Note: This information is provided for reference purposes only.
Although the information provided here was accurate and current
when first created, it is now outdated.
Staff Paper # 5
TOPIC: IMPROVING TRANSPARENCY IN THE REGISTRATION AND REREGISTRATION
In light of the Agency's increased efforts to meet the public's desire for
more information on pesticide regulatory decisions, OPP has been exploring
different facets of its registration and reregistration processes to identify
opportunities for greater transparency in its regulatory programs. While
some changes have been accomplished in the science review process, additional
improvements in the transparency of both the registration and reregistration
decision-making processes are being considered.
Currently, FIFRA requires the Agency to provide notice to the public for
certain types of regulatory actions:
Receipt of an application for registration of a new active ingredient
Receipt of an application for a change in the use pattern of an active ingredient
Deletion of uses from the registration of a product
Cancellation of a product's registration
In addition, FFDCA requires the Agency to publish at least two public notices
in establishing or amending a tolerance or an exemption from tolerance. These
Notice of Filing of a Pesticide Tolerance Petition
Final Rule Establishing a Pesticide Tolerance or Exemption from Tolerance
If the Agency's assessment differs significantly from the findings articulated
in the Notice of Filing, the Agency may issue a Proposed Rule inviting public
comment before issuing its final determination.
Furthermore, the Agency routinely brings issues of emerging science to the
public for review and comment through the FIFRA Scientific Advisory Panel
Except for comments received through the SAP process, historically the Agency
generally receives few, if any, comments in response to any of these notices.
The reasons for this low response could range from few concerns with the
Agency's proposed action, to too many notices for which to prepare responses,
to confusion over the technical merits of the proposed action, to inability
to receive technical information in a timely manner. Nevertheless, the Agency
believes that in order to meet the demands for increased transparency in
its decisionmaking and to allow for increased consultation with all interested
stakeholders, EPA should identify areas for increased public participation.
OPTIONS FOR CONSIDERATION:
Stay the current course. Few comments are received. Resources should
be devoted to other activities.
Find ways to make information better available before the decision.
This could be done either through increased docketing, greater use of the
Internet, or some combination of the two. All OPP Federal Register Notices
are currently available through EPA's Website. Increasingly, links are being
created to available background and related information on the posted action.
OPP could explore expanded use of the Internet for proposed actions in addition
to use of the electronic Federal Register publications. These activities
could include Web published fact sheets, issue papers, discussion sites,
Increase use of Pesticide Registration (PR) Notices for Science Policy.
The Agency routinely issues PR Notices to announce innovations in registration
processes, label upgrading efforts, and registration guidance. The Agency
could consider expanding the use of these notices to include announcement
of interim and evolving science policy. For example, the Agency could provide
a manual that is continuously updated to reflect developments in FQPA science
Finalize Rules. EPA has issued proposed rulemakings that address the
Antimicrobial and section 18 provisions of FQPA. By finalizing these rules,
EPA would provide the regulated community a better understanding of how these
two programs operate.
Make information available and commit to X-days of a comment period.
Both Canada's Pest Management Regulatory Agency and California's Department
of Pesticide Regulation have adopted public notice processes that differ
somewhat from the one traditionally employed by EPA. In general, both the
Canadian and California approaches provide for a public "posting" period
for all actions 30-days or more prior to issuance of the final decision.
In this posting, the agency makes all information, data, assessments, and
characterizations available to the public for comment.
Greater distribution of registration schedules and registration status.
During the past year, the Registration program has experimented with the
use of the Internet to provide status reports on emergency exemption requests.
These reports have been widely received. The program could explore the use
of similar databases to report on the status of pending registrations for
new chemicals, new uses, minor uses, etc. The Office of Pollution Prevention
and Toxics is currently experimenting with a very simple system to report
on premanufacture notification review status.
Formal Notice and Comment Periods for Regulatory Decisions.
QUESTIONS THAT THE TRAC MIGHT ADDRESS:
The Agency is aware that manufacturers, growers, and public interest groups
have concerns regarding the "transparency" of EPA's registration and
reregistration decision-making process.
Are there common approaches among the stakeholders whereby EPA could
improve the "transparency" of its regulatory process?
The Agency is also aware that stakeholders are interested in a higher degree
of participation throughout the regulatory process.
At what stage(s) of the current regulatory process is it most important
for stakeholders to participate?
Do the options that have been put forward to EPA for consideration
fully capture the range of options for improving participation and transparency
in the regulatory process?
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updated May 22, 1998