Alkenyl Ether of Alkanetriol Polymer; Proposed Significant New Use Rule

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