Chem-News March 1993
UNITED STATES ENVIRONMENTAL PROTECTION AGENCY
Delaney Clause update
The U.S. Environmental Protection Agency has compiled the following lists of
pesticides and their uses to evaluate those that may possibly be affected by
the recent Ninth Circuit Court of Appeals decision (Les vs Reilly) concerning
the Delaney clause. These lists are being released in conjunction with a
notice issued on February 5, 1993 (available from PMEP) soliciting public
comment on a variety of issues concerning the Delaney clause and whether EPA
should modify its policy for regulating pesticides in processed food. Whether
or not many of these uses are affected depends on the resolution of several
complex scientific and policy issues described in that notice.
The Delaney clause in the Federal Food, Drug, and Cosmetic Act (FFDCA)
provides that no additive including pesticides may be approved in processed
food if it has been found to induce cancer in man or animals. EPA regulates
pesticide residues in food under FFDCA and has interpreted the Delaney clause
as subject to an exception for carcinogenic pesticides that pose only a
negligible risk. This interpretation was adopted in 1988 upon the
recommendation of the National Academy of Sciences.
The EPA does not believe that the pesticides in the following lists pose an
unreasonable risk to public health. The current debate is not about health
risks, but about the legal interpretation of the statute. However, the Agency
does believe that the impact of the Ninth Circuit Court's decision upon
pesticide users and food processors could be substantial.
In July 1992, the Ninth Circuit overturned EPA's interpretation of the Delaney
clause, holding that the Delaney clause bars tolerances (maximum allowable
levels of residues in food) for carcinogenic pesticides in processed food
without regard to the degree of risk. On February 22, 1993, the U.S. Supreme
Court declined to review the petition for writ of certiorari that had been
filed by the National Agricultural Chemicals Association (NACA). The decision
not to review the Delaney amendment to the Federal, Food, Drug and Cosmetic
Act essentially means that EPA is now required to begin evaluating pesticides
under the Delaney clause.
The pesticide uses affected by the Court's refusal to review Delaney may be
considerably smaller than the attached lists. First, EPA has not made a final
determination whether these pesticides meet the "induce cancer" standard in
the Delaney clause. Second, many of the pesticide uses on the attached lists
involve animal feeds, and EPA has not evaluated whether those uses qualify for
the limited exemption to the Delaney clause for animal feeds. Finally, the
notice EPA issued on February 5, 1993 requesting comment discusses several
policy issues, the resolution of which will affect precisely what pesticide
uses are affected and the extent of that effect.
Conversely, these lists should not be viewed as definitive or final because
there may be additional pesticides that are affected, but are not included in
these list. Because the Agency continues to receive data on carcinogenicity
and processing studies through its reregistration and tolerance reassessment
programs, the number of pesticides and uses could grow considerably. The
release of these lists does not affect the regulatory status of any of the
pesticides or uses listed. If EPA proposes to revoke tolerances under the
FFDCA, the Agency will use appropriate procedures in each instance, including
seeking public notices and comments.
Pesticide Uses Potentially Affected by Revocation of All Section 409 and
Corresponding Section 408 Tolerances
The following lists of pesticides and their uses may potentially be affected
should EPA be held to a strict interpretation of the Delaney clause. The
following pesticides do not constitute a list of active ingredients which EPA
has determined to "induce cancer" within the meaning of the Delaney clause,
but rather presents lists of pesticides which may possibly fall within that
standard based on EPA's evaluation of the potential carcinogenicity of the
pesticides under its cancer classification guidelines. Likewise, these lists
should not be viewed as definitive or final because they include some
pesticides that ultimately many not be affected; there also may be additional
pesticides that are affected, but are not included in today's lists. Because
the Agency continues to receive data on carcinogenicity and processing studies
through its reregistration program, the number of pesticides and uses could
grow considerably. The release of these lists does not affect the regulatory
status of any of the pesticides or uses listed. If EPA proposes to revoke
tolerances under the Federal Food, Drug and Cosmetic Act, the Agency will use
appropriate procedures in each instance, including seeking notice and comment
where appropriate.
List I
REGISTERED PROCESSED FOOD/FEED
PESTIClDE RAW CROP (408s) WITH 409 TOLERANCE(S)
_________ _______________ _____________________
Acephate Cotton Seed Hulls (186.100)
Meal (186.100)
Soybeans Meal ( 186.100)
Food handling
establishments (185.100)
*Benomyl Apples Pomace (Dried) (186.350)
Citrus Pulp (dried) (186.350)
*Grapes Pomace (dried) (186.350)
*Raisins (185.350)
Raisin Waste (186.350)
Rice Hulls (186.350)
*Tomatoes *Puree or Catsup (185.350)
Captan Grapes Raisins (185.500)
Corn Seed (detreated)(186.500)
*Dichlorvos *Packaged goods (Proposed
for revocation) (185.1900)
*Dicofol *Tea (dried)(Processed for
revocation)(185.410)
Dimethipin Cotton Seed Hulls (186.2050)
Dimethoate Citrus Pulp (dried)(186.2100)
Ethylene Oxide Whole spices Ground Spices (185.2850)
Copra, Black Walnut Meats
*Mancozeb *Barley *Bran (185.6300) (revocation
Proposed)
Flour (185.6300)
Milled Fractions (186.6300)
*Grapes *Raisins (185.6300)
*Oats *Bran (185.6300)
revocation proposed)
Milled fractions (186.6300)
Flour (185.6300)
Rye Flour (185.6300)
*Bran (185.6300)
Milled Fractions (186.6300)
*Wheat *Bran (185.6300)
Flour (185.6300)
Milled Fractions (186.6300)
Methomyl Dried hops (185.4100)
Norflurazon Citrus Fruit Molasses (186.4450)
Pulp (dried) (186.4450)
Dried hops (185.4450)
Oxyflurofen Cotton Seed Oil (185.4600)
Peppermint Oil (185.4600)
Spearmint Oil (185.4600)
Soybean Oil (185.4600)
*Phosmet *Cotton *Seed oil (Crude and
Refined)(185.3950)
Propargite Apples Dried pomace (186.5000)
Grapes Raisins (185.5000),Dried pomace
(186.5000)
Figs Dried (185.5000)
Citrus Pulp (186.5000)
Hops Dried hops (185.5000)
Tea Dried tea (185.5000)
Simazine Sugarcane Molasses, byproducts
(185.5350)
Syrup, byproducts (185.5350)
Potable water (185.5350)
Thiophanate- Apples Pomace (dried)(186.5700)
methyl
Triadimefon Apples Pomace (186.800)
(Bayleton)
Barley Milled Fractions, excluding
flour (185.800)
Grapes Pomace (186.800)
Raisin Waste (186.800)
Wheat Milled Fractions excluding
flour (185.800
*Trifluralin *Peppermint *Oil (185.5900)
(Treflan)
*Spearmint *Oil (185.5900)
List II
The following list of pesticides do not have established section 409 food
additive tolerances, but based upon data indicating concentration during
processing, would require food additive tolerances under EPA's current policy.
REGISTERED CROP(S) WITH SECTION PROCESSED FOOD(S) WITH
PESTICIDE 408 T0LERANCE(S) NO SECTION 409 TOLERANCE(S)
__________ ____________________ __________________________
Acephate soybean Hulls
Alachlor peanuts Meal
sorghum Flour, Bran, and Germ
soybeans Hulls, Meal
sunflower seed Meal
Asulum sugarcane Bagasse and Molasses
Atrazine sugarcane Bagasse, Molasses
Benomyl rice Bran
Captan apples Dried Pomace
grapes Raisin Waste, Juice and Dried
Pomace
plums Prunes
tomatoes Dried Pomace
Chlorothalonil soybeans Hulls
potatoes Wet Peel
Dicamba barley Hulls, Bran, Pearl Barley
millet Hulls, Meal
oats Hulls, Rolled Oats
wheat Bran, Shorts, Middlings
Dichlorvos Food handling establishments
Dicofol apples Dried Pomace
citrus Oil
grapes Dried Pomace, Raisins, Raisin
Waste
Dried Hops
Dimethoate apples Juice
citrus Oil
Hexazinone sugarcane Bagasse and Molasses
Lindane tomatoes Dried Pomace
Linuron potatoes Dry & Wet Peel,Dehydrated
Granules,
Chips
Mancozeb apples Dried Pomace
grapes Raisin Waste
sugar beets Pulp
wheat Middlings
Maneb apples Dried Pomace
sugar beets Pulp
grapes Raisin Waste
Methidathion citrus Oil
Metiram apples Dried Pomace
sugar beets Pulp
Metolachlor peanuts Meal
Methomyl wheat Bran
Oxyflurofen apples Dried Pomace
PCNB potatoes Wet and Dried Peel
tomatoes Dried Pomace
Permethrin tomatoes Dried Pomace (Restricted to
fresh tomatoes)
Phosmet citrus Oil
Propargite citrus Oil
plums Prunes
grapes Raisin Waste
Simazine sugarcane Bagasse
Triadimefon pineapple Bran
Summary of EPA Announcement Relating to the Delaney clause
The Delaney clause in the Federal Food, Drug and Cosmetic Act (FFDCA) provides
that no additive (including pesticides) may be approved for processed food if
it has been found to induce cancer in man or animals;
EPA regulates pesticides residues in food under FFDCA and has interpreted the
Delaney clause as subject to an exception for carcinogenic pesticides that
pose only a negligible risk (this interpretation was adopted in 1988 upon the
recommendation of the National Academy of Sciences).
In July l992, the Ninth Circuit Court of Appeals overturned EPA's
interpretation of the Delaney clause, holding that the Delaney clause bars
tolerances (maximum allowable levels of residues in food) for carcinogenic
pesticides in processed food, regardless of the degree of risk.
On February 22, 1993 The U.S. Supreme Court declined to review the petition
for writ of certiorari that had been filed by the National Agricultural
Chemicals Association (NACA). The decision not to review the Delaney
amendment to the Federal, Food, Drug and Cosmetic Act essentially means that
EPA is now required to begin evaluating pesticides under the Delaney clause.
The Agency has developed a list that includes pesticide/crop combinations
which may possibly be affected by the recent Ninth Circuit Court of Appeals
decision overturning EPA's de minimis policy.
EPA does not believe that the pesticides in these lists pose an unreasonable
risk to public health based on the available data.
These lists do not represent an EPA conclusion that each of these pesticides
uses will be cancelled. Rather, these lists describe the universe of
pesticide uses which could be affected.
Whether or not many of these uses are affected depends on the resolution of
several complex policy as well as scientific issues.
On February 5, 1993, the Agency issued a Federal Register Notice asking the
public to comment on these scientific policy issues.
The release of these lists does not affect the regulatory status of any of the
pesticides or uses listed.
If EPA proposes to revoke tolerances under the FFDCA, the Agency will use
appropriate procedures in each instance, including seeking public comment.
WGS/3/93
Disclaimer: Please read
the pesticide label prior to use. The information contained at this web
site is not a substitute for a pesticide label. Trade names used herein
are for convenience only; no endorsement of products is intended, nor is
criticism of unnamed products implied. Most of this information is historical
in nature and may no longer be applicable.
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