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EBDCs (General Information) Mancozeb Fact Sheet

MANCOZEB FACT SHEET

On May 6, 1992 EPA issued a Decision denying a 1989 petition by the State of 
California, Natural Resources Defense Council (RDC) and others to revoke the 
food additive regulations for the pesticide mancozeb on raisins and the bran 
of barley, oats, rye, and wheat.  This decision is based on EPA's finding that 
mancozeb in these foods poses a de minimis cancer risk and on EPA's 
interpretation that the Delaney clause in the Federal Food, Drug and Cosmetic 
Act contains an exception for potentially carcinogenic pesticides which pose a 
de minimis risk.

Background:

The fungicide mancozeb is one of a group of pesticides known as ethylene 
bisdithiocarbamates (EBDCs) registered for use on a variety of vegetable, 
fruit, nut and grain crops.

On May 25, 1989, the State of California, the NRC, Public citizen, the AFL-
CIO, and several others petitioned EPA to revoke 14 food additive regulations. 
Seven pesticides were involved in the petition, including mancozeb.

The petitioners cited the Delaney clause in section 409 of the Federal Food, 
Drug and Cosmetic Act (FFDCA) as the basis for the request.  Interpreted 
literally, the Delaney clause appears to bar absolutely the issuance of a 
regulation for a food additive that has been found to induce cancer in test 
animals.  FFDCA requires that food additive tolerances be established when a 
pesticide is applied directly in food processing or concentrates in processed 
food to a level greater than in the raw commodity.

The petitioners argued these food additive regulations should be revoked 
because the pesticides to which the regulations applied were animal 
carcinogens and, consequently, the regulations violated the Delaney anti-
cancer clause.  That petition included the food additive regulations for the 
use of mancozeb on raisins, and bran of barley, oats, rye, and wheat.

EPA'S final order in response to that petition postponed a decision on the 
mancozeb food additive regulations pending completion of an administrative 
review known as a "Special Review" for EBDC chemicals.  The Special Review was 
recently concluded and resulted in a finding that the potential risks for the 
five mancozeb used in the petition range from two in one billion to two in 100 
billion.  EPA concluded that the risks are de minimis and, therefore, that the 
food additive regulations should not be revoked.


COMMUNICATIONS PLAN FOR THE OFFICE OF PESTICIDE PROGRAMS

Key Word Title:  Mancozeb

Official Title:  Section 409 Tolerances; Order Regarding Mancozeb Food
                 Additive Regulations

Importance:  Medium

Projected Announcement Date:  mid May 1992

Contact Person:  Dennis Ulterback
                 SRRD/Special Review Branch
                 703-308-8026

Background:

The fungicide mancozeb is one of a group of pesticides known as ethylene 
bisdithiocarbamates (EBDCs) registered for use on a variety of vegetable, 
fruit, nut and grain crops.

On May 25, 1989, the State of California, the Natural Resources Defense 
Council, Public Citizen, the AFL-CI0, and several others petitioned EPA to 
revoke certain food additive regulations for seven carcinogenic pesticides 
including mancozeb.  The petitioners cited the Delaney clause in Section 409 
of the Federal Food, Drug and Cosmetic Act (FFDCA) as the basis for the 
request.  Interpreted literally, the Delaney clause appears to bar absolutely
the issuance of a regulation for a food additive that has been found to induce 
cancer in test animals.  FFDCA requires that food additive tolerances be 
established when a pesticide is applied directly in food processing or 
concentrates in processed food to a level greater than in the raw commodity.

EPA issued a final Order on the petition (February 25, 1991) postponing a 
decision on the mancozeb food additive regulations pending completion of an 
administrative review known as a "Special Review" or EBDC chemicals.  The 
Special Review of EC pesticides was issued on Feb 13, l992 and resulted in a 
determination that the five mancozeb uses in the petition should not be 
cancelled. Based on the information in the Special Review, EPA determined that 
the five uses pose only a de minimis risk of cancer.  As a result, the Agency 
has decided not to revoke the related food additive regulations.

Action/Effect of Action:

EPA is issuing a final order which denies the 1989 State of California/NRDC 
petition request to revoke the food additive regulations for the pesticide 
mancozeb for raisins and bran or barley, oats, rye, and wheat.

Message:

This decision is based on EPA's finding that mancozeb in these foods poses a 
de minimis cancer risk and on EPA's interpretation that the Delaney clause in 
the Federal Food, Drug and Cosmetic Act contains an exception for potentially 
carcinogenic pesticides which pose a de minimis risk.  Therefore, EPA will not 
revoke the food additive regulations for the use of mancozeb on raisins and 
bran of barley, oats, rye, and wheat as requested in the State of California's 
1989 petition.

Audience / Anticipated Reaction:

The primary audience will consist of the original petitioners, environmental 
groups, and mancozeb users.  Petitioners/some environmental groups may argue 
with this decision since they still advocate a "zero risk of cancer" approach 
to pesticide regulation.

Since users will be able to continue using mancozeb, we foresee little 
reaction from them.  There has been little public response to our original 
February 1991 Order.

Strategy:

The Federal Register notice was signed by Linda Fisher on May 6, 1992 and will 
be published in the Federal Register on about May 13, 1992.  A press advisory 
will be issued on May 15.  A fact sheet on mancozeb will be provided to the 
recipients.  Copies of the FR notice, fact sheet, and the press advisory will 
be mailed to those listed on the attached notification plan.

Notification Plan:  see attached sheets for timing instructions and list of 
names.  SRRD/SR will also notify Codex members.