assessments for the organophosphate pesticides, both founded on unprecedented
stakeholder participation. The TRAC was established by EPA and USDA in May 1998,
and has met five times since then. Two Working Groups were also established, and
they have met a total of ten times. This morning we would like to describe for
you how we are implementing the recommendations of the TRAC and highlight some
of the outcomes and accomplishments. Key Science Policies As FQPA was
immediately effective, the Agency needed to put into place procedures that
allowed for early decision- making, both in setting new tolerances for emergency
exemptions and new registrations and in tolerance reassessments. The Food Safety
Advisory Committee, established after FQPA was enacted into law, assisted EPA in
developing an initial decision logic to ensure that the Agency could continue to
make decisions while important science policies were being developed.
Last
October, EPA and USDA announced a framework for addressing nine key science
policy issues, based on work done with the TRAC. As part of the framework, EPA
published a schedule for releasing for public comment draft documents on each of
these science policy areas. To date, 11 papers out of 19, covering seven of the
nine science policy areas, have been released for public comment. The Agency has
also identified four additional related policy papers not on the original list,
one of which has been released for comment. This paper focused on anticipated
residue data for the organophosphates. A complete list of the science polices
and their current schedule for public notice and comment is attached in Table 1.
The nine issues include:
- applying the FQPA 10-fold safety factor
-
using "Monte Carlo" analyses for dietary exposure assessment
- interpreting
"no residues detected" for exposure assessments
- estimating dietary
exposure
- factoring in drinking water exposure
- assessing residential
exposure
- aggregating exposures from all non-occupational sources
-
conducting cumulative risk assessment for organophosphates (OP) or other
pesticides with a common mechanism of toxicity
- selecting appropriate
toxicity endpoints for risk assessments of organophosphate pesticides.
As
proposed to the TRAC, the Agency has been applying the science policies, as
appropriate, in making regulatory decisions for both new tolerance decisions and
for tolerance reassessments at the same time the policies are being refined
through peer review and public comment. Our approach is fully and clearly set
forth in each of the science policy papers published. We are utilizing our
interim science polices in our risk assessments with the full knowledge that, as
these policies are further refined, some of our decisions may need to be
revisited. EPA currently expects to have virtually all of its science policies
finalized before organophosphate risk management decisions are completed. The OP
Pilot Process To implement FQPA effectively and fairly, a well- defined and
clearly communicated process must be followed.
Because of intense
interest in and the potential impacts of the tolerance reassessment process for
the organophosphate pesticides, EPA and USDA turned to the TRAC to provide
advice on possible regulatory approaches to reassessing the organophosphate
pesticides--one that is both consistent and predictable. The TRAC was asked to
help find a more effective way for the public to participate at critical
junctures in the development of OP risk assessment and risk management
decisions.
As a result of the TRAC discussions, EPA and USDA have set forth
a pilot process for the organophosphate pesticides, complete with self- imposed
deadlines for releasing the preliminary risk assessments, further refining the
risk assessments, and providing for public participation on risk mitigation
measures and practical transition strategies. The six phases are as follows (a
more comprehensive description of each of the phases can be found in Table 2):
Phase 1 - EPA completes the preliminary risk assessment and sends it to the
registrant and USDA for review.
Phase 2 - EPA addresses the comments it has
received and amends the document.
Phase 3 - EPA releases the preliminary
risk assessment for public notice and comment.
Phase 4 - EPA addresses the
comments received and refines the risk assessment. The refined risk assessment
is shared with USDA for review.
Phase 5 - The refined risk assessment
document is released for public notice and comment. If warranted, EPA solicits
the submission of risk management proposals.
Phase 6 - USDA and EPA work
together to develop risk management strategies which will serve as the basis of
EPA's risk management decision.
Recently, EPA and USDA met with a Working
Group of the TRAC and identified the objectives and activities of phase 4 and
phase 5. The fundamental principles of these two phases are: (1)
intergovernmental review of the refined risk assessment, (2) presentation of the
findings in a clear and understandable way to affected stakeholders and the
public, (3) public participation in risk mitigation approaches, and (4) USDA and
EPA collaboration in designing an appropriate and acceptable method to lower the
risk to an acceptable level.
Thus far, 27 organophosphate pesticides have
made it to phase 4, refining the risk assessments. Ten OPs have been sent to
USDA, and the Department has completed its review of the revised risk
assessments for four of them. The Department relies on experts from a number of
internal offices for its review, and often consults with experts from Land Grant
Universities and Extension Service as well. USDA's review, led by the Office of
Pest Management Policy (OPMP), focuses on how EPA utilizes the data provided by
USDA, such as use and usage data, pesticide residue data, and food consumption
data, as well as the assumptions used by EPA and on possible strategies for
managing the risk. Our recent experience with this process is that data and
information provided by USDA has greatly assisted in the refinement of OP risk
assessments.
EPA and USDA believe that the pilot process has served as a
useful model to provide greater transparency and to encourage greater public
understanding and participation. In addition, this novel approach has definitely
delivered positive results--the public's ideas and input have been extremely
useful. We are pleased to see that, in many instances, the new notice and
comment process is resulting in the submission of additional health and
environmental effects data, use data, and other relevant information which EPA
is using to refine the risk assessments. The bottom line is that this pilot
process has improved timeliness and quality of the data submitted to the Agency,
and required a higher degree of discipline of all parties, particularly the two
government agencies present here today.
Reassessing the OPs While not all
individual organophosphate tolerances will be reassessed by the first deadline,
we are making significant progress with this group of chemicals. So far, over
three hundred organophosphate tolerances have been reassessed through tolerance
revocation actions resulting from voluntary cancellations by the registrants of
nine of the chemicals. Preliminary risk assessments for 10 OPs are now being
prepared and are scheduled to begin Phase 1 this spring. Two OPs are in Phase 2;
none are in Phase 3; and 27 OPs are in Phase 4. We expect that the tolerance
reassessment for all the organophosphate pesticides will be completed in the
year 2000.
"A Reasonable Transition for Agriculture" FQPA set new standards
for pesticide use in food and feed crop production, and both agencies recognize
that how the law is implemented may have important and far reaching
consequences. We are particularly conscious of the potential impacts on minor
crop growers and integrated pest management programs. USDA and EPA will continue
to work with growers and registrants to focus attention and resources on those
situations where limited crop protection alternatives exist.
FQPA reinforced
our commitment to bring new and safer technologies to the marketplace. To be
sure that pesticide users have access to a range of safer pest control tools,
EPA is assigning priority to and expediting the review of reduced risk
pesticides which might be used as alternatives to riskier pesticides--with
special emphasis on organophosphate alternatives. Of 27 new pesticide active
ingredients registered in FY 1998, 14 were done as a result of expedited review.
Both EPA and USDA also are focusing on reducing the risks of existing
pesticides in a manner that accommodates growers' needs. Many existing
pesticides will almost certainly be found to meet the new standard. However,
when the risk of a pesticide is above the safety standard set by law, EPA must
take regulatory action to manage the risk. EPA has identified a range of
regulatory approaches for achieving risk management. This includes a number of
options from amending the product label (a lower application rate, longer
pre-harvest interval, or decreased number of seasonal applications may be enough
to bring the risk down to acceptable levels) to the elimination of some
agricultural and non-agricultural uses. We all agree, the most appropriate
approach is dependent upon the level of risk.
Through the course of our
growing experience with risk assessments, the data used, and the analytical
factors, USDA and EPA have come to realize that, in some cases, a limited subset
of commodities may be the most significant contributors to the total risk. EPA,
in its risk assessments, will attempt to identify those crops/uses that
contribute most to the risk, so that both the government and the growers can
work together to devise effective and sensible solutions.
USDA is taking the
lead role, in cooperation with EPA, in developing transition strategies for
growers. USDA's strategy is, regardless of whether there are pending regulatory
pressures, it is prudent for USDA to begin to work with growers and processors
of the commodities that are anticipated to be major risk contributors and to
proactively research and develop additional pest management tools, and for EPA
to aggressively pursue the registration of promising new pest management tools.
This approach will focus early attention on finding sound and effective
approaches for mitigating risks and also serve to facilitate the transition
process by minimizing any negative impacts on growers as the regulatory
decision-making process proceeds.
Earlier this month, USDA presented
transition considerations to one of the TRAC Working Groups and received some
valuable input from the TRAC membership and EPA. On the basis of this
discussion, USDA's Office of Pest Management Policy will begin to engage willing
commodity groups, crop consultants, and food processors in establishing a
foundation for constructing and implementing broad-based, commodity-specific
transition plans. With the resulting information from this process, and
Congressional support for USDA's proposed FY2000 FQPA implementation budget,
USDA believes that U.S. agriculture will be insured with aggressive and reliable
pest management strategies and a new research and implementation infrastructure
that stays far ahead of the always evolving pesticide regulatory process.
Furthermore, the remaining TRAC meetings will focus on formulating ways to gain
grower input on practical, feasible, and affordable mitigation measures.
In
today's competitive global market, The Administration is also very concerned
about ensuring a level playing field for domestic growers. All food sold in this
country, whether grown domestically or elsewhere, will be subject to the same
tolerance standards.
Any imported produce containing residues above the
tolerance level, or any food with quantifiable residues for a pesticide that
does not have a U.S. tolerance or exemption from tolerance for that food, will
be considered adulterated and subject to FDA's enforcement authorities. We are
concerned that food coming into our ports meet our stringent standards. EPA and
USDA are interested in finding new ways to address the issue of imported
produce. Some possible options would include encouraging advancements in
technology to improve the ability to detect minute residues; promoting increased
monitoring by the government and the private sector, possibly including growers
or distributors; or requiring some form of certification or testing on the
production end to ensure that there is a U.S. tolerance established for the
commodity and that residues are within that tolerance level. EPA will continue
to work with USDA, the Food and Drug Administration, as well as with our major
trading partners through the North American Free Trade Agreement (NAFTA) and
other international forums to ensure all food consumed in the U.S. meets our
standards.
Some of Our Accomplishments Although EPA faced an initial
adjustment period, the Agency's pesticide program is now performing at
historically high levels that reach or exceed pre-FQPA levels. The pace at which
regulatory decisions are made, in all facets of the program, is impressive. For
example, the antimicrobial division has virtually eliminated its backlog of
pending actions; 83 new pesticides have been registered; the current review time
for FIFRA Section 18 emergency exemption requests is the best in EPA's history;
63 Reregistration Eligibility Decision documents have been issued; and over two
thousand existing tolerances have been reassessed.
EPA is pleased to report
that it expects to meet the FQPA deadline of reassessing 33% of all food
tolerances by August 1999. Although we are working hard to meet our risk- and
hazard-based priorities, a number of pesticides which may pose high risk will
not be reassessed in the first 33% given the complexities involved. As of
January of this year, of the 9,728 tolerances subject to reassessment, EPA has
reassessed 2,308 tolerances, of which 303 are for organophosphate pesticides. We
expect to reassess approximately 1,000 more tolerances by August to surpass the
33% target. This "first third" will consist of reassessments from tolerance
revocations, reregistrations, and registration actions.
EPA has also
reassessed a number of non-OP priority pesticide tolerances including 220
tolerances of the carbamates, 50 tolerances of the organochlorine, 187
tolerances of pesticides which are probable (B1) human carcinogens, 105
tolerances of pesticides which are possible (B2) human carcinogens, and 145
tolerances for other, unquantified C carcinogens for a total of 437 tolerances
altogether. Another class of high priority chemicals, identified as possible
carcinogens, are the high hazard "inerts." There are three such ingredients,
formaldehyde, rhodamine B, and phenol, with a total of 24 associated tolerances.
Formaldehyde, which has 22 of the 24 tolerances, is currently under review and
should be reassessed by August 1999.
Resource Needs The new statute has
significantly redirected, and added to, our programs' priorities and
responsibilities. With the development and implementation of new policies,
procedures, and outreach projects, resource needs to support these new
activities are growing. For this reason, additional funding is important for
ensuring smooth implementation of FQPA.
Both Administrator Browner and
Secretary Glickman have identified implementation of FQPA as one of their top
priorities. For EPA, the Agency is seeking increased funding that will be
dedicated to accelerate registration of new pesticides, including reduced risk
and biopesticides. USDA is devoting significant effort and is requesting
additional funding in its FY 2000 budget to help grower groups develop
strategies that will result in reduced risk but still ensure adequate pest
control.
An important part of achieving the Administration's goals in
implementing FQPA as laid out in the Vice President's memo and the
recommendations of the TRAC is winning Congressional support and approval of the
President's Budget currently pending before Congress. The FY2000 budget provides
targeted increases to FQPA and other high priority initiatives within overall
legislated budget targets.
The Future FQPA implementation is proceeding
significantly and efficiently. We now have a process in place through which we
can successfully tackle all of the provisions of the law. While we know that
there are still important issues that need to be resolved, we are confident that
with continued broad stakeholder input, we will reach sound, open, and
common-sense solutions. The FSAC and TRAC's contributions have been
immeasurable. EPA and USDA will continue to seek broad stakeholder input and are
exploring options, including use of the Pesticide Program Dialogue Committee and
other forums, to provide stakeholder input on all pesticide issues.
Conclusion Throughout the implementation process of FQPA, it is important
not to lose sight of the fact that agriculture in this country, and throughout
the world, is constantly changing. Farmers, like all others in business, must
keep pace to remain profitable. New technologies, global markets, fluctuating
commodity prices, and government regulations affect not only the producer, but
everyone who shops at a grocery store. FQPA presents EPA, USDA, and our many
stakeholders with a unique and important opportunity to help farmers and other
pesticide users move to safer pest control tools and methods while improving
public health protection.
Meeting the FQPA mandates demands an effective
multi-front effort to complete the many necessary tasks. While the last three
years have been busy, the last ten months have been even busier. As you can see,
much has happened since the last time EPA and USDA appeared before your
subcommittee. Indeed, significant progress has been made to date, and we are
proceeding at an expeditious rate. We have reaffirmed our commitment to using
sound science in all our decisions so that they are reasonable and consistent;
we are committed to transparency so that our process can be understood and
followed by registrants, growers, the environmental community, and all
interested people; we have begun the development of transition strategies so
that growers have the tools necessary to respond to changing pest control needs;
and we are and will continue to extensively consult with all stakeholders on any
issue related to pesticides so that we can achieve a workable, open, and
accountable regulatory process.
Thank you for the invitation to appear
before your subcommittee this morning. We will be happy to answer any questions
you may have.
TABLE 1 (NOTE: Table not transmittable)
TABLE 2
PILOT
PROCESS FOR ORGANOPHOSPHATE TOLERANCE REASSESMENT
Registrant "Error Only"
Review. EPA sends its preliminary risk assessment to the registrant(s) for a
30-day error correction review only. The registrant(s) are not allowed to
comment on the assessment itself. The preliminary risk assessment is also shared
with USDA. Both the registrant(s) and USDA are asked to correct any Phase 1
computational or other errors that EPA has made in developing its preliminary
assessment.
Consideration of Registrants' and USDA's Comments. EPA
summarizes and considers the comments it receives. EPA corrects any errors
identified and amends the preliminary risk assessment document. During this
phase Phase 2 EPA opens a Public Docket for the chemical.
Preliminary Risk
Assessment is Released for Public Comment. EPA publishes a Federal Register
Notice announcing the availability of the preliminary risk assessment. The
public review period is 60 days. Registrant's, grower groups, other
stakeholders, and the public at large are encouraged to submit data and other
information that would aid EPA in refining the risk assessment. Suggestions for
risk mitigation proposals to Phase 3 address any risk concerns identified in the
document are also solicited. Stakeholder meetings may occur.
Refining the
Risk Assessment. At the close of the comment period, EPA summarizes and
considers the comments, data, and other information received during Phase 3. EPA
refines the risk assessment and identifies any crops that are driving the risk.
The document is sent to USDA for review. Following receipt of USDA's Phase 4
comments, EPA and USDA will hold a technical briefing. Calls for Risk Management
Ideas. EPA releases the refined risk assessment and announces in the Federal
Register its availability along with a formal call for risk management
proposals. Registrants, growers, other stakeholders, and the public are
encouraged to respond and have 60-days in which to submit their proposals. EPA
Phase 5 and USDA may hold stakeholder meetings.
Development of Risk
Management Strategies. EPA considers all of the risk management proposal
received. With input from USDA, EPA develops a set of risk management options
that will ultimately contribute to the Agency's risk Phase 6 management decision
for the pesticide chemical.
END
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April 24, 1999