Federal law requires registrants of pesticides to inform EPA about harmful effects of their products. These effects include, for example, unexpected levels of toxicity observed in test animals or incidents such as death or hospitalization of a person.
Information reportable under this provision includes not only new information derived from scientific studies, but also reports of incidents of harmful effects resulting from the use of pesticide products. Thus, the requirement provides an important check on the correctness of the original decision to register a pesticide.
The regulations and guidance documents below provide registrants details on what, when and how to report this information. Please click on any of the documents that follow for more information. PR Notices are formatted in Adobe's Portable Document Format (PDF).
Final 6(a)(2) Regulations - Federal Register - 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.
Pesticide Registration Notice 98-3-Guidance on Final FIFRA Section 6(a)(2) Regulations for Pesticide Product Registrants - April 3, 1998 (PDF)** (24 pp, 71 K, 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.
Technical Corrections to 6(a)(2) Regulations - Federal Register - 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 - Federal Register - 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.
Pesticide Registration Notice 98-4 - Additional Guidance on Final FIFRA Section 6(a)(2) Regulations for Pesticide Product Registrants - August 4, 1998 (PDF)** (13 pp, 31 K, 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.
Notice of Class Determination 1-99 - Disclosure of Adverse Effects Information - Federal Register - 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) (5 pp, 203 K, about 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.
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. OPP 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, 1998. -- 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.
* The URL for Federal Register Notices related to EPA issues is http://www.gpo.gov/fdsys/browse/collection.action?collectionCode=FR - Select the date of the desired notice and proceed through the Table of Contents for that day.
** The URL for the Office of Pesticide Programs' Pesticide Registration Notices (PRN's) is http://www2.epa.gov/pesticide-registration/pesticide-registration-notices-year - The PRN's are arranged chronologically with the most recent on top.
For questions about the 6(a)(2) regulations and guidance contact:
Robert Miller, (firstname.lastname@example.org)
U.S. Environmental Protection Agency
Office of Pesticide Programs (7502P)
William Jefferson Clinton Building
1200 Pennsylvania Ave. NW
Washington, D.C. 20460