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EBDCs (General Information) Status of Special Review Conducted by EPA 2/92

                                                       February 13, 1992
Dear Colleague:

     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 
changes

     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.

                                        Sincerely,

                                        Janet Ollinger, Ph.D.
                                        Chairperson
                                        EBDC/ETU Task Force


FOR IMMEDIATE RELEASE

From:     EBDC/ETU Task Force
          1850 K Street, N.W.
          Suite 450
          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 
diseases.

    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 
Answers, contact:

     Edward M. Ruckert
     Counsel for the EBDC/ETU Task Force
     (202) 778-8214

     For specific information concerning the member companies of the 
Task Force, contact any of the company representatives listed below:

     George Bochanski
     Rohm and Haas Company
     (215) 592-3248

     James Murphy
     BASF Corporation
     (201) 316-3280

     Trish Williams
     Du Pont Company
     (302) 992-6810

     William Spencer
     Elf ATOCHEM North America, Inc.
     (215) 587-7885

                      TABLE 1.  ACCEPTABLE USES OF EBDCS

                                    Almonds
                                    Apples
                                   Asparagus
                                    Bananas
                                    Barley
                                    Broccoli
                                Brussels sprouts
                                    Cabbage
                                   Cantaloupe
                                   Cauliflower
                                  Casaba melons
                           Corn -- Field, Pop and Sweet
                                     Cotton
                                Crabapples/quince
                                   Cranberries
                                 Crenshaw melons
                                   Cucumbers
                                  Dried beans
                                    Eggplant
                                     Endive
                                     Fennel
                                      Figs
                                     Grapes
                                 Honeydew melons
                                      Kale
                                    Kohlrabi
                            Lettuce -- Head and Leaf
                                    Meat/Milk
                                      Oats
                           Onions -- Dry bulb and Green
                                     Papaya
                                     Peanuts
                                      Pears
                                     Pecans
                                     Peppers
                                    Pineapple
                                    Potatoes
                                    Pumpkins
                                      Rye
                           Squash -- Summer and Winter
                                   Sugar beets
                                    Tomatoes
                                   Watermelon
                                      Wheat

                          EBDC SPECIAL REVIEW
                       KEY QUESTIONS AND ANSWERS
                          EBDC/ETU TASK FORCE*
 
                             FEBRUARY, 1992

                                                   *BASF Corporation
                              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 
RELY ON?

     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 
TOLERANCES?

     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.