[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-Hotline@epamail.epa.gov.
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
