UNITED STATES ENVIRONMENTAL PROTECTION AGENCY WASHINGTON, D.C. 20460 December 31, 1991 PR NOTICE 91-8 NOTICE TO PRODUCERS, FORMULATORS, DISTRIBUTORS AND REGISTRANTS OF PESTICIDES ATTENTION: Persons Responsible for Federal Registration and Reregistration of Pesticides SUBJECT: Revised Policy To Provide Applicants Other Than Basic Manufacturers An Opportunity To Submit Generic Data and Receive Data Compensation For It I. PURPOSR AND APPLICABILITY This Notice alters the Agency's policies and procedures so that persons other than the basic registrants of manufacturing use products (MPs) may generate and submit generic data to support registration and reregistration activities, including minor use support without forfeiting any rights which may exist in data compensation under the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA), Section 3(c)(1)(D). To make these changes in the most expeditious manner, this Notice addresses a revised labeling policy which remedies previous inequities. To achieve the purpose of this notice, all Manufacturing Use Product (MP) labels will need to be revised as described in this Notice. (Technical Grade products are also considered MPs.) In addition, formulators using MP products must comply with the labeling of the MP. This is limited to the FIFRA Section 4 registration program and the Section 4 reregistration program. III. BACKGROUND The data compensation obligations to be shared by the Agency and the pesticide industry are described in 40 CFR Section 152 subpart E. The Agency has established an intricate system of policies and procedures to assure data compensation rights to data submitters. A part of that system was based on the industry's routine data submission practices. Until recently, it was common practice for manufacturers of active ingredients (basic producers of the active ingredient) to submit essentially all of the "generic" data to support the specific use patterns for which the active ingredient could be registered and subsequently be used. In most cases the basic manufacturer of the active ingredient obtained a registration for an MP. It was also common for several manufacturers to produce the same active ingredient. Often the various basic manufacturers chose to submit data (or cite existing data) to support a subset of all the uses which eventually were registered for the active ingredient. Because of the data compensation program, there was a need to link the MP registrants with the uses they supported. It was especially important for formulators to know when they could properly invoke the formulators' exemption provision (refer to 40 CFR 152.85) to relieve them from making offers to pay compensation for generic data. Therefore, EPA established a labeling policy which required MP registrants to identify in their labeling only those uses which they supported for registration (or reregistration). EPA established this policy in the mid-1980s as a part of the Registration Standards procedures and also imposed the requirement for new MP registrations. An example of this labeling follows: For Formulation Into An End-use Insecticide Only For Use on Cotton, Corn (Preemergence), Peas and Outdoor Ornamentals. The only use patterns that could be listed were either those that the MP registrant had supported with data that it had submitted or for which it had offered to pay the original data submitter. That specific language meant that the only lawful use of the MP was strictly limited to the uses listed on the label, otherwise the product would be used in a manner inconsistent with its labeling in violation of FIFRA Section 1~(a)(2)(G). This labeling scheme became a problem when MP registrants elected not to submit generic data to support certain minor crops or minor uses on major crops for an active ingredients due to data generation costs. Such decisions by MP producers resulted in certain user groups and end-use formulators deciding to fill the void themselves by submitting generic data to support the registration or reregistration of those uses. However, because of the MP labeling policy, if an MP registrant chose not to support a given use, the MP product could not be formulated for that use, even if an end-use formulator had generated data for that use. Under the existing policy, data generating end-use formulators wishing to maintain a given use must provide their data to the MP registrant so that the MP registrant can retain (or add) the use on its label and thereby permit reformulation of its product for that use. By essentially giving away this data to the MP registrants, the end-use formulators may effectively forfeit data compensation rights. Therefore, several end-use registrants and user groups have requested that the Agency remedy the problem. The Agency agrees that the policy needs to be revised to reflect the needs of those other than MP registrants who wish to generate and submit generic data to support registration and reregistration activities. IV. AGENCY ACTION The Agency is altering its policy with regard to appropriate MP labeling. This change will provide persons, who wish to submit generic data for unsupported uses of a specific active ingredient, a mechanism to do so and also assure data compensation rights to all data submitters entitled to compensation under the law. EPA will continue to require MP labels to include a specific list of those uses for which the MP may be reformulated. An additional statement should also appear on the MP label which permits reformulation of the MP for uses other than those supported by the registrant and listed on the MP label. The complete labeling statement, that includes the revision, is set forth in Section V of this Notice. V. ACTION TO BE TAKEN BY MP APPLICANTS/REGISTRANTS MP labeling should be revised to incorporate the following information. Under the heading "Directions For Use" add this statement: "Only For Formulation Into An _________, [fill blank with Insecticide, Herbicide, or the applicable term(s) which describes the type of pesticidal use(s)] For (1) The Following use(s): _________; (fill blank(s) with only those uses that are being supported by you the MP registrant or applicant.) Conclude this statement by adding. (2) Uses For Which USEPA Has Accepted The Required Data And/Or Citations of Data That The Formulator Has Submitted In Support Of Registration; and (3) Uses For Experimental Purposes That Are In Compliance With USEPA Requirements." The Agency recognizes that some MP manufacturers may have concerns over liability which may result from a uses they have not support with scientific data. Therefore, EPA will permit MP registrants/applicants to amend or include on their labels an additional liability disclaimer for the unsupported (unlisted) uses that disclaims liability for crop damage or failed efficacy resulting from the use of a formulated product containing an MP registrant's product. Any such disclaimer must otherwise be consistent with 40 CFR 156.10(a)(5). VI. EFFECTIVE DATE The revised statement(s) should be placed on labeling that is sold or distributed for all registered MPs on or before January 1, 1993. This may be accomplished by stickering existing labeling until you have an opportunity to reprint the labeling. Please submit revised labeling to the Agency's appropriate Product Manager(s). If you use the exact language described in V above (with or without the liability statement) and make no other labeling changes, you need not await approval by the Agency before using the revised labeling. Otherwise, you must submit an amendment and await Agency approval prior to selling or distributing your MP with the revised labeling. If a Reregistration Eligibility Document (RED) is issued by the Agency before January 1, 1993 that affects the relabeling of an MP product, the registrant must comply with the relabeling schedule in the RED. This Notice is effective upon date of issuance for applicants seeking to register a new MP. VII. ACTION PERTAINING TO OTHER APPLICANTS/REGISTRANTS As a result of this policy, those applicants/registrants who do not develop data but who wish to rely on a third party's data will not be covered by the formulator's exemption for the uses not specifically listed on the MP label. Therefore, such applicants/registrants will be required to submit data or cite the applicable data and offer to pay the data submitter in order to register or reregister a use not supported by the MP registrant. As in the past, any data submitter who wishes data compensation, must request that their firm's name and address be added to the data submitters' list at the next printing. This request should include the name of the active ingredient and the data for which compensation is desired. Submit such requests to Ms. Sherada Hobgood at the address provided under "IX" below. VIII. EXCEPTIONS This policy will not enable third parties to produce data to continue uses that have been discontinued in connection with a Special Review proceeding or other EPA regulatory action for the purpose of reducing risk associated with that particular use. IX. ADDITIONAL INFORMATION You may contact: Herbert Harrison Registration Division (H7505-C), USEPA 401 M Street, SW Washington, DC 20460 (703) 305-55200 Anne Lindsay, Director Registration Division (H7505-C) ----------------------- CERIS-Net Posting Date: 04.01.92 DISCLAIMER: PR Notices prior to 1992 were received from Ken Olds, US Army, Environmental Hygiene Unit, Aberdeen Proving Grounds, Maryland. 1992 PR Notices are sent to CERIS/NPIRS by the U.S. EPA Documents Center in WordPerfect document format. CERIS/NPIRS converts files to ASCII text, with editing to facilitate file transfer, before posting on the CERIS-Net system. This information is available by anonymous FTP from ceris.purdue.edu in the pub/info/prnotice directory. Contact Ed Ramsey of CERIS at 317/494-0442 for access information.