UNITED STATES ENVIRONMENTAL PROTECTION AGENCY WASHINGTON, D.C. 20460 March 19, 1992 PR NOTICE 92-3 NOTICE TO MANUFACTURERS, FORMULATORS, DISTRIBUTORS, AND REGISTRANTS OF PESTICIDE PRODUCTS ATTENTION: Persons Responsible for Federal Registration of Pesticide Products SUBJECT: Pesticides and the Clean Air Act: Stratospheric Ozone Protection This notice is to alert pesticide registrants to new provisions of the Clean Air Act (CAA) which will affect registrations, and inform them of how they must or may comply with new requirements within the framework of FIFRA. Changes in formulation or labeling may be necessary, some as early as November, 1992. Applications for registration must be approved or notifications submitted earlier than CAA compliance dates if registrants wish to minimize disruption of pesticide distribution and sale. The Appendix to this Notice gives a general timeline of activities under the CAA and related activities under FIFRA. The requirements of the CAA concerning stratospheric ozone protection and this notice are directed to registrants of products containing or manufactured with: - Chlorofluorocarbons (CFCs) - Hydrochlorofluorocarbons (HCFCs), - Carbon tetrachloride and - Methyl chloroform While no action is required immediately by this notice, registrants should be aware of the short timeframes imposed under the Clean Air Act. These timeframes in most cases are imposed by law, and it is not within the discretion of the Agency to extend them. Moreover, sale and distribution of affected pesticide products not in compliance may be prohibited under the CAA without provision for depletion of existing stocks. Registrants are strongly encouraged to begin planning for an orderly transition process at this time, and to take action to bring pesticide products into compliance at the earliest possible time after regulations are promulgated. EPA expects to issue additional PR Notices as needed to keep registrants informed of their obligations under FIFRA that may be affected by CAA requirements. Nonetheless, registrants are responsible for determining whether their currently registered products are affected, and for the timely submission of applications for new registration or notifications. EPA cannot guarantee that applications submitted close to compliance dates of the CAA can be reviewed and approved before the sale and distribution prohibitions become effective. Registrants must comply with both FIFRA and CAA requirements in order to continue to sell and distribute affected products. Registrants must also ensure that supplemental registrants of distributor products remain in compliance with FIFRA requirements. I. BACKGROUND On November 15, 1990, Congress passed amendments to the Clean Air Act, including, among other things, provisions designed to protect the stratospheric ozone layer from deterioration by "ozone-depleting" chemicals. Title VI of the CAA, entitled "Stratospheric Ozone Protection," contains several provisions that will affect the registrations of some pesticide products. Briefly, the principal provisions of Title VI affecting pesticide products in the immediate future are the following. Each of these is discussed further in this notice. 1. CAA sec. 602 designates ozone-depleting chemicals as Class I or Class II substances for purposes of regulatory activities [See Unit II]. 2. CAA sec. 604 mandates a phaseout of the production and consumption of Class I substances over the next 10 years [See Unit III]. 3. CAA sec. 610 bans certain non-essential products containing or manufactured with Class I and Class II substances in two phases. In the first phase, EPA will issue regulations banning non-essential products and uses of Class I CFCs by November 1992, followed by a ban on non-essential products and uses of Class II substances by January 1994 [See Unit IV]. 4. CAA sec. 611 requires the labeling of products containing and manufactured with Class I and II substances. The earliest compliance date for labeling, which includes products containing Class I substances, is May, 1993 [See Unit V]. II. DESIGNATION OF CLASS I AND CLASS II SUBSTANCES (CAA sec. 602) A. What the CAA Requires. Section 602 lists those chemicals that are "ozone-depleting" and assigns them to two classes for purposes of regulatory action. 1. Class I substances: - Fully halogenated chlorofluorocarbons (CFCs). Agency records indicate that up to 170 products contain CFCs, either as active ingredients or as inert ingredients. - Halons. EPA does not believe that halons are contained in any currently registered pesticide product. - Carbon tetrachloride. Agency records indicate few, if any, remaining products contain carbon tetrachloride, which is a List 1 inert ingredient. - Methyl chloroform [1,1,1-trichloroethane]. Agency records indicate up to 750 products currently contain methyl chloroform, which is a List 2 inert ingredient. 2. Class II substances: - Non-fully halogenated chlorofluorocarbons (HCFCs) B. What Registrants Should Do. Identify which of your registered products contain Class I or Class II substances for future reference and response to specific regulatory requirements. III. PHASEOUT OF PRODUCTION AND CONSUMPTION OF CLASS I SUBSTANCES A. What the CAA Requires. CAA sec. 604 requires the phaseout of production and consumption of Class I substances by the year 2000 (2002 for methyl chloroform), with very limited exceptions for medical devices and aviation safety uses. Consequently, registrants of pesticide products currently produced with or containing Class I substances may find that sources of CFCs, carbon tetrachloride, and methyl chloroform will be increasingly difficult to obtain, and at substantially higher cost. EPA expects that pesticide use of Class I substances will become marginal, and registrants will seek available substitutes as Class I substances are redirected to higher-valued non-pesticide uses. B. What Registrants Must Do to Remain in Compliance with FIFRA. 1. Production process changes. A registrant of a technical grade active ingredient or manufacturing use product who uses a Class I substance as a starting material or manufacturing process component, and who wishes to use a different process or an alternative starting material, must inform the Agency of the change. A registrant may use a notification procedure for this purpose, provided that the change in the identity of the starting material or the process resulting from substitution does not result in: - A change in the certified limits of the active ingredient in the manufacturing use product being produced; or - The formation of any new impurity associated with the active ingredient, at a level greater than 0.1% by weight of the technical grade active ingredient, or an increase in the level of any impurity of toxicological significance; or - A change in the nominal concentration of the active ingredient, such that the label ingredients statement would change. A notification must be submitted in accordance with procedures outlined in PR Notice 88-6. A description of the new production process identifying where the change has occurred must be submitted with the notification. If the certified limits, impurities or nominal concentration of the ingredient would change (as bulleted above), an application for amended registration of the manufacturing use product must be submitted, together with a Confidential Statement of of Formula, and draft labeling if a change in nominal concentration would result in a revision of the label ingredients statement. 2. Formulation changes. A registrant who wishes to change his formulation to delete a Class I substance or to substitute an alternative must submit an APPLICATION FOR NEW REGISTRATION to the appropriate Product Manager in the Registration Division. Removal of an ingredient or substitution may result in a product of substantially different composition, characteristics, and labeling, particularly with respect to toxicity, flammability, or efficacy. NEW REGISTRATION IS REQUIRED; amendment of an existing registration will not be acceptable. At the same time, the registrant should request cancellation of his old product to be effective on the date of issuance of the new registration. Existing stocks provisions for such cancellation will normally be one year for the registrant, unless a CAA compliance date which prohibits distribution or sale of existing stocks occurs earlier than one year. In order to meet the timeframes of the CAA and FIFRA, we encourage the early submission of applications to delete or substitute for Class I Substances. EPA will accord fast-track review status under FIFRA sec. 3(c)(3) for applications meeting the criteria of that section. The applicant should indicate that the application is in response to Clean Air Act requirements to ensure expeditious review. 3. Class I substances no longer acceptable in pesticide products - Effective immediately, EPA does not intend to accept applications for new registration of aerosol or pressurized products containing CFCs (refer to Unit IV describing the ban on non-essential products). - Producers are strongly discouraged from submitting applications for new products containing other Class I substances. Because the continued registration of new products containing Class I substances is contrary to the goals and objectives of the Clean Air Act in phasing out Class I substances, EPA may decide in the future to refuse to accept such applications. IV. BAN ON NON-ESSENTIAL USES AND PRODUCTS A. What the CAA Requires. Under CAA sec. 610, the Agency is required to ban non-essential products and uses of ozone-depleting chemicals, in two phases addressing Class I and Class II substances respectively. 1. Ban on CFC-containing aerosols and pressurized products. In the first phase of the ban, the Agency has proposed (57 FR 1992, January 16, 1992) to ban the sale and distribution of all aerosols and pressurized products containing CFCs. This proposal is based primarily upon a determination that alternatives are available for all CFC uses in aerosols and pressurized products. - Comments on this proposal were due by February 18, 1992. - A final rule will be issued as soon as possible, since: - Sale and distribution of affected products by any person will be prohibited as of November 15, 1992. 2. Ban on carbon tetrachloride and methyl chloroform-containing products. Before 1994, EPA expects to issue additional regulations that will likely have the effect of banning or severely limiting non-essential uses of carbon tetrachloride and methyl chloroform in pesticide products. Comment opportunity will be provided. 3. Ban on HCFC-containing products. As of January 1, 1994, sale and distribution of all aerosol and pressurized products containing Class II substances (HCFCs) will be prohibited. Exceptions to this last prohibition may be granted only on the basis of flammability or worker safety concerns. The Agency intends to describe the procedures for seeking an exception before 1994. B. What Registrants Must Do to Remain in Compliance with FIFRA. 1. Comment Opportunity. Registrants may comment upon the Agency's current proposal of non-essentiality and present justification why their product(s) or the use of CFCs in their product(s) should be considered essential. EPA will respond to comments received in the final rule or in the public docket. 2. Registrant Actions After Ban. As soon as possible after a final rule has been issued banning non-essential uses, registrants of products containing those banned substances should submit an application for new registration if they wish to delete the substance, or to substitute an alternative chemical, as described in Unit III.B.2. of this notice. Registrants who do not intend to delete or substitute should request cancellation of registration, with existing stocks provisions governed by the November 15, 1992, CAA compliance date for the non-essential ban. 3. Early Submission Desirable. Registrants are encouraged not to wait for the issuance of regulations before seeking substitutes and submitting applications. Applications may be submitted at any time for the purpose of deleting or substituting for Class I or II substances. EPA recommends that applications for new registration be submitted no later than 6 months before the compliance date of a rule prohibiting sale and distribution to ensure sufficient time for Agency review and approval. This will avoid the disruption that may occur if the CAA bans sale and distribution of the old product before the Agency authorizes sale and distribution under FIFRA of a new reformulated product. 4. Aerosols and Pressurized Products Affected by Current Ban. Applications for new registration for aerosols and pressurized products containing CFCs should be submitted no later than May 15, 1992, in order for the Agency to have time to review and approve them before November 15, 1992. Applicants should indicate that the application is in response to Clean Air Act requirements to ensure expeditious review. 5. Future Bans. Based on a determination that safe alternatives exist for Class I and Class II substances, the Agency may ban additional non-essential products and uses of carbon tetrachloride, methyl chloroform, or HCFCs. Registrants should plan to submit needed applications no later than 6 months before the compliance date of such a ban, or by July 1, 1993, six months before the statutory ban on sale and distribution of products containing non-essential Class II substances (January 1, 1994). By this date, EPA expects to have issued non-essential ban regulations for all ozone-deplating substances. 6. Aerosol products Containing CFCs not Acceptable for Registration. - Effective immediately, EPA does not intend to accept applications for new registration of aerosol or pressurized products containing CFCs. - Effective on the date of proposed regulations banning remaining Class I or II substances, or as of January 1, 1994, whichever is earlier, the Agency will no longer accept applications for new registration of products containing those Class I or II substances. V. LABELING REQUIREMENT FOR PRODUCTS CONTAINING OR MANUFACTURED WITH CLASS I AND II SUBSTANCES A. What the CAA Requires. CAA sec. 611 requires the labeling of all products containing or manufactured with Class I or Class II substances, unless EPA makes certain determinations concerning availability of substitutes. The required labeling statements are set by the CAA, and may not be changed. Regulations will be issued no later than May 15, 1992, which will contain any determinations about availability of substitutes for Class I products. 1. Products containing Class I substances. All products that contain Class I substances (CFCs, carbon tetrachloride and methyl chloroform) and that are sold or distributed after May 15, 1993, must be labeled with the following statement: +----------------------------------------------------------+ |WARNING: Contains [name of substance], a substance which | | | |harms public health and the environment by destroying | | | |ozone in the upper atmosphere. | +----------------------------------------------------------+ 2. Products manufactured with Class I or Class II substances. These products may be required to be labeled with a similar statement, depending upon the Agency's determination of substitutes. As a practical matter, if EPA determines that substitutes exist, the products will be required to be labeled. B. What Registrants Must Do to Revise Labels and Remain in Compliance with FIFRA (Assuming products are not reformulated to remove CFCs) 1. Evaluate products for applicability. Registrants should evaluate their products to determine whether the labeling statement will likely be required, and be prepared to add the required labeling statement to labeling within the year timeframe (May 1992 - May 1993) allowed for compliance. 2. TAKE NO IMMEDIATE ACTION. Registrants should not revise labeling immediately in anticipation of the requirement. Although the wording is set by law, the regulation to be issued in May 1992 will describe the placement and format of the statement, and will describe alternative labeling for some products. Registrants who revise labeling in anticipation of the requirement's being imposed may find that their labels do not comply when the regulations are issued. 3. Non-notification process. The CAA prohibits any approval process for the addition of the CFC warning statement under any other law, including FIFRA. Consequently, registrants may add the statement as a non-notification under 40 CFR 152.46(b)(3), which permits the addition of non-mandatory statements required by other statutes. 4. Relationship to current FIFRA labeling. In drafting its regulations, the Agency has considered ways to accommodate products (such as pesticide products) which are required to be labeled by other laws, consistent with the objective of providing purchaser choice at the point of purchase. The proposed rule prescribes requirements that do not detract from or interfere with requirements for FIFRA labeling, and that provide maximum flexibility for registrants to comply with both laws. 5. Inerts Strategy labeling. The CAA labeling requirement will not conflict with or be redundant to any labeling required under the Inerts Strategy. Of the Class I and II substances, only carbon tetrachloride, a List 1 inert, is required to be labeled for under FIFRA. EPA believes there are few, if any, products containing carbon tetrachloride currently registered. Several CFCs, HCFCs, and methyl chloroform are List 2 inerts, but there is no current labeling requirement for List 2 inerts. 6. Continued Acceptability of Products for Registration. EPA will accept applications for new registration of products that must be labeled only if such products have not been banned as non-essential uses of Class I or II substances. After May 1992, when the CAA labeling rule will become final, EPA expects that draft labels submitted for registration will bear the new statement. VI. EXISTING STOCKS EPA emphasizes that registrants should act quickly to move existing stocks of old products that have been replaced with new reformulated or relabeled products into and through channels of trade. Unlike FIFRA, which allows Agency discretion in determining the length and applicability of existing stocks cutoff dates, the CAA leaves the Agency little or no discretion to apply flexible existing stocks provisions: - The timeframes are short, generally no more than one year after the effective date of a final rule. - Some provisions will apply to all persons who distribute or sell the product. In this case, no distinction is made among registrants, wholesalers, distributers, and retailers. - Some provisions will apply to products "introduced into interstatecommerce," which may permit the Agency to limit the compliance date to initial registrant sale and distribution only. For example, registrants who are accustomed to one year for moving old products into channels of trade with unlimited time to move through channels of trade may, under the CAA, be confronted with a compressed schedule that calls for existing stocks to move out of channels of trade to end users within one year. Registrants are urged to keep their distributors and supplemental registrants informed of activities affecting sale and distribution of existing stocks of pesticide products. VII. POTENTIAL METHYL BROMIDE PHASEOUT Registrants should be aware of developments that will affect the registration of pesticide products containing methyl bromide. - In November the 1991 United Nations Environment Programme issued a scientific assessment document entitled "Environmental Effects of Ozone Depletion: 1991 Update," which implicates methyl bromide as a potent ozone depleting substance, with an ozone depletion potential (ODP) of between 0.44 and 0.69, as compared to CFC-11. - EPA is required by section 602 of the Clean Air Act to list as a Class I ozone depleter any substance with an ODP of 0.2 or greater and to phase out all production by no later than the year 2000: Methyl bromide appears to meet this criterion. Once designated, EPA must develop a schedule for the phaseout of methyl bromide production and consumption. - The Agency has been petitioned by several environmental organizations to accelerate the schedule of phaseout of ozone depleters, including methyl bromide once listed. - The international community that are signatories of the Montreal Protocol on phaseout of ozone-depleting substances will be considering at its next meeting in November 1992 whether to designate methyl bromide as an ozone depleter, and, if so, how to phase out its use under the Montreal Protocol. Registrants should be aware that, given these events, methyl bromide is under consideration as a chemical to be listed and phased out as an ozone depleter by the Agency under the Clean Air Act. A proposed rule will be developed in the next several months. Thereafter, a schedule for its phaseout will be developed in conjunction with the international community. Ultimately methyl bromide has the potential to be phased out and unavailable for pesticide use. The phaseout of methyl bromide is due to action under the Clean Air Act, not FIFRA. Unlike FIFRA, the Clean Air Act does not contain a risk/benefit balancing process that would allow retention of essential or high benefit uses, nor does the listing and phaseout of ozone depleters depend on the availability of alternative products. Registrants are urged to communicate with user groups who currently rely on methyl bromide for fumigant use and alert them to this situation. VIII. FOR FURTHER INFORMATION General information on the policies in this notice may be obtained from Jean M. Frane, Policy and Special Projects Staff, OPP, at 703-305-5944. Information on specific products or on submitting applications to comply with CAA requirements may be obtained from your Product Manager in the Registration Division, OPP. Douglas D. Campt Director, Office of Pesticide Programs APPENDIX CURRENT TIMELINE OF CLEAN AIR ACT REQUIREMENTS AFFECTING PESTICIDES January 1, 1992 Phaseout continues - CFCs at 80% Carbon tetrachloride at 90% Methyl chloroform at 100% January 1992 Agency proposes ban on non-essential uses of aerosol and pressurized products containing CFCs. Jan - Feb 1992 Comment period Spring 1992 Final rule banning non-essential uses Spring 1992 Agency proposes labeling regulations for products manufactured with or containing Class I or II substances May 15, 1992 Recommended submission date for applications for new registration to delete or substitute for banned CFCs. May 15, 1992 Final regulations requiring labeling of products November 15, 1992 Sale and distribution of banned non- essential products prohibited. November 15, 1992 Agency issues determinations of safe for Class I and II substances. Thereafter, new substitutions of alternatives not determined to be safe will be subject to a 90-day EPA approval process. January 1, 1993 Phaseout continues - CFCs at 75% Carbon tetrachloride at 80% Methyl chloroform at 90% May 15, 1993 All products introduced into commerce must bear required labeling statement July 1, 1993 Recommended last date for submission of applications for new registration to delete or substitute ingredients for Class I or II substances. January 1, 1994 Phaseout continues - CFCs at 65% Carbon tetrachloride at 70% Methyl chloroform at 85% January 1, 1994 Sale and distribution of aerosol and pressurized products containing HCFCs banned unless exception has been granted. January 1 of Phaseout continues to year 2000 (2002 for methyl chloroform) succeeding years ----------------------- CERIS-Net Posting Date: 04.09.92 DISCLAIMER: 1992 PR Notices are sent to CERIS/NPIRS by the U.S. EPA Documents Center in WordPerfect document format. 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