FRIDAY January 22, 1993 Part IV Environmental Protection Agency Incentives for Development and Registration of Reduced-Risk Pesticides Program Update; Notice (This reprint was prepared from the electronic file that accompanied the original signed documents transmitted to the Office of the Federal Register. This file was certified to be a true copy of the original.) (This document appeared at 58 FR 5853 - 5855.) Federal Register / Vol. 58, No. 13 / Friday, January 22, 1993 / Notices ENVIRONMENTAL PROTECTION AGENCY [OPP - 36184B;FRL - 4184 - 7] Incentives for Development and Registration of Reduced-Risk Pesticides Program Update AGENCY: Environmental Protection Agency (EPA). ACTION: Notice. SUMMARY: This notice is a follow-up to the Environmental Protection Agency's initiative to establish incentives for the development, registration, and use of reduced-risk pesticides (57 FR 32140; July 20, 1992). It serves as an interim report of EPA's progress, an overview of plans for the future and describes the Agency's short-term and long-term strategies. A Pesticide Regulation (PR) Notice is being prepared and will be sent to all parties holding Federal pesticide registrations. The PR Notice will provide guidance on the EPA's interim process for identifying new active ingredients which may be eligible for priority treatment as lower-risk pesticides. Applicants seeking a new active ingredient registration are invited to provide an explanation accompanied by any supporting information on why their application and any associated tolerance petitions may qualify for special consideration as a reduced-risk pesticide. EPA's long-term plans include (1) developing criteria for identifying lower risk pesticides to use as a factor in setting priorities and scheduling reviews of applications to register new pesticides, (2) streamlining the overall registration process, (3) improving the information content of pesticide labels and promoting other educational efforts to better inform the public and encourage more informed user choice, and (4) considering legislative approaches to encourage the registration of new reduced-risk pesticides by extending the periods of exclusive use under FIFRA or patent term protection, to qualifying pesticides. FOR FURTHER INFORMATION CONTACT: Stephanie R. Irene, Registration Division [H7505C], Office of Pesticide Programs, Environmental Protection Agency, 401 M St., SW., Washington, DC 20460, (703) 305 - 5447. SUPPLEMENTARY INFORMATION: Electronic Availability: This document is available as an electronic file on The Federal Bulletin Board at 9:00 a.m. on the date of publication in the Federal Register. By modem dial (202) 512 - 1387 or call (202) 512 - 1530 for disks or paper copies. This file is also available in Postscript, Wordperfect and ASCII. I. Background A. Introduction EPA has embarked on a reduced-risk pesticide initiative with the primary objective of encouraging the development, registration and use of lower risk pesticides and pest management practices in order to lessen risks to human health and the environment. Because of the significance and complexity of the topic, EPA announced its interest in developing new policies in this area and solicited public comment via a Federal Register notice published July 20, 1992 (57 FR 32140), and a public workshop held October 5 and 6, 1992. B. Public Involvement 1. Federal Register Notice. EPA identified two basic objectives for a reduced-risk policy with several possible actions for implementing each. The first objective is to create incentives for the development, registration, and use of lower risk pesticides; the second is to encourage the replacement of higher risk pesticides on the market. EPA also invited discussion on how the EPA should identify lower-risk and higher-risk pesticides. EPA listed several possible incentives to encourage lower risk pesticides, including early counseling of applicants for registration, giving priority status to potentially lower risk pesticides in the review process, waiving fees, reducing or deferring data requirements, and allowing safety claims in labeling and in advertising to foster competition in favor of reduced-risk products. EPA described possible approaches for encouraging the replacement of higher risk pesticides, such as those which may in the past have been retained only because there were no cost-effective, lower-risk alternatives. The Agency suggested several possible actions with respect to such pesticides, including publishing a list of higher risk uses, screening applications claiming to replace higher risk uses and giving qualifying applications priority for review and waiving fees. EPA also suggested the possibility of reevaluating the registration of higher risk pesticides for potential regulatory action, i.e., restriction or cancellation, when safer, effective alternatives are registered. 2. Public workshop. Due to the potential impacts and complexity of this topic, EPA conducted a public workshop on October 5 and 6, 1992 to further explore the issues. Over 200 participants attended. The Agency appreciates the interest and enthusiasm of all attendees who provided candid, albeit differing viewpoints on how the Office of Pesticide Programs could accomplish its intended goals. The period for accepting written comments was extended to November 5 to incorporate additional ideas and responses generated from the workshop. EPA has received a total of 152 written comments. EPA would like to thank everyone who provided valuable input by participating in the workshop and/or responding to the Federal Register notice. Many of the comments provided imaginative ideas and suggestions and will greatly assist the Agency in policy formulation. II. Strategy A. Short Term Approach EPA is implementing an interim strategy while policy is being developed. The Agency wishes to capture good ideas that can be implemented quickly. The Office of Pesticide Programs (OPP) will be issuing a Pesticide Regulation (PR) Notice to all pesticide registrants. This PR Notice will announce that, in scheduling the review of pesticide applications involving new active ingredients, one of the factors EPA will consider is the opportunity for reduced risk. The Notice will provide general guidance and describe the type of information that OPP will need to evaluate such requests. By adopting this voluntary pilot program, EPA can test its feasibility, obtain additional comments from outside sources, and improve the Agency's ability to devise a long term strategy. Applicants who believe they have developed a qualifying new active ingredient will be invited to submit a rationale substantiating their case as part of their application for registration. The applicants will be asked to discuss why their product(s) presents a reduced risk and make a comparison between the risks posed by the new active ingredient under consideration and the other pesticides for that use. Registrants should consider human health, environmental fate and ecological effects, other hazards and pest resistance management. In addition, they may consider the cost of the product relative to substitutes. An application's review priority will depend on the Agency's determination that the new active ingredient may pose significantly lower risks. The PR Notice will give additional details on topics that should be addressed in any such request for special consideration. B. Long Term Approach To develop a more comprehensive reduced-risk policy, EPA will focus on four major issues. The plan is first to develop specific criteria for identifying lower risk pesticides for accelerated review and to work on streamlining the entire registration process for all products. Exploration of potential product label reform and the possible extension of exclusive use or patent terms, which could require more complex rulemaking or legislative changes, will follow. While EPA has decided not to publish a list of higher risk pesticides at this time, it may revisit the issue after the completion of the reregistration program, when a more complete data base should permit more reliable comparisons among pesticides. The four main elements of the longer term strategies are described below: 1. Developing criteria. EPA intends to establish a list of criteria for identifying a reduced-risk pesticide. These criteria should be science-based, and they should provide assurance of protection of public health and the environment. The application of each criterion should be sufficiently objective that incoming pesticide applications may be screened quickly to identify lower risk candidates before the detailed review begins. Therefore, the initial identification process should not significantly delay review of an incoming application regardless of whether it ultimately conforms to the reduced-risk standard. EPA intends to work with industry and academia to develop the criteria. 2. Streamlining the registration process. EPA currently has in place several teams or workgroups whose charge is to analyze the registration process to recommend efficiencies. The streamlining sought will affect all incoming actions and not be limited to those claiming lower risk. Areas where internal process improvements are being developed are new chemicals and tolerances, Fast Track registrations, and Special Local Needs (section 24(c)) registrations. Additionally, OPP is focusing on streamlining ecological effects and environmental fate data requirements, and revising pesticide tolerance crop groupings. Finally, we are considering the possibility of exempting from FIFRA registration requirements pesticidal materials recognized to be of low risk. Candidates may include some of the materials which EPA has recently found eligible for reregistration, such as dried blood and putrescent egg solids. 3. Pesticide label reform and informational outreach. In order to promote the goal of encouraging pesticide users to choose and utilize reduced-risk pesticides, EPA is considering revising its pesticide labeling policy, for example, by allowing registrants to make safety claims on their labels. Several workgroups within the Agency are addressing the complex and multifaceted issues which arise with labeling. These groups were established to seek improvements in the scope and utility of, policy for, and the process for developing pesticide labeling. EPA will also consider other mechanisms to reach interested persons with improved information about pesticides that may affect them, others, or the environment in general. The Agency plans to improve the informational content of pesticide labels and develop other educational sources e.g., pesticide fact sheets and training programs to permit more informed choices by users and other affected parties. In addition, the Agency is considering allowing comparative-safety-and-efficacy claims in advertising materials to inform users of risks and benefits. 4. Extending exclusive use or patent term extension incentives. One of the strongest and more significant economic incentives, as expressed by representatives of the pesticide industry, would be the extension of the exclusive use period of a pesticide as established in FIFRA section 3(c)(1)(D) or the granting of an extension of the patent term for a lower risk pesticide. Currently, a portion of an applicant's period of patent protection is taken up by the Agency's review process, thus shortening the actual time the product is on the market under patent. If this period is extended, the registrants believe they would be able to recoup their research and development expenses more quickly, thereby encouraging the development of new pesticides. EPA will examine the options in this area for providing meaningful incentives for the development of lower risk pesticides. EPA realizes that developing a comprehensive Reduced-Risk Policy incorporating the listed objectives will require significant time and resources. It believes, however, that the immediate actions being taken will result in progress toward the end of lessening risks from pesticides to human health and the environment. Dated: January 13, 1993. William K. Reilly, Administrator, Environmental Protection Agency. [FR Doc. 93 - 1499 Filed 1 - 21 - 93; 8:45 am] BILLING CODE 6560 - 50 - F