Document ga38OyD3w1j4R5aaE8X9O1pBV

y * os% UNITED STATES ENVIRONMENTAL PROTECTION AGENCY WASHINGTON, D.C. 20460 O FF IC E O F P R EV EN TIO N . P E S T IC ID E S AND TO X IC S U B S T A N C ES Paul E. Merrell Bradley & Merrell c/o Jones, Jones, Close & Brown Seventh Floor 300 South Fourth Street Las Vegas, Nevada 89101-6026 MAY I 0 1994 RE: RIN-3726-93 Dear Mr. Merrell: On March 29, 1994, I sent you non-confidentia1 records concerning 2,4-D, 2,4-DB and 2,4-DP and dioxins. In addition to these records, I sent you a blank copy of the Affirmation of Non multinational Status form that I needed you to complete and return so that I may begin the process of sending the remaining records to the submitting companies in order that they may substantiate any claims of confidentiality for these records. As of this date, I have not received a completed Affirmation of Non multinational Status form. Please return a completed Affirmation on Non-multinational form or contact me on (703) 305-6440 or my supervisor, Susan Lawrence, on (703) 305-5805 by June 3, 1994. Sincerely Enclosure Michael Yanchulis Public Response Section Office of Pesticide Programs Recycle d /R e c y d a b le Printed with Soy/Canola Ink on paper that < <9 contains at least 50% recycled fiber EXPLANATION OF THE AFFIRMATION OF NON-MULTINATIONAL STATUS Pesticide information that is responsive to your recent FOI request includes information that was submitted to EPA by pesticide applicants or registrants under the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA). In the 1978 amendments to FIFRA, Congress expressly limited who may receive this information and how it may be used by recipients. These limits, expressed in FIFRA section 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 M ultinational Pesticide Producers" in section 10(g), abbreviated "Multinational" herein.) FIFRA section 10(g) therefore requires EPA to avoid knowingly disclosing this information to a M ultinational, or to agents or employees of a M ultinational. N um bered paragraphs (1) and (2) of the "Affirmation of Non-M ultinational Status" are designed to allow EPA to implement this requirement. Section 10(g) also requires each person w ho 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. N um bered paragraph (3) of the Affirmation is designed to allow EPA to implement this requirement. TTie rem ainder 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-subm itted pesticide inform ation to furnish a false or misleading Affirmation of Non-M ultinational Status to EPA; such violations are punishable under 18 U SC 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) w ould not restrict an intent to publish or deliver brief excerpts from such information or sum m aries or critiques of it, identified as such, since these likely w ould not be useful in satisfying data requirem ents im posed 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 dear 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 firrns who have subm itted data to EPA, however, argue vigorously that section 10(g) governs the use or disdosure of data by persons who have obtained it from EPA. Accordingly, you should be aware that if your disdosure 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 disdosing data to a M ultinational or allowing such disdosure. You may therefore wish to take steps to avoid inadvertent disdosure of the data by keeping it in a secure place. Before publishing it or deliberately disdosing it to others, you may wish to seek legal advice. October 1984 AFFIRMATION OF NON--MULTINATIONAL STATUS This affirmation is required by the EPA interim procedures to implement Section 10(g) of the Federal Insecticide, Fungicide, and Rodenticide Act. Section 10(g) is reproduced on the reverse side for your reference. a1 * mi i i w M B a i ' % I ^ > . ,, >- i.* s I have requested access to information submitted by an applicant or registrant under the Federal Insecticide, Fungicide,, and Rodentidde: Act (7 U.S.C. 136 e seq.) to the Environmental Protection Agency. I herby affirm that: J , :: ...... (1) l am not a business, .: ..-;x. V. . , . Y - ^ Y . ; Y : , . . ' ... . . : ;Y-Y.- 5.:' ., - . ' .... or other entity engaged: in the production, sale, or distribution of pesticides in countries other than the United States or in addition to the United: States; and la m not an employee or agent of any such business or entity; (2) I do not seek: access to the information for purposes of delivering i to r offering it for sale to any such business o r: entity or to any of its employees or agents; 6 ) I will not purposefully deliver the information (or negligently cause it to be delivered) to any such entity or to any of its employees or agents. . lam : aware that Im ay be subject: to criminal penalties under 18 U.S.C. 1001 if I have made any statement of material fa d s knowing that such statement is false o r i f ! willfully conceal an v material fad . Date t *7 _________ zf) , Name f k c j , ; N V Signature y/ .7 / ^ ..... ________________ '' ' ________________________________ '* ' VYY;Y . :YY:.:;:;Y' .,:,Y:Y: Y . YY, Y ' RETURN THIS FORM TO: Public Response & Program Resources Branch (7506C), Office of Pesticide Programs, U.S. Environmental Protection Agency, Washington, D.C. 20460 For office use only: rin 3> -/tC ~ 9z Date marled MAY I o 1994 Caseworker (3/94) 1 T h e Federal In secticid e, Fungicide, and R odentidde A ct as Am ended Public Law 92-516 October 21, J_972 as amended by Public Lw 94-140 November 28, 1975 and Public Law 9E>396 Septem ber 30, 1978 Tx. -me ta .U L " SEC. I f. PROTECTION OF TRADE SECRETS AND OTHER INFOR MATION. --f f j Diackrsure to Foreifn and Multinational Pesticide Producers. -- . *4tl) The Administrator shall not knowingly disclose information submitted by an applicant or registrant under this Act to any employee -or agent of any business or other entity engaged in the production, sale, or distribution of pesticides in countries other than the United Slates or in addition to the United Slates or to any other person who intends to deliver such data to such foreign or multinational business or entity unless the applicant or registrant has consented to such disclosure. The Administrator shall require an affirmation from any person who intends to inspect data that such person does not seek access to the data for pur poses of delivering it or offering it for sale to any such business or entity or its agents or employees and will not purposefully deliver or negligent ly cause the data to be delivered to such business or entity or its agents o r employees. Notwithstanding any other provision of this subsection, the Administrator may disdose information to any person in connection with a public proceeding under law or regulation, subject to restrictions on the availability of information contained elsewhere in this A d . which information is relevant to the determination by the Administrator with respect to whether a pesticide, or any ingredient of a pesticide, causes unreasonable adverse effects on health or the environment. **t2) The Administrator shall maintain records o f the names of per sons to whom data are disclosed under this subsection and the persons or organizations they represent and shall inform the applicant or registrant of the names and affiliation o f such persons. " (3) Section 1001 of title 18 of the United States Code shall apply to any affirmation made under paragraph (1) o f this subsection.