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

-------
 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.
       Page 2
Office of Pesticide Programs, Biological & Economic Analysis Division

-------
' 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
                                      Page 3

-------
 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
        Page 4
Office of Pesticide Programs, Biological & Economic Analysis Division

-------