[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
