Tolerance Reassessment Advisory Committee

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 Although the information provided here was accurate and current when first created, it is now outdated.

TRAC 5/28-29/98
Staff Paper # 5

TOPIC: IMPROVING TRANSPARENCY IN THE REGISTRATION AND REREGISTRATION PROCESSES

BACKGROUND:

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 include:

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 process.

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, etc.

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 policy.

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?

TRAC 5/28-29/98 Staff Paper # 5

TRAC 5/28-29/98
Staff Paper # 5