98-4562. Flammability Labeling Requirements for Total Release Fogger Pesticides  

  • [Federal Register Volume 63, Number 35 (Monday, February 23, 1998)]
    [Rules and Regulations]
    [Pages 9078-9083]
    From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
    [FR Doc No: 98-4562]
    
    
    
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    _______________________________________________________________________
    
    Part IV
    
    
    
    
    
    Environmental Protection Agency
    
    
    
    
    
    _______________________________________________________________________
    
    
    
    40 CFR Part 156
    
    
    
    Flammability Labeling Requirements for Total Release Fogger Pesticides; 
    Final Rule
    
    Federal Register / Vol. 63, No. 35 / Monday, February 23, 1998 / 
    Rules and Regulations
    
    [[Page 9078]]
    
    
    
    ENVIRONMENTAL PROTECTION AGENCY
    
    40 CFR Part 156
    
    [OPP-36189; FRL-5748-7]
    RIN 2070-AC60
    
    
    Flammability Labeling Requirements for Total Release Fogger 
    Pesticides
    
    AGENCY: Environmental Protection Agency (EPA).
    
    ACTION: Direct final rule.
    
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    SUMMARY: This rule requires specific precautionary labeling relating to 
    the flammability of total release fogger pesticides. EPA has found 
    that, as currently labeled, total release foggers pose 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 required by this rule 
    will reduce the potential for fires and explosions by alerting 
    consumers to the dangers of total release foggers. The required 
    labeling will also provide specific directions for proper use of these 
    products with minimal costs to industry or consumers. Although EPA 
    issued a proposed rule and received public comments in 1994, this 
    action includes some labeling requirements that differ from those 
    discussed in the proposal. EPA is therefore issuing this action as a 
    direct final rule in order to provide an opportunity for affected 
    entities to submit adverse comments on the new labeling requirements. 
    If EPA receives any adverse comments on the addition of these labeling 
    requirements for pesticides within 30 days from the date of this final 
    rule, EPA will withdraw that paragraph of the rule to which adverse 
    comments pertain. At that point, EPA will issue a proposed rule 
    addressing this issue and will provide a 30-day period for public 
    comment. If no adverse comments are received, the rule will become 
    effective on the date specified.
    
    DATES: This rule will become effective on April 24, 1998. Comments must 
    be received by March 25, 1998.
    
    ADDRESSES: By mail, submit written comments to: Public Information and 
    Records Integrity Branch, Information Resources and Services Division 
    (7502C), Office of Pesticide Programs, Environmental Protection Agency, 
    401 M St., SW., Washington, DC 20460. In person, deliver comments to: 
    Rm. 119, CM #2, 1921 Jefferson Davis Highway, Arlington, VA.
        Comments and data may also be submitted electronically to: docket@epamail.epa.gov. Follow the instructions under Unit VIII. of 
    this document. No Confidential Business Information (CBI) should be 
    submitted through e-mail.
        Information submitted as a comment concerning this document may be 
    claimed confidential by marking any part or all of that information as 
    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 included in the 
    public docket by EPA without prior notice. The public docket is 
    available for public inspection in Rm. 119 at the Virginia address 
    given above, from 8:30 a.m. to 4 p.m., Monday through Friday, excluding 
    legal holidays.
    FOR FURTHER INFORMATION CONTACT: By mail: Jim Downing, Labeling Team, 
    Field and External Affairs Division (7506C), Office of Pesticide 
    Programs, Environmental Protection Agency, 401 M St., SW., Washington, 
    DC 20460. Office location, telephone number, and e-mail address: 
    Crystal Mall #2, 1921 Jefferson Davis Highway, Arlington VA, 703-308-
    9071, e-mail: downing.jim@epamail.epa.gov.
    
    SUPPLEMENTARY INFORMATION:
    
    I. Regulated Entities
    
                                                                            
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                                                    Examples of Regulated   
                     Category                             Entities          
    ------------------------------------------------------------------------
    Industry                                    Persons who sell and        
                                                 distribute total release   
                                                 fogger products.           
    ------------------------------------------------------------------------
    
        This table is not exhaustive, but is a guide to the entities EPA 
    believes are regulated by this action. Read carefully the applicability 
    criteria in Sec. 156.10(h)(2)(iii)(C) of the regulatory text to decide 
    whether this rule applies to you.
    
    II. Background
    
    A. Authority
    
        This amendment to the labeling requirements for pesticides and 
    devices (40 CFR 156.10) is issued under the authority of sections 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.
        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 misbranded in a number of circumstances. Sections 2(q)(1)(E) 
    through (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 or if the label does 
    not contain a warning or caution statement 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 section 2(bb) defines the 
    term ``unreasonable adverse effects on the environment'' to include 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. With this final rule, EPA is giving notice of its 
    determination that total release fogger pesticides that are not labeled 
    in accordance with the directions for use and warning statements 
    required by this rule will be considered misbranded and subject to 
    possible enforcement action.
        Each provision described above is designed to prevent the sale or 
    distribution of pesticides that, due to inadequate labeling, might 
    cause unreasonable adverse effects to the environment.
    
    B. Proposed Rule
    
        EPA issued in the Federal Register of April 15, 1994 (59 FR 18058) 
    (FRL-4186-4), a proposal to require additional precautionary labeling 
    relating to the flammability of total release fogger pesticides. From 
    the review of the fire/explosion incidents involving total release 
    foggers, EPA found that foggers as currently labeled present a risk of 
    unreasonable adverse effects from fires and/or explosions caused by a 
    build up of extremely
    
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    flammable propellants. EPA concluded that this risk is not adequately 
    addressed in current labeling of total release foggers. To mitigate 
    this risk, EPA proposed specific label requirements including physical 
    and chemical hazards warning statements, graphic symbols, and specific 
    directions for total release foggers, which if complied with, would be 
    adequate to human health and the environment. Comments about the scope 
    of the proposed rule were also solicited.
        Because comments received in response to the proposal have caused 
    the Agency to include in this final rule certain requirements which 
    were not discussed in the proposal (see discussion in Unit III.B., of 
    this preamble), EPA is issuing this action as a direct final rule in 
    order to provide an opportunity for affected entities to submit adverse 
    comments on the new labeling requirements.
    
    C. Hazards Caused by Total Release Foggers
    
        For several years EPA has received reports of incidents of fires 
    and explosions involving total release foggers. For instance, the New 
    York City Fire Department (NYCFD) reported 40 incidents of fires or 
    explosions (28% resulting in personal injuries) 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. In its proposal, the Agency identified many 
    incidents, and solicited for additional incidents involving foggers. 
    However, no additional incidents were submitted in the comments, but 
    the Agency did receive reports of several incidents connected with use 
    of foggers from various other locations around the country from states 
    and media articles which revealed extensive property damage. These 
    reports are in the public information docket for this rule.
        Fire experts have indicated to the Agency that the actual number of 
    such incidents occurring around the country is much higher. Due to the 
    lack of a nationwide reporting system that could capture these type of 
    fire incidents, EPA believes the reports it has received are only the 
    ``tip of the iceberg''; annually, there are many more such incidents 
    occurring for which EPA does not receive reports.
    
    III. Comments Received on the Proposed Rule
    
        Twenty-two comments from registrants, trade associations, public 
    interest groups, and others were received on the proposed rule. Most of 
    the comments generally agreed with the need for label improvement for 
    total release foggers. The significant comments are presented below 
    with EPA's response to the comment. A detailed response to comments is 
    available in the public record.
    
    A. Graphic Symbols
    
        EPA proposed the use of graphic symbols (one symbol depicting fire 
    and one symbol representing explosive potential) to alert users of the 
    potential dangers of misuse of total release foggers. Six commenters 
    expressed concern with the use of graphic symbols or they were 
    definitely opposed to the use of graphic symbols. Their biggest 
    concerns were that the proposed symbols would be confusing, and could 
    unduly alarm consumers or that consumers might ``misunderstand or 
    misinterpret'' the meaning of the symbols. One commenter stated, ``We 
    have a strong concern that users will not understand the graphic 
    symbols. For example, the bursting symbol may actually portray to a 
    person that the product is meant to burst to disperse the product 
    properly during usage when such, of course, is not the case. On the 
    other hand, the symbol may be interpreted by others to mean that it 
    presents far more of a danger than actually exists. Unlike an 
    industrial worker audience, consumers are not generally educated as to 
    the meaning of symbols.''
        As an alternative, one of the six commenters suggested using the 
    fire symbol, but not the proposed explosion (bursting) symbol. One of 
    the commenters supporting the use of symbols encouraged the use of the 
    internationally accepted graphic symbol for fire.
        The Agency has decided to retain the use of the fire symbol, but to 
    eliminate the proposed explosion symbol. The Agency believes the fire 
    symbol is widely recognized and is necessary to capture the pesticide 
    user's attention to alert the user to the potential hazards of these 
    products. EPA's fire symbol is similar to many other fire symbols used 
    by other agencies for many years. The U.S. Department of 
    Transportation, the European Community, and Canada use a fire symbol 
    that incorporates a fire as a symbol of flammability. Because there are 
    slight variations in the presentation of the fire symbol among various 
    authorities, and to allow maximum flexibility, EPA has decided to allow 
    use of an ``equivalent'' fire symbol as an alternative to the one in 
    the proposed rule. Since a fire graphic is widely understood by the 
    public, EPA believes that slight variations among existing symbols will 
    not reduce the value of the information conveyed by the symbol. On the 
    other hand, the Agency agreed with several commenters that the 
    explosion symbol on total release foggers could be misunderstood or 
    misinterpreted or that it might not be effective. Therefore the 
    proposed explosion symbol was omitted from the final rule.
    
    B. Number of Foggers to be Used and Pilot Lights
    
        EPA proposed to limit the number of foggers to be used. By limiting 
    the use to one fogger per room and eliminating all ignition sources, 
    the risks of fire and/or explosions can be substantially reduced, if 
    not eliminated. From an evaluation of the incidents, the Agency 
    recognizes that fires/explosions are generally due to excessively high 
    concentrations of highly flammable gases (propellent in the foggers) in 
    the area being fogged. This is caused by too many foggers being used 
    with the presence of an ignition source. Furthermore, the Agency has 
    learned from fire officials that the elimination of ignition sources is 
    very important to safe use of foggers containing highly flammable 
    propellants. Several fire officials EPA talked with acknowledged the 
    risk of consumers extinguishing and relighting their pilot lights. 
    However, they agreed that those risks were far outweighed by the risks 
    associated with activation of foggers with pilot lights unextinguished. 
    A record of these conversations is available in the public information 
    docket. Therefore, EPA has concluded that limiting the number of 
    foggers to be used and eliminating all ignition sources are paramount 
    to continued safe use of total release foggers. No commenter disagreed 
    with the proposal to eliminate all ignition sources before using a 
    total release fogger. In fact, two commenters recommended the label 
    instruct users to extinguish pilot lights and other ignition sources. 
    In earlier comments on a previous notice dated February 19, 1991 (56 FR 
    6856), a commenter had raised the issue of the hazard of instructing 
    fogger users (consumers) to turn off their gas pilot lights; the danger 
    of consumers extinguishing and relighting their own pilot lights was 
    emphasized.
        After consultation with fire safety professionals and gas industry 
    representatives, the Agency has decided to instruct users to turn off 
    all ignition sources such as pilot lights, other open flames and 
    running electrical appliances. One fire professional suggested 
    referring fogger users to their
    
    [[Page 9080]]
    
    gas utility or management company for assistance in extinguishing and 
    relighting pilot lights. The Agency believes the risks of consumers 
    improperly extinguishing and relighting pilot lights are outweighed by 
    the benefits of eliminating all ignition sources before total release 
    foggers are used; and that instructing consumers to contact their gas 
    utility or management company for assistance will further reduce any 
    risks.
        This approach of limiting the number of foggers used and 
    extinguishing pilot lights will also eliminate the issues from the 
    proposed rule of the six-foot ``buffer zone'' and the square footage 
    limitation. As was pointed out by one commenter, the flammability of 
    total release fogger use is not a function of distance from an ignition 
    source, but a function of the concentration of the highly flammable 
    (propellant) gas. By eliminating sources of ignition altogether, risks 
    can be reduced without complex decisions by consumers about distances 
    between foggers and ignition sources. By simplifying the label 
    instructions, EPA believes consumers are more likely to be able to 
    comply.
        One commenter, S.C. Johnson Son, Inc. conducted a consumer-based 
    label testing and development program to determine the most effective 
    method of improving consumer comprehension regarding the proper use of 
    total release foggers. This study included qualitative research to 
    decide which fogger labeling best communicates proper use and safety 
    information and evaluated consumers' perceptions of room size. 
    Quantitative research, also a part of the study program, tested various 
    fogger labels, including a fogger label amended according to the 
    proposed rule. An ``optimized label'' developed from the quantitative 
    research was also tested, which included the simpler instructions ``Do 
    not use more than one fogger in a room.'' and ``Extinguish All Flames 
    and Pilot Lights.''
        The results of the S.C. Johnson study suggested limiting the user 
    to only one fogger per room, as is shown in the final rule language. 
    The study showed that consumers have difficulty accurately estimating 
    room size. Less than 10% of consumers could accurately estimate cubic 
    feet. Therefore, the approach (``DO NOT use more than one fogger per 
    ____ square feet.'') of the proposed rule was judged by EPA not to be 
    very effective after all. However, limiting the use to one fogger per 
    room to manage the concentration of highly flammable gases in the area 
    to be fogged was judged to be the most effective. Furthermore, EPA has 
    determined that a limit of one fogger per room will be adequately 
    protective. An added safety factor is the limit of ``Do not use in a 
    room 5 ft. x 5 ft. or smaller. . .'', as was shown on the ``optimized 
    label'' used in the S.C. Johnson study. This limit would help a fogger 
    user avoid using too many foggers in a dwelling with many small rooms. 
    This limit of a room 5 ft. x 5 ft. (the typical ``walk-in'' closet or 
    small bathroom) or smaller was judged to be appropriate.
        The Agency has attempted to allow efficacious, but not excessive 
    use, while creating a restriction that can be easily understood and 
    carried out by the typical fogger user. The circumstances in which 
    foggers can be used vary widely. Room size, natural ventilation, 
    ambient temperatures, humidity, presence and proximity of ignition 
    sources, etc. are different from structure to structure, yet each 
    factor can have an impact on risk. While the one fogger per room 
    approach may allow for more concentrated use than that permitted by the 
    language of the proposed rule, it is still within a safe level of use 
    considering the fact that the ignition sources will be eliminated as 
    well. EPA also believes that the efficacy of foggers will be unaffected 
    by this requirement. Users are far more likely to understand and 
    successfully follow the one fogger per room approach than would have 
    been the case from the formula approach of the proposed rule (``DO NOT 
    use more than one fogger per ____ square feet.''). Based on the above, 
    EPA has determined that the ``one fogger per room'' label language 
    achieves equivalent risk mitigation as the language of the proposed 
    rule and has adopted this language and included it in the final rule.
    
    C. Flammability Terminology
    
        EPA proposed the use of the term ``extremely flammable'' to 
    describe the hazard of the hydrocarbon propellant. Several commenters 
    opposed the use of this term, stating that it would conflict with 
    required flammability labeling already required in the Physical and 
    Chemical Hazards statement for the product as a whole. EPA currently 
    requires that a pressurized product bear a hazard statement of either 
    ``Flammable'' or ``Extremely Flammable'' based on flash point and flame 
    extension test results. The commenter's point is that a fogger that 
    bears the statement ``Extremely Flammable'' under the proposal because 
    it contains a flammable propellant might, based upon flammability 
    characteristics of the product as a whole, bear only the term 
    ``Flammable.''
        EPA acknowledges that sometimes this could be true. However, EPA 
    also believes it likely that total release foggers containing 
    significant levels of hydrocarbon propellant requiring ``Extremely 
    Flammable'' labeling under this rule would also require ``Extremely 
    Flammable'' labeling under the current regulations. The ``Extremely 
    Flammable'' term is required only when the propellant has a flash point 
    of <20 deg.f.="" the="" same="" flash="" point="" triggers="" the="" flammability="" hazard="" warning="" for="" the="" product="" as="" a="" whole.="" thus,="" a="" product="" would="" have="" to="" have="" a="" significant="" amount="" of="" non-propellant="" ingredients="" with="" flash="" points="" above="" 20="" deg.f="" to="" compensate="" for="" the="" extremely="" flammable="" nature="" of="" the="" propellant.="" even="" if="" this="" were="" the="" case,="" some="" number="" of="" products="" would="" likely="" fail="" the="" flame="" extension="" test="" for="" pressurized="" products="" (flashback="" to="" the="" valve="" opening)="" and="" would="" still="" require="" the="" ``extremely="" flammable''="" statement.="" because="" of="" the="" potential="" for="" confusion="" with="" some="" fogger="" products,="" epa="" has="" decided="" to="" require="" the="" term="" ``highly="" flammable''="" instead="" of="" ``extremely="" flammable.''="" the="" agency="" believes="" that="" most="" consumers="" would="" not="" distinguish="" between="" the="" two="" terms="" and="" believes="" the="" same="" message="" would="" be="" conveyed="" to="" the="" fogger="" user.="" epa="" recognizes="" that="" it="" is="" very="" important="" that="" the="" user="" know="" the="" product="" contains="" highly="" or="" very="" flammable="" ingredients.="" this="" terminology,="" in="" addition="" to="" the="" fire="" symbol,="" is="" extremely="" important="" in="" communicating="" to="" the="" user="" the="" hazards="" of="" total="" release="" foggers="" containing="" extremely="" flammable="" propellants.="" d.="" format="" epa="" did="" not="" propose="" specific="" formatting="" or="" presentation="" criteria="" for="" the="" required="" label="" language.="" however,="" several="" commenters="" suggested="" setting="" off="" the="" warning="" language="" contained="" in="" the="" final="" rule="" with="" boxes,="" contrasting="" colors,="" and="" pictograms="" on="" the="" total="" release="" fogger="" labels.="" many="" of="" these="" formatting="" ideas="" were="" a="" part="" of="" the="" s.c.="" johnson="" consumer="" study="" mentioned="" earlier.="" epa="" is="" not="" prescribing="" such="" formatting="" in="" this="" rule.="" however,="" registrants="" are="" encouraged="" to="" use="" formatting="" appropriate="" for="" the="" hazard="" statement="" that="" will="" highlight="" the="" statement="" for="" consumers.="" e.="" general="" comments="" epa="" solicited="" comments="" concerning="" the="" scope="" of="" the="" proposed="" rule,="" i.e.,="" for="" total="" release="" foggers="" only.="" most="" comments="" concurred="" with="" epa's="" decision="" to="" limit="" labeling="" changes="" to="" the="" total="" release="" foggers.="" two="" comments="" indicated="" that="" regulatory="" changes="" should="" be="" extended="" to="" aerosol="" pesticide="" products="" overall.="" however,="" no="" additional="" data="" were="" submitted="" [[page="" 9081]]="" indicating="" unreasonable="" adverse="" effects="" from="" other="" aerosol="" pesticide="" products,="" so="" epa="" has="" decided="" to="" limit="" the="" scope="" of="" this="" rule="" to="" total="" release="" foggers="" as="" proposed.="" iv.="" provisions="" of="" the="" final="" rule="" this="" final="" rule="" amends="" 40="" cfr="" 156.10="" to="" add="" required="" label="" language="" to="" the="" ``directions="" for="" use''="" and="" the="" ``physical="" and="" chemical="" hazards''="" warning="" statements.="" this="" new="" language="" warns="" fogger="" users="" about="" the="" hazard="" of="" a="" concentration="" of="" gases="" that="" could="" cause="" a="" fire="" or="" explosion.="" these="" warnings="" limit="" the="" number="" of="" foggers="" that="" can="" be="" released="" within="" the="" dwelling.="" the="" precautionary="" label="" language="" reads="" as="" outlined="" in="" units="" iv.a.="" and="" iv.b.="" of="" this="" preamble.="" a.="" labeling="" changes="" to="" the="" ``physical="" and="" chemical="" hazards''="" section="" this="" product="" contains="" a="" highly="" flammable="" ingredient.="" it="" may="" cause="" a="" fire="" or="" explosion="" if="" not="" used="" properly.="" follow="" the="" ``directions="" for="" use''="" on="" this="" label="" very="" carefully.="" this="" wording="" is="" slightly="" different="" from="" that="" which="" was="" contained="" in="" the="" proposed="" rule.="" in="" the="" final="" rule,="" the="" agency="" decided="" to="" alter="" the="" wording="" to="" improve="" communication.="" in="" addition="" to="" the="" above="" label="" language,="" epa="" is="" requiring="" on="" all="" total="" release="" foggers="" the="" use="" of="" a="" standard="" graphic="" symbol="" representing="" fire.="" b.="" labeling="" changes="" to="" the="" ``directions="" for="" use''="" section="" do="" not="" use="" more="" than="" one="" fogger="" per="" room.="" do="" not="" use="" in="" small,="" enclosed="" spaces="" such="" as="" closets,="" cabinets,="" or="" under="" counters="" or="" tables.="" do="" not="" use="" in="" a="" room="" 5="" ft.="" x="" 5="" ft.="" or="" smaller;="" instead,="" allow="" fog="" to="" enter="" from="" other="" rooms.="" turn="" off="" all="" ignition="" sources="" such="" as="" pilot="" lights="" (shut="" off="" gas="" valves),="" other="" open="" flames,="" or="" running="" electrical="" appliances="" that="" cycle="" off="" and="" on="" (i.e.,="" refrigerators,="" thermostats,="" etc.).="" call="" your="" gas="" utility="" or="" management="" company="" if="" you="" need="" assistance="" with="" your="" pilot="" lights.="" v.="" risks/benefits="" of="" this="" rule="" as="" discussed="" in="" the="" proposed="" rule,="" the="" agency="" recognizes="" the="" benefits="" of="" total="" release="" foggers="" and="" has="" taken="" into="" consideration="" these="" benefits="" regarding="" the="" agency's="" assessment="" of="" the="" risks="" of="" total="" release="" foggers.="" the="" agency="" has="" determined="" that="" these="" label="" changes="" will="" be="" adequate="" to="" reduce="" the="" risks="" from="" total="" release="" foggers.="" epa="" believes="" fewer="" fires/explosions="" with="" loss="" of="" life="" or="" property="" will="" result="" from="" the="" better="" labeling="" of="" these="" products.="" further,="" these="" labeling="" requirements="" do="" not="" reduce="" the="" benefits="" of="" these="" products,="" but="" provide="" for="" safer="" use.="" overall,="" as="" was="" concluded="" in="" the="" proposed="" rule,="" epa="" believes="" these="" label="" changes="" are="" needed="" and="" that="" the="" benefits="" of="" such="" changes="" outweigh="" the="" risks.="" the="" modification="" to="" the="" required="" label="" language="" mentioned="" above="" does="" not="" change="" in="" any="" way="" the="" agency's="" risk-benefit="" determination.="" labeling="" for="" improved="" hazard="" warnings="" of="" foggers="" does="" not="" affect="" the="" sale="" or="" use="" of="" such="" products.="" vi.="" implementation="" under="" 40="" cfr="" 152.130,="" epa="" may="" prescribe="" timeframes="" for="" the="" implementation="" of="" agency="" directed="" label="" changes.="" this="" unit="" describes="" how="" epa="" will="" implement="" the="" changes="" in="" this="" rule.="" epa="" will="" provide="" detailed="" instructions="" directly="" to="" registrants.="" after="" the="" effective="" date="" of="" the="" final="" rule,="" applications="" for="" new="" registrations="" of="" total="" release="" foggers="" will="" not="" be="" approved="" unless="" they="" comply="" with="" these="" labeling="" requirements.="" further,="" no="" total="" release="" fogger="" products="" containing="" an="" extremely="" flammable="" propellant="" may="" be="" distributed="" or="" sold="" by="" registrants="" after="" october="" 1,="" 1999,="" unless="" the="" product="" bears="" the="" amended="" label="" language="" required="" by="" this="" rule.="" thereafter,="" epa="" may="" initiate="" cancellation="" proceedings="" under="" fifra="" section="" 6,="" or="" an="" enforcement="" action="" for="" misbranding="" under="" fifra="" section="" 12(a)(1)(e),="" for="" any="" total="" release="" fogger="" product="" not="" in="" compliance="" with="" the="" requirements="" of="" fifra="" and="" this="" rule.="" vii.="" statutory="" review="" a="" draft="" of="" this="" rule="" was="" provided="" to="" the="" secretary="" of="" agriculture="" (usda),="" 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.="" the="" fifra="" scientific="" advisory="" panel="" waived="" its="" review="" of="" this="" rule.="" viii.="" public="" record="" and="" electronic="" submissions="" the="" official="" record="" for="" this="" rulemaking,="" as="" well="" as="" the="" public="" version,="" has="" been="" established="" for="" this="" rulemaking="" under="" docket="" control="" number="" ``opp-36189''="" (including="" comments="" and="" data="" submitted="" electronically="" as="" described="" below).="" a="" public="" version="" of="" this="" record,="" including="" printed,="" paper="" versions="" of="" electronic="" comments,="" which="" does="" not="" include="" any="" information="" claimed="" as="" cbi,="" is="" available="" for="" inspection="" from="" 8:30="" a.m.="" to="" 4="" p.m.,="" monday="" through="" friday,="" excluding="" legal="" holidays.="" the="" official="" rulemaking="" record="" is="" located="" at="" the="" virginia="" address="" in="" addresses="" at="" the="" beginning="" of="" this="" document.="" electronic="" comments="" can="" be="" sent="" directly="" to="" epa="" at:="">opp-docket@epamail.epa.gov
    
    
        Electronic comments must be submitted as an ASCII file avoiding the 
    use of special characters and any form of encryption. Comment and data 
    will also be accepted on disks in Wordperfect 5.1/6.1 or ASCII file 
    format. All comments and data in electronic form must be identified by 
    the docket control number ``OPP-36189.'' Electronic comments on this 
    final rule may be filed online at many Federal Depository Libraries.
    
    IX. Regulatory Assessment Requirements
    
    A. Executive Order 12866
    
        Under Executive Order 12866, entitled Regulatory Planning and 
    Review (58 FR 51735, October 4, 1993), this action is not a 
    ``significant regulatory action'' subject to review by the Office of 
    Management and Budget (OMB).
        According to the Economic Assessment conducted by the Agency, the 
    costs per product of this rule were between $8,000 and $13,000. The 
    total costs for the industry would be between $1.87 million and $3 
    million (net present value). A copy of the Economic Assessment is 
    available in the public docket for this rule.
    
    B. Regulatory Flexibility Act
    
        Under section 605(b) of the Regulatory Flexibility Act (5 U.S.C. 
    601 et seq.), the Agency hereby certifies that this action will not 
    have a significant economic impact on a substantial number of small 
    entities. This action does not impact any small entities. Information 
    relating to this determination is provided upon request to the Chief 
    Counsel for Advocacy of the Small Business Administration, and is 
    included in the docket for this rulemaking.
        The label changes for aerosol pesticides, known as total release 
    foggers, will not impose a significant adverse economic impact on a 
    substantial number of small entities. The estimated cost impacts 
    associated with the label changes are less than 1% (0.07%) of the 
    annual revenues for small businesses. One of the main benefits of the 
    rule is to reduce the number of accidents that occur from the misuse of 
    total release foggers.
        EPA will allow all registrants almost 2 years to incorporate the 
    label changes. This compliance time will allow all registrants, 
    including those that are small businesses, to revise labels in the
    
    [[Page 9082]]
    
    normal course of business, thus minimizing the economic impact. 
    Therefore, no regulatory flexibility analysis was prepared. However, 
    the economic assessment for this rule is available in the public docket 
    for this rule.
    
    C. Paperwork Reduction Act
    
        OMB has approved the information collection requirements contained 
    in this rule under the provisions of the Paperwork Reduction Act (PRA), 
    44 U.S.C. 3501 et seq. In accordance with the procedures at 5 CFR 
    1320.11, OMB has assigned OMB control number 2070-0060 (EPA ICR No. 
    277.10) to this activity. An Agency may not conduct or sponsor, and a 
    person is not required to respond to a collection of information 
    subject to OMB approval under the PRA unless it displays a currently 
    valid OMB control number. The OMB control numbers for EPA's 
    regulations, after initial publication in the Federal Register, are 
    maintained in a list at 40 CFR part 9.
        Public reporting burden for this collection of information 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 information.
        Under the PRA, ``burden'' means the total time, effort, or 
    financial resources expended by persons to generate, maintain, retain, 
    or disclose or provide information to or for a Federal agency. This 
    includes the time needed to review instructions; develop, acquire, 
    install, and utilize technology and systems for the purposes of 
    collecting, validating, and verifying information, processing and 
    maintaining information, and disclosing and providing information; 
    adjust the existing ways to comply with any previously applicable 
    instructions and requirements; train personnel to be able to respond to 
    a collection of information; search data sources; complete and review 
    the collection of information; and transmit or otherwise disclose the 
    information.
        Send any comments on the burden estimates and any suggested methods 
    for minimizing respondent burden, including through the use of 
    automated collection techniques within 30 days to EPA at the address 
    provided above, with a copy to the Office of Information and Regulatory 
    Affairs, Office of Management and Budget, 725 17th St., NW., 
    Washington, DC 20503, marked ``Attention: Desk Officer for EPA.'' 
    Please remember to include the ICR number in any correspondence.
    
    D. Unfunded Mandates Reform Act and Executive Order 12875
    
        Under Title II of the Unfunded Mandates Reform Act of 1995 (Pub. L. 
    104-4), this action does not result in the expenditure of $100 million 
    or more by any State, local, or tribal governments, or by anyone in the 
    private sector, and will not result in any ``unfunded mandates'' as 
    defined by Title II. The costs associated with this action are 
    described in the Executive Order 12866 unit above.
        Under Executive Order 12875 (58 FR 58093, October 28, 1993), EPA 
    must consult with representatives of affected State, local, and tribal 
    governments before promulgating a discretionary regulation containing 
    an unfunded mandate. This action does not contain any mandates on 
    States, localities, or tribes and is therefore not subject to the 
    requirements of Executive Order 12875.
    
    E. Submission to Congress and the General Accounting Office
    
        Under 5 U.S.C. 801(a)(1)(A) as added by the Small Business 
    Regulatory Enforcement Fairness Act of 1996, EPA submitted a report 
    containing this rule and other required information to the U.S. Senate, 
    the U.S. House of Representatives and the Comptroller General of the 
    United States prior to publication of this rule in today's Federal 
    Register. This rule is not a ``major rule'' as defined by 5 U.S.C. 
    804(2).
    
    List of Subjects in 40 CFR Part 156
    
        Environmental protection, Labeling, Occupational safety and health, 
    Pesticides and pests, Reporting and recordkeeping requirements.
    
        Dated: February 4, 1998.
    Carol M. Browner
    Administrator.
        Therefore, 40 CFR part 156 is 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 Sec. 156.10, by revising paragraph (h)(2)(iii) and adding 
    paragraph (i)(2)(x)(D) to read as follows:
    
    
    Sec. 156.10   Labeling requirements.
    
          *    *    *    *    *
        (h) *  *  *
        (2) *  *  *
        (iii) Physical or chemical hazards. (A) Warning statements on the 
    flammability or explosive characteristics of all pesticides are 
    required as set out in Table 1 and Table 2 of this paragraph as 
    follows:
    
                        Table 1.--Pressurized Containers                    
    ------------------------------------------------------------------------
                  Flash Point                         Required Text         
    ------------------------------------------------------------------------
    Flash point at or below 20  deg.F; if    Extremely flammable. Contents  
     there is a flashback at any valve        under pressure. Keep away from
     opening                                  fire, sparks, and heated      
                                              surfaces. Do not puncture or  
                                              incinerate container. Exposure
                                              to temperatures above 130     
                                              deg.F may cause bursting      
                                                                            
    Flash point above 20  deg.F and not      Flammable. Contents under      
     over 80  deg.F or if the flame           pressure. Keep away from heat,
     extension is more than 18 inches long    sparks, and open flame. Do not
     at a distance of 6 inches from the       puncture or incinerate        
     flame                                    container. Exposure to        
                                              temperatures above 130  deg.F 
                                              may cause bursting            
                                                                            
    All other pressurized containers         Contents under pressure. Do not
                                              use or store near heat or open
                                              flame. Do not puncture or     
                                              incinerate container. Exposure
                                              to temperatures above 130     
                                              deg.F may cause bursting.     
    ------------------------------------------------------------------------
    
    
                       Table 2.--Nonpressurized Containers                  
    ------------------------------------------------------------------------
                  Flash Point                         Required Text         
    ------------------------------------------------------------------------
    At or below 20  deg.F                    Extremely flammable. Keep away 
                                              from fire, sparks, and heated 
                                              surfaces.                     
                                                                            
    Above 20  deg.F and not over 80  deg.F   Flammable. Keep away from heat 
                                              and open flame.               
                                                                            
    
    [[Page 9083]]
    
                                                                            
    Above 80  deg.F and not over 150  deg.F  Do not use or store near heat  
                                              or open flame.                
    ------------------------------------------------------------------------
    
        (B) A ``total release fogger'' is defined as a pesticide product in 
    a pressurized container 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.
        (C)(1) 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 a highly flammable ingredient. It may 
    cause a fire or explosion if not used properly. Follow the 
    ``Directions for Use'' on this label very carefully.
    
        (2) A graphic symbol depicting fire such as illustrated in this 
    paragraph or an equivalent symbol, must be displayed along with the 
    required language 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.
    [GRAPHIC] [TIFF OMITTED] TR23FE98.000
    
        (i) * * *
        (2) * * *
        (x) * * *
        (D) For total release foggers as defined in paragraph 
    (h)(2)(iii)(B) of this section, the following statements must be 
    included in the ``Directions for Use'':
    
        DO NOT use more than one fogger per room. DO NOT use in small, 
    enclosed spaces such as closets, cabinets, or under counters or 
    tables. Do not use in a room 5 ft. x 5 ft. or smaller; instead, 
    allow fog to enter from other rooms. Turn off ALL ignition sources 
    such as pilot lights (shut off gas valves), other open flames, or 
    running electrical appliances that cycle off and on (i.e., 
    refrigerators, thermostats, etc.). Call your gas utility or 
    management company if you need assistance with your pilot lights.''
    
        *    *    *    *    *
    
    [FR Doc. 98-4562 Filed 2-20-98; 8:45 am]
    BILLING CODE 6560-50-F
    
    
    

Document Information

Effective Date:
4/24/1998
Published:
02/23/1998
Department:
Environmental Protection Agency
Entry Type:
Rule
Action:
Direct final rule.
Document Number:
98-4562
Dates:
This rule will become effective on April 24, 1998. Comments must be received by March 25, 1998.
Pages:
9078-9083 (6 pages)
Docket Numbers:
OPP-36189, FRL-5748-7
RINs:
2070-AC60: Pesticide Flammability Labeling Requirements for Total Release Foggers
RIN Links:
https://www.federalregister.gov/regulations/2070-AC60/pesticide-flammability-labeling-requirements-for-total-release-foggers
PDF File:
98-4562.pdf
CFR: (1)
40 CFR 156.10