Adverse Effects Reporting: FIFRA 6(a)(2)
Section 6(a)(2) of the Federal Insecticide, Fungicide and Rodenticide Act (FIFRA) requires pesticide product registrants to submit adverse effects information about their products to the EPA. The following regulations and guidance documents have been published which provide registrants details on what, when and how to report this information.
Addresses to Use When Submitting InformationRegistrants' 6(a)(2) submissions through the U.S. mail must be mailed to the following address:
Document Processing Desk -6(a)(2)
Office of Pesticide Programs- 7504P
U.S. Environmental Protection Agency
William Jefferson Clinton Building
1200 Pennsylvania Ave., NW
Washington, DC 20460-0001
Registrants' 6(a)(2) submissions via courier service must be addressed
For all deliveries, see "Visiting the Office of Pesticide Programs" for office location and building access information
Document Processing Desk - 6(a)(2)
Office of Pesticide Programs
Document Processing Room S-4900
One Potomac Yard
2777 S. Crystal Drive
Arlington, VA 22202
Federal Register Notices
Final 6(a)(2) Regulations – September 19, 1997 (62 FR 49369) –The regulations describe the various types of adverse effects information and specify how and when to submit the information. The preamble discusses all the comments that were received during the rule-making process and the decisions that EPA made on each issue. The final regulations serve as the foundation for the entire regulatory program.
Technical Corrections to 6(a)(2) Regulations – June 19, 1998 (63 FR 33580) – This notice corrected the definition of registrant that appeared in the September 19, 1997 regulations and thereby narrowed the reach of the 6(a)(2) regulations. It also clearly established time frames for reporting the various types of adverse effects information and specified the information to be submitted about incidents.
Deferral of Compliance Date – August 3, 1998 (63 FR 41192) – This notice sets August 17, 1998 as the date when registrants must begin to comply with the new regulations. This supersedes the original effective date of the regulations which was June 16, 1998.
Notice of Class Determination 1-99 – Disclosure of Adverse Effects Information – December 15, 1999 (64 FR 70019) – On September 28, 1999, EPA issued Class Determination 1-99 regarding disclosure of adverse effects information submitted under FIFRA section 6(a)(2). Notice of its availability was published in the Federal Register on December 15, 1999. Class Determination 1-99 (PDF) (203 KB, PDF) establishes certain information submitted under 6(a)(2) as a class. It states that the provisions in FIFRA section 10(d)(1) regarding safety and efficacy information apply to adverse effects information submitted under 6(a)(2). The class determination affirms that with the exception of information that discloses manufacturing processes, methods for detecting inert ingredients, or the identity of inert ingredients (provisions of 10(d)(1)(A), (B), and (C)), safety and efficacy information is not entitled to confidential treatment.
Pesticide Registration Notices
PR Notices are formatted in Adobe's Portable Document Format (PDF). See EPA's PDF page to learn more.PR Notice 98-3 – Guidance on Final FIFRA Section 6(a)(2) Regulations for Pesticide Product Registrants – April 3, 1998 (PDF) (24 pp, 72K, About PDF) – PRN 98-3 provides registrants guidance on a number of questions and issues raised after the regulations were published. Topics addressed include role of agents, aggregate reporting of incidents, expanded definitions of incident severity categories, waiver requests, and property damage incidents.
PR Notice 98-4 – Additional Guidance on Final FIFRA Section 6(a)(2) Regulations for Pesticide Product Registrants – August 4, 1998 (PDF) (13 pp, 31K, About PDF) – PRN 98-4 provides registrants guidance on additional questions and issues. These include issues addressed in the technical corrections such as definition of registrant, reporting timeframes, and required information. It also dropped the requirement to report incidents in which an adverse effect has not occurred but may occur in the future.
PR Notice 2000-8 - Reportability of Attorney's Opinions and Conclusions under 40 CFR Part 159 and FIFRA Section 6(a)(2) (PDF) (3 pp, 8K, About PDF)
PRN 2000-8 informs registrants of EPA's opinion that an attorney's professional legal judgment is not an opinion or conclusion that is reportable under 40 CFR part 159. Opinions and conclusions of attorneys other than the attorney's professional legal judgment can be reportable under part 159. Factual information upon which an attorney's professional legal judgment is based must be reported if it meets the criteria of part 159.
Voluntary Incident Reporting Forms and Instructions – A work group comprising representatives of registrant companies and trade associations designed forms and instructions for capturing and submitting incident reports. EPA staff provided input to the process. Use of the forms is voluntary and information submitted using the forms will be accepted by the Agency. Other formats that meet the requirements of the regulations will be acceptable to the Agency as well.
Code of Federal Regulations – 40 CFR, Chapter I, Part 159, Sub-Part D – Reporting Requirements for Risk/Benefit Information – Revised as of July 1, 2002. – The Code of Federal Regulations codifies the 6(a)(2) regulations that were published in the Federal Register notices listed above. It integrates the language in the September 19, 1997 regulations with the technical corrections published on June 19, 1998. As a result, this presentation of the regulations is much easier to work with than the separate Federal Register notices. 40 CFR does not, however, include the preambles to the regulations that were part of the Federal Register notices. The preambles explain the bases for the Agency's decisions on the various issues raised by the regulatory program and provide insights which may be valuable to the public.