[Federal Register Volume 59, Number 73 (Friday, April 15, 1994)] [Unknown Section] [Page 0] From the Federal Register Online via the Government Publishing Office [www.gpo.gov] [FR Doc No: 94-8729] [[Page Unknown]] [Federal Register: April 15, 1994] ======================================================================= ----------------------------------------------------------------------- ENVIRONMENTAL PROTECTION AGENCY 40 CFR Part 156 [OPP-36189; FRL-4186-4] Flammability Labeling Requirements for Total Release Fogger Pesticides AGENCY: Environmental Protection Agency (EPA). ACTION: Proposed rule. ----------------------------------------------------------------------- SUMMARY: EPA proposes to require additional precautionary labeling relating to the flammability of total release fogger pesticides. EPA has found that total release foggers as currently labeled represent an unreasonable risk to property and pesticide users from fires and explosions that can be caused by a build-up of extremely flammable propellants. EPA expects that the additional flammability label warnings would reduce the potential for fires and explosions by alerting consumers to the dangers of total release foggers and providing specific directions for proper use of these products with minimal costs to industry or consumers. Specific label requirements are proposed, including physical and chemical hazards warning statements and specific directions for use for total release foggers. DATES: Written comments, identified by the document control number [OPP-36189], must be received on or before June 14, 1994. ADDRESSES: By mail, submit comments to: Public Response and Program Resources Branch, Field Operations Division (7506C), Office of Pesticide Programs, Environmental Protection Agency, 401 M St., SW., Washington, DC 20460. In person, bring comments to: Room 1132, CM #2, 1921 Jefferson Davis Highway, Arlington, VA. Information submitted in any comment concerning this proposed rule may be claimed as confidential by marking any part or all of that information as ``Confidential Business Information'' (CBI). Information so marked will not be disclosed except in accordance with procedures set forth in 40 CFR part 2. A copy of the comment that does not contain CBI must be submitted for inclusion in the public record. Information not marked confidential will be put in the public record by EPA without further notice to the submitter. All written comments will be available for public inspection in Room 1132 at the Virginia address given above, from 8:00 a.m. to 4:30 p.m., Monday through Friday, excluding legal holidays. FOR FURTHER INFORMATION CONTACT: By mail: Jim Downing, Registration Division (7505W), Environmental Protection Agency, 401 M St., SW., Washington, DC 20460. Office location and telephone number: Sixth Floor, 2800 Crystal Drive, Arlington, VA (703-308-8319). SUPPLEMENTARY INFORMATION: I. Introduction A. Authority This proposed amendment to the labeling requirements for pesticides and devices, 40 CFR 156.10, is issued under the authority of sections 2, 3, 6, 12, and 25 of the Federal Insecticide, Fungicide, and Rodenticide Act, as amended (FIFRA), 7 U.S.C. 136 through 136y. FIFRA section 25(a) authorizes the Administrator of EPA to prescribe regulations to carry out the provisions of FIFRA. The statutory standard that is the basis for Agency regulation of pesticide labeling is contained in section 2(q) of FIFRA, which defines a ``misbranded'' pesticide and enumerates specific labeling deficiencies that constitute misbranding. EPA's labeling regulations interpret and elaborate upon the statutory standard. EPA imposes labeling requirements pursuant to its authority to regulate pesticide distribution and sale. FIFRA section 3 provides that no person may distribute or sell in the United States any pesticide that is not registered under FIFRA. Under FIFRA section 3(c)(5), the labeling of the pesticide must comply with the requirements of FIFRA. Sections 12(a)(1)(E) and (F) of FIFRA provide that it is unlawful to distribute or sell a pesticide or device that is misbranded. Under FIFRA section 2(q), a pesticide may be considered to be misbranded in a number of circumstances. Of most significance to this proposal, sections 2(q)(1)(E)-(G) provide part of the basis for EPA's authority to impose label restrictions to protect health and the environment. Specifically, sections 2(q)(1)(F) and (G) provide that a pesticide is misbranded if its labeling does not contain directions for use which are necessary for effecting the purposes for which the pesticide is intended and if complied with, together with any requirements imposed under section 3(d) of FIFRA, are adequate to protect health and the environment, or if the label does not contain a warning or caution statement which may be necessary and if complied with, together with any requirements imposed under section 3(d) of this Act, is adequate to protect health and the environment. Under FIFRA section 2(x), the term ``protect health and the environment'' means protect against any unreasonable adverse effects on the environment. FIFRA defines the term ``unreasonable adverse effects on the environment'' as any unreasonable risk to humans or the environment, taking into account the economic, social, and environmental costs and benefits of the use of any pesticide. In this proposal, EPA is giving notice of its determination that pesticide total release foggers that are not labeled in accordance with the directions for use and warning statements required by this rule would be considered to cause unreasonable adverse effects on the environment and thus, would be considered to be misbranded and subject to possible enforcement action. In addition, before a product may be registered as a pesticide under FIFRA, it must be shown that when used in accordance with widespread and commonly recognized practice, it will not generally cause unreasonable adverse effects on the environment. Pesticide total release foggers that do not comply with the proposed rule's label requirements designed to warn of hazards and provide directions for proper use to minimize risk would be considered to pose unreasonable adverse effects on the environment, and thus, failure to comply with these label requirements could result in a denial of an application for registration. FIFRA section 6(b) also provides that the Administrator of EPA may issue a notice of intent to cancel a pesticide registration if it appears that the pesticide or its labeling or other materials required to be submitted under FIFRA do not comply with the provisions of FIFRA, or if the pesticide, when used in accordance with widespread and commonly recognized practice, generally causes unreasonable adverse effects on the environment. Total release foggers that are not labeled in accordance with the requirements in this rule would not have labeling that complies with FIFRA and would be determined to pose unreasonable adverse effects on the environment. Thus, failure to comply with these proposed label requirements could result in initiation of cancellation proceedings under FIFRA section 6(b). Each of the provisions described above is designed to prevent the registration, sale or distribution of pesticides which, due to inadequate labeling might cause unreasonable adverse effects on the environment. Section 25 (a) provides EPA with the authority to promulgate regulations to carry out the purposes of these provisions. This rule is being proposed under these authorities. B. Background On February 20, 1991, EPA published in the Federal Register (56 FR 6856) a Notice concerning Pesticide Aerosol Flammability and solicited comments in three areas related to the potential hazards due to fires and explosions that could be caused by a build-up of flammable gases used as propellants in aerosol pesticide products: (1) Revised precautionary label language; (2) the use of a modified closed drum test to determine flammability; and (3) static electricity generation in connection with the use of aerosol pesticide products containing extremely flammable hydrocarbon propellants. Aerosol pesticide products are considered to be those that are sold under pressure where the pesticide cannot be poured or dispensed from the container as a liquid, the container is not designed to allow the opening of the container for dispensing as a liquid, and where the containers are designed to contain pressurized materials. The February 1991 Notice was prompted by evidence of an increase in fires and explosions caused by certain aerosol pesticide products related to the use of hydrocarbon propellants in those pesticides. Fourteen comments were received in response to the February 20, 1991 Notice. The major comments are summarized as follows: 1. Five of the commenters from the aerosol pesticide industry did not believe that EPA needed to take any action regarding the labeling issue. They maintained that the existing labeling regulations were adequate. EPA disagrees. EPA believes that the continued receipt of reports of fires and explosions related to use of total release foggers indicates that further regulatory action is warranted. 2. Seven of the comments (three industry representatives , two trade associations and two government agencies) agreed with EPA that additional precautionary label language should be required. Two of these seven comments specifically indicated that EPA should require additional label requirements for the total release foggers, but not require any additional label requirements for other aerosol pesticide products. Generally these commenters agreed that the additional language should deal with the following areas of concern: Limits on the number of foggers to be used; use of foggers in extremely small rooms, closets, or cabinets; and placement of total release foggers in proximity to pilot lights and other ignition sources. One commenter thought that labels should direct users to turn off pilot lights and electrical appliances before using total release foggers, but several other commenters recommended against such directions, citing the potential hazards presented by inexperienced persons relighting pilot lights. EPA agrees with most of these comments and has incorporated suggestions from the commenters or asked for additional information where there were questions. 3. One commenter suggested the use of graphic or figurative symbols in conjunction with the additional language to help convey the hazards associated with these products. An industry trade group suggested the use of collateral labeling, such as package inserts, pamphlets, cards, etc. Also, a local government suggested a public education program to inform the general public of the hazards of total release foggers. EPA agrees and is proposing a graphic symbol for the labels of total release foggers. In addition, EPA has prepared a fact sheet on these products and is considering additional informational materials. 4. Most of the comments received (both industry and government), made reference to the modified closed drum test to determine flammability of pressurized products. Several commenters stated that the closed drum test as modified by EPA would be inappropriate, was not workable and was dangerous to the person conducting the test. Another commenter stated that current tests were sufficient and that the drum test was not required by DOT or CPSC and would therefore lead to inconsistent labeling. However, a comment from DOT noted that it used ASTM's D3065 drum tests. This comment recommended uniformity and noted that DOT was evaluating a report from the Bureau of Mines which recommended only the ``Flame Projection Method'' for determining the flammability of aerosols. Another commenter stated that no test exists to evaluate the flash point of a formula and that the modified closed drum test will still only evaluate the propellant. Another commenter stated that EPA's modifications to the drum test are major and need to be verified. Another commenter endorsed all of EPA's modifications to the closed drum test for total release foggers. Because there are many issues which need to be resolved regarding flammability testing and the hazards of aerosol products in general, EPA will consider the testing methods at a later date. Three comments were received (an industry representative, an industry trade association and a fire department) relative to the static electricity generation or triboelectric ignition (autoignition) potential. The comments indicated that at the present time, there are no data to confirm an autoignition problem. Therefore, EPA is not proposing, at this time, to impose any requirements regarding autoignition. EPA notes that there has been some confusion relative to the correct flammability test for aerosol pesticide products. The current requirements for aerosol pesticide product flammability testing include the flame extension test, which tests the entire contents of the product, including the propellant, and the flash point test for the liquid component. EPA would be very interested in further information or data regarding the testing methods and the autoignition problem and solicits comments regarding same. This proposed rule only addresses the proposed precautionary label requirements. EPA has chosen to focus the proposed precautionary label requirements on the total release foggers containing extremely flammable propellants, since these aerosol products seem to be the products of most concern regarding potential fires and explosions. A total release fogger, as referred to in this proposal, is an aerosol pesticide product designed to automatically release the total contents in one operation, for the purpose of creating a permeating fog within a confined space to deliver the pesticide throughout the space. Under this proposal, an extremely flammable propellant is one which meets EPA's current definition of extremely flammable (40 CFR 156.10), that is, having a flash point at or below 20 deg. F. EPA is proposing to require precautionary label language that would better communicate to pesticide users the hazards of the total release foggers and directions for the proper use of these products. EPA solicits comments about applying the requirement of the proposed label language to all total release foggers in the future, as opposed to just the foggers containing extremely flammable propellants. Because of the phaseout of nonflammable CFC's, EPA believes that most, if not all, total release foggers contain extremely flammable propellants. Comments specifically proposing other criteria for selecting additional fogging products subject to these new labeling requirements are welcome. Also, EPA believes other communication methods (such as brochures, product hang- tags, posters and signs, etc.) may be useful to reinforce these label requirements. EPA is interested in any other communication vehicles that could be used and would like comments on this issue. In addition, EPA solicits comments and information on the hazards of other aerosol pesticide products for possible future rulemaking. II. The Hazards Caused By Total Release Foggers A. Summary EPA believes that additional precautionary labeling on total release foggers is necessary due to the nature of incidents of fires and explosions reported. The New York City Fire Department (NYCFD) reported 40 incidents of fires or explosions (28% resulting in personal injuries) that were reported to be caused by total release foggers over a 12 year period. Fifteen of the 40 reported incidents occurred in 1990 and 1991 alone. In 32 of those 40 documented incidents, the specific total release fogger product involved was identified. Fire experts believe the actual number of such incidents occurring around the country is much higher. However, they recognize that most fire investigation personnel are not experienced in determining such causes. The NYCFD indicated that building superintendents and emergency service personnel frequently attribute a total release fogger explosion to a gas leak. This is a logical and common mistake for a person inexperienced in investigating fires caused by total release foggers. Additionally, in most of the 40 documented incidents, it was determined that the products were not used properly; generally too many foggers were used for the space treated or as recommended on the label for a small space. EPA has been informed of other similar incidents that have occurred in at least three other states. EPA believes that total release foggers containing extremely flammable propellants present a risk that is not adequately addressed by current label warnings and use directions. B. Specific Incidents What follows is a discussion of some of the incidents that have been reported to EPA. All of the incident reports EPA has received are included in the public docket. One explosion that occurred on August 23, 1991 in the Bronx, NYC involved a waterbased total release fogger. However, the product also contained a significant amount of an extremely flammable hydrocarbon propellant. The fire investigation report indicated that at least six cans of the product were used in the two bedroom apartment. The resulting explosion, which caused considerable property damage, and indirectly caused bodily injury to persons in the adjoining apartment, was determined to be ignited by the cycling of the refrigerator motor. The total release fogger product label stated the warning: ``Use one unit for each 6,000 cubic feet of unobstructed area. Do not use this unit in an area less than 100 cubic feet.'' Although the apartment dweller used far more cans than the label called for, in this case EPA has concluded that the label directions for use are inadequate to properly warn the user of the hazard. Another house fire/explosion incident occurred in South Bend, Indiana. In this case, a two story, 1,500 square feet house was completely destroyed by an explosion and fire caused by an excessive use of total release foggers. The homeowner used four large foggers which dispersed vapors throughout the house via the central air conditioning system. Ignition was caused by a water heater pilot light. Based on the volume of the house, the fire investigator calculated that four times ``the required fumigant aerosol mist'' was used in this incident. With this incident, EPA could not conclude whether or not the products involved were used correctly or if the labeling was adequate to warn the user of the hazard. In the South Bend Fire Department report, additional reference is made to four Albuquerque (New Mexico) explosions in residential homes and two in mobile homes (one in Texas and one in Peru, Indiana), ``all caused by excessive aerosol fumigants applied in relation to volume,'' as stated by the fire investigator. On July 4, 1989, a chemist used two small total release foggers 6 feet apart in a large kitchen cabinet with the doors open. An explosion resulted when he touched one of the foggers that was malfunctioning after it had been activated. The product's label read: ``Use additional units for remote rooms or where free flow of mist is not assured.'' and ``Open cabinets and doors to areas to be treated.'' A more recent fire and explosion resulting from use of a total release fogger was reported to EPA from Jamestown, New York. In this incident, a man used a large total release fogger in the basement of a downtown store with an open flame coal heater operating, in addition to a gas water heater. The resulting fire totally demolished the building and three adjoining buildings. After reviewing several total release fogger labels, EPA has reached the general conclusion that the total release foggers present a risk which is not adequately addressed by current label warnings and use directions. EPA believes that the information gathered so far is sufficient to justify the label changes proposed in this notice of Proposed Rulemaking. However, EPA is requesting additional information from fire departments and other organizations with such information relative to similar incidents involving the use of total release foggers that may further support the proposed label changes, or indicate better changes to reduce the risks. C. Technical Reference The National Fire Protection Association (NFPA) has published the Fire Protection Handbook, 17th Edition, 1991. This association, organized in 1896, has the mission of safeguarding people, their property, and the environment from destructive fire, using scientific and engineering techniques and education. The NFPA's handbook references the problem of insecticidal fogging, which may include insecticidal fog generators, total release foggers, and other indoor fogging products: ``Insecticidal fogging presents combustion, explosion, and flash fire hazards. Safeguards include: (1) The use of solvents having flash points well above normal ambient temperatures, and (2) limiting the quantities applied to structures in relation to their volume.'' A copy of this reference is included in the public docket and is available for inspection at the address shown above. D. Potential Hazards With Regard to the ``Storage and Disposal'' Statements EPA is concerned about the storage and disposal practices of total release foggers, and indeed all aerosol pesticide products. Some hazards posed by inappropriate storage and disposal statements on some product labels and incorrect storage and disposal practices (specifically incineration) are common to all aerosol pesticide containers and are not limited solely to the total release foggers. Therefore, in the future, EPA intends to revise the ``Storage and Disposal'' statements for all aerosol pesticide products, including the total release foggers. III. Options First, EPA considered whether the hazards associated with aerosol pesticide products in general, or specifically, total release foggers, were significant enough that they should be canceled under FIFRA section 6, or alternatively, classified for restricted use under FIFRA section 3(d). Under section 6, EPA would propose cancellation of the products if the risks outweighed the benefits. Under section 6, before taking any final action to cancel a registration, the Administrator must consider measures short of cancellation, such as labeling, that could sufficiently reduce risks. With regard to the restricted use classification standard, EPA would determine if other additional regulatory restrictions would mitigate the hazards. Such restrictions could take the form of classification of these products as Restricted Use Pesticide products so that no one except certified applicators could use the products. Thus, as discussed above and in Unit I. A. of this preamble, EPA has several procedural options available to implement label changes that are necessary to bring the risks of a pesticide in line with the benefits of that pesticide. EPA has determined that labeling changes will provide sufficient warning of the hazards with the use of the total release foggers, and sufficient directions for proper use of these products, and that with these labeling changes, neither restriction nor cancellation is necessary. Products not in compliance with the proposed labeling requirements specified in this rule would pose unreasonable adverse effects on human health or the environment and, thus, could be subject to cancellation action. Having determined that appropriate precautionary labeling would be required to mitigate the hazards, EPA then considered the scope of the necessary warnings. EPA considered several approaches to the problem of these hazardous pesticide products. An economic analysis has been completed for this proposed rule and is in the public docket and available for inspection at the Virginia address shown above. One approach would be to require label changes for all aerosol pesticide products to warn users of potential hazards. However, while EPA has considerable information on the hazards posed by total release foggers from commenters and others, information on the hazards of other aerosol products is more limited. EPA would be very interested in any information or data regarding similar hazards with other aerosol pesticide products, and solicits such information. Accordingly, today's proposal is limited to labeling of total release foggers. IV. Today's Proposal A. Proposed Amendments The current labeling regulations (40 CFR 156.10) do not provide any specific requirements for the total release foggers. The ``Physical and Chemical Hazards'' warning statements required for aerosol pesticides have been judged by EPA to be inadequate for the total release foggers. Although many of these products do not meet the criteria for Extremely Flammable or Flammable warning statements, when the product as a whole is tested, they contain extremely flammable propellants. These propellants have an extremely low flash point, the temperature at which they will catch fire if exposed to an ignition source. EPA uses a flash point of 20 deg. F as the cut-off for ``extremely flammable.'' Other Agencies may vary somewhat in the temperature cut-off that defines ``extremely flammable.'' EPA believes this is due to the unique nature of the use pattern for foggers. When used, the entire contents of the fogger are released and are dispersed into the space surrounding the fogger. A fire/explosion hazard may be created if an ignition source comes in contact with the released extremely flammable propellants. The proposed amendments to 40 CFR 156.10 would add required label language to the ``Directions for Use'' and the ``Physical and Chemical Hazards'' warning statements. This new language would warn users about the hazard of a concentration of gases that could cause a fire or explosion. The warnings would limit the number of foggers that can be released in a certain volume within the dwelling. The proposed precautionary label language reads: To avoid an explosion or fire hazard from the concentration of gases: Do NOT use more than one fogger per ____ square feet. DO NOT use in small, enclosed spaces including, but not limited to closets, cabinets or under counters or tables. DO NOT place within 6 feet of ignition sources including, but not limited to pilot lights, open flames or running electrical appliances that cycle off and on (i.e., refrigerators). Calculation of the dosage rate using square footage should be based upon a rate not to exceed one ounce of product per 1,000 cubic feet of space. Parenthetical language must provide the user with an idea of the typical room size and number of rooms this is equal to. For example, ``(This is equal to x rooms that measure x by x feet with an 8 foot ceiling.).'' The applicant/registrant would be required to propose the appropriate minimum volume based on the container size using the general guide that the limitation shall not exceed 1 ounce of product per 1,000 cubic feet of space, a proposed limitation based on discussions with producers of these products. EPA requests comments on this limitation. Use of the foggers in certain small volume areas, such as closets, cabinets or under counters or tables, etc. would be prohibited. The precautionary language would establish a use prohibition buffer zone (6 feet) from an ignition source, including, but not limited to, pilot lights, open flames and electrical appliances that cycle on and off, such as refrigerator compressors. This buffer zone is currently included on the labels of some of these products and EPA believes this buffer zone setback would decrease the risk of a fire or explosion by minimizing the potential for a propellant or other gas to reach its lower explosive limit (LEL) near a flame or other ignition source. The Agency has considered buffer zone distances as low as 3 feet to as much as 10 feet, but indications from the incident information do not support these buffer zones. EPA is aware that a 6 foot buffer zone would not guarantee the prevention of fire or explosion, however, EPA believes this 6 foot set-back will minimize risk while still allowing for reasonable use of the product. However, EPA will consider and may in the final rule, establish a buffer zone within this range if evidence can be presented to support a different buffer zone from that which is proposed. Because the substances used as propellants tend to be heavier than air, these gases may accumulate near the floor instead of being completely mixed with the air in the use area. Also, drafts within the rooms may blow the gases toward an ignition source. EPA requests comments on the buffer zone setback, particularly regarding the appropriateness of a 6 foot setback from an ignition source and on experiences with non-ideal conditions (e.g., incomplete mixing or drafts) increasing the potential for fires or explosions. EPA also considered requiring total release fogger users to turn off a pilot light and unplug electric appliances. However, EPA believes that there are safety concerns involved with relighting pilot lights and unplugging/plugging back in electrical appliances such as refrigerators. There is concern that improper relighting of pilot lights or replugging of appliances may pose a greater risk of fires or other hazards than leaving this source alone and following the other precautions. EPA requests comments on the option of directing users to eliminate potential ignition sources by turning off pilot lights and electrical appliances before using total release foggers. In addition to the proposed label language, EPA is proposing to require the use of a standard graphic symbol representing fire and explosion on all total release foggers. EPA is aware of several different symbols used to depict flammability. The DOT uses a graphic symbol to depict flammability, as does the Canadian government. Some registrants have adopted graphic symbols on their own and the CPSC has investigated a number of different graphic symbols for this purpose. During the comment period, EPA would entertain an alternative symbol from that which is proposed in this notice. The new required language would replace other precautionary language already on some fogger products. Therefore, any language already on a total release fogger label that is inconsistent with the new required language would be required to be removed and replaced with the language proposed in this rule. In addition to the required label changes, applicants/registrants would be encouraged to use other hazard communication mechanisms regarding these products to reinforce the required precautionary language. EPA has identified approximately 223 total release foggers registered by 63 registrants that would be subject to these new labeling requirements. A listing of these registrants and products is included in the public docket. Any total release fogger inadvertently omitted from this list would still be subject to this rule. B. Benefits of Total Release Foggers In considering whether to propose the required label changes described above, EPA considered the benefits of allowing total release fogger products to remain without these label changes. The benefits of these products without the proposed changes are potentially cheaper prices for the products. The cost ramifications of the proposed rule will be felt by consumers to the extent that manufacturers are able to pass their increase in cost on to consumers in the form of a higher price for products. Although the label change is required of all firms in the industry, companies will vary in their ability to absorb the cost of those changes. However, since the cost of changing labels is a one-time cost and does not affect the variable cost of production, it is not likely that a significant portion of that cost would be passed on to consumers. If the required label changes can be completely absorbed within the plans a company already has, there will be essentially no cost of the required changes. However, if a label change is not planned, the costs of making these changes will be the costs associated with developing new product labels and submitting them for approval to EPA and State agencies and the actual cost of converting the printing process from an old to a new label. These costs have been estimated at between $8,000 and $13,000 per product. These costs are a one-time cost, and are not of an on-going nature. Registrants are being given time to comply with the labeling changes in the proposed rule, and already-labeled products are being permitted to clear the channels of trade, which should allow registrants to absorb these label changes into their ongoing label maintenance program. C. Risk/Benefit Determination After evaluating the risks and benefits of maintaining the current labeling for total release foggers, EPA believes that proposed additional precautionary labeling is necessary to protect the public health and environment. The economic benefits of continuing to allow the existing total release fogger labeling to remain unamended were not judged of sufficient magnitude to offset the risks of fires and explosions that can result in personal injury and property damage. Such incidents continue to be reported to EPA. Accordingly, EPA has concluded that products which do not bear the proposed additional precautionary labeling will cause unreasonable adverse effects to man or the environment. V. Implementation Implementation of these additional label requirements would be conducted by the appropriate Registration Division Product Managers within the Office of Pesticide Programs. EPA would require that revised labels with an application to amend the registration be submitted for existing product registrations no later than 3 months from the effective date of the final rule. Failure to submit an application for amendment with the revised labeling could result in EPA's issuance of a Notice of Intent to Cancel or Suspend under FIFRA section 6 and/or enforcement action pursuant to section 12. New registration applications would be denied unless they comply with these proposed labeling requirements. The details of this implementation would be set out in a Pesticide Regulation (PR) Notice sent to all affected registrants. No total release fogger product containing an extremely flammable propellant, would be permitted to be distributed or sold by registrants and supplemental registrants after 18 months from the date of publication of the final rule unless the product bears the amended label language required by the final rule and approved by the Registration Division. Thereafter, EPA may initiate cancellation or suspension proceedings under FIFRA section 6, or an enforcement action for misbranding under FIFRA section 12(a)(1)(E), for any total release fogger registration not in compliance with the requirements of FIFRA and the final rule. All affected products distributed or sold by any person other than the registrant after 42 months from the date of the publication of the final rule would be required to bear the amended label language required by the final rule and approved by the Registration Division. VI. Economic Assessment In order to satisfy requirements for analysis as specified by Executive Order 12866 and the Regulatory Flexibility Act, EPA has analyzed the costs and benefits of this proposal. This analysis (Economic Assessment: Proposed Flammability Labeling Requirements for Total Release Foggers) is included in the public docket. VII. Invitation To Comment Interested persons are invited to submit written comments on this proposed regulation. Comments are requested relative to any and all aspects of this proposal, especially in those areas mentioned throughout this Preamble. All comments should be submitted to the address and in the manner listed in the ``ADDRESSES'' section above. All written comments will be available for public inspection in the public docket, from 8:00 a.m. to 4:30 p.m., Monday through Friday, excluding legal holidays. The public docket is located in Room 1132, CM #2, 1921 Jefferson Davis Highway, Arlington, VA. VIII. Statutory Requirements The FIFRA Scientific Advisory Panel has waived scientific review and comment on this proposed rule. This proposed rule has been sent to the Secretary of Agriculture, the Committee on Agriculture, Nutrition, and Forestry of the United States Senate, and to the Committee on Agriculture, of the U.S. House of Representatives. No comments have been received from either house. The Secretary of Agriculture commented without objection to this proposal. IX. Regulatory Assessment Requirements A. Executive Order 12866 Under Executive Order 12866 (58 FR 51735, October 4, 1993), the Agency must determine whether the regulatory action is ``significant' and therefore, subject to review by the Office of Management and Budget (OMB) and the requirements of the Executive Order. Under section 3(f), the order defines ``significant'' as those actions likely to lead to a rule (1) having an annual effect on the economy of $100 million or more, or adversely and materially affecting a sector of the economy, productivity, competition, jobs, the environment, public health or safety, or State, local or tribal governments or communities (``economically significant''); (2) creating serious inconsistency or otherwise interfering with an action taken or planned by another agency; (3) materially altering the budgetary impacts of entitlements, grants, user fees, or loan programs; or (4) raising novel legal or policy issues arising out of legal mandates, the President's priorities, or the principles set forth in this Executive Order. Under the terms of this Executive Order, it has been determined that this rule is not ``significant'' and is therefore, not subject to OMB review. B. Regulatory Flexibility Act This proposed rule has been reviewed by the OMB under the provision of section 3(a) of the Regulatory Flexibility Act of 1980 (Pub. L. 96- 354; 94 Stat. 1164, 5 U.S.C. 601 et seq.) and it has been determined that it will not have a significant economic impact on small businesses, small organizations and small governmental jurisdictions. Allowing sufficient time to incorporate the proposed label changes is expected to minimize the impact of this action for entities of all sizes, but is particularly important to smaller entities who typically do not modify labels as frequently as relatively larger ones. Assuming a worst case scenario, that the full cost of label modification is associated with regulation requirements and the maximum expected incremental cost impact will be incurred, the increased cost is expected to represent roughly 0.2 percent of annual revenues on average for all businesses categorized as small. The likelihood that small businesses will incur the maximum cost increase is low. The maximum cost increase represents costs associated with lithograph cans which are utilized less by smaller businesses due to minimum quantity order requirements. Accordingly, EPA certifies that this regulatory action does not require a separate, detailed regulatory flexibility analysis under the Regulatory Flexibility Act. C. Paperwork Reduction Act The information collection requirements contained in this rule have been approved by OMB under the provisions of the Paperwork Reduction Act, 44 U.S.C. 3501 et seq., and have been assigned OMB Control Number 2070-0060. The reporting burden for registrants is estimated to average 0.85 hours per product, including time for reviewing instructions, searching existing data sources, gathering and maintaining the data needed, and completing and reviewing the collection of information. Send comments regarding this burden estimate or any other aspect of this collection of information, including suggestions for reducing this burden, to Chief, Information Policy Branch, PM-223, U.S. Environmental Protection Agency, 401 M St., SW., Washington, DC 20460 and to the Office of Management and Budget, Washington, D.C. 20503, marked ``Attention: Desk Officer for EPA.'' List of Subjects in 40 CFR Part 156 Environmental protection, Administrative practice and procedure, Pesticides and pests, Labeling. Dated: March 22, 1994. Carol M. Browner, Administrator. Therefore, it is proposed that 40 CFR chapter I, subchapter E, part 156 be amended as follows: PART 156 -- [AMENDED] 1. The authority citation for part 156 continues to read as follows: Authority: 7 U.S.C. 136 - 136y. 2. In Section 156.10, by designating the text after the italic heading in paragraph (h)(2)(iii) as paragraph (h)(2)(iii)(A), and by adding new paragraphs (h)(2)(iii)(B), and (i)(2)(x)(D), to read as follows: Sec. 156.10 Labeling requirements. * * * * * (h) * * * (2) * * * (iii) * * * (B)(1) A total release fogger is an aerosol pesticide product designed to automatically release the total contents in one operation, for the purpose of creating a permeating fog within a confined space to deliver the pesticide throughout the space. If the pesticide product is a total release fogger containing a propellant with a flash point at or below 20 deg. F, then the following special instructions must be added to the ``Physical and Chemical Hazards'' warning statement: This product contains an extremely flammable propellant. Improper use could cause explosion or fire. Follow very carefully the ``Directions for Use'' on this label. (2) In addition to this required language, the graphic symbol illustrated below must be displayed adjoining the ``Physical and Chemical Hazards'' warning statement. The graphic symbol must be no smaller than twice the size of the first character of the human hazard signal word.![]()
TP15AP94.041 Extremely Flammable Ingredient Ingrediente extremadamente inflamable ![]()
TP15AP94.042 Explosive Potential Potencialmente explosivo * * * * * (i) * * * (2) * * * (x) * * * (D)(1) For total release foggers as defined in paragraph (h)(2)(iii)(B) of this section, the following precautions must be included in the ``Directions for Use'': To avoid an explosion or fire hazard from the concentration of gases: DO NOT use more than one fogger per ____ square feet (This is equal to x rooms that measure x by x feet with an 8 foot ceiling.). DO NOT use in small, enclosed spaces including but not limited to closets, cabinets or under counters or tables. DO NOT place within 6 feet of ignition sources including but not limited to pilot lights, open flames or running electrical appliances that cycle off and on (i.e., refrigerators). (2) Calculation of the dosage rate using square footage should be based upon a rate not to exceed one ounce of product per 1,000 cubic feet of space. Parenthetical language must provide the user with an idea of the typical room size and number of rooms this is equal to. For example, ``(This is equal to x rooms that measure x by x feet with an 8 foot ceiling.).'' * * * * * [FR Doc. 94-8729 Filed 4-14-94; 8:45 am] BILLING CODE 6560-50-F