UNITED STATES ENVIRONMENTAL PROTECTION AGENCY WASHINGTON, D.C. 20460 PR Notice 78-3 NOTICE TO MANUFACTURERS, FORMULATORS, DISTRIBUTORS, AND REGISTRANTS Attention: Persons Responsible for Federal Registration of Pesticides SUBJECT: Ban on manufacture, processing and distribution of certain chlorofluorocarbon propellants I. BACKGROUND On March 17, 1978, the EPA published in the Federal Register (43 FR 11318) a final regulation (40 CFR Part 762) prohibiting the manufacture, processing and distribution of fully halogenated chlorofluoroalkanes (chlorofluorocarbons) for non-essential aerosol uses. The rule was promulgated under the authority of Section 6 of the Toxic Substances Control Act (TSCA). Since this ban affects a large number of pesticide products, the Registration Division is seeking particularly to notify pesticide registrants of pertinent provisions exemptions of the regulation. The Notice also discusses the status of current and pending registrations of products that contain the affected chlorofluorocarbons. This is the fourth PR Notice addressing the chlorofluorocarbon issue. PR Notices 75-6 (December 4, 1975) and 76-3 (October 18, 1976) urged registrants to seek and use suitable substitutes. PR Notice 76-3 also required registrants to place an advisory statement on products containing chlorofluorocarbons. PR Notice 77-1 (January 31, 1977) subsequently permitted a negative advisory statement to appear on labeling. PR Notices 76-3 and 77-1 have been rendered obsolete by the TSCA regulation and are rescinded, effective December 15, 1978. II. PROVISIONS OF THE REGULATION A. Affected Chlorofluorocarbon Propellants The propellants specifically prohibited by the regulation are those "fully halogenated chlorofluoroalkanes" which are used as "aerosol propellants." The Registration Division is aware of only three propellants meeting the description which are used in pesticide products: 1. trichlorofluoromethane - Freon 11 2. dichlodifluoromethane - Freon 12 3. 1,2-dichloro-1,1,2,2-tetrafluoroethane - Freon 114 Since Freon 21 (dichloromonofluoromethane) and Freon 22 (chlorodifluoromethane) are not fully halogenated chlorofluoroalkanes, they may continue to be used in pesticide products pending further regulatory action by the Agency. B. Affected Uses The ban affects only aerosol propellant uses, in which the chlorofluorocarbon acts to propel another substance from the container. Thus any product which contains only a chlorofluorocarbon, or in which the chlorofluorocarbon is an active ingredient and not a propellant, may continue to be produced and distributed after the effective date of the ban, pending further regulatory action. C. Effective Dates of Prohibition 1. Manufacture of chlorofluorocarbons for non-essential propellant uses is prohibited after October 15, 1978. 2. Importation of chlorofluorocarbon propellants and articles is prohibited after December 15,1978. 3. Processing and distribution of affected chlorofluorocarbons is prohibited after December 15, 1978. Processing includes the formulation of the propellants into pesticide products. This second provision directly affects a large number of pesticide registrants and products. After December 15, 1978, manufacturers and formulators will neither be able to obtain new stocks of the prohibited chlorofluorocarbons from suppliers, nor be permitted to formulate stocks on hand into aerosol products, except for those uses which have been specifically exempted (see II.D. below). No actual prohibition on distribution of finished aerosol pesticide products has been imposed by the regulation. Any such product already produced by the December 15 deadline may continue to be distributed until stocks are exhausted. D. Exemptions for Essential Uses Two pesticide uses are considered essential and are specifically exempted from the prohibition by Section 762.21 of the regulation: 1. Flying insect pesticides for use in non-residential food handling areas. (However, this exemption does NOT include total release or metered-valve aerosol products.) 2. Pesticides for space spraying of aircraft (as in quarantine programs). III. STATUS OF PRODUCTS CONTAINING THE PROHIBITED PROPELLANTS A. Products Bearing Only Exempted Uses Products intended, and labeled, solely for exempted uses as given in D. above may continue to be manufactured and distributed in commerce. No action on the part of registrants to change or amend the registration of such products is necessary at this time. Product labeling must be explicit to be acceptable under the exemption. The use directions for D.1., for example, must include terms such as "non- residential food handling areas" or "edible product areas of food processing plants," and must list only flying insects to be controlled. Manufacturers and processors of exempted use pesticides are required to submit annual reports through 1982 describing the number of pounds of chlorofluorocarbon propellants purchased and for what purpose (40 CFR Part 712). For further information on the reporting requirements, registrants may contact Judy Kosovich, Pesticides and Toxic Substances Enforcement Division (EN-342), 401 M St., S.W., Washington, D.C. 20460, telephone (202) 755-9404. B. Products Bearing Other Uses in Addition to Exempted Uses In order to bring these products into compliance with the exemptions, registrants should submit applications by September 15, 1978, to amend their registrations, deleting the non-exempted uses. Alternatively, registrants may reformulate their products to delete the prohibited propellant, provided in III.C. below. C. All Other Registered Products All registrants of products other than A. or B. above should revise their formulations to delete the prohibited propellant. Applications for this purpose should be submitted by September 15, 1978, to enable the Registration Division to process them by the December 15, 1978, effective date of the ban. Products for which applications are not received by September 15 will be referred to the Toxic Substances Enforcement Division of EPA for enforcement action under Sections 15-17 of the TSCA, after December 15, 1978. Applications should be submitted to the appropriate Product Manager in the Registration Division, and must include the following: 1. Application for Amended Registration (EPA Form 8570-11) 2. Confidential Statement of Formula (EPA Form 8570-4) 3. Draft labeling, revised to reflect the ingredients statement, precautionary labeling, and use directions of the new formulation. 4. Data on the chemistry of the new formulation as required by Section 162.8 of the Regulations. 5. If aerosol claims and directions for use are to be retained, data on particle size and product performance to support such claims. Amended product registrations will retain their current registration numbers. Registrants of products with alternative formulations under PR Notice 74-2 should submit amended applications confirming that they are deleting the chlorofluorocarbon formulation from their registration. D. Pending Applications for Registration Pending applications for registration of products containing the affected chlorofluorocarbons will not be processed further towards registration. Each applicant will be sent a letter informing him that his application may not be processed, and providing him the opportunity to revise his application within 75 days. After the 75-day period, pending applications which have not been revised will be considered withdrawn. Products solely for exempted uses will continue to be processed towards registration. E. New Applications for Registration Beginning immediately the Registration Division will not accept applications for formulations containing the prohibited chlorofluorocarbons, other than those solely for exempted uses. IV. FURTHER INFORMATION Questions concerning the prohibition on chlorofluorocarbon propellants may be directed to Perry Brunner, Office of Toxic Substances (TS-794), EPA, 401 M St., S.W., Washington, D.C. 20460, telephone (202) 426-9000. copies of the Federal Register notice of March 17, 1978, and the supporting document on essential uses may also be obtained from him. Questions concerning the status of individual pesticide products or applications or the procedures set out in this Notice may be directed to the appropriate Product Manager within the Registration Division. Douglas D. Campt Acting Director Registration Division (WH-567)