[Federal Register Volume 59, Number 211 (Wednesday, November 2, 1994)]
[Proposed Rules]
[Page 0]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 94-27102]
[[Page Unknown]]
[Federal Register: November 2, 1994]
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ENVIRONMENTAL PROTECTION AGENCY
40 CFR Part 721
[OPPTS-50611; FRL-4582-2]
RIN 2070-AB27
Dihydro-7a-methyl-1H,3H,5H-oxazolo[3,4-c]oxazole; 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 dihydro-7a-methyl-1H,3H,5H-oxazolo[3,4-
c]oxazole, which is the subject of premanufacture notice (PMN) P-91-
1324. 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 December
2, 1994.
ADDRESSES: All comments must be sent in triplicate to: OPPT TSCA
Document Receipt Officer (7407), Office of Pollution Prevention and
Toxics, Environmental Protection Agency, Rm. E-G99, 401 M St., SW.,
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-50611. 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 dihydro-7a-methyl-1H,3H,5H-oxazolo[3,4-
c]oxazole 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 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 these sections for further information.
III. Background
EPA is proposing to establish significant new use and recordkeeping
requirements for the following chemical name dihydro-7a-methyl-
1H,3H,5H-oxazolo[3,4-c]oxazole. The proposed SNUR designates as
significant new uses:
1. Exposure to the PMN substance without ocular protection
(chemical goggles or equivalent eye protection).
2. Any predictable or purposeful release of the PMN substance to
surface water above 500 ppb (parts per billion).
On August 19, 1991, EPA received a PMN (P-91-1324) for dihydro-7a-
methyl-1H,3H,5H-oxazolo[3,4-c]oxazole. EPA had concerns that the
substance may be a severe eye irritant based on test data available on
other aliphatic amines and oxazoles. Also, based on that data,
irritation to the exposed eye is exacerbated by irrigation. In a letter
to the Company dated December 6, 1991, EPA predicted that releases of
spent metalworking fluids containing the PMN substance could result in
surface water concentrations as high as 16 ppm (parts per million).
Assuming rapid hydrolysis of the PMN substance, the resulting surface
water concentration is expected to significantly exceed the Agency's
level of concern for the hydrolysis product. To mitigate the Agency's
concern regarding aquatic toxicity, the company was required to perform
a 96-h bioassay in algae (40 CFR 797.1050), a 48-h LC50 test in
daphnids (40 CFR 797.1300), and a 96-h LC50 test in fish (40 CFR
797.1400). Based on the results of this information, the Agency would
reassess its surface water concentration estimates for the PMN
substance and its hydrolysis products. The letter also recommended that
each worker exposed to the PMN substance be required to wear adequate
ocular protection once they were allowed to manufacture or import.
EPA has concerns for environmental effects of the PMN substance
based on quantitative structure activity relationships (``QSARs'')
derived from test data on analogous aliphatic amines and oxazoles. The
following ecotoxicity values for the PMN substance were predicted: 307
mg/L for fish 96-h LC50, 19 mg/L for daphnid 48-h LC50, and 21 mg/L for
algal 96-h EC50, and algal chronic value (ChV) = 3.4 mg/L, with a
concentration of concern of 0.200 mg/L.
The Company suspended the PMN review period and conducted the 96-h
bioassay in algae, 48-h LC50 test in Daphnia, and 96-h LC50 test in
fish. The data was completed and submitted to the Agency for validation
and review. The results of the studies were acceptable; however,
suggestions from the Agency in performing the studies were not
followed.
For the aquatic toxicity testing, the Agency recommended that the
PMN substance be tested two ways: The PMN substance added directly to
the exposure vessels and organisms added within 10 minutes, and the PMN
substance tested completely hydrolyzed.
The Company tested the PMN substance two ways, but they did not
test by direct dilution. Direct dilution is adding the PMN substance
directly to exposure vessels without the preparation of a stock
solution. They prepared an aqueous stock solution which they added to
the exposure vessels. Preparing an aqueous stock solution resulted in
some unknown amount of hydrolysis, thus reducing the difference between
the two recommended tests, i.e. unhydrolyzed PMN versus completely
hydrolyzed PMN substance. The Agency accepted the test data, however,
because (1) the unhydrolyzed PMN substance was predicted to be less
toxic than the hydrolysis products of the PMN substance and (2) the
hydrolysis t1/2 (half-life) of the PMN substance appeared to be
much shorter than predicted during the initial review. The results from
the first type, i.e., case (1), of toxicity study were as follows:
Fish 96-h LC50 46.0 mg/L
Daphnid 48-h LC50 34.0
Green algal 96-h EC50 1.33
Fish chronic value (ChV) 5.0
Daphnid ChV 3.0
Algal ChV 1.0
The fish and daphnid ChVs were predicted assuming an acute to chronic
ratio (ACR) = 10.0. In reviewing the studies where complete hydrolysis
had taken place, i.e., case (2), the results were as follows:
Fish 96-h LC50 200.0 mg/L
Daphnid 48-h LC50 100.0
Green algal 96-h EC50 5.8
Fish ChV 20.0
Daphnid ChV 10.0
Algal ChV 4.6
Assessment factor (AsF) 10.0
Concentration of concern (COC) 0.500 mg/L
(ppm)
The fish and daphnid acute toxicity values were predicted by
calculating the difference between the partially and completely
hydrolyzed chemical using test data for green algal 96-h EC50 values,
i.e., a factor of 4.0. The fish and daphnid ChVs were predicted
assuming an ACR = 10.0. No other additional testing was recommended by
the Agency.
The review period inadvertently expired prior to EPA making a final
determination on the PMN substance. The Company stated that they did
not expect to commence manufacturing the PMN substance any time in the
near future, but did not withdraw the PMN from review.
The only releases which may exceed the concern concentration would
occur during use. It was predicted that 99 percent of the PMN substance
would undergo hydrolysis; however, negligible removal of the hydrolysis
products was expected during wastewater treatment. The surface water
concentration of hydrolysis products resulting from releases from large
metalworking shops is the only situation in which EPA expects the
concern concentration would be exceeded.
Based on the completed review of toxicity data on the PMN chemical
submitted to the Agency and the use scenario described in the PMN
application, releases to surface water exceeding 500 ppb would be toxic
to aquatic organisms. Therefore, the issuance of a Non-5(e) Notice and
Comment SNUR requiring the use of ocular protection for workers who
will be exposed to the PMN substance and any releases of the PMN
substance to surface water resulting in surface water concentrations
above 500 ppb would be considered a significant new use.
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 final rule. If
uses which commence between that date and the effective date of the
final rule 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 identified in this SNUR
after the proposed date of the final 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-50611).
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-50611). 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
NCIC 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 all the requirements of the Executive Order
(i.e., Regulatory Impact Analysis, review by the Office of Management
and Budget (OMB)). Under section 3(f), the order defines a
``significant regulatory action'' as an action likely to lead to 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, it has been determined that this 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 determined that
approximately 10 percent of the parties affected by the rule could be
small businesses. However, EPA expects to receive few SNUNs for these
substances. Therefore, EPA believes that the number of small businesses
affected by the rule will not be substantial, even if all of the SNUR
notice 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), U.S. 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: October 25, 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. 721.5540 to subpart E to read as follows:
Sec. 721.5540 Dihydro-7a-methyl-1H,3H,5H-oxazolo[3,4-c]oxazole.
(a) Chemical substances and significant new uses subject to
reporting. (1) The chemical substance dihydro-7a-methyl-1H,3H,5H-
oxazolo[3,4-c]oxazole 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 Sec. 721.63(a)(2)(iii) (data indicate that irritation is
exacerbated by irrigation), (a)(3).
(ii) Release to water. Requirements as specified in
Sec. 721.90(a)(4), (b)(4), and (c)(4) (where N = 500 ppb).
(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 recordkeeping requirements
specified in Sec. 721.125(a) through (e), (i), and (k) 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. 94-27102 Filed 11-1-94; 8:45 am]
BILLING CODE 6560-50-F
