EPA730-N-95-002
UNITED STATES ENVIRONMENTAL PROTECTION AGENCY
WASHINGTON, D.C. 20460
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JUL i 3 b9o
OFFICE OF
PREVENTION, PESTICIDES AND
TOXIC SUBSTANCES
PESTICIDE REGULATION (PR) NOTICE 95-4
NOTICE TO MANUFACTURERS, FORMULATORS, PRODUCERS
AND REGISTRANTS OF PESTICIDE PRODUCTS
ATTENTION: Persons Responsible For Registration of Pesticide Products
SUBJECT: Regulatory Status of Methyl Bromide and Priority Review of Methyl
Bromide Alternatives
This notice is to inform registrants, producers, and users of methyl bromide about the
Environmental Protection Agency's (EPA) policies and obligations under the Federal
Insecticide, Fungicide, and Rodenticide Act (FIFRA), the U.S. Clean Air Act (CAA), and the
Montreal Protocol to regulate methyl bromide. It is also intended to inform registrants of
EPA's commitment to giving priority review to methyl bromide alternatives, consistent with
the Agency's reduced risk initiative.
I. BACKGROUND
EPA regulatory changes will affect the continued availability of the pesticide methyl
bromide, which is subject to regulation as an ozone depleting chemical under the CAA and as
a pesticide under FIFRA. Action is also being taken under the Montreal Protocol, an
international agreement on ozone depletion issues.
A. Status of Methyl Bromide Under FIFRA
Methyl bromide is a broad spectrum fumigant used against insects, fungi, bacteria,
nematodes and weeds in soil, structural, and commodity/quarantine fumigation. Major
commodities for preplant soil treatments are strawberries, tomatoes, peppers, eggplant, tobacco
Recycled/Ftecydabte
Printed with Soy/Canola Ink on paper that
contains at least 50% recycled fiber
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and ornamentals. Durable food commodities such as grain, coffee beans and nuts, as well as
perishable food commodities., mainly fruits and vegetables, are fumigated predominantly to
control insect pests. Forestry products, cut flowers, warehouses, railroad cars, grain mills, and
domestic dwellings may also be fumigated.
As a pesticide, methyl bromide must be registered by EPA under FIFRA. Registration
is intended to ensure that a pesticide, when used according to label directions, will not have
unreasonable adverse effects on people or the environment. Registration entails the
submission of data on the characteristics of a pesticide and its health and environmental
effects, an assessment of risks and benefits, and a review of product labeling for adequacy.
Currently there are three major producers of methyl bromide and nearly 100 products
registered for soil, structural, and commodity/quarantine fumigation. Because of its toxicity to
humans and non-target organisms, methyl bromide is a restricted use pesticide, to be used
only by trained and certified applicators or persons under their direct supervision.
Under FIFRA section 4, methyl bromide must undergo reregistration and the data
supporting its registration must be brought up to current scientific standards. If registrants
decline to support reregistration by not supplying the necessary data and paying the required
fees, the pesticide may be suspended and/or canceled. Methyl bromide is being supported for
reregistration, although some uses may be dropped. The last data required from registrants
are due in late 1997.
B. Status of Methyl Bromide Under the Clean Air Act (CAA)
Independent of FIFRA reregistration requirements and decisions, methyl bromide is
subject to the provisions of the CAA. The CAA, among other things, designates certain
chemicals as "class I ozone depleting chemicals," depending upon their scientifically
determined "ozone depletion potential" (OOP), a numerical comparison with the ODP of
CFC-11 (Freon), which is defined as having an ODP of 1.
The CAA requires theit if a chemical has an ODP greater than 0.2, as determined by
the Administrator, EPA must add it to the class I list and propose a phase out schedule that
eliminates production and importation within seven years. The latest international scientific
assessment estimates the ODP of methyl bromide as 0.6. Therefore, under the CAA, EPA is
obligated to phase out methyl bromide.
On December 10, 1993, EPA issued a final rule under the CAA that froze production
at 1991 levels starting in 1994, makes no interim reductions, but eliminates methyl bromide
production and importation by the year 2001. The scientific basis for the rule is supported
by a consensus of atmospheric scientists, including experts at the National Aeronautics and
Space Administration and the National Oceanic and Atmospheric Administration, as well as
experts assembled under the Montreal Protocol. Scientists believe that in the short-term,
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bromine from methyl bromide is a more significant ozone depleter than is chlorine from
CFC's.
The CAA is more stringent on the phase out of methyl bromide than actions now
planned under the Montreal Protocol, as described below. The Montreal Protocol contains an
exemption for "essential uses," which allows methyl bromide use to continue in the absence of
alternatives. The CAA does not allow for such exemptions. Unlike FIFRA, the CAA does
not take into account the weighing of the risks and benefits of methyl bromide use.
C. Status of Methyl Bromide Under the Montreal Protocol
As a signatory of the Montreal Protocol, the United States must also list and regulate a
chemical if the international community, through the Montreal Protocol Agreement,
determines that it should be regulated. Methyl bromide has been identified by the United
Nations Environmental Programme (UNEP) as a significant ozone depleting chemical.
At their November 1992 meeting, the parties to the Protocol listed methyl bromide as
an ozone depleter and agreed to freeze production at 1991 levels beginning in 1995, except
for quarantine and pre-shipment applications. The parties also agreed to make every effort to
reduce methyl bromide emissions and to decide on a general control scheme no later than the
1995 meeting. An international expert assessment team has reviewed methyl bromide issues
in preparation for the upcoming meeting this fall.
II. DISCUSSION
Based on the above, production and availability of methyl bromide will be severely
restricted in the future. Both the EPA Office of Pesticide Programs (OPP) and the Office of
Air and Radiation have urged registrants and users to invest resources in identifying
alternatives and ways of recycling or reducing the atmospheric emissions of methyl bromide.
The U.S. Department of Agriculture (USDA) has made a major research commitment to
finding alternatives to methyl bromide.
A. Methyl Bromide Alternatives Task Force
EPA has established a Methyl Bromide Alternatives Task Force comprised of
representatives of the Office of Pesticide Programs, with active participation from the Office
of Air and Radiation and EPA Region 9. The mission of this Task Force is to coordinate
FIFRA, CAA and Montreal Protocol activities and to work with USDA, commodity groups,
and others to give priority to the development, registration, and adoption of alternatives to
methyl bromide, including both chemical and non-chemical pest control strategies. Members
of the Task Force also meet quarterly with representatives of the U.S. Department of
Agriculture concerned about methyl bromide alternatives development.
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B. Opportunities to Replace Methyl Bromide
EPA recognizes the technical challenges to replacing methyl bromide. No one
alternative will likely replace the wide array of uses that methyl bromide currently covers.
Methyl bromide users need to prioritize key uses for research purposes so that alternative pest
control methods can be found.
EPA intends to take an active role in managing the regulatory process for the
development of suitable alternatives to methyl bromide use. There are several possible
mechanisms for replacing methyl bromide, or reducing its use. In addition to proposals to
expand registration of existing chemicals, registrants and users also need to investigate new
use practices (e.g., recycling, capture, better tarping, and improved injection methods), new
pesticide active ingredients, new combinations of active ingredients, and non-chemical control
methods.
In terms of chemical alternatives to methyl bromide, the practical short-term focus may
be on chemicals already registered that have substantially complete data bases. However, a
number of potential alternative chemicals may also face regulatory difficulties in the future.
Therefore, efforts toward development of less risky alternatives are being encouraged by the
Agency through an expedited review process.
C. Priority Review of Methyl Bromide Alternatives
EPA is committed to expediting review of potential methyl bromide alternatives, in
particular those judged to be reduced risk alternatives. The Agency will also expedite
requests for information about registration of methyl bromide alternatives and all related
registration requests.
In order to ensure that registration applications receive expedited review, applicants
should include with their submissions a statement of the methyl bromide use sites for which
the pesticide represents a potential alternative and a request for expedited review. Where all
necessary data have been submitted, EPA will work to ensure that decisions for registration of
biological pesticides are made within eight months; decisions on petitions for a new food use
of a registered pesticide are made within six months; and decisions on registration of new
active ingredients as reduced risk pesticides are made within 12 months. These time frames
are consistent with an August 1994 Memorandum of Understanding (MOU) between EPA and
USDA, designed to expedite research, development, education, and registration of products
which meet key pest control needs. The Agency will work to meet these time frames to the
maximum extent possible.
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D. Policies on Reregistration and Emergency Exemption Requirements for Methyl Bromide
under FIFRA
EPA is looking broadly at the possibilities for reducing risks from methyl bromide
emissions and fostering development of alternatives in the context of emergency exemption
applications under section 18 of FIFRA and its registration and reregistration policies.
On January 13, 1995, OPP issued a memorandum to state pesticide agencies and
federal agencies informing them of OPP's position on the continued use of methyl bromide
under section 18 of FIFRA. The memorandum states that future emergency exemption
requests for methyl bromide must document the steps taken to find an appropriate alternative
and include a commitment to pursue work on alternatives as a condition of the requested
exemption. These steps may include, but are not necessarily limited to, a summary of the
results of completed comparative product performance evaluations of methyl bromide
alternatives. Where possible, these studies should include an assessment of the relative
economic values of the alternatives tested. EPA believes these requirements are essential and
in the best interest of requestors, given the fact that methyl bromide will not be produced or
imported after the 2001 CAA. phase out date and, thus, cannot be relied upon to meet future
pest control needs.
With respect to reregistration, as noted above, methyl bromide is currently being
supported for reregistration and the last data required from registrants are due in late 1997.
The Agency must require and process data to evaluate whether methyl bromide is eligible for
reregistration under FIFRA, regardless of activities under the CAA or the Montreal Protocol.
Therefore, registrants must continue to fulfill reregistration data requirements even though
methyl bromide will be phased out by 2001 under the CAA.
III. FURTHER INFORMATION
Questions regarding this notice can be directed to Paul F. Schuda, Chairperson of the
Methyl Bromide Alternatives Task Force, at (703) 305-7565 or Tracy Perry of the Policy and
Special Projects Staff, OPP at (703) 305-7461.
Daniel M. Barolo, Director
Office of Pesticide Programs
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