Dipropylene glycol dimethyl ether; Proposed Significant New Use Rule

ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 721

[OPPTS-50621; FRL-4872-1]

RIN 2070-AB27

Dipropylene glycol dimethyl ether; Proposed Significant New Use

Rule

AGENCY: Environmental Protection Agency (EPA).

ACTION: Proposed rule.

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SUMMARY: EPA is proposing a significant new use rule (SNUR) under

section 5(a)(2) of the Toxic Substances Control Act (TSCA) for the

chemical substance described as modified propylene glycol ether, which

is the subject of premanufacture notice (PMN) P-93-507. This proposal

would require certain persons who intend to manufacture, import, or

process this substance for a significant new use to notify EPA at least

90 days before commencing any manufacturing or processing activities

for a use designated by this SNUR as a significant new use. The

required notice would provide EPA with the opportunity to evaluate the

intended use and, if necessary, to prohibit or limit that activity

before it can occur.

DATES: Written comments must be received by EPA on or before September

21, 1994.

ADDRESSES: All comments must be sent in triplicate to: Environmental

Protection Agency, OPPT Document Control Officer (7407), 401 M St.,

SW., Rm. E-G99, Washington, DC 20460. Comments that are claimed as

confidential business information (CBI) must be clearly marked CBI. If

CBI is claimed, three additional copies of the comments without the CBI

must also be submitted. Nonconfidential versions of comments on this

proposed rule will be placed in the rulemaking record and will be

available for public inspection in the TSCA Nonconfidential Information

Center (NCIC) located in Rm. NE-B607. Comments should include the

docket control number. The docket control number for the chemical

substance in this SNUR is OPPTS-50621. Unit VI. of this preamble

contains additional information on submitting comments containing

information claimed as CBI.

FOR FURTHER INFORMATION CONTACT: Susan B. Hazen, Director,

Environmental Assistance Division (7408), Office of Pollution

Prevention and Toxics, Environmental Protection Agency, Rm. E-543B, 401

M St., SW., Washington, DC 20460, Telephone: (202) 554-1404, TDD: (202)

554-0551.

SUPPLEMENTARY INFORMATION: This proposed SNUR would require persons to

notify EPA at least 90 days before commencing the manufacture, import,

or processing of the substance identified as modified propylene glycol

ether for the significant new uses described herein. The required

notice would provide EPA with information with which to evaluate an

intended use and associated activities.

I. Authority

Section 5(a)(2) of TSCA (15 U.S.C. 2604(a)(2)) authorizes EPA to

determine that a use of a chemical substance is a ``significant new

use.'' EPA must make this determination by rule after considering all

relevant factors, including those listed in section 5(a)(2). Once EPA

determines that a use of a chemical substance is a significant new use,

section 5(a)(1)(B) of TSCA requires persons to submit a notice to EPA

at least 90 days before they manufacture, import, or process the

chemical substance for that use. Section 26(c) of TSCA authorizes EPA

to take action under section 5(a)(2) with respect to a category of

chemical substances. Persons subject to this SNUR would comply with the

same notice requirements and EPA regulatory procedures as submitters of

premanufacture notices under section 5(a)(1) of TSCA. In particular,

these requirements include the information submission requirements of

section 5(b) and (d)(1), the exemptions authorized by section 5(h)(1),

(h)(2), (h)(3), and (h)(5), and the regulations at 40 CFR part 720.

Once EPA receives a significant new use notice (SNUN), EPA may take

regulatory action under section 5(e), 5(f), 6, or 7 to control the

activities for which it has received a SNUN. If EPA does not take

action, section 5(g) of TSCA requires EPA to explain in the Federal

Register its reasons for not taking action.

Persons who intend to export a substance identified in a proposed

or final SNUR are subject to the export notification provisions of TSCA

section 12(b). The regulations that interpret section 12(b) appear at

40 CFR part 707.

II. Applicability of General Provisions

General regulatory provisions applicable to SNURs are codified at

40 CFR part 721, subpart A. Regulatory provisions covering user fees

applicable to significant new use notices are codified at 40 CFR part

700 under the authority of TSCA section 26(b). Interested persons may

refer to these sections for further information.

III. Background

EPA is proposing to establish significant new use and recordkeeping

requirements for the chemical dipropylene glycol dimethyl ether. The

proposed SNUR designates as significant new uses:

(1) Any manner or method of manufacturing, importing, or processing

associated with any use of the substance without the use of dermal

protection, including gloves, that provides an impervious barrier to

the substance.

(2) Annual manufacture and importation volume for any use greater

than 4 times the yearly volume specified in the PMN for the substance

(annual production total must include quantities manufactured for

export and for all domestic uses).

(3) Use of the substance in a consumer product.

On February 2, 1993, EPA received a PMN, designated as P-93-507,

for a modified propylene glycol ether. Based on test data on the PMN

substance, submitted with the PMN and during the review period, EPA has

concerns for the substance's potential to cause adverse systemic,

maternal, and fetal effects. The greatest potential for risk appears to

be associated with the dermal route of exposure. The extent to which

the Agency expects that adverse effects may occur relates in large part

to the isomer mix of the PMN substance, which is a combination of three

individual isomers.

If the ratio of these isomers in the PMN substance is maintained at

certain levels, the Agency considers the potential risk to workers

during manufacturing, processing, and use to be reasonable; however, if

the formulation contains a high percentage of an isomer for which the

suspected human health hazard is significant, the Agency might consider

the risk to workers to be unreasonable. Although the Agency does not

consider the higher risk formulations likely to be made, and is

reasonably confident that the isomer of greatest potential concern will

be present at low levels (<5 percent) in the formulation, the PMN

submitter was not able to specify with certainty the percentage at

which each isomer would be present in the PMN substance. Consequently,

there is potential for the PMN substance to be formulated in isomer

ratios that may present an unreasonable risk to human health as

described above.

In deciding not to regulate the PMN submitter through an

administrative consent order, the Agency balanced the potential risks

from certain isomer formulations with the benefits to worker safety

offered by the PMN substance as a substitute for more potentially

hazardous glycol ethers. Another factor in the Agency's decision not to

regulate the PMN substance through an order was the product stewardship

program that the submitter had established for the substance, which

included up-front glove testing to ensure that accurate information on

dermal protection would be communicated to workers exposed to the

substance.

The results of the glove testing indicated that permeation at rates

that might present an unreasonable risk could occur with certain glove

models. The Agency considers it prudent and necessary, therefore, that

any glove or dermal protective clothing intended for use in handling

the PMN substance be tested, or the specifications from the

manufacturer or supplier evaluated, prior to use. This testing or

evaluation must ensure that the protective item will be impervious to

the PMN substance for the expected duration and conditions of exposure,

which includes the likely combinations of other chemicals to which the

item may be exposed in the work area. (Each piece of personal

protective equipment must be selected and used in accordance with 29

CFR 1910.132 and 1910.133.) Handling the PMN substance without the use

of equipment that provides an impervious barrier to it would be

considered a significant new use requiring Agency notice and

appropriate justification.

Based in part on the submitter's commitment to incorporate the

results of the glove study in its product literature, the Agency

considered regulation of the submitter to require use of dermal

protective equipment under a consent order unnecessary, especially in

view of the substance's relative human health advantages. The balance

in favor of non-regulation might shift, however, if aspects of the

manufacture and use of the PMN substance were to change from those on

which the Agency's risk assessment was originally based.

The production volume estimated by the submitter in its PMN, for

example, is expected to result in relatively few workers being exposed

to the PMN substance. If the production level were to increase

substantially, however, the number of workers and the duration of

exposure--especially during manufacture--would increase

proportionately. As a consequence, EPA would need to revisit its

original risk assessment, consider whether a potential unreasonable

risk might result at the higher production levels and whether to

regulate to mitigate that risk.

Of course, if this increase in production volume were coupled with

formulation of the PMN substance with a proportionally greater amount

of the isomers of concern, the potential risk to workers would increase

as well. The filing of a SNUN based on production volume would afford

the Agency an opportunity to evaluate not only the increased worker

exposures and risks, but also the risks associated with a particular

isomer formulation of the PMN substance, the knowledge of which would

be based on actual production experience.

For purposes of determining the annual PMN production volume and

compliance with the volume limitation, quantities of the PMN substance

manufactured for both domestic use and export should be totaled (i.e.

considered in aggregate), even if the export volumes were formerly

manufactured ``for export only.'' Once domestic manufacture is intended

or commences, all volumes produced--both for domestic consumption and

export--are subject to PMN reporting requirements and TSCA section 5

regulation. Also, the annual production total should reflect

manufacture or import volumes for any and all uses; the total should

not be calculated on a per-use-basis. (See 40 CFR 720.45 and associated

Agency guidance documents and instructions.)

In addition, while the potential risk to workers from exposure to

the PMN substance might be considered reasonable, similar exposures and

risks to the general population by way of consumer uses for the PMN

substance might not. The Agency considers potential risks to workers to

be mitigated in part by the greater level of protective measures

normally found in the workplace and the generally greater awareness

among workers of the potential hazards associated with the substances

they handle. Consumers, on the other hand, usually are not as aware of

potential hazards, do not have access to the same types of information

and protections available to workers, and therefore are potentially at

greater risk if exposed to a hazardous new substance in a consumer

product. Thus, in an effort to prevent an unreasonable risk to the

general population, the PMN substance cannot be manufactured or

processed for a consumer use until that use and the potential exposures

and risks associated with it have been reviewed and evaluated by the

Agency.

In summary, for the reasons described above, the Agency has

designated handling the PMN substance without adequate dermal

protection, production volume when it reaches a substantial level per

year, and any consumer use of the PMN substance as significant new

uses.

IV. Applicability of SNUR to Uses Occurring Before Effective Date

of the Final SNUR

EPA has decided that the intent of section 5(a)(1)(B) is best

served by designating a use as a significant new use as of the date of

proposal rather than as of the effective date of the rule. If uses

which had commenced between that date and the effective date of this

rulemaking were considered ongoing, rather than new, any person could

defeat the SNUR by initiating a significant new use before the

effective date. This would make it difficult for EPA to establish SNUR

notice requirements. Thus, persons who begin commercial manufacture,

import, or processing of the substance for uses regulated under this

SNUR after the date of this proposed rule will have to cease any such

activity before the effective date of the rule. To resume their

activities, such persons would have to comply with all applicable SNUR

notice requirements and wait until the notice review period, including

all extensions, expires. EPA, not wishing to unnecessarily disrupt the

activities of persons who begin commercial manufacture, import, or

processing of a significant new use before the effective date of the

SNUR, has promulgated provisions to allow such persons to comply with

this proposed SNUR before it is promulgated. If a person were to meet

the conditions of advance compliance as codified at Sec. 721.45(h), the

person would be considered to have met the requirements of the final

SNUR for those activities. If persons who begin commercial manufacture,

import, or processing of the substance between proposal and the

effective date of the SNUR do not meet the conditions of advance

compliance, they must cease that activity before the effective date of

the rule. To resume their activities, these persons would have to

comply with all applicable SNUR notice requirements and wait until the

notice review period, including all extensions, expires.

V. Economic Analysis

EPA has evaluated the potential costs of establishing significant

new use notice requirements for potential manufacturers, importers, and

processors of the chemical substance. The Agency's complete economic

analysis is available in the public record for this proposed rule

(OPPTS-50621).

VI. Comments Containing Confidential Business Information

Any person who submits comments claimed as CBI must mark the

comments as ``confidential,'' ``trade secret,'' or other appropriate

designation. Comments not claimed as confidential at the time of

submission will be placed in the public file. Any comments marked as

confidential will be treated in accordance with procedures in 40 CFR

part 2. Any party submitting comments claimed to be confidential must

prepare and submit a nonconfidential public version in triplicate of

the comments that EPA can place in the public file.

VII. Rulemaking Record

EPA has established a record for this rulemaking (docket control

number OPPTS-50621). The record includes basic information considered

by the Agency in developing this proposed rule. EPA will supplement the

record with additional information as it is received.

EPA will accept additional materials for inclusion in the record at

any time between this proposal and designation of the complete record.

EPA will identify the complete rulemaking record by the date of

promulgation. A public version of the record, without any CBI, is

available in the TSCA Nonconfidential Information Center (NCIC) from 12

noon to 4 p.m., Monday through Friday, except legal holidays. The TSCA

Nonconfidential Information Center is located in Rm. NE-B607, 401 M

St., SW., Washington, DC.

VIII. 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 a ``significant regulatory action'' as an action that

is likely to result in 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 (also referred to as ``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 entitlement, grants, user

fees, or loan programs or the rights and obligations of recipients

thereof; 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.

Pursuant to the terms of this Executive Order, EPA has determined

that this proposed rule is not ``significant'' and is therefore not

subject to OMB review.

B. Regulatory Flexibility Act

Under the Regulatory Flexibility Act (5 U.S.C. 605(b)), EPA has

determined that this proposed rule would not have a significant impact

on a substantial number of small businesses. EPA has not determined

whether parties affected by this proposed rule would likely be small

businesses. However, EPA expects to receive few SNUNs for this

substance. Therefore, EPA believes that the number of small businesses

affected by the proposed rule would not be substantial, even if all of

the SNUN submitters were small firms.

C. Paperwork Reduction Act

OMB has approved the information collection requirements contained

in this proposed rule under the provisions of the Paperwork Reduction

Act (44 U.S.C. 3501 et seq.), and has assigned OMB control number 2070-

0012. Public reporting burden for this collection of information is

estimated to vary from 30 to 170 hours per response, with an average of

100 hours per response, 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 the burden estimate or any other aspect of

this collection of information, including suggestions for reducing this

burden, to Chief, Information Policy Branch (2131), Environmental

Protection Agency, 401 M St., SW., Washington, DC 20460; and to Office

of Information and Regulatory Affairs, Office of Management and Budget,

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

final rule will respond to any OMB or public comments on the

information requirements contained in this proposal.

List of Subjects in 40 CFR Part 721

Environmental protection, Chemicals, Hazardous materials, Reporting

and recordkeeping requirements, Significant new uses.

Dated: August 12, 1994.

Joseph A. Carra,

Acting Director, Office of Pollution Prevention and Toxics.

Therefore, it is proposed that 40 CFR part 721 be amended as

follows:

PART 721--[AMENDED]

1. The authority citation for part 721 would continue to read as

follows:

Authority: 15 U.S.C. 2604, 2607, and 2625(c).

2. By adding new Sec. 721.3550 to subpart E to read as follows:

Sec. 721.3550 Dipropylene glycol dimethyl ether.

(a) Chemical substances and significant new uses subject to

reporting. (1) The chemical substance identified as dipropylene glycol

dimethyl ether (PMN P-93-507) is subject to reporting under this

section for the significant new uses described in paragraph (a)(2) of

this section.

(2) The significant new uses are:

(i) Protection in the workplace. Requirements as specified in 40

CFR 721.63(a)(1), (a)(2)(i), and (a)(3).

(ii) Industrial, commercial, and consumer activities. Requirements

as specified in 40 CFR 721.80(o) and annual manufacture and importation

volume for any use greater than 4 times the yearly volume specified in

the PMN for the substance.

(b) Specific requirements. The provisions of subpart A of this part

apply to this section except as modified by this paragraph.

(1) Recordkeeping requirements. Recordkeeping requirements

specified in Sec. 721.125(a), (b), (c), and (i) are applicable to

manufacturers, importers, and processors of this substance.

(2) Limitations or revocation of certain notification requirements.

The provisions of Sec. 721.185 apply to this significant new use rule.

[FR Doc. 94-20557 Filed 8-19-94; 8:45 am]

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