Incident Reporting
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** -- 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**
-- 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 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.epa.gov/fedrgstr
- 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://www.epa.gov/PR_Notices
- The PRN's are arranged chronologically with the most recent on top.
For questions about the 6(a)(2) regulations and guidance contact:
Kathryn S. Bouvé, 6(a)(2) Officer
U.S. Environmental Protection Agency
Office of Pesticide Programs (7502C)
Ariel Rios Building
1200 Pennsylvania Ave. NW
Washington, D.C. 20460
703-305-5032
or email bouve.kate@epa.gov
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