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Disclosure of Studies

FIFRA section 10(g) and the Affirmation of Non-multinational Status Form

In order to receive proprietary pesticide studies or data submitted under FIFRA, a requester must be able to sign the Affirmation of Non-multinational Status form (1pp, 193K, about PDF). In the 1978 amendments to FIFRA, Congress expressly limited who may receive such information and how it may be used by recipients.

These limits, expressed in FIFRA 10(g), were imposed by Congress to protect registrants of pesticides in the U.S. against unauthorized use of their health and safety data by competitors to obtain pesticide registrations in foreign countries. (Those who obtain pesticide registrations in foreign countries are called "Foreign or Multinational Pesticide Producers" in section 10(g), abbreviated "Multinational" herein.)

FIFRA section 10(g) therefore requires EPA to avoid knowingly disclosing this information to a Multinational, or to agents or employees of a Multinational. Numbered paragraphs (1) and (2) of the "Affirmation of Non-Multinational Status" are designed to allow EPA to implement this requirement. Section 10(g) also requires each person who seeks to obtain this information from EPA to affirm that he or she does not intend to, and will not purposefully or negligently deliver (or cause delivery of) the information to a Multinational. Numbered paragraph (3) of the Affirmation is designed to allow EPA to implement this requirement. The remainder of this explanation is provided to further assist you in understanding section 10(g) and the implications of signing the Affirmation.

Section 10(g) makes it unlawful for a person requesting registrant-submitted pesticide information to furnish a false or misleading Affirmation of Non-Multinational Status to EPA; such violations are punishable under 18 USC 1001. Thus, for example, it is EPA's position that it would be unlawful for a person to execute the Affirmation while having the intent to publish (or otherwise to deliver in any way to a Multinational in its entirety) a previously unpublished toxicity study submitted by a registrant. This is because the information delivered likely could be used to satisfy a data requirement imposed by a foreign country as a condition of producing, distributing, selling, shipping, or using the product in that country. However, section 10(g) would not restrict an intent to publish or deliver brief excerpts from such information or summaries or critiques of it, identified as such, since these likely would not be useful in satisfying data requirements imposed by other countries. Of course, the prohibition does not apply to publication or delivery of information that is already freely available to the public (such as data that has been published) or to publication of data with the consent of the registrant that submitted it to EPA.

It is less clear whether the statute imposes any other duties or prohibitions on persons once they have received the information from EPA, and EPA has taken no position on this issue. Some firms who have submitted data to EPA, however, argue vigorously that section 10(g) governs the use or disclosure of data by persons who have obtained it from EPA. Accordingly, you should be aware that if your disclosure of data obtained by you from EPA results in its becoming available to a Multinational (in a form that enables it to be used to satisfy foreign data requirements), it is possible that the firm that submitted it to EPA may seek relief against you in court, and may argue in court that you were required by section 10(g) to guard against disclosing data to a Multinational or allowing such disclosure. You may therefore wish to take steps to avoid inadvertent disclosure of the data by keeping it in a secure place. Before publishing it or deliberately disclosing it to others, you may wish to seek legal advice.

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