Flammability Labeling Requirements for Total Release Fogger Pesticides

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