# + 2

(,1 1/,1(

Citation: 48 Fed. Reg. 21723 1983

Content downloaded/printed from HeinOnline (http://heinonline.org) Wed Jul 25 09:57:01 2012

-- Your use of this HeinOnline PDF indicates your acceptance of HeinOnline's Terms and Conditions of the license agreement available at http://heinonline.org/HOL/License

-- The search text of this PDF is generated from uncorrected OCR text.

### Federal Register / Vol. 48, No. 94 / Friday, May 13, 1983 / Rules and Regulations

substance until information sufficient to evaluate its health and environmental effects isprovided. EPA can take this action ifitdetermines that the available information is insufficient for a reasoned evaluation and either (1)the substance maypresent an unreasonable risk of injury to health or the environment, or (2)the substance will be produced in substantial quantities and there maybe significant orsubstantial human exposure to the substance orsubstantial release to the environment. Under section 5(f), EPA mayregulate a new chemical substance ifit finds that there is a reasonable basis to conclude that the manufacture, processing, distribution in commerce, use, or disposal ofthe substance will present an unreasonable risk of injuryto health or the environment.

IfEPA has notprohibited manufacture

or import ofthe chemical substance during thereview period, these activities maybegin as soon asthe review period expires, subject to restrictions ortesting requirements imposed during the review period.When manufacture or import begins and thenotice submitter provides

a notice ofcommencement, EPA adds the substance to the inventory. Thereafter, any person may manufacture

or import the substance without submitting a section 5notice to EPA (unless EPAhas issued a significant new
use rule on the chemical under section 5(a)(2)).

Certain chemicals are exempt from the section 5notice requirements. They include categories ofsubstances excluded from theTSCA definition of chemical substance: tobacco and tobacco products; nuclear materials; firearms and ammunition; and substances used solely as pesticides, foods, food additives, drugs, or cosmetics. In addition, section 5(h) authorizes exemptions from section 5 notice requirements for new chemical substances produced for testmarketing

or research and development, and for substances which exist temporarily as a result ofa chemical reaction in the manufacture orprocessing ofanother chemical substance towhich there is no human or environmental exposure. Also, under section 5(h)(4) EPA may,upon application and byrule, exempt the manufacturer or importer ofany new chemical substance from all or partof the section 5requirements if the Agency determines that the manufacture, processing, distribution in commerce, use, and disposal ofthe substance will not present an unreasonable risk of injury to health or the environment.

Section5(d)(2) ofthe Actrequires EPA to publish certain information on section 5notices in the Federal Register, including at the least: (1) information on the identity and uses ofthe new substance, (2) a description oftest data submitted under section 5(b), and (3) the results ofthe tests. In addition, at the beginning ofevery month, EPA must publish a list of: (1)new chemical substances undergoing section 5 review and (2) new chemical substances for which the notice review periods have expired since theprevious monthly Federal Register notice.

Under section 14 ofthe Act,EPA is prohibited from disclosing confidential business information submitted under TSCA, including section 5, except in certain circumstances. Specifically, EPA may disclose confidential business information ifit determines that disclosure is necessary to protect human health orthe environment against an unreasonable risk ofinjury to health or the environment, and, to the extent necessary, ifthe information is relevant in any proceeding under the Act. Also, EPA is not prohibited from disclosing health and safety studies (including underlying data) on chemical substances forwhich a section 5notice was received. However, the Act does not authorize EPA to reveal any such data that would disclose confidential
processes or portions ofa mixture.

B.Background

Section 5notice requirements went into effect on July 1, 1979, 30 days after the publication ofthe Initial Inventory. On that date, persons who intended to manufacture new chemical substances,

or import them in bulk, became subject
to section 5 notice requirements. On July 30, 1980, EPA published a Cumulative Supplement to the Initial Inventory, which included chemical substances reported by processors and users and substances imported as part ofmixtures

or articles. This supplement, together with the InitialInventory, make up the Revised Inventory. Thirty days after publication ofthe Revised Inventory, on August 30, 1980, section 5 notice requirements went into effect for
persons who imported new chemical substances as part ofa mixture. Under the Interim Policy and this final section 5 notice rule,importers ofnew chemical substances as part of an article are not subject to the section 5notification requirements.

Since section 5 notice requirements
went into effect, EPA has operated the notice review program under an Interim Policy. In thepreamble to the January 10, 1979, proposed section 5notice rule, EPA announced its Interim Policy for handling notices submitted before the publication ofthe Inventory. EPA modified this policy in an Interim Policy Statement published in the Federal Register ofMay 15, 1979 (44 FR 28564). This statement extended the Interim Policy's coverage to all notices filed before the effective date ofthe final section 5 rule and notice form.

EPA issued a Revised Interim Policy Statement in the Federal Register of November 7, 1980 (45FR 74378). This

statement clarified the May 15 statement and discussed in more detail the type of information EPA expected to receive in notices,EPA's interim procedures for handling confidential information, and procedures for submitting and reviewing test-marketing exemption applications. The operation ofthe review program under the Interim Policy is discussed later in this preamble.

EPA proposed a rule to implement section 5notice requirements in the Federal Register ofJanuary 10, 1979 (44 FR 2242). This proposal included a description ofthe applicability of section 5 requirements, the general procedures for submitting notices, information requirements in the notices, and EPA'sprocedures for processing information in notices, including confidential business information. EPA also proposed notice forms for manufacturers, importers, foreign manufacturers and suppliers, and
processors and customers.

In response to public comment on the January 10 proposal, EPA reproposed certain parts ofthe rule and forms in the Federal Register ofOctober 16, 1979 (44 FR 59764). In particular, the reproposal shortened the notice form, reducing the information required; itrevised procedures for asserting and substantiating claims ofconfidentiality; and itrevised the proposed supplemental reporting requirement under section 8(a) ofTSCA. In addition, EPA proposed in the Federal Register of August 15, 1980 (45 FR 54642) that
persons notify EPA before they processed for TSCA commercial
purposes substances that were manufactured or imported forpurposes exempt from TSCA reporting. In the Federal Register ofSeptember 23, 1980, EPA proposed a clarification of reporting responsibilities of importers in the January proposal (45 FR 63806). Finally, EFA issued a statement in the Federal Register ofJuly 2, 1982 (47 FR 28969) stating that, under the Interim Policy, submitters were no longer required to substantiate confidentiality claims at the time a notice is submitted.

With this notice, EPA is now promulgating final section 5 notice requirements and review procedures. This rule modifies the earlier proposals 

### 21723

HeinOnline -- 48 Fed. Reg. 21723 1983

### Federal Register / Vol. 48, No. 94 / Friday, May 13, 1983 / Rules and Regulations

inlight ofEPA's experience under the Interim Policy and public comments on the rule. The rule will become effective 30 days afterpublication ofthis notice. Until then, EPA will continue to operate the notice review program under the 

### Interim and Revised Interim Policy Statements.
II.General Approach to Notice Review

In conducting its review ofa new chemical substance, EPA assesses the risks associated with all phases ofthe life cycle of the substance, including its manufacture, import,processing, distribution in commerce, use, and disposal. The review is based on information provided bythe submitter in the notice and on information EPA may obtain elsewhere, for example, in the literature searches on new substances and their structural analogues thatEPA conducts as part ofits new chemical review. However, it is ultimately the notice submitter's responsibility to provide enough information for an adequate risk assessment.

In conducting its review, EPA considers a number ofdifferent factors, including the potential toxicity ofthe substance which is determined from test data submitted in the notice or obtained elsewhere, data on structural analogues, and structure-activity analyses. EPA also reviews thepotential forhumans and the environment to beexposed to the substance during usesproposed by the notice submitter.Also, because EPA mustassess the "reasonableness" ofany risk,it considers such nonrisk factors as thepossible economic benefits ofthe substance andthe availability of substitutes-or whether a substance is intended as a substitute fora more toxic substance.

Because the Act explicitly requires EPA to assess risks associated with the entire life cycle ofnew chemicals, EPA evaluates boththe new chemical substance and related substances, such

as impurities, byproducts, degradation products, unintended reaction products, and other chemical substances associated with the manufacture, processing, distribution in commerce, use, or disposal of the new chemical substance, even ifthese related substances are on theInventory.

On thebasis ofits assessment, EPA may take action during thereview period under section 5(e) to regulate the substance while EPAobtains more data,

orunder section 5(f) to regulate manufacturing, processing, distribution in commerce, use, or disposal, ifEPA determines that the substance will present an unreasonable risk.EPA may also issue a follow-up reporting requirement under section 5(a)(2) or8(a) or regulate the chemical under section 5(b)(4) (risk list). EPA, however, can regulate a substance only ifit takes positive action, either by orderor by rule. Without such action duringthe review period, a substance can enter commercial production unregulated under TSCA. As a result, section 5ofthe Act does not establish a registration program, and EPAhas notin any sense "approved" substances that have passed throughreview without regulation.

From commencement ofthe notice review program on July 1,1979, toMarch 31, 1983, EPA received 2,201 valid premanufacture notices. Ofthe total number,the review periodhad expired

on 1,878 and 777had entered commercial production. In addition,EPA reviewed 196 test-marketing exemption applications under section 5(h)(1) of the Act and granted 173 such exemptions. During thisperiod, EPA issued seven section 5(e) orders regulating the production of 18 new chemical substances pending thedevelopment of additional data, and entered into voluntary control agreements with the submitters of49notices. In addition, submitters withdrew nine section 5 notices in the face oflikelyregulation.

Under the Interim Policy, EPA has gained experience inreviewing notices, which it has usedin developing the final section 5notice rule, andit has established review procedures that will continue when thisrule is effective. The following sections outline ourgeneral review procedures fornotices on new chemicals.
A.NoticeReviewProcess

The noticereview process established by EPA has six majorphases: prenotice communication, process start-up, initial review, detailed review, regulatory response, and process closeout.All new chemicals are not subject to each phase.

1.PrenoticeCommunication.The EPA Office ofToxic Substances, which is responsible forthe section 5notice review program, employs a Prenotice Communications Coordinator to assist persons preparing a notice or considering the submission ofa notice. The Prenotice Communications Coordinator provides guidance on a wide variety oftopics, and refers persons to the appropriate EPA staff members forguidance on other questions. Topics forprenotice inquiries include the scope ofTSCA and this rule, the contents of theTSCA Chemical Substance Inventory, the notice form, section 5exemptions, premanufacture testing,confidentiality and generic name development, andnotice review procedures. The Prenotice Communications Coordinator can be reached by telephone at 202-382-3745 or by writing
to the Prenotice Communications Coordinator, Chemical Control Division * (TS-794), Environmental Protection Agency, 401 M Street, SW., Washington, D.C. 20460.

2. ProcessStart-up.Process start-up begins when EPAreceives a notice. The OTS Document Control Officer assigns a premanufacture notice number to the notice and acknowledges the receipt of the notice to the submitter. The acknowledgment includes the date when the OTS Document Control Office received the notice. The 90-day review period begins on the date ofreceipt.

During process start-up, OTS staff review the notice to determine whether the substance and proposed uses are subject to section 5 noticerequirements and whether all required information has been submitted. In addition, the Chemical Substance Inventory is searched to ensure that a section 5 notice is required, and the Federal Register notice required under section 5(d)(2) is prepared. This notice includes the identity ofthe new chemical substance; the premanufacture notice number; the name ofthe submitter; information on production, exposure, and use; and test results. Information claimed as confidential is omitted from the notice or masked by generic descriptions. At the same time, the OTS Reading Room establishes a public file containing a nonconfidential version of the notice.

A Notice Manager is assigned to each notice. The'Notice Manager coordinates thereview and serves as the EPA
contact on all matters concerning the notice. Persons wishing to contact the
managers of particular notices can obtain their names and telephone numbers from the Prenotice Communications Coordinator.

3.Initial Review.During the initial review period, EPA identifies chemical substances which require more detailed review and which are candidates for possible regulatory action. During this phase, EPA conducts a preliminary analysis ofthe chemical identity, physical and chemical properties, proposed uses, potential toxicity, environmental effects, human exposure, environmental release, and economic benefits. EPAuses the information contained in the notice, in certain cases searches the scientific literature for data

on the substance and related substances, and,when necessary, seeks additional information from the submitter. Initial review ends when the staffreviews available risk data and 

### 21724

HeinOnline -- 48 Fed. Reg. 21724 1983

### Federal Register / Vol. 48, No. 94 / Friday, May 13, 1983 / Rules and Regulations

nonrisk information and decides whether more detailed review is necessary, possiblyin support ofan action under section 5(e) or 5(f), or under other sections of theAct.

4.Detailed Review.During detailed review, the Agency assesses the

concerns it identified during initial review. EPA also examines thebenefits to society ofthe new chemical substance and the availability of substitutes. After assessing therisks and certain nonrisk information, EPA analyzes possible regulatory or other control measures. Ifnecessary, EPA extends the notice review period under section 5(c).

5.RegulatoryResponse.After completion ofits detailedreview, EPA may decide to regulate the substance during the review period. Itmay issue

an order under section 5(e) ifEPA finds that the substance may present an unreasonable risk ofinjuryto health or the environment, orthat it maybe produced in substantial quantities, pending the development of additional data. EPA may control the substance under section 5(f)ifit finds that the substance willpresent an unreasonable risk. EPA may alsoidentify the substance as a candidate for regulation under section 5(a)(2), 5(b)(4), or8.

6.ProcessCloseoutandEntryon the Inventory.IfEPA does not take action to regulate a substance during thereview period, the submitter may manufacture

or import the new chemical substance without restriction, as soon as the notice review period expires.The submitter must notifyEPA by letter when manufacture orimportbegins. This letter mustbe sent to the Document Control Officer (TS-793), Office of Pesticides and Toxic Substances, 401 M Street, SW., Washington, D.C. 20460. This notice ofcommencement must contain: the specific identity ofthe chemical substance, its premanufacture notice number,and the date when manufacture or importbegins. When EPA receives this letter,the substance is added to the Inventory.
B. Test-MarketingExemptionl Applications

Under section 5(h)(1) of the Act, persons may apply for an exemption from section 5(a) or5(b) reporting requirements to manufacture orimport a
new chemical substance for testmarketing purposes. EPA may grant an exemption ifthe applicant shows to EPA's satisfaction that the testmarketing activities will notpresent any unreasonable risk ofinjury to health or the environment. Therefore, EPA must make an affirmative finding that the test marketing willnotpresent any unreasonable risk, and manufacture or import cannot begin until EPA grants the exemption. This standard differs from the finding EPAmust make to take regulatory action on a new chemical under section 5(e); to act under section 5(e), EPA mustconclude onlythat there maybe an unreasonable risk.Under section 5(h)(6), EPA has only 45 days to approve or deny an exemption application. This limits the extent to which EPA can gather information beyond that contained in the testmarketing application.

To ensure an adequate review, testmarketing exemption applicants should include in their applications, at a minimum: (1)all existing dataregarding health and environmental effects of the substance, including physical/chemical properties or,in the absence ofsuch data, a discussion oftoxicitybased on structure-activity relationships and relevant data on chemical analogues; (2) the maximum amount tobe manufactured or imported fortest marketing; (3)the maximum number of persons who may-be provided the substance during testmaketing; (4)the maximum number ofpersons who may be exposed to the substance as a result of testmarketing; (5)information on estimated duration and routes of exposure; and (6) a description ofthe test-marketing activity, including the length oftime that willbe required and howthe activity maybe distinguished from full-scale commercial production and from research and development. These items are set out in §720.38(b) of the finalrule.
C.Regulatory Actions By March 31, 1983,EPA had issued

seven orders under section 5(e) to control a total of18 new chemical substances. The first three orders would have prohibited production of thenew substances pending the development of further information. However, in each of the three cases, themanufactuper or importer withdrew its notice from review,rather than allow the orderto go into effect.EPA also issued four consent 5(e) orders. These consent orders allow manufacture ofthe new chemical substance under specific restrictions pending thedevelopment ofadditional information. In addition, nine section 5 notices have been withdrawn by submitters in the face oflikely regulation under section 5(e) or 5(f), but before orders were actually issued.

EPA has also reached voluntary agreements with a number ofnotice submitters rather than taking formal regulatory action. ByMarch 31, 1983, the submitters of19 notices had agreed to conduct testingin response to EPA concerns. Measures to control exposure, including labeling, Material Safety Data Sheets, and workerprotection devices, where agreed to by the submitters of 30 notices, and the review periods for an additional 43 notices were suspended in response to EPA's concerns, to allow the submitters time to develop additional information voluntarily.

Ill. Provisions ofthe Rule

This unit discusses theprovisions of the rule and specifically points out where these provisions differ from the January 1979, October 1979, and August 1980 proposals. In a separate document, Response to Comments on the Premanufacture Notice Requirements and Review Procedures, EPA discusses in more detail its response to comments

on the earlier proposals. The Response to Comments is available in the OTS Public Reading Room.

A. Applicability

1. WhoMustReport.Section 720.22 of the rule specifies who is subject to the section 5'notice requirements. These provisions closely followthose proposed in January 1979, which were based on the reporting requirements for the Initial Inventory. A detailed discussion ofwho
must report follows.

a. US.manufacturers.Persons who intend to produce ormanufacture a new chemical substance in the United States for a commercial purpose must submit a notice. Only manufacturers that are incorporated, licensed, or doing business in the United States may submit a notice. Persons who extract a
new chemical substance from a previously existing substance, or a complex combination ofsubstances, are manufacturers ofthat new chemical substance.

EPA has revised the definition of "manufacturer" in the final rule to include certain persons whocontract with a manufacturer to make a chemical substance (sometimes known as "toll manufacture"). Under the definition in the final rule, a person who contracts with a manufacturer is also a manufacturer ifthe substance is manufactured orproduced exclusively for that person, and that person specifies the identity of the substance and controls the total amount produced and thebasic technology for the plant process. In this situation, the person who contracts with the actual manufacturer must submit the notice. This provision does not apply to the person who simply orders a specific chemical or a chemical with certain properties from a manufacturer. Instead, this provision only applies to the .. . .. 21...

. 

### 21725

HeinOnline -- 48 Fed. Reg. 21725 1983

### Federal Register / Vol. 48, No. 94 / Friday. May 13, 1983 / Rules and Regulations

situationwhere the person not only specifies the chemical identity, but spells outthe basic process formaking thechemical (althought the actual manufacturer may make adjustments in the specified process that are necessary to adapt theprocess to the manufacturer's own equipment.)

Therule further restricts this provision to persons who have an exclusive relationship with the manufacturer (i.e., the manufacturer does not sell the chemical to anyone else). As a result, theperson placing the order also determines the total amount to be manufactured. Therefore, ifmore than one person orders thenew chemical, neither of themhas specified the total amount to be manufactured and neither is responsible for submitting the notice; instead,the person who actually manufactures thechemical must submit the notice.

EPAhas added thisprovision to deal with the situation in which oneperson decides to manufacture a specified amount of a certain chemical using a certain process, but contracts with a manufacturer to actually make the chemical. In this case, EPAbelieves the person contrhcting with the manufacturer is the mostknowledgeable party and should beresponsible for submitting the notice. EPArecognizes, however, that the actual manufacturer will oftenhave extensive information that would be useful toEPA in its review ofthe new chemical. Therefore, EPA strongly encouragesjoint submissions (see §720.40(e)) in this situation. Sinceboth persons involved in the transaction aremanufacturers, both

are liable for themanufacture ofthe

new chemical ifa notice has notbeen submitted, or thereview period has not expired.

EPA did not adopt the proposed requirement that manufacturers ofnew chemicals solely forexport submit notices under section 5(a) of theAct. ("Manufacture solely forexport" is defined in §720.3(s) ofthe rule.)Instead, EPA will soon propose that manufacturers ofchemicals solely for export submit notices to EPA under section 8(a) priorto manufacture. EPA eliminated the requirement that manufacturers ofnew chemical substances solely forexport submit a section 5notice in response to comments that questioned EPA's legal authority to require such reporting. These comments will be addressed more fully in the preamble to theproposed section 8(a) reporting rule for exportonly chemicals.

The definition of"manufacture solely for export" places certain restrictions on domestic activity. The manufacturer of an export-only chemical may process it only at sites under the control ofthe manufacturer. Distribution in commerce is limited to the activities necessary to export the chemical. Also, the manufacturer ofan export-only chemical may not use the chemical for any purpose, except in small quantities solely forresearch and development.

b.Importers.Under §720.22(b) ofthis rule, persons who intend to import a

new chemical substance for a commercial purpose are subject to section 5notice requirements. This includes chemicals imported in bulk or

as part ofa mixture. Because it would be enormously difficult foran importer
to determine the identity and Inventory
status ofeach chemical substance in imported articles (e.g., automobiles), the rule does not require persons to submit notices on new substances imported as part of articles. However, new chemicals imported in containers used for transportation orfor other purposes

are imported in bulk, not as part of an article, and are subject to the notice requirements.

EPAhas eliminated the separate importer notice forms; importers must

now complete the general notice form. In their notices, however, importers are required to provide information only on exposure which occurs within the United States.

In the January 1979 proposal and in § 720,3(1) ofthis rule, EPAdefines. importer to include the person primarily liable for the payment ofduties, the consignee, the importer ofrecord, the actual owner, and any transferee. This definition, which is adopted from the definition ofthe U.S. Customs Service of the Treasury Department, is consistent with otherdefinitions ofimporter issued under the Act.

Several commenters on the January 1979 proposal suggested that EPA's definition ofimporter did not adequately indicate which party in an import transaction was responsible for submitting a section 5notice. In
response to these comments, EPA clarified importer reporting responsibilities under section 5in the Federal Register ofSeptember 23, 1980 (45 FR 63806). This clarification has been incorporated into the final rulein § 720.3(z) and § 720.22(b).

Under § 720.22(b), the "principal importer" in any transaction leading to the import ofa new chemical substance
must submit a section 5notice. The principal importer is the first importer who selects the new chemical substance and determines the total amount to be imported. The principal importer must know that the substance will be imported, and only a person incorporated, licensed, or doing business in the United States may submit the notice. Occasionally, no one person may fit this definition exactly. In this case, the Prenotice Communications Coordinator should be contacted to determine the appropriate person to submit the notice. Otherwise, the incorrect party may submit the notice, and the notice review period will not begin to run until EPAdetermines who should have submitted the notice and that person actually submits it.Early consultation with the Prenotice Communication Coordinator will avoid this delay. Ifimport ofa new chemical substance occurs before the principal importer submits a notice and the review period expires, all importers involved in the transaction are liable.

The following paragraphs further explain the definition ofprincipal imported.

i.Selecting thechemicalsubstanceto be importer. The principal importer selects the new chemical substance for import. Selecting the substance to be imported includes selecting it by a trade

name orgeneric name as well as by its specific chemical identity. Therefore, the principal importer need not know the specific chemical identity ofthe imported substance. If the specific chemical identity ofthe new chemical substance is known only to the foreign manufacturer or supplier, and the manufacturer or supplier does not wish
to reveal the identity to the U.S. importer, it can report the identity directly to EPA. (See § 720.40(e) ofthe rule.) In this way, foreign companies can protect confidential business information. In any case, however, EPA
must know the identity ofthe substance before thereview period can begin.

Importers, like manufacturers, are responsible for determining whether their substances are on the Inventory and therefore whether they are new chemical substances subject to section 5 notice requirements. A principal importer that does notknow the identity of a chemical substance it intends to import may have its foreign manufacturer or supplier, or some other
person, report the chemical identity to EPA using the bona fide procedures described in § 720.25 of therule. The principal importer would provide the evidence of a bona fide intent to import the chemical. EPA will then search the Inventory for the substance. If anotice is required, EPA will inform the importer. As a result, confidential chemical identitywill be protected, and importers need not file unnecessary notices. 

### 21726

HeinOnline -- 48 Fed. Reg. 21726 1983

### Federal Register 

## / Vol. 48, No. 94 / Friday, May 13, 1983 / Rules and Regulations

ii. Knowing thatthe substancewillbe imported. A principal importer must know that the new chemical substance will be imported intothe United States, rather than manufactured domestically. Ifa person orders a new chemical substance directly from a foreign firm, EPA will consider that person to know that he or she is importing the substance. If a person orders a chemical from a U.S. firm and does notknow and has no reason to know that the U.S. firm will fill the order by importing a new chemical, the person would not be subject to notification requirements or liable under section 15 for failure to submit a notice. In that case, the U.S. firm filling the order wouldbe required
to report.

iii. Specifyingthe totalamountto be imported.The principal importer specifies the total amount of the chemical substance to be imported. If orders are collected from several customers, theperson who collects the orders is theperson who specifies the total amount to be imported and is subject to the notice requirements ofthis rule. Individual customers of the principal importer do not specify the total amount, even though one might have a disproportionately large order.

iv.Incorporated, licensed,ordoing businessin the UnitedStates.A principal importer mustbe incorporated, licensed, or doing business under the laws ofthe United States.

c.Processors. In August 1980, EPA proposed that persons be required to submit a section 5 notice toEPA before they processed for TSCA commercial
purposes substances previously exempt from reporting. Specifically, this applied
to byproducts; tobacco and tobacco products; nuclear materials; substances used solely as pesticides, firearms, ammunition, foods, food additives, drugs, and cosmetics; substances manufactured before January 1, 1975, and not processed and reported for the Inventory after that date; research and development (R and D) chemicals; and substances granted test-marketing exemptions.

EPA proposed processor notification requirements to close a gap in section 5 rules. EPA recognized that notmany chemicals would be subject to notification requirements under this portion ofthe rule; however, EPA saw a need to review therisks associated with the processing and use ofpreviously exempt substances for TSCA purposes before these activities occurred.

Persons who commented on the proposal argued that the requirement

was unnecessary for R and D and testmarketed substances. They argued that manufacturers oftest-marketed substances know how persons who buy the substances are using them because this information is necessary to make

sure they are in compliance with the
terms ofthe particular exemption. Also, manufacturers ofR and D chemicals often know how their customers are using these chemicals. Therefore, EPA has eliminated the processor notification requirement forR and D and testmarketed substances. Ofcourse, ifa company that manufactures or imports a chemical for R and D or test-marketing purposes learns that its customer is using the chemical substance for nonexempt commercial purposes, manufacture orimport ofthe chemical substance for sale to that customer for that purpose must cease until a section 5 notice is submitted and the review period expires.

EPA now also believes processor notification is inappropriate for nuclear materials, tobacco, and tobacco products because these substances are exempt from TSCA,regardless ofhow they are used. In addition, EPA believes that notification by processors of pesticides for nonexempt commercial

uses is unnecessary because the uses of registered pesticides are regulated under the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA). Of course, ifa person intends to manufacture a pesticide for nonpesticide uses, these

uses would not be subject to FIFRA. However, in this case, the manufacturer would be required by the statute to notify EPA under section 5(a)(1)(A) if the substance were not on the Inventory.

EPA also believes that notification for the processing offood and food additives for nonexempt purposes is unnecessary. These substances will already have been approved for human ingestion by the Food and Drug Administration (FDA). FDA also has jurisdiction over cosmetics and devices,

as defined by the Federal Food, Drug, and Cosmetic Act. Therefore, EPA believes that notification by processors offood, food additives, and cosmetics is
unnecessary, especially since persons would still be required under section 5(a)(1)(A) to notify EPA before they manufactured these substances for nonexempt uses.

Finally, EPAbelieves that processor notification requirements are unnecessary for the nonexempt processing ofbyproducts which have no separate commercial purpose. As is true ofR and D and test-marketed substances, the manufacturer ofa byproduct is expected toknow ofany nonexempt uses planned by-its
customer. In such cases, the byproduct would then be manufactured for a commercial purpose and the 

### manufacturer would be required to submit a notice. Notification requirements are also unnecessary for nonexempt processing ofsubstances which have notbeen manufactured sinceJanuary 1975, since such processing rarely occurs.

Based on public comments and its reevaluation ofthe proposal, EPA now believes that processor notice requirements are unnecessary. Therefore, EPA has notincluded these requirements in the finalrule.

d.Agents and jointsubmitters.Under §720.40(e) ofthe rule, persons required to submit a section 5(a) notice may designate an agent to submit the notice for them. Boththe person originally subject to the noticerequirements and the agent mustsign the certification on the form.Therefore, bothpersons are responsible for false or misleading statements in the notice. The person originally subject to the notice requirements remains responsible for the submission to EPA ofallrequired information knownto or reasonably ascertainable byhim orher and all test data in the person's possession or control.

Persons may also submitjoint section 5(a) notices to EPA. For example, a principal importer may ask other parties inthe U.S., such as customers, to complete certain sections ofthe form if they have relevant information. All persons submitting the noticemust sign the certification on the form. Theymust also assert all confidentiality claims according to theprocedures ofthis rule. However, the person responsible forthe notice under section 5(a) is not absolved of statutory noticerequirements by arranging ajoint submission. This person is required to complete all mandatory sections ofthe form, to the extent that he orshe knows or can reasonably ascertain the required information, even ifanother person also submits a certain section. Ifajoint notice is submitted, thenotice review period willnot begin untilEPA has received allrequired parts ofthe notice. Therefore, the person subject to the notice requirements should indicate to EPAwho else willbe submitting parts of the notice and identify those parts.EPA will acknowledge receipt ofthe notice when it has received submissions from all ofthejoint submitters.

2. Whatchemicalsubstancesmustbe reported.Section 5(a)(1)(A) ofthe Act requires persons to notify EPA before manufacturing or importing any new chemical substance, except for substances exempt under section 5(h). New chemical substances are chemical substances riotincluded in the TSCA 21727

HeinOnline -- 48 Fed. Reg. 21727 1983

### Federal Register / Vol. 48, No. 94 / Friday, May 13, 1983 / Rules and Regulations

Chemical Substance Inventory compiled and updated under section 8(b).

Under section 3(2) ofTSCA and 

### § 720.3(e) ofthe rule, chemical substances are defined as any organic

orinorganic substance ofparticular molecular identity, including any combination ofsuch substances occurring in whole or inpart as a result of a chemical reaction oroccurring in nature, and any element or uncombined radical. However, the following substances are excluded from the TSCA definition ofchemical substance: mixtures; tobacco and tobacco products; nuclear materials; firearms and ammunition; and substances used solely

as pesticides, foods, food additives, drugs, and cosmetics.

Manufacturers and importers are responsible for determining whether a substance is a new chemical substance under TSCA and therefore whether they

are subject to section 5notice requirements. The published Inventory will enable persons to determine whether many specific chemical substances have been entered on the list and therefore are not new. However, in difficult cases, EPA will assist persons in ascertaining whether specific substances are on the Inventory.

Ifa chemical substance is listed on the public Inventory under a generic

name to mask its confidential identity,
persons will not be able to determine if

a specific substance falling into that category is a new chemical substance. Therefore, under § 720.25(b) ofthe rule, EPA has established procedures for informing persons whether a substance they intend to manufacture orimport is

a substance on the confidential Inventory, or whether it is a new substance subject to the section 5 notification requirements. Under these procedures, persons requesting this information fromEPA first must demonstrate a bona fide intent to manufacture or import the substance by submitting the items listed in § 720.25(b)(2). These items have not changed from theproposed rule, except that the person need not have a sample ofthe substance available. EPAhas found that samples are unnecessary to establish aperson's intent to manufacture orimport the chemical or to determine whether the chemical substance is on the Inventory. If an importer cannot provide certain requested itemsrelated to chemical identity because its foreign manufacturer or supplier claims them confidential, the importer can request the foreign manufacturer or supplier to send them directly to EPA.

EPA will respond to these inquiries within 30 days ofreceipt of a complete request. Ifthe Agency determines that a substance is not on the Inventory, it will notify theperson submitting the bona fide inquiry that a section 5notice must be submitted before the substance is manufactured or imported. If EPA determines that the substance is on the Inventory, it will inform the person that

a notice is not required. At the same time, EPA will inform theperson who originally submitted the confidential substance for the Inventory that another
person has demonstrated a bona fide intent to manufacture or import the substance and has been notified that the substance is on the confidential Inventory.

3.Exempt chemicalsubstances. Section 5(h) ofthe Act exempts, or authorizes EPA to exempt, certain chemical substances from section 5 notice requirements. In §§720.36 and 720.38 ofthis rule, EPA clarifies several ofthese exemptions. The sections have
not been substantively changed from the corresponding sections ofthe January 1979 proposal. Themost important ofthe exemptions are discussed below.

a.Smallquantities solely forresearch anddevelopment.Chemical substances manufactured or imported only in small quantities solely forresearch and development (R and D) are exempted from section 5notice requirements ifthe submitter complies with § 720.36 ofthis rule.

Like the Inventory reporting rules, this rule defines "small quantities solely for research and development" as quantities that are not greater than reasonably necessary for scientific. experimentation, research, or analysis (including activities associated with product development). As the Inventory rule and support documents indicate, research and development activities include tests ofphysical, chemical, production and performance characteristics. The chemical mustbe used by, ordirectly under the supervision of,a technically qualified
person. Themanufacturer or importer
must evaluate information on the chemical and inform all persons engaged in experimentation, research, or analysis on the new chemical substance ofany risk to health.

The section 5notice rule deletes a note included in the Inventory definition. The note provided that, for
purposes ofthe Inventory, any substance manufactured, imported, or processed in quantities ofless than 1,000 pounds a year would be presumed to be manufactured solely in small quantities for R and D, unless the submitter could certify that the substance was used for purposes unrelated to R and D. This note was intended to provide guidance for manufacturers in evaluating low volume chemicals to determine whether they were eligible for the Inventory. Ifthe note were included in the section 5notice rule, however, it might be misconstrued to mean that section 5 notices arenot required for
any substance produced in quantities of less than 1,000 pounds a year, or that section 5notices must be submitted for all substances produced in quantities greater than 1,000 pounds a year. This deletion does not change the R and D exemption ofthe Inventory reporting. rule, but it eliminates a possible source ofmisunderstanding abouthow substances qualify for such exemptions. In the future, the Agency may clarify the R and D exemption by establishing a

more precise definition of "small quantities" for specific substances or groups ofsubstances.

The final rulemakes clear the manufacturer's responsibility under section 5(h)(3) to ensure that certain
persons arenotified ofany risk to health that the manufacturer believes may be associated with R and D activities on a substance. This notification must go to all persons engaged in experimentation, research, or analysis on the substance, including manufacture, processing, use, transport, storage, or disposal ofthe substance for research and development
purposes. The technically qualified individual supervising the R and D activities must ensure that the notice to these persons is adequate. The rule does
notprescribe methods ofnotification. Rather, it identifies certain acceptable procedures, and leaves it to the individual manufacturers or importers to

ensure that they adequately inform all the persons who must be notified.

Section §720.36(d) states that,upon request, manufacturers and importers
must make available to EPA any information evaluated by the manufacturer or importer in determining the need for notification. This provision differs from § 720.38(d) of theproposed rule which would have required the manufacturer or importer to make this information available to any person exposed to the R and D substance, as well as EPA. EPA has dropped this requirement because it reduces the burden on manufacturers or importers since making this informatioD available
to persons exposed to the R and D substance often would require preparation ofnonconfidential summaries, and possible disclosure of sensitive information such as medical records. This change will not endanger the health ofexposed persons since they willbe notified ofany risk by the 

### 21728

HeinOnline -- 48 Fed. Reg. 21728 1983

### Federal Register / Vol. 48, No. 94 / Friday, May 13,1983 / Rules and Regulations

manufacturer or importer. In addition, EPA will have access to this information, so it can ensure that the notification of'exposed persons is adequate.

The R and D provisions apply to all substances manufactured or imported after the effective date of the final rule, including substances manufactured or imported earlier under the R and D exemption. Therefore, persons that have been manufacturing or importing a chemical under a R and D exemption before the effective date ofthe final rule
cannot continue to manufacture, import, process, distribute in commerce, use, or dispose ofthis chemical under the exemption until they have complied with all therequirements described in §720.36.

b. Test-marketingexemptions. Section 5(h)(1) ofTSCA and § 720.38 of this rule authorizes EPA, upon application, to grant exemptions from any requirements ofsection 5(a) or 5(b) ofthe Act for testmarketing purposes. To grant such an exemption, the Agency must find that the testmarketing will not present any unreasonable risk of injury to health or the environment. Section 5(h)(6) and §720.38(d) provide thatEPA must either
approve ordeny the application within 45 days of its receipt and mustpublish a notice ofits decision inthe Federal Register. IfEPA grants an exemption, it
may impose restrictions on the testmarketing activities. The manufacturer

or importer must submit a section 5 notice for activities beyond those permitted under the exemption.

In Unit II.B. ofthis preamble, EPA provides guidance to persons submitting test-marketing exemption applications and describes the information these applications shouldinclude.

c. Nonisolated intermediates. Under § 720.30(g)(8) oftherule, "any nonisolated intermediate" is not subject
to the notice requirements. Intermediates are defined in §720.3(n)

as substances that are consumed in whole orin part in chemical reactions used for the intentional manufacture of other substances ormixtures, or that are intentionally present for the purpose of altering the rate ofsuch reactions. Under § 720.3(w), a nonisolated intermediate is an intermediate that is
not intentionally removed from the equipment in which it is manufactured.

This definition modifies the definition ofintermediate in the Inventory reporting rule (40 CFR Part 710). Under the Inventory rule, substances that were not intentionally removed from the equipment in which they were manufactured were not considered intermediates and were not subject to thereporting requirements ofthe Inventory rule. 

### Inthe section 5

### notice rule,EPA has defined these substances

as intermediates, buthas exempted them from reporting requirements as "nonisolated intermediates." The change in definition is only forthe sake ofclarity, and does not change the status ofthese substances.

EPA is exempting nonisolated intermediates for several reasons. First, such substances are often extremely difficult to identify; in developing the reporting rule for the TSCA Inventory, EPAreceived numerous comments on this point. Second, because exposure to such substances generally is limited, they generally pose little riskto human health and the environment. Third,in excluding nonisolated intermediates from the Inventory, theInventory reporting rule stated that these and other excluded substances will notbe subject to the section 5notice

- 

### requirements. (See §710.4(d).)

d.Byproducts.This rule expands the definition ofbyproduct contained in the Inventory ruleto include substances which are formed without a separate commerical purpose during the processing, use, and disposal ofthe new chemical. Section 5(d)(1)(A) ofthe Act authorizes EPA to require information

on such substances. This expanded definition is consistent with the definition of"byproduct" proposed in January 1979. Under both theproposed rule andthe finalrule, substances which

were not eligible forinclusion onthe Inventory are not subject to the section 5noticerequirements.
B.InformationSubmissions

1.Scope ofinformationrequirements. On January 10, 1979, EPA proposed 

### notice requirements which included a notice form requiring reporting of detailed information onproduction, processing, use, and exposure of a new chemical substance. Themandatory section ofthe form was designed togive EPA enough information to conduct a detailed review forpossible regulatory action under section 5(e) or5(f). The form included an optional section, asking forinformation onindustrial hygiene, engineering safeguards, and certain nonrisk factors. Basedon public comments on theJanuary proposal and EPA's early experience inreviewing notices,EPA reproposed a shortened formon October 16, 1979.This proposed formwas designed to require only informationneeded for an initial assessment ofa new chemical substance. Under both proposals, ifEPA determined that it needed more informationfrom the submitter or other persons, it could ask thosepersons to submit itvoluntarily, or it could require the information through mandatory supplemental reporting under section 8 ("letter-writing" authority) oraction under section 5(e).

In revising the information requirements for the final rule, EPA has considered the comments received on the previous proposals and EPA's information needs identified in its review ofover 2,200 notices under the Interim Policy.The requirements are limited to (1) information clearly specified in the statute in sections 8(a)(2) (A) through (G) except (E), and (2) other information that is essential to the initial review ofthe potential health and environmental risks presented by a

new substance and which reasonably falls within the intent ofsection 5(d)(1).

This rule further reduces the information requirements from those of the October 1979 proposal. Several
commenters on the October 1979 proposal stated that EPA failed to require information identified in the January 1979 proposal as necessary for review ofthe risks associated with new chemicals. EPA agrees that much of this information can be important in the review ofa new chemical substance. However, the Agency does not believe it is reasonable to require all such information for every substance reviewed under section 5 since EPA has found that detailed information is necessary only after it identifies a specific risk concern. The information required on the final notice form is sufficient for EPA to identify substances ofpotential concern and to determine what additional information is needed in those cases for which more detailed review is necessary.

Under the Interim Policy, EPA has contacted submitters during the review period and requested that they supply additionat1 information when this information was important for its review. Submitters have been generally cooperative in providing the information. In developing this rule, EPA has assumed that such cooperation will continue in the future. Failure to supply such information when it is important to the review may unnecessarily complicate the review, and may result in extension ofthe review period under section 5(c). If EPA does not receive the information it believes is necessary for review, it will take action under section 5(e),when appropriate, to regulate the substance pending submission ofthe information.

Notice submitters must provide all information requested in the form to the
extent that they know orcan reasonably ascertain it. Submitters are also required
to provide test data in their possession 

### 21729

HeinOnline -- 48 Fed. Reg. 21729 1983

### Federal Register 

## I Vol. 48, No. 94 

## / Friday, May 13, 1983 / Rules and Regulations

or control and descriptions ofother data known to or reasonably ascertainable by them, ifthose data concern the environmental orhealth effects ofthe substance. These requirements are described in more detail in the following sections. In addition to required information, submitters may provide EPA with any other information they believe should be considered in its review ofthe substance. The notice is incomplete, and thereview period will
not begin, unless information in the notice form and attachments is in English, except that published scientific literature submitted with the notice need
not be translated.

TheImporter Form proposed in October 1979 has been incorporated into the general notice form resulting in a single form that will be used by all submitters reporting under section 5{a)(1)(A). This change will simplify notification for submitters since they will have to become familiar with only

one form and there will be no confusion

as to which form shouldbe submitted. EPA recognizes that some importers
may not have the same amount of information available to them as domestic manufacturers. Importers,just

as domestic manufacturers, need only submit information specified on the form
to the extent that they know orcan reasonably ascertain it. Importer notices, however, will be held to the

same standard as domestic notices in determining whether the notice is complete or whether action under section 5(e) isnecessary to obtain additional information.

The units below discuss the level of detail required in completing the form, and other general issues.

a. Known to orreasonably ascertainable by. Section 5(d)(1)A) of the Act requires that notices contain certain information on chemical identity,
use, and exposure insofar as itis "known to the person submitting the notice or insofar as reasonably ascertainable." This rule defines known

orreasonably ascertainable information

as "all information in a person's possession or control, plus all information that a reasonable person similarly situated might be expected to possess, control, or know," In response to commenters who believed that the phrase "or could obtain without unreasonable burden or cost" is unclear, EPA has dropped thisphrase from the definition. This is not a subslantive change, however, since such information is included in "information that a reasonable person.

. . might be expected to possess, control or know." Therefore under the new definition,just as it is in the proposed definition, cost and burden are factors in determining whether information is known to or reasonably ascertainable by the submitter.

Many commenters on the January and October proposals expressed difficulty indetermining what information EPA considers to be "reasonably ascertainable." Specifically, they were uncertain about the effort that EPA expects them to make in obtaining certain types ofinformation, and what would constitute an "unreasonable burden orcost." In two parts below-" Information From Other Persons" and "Test Data"-EPA discusses in more detail its interpretation of "reasonably ascertainable" in specific contexts. Also, in Unit C.1.c. below, "Incomplete Submissions," EPA briefly describes notices received under the Interim Policy that did not contain "reasonably ascertainable" information. However, EPA believes that it is not possible to define "know to orreasonably ascertainable" more explicitly.

Also, as discussed in the preamble to the October 1979 proposal, a detailed definition of "reasonably ascertainable"
may result in inequitable treatment of notice submitters. What would be a reasonable effort for one company under certain circumstances might be extremely burdensome for the same company under different circumstances,

orfor another company in the same situation. The meaning ofthis phrase will depend on the specific circumstances surrounding the development ofthe new chemical. The nature of the substance, the projected sales volume and profit, and the size of the company are factors in determining what information can reasonably be obtained. Therefore, EPA believes that "reasonably ascertainable" can be defined only on a case-by-case basis and that notice submitters mustbe responsible for deciding when and how
toobtain required data, and when required information is not reasonably ascertainable. Certainly, in most instances, data-gathering that is so costly as to preclude commercialization is not reasonable.

To minimize the burden on submitters, EPA has dropped theprovision in the proposed rule thatwould have required submitters to provide a briefdescription oftheir procedures for identifying data that are known to or reasonably ascertainable by them. EPA believes this provision is unnecessary; EPA generaiiy canjudge from the notice itself whether it includes information that is known to or reasonably ascertainable by the submitter. EPA will also check 

### this as part ofits compliance inspections.

b. Information from other persons.In many cases, persons other than the notice submitter may have information necessary oruseful forEPA's review. For example, processors and other customers may haveinformation on exposure associated with use or release, and foreign manufacturers and suppliers may have information on chemical identity, impurities, and health and safety data. Some ofthis information must be submitted because it is considered to be in the submitter's possession or control, for example, information that the submitter's parent company or subsidiary hasifthe related company was involved with Rand D, testmarketing, or commercial development ofthe new chemical. Other information may be reasonably ascertainable bythe submitter, ifnot already known, and therefore also must be included in the notice.

EPA, however, has not adopted the requirement proposed in January 1979, that submitters contactcustomers and ask them to submit a Processing and Consumer Use Form.EPA alsohas eliminated the request in the October 1979 form that submitters report the number ofcustomers intending to use the new chemical substance in ways not known to the submitter and to report the percentage ofproduction volume allocated to those customers duringthe first three years ofproduction.The form does, however, ask submitters to estimate how much ofthe substance will be manufactured or imported foreach known category ofuse.

EPA has eliminated mandatory customer contact because information from processors and other customers often is not necessary for substances that do not undergo detailedreview. EPA has found that when this information is necessary. EPA reviewers

can generally obtain it eitherinformally from the submitter or from thepublished literature. Submitters, however, are still encouraged to obtain use and exposure data from potential customers for inclusion in thenotice. The more complete the information in a notice, the less likely it is that EPA willneed to seek more information later,possibly requiring an extensionofthe review period under section 5(c), or regulatory action to obtain information under section 5(e).

The elimination ofmandatory customer contact will reduce the burden

on submitters andtheir customers without significantly reducing the effectiveness ofEPA's review.By requiring the submitter to estimate how 21730

HeinOnline -- 48 Fed. Reg. 21730 1983

### Federal Register / Vol. 48, No. 94 / Friday, May 13, 1983 / Rules and Regulations

much ofa substance will be manufactured for known uses, EPA will be able to determine whether processing and use are likely to cause a problem, or wh-ther more information is needed.

Inthe final rule, EPA has also eliminated therequirement that importers contact foreign manufacturers and suppliers, since muchof the information they could provide (e.g., exposure to workers and release to the environment outside the U.S.) is not subject to EPA's review, and EPA generally does not have the authority to require foreign companies to report. More importantly, EPA believes that under the notice requirements in the finalrule, theprincipal importer will
contact its foreign manufacturer or supplier when necessary toobtain required information. For instance, ifthe principal importer does notknow the specific identity ofthenew substance, it will contact the foreign manufacturer to obtain it; otherwise, the submission will be incomplete and EPA willnot review it. Of course, the principal importer is encouraged to have its foreign manufacturer or supplier submit any other information useful for review to the importer or directly toEPA.

c. Testdataandotherdata.Section 720.50 ofthe rule describes notice requirements for test data and other data related to thehealth and environmental effects ofa new chemical substance. Under section 5(d)(1)(B) of the Act, submitters mustreport all test data related tohealth and environmental effects which is in their possession orcontrol. Under section 5(d)(1)(C), they mustprovide a description of"any other" health and environmental effects data which they know oforcan reasonably ascertain.

Health and environmental effects data

on both the new chemical substance and related substances are necessary for an effective evaluation ofrisks that maybe presented by a new substance. Therefore, the requirements to submit data apply to both the new chemical substance and related chemicals. Related chemicals include impurities, byproducts, degradation products, unintended reaction products, and other chemical substances related to the manufacture, processing, distribution in
commerce, use, ordisposal ofthe new substance.

To eliminate unnecessary reporting, §720.50(c) imposes lesser requirements fordata onrelated chemicals than are imposed for data on thenew substance itself.Unlike the October 1979 proposed rule, the final rule does not limit the reduced requirements to related chemicals on the Inventory. Instead, they apply to all related chemicals, regardless oftheir Inventory status. The submitter isnot required toprovide published data on these substances because EPA can obtain the data elsewhere, regardless ofwhether or not they are on the Inventory. Therefore, submitters need only describe unpublished data on related chemicals.

i. Definitionoftestdata.Section 720.3(gg) defines "test data." Tests, in EPA's definition, include both formal and informal tests and experiments. However, EPA no longer includes recorded observations, monitoring, or measurements as "tests"; instead, these would be "test data" ifthey were obtained in the course ofa test or experiment. EPA believes this change

more closely reflects the general understanding ofthese terms. Test data also include objectives, experimental methods and materials, protocols, results, and data analyses of tests and experiments, as well as raw data and other information relevant to the development and analysis ofthe data.

In the January 1979 proposal, the definition of"test data" included risk
assessments. The final rule eliminates this provision, since EPA no longer believes that an analysis oftherisk presented by the combined effects of hazard and exposure is described by the word "test." EPA has also eliminated the word "study" fromthe final definition of "test data" for the same

reasons. Risk assessments are more appropriately included within the term "health and safety study," which is defined in § 720.3(k). EPA has added risk assessments to the examples of health and safety studies listed in § 720.3(k)(2).

In addition to reflecting more adequately the use ofthe term "test data" in the Act, the new definition will reduce the burden on submitters. Since risk assessments are now "other data" under the final rule, not "test data," submitters need only describe risk
assessments which are known or reasonably ascertainable. Under the proposal, submitters were required to , provide copies ofall risk assessments which were'in their possession or control.

The new definition of "test data," and the reduced reporting requirements which result, will not significantly affect EPA's ability to review the risk presented by new substances. Ifa risk
assessment described by the submitter is needed forreview, EPA will ask the submitter to provide it voluntarily. Ifthe submitter doesnot provide it, EPA may 'extend the review period or take action
to obtain it under section 5(e) of the Act.

ii.Notice requirements fortestdata. Section 720.50(a)(2) ofthe rule requires submitters to provide full reports on test data in their possession or control that

are relevant to the health and environmental effects ofthe manufacture, processing, distribution in

commerce, use, or disposal of the new chemical substance. These include data

on the new chemical substance in pure form, technical grade, and formulated form. Therule requires a full report to be submitted for data on health effects, ecological effects, environmental fate characteristics, monitoring data, and physical and chemical properties related
to health and environmental effects.

A full report mustinclude experimental methods and materials, results, discussion and data analyses, conclusions, references, and the name and address ofthe laboratory that developed the data. EPA has dropped the requirement that the submitter provide data in a specified "full report format"; any format is acceptable ifit includes the items listed. Ifthe test data have been published in the open scientific literature, §720.50(a)(3)(ii) authorizes submitters to provide only a standard literature citation. This provision reduces the requirements of the January 1979 proposal, which allowed submitters to cite articles containing testdata only ifthe periodical in which the articles appeared was listed in Appendix Iofthe proposed form. Any other test data in the submitter's possession orcontrol
may be submitted in summary form. However, the submitter mustprovide a full report upon request by EPA.

Sections 720.50 (a)(4)(i) and (b)(4) of the rule exempt incomplete reports (e.g., from ongoing studies) from the full report requirements. However, submitters must describe the nature and objective ofany incomplete study, report, or test; name and address ofthe laboratory developing the data; progress to date; types ofdata collected; significant preliminary results; and anticipated completion date. In addition, ifthe study orreport yields significant preliminary or final results before the end ofthe notice review period, and if the results were not submitted with the notice, the submitter mustprovide the relevant study, report, or test results to the OTS Document Control Officer within 10 days ofreceipt; but in no event later than 5days before the end ofthe notice review period. If the information becomes available duringthe last 5 days of the review period, the submitter must immediately inform its EPA contact for that notice by telephone. (See "New Information" below.)

iii. PossessionorcontroL In the final rule, EPA haii retained the definition of 

### 21731

HeinOnline -- 48 Fed. Reg. 21731 1983

### Federal Register / Vol. 48, No. 94 

## / Friday, May 13, 1983 / Rules and Regulations

"possession orcontrol" proposed on January 10, 1979. Several commenters on the January proposal suggested that this definition would impose an undue burden on notice submitters, while others believed thatEPA's definition did
not go far enough.EPA, however, believes that its proposed definition is appropriate. Under this definition, the Agency is likely to obtain all relevant data without imposing an unreasonable burden. In particular, by limiting the definition to affiliated companies associated with the development ofthe

new chemical substance, EPA has focused the information requirement on the companies most likely to have relevant data and to profit fromthe new substance. Comments on "possession or control" are addressed more specifically in EPA's Response to Comments, which is available in the Public Reading Room.

iv. Otherdataknown to orreasonably ascertainable by thesubmitter.Section 5[d)(1)(C) requires submitters to describe "any other data," including data from health and safety studies; on health and environmental effects that they know orcan reasonably ascertain. In §720.50(b) of the rule, EPA interprets "any other data" to be (1)test data not in the submitter's possession orcontrol but known toor reasonably ascertainable by the submitter, and (2)
any data, other than test data, that the submitter possesses,controls, knows, or

can reasonably ascertain. Forexample, ifthe submitterknows oftoxicity or environmental fate data in the possession or control ofanother person, the submitteris required under section 5(d)(1)(C) and §720.50(b) to describe those data to EPA. If the data have been published in the open literature, the submitterneed onlyprovide a standard citation. Ifthe data have not been published, or the study is incomplete, the submitter need onlydescribe the data and provide a summaryof the results (ifavailable), or provide the

names and addresses ofpersons who have the data.

The final rule requires less information to describe data from incomplete studies than was required by the January 1979proposal. EPA recognizes that information such as a study's nature and purpose, progress to date, and significantly preliminary results on another persons's ongoing study will seldom be available to the submitter. Also, as a result ofthe revised definition of"test data," discussed inUnit B.l.c.i. above, risk
assessments are "other data" under the final rule, and must bedescribed to EPA

as required by §720.50[b). Section 720.50(b)(1)(ii) clarifies EPA's interpretation of"known to or reasonably ascertainable" as it applies
to data submitted under section 5(b)(1)(C). In thiscontext, known to or reasonably ascertainable includes data known to employees or other agents associated with research and development test marketing, or commercial marketing ofa new chemical substance. These data include data learned by employees as a result of discussions, symposia, and scientific articles.

v.Datathatneednotbesubmitted. Efficacy data and monitoring data on exposure ofhuman or ecological populations outside the United States need not be submitted. In addition,
persons are not required to resubmit any data previously submitted to EPA, as long as they were not claimed confidential. Submitters should identify the data previously submitted, the date it was submitted, and the EPAoffice which received it.However, it is sometimes difficult ortime-consuming for the Office ofToxic Substances to obtain such information from other EPA offices in time to complete its review. Therefore. EPA encourages submitters
to include all relevant information with the notice.

Relevant data previously submitted to another Federal agency must be included with the section 5 notice. This represents a change from the proposed rules which would not have required notices to include information already submitted to other agencies. EPAmade this changebecause experience under the Interim Policy indicates that it is difficult to obtain information from other agencies in time to analyze and use it during the 90-day review period. EPA does not believe this change will be burdensome to submitters, since relatively fewdata described or submitted as part ofsection 5 notices have been previously submitted to other Federal agencies.

d. Newinformationordata.During the notice review period, submitten may obtain additional information that
may be relevant to EPA's review. Section 720.40ff) oftherule requires submitters to provide EPA with this information ifit materially adds to. changes, ormakes significantly more complete the information contained in the original notice. Examples of information that mustbe submitted under this provision include: preliminary

orfinal results ofhealth and environmental effects testsnot previouslyknown to the submitter, or not complete at the time ofnotice submission; new uses not described in ,the notice; significant increases in estimated production volume; new information significantly adding to information on chemical identity (e.g., significant changes in impurity levels,

new information characterizing complex reaction products or polymers); and similar information.

The proposed rule would have required thisinformation to be submitted to EPA "immediately." Commenters asked for more specific guidance on how long they would have
to submit new information. The final rule now specifies that the information
mustbe submitted within 10 days of receipt,but no later then 5 days before the end of the review period. Ifthe information becomes available during the last 5 days ofthereview period, the submitter must telephoneits EPA
contact for the notice "immediately." EPAinterprets this to mean as soon as possible, generally within 24 hours.

2. Section-by-SectionReview ofthe NoticeForm.The following paragraphs describe themajor differences between the form proposed on October 16, 1979, and the finalform issued with this rule.

a. Submitteridentification. This section remains generally the same as in the October form. However, submitters

are now asked toprovide prenotice communication, bona fiderequest, and test-marketing exemption numbers to help coordinate the Agency's review. The parent company no longer mustbe identifed because the Agency believes that itcan be obtain thisinformation from the submitter during thereview period in the few instances itis needed.

The form also eliminates the requirement that submitters state the intended date ofcommencement of manufacture or import and submit evidence ofintent to manufacture ifthe intended dateis more than 3years after the date of the notice. EPA agrees with
commenters that the submitter's certification onthe form is sufficient evidence ofintentto manufacture or import.However, EPA generally
encourages manufacturers and importers to submit notices as close as isfeasible to 180 days before manufacture orimport is expected to begin, since earlynotices aremore likely to have more complete information.

b. Chemicalidentity.For the most part,the requirements'for information

on the new substance's identity remain the same as in the October 1979 proposal. However, manufacturers and importers ofnew polymers must provide 'slightlydifferent information than that specified in October. Instead of providing the range of composition of 

### 21732

HeinOnline -- 48 Fed. Reg. 21732 1983

### Federal Register 

## / Vol. 48, No. 94 / Friday, May 13, 1983 / Rules and Regulations

each monomer in the polymer, manufacturers need only estimate the typical composition ofthe monomers and other reactants, e.g., catalysts and initiators. This information is necessary to evaluate fully the composition ofthe polymer. Submitters also must provide a representative structural diagram. The Agency has found that the majority of submitters have been able to develop such diagrams. To define further the composition of the new polymer, submitters mustprovide an estimate of the percent of thepolymer composition below 500 and 1,000 molecular weight and describe how the estimates were made. The Agency believes that such information is essential to characterize fully the unique identity ofthe new polymer and its associated risks.

The rule requires that manufacturers provide at least one generic name for the substance, when chemical identity has been claimed confidential. EPA
agrees with commenters that the requirement to provide three names, contained in the October proposal, is
unnecessary, since the three names generally mask the identity ofthe substance to a similar degree. EPA
encourages submitters to consult with EPA to develop a useful generic name before submitting the notice. If EPA determines that the generic name provided with the notice is inadequate, submitters willbe required to develop a

new name when the identity is added to the Inventory upon commencement of manufacture.

In general, the specific chemical identity ofa substance is a critical element ofthe notice. Ifa submission does not adequately provide this information, EPA will determine that it is incomplete. If the submitter does not know the identity ofa new chemical substance-for example, because it imports the substance under a trademark or makes itfrom unknown reactants-the submitter may authorize another person to report the specific identity or information that allows EPA
to determine the identity. The submission, however, willbe considered incomplete and the review periodwill
not begin until EPA receives this information.For a discussion of incomplete submissions, see Unit III.C.1.e. below.

c.Production anduseinformation. Thisrule requires reasonable estimates ofthe maximum production volume during the first year ofproduction and the maximum 1?-month production volume during the first 3 years of production. EPAbelieves that these projections provide sufficient information to perform its exposure assessment and economic analysis. The proposed rule would have required submitters to report both maximum and minimum projections for eabh ofthe first 3 years ofmanufacture. Since EPA's review ofnotices under the Interim Policy has typically focused on the first
year production volume and anticipated maximum volume, more detailed requirements are notjustified.

The final rule requires information on the intended categories ofuse ofthe

new substance in a level of detail similar to that contained in the January proposal. However, it does not require that the submitter consult the standard

use classification system developed by EPA forproviding its use description. EPA believes that the general concepts of "function" and "application" provide

an appropriate method ofcategorizing

uses. A description ofuse in terms ofthe substance's chemical function and the general application ofthat function will provide EPA with sufficient information
to identify the populations exposed to the new substance and the nature of that exposure. The submitter also must provide the estimated percent of production volume devoted to each category ofuse.

Many commenters stated that EPA does not have the authority to require information beyond the broadest category ofuse (e.g., surfactant, photographic chemical) or that use information, at the level of detail required, is not typically known by the manufacturer.EPA disagrees. The category ofuse description required under these rules is consistent with the general intent under section 5(d)(1) to provide EPAwith the information
necessary for review. Adequate information on the use of a substance is critical in the evaluation ofthe potential risks associated withhuman exposure to and environmental release ofthe new substance in that use. EPA has found that the information required in this section is the minimum necessary to conduct a review of such risks. In addition,EPA has found that such information is available to the great majority ofnotice submitters because substances are typically manufactured fora particular use.

Under section 5(d)(2) of the Act, EPA
must issue the uses orintended uses ofa

new substance for publication in the Federal Register. EPA willpublish the

use as reported in the notice unless it is claimed confidential. Consistent with the Act's requirements and the October proposal, this rule requires manufacturers who claim use tobe confidential to provide a nonconfidential (generic) use description which EPA can issue for publication in the Federal Register.

d.Hazardinformation. This rule retains the requirement to submit a copy

orreasonable facsimile ofany hazard information which will be provided to workers orcustomers, e.g., a Material Safety Data Sheet. Several commenters stated that hazard information is not required under section 8(a)(2). EPA believes that such information falls clearly within the requirements of section 5(d)(1)(C) ofthe Act since it provides data on the potential exposure and health effects of the new substance. Such information has been an important factor in EPA's evaluation ofnew substances under the Interim Policy.

e. Transportation anddetection methods.EPA has eliminated proposed questions on transport and detection methods. Again, experience indicates that data in response to these questions is not especially useful in notice review.

f.Humanexposureandenvironmental releaseinformation.EPA has retained therequirement that submitters describe the manufacture and processing operations involving the new chemical substance at sites they control. Commenters on the October proposal stated that providing this informatioh would be unduly burdensome and might jeopardize the confidentiality ofprocess information. However, in its review of notices under the Interim Policy, EPA has found the process description
necessary to make qualitative estimates ofpotential workplace exposure, to estimate the amounts ofthe new substance and byproducts released, and
to evaluate estimates provided in other parts ofthe form. EPA has also found that process descriptions based on known or reasonably ascertainable information may be developed by submitters in less time than was originally anticipated, and that OTS procedures adequately protect any confidential business information contained in the notice.

In response to these comments, however,the Agency has reduced the
amount ofinformation it willrequire in theprocess description from the requirement proposed in October. EPA does not require that a mass balance of materials entering and leaving majorunit operations and chemical conversions beprovided, nor must submitters report the methods of transfer of materials and whether the operations are open or closed to the workplace. Based on its experience under the Interim Policy, EPA has found that identification ofmajorunit operations and chemical conversions, identity and mass of materials entering 

### ' 21733

HeinOnline -- 48 Fed. Reg. 21733 1983

### Feaeral Register / Vol. 48, No. 94 / Friday, May 13, 1983 / Rules and Regulations

the process, and points ofrelease ofthe

new substance is sufficient for its initial review and is information known to or reasonably ascertainable by submitters.

The sections of the form on occupational exposure to and environmental release ofthe new substance are largely unchanged from the October form. Instead ofrequiring the specific routes by which workers will be exposed, submitters need only identify the activities ofworkers. This

more generic approach will still provide EPA with a more accurate indication of exposure potential. Submitters also are not required toprovide estimates ofthe concentration ofthe new substance in the workplace because EPA can make such estimates from the process description to the extent necessary for its initial review. Submitters are now required to identify the type ofcontrol technology used to control environmental release since control equipment is frequently used and since manufacturers typically have identified the equipment that will be used by the time the notice is submitted. The final rule does not require estimates ofthe duration ofrelease for each point of release. EPA will instead use reasonable estimates based on the duration ofthe process in its release analysis.

g. Sitescontrolled by others.The section on industrial sites controlied by others has been modified to require general information on the activities of
customers who process and use the new chemical substance. Submitters must provide a narrative description of processing and activities focusing on those aspects which relate to the potential forhuman exposure and environmental release ofthe new chemical substance to the extent that they know or can ascertain this information.

The October proposal would have required submitters to provide the same quantitative estimates for sites controlled by others as for the sites which they controlled themselves. However,manufacturers typically do
not have such detailed quantitative information on activities not under their control. Furthermore, the specific circumstances ofcustomers' operations may vary, and all customers may not yet be known, so that itmay be difficult to make quantitative estimates.The narrative description required in the form will provide sufficient information for EPA to evaluate potential worker exposure and environmental release at customers' sites for EPA's initial review, and allow identification ofadditional information needs where the Agency has identified a specific concern. In this case, EPAmay contact the submitter or possible customers to obtain additional information.

h. Consumerandcommercialuser exposure.EPA has eliminated this section from the final form. Thus, manufacturer estimates ofexposure that would result fromcommercial and

consumer use ofthe new chemical substances or final products containing the new substance are not required. EPA intends to use the information provided in the "use" section ofthe form and other information, such as production volume, physical/chemical properties, and itsnwn knowledge oftypical commercial and consumer exposure scenarios, to evaluate commercial and

consumer exposure. EPA's experience "underthe Interim Policy indicates that it

can conduct such an evaluation where the submitter provides the information required in other sections of the form.

i.List ofattachments. The list of attachments is generally the same as it

was in the October form. For a discussion oftest data requirements, see Unit III.B.1.c. of this preamble.



### j. Optionalinformation. The final form does not contain a detailed optional information section as was proposed in the January 1979form. EPA believes such a detailed section may limit the information that might be submitted and, by identifying specific questions, may make optional information seem mandatory. The Instructions Manual describes generally those items in which additional information would be most helpful in EPA's review. For example, submitters may wish to provide information on relative risk, process chemistry, efficacy, additional exposure and environmental release information, industrial hygiene, engineering safeguards, use restrictions, and economic and otherbenefits ofthe new substance. Information in these areas may eliminate the need for extensive communication between EPA and the submitter during thereview period and may reduce the possibility ofan extension ofthe notice review period under section 5(c) orregulation under section 5(e) or5(f). Although submitters

are encouraged to submit optional information, they are inno way required
to do so.

k. Federal Register notice.EPA has eliminated the section ofthe October formwhich requested information for the section 5(d)(2) Federal Register notice. Sections for generic descriptions ofconfidential chemical identity and category ofuse have been moved to other parts of the form. In compiling the section 5(d)(2) notice, the Agency will assemble the necessary information from the various parts of the notice. For



### a further discussion ofgeneric descriptions, see Unit III.D. ofthis preamble.

I. Confidentiality claims.Submitters
may assert claims of confidentiality for
any information on the notice form and
any attachments to the form, although they should note that under section 14(b), claims forinformation in health and safety studies will be denied unless disclosure would reveal process information, proportions of a mixture, or information unnecessary to interpret the study. (See Unit III.D.4) Instructions for making claims are given on the form. If chemical identity or use is claimed confidential, the submitter must provide

a generic chemical name or generic use that is as specific as possible.

EPA no longer requires substantiation ofconfidentiality claims when the notice is submitted. However, any submitter that claims information confidential
must supply two copies of the notice: One complete copy, and one "sanitized" copy with all confidential information deleted. EPA will put the sanitized copy in the public record. The notice is incomplete, and the review period does
not begin, until EPA has received both the complete notice and the sanitized notice. EPA explains its confidentiality policy in more detail inUnit III.D. ofthis preamble.

C.NoticeandReview Procedures
1.SubmissionandProcessing of Notices.

a.Acknowledgement ofreceipt.Under §720.65(a), EPA will acknowledge receipt ofeach notice by letter to the submitter. The 90-day notice review periodbegins on the date ofreceipt indicated on the letter of acknowledgement.

b. Consolidated notices.In the course ofreviewing section 5 notices under the Interim Policy, groups ofnotices were often submitted for substances which

were similar in structure and use.These notices contained a large amount of duplicative information, such as exposure, release, or use data. In
response to requests for relief from submitters, EPA has developed procedures for submission of a "consolidated" notice. Persons who intend to manufacture or import two or

more structurally related new chemical substances may contact the Prenotice * Communications Coordinator to obtain approval to submit a single "consolidated" section 5 notice for the related substances. The submitter must identify each new chemical substance individually; a consolidated notice
cannot be submitted for an open-ended 

### 21734

HeinOnline -- 48 Fed. Reg. 21734 1983

### Federal Register / Vol. 48, No. 94 / Friday, May 13, 1983 / Rules and Regulations

category ofchemicals. A consolidated section 5 notice is suitable for chemical substances with the same or similar

uses and for which there are similar test data or other information. Manufacturers may not submit a consolidated notice on a series of intermediates and a final product in a given process because these chemicals do not sufficiently share common test data orother information.

EPA will not accept a consolidated notice unless the submitter has contacted the Prenotice Communications Coordinator to determine whether the group of chemicals are sufficiently similar that they are suitable for review in a consolidated notice. EPA encourages submitters to submit consolidated notices when appropriate; such notices will reduce the burden on the submitter of preparing multiple section 5 notices sharing common information. Consolidated notices also will improve the efficiency and consistency ofEPA's review by allowing the staffto review structurally related chemicals, and the data and other information that are

common to them, at the same time.

c. Incompletesubmissions.Under § 720.65(c) of this rule, EPA may determine that a submission is incomplete, and therefore does not constitute a notice under section 5of the Act. For example, failure to provide chemical identity or otherwise to supply information required in the notice form, if that information is known to or reasonably ascertainable by the submitter, willresult in a submission that does not constitute a notice. A submission is incomplete if all information (except information published in the scientific literature) is
not in English or test data and other data are not complete. A submission is also incomplete ifthe submitter claims information confidential and does not submit a second copy of the notice from which all confidential information has been deleted. The review period will not begin until the submission is complete.

Ifa submission is incomplete, EPA
may first request the missing information from the submitter by telephone. Ifthe submitter does not provide it quickly, EPA will inform the submitter in writing within 30 days of receiving the submission thatit is incomplete. However, ifEPA obtains additional information during the notice review period, from the submitter or elsewhere, that indicates the original submission was incomplete, EPA may declare the notice incomplete within 30 days ofreceiving the new information.

Under § 720.65(c) (4)and (5), submitters may file objections to an EPA finding that a submission is incomplete with the Director ofthe Office ofToxic Substances ("theDirector"). The Director, orhis orher delegate, will determine whether the original submission was complete or incomplete,

or will modify the requirements for completing the submission. Ifthe Director affirms that the original submission was incomplete, the notice period will not begin to run until EPA receives the missing information. If the Director finds that the original submission was complete, the 90-day review period will resume on the date that EPA notifies the submitter that the notice is complete. Therefore, ifEPA informed the submitter that the notice

was incomplete on the 15th day, the day after EPA finds the notice was complete would be the 16th day. However, ifEPA

can complete its review by the date 90 days from the date ofthe original submission, the Director may inform the submitter that the review period began when EPA received the original notice and has run without interruption. EPA recognizes that resuming the review period on the date EPAnotified the submitter that the submission was incomplete may conceivably delay the
start of manufacture or importation in

some cases; however, EPAhas an overriding responsibility to conduct an adequate review which ensures against

a potential risk tohuman health or the environment. EPAwill avoid delaying the starting date whenever possible.

IfEPA identifies a minor problem in the submission, such as failure to date it

or a typographical error that renders an entry ambiguous, it may,under § 720.65(b), ask the submitter to correct the notice. The submitter is under no obligation to make the correction, but failure to do so may cause EPA to extend the review period under section 5(c) of the Act. Of course, ifthe submitter corrects the minorproblem, EPA may still extend the period under section 5(c) ifgood cause otherwise exists.

The final rule modifies the procedures for incomplete submissions proposed in January 1979. Under the proposed procedures, submitters had no formal appeal procedures ifEPA determined that a submission did not meet the standards forreview, and the review period for submissions with minor errors could be stopped until the errors were corrected. EPA has changed these requirements in response to comments and because ofits experience under the Interim Policy.

EPA,however, disagrees with
commenters who argued that EPAhas

no authority to determine that a submission is incomplete, and that EPA's only remedy is section 5(e). The Act explicitly requires the submitter to provide certain information in a section 5(a) notice that is known to or reasonably ascertainable by the submitter. A submission that fails to meet the minimum statutory requirements, therefore, is not a complete notice under the Act, and EPA isjustified in refusing to review it. Section 5(e) is not an appropriate remedy for this situation. The purpose of section 5(e] is to allow EPA to regulate

new chemical substances "pending the development ofinformation" necessary for a reasoned evaluation ofhealth and environmental effects. Its purpose is not togather information that the submitter already knows or can reasonably ascertain and that is required by the Act
to be submitted in the initial notice.

Under the Interim Policy, EPA has received several submissions that, it believed, did not include required information thatwas known or reasonably ascertainable by the submitter and which therefore did not meet the statutory requirements. For example, one submission did not include the molecular structure of the new chemical substance. EPA scientists determined that representative molecular structures for the substance

were in factknown to or reasonably ascertainable by the submitter, because

a knowledgeable chemist would be able
to derive the structure from process information. Therefore"the notice review period did not begin until this information was provided to EPA.

In another case, the submitter described the category ofuse ofa new chemical substance only as "photographic chemical" without specifying its end use in terms ofits function and application (e.g., reducing agent in developer solution). The term "photographic chemical" was inadequate for EPA's assessment of potential human exposure and environmental release. In a third type of problem, submitters often have described the chemistry ofthe manufacturing operation without indicating the order and type (e.g., distillation, mixing) of the manufacturing steps. For example, manufacturers of coatings for manufactured parts have sometimes failed to provide information

on coating operations at sites they do
not control. In such cases, ifEPA staff
cannot quickly obtain the information from the submitter in response to a telephone request, EPA will declare the notice incomplete and the review period willnot begin until EPA receives the information. 

### 21735

HeinOnline -- 48 Fed. Reg. 21735 1983

### Federal Register / Vol. 48, No. 94 / Friday, May 13, 1983 / Rules and Regulations

d. Extensionof reviewperiod.Section 5(c] ofthe Act provides thatEPA may extend the 90-day review period forup to an additional 90 days for good cause. Section 720.75(c) ofthis ruleprovides that EPA will notify the submitter ifEPA extends the period and gives examples ofcircumstances thatEPA believes could constitute good cause for extension. EPAwill also issue for publication a Federal Register notice when itextends a review period under section 5(c). The notice will describe the extension and give the reasons for it.

e. Suspensionof reviewperiod. Section 720.75(b) ofthjs rule provides that a notice submittermay voluntarily suspend the running ofthe review period at any time,but only ifthe Director, orhis or her delegate, agrees. If the Director does not agree, EPA will notify the submitter and the review period will continue to run. The suspension mustbe for a specified period of time. If the notice submitter makes therequest orally, the Director
may grant a suspension for 15 days. EPA will send the submitter a written confirmation ofthe suspension ifit is granted orally. TheDirector will extend the suspension ifthe OTS Document Control Officer receives a written confirmation ofthe request within 15 days ofthe approved oralrequest. In this case, the running of the review period is suspended as of the date ofthe confirmed oral request. The notice submitter also may request a suspension in writing. In this case, the suspension begins the date the Document Control Officer receives the request, ifEPA
approves the request.

Under the Interim Policy, EPAhas found suspension of the review period
may be beneficial when questions concerning anew chemical substance that arise during the notice review period can be adequately addressed by the notice submitter. Suspension ofthe review period is often helpful in these

cases because a submitter may not be able to respond toEPA's concerns within thereview period, even ifEPA extends the period to 180 days under section 5(c).For example, in one instance the Agency needed more detailed use and exposure information which the submitter was able to obtain from potential customers. In other cases, the notice review period was suspended
to allow time for voluntary health effects testing, and for chemical analysis
to determine the levels ofcertain impurities. Voluntary suspensions benefit both EPA and notice submitters because they save EPAresources and often eliminate the need for regulatory action. 

### f.Closeoutandcommencementof manufacture. Under § 720.75(d), EPA will notify submitters when the notice review period has ended, ifEPA has not taken action under section 5(e) or 5(f) of the Act. EPA will inform submitters that they can begin manufacture or import forcommercial purposes. This action does not constitute EPA approval or certification ofthe substance and does
not preclude laterregulatory action by EPA. Submitters may begin to manufacture orimport a new chemical substance after the close ofthereview period, even ifthey have not been notified by EPA that the review period has ended. In the final rule, EPA has dropped the notice of continuing review proposed in January 1979, since the closeout notification can serve the same purpose, i.e., informing the submitter of
any concerns EPAmay have aboutthe

new chemical substance, and any regulatory actionsbeing considered. Also, there is no obligation that EPA inform a submitter that it is contemplating regulation ofthe new chemical substance.

Section 720.102 requires that submitters notify EPA when they begin
to manufacture or import the new chemical substance, so EPA may add the substance to the Inventory.The submitter mustprovide chemical identity, premanufacture notice number, and the date that manufacture or import for commercial purposes begins. EPA proposed this requirement in January 1979and believes that most notice submitters to date have notified EPA when they began manufacture or import. However, anypersons who already have begun tomanufacture or import a chemical substance after undergoing notice review, but who have not yet submitted a notice ofcommencement or manufacture, must submit the notice by the effective date ofthis rule to allow EPA to update the Inventory.

2. SupplementalReporting.In January 1979, EPAproposed supplemental reporting ("letter-writing") authority which would have enabled EPA to obtain additional written information on

a new chemical substance orrelated chemicals during the notice review period. EPA alsoproposed an analogous provision forrequesting health and safety studies.EPA based its authority
to obtain certain information known to

or reasonably ascertainable by the submitter and others on section 8 ofthe Act. Even after the scope ofreporting

was narrowed in the October 1979 reproposal, many commenters objected
to the supplemental reporting provisions, arguing that EPA does not have authority to require such reporting. Since the reporting requirements in the final rules are reduced from those in the proposed rules, the ability ofEPA to obtain additional information during the review period is especially important. While EPA stillbelieves it has the authority under section 8 to obtain additional information from the submitter and others who may have information about the new chemical substance during the notice review period, EPA has not adopted supplemental reporting authority because it has proved unnecessary to an effective section 5notice review
program. EPA also has eliminated the provision for requesting health and safety studies on the new chemical substances orrelated chemicals. EPA has found that telephone calls to submitters are generally adequate to obtain additional information during the notice review period. In the occasional

case where a submitter is unwilling to provide the information, EPA has the option oftaking action under section 5(e) (regulation ofa new chemical substance pending development ofnew information) or sectiqn 11 (subpoena authority). Although these actions are

more resource-intensive and timeconsuming than a supplemental reporting request, such formal actions will rarely be necessary. However, EPA is prepared to act under these authorities when submitters do not provide the necessary information.

3. Actions UnderSections5(e) and 5(f). In the final rule, EPA has deleted §§720.36 and 720.37 of the January 1979 proposal, which described EPA's procedures for taking action under sections 5(e) and 5(f). It is not necessary to include these provisions in the rule, because many ofthe procedures are already set out in the statute, and because submitters willbe notified of theremaining procedures when EPA takes action against a specific substance. In dropping these sections, EPA has deleted theprovision that would allow it to notifypersons other than the notice submitter, who would be affected by the order, ofthe basis ofa proposed section 5(d) or 5(f)action. Many commenters objected to this provision, arguing that only the notice submitter couldbe subject to a section 5(e) or 5(f) order.EPA will notify only those persons subject to a section 5(e) or 5(f)order, and it will allow only those
persons to file objections to the order. Of course, any person who uses a new chemical substance that theperson knows orhas reason to know was manufactured, imported, processed, or distributed in commerce in violation of a 

### 21736

HeinOnline -- 48 Fed. Reg. 21736 1983

### Federal Register / Vol. 48, No. 94 / Friday, May 13, 1983 / Rules and Regulations

section 5(e) or 5(f) order is in violation ofsection 15 of TSCA.

EPA has also eliminated § 720.37(b)(6) of the January 1979 proposal, which provided thatEPA would consider subsequent notice submissions for substances subject to a section 5(f) 

### orderto be applications for modification

or revocation ofthe order,rather than section 5notices. This section was eliminated because EPArecognizes that

a subsequent submission for a chemical substance subject to a section 5(f) order might describe different conditions of exposure which might notpresent an unreasonable risk. Therefore, EPA will consider these submissions to be section 5notices, andthey willundergo review.

4.Recordkeeping.The final rule retains the provision in the proposed rule that requires notice submitters to retain documentation of information in the notice. Thiswould include the

sources ofinformation provided in the notice, e.g., production volume estimates in marketing plans. Submitters alsomust keep records ofproduction volume for the firstthree years ofproduction and the date ofcommencement of manufacture or import,and documentation ofthis information. In addition, submitters must keep copies of "other data," which they were required to describe in §720.50(b), ifthey are in the submitter's possession orcontrol. This information mustbe retained for5 years from the date ofcommencement of manufacture.

EPA has dropped the provision that the submitter retain health and safety data referenced in the notice for30 years. EPAbelieves this provision is unnecessary because the submitter must include these data, ora standard literature citation to these data, with its notice. Therefore, EPAwill already have thedata in its own files.

Persons who manufacture or import a chemical substance under the terms of

an R and Dexemption must retain documentation of compliance with the exemption requirements, including copies of theinformation they used to determine the heed to make any notification ofrisk to health orto persons exposed to the chemicals. This information mustbe retained for5years from the final date ofmanufacture or import under the exemption.

Persons who aregranted a testmarketing exemption application must retain documentation of information submitted in the notice.They also must document compliance with any restrictions EPA imposes when it grants the exemption. This information must be retained for five years from the final date ofmanufacture or import underthe exemption. 5. ComplianceandInspections.It is unlawful for any person to fail orrefuse
to comply with any provision of section 5 or any rule promulgated under section 5. Manufacture orprocessing ofnew chemical substances without complying with section 5 and this rule is a violation ofsection 15. When more than one manufacturer orimporter isinvolved in

a transaction, each oneis liable for manufacture or import of a new chemical substance ifa notice has not been submitted or the review period has
not expired, even though only one person involved in each transaction (e.g., theprincipal importer) may submit the notice.

Section 15 ofTSCA makes it unlawful for anyperson to: (i) Use for commercial
purposes a chemical substance or mixture which such person knew orhad

reason to know was manufactured, processed, ordistributed in commerce in violation ofthis rule.

(ii) Fail orrefuse to establish and maintain records or topermit access to

orcopying ofrecords as required by the Act or a rule promulgated under the Act.

(iii)Fail or refuse to permit entry or inspection as required by section 11.

Violators may be subject to criminal and civil liability. Persons who submit materially misleading or false information in connection with the requirement ofany provision ofthis rule
may be subject to penalties calculated

as ifthey never filed their notices. Under the penalty provision ofsection 16 ofTSCA, any person who violates section 15 could be subject to a civil penalty of up to $25,000 foreach violation. Each day of operation in violation could constitute a separate violation. Knowing or willful violations of this rule could lead to the imposition ofcriminal penalties ofup to $25,000 for each day ofviolation and imprisonment for up to one year. Other remedies are available to EPA under sections 7 and 17 ofTSCA such as seeking an injunction to restrain violations of the rule and the seizure of chemical substances manufactured orprocessed in violation of therule.

Individuals as well as corporations could be subject to enforcement actions. Sections 15 and 16 apply to "any person" who violates various provisions ofTSCA.Thus, in actions under section 16, EPA may, at its discretion, proceed against individuals, such as corporate officials, as well as the companies themselves. In particular, this includes individuals who report false information

or who cause it to be reported.

EPA will also direct its resources to detecting violations ofother aspects of the section 5notice rule, particularly the terms ofexemptions for research and development and for test marketing.

EPA will conduct inspections under section 11 ofTSCA to assess compliance with the requirements of section 5 and this final rule. Inspectors will compare the information in the submitter's notice with the actual conditions of manufacture or import to verify that the information was correct, estimates were reasonable, and any exposure controls described in the notice are in place.

D. Confidentiality

The Act recognizes the importance to industry ofmaintaining the confidentiality ofcertain business information; section 14 allows a submitter to claim confidentiality for any information submitted to EPA under the Act.-However, the Act also makes clear that the public interest in chemical regulation must also be considered, and in certain cases, outweighs the protection ofconfidential business information. Thus, section 14 also provides that health and safety studies
may be revealed and that any confidential information may be revealed ifnecessary to protect health

or the environment from an unreasonable risk ofinjury.

Certain provisions ofsection 5 also highlight EPA's responsibility to provide meaningful information to the public concerning new chemical substances. Section 5(d)(1) states explicitly that a section 5 notice mustbe made available for "examination by interested persons," subject to the confidentiality provisions of section 14. Further, section 5(d)(2) requires EPA to issue forpublication a Federal Register notice upon receipt of each section 5 notice, that identifies the chemical substance, lists the intended
uses, and describes test data, also subject to the confidentiality provisions ofsection 14. More generally, the Act includes a variety ofprovisions under which citizens can petition EPA to take particular actions on section 5 notices. These provisions indicate that Congress intended informed citizen involvement inreview ofnew chemical substances, although EPA is to be the primary decisio.nmaker. Public participation
cannot be effective unless meaningful information is made available to interested persons.

In addition to these responsibilities which are related directly to the Act, EPA has general responsibilities under the Freedom ofInformation Act (FOIA). Under the FOIA,persons may request disclosure ofany information submitted in a notice. When such a request is made, EPA, in accordance with the 

### 21737

HeinOnline -- 48 Fed. Reg. 21737 1983

### Federal Register 

## / Vol. 48, No. 94 / Friday, May 13, 1983 

## / Rules and Regulations

procedures of40 CFR Part 2, Subpart B,
must review information which is claimed confidential to determine whether it is entitled to confidential
treatment. IfEPA determines that the information is confidential and therefore does not disclose it, the FOIA requester may bring an action in Federal court to review EPA's decision.

The confidentiality provisions in the final rule take into account various requirements under the Act, including the need: (1) to provide nonconfidential information to the public, (2) togive EPA information itneeds to respond to FOIA requests, (3)to allow pqrsons to assert claims ofconfidentiality with the minimum burden, and (4) to reduce uncertainty about the criteria EPA will

use in making its confidentiality determinations. In determining the final confidentiality provisions, EPA also considered its experience with section 5 notices under the Interim Policy as well

as comments received on the January 1979 and October 1979 proposals. EPA believes these provisions represent a balance between the industry's need for confidentiality ofbusiness information and the public interest in having access to information about new chemicals.

1.AssertionofConfidentialityClaims. A person may assert a claim of confidentiality for any information submitted to EPA. Submitters must assert the claim when they submit the confidential information. If the

- information to be claimed confidential is contained on the notice form, submitters
must assert their claims by marking the box on the form adjacent to the item.To
assert a claim for information in an attachment to the form, submitters must clearly mark all confidential items in the attachment.

Any submitter that claims information confidential must provide two copies of its submission: a complete copy ofthe notice including all confidential information and a "sanitizied" copy in which all confidential information has been deleted. EPA will assume that the submitter has prepared a sanitized copy that accurately deletes any information claimed confidential. EPAwill place the submitter's sanitized copy in the public file. If the submitter does not provide a sanitized copy, the submission is incomplete and the notice period will
not begin. EPAbelieves this provision is in the best interest ofthe submitter, the public, and EPA.

Alternatively, ifthe submitter does
not provide the sanitized copy with the notice, EPA could consider the submission complete and allow the submitter to provide the sanitized version early in the notice review period. However, this would deprive the public ofaccess to the notice information for a significant portion of the review period. EPA could also
prepare the sanitized copy itself. However, this would require substantial EPA resources and there is a chance that EPA inadvertently would not delete all ofthe information claimed confidential. In addition, EPA believes It is more efficient for the submitter, which is more familiar than EPA with the nature, extent, and rationale for the claims, to prepare the sanitized copy. EPA also considered the alternative of putting the entire notice, including information claimed confidential, in the public file ifthe submitter did not provide a sanitized version. However, EPA believes this would be unnecessarily harsh. Therefore, EPA believes that treating the notice as incomplete until it receives the sanitized version is the most equitable policy.

2. GenericInformation.A submitter that claims chemical identity or use confidential mustprovide generic information for release to the public. By requiring generic chemical names and

uses, EPAcan meet its obligation to provide thepublic with important information on therisks ofnew substances without revealing confidential business information. EPA requires that the generic information be provided on the notice form so it can include this information in the section 5(d)(2) Federal Register.notice. IfEPA had to request the generic information after it received the notice, ordevelop the generic information itself, EPA could
not meet therequirement that the Federal Register notice be published 5 days after EPA receives the notice form.

Unlike the proposed rule, the final rule does not state that the generic chemical

name mustdisclose "toxicologically significant information to the maximum
extent possible"; instead, the generic

name should reveal the substance's chemcial identity to the maximum
extent possible. EPA has found that, prior to a.substantive review ofthe hazard potential ofa new substance, it is often difficult to identify toxicologically significant portions of the molecule. Therefore, at thebeginning ofthe notice review period, it is more useful to require instead that the chemical identity be revealed as fully as possible. The generic use should also be

as specific as possible. EPA encourages submitters to contact the EPA Prenotice Communications Coordinator to discuss appropriate generic names and uses before actually submitting the notice.

The proposed rule would have required that submitters provide three generic chemical names with the section 5 notice; however, the final rule requires only one. EPA's experience in the section 5 program has shown that three

names are not necessary since, generally, all three names provided are similar in specificity. EPAwill publish the generic name given in the notice in the section 5(d)(2) Federal Register notice. However, when the manufacturer

or importer submits a notice of
commencement ofmanufacture using the same generic name, EPA may determine that the generic name is more generic than necessary to protect confidential chemical identity EPA will then propose a more specific name. If that name is unacceptable, the submitter
must explain why EPA's name would disclose confidential business information and propose an alternative. EPA will publish the submitter's alternative name ifit is acceptable. Otherwise, EPA will put the generic

name it devised on the public Inventory, 30 days after giving notice to the submitter.

EPA has not adopted the proposed requirement that submitters provide generic information on physical/ chemical properties (in terms ofranges) and submitter's identity (in terms of geographic location, annual sales, and type ofcompany) ifthey are claimed confidential. EPA made this change in
response to commenters who stated that it is difficult to develop generic descriptions ofphysical/chemical properties and submitter's identity which provide useful information without disclosing confidential business information. Also, unlike chemical identity and category ofuse, EPA is not required toissue any information concerning physical/chemical properties

or the submitter's identity for publication in the Federal Register. Therefore, generic information on these categories is not necessary.

3.SubstantiationofClaims.Thefinal rule does not require substantiation of
any confidentiality claims when a section 5 notice is submitted. However,

a confidentiality claim for chemical identity mustbe substantiated when the notice ofcommencement ofmanufacture is submitted.

This approach reflects a substantial modification of the confidentiality procedures proposed in January 1979 and October 1979. The January proposal would have required submitters to substantiate confidentiality claims at the time of submission onlyfor chemical identity and health and safety data, while the October proposal would have required substantiation ofall confidentiality claims at the time of submission (though it allowed assertion and substantiation by category.) EPA 

### 21738

HeinOnline -- 48 Fed. Reg. 21738 1983

### Federal Register / Vol. 48, No. 94 / Friday, May 13, 1983 / Rules and Regulations

believed that this "up-front" substantiation would be necessary to allow EPA to respond to FOIA requests in a timely manner.

Under the Interim Policy, submitters

were encouraged to substantiate all confidentiality claims when the notice

was submitted; ifthey did not substantiate their claims, EPA sent a letter requesting substantiation. EPA changed this policy in a notice published in the Federal Register of July 3, 1982 (47 FR 28969). In-that notice,EPA explained that because EPA had not received large numbers ofFOIA requests, "up-front" substantiation ofclaims was not necessary to make timely responses to FOIArequests. Also, the substantiation requirement had not reduced the number ofconfidentiality claims as expected. The final rule adopts the same policy. EPAwill request substantiation for information submitted in section 5 notices only when it receives an FOIA request forthe information claimed confidential, orwhen EPAhas its own

reasons for making a final confidentiality determination, for example, when EPA is contemplating regulatory action. By not requiring "upfront" substantiation of all claims, submitters will not have to incur the burden ofsubstantiation unnecessarily.

The final rule requires submitters to substantiate claims ofconfidentiality for chemical identity at the time a notice of
commencement ofmanufacture or import is submitted, and provides that EPA may disclose a chemical identity claimed as confidential but not accompanied by adequate substantiation. As EPA stated in the Interim Policy ofMay 15, 1979, all information submitted to EPA under the section 5 notice program before the effective date ofthe final rule will become subject to the confidentiality policies ofthis rule (45FR 28567). The Interim Policy does not require submitters to substantiate claims of confidentiality when the notice of
commencement is submitted, although EPA encourages them to do ao. As a result, EPA has received notices of
commencement inwhich chemical identity was claimed confidential without any accompanying substantiation. Under the final rule, these chemical identities could be disclosed when it goes into effect.

In the May 1979 Interim Policy EPA stated that it would give submitters "ample opportunity to update or modify confidentiality claims prior to becoming subject to any new requirements." EPA believes that 45 days after the effective date of this rule is an ample period for submitters with unsubstantiated claims ofconfidentiality ofchemical identity in notices ofcommencement of manufacture or import to substantiate those claims. EPA will notify each affected person by letter. IfEPAhas not received substantiation for the claim within 45 days after the effective date of this rule, it may place the specific chemical identity on the public Inventory consistent with EPA's general procedures forhandling confidential information in 40 CFR Part 2.

4.HealthandSafetyStudies. Section 14(a) ofTSCAprohibits EPA from disclosing confidential.business information reported under the Act except in certain specific circumstances. Section 14(b), however, states thatEPA isnot prohibited from disclosing health and safety studies ofsubstances for which section 5notification is required, unless disclosure reveals confidential
processes orportions ofa mixture. Therefore, EPA cannot refuse to disclose such information in response to an FOIA request, and EPAwill deny any claim of confidentiality for the protocol, data, analysis, and results in a health and safety study ifthe submitter does not establish that disclosure would reveal the following confidential information: (1)process information, (2) portions ofa mixture, or (3)information unrelated to the effects of the substance on human health and the environment.

In some submissions, chemical identity may be claimed confidential and attachments to the notice form may contain health and safety studies on the

new chemical. EPA will disclose the specific chemical identity that is the subject ofthose studies ifdisclosure of chemical identity: (1) is necessary to interpret the health and safety study, and (2) would not reveal confidential
process ormixture information. Disclosure of chemical identity is discussed inmore detail below.

5.Specific Chemical Identity.A major issue in this rulemaking has been the confidentiality ofthe specific chemical identity that is the subject of a section 5 notice.This issue is ofparticular

concern when health and safety studies

are submitted for the substance. Under section 14(b) ofTSCA,EPA may not withhold from the public data from health and safety studies unless the data would disclose confidential manufacturing orprocessing processes

or theproportions ofspecific chemical substances in a mixture. The disclosure requirement applies to data in the study and data underlying the study.

As EPA stated in the January 1979 proposal, the Agency considers the specific chemical identity always to be part ofa health and safety study even when it does not appear in the study. Consequently, the chemical identity wouldbe subject to the disclosure requirements ofsection 14(b). However, inmany cases the chemical identity is

one of the most commercially sensitive pieces ofinformation in the section 5 notice.Because ofthe substantial

concern expressed by industry about the harm ofdisclosing confidential chemical identities, EPA explored ways of limiting the commercial harm of such disclosure while still meeting the requirements of section 14(b) ofTSCA and providing the public with adequate information about health and safety studies.

In January 1979, EPA proposed that confidential chemical identities would
not be released prior to commencement ofmanufacture or import, even when health and safety studies had been submitted in the notice. After
commencement ofmanufacture, chemical identity would be disclosed if health and safety studies had been submitted and the identity was not exempt under section 14(b) by virtue of revealing a confidential process or confidential proportions ofsubstances in a mixture. Because ofthe sensitivity ofthis issue,under its Interim Policy, EPAhas honored claims of confidentiality for specific chemical identity, even when health and safety studies have been submitted, reserving a final decision on the issue for this final rule.

This issue generated a great deal of
comment. Industryhas expressed its

concerns about disclosure of confidential chemical identities at any time, while public interest groups and others are concerned that health and safety studies would be meaningless without knowledge ofthe specific chemical identity involved. In an attempt to meet both these concerns, EPA has chosen an approach that balances the need for confidentiality, the need to understand health and safety studies, and the provisions of TSCA.

Under §720.85 ofthe rule, in the absence of anyhqalth and safety studies,chemical identity will be held confidential as long as it meets the general tests for confidentiality in 40 CFR Part 2.This is true both before and after commencement ofmanufacture or import. Under § 720.90(c) oftherule, if
any health and safety studies have been submitted for the chemical substance in question, the specific chemical identity willbe held confidential only if disclosure would reveal confidential manufacturing orprocessing processes

or the confidential proportions of

### 21739

HeinOnline -- 48 Fed. Reg. 21739 1983

### Federal Register / Vol. 48, No. 94 / Friday, May 13, 1983 / Rules and Regulations

substances in a mixture, or ifthe specific chemical identity is not necessary to interpret any of the studies.

This solution willresult in disclosure ofa confidential chemical identity only when it isnecessary to interpret a health and safety study, unless disclosure would reveal confidential
process or mixture information that is protected under section 14(b). This
meets concerns expressed by both industry and public interest gtioups. Industry was concerned that a rule mandating disclosure even when disclosure would not serve anypublic interest would unnecessarily penalize companies conducting health and safety studies. One the other hand, public interest groups were concerned that disclosure ofhealth and safety studies without the identity of the substance involved would be meaningless if knowledge of the specific identity were necessary to understand the study. Under this approach, companies will be able to present arguments that disclosure ofthe specific chemical identity is not necessary to interpret a study and, at the same time, members of the public requesting access to studies willbe able to argue why disclosure of the specific identity is necessary.

This solution to the issue of confidential chemical identities'also has

an impact on development ofgeneric chemical names. Companies that claim specific chemical identity confidential in their notices who wish to argue that knowledge ofthe specific identity isnot necessary to interpret their health and safety studies are encouraged to choose generic names which are sufficiently specific to interpret their health and safety studies. Sufficiently specificgeneric names will tend to support arguments that disclosure ofthe specific chemical identity is not necessary to understand the study.

IV. Related Rulemaking and Other Actions

A. Section5(h)(4)Exemptions
Under section 5(h)(4), EPA may, upon application and by rule, exempt manufacturers or importers from all or part ofthe requirements ofsection 5 ifit determines that the manufacture, import, processing, distribution in commerce, use, or disposal ofa new chemical substance will not present an unreasonable risk ofinjury to health or the environment. Based on its experience in the section 5 review
program to date, EPAhas promulgated

one section 5(h)(4) exemption rule and proposed two others.

EPApromulgated an exemption for

new chemicals used in certain'instant photographic and peel-apart film articles, published in the Federal Register ofJune 4, 1982 (47 FR 24308). Persons may manufacture these chemicals without undergoing the full 90-day section 5 review, as long as the manufacturer uses certain exposure controls.

EPA also proposed rules to exempt certain site-limited intermediates, low volume chemicals, and polymers, which

were published in the Federal Register ofAugust 4, 1982 (47 FR-33896). The proposed exemption for site-limited intermediates and chemicals manufactured at 10,000 kg or less per year would exempt these chemicals if they do not have certain adverse health

or environmentaleffects and the manufacturer or importer submits a short notice to EPA 14 days before manufacture begins. A qualified expert would assess the new chemical (unless it was manufactured at 1,000 kg or less
per year) to ensure that it met the exemption criteria. The polymer exemption would allow manufacture or import ofcertain new polymers as long

as EPA is notified when manufacture begins. Other new polymers would undergo an abbreviated 14-day section 5 notice review.

EPA is reviewing the comments on these proposed exemptions and intends
to issue final exemption rules in mid1983. If the provisions of the final rules

are similar to theprovisions in the proposed rules, EPA expects that approximately 60 percent ofall new chemicals will qualify for one ormore of these exemptions.

B.New ChemicalFollow-UpRules

EPA will promulgate follow-up reporting rules on certain new chemical substances under section 5(a)(2) and 8(a) ofTSCA. Such rules will allow EPA
to obtain information on selected new chemical substances after they have entered commercial production, and to

reassess certain new chemical substances before they are produced for

new uses that may significantly increase their risk to human health or the environment.

EPAhas proposed significant new use rules (SNURs) and section 8(a) rules for chemical substances in the Federal Register and will continue to do so. A SNUR requires persons to notify EPA90 days before they manufacture, import, or process the substances subject to the rules fora significant new use, as defined by therule. The same reporting requirements, review procedures, and authorities that apply to notices for new substances apply to SNUR notices. However, ifafter receipt ofa SNUR notice, EPA does not act to regulate the 

### chemical, it must state its reasons in the Federal Register. Section 8(a) rules require limited reporting ofinformation; these rules willbe used primarily to monitor changes in exposures to chemicals of concern.

Follow-up is an important complement
to the section 5notice review program, which is necessarily limited by the nature ofnotices on new substances and the section 5review process. Notices describe the specific uses for which the submitter intends to manufacture or import a new chemical substance and the exposures associated with the intended methods ofmanufacture, processing. uses, and disposal. EPAwill generally base its review and any regulation under section 5(e) or 5(f] on these uses and exposures. In some cases, a substance may raise concern, but the exposure predicted from the information in the notice maynot present a significant risk. In these cases, EPA might nottake action against the substance during thereview period. However, once such a substance has completed section 5review and has entered commerce, anyone may manufacture, import, orprocess it for any usewithout EPA review, even a use likely to result in high levels ofexposure thatwould significantly increase risk. In such a case, EPA mightrequire reporting under a SNUR or section 8(a) rule to

ensure review and theopportunity to control these risks before they occur.
C.TestingGuidelines

EPA issued premanufacture testing guidelines which were published in the Federal Register ofJanuary 27, 1981 (46 FR 8985). In these guidelines, EPA recommends that notice submitters use the Organization forEconomic Cooperation and Development (OECD) Minimum Premarket Data set as a starting point in setting up a testing program for new chemicals. EPAis not requiring these data, and a submission that does not contain themwould be complete ifit otherwise meets the requirements of the Act. Instead, EPA intends that submitters use the testing guidelines flexibly, tailoring their evaluations of new chemicals to the specific new chemicals in question. EPA also encourages submitters to follow any Good Laboratory Practides issued under TSCA.

V. Related Documents

A. Responseto Comments

During this rulemaking, EPA has solicited public comment on several proposals and other public documents. These include theJanuary 10, 1979, 21740

HeinOnline -- 48 Fed. Reg. 21740 1983

### Federal Register / Vol. 48, No. 94 / Friday, May 13, 1983 / Rules and Regulations

proposed rule (44 FR 2242); the October 16, 1979, proposed rule (44 FR 59764); the methodology for the Economic Impact Analysis (44 FR 39450); the proposed
processor reporting requirement (45 FR 54642); the clarification ofthe importer definition (45 FR 63806); the draft Regulatory Analysis and theproposed Economic Impact Analysis (45FR 74945); and the notice on substantiation ofconfidentiality claims (47 FR 28969). EPA received numerous comments from individual companies, trade associations, labor unions, public interest organizations, and other groups. and individuals. These comments were carefully considered in developing the final rule.

EPA has prepared a detailed Response to Comments on the Premanufacture Notice Requirements and Review Procedures for New Chemical Substances. In this document, EPA has summarized the major
comments thatit received on the documents listed above and gives its
response to each. The Response to Comments is available in the Public Reading Room.

B. Instructions Manual

EPAis also distributing an Instructions Manual for Premanufacture Notification ofNew Chemical Substances. All persons subject to section 5 notice requirements, or who believe that these requirements may apply to them, should obtain a copy of this manual from the OTS Industry Assistance Office. In the manual, EPA describes: (1)EPA's statutory authority under section 5ofthe Act; (2) section 5 reporting requirements; (3)EPA notice review procedures; (4) procedures for asserting and substantiating confidentiality claims; and (5) instructions for completing the notice form.

VI. Regulatory Impact Analysis

Under Executive Order 12291, EPA
must determine whether a rule is "major" and therefore subject to the Regulatory Impact Analysis requirement. EPA considers this rule to be major. Although the rule will not have an annual effect on the economy of $100 million or more, the costs of complying with the rulewill result in an increase in costs forchemical manufacturers and photographic companies, and there may be some effects on innovation. Also, EPA will incur certain costs to conduct the notice review program. EPAbased its classification ofthis rule as "major" on various studies conducted on the cost of compliance with section 5notice requirements and the effect ofthese requirements on new chemical innovation. EPAhas prepared a Regulatory Impact Analysis to accompany this rule which summarizes these studies.

EPA included briefregulatory analyses ofthe January 1979 and October 1979 proposed rules in the preambles to those rules. In November 1980, EPAissued an extensive draft Regulatory Analysis. TheRegulatory Impact Analysis that accompanies this rule compares the notice formproposed by EPA in October 1979, a form proposed by the Chemical Manufacturers Association (CMA] in 1979, an in-house draft form comparable
to the form required in thisrule, and the final form. The Regulatory Impact Analysis concludes that theprimary 

### economic effect ofthe finalform is that industry's cost is between $5 million and $12 million annually to complete the notices. These costs are similar to the
costs ofthe CMA form and considerably 

### less than the costs ofEPA's October 1979 form.



### The Analysis also concludes that while the October 1979 form makes it easier forEPA to identify problem chemicals and take action, the probability ofEPA identifying these problem chemical isnot significantly lower with the other forms. Thus the incremental benefits ofthe lengthier October 1979 form are small.

The thirdmajor finding ofthe Regulatory Impact Analysis concerns the distributional effect ofthe existing notice review program. Based on data from several industry-commissioned surveys and on data in confidential section 5notice files, it appears that there hasbeen no significant reduction in the number ofnew chemical innovations since 1979 amongthe largest companies, butlimited data suggest that there probably hasbeen a decline in innovation activity by smaller companies, which tend to produce low volume chemicals. To help reduce this effect on small companies,EPA employs consultants to assist them in preparing notices, at no expense to the submitters.

The fourth major finding ofthe Analysis is thatpromulgation ofthe proposed section 5(h)(4) exemptions to the section 5notification program would reduce the annual costto industry of complying with section 5notification requirements by 19 to 30 percent, to between $4.2 and $9.1 million annually. In addition, theproposed exemptions will significantly'reduce the burden of thenqw chemical review requirements

on small firms. IfEPA promulgates the provisions in theproposed exemption rules,there will be cost savings of11 to 35 percent of total notification costs for firms with sales less than $100 million annually.

These findings on cost to submitters

were reached by calculating the cost of filing the notice form, the cost ofdelay (the present value ofprofits delayed because of the notice review process), the cost ofmaintaining confidentiality, and the cost ofimplementing voluntary controls on the ntenufacturing, processing or marketing of a particular

new substance when requested by EPA. The benefit findings were based on EPA's analysis of each case in which it took action on a new chemical substance, to determine what types of information were critical to the decision
to seek controls and whether that information would be required on all fourforms. Ifthe information would not have been in the submission and ifEPA would not have identified the problem through telephone contact or other

means, thepotential for adverse health effects occasioned by not identifying the problem were determined. The Regulatory Impact Analysis is available for review in the Public Document Room.

This regulation was submitted to the Office ofManagement and Budget for review as required by Executive Order 12291.

VII. Applicability of Paperwork Reduction Act an Regulatory Flexibility Act

Under the Paperwork Reduction Act of 1980, 44 U.S.C. 3501 etseq., the information provisions in this rule must be submitted for approval to the Office ofManagement and Budget (OMB). The Agency previously submitted information collection requirements to OMB under the Premanufacture Notification (PMN) Interim Policy which

were assigned OMB control number 2000-0054. Theinformation collection requirements in this final rule were approved by OMB and assigned OMB control number 2070-0012.

As required by the Regulatory Flexibility Act (5 U.S.C. 605(b)), EPA has assessed the impact ofthis rule on small businesses. In various analyses ofthe chemical industry, small business has been defined in numerous ways, particularly in terms of annual sales levels. To account for different interpretations ofthe term "small business" within the chemical industry, the Agency analyzed the effect ofthis rule using two annual sales levels to define small, $30 million and $100 million.

EPA estimates that firms with sales less than $30 million per year will 

### 21741

HeinOnline -- 48 Fed. Reg. 21741 1983

### Federal Register / Vol. 48, No. 94 / Friday, May 13, 1983 / Rules and Regulations

absorb about 7percent oftotal industryrelated costs to complywith thisrule, or about $0.36 to $0.91 million annually. 

### Firms with sales less than $100 million per yearwill incurabout 13 percent of total industry costs,or about $0.67 to $1.69 million annually.The proposed exemptions will substantially reduce the reporting burden for small companies, however. Taken together, theproposed exemption rules would reduce total program costs forfirms with sales less than $30million and $100 millionper year by 11 to 33 percent and 11 to 35 percent, respectively.

VIII. Public Record

EPA has established a publicrecord for this rulemaking (docketnumber OTS-50002), which is available for inspection in Rm. E-107, 401 M St. SW., Washington, D.C. 20460 from 8:00 a.m. to 4:00 p.m., Monday through Friday, except legal holidays. This record includes all the information considered by EPA in developing thisrule except for confidential business information which has been segregated. While part ofthe record, such information is not available to the public.

The listbelow describes the information in the record. This list,in accordance with section 19(a)(13) of the Act,identifies the complete rulemaking record:

1.USEPA-OTS. Premanufacture Notification Requirements and Review Procedures. Notice ofProposed Rulemaking.

2.USEPA-OTS. Premanufacture Notification Requirements and Review Procedures: Support Document.

3.USEPA-OTS. Impact ofTSCA Premanufacturing ReviewRequirements (EPA230/2-12/76-005).

4.Seven working drafts ofproposed 40 CFR Part720 dated from June 20, 1978 to December 3,1978; three working drafts ofthe preamble to proposed 40 CFR Part 720 dated from October 28, 1978, to December 3,1978; eight working drafts oftheproposed Premanufacture Notice Form dated from July 30, 1978, to December 3,1978; two working drafts of the Premanufacture Notice Form for Importers dated fromOctober 5,1978,to December 3,1978; three working drafts ofthe Premanufacture Notice Form for Foreign Manufacturers/Suppliers dated from October 5,1978, to December 3, 1978; and one draft of the Processing and Consumer Use Form dated December 3,1978.

5.USEPA-OTS. Reproposal of Premanufacture Notice Forms and Provisions of Rules; Notice ofProposed Rulemaking. 6. USEPA-OTS. Impact ofTSCA Proposed Premanufacturing Notification Requirements; contract No. 68-014717.

7. Working drafts ofthe proposed Premanufacture Notice Forms dated June 28, 1979, July 13, 1979, and August 7, 1979.

8. EPA Documents distributed at the meetings ofthe Administrator's Toxic Substances Advisory Committee (ATSAC), August 14, 1979, and September 25, 1979.

9. EPAmaterials on the planned reproposal ofthe Premanufacture Notice Forms distributed at the Embassy Officials Briefing, September 11, 1979.

10. USEPA-OTS. Premanufacture Notification and Review: Economic Impact.

11. USEPA-OTS. Proposed Processor Reporting Requirements. Notice of Proposed Rulemaking.

12. USEPA-OTS. Cost Estimations of Alternative Processor Notification Requirements; contract no. 68-01-5878.

13. USEPA-OTS. Premanufacture Notification and Review Procedures: Clarification ofImporter Reporting Responsibilities.

14. USEPA-OTS. Draft Regulatory Analysis. Premanufacture Notification and Review Procedures.

15. USEPA-OTS. Proposed Economic Impact Analysis ofProposed Section 5 Notice Requirements; contract no. 68- 01-5878.

46.USEPA-OTS. Regulatory Impact Analysis ofSection 5Notice Requirements; contract no. 68-01-5878.

17. USEPA-OTS. Response to Comments on New Chemical Notice Requirements &Review Procedures.

18. All factual information and raw data ofany sort considered during the rulemaking.

19. EPA correspondence to persons outside EPA concerning this rule.

20 Correspondence (including
comments on theproposed rule) received from persons outside EPA before the close ofthe comment periods, and correspondence received after the close ofthe comment periods if considered.

21. EPAmemoranda summarizing meetings and telephone conversations with outside persons relevant to the development of this rulemaking.

The docket ofthe record detailing its specific contents is available in the OTS Reading Room.

Listof Subjects in 40 CFR Part720

Chemicals, Environmental protection, Premanufacture notification, Hazardous materials, Recordkeeping and reporting requirements. Dated: April 26, 1983.
Lee L.Verstandig, ActingAdministrator.

Therefore, 40 CFR Chapter Iis amended by adding Part 720 to read as follows: PART 720-PREMANUFACTURE
NOTIFICATION Subpart A-General Provisions

Sec. 720.1 Scope. 720.3 Definitions. Subpart B-Applicability
720.22 Persons who must report. 720.25 Determining whether a chemical substance is on the Inventory. 720.30 Chemicals not subject to notification requirements. 720.36 Exemptions for research and development. 720.38 Exemptions for testmarketing. Subpart C-Notice Form

720.40 General. 720.45 Informiation that must beincluded in the notice form. 720.50 Submission of testdata and other data concerning the health and environmental effects ofa substance. 720.57 Imports. Subpart D-Disposition of Notices

720.60 General. 720.62 Notice thatnotification is not required. 720.65 Acknowledgement ofreceipt ofa notice; errors in thenotice; incomplete submissions; false and misleading
statements. 720.70 Notice in the Federal Register. 720.75 Notice review period. 720.78 Recordkeeping. Subpart E-Confidentiality and Public Accessto Information

720.80 General provisions. 720.85 Chemical identity. 720.87 Categories or proposed categories of

uses ofa new chemical substance. 720.90 Data from health and safety studies. 720.95 Public file. Subpart F-Commencement of Manufacture orImport

720.102 Notice ofcommencement of manufacture orimport. Subpart G-Compllance and Inspections

720.120 Compliance. 720.122 Inspections. Appendix A-Premanufacture Notice for New Chemical Substances Authority: Toxic Substances Control Act, 15 U.S.C. 2604, 2607, 2613.
Subpart A--General Provisions

§720.1 Scope.

This Part establishes procedures for the reporting ofnew chemical substances by manufacturers and 

### 21742

HeinOnline -- 48 Fed. Reg. 21742 1983l1'p dlral Ro~i.ter 

## I Vol. 48. No. 94 / 

### Fridav. May 13, 1983 / 

### Rules and Regulations274---

importers under section 5 ofthe Toxic Substances Control Act, 15 U.S.C. 2604. The rule defines the persons and chemical substances subject to the reporting requirements, prescribes the

contents ofsection 5notices, and establishes procedures for submitting notices. The rule also establishes EPA policy regarding claims of confidentiality for, and public disclosure of,various categories ofinformation submitted in connection with section 5 notices (OMB Control No. 2070-0012).
§720.3 Definitions.

(a)(1) For the purposes ofthis Part. the

terms "cosmetic," "device," "drug," "food," and "food additive" have the meanings contained in the Federal Food, Drug, and Cosmetic Act, 21 U.S.C.321 et
seq., and the regulations issued.under it, In addition, the term "food" includes poultry and poultry products, as defined in the Poultry Products Inspection Act, 21 U.S.C. 453 etseq.;meats and meat food products, as defined in the Federal Meat Inspection Act, 21 U.S.C. 60 etseq.; and eggs and egg products, as defined in the Egg Products Inspection Act, 21 U.S.C. 1033 et seq.

(2) The term "pesticide" has the meaning contained in the Federal Insecticide, Fungicide, and Rodenticide Act, 7U.S.C. 136 et seq.and the regulations issued under it.

(3) The terms "byproduct material." "source material," and "special nuclear material" have the meanings contained in the Atomic Energy Act of 1954,42 U.S.C 2014 etseq. and the regulations issued under it.

(b) "Act" means the Toxic Substances Control Act, 15 U.S.C. 2601 et seq.

(c) "Article" means a manufactured item (1)which isformed to a specific shape or design during manufacture, (2) which has end use function(s) dependent in whole or in part upon its shape or design during end use, and (3) which has either no change ofchemical composition during its end use oronly those changes ofcomposition which have no commercial purpose separate from that ofthe article and thatmay

occur as described in § 720.36(g)(5), except that fluids and particles are not considered articles regardless ofshape

or design.

(d) "Byproduct" means a chemical substance produced without a separate commercial intent during the manufacture, processing, use, or disposal ofanother chemical substance

or mixture. (e) "Chemical substance" means any organic or inorganic substance ofa particular molecular identity, including
any combination of such substances occurring in whole or in part as a result ofa chemical reaction oroccurring in nature, and any chemical element or uncombined radical, except that "chemical substance" doesnot include:

(1)Any mixture. (2)Any pesticide when manufactured, processed, ordistributed in commerce for use as a pesticide.

(3)Tobacco or any tobacco product. (4) Any source material, special nuclear material, orbyproduct material.

(5) Any pistol, firearm, revolver, shells, or cartridges.

(6) Any food, food additive, drug, cosmetic, or device, when manufactured, processed, or distributed in commerce foruse as a food, food additive, drug, cosmetic, or device.

(f) "Commerce" means trade, traffic, transportation, or other commerce (1) between a place in a State and any place outside ofsuch State, or (2) which affects trade, traffic, transportation, or

commerce between a place in a State and any place outside ofsuch State.

(g)"Customs territory ofthe United States" means the 50 States, Puerto Rico, and the District ofColumbia.

(h) "Director" means the Director of the EPAOffice ofToxic Substances.

(i) "Distribute in commerce" means to sell in commerce, to introduce ordeliver for introduction into commerce, or to hold after introduction into commerce.

(j) "EPA"means the U.S. Environmental Protection Agency.

(k) "Health and safety study" or "study" means any study of any effect ofa chemical substance ormixture on health or the environment or on both, including underlying data and epidemiological studies, studies of occupational exposure to a chemical substance or mixture, toxicological, clinical, and ecological, orother studies ofa chemical substance or mixture, and
any testperformed under the Act. Chemical identity is always part ofa health and safety study.

(1)Not only is information which arises as a result ofa formal, disciplined study included, but other information relating to the effects of a chemical substance ormixture on health orthe environment is also included. Any data that bear on the effects ofa chemical substance on health or the environment would be included.

(2) Examples include: (i)Long- and short-term tests of mutagenicity, carcinogenicity, or teratogenicity; data on behavioral disorders; dermatoxicity; pharmacological effects; mammalian absorption, distribution, metabolism, and excretion; cumulative, additive, and synergistic effects; acute, subchronic, and chronic effects; and structure/ activity analyses. (ii) Tests for ecological or other environmental effects on invertebrates, fish, or other animals, and plants, including: acute toxicity tests, chronic toxicity tests, critical life stage tests, behavioral tests, algal growth tests, seed germination tests, plant growth or damage tests, microbial function tests, bioconcentration orbioaccumulation tests, and model ecosystem (microcosm) studies.

(iii)Assessments ofhuman and environmental exposure, including workplace exposure, and impacts ofa particular chemical substance or mixture on the environment, including

surveys, tests, and studies of: biological, photochemical, and chemical degradation; air, water, and soil transport; biomagnification and bioconcentration; and chemical and physical properties, e.g., boiling point,
vapor pressure, evaporation rates from soil and water, octanol/water partition coefficient, and water solubility.

(iv)Monitoring data, when they have been aggregated and analyzed to

measure the exposure ofhumans orthe environment to a chemical substance or mixture.

(v)Any assessments ofrisk tohealth and the environment resulting fromthe manufacture, processing, distribution in

commerce, use, or disposal ofthe chemical substance.

(1)"Importer" means any person who imports a chemical substance, including

a chemical substance as part ofa mixture or article, into the customs territory of the United States. "Importer" includes theperson primarily liable for the payment ofany duties on the merchandise or an authorized agent acting on his orher behalf.The term also includes, as appropriate:

(1)The consignee. (2) The importer ofrecord. (3)The actual owner ifan actual owner's declaration and superseding bond has been filed in accordance with 19 CFR 141.20; or

(4) The transferee, ifthe right to draw merchandise in a bonded warehouse has been transferred in accordance with Subpart C of19 CFR 144. (See "principal importer.")

(m) "Impurity" means a chemical substance which is unintentionally present with another chemical substance.

(n) "Intermediate" means any chemical substance that is ensumed, in whole or in part, in chemical reactions used for the intentional manufacture of another chemical substance(s) or mixture(s), or that is intentionally present for thepurpose ofaltering the

rates of such chemical reactions. 

### Federal Reuister / Vol. 48 No. 94 / Friday, May 13, 1983 / Rules and Regulations 21743

HeinOnline -- 48 Fed. Reg. 21743 1983

### Federal Register / Vol. 48, No. 94 / Friday, May 13, 1983 / Rules and Regulations

(o) "Inventory" means the list of 

### chemical substances manufactured or processed in the United States that EPA compiled and keeps current under section 8(b) ofthe Act.

(p)"Known to or reasonably ascertainable by" means all information in a person's possession or control,plus all information that a reasonable person similarly situated might be expected to possess, control, orknow.

(q) "Manufacture" means to produce

or manufacture in the United Stateg-or import into the customs territory ofthe United States.

(r)"Manufacture or import for commercial purposes" means:

(1)

### To import,produce, ormanufacture with thepurpose of obtaining an immediate oreventual commercial advantage for the manufacturer or importer, and includes, among other things, "manufacture" ofany amount of

a chemical substance ormixture:

(i)For commercial distribution, including for testmarketing.

(ii)For use by the manufacturer, including use forproduct research and development oras an intermediate.

(2) 

### The term also applies to substances that are produced coincidentally during the manufacture, processing, use, ordisposal ofanother substance ormixture, including byproducts that are separated from that other substance ormixture and impurities that remain in that substance

ormixture. Byproducts and impurities without separate commercial value are nonetheless produced for the purpose of obtaining a commercial advantage, since they are part ofthe manufacture ofa chemical substance for commercial purposes.

(s) "Manufacture solely forexport"

means: to manufacture fora commercial purpose solely for exportfrom the United States under the following restrictions on domestic activity:

(1)Processing is limited solely to sites under the control of the manufacturer.

(2) 

### Distribution in commerce is limited to purposes ofexport.

(3) 

### The manufacturer may notuse the substance except in small quantities solely forresearch and development.

(t) 

### "Manufacturer" means a person who imports, produces, or manufactures

a chemical substance. Aperson who extracts a component chemical substance from a previously existing chemical substance ora complex combination ofsubstances is a manufacturer of that component chemical substance. Aperson who contracts with a manufacturer to manufacture orproduce a chemical substance is also a manufacturer if(1) 

### the manufacturer manufactures or produces the substance exclusively for that person, and (2) 

### that person specifies the identity of the substance and controls the total amount produced and the basic technology for theplant
process.

(u) "Mixture" means any combination of two or more chemical substances if the combination does not occur in nature and is not, in whole orinpart, the result ofa chemical reaction; except "mixture" does include (1)any combination which occurs, in whole or in part, as a result ofa chemical reaction ifthe combination could havebeen manufactured for commercial purposes without a chemicalreaction atthe time the chemical substances comprising the combination were combined, and ifall ofthe chemical substances comprising the combination are not new chemical substances, and (2)hydrates ofa chemical substance orhydrated ions formed by association ofa chemical substance with water,so long as the nonhydrated form is itself not a new chemical substance.

(v) "New chemical substance" means any chemical substance which is not included on the Inventory.

(w)"Nonisolated intermediate" means any intermediate that is not intentionally removed from the equipment in which it is manufactured, including the reaction vessel in which it is manufactured, equipment which is ancillary to the reaction vessel, and any equipment through which the chemical substance passes during a continuous flow process,but notincluding tanks or othervessels in which the substance is stored after its manufacture.

(x) "Person" means any natural person, firm, company, corporation, joint-venture, partnership, sole proprietorship, association, or any other business entity, any State orpolitical subdivision thereof,any municipality, any interstate body,and any department, agency orinstrumentality of the Federal Government.

(y) "Possession or control" means in possession or control ofthe submitter,

or ofany subsidiary, partnership in which the submitter is a general partner, parent company, or any company or partnership which theparent company
owns or controls,ifthe subsidiary, parent company, or other company or partnership is associated with the submitter in the research, deveiopment, test marketing, or commercial marketing ofthe chemical substance in question. (Aparent company owns orcontrols another company if theparent owns or controls 50percent ormore ofthe other company's voting stock.A parent company owns or controls any partnership in which itis ageneral partner.) Information is included within this definition ifit is:

(1)In the submitter's own files including files maintained by employees in the course of their employment.

(2) In commercially available data bases to which the submitter has purchased access.

(3) Maintained in the files in the

course of employment by other agents of the submitter who are associated with research, development, test marketing,

orcommercial marketing ofthe chemical substance in question.

(z) "Principal importer" means the first importer who, knowing that a new chemical substance willbe imported rather than manufactured domestically, specifies the identity ofthe chemical substance and the total amount to be imported. Only persons who are incorporated, licensed, ordoing business in the United States may be principal importers.

(aa) "Process" means the preparation ofa chemical substance or mixture, after its manufacture, fordistribution in

commerce (1) in the same form or physical state as, or in a different form

orphysical state from, that inwhich it

was received by the person so preparing such substance ormixture, or (2) as part ofa mixture or article containing the chemical substance or mixture.

(bb) "Processor" means any person who processes a chemical substance or mixture.

(cc) "Small quantities solely for research and development" (or "small quantities solely forpurposes of scientific experimentation or analysis or chemical research on, or analysis of, such substance or another substance, including such research or analysis for the development ofa product") means quantities of a chemical substance manufactured, imported, orprocessed or proposed to be manufactured, imported,

or processed solely for research and development that are not greater than reasonably necessary for such purposes.

(dd) "State" means any State ofthe United States and the Districtof Columbia, the Commonwealth ofPuerto Rico, the Virgin Islands, Guam, the Canal Zone, American Samoa, the Northern Mariana Islands, and any other territory orpossession ofthe United States.

(ee) "Technically qualified individual"

means a person orpersons (1) who, because ofeducation, training, or experience, or a combination of these factors, is capable ofunderstanding the health and environmental risks associated with the chemical substance which is used under his or her supervision, (2) who is responsible for 

### 21744

HeinOnline -- 48 Fed. Reg. 21744 1983

### Federal Register / Vol. 48, No. 94 / Friday, May 13, 1983 / Rules and Regulations

enforcing appropriate methods of conducting scientific experimentation, analysis, or chemical research to minimize such risks, and (3) who is responsible for. the safety assessments and clearances related to the procurement, storage, use, and disposal ofthe chemical substance as may be appropriate or required within the scope ofconducting a research and development activity.

(ff) "Test data" means data from a formal orinformal test or experiment, including information concerning the objectives, experimental methods and materials, protocols, results, data analyses, recorded observations, monitoring data, measurements, and conclusions from a test orexperiment.

(gg) "Test marketing" means the distribution in commerce ofno more than apredetermined amount ofa chemical substance, mixture, or article containing that chemical substance or mixture, by a manufacturer or processor, to no more than a defined number of potential customers to explore market capability in a competitive situation during a predetermined testingperiod prior to the broader distribution ofthat chemical substance, mixture, or article in commerce.

(hh) "United States," when used in the geographic sense, means all of the
States.
Subpart B-Applicability §720.22 Persons who must report.

(a) (1) Any person who intends to manufacture a new chemical substance in the United States for commercial
purposes must submit a notice unless the substance is excluded under 

### § 720.30.

(2) Ifa person contracts with a manufacturer to manufacture orproduce

a new chemical substance, and (i) the manufacturer manufactures orproduces the substance exclusively for that
person, and (ii) that person specifies the identity ofthe substance, and controls the total amount produced and the basic technology for theplant process, that person must submit the notice. If it is unclear who must report,EPA should be contacted to determine who must submit the notice.

(3) Only manufacturers that are incorporated, licensed, or doing business inthe United Statesmay submit a notice.

(b)(1) Any person who intends to import a new chemical substance into theUnited States for commercial
purposes must submit a notice, unless the substance is excluded under §720.30

orunless the substance is imported as part ofan article. (2) When several persons are involved in an import transaction, the notice must be submitted by theprincipal importer. If no one person fits the principal importer definition in a particular transaction, the importer should contact EPA to determine who must submit the notice for that transaction. §720.25 Determining whether achemical substance Isonthe Inventory.

(a) A new chemical substance is a chemical that is not on the Inventory.

(b)(1) A chemical substance is listed

on the Inventory by specific chemical

name ifits identity is not confidential. If its identity is confidential, it is listed by specific name in the confidential portion ofthe Inventory. The confidential chemical substance is also listed on the public Inventory by a generic name which masks the specific identity. A
person who intends to manufacture or import a chemical substance not listed

on the Inventory by specific chemical

name may ask EPA whether the substance is included on the confidential Inventory. EPA will answer such an inquiry only ifEPA determines that the person has a bona fide intent to manufacture or import the chemical substance for commercial purposes.

(2) To establish a bona fide intent to manufacture or import a chemical substance, the person who proposes to manufacture orimport the substance
must submit to EPA:

(i) The specific chemical identity of the substance that theperson intends to manufacture orimport.

(ii) A signed statement that theperson intends to manufacture orimport that chemical substance for commercial
purposes.

(iii) A description of theresearch and development activities conducted to date, and the purpose for which the
person will manufacture or import the chemical substance.

(iv) An elemental analysis. (v) Either an X-ray diffractionpattern (for inorganic substances), a mass spectrum (for most other substances), or

an infrared spectrum ofthe particular chemical substance, orif such data do
not resolve uncertainties with respect to theidentity ofthe chemical substance, additional or alternative spectra or other data to identify the substance.

(3) Ifan importer cannot provide all the information required by paragraph (b)(2) ofthis section because it is claimed confidential business information by its foreign manufacturer

or supplier, the foreign manufacturer or supplier may supply the information directly to EPA.

(4) EPA willreview the information submitted by the proposed manufacturer orimporter under thisparagraph to determine whether it has a bona fide intent tomanufacture or import the chemical substance. If necessary, 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).

(5) Ifthe proposed manufacturer or importer has shown a bona fideintent to manufacture or import the substance, and provide sufficient unambiguous chemical identity information so EPA

can make a conclusive determination of the chemical substance's Inventory status, EPA will search the confidential Inventory and inform the proposed manufacturer orimporter whether the chemical substance is on the confidential Inventory.

(6) If the chemical substance is found

on the confidential Inventory, EPA will notify the person(s) who originally reported the chemical substance that another person has demonstrated a bona fide intent to manufacture or import the substance and therefore was told that the chemical substance is on the Inventory.

(7) A disclosure ofa confidential chemical identity to a person with a bonafide.intent to manufacture or import the particular chemical substance will not be considered a public disclosure ofconfidential business information under section 14 of the Act.

(8) EPA will answer an inquiry on whether a particular chemical substance is on the confidential Inventory within 30 days after receipt ofa complete submission under paragraph (b)(2) of this section (OMB Control No. 2070- 0012).
§720.30 Chemicals notsubject to notification requirements.

Thefollowing substances are not subject to the notification requirements ofthis Part:

(a) Any substance which is not a "chemical substance" as defined in § 720.3(e).

(b) Any mixture as defined in § 720.3(u).'

(c) Any new chemical substance which willbe manufactured or imported in small quantities solely for research and development under §720.36.

(d) Any new chemical substance which willbe manufactured or imported

'A new chemical substance that is manufactured

or imported as part ofamixture is subject tothe requirements ofthis Part.This exclusion applies only to a mixture as a whole andnot to any chemical substances which are partofthe mixture. 

### 21745

HeinOnline -- 48 Fed. Reg. 21745 1983

### Federal Register / Vol. 48, No. 94 / Friday, May 13, 1983 / Rules and Regulations

solely for test-marketing purposes under

an exemption granted under §720.38.

(e) Any new chemical substance manufactured solely for export.

(f)Any new chemical substance which is manufactured orimported under the terms ofa rule promulgated under section 5(h)(4) ofthe Act.

(g)Any byproduct ifits only commercial purpose is foruse by public

orprivate organizations that (1)burn it

as a fuel, (2) dispose of itas a waste, including in a landfill or for enriching soil, or (3) extract component chemical substances from it for commercial purposes. (This exclusion only applies to the byproduct; it does not apply to the component substances extracted from the byproduct.)

(h) The chemical substances described below: (Although they are manufactured forcommercial purposes under the Act,they are not manufactured for distribution in

commerce as chemical substances per
se and have no commercial purpose separate from the substance, mixture, or article ofwhich they are a part.)

(1)Any impurity. (2) Any byproduct which is not used for commercial purposes.

(3)Any chemical substance which results from a chemical reaction that

occurs incidental to exposure ofanother chemical substance, mixture, orarticle
to environmental factors such as air, moisture, microbial organisms, or sunlight.

(4) Any chemical substance which results from a chemical reaction that

occurs incidental to storage ordisposal of another chemical substance, mixture,

or article.

(5) Any chemical substance which results from a chemical reaction that

occurs upon end use ofanother chemical substance, mixture, or article such as an adhesive, paint, miscellaneous cleanser

or otherhousekeeping product, fuel additive, water softening and treatment agent, photographic film, battery, match,

or safety flare, and which is not itself manufactured or imported for distribution in commerce or for use as
an intermediate.

(6) Any chemical substance which results from a chemical reaction that

occurs upon use ofcurable plastic or rubber molding compounds, inks, drying oils, metal finishing compounds, adhesives, or paints, or any other chemical substance formed during the manufacture ofan article destined for the marketplace without further chemical change of the chemical substance except for those chemical changes that occur as described elsewhere in this paragraph. (7) Any chemical substance which 

### results from a chemical reaction that

occurs when (i)a stabilizer, colorant, odorant, antioxidant, filler, solvent, carrier, surfactant, plasticizer, corrosion inhibitor, antifoamer ordefoamer, dispersant, precipitation inhibitor, binder, emulsifier, deemulsifier, dewatering agent, agglomerating agent, adhesion promoter,flow modifier, pH neutralizer, sequesterant, coagulant, flocculant, fire retardant,lubricant, chelating agent, or quality control reagent functions as intented, or (ii) a chemical substance, which is intended solely to impart a specific physiochemical characteristic, functions

as intended.

(8)Any nonisolated intermediate.
§720.36 Exemptionsfor research and development.



### (a) This Part does not apply to a chemical substance if:

(1)The chemical substance is manufactured orimported only in small quantities solely forresearch' and development.

(2)The manufacturer orimporter (i) evaluates the chemical substance in accordance with paragraph (b)ofthis section, and (ii) notifies all persons engaged in experimentation, research, or analysis on the new chemical substance, including the manufacture, processing,
use, transport, storage, and disposal of the substance associated with research and development activities, of any risk tohealth, identified underparagraph (b) ofthis section, which maybe associated with the substance, in accordance with paragraph (c) ofthis section. A technically qualified individual must
ensure the adequacy of thenotification.

(3)The chemical substance is used by,

or directly under the supervision of,a technically qualified individual.

(b)(1) The manufacturer or importer mustevaluate any information ortest data in its possession orcontrol to determine whether there is reason to believe there is anyrisk to health associated with the chemical substance. Thisinformation must include:

(i)Any information concerning any significant adverse reaction bypersons exposed to the substance which may reasonably be associated with such exposure.

(ii)Any information provided to the manufacturer or importer by a supplier

orany other person concerning a health risk believed to be associated with the substance.

(2)In addition, the manufacturer or importer mustdetermine whether the substance is subject to any rule or order proposed or promulgated under section 4, 5, or6 ofthe Act; or the notice requirements ofsection 8(e) of the Act. In addition, the manufacturer or importer must ascertain whether EPA, under section 5(h)(3) of the Act, has determined that any risk to health may be associated with the substance.

(c) The manufacturer orimporter must

assure that persons are notified by

means ofa container labeling system, conspicuous placement ofnotices in

areas where exposure may occur, written notification to each person, or any other method ofnotification which adequately informs persons ofrisks which the manufacturer or importer has

reason to believe may be associated with the substance, as determined under paragraph (b) ofthis section. The adequacy ofthe notification is the responsibility ofthe manufacturer or importer. Ifthe importer is not the manufacturer, it is the importer's responsibility to make the necessary evaluation and notification ofany risks
to health which may be associated with the substance. In making such evaluations, the importer must obtain that information described in paragraph (b) ofthis section which is reasonably ascertainable.

(d) Uponrequest, the manufacturer or importer must make available to EPA any information evaluated by the manufacturer or importer in determining the need for notification under paragraph (a)(2)(ii) ofthis section.

(e) The requirements for this exemption apply to all new chemical substances, including chemical substances manufactured or imported under such an exemption before the effective date of this rule. §720.38 Exemptions fortest marketing.

(a) Any person may apply for an exemption to manufacture orimport a

new chemical substance for test marketing. EPA may grant the exemption if theperson demonstrates that the chemical substance will not present an unreasonable risk to injury to health orthe environment as a result of the test marketing.

(b) Persons applying for a testmarketing exemption should provide the following information:

(1)All existing data regarding health and environmental effects of the chemical substance, including physical/ chemical properties or,in the absence of such data, a discussion of toxicity based

on structure-activity relationships (SAR) and relevant data on chemical analogues.

(2) The maximum quantity ofthe chemical substance which the applicant will manufacture or import fortest. marketing. 

### 21746

HeinOnline -- 48 Fed. Reg. 21746 1983

### Federal Register / Vol. 48, No. 94 / Friday, May 13, 1983 / Rules and Regulations

(3) The maximum number ofpersons who may be provided the chemical substance duringtest marketing.

(4) The maximum number ofpersons who may be exposed to the chemical substance as a result oftest marketing, including information regarding duration and route ofsuch exposures.

(5) A description ofthe test-marketing activity, including its length and how it

can be distinguished from full-scale commercial production and research and development.

(c) In accordance with section 5(h)(6) ofthe Act, afterEPA receives an application for exemption under this section, the Agency will file with the Office ofthe Federal Register a notice containing a summary ofthe information provided in the application, to the extent it has not been claimed confidential.

(d) No laterthan 45 days after EPA receives an application, the Agency will either approve ordeny the application. Thereafter, EPA willpublish a notice in the Federal Register explaining the

reasons for approval or denial.

(e) In approving an application for exemption, EPA may impose any restrictions necessary to ensure that the substance will not present an unreasonable risk ofinjury to health and the environment as a result of test marketing (OMB Control No. 2070-0012).
Subpart C-Notice Form
§720.40 General.

(a) Useofthe notice form.Each
person who isrequired by Subpart B to submit a notice must complete, sign, and submit a notice containing the information in the form and manner set forth in EPAForm No. 7710-25 2under Appendix A ofthis part. Except as otherwise provided inSubpart C, each notice mustbe submitted with all referenced attachments. The information

on the form and all attachments (unless the attachment appears in the open scientific literature) must be in English. All information submitted must be true and correct.

(b) When to submitanotice.Each
person who is required to submit a notice must submit the notice at least 90 calendar days before manufacture or import ofthe new chemical substance forcommercial purposes begins.

(c) Wheretosubmitanotice.Each
person who submits a notice must submit it to the address listed on the notice form.

(d) Generalnoticerequirements. Each
person who submits a notice must

2Copies may be obtained from: Industry Assistance Office (TS-799), Office ofToxic Substances, Environmental ProtectionAgency, 401 M St.. SW. Washington, D.C. 20460. provide the information described in §720.45 and specified on the notice form, to the extent such information is known to or reasonably ascertainable by the submitter. In accordance with § 720.50, the notice must also include
any test data in the su5mitter's possession or control and descriptions ofother data which are known to or reasonably ascertainable by the submitter and which concern the health and environmental effects ofthe new chemical substance.

(e)Agencyor jointsubmissions.(1)A manufacturer orimporter may designate

an agent to submit the notice. Both the manufacturer orimporter and the agent must sign the certification on the form.

(2) A manufacturer or importer mIay authorize another person, (e.g., a foreign manufacturer or supplier, or a toll manufacturer) to report some of the information required in the notice to EPA on its behalf. Ifseparate portions of

ajoint notice arenot submitted together, the submitter should indicate which information willbe supplied by another
person and identify that person. The other person must submit the information on the appropriate part of the notice form.The manufacturer or importer and any other person supplying the information must sign the certification provided on their respective notice forms.

(3)If EPAreceives a submission which does not include information required by thisrule, which the submitter indicates that it has authorized another person toprovide, the notice review period will not begin until EPA receives that information.

(f) New information.During the notice review period, ifthe submitter
possesses, controls, or knows ofnew information that materially adds to, changes, or otherwise makes significantly more complete the information included in the notice, the submitter must that information to the address listed on the notice form within
ten days ofreceiving the new information, but no later than five days before the end ofthe notice review period. The new submission must clearly identify the submitter and the notice to which the new information is related. If the new information becomes available during the last five days of the notice review period, the submitter must immediately inform its EPA contract for that notice by telephone.

(g) Chemicalsubstancessubjectto a section4 testrule.

(1)Except as provided in paragraph (g)(3) ofthis section, if (i) A person intends to manufacture orimport a new chemical substance which is subject to the notification requirements ofthis Part, and (ii) The chemical substance is subject to a testrule promulgated under section 4 ofthe Actbefore the notice is submitted, section 5(b)(1) ofthe Act requires the person to submit the test data required by the testing rule with the notice. Theperson must submit the data in the form and manner specified in the test rile and in accordance with § 720.50. Ifthe person does not submit the test data, the submission is incomplete and EPAwill follow the procedures in § 720.65.

(2) IfEPAhas granted the submitter

an exemption under section 4(c) ofthe Act from the requirement to conduct
tests and submit data, the submitter may not submit a notice until EPA receives the test data.

(3) IfEPA has granted the submitter

an exemption under section 4(c) of the Act and if another person previously has submitted the testdata to EPA, the exempted person may either submit the
test data orprovide the following information as part ofthe notice:

(i) The name, title, and address ofthe
person who submitted the test data to EPA.

(ii) The date the test data were submitted to EPA.

(iii) A citation for the test rule. (iv)A description ofthe exemption and a reference identifying it.

(h) Chemicalsubstancessubjectto a section5(b)(4)rule.(1) If a person (i) intends to manufacture orimport a new chemical substance which is subject to the notification requirements ofthis part and which is subject to a ruleissued under section 5 (b)(4) ofthe Act; and (ii) is not required by a rule issuedunder section 4 ofthe Act to submit test data for the substance before the submission of a notice, the person must submit to EPA data described in paragraph (h)(2) of this section at the time the notice is submitted.

(2) Data submitted under paragraph (h)(1) ofthis section.must be data which theperson submitting the notice believes show that the manufacture, processing, distribution in commerce,

use and disposal of the substance, or any combination ofsuch activities, will
not present an unreasonable risk of injury tohealth or theenvironment 

### (OMB Control No. 2070-0012). §720.45 Information that must be IncludedInthe noticeform.

Each person who submits a notice
must include the information specified in the notice form to the extent it is known to orreasonably ascertainable by the submitter. However, no person is required to include information which relates solely to exposure of human or 

### 21747

HeinOnline -- 48 Fed. Reg. 21747 1983

### Federal Register / Vol. 48, No. 94 / Friday, May 13, 1983 / Rules and Regulations

ecological populations outside of the United States. The notice form requires the following information relating to the manufacture, processing, distribution in
commerce, use, and disposal of the new chemical substance:

(a)(1) Forsubstances whose composition can be represented by a definite structural diagram (class 1 substances), the notice mustprovide the chemical name (preferably Chemical Abstracts Service (CAS) or International Union ofPure and Applied Chemistry (IUPAC) homenclature), the molecular formula, CAS Registry Number (if available), and a structural diagram.

(2) For chemical substances that cannot be fully represented by a structural diagram (class 2 substances), the notice mustprovide the chemical
name, the CAS Registry Number (if available), and molecular formula. The notice must identify the immediate precursors and reactants by name and CAS Registry Number (ifthe number is available). The notice must include a partial or incomplete structural diagram ifpossible. Chemical names for such substances should be developed according to the guidelines in the TSCA Chemical Substance Inventory, Initial Inventory, Volume 1.

(3) Forpolymers, the notice must identify monomers and other reactants used in the manufacture ofthe polymer by chemical name and CAS Registry Number (ifavailable). The notice must indicate the typical percent ofeach

monomer and other reactant in the polymer (by weight percent oftotal polymer); the maximum residual of each

monomer present in the polymer; and a partial or incomplete structural diagram, ifpossible. The notice mustprovide estimates ofthe minimum numberaverage molecular weight ofthe polymer and the amount oflow weight species below 500 and below 1,000 molecular weight and describe how the estimates

were obtained.

(b) The impurities anticipated to be present in the substance by name, CAS Registry number, and weight percent of the total substance.

(c) Known synonyms or trade names ofthe new chemical substance.

(d) A description ofthe byproducts resulting from the manufacture, processing, use, and disposal ofthe new chemical substance.

(e) The estimated maximum amount to be manufactured or imported during the first year ofproduction and the estimated maximum amount to be manufactured orimported during any 12-month period during the first three years ofproduction.

(f) A description ofintended categories ofuse by function and application, the estimated percent of production volume devoted to each category ofuse, and the percent ofthe

new substance in the formulation for each commercial or consumer use.

(g)For sites controlled by the submitter:

(1) The identity ofsites where the new substance will be manufactured, processed, orused.

(2) A process description of each manufacture, processing, and use operation which includes a diagram of the major unit operations and chemical conversions, the identity and entrypoint ofall feedstocks, and the points of release ofthe new chemical substance.

(3)Worker exposure information, including worker activities, physical form ofthe new substance to which workers may be exposed, the number of workers, and the duration ofactivities.

(4) Information on release ofthe new substance to the environment, including the quantity and media ofrelease and type ofcontrol technology used.

(h) For sites not controlled by the submitter, a description of each type of processing and use operation involving the new chemical substance, including identification ofthe estimated number of processing or use sites, situations in which worker exposure to and/or environmental release of the new chemical substance will occur, the number ofworkers exposed and the duration ofexposure, and controls which limit worker exposure and environmental release.
§720.50 Submission oftestdata and otherdata concerning the health and environmental effects ofasubstance.

(a) Testdataon thenewchemical substanceinthepossessionorcontrolof thesubmitter.(1) Except as provided in paragraph (d) ofthis section, each notice
must contain all test data in the submitter's possession or control which

are related to the effects on health or the environment ofany manufacture, processing, distribution in commerce, use, or disposal ofthe new chemical substance or any mixture or article containing the new chemical substance,

or any combination ofsuch activities. This includes test data concerning the

new chemical substance in a pure, technical grade, or formulated form.

12) A full report or standard literature citation must be submitted for the following types oftest data:

(i) Health effects data. (ii) Ecological effects data. (iii) Physical and chemical properties data.

(iv) Environmental fate characteristics. 

### (v)Monitoring data and other test data related to human exposure to or environmental release of the chemical substance.

(3)(i) Ifthe data do no appear in the open scientific literature, the submitter must provide a fullreport. Afullreport includes the experimental methods and materials, results, discussion and data analysis, conclusions, references, and the name and address ofthe laboratory that developed the data.

(ii) Ifthe data appear in the open scientific literature, the submitter need onlyprovide a standard literature citation. A standard literature citation includes author, title, periodical name, date ofpublication, volume, andpage numbers.

(4)(i)Ifa study,report, or test is incomplete when aperson submits a notice, the submitter must identify the nature and purpose ofthe study; name and address ofthe laboratory developing the data; progress to date; types ofdata collected; significant preliminary results; and anticipated completion date.

(ii) Ifa testor experiment is completed before the notice review period ends, theperson must submit the study, report, ortest to the address listed on the notice form, as specified in paragraph (a)(3)(i) ofthis section, within ten days ofreceiving it, butno later than five days before the end ofthe review period. Ifthe testor experiment is completed during thelast five days of the review period, the submitter must immediately informits EPA contact for that notice bytelephone.

(5)For test data inthe submitter's possession or control which are not listed in paragraph (a)(2) ofthis section,

a person is notrequired to submit a complete report.The person must submit a summary of the data. IfEPA so requests, theperson must submit a full report within ten days of therequest, butno later than five days before the end of thereview period.

(6)All test data described by paragraph (a) are subject to these requirements, regardless of their age, quality, or results.

(b] Otherdataconcerningthehealth andenvironmentaleffectsofthenew chemicalsubstancethatareknown to

orreasonably ascertainable by the submitter.(1] Except as provided in 

### paragraph (d) of this section, any person who submits a notice must describe the following data, including any data from

a health and safety study, ifthe data are related to the effects on health or the environment ofany manufacture, processing, distribution in commerce, use, or disposal ofthe new chemical 21748

HeinOnline -- 48 Fed. Reg. 21748 1983

### Federal Register / Vol. 48, No. 94 / Friday, May 13, 1983 / Rules and Regulations

substance, ofany mixture or article containing the new chemical substance.

or ofany combination of such activities:

(i) Any data, other than test data, in the submitter's possession or control.

(ii) Any data, including test data. which are not in the submitter's possession orcontrol, but which are known to orreasonably ascertainable by the submitter. For the purposes of this section, data are known to or reasonably ascertainable by the submitter ifthe data are known to any ofits employees orother agents who are associated with theresearch and development, testmarketing, or commercial marketing ofthe substance.

(2) Data that mustbe described include data concerning the new chemical substance in a pure, technical grade,or formulated form.

(3) The description of datareported under this paragraph mustinclude:

(i) Ifthe data appear in the open scientific literature, a standard literature citation,which includes the author, title, periodical name, date ofpublication. volume, and pages.

(ii) Ifthe data are not contained in the
open scientific literature, a description ofthe type of data and summary ofthe results, ifavailable, and the names and addresses ofpersons the submitter believes may have possession or control ofthe data.

(4) All data described by this paragraph are subject to these requirements, regardless oftheir age, quality, orresults; and regardless of whether they are complete at the time the notice is submitted.

(c) Dataconcerning related chemicals.A person must submit test data ordescriptions ofother data concerning impurities, byproducts, degradation products, unintended reaction products, or other chemical substances ormixtures related to"the manufacture, processing, distribution in
commerce, use, or disposal ofthe new chemical substance only if the data have
not beenpublished inthe open scientific literature. The submittermay either submit these data with thenotice or describe them in accordance with § 720.50(b)(3)(ii), rather than providing a full report.

(d)Datathatneednotbesubmitted- (1) Data previouslysubmittedtoEPA. (i) A person need not submit any data previously submitted to EPAwith no claims ofconfidentiality ifthe notice includes the office or person to whom the data were submitted, the date of submission, and,ifappropriate, a standard literature citation as specified in paragraph (a)(3)(ii) ofthis section.

(ii) Fordata previously submitted to EPAwith a claim ofconfidentiality, the person mustresubmit the datawith the 

### notice and any claim ofconfidentiality, under §720.80.

(2)

### Efficacydata.This Partdoes not require submission ofany data related solely to product dfficacy.This does not exempt aperson from submitting any of thedata specified in paragraph (a), (b),

.or (c) ofthis section.

.(3) 

### Non-U.S.exposuredata.ThisPart doesnot require submission ofany data whichrelates only to exposure of humans or theenvironment outside the United States.This doesnot exclude nonexposure data such as data on health effects (including epidemiological studies), ecological effects,physical and chemicalproperties, or environmental fate characteristics.
§720.57 Imports.



### (a) Except as otherwise provided in this section, the provisions ofthis Subpart Capply to each person who submits a notice fora new chemcial substance which he or she intends to import for a commercial purpose. In addition, each importer mustcomply with this section.

(b)EPA willhold theprincipal importer, or theimporter thatEPA determines must submit thenotice when there is noprincipal importer under §720.22[b) (2), liable for complying with this Part, for completing thenotice form and forthe completeness and truthfulness ofall information whichit submits. Subpart 0-DispositionofNotices
§720.60 GeneraL

This subpart establishes procedures that EPA will follow in reviewing 

### notices.
§720.62 Noticethatnotification Is not required.

When EPA receives anotice, EPA will review it to determine whether the chemical substance is subject to the requirements ofthis Part. IfEPA determines that the chemical substance is not subject to these requirements, EPA will notify the submitter that section 5 ofthe Act does not prevent the manufacture or import ofthe substance and that the submission is not a notice under this Part (0MB Control No. 2070- 0012). §720.65 Acknowledgment of receipt of a notice;errorsinthe notice; Incomplete submissions;false and misleading statements.

(a)Notificationtosubmitter.EPAwill acknowledge receipt ofeach notice by sending the submitter a letter that identifies the premanufacture notice number assigned to the new chemical 

### substance and the date onwhich the review period begins. The review period will begin onthe date the notice is received bythe Office ofToxic Substances Document Control Officer. The acknowledgment does not constitute a finding by EPA that the notice, as submitted, isin compliance with this Part.

(b)Errorsinthenotice.(1)Within 30 days ofreceipt ofthe notice, EPA may request that the submitter remedy errors in the notice. The following are examples of sucherrors:

(i)Failure to date the notice form. (ii)Typographical errors that cause data to be misleading or answers to any questions to be unclear.

(iii) Contradictory information. (iv) Ambiguous statements or information. (2)In the request to correct the notice, EPA will explain the action which the submitter must take to correct the notice.

(3)Ifthe submitter fails to correct the notice within 15days ofreceipt ofthe request.EPA may extendthe notice period under section(5)(c) ofthe Act, in accordance with §720.75(c).

(c)Incompletesubmissions.(1)A submission isnotcomplete, andthe notification perioddoes notbegin, if:

(i)The wrongperson submits the notice form.

(ii)The submitter does not sign the notice form.

(iii) Some or allofthe information in thenotice or the attachments are notin English,except for published scientific literature.

(iv) The submitter does notuse the notice form.

(v)The submitter does notprovide information that isrequired by section 5(d)(1) (B)and (C)ofthe Act and § 720.50.



### (vi) The submitter does notprovide information required on thenotice form andby §720.45 orindicate that it is not known to or reasonably ascertainable by the submitter.

(vii)The submitter does not submit a second copy ofthe submission with all confidential information deleted for the public file. as required by §720.80(b)(2).

(viii) The submitter does notinclude any informationrequired by section 5(b)(1) oftheAct and pursuant to arule promulgated under section 4 ofthe Act,

as required by §720.40(g).

(ix)The submitter does not submit data which the submitter believes show that thechemical substance will not present anunreasonable risk ofinjury to health orthe environment, ifEPA has listed the chemical substance under 21749

HeinOnline -- 48 Fed. Reg. 21749 1983

### Federal Register / Vol. 48, No. 94 / Friday, May 13, 1983 / Rules and Regulations

section 5(b)(4) ofthe Act, as required in § 720.40(h).

(2)(i) IfEPAreceives an incomplete submission, the Director, or his orher delegate, will notify the submitter within 30 days ofreceipt that the submission is incomplete and that the notice review period will not begin until EPA receives

a complete notice.

(ii) IfEPA obtains additional information during the notice review period that indicates the original submission was incomplete, the Director, or his orher delegate, may declare the submission incomplete within 30 days after EPA obtains the additional information and so notify the submitter.

(3] The notification that a submission is incomplete under paragraph (c)(2) (i)

or (ii) ofthis section will include:

(i)A statement ofthe basis ofEPA's determination that the submission is incomplete.

(ii) The requirements for correcting the incomplete submission.

(iii) Information on procedures under paragraph (c)(4) of this section for filing objections to the determination or requesting modification of the requirements for completing the submission.

(4)Within tendays after receipt of notification by EPA that a submission is incomplete, the submittermay file written objections requesting that EPA accept the submission as a complete notice or modify the requirements necessary to complete the submission.

(5)(i) EPA will consider the objections filed by the submitter. The Director, or his or her delegate, will determine whether the submissionwas complete or incomplete, or whether to modify the requirements for completing the submission. EPA will notify the submitter in writing ofEPA's response within ten days ofreceiving the objections.

(ii) Ifthe Director, or his orher delegate, determines, in response to the objection, that the submission was complete, the notice review period will be deemed suspended on the date EPA declared the notice incomplete, and will

resume on the date that the notice is declared complete. The submitter need not correct the notice as EPA originally requested. IfEPA can complete its review within 90 days from the date of the original submission, the Director, or his orher delegate, may inform the submitter that the running ofthe review period will resume on the date EPA originally declared itincomplete.

(iii)Ifthe Director, or his orher delegate, modifies the requirements for *completing the submission or concurs with EPA's original determination, the 

### notice review period willbegin when EPAreceives a complete notice.

(d)Materially false ormisleading
statements.IfEPA discovers at any time thatperson submitted materially false or misleading statements in the notice, EPA may find that the notice was incomplete from the date it was submitted, and take any other appropriate action.
§720.70 Notice Inthe Federal Register.



### (a)FilingofFederal Register notice.In accordance with section 5(d)(2) ofthe Act, after EPAreceives a notice, EPA will file with theOffice of theFederal Register a riotice including the information specified in paragraph (b)of this section.

(b) Contentsofnotice.(1)In thepublic interest, the specific chemical identity listed in the notice will be published in theFederal Registerunless the submitter has claimed chemical identity confidential. Ifthe submitter claims confidentiality, a generic name will be published in accordance with §720.85(a)(3).

(2)The categories ofuse of thenew chemical substance will be published as reported in thenotice unless this information is claimed confidential. If confidentiality is claimed, the generic information which is submitted under §720.87(b) willbe published.

(3)A listof data submitted in accordance with §720.50(a) willbe published. In addition, fortest data submitted in accordance with §720.40(g), a summary ofthe data will be published.

(4)The submitter's identity will be published, unless the submitter has claimed it confidential.

§720.75 Notice review period.



### (a)Length ofnoticereview period. The notice review period specified in section 5(a) ofthe Act runsfor 90days from the date the Document Control Officer for the Office ofToxic Substances receives a complete notice,

or the date EPA determines the notice is complete under §720.65(c), unless the Agency extends the periodunder section 5(c) ofTSCA and paragraph (c) ofthis section.

(b) Suspensionofthe runningofthe noticereviewperiod(1)A submitter may voluntarily suspend the running of 

### the notice review periodif theDirector

orhis or her delegate agrees. Ifthe Director doesnot agree, the review period will continue to run, and EPA willnotify the submitter. A submitter may request a suspension at any time duringthe notice review period. The suspension must be fora specified period of time. (2) A request for suspension may be made in writing to the Document Control Officer (TS-793), Office of Pesticides and Toxic Substances, 401 M Street SW., Washington, D.C. 20460. The suspension also may be made orally, including by telephone, to the submitter's EPA contact for that notice. EPAwill send the submitter a written confirmation that the suspension has been granted (OMB Control No. 2070- 0012).

(i) An oral request may begranted for 15 days only.To obtain a longer suspension, the Document Control Officer forthe Office ofToxic Substances must receive written confirmation ofthe oral request. The notice review period is suspended as of the date ofthe oral request.

(ii) If the submitter has not made a previous oral request, the running ofthe notice review period is suspended as of the date ofreceipt ofthe written request by the Document Control Officer for the Office ofToxic Substances.

(c)Extensionof noticereviewperiod. (1) At any time during the notice review period, EPA may determine that good

cause exists to extend the notice review period specified in paragraph (a) of this section.

(2) If EPAmakes such a determination, EPA will:

(i)Notify the submitter that EPA is extending the notice review period for a specified length oftime, and state the

reasons for the extension.

(ii) Issue a notice forpublication in the Federal Register which states that EPA is extending the notice review period and gives the reasons for the extension.

(3) The initial extension may be for a period of up to 90 days. Ifthe initial extension is forless than 90 days, EPA may make additional extensions. However, the total period ofextensions
may not exceed 90 days for any notice.

(4) Thefollowing are examples of situations in which EPAmay find that good cause exists for extending the notice review period:

(i) EPA has reviewed the notice and determined that there is a significant possibility that the chemical substance will be regulated under section 5(e) or section 5(f) ofthe Act, but EPA is unable
to initiate regulatory action within the initial 90-day period.

(ii) EPA has reviewed the submission and is seeking additional information.

(iii) EPA has received significant additional information during the notice review period.

(iv) The submitter has failed to correct

a notice after receiving EPA's request under § 720.65(b). 

### 21750

HeinOnline -- 48 Fed. Reg. 21750 1983

### Federal Register / Vol. 48, No. 94 / Friday, May 13, 1983 / Rules and Regulations

(d)Notice ofexpirationof notice reviewperiod. EPA will notify the submitter that the notice review period has expired or that EPA has completed its review ofthe notice. Expiration ofthe review period does not constitute EPA approval or certification ofthe new chemical substance, and does not mean that EPAmay not take regulatory action against the substance in the future. After expiration ofthe statutory notice review period, in the absence ofregulatory action by EPA under section 5(e), 5(f), or 6(a) of the Act, the submitter may manufacture or import the chemical substance even if the submitterhas not received notice ofexpiration.

(e) Withdrawalofanoticeby the submitter.(1) A submitter may withdraw a notice during the notice review period. A statement of withdrawal must be made in writing to the Document Control Officer (TS-793). Office ofPesticides andToxic Substances, 401 M St.SW., Washington, D.C. 20460.The withdrawal is effective
upon receipt ofthe statement by the Document Control Officer (OMB Control No. 2070-0012).

(2) If a manufacturer orimporter which withdrew anotice later resubmits

a notice for the same chemical substance, a new notice review period begins. §270.78 Recordkeeping

(a) Any person who submits a notice under this Part must retain documentation ofinformation in the notice,including (1)other data, as defined in §720.50(b), in the submitter's possession or control; and (2) records of production volume for the first three
years ofproduction orimport, the date ofcommencement of manufacture or import, and documentation ofthis information.This information must be retained for five years from the date of
commencement ofmanufacture of import.

(b) Persons who manufacture or import a chemical substance under the
terms ofa research and development exemption must retain documentation of compliance with the exemption, including copies ofthe information they used to determine the need to make any notification ofrisk to health under § 720.36 for five years from the final date of manufacture orimport underthe exemption.

(c) Any person who obtains a testmarketing exemption under this Part
mustretain documentation of information in the application and documentation of compliance with any restrictions imposed by EPA when it granted the application. This information must be retained for five years from the final date ofmanufacture

or import under the exemption (OMB Contrbl No. 2070-0012). Subpart E-Confidentiality and Public

Accessto Information
§720.80 General provisions.

(a) A person may assert a claim of confidentiality for any information which he orshe submits to EPAunder this Part.

(b)Any claim ofconfidentiality must accompany the information when itis submitted to EPA.

(1)(i) For information submitted on the notice form, the claim(s) mustbe asserted on the form in the manner prescribed on the notice form. (ii)When a person submits information in an attachment, the claim(s) must be asserted in the attachment as described on the notice form.

(2) Theperson must submit two copies ofeach notice form and any attachments ifany information is claimed confidential.

(i)One copy ofthe form and attachments mustbe complete. In that
copy,the submitter must mark the information which is claimed confidential in the manner prescribed on the notice form.

(ii) The second copy must be complete except that all information claimed as confidential in the first copy must be deleted. EPA willplace the second copy in the public file.

(iii) Ifthe submitter does not provide the second copy, the submission is incomplete and the noticereview period does not begin to run until EPA receives the second copy, in accordance with § 720.65(c)(vi). I

(c) EPAwill disclose information that is subject to a claim ofconfidentiality assertedunder this section onlyto the

extent permitted bythe Act, this Subpart, and Part 2of thisTitle.

(d) Ifa notice submitter does not assert a claim of confidentiality for information at the time it is submitted to EPA, EPAmay make the information public and place it in thepublic file without further notice to the submitter (OMB Control No. 2070-0012).
§720.85 Chemical Identity.

(a)Claimsapplicableto theperiod priorto commencementof manufacture

orimport.(1)(i) A person who submits information to EPA underthis Part may assert a claim ofconfidentiality for the chemical identity ofthe new chemical substance. This claim will apply only to theperiod prior to the commencement of manufacture orimport for commercial
purposes. A submitter may assert this claim only ifthe submitter believes that public disclosure prior to
commencement ofmanufacture or import ofthe fact that anyone intends to manufacture or import the specific chemical substance forcommercial
purposes would reveal confidential business information. (ii) Ifthe notice includes a health and safety study concerning the new chemical substance and ifthe claim for confidentiality with respect to the chemical identity is denied in accordance with §720.90(c), EPA will deny a claim asserted under this paragraph.

(2) Any person who asserts a claim of confidentiality for chemical identity underthis paragraph must provide one ofthe following items at the timethe notice is submitted:

(i) The generic name which was accepted by EPA in theprenotice consultation conducted under paragraph (a)(3) ofthis section.

(ii) One generic name that is only as generic as necessary to protect the confidential chemical identity ofthe particular chemical substance. The

name should reveal the specific chemical identity to the maximum

extent possible. The generic name will be subject to EPA review and approval
at the time a notice ofcommencement is submitted.

(3)(i) Any person who intends to
assert a claim ofconfidentiality for the chemical identity ofa new chemical substance may seek a determination by EPA ofan appropriate generic name for the substance before submitting a notice. For this purpose, the person should submit to EPA:

(A) The chemical identity ofthe substance.

(B) Aproposed generic name(s) which in only as generic as necessary to protect the confidential chemical identity of the new chemical substance. The name(s) should reveal the chemical identity of the substance to the maximum extent possible.

(ii) Within 30 days, EPA willinform the submitter either that one ofthe proposed generic names is adequate or that none is adequate and further consultation is necessary.

(4) Ifa submitter claims chemical identity to be confidential under this paragraph, and ifthe submitter complies with paragraph (a)(2) of this section, EPA will issue forpublication in the Federal Register notice described in § 720.70 the generic name proposed by the submitter or one agreed upon by EPA and the submitter.

(b) Claimsapplicableto theperiod aftercommencement ofmanufactureor 

### 21751

HeinOnline -- 48 Fed. Reg. 21751 1983

### Federal Register / Vol. 48, No. 94 / Friday, May 13, 1983 / Rules and Regulations

import.(1)Any claim ofconfidentiality under paragraph (a) ofthis section is applicable onlyuntil the substance is manufactured or imported for commercial purposes and becomes eligible for inclusion on the Inventory. To maintain the confidential status of the chemical identity when the substance is added to the Inventory, a submitter must reassert the confidentiality claim and substantiate the claim in the notice of
commencement ofmanufacture required

uner §720.102. A submitter may not claim the chemical indentity confidential for the period after commencement ofmanufacture or import unless the submitter claimed the chemical identity confidential for the periodprior to commencement of manufacture or import under paragraph (a) ofthis section.

(2)(i) A person who believes that public disclosure of the fact that anyone manfactures or imports the new chemical substance for commercial
purposes would reveal confidential business information may assert a claim ofconfidentiality under this paragraph.

(ii) Ifthe notice includes a health and safety study concerning the new chemical substance, and ifthe claim for confidentiality with respect to the chemical identity is denied in accordance with § 720.90(c), EPA will deny a claim asserted under this paragraph. (3)Any person who asserts a confidentiality claim for chemical identity must:

(i) Comply with the requirements of paragraph (a)(3) ofthis section regarding submission of ageneric name.

(ii) Agree thatEPA may disclose to a person with a bona fideintent to manufacture or import the chemical substance the fact that the particular chemical substance is included on the confidential Inventory forpurposes of notification under section 5(a)(1)(A) of the Act.

(iii) Have available forthe particular chemical substance, and agree to furnish
to EPA upon request:

(A) An elemental analysis. (B) Either an X-ray diffraction pattern (for inorganic substances), a mass spectrum (formost 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 chemical substance.

(iv)Provide a detailed written substantiation of the claim, by answering the following questions:

(A) What harmful effects to your competitive position, ifany, do you think would result ifEPA publishes on the Inventory the identity ofthe chemical substance? How could a competitor use such information given the fact that the identity ofthe substance otherWise would appear on the Inventory ofchemical substances with no link between the substance and
your company or industry? How substantial would the harmful effects of disclosure be? What is the casual relationship between the disclosure and the harmful effects?

(B) For what period of time should confidential treatment be given? Until a specific date, the occurrence ofa specific event, or permanently? Why?

(C) Has the chemical substance been patented? Ifso, have you granted licenses to others with respect to the patent as it applies to the chemical substance? Ifthe chemical substance has been patented and therefore disclosed through the patent, why should it be treated as confidential for
purposes ofthe Inventory?

(D) Has the identity of the chemical substance been kept confidential to the
extent that your competitors do not know it is being manufactured on imported for acommercial purpose by anyone?

(E)Is the fact that someone is manufacturing or importing this chemical substance forcommercial
purposes available to the public, e.g., in technical journals orother publications; in libraries; or in State, local, or Federal
agency public files?

(F)What measures have you taken to prevent undesired disclosure ofthe fact thatyou are manufacturing or importing this substance for a commercial purpose?

(G) To what extent has the fact that
you are manufacturing or importing this chemical substance for a commercial
purpose been disclosed to others? What precautions have you taken inregard to these disclosures? Has this information been disclosed to the public orto competitors?

(H) In what form does this particular chemical substance leave the site of manufacture, e.g., as part of a product; in an effluent or emission stream? Ifso, what measures have you taken to guard against discovery ofits identity?

(I) If the chemical substance leaves the site ofmanufacture in a product that is available to either the public or your competitors, can they identify the substance by analyzing the product? (J)

For what purpose do you manufacture orimport the substance?

(K) Has EPA, another Federal agency,

or any Federal court made any pertinent confidentiality determinations regarding this chemical substance? If so, copies of 

### such determinations must be included in the substantiation.

(L)Ifthe notice includes a health and safety study concerning the new chemical substance, the submitter must also answer the questions in §720.90 (b) (2).

(4)Ifthe submitter does notmeet the requirements ofthis paragraph, EPA will deny the claim ofconfidentiality.

(5)(i)EPA willpublish a generic name
on the public Inventory if:

(A)The submitter asserts a claim of confidentiality in accordance with this pargraph.

(B) No claim forconfidentiality ofthe specific chemical identity aspart ofa health and safety study hasbeen denied in accordance with Part 2 ofthis Title or § 720.90.



### (ii)Publication of ageneric name on thepublic Inventory does not create a category for purposes ofthe Inventory. Any person who has a bona fide intent to manufacture or import a chemical substance whichis described bya generic name on the public Inventory may submit an inquiry to EPA under §720.25 (b)to determine whether the particular chemical substance is included on the confidential Inventory.

(iii)Upon receipt ofarequest described in §720.25 (b), EPA may 

### require 'the submitter which originally asserted confidentiality for a chemical substance to submit toEPA the information listed in paragraph (b) (3) (iii) ofthis section.

(iv) Failure to submit any ofthe information required under paragraph (b) (3)(iii) ofthis section within ten days of a request byEPA underthis paragraph is a waiver ofthe original submitter's confidentiality claim. Inthis event, EPA mayplace the specific chemical identity on the public Inventory without further notice to the original submitter.

(6) Ifa submitter asserts a claim of confidentiality,underthis paragraph, EPA will examine the generic chemical

name proposed bythe submitter.

(i)IfEPA determines that thegeneric

name proposed bythe submitter is only

as generic as necessary to protect the confidential identity of theparticular chemical substance, EPA willplace that generic name on the public Inventory.

(ii) IfEPA determines that the generic

name proposed bythe submitter is more generic than necessary to protect the confidential identity,EPA will propose in writing, for review by the submitter,

an alternative generic name that will reveal thechemical identity of the chemical substance to the maximum extent possible. 

### 21752

HeinOnline -- 48 Fed. Reg. 21752 1983

### Federal Register / Vol. 48, No. 94 / Friday, May 13, 1983 / Rules and Regulations

(iii) Ifthe generio name proposed by EPA is acceptable to the submitter, EPA willplace that generic name on the public Inventory.

(iv)If the generic name proposed by EPA is not acceptable to the submitter, the submitter must explain in detail why disclosure ofthat generic name would reveal confidential business information and propose another generic name which is only as generic as necessary to protect the confidential identity. IfEPA does not receive a response from the submitter within 30 days after the submitter receives the proposed name, EPA will place EPA's chosen generic

name on the public Inventory. Ifthe submitter does provide the information requested, EPA willreview the response. Ifthe submitter's proposed generic name is acceptable, EPA will publish that generic name on thepublic Inventory. Ifthe submitter's proposed generic name is not acceptable, EPAwill notify the submitter ofEPA's choice ofa generic name. Thirty days after this notification, EPAwill place the chosen generic name on the publicInventory.
§720.87 Categories or proposed categories of uses of anew chemical substance. (a)A person who submits information
to EPA under this Parton the categories

or proposed categories ofuse ofa new chemical substance may assert a claim of confidentiality forthis information.

(b] A submitter that asserts such a claim must:

(1) Report thecategories or proposed categories ofuse of the chemical substance.

(2) Provide, in nonconfidential form, a description of the uses that is only as generic as necessary to protect the confidential business information. The generic use description will be included in the Federal Register notice described in § 720.70.

(c) Theperson must submit the information required byparagraph (b)of this section in the manner specified in the notice form.
§720.90 Data from healthand safety studies.

(a)Informationotherthanspecific 

### chemicalidentity.Except asprovided in paragraph (b)ofthis section, EPA will deny any claim ofconfidentiality with respect to information included in a health and safety study, unless the information would disclose confidential business information concerning:

(1) Processes used in the manufacture

or processing ofa chemical substance or mixture. (2) In the case ofa mixture, the portion ofthe mixture comprised by any 

### of thechemical substances in the mixture.

(3)Informaton which is notin any way related to the effects ofa substance

on human health or the environment, such asthe name of the submitting company, cost orother financial data, product development ormarketing plans, and advertising plans, forwhich the person submits a claim of confidentiality in accordance with § 720.80.



### (b)Specificchemicalidentity.(1) Claimsapplicabletoperiod priorto commencementof manufacture. A claim ofconfidentiality forthe period prior to commencement ofmanufacture or import forthe chemical identity ofa chemical substance for whicha health and safety study was submitted mustbe asserted in conjunction with a claim asserted under §720.85(a).

(2) Claimsapplicabletoperiodafter
commencementof manufactureor import forcommercialpurposes. To maintain the confidential status ofthe chemical identity ofa chemical substance for which a health and safety study was submitted after commencement ofmanufacture or import, the claim mustbe reasserted and substantiated in conjunctionwith a claim under §720.85(b). In addition to the questions set forth in §720.85(b)(3)(iv) of thisPart, the submitter must answer thefollowing questions:

(i)Would disclosure ofthe chemical identity disclose processes used inthe manufacture orprocessing ofa chemical substance or mixture? Describe how this would occur.In responding tothe q uestionin §720.85(b)(3)(iv)(A), explain atharmful competitive effects would

occur from disclosure ofthis process information.

(ii)Would disclosure ofthe chemical identity disclose the portion of amixture comprised by any ofthe substances in the mixture? Describe how this would

occur. Inresponding to the question in §720.85(b)(3)(iv)(A), explain what harmful competitive effects would occur from disclosure of thisinformation.

(iii) Do you assert that disclosure of the chemical identity is notnecessary to interpret any of thehealth and safety studies you have submitted? If so, explain how a less specific identity would be sufficient to interpret the studies.

(c)Denialofconfidentialityclaim. EPA will deny a claim ofconfidentiality forchemical identity underparagraph (b) ofthis section, unless:

(1)The informationwould disclose processes used in the manufacture or processing ofa chemical substance or mixture. (2)In the case of a mixture, the information would disclose theportion ofthe mixture comprised by any of the substances in the mixture.

(3)The specific chemical identity is not necessary to interpret a health and safety study.

(d) Useof genericnames.When EPA discloses a health and safety study containing a specific chemical identity, which the submitter has claimed confidential, and ifthe Agency hasnot denied the claim under paragraph (c) of this section, EPA willidentify the chemical substance by thegeneric name selected under §720.85. (OMB Control No. 2070-0012)

§720.95 Publicfile.



### All information submitted with a notice, including any health and safety study and other supporting documentation, will become part ofthe public file for that notice, unless such materials are claimed confidential. In addition, EPA may add materials to the public file, subject to SubpartEofthis Part.Any ofthe nonconfidential material described above will be available for public inspection in the Office ofToxic Substances Public Reading Room,Rm. E-107,401 M St., SW.,Washington, DC 20460, during normal business hours. Subpart F-Commencement of Manufacture orImport §720.102 Noticeofcommencement of manufacture orImport.

(a)Applicability. Any person who

commences tomanufacture orimport a
new chemical substance for a commercial purpose for which that person previously submitted a section 5 notice under thisPart must submit a notice ofcommencement ofmanufacture

or import.

(b) When toreport.(1)Ifmanufacture

or importfor commercial purposes begins on orafter the effective date of this rule, the submitter must submit the notice toEPA onthe first day of such manufacture orimport.

(2)Ifmanufacture or import for commercial purposes began or will begin before the effective date ofthis rule, the submitter must submit the notice bythe effective date ofthis rule.

(c)Informationtobereported. The notice must contain thefollowing information: specific chemical identity, premanufacture notice number, andthe date when manufacture orimport

commences. Iftheperson claimed chemical identity confidential in the commencement notice, and wants the identity to be listed on the confidenial 21753

HeinOnline -- 48 Fed. Reg. 21753 1983

### Federal Register / Vol. 48, No. 94 / Friday, May 13, 1983 / Rules and Regulations

Inventory, the claim must be reasserted and substantiated in accordance with § 720.85(b). Otherwise, EPA will list the specific chemical identity on the public Inventory (OMB Control No. 2070-0012).
Subpart G-Compliance and Inspections
§720.120 Compliance.

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

(b) A person who manufactures or imports a new chemical substance before a notice is submitted and the notice review period expires is in violation ofsection 15 ofthe Act even if that person was not requied to submit the notice under § 720.22 ofthis Part.

(c) Using for commercial purposes a chemical substance ormixture which a person knew orhad reason to know was manufactured, processed, or distributed in commerce in violation of section 5 of this rule is a violation ofsection 15 of the Act (15 U.S.C. 2614].

(d) Failure or refusal to establish and maintain records or to permit access to

or copying ofrecords, as required by the Act, is a violation ofsection 15 of the Act (15 U.S.C. 2614).

(e) Failure or refusal to permit entry or inspection as required by section 11 is a violation ofsection 15 of the Act (15 U.S.C. 2614).

(f) Violators may be subject to the civil and criminal penalties in section 16 ofthe Act (15 U.S.C. 2615) for each violation. Persons who submit materially misleading or false information in connection with the requirements ofany provision ofthis rule may be subject to penalties calculated as ifthey never filed their notices.

(g) EPA may seek to enjoin the manufacture orprocessing ofa chemical substance inviolation ofthis rule or act to seize any chemical substance manufactured orprocessed inviolation of this rule or take other actions under the authority ofsection 7of this Act (15 U.S.C. 2606) or section 17 or this Act (15 U.S.C. 2616).
§720.122 Inspections.

EPA will conduct inspections under section 11 ofthe Act to assure compliance with section 5 ofthe Act and this rule, to verify that information submitted to EPA under thisrule is true and correct, and to audit data submitted
to EPA under this rule.

BILLINGCODE 6560-50-M 

### 21754

HeinOnline -- 48 Fed. Reg. 21754 1983