[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]


-----------------------------------------------------------------------


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.

-----------------------------------------------------------------------

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