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Citation: 55 Fed. Reg. 17376 1990

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### Federal Register / Vol. 55, No. 79 / Tuesday, April 24, 1990 / Rules and Regulations

ENVIRONMENTAL PROTECTION

AGENCY

40 CFR Part 721

[OPTS-50575; FRL-3658--51 RIN 2070-AB27

Significant New Uses of Certain Chemical Substances

AGENCY: Environmental Protection Agency (EPA). ACTION: Final rule.

SUMMARY: EPAis promulgating 

### significant new use rules (SNUR) under section 5(a)(2) ofthe Toxic Substances Control Act (TSCA) for several chemical substances which were the subject of premanufacture notices (PMNs), and are

now subject to TSCA section 5(e)
consent orders issued by EPA. Today's_ action requires certain persons who intend to manufacture, import, or process these substances for a significant new use to notify EPA at least 90 days before commencing the manufacturing or processing activity designated by this SNUR as a significant

new use. The required notice will provide EPA with the opportunity to evaluate the intended use, and, if
necessary, to prohibit or limit that activity before itoccurs. EPAis promulgating these SNURs using direct final procedures. EFFECTIVE DATE: The effective date of this rule is June 25, 1990.

Comment.IfEPA receives notice before May 24, 1990that someone, wishes to submit adverse or critical
comments on EPA's action in establishing a SNUR forone or more of the chemical substances subject to this rule,EPA will withdraw the SNUR for each substance forwhich the notice of intent to comment is received, and will issue a proposed SNUR providing a 30-' day period forpublic comment. ADDRESSES: Each comment or notice of intent to submit adverse or critical
comments must bear the docket control number [OPTS-50575] and the specific CFR section number for the substance being addressed. Since some comments may contain confidential business information (CBI), all comments should be sent in triplicate.to: TSCA Document Receipt Office (TS-790), Office ofToxic Substances, Environmental Protection Agency, Rm. E-105, 401 M St., SW., Washington, DC20460, Attn: Significant New Use Rules.

Nonconfidential versions of comments

on this rule will beplaced in the rulemaking record and will be available for public inspection. Unit X ofthis 

### preamble contains additional information on submitting comments containing CBI.

FOR FURTHER INFORMATION CONTACT. 

### Michael M. Stahl, Director, Environmental Assistance Division (TS799), Office ofToxic Substances, Environmental Protection Agency, Rm. E-543B, 401 M St., SW., Washington, DC 20460, Telephone: (202) 554-1404, TDD: (202] 554-0551.

SUPPLEMENTARY INFORMATION: This rule 

### describes significant new uses and recordkeeping requirements forcertain persons who intend to manufacture, import, orprocess certain chemical substances designated in the rule. Each ofthe following substances designated in today's rule was the subject of a PMN and a TSCA section 5(e) consent order issued by EPA. The substances are identified by generic chemical names because the specific names have been claimed as CBI (see UnitVII).

PMN Number Chemical Name

P--89-448 (generic) Alkanepolyol phosphate ester P-89-650 (generic) Substituted ethylene diamine, methyl sulfate quatemized P-89-653 (generic) Adipic acid, polymer with 1,4-cyclohexanedimethanol, dipropylene glycol, alkanepolyol, substituted alkanolamines, and carbomonocyclic dicarboxylic acid P-89-703, P- (generic) Reaction products of

89-755, and secondary alkyl amines with a P-89-756 substituted bonzenesuffonic acid and sulfuric acid



### Thisis the first rule EPAhas issued using the expedited procedures and standard significant new use designations established in EPA's recent amendments to40 CFR part 721. (See 54 FR 31308, July 27, 1989.) The preamble to this rule explains in detail the background and rationale supporting the

use ofthe new expedited process. Where appropriate, future rules issued using the expedited process will contain

an abbreviated version ofthis background information but will cross- reference the more complete explanation in the preamble ofthis rule.

I. Authority

Section 5(a)(2) ofTSCA (15 U.S.C. 2604(a)(2)) authorizes EPA to determine that a use ofa 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) ofTSCA requires persons to submit a notice to EPA at least 90 days before they manufacture, import, or process the substance forthat

use.The mechanism for reporting under this requirement is established under 40 CFR 720.10.

II. Objectives and Rationale for Expedited SNUR Process

A. PMNReview andUseofSection5(e) Orders

A limited amount of toxicity data is typically submitted with PMNs. Thus EPA bases its review ofnew substances primarily on structure-activity relationships (SAR). During PMN review, EPAmay determine that "the information available* **is insufficient
to permit a reasoned evaluation ofthe health and environmental effects" ofthe

new chemical substance that is the subject ofthe PMN. At the same time, EPA may determine, under section 5(e)(1)(A)(ii)(I), based on SAR analysis that activities involving the new substance "may present an unreasonable risk of injury to health or the environment." When EPA makes these two findings, it acts under section 5(e) to regulate the activities involving the new substance which contribute to the potential risk.

In most such circumstances, EPA believes that it is appropriate to negotiate an order (known as a "consent order") under section 5(e) with the PMN submitter to control human exposure and/or environmental releases until test data or other information sufficient to

assess adequately the potential hazard become available. Section 5(e) consent orders have specified a variety of control measures, including protective equipment, use limitations, process restrictions, labeling requirements, and limits on environmental release. Some
recent consent orders have included testing requirements that are triggered when specified levels ofproduction volume or other indices ofincreased
exposure are reached; under these orders, the submitter may not exceed the production volume limitation or other restriction imposed by EPA until
test data specified by EPA have been submitted to and reviewed by EPA.

In other instances, during PMN review EPA may determine under section 5(e)(1)(A)(ii)[Il) that a new substance will be produced in substantial quantities and "may reasonably be anticipated to enter the environment in substantial quantities or there is ormay be significant or substantial human exposure to the substance," and that the available information is insufficient to determine the effects ofthe substance. 

### 17376

### Federal Register 

## / Vol. 55, No. 79 / Tuesday, April 24, 1990 / Rules and Regulations

Consent orders issued to address

concerns under section 5(e)(1)(A)(ii)(II) may include recordkeeping provisions and production volume limits.
B. Useof SNURS asaFollow-Up Tool forSubstancesSubject toSection5(e) ConsentOrders

Section 5(e) orders apply only to PMN submitters. When a PMN submitter

commences commercial manufacture of the substance and submits aNotice of Commencement ofManufacture to EPA, EPA adds the substance to the TSCA Chemical Substance Inventory maintained pursuant to section 8(b) of TSCA. When a substance is listed on the Inventory, it is no longer a "new chemical substance" for which a PMN would be required under section 5(a)(1)(A). Thus, under section 5(e) alone other persons would be able to manufacture, import,or process the substance without EPA review and without the restrictions imposed on the •PMN submitter by the section 5(e) order.

EPA uses its SNUR authority to extend limitations in section 5(e) orders to other manufacturers, importers, and processors. This ensures that the original PMN submitters and subsequent manufacturers, importers, and processors are treated in an essentially equivalent manner.These SNURs are framed so thatnon-compliance with the control measures orother restrictions in the section 5(e) consent orders is, defined as a "significant new use." Thus, other manufacturers, importers, and processors ofthe substances must either observe the SNUR restrictions or submit a significant new use notice to 'EPA at least 90 days before initiating activities that deviate fromthese restrictions. After receiving and reviewing such a notice, EPA has the option ofeither permitting the new use
or acting under section 5(e) or (f)to regulate the new submitter's activities.

In addition to assuring that all manufacturers, importers, and processors are subject to similar reporting requirements and restrictions, SNURs for these substances have the following objectives: That EPA will receive notice ofany company's intent tomanufacture, import, or process a chemical substance listed on the TSCA Inventory for a significant new use before that activity begins; that EPA will have an opportunity to review and evaluate data submitted in a SNUR notice before the notice submitter begins manufacturing, importing, orprocessing

a listed chemical substance for a significant new use; and that, when necessary to prevent unreasonable risks, EPAwill be able to regulate prospective manufacturers, importers, or processors of a listed chemical substance before a significant new use ofthat substance occurs.
C.Substances ThatMayRaise ConcernsButAreNotRegulated Under Section5(e)

-

EPA also reviews some new substances that do not warrant action under section 5(e) but merit other follow-up monitoring and evaluation. On the basis oftest data or structureactivity relationships analysis, EPA may identify potential health or environmental effects that could create

a basis for concern if,because of changes inuse and related activities, the substance's exposure orrelease potential later changes or increases beyond that described in the PMN.

In most such cases, EPA believes it is appropriate to use SNUR authority to monitor the commercial development of these substances so that EPA can be apprised ofsignificant increases in
exposure potential, which may warrant control measures ortesting.

D.Rationale forSignificant New Use Designations

To determine what constitutes significant new uses, EPA considers relevant information about the toxicity ofthe substance, likely exposures associated with possible uses, and the four factors listed in section 5(a)(2) of TSCA. EPA designates the significant

new uses ofeach substance based on these considerations.

In cases where significant new use designations are based on provisions in the section 5(e) order, EPA has already made a determination eitherunder section 5(e)(1)(A)(ii)(I) (i.e., that activities involving the substance may present an unreasonable risk ofinjury to health orthe environment), orunder section 5(e)(1)(A)(ii)(II) (i.e., that the substance-may be produced in substantial quantities and may enter the environment in substantial quantities or there may be significant or substantial human exposure). While such a finding is not necessary to promulgate a SNUR. it strongly supports a determination that the uses ofthe substance designated in the rule would be significant new uses of the substance. In this and future SNURs, for each substance subject to a section 5(e) order,EPA will specify the findings that served as the basis ofthe order.

For substances not subject to a section 5(e) order or when EPA believes that SNUR requirements should include provisions which did not appear in a section 5(e) order, the additional provisions will conform to the criteria in 40 CFR 721.170, and the basis for these additional provisions will be explained.

E.ConversionofSection 5(e) Orders IntoSNURS

The standard significant new use designations in subparts B and C of40 CFR part 721 are designed to be consistent with standard provisions for section 5(e) consent orders. Because section 5(e) orders are framed to apply only to PMN submitters, however, minor wording changes may be needed to convert the orders' provisions into generally applicable requirements. Under § 721.160(b), EPA may make such wording changes provided that they do
not depart from the section 5(e) order's substantive requirements. All ofthe SNURs in today's rule are based on recently issued section 5(e) orders, and only minor wording changes are necessary to convert the requirements into SNURs.

Some earlier section 5(e) orders contain provisions thatrequire major wording changes to be converted into SNURs. Where a particular requirement in a section 5(e) order is worded so differently from the corresponding SNUR provision that the basis for selecting the SNUR provision would not otherwise be evident, EPA will provide

an explanation for its choice ofSNUR provisions.

IIL. Applicability of General Provisions

General provisions for SNURs appear under subpart A of40 CFR part 721. These provisions describe persons subject to the rule, recordkeeping requirements, exemptions to reporting requirements, and conditions of advance compliance foruses occurring before the effective date of the final rule. See 53 FR 28358 (July 27, 1988).

EPA has recently amended 40 CFR part 721 by establishing new subparts B, C, and D. See 54 FR 31306 (July 27, 1989). Subpart B establishes standard significant new use designations. Subpart C establishes recordkeeping requirements. Each standard significant

newuse and recordkeeping requirement will apply to a specific substance only if itis cited in the SNUR for that substance. Subpart D contains expedited procedures for establishing significant new use requirements for certain new substances that are regulated under a section 5(e) consent order. Subpart D also contains criteria
to determine whether uses not identified in the PMN ofnon-section 5(e) substances will be considered candidates for a SNUR under expedited procedures. SNURS for specific substances are contained in subpart E. 

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### 17378 Federal Register / Vol. 55, No. 79 / Tuesday, April 24, 1990 / Rules and Regulations

Rules on user fees appear at 40 CFR part 700.

Persons subject to this SNUR must comply with the same notice requirements and EPA regulatory procedures as submitters ofPMNs under section 5(a)(1)(A) ofTSCA. In particular, these requirements include the information submission requirements of section 5(b) and (d)(1), the exemptions authorized by section 5(h)(1), (2), (3), and (5), and the rules in 40 CFR part 720. Once EPAreceives a SNUR notice, EPA may take regulatory action under section 5(e), 5(f), 6, or7 to control the activities on which it has received the SNUR notice. IfEPA does not take action, EPA is required under section 5(g) 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 ofTSCA section 12(b). The rules that interpret section 12(b) appear at 40 CFR part 707. Persons who intend to import a chemical substance identified in a final SNUR are subject to the TSCA section 13 import certification requirements which are codified at 19 CFR 12.118 through 12.127 and 127.28 and must certify that they are in compliance with the SNUR requirements. The EPA policy in support ofthe import certification appears at 40 CFR part 707.

IV. Substances Subject to this Rule

EPA is establishing significant new
use and recordkeeping requirements for the following chemical substances under 40 CFR part 721 subpart E. In this unit, EPAprovides a brief description for each substance, including its PMN number, chemical name (genericname if the specific name is claimed as CBI), CAS number (if applicable), basis for the action taken by EPA in the section 5(e) consent order for the substance (including the statutory citation and specific finding), and the CFR citation assigned in the regulatory text section of this rule. The specific uses which are designated as significant new uses are cited in the regulatory text section of the rule by reference to40 CFR part 721 subpart B where the significant new
uses are described in detail. Where the underlying section 5(e) order prohibits the PMN submitter from exceeding a specified production limit without performing specific tests to determine the health or environmental effects ofa substance, the tests are described in this Unit. As explained further in Unit VI, the SNUR for such substances-contains the same production limit, and, exceeding the production limit is defined

as a significant new use. Persons who 

### intend to exceed the production limit must notify the Agency by submitting a significant new use notice at least 90 days in advance.In addition, this unit describes tests that are recommended byEPA to provide sufficient information to evaluate the substance, but for which

no production limithas been established in the section 5(e) order. Descriptions of recommended tests are provided for informational purposes.

Each ofthese SNURs regulates a chemical substance subject to a section 5(e) order where the finding under TSCA is based solely on substantial production volume and substantial human orenvironmental exposure. In each of these cases, there was limited or
no toxicity data available for the PMN substance, a potentially substantial production volume, and a potentially substantial human or environmental exposure. In such cases, EPA regulates

new chemicals under section 5(e) by requiring certain toxicity tests. For instance chemicals with potentially substantial releases to surface waters would be subject to toxicity testing of aquatic organisms and chemicals with potentially substantial human exposures would be subject to health effects testing for mutagenicity, acute effects, and subchronic effects.

Each ofthese SNURs involves information which has been claimed as CBI. When a generic chemical name appears in thisUnit, the specific name is claimed as CBI. In addition, each ofthe SNURs identified in this Unitinvolves a production limit as a significant new
use.Because theproduction volume limit is contained in the section 5(e) order andhas been claimed as CBI, the regulatory textincorporates the production volume by reference to the section 5(e) order.The procedures for determining whether a specific substance and/or a specific significant

new use which are CBI are covered by a specific SNUR are described inUnit VII.

PMN Number P-89-448 Chemicalname: (generic)Alkanepolyol phosphate ester. CAS number. Not applicable. Effective dateofsection5(e) consent order. October 12, 1989. Basis forsection5(e)order. The Order

was issued under section 5(e)(1)(A)(i) and (ii)(lI) ofTSCA based on a finding that this substance is expected tobe produced in substantial quantities and there may be significant or substantial human exposure. Recommendedtesting:EPA has determined that the results ofa mouse micronucleus assay (40 CFR 798.5395) 

### and a 28-day repeated dose oral study inrats (OECD Guideline No.407), with the following modifications: (a) for all
test doses, a neurotoxicity functional observational battery (40CFR 798.6050), and (b) for the highest test dose group only,histopathologic examination extended to include the testes/ovaries and lungs, plus neuropathology (40 CFR 798.6400) would help characterize possible effects of the substance. The PMN submitter has agreed not to exceed the production volume limit without performing these tests. CFRcitation:40 CFR 721.288.

PMN Number P-89-650

Chemical name: (generic) Substituted ethylene diamine, methyl sulfate quaternized. CAS number. Not applicable. Effective dateofsection5(e)consent order October 23, 1989. Basis forsection5(e) order. The Order

was issued under section 5(e)(1)(A)(i) and (ii)(II) ofTSCA based on a finding that this substance is expected tobe produced in substantial quantities and there may be substantial environmental releases and significant or substantial human exposure Recommended testing:EPA has determined that the results ofan acute algal study (40 CFR 797.1050), acute daphnid study (40 CFR 797.1300), and
acute fish study (40 CFR 797.1400) would help characterize possible effects ofthe substance. The PMN submitter has agreed not to exceed the production volume limit without performing these
tests. CFR citation:40 CFR 721.1082.

PMN Number P-89-653

Chemicalname: (generic) Adipic acid, polymer with 1,4- cyclohexanedimethanol, dipropylene glycol, alkanepolyol, substituted alkanolamines, and carbomonocyclic dicarboxylic acid. CAS number. Not applicable. Effective dateofsection5(e) consent order. October 31, 1989. Basis forsection5(e) order. The Order

was issued under section 5(e)(1)(A)(i) and (ii)(1I) ofTSCA based on a finding that this substance is expected to be produced in substantial quantities and there may be significant or substantial human exposure. Recommendedtesting:EPA has determined that the results of28-day oral (OECD 407), acute oral (40 CFR 798.1175), Ames assay (40 CFR 798.5265), and mouse micronucleus (40 CFR 798.5395) studies would help characterize possible effects ofthe substance. The PMN submitter has

### Federal Register / Vol. 55, No. 79 / Tuesday, April 24, 1990 1 Rules and Regulations

agreed not to exceed the production volume limit without performing these
tests. CFR citation:40 CFR 721.266.

PMN Numbers,P-89-703,.P-89-755, and P491-756
Chemicalname:(generic)Reaction products-of'secondary alkyl amines with

a substituted benzenesulfonic acid and sulfuric acid. CAS numbers:Not applicable. Effective,dateofsection5(e) consent order:October,12, 1989. Basis forsection 5(e)order:The Order

was issued under section 5(e)(1)(A)(il and (ii)(II) ofTSCA based on a finding that each of.these substances is, expected to,be produced in.substantial quantities and there maybesignificant

or substantial human exposure.. Recommendedtesting:EPA. has determined that the results ofa 28-day repeated dose oral study in rats (OECD Guideline No. 407), with the following modifications: (a) for all test doses, a neurotoxicity functional.observationalbattery (40'CFR 798.6050), and (b) for the highest test dose group only, histopathologic examination extended
to include the testes/ovaries and lungs, plus neuropathology (40CFR 79&6400), and a one-species oral developmental toxicity test (40 CFR 79&4900) for each ofthese three substances wouldhelp characterize.their possible.effects. The PMN submitter has.agreed notto exceed the production volume.limits,without performing these tests. CFRcitation:40 CFR 721.295.

V. Direct Final Rule Procedure

EPA is issuing,today's SNURs as direct final rules, as described in 40 CFR 721.160(c)(3) and 721.170(d)(4), This approach reduces the time, relative to notice and comment rulemaking, during which a person may legally engage in a significant new use before' the.SNUR effective date and also conserves EPA

resources while providing an adequate opportunity forpublic comment. For further information on,thisprocedure, refer to the.preamble to EPA's final rule amending part 721 (54 FR 31298,,July 27, 1989).

•Direct final SNURS will go into effect 60 days after the date ofpublication in the Federal.Register, unless; EPA receives a written notice within 30 days. after the date ofpublication.that

someone wishes to make adverse or critical comments on a specific.SNUR. If EPA receives,such a notice, EPA will issue a.notice to withdraw the.direct final SNUR(s) for the specific. substance(s) to which the adverse or critical comments apply..Any person 

### who submits a notice ofintent to submit adverse or critical commentsmust identify the substance and the new use to whichit applies. EPA will not withdraw a SNUR for a substance not identified in a notice. IfEPA receives such anotice, EPA will then propose.a SNUR for the specific substance(s) with

a 30-day comment period.

VI. TestData and Other-Information

EPA recognizes that section 5 of TSCA does not require persons to develop any particular test data before submitting a SNUR notice.Persons are only required to submit testdata in their possession or control and to describe any other data known to orreasonably ascertainable by them.However, EPA suggests potential SNUR notice submitters consider conducting tests that would permit a reasoned evaluation ofthe'potential risks posed by a particular substance when utilized for

an intended use.

EPAhas established production limits in the,section,5(e) consent orders for the substances.that are,subject to this rule. Under the consent orders, the production limit-cannot,be exceeded unless the PMN submitters first submit the results.oftests that would permit a reasoned evaluation of the potential risks posed by these substances. Each such order contains detailed procedures for dealing,with situations where the resulting data are invalid or equivocal,

or show that the substance will present

an unreasonable risk ofinjury under the
exposure limitations in the order. SNURs contain'the same production. limits as the consent orders; exceeding these production limits is defined as a significant new use.

Although SNURs in today's rule contain the same production limits established in the section 5(e): consent orders,,the rule does,not set out requirements for specific testsor protocols. A listing ofthe tests specified in the section 5(e) order for each, substance subject to.today's rule is included inUnit IV. The studies specified in the section 5(e) order may not be the only means ofaddressing the potential risks.of the substance. However, SNUR notices.submitted.for significant new uses without any test data may increase the likelihood that EPA will take action under section 5[e), particularly ifsatisfactory test results have not been obtained from.a prior submitter.

EPA believes it is likely that in most

cases the PMN submitter willconduct the,tests identified in the section 5(e) order.Accordingly, before beginning to conduct a study, a person subject to the SNUR shouldcontact EPA to determine whether the.study has already been produced. EPA encourages persons to, consult with EPA before selecting.a protocol for testing,a substance. As part ofthis pre-notice consultation,EPA will discuss,the test data it believes
necessary to:evaluate.a significant new'

use ofthe substance. Test data should be developed according to TSCA good laboratory practice standards at 40 CFR part 792..Failure to do so may lead EPA
to find.such data-to- beinsufficient to evaluate reasonably thehealth or' environmental effects of the:substance.

SNUR notice,submitters should be

aware that.EPA will be better ableto evaluate SNUR notices which provide detailed information on: (1).Human
exposure and environmental
.release that may result from the.significant new

use ofthe.chemical substances; (2) potential benefits ofthe substances; and (3) information on risks posed by,the substances compared to risks.posed by potential substitutes.
VII. Determining When aSubstance or Use Is Designated in.the.Rule

In some instances, EPA establishes a significant new use set at production volumes which have been:claimed as CBI1. Other informationb, including the specific chemical name of the substance,
may also be claimed CB. EPA has decided it.is appropriate to keep this information confidential to protect the interest of theoriginal PMN submitters

EPA will:reveal whether a specific chemical substance is-subject to one of these SNURs-only to a manufacturer or importer who has shown,a'bona fide intent to manufacture or'import the substance. To establish a bona fide intent,the person must submit the information required under 40 CFR 721.11(b),. EPA will make a determination as to whether the person has established a bona fide intent to manufacture.or importthe substance. If the person has.established a bona fide intent, EPA will inform the person whether the chemical substance is included in the TSCA Inventory and subject to a specific SNUR.

Each ofthese SNURs designates, exceeding a specific aggregate production volume as the significant

new use by reference to 40 CFR 721.80(q). Section 721.80(q) is used'when the specific.volume is identified in the section 5(e) consent order but has been claimed as CBI. EPA promulgated a: procedure to deal with the situation. where a'specific significant new use.is CBI. This procedure appears in40 CFR 721.575(b)(1) and is similar to that in § 721.11 for situations where the chemical identity of the.substance

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### 17380 Federal Register / Vol. 55, No. 79 / Tuesday, April 24, 1990 / Rules and Regulations

subject to a SNUR is CBI. This procedure is incorporated by reference into each ofthese SNURs.

Under the procedure incorporated from §721.575(b)(1), a manufacturer or importer (processors are not affected by the production volume significant new

use unless they are also manufacturing

or importing the substance] must show that it has a bona fide intent to manufacture or import the substance and must identify the specific use for which itintends to manufacture or import the substance. In the case of these SNURs, the use would be the specific aggregate manufacturing and import volume intended by the person. If EPA concludes that the person has shown a bona fide intent to manufacture

orimport the substance, EPA will tell the person whether the production volume identified in the bona fide submission would be a significant new
use under the rule. Since the chemical identities ofthe substances subject to these SNURs are also CBI, manufacturers and processors can combine the bona fide submission under the procedure in § 721.575(b)(1) with that under § 721.11 into a single step.

Ifa manufacturer or importer is told that the production volume identified in the bona fide submission would not be a significant new use, i.e. it is below the level that wouldbe a significant new use, that person can manufacturer or import the substance as long as the aggregate amount does not exceed that identified in the bona fide submission to EPA. If the person later intends to exceed that volume, a new bona fide submission would be necessary to determine whether that higher volume would be a significant new use. EPA is considering whether to adopt a special procedure for use when CBI production

are designated as significant new uses. Under that procedure, if a person showed a bona fide intent to manufacture or import the substance, under the procedure described in § 721.11, the person would automatically be told any production volume that would be a significant new use. Thus the person would not have tomake multiple bona fidesubmissions to EPA for the

same substance to remain in compliance with the SNUR, as could be the case under the procedures in §721.575(b)(1).

VIII. Applicability ofRule to Uses Occurring Before Effective Date ofthe Final Rule

To establish a significant new use, EPA must determine that the use is not ongoing. The chemical substances subject to this rule have recently undergone premanufacture review. In those cases where a section 5(e) order 

### has been issued, the notice submitter is prohibited by the section 5(e) order from undertaking activities which EPA is designating as a significant new use.If a Notice ofCommencement of Manufacture (NOC) has not yetbeen submitted to EPA forthe substance and the substance has not yetbeen added to the TSCA Chemical Inventory, no other person may commence such activities without first submitting a PMN to EPA. Therefore, EPA has concluded that in

cases where EPA has not received a NOC, the uses designated in the SNUR

are not ongoing. Those who submitted the PMNs covered by thisrule have not submitted NOCs for these substances.

However, EPArecognizes that ifa substance identified in a SNUR is added to the Inventory prior to the effective date ofthe rule, the substance may be manufactured, imported, orprocessed by otherpersons for a significant new
use as defined in thisrule before the effective date ofthe rule.

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 ofpublication rather than as ofthe effective date ofthe rule. If the uses which had commenced between the date ofpublication and the effective date 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 substances regulated through this SNUR willhave to cease.any such activity before the effective date of this rule. To resume their activities, these persons wouldhave to comply with all applicable SNUR noticerequirements and wait until the notice review period, including all extensions, expires.

EPA has promulgated provisions to allow such persons to comply with this SNUR before the effective date. If a person were to meet the conditions of advance compliance in 40 CFR 721.45(h), the person will be considered to have met the requirements ofthe final SNUR forthose activities. If persons who begin commercial manufacture, import, or processing ofthe substance between publication and the effective date ofthe 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. IX. Economic Analysis

EPA has evaluated the potential costs ofestablishing significant new use notice requirements for potential manufacturers, importers, and
processors ofthe chemical substances subject to this rule. EPA's complete economic analysis is available inthe public record for this rule.

X. Rulemaking Record

EPA has established a record for this rulemaking (docket control number OPTS-50575). The record includes information iconsidered by EPAin developing this rule.

A public version ofthis record containing nonconfidential materials is available forreviewing and copying from 8 a.m. to 4 p.m., Monday through Friday, except legal holidays, in the TSCA Public Docket Office, located at Rm. NE-GO04, 401 M St., SW., Washington, DC.

Any person who submits comments claimed as CBImust 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 person submitting
comments claimed to be confidential
must prepare and submit a public version ofthe comments that EPA can place in the public file.
XI. Regulatory Assessment Requirements

A. Executive Order 12291

Under Executive Order 12291, EPA
mustjudge whether a rule is "major" and therefore requires a Regulatory Impact Analysis. EPA has determined that this rule will not be a "major" rule because itwill not have an effect on the
economy of$100 million ormore, and it will not have a significant effect on competition, costs, or prices. While there is no precise way to calculate the total annual cost ofcompliance with this rule,EPA estimates that the cost for submitting a significant new use notice would be approximately $4,500 to $11,000, including a $2,500 user fee payable to EPA to offset EPA costs in processing the notice. EPAbelieves that, because of the nature ofthe rule and the substances involved, there will be few SNUR notices submitted. Furthermore, while the expense ofa notice and the uncertainty ofpossible EPAregulation may discourage certain innovation, that impact will be limited because such

### Federal Register / Vol. 55. No. 79 / Tuesday, April 24, 1990 / Rules and Regulations3

factors!are unlikely to discourage: an innovation that has high potential value.

This regulation was submitted to the Office ofManagement and Budget (OMB) forreview asrequired by Executive Order 12291.

A RegulatoryFlexibility Act
Under the Regulatory Flexibility Act (5U.S.C. 605(b)), EPA has determined that this;rule willnot have a significant impact on a substantialnumber ofsmall businesses. EPA has not determined whether parties affected by this rulewill likely be small businesses. However, EPAexpects to receive few SNUR notices forthe substances. Therefore, EPAbelieves that the number ofsmall businesses affected by this rulewill not be substantial, even ifall ofthe SNUR notice submitters were small firms.
C.Paperwork ReductionAct

The information collection 

### requirements contained in this rule have been approved by OMB under the provisions ofthe Paperwork Reduction Act (44 U.S.C. 3501 etseq.), and have been assigned OMB control number 2070-0012.

Public reporting burden forthis collection ofinformation is estimated to vary from 30 to 170 hours per response, with an average of100 hours per response, including time forreviewing instructions, searching existing data
sources, gathering and maintaining the data needed, 6nd completing and reviewing the collection ofinformation.

Send comments regarding the burden estimate or any other aspect ofthis collection ofinformation, including suggestions for reducing this burden, to Chief, Information Policy Branch, PM223, U.S.Environmental Protection Agency, 401 M St., SW., Washington, DC 20460; and to Office ofManagement and Budget,Paperwork Reduction Project (2070-0012), Washington, DC 20503.
List ofSubjects in 40 CFR Part 721 Chemicals, Environmental protection, Hazardous materials, Recordkeeping and reporting requirements, Significant

new uses.

Dated: April 13, 1990. 

### Victor J. Kimm, ActingAssistantAdministrator forPesticides andToxicSubstances.

Therefore, 40 CFR part 721 is amended



### as follows:

PART 721-[AMENDED]



### 1.The authority citation for part 721 continues to read as follows:

Authority: 15 U.S.C. 2604 and 2607. 2. By adding new §721.266 to subpart E to read as follows: 

### §721.266 Adipicacid, polymerwith 1,4- cyclohexane-dimethanol, dipropylene glycol,alkanepolyol, substituted alkanolamlnes, and carbomonocyclic dicarboxylc'acid(generic!name)..
(a) Chemical'substance and significant.newusessubjectta reporting.(1) Thechemical substance identified-generically as adipic,acid., polymer with 1,4

- cyclohexanedimethanol, dipropylene glycol, alkanepolyol, substituted alkanolamines, and carbomonocyclic dicarboxylic acid (PMN P-89--653) is subject to reporting under this section for the significant new uses described in paragraph (a)(2) ofthis section.

(2) The significant new uses are: (i)Industrial, commercial, and

consumeractivities. Uses as specified in § 721.80(q).

(ii) [Reserved] (b) Specificrequirements. The provisions of subpart A ofthis part apply to this section except as modified by this paragraph.

(1)Recordkeeping.The following recordkeeping requirements are applicable to manufacturers, importers, and processors ofthis substance: recordkeeping requirements specified in § 721.125(a), (b), (c), and (i).

(2) Limitationsorrevocationof certainnotificationrequirements. The provisions of § 721.185 apply to this section.

(3)Determiningwhethera specific

useis subjectto thissection.The provisions of §721.575(b)(1) apply to this section. (Approved by the Office ofManagement and Budget under OMB controlnumber 2070- 0012)

3. By adding new § 721.288 to subpart Eto read as follows: §721.288 Alkanepolyol phosphate ester (generic name).

(a) Chemicalsubstanceand significant new uses subjectto reporting. (1)The chemical substance identified generically as alkanepolyol phosphate ester (P-89-448) is subject to reporting under this section for the significant new uses described in paragraph (a)(2) ofthis section.

(2) The significant new uses are: (i)Industrial, commercial, and

consumeractivities.Uses as specified in §721.80(q).

(ii) [Reserved] (b) Specific requirements.The provisions ofsubpart A of thispart apply to this section except as modified by this paragraph. (1) Recordkeeping.The following recordkeeping: requirements are! applicable to manufacturers, importers, and processors ofthis.substance: Recordkeeping requirements specified in §721.125(a), (b,. (c), and (i). (2) Limitationsorrevocationof certain notificationrequirements. The provisions of §- 721.185 apply to this section.

(3)Determiningwhethera specific

use is subjectto thissection,The provisions of §721.575(b](1) apply to this section. (Approvedby the Office ofManagement and Budget under OMB control number2070- 0012)

4. By adding new § 721.295 to subpart E to read as follows: §721.295 Reaction productsof secondary alkyl amines with asubstituted benzenesuifonic acidand sulfuricacid (generic name). (a) Chemicalsubstancesand significant new uses subjectto reporting. (1) The chemical substances identified generically as reaction products of secondary alkyl amines with

a substituted benzenesulfonic acid and sulfuric acid (PMNs P-89-703, P-89--755, and P-89-756) are subject to reporting under this section for significant new

uses described in paragraph (a)(2) of this section. (2) The significant new uses are: (i) Industrial, commercial,and

consumeractivities. Uses as specified in § 721.80(q).

(ii) [Reserved] (b) Specificrequirements.The provisions ofsubpart A ofthis part apply to this section except as modified by this paragraph.

(1)Recordkeeping.The following recordkeeping requirements are applicable to manufacturers, importers, and processors ofthese substances: Recordkeeping requirements specified in §721.125(a), (b), (c), and (i).

(2) Limitationsorrevocationof certainnotificationrequirements.The provisions of § 721.185 apply to this section.

(3)Determiningwhethera specific

use issubjectto thissection.The provisions of §721.575(b)(1) apply to this section. (Approved by the Office ofManagement and Budget under OMB control number 2070- 0012)

5. By adding new §721.1002 to subpart Eto read as follows:
§721.1082 Substitutedethylene diamine, methyl sulfate quatemized (generic name).

(a) Chemicalsubstanceand significant new usessubjectto II 

### 17381

### 17382' Federal Register / Vol. 55, No. 79 / Tuesday, April 24, 1990 / Rules and Regulations

reporting.(1) The chemical substance identified generically as ethylene diamine, methyl sulfate quaternized (P89-650) is subject to reporting under this section for the significant new uses described in paragraph (a)(2) ofthis section.

(2) The significant new uses are: (i)Industrial, commercial,and

consumeractivities.Uses as specified in §721.80(q).

(ii) [Reserved] 

### (b) Specific requirements. The provisions ofsubpart A of thispart apply to this section except as modified by this paragraph.

(1) Recordkeeping.The following recordkeeping requirements are applicable to manufacturers, importers, and processors ofthis substance: Recordkeeping requirements specified in §721.125(a), 

### (b), (c), and (i).

(2)

### Limitationsorrevocationof certainnotificationrequirements.The provisions of §721.185 apply to this 

### section.

(3) 

### Determiningwhetheraspecific

useissubjectto thissection.The provisions of §721.575(b)(1) apply to this section. (Approved by the Office ofManagement and Budget under OMB control number 2070- 0012)
[FR Doc. 90-9466 Filed4-23-90; 8:45 am.]

BILLING CODE 6560-50-D