EPA Chemical and Biological Investigations Branch pesticide examination services i A- ------- U.S. Environmental Protection Agency Office of Pesticide Programs Technical Services Division Chemical and Biological Investigations Branch March 1975 Printed on recycled paper ------- 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 manthey have helped to increase food production; control animal and plant pests; and protect public health and welfarethey 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. ------- ------- 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. ------- ------- 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. ------- ------- 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 evaluatedan 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. ------- ------- 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 ------- 10 ------- 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. 11 ------- 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 12 ------- 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. ------- ft* U.S. ENVIRONMENTAL PROTECTION AGENCY WASHINGTON. D.C. 20460 OFFICIAL BUSINESS PENALTY FOR PRIVATE USE $300 POSTAGE AND FEES PAID ENVIRONMENTAL PROTECTION AGENCY EPA-335 THIRD CLASS BULK RATE ------- |