[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]


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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.

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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