United States Prevention, Pesticides EPA-738-R-02-011
Environmental Protection and Toxic Substances July 31, 2002
Agency (7508C)
Reregistration
Eligibility Decision (RED)
Benomyl
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July 31,2002
This document serves as and explains EPA's reregistration eligibility decision (RED) for benomyl.
Benomyl was scheduled for reregistration in 2002; however, the registrants of benomyl have requested voluntary
cancellation. The following provides background information on the pesticide registration, reregistration, and
tolerance reassessment, an overview of the uses and health effects associated with benomyl, and a summary of
the terms of its cancellation. Because of the voluntary cancellation decision, EPA did not complete risk
assessments for benomyl.
Introduction
In 1988, the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) was amended to accelerate
the reregistration of products with active ingredients registered prior to November 1, 1984. The amended Act
provides a schedule for the reregistration process to be completed in nine years. There are five phases to the
reregistration process. The first four phases of the process focus on identification of data requirements to support
the reregistration of an active ingredient and the generation and submission of data to fulfill the requirements. The
fifth phase is a review by the U.S. Environmental Protection Agency (referred to as "the Agency") of all data
submitted to support reregistration.
FIFRA Section 4(g)(2)(A) states that in Phase 5 "the Administrator shall determine whether pesticides
containing such active ingredient are eligible for reregistration" before calling in data on products and either
reregistering products or taking "other appropriate regulatory action." Thus, reregistration involves a thorough
review of the scientific data base underlying a pesticide's registration. The purpose of the Agency's review is to
reassess the potential hazards arising from the currently registered uses of the pesticide; to determine the need for
additional data on health and environmental effects; and to determine whether the pesticide meets the "no
unreasonable adverse effects" criterion of FIFRA.
On August 3, 1996, the Food Quality Protection Act of 1996 (FQPA) (Public Law 104-170) was
signed into law. FQPA amends both the Federal Food, Drug, and Cosmetic Act (FFDCA), 21 U.S.C. 301 et
seq., and the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA), 7 U.S.C.136 et seq. The FQPA
amendments went into effect immediately. This document presents the Agency's decision regarding the
reregistration eligibility of the registered uses of benomyl.
Background
Benomyl was first registered in 1969 by E.I. du Pont de Nemours and Co.(DuPont). EPA issued a
Registration Standard for benomyl in June 1987. A June 1992 Data Call-in (DCI) required additional data.
DuPont voluntarily canceled registrations for dry flowable (DF) products in 1995. Over the years, DuPont also
canceled the following use sites: post harvest use on apples, citrus, pineapple, bananas, pears, and stone fruit;
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flowers; ornamentals; bulbs; shade trees; greenhouse, dip treatment for sugarcane, drench treatment for
strawberry plants; and turf and residential uses. On April 18, 2001, DuPont requested voluntary cancellation of
all its benomyl registrations. EPA published a Federal Register Notice on May 23, 2001 (Federal Register
Notice, OPP-66288; FRL-6794-9), announcing receipt of DuPont's request for cancellation and inviting the
public to comment during the next 30 days. The Agency considered the comments submitted and on August 8,
2001, the cancellation of benomyl registrations became effective. All other companies holding benomyl product
registrations, except one end-use registrant, have requested and obtained voluntary cancellation of their benomyl
products. See 6(f) notice in the Federal Register (FR) on October 12, 2001, and cancellation order on January
15, 2002. The remaining end-use registrant requested a voluntary cancellation of its registration on July 31, 2002
(described more fully below). Upon the effective date of the remaining voluntary cancellation request, all benomyl
registrations will be canceled.
Uses
Benomyl was registered as a systemic foliar fungicide for control of a wide range of diseases of fruits,
nuts, vegetables, and field crops. Benomyl was formulated as a wettable powder (WP) and wettable powder in
water soluble film (i.e., packets WSP), both of which contained 50 percent active ingredient. These formulations
were applied as delayed dormant, foliar, seed, and seed piece treatments. Application techniques included
airblast, aerial, tractor-drawn equipment (groundboom or spreader), chemigation, and hand held equipment.
Benomyl was registered for use on the following crops: almonds, apples, anise, apricots, asparagus, avocado,
banana, barley, bean vine, blueberries, brassica (broccoli, Brussels sprouts, cabbage, chicory, Chinese cabbage,
cauliflower, collards, kale, kohlrabi, mustard greens, rutabagas, and turnips), caneberries (raspberries,
blackberries, boysenberries, loganberries, and dewberries), cardoon, carrots, celery, cherries, citrus, conifers,
corn, cucurbits (cucumber, melons, pumpkins, and squash), currants, dandelions, dill, figs, grapes, macadamia
nuts, mangoes, mushrooms, nectarines, onions, oats, papayas, peaches, peanuts, pears, peas, pecans, peppers,
pineapple, pistachio, plums, prunes, rape, rice, rye, soybeans, spinach, strawberry, sugar beets, tomatoes, wheat,
and yams.
Health Effects
Benomyl rapidly degrades to carbendizim (MBC) which is also of lexicological concern. MBC is the
primary metabolite of thiophanate methyl, another fungicide, and is also registered as an active ingredient.
Effects associated with both benomyl and MBC include liver toxicity, developmental toxicity (such as
fetal eye and brain malformations and increased mortality), and reproductive (testicular) effects.
Both benomyl and MBC are also considered possible human carcinogens.
Data Gaps
The following set forth the substantive data gaps for benomyl/MBC:
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Toxicology
Developmental neurotoxicity (DNT) study in rats (benomyl)
DNT in rats (MBC)
21-day dermal in rats (MBC)
2-generation rat reproduction and subchronic studies (MBC)
Product chemistry
• UV/Visible Absorption (benomyl tgai)
• Enforcement analytical methods (benomyl tgai)
Residue Chemistry
• Limited or full rotational crop residue studies (or modify labels to prohibit crop rotations)
• Lab validation for residue method used to recover the metabolite 2-AB and an Agency
method try-out for use as an enforcement method.
Multiresidue data for 2-AB, 4-HBC and 5-HBC.
• Storage stability data to support tolerances in plant and animal commodities
Additional residue data for apricots and nectarines
Occupational Exposure
Mixer/loader, applicator exposure for commercial seed/seedling treatment uses and dip
uses.
Environmental Fate and Effects
There are no outstanding data requirements for benomyl or MBC except for plant toxicity data.
Outstanding plant toxicity studies using benomyl TEP (50% WP):
• 850.4100 - Tier I Seedling Emergence
850.4150- Tier I Vegetative Vigor
850.4400- TierlLemnagibba
• 850.5400 - Tier I Algal toxicity using: Pseudokirschneria subcapitata (Selenastrum
capricornutum\ Anabaenaflos-aquae, Navicula pelliculosa, and Skeletonema
costatum.
A formulation other than the 50WP may trigger additional ecotoxicity studies for aquatic and terrestrial
plants and animals (to be evaluated on a case-by-case basis).
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Since the source has been canceled, a generic data exemption no longer applies.
Tolerances
100 tolerances existed for food and feed items such as fruits and nuts, vegetables, soybeans, grains,
meat, milk, and eggs. EPA published an FR notice January 15, 2002, proposing to revoke tolerances for
benomyl (67 FR1917-02). On July 17, 2002, EPA revoked all tolerances for residues of the fungicide benomyl
(67 FR 46900-01). The July 17th notice describes the effective dates for tolerance revocation. These dates
allow adequate time for commodities which may contain benomyl residue to clear the channels of trade.
Regulatory Conclusion
The Agency has completed its reregistration eligibility decision for the pesticide benomyl. All registered
sources of benomyl have been canceled and all tolerances have been revoked. One end use registration remains;
however, on July 31, 2002, the registrant requested that the registration be voluntarily canceled. Once the
voluntary cancellation is granted, there will be no registered products containing benomyl.
All Dupont registrations of pesticide products that contain benomyl were effectively canceled on August
8, 2001, and the Agency believed all other registrants'benomyl product registrations were canceled effective
January 15, 2002. It has come to the Agency's attention that one end use registration for benomyl still remains.
On July 31, 2002, the registrant of the remaining end use registration, Fli-Yield Chemical Company ("Ffi-Yield"),
requested that its registration (EPA Reg. No. 34911-27) be voluntarily canceled. Hi-Yield has stated that there
are no inventories of remaining stocks of this product, therefore, no new existing stocks will be permitted.
The Agency has determined that it is not necessary to assess the risks of benomyl products because there
are no tolerances for benomyl and only one inactive end-use product remains, however, this product is being
voluntarily canceled. In view of the substantive data gaps, the absence of necessary tolerances, and the absence
of a registered source of benomyl manufacturing use product, the Agency finds that benomyl does not meet the
statutory requirements of reregistration.
Through the cancellation order dated January 15, 2002, sale and distribution of existing stocks of
products already in the channels of trade is permitted until December 31, 2002.
EPA expects that use of any remaining benomyl products will end in 2003 given that production ceased
in 2001 and the sale and distribution of benomyl products will end on December 31, 2002.
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Lois A. Rossi, Director
Special Review and Reregistration Division
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