Regulating Pesticides (1980) / Chapter Skim
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2. FIFRA and the RPAR Process
2. FIFRA and the RPAR Process
Pages 18-45
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From page 18... ...
On the other hand, depriving agriculture of an important tool for which there is no substitute may involve risks and economic costs both to the industry and to society that are - also unacceptable. Pesticides, depending upon the dose or exposure level, may produce acute or chronic toxic effects in nontarget organisms, including humans.
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From page 19... ...
in their book, Tragic Choices, explain why society is reluctant to attempt rational trade-o~s: When tragic choices are made through the pure market within an ex~st~g distribution of wealth, costs arise which are external to the immediate decision makers and are borne instead by the rest of us. These external costs may limit our willingness to permit a market: The social costs of Indentured labor, for example, surely include one's outrage at inducing the poor to sell themselves, and this cost must be considered before the society allows peonage.
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From page 20... ...
The legislation tells the Agency that pesticides are to be assessed rationally, that some risk is acceptable, but that in any given case the Agency may be conservative in deciding to prefer risk avoidance over economic benefits: in short, that EPA has great but not unlimited discretion to regulate pesticides. Knowledge of the background and structure of the laws regulating pesticides is essential to understanding the problem with which this report is concerned: How can EPA improve its procedures for rational evaluation and regulation of pesticides?
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From page 21... ...
required for the first time that all pesticides be registered before they could be marketed and that the label specify the content. This law is an extension of classic consumer protection objectives.
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From page 22... ...
The 1964 amendments expressly directed the USDA'S attention to safety considerations for the first time. Eight years later, FIFRA was supplemented by the Federal Environmental Pesticide Control Act of 1972 (FEPCA)
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From page 23... ...
Further, in connection with final action, the Administrator must prepare and publish an agricultural economic impact statement. To ensure that the Administrator receives the views of the agricultural community, proposed cancellation and suspension notices must be sent
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From page 24... ...
The 1964 legislation required the USDA to suspend a pesticide and institute cancellation proceedings if suspension were necessary to "prevent imminent hazard." In a major decision interpreting the phrase, the court transformed FIFING from a consumer protection to a regulatory statute by holding that once a substantial question of
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From page 25... ...
In such situations, the most the courts can do is attempt to understand the issues, make sure that the Agency has considered all relevant factors and that all parties have had adequate and real participation in the decision process, insist that the Agency has disclosed the basis of its reasoning sufficiently to pendant a court to conclude that the decisionfollows from the evidence, and make sure that there is some objective basis for the decision. However, in the end' as long as EPA bases its cancellation or suspension decisions on a risk analysis that has respectable scientific support, its discretion is practically unreviewable.
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From page 26... ...
EPA 1976) The other side of a benefit-risk analysis is an evaluation of the benefits of a pesticide's use.
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From page 27... ...
As pesticide issues become more difficult to resolve, and better benefit evidence is generated, the hard-look doctrine, which courts follow with respect to judicial review, may require EPA to present a more technically acceptable benefit component of the benefit-risk analysis. A benefit advisory panel to parallel the Scientific Advisory Panel might do much to strengthen EPA'S benefits presentation (see Chapter 51.
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From page 28... ...
THE RPAR PROCESS: A DESCRIPTION The preceding discussion of the legislative framework describes the evolution of EPA'S current mandate to protect public health and the environment from "unreasonable adverse effects" of pesticide use. The mandate is interpreted to authorize an evaluation and weighing of costs (or risks)
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From page 29... ...
; 2. Chronic toxicity determined by oncogenic ejects induced in humans or in experimental animals as a result of oral or dermal exposure, or inhalation; mutagenic ejects induced, as determined by multitest evidence; any other chronic ejects produced in test animals; anticipated significant population reduction in nontarget organisms; or anticipated fatality to endangered species; or 3.
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From page 30... ...
The same basic ingredients appear repeatedly, singly or in combination, in the 35,000 pesticide formulations for which reregistration is being sought. Edwin Johnson, head of EPA'S pesticide program, told a meeting of the Association of American Pesticide Control Officials in Williamsburg, Virginia, August 10, 1978, that most large-volume, food-use pesticides can be regulated by about 200 generic standards; all active registrations can be handled by 514 standards; and only about 65 active ingredients are of major significance (on the basis of volume of production, number of registered products in which they appear, tolerances issued, and volume and type of use)
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From page 31... ...
The line of administrative responsibility for regulating pesticides currently runs from the Deputy Assistant Administrator of oPP, to the Assistant Administra tor of the Office of Toxic Substances, to the EPA Deputy Administrator and the Administrator. Other branches of EPA that assist oPP are the Office of General Counsel, the Office of Enforcement, the Office of Research and Development, and the Carcinogen Assessment Group (CAG)
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From page 32... ...
Environmental Fate Branch Plant Sciences | Branch . Residue Chemistry Branch 1 1 Ecological Effects Branch | Economic Analysis Branch FIGURE 2.2 Organization of EPA Office of Pesticide Programs, April 1978.
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From page 33... ...
Position Documents 1 and 4 are published in the Federal Register in support of and together with the official notification of a rebuttable presumption against registration and continued registration and the final notice of determination, respectively. The proposed determination concluding the RPAR is also published in the Federal Register prior to the final notice.
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From page 34... ...
34 ~ o O hi__ + it- ~ LL C)
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From page 35... ...
and presenting the benefit-risk analysis supporting the proposed action. The collection of benefit data, like risk data, begins well before PD 1 iS issued, even though the benefit assessment does not appear in a position document until PD 3.
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From page 36... ...
Organizational Arrangements Risk Assessment Lead organizational responsibility for conducting risk assessments in oPP lies with the Hazard Evaluation Division (HED) , which is divided into four branches: Toxicology, Environmental Fate, Residue Chemistry, and Ecological Erects.
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From page 37... ...
Benefit Assessment Lead organizational responsibility for conducting benefit analysis in oPP lies with BFSD, which is divided into three branches that are organized along disciplinary lines: Animal Science and Index, Plant Sciences, and Economic Analysis. Table 2.2 shows the major components of oPP's pesticide benefit analysis and the lead organizational responsibilities for analysis.
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From page 38... ...
. TABLE 2.1 Components of Pesticide Risk Assessment and Principal Organizational Responsibilities in the Office of Pesticide Programs Component Background Chemical and physical properties Environmental fate and persistence Human exposure analysis Dermal Respiratory Dietary (food and water)
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From page 39... ...
SPRD is composed of five chemical review branches and a Regulatory Analysis and Laboratory Audit Branch. At the conclusion of the benefit and risk assessments, an effort to weigh the benefits and risks is undertaken by the RPAR team under the general supervision of SPRD'S Regulatory Analysis Branch.
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From page 40... ...
. procedure involves determining trade-offs between risks and benefits associated with each regulatory option and presenting them to the Deputy Assistant Administrator for Pesticide Programs.
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From page 41... ...
While the project manager is coordinating the risk data validation procedure and evaluating the status of existing and needed data, risk and benefit assessment teams are formed and begin initial analyses. The risk analysis involves linking uses of the RPAR pesticide with hazards considered valid.
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From page 42... ...
Following the RPAR notice, the RPAR team determines the uses of the pesticide to be analyzed in depth and develops a range of draft regulatory options. The determination of which uses to analyze in depth depends significantly upon data supplied by the USDA/EPA benefit assessment team.
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From page 43... ...
Some are required by law, others have been created by EPA for the RPAR procedure, and still others are imposed by outside interests. The first scientific review, which occurs before the RPAR notice is ssued, involves only the risk data.
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From page 44... ...
Occurs as a residue immediately following application in or on the feed of a mammalian species representative of the species likely to be exposed to such feed in amounts equivalent to the average daily intake of such representative species, at levels equal to or greater than the acute oral LD50 measured in mammalian test animals as specified in the Registration Guidelines.
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From page 45... ...
Notice of Intent to Establish a Generic Standards System for the Registration of Pesticide Products; Solicitation of Public Views. Proposed Federal Register Document, Office of Pesticide Programs, Washington, D.C.
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