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gram, and provide an efficient and equitable regulatory program 21 for producers and distributors of pesticides.

A3

1986

The major provisions of the bill include—

-Provisions for public access to pesticide health and safety data.
-New requirements for conditional pesticide registration.

-A new reregistration program to ensure that pesticides with
older registrations are reexamined and found to be safe.

-An expanded program for regulation of inert ingredients in pesticides.

-Provisions to enable State agencies to obtain pesticide data from EPA.

-Improvements to the public interim administrative review process (used to review currently registered pesticides for health and safety risks), and the procedures to be followed if a pesticide registration is to be cancelled or denied.

-Provisions for requiring changes in pesticide labels under expedited procedures.

-Sanctions for submission of false health or safety data on a pesticide, and procedures to ensure replacement of invalid data.

-Requirements for withdrawal of tolerances for pesticide residues on raw agricultural commodities if the pesticide registration is suspended or cancelled.

-Updating of provisions relating to recordkeeping and inspections under the Act.

-Warning and information requirements for exported pesticides. -Improved procedures for training and certifying applicators of pesticides, including refresher training.

-Requirements for recordkeeping by pesticide dealers and applicators, and access to certain records for employees and custom

ers.

-Required cooperation or cost-sharing in the development of
health and safety data on currently registered major agricul-
tural pesticides.

-Revisions of the rules under which the compensation must be
paid when an applicant for registration of a pesticide uses an-
other person's data in the pesticide registration process.
-A requirement for the establishment of criteria under which
State pesticide registrations for special local needs could be dis-
approved.

-Clarification of the "use inconsistent" definition.

-Provisions to reduce burdensome requests for information under the Act.

-Strengthening of the enforcement and penalty provisions of the Act.

-New procedures for judicial review of the regulation promulgated under the Act, with special provisions for agricultural producers.

-Coordination of action by EPA and the Department of Labor (under OSHA) with respect to pesticide worker safety, and requirements for training and worker protection regulations under the Act.

UNIVERSITY OF MICHIGAN LIBRARIES

-A requirement that the Administrator use authorities under the Act to protect drinking water and groundwater against pesticide contamination.

-Establishment of liability rules to protect farmers who use pesticides correctly.

Following are brief descriptions of the major provisions of the

bill:

DETAILED EXPLANATION

Preregistration access to data: The bill provides for public access to health and safety data submitted to support an application for the registration of a pesticide containing a new active ingredient, or to authorize the initial food use of a pesticide active ingredient. Public access would only be granted for the purpose of allowing public comment on the application. A person seeking access to data supporting an application for registration must affirm that the person is not directly or indirectly, or acting on behalf of someone, in the pesticide business. Criminal penalties would be required for wrongful disclosures of information. (Secs. 101 and 102.)

Conditional registrations: The bill will prohibit conditional registration amendments of a pesticide for additional uses unless the additional use is in the public interest. A conditional amendment to add a use could not be granted if data concerning possible chronic effects have not been submitted, and the registrant has had a reasonable time to submit the data, unless the amendment is to add a minor use. (Sec. 103.)

Reregistration of registered pesticides: The bill will require the Administrator of the Environmental Protection Agency to reregister pesticides with active ingredients contained in pesticides registered before November 1, 1984, with outstanding data requirements. Reregistration would be completed in five phases:

(1) EPA would publish a priority list of the active ingredients contained in pesticides that must be reregistered. Priority would be given to active ingredients that have not already been assigned reregistration requirements, and that are in use on or in food or feed and may result in postharvest residues or residues of potential toxicological concern in potable groundwater, edible fish, or shellfish, have significant outstanding data requirements, or are used where workers exposure is most likely.

(2) Registrants must notify the Administrator whether or not the registrant intends to seek reregistration of a listed pesticide. Registrants must also identify and agree to replace missing and inadequate data for the pesticide.

(3) Registrants must summarize studies previously submitted in support of reregistration, reformat certain data in the studies according to EPA guidelines, and promise to fill outstanding data requirements.

(4) The Administrator must review submissions to determine if all data that are missing or inadequate were identified. Outstanding data requirements for each active ingredient must be published, and four years would be allowed for the submission of required data.

(5) EPA must conduct a thorough examination of all data, and determine if the pesticide is eligible for reregistration. Applicants for reregistration of the pesticide must then supply supplemental product-specific data. The Administrator must make a final decision on reregistration not later than one year after the submissionof all required data.

The bill provides for the payment of reregistration fees based on active ingredients. Collectively, registrants of each pesticide registered for a major use on food or feed must pay an initial fee of $50,000 with the phase two submission. A final fee of $100,000 would be paid under phase three.

Registrants of each pesticide registered for a major use on food or feed for which registration requirements already have been issued, must collectively pay a fee of $100,000 at a time to be determined by the Adminstrator.

Registrants of each pesticide not registered for a major food or feed use must collectively pay a fee determined by the Administrator (but not greater than $150,000 or less than $75,000). If registration requirements already have been issued for the pesticide, the fee could not be greater than $100,000 or less than $50,000.

Fees could be reduced or waived for minor use pesticides, pesticides for which the value or volume of use is small, certain small businesses, and antimicrobial active ingredients for which production levels do not exceed 1,000,000 pounds per year. Fees are to be apportioned, according to domestic market share, among registrants. (Secs. 104 and 105.)

Inert ingredients: The bill will direct the Administrator to establish a priority list of between 50 and 75 inert ingredients. Listed would be (1) inerts that appear to cause a pesticide to trigger a public interim administrative review; (2) inerts for which additional data are reasonably necessary to assess whether they may cause unreasonable adverse effects, that are similar in molecular structure to chemicals known to cause unreasonable adverse effects, and that have significant use in pesticides or to which there is significant exposure from pesticides; and (3) inerts for which additional data are needed to assess whether they may result in unreasonable adverse effects and to which there is significant exposure from pesticides. Within one year, the Administrator must determine if additional data on a listed inert ingredient are needed, and such data must be submitted within four years. Within one year after submission of the data, the Administrator must take appropriate regulatory action.

The bill would require modification of pesticide ingredient statements to show the name of each inert ingredient in a pesticide that the Administrator determines must appear in the statement because of the hazard that may be posed by the use pattern and concentration level of the inert ingredient, and the name of any inert ingredient for which the Administrator has required additional data because it appears to cause a pesticide to trigger a public interim administrative review (Secs. 106 through 109.)

Public right to know: The bill will require that any producer operating a pesticide production establishment to prepare or obtain a fact sheet, summarizing relevant health, safety, and environmental data for each active ingredient manufactured or used at the estab

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