EBDCs (General Information) Status of Special Review Conducted by EPA 2/92
February 13, 1992
This is to update you on the status of the Special Review of EBDCs
which has been conducted by the Environmental Protection Agency ("EPA"
or "Agency"). These fungicides include mancozeb, maneb, and metiram.
EPA recently completed the Special Review by announcing Position
Document 4 ("PD4"). In its decision, EPA announced that these important
fungicides can continue to be safely used on a wide variety of crops, to
protect them from various plant diseases. Specifically, EPA determined
that the use of EBDCs is appropriate for the 45 crops listed in Table 1.
For those crops not included, the principal manufacturers of EBDCs,
which include BASF Corporation, E.I. du Pont de Nemours & Company, Inc.,
Elf ATOCHEM North America, Inc. and Rohm and Haas Company, have
committed to EPA that they will work with representatives of commodity
groups who are interested in using EBDCs on other crops, to develop
additional data that could support the use of EBDCs on those crops.
EPA initiated the EBDC Special Review in 1987. The review was
intended to assess the risk/benefit profile of EBDCs. In response to
the Special Review, the basic manufacturers formed the EBDC/ETU Task
Force. The Task Force, in conjunction with various agricultural
commodity groups, made a substantial commitment to conduct additional
studies that provided the Agency with updated scientific data on the
risks and benefits of EBDCs. For example, an extensive market basket
survey of various foods was undertaken to better identify the potential
consumer exposure to EBDCs and a breakdown product, ethylenethiourea
("ETU"). After collection and analysis of approximately 6,000 food
samples, it was determined that more than 80 percent of these samples
showed no residues of EBDCs or ETU. Of the remaining limited number of
samples, most of these contained residues at trace amounts, generally
near the very low limits of detection. This confirms that consumer
exposure to EBDCs is extremely low, virtually non-existent.
In addition, an analysis of data used to calculate the toxicity
factor or Q* led to a significant reduction in this number. The Q* is a
key component used in calculating the theoretical risk of EBDCs. This
modification was made after an extensive review of all applicable data
by an independent review panel of noted statisticians and by the FIFRA
Scientific Advisory Panel.
The Task Force and agricultural commodity groups also submitted
data to EPA on the substantial benefits of EBDCs. These data allowed
the Agency to refine the benefit profile. In PD 2/3, the Agency
estimated that the overall benefits of EBDCs was $136 to $380 million.
After receipt of additional information, the EPA concluded in PD4 that
the overall benefits of EBDCs exceeded $260-$500 million. This change
was a direct result of the new information provided to the Agency.
Efforts will be made to allow growers to use EBDCs for the 1992
growing season. EPA is expected to shortly approve necessary label
Tolerances for the crops that were maintained will remain at their
current level. EPA may issue a proposal for revoking the other
tolerances in the future.
The Task Force commends EPA and its staff on the manner in which
the Special Review was conducted. The Agency sought to make a sound
scientific regulatory decision and they achieved that goal. As a
result, the current label uses can be substantially expanded.
In case you have questions on EBDCs, we have enclosed a series of
"Questions and Answers." Please contact me at (215) 592-3058 if any
additional information is required.
Janet Ollinger, Ph.D.
EBDC/ETU Task Force
FOR IMMEDIATE RELEASE
From: EBDC/ETU Task Force
1850 K Street, N.W.
Washington, D.C. 20006
Contact: Edward M. Ruckert (202) 778-8214
Counsel for the EBDC/ETU Task Force
INDUSTRY TASK FORCE APPLAUDS EPA FINDINGS ON EBDCS
WASHINGTON, D.C., February 13 , 1992 -- The EBDC/ETU Task Force,
composed of BASF Corporation, the Du Pont Company, Elf ATOCHEM North
America, Inc. and Rohm and Haas Company, today announced that it is
gratified that the EPA has reached a successful completion of its review
of ethylenebisdithiocarbamates (EBDCs). These companies represent the
major manufacturers of EBDCs. Based on EPA's review, these important
fungicides can continue to be safely used on a wide variety of crops in
the United States to protect America's food supply from various plant
EBDCs are a class of agricultural fungicides that include mancozeb,
maneb and metiram. In its decision, EPA has determined that use of
EBDCs may be continued on 45 crops. See Table 1.
EPA has determined that the benefits associated with the continued
use of these fungicides is $260-$500 million.
EPA initiated its review of EBDCs in 1987. In response, the
EBDC/ETU Task Force, in conjunction with various agricultural commodity
groups, committed to conduct additional studies providing the Agency
with updated scientific data on the risks and benefits of EBDCs. This
included undertaking one of the most extensive "market basket" studies
ever conducted, involving the collection and analysis of approximately
6,000 food samples. Through this study, potential consumer exposure to
residues of EBDCs was determined to be virtually non-existent.
Dr. Janet Ollinger, Chairperson of the Task Force, said "EBDCs are
much needed fungicides used on many fruits and vegetables grown in the
United States. Consequently, the outcome of the Agency's review is
particularly important to American agriculture. The Task Force
compliments EPA in its handling of the EBDC review. With the
involvement of all interested parties, the Agency was able to make its
regulatory decision based upon sound, scientific information. The
Agency's personnel are to be commended for their work in successfully
completing the EBDC review process."
# # #
NOTE TO EDITORS:
For more specific Task Force information including Questions and
Edward M. Ruckert
Counsel for the EBDC/ETU Task Force
For specific information concerning the member companies of the
Task Force, contact any of the company representatives listed below:
Rohm and Haas Company
Du Pont Company
Elf ATOCHEM North America, Inc.
TABLE 1. ACCEPTABLE USES OF EBDCS
Corn -- Field, Pop and Sweet
Lettuce -- Head and Leaf
Onions -- Dry bulb and Green
Squash -- Summer and Winter
EBDC SPECIAL REVIEW
KEY QUESTIONS AND ANSWERS
EBDC/ETU TASK FORCE*
E.I. du Pont de Nemours and Company, Inc.
Elf ATOCHEM North America, Inc.
Rohm and Haas Company
Questions and Answers Concerning
Completion of the EBDC Special Review
1. WHAT ARE EBDCS?
EBDCs (ethylenebisdithiocarbamates) are a class of agricultural
fungicides including mancozeb, maneb and metiram. They have been
important crop protection tools for more than 40 years.
2. WHAT IS A SPECIAL REVIEW?
A Special Review is an administrative process conducted by the
Environmental Protection Agency to evaluate the risks and benefits of a
pesticide. If the Agency determines that the benefits are substantial
and the risks are negligible, the use can be maintained. If the Agency
determines that the risks of use of a pesticide exceed its benefits,
that use will be canceled by EPA.
3. WHY WAS THE SPECIAL REVIEW OF EBDCS INITIATED?
The EBDC Special Review commenced in 1987. EBDCs themselves are
known to be generally nontoxic. EPA, however, had concerns about ETU
(ethylenethiourea), a degradation product of EBDC fungicides. Animal
studies using extremely high levels of ETU have shown an increase in
animal tumors. However, actual exposure to ETU in consumers is so low
that high margins of safety exist.
4. WHEN THE SPECIAL REVIEW WAS INITIATED, WHAT WAS THE RESPONSE OF THE
MAJOR MANUFACTURERS OF EBDCS?
The major manufacturers of EBDCs are Elf Atochem Worth America,
Inc., BASF Corporation, the Du Pont Company and Rohm and Haas Company.
These companies formed the EBDC/ETU Task Force when the Special Review
was initiated. The purpose of the Task Force was to conduct additional
studies that would allow EPA to better define the risk/benefit profile
of these fungicides. This also included communicating with interested
agricultural commodity groups and working with them to provide reliable
data to the Agency.
5. WHEN DID EPA COMPLETE ITS EBDC SPECIAL REVIEW?
On February 13, 1992, EPA completed the Special Review of EBDCs by
announcing Position Document 4 ("PD4").
6. WHAT DID EPA CONCLUDE AS ITS FINAL REGULATORY DECISION ABOUT THE
CONTINUED USE OF EBDCS?
EPA announced in PD4 that the use of EBDCs on 45 crops was
appropriate. For these crops, the EPA determined that the benefits of
use outweighed the risks of use.
7. WHAT IS THE REACTION TO THE AGENCY'S DECISION TO CANCEL CERTAIN CROP
USES FOR EBDCS?
At the time the EBDC Special Review was initiated, there were 55
registered uses. To allow the review process to proceed, and to reduce
the theoretical risk determined on the basis of the then existing data
base, the manufacturers voluntarily withdrew 42 of these crop uses.
Based on the development of subsequent data, the Agency determined that
many of these uses could be added back to the registrations. The
manufacturers are pleased with this result.
8. WHAT DID EPA DETERMINE IS THE THEORETICAL RISK TO EBDCS?
In PD4, EPA determined that the theoretical risk from exposure to
EBDCs on the 45 crops cumulatively is negligible. The total theoretical
risk from all these uses was approximately one in a million (1 x 10-6).
The risk for each individual crop use was even lower, ranging between
10-7 to 10-1l (one in a hundred billion).
9. WHAT INFORMATION DID EPA USE IN REACHING ITS FINAL DECISION?
The decision was based on one of the most extensive databases the
Agency has ever assembled on any agricultural chemical. It included a
Market Basket Survey, additional toxicity data and analysis, and
substantial benefits data. The data and analyses were subjected to
rigorous scientific review. The data included information both on the
risks of EBDCs and their benefits.
10. HOW DOES EPA DETERMINE THE RISK OF A PESTICIDE?
EPA uses a mathematical approach to determine the risk of a
pesticide. Simply stated, this is Risk = Exposure x Toxicity. The
toxicity factor is known as Q*. Exposure is the amount of the pesticide
that a consumer might ingest. For EBDCs, a Market Basket Survey
demonstrated that actual exposure to these fungicides is very low.
11. HOW DID EPA DETERMINE POTENTIAL EXPOSURE TO EBDCS AND ETU?
The Agency principally relied on the Market Basket Survey to
determine consumer exposure to these materials. The Survey involved the
collection and analysis of almost 6,000 food samples, including both
fresh and processed foods, collected from hundreds of supermarkets
throughout the United States. More than 80 percent of these food
samples did not show any residues of EBDC or ETU. For the remaining
samples, most of these had trace residues, generally near the very low
limits of detection associated with the analytical methodology.
Essentially, these residues were between one-tenth and one-one hundredth
of the maximum residues legally permitted to be present.
12. WHAT IS A Q* (Q STAR)?
The Q* is used by EPA in its risk assessment process to measure the
toxic potency of a chemical. The Q* factor is a number that scientists
have calculated based on toxicity studies performed on laboratory
animals exposed to the chemical. The Agency uses it in determining the
theoretical lifetime risk that the consumer may have from eating foods
treated with a particular agricultural chemical.
13. IN DETERMINING THE Q* IN PD4, WHAT INFORMATION DID EPA GENERALLY
EPA relied on recently available data derived from a study of ETU
performed by the National Toxicology Program, an agency of the U.S.
Department of Health and Human Services. The EPA included in its
deliberations an analysis of these data by an Independent Review Panel
comprised of some of the leading statisticians in the United States.
Their unanimous conclusion was that the Q~ value should be reduced from
the preliminary estimate of 0.6 to 0.1. Their scientific approach
subsequently was confirmed by the FIFRA Scientific Advisory Panel.
14. WHAT ARE THE BENEFITS OF EBDCS?
The EPA has determined that the benefits of use are significant.
The total economic benefits exceed $260-$500 million. Use of EBDC
fungicides prevents disease development in a variety of crops. There are
approximately 400 plant diseases controlled by EBDCs. Further, their use
assists the implementation of Integrated Pest Management Programs to
reduce overall applications of all chemicals used. This not only assists
in protecting the environment, but also helps farmers produce wholesome
crops more economically.
15. WHAT IMPACT WILL THE COMPLETION OF THE SPECIAL REVIEW HAVE ON
At this time, it is expected that tolerances for the 45 crops will
remain unchanged. A lower tolerance for apples, based on the residues
found using a new use-pattern, may be proposed shortly. For crops other
than the aforementioned 45 crops, any existing tolerances may be
proposed by EPA for cancellation.
16. WILL THE GROWERS BE ABLE TO FULLY USE EBDCS THIS YEAR?
The Task Force members have submitted the necessary amended labels
to EPA to make the appropriate changes to the product registrations.
The Agency is actively reviewing the labels. We hope to have the
necessary changes approved and issued by this Spring.
17. DOES THE TASK FORCE ANTICIPATE FURTHER STUDY OF EBDCS?
We believe that the EPA has made its final determination on the
safety of EBDCs. However, as responsible companies we will continue to
exercise product stewardship over all of our agricultural products,
including EBDCs, to assure safety and effectiveness. We will continue
to cooperate with regulatory and scientific agencies to ensure that
these products remain available to the agricultural community.
18. WHAT WAS THE RESPONSE OF THE TASK FORCE TO EPA'S HANDLING OF THE
EBDC SPECIAL REVIEW?
The Task Force commends EPA and its personnel on the manner in which the
Special Review was conducted. The Agency sought to assure that the
final regulatory decision was made on sound, credible science and we
believe it accomplished this goal.