EPA
Chemical
and Biological
Investigations
Branch
pesticide
examination
services
         i A-

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           U.S. Environmental Protection Agency
           Office of Pesticide Programs
           Technical Services Division
           Chemical and Biological Investigations Branch
March 1975
                 Printed on recycled paper

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D
       o you need chemical or biological evaluations to
       support regulatory or policy decisions on the
       continued usefulness and effectiveness of pesticides?

If so, the U.S. Environmental Protection Agency (EPA) has
a team of experts available to you.

EPA requires the best in scientific support to carry out
effectively its regulatory responsibilities under the Federal
Insecticide, Fungicide and Rodenticide Act (FIFRA) of
1947 and the 1972 Amendments to the Act. Such support is
provided to the Agency by the Chemical and Biological
Investigations Branch (CBIB), Technical Services Division,
a part of the Agency's Office of Pesticide Programs.

The services of this Branch are also available to other
Federal agencies and to State and local governments as well
as to EPA's regional offices.

With a professional and supporting staff of over 70, the
Branch provides scientific data and technical support services
through laboratory and field operations located in Beltsville,
Maryland; Corvallis, Oregon, and Bay St. Louis, Mississippi.

CBIB's biological and chemical evaluations are used to
assess the safety and-effectiveness of pesticides on a
continuing basis. For although pesticides are of great benefit
to man—they have helped to increase food production;
control animal and plant pests; and protect public health
and welfare—they must be carefully used and monitored.
Because they can be harmful to both human life and to the
environment, strong legislation has established safeguards for
their use. FIFRA, as amended, regulates inter-  and intra-
state marketing of pesticides and requires that such products
be registered with EPA on their proven effectiveness and
safety to humans, livestock, wildlife and the environment.

The Branch provides the essential scientific support for
EPA's authorities under FIFRA, as amended, including:
   • evaluating registered pesticide products
   • evaluating products on experimental permits in
     connection with projects on environmental safety,
     biological responses and pesticide-related accidents
     or episodes
   • evaluating pesticides and devices for biological activity
     to determine if they are effective as claimed, if
     directions for their use are adequate, and if they
     are safe for both humans and the environment.

In addition, the Branch's scientific data and technical support
includes the development and distribution of standard
methods, quality assurance through distribution of standard
reference chemicals and monthly check samples, and
ingredient analyses.

A description of the Branch's scientific capability and the
availability of the services it offers to EPA regional offices,
and to State and local governments follows.

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        Staff members of CBIB representing biological
        disciplines such as pharmacology, virology, animal
        biology, microbiology, plant biology, and entomology
        engage in a wide variety of activities associated
        with pesticide evaluation. The following services are
        representative of those normally performed by the
        Branch.
Pharmacologists (toxicologists) conduct studies which provide a
        basis for evaluating the safety of pesticides to man
        and animals. Since safety is a universal concern
        throughout the entire armamentarium of pesticides,
        these studies are made on all types of products
        including kitchen cleansers, crop dusts, slimicides,
        diaper fresheners, and pest control collars for pets.
        Toxicological studies help predict the hazard associated
        with accidental ocular and dermal exposure,
        determine toxicity categories of pesticide products for
        appropriate precautionary statements on labels,
        detect contamination of products, demonstrate sys-
        temic absorption, determine the propensity for
        inducing allergenic sensitization, and reveal other
        toxic and pathological responses.
        Typical studies:
        • Pet collars (dog and cat) are evaluated for toxic
        effects, such as dermal irritation and acute ingestion.
        • Pesticides allegedly involved in accidents or incidents
        are investigated to determine whether and to what
        extent the product contributed to the chain of events.
        • Dioxins are detected by enzyme induction using
        chick embryo livers.
        • Pesticides are examined for toxicity problems to
        evaluate hazard to the applicator, the environment, and
        animals to which applications are made. These
        evaluations may result in important amendments to
        the label and/or changes in the formula.


Virologists evaluate pesticides used to control human, animal
        and bacterial viruses on inanimate surfaces in medical
        facilities, homes, animal quarters, dairy plants and
        poultry farms. These evaluations help maintain human
        and animal health and control contamination in
        cultured dairy products. Viruses are propagated in
        tissue culture and embryonated eggs. Representative .
        human and animal viruses include those which
        cause respiratory infection, mumps, acute infectious
        fever, enterovirus infection, herpesvirus infection, fowl
        disease, and animal tumor and dairy culture contam-
        ination. In addition, biological insect control agents
        such as nuclear polyhedrosis virus and Bacillus
        thuringiensis are cultivated in insect cell lines. Purified
        insect viruses and delta endotoxin produced by Bacillus
        thuringiensis are utilized to develop reference
        standards for the bioassay testing program.

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        Typical studies:
        • New viral recovery techniques have been developed
        to assess  the virucidal activity of disinfectant spray
        products.
        • A bioassay has been established to determine the
        potency of commercial formulations of Bacillus
        thuringiensis.
        • Laboratory capability for cultivating insect viruses
        in insect  cell culture and the plaque technique for
        quantitative assay of insect viruses have been
        established.
Animal biologists evaluate the efficacy of rodenticides, avicides,
        repellents and devices for controlling or repelling
        vertebrate pests. Aquatic biologists determine the
        relative toxicity of pesticides to aquatic organisms by
        using standard bioassays. Such information may be
        used as a basis for upgrading precautionary labeling or
        to restrict use of products in or adjacent to aquatic
        environments.
        Typical studies:
        •  Basic studies are conducted to determine the toxic
        effects of formulation types on aquatic organisms.
        •  Special tests, conducted  under field conditions of use,
        provide data for assessments of the effectiveness of
        rodenticides.
Microbiologists help maintain the public health by detecting
        ineffective products used for sanitation in medical
        facilities, food handling establishments, dairies, water
        supplies, industrial operations, and homes. Products
        intended for use as germicides, disinfectants,
        sterilizers, sanitizers, sporicides, fungicides and
        bacteriostatic agents must be accurately evaluated for
        effectiveness according to claims on the label. Cultures
        of test organisms including those causing typhoid
        fever,  staph infections, athlete's foot, and tuberculosis
        are maintained. While most pesticides do not receive
        pre-registration examination, EPA routinely examines
        sporicidal products used in sterilizing surgical
        instruments for biological activity before final
        registration takes place.
        Typical studies:
        •  Disinfectants used in hospitals are routinely
        evaluated to determine effectiveness against pathogenic
        organisms.
        •  Bactericides are tested for effectiveness against
        microorganisms found in laundries and
        swimming pools.
        •  Products claiming to control the organism causing
        tuberculosis  are examined to determine their
        effectiveness.

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Plant biologists maintain greenhouses and field plots including
        orchards, shade trees, ornamentals, vegetables,
        and turf. These facilities are used in the evaluation
        of products formulated to regulate plant growth
        and to control weeds, plant diseases, and aquatic
        plants.

        Laboratory, greenhouse, and field tests provide data on
        product effectiveness, the nature of biological
        activity, and phytotoxicity.  With plant biology
        laboratories in the East (Beltsville, Maryland) and
        Pacific Northwest (Corvallis, Oregon), the Branch has
        the capability to evaluate pesticide products under
        different geographic conditions and  against
        different pest and plant species.


        Typical studies:
        • Pre- and post-emergence types of herbicides are
        investigated to determine whether performance
        claims are justified.

        • Investigations of complaints of phytotoxicity are
        important because they have revealed contamination,
        misuse, and drift of a serious nature.

        • Examination of products bearing  claims for control
        of fungi attacking wood, leather, seeds, and plants
        are routine, but important because of potential
        losses that would be incurred by use of ineffective
        products.
Entomologists rear and maintain cultures of test organisms in
        various stages of development to assess product
        claims for controlling insect pests in or on crops,
        ornamentals, livestock, pets, fabrics, and homes. Data
        gathered from laboratory, greenhouse, and field
        evaluations in addition to information gained from
        environmental responses are used to determine
        important pesticide  characteristics. Parallel inves-
        tigations in the field and greenhouse on some types of
        crops are important for correlation in methods
        development, modification, and validation. Entomology
        laboratories are located in Beltsville and Corvallis.
        Typical studies:
        • Insecticidal products for ornamental plants, food
        crops, and shade trees are evaluated—an impor-
        tant function is to assure  product effectiveness
        and safety.

        • Claims for residual effectiveness, particularly those
        concerning insecticides for home use, are investi-
        gated to determine whether the claims are valid.

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The CBIB chemical laboratories in Beltsville are
divided into three units: the Methods Development
Coordination and Training Unit, the Chemical
Reference Standards and Quality Control Unit, and
the Residue and Special Projects Unit
The Metnods Development Coordination and
Training Unit develops and validates chemical
methodology used for the enforcement of FIFRA,
as amended. This unit distributes the Manual of
Chemical Methods for  Pesticides and Devices,
publishes revisions, and generally assures that current
methods are available for chemical analysis of
pesticides formulations. The manual is for use by State
and Federal pesticide laboratories in the analysis of
commercial pesticide formulations. The laboratory also
is a referee for EPA Product Analysis Laboratories
(PAL) and State laboratories when a manufacturer
contests the analyses. In addition to developing
chemical methodology, the laboratory serves as a
training unit for inexperienced chemists working for
State, local, and Federal agencies. This training
is provided  upon request  from State and Federal
agencies.
The Chemical Reference Standards and Quality
Control Unit provides technical pesticide standards
to any requesting State, local, university, foreign,
or Federal pesticide laboratory. These standard
chemicals are listed in the Catalogue of Pesticide
Standards for Pesticide Formulation Analysis, which
the unit maintains and distributes. In addition, its
quality assurance program monitors the results of  anal-
yses performed on pesticide formulations of pre-
determined composition, which are distributed to all
EPA-PAL and the State laboratories engaged in
chemical pesticide analyses for the enforcement
activity.  Each month samples are sent routinely to
these analytical laboratories, or they may be  sent
immediately if certain commercial formulations have
been discovered to present a problem. The sample
analyses results then are sent to the CBIB unit to be
statistically analyzed for accuracy. If a laboratory
reports an analysis with variance outside limits of the
true value of the formulation components, it  is notified
by CBIB. The laboratory then reviews its techniques
and procedures to determine the cause for the faulty
analysis. This program assures and maintains an
established level of competence for pesticide
analytical laboratories.
The Residue and Special Projects Unit provides
chemical analytical support necessary for the Branch's
biological laboratories. The combined results are
used by EPA's Pesticide Registration Division, OPP,
to help determine what registration actions are needed
for various products. This laboratory also supports
EPA regional and State investigators by supplying
chemical information on pesticide related accidents. It

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provides chemical analyses for requesting State,
local, or Federal agencies when information is needed
to initiate action with respect to pesticide studies,
programs, pollution or enforcement actions.
All chemical units participate in cooperative projects
where specific information may be needed to make
scientific or administrative decisions.
The Beltsville Chemistry Laboratory also cooperates
with and-provides leadership in various national
scientific organizations which distribute information
worldwide for the study and control of pesticides.
Typical studies:
•  Samples furnished by field teams investigating
accidents allegedly caused by pesticides are analyzed
chemically.
•  The dioxin content of  2,4-D and 2,4,5-T products
has been determined.
•  Problems involving pesticides as pollutants of water,
air and soil are investigated.
The Product Analysis Laboratory at Bay St. Louis,
Mississippi, provides pesticide formulation  analyses for
regional enforcement activity. Samples from com-
mercial products offered  for sale to consumers are col-
lected by EPA field investigators and sent to this
laboratory for chemical analysis to determine the con-
tents, contamination, adulteration, or overformulation.
Typical studies:
•  The spectrum of pesticide chemical formulations are
routinely examined.
•  Pesticides were surveyed for arsenical contamination.
•  Pressurized pesticides were surveyed for vinyl
chloride propellants.
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To coordinate the development and standardization of
methods for pesticides and devices, the Chemical
and Biological Investigations Branch maintains liaison
with national and international standards organizations
such as the Association of Official Analytical
Chemists (AOAC) and American Society for
Testing Materials (ASTM).
These methods serve as a basis to develop effective
guidelines for registration and enforcement actions. The
Agency encourages the offices within EPA as well
as other Federal, State and local agencies to use
the Branch's  services and capabilities.
   Scientific support is available for:
   •  Registration activities
   •  Enforcement actions
   •  Policy decisions
   • Investigations of pesticide-related accidents
   • Studies on environmental contamination related
       to chemical residues
   • Other analytical problems
   Analyses are performed on:
   • Official product samples collected by EPA
     regional investigators from channels of trade,
     establishment inspections, and ports of entry to
     evaluate composition for comparison with
     ingredients declared on the label, contamination,
     adulteration, required color, overformulation,
     net contents, physical characteristics, etc.
   • Samples collected as a result of pesticide-related
     accidents
   » Reference samples
   • Samples of pesticides involved in special projects
   • or programs
   • Samples from Federal agencies or other groups
     engaged in cooperative projects
 Consultation is available on request in connection with
 all laboratory services offered.
   Direct your request for these services to:
     CHIEF, CHEMICAL AND BIOLOGICAL
        INVESTIGATIONS BRANCH
     ENVIRONMENTAL PROTECTION AGENCY
     BUILDING 402, AGRICULTURAL RESEARCH
        CENTER-EAST
     BELTSVILLE, MARYLAND 20705
     PHONE: (301) 344-2187
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Manuals Available:
Manual of Chemical Methods for Pesticides and
Devices.
Write:  SUPERVISOR, METHODS DEVELOPMENT UNIT,
       CHEMICAL AND BIOLOGICAL INVESTIGATIONS
       BRANCH, EPA, BUILDING 306, AGRICULTURAL
       RESEARCH CENTER-EAST, BELTSVILLE,
       MARYLAND 20705.
Manual of Biological Methods for Pesticides and
Devices.
Write:  BIOLOGICAL METHODS COORDINATOR,
       NORTHWEST BIOLOGICAL INVESTIGATIONS
       STATION, EPA, 3320 ORCHARD STREET,
       CORVALLIS, OREGON 97331.
Catalogue of Pesticide Standards for Pesticide
Formulation Analysis.
Write:  SUPERVISOR, CHEMICAL REFERENCE
       STANDARDS AND QUALITY CONTROL UNIT,
       CHEMICAL AND BIOLOGICAL INVESTIGATIONS
       BRANCH, EPA, BUILDING 306, AGRICULTURAL
       RESEARCH CENTER-EAST, BELTSVILLE,
       MARYLAND 20705.

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                                                                        ft*
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PROTECTION AGENCY
WASHINGTON. D.C.  20460
OFFICIAL BUSINESS
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