| | 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 Information
Registrants' 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- 7504C
U.S. Environmental Protection Agency
Ariel Rios Building
1200 Pennsylvania Ave., NW
Washington, DC 20460-0001
Registrants' 6(a)(2) submissions via courier service must be addressed
as follows:
Document Processing Desk - 6(a)(2)
Office of Pesticide Programs
Crystal Mall #2, Rm. 266A
1801 South Bell Street
Arlington, VA 22202-4501
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 (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).
PR 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. (72 KB, PDF)
PR 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. (31 KB, PDF)
PR Notice 2000-8
- Reportability of Attorney's Opinions and Conclusions under 40 CFR
Part 159 and FIFRA Section 6(a)(2)
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.
Related Information
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.
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