[Federal Register Volume 62, Number 213 (Tuesday, November 4, 1997)]
[Rules and Regulations]
[Pages 59579-59583]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 97-29153]


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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 721

[OPPTS-50621B; FRL-5745-1]
RIN 2070-AB27


Dipropylene Glycol Dimethyl Ether; Final Significant New Use Rule

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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SUMMARY: EPA is promulgating a significant new use rule (SNUR) under 
section 5(a)(2) of the Toxic Substances Control Act (TSCA) for the 
chemical substance described as dipropylene glycol dimethyl ether 
(DGDE), which was the subject of premanufacture notice (PMN) P-93-507. 
This final rule will require persons who intend to manufacture, import, 
or process this substance for a use designated by this SNUR as a 
``significant new use'' to notify EPA at least 90 days before 
commencing those manufacturing or processing activities. The notice 
will provide EPA with the opportunity to evaluate the intended use and, 
if necessary, prohibit or limit that activity before it can occur.


[[Page 59580]]


DATES: The effective date of this rule is January 5, 1998. This rule 
shall be promulgated for purposes of judicial review at 1 p.m. (e.s.t.) 
on November 18, 1997.

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; e-mail: TSCA-H[email protected].

SUPPLEMENTARY INFORMATION:
    Electronic Availability: Electronic copies of this document are 
available from the EPA Home Page at the Federal Register-Environmental 
Documents entry for this document under ``Laws and Regulations'' 
(http://www.epa.gov/fedrgstr/).
    The proposed SNUR for dipropylene glycol dimethyl ether was 
published in the Federal Register on August 22, 1994 (59 FR 43079). 
While background information is presented here, readers should also 
consult the preamble of that proposed rule for further information on 
the objectives and rationale for this final rule.

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 
promulgates a final significant new use rule, section 5(a)(1)(B) of 
TSCA and 40 CFR part 721 require persons to submit a notice to EPA at 
least 90 days before they manufacture, import, or process the chemical 
substance for the significant new uses. 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 must 
comply with most of the same requirements as submitters of 
premanufacture notices under section 5(a)(1) of TSCA. These 
requirements include the information submission requirements of 
sections 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 SNUR notice, EPA may take regulatory action under 
section 5(e), 5(f), 6, or 7 to control the activities for which it has 
received a SNUR notice. 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 those sections for further information.

III. Discussion of Comments and Final Rule

    Almost all public comments on the proposed SNUR for dipropylene 
glycol dimethyl ether (DGDE) were submitted to EPA by the PMN 
submitter. The other comments, which were general in nature and spoke 
to the advantages of the PMN substance over similar products, are 
discussed in Comment 5 and in the EPA Response.
    The comments addressed each requirement of the proposed SNUR and 
also furnished substantial background material in the form of 
toxicological studies and technical information on the PMN substance 
and analogous chemical substances. Nearly all this information had 
previously been submitted to the Agency, considered during the PMN 
review period, and incorporated into the Agency's regulatory decision. 
The results of this toxicological review and analysis are reflected in 
the Agency's risk assessment document, which is part of the public 
record for this SNUR. It is important to note that although the risk 
assessment document does not specifically reference studies submitted 
following the PMN review period, most notably a reproductive toxicity 
study on the PMN substance, these studies were considered in EPA's 
final assessment of DGDE and support the Agency's decision. The 
comments also suggested language for revising the proposed SNUR, 
specifically to have the SNUR apply only to the substance when it was 
manufactured, imported, or processed containing greater than 5 percent 
by weight of the isomer propane 2,2'-oxybis[1-methoxy-. The Agency has 
particularly strong concerns for adverse health effects of that isomer 
and has adopted the above suggested approach in this final rule.
    The proposed rule for DGDE listed the following uses as significant 
new uses that would require notice to the Agency 90 days prior to 
commencement:
    (1) Manufacturing or processing the substance without use of dermal 
protection that provides an impervious barrier to the substance.
    (2) Annual manufacture and importation volume for any domestic use 
greater than 4 times the yearly volume specified in the PMN for the 
substance.
    (3) Use of the substance in a consumer product.
    After careful consideration of all public comments on the proposed 
SNUR, the Agency has decided to issue the final rule with several 
changes from the proposed version. Based upon toxicological and 
background information submitted to the public docket by the PMN 
submitter, the Agency no longer has concerns for use of the PMN 
substance in consumer uses or without a strict requirement for dermal 
protection. In the final SNUR, the significant new uses defined above 
in the proposed SNUR will apply to DGDE only when containing more than 
5 percent of the above mentioned isomer, thereby addressing EPA's 
primary health concerns for the toxicity of the isomer. Accordingly, to 
reflect the Agency's concern for the isomer, the production volume 
limit contained in the proposed rule has been intentionally omitted and 
the Agency is now requiring notice of any volume of the substance as 
defined by this final rule when used either without dermal protection 
or in consumer uses.
    1. Comment. The PMN submitter argues that the dermal protection 
provision is unnecessary since its material safety data sheet (MSDS) 
for DGDE provides adequate warnings and guidance as to appropriate 
protective equipment. In addition, the company stated that its product 
stewardship program and corporate responsibility ethic also obviate the 
need for this provision.
    EPA Response. Hazard communication is not equivalent to, and does 
not ensure, the actual use of protective equipment; it is merely a 
means of encouragement towards that end. The Agency did not take issue 
with the adequacy of the warnings and information on how to protect 
against dermal exposure to DGDE that is contained in the PMN 
submitter's MSDS. It is important to note, however, that the PMN 
submitter's MSDS is in its current form, which EPA now considers 
satisfactory, as a result of glove testing required by the Agency. The 
company's research safety sheet for DGDE, which is the precursor to its 
MSDS, contained no special handling precautions to ensure that 
individuals who might come into

[[Page 59581]]

contact with the substance would use adequate dermal protection.
    The dermal protection requirement is designed to ensure that all 
manufacturers and processors of DGDE, with the isomer of concern 
present at greater than 5 percent, provide workers with adequate 
protection against dermal exposure to the substance. While a company's 
product stewardship program and Responsible Care ethic cannot 
in themselves alleviate the need for this provision, the Agency will 
consider, as explained in the proposed rule, the product stewardship 
program of a future significant new use notice (SNUN) submitter in its 
decision on how to regulate DGDE.
    Ultimately, however, the Agency must ensure that all workers who 
might be exposed to DGDE containing greater than 5 percent by weight of 
the isomer propane 2,2'-oxybis[1-methoxy-, at all potential 
manufacturing sites and downstream locations, are adequately protected, 
not just warned, against its health risks. Hence, the Agency retains 
this provision in the final SNUR as proposed.
    2. Comment. The PMN submitter informed the Agency that the 
company's annual domestic production of DGDE has exceeded 4 times the 
yearly volume specified in the PMN and expects this to continue. The 
comment provides specific information on the quantities of DGDE 
manufactured in the United States solely for export (claimed by the PMN 
submitter as confidential business information), which accounts for the 
exceedance of the volume limit contained in the proposed SNUR. The 
comment also states that the Agency was informed about the company's 
production levels during the PMN review period.
    EPA Response. The limitation on the isomeric make-up of DGDE 
effectively addresses any Agency concerns for risk, regardless of 
ultimate production volume. For more information on the isomeric make-
up of the PMN submitter's DGDE formulation, see the discussion in the 
proposed rule (59 FR 43079, August 22, 1994).
    3. Comment. The PMN submitter states that the Agency has never 
defined under TSCA what a ``consumer use'' is and that, therefore, the 
proposed SNUR provision requiring notice prior to use in a consumer 
product is vague and unenforceable.
    EPA Response. The Agency disagrees with the PMN submitter's 
assertion that ``use in a consumer product'' is a vague concept and an 
inappropriate SNUR provision. Although the Agency may not have 
specifically defined the term ``consumer use'' under TSCA, the 
definitions section for SNURs, 40 CFR 721.3, defines both consumer and 
consumer product. The meaning of ``consumer use'' is clear from the 
definition of these terms.
    Consumer is defined at 40 CFR 721.3 as a private individual who 
uses a chemical substance or any product containing the chemical 
substance in or around a permanent or temporary household or residence, 
during recreation, or for any personal use or enjoyment. Consumer 
product is described as a chemical substance that is directly, or as 
part of a mixture, sold or made available to consumers for their use in 
or around a permanent or temporary household or residence, in or around 
a school, or in recreation. It is plain from reading these definitions 
what the Agency intends when it designates ``use of the PMN substance 
in a consumer product'' as a significant new use. It is the regulated 
community's responsibility to know, through research and development 
activities, market research or other means, whether its products will 
be or are likely to be used in consumer applications. The Agency 
believes it is reasonable to assume that companies have knowledge of 
potential distribution patterns and uses for their products. In 
deciding whether it is appropriate to submit a SNUN to the Agency, a 
company should use a standard based on reasonableness. If the company 
believes or has reason to believe, based on reasonably ascertainable 
information obtained in the course of conducting its business, that the 
substance will or will likely be used by a consumer, they should comply 
with the SNUR requirement. If there is any uncertainty as to the 
provision's applicability in a given case or need for clarification of 
the definitions, the company should contact the Agency for guidance.
    Glycol ethers, like DGDE, are present in many consumer products, 
some of which, like hand lotions, may involve significant contact with 
skin and other types of human exposures. Since the Agency continues to 
have concerns when the use of DGDE in a consumer product may expose the 
general population to a potentially significant health risk, the final 
rule requires submission of a SNUN prior to any use of DGDE, as defined 
by this SNUR, in a consumer product.
    4. Comment. As part of its public comments on the SNUR, the PMN 
submitter provided a substantial amount of information, in the form of 
toxicity studies and background documents, on the potential toxicity of 
the PMN substance and related chemicals. The company believes that the 
Agency has taken a more restrictive approach with DGDE than it has in 
the past with similar PMN substances.
    EPA Response. As stated above, the Agency has decided to limit 
applicability of this restrictive approach only to DGDE with greater 
than 5 percent by weight of the isomer, propane, 2,2'-oxybis[1-methoxy- 
(CAS No. 189354-80-1). Nearly all of the company's toxicological and 
background information was available to the Agency during the PMN 
review period and incorporated into EPA's risk assessment of DGDE, 
which is available in the public record (the risk assessment document 
in the public record, however, has not been updated with studies 
submitted following the PMN review period). While EPA does not intend 
to comment on each toxicity study and background document in this 
response, a brief review of the Agency's hazard assessment of DGDE, 
especially as it compares to similar compounds, should be helpful in 
understanding the regulatory approach selected for this substance.
    In its comments, the PMN submitter mentions two PMN substances--
both propylene glycol monoethers--that were not regulated by the 
Agency. From the standpoint of toxicity, data indicate that the P-
series glycol ethers should be broken down into two groups: secondary 
and primary alcohols. Because of DGDE's isomeric ratio and the way it 
is metabolized, the substance has the potential to form much more 
primary alcohol in vivo (i.e., 2-methoxy-1-propanol, 2-(2-
methoxypropoxy)-1-propanol, and 2-(2-methoxy-1-methylethoxy)-1-
propanol) than is present in the monoethers, which are generally 90-95 
percent secondary alcohol, and 5-10 percent primary alcohol. Available 
toxicity data show that the primary alcohols are more toxic than the 
secondary alcohols.
    The test data provided by the PMN submitter indicate that DGDE's 
potential human health hazard falls between the ethylene glycol ethers 
it will replace, namely, glyme (1,2-dimethoxyethane) and diglyme (1-
methoxy-2-methoxyethoxyethane) and the P-series glycol ethers mentioned 
in the company's comments. The data indicate no observable effects 
levels (NOELs) from the toxicity studies on DGDE, glyme, and diglyme 
are similar, but the effects seen with glyme and diglyme are more 
severe. The toxic effects observed with DGDE and the P-series mono 
glycol ethers are similar, but the NOEL for the P-series mono glycol 
ethers is approximately 10-fold higher, indicating relatively less 
toxicity for the P-series.

[[Page 59582]]

    In other words, if the Agency were ranking the glycol ethers 
currently under discussion according to relative toxicity/hazard, the 
glycol ethers would fall in the following order (from high to low): E-
series glycol ethers like glyme and diglyme; then DGDE, the PMN 
substance; and lastly the P-series glycol ethers, such as those 
referenced by the PMN submitter in its comments. The Agency's risk 
assessments have reflected and have been consistent with this relative 
hazard ranking, allowing for variations in the degree of exposure/use 
patterns, and its regulatory decisions have corresponded as well.
    5. Comment. The PMN submitter and two other commenters, the only 
other parties to address the proposed rule, objected to regulation of 
DGDE because the substance represents an improvement over existing 
glycol ethers in both performance and safety characteristics. They 
believe that the manufacture or commercial availability of DGDE should 
not be restricted in any way.
    EPA Response. While the Agency acknowledges that the PMN 
submitter's DGDE may hold safety advantages over some substances for 
which it is intended to substitute, the extent of this advantage, and 
whether there is an advantage at all, depends in large part on the 
formulation of the substance. Consequently, the Agency has modified the 
proposed SNUR to apply only to DGDE with greater than 5 percent by 
weight of the isomer, propane, 2,2'-oxybis[1-methoxy- (CAS No. 189354-
80-1). Specifically, the ``safer substitute'' qualities of DGDE are a 
function, as mentioned earlier and discussed in the proposed SNUR, of 
the percentage mix of the three isomers of which it is constituted and 
also of the hazard/exposure profiles of the specific potential 
substitutes.

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 proposed date of this rule will have to cease any such 
activity before the effective date of this 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 under 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 rule (OPPTS-
50621B).

VI. Public Record

    The official record for this rulemaking, as well as the public 
version, has been established for this rulemaking under docket control 
number OPPTS-50621B (including comments and data submitted 
electronically). A public version of this record, including printed, 
paper versions of electronic comments, which does not include any 
information claimed as confidential business information (CBI), is 
available for inspection from 12 noon to 4 p.m., Monday through Friday, 
excluding legal holidays. The official rulemaking record is located in 
the TSCA Nonconfidential Information Center, Rm. NE-B607, 401 M St., 
SW., Washington, DC.

VII. Regulatory Assessment Requirements

    Under Executive Order 12866 (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). In addition, this action 
does not impose any enforceable duty or contain any unfunded mandate as 
described in the Unfunded Mandates Reform Act of 1995 (Pub. L. 104-4), 
or require prior consultation with State officials as specified by 
Executive Order 12875 (58 FR 58093, October 28, 1993), or involve 
special considerations of environmental justice related issues as 
required by Executive Order 12898 (59 FR 7629, February 16, 1994).
    An agency may not conduct or sponsor, and a person is not required 
to respond to, an information collection request unless it displays a 
currently valid OMB control number. The information collection 
requirements related to this action have already been approved by OMB 
pursuant to the Paperwork Reduction Act (PRA), 44 U.S.C. 3501 et seq., 
under OMB control number 2070-0012 (EPA ICR No. 574). This action does 
not impose any burdens requiring additional OMB approval. The public 
reporting burden for this collection of information is estimated to 
average 100 hours per response. The burden estimate includes the time 
needed to review instructions, search existing data sources, gather and 
maintain the data needed, and complete and review the collection of 
information.
    In addition, pursuant to section 605(b) of the Regulatory 
Flexibility Act (RFA) (5 U.S.C. 601 et seq.), the Agency has determined 
that the promulgation of a SNUR does not have a significant adverse 
economic impact on a substantial number of small entities. The Agency's 
generic certification for promulgation of new SNURs appears on June 2, 
1997 (62 FR 29684) (FRL-5597-1) and was provided to the Chief Counsel 
for Advocacy of the Small Business Administration.

VIII. 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, the Agency has 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 General Accounting Office prior to publication of this rule in 
today's Federal Register. This is not a major rule as defined by 5 
U.S.C. 804(2).

[[Page 59583]]

List of Subjects in 40 CFR Part 721

    Environmental protection, Chemicals, Hazardous substances, 
Reporting and recordkeeping requirements.

    Dated: October 28, 1997.

Charles M. Auer,

Director, Chemical Control Division, Office of Pollution Prevention and 
Toxics.

    Therefore, 40 CFR part 721 is amended as follows:

PART 721--[AMENDED]

    1. The authority citation for part 721 continues 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; CAS No. 11109-77-4) is subject to 
reporting under this section for the significant new uses described in 
paragraph (a)(2) of this section. This class 2 substance is exempt from 
the notification requirements of this rule if it contains less than 5 
percent by weight of the specific isomer, propane, 2,2'-oxybis[1-
methoxy- (CAS No. 189354-80-1), which is one of the possible products 
of the manufacturing process for PMN P-93-507.
    (2) The significant new uses are:
    (i) Protection in the workplace. Requirements as specified in 
Sec. 721.63 (a)(1), (a)(2)(i), and (a)(3).
    (ii) Industrial, commercial, and consumer activities. Requirements 
as specified in Sec. 721.80(o).
    (b) Specific requirements. The provisions of subpart A of this part 
apply to this section except as modified by this paragraph.
    (1) Recordkeeping requirements. The following recordkeeping 
requirements specified in Sec. 721.125 (a), (b), (c), (d), and (e) 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 section.

[FR Doc. 97-29153 Filed 11-3-97; 8:45 am]
BILLING CODE 6560-50-F