[Federal Register Volume 59, Number 161 (Monday, August 22, 1994)]
[Unknown Section]
[Page 0]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 94-20557]


[[Page Unknown]]

[Federal Register: August 22, 1994]


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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]
BILLING CODE 6560-50-F