United States
Environmental Protection
Agency
Prevention, Pesticides,
And Toxic Substances
(7503W)
EPA 733-F-94-001
June 1994
The Rote of BEAD
in Pesticide Regulation
Introduction
The United States Environmental Protection Agency
(EPA) has been charged by Congress through various
Acts with protecting human health and improving the
quality of the environment. As a regulatory agency in
the executive branch, EPA creates and implements Rules
and Regulations carrying out these Acts.
The Office of Pesticide Programs (OPP) of the EPA is
responsible for regulating the use of pesticides to ensure
that they will not pose unreasonable adverse risk to
human health or the environment. All pesticides which
are sold and distributed in the U.S. must be registered by
EPA. Each pesticide product must bear a label which
identifies the product, describes how the product should
be used, and provides appropriate precautionary and
safety information. OPP's responsibilities to ensure a
safe food supply, as well as a healthy environment,
overlap with those of the U.S. Department of
Agriculture, the Department of the Interior, and the
Food and Drug Administration.
Pesticide regulation is administered through two
primary authorities: the Federal Insecticide, Fungicide and
Rodenticide Act (FIFRA) and the Federal Food, Drug and
Cosmetic Act (FFDCA). Pesticide regulation under FIFRA
requires the Agency to balance risks to human health and
the environment against the benefits to the economic and
social aspects of society. Real or potential risks to man
and the environment are the result of the interaction of
two factors: the toxicity of the chemical or biological
agent and the degree to which people and the environ-
ment are exposed. Benefits describe how well a pesticide
prevents negative impacts to public health, industry, or
agriculture. Pesticides can benefit society by controlling
pests that cause or carry human or animal diseases (e.g.,
bacteria in cooling water systems or toilet bowls); cause
environmental damage (e.g., gypsy moths in forests); foul
industrial materials (e.g., bacteria and fungi in paint or
fuels); or reduce food production (eg., weeds, diseases,
insects).
The Biological and Economic Analysis Division
(BEAD) is comprised of agricultural scientists, chemists,
economists, information management specialists,
microbiologists, policy analysts, statisticians, and
toxicologists. BEAD provides data and analyses to
support pesticide product registration decisions and
supports the development of regulations, policies,
guidance, and initiatives affecting pesticide regulation.
Support For Pesticide
Registration Decisions
Compile Pesticide
Use Information
One of the basic functions of BEAD is to provide
scientists throughout OPP with data concerning what is
being treated (crops, equipment, premises), why it is
being treated (what pests are being controlled), how the
pesticide is applied (application equipment, application
timing, safety precautions, application limitations), and
the quantity of pesticide used (application rates, area or
number of units treated, number of applications per
season or year, total pesticide applied per season or
year). This pesticide use information is used by OPP
to: 1) determine data requirements for pesticide re-
gistration, 2) estimate human and environmental
exposure to a pesticide for risk analysis, and 3) conduct
benefits and economic analyses for various regulatory
actions.
Recycled/Recyclable
Primed with Soy/Canola InX on paper that
contains at least 50% recycled fiber
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Provide Input To Specific
Regulatory Actions
Conditional Registration
A registrant may request a conditional registration based
on preliminary data while a full product registration is
still pending. In addition to requirements concerning
risk, one of the requirements for some conditional
registrations is that the Agency finds that the proposed
use of the pesticide is in the public interest. BEAD
assists in this effort by analyzing: 1) if there is a need for
the pesticide product which is not being nuf by other
currently available pest control methods, ana 2) if use of
the proposed product would result in significant benefits
to the product users and to society.
Emergency Exemptions
In an emergency situation, FIFRA, Section 18 allows EPA
to grant petitioners a limited exemption from the
requirement to federally register a pesticide product prior
to its use on a specific site. BEAD evaluates the pest
situation described by the petition to determine if a
specific site meets the definition of an "emergency" as
defined by EPA's regulations, and to determine if the
requested pesticide would avert the significant economic
losses directly attributed to the emergency condition.
Reregistration
EPA periodically reviews pesticides which are already
registered to determine if the data supporting these
registrations meet current standards. Amendments to
FIFRA in 1988 specify a five-phase process with a nine
year deadline for the complete review (reregistration) of
products registered prior to 11/1/84. The main role of
BEAD in the reregistration process is to define the
currently registered use practices for each pesticide. To
this end, BEAD is developing an electronic database
which captures pesticide use information from product
labels. This summary of currently registered uses,
application methods, and limitations is used to de-
termine reregistration data requirements and to define
exposure to pesticides as part of a risk analysis. BEAD
also plays a key role in maintaining vocabulary terms for
electronic databases and printed material which describe
pesticides and their use in order to facilitate
communication, interpretation, and database retrieval.
Special Reviews
Special Review is a process where the registration of a
currently registered pesticide is re-examined in light of
data which indicate that there may be unacceptable risks
associated with the pesticide's use. The goal of the
Special Review process is to reduce the risks posed by a
pesticide to an acceptable level while taking into
consideration the benefits provided by the use of that
pesticide. In conducting the benefits analysis for this
process, BEAD identifies: 1) what alternative pest
control methods could legally substitute for the
pesticide undergoing Special Review, and 2) the
economic impact'to pesticide users and consumers (not
to the pesticide registrants) that would occur if these
alternative pest control methods were used instead of
the pesticide undergoing Special Review. For example,
with a pesticide used to control an agricultural pest, the
Agency is required to take into account the impacts on
production and prices of agricultural commodities, retail
food prices, and other effects on the agricultural
economy. Utilizing this benefits analysis, EPA can
determine which pesticide risk reduction measures
should be taken (such as the imposition of use
restrictions, reduction of application rates, or
cancellation of all or some uses).
Waivers
A registrant may request that EPA waive certain data
required as part of the registration process due to
financial hardship that would adversely affect the
registrant's ability to produce the pesticide. A waiver
may be granted where the financial hardship outweighs
the need for the data. BEAD analyzes a registrant's
ability to pay for the development of the necessary data
based on the registrant's financial capabilities.
Pesticide To'lerances
A pesticide tolerance is the legal level of a pesticide that
may remain in or on a food or feed crop. Pesticide use
information provided by BEAD is used by OPP when
setting tolerances. BEAD also maintains the database of
tolerances set by OPP. Tolerances are updated monthly
and are made publicly available through both the
Government Printing Office (GPO) and EPA
Validate Analytical
Laboratory Methods
BEAD operates pesticide labs located in Beltsville,
Maryland and Bay St. Louis (Stennis Space Center),
Mississippi. These labs have unique capabilities in the
areas of food, product, and/or environmental chemistry.
The Analytical Chemistry Lab (ACL) evaluates
analytical pesticide detection methods for foods and
fibers to make sure they are suitable for enforcement
monitoring. This internationally recognized work is
essential to registration and/or reregistration decisions.
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' Each method that is tested by ACL allows a chemist to
i isolate, identify, and measure the concentration of a
known chemical or material. ACL also evaluates product
chemistry methods to make sure they are suitable for
determining the concentration of pesticide active
ingredients in technical arid end use formulations. More
recently, this lab has started a preregistration testing
program for antimicrobial methods and products.
The Environmental Chemistry Lab (ECL) evaluates soil
and water testing methods to determine if they are
suitable for generating data for environmental fate,
exposure, and ecological effects studies used to support
pesticide registration and/or reregistration decisions.
ECL has highly specialized and internationally recog-
nized capabilities to identify and measure extremely
small amounts of pesticide contaminants (such as
dioxins). ECL is currently using that capability to
determine the amounts of dioxins in specific pesticide
products that are widely used around the home.
The Microbiology Laboratory participates in
collaborative efforts with the Association of Analytical
Chemists (AOAC) to improve efficacy test methods for
antimicrobial products of public health significance (e.g.,
those used in hospitals, drinking water, swimming pools).
The lab also provides support for compliance and
enforcement actions by conducting Good Laboratory
Practice and laboratory data audits.
BEAD'S pesticide labs provide technical support to the
State Enforcement Laboratories hi order to identify and
measure inadvertent pesticide residues for misuse cases.
They also supply the states with reference standards for
calibrating their instruments and for determining the
known quantity of the pesticide. Finally, the labs provide
technical assistance to the EPA and State enforcement
labs by giving them methods from EPA files, helping
them solve problems with specific methods, and assisting
in conducting laboratory audits.
Development Of Regulations,
Policies, Guidance, And
Initiatives
OPP develops regulations, policies, guidelines, and
guidance to ensure implementation and enforcement of
statutory requirements regarding pesticides. Examples
include regulations for pesticide storage and disposal,
guidance for developing state management plans for
groundwater protection, and policies regarding
registration of reduced risk ("safer") pesticides. OPP
also provides recommendations, data and analyses, and
testimony support for new or amended legislation
affecting FIFRA as well as other legislation affecting
pesticides (such as FFDCA and the Clean Water Act).
Finally, OPP undertakes a number of special projects
such as the harmonization of data requirements among
international pesticide regulations or the reduced
pesticide use/risk initiative.
BEAD provides a broad variety of support to OPP
ranging from basic pesticide use data previously
described to typical cultural practices, individual
industry profiles, and detailed impact analyses of
proposed regulations and policies. Impact analyses vary
in scope and provide vital information for decision
makers. The scope of many of these analyses is
mandated by Executive Order or statute. The primary
mandates are outlined below.
Regulations And Policies
Executive Order 12866
E.O. 12866 establishes procedures to be followed by
agencies and the Office of Information and Regulatory
Affairs (OIRA) in reviewing and promulgating
regulations. An objective of the E.O. is to enhance
planning and coordination with respect to both new and
existing regulations and to ensure that agencies tailor
regulations to impose the least burden on society. A key
principle of E.O. 12866 charges agencies with assessing
both the costs and the benefits of the intended
regulation and alternatives in order to choose the best
alternative action being considered and to insure that ,
the benefits of the intended action justify the costs.
BEAD has the primary responsibility of conducting
the benefit-cost analysis of proposed regulatory actions
being developed by OPP. This helps OPP choose the
best alternative action and to determine if a regulatory
action is deemed to have "significant" economic impacts
as defined by the E.O. If so, a more extensive analysis is
required. The analysis of costs should include: 1) the
direct cost both to the government hi administering the
regulation and to businesses or others in complying with
the regulatory requirements, and 2) any adverse effects
on the functioning of the economy. An analysis of the
benefits anticipated includes the promotion of the
efficient functioning of the economy and private
markets, the enhancement of health and safety, and the
protection of the natural environment.
Office of Pesticide Programs, Biological & Economic Analysis Division
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Regulatory Flexibility Act
The Regulatory Flexibility Act mandates that if a
regulation wiU have "a significant economic impact on a
substantial number of small entities," the Agency
generally must perform a Regulatory Flexibility Analysis
(RFA) that explores options for minimizing those
impacts. The Act establishes that agencies shall endeavor
to fit regulatory and informational requirements to the
scale of the businesses, organizations, and governmental
Jurisdictions subject to regulation. To achieve this
principle, agencies are required to solicit and consider
flexible regulatory proposals.
BEAD attempts to provide a profile of affected entities
in terms of size and evaluates the impacts imposed on
small entities to determine the extent of the impacts and
whether or not they are disproportional relative to
impacts on larger entities. Reasonably feasible and
effective alternatives to the proposed regulation are also
analyzed,
Paperwork Reduction Act
The Paperwork Reduction Act controls the paperwork
burden on the public by requiring agencies to submit an
Information Collection Request (ICR) to the Office of
Management and Budget (OMB) prior to any collection
of information from the public. Information collection
may take the form of written or oral questions as well as
data reporting regulations. The Paperwork Reduction
Act requires the public to participate in the Federal
paperwork review process.
BEAD'S role is to provide estimates of the burden both
on the information respondent and on the Agency.
Burden is estimated based on the hours required to fulfill
collection of the information. BEAD disaggregates
estimates of total annual reporting and record keeping
burden for each collection of information into discrete
components applicable to each separate collection of
information. The actual costs to be incurred by the
respondent and the Agency due to the informatiort
collection request are estimated based on the burden
hours.
Assessment Guidelines is a document which explains in
greater detail how the tests required by this regulation
should be conducted. BEAD is currently revising a
portion of both the data requirements and the
guidelines to include additional testing on comparative
product performance, that will improve the quality of
data used by EPA to assess pesticide benefits.
Pesticide Use/Risk Reduction
The Pesticide Use/Risk Reduction Initiative, announced
in June 1993, is a joint effort of the United States
Department of Agriculture, the United States Food and
Drug Administration and EPA to reduce the use of
pesticides that pose unreasonable risks to humans and
the environment. Through a coordinated strategy, the
federal government is committed to work with all
affected interests (including commodity organizations,
public interest groups, federal, state and local
government agencies, researchers and industry
representatives) to develop a plan which reduces the
risks posed by pesticides while maintaining cost-
effective pest control methods. As part of this initiative,
BEAD serves as the lead organization in the Office of
Pesticide Programs, coordinating OPP's activities in
support of the initiative. This includes coordinating
EPA's efforts with those of USDA and FDA, providing
pesticide usage data, conducting economic and
biological analyses of policy options and meeting with
affected interests to identify opportunities for the
reduction in pesticide use and risk.
Need additional information write or call:
U.S. Environmental Protection Agency
401 M St., SW (7503W)
Washington, DC 20460
(703) 308-8200
Guidance And Initiatives
Registration Data Requirements And
Testing Guidelines
40 CFR Part 158 is the regulation which prescribes
which data are required to support the registration of a
pesticide. This includes data used to determine both the
risks and the benefits of a given pesticide. The Pesticide
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