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Citation: 49 Fed. Reg. 35011 1984

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-- The search text of this PDF is generated from uncorrected OCR text.Federal Register / Vol. 49, No. 173 / Wednesday, September 5, 1984 / Rules and Regulations 3501

FOR FURTHER INFORMATION CONTACT:. John A.Gwynn, Chief, Grants Policy and Procedures Branch (PM-216), Environmental Protection Agency, Washington, D.C.20460, (202) 382-5268.
SUPPLEMENTARY INFORMATION: EPA implements the OMB Circulars and Federal regulations which establish cost principles forFederal assistance agreements through the EPA's "General Regulation forAssistance Programs" at 40 CFR 30.410. Section 30.410 lists the Circulars and regulations applicable to various types ofrecipient organizations. Section 30.410(c) applies OMB Circular A-122 to nonprofit recipient organizations, except educational institutions.

Section 30.410 does not list the dates that 0MB Circulars and Federal regulations are issued orrevised. Unless

a circular orregulation indicates otherwise, EPA applies the version of the Circular orregulation thatis m effect

on the date an assistance agreement is awarded. The Federal Register preamble for the revised Circular A-122 issued on April 27,1984 (49 FR 18620) specified thatthe revision would affect only agreements awarded afterMay 29,1984, the effective date ofthe revised Circular. Accordingly, EPAwill apply the revised Circular to all assistance agreements awarded after that date.

EPA's general regulationrestricts using assistance funds for advocacy purposes at 40 CFR 30.601. Section 30.601 prohibits the use ofassistance funds for "lobbying orinfluencing legislation before Congress" or "partisan

orpolitical advocacy purposes." For nonprofit recipient organizations other than educational institutions, EPAwill implement this prohibition consistent with § 30.410(c) and the requirements of OMB Circular A-122 as revised.

Dated: August 22.1984. Harvey G. Pippen, Jr., Director, Grants Administration Division.

JFRDoc. 84-23422 Filed9-4-E 8:45 am]

BILUNG CODE 6560-50-M

40 CFR Part721 [OPTS-50501A; FRL-2541-8]
Significant New Uses of Chemical Substances;,Certain Chemicals

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

SUMMARY: EPAis issuing a final significant newuse rule (SNUR) under section 5(a)(2) ofthe Toxic Substances Control-Act (TSCA), 15 U.S.C. 2604(a)(2), to require persons tonotify EPA atleast g0 days before manufacturing, importing, orprocessing potassium NNbis (hydroxyethyl) cocoamme oxide phosphate and potassium N,N-bis (hydroxyethyl) tallowamme oxide phosphate foruse in consumer product formulations containing greater than five percent by weight ofthese substances. These chenucal substances

were the subject ofpremanufacture notices (PMNs) P-82-400 andP-82-409 and a TSCA section 5(e) consent order prohibiting use ofthe substances in

consumer products. Subpart Aof the rule contains general procedural provisions applicable to all SNURs. Subpart Bcontains provisions unique to the two substances. DATES. This rule shall bepromulgated forpurposes ofjudicial review at 1:00 p.m. eastern time on September 19,1984. Tis rule is effective October 19, 194.
FOR FURTHER INFORMATION CONTACT:. Edward A. Klein, Director, TSCA Assistance Office (TS-799), Office of Toxic Substances, Environmental Protection Agency, Rm. E--543, 401 M St.. SW..Washington, D.C. 20460,Toll free: (800-424-9065), InWashington, D.C.. (554-1404), Outside the USA: (Operator202-554-1404).

SUPPLEMENTARY INFORMATION: OMB Control Number 2070-012.

I.Introduction

Section 5(a)(2) ofTSCA authorizes EPAto determine that a use ofa chemical substance is a significant new
use.EPA must make this determination by rule, after considering allrelevant factors, including those listed in section 5(a)(2) ofTSCA. Once ause is determined tobe a significant new use, persons must, under section 5(a)(1)(B), submit anotice to EPA at least 90 days before they manufacture, import, or process the substance for that use.Such

a notice is generally subject to the same statutory requirements and procedures

as a PMN submitted under section 5(a)(1)(A). In particular, these include the information subission requirements ofsection 5(b) and (d)(1). certain exemptions authorized by section 5(h), and the regulatory authorities ofsection 5(e) and (f). IfEPA does not take regulatory action under section 5, 6, or7 to control activities on which it has received a SNUR notice, section 5(g) requires the Agency to explain m the Federal Register its

reasons fornot taking action.

Substances covered by proposed or final SNURs are subject to the export reportingrequirements ofTSCA section 12(b). EPA regulations interpreting section 12(b) requirements appear at 40 CFR Part 707 Substances covered by final SNURs are subject to TSCA section 13 import certification requirements at 19 CFR 12.118 through 12.127 and 127.28 published in the Federal Register ofAugust 1, 1933 (48FR 34734). The EPA policy in support of these requirements appears at40 CFR Part 707 published m the Federal Register ofDecember13,1983 (48 FR 55462).

IL Organization ofThis Rule

A. General

Thisrule establishes a new Part 721 in Title 40 ofthe Code ofFederal Regulations (CFR) which is structured into two major subparts. Subpart A contains proceduralprovisions that apply to this SNUR and will apply to all SNURs. Since theseprovisions would otherwise be repeated in each SNUR applying tospecific chemical substances, the Agency decided to promulgate Subpart A. Infuture SNURs the provisions ofSubpart Awill apply unless modified m the particular SNUR
at that time.

Subpart Bwill contain the specific chemical substances and significant

new uses forthose substances as each SNUR ispromulgated, including modifications ofthe Subpart A provisions for specific substances for which the general provisions ofSubpart A areinappropriate. At tls time, Subpart B consists of§721.575 which identifies two chemical substances and the significant new use ofthose substances discussed in Unit V ofthis preamble.

The structure ofPart 721 in two subparts was originally proposed in the Federal Register ofNovember 26,1980 (45 FR7970). Those sections which appear in Subpart A ofPart721 have been proposed either individually or collectively and discussed in the Federal Register aspart ofa number of individual SNUR proposals. In adopting Subpart A, EPA has consideredpublic
comments submitted on the procedural aspects ofall SNURs proposed to date. However, the Agency will consider any further comments which are submitted regarding theprovisions ofSubpart A.

B. Organization of

Subpart A Subpart A codifies the general procedures forreporting on significant

new uses.The subpart contains nine sections whlch are summarizedbelow.

1.Section 721.1 describes the scope and applicability ofPart721. This section explains the interrelation of Subparts A and Band the relationship ofPart 721 to the PMN rules m Part 720. The section also states that. where the

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provisions ofParts 721 and 720 conflict, Part 721 controls. Similarly, ifSubparts A and B conflict, Subpart B will govern.

2. Section 721.3 contains definitions applicable to significant new use reporting. Generally, the definitions in section 3 ofTSCA and those contained in the PMN rules will apply to SNUR reporting. Additional definitions have been provided in §721.3 where no PMN definition exists or where the existing PMN definitions are inappropriate for SNUR reporting. As new definitions are considered forparticular substances and significant new uses, they will be proposed as additions to Subpart A or B

as required.

3. Section 721.5 contains the general scheme for determining who must report

on significant new uses. EPA has chosen the most inclusive requirements for reporting consistent with section 5(a)(1)(B) ofTSCA. There will be occasions, such as with the rule being codified here at §721.575 m Subpart B, where the Agency will not require reporting from each ofthose persons specified in § 721.5. In cases such as these, EPA will promulgate specific language, such as is contained in §721.575, to narrow the scope of the Subpart A requirements.

Section 5(a)(1)(B) ofTSCA requires
persons to submit a SNUR notice to EPA 90 days before they manufacture, import, or process a substance for a significant new use. Therefore, the language of §721.5 makes clear that manufacturers, importers, and
processors are subject to SNUR notice requirements.

Section 721.5 is designed to cover a variety of situations. Paragraph (a)(1) requires manufacturers, importers, and
processors who intend to engage in a designated significant new use to report. Paragraph (a)(2) requires manufacturers, importers, and processors who are themselves not commencing a significant new use, but who intend to distribute a substance subject to a SNUR in commerce, to submit a significant new use notice unless: (1) They do not have a reasonable belief that their customers intend to engage in

a significant new use without submitting the required notice and (2) they can document that they have notified their
customers that the substance is subject
to a SNUR. EPA adopted this provision because the Agency concluded that ifa manufacturer, importer, or processor of

a chemical substance subject to a SNUR distributes the substance in commerce (unless the manufacturer, importer, or processor has complied with the two provisionh specified above), that person "intends" the significant new use to take place, even ifit does not know whether its customers intend to engage in the significant new use.Therefore, EPAhas provided, under §721.5(a)(2), the means by which persons who manufacture, import,process, or distribute the substance in commerce but who donot intend to commence a significant new
use may demonstrate that they lack this intent by compliance with the two provisions specified above. The term "customer" is defined m §721.3.

Section 721.5(b) provides that a processor who engages in a significant

new use isnot required toreport ifit can document that it has a reasonable belief that the substance intended to be processed is not subject to a SNUR. Examples ofsuch documentation include: (1) A letter from a supplier assuring thepurchaser that the substance is not subject t. a SNUR, (2) a written response from EPA to a bona fideinquiry made under §721.6 indicating that the substance in question is not subject to a SNUR, and (3) written eviaence (such as that which would be submitted with a bona fide inquiry under §721.6) which demonstrates that the chemical structure ofthe substance
in question would not be included in the specific orgeneric chemical name identified in Subpart B ofPart 721. This provision is consistent with paragraph (a)(2) to ensure that a significant new
use notice is submitted by a person who actually intends to engage in a significant new usebefore that use takes place.

Section 721.5(c) provides that ifa manufacturer, importer, or processor laterhas a reasonable beliefthat a customer is processing the substance for

a significant new use without submitting

a significant new use notice, the manufacturer, importer, orprocessor must submit a notice unless it ceases supplying the substance to the processor,notifies EPA enforcement authorities, and does not resume supplying the substance to the processor until all required significant new use notices have been submitted to-EPA and the notice review periods have run withoutregulatory actionby EPA. This section ensures that there willbe no intentional violations ofSNURs afterthe manufacture, import, orprocessing ofa substance identified in Subpart BofPart 721 has begun.

EPA believes that this approach will result in maximum compliance with SNURs because it clearly sets out the relative responsibilities of manufacturers, importers, and processors forreporting under section 5(a)(1)(B) ofTSCA.

EPA has received comments on the issues ofwho should be required to submit a significant new use notice and who should be liable forfailure to submit a notice. EPA believes section 5(a)(1)(B) ofTSCA clearly provides that manufacturers, importers, and processors are liable for submission of notices when they manufacture, import,

orprocess a substance for a significant

new use. Some comments stated that manufacturers should not be held responsible forthe failure ofa processor to file a SNUR notice. Commenters also stated thatEPA could not require manufacturers to inform their customers that their products are subject to SNUR reporting (or that they should be required to so so only when the chemical identity is confidential). Rather thanmake amanufacturer, importer, or processor liable when a customer processes a substance for a significant

new use without submitting a significant

new use notice to EPA, EPAis promulgating a scheme intended to

ensure good faith compliance with SNURs by enabling those persons who distribute a substance subject to a SNUR in commerce (but who do not themselves commence a significant new use) either to submit a notice or to inform their customers ofthe SNUR.

Section 721.5(d) provides that any significant new use notice submitted by

animporter must be submitted by the principal importer. The rationale for doing so is the same as for the requirement in the PMN rule, "Principal Importer" is defined in §721.3 and Is very similar to the definition in the PMN rule §720.3(z). The definition has been modified for this rule to apply to SNURs rather than new chemical substances. For a detailed explanation ofthe principal importer concept and Its application, see the preamble to the PMN rule published in the Federal Register ofMay 13, 1983 (48FR 21726 and 21727).

4. Section 721.6 contains procedures fordetermining whether a chemical substance is subject to a SNUR when the substance is identified by a generic chemical name in Subpart B.This section allows any person who intends to manufacture, import, orprocess a chenucal substance described by a generic chemical name in Subpart Bto askEPA whether their chemical substance is subject to a SNUR. The process for doing so is very similar to theprocess required for manufacturers and importers to show a bona fide intent to manufacture orimport under 40 CFR 710.7(g)(2) ofthe Inventory Reporting Rules and 40 CFR 720.25(b)(2) ofthe Premanufacture Notification Rules as published in the Federal Register ofMay 13, 1983 (48 FR 21722). In instances such

as this SNUR, where the two chemical

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substances are specifically identified, the provisions of §721.6 will not apply.

Section 721.6 allows manufacturers, importers, and processors to determine whether they are subject to SNURs while protecting confidential business information (CBI) from unnecessary disclosure. EPAproposed several SNURs in winch the specific chemical identities ofthe substances involved

were claimed as confidential by the submitters of the PMNs forthose substances. In the proposals, EPA identified the substances involved by generic chemical names and PMN numbers. After considering comments

on theseproposals, EPA has concluded that, ingeneral, it will not be necessary to reveal the specific chemical identities ofsuch substances during the rulemaking or in the final rules. However, in future SNURs, EPAwill continue to consider on a case-by-case basis whether disclosure ofspecific chemical identity is necessary.

5. Section 721.7 explains the applicability ofTSCA section 12 and section 13 requirements forexports and imports ofsubstances subject to SNURs. These requirements are summarized in Unit I oftispreamble.

6. As discussed in previously proposed SNURs, and as §721.10 provides, SNUR notice submitters must

use the PMN form and follow the PMN procedures which have been codified in Part720. In specific SNURs, such as this

one,EPA may modify the form requirements to avoid collecting information not relevant to review ofthe significant new use. The Agency will process the notice according to the procedures in Part 720 except to the extent these may be modified in specific additions to Subpart B.

EPA willissue a summary ofeach notice in the Federal Register under section 5(d)(2). The review period for the notice will run90 days from EPA's receipt ofthe notice. Under section 5(c), this periodmay be extended up to an additional 90 days forgood cause. The submitter may notmanufacture, import,

orprocess the substance for the significantnew use until the review period, including extensions, has expired.

The Agency mayregulate the substance during the reviewperiod. Ifa significantnew use notice is submitted for a chemical substance without information sufficient tojudge the toxicity and exposure potential ofthe substance, EPAmay issue a section 5(e) order limiting orprohibiting the use until sufficient information is developed. In addition, section5ff) authorizes EPA to prohibit a significant new use that presents or will present an unreasonable risk to health orthe environment. EPA may also refer information In a SNUR notice to other EPA offices and other Federal agencies. IfEPA does not take action under section 5, 6,or7 to control activities forwhich ithas received a significant new use notice, section 5(g) requires the Agency to explain in the Federal Registerits reasons for not taking action.

Section 721.10(b) allows two ormore persons who are required to submit a notice for the same chemical substance and significant new use to submit ajoint notice toEPA. EPAbelieves that in many cases a manufacturer and a processor may work together to develop

a significant new use and that each would have information important to the assessment of the use. However,EPA does not want to receive duplicative information and wishes to avoid the burden on the submitters ofsuch duplication. Accordingly, §721.10[b) provides that ajointnotice can be submitted as long as it contains all information that either person is required to report. Ajointnotice maybe

a single submission signed byboth parties or coordinated separate submissions by both parties.Both parties would remain liable individually forfailure to submit required information in the jointnotice, including information which isknown to or reasonably ascertainable by them and test data in their possession or controL

Section 721.10(d) makes clear that a person submitting a significant new use notice cannot manufacture, import, or process the substance forthe significant

new use until the notice review period, including all extensions and suspensions, has expired. As with PMNs, EPA expects that significant new
use notice submitters may,on occasion. suspend the notice review period, in accordance with § 720.75[b) ofthe PMN rule which applies to SNURs under §721.10(c), to give the submitter sufficient time to meet concerns raised by EPA during review.

7 Section 721.13 establishes enforcement and compliance provisions for SNURs which have been discussed in previous SNUR proposals.

Itis unlawful for anyperson tofail or refuse to comply with any provision of section 5 ofTSCA or any rule promulgated under section 5. Manufacture, import, orprocessing ofa chemical substance for asignificant new
usewithout prior submission ofa SNUR notice is a violation ofsection 15 of TSCA.

Section 15 also makes it unlawful for any person to:

a. Use for commercial purposes a chemical substance or mixture winch such person knew orhad reasonto know was manufactured, processed, or distributed in commerce in violation ofa SNUR.

b. Fail orrefuse topermit entry or inspection as required by section 11of TSCA.

c.Fail orrefuse topermit access to or copying ofrecords, as required by
TSCA.

Violators may be subjectto vanous penalties and toboth crminal and civil liability. Persons who submitmaterially misleading or false information in connection with therequirement ofany provision ofa SNUR maybe subject to penalties calculated as iftheynever filed their notices. Under thepenalty provision ofsection 16 ofTSCA. any person who violates sectiQn 15 could be subjectto a civil penalty ofup to $25,000 for each violation. Each day ofoperation inviolation could constitute a separate violation. Knowing orwillful -violations ofa SNUR could lead to the unposition ofcriminal penalties ofup to one yearof imprisonment. Other remedies are available toEPA under sections 7 and 17 ofTSCA such as seeking an injunction torestraniviolations ofa SNUR and the seizure ofchencal substances manufactured, imported, or processedin violation ofaSNUR.

Individuals, as well as corporations, could be subject to enforcement actions. Sections 15 and 16 ofTSCA apply to "any person" who volatesvarious provisions ofTSCA. EPAmay,atits 'discretion, proceed against individuals

as well as companies. Inparticular,EPA
mayproceed against individuals who report false information orcause itto be reported.

8. Section 721.17 establishes general recordkeeping requirements forSNUR notice submitters. Theseprovisions require the maintenance of documentation ofthe information contained ma SNUR notice fora period offive years following the dateofthe notice submission. These provisions are consistent withthose required ofPMN submitters in §720.78 in the

### P MN rule, and theAgency believes they should apply to SNURnotice submitters to

ensure compliancewith thenotice requirements.

9. Section 721.19 establishes general exemptions to significant new use reporting requirements. Under this approach, persons who manufacture, import, or process chemical substances identified in Subpart B will notbe subject to the reporting requirements for significant new uses underthe following circumstances:

a. Theperson has applied for andhas been granted an exemption for test

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marketing the substance for the significant new use in accordance with section 5(h)(1) ofthe Act and §720.38,of the PMN rule.

b.The person manufactures, imports,

or processes the substance in small quantities solely for research and development in accordance with section 5(h)(3) ofTSCA.

c.The person has applied for and been granted an exemption under section 5(h)(5) ofTSCA.

d.The person manufactures, imports,

orprocesses the substance only-as an impurity.

e. The person manufactures, imports,

orprocesses the substance only as a byproduct which is used only by public

or private-orgamzations that: (1) Bum it

as a fuel, (2) dispose ofit as a waste, including m a landfill orfor enriching soil, or (3)extract component chemical substances from it for commercial purposes.

f.The person imports orprocesses the substance as part ofan article.

g.The person manufactures or processes the substance solely for export and, when distributed m commerce, labels the substance in accordance with 

### sction 12(a)(1)(B) of TSCA.

The first three exemptions come directly from section 5(h) ofTSCA. On May 13, 1983, EPA issued itsfinal premanufacture notification rules (40 CFR Part720), including §720.36 which contained detailed rules for the section 5(h)(3) exemption forchemical substances manufactured orimported M" small quantities solely for research and development. In the FederalRegister of September 13, 1983 (48FR 41132), EPA stayed the effectiveness of §720.36, among other provisions ofthe PMN rule, pending further rulemaking torevise the provisions. Because §720.36 is not m effect,.EPA will rely on the general definition of "small quantities solely for research and development" in §720.3(cc) and section 5(h)(3) ofTSCA to determine whether a manufacturer, importer, orprocessor qualifies under this exemption. Upon promulgation ofa revised §720.36, EPA intends to amend §721.19(b) to adopt the provisions ofthe revised §720.36.

Section 721.19 also contains exemptions from reporting when the person manufactures, inports, or processes the specific substances as byproducts orimpurities to conform to similar exemptions m the PMN rule (see §720.30 (g)and (h)(1), respectively, of the PMN rule). Persons are also exempt when they import orprocess the specific substances as part ofan article because EPAbelieves thatpeople and the environment will generally not be exposed to substances in articles. However, for specific significant new
uses ofspecific chemical substances, EPA may decide to eliminate one or all ofthese three exemptions ifEPA decides thatreview under a SNUR is warranted for specific substances as impurities orbyproducts orin articles.

EPA has also exempted persons from reporting when they manufacture or process the specific substances solely for export from the United States.While EPA might be concerned about worker exposure or environmental release during manufacture and processing of substances solely for export, section 12(a) ofTSCA exempts substances manufactured, pro-cessed, or distributed in commerce solely forexport from regulation under section 5(a)(2) unless EPA finds that the activities willpresent

an unreasonable risk ofinjury to health

or the environment in the United States. Inmost cases for SNURs, especially for PMN substances which have not been tested, EPA believes it will not have made a "will present an unreasonable risk" finding and, thus, could not

overcome the section 12(a)bar. In cases where the significant new use of

concern would mvoive activities which

occur only outside the United States, EPA would not havejurisdiction.

The PMN rule defines the term "manufacture solelyfor export" in §720.3(s) ("manufacture" includes import) which specifies that sucha substance cannot be used in the United States. Section 721.3 ofthis rule defines the term "process solely for export" in a similar fashion. Processing mustbe performed at sites under the control of the processor, distribution in commerce is limited to purposes ofexport, and the substance may not be used by the

- processor other thanm small quantities solely for research and development. In addition, forboth manufacture and processing, the substance mustbe labeled in accordance with section 12(a)(1)(B) ofTSCA when distributed in

commerce. If aperson manufactures or processes a substance both for export and for use in the United States, such manufacture orprocessing is not "solely for export" because the substance is manufactured orprocessed for use in the United States.
C. Organization of

Subpart B Subpart BofPart 721 will identify the specific chemical substances and significant new uses subject to reporting.In addition, this subpart will contain additional requirements or modifications ofSubpart Arequirements and procedures necessary for specific substances. At this time, Subpart B contains only §721.575 which identifies two chemical substances and significant

new uses which are the subject ofthis rulemaking, as well as provisions specifically applicable to the two substances.

The Agency believes that there may be circuitstances that will lead to the modification ofthe significant new use descriptions containedin Subpart B. When a significant new use notice Is submitted, EPA will review the use to determine whether any regulatory action is necessary. Iffollowing its review, EPA allows the use to occur, the Agency will consider amending the SNUR to modify or eliminate the significant new
use description ifit finds that a change is warranted or that further notice of that use under a SNUR is not warranted. EPAmay also amend Subpart B to eliminate or modify other use descriptions ifit determines, based on data available to EPA, that a substance

no longer presents health or environmental concerns for those uses. I. Background ofSubstances Subject to Specific SNUR

The two chemical substances covered by §721.575 were the subject ofPMNs, They are potassium N,N-bis

- (hydroxyethyl) cocamine oxide phosphate, which was the subject ofP82-400 and potassium N,N-bis (hydroxyethyl) tallowamine oxide phosphate, which was the subject ofP82-409. For convenience, the chemical substances will bereferred toby their PMN numbers in this preamble.

On June 1 and 2,1982, EPA received
two PMNs which the Agency designated

as P-82-400 and P-82-409. EPA announced receipt ofthe two PMNs in the Federal Register ofJune 11, 1982 (47 FR 25401). The notice submitter stated In the PMNs that the substances, which are amphoteric surfactants, will be used primarily in industrial cleaning products and could be used in general purpose cleaners and in personal care products. The PMN submissions included test data for acute oral toxicity and eye and skin irritation. The two substances were tested for skin and eye irritation potential at concentrations of45 to 50 percent using rabbits. The reported primary skin irritation scores were 6.05 forP-82-400 and 6.12 forP-82-409 (with 8 the maximum possible score). The reported ocular irritation scores for the substances ranged from 5.8 to 42.2 forP82-400 and 37.0 to 103.3 forP-82-409 (with 110 the maximum score). Based on these results, EPA concluded thatboth substances are severe primary skin and eye irritants at concentrations of45 to 50 percent. In addition, the substances may be severe primary skin and eye irritants

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at lower concentrations. A more detailed analysis ofthe possible health hazard posedby the substances appears in the section 5(e) consent order for these substances wich is included in the record for this rulemaking.

The PMNs contained no data for eye and skin irritation at lower concentrations that are likely to be found in consumer products. Since irritation effects ofrelatively low concentrations were not known and could notbereliably estimated from the available data,EPA concluded that information available to the Agency was insufficient to permit a fully reasoned evaluation ofpotential health effects of the two substances at the lower concentrations. EPA further determined that, in the absence ofsufficient information to make such an evaluation, the two substances may present an unreasonable risk ofinjury tohuman health.

Based on these findings, EPA negotiated a section 5(e) consent order with the notice submitter.The order became effective on September 14,1982, and prohibited the notice submitter from manufacturing, processing, or distributing either P-82-400 or P-82-409 foruse as a "consumer chemical." The order defined "consumer chemical" as "any chemical which is (1) sold or made available directly toconsumers fortheir
,use; or (2)present ina solution, mixture, suspension, or gelatinwhich is sold or made available to consumers for their use." In addition, the orderprohibited the notice submitter from manufacturing, processing, or distributing eitherP-82- 400 orP-82-409 unless amaterial safety data sheet (MSDS) was distributed to each vendee or other recipient ofthe substances. The order required that the MSDS state that the substances were not to be manufactured, processed, or distributed for use as consumer chemicals. In addition, the notice submitter stated thatthe MSDS would: (1) Warn thatpreliminary screening suggested that the substances may
cause severe skin and eye irritation and (2)recommend the use ofprotective gloves and eye protection by workers who may be exposed to the substances.
IV. Reasons for Issuing Tis SNUR

As stated above, EPAissued a section 5(e) consent order to prohibit manufacture ofthe two substances for

use as consumer chemicals pending development offurther information on the substances' potentialhealth effects; however, the terms ofthe order apply only to the notice submitter. Since the notice submitter commenced commercial manufacture ofthe substances forindustrial use and submitted anotice ofcommencement of manufacture to EPA, the Agency added the substances to the TSCA Cheucal Substance Inventory. Once a substance has been added to the Inventory, any person may manufacture, import, or process the substance forany use.For tlus reason, in the Federal Registcr of February 17,1983 (48FR 7142), EPA proposed designating use ofthe substances as consumer chemicals a significant new use so that the Agency could review such use before itoccurs.

Since proposal ofthis SNUR, EPA received a second set ofdata from tests performed by the notice submitter on these substances. These data indicate that, when tested at concentrations of five percent by weight, the substances

are minor eye irritants and not irritating to the skin ofrabbits. The results of these studies have mitigated EPAs

concerns for use of these substances in

consumer products at concentrations less than or equal to five percent by weight. Accordingly, EPAis now adjusting the definition ofsignificant

new use torequire reporting by processors only when these substances will be used in consumer products at concentrations greater than five percent by weight. These data submissions have been added to the record ofthis rilemaking.

EPA considered otherpossible approaches. One alternative approach

was not to place the substances on the Inventory while the section 5(e) order

was in effect. One commenter disagreed with this option. Under this approach, because the substances would not be on the Inventory, another person would have to submit a PMN ifthatperson intended to manufacture the substances for any use, even an industrial use about which EPAhas little concern. EPA rejected this alternative as being overly broad and inconsistent with its Inventory policies.

Another alternative was to promulgate a section 8(a) reporting rule for the substances. Under such a rule, EPA could have required any person to report toEPA before manufacturing, importing, orprocessing the substances for use as a consumer chermcal. Because the substances were subject to a section 5(e) order,the small business exemption of section 8(a) would not have applied. However, ifEPA received a report under section 8(a) indicating that aperson intended to manufacture, import, or process the substances for use as a
consumer chemical, the Agency could not take immediate action under section 5(e) as itcan under a SNUR and thus would not be able toregulate the substances pending development of information ofeffects of the substances
at concentrations being formulated. Tins approach would have allowed
unnecessary risks to human health during the time needed fordata development.

TheAgency also considered withdrawing the proposed ruleafter receiving the data which indicated that these substances would present little or

norisks to human health at concentrations offive percent orless. The Agency considered tus alternative because the PMN submitterhad indicated thatithad no forseeable plans for use ofthese substances in consumer products at concentrations greater than five percent byweight. However, the Agency cannotbe confidentthat other manufacturers orprocessors vll not recommend the use ofthese substances in consumer products athigher concentrations. Therefore, theAgency believes the approach ithas selected is

more appropriate.

Inresponse to the proposed SNUR,

some commenters stated that other Federal agencies, namely theFood and Drug Administration andthe Consumer Product Safety Commission. already effectively control the risks ofconcern in this instance. One commenter suggested that section 9 ofTSCA needed to be invoked affirmatively to retain EPA'sjurisdiction ofcases such

as thesewhere a number ofFederal agencies may sharejurisdiction. The Agency disagrees with both ofthese
comments. EPA believes that Congress intended TSCA to provide the Agency with the necessary authority to prevent

or controlrisks posedby new chemical substances which have many useful applications not specifically excluded from TSCAjurisdiction by Congress, Including uses in consumer products. In instances such as these, several Federal agencies may have complementary, not exclusive, roles. EPAbelieves this is consistent withCongress' intent andwill continue to review new substances wich may presentunreasonable risks and act to control those risks when appropriate. Ininstances where EPA believes another agency is more properly suited to evaluate and control a specific risk.it may then refer that case to thatAgency. Generally, section 9 of TSCA does not apply to SNURs. A referral under section 9occurs only when the Agency makes a finding that

an activity "presents orwillpresent an unreasonable risk." The Agency does
notmake such a findingin a SNUR rulemaking.

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V Significant New Uses Subjectto Reporting

To determine what would constitute a significant new use ofthese chemical substances, EPA considered relevant information about the toxicity ofthe substances and likely exposures associated with possible uses as well as the four factors listed m section 5(a)(2) ofTSCA. Inparticular, EPA considered the extent to which potential uses may affect human exposure.Based on these considerations, EPAhas decided to define "use m a consumer product m formulations contaimng greater than five percent by weight" as a significant

new use ofP-82-400 and P-82-409.

The Agency has defined "consumer product" as "any chemical substance wluch is directly, or as part ofa mixture, soldor made available to consumers for their use in or around apermanent or temporary household orresidence, m or around a school, or mrecreation." This definition of "consumer product" is consistent with the definition of "consumer product" in the Consumer Product Safety Act, 15 U.S.C. 2051. Because this definition is unique to the circumstances of these two substances, the Agency has included itin §721.575

as a supplement to the definitions in §721.3 of Subpart A. Examples of chemical substances present in a mixture which is sold ormade available toconsumers for theiruse include substances used as surfactants in household all-purpose cleaners, rug shampoos, orlaundry detergents which

are sold ormade available to

consumers. In this rule EPA defines "6consumer"as a natural person who

uses products forpersonal rather than business purposes.

In response to comments, the Agency has made slight changes m the significant new use description from the proposed language. These changes are not intended to alter the meaning or spirit of the proposed language, only to simplify the description. EPA's basis for this significant new use determination is explained below.

EPA believes that the use ofP-82-400

or P-82-409 in a consumer product in concentrations greater than five percent by weightmay change the duration and type ofexposure relative to the likely exposures associated with the nonconsumer uses allowed under the section 5(e) consent order.The largest identified market forthe substances for which manufacture has been permitted under the section 5(e) order isuse in industrial cleaners containing alkaline materials such as caustic (sodium hydroxide), ammonia, or metasilicates. Industrial workers are believed to have experience m the safe handling of substances ofthisnature. Because of the presence ofalkaline material, these products will generally carry labeling which warns ofpotential skin and eye irritation. This labeling will further encourage the use ofprotective equipment to limitpotential exposure to the substances during industrial use.

The PMN submitter indicated thatP82-400 and P-82-409 could be used in

consumer products such as liquid soaps, household all-purpose cleaners, rug shampoos, scouring pads, oven and pot and pan cleaners, and laundry detergents. Use ofmay ofthese products would involve direct contact with the skin. Users ofconsumer products are not likely to expect products such as liquid soaps, household all-purpose cleaners, rug shampoos, and laundry detergents to

cause severe eye or skin irritation. Thus, the likelihood ofeye and skin exposures is greater since users ofhousehold products are unlikely to take the same precautions as do workers using industrial cleaners. In addition, any use ofthese substances in consumer products could expose far more people to the substances. Users of these

consumer products would constitute a different, much larger segment ofthe general population than the workers potentially exposed to industrial cleaners. Therefore, EPA believes that

use ofthe substances in a consumer product at concentrations greater than five percent by weight would increase potential human exposure.

Finally, EPA has already determined in the section 5(e) consent order that use ofthe substances as a consumer chemical may present an unreasonable risk.While such a finding is not necessary to promulgate a SNUR, it strongly supports the determination that this use ofthe substances would be significant.

VI. Persons Subject to SNUR Notice Requirements Under §721.575

Section 5(a)(1)(B) ofTSCA requires persons to submit a notice toEPA before they manufacture orprocess a substance subject to a SNUR for a significant new use. As previously explained, the language ofTSCA and §721.5 makes clear that manufacturers (including importers) and processors are subject to SNUR notice requirements. Under §721.5(a)(2) a manufacturer, importer, orprocessornf a substance subject to a SNUR who does not intend to commence a significant new use but who intends to distribute the substance in commerce must submit a significant

new use noticeunless the person: (1) Has a reasonable belief at the time of distribution thatits customers do not intend to engage in a significant new use without first submitting a significant

new use notice and (2)can document that the person has notified its
customers of the SNUR. As explained in Unit II.B.3 ofthis preamble, this ensures that EPAjwill receive a significant now

use notice from that distributor who knows or has a reasonable belief that a customer intends to engage in the significant new use without submitting the required notice or does not notify its
customers ofthe SNUR. For these substances and this significant new use, EPAbelieves thatit willprobably be processors who actually formulate

consumer products containing either of the two substances at greater than five percent by weight and who most likely will trigger the reporting requirements of §721.5.

EPA considered allowing manufacturers andprocessors to decide which party should submit what information to EPA so long as all appropriate information was submitted. Some commenters preferred this alternative. However, EPA believes that, in this case, the reporting scheme contained in §721.5 is more likely to result inEPA receiving the most complete and accurate information on the particular substances and significant

new use.

EPA has also concluded that ifthese
two substances are distributed in

commerce as part of a mixture inWhich they occur at concentrations offive percent orless by weight ofthe mixture,

no customer is likely to reformulate the mixture in such a way that either P-82- 400 and P-82-409 could occur in a

comsumer product atgreater than five percent. Accordingly, §721.575(b)(2) provides that, in this instance, §721.5(a)(2) does not apply and such a distributor would not be required to submit a significant new use notice or notify customers ofthe SNUR,

VII. Uses Subject to SNUR Notice Requirements

EPA recognizes that when chemical substances identified in a proposed SNUR are listed on the Inventory, they may be manufactured, imported, or processed for "significant new uses" as defined in the proposal before promulgation ofthe final rule.The
statute and itslegislative history do not make clear whether uses commenced after proposal but before promulgation may be considered significant new uses subject to SNUR notification. However, EPAbelieves that the intent ofsection 5(a)(1)(B) is best served by determining whether a use is a significant new use as of the SNUR proposal date. Ifuses

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commenced during the proposal period

were not considered significant new

uses itwould be almost impossible for the Agency to establish SNUR notice requirements since anyperson could defeat the SNUR by mitiating the proposed significant new use before the rule becomes final.This is contrary to the general intent ofsection 5(a)(1)(B). One commenter supported EPA's interpretation on this issue; another disagreed. However, none ofthe
commenters indicated that the significant new use established in ths rule has occurred.

For the purposes of tlus rule,even if these substances were manufactured, imported, orprocessed between proposal andpromulgation for the significant new use, such activities may not continue after the effective date of this rule.Any such person must cease such activity'until the person has complied with all SNUR notice requirements. EPArecogmzes that this interpretation could disrupt commercial activities ofpersons who commenced manufacture orprocessing for the significant newuse during the proposal period; however, the Agency believes that thesepersons were given adequate notice oftis interpretation by the terms ofthe proposal.

VIIL Procedures forInforming Persons ofthe Existence ofThis Significant New Use Rule

The rule will be codified in the CFR. While tis Federal Register notice provides legal notice ofthe nile, EPA explored additional ways to inform potential SNUR notice submitters ofthe existence ofthe rule.

EPA will publish information conceriung this and other final SNURs in the TSCA Chemicals-m-Progress Bulletin, published by the TSCA Assistance Office ofEPA's Office of Toxic Substances. EPA will also use the TSCA Chemical Substance Inventory to informpersons ofthe existence oftis and other final SNURs through footnotes referring to the chencal identities ofthe substances subject to SNURs. The footnotes will refer to an Inventory Appendix which will give a Federal Register and CFR citationfor the SNUR. Commenters supported the use ofall available means ofinforming persons of the existence ofSNURs.

IX. Required Information

As discussed in the proposal, and consistent with other proposed SNURs, under §721.10 the Agency willrequire SNUR notice submifters to use the PMIN form publishedin the Federal Register of -May13, 1983 (48FR 21722). However, for thepurposes ofreviewing these two substances, EPA is Interested only in information concerning the formulation and use of the substances in consumer products. Because EPA does not wish to collect information about worker
exposure during manufacture and processing, 

### § .721.575(b)(3) specifies that submitters must complete only those sections of the form dealing with the chemcal identity, the submitter, and the specific use. In addition, anyhealth and safety data relating to these substances
mustbe attached. Therefore, submitters must complete only Parts Iand M ofthe form as it appears in Appendix A to40 CFR Part 720.

X. TestData

EPA recogmzes that underTSCA section 5, aperson is not required to develop anyparticular test data before submitting a significant new use notice. Rather, a person is required only to submit test data in his possession or control and to describe any other data known to orreasonable ascertainable by that person. However, in view of the potential healthrisk that may be posed by the significant new use ofP-82-400 and P-82-409, EPA encourages possible SNUR notice submitters to test the substances to evaluate the potential for skin and eye irritation at the concentrations the submitters propose to

use in consumer products. If a SNUR notice is submitted for a significant new

use involving consumer exposure without such test data.EPA would very likely take action under section 5[e).

As part ofan optional prenotice consultation, EPAwill discuss the test data it believes necessary to evaluate a significant new use ofthe substances. Data should be developed and submitted in accordance with the TSCA good laboratory practices regulations under 40 CFR Part 792 published in the Federal Register ofNovember 29,1983 (48FR 53922). EPA encourages persons to consult with the agency before selecting a protocol for testing the substances.
XI. Exemptions

Section 721.19 contains an exemption.
not in the proposal, for substances manufactured, imported, orprocessed only as an impurity or as a byproduct for certain purposes. EPAhas decided not to modify tis general provision for these particular substances. Therefore, if the substances appear in a consumer product only as an impurity, or are produced as abyproduct, and meet the requirements of §721.19. they are not subject to SNUR notice requirements. The Agency is adopting tis policy because identification ofthe presence of the substances when used as an impurity can be very difficult and because the agency does notbelieve that these substances would give riseto significant exposures ifthey appear as

an impurity.The limited byproduct exemption would not give rise to

consumer exposure. The Agencyhas also decided to exempt these substances from significant new usereporting if they are imported orprocessed as part ofan article. This decision was made in response to a comment received on this Issue andbecause theidentified risks from uses ofthese substances in articles

are not likely to occur. XUI Relationship ofSection 5(e) Order and SNUR

The originalPMN submitterforP-82- 400 and P-82-409 is subject to a TSCA section 5(e) consent order wich prohibits it from manufacturing, processing, or distributing these substances in commerce foruse as a

consumer chemical. Once this SNUR
goes into effect, the submitterwillalso be subject to the SNUR. Since the SNUR prevents anymanufacturer, importer,or processor from engaging in the significant new use without notice to EPA, EPA has determined that itisno longer necessary to continue the section 5(e) consent order.Accordingly, once the SNUR goes into effect. EPAwill revoke the section 5(e) consent order thereby leaving the original submitter subject to the samerequirements as otherpersons.
MII. Econonc Analysis

TheAgency has evaluated the potential costs ofestablishing significant new usereporting requirements forP-82-400 and P-82-409. This evaluation is summarized below.

Persons who intend to manufacture, import, orprocess the substances for the significant new use, as defined in this rule,would be required to submita SN

TURnotice with the information required by statute and this rule. The
cost ofsubmitting a SNUR notice can be estimated fromthe cost ofsubmitting a PMN, wich has been estimated to range between $1.300 and $7,500 per substance. However,because thisrule requires that only a portion ofthe PMN form be completed. costs may actually be lower.

Although the SNUR does not require that persons submitting notices perform additional testing. EPA expects that

some additional test datawill be developed. EPArecommends that the substances be tested to evaluate the potential for skinand eye irritation at the concentrations at which theywill be found in consumer products.The direct 

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## / Vol. 49, No. 173 / Wednesday, September 5, 1984 / Rules and Regulations

costs ofsuch tests would be about $1,600 per substance. The dermal irritation test would cost from $300 to $1,000, with a most likely cost of$700. The eye irritation test would cost from $450 to $1,350, with a most likely cost of $900.

The SNUR may also result m delay costs. The delay caused by the preparation ofa SNUR notice and the statutory notice review period could reduce future profits. EPA estimates that these delay costs could range from zero to $6,128.

Total direct costs, including notification, testing, and delay, would
range from $2,100 to $16,078 per substance. It the original PMN submitter also intends to undertake the significant

new use, the direct costs could add from less than 0.1 percent to 3.5 percent to the estimated price of the substances.

EPA has not estimated any indirect
costs that may result from this SNUR. Indirect costs may result from decisions
not to manufacture or process these substances because ofuncertainty about possible Agency regulatory action or due to the magnitude ofthe direct costs. The cost ofthis impact would be whatever profits or benefits to

consumers that use ofthe substances would have generated. In addition, EPA has not estimated the potential public benefits gained through the avoidance of potential health and environmental problems. While the Agency acknowledges that indirect costs and benefits exist, it is impossible at this time to precisely estimate their extent

A more complete economic analysis ofthis SNUR and other regulatory options is included in the rulemaking record and is available forpublic review.

XIV Judicial Reviewjudicial review ofthis final rule may be available under section 19 ofTSCA in the United States Courts ofAppeals for the District of Columbia Circuit or for the circuit m which the person seeking review resides or has his/her principal place ofbusiness. To provide all'interested persons an equal opportunity to file a thnely.petition for judical review and to avoid so called "races to the courthouse," EPA has decided to promulgate this rule for purposes ofjudicial review two weeks after publication in the Federal Register,

as reflected in "DATES" in this document. The effective date has, m turn, been calculated from the promulgation date.

XV Rulemakmg Record

EPA has established a record for this rulemaking (docket control number OPTS-50501A). The complete record is available to the public from 8:00 a.m. to 4:00 p.m., Monday through Friday, except legal holidays in the OPTS Reading Room, Rm..E-107, 401 M St., SW,, Washington, D.C.

The record includes basic information considered by the Agency in developing this rule. The record includes the following:

1. The PMNs for these substances. 2. The Federal Register notice of receipt ofthe PMNs.

3. A copy ofthe section 5(e) consent order.

4.The economic analysis ofthe proposed rule.

5. Test data received from the PMN submitter.

6. Public comments. 7 OMB comments.

XV1. Regulatory Assessment Requirements

A. Executive Order12291

Under Executive Order 12291, EPA
must judge whether a regulation is "Major" and therefore requires a Regulatory Impact Analysis. EPAhas determined that this rule is not a "Major Rule" because it does not have an effect

on the economy of$100 million or more and it will not have a significant effect

on competition, costs, or prices. While there is no precise way to calculate the annual cost ofthis rule, EPAbelieves the rest will be low. Even ifEPA receives 50 SNUR'notices, the direct
cost of the rule will be under $1 million. In addition, because of the nature ofthe rule and the substances subject to it, EPA believes that there will be few significant new use notices submitted. Further, while the expense ofa notice and the uncertainty ofpossible EPA regulation may discourage certain innovation, thatimpact will be limited because such factors are unlikely to discourage an innovation which has lhgh potential value. Finally, this SNUR may encourage innovation in safe chemical substances or highly beneficial

uses.

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

B.Regulatory Flexibility Act

Under the Regulatory Flexibility Act, 5 U.S.C. 605(b), EPA certifies that this rule will not have a significant economic impact on a substantial number of small businesses. EPArecognizes that the submitter ofPMNs P-82-400 and P-82z409, who is also a possible submitter of

a SNUR notice, is a small business. The Agency cannot determine whether other parties affected by this rule are likely to be small businesses. However, EPA believes that the number of small businesses affected by this rule would
not be substantial, even ifall the potential significant new uses were developed by small companies. EPA expects to receive few SNUR notices for the substances. The Agency hopes that

one ofthe first notice submitters will test the substances to determine their potential for skin and eye irritation at concentrations greater than five percent for which SNUR reporting is required. With these data, EPA would be able to evaluate the risks posed by the substances used in consumer products and, ifnecessary, take action to control those risks. Iftest results indicate that there are no risks at a certain concentration, EPA will likely alter the reporting triggers to reflect those results. As more test data become available, reporting triggers will continue to be refined to identify those levels at which acute effects are negligible. Because

uses m consumer products above levels at which consumers wotld suffer effects will be discouraged by responsible manufacturers, fewer businesses will be directly affected by this rule. In addition, the cost ofthe testing that may be encouraged by this rule should not have a major impact on a small business that may want to use these substances

as in consumer products.

C.Paperwork ReductionAct

The information reporting requirements contained in this rule have been approved by OMB under the provisions of the Paperwork Reduction Act,44 U.S.C. 3501 etseq., andhave been assigned OMB control number 2070-0012.

List of Subjects in 40 CFR Part 721

Intergovernmental relations, Chemicals, Hazardous materials, Recordkeeping and reporting requirements, Significant new uses.

Dated: August 27,1984. William D.Ruckolshaus, Adminstrator.

Therefore, a new Part 721 is added to 40 CFR Chapter I,to read as follows:

PART 721-SIGNIFICANT NEW USES OF CHEMICAL SUBSTANCES Subpart A-General Provislons

Sec. 721.1 Scope and applicability. 721.3 Definitions. 721.5 Persons who must report. 721.6 Applicability determination when the specific chemical identity is confidential. 721.7 Exports and imports.

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721.10 Notice requirements and procedures. 721.13 Compliance and enforcement. 721.17 Recordkeepmg. 721.19 Exemptions.
Subpart B-Significant NewUses of Specific Chemical Substances

721.575 Potassium N,N-bis (hydroxyethyl)

cocoamme oxide phosphate and potassium N,N-bis (hydroxyethyl) tallowamne oxide phosphate.

Authority:.Sacs. 5. 8; Pub. L 94-469; 90 Stat. 2003. 2027 (15 U.S.C. 2601 -etseq.).

Subpart A-General Provisions

§721.1 Scope and applicability.

(a)This part identifies -usesof chemical substances which EPA has deternined are significant new uses under the authority of section 5(a)(2) of the Toxic Substances Control Act. In addition,it specifies procedures for manufacturers, importers, and
processors to report on those significant

new uses. This Subpart A contains general provisions applicable to this Part.The chemical substances and significant new uses subject to this Part

are ideihtified in Subpart B.

(Ib) This Subpart A contains provisions governing submission and review ofnotices for the chemical substances and significant new uses identified in Subpart B of thisPart. The provisions oftiis Subpart A apply to the chemical substances and significant

newuses identified inSubpart B ofthis Part except to the extent they are specifically modified orsupplanted by specific requirements in SubpartB. In the event ofa conflict between the provisions ofthis SubpartA and the provisions of Subpart B ofthis Part, the provisions ofSubpartB shall govern.

(c) The provisions ofPart-720 ofthis chapter apply to this Part 721. For
purposes ofthis Part 721, wherever the phrase "new chemical substance"
appears in Part 720 ofthis Chapter, it shall mean the chemical substance subject to this Part 721. In the event ofa conflict between the provisions ofPart 720 ofthis chapter and the provisions of this Part 721, the provisions ofthis Part 721 shall govern.
§721.3 Definitions.

The definitions in section 3 ofthe Act, 15 U.S.C. 2602, and §720.3 ofthis chapter apply to this part.In addition, the following definitions apply to this Part-

"CAS Number" means Chemical Abstracts Service Registry Number assigned to a chemical substance on the Inventory.

"Customer" means any person to whom amanufacturer, importer, or processor distributes any quantity ofa chemical substance, or of a mixture containing the chemical substance, whether or not a sale is involved.

"Principal importer" means the first importer who, knowing that a chemical substance will be imported for a significant new use rather than manufactured domestically, specifies the chemical substance and the amount
to be imported. Only persons who are incorporated, licensed, or doing business in the United States may be principal importers.

"Process for commercial purposes"

means the preparation ofa chemical substance or mixture containing the chemical substance, after manufacture of the substance, for distribution in

commerce with the purpose ofobtaining

an immediate or eventual commercial advantage for the processor. Processing ofany amount ofa chemical substance

or mixture containing the chemical substance is included in flus definition. If a chemical substance ormuxture containing impurities is processed for commercial purposes, then the impurities also are processred for commercial purposes.

"Process solely for export" means to
process for commercial purposes solely for export from the United States under the following restriction on domestic activity:.Processing must be performed
at sites under the control ofthe
processor distribution in commerce is limited to purposes ofexport; and the
processor may not use the chemical substance except in small quantities solely for research and development.
§721.5 Personswho must report

(a)The following persons must submit

a significant new use notice as specified under the provisions ofsection 5(a)(1)(B] of the Act,Part 720 of this chapter, and § 721.10.

(1) A person who intends to manufacture, import, or process for commercial purposes a chemical substance identified in Subpart B of this Part, and intends to engage in a significant new use ofthe substance identified in Subpart B.

(2) A person who intends to manufacture, import. or process for commercial purposes a chemical substance identified in Subpart B ofthis Part, and intends to distribute the substance in commerce. A person described in this paragraph is not required to submit a significant newuse notice ifthat person (i) does not have a reasonable belief, at the time of commercial distribution of the chemical substance, that hs/her customers intend
to engage in a significant new use of that substance without submitting a notice under tisPart, and (i} can document that the person has notified all customers, in writing, ofthe specific section in Subpart B ofthisPartwhich identifies the substance and the significant new uses subject to thisPart.

(b)A person who processes a chemical substance identified in Subpart B ofthis partfor a significant new use of that substance is notrequired to submit

a significant new usenotice ifthat
person can document thatit has processed the chemical substance with

areasonable beliefthat the substance is
not identifiedin Subpart B ofthisPart. (c)Ifat any time after commencing distribution in commerce of a chemical substance identified in Subpart B ofthis part a person described in paragraph (a)(2) ofthis section has a reasonable beliefthat a customeris engaging in a significant new use ofthat substance identified in Subpart B without submitting a notice under thisPart the
person is required to submit a significant new use notice for that chemical substance and significantnew use, unless the person is able to document that ithas done the following:

(1)Ceased supplying the chemical substance to the customer when the
person has areasonable beliefthat the
customer isprocessing the substance for

a significant new usewithout submitting

a notice under this Part,

(2] Notified EPAenforcement authorities of theperson's reasonable beliefthatthe customeris processing the chemical substance for a significant

new use without submitting anotice under this Part. promptly uponreaching that belief,and

(3) Not resumed supplying the chemical substance to the customer until all notices required under thisPart have been submitted toEPA and thenotice review periods have ended without regulatory action byEPA.

(d) Any notice ofimport must be submitted by the principal importer.

§721.6 Applicability determinationwhen the specific chemical Identity Is confidential.

(a) A person who intends to manufacture, import, orprocess a chemical substance which is described by a generic chemical name in Subpart B ofthis Part may askEPA whether the substance is subject to the requirements ofthis Part.EPAwill answer such an inquiry only ifEPA determines that the personhas a bonafideintent to manufacture, import, orprocess the chemical substance forcommercial purposes.

(b)To establish a bona fide intent to manufacture, import, ofprocess a

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chemical substance, the person who

- intends to manufacture, import, or process the chemical substance must submit the following in writing to the Office ofToxic Substances, TS-799, 401 M St. SW., Washington, D.C. 20460:

(1)The specific chemical identity of the chemical substance that the person intends to manufacture, import, or process.

(2) A signed statement that the person intends to manufacture, import, or process the chemical substance for commercial purposes.

(3)A description ofthe research and development activities conducted to date, and the purpose forwhich the person will manufacture, import, or process the chemical substance.

(4) An elemental analysis. (5)Either an X-ray diffraction pattern (for inorganic substances), a mass spectrum (for most other substances), or an infrared spectrum ofthe particular chemical substance, or, ifsuch data do not resolve uncertainties with respect to the identity ofthe chemical substance, additional or alternative spectra or other data to identify the substance.

(c) If an importer or processor cannot provide all the information required in paragraph (b) ofthis section because it is claimed as confidential business information by the importer's or processor's manufacturer or supplier, the manufacturer or supplier may supply the information directly toEPA.

(d) EPA will review the information submitted by the manufacturer, importer, orprocessor under paragraph (b) ofthis section to determine whether thatperson has shown a bonafide intent to manufacture, import, or process the chemical substance. Ifnecessary, EPA will compare this information either to the information requested for the confidential chemical substance under §710.7(e)(2)(v) ofthis chapter or the information requested under §720.85(b)(3)(iii] of this chapter.

(e) If the manufacturer, importer, or processor has shown a bonafideintent to manufacture, import, orprocess the substance and has provided sufficient unambiguous chemical identity information to enable EPA to make a conclusive determination as to'the identity ofthe substance, EPA will inform the manufacturer, importer, or processor whether the chemical substance is subject to this Part and, if so, which section in Subpart Bofthis part applies.

(f)A disclosure to a person with a bona fide intent to manufacture, import,

or process a particular chemical substance that the substance is subject to this Part will not be considered public disclosure ofconfidential business information under section 14 of the Act.

(g)EPA will answer an inquiry on whether a particular chemical substance is subject to this part within 30 days afterreceipt ofa complete submission under paragraph (b) ofthis section.
§721.7 Exports and imports.

The chemical substances identified in Subpart B ofthis Part are subject to the export notification requirements of section 12(b) ofthe Act and Part 707 of this chapter. The substances also are subject to import certification requirements in 19 CFR 12.118 through 12.127 and 127.28 under the authority of section 13 of the Act. The EPA policy in support ofthe import certification requirements is set forth in Part 707 of this chapter.

§721.10 Notice requirementi; and procedures.

(a) Each person who is required to submit a significant new use notice under this part must submit the notice at least 90 calendar days before commencing manufacture, import, or processing ofa chemical substance identified n Subpart B ofthis Part for a significant new use. The submitter must comply with any applicable requirement ofsection 5(b) of the Act, and the notice must include the information and test data specified in section 5(d)(1) of the Act. The notice must be submitted on the notice form m Appendix A toPart 720 ofthis chapter and must comply with the requirements ofPart 720,. except to the extent that they are inconsistent with this Part 721.

(b) Iftwo ormore persons are required to submit a significant new use notice forthe same chemical substance and significant new use identified in Subpart B of this part, they may submit

a jointnotice to EPA. Persons submitting

a joint notice must individually complete the certification section ofPart I ofthe required notification form. Persons who

are required to submit individually, but elect to submitjointly, remain individually liable for the failure to submitrequired information which is known to orreasonably ascertainable by them and test data in their possession or control.

(c) EPA will process the notice in accordance with the procedures ofPart 720-ofthis chapter, except to the extent they are inconsistent with this Part 721.

(d) Any person submitting a significant new usenotice in response to the requirements ofthis Part 721 shall not commence manufacture, import, or processing of a chemical substance identified in Subpart B ofthis Part for a significant new use until the notice review period, including all'extensions and suspensions, has expired.

§721.13 Compliance and enforcement.

(a) Failure to comply with any provision ofthis Part is a violation of section-15(1) ofthe Act (15 U.S.C. 2614),

(b) Using for commercial purposes a chemical substance which a person knew or had reason to know was manufactured, imported, or processed In violation ofthis part is a violation of section 15(2) ofthe Act (15 U.S.C. 2014),

(c) Failure or refusal to permit access to or copying ofrecords, as required by section -1 ofthe Act, Is a violation of section 15(3) ofthe Act (15 U.S.C. 2614),

(d)Failure or refusal to.permit entry

orinspection, as required by section 11 ofthe Act, Is a violation ofsection 15(4) ofthe Act (15 U.S.C. 2614).

(e) Violators ofthe Act or ofthis Part may be subject to the civil and criminal penalties in section 16 ofthe Act (15 U.S.C. 2615) foreach violation. The submission offalse or misleading information in connection with the requirement ofany provision ofthis Part may subject persons to penalties / calculated as if they neverfiled a notice.

(f)Under the authority ofsections 7 and 17 ofTSCA, EPAmay:

(1)Seek to enjoin the manufacture, import, or processing ofa chemical substance in violation of this part.

(2) Act to seize any chemical substance which is being manufactured, imported, orprocessed in violation of this Part.

(3)Take any other appropriate action.

§721.17 Recordkeeping.

Any person subject to the requirements of this part mustretain documentation ofinformation contained in that person's significant new use notice. This documentation must be maintained for a period offive years from the date ofthe submission ofthe significant new use notice.

§ 721.19 Exemptions.

The persons identified in §721,5 are not subject to the notification requirements of §721.10 for a chemical substance identified in Subpart Bofthis part if:

(a) The person has applied for and has been granted an exemption for test marketing the substance for a significant

new use identified in Subpart Bin accordance with section 5(h)(1) of the Act and §720.38 of this chapter.

(b) The person manufactures, imports,

or processes the substance in small quantities solely for research and development in accordance with section 5(h)(3) ofthe Act.

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(c) The person has applied for and been granted an exemption under section 5(h)(5) ofthe Act. (d) The person manufactures, imports,

or processes the substance only as an impurity.

(e) The person manufactures, imports,

or processes the substance only as a byproduct which is used only by public

or private organizations that (1) burn it

as a fuel, [2) dispose ofit as a waste, including in a landfill or for enriching soil, or (3) extract coniponent chemical substances from it for commercial
purposes.

(f) The person imports or processes the substance as part ofan article.

(g) The person manufactures or processes the substance solely for export and, when distributing the substance in commerce, labels the substance in accordance with section 12(a)(1)(B) ofthe Act.

Subpart B-Significant New Uses for Specific Chemical Substances

§721.575 Potassium N,N-bis (hydroxyethyl) cocoamine oxide phosphate, and potassium N,N-bis -(hydroxyethyl) tallowamine oxide phosphate.

(a) Chemicalsubstancesand significant new usesubjectto reporting. (1) The following chemical substances, identified by their chemical names and CAS Number are subject to reporting under this Part for the significant new

use identified in paragraph (a](2) ofthis section: Potassium N,N-bis (hydroxyethyl) cocoamie oxide phosphate (CAS Number 855712-26-1), and potassium N,N-bis (hydroxyethyl) tallowarmne oxide phosphate (CAS Number 855712-27-2).

(2) The significant new use is: Use in a

consumer product at concentrations greater than five percentby weight.

(b) SpecificRequirements. The provisions ofSubpart A ofthis Part apply to this section except as modified by this paragraph.

(1) Definitions.In addition to the definitions in § 721.3, the following definitions apply to this section:

"Consumer" means any natural
person who usesproducts for personal rather than business purposes.

"Consumer product" means any chemical substance which is directly, or

as part'ofa mixture, sold or made available to consumers for their use in

or around apermanent or temporary household or residence, in or around a school, or in recreation. (2) Personswho mustreport.The provisions of § 721.5 apply to determine
persons who must report under this section, except § 721.5(a)(2) does not apply to a person who intends to distribute either ofthe substances in

commerce as part ofa mixture at concentrations offive percent orless by weight ofthe mixture.

(3) Noticerequirementsand procedures. Section 721.10 applies to this section, except a person bubmitting

anotice must complete only Parts I and 1 ofthe notice form.

BILUNG CODE essa-Zr.-M

DEPARTMENT OF COMMERCE

National Oceanic and Atmospheric

Administration

50 CFR Part 652

[Docket No. 31220-245]

Atlantic Surf Clam and Ocean Quahog Fisheries

AGENCY: National Marne Fisheries Service (NMFS), NOAA. Commerce.

ACTION: Notice ofMid-Atlantic Area closure.

SUMMARY. NOAA issues this notice closing the mid-Atlantic surf clam fishery. The action is necessarybecause harvest from the fishery will exceed the quarterly quota for the third calender quarter.The intended effect of the closure is to prevent harvests from exceeding the annual quota for the fishery.

EFFECTIVE DATES: 0001 hours Eastern Daylight Time (EDT) September 16,1984. through 2400 hours EDT September 29. 1984.

FOR FURTHER INFORMATION CONTACT: Bruce Nicholls, Surf Clam Management Coordinator, 617-281-2600, ext. 324.

SUPPLEMENTARY INFORMATION The regulations implementing Amendment 3
to the Fishery Management Plan for Atlantic SurfClam and Ocean Quahog Fisheries were published onJanuary 29. 1982 (47FR 4268). The regulations contain at § 652.22(d) a provision requiring that. ifthe Regional Director determines the quota for surfclams for
any time period will be exceeded, the Secretary of Commerce will publish a notice in the Federal Register stating the determination and setting a date and time for closure ofthe fishery.

Harvest ofsurf clamsin the MidAtlantic Area has been significantly higher during 1934 than in previous
years.This is probably because significant numbers ofsurf clams from the strong 1976 and1977 year classes

are now reaching the minmum.legal size for harvest, thus elevating catch per hourfished. OnFebruary 26.1934(49 FR 6498, February 22,1934), the Regional Directorreduced allowable fishing time from24 to 12 hours perweek in an attempt to controlharvest rates. Despite this reduction, and a tvo-week closure
at the end ofthe second calendar quarter (49FR 23355,June 6,1934), rates continue to exceed quarterly quota guidelines. The Regional Directorhas determined that the Mid-Atlantic Area surf clam quota for thethird calendar quarter of 1934 will bereached on or about August 31,1934. Fllowing consultation with industry spokespersons and the Mid-Atlantic Fishery Management Council, the regional Directorhas determined to close the mid-Atlantic fishery forthe period from September 16,1934, through September 29,1984.

Closure of the fishery .illcommence at 0001 hours EDT on September 16, 1984. Thefishery will remain closed until 2400 hours EDT on September 29, 1984. This closure applies only to surf clams taken in the fishery conservation

zone in the Mid-Atlantic Area.

Thefishery will reopen at 0001 hours EDT on September 30,1984, with 12 hours fishing time per week. Atthat time, the Regional Directorwill evaluate the status ofthe fishery and quotas. If additional closure periods are required to bringharvests down to the level provided bythe quotas, they will be considered forlater in theyear.

Other Matters

This action is taken under the authority of50 CFR Part652 andis taken in compliance withExecutive Order 12291. (16U.S.C.1801 etseq. Listof Subjects in 50 CFR Part652

Fisheries. Dated: August 29,1934. Carmen J. Blondin, Deputy AzstantAdmuustrator farFishernL Rez-ourceMnaement National Mariae Fisheries Service.

FRU COS-r4 9--1%4-8k 43amj BUMLII ODE 35106-22-U

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