[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