Flammability Labeling Requirements for Total Release Fogger Pesticides

SUMMARY: This rule requires specific precautionary labeling relating to

the flammability of total release fogger pesticides. EPA has found

that, as currently labeled, total release foggers pose an unreasonable

risk to property and pesticide users from fires and explosions that can

be caused by a build up of extremely flammable propellants. EPA expects

that the additional flammability label warnings required by this rule

will reduce the potential for fires and explosions by alerting

consumers to the dangers of total release foggers. The required

labeling will also provide specific directions for proper use of these

products with minimal costs to industry or consumers. Although EPA

issued a proposed rule and received public comments in 1994, this

action includes some labeling requirements that differ from those

discussed in the proposal. EPA is therefore issuing this action as a

direct final rule in order to provide an opportunity for affected

entities to submit adverse comments on the new labeling requirements.

If EPA receives any adverse comments on the addition of these labeling

requirements for pesticides within 30 days from the date of this final

rule, EPA will withdraw that paragraph of the rule to which adverse

comments pertain. At that point, EPA will issue a proposed rule

addressing this issue and will provide a 30-day period for public

comment. If no adverse comments are received, the rule will become

effective on the date specified.

DATES: This rule will become effective on April 24, 1998. Comments must

be received by March 25, 1998.

ADDRESSES: By mail, submit written comments to: Public Information and

Records Integrity Branch, Information Resources and Services Division

(7502C), Office of Pesticide Programs, Environmental Protection Agency,

401 M St., SW., Washington, DC 20460. In person, deliver comments to:

Rm. 119, CM #2, 1921 Jefferson Davis Highway, Arlington, VA.

Comments and data may also be submitted electronically to: opp-

[email protected]. Follow the instructions under Unit VIII. of

this document. No Confidential Business Information (CBI) should be

submitted through e-mail.

Information submitted as a comment concerning this document may be

claimed confidential by marking any part or all of that information as

CBI. Information so marked will not be disclosed except in accordance

with procedures set forth in 40 CFR part 2. A copy of the comment that

does not contain CBI must be submitted for inclusion in the public

record. Information not marked confidential will be included in the

public docket by EPA without prior notice. The public docket is

available for public inspection in Rm. 119 at the Virginia address

given above, from 8:30 a.m. to 4 p.m., Monday through Friday, excluding

legal holidays.

FOR FURTHER INFORMATION CONTACT: By mail: Jim Downing, Labeling Team,

Field and External Affairs Division (7506C), Office of Pesticide

Programs, Environmental Protection Agency, 401 M St., SW., Washington,

DC 20460. Office location, telephone number, and e-mail address:

Crystal Mall #2, 1921 Jefferson Davis Highway, Arlington VA, 703-308-

9071, e-mail: [email protected].

SUPPLEMENTARY INFORMATION:

I. Regulated Entities

------------------------------------------------------------------------

Examples of Regulated

Category Entities

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Industry Persons who sell and

distribute total release

fogger products.

------------------------------------------------------------------------

This table is not exhaustive, but is a guide to the entities EPA

believes are regulated by this action. Read carefully the applicability

criteria in Sec. 156.10(h)(2)(iii)(C) of the regulatory text to decide

whether this rule applies to you.

II. Background

A. Authority

This amendment to the labeling requirements for pesticides and

devices (40 CFR 156.10) is issued under the authority of sections 3, 6,

12, and 25 of the Federal Insecticide, Fungicide, and Rodenticide Act,

as amended (FIFRA), 7 U.S.C. 136 through 136y. FIFRA section 25(a)

authorizes the Administrator of EPA to prescribe regulations to carry

out the provisions of FIFRA. The statutory standard that is the basis

for Agency regulation of pesticide labeling is contained in section

2(q) of FIFRA, which defines a ``misbranded'' pesticide and enumerates

specific labeling deficiencies that constitute misbranding. EPA's

labeling regulations interpret and elaborate upon the statutory

standard.

Under FIFRA section 3(c)(5), the labeling of the pesticide must

comply with the requirements of FIFRA. Sections 12(a)(1)(E) and (F) of

FIFRA provide that it is unlawful to distribute or sell a pesticide or

device that is misbranded. Under FIFRA section 2(q), a pesticide may be

considered misbranded in a number of circumstances. Sections 2(q)(1)(E)

through (G) provide part of the basis for EPA's authority to impose

label restrictions to protect health and the environment. Specifically,

sections 2(q)(1)(F) and (G) provide that a pesticide is misbranded if

its labeling does not contain directions for use or if the label does

not contain a warning or caution statement adequate to protect health

and the environment. Under FIFRA section 2(x), the term ``protect

health and the environment'' means protect against any unreasonable

adverse effects on the environment. FIFRA section 2(bb) defines the

term ``unreasonable adverse effects on the environment'' to include any

unreasonable risk to humans or the environment, taking into account the

economic, social, and environmental costs and benefits of the use of

any pesticide. With this final rule, EPA is giving notice of its

determination that total release fogger pesticides that are not labeled

in accordance with the directions for use and warning statements

required by this rule will be considered misbranded and subject to

possible enforcement action.

Each provision described above is designed to prevent the sale or

distribution of pesticides that, due to inadequate labeling, might

cause unreasonable adverse effects to the environment.

B. Proposed Rule

EPA issued in the Federal Register of April 15, 1994 (59 FR 18058)

(FRL-4186-4), a proposal to require additional precautionary labeling

relating to the flammability of total release fogger pesticides. From

the review of the fire/explosion incidents involving total release

foggers, EPA found that foggers as currently labeled present a risk of

unreasonable adverse effects from fires and/or explosions caused by a

build up of extremely

[[Page 9079]]

flammable propellants. EPA concluded that this risk is not adequately

addressed in current labeling of total release foggers. To mitigate

this risk, EPA proposed specific label requirements including physical

and chemical hazards warning statements, graphic symbols, and specific

directions for total release foggers, which if complied with, would be

adequate to human health and the environment. Comments about the scope

of the proposed rule were also solicited.

Because comments received in response to the proposal have caused

the Agency to include in this final rule certain requirements which

were not discussed in the proposal (see discussion in Unit III.B., of

this preamble), EPA is issuing this action as a direct final rule in

order to provide an opportunity for affected entities to submit adverse

comments on the new labeling requirements.

C. Hazards Caused by Total Release Foggers

For several years EPA has received reports of incidents of fires

and explosions involving total release foggers. For instance, the New

York City Fire Department (NYCFD) reported 40 incidents of fires or

explosions (28% resulting in personal injuries) reported to be caused

by total release foggers over a 12-year period. Fifteen of the 40

reported incidents occurred in 1990 and 1991 alone. In 32 of those 40

documented incidents, the specific total release fogger product

involved was identified. In its proposal, the Agency identified many

incidents, and solicited for additional incidents involving foggers.

However, no additional incidents were submitted in the comments, but

the Agency did receive reports of several incidents connected with use

of foggers from various other locations around the country from states

and media articles which revealed extensive property damage. These

reports are in the public information docket for this rule.

Fire experts have indicated to the Agency that the actual number of

such incidents occurring around the country is much higher. Due to the

lack of a nationwide reporting system that could capture these type of

fire incidents, EPA believes the reports it has received are only the

``tip of the iceberg''; annually, there are many more such incidents

occurring for which EPA does not receive reports.

III. Comments Received on the Proposed Rule

Twenty-two comments from registrants, trade associations, public

interest groups, and others were received on the proposed rule. Most of

the comments generally agreed with the need for label improvement for

total release foggers. The significant comments are presented below

with EPA's response to the comment. A detailed response to comments is

available in the public record.

A. Graphic Symbols

EPA proposed the use of graphic symbols (one symbol depicting fire

and one symbol representing explosive potential) to alert users of the

potential dangers of misuse of total release foggers. Six commenters

expressed concern with the use of graphic symbols or they were

definitely opposed to the use of graphic symbols. Their biggest

concerns were that the proposed symbols would be confusing, and could

unduly alarm consumers or that consumers might ``misunderstand or

misinterpret'' the meaning of the symbols. One commenter stated, ``We

have a strong concern that users will not understand the graphic

symbols. For example, the bursting symbol may actually portray to a

person that the product is meant to burst to disperse the product

properly during usage when such, of course, is not the case. On the

other hand, the symbol may be interpreted by others to mean that it

presents far more of a danger than actually exists. Unlike an

industrial worker audience, consumers are not generally educated as to

the meaning of symbols.''

As an alternative, one of the six commenters suggested using the

fire symbol, but not the proposed explosion (bursting) symbol. One of

the commenters supporting the use of symbols encouraged the use of the

internationally accepted graphic symbol for fire.

The Agency has decided to retain the use of the fire symbol, but to

eliminate the proposed explosion symbol. The Agency believes the fire

symbol is widely recognized and is necessary to capture the pesticide

user's attention to alert the user to the potential hazards of these

products. EPA's fire symbol is similar to many other fire symbols used

by other agencies for many years. The U.S. Department of

Transportation, the European Community, and Canada use a fire symbol

that incorporates a fire as a symbol of flammability. Because there are

slight variations in the presentation of the fire symbol among various

authorities, and to allow maximum flexibility, EPA has decided to allow

use of an ``equivalent'' fire symbol as an alternative to the one in

the proposed rule. Since a fire graphic is widely understood by the

public, EPA believes that slight variations among existing symbols will

not reduce the value of the information conveyed by the symbol. On the

other hand, the Agency agreed with several commenters that the

explosion symbol on total release foggers could be misunderstood or

misinterpreted or that it might not be effective. Therefore the

proposed explosion symbol was omitted from the final rule.

B. Number of Foggers to be Used and Pilot Lights

EPA proposed to limit the number of foggers to be used. By limiting

the use to one fogger per room and eliminating all ignition sources,

the risks of fire and/or explosions can be substantially reduced, if

not eliminated. From an evaluation of the incidents, the Agency

recognizes that fires/explosions are generally due to excessively high

concentrations of highly flammable gases (propellent in the foggers) in

the area being fogged. This is caused by too many foggers being used

with the presence of an ignition source. Furthermore, the Agency has

learned from fire officials that the elimination of ignition sources is

very important to safe use of foggers containing highly flammable

propellants. Several fire officials EPA talked with acknowledged the

risk of consumers extinguishing and relighting their pilot lights.

However, they agreed that those risks were far outweighed by the risks

associated with activation of foggers with pilot lights unextinguished.

A record of these conversations is available in the public information

docket. Therefore, EPA has concluded that limiting the number of

foggers to be used and eliminating all ignition sources are paramount

to continued safe use of total release foggers. No commenter disagreed

with the proposal to eliminate all ignition sources before using a

total release fogger. In fact, two commenters recommended the label

instruct users to extinguish pilot lights and other ignition sources.

In earlier comments on a previous notice dated February 19, 1991 (56 FR

6856), a commenter had raised the issue of the hazard of instructing

fogger users (consumers) to turn off their gas pilot lights; the danger

of consumers extinguishing and relighting their own pilot lights was

emphasized.

After consultation with fire safety professionals and gas industry

representatives, the Agency has decided to instruct users to turn off

all ignition sources such as pilot lights, other open flames and

running electrical appliances. One fire professional suggested

referring fogger users to their

[[Page 9080]]

gas utility or management company for assistance in extinguishing and

relighting pilot lights. The Agency believes the risks of consumers

improperly extinguishing and relighting pilot lights are outweighed by

the benefits of eliminating all ignition sources before total release

foggers are used; and that instructing consumers to contact their gas

utility or management company for assistance will further reduce any

risks.

This approach of limiting the number of foggers used and

extinguishing pilot lights will also eliminate the issues from the

proposed rule of the six-foot ``buffer zone'' and the square footage

limitation. As was pointed out by one commenter, the flammability of

total release fogger use is not a function of distance from an ignition

source, but a function of the concentration of the highly flammable

(propellant) gas. By eliminating sources of ignition altogether, risks

can be reduced without complex decisions by consumers about distances

between foggers and ignition sources. By simplifying the label

instructions, EPA believes consumers are more likely to be able to

comply.

One commenter, S.C. Johnson Son, Inc. conducted a consumer-based

label testing and development program to determine the most effective

method of improving consumer comprehension regarding the proper use of

total release foggers. This study included qualitative research to

decide which fogger labeling best communicates proper use and safety

information and evaluated consumers' perceptions of room size.

Quantitative research, also a part of the study program, tested various

fogger labels, including a fogger label amended according to the

proposed rule. An ``optimized label'' developed from the quantitative

research was also tested, which included the simpler instructions ``Do

not use more than one fogger in a room.'' and ``Extinguish All Flames

and Pilot Lights.''

The results of the S.C. Johnson study suggested limiting the user

to only one fogger per room, as is shown in the final rule language.

The study showed that consumers have difficulty accurately estimating

room size. Less than 10% of consumers could accurately estimate cubic

feet. Therefore, the approach (``DO NOT use more than one fogger per

____ square feet.'') of the proposed rule was judged by EPA not to be

very effective after all. However, limiting the use to one fogger per

room to manage the concentration of highly flammable gases in the area

to be fogged was judged to be the most effective. Furthermore, EPA has

determined that a limit of one fogger per room will be adequately

protective. An added safety factor is the limit of ``Do not use in a

room 5 ft. x 5 ft. or smaller. . .'', as was shown on the ``optimized

label'' used in the S.C. Johnson study. This limit would help a fogger

user avoid using too many foggers in a dwelling with many small rooms.

This limit of a room 5 ft. x 5 ft. (the typical ``walk-in'' closet or

small bathroom) or smaller was judged to be appropriate.

The Agency has attempted to allow efficacious, but not excessive

use, while creating a restriction that can be easily understood and

carried out by the typical fogger user. The circumstances in which

foggers can be used vary widely. Room size, natural ventilation,

ambient temperatures, humidity, presence and proximity of ignition

sources, etc. are different from structure to structure, yet each

factor can have an impact on risk. While the one fogger per room

approach may allow for more concentrated use than that permitted by the

language of the proposed rule, it is still within a safe level of use

considering the fact that the ignition sources will be eliminated as

well. EPA also believes that the efficacy of foggers will be unaffected

by this requirement. Users are far more likely to understand and

successfully follow the one fogger per room approach than would have

been the case from the formula approach of the proposed rule (``DO NOT

use more than one fogger per ____ square feet.''). Based on the above,

EPA has determined that the ``one fogger per room'' label language

achieves equivalent risk mitigation as the language of the proposed

rule and has adopted this language and included it in the final rule.

C. Flammability Terminology

EPA proposed the use of the term ``extremely flammable'' to

describe the hazard of the hydrocarbon propellant. Several commenters

opposed the use of this term, stating that it would conflict with

required flammability labeling already required in the Physical and

Chemical Hazards statement for the product as a whole. EPA currently

requires that a pressurized product bear a hazard statement of either

``Flammable'' or ``Extremely Flammable'' based on flash point and flame

extension test results. The commenter's point is that a fogger that

bears the statement ``Extremely Flammable'' under the proposal because

it contains a flammable propellant might, based upon flammability

characteristics of the product as a whole, bear only the term

``Flammable.''

EPA acknowledges that sometimes this could be true. However, EPA

also believes it likely that total release foggers containing

significant levels of hydrocarbon propellant requiring ``Extremely

Flammable'' labeling under this rule would also require ``Extremely

Flammable'' labeling under the current regulations. The ``Extremely

Flammable'' term is required only when the propellant has a flash point

of [email protected]

Electronic comments must be submitted as an ASCII file avoiding the

use of special characters and any form of encryption. Comment and data

will also be accepted on disks in Wordperfect 5.1/6.1 or ASCII file

format. All comments and data in electronic form must be identified by

the docket control number ``OPP-36189.'' Electronic comments on this

final rule may be filed online at many Federal Depository Libraries.

IX. Regulatory Assessment Requirements

A. Executive Order 12866

Under Executive Order 12866, entitled Regulatory Planning and

Review (58 FR 51735, October 4, 1993), this action is not a

``significant regulatory action'' subject to review by the Office of

Management and Budget (OMB).

According to the Economic Assessment conducted by the Agency, the

costs per product of this rule were between $8,000 and $13,000. The

total costs for the industry would be between $1.87 million and $3

million (net present value). A copy of the Economic Assessment is

available in the public docket for this rule.

B. Regulatory Flexibility Act

Under section 605(b) of the Regulatory Flexibility Act (5 U.S.C.

601 et seq.), the Agency hereby certifies that this action will not

have a significant economic impact on a substantial number of small

entities. This action does not impact any small entities. Information

relating to this determination is provided upon request to the Chief

Counsel for Advocacy of the Small Business Administration, and is

included in the docket for this rulemaking.

The label changes for aerosol pesticides, known as total release

foggers, will not impose a significant adverse economic impact on a

substantial number of small entities. The estimated cost impacts

associated with the label changes are less than 1% (0.07%) of the

annual revenues for small businesses. One of the main benefits of the

rule is to reduce the number of accidents that occur from the misuse of

total release foggers.

EPA will allow all registrants almost 2 years to incorporate the

label changes. This compliance time will allow all registrants,

including those that are small businesses, to revise labels in the

[[Page 9082]]

normal course of business, thus minimizing the economic impact.

Therefore, no regulatory flexibility analysis was prepared. However,

the economic assessment for this rule is available in the public docket

for this rule.

C. Paperwork Reduction Act

OMB has approved the information collection requirements contained

in this rule under the provisions of the Paperwork Reduction Act (PRA),

44 U.S.C. 3501 et seq. In accordance with the procedures at 5 CFR

1320.11, OMB has assigned OMB control number 2070-0060 (EPA ICR No.

277.10) to this activity. An Agency may not conduct or sponsor, and a

person is not required to respond to a collection of information

subject to OMB approval under the PRA unless it displays a currently

valid OMB control number. The OMB control numbers for EPA's

regulations, after initial publication in the Federal Register, are

maintained in a list at 40 CFR part 9.

Public reporting burden for this collection of information is

estimated to average 0.85 hours per product, including time for

reviewing instructions, searching existing data sources, gathering and

maintaining the data needed, and completing and reviewing the

collection information.

Under the PRA, ``burden'' means the total time, effort, or

financial resources expended by persons to generate, maintain, retain,

or disclose or provide information to or for a Federal agency. This

includes the time needed to review instructions; develop, acquire,

install, and utilize technology and systems for the purposes of

collecting, validating, and verifying information, processing and

maintaining information, and disclosing and providing information;

adjust the existing ways to comply with any previously applicable

instructions and requirements; train personnel to be able to respond to

a collection of information; search data sources; complete and review

the collection of information; and transmit or otherwise disclose the

information.

Send any comments on the burden estimates and any suggested methods

for minimizing respondent burden, including through the use of

automated collection techniques within 30 days to EPA at the address

provided above, with a copy to the Office of Information and Regulatory

Affairs, Office of Management and Budget, 725 17th St., NW.,

Washington, DC 20503, marked ``Attention: Desk Officer for EPA.''

Please remember to include the ICR number in any correspondence.

D. Unfunded Mandates Reform Act and Executive Order 12875

Under Title II of the Unfunded Mandates Reform Act of 1995 (Pub. L.

104-4), this action does not result in the expenditure of $100 million

or more by any State, local, or tribal governments, or by anyone in the

private sector, and will not result in any ``unfunded mandates'' as

defined by Title II. The costs associated with this action are

described in the Executive Order 12866 unit above.

Under Executive Order 12875 (58 FR 58093, October 28, 1993), EPA

must consult with representatives of affected State, local, and tribal

governments before promulgating a discretionary regulation containing

an unfunded mandate. This action does not contain any mandates on

States, localities, or tribes and is therefore not subject to the

requirements of Executive Order 12875.

E. Submission to Congress and the General Accounting Office

Under 5 U.S.C. 801(a)(1)(A) as added by the Small Business

Regulatory Enforcement Fairness Act of 1996, EPA submitted a report

containing this rule and other required information to the U.S. Senate,

the U.S. House of Representatives and the Comptroller General of the

United States prior to publication of this rule in today's Federal

Register. This rule is not a ``major rule'' as defined by 5 U.S.C.

804(2).

List of Subjects in 40 CFR Part 156

Environmental protection, Labeling, Occupational safety and health,

Pesticides and pests, Reporting and recordkeeping requirements.

Dated: February 4, 1998.

Carol M. Browner

Administrator.

Therefore, 40 CFR part 156 is amended as follows:

PART 156--[AMENDED]

1. The authority citation for part 156 continues to read as

follows:

Authority: 7 U.S.C. 136 - 136y.

2. In Sec. 156.10, by revising paragraph (h)(2)(iii) and adding

paragraph (i)(2)(x)(D) to read as follows:

Sec. 156.10 Labeling requirements.

* * * * *

(h) * * *

(2) * * *

(iii) Physical or chemical hazards. (A) Warning statements on the

flammability or explosive characteristics of all pesticides are

required as set out in Table 1 and Table 2 of this paragraph as

follows:

Table 1.--Pressurized Containers

------------------------------------------------------------------------

Flash Point Required Text

------------------------------------------------------------------------

Flash point at or below 20 deg.F; if Extremely flammable. Contents

there is a flashback at any valve under pressure. Keep away from

opening fire, sparks, and heated

surfaces. Do not puncture or

incinerate container. Exposure

to temperatures above 130

deg.F may cause bursting

Flash point above 20 deg.F and not Flammable. Contents under

over 80 deg.F or if the flame pressure. Keep away from heat,

extension is more than 18 inches long sparks, and open flame. Do not

at a distance of 6 inches from the puncture or incinerate

flame container. Exposure to

temperatures above 130 deg.F

may cause bursting

All other pressurized containers Contents under pressure. Do not

use or store near heat or open

flame. Do not puncture or

incinerate container. Exposure

to temperatures above 130

deg.F may cause bursting.

------------------------------------------------------------------------

Table 2.--Nonpressurized Containers

------------------------------------------------------------------------

Flash Point Required Text

------------------------------------------------------------------------

At or below 20 deg.F Extremely flammable. Keep away

from fire, sparks, and heated

surfaces.

Above 20 deg.F and not over 80 deg.F Flammable. Keep away from heat

and open flame.

[[Page 9083]]

Above 80 deg.F and not over 150 deg.F Do not use or store near heat

or open flame.

------------------------------------------------------------------------

(B) A ``total release fogger'' is defined as a pesticide product in

a pressurized container designed to automatically release the total

contents in one operation, for the purpose of creating a permeating fog

within a confined space to deliver the pesticide throughout the space.

(C)(1) If the pesticide product is a total release fogger

containing a propellant with a flash point at or below 20 deg.F, then

the following special instructions must be added to the ``Physical and

Chemical Hazards'' warning statement:

This product contains a highly flammable ingredient. It may

cause a fire or explosion if not used properly. Follow the

``Directions for Use'' on this label very carefully.

(2) A graphic symbol depicting fire such as illustrated in this

paragraph or an equivalent symbol, must be displayed along with the

required language adjoining the ``Physical and Chemical Hazards''

warning statement. The graphic symbol must be no smaller than twice the

size of the first character of the human hazard signal word.

[GRAPHIC] [TIFF OMITTED] TR23FE98.000

(i) * * *

(2) * * *

(x) * * *

(D) For total release foggers as defined in paragraph

(h)(2)(iii)(B) of this section, the following statements must be

included in the ``Directions for Use'':

DO NOT use more than one fogger per room. DO NOT use in small,

enclosed spaces such as closets, cabinets, or under counters or

tables. Do not use in a room 5 ft. x 5 ft. or smaller; instead,

allow fog to enter from other rooms. Turn off ALL ignition sources

such as pilot lights (shut off gas valves), other open flames, or

running electrical appliances that cycle off and on (i.e.,

refrigerators, thermostats, etc.). Call your gas utility or

management company if you need assistance with your pilot lights.''

* * * * *

[FR Doc. 98-4562 Filed 2-20-98; 8:45 am]

BILLING CODE 6560-50-F