[Federal Register Volume 59, Number 242 (Monday, December 19, 1994)]
[Unknown Section]
[Page 0]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 94-30733]
[[Page Unknown]]
[Federal Register: December 19, 1994]
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ENVIRONMENTAL PROTECTION AGENCY
40 CFR Part 721
[OPPTS-50612D; FRL-4774-9]
RIN 2070-AB27
Alkenyl Ether of Alkanetriol Polymer; 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 generically as an alkenyl ether of
alkanetriol polymer, which is the subject of premanufacture notice
(PMN) P-93-458. 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,
importing, 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 by January 18, 1995.
ADDRESSES: Each comment must bear the docket control number OPPTS-
50612D. All comments should be sent in triplicate to: OPPT Document
Control Officer (7407), Office of Pollution Prevention and Toxics,
Environmental Protection Agency, Rm. E-G99, 401 M St., SW., Washington,
DC 20460. All comments which are claimed confidential must be clearly
marked as such. Three additional sanitized copies of any comments
containing confidential business information (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.
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 P-93-458 for the significant new uses designated
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. On July 27, 1988 (53 FR 28354), and July
27, 1989 (54 FR 31298), EPA promulgated amendments to the general
provisions which apply to this SNUR. In the Federal Register of August
17, 1988 (53 FR 31252), EPA promulgated a ``User Fee Rule'' (40 CFR
part 700) under the authority of TSCA section 26(b). Provisions
requiring persons submitting SNUNs to submit certain fees to EPA are
discussed in detail in that Federal Register document. Interested
persons should refer to these documents for further information.
III. Background
EPA published a direct final SNUR for the chemical substance, which
was the subject of PMN P-93-458 in the Federal Register of October 4,
1993 (58 FR 51672). EPA received adverse comments following publication
for this chemical substance. Therefore, as required by Sec. 721.160,
the final SNUR for P-93-458 is being withdrawn elsewhere in this issue
of the Federal Register and this proposed rule on the substance is
being issued. EPA is not soliciting and will not respond to comments on
any of the other SNURs that were published in the October 4, 1993,
Federal Register because those rules became effective on December 3,
1993, or are being withdrawn and proposed in a separate action. The
supporting rationale and background to this proposal are more fully set
out in the preamble to the direct final SNUR for this substance and in
the preamble to EPA's first direct final SNURs published in the Federal
Register of April 24, 1990 (55 FR 17376). Consult that preamble for
further information on the objectives, rationale, and procedures for
the proposal and on the basis for significant new use designations
including provisions for developing test data.
The SNUR for P-93-458 stated that EPA was concerned for potential
environmental effects of the substance at concentrations as low as 1
ppb (part per billion) (the concern level) based on the submitted test
data and by analogy to nonionic surfactants. The SNUR also stated that
use of the substance as a thickening agent for textile printing does
not present an unreasonable risk due to the fact that the material
would not be released to surface waters at concentrations greater than
1 ppb. As a result, EPA proposed that the significant new use for this
material is any use which may result in release of the substance to
surface waters at concentrations greater than 1 ppb.
The commenter was the submitter of P-93-458. The commenter stated
that the substance is not comparable to nonionic surfactants because
the class of nonionic detergents have different proportions of
hydrophobic and hydrophilic groups and that the determination to
regulate this substance should be based on the data provided within the
PMN. EPA used the toxicity data supplied in the PMN to evaluate the
acute effects of the substance. However, EPA also used data from
chronic toxicity tests on similar chemicals to evaluate potential
chronic toxicity of the substance. The substance is classified as a
nonionic surfactant by EPA because it has the chemical structural
characteristics of nonionic surfactants. The class of nonionic
surfactants which EPA has the most data for are the alcohol
ethoxylates. EPA realized that this approach may overestimate the
toxicity of the substance, but when evaluating potential chronic
toxicity in the absence of chronic toxicity data on the specific
substance, EPA will use the best relevant data set, even if this may
predict higher toxicity, and err on the side of safety rather than
underestimate toxicity. Classifying the substance as a nonionic
surfactant does not assume that the PMN substance will be a strong
detergent.
The commenter stated that on the basis of the acute toxicity
studies provided in the PMN, where no mortality or immobilization were
found in the fish and daphnids, a high assessment factor should not be
used and the maximum environmental concentration of 1 ppb is too
conservative. EPA agrees that no effects were observed during fish and
daphnid acute toxicity tests. However, the hardness of the dilution
water in the acute tests was 250.0 and 246.0 mg/L as CaCO3, for
fish and daphnids, respectively. Hard water is known to decrease the
effectiveness of detergents and surfactants. EPA recommends a hardness
of less than 180 mg/L for freshwater fish, and daphnid acute and
chronic toxicity tests. It is possible that if the hardness of the
dilution water had been less than 180 mg/L, toxic effects would have
been observed. In addition, effects were observed for green algae. EPA
has evaluated toxicity data for chemicals which produce no effects at
saturation during short-term exposures, but do have toxic effects at
longer exposures during the fish early life stage toxicity test and the
daphnid reproduction test. EPA has reviewed the submitted acute
toxicity and its analogue data. Based on predicted chronic toxicity
values of 1 ppm for fish and daphnids, a measured chronic toxicity
value of 1 ppm for algae and an assessment factor of 10, the revised
concern concentration is 100 ppb.
The commenter stated that EPA had not established that release to
surface waters above 1 ppb was indeed a new use. The commenter noted
that a Notice of Commencement (NOC) had been filed for the substance on
June 16, 1993. The commenter and its customers have been using the
substance since that time without the determination required under 40
CFR 721.90(a)(4), (b)(4), and (c)(4). The commenter also stated that
release of the substance to surface waters at a concentration greater
than 1 ppb did not constitute a change in the type and extent of
exposures, production volume, or the manufacturing process specified in
the PMN as required under section 5(a)(2) of TSCA. The commenter
asserted that the data submitted in the PMN does not indicate that the
uses other than that submitted in the PMN may be a significant risk to
the environment.
EPA disagrees with these assertions. Based on information in the
PMN supplied by the commenter, EPA estimated reasonable worst case
water releases during processing and use. None of these estimated water
releases were expected to exceed 1 ppb under even reasonable worst case
assumptions. The basis for the assumptions made by EPA, including the
information in the PMN and EPA's exposure estimates can be found in the
public docket for this substance (OPPTS-50612). If any interested
parties have data demonstrating releases to surface waters above 1 ppb
(or the new concern level of 100 ppb), they should furnish that data
with their comments. The mere fact that an NOC has been received or
that the determination required under 40 CFR 721.90(a)(4), (b)(4), and
(c)(4) has not been made by the submitter or its customers is not
evidence that releases exceeding the concern level have occurred.
EPA identified several other uses for the substance including use
as a paper binder, a flocculation aid for paper manufacturing, and a
surfactant intermediate. In addition, the commenter noted on the PMN
that they intended to import the substance. The commenter or any other
manufacturer could elect to manufacture the substance in the United
States. Any manufacturer, importer, or processor could use or
distribute the substance in commerce for the other uses cited in this
paragraph. If domestic manufacture or the other uses of the substance
occur, it is possible that a change in the projected volume of
manufacturing and processing, the type, form, magnitude, and duration
of exposure, or the reasonably anticipated manner and methods of
manufacturing, processing, distribution in commerce, and disposal could
also occur, resulting in surface water concentrations above the concern
level of 100 ppb.
IV. Substance Subject to This Rule
EPA is proposing significant new use and recordkeeping requirements
for the following chemical substance under 40 CFR part 721.
PMN Number P-93-458
Chemical name: (generic) Alkenyl ether of alkanetriol polymer.
CAS number: Not available.
Basis for action: The PMN substance will be used as a thickening agent
for textile printing. Based on analogy to nonionic surfactants and on
the submitted acute aquatic toxicity data, EPA is concerned that
toxicity to aquatic organisms may occur at a concentration as low as
100 ppb of the PMN substance in surface waters. EPA determined that use
of the substance as described in the PMN did not present an
unreasonable risk because the substance would not be released to
surface waters at concentrations above 100 ppb. EPA has determined that
other uses of the substance may result in releases to surface water at
concentrations above 100 ppb. Based on this information, the PMN
substance meets the concern criteria under Sec. 721.170(b)(4)(iii).
Recommended testing: EPA has determined a chronic 60-day fish early
life stage toxicity test in rainbow trout (40 CFR 797.1600) and a 21-
day chronic daphnid toxicity test (40 CFR 797.1330), where the dilution
water hardness is less than 180 mg/L, would help characterize the
environmental effects of the PMN substance.
CFR citation: 40 CFR 721.3367.
V. 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. Because this
SNUR was first published on October 4, 1993, as a direct final rule,
that date will serve as the date after which uses will be considered to
be new uses. 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
through this SNUR after October 4, 1993, 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 for a proposed 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.
VI. Economic Analysis
EPA has evaluated the potential costs of establishing SNUN
requirements for potential manufacturers, importers, and processors of
the chemical substance at the time of the direct final rule. The
analysis is unchanged for the substance in this proposed rule. The
Agency's complete economic analysis is available in the public record
for this proposed rule (OPPTS-50612D).
VII. 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 the 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.
VIII. Rulemaking Record
EPA has established a record for this rulemaking (docket control
number OPPTS-50612D). 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 20460.
IX. 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, it has been
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 the
substance. Therefore, EPA believes that the number of small businesses
affected by the 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 proposed rule.
List of Subjects in 40 CFR Part 721
Environmental protection, Chemicals, Hazardous materials, Reporting
and recordkeeping requirements, Significant new uses.
Dated: December 1, 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. 721.3367 to subpart E to read as follows:
Sec. 721.3367 Alkenyl ether of alkanetriol polymer.
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified generically as alkenyl
ether of alkanetriol polymer (PMN P-93-458) 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) Release to water. Requirements as specified in
Sec. 721.90(a)(4), (b)(4), and (c)(4) (where N = 100 ppb (parts per
billion)).
(ii) [Reserved]
(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 as
specified in Sec. 721.125(a), (b), (c), 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 section.
[FR Doc. 94-30733 Filed 12-16-94; 8:45 am]
BILLING CODE 6560-50-F
