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Citation: 42 Fed. Reg. 64572 1977

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# 64572
[6560-01]
Title40-ProtectionofEnvironment

CHAPTER I-ENVIRONMENTAL PROTECTION AGENCY
SUBCHAPTER R-TOXIC SUBSTANCES CONTROL 

### [OTS-081002A; FRL 817-1l 

## PART 710-INVENTORY REPORTING REGULATIONS AGENCY: Environmental Protection Agency. ACTION: Final rules. SUMMARY: Thisnoticepromulgates the Inventory reportingregulations proposed

on March 9 and August 2, 1977 in the FEDERAL 

## REGISTER and supplemented thereafter. Specifically,theseregulations require some persons who manufacture

orimportchemical substances:

(1) To report the identity of each chemical substance manufactured at each site of manufacture, or imported Into theUnited States, fora commercial purpose; (2) To estimate the amount of each chemical substance manufactured at each site, or imported during calendar year 1977; and (3) To indicate whether each such chemical substanceismanufactured and usedonlywithin onesite.

Baseduponthereportsofmanufactur-

ers and importers, EPA will publish an initial inventory of chemical substances. After publication of the initial inventory, these regulations authorize reporting by processors ofadditional chemical substances. EPA will publish-a revised inventory including these substances in 1979. DATES: These regulations are effective January 1, 1978.Reporting forthe initial inventory bymanufacturers and Importers 6f chemical substances will begin January 1, 1978 and end May 1, 1978. During the 210 days afterpublication of theInitial inventory in late 1978, processors of chemical substances, and importersof chemical substances aspartof mixtures or articles, may report additional chemical substances for a revised inventory. (NOTE: Many of the terms used inthese regulations, such as "manufacturer" and "processor" have a specialmeaning forpurposes oftheseregulations. Persons shouldread the regulations, especially the definition section carefully, and be sure they understand thespecial meaningsoftheseterms.) VoR FURTHER INFORMATION CONTACT:

Mr.John B.Ritch,Jr.,Director,Office of Industry Assistance, Office ofToxic Substances (TS-788), Environmental Protection Agency, 401 M Street, SW, Wa-shington, D.C. 20460, 202-755-0535. To obtainreportingforms andinstructions, call this toll-free number 800- 424-9065. SUPPLEMENTARY INFORMATION; The regulations are promulgated under the authority of subsection 8(a) of the Toxic Substances Control Act (90 Stat. 2003; 15U.S.C. 2601 et seq.) hereinafter referred to asTSCA. 

## RULES AND REGULATIONS

OnMarch 9, 1977, EPAfirst published in the FEDERAL REGISTER 

### (42 

## Fn 13130) 

## proposedinventoryreportingregulations
to govern reporting of chemical substances required by subsection 8(a) of TSCA. OnApril 12, 1977, EPA published

a supplemental notice of proposed rulemaking in the FEDERAL 

## REGISTER (42 

## FR 19298) providing additional information pertaining to the proposed inventory regulations. This notice set forth instructions foruse of a Candidate Listof Chemical Substances and specified minerals which EPA proposed to include in theinventory of chemical substances.

On April 18, 1977, EPA held a public meeting inWashington, D.C. to provide interested persons an opportunity to comment publicly on theproposedregulations.OnApril28, 1977,EPApublished

anotice of availability of the Candidate List of Chemical Substances for use in reporting chemicals for inclusion on the inventory (42FR21639). OnJuly 8, 1977, the Agency published a notice to amend theprocedures forsecuring acopy ofthe Candidate List on computer-readable tape (42 PR35183). EPA ispreparing to supplement the Candidate List with at 'least one additional listofsubstances.As

soon as any supplementary list is available, EPA will publish anotice of availability inthe FEDERAL

## REGISTERto enable persons to request copies.

On August2, 1977, EPAreproposedthe inventoryreportingregulations. In order
to provide interested persons an opportunity to comment publicly on the proposed regulations, EPA held a public meeting in Washington, D.C. on August 24, 1977. Atranscript ofthepublic meeting is available for public inspection in the Office ofToxic Substances atthe addressprovided above.Finally,onOctober 3, 1977, EPApublished a supplementary notice to the August 2 proposal. This

- 

## notice clarified the applicability of the"

reporting regulations to importers and invited comment on draft reporting forms.

EPAhasreceivedover400 commentsin response tothe notices ofproposedrulemakingpublished on March 9, August 2, and October 3, 1977. These comments

were received from trade associations, business firms, environmental organizations, labor unions, state and federal agencies and others. Appendix A ofthis notice summarizes and responds to the *significant Issues raised in these comments. The major Issues that were resolvedinpromulgation ofthesefinalregulations are discussed below.

Appendix B of these regulations includes copies of thereporting forms for these regulations. These forms are published here as samples of the official forms which willbe available from-EPA. These formsmay notbe usedforreportIng.Theofficial forms;which willbe distributed to persons included on EPA's mailing list,each has a unique Identifying number forpurposes ofprocessing. AuTHoRIY, PURPOSE AND SCOPE OF THE

* REGULATIONS


## These regulations are promulgated pursuant tothe authority ofsection 8(a) of TSCA. They accomplish two of the purposes containedIn thatsection of the Act.Inthefirstplace,Inaccordance with section 8(a) (1) ofthe Act, they require reporting for compilation of the Inventory of chemical substances manufacturedorprocessed foracommercial purposein theUnited States. TheAdministratorIsrequired to compile andpublish

an inventory of chemical substances under section 8(b) of the Act. In the second place, under the authority of TSCA section 8(a) (1)(A), these regulationsrequirereporting ofproduction and siteInformation on chemical substances, which isreasonably necessary for establishingaprofile ofthe chemicalindustry, monitoring chemical substances In the environment, and settingAgency prioritiesforimplementing otherprovisionsof TSCA.



## In the interest of accomplishing these objectives, §710.3(a) requires any person who manufactured or Imported chemicalsubstances during calendaryear 1977 to report concerning all such substances If (a) thirty percent or more of the weight of the products consists of products of the types described under Standard Industrial Classification (SIC) groups 28 or 2911, or (b) If the total pounds ofreportable chemicalsubstances manufactured or Imported equals one millionpounds ormore.In addition, any person who manufactured at a site or imported achemical substance in100,000 pound quantities or greater during calendar ear 1977 must report concerning thatchenical substance.

By directing the reporting requirements to those persons who are significantly engaged In manufacturing chemical substances, EPAwill create a profile ofthe chemical industryuseful Infuture implementation ofTSCA.As aminimum, the Agency will know the site of manufacture of all chemicals manufactured inquantities greaterthan100,000pounds. Moreover, for every plant site substaitially engaged in producing chemical substances orchemical productsfor com- mercial purposes, EPA will know the Identities of the substances manufactured there and the relative quantities inwhichthey areproduced.

As discussed further inthe response to comments (Appendix A); EPA desires to minimize duplicative reporting to the extent consistent with its needs in Implementing TSCA. Manufacturers and Importers who do not meet the criteria forrequired reporting donotneed toreport individually. Instead, they mayre- port through a trade association or rely upon another manufacturer or an Importer to report the substances for Inclusion on the inventory. Further, in tie interestofminimizingduplicativereporting,personswhoareprocessorsofachemical substance theyneither manufacturo

nor import are notsubject to the initial reporting requirements. Persons who process or use chemical substances for commercial purposes may report those chemical substances not included in the Initialinventory during aspecial reporting period. In addition, persons who ImFEDERAL REGISTER, VOL 42, NO. 247--FRIDAY, DECEMBER 23, 1977



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## RULES AND REGULATIONS

port chemical substances as a part of a nx&=e or article may report during thespecialreportingperiod.EPAexpects to publish a revised inventorybased on these additional reports sometimein fall 1979.
SMALL LUNUFACTURER



## Asprovided inTSCA section 8(a) and discussedinthepreambleto theAugust 2 proposal,EPAmayrequire "small manu- facturers" to submit only information necessary for compilation of the inventoryor concerning'a chemical substance which is subject to a proposed rule or order under TSCA section 4, 5 or 6 or court actionunder section 5 or7.Atthis time, any person who is required to re- port'and whois a small manufacturer is onlyrequired to submit information re- quired for compilation ofthe inventory. Accordingly, any "small manufacturer" need only identify chemical substances and report certain limited information required for purposes of the inventory. Small manufacturers are exempt from reporting production volumes and, if a small manufacturer has more than one plant site,heneednot separately report foreach site.Since theseregulations define "manufacture" to include "import," the provision applies equally to "small importers."

The definition of "smallmanufacturer

or importer" proposed in August has beenrevised toexempt from these additionalreportingrequirementsthoseman- ufacturers and importers withthtalsales ofless than $5 million. This exemption, however, does not apply with respect to any chemical substance produced by a manufacturer atone site or imported in quantities equalto ofgreater than 100,- 000 pounds during calendar yebr 1977. Accordingly, no manufacturer will be considered a "smallmanufacturer orimporter"withrespecttoanychemicalsubstance manufactured at one site orimported in quantities over 100,000 pounds.

-In deciding howtodefine "smallman- ufacturer or importer," EPA considered both the relative burden to manufacturers andimporterstosubmitadditional information andthevalueofthatinformation to EPA and other federal agencies.Under this definition,thetotal cost of reporting for the inventory for the marginal small firm, inmost cases, will be about 1 percent of profits. While the firmsexemptedunderthisdefinitionrepresent nearly 80 percent of chemical firms, theyaccount foronly 4percent of sales ofchemical substances and only 6 percent of employment in SIC groups 28and2911.

In the interest ofcreating a database that is atleast complete with respect to thevolumesofthosechemical substances produced in substantial-quantities, this definitiondoesnotexemptanymanufacturerorimporterfromreportingthevol-

umes ofindividual substances produced inquantities ofover 100,000pounds during calendar year 1977. Reporting pro- duction volumewill involve simply pro- viding thedigitthatis associated with a broad range (e.g., "4" is for production between1millionand10 millionpounds), asprovidedinthe table at §710.5(d) (4). Since themanufacturer or importerwill already bereporting the names of substances,the additionalburden ofsupplying production information in terms of large ranges should be minimal, especiallyfor substances produced insignificant quantities.
REPORTING 

## SCEDULE AM 

## EuroncE.Max

Theseregulationsprovideforpublication ofan initial inventorybasedonre- porting bymanufacturers and importers ofchemical substances, followedbypublication of a revised inventory based on reporting byprocessors ofchemical substances and Importers of chemical substances aspart ofmixtures and articles. Reporting for the initial inventory will beginonJanuary 1,1978, andendMay 1, 1978. Manufacturers and Importers of chemical substancesmustreport,asprovided In §710.3(a), during thisfirst re- porting period. Processors are only subjecttothesecondreportingperiodwhich will beginafterpublication oftheinitial inventory andend210 dayslater.

Thirtydays afterpublicationoftheinitialinventory,premanufacture notification willbegin.After that date,anyper-
son who intends to manufacture or import (inbulk) a chemical substancenot included on the inventory must submit premanufacture notice under section 5 (a) (1)(A). Processors and users of a chemical substance for a commercial purpose, andimportersofa chemicalsubstance as a part of a mixture or article willbe ableto supplement theinitial inventory during the second reporting period, as provided in §710.3(b). TSCA section 15(1) makes it unlawful foranypersontofailorrefuse to comply withthepremanufacturenotificationre- quirements of section 5. TSCA section 15(2) makes Itunlawful fora person to
use for a commercial purpose any substancewhich hehadreasontoknowwas manufactured in violation of section 5. Sections 15(1) and 15(2) as they relate to section 5(a)(1)(A) will not be ap- plied topersons whoprocess orusefora commercialpurpose chemical substances not on the inventory or who import chemical substances as a part of a mixtureuntil afterpublicationoftherevised inventory. By reporting any chemical substance, not included on the initial inventory during the second reporting period,these persons willbe abletoprotect themelves from prosecution under section 15(2) withrespecttotherequirements of section 5(a) (1)(A) of TSCA. Imnporters- of a chemical substance as part of a mixture or article will not be subject to premanufacture notification requirements for "new" chemical substancesuntil 30 daysafterpublication of the revised-inventory. Under these re- porting requirements, persons who import chemicalsubstances aspart ofart!- cles do not have to report concerning those chemical substances forthe initial inventory. EPA Is still considering whether importers of certain chemical substances aspart ofarticleswillbesubject to premanufacture notification requirements under section 5(a)(1) (A). 

# 64573

EPAwill address this Issuepriortopublication. of the Initial inventory. Refer to comments 18 to23 forfurther clarification of these Issues concerning importers of chemical substances.

Finally,EPA recognizes that it is inevitable, considering thelargevolume of Information to be compiled and transmitted,thattheremaybe someunintentional clerical errors In reporting. Accordingly,thenote in §710.1(b) ofthese regulations provides that EPA does not 

## intend to focus its enforcement efforts
onreporting violations thatare clerical innature.Instead,EPAwill givepriority tobringing actions against persons wh6 

## (1) report falseinformation, (2) report forinclusion onthe inventory chemical substances which are excluded under section 710.4() of these regulations, (3) fail to report, or (4) fall to maintain records documenting reported information.

C0r urDErfxAL= 

## As discussed in the preamble to the August proposal, there is an apparent conflict between section 14 and sections 8(b) and 5(a) of TSCA withrespect to the inclusion oftheIdentities ofcertain chemical substances on the inventory. Section 8(b) requires EPAto publish a list of "each chemical substance

-- which is manufactured or processed in the United States. Such list shall include eachchemical substance which anyper- sonreports,undersection 5orsubsection (a) of this section, is manufactured or processed in the United States." (emphasis added) Thelisthas twopurposes, to inform the public concerning which chemical substances are manufactured br processed for a commercial purpose andto whichthepublicmaybeexposed, and to define what constitutes a "'new chemical substances" for purposes of premanufacture notification requirementsundersection 5(a). However, sec- tion 14 states that any Information re- ported to EPAunder TSCA that is ex- emptfrom disclosureundertheFreedom ofInformation Act fourth exemption (5 

## U.S.C. 552(b) (4)) may not be disclosed except in specific circumstances set out 

## in section 14 (a) and (b).

In the absence oftherequirements of section 8(b) and 5(a). EPA would publish aninventory thatwouldnotinclude the Identities of specific chemical substances forwhich the factthattheparticular substance is manufactured or processed for commercial purposes is confidential. In the absence of the re- quirementsofsection14.EPAwouldpub- lkih a list of all chemical substances manufactured or processed for com- mercial purposes. Since the termmanu- facture includes "to import", this discussion and the regulations apply equally toimported chemical substances.

Having no explicit statutory guidance about how to resolve this conflict, EPA hasattempted tobalancetheconcernsof section 14withthoseofsections 8(b) and 5(a). EPAbalievesthat Congress didnot intend manufacturers to be required to furnish EPA premanufacture notification on existing chemical substances whose Identities for purposes ofthe inFEDERAL REGISTER, VOL 42, NO. 247-FRIDAY, DECEMBER 23, 1977



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ventory have been claimed as trade, secret. EPA believes that Congress did intend EPA to preserve confidentiality tothemaximumextentpracticablewithout Impairing administration of TSCA. Accordingly, EPAhas developed theap- proachsetforthin§710.7, andexplained ingreaterdetailinAppendixA,Response to Significant Comments. Theapproach balances confidentiality under section 14 with the regulatory scheme of sections 8(b) and 5(a). This approach will be used for the submission of confidential identities for the Inventory now under section 8(a) andsubsequently undersection 5(a) (1)(A). Should the approach fall to achieve its statedpurposes, EPA will re-examine the approach and consider alternatives.

EPA will allow manufacturers, importers andprocessors to claimas confidentialthefactthataparticularchemical substance is manufactured or proc- essed IntheUnited States for commercial purposes. The manufacturer or processormaking sucha claimmustpro- vide certain information and agree to certain provisions specified in §710.7(e) of these regulations. EPA will make a final determination concerning entitle-, ment to confidentiality, in accordance withEPA'sprocedures forhandlingconfidentiality of business information in 40CFRPart2, Subpart B (41 FR36906, September 1, 1976). If EPA determines thatthefacttheparticular chemical substance Is manufactured orprocessed in the United States for commercial purposes is confidential, EPAwill not place the specific chemical Identity on the published inventory. Instead, EPA will publish a generic chemical name in an appendixtotheinventory.

Thegenericchemicalnamewillinform thepublic ofatleastthegenerictypes of confidential chemical substances manufactured or processed for a commercial purposeintheUnitedStates.Further,the genericnamewillbehelpful tomanufacturers who consult the appendix to the Inventory to determine whether they mustsubmitpremanufacturenotification undersection 5(a)(1)(A) foraproposed "new" chemical substance. The generic
name will alert them to the possibility that the proposed "new" chemical substance may be included on the inventory underthatname.Thegeneric name willnotestablishacategory ofchemical substancesforpurposes of-theinventory and premanufacture notification requirements.

EPAwantsto avoid the anti-competi- tive Impacts whichmay ariseifnewentrants into an existing market were required to givepremanufacture notification while the existing manufacturer who claimedtheidentity ofthechemical substance as confidential was able to continue to manufacture it.If a manufacturer is required to give premanu- facture notification on a.chemical substance,he cannotmanufacture thesubstance for at least the 90-day notice period. This delay may be considerably longex if atesting rule under section 4 requires the manufacturer to develop and submitcertaintest data.EPA isalso RULES AND REGULATIONS

interested In distinguishing a "fishing. expedition" bya competitor from a bona fe inquiry concerning the Identities of c6nfidential chemical substances on the inventory.

Accordingly, §710.7(g) permits aninquiring manufacturer to submit certain information toestablishhisbona fideintent to manufacture the chemical substance. A manufacturer Is not required .to establish this intent; he can simply submit apremanuacturenotification.If

a manufacturer establishesbonafideintent to manufacture a chemical substance,EPAwilltell theinquiringmanu- facturerwhether the chemical substance' is included on the.inventory as a con- fidential identity,andtherefore,whether hemustsubmitpremanufacturenotifica- tion under TSCA section 5(a)(1) (A). The submitter who claimed that the specific chemical identity shouldnot appear ontheinventory willberequired by §710.7(e)(2) to agree to have available andfurnish toEPA uponrequest certain identifying information onthe chemical substance and agree thatEPAmay discloseto aperson with a bona. lfde intent to manufacture the substance whether the particular chemical substance is ineluded onthe inventory.Failure to furnish this information to EPA upon re- quest will be construed as a. waiver of the claim of confidentiality, and the specific identitywillbeplaced ontheinventory. The Agency believes that this resolution of the conflict between sec- tions 5(a), 8(b), and 14-of the statute balances the equities and interests ofall paxties.

There areseveralotherissuesconcern- ingconfidentiality thathavebeenraised by these regulations. These issues and further elaboration of the above ap- proach are-discussedinAppendix A, Sig- nificant Comments and Responses.
DEFINITIONS 

## EPA wishes to emphasize that the termsused in theseregulations may not be wholly consistent with the ordinary usage of such terms. For egample, the term"manufacturer" includes importers. As used in these regulations, the terms "manufacturer" and "processor" may both apply to a person who normally would considerhimself oneor theother. "Intermediate" refers only to those intermediates which are isolated or re- movedfromtheequipmentinwhichthey

aremanufactured. Personsshouldbesure they understandthe special meanings of thetermsusedforpurposes ofthesereg- ulations. OrrcAL RECORD OFRULEmAING 

## TSCA section 19(a) (3) defines the term "rulemaking record" for the purposes ofjudicial review ofasection 8(a) regulationas (1) therulebeingreviewed, (2) anywritten submissionofinterested parties respecting the promulgation of such ruleand (3) anyotherinformation which theAdministrator considers tobe relevant tosuch rule andwhich theAdninistrator identified on or before the date of the promulgation of such rule, in a notice published in the FEDERAL REsisTrr.. 

## Accordingly, TSCA requires the Agency to publishin theFEDERAL REosrR thelist ofdocumentsthat constitute the record of this rulemaking. Public comments are exempt from FEDERAL REGISTER listing under section 19(a) (3) andhave notbeen listed.Afull listing of the public comments is available on re- quest from the Record and Hearing Clerk. In .addition, those documents listed below as part of this rulemaldng record are available at the Offilce ofthe Record and Hearing Clerk In the Office of Toxic Substance.

The factual and policy considerations thatare thebasis ofthis rule were pub- lished in the preambles to the March 9 and August 2, 1977 proposed rules and October 3, 1977 supplemental notice. In response to public comment, EPA has prepared a document analyzing the Impactsoftheseregulationswhich theAdminis-trator hereby Identifies under TSCAsection 19(a) (3)(E) aspart ofthe record of this rulemaking. This document surveys Information generally available to the public. It Is entitled, "Analysis of Options for Definition of Small Business and 11stimated Cost of the Initial Section 8(a) Reporting Requirements," prepared by ArthurD. Little,Inc.,Cambridge, Mazsacbusett, con- tract number 68-01-4381 (November 1977).

During development of this rule,EPA has conducted two public meetings and several informal meetings attended by interested members ofthe public. Transcripts ofthethree public meetings and minutesofseveral informalmeetingsare hereby included under section 19(a) (3) (e) aspartofthisrulemaking.

1. Transcript of public meeting on TSCA Inventory Reporting Regulations
as proposed March 9, 1977-(Aprll 18, 1977).

2. Transcript of public meeting on TSCAInventory Reporting Regulations,

as proposed August 2, 1977-August 24, 1977).

Informalmeetings were held with interestedmembersofindustry,labor,and environmental groups on the following dates.Minutes ofthese meetings are includedintherecord.
December13, 1976 ,ay6, 1077 December 21,1976 ?Say 17,1977 January 6,1977 June9, 1977 January7.1977 August 4,1977 January19,1977 AUgust 18,1977 April14,1977 September30,1977 April21,1977 October0,1977 April27,1977 October 31,1077



## Transcripts of the informal meetings heldMay 6 (withthe American Import-
ers Association) and May 17 (concern- ingconfidentiality) are also included In therecord.

In addition, duringtile development of these rules, Agency staff members had phone conversations with interested members ofthe public. Phone conversations relevantto thisrulemaking are included inthe record ofthisrulemaking, A listing ofthese materials is available uponrequest fromtheRecord andHearingCIer.'

FEDERAL REGISTER, VOL 42, NO. 247-FRIDAY, DECEMBER 23, 1977



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## RULES AND REGULATIONS

EFFETc EDATE
These regulations shall take effect on January 1, 1978. In accordance with 5 U.S.C. 553(d) (3), the Administrator finds for good cause that the effective date oftheseregulations willnotbepostponed until 30 days after publication in theFEDERAL 

## REGIsTER. TSCA section8(b) provides that'a chemical substance may be included on the inventory only if it

was manufactured or processed within three years before the effective date of these regulations. If these regulations

are effective on January 1, 1978, any chemical substance manufactured or processedforacommercial purpose since January 1, 1975 maybereported for the inventory. The January 1, 1975 datehas been relied on by the industry in preparingforreportingunderthese regulations.Any greater delay inthe effective-

ness of-theseregulations would interfere with orderly and timely reporting for theinventory. ECONOMIC 

## IsePACT AHALYSIS STATEMENT

EPA has determined that the regulation does notrequire the compilation of

anEconomic ImpactAnalysis Statement

as required by Executive Order 11821. This determination is based on the cost estimate prepared by Arthur D. Little, Inc.,aspart oftheir report, "Analysis of Options forDefinition ofSmall Business and Estimated Cost of the Initial Section 8(a) Reporting Requirements," (November 1977), which is part of the rulemnaking record.The total cost to indu~try of complying with the requirements ofthis regulation does notexceed $15 million. Accordingly, EPA has not performed an EconomicImpact Analysis because the cost does not exceed the. criteria for amajorAgency action.

TheEnvironmental ProtectionAgency has determined that this document does not contain a major proposal requiring preparation of an Economic Impact Analysis Statement Under Executive Order 11821 and OMB CircularA-107.

Dated: December 12, 1977.

DOUGLAS COSTLE, 

### Administrator.


## Part 710 isestablished toread as follows:
Sec. 710.1 Scope and compliance. 710.2 Definitions. 710.3 Applicability: Reporting for the Initial andrevised inventory. 710A Scope ofthe inventory. 710.5 How toreport for the inventory. 710.6 When toreport. 710.7 Confidentiality. 710.8 Effective date.

Au rnsr=: -Subsection 8(a), Toxic Substances Control Act (TSCA) (90 Stat. 2003, (15 U.S.C. 2607(a))). 

## § 710.1 Scope andcompliance.



## (a) This Part establishes regulations governing reporting by certain persons who manufacture, import, or process chemical subsances for commercial purposes under section 8(a) of the Toxic Substances Control Act (15 U.S.C. 2607 

## (a)).Section 8(a)authorizesthiAdminIstrator torequire reporting ofinformation necessary foradministration ofthe ActandrequiresEPAtoIssueregulations for the purpose of compiling anInventory of chemical substances manufacturedorprocessedfor a commercialpurpose, as required by section 8(b) of the Act. Following an initial reporting period, EPA will publish an initial inventory of chemical substances manufactured or imported for commercial purposes. After a supplemental reporting period, EPA will. publish a revised inventory includingthoseadditionalchemical substances processed or used for commercial purposes or imported for commercial purposes as a partofa mixture or article. Further, In accordance with section 8(b), EPAperiodically will amend the inventory to include new chemical substanceswhich aremanufactured orimportedfora commercial purpose andreported under section 5(a)(1) oftheAct.EPA alsowillrevise thegcategories ofchemical substances and make other amendments as appropriate. (b) Section 15(3) of TSCA makes It unlawful for anypersonto fail orrefuse to submit information required under these reportingregulations. In addition, section 15(3) makes Itunlawfulfor any personto fail tokeep, andpermit access to,records'required bytheseregulations. Section 16provides thatany personwho violates a provision ofsection 15 is liable totheUnited Statesfor a civil penalty and maybe criminally prosecuted. Pursuant to section 17, the Government may seek judicial relief to compel submission of section 8(a) information and to otherwise restrain any violation of section 15.

Noz -As a matter of traditional Agency policy, EPA does not intend to concentrate itsenforcement efforts on Insignificant 

## clerical errors Inreporting. 

## (C) Each person who reports under theseregulations shallmaintain records that documentinformationreportedun- der theseregulations and,in accordance with the Act, permit access to,and the copyingofsuch records byEPA officials. §710.2 Definitions.

Forthepurposes ofthis Part: (a) The following terms shall have the meaning containedintheFederalFood,Drug,and Cosmetic Act, 21 U.S.C. 321 et seq,, and the regulations .issued under such Act: "cosmetic," "device," "drug," "food."and "food additive." In addition, the term "food" includes poultryandpoultryproducts, as defined In thePoultry Products Inspection Act, 21 U.S.C. 453 et seq.; meats andmeatfoodproducts, asdefined in the Federal leat Inspection Act, 21 U.S.C. 60 etseq.; and eggs andeggproducts, as defined inthe EggProducts InspectionAct. 21U.S.C. 1033 etseq.

(b) The term "pesticide" shall have the meaning contained in the Federal Insecticide, Fungicide, and Rodenticide Act, 7U.S.C. 136etseq., and the regulations issued thereunder. (c) Thefollowingtermsshallhavethe meaning containedintheAtomicEnergy Act of 1954, 42 U.S.C. 2014 et seq., and the regulations Issued thereunder: "byproduct material." "source material," and"specialnuclear material." (d)"Act"meanstheToxicSubstances ControlAct, 15U.S.C. 2601 etseq. - (e)"Administrator" means the Administrator of the U.S. Environmental Protection Agency,-any employee or au- thorizedrepresentative oftheAgency to whom the Administrator may either herein orby order delegatehisauthority to carry out his functions, or any other personwho shallby operation oflawbe authorized to carry out such functions. (f) An "article" is a manufactured Item (1)which is formed to a specific shapeordesign duringmanufacture, (2) whichhasendusefunction(s) dependent inwhole orinpartuponItsshape ordesign during end use,and (3) which has eithernochange ofchemicalcomposition during its enduseor onlythosechanges ofcomposition whichhavenocommercial purpose separatefromthatofthearticle andthatmayoccurasdescribedIn§710.4 (d) (5); except that fluids and particles

are notconsidered articles regardless of shape ordesign. (g) "Byproduct" means a chemical substance produced without separate commercial intent during the manufacture or processing of another chemical substance(s) ormixture(s).

(h) "Chemical substance" means any organic or inorganic substance of a particular molecular identity, including any combination of such substances occurringinwholeorin part as aresult of

a chemical reaction or occurring in na- ture, and any chemical element or uncombined radical; exceptthat "chemical substance" does not include:

(1) Any mixture, (2) Anypesticidewhenmanufactured, processed, ordistributedincommercefor

use as apesticide, (3) Tobacco or any tobacco product, but not including any derivative products,

(4) Any source material, special nu- clear material, or byproduct material,

(5) Any pistol, firearm, revolver, shells, and cartridges,and

(6) Anyfood.food additive,drug,cos- metic, or device, when manufactured, processed, or distributed in commerce for use as a food, food additive, drug, cosmetic, or device.

(I) "Commerce" means trade, traffic, transportation, or other commerce (1) between aplace in aState andanyplace outside of such State, or (2) which affects trade, traffic, transportation, or
commerce described in clause (1). (j)'istribute in commerce" and "distribution in commerce" when used to describe an action taken withrespect to a chemical substance or mixture or article containing a substance or mixture,mean tosellorthesaleof,thesubstance, mixture, or article in commerce; to introduce or deliver for introduction into commerce, or the introduction or delivery for introduction into commerce of,the substance, mixture,or article; or tohold, ortheholding of,the substance, mixture, or article afterItsintroduction into commerce.

FEDERAL REGISTER, VOL 42, NO. 247-FRIDAY, DECEMBER 23, 1977 

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(k)"EPA"means the U.S. Environmental Protection Agency. (1) "Importer" meansany personwho Imports any chemical substance or any chemical substance aspartofa mixture

or article Into the customs territory of the U.S. and includes: (1) The person primarily liable forthe payment of any dutieson themerchandise, or (2) an au- thorized agent acting onhis behalf (a& defined in 19 CFR 1.11).

(in) "Impurity"meansachemicalsubstance which is unintentionally present with another chemical substance. (n) "Intermediate" means anychemical' substance (1)which is intentionally removedfrom theequipmentinwhich it Ismanufactured, and (2) which eitheris consumed in whole or inpart in chemical reaction(s) used for the intentional manufacture of other chemical substance(s) ormixture(s), orisintentionally present for the purpose of altering the rate of such chemical reaction(s).

Noi

-- The "equipment in which it was 

## manufactured" Includes the reaction vessel In which the chemicalsubstance was manu- factured and other equipment which is strictly ancillary tothe reaction vessel, and any other equipment through which the chemical substance mayflow during acon- tinuous flow process, but does not include tanks or other vessels inwhich the chemical substance Is stored after itsmanufacture.
(o)"Manufacture" means to produce

or manufacture in the United States or Import intothe customs territory of the United States.

(p) "Manufacture or import 'forcom- mercialpurposes' '" means to manufacture or import: (1) For distribution in commerce, including for test marketing purposes, or (2) For use by the manufacturer, including foruseas anintermediate. (q) "Mixture" means any combination of two ormorechemical substances If the combination does not occur in nature and is not, in whole or in part, the result of a chemical reaction; ex- cept that "mixture" does include (1) any combination which occurs, in whole

or In part,as a resultofa chemical reac- tion if the combination could have been manufactured for commercial purposes without a chemical reaction at the time the chemical substances comprising the combination were combinedand if, after theeffective date ofpremanufacture no- tification requirements, none of the chemical substances comprising the combination is a new chemical substance, and (2) hydrates of a chemical substance or hydrated ions formed by association ofa chemical substancewith water. (r)"New chemical substance" means any chemical substance which isnot included in the inventory compiled and published under subsection 8(b) of the Act. (s)"Person" means any natural or juridicial person including any individual, corporation, partnership, or association, any State or political subdivision thereof, or any municipality-, any interstate body and any department, RULES AND REGULATIONS

agency, or Instrumentality of the Fed- processed for research anddevelopment puteralgovernment, poses. Noperson mayreport fortheinventory 

## (t) 'Process" means the preparation any chemical substance in such quantities unless thatperson can certify that the sub- 

## of a chemical substance or mixture, at- stance was not manufactured, Imported, or ter its manufacture, for distribution in processed solely in small quantities for re

## commerce (1) in the sameform orphys- search and development, as defined In this ical state as, or in a different form or section. physicalstate from,thatin whichit was (z) "State" means any State of the received bythe personsopreparing such United States, the District of Columbia, substance ormixture, or (2) aspart ofa the.Commonwealth of Puerto Rico, tho mixture orarticlecontaining thechemi- Virgin Islands, Guam, the Canal Zone,

ca substance or mixture. American Samoa, theNorthern Mariana

(u) "Process for 'qommereial pur- Islands, or any other territory or pos- poses'" means to process (1) for dis- sessionoftheUnitedStates. tribution in commerce, including for (aa) "Technically qualfiledindividual" test marketing purposes, or (2) for use means a person (1) who because of his

as an intermediate. education, training, or experience, or a (v) "Processor" means any person combination of these factors, Is capable who processes a chemical substance or of appreciating the health and environmixture. mental risks associated vith the chemi- (w) "Site" means a contiguous prop- cal substance which is used under his erty unit. Property divided only by a supervision, (2) who is responsible for public right-of-way-shall be considered enforcing appropriated methods of con-
one site There may be more than one ducting scientific experimentation, analmanufacturing plant on a single site. ysis, or chemical research In order to For the purposes of imported chemical minimize such risks, and (3) who is re- substances, thesiteshallbe thebusiness sponsible forthesafety assessments and address of the importer. clearances related to the procurement, (x) "Smallmanufacturerorimporter" storage,use, anddisposalofthe chemical

means a manufacturer or importer substance as may be appropriate or re- whose total annual sales are less than quired within the scope of conducting $5,000,000, based upon the manufac- the research and development activity. turer's orimporter's latest complete fis- The responsibilities In clause (3) ofthis cal year as of January 1, 1978, except paragraph may be delegated to another that no manufacturer or importer Is a individual, or other individuals, as long "small manufacturer or importer" with as each meets the criteria in clause (1) respect toany chemical substance which ofthisparagraph. suchperson manufactured atone site or (bb) "Testmarketing" means the disimported in quantities greater than tribution incommerce ofno more than a 100,000 pounds during calendar year predetermined amount of a chemical 1977. In the ease ofa company which Is substance, mixture, or article containing owned or controlled by another com-, thatchemical substance ormixture,by a pany, total annual sales shall be based manufacturer or processor to no more
on the total annual sales of the owned than a defined number of potential

orcontrolled company, the parent com- customers to explore market capability pany, and all companies owned or con- In a competitive situation during a pretrolled by the parent company taken determined testing period prior to the together, broader distribution of that chemical

Nos.-The 

### purpose of the exception o 

### substance, mixture or article in comthe defnition Is to ensure that manufac- 

## merce. turers and importers report production Vol- (cc) "United States," when usedIn the

umesforall chemical substances which they geographic sense, means

## all oftheStates, manufactured at one site or imported in territories, andpossessions of theUnited quantities equal to"or greater than 100,0e0 States. pounds during calendar year 1977. 

## § 710.3 Applicability Reporting for the 

## (y> "Small quantities for purposes of initial inventory and revised invenscientific experimentation or analysis or tory: Who mu, report; who -ihould chemical research on, or analysis of, report. such substance oranother substance, in- Based on reports from manufacturers cluding any such research or analysis and some importers of chemical subfor the development of a product" stances, EPA will compile an initialn- (hereinafter -sometimes shortened to ventory of chemical substances manu- "small quantities for research and de- factured for commerci.lpurposes. Paravelopment") means quantities of a graph (a) of this section Identifies who chemical substance manufactured, i- mustreportforthisinitial Inventoryand ported, or processed or proposed to be who should report. After publication of manufactured, imported, or processed theinitial inventory.EPA will compile a that (1) areno greater than reasonably revised inventory ofchemical substances necessary for such purposes and (2) af- manufactured or procesed for a comter the publication of the revised in- mercial purpose based on reports from ventory, are used by, or directly under processors of chemical substances, and the supervision of, a technically quali- from importers of chemical substances fiedindividual(s), as a part of mixtures or articles. ParaNoTz.-Any chemical substances manu- 

### graph (b) of this section Identifies who factured, imported orprocessed in quantities of less than 1,000 pounds annually shall be 

### may 

## report for this revised inventory. presumed to be manufactured, imported, or Paragraph (c) of this section Identifies

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## RULES AND REGULATIONS

the persons not subject to the initial inventory.

(a) The initialinventory-(-)Domesticmanufacturerswhomust reportcon- cerningchemical substances.Any per-
son who manufactured a chemical sub

## stance(s) in the United States for a commercial purposeduringcalendaryear 1977 must report concerning:'

(i) Allchemical substanceswhich that person manufactured in the United States during calendaryear 1977ateach site forwhich: (A) Thirty percent or more of the i'weight oftheproducts distributed from

thatsite consists ofproducts ofthe types *described under Standard Industrial

Classification (SIC) Group 28or2911, or

(B) The total pounds of reportable chemical substances- manufactured at that site equals one million pounds or
more; and 

## (ii) Any chemical substance not re- portedunderparagraph (a) (1)(1)ofthis section that was manufactured at a site during calendar year 1977 in quanti- ties equal to or greater than 100.000 pounds.

Nom-Any person who is a "small manu- facturer," as defined in §710.2, and who has

more than onesite.Is exempt from separately reporting the chemical substances manufactured at each site. 

## (2) Importerswho must rjportcon- cerning chemical substances.Any per- son who imported a chemical substance into theUnited States for a commercial purpose during calendar year 1977 must reportconcerning: (i) All chemical substances which that person imported into the United States duringcalendar year 1977if:

(A) Thirty percent or more of the weight oftheproductsimported consists ofproducts of the types describedunder Standard Industrial Classification (SIC) Group28 or2911.or

(B) "Thetotal pounds of reportable chemical substances imported equals one million pourds or more; and 

## (ii) Any chemical substance not re- ported under paragraph (a) (2) (1) of this section that was imported during calendar year 1977 in quantities equal
to or greater.than 1O0,000 pounds.

Norm-These reporting requirements include all chemical substances imported ill bulk form,including in cans, bottles, drums. barrels, packages, tanks, bags and other con- tatners, but do not include chemical sub

## stances imported as part of mixtures or articles. 

## (3) Othermanufacturersandimport-

ers Who should report chemical substances. (I) In order to ensure that a chPmical substance Is included in the initial inventory, anypersonwho manu- factures or imports, or who has manu- factured or imported a chemical substance (including the importation of a chemical substance as part ofa mixture
or an article) for a commercial purpose since January 1, 1975, may report con

## cerning thatchemical substance. 'ii) 

## Any person permitted to report under paragraph (a)(3) of this section may either report individually or, in accordance with §710.5(f), authorize a tradeassociation orother agenttoreport
onhisbehalf.

(b) Revised inventory. (1) During the reporting period for the revised inventory (§ 710.6(c)), a person may re- port concerning a chemical substance which was not included in the initial inventoryif:

(i) Theperson has procesed orused thechemical substance (includinguseIn the manufacture ofa mixture orarticle containingthat chemical substance) for
a commercial purpose since January 1, 1975; or

(ii) The person has Imported the chemical substance aspart ofamixture

orarticle fora commercial purposesince January 1,1975. (2) Anypersonpermittedtoreportun- der paragraph (b)of thissection either mayreportinlividuallyor,Inaccordance with §710.5(f), may authorize a trade association or other agent to report on hisbehalf.

Noarc-The premanufacturo notification requirements of sectlon 5(a)(1) (A) of the 

## Actfor manufacturers ofnew chemical substances and Importers 

## of newchemical substances In bulk will begin 30 days afterthe publlcatlon ofthe initial Inventory and will 

## apply toallchemicalsubstancesnotincluded in theInitialinventory. Thepremanufacture notification requirements of section 5(a) (1) (A) will not- be applied to Importer of chemical substances as part of a mixture until 30 days after publication of the re- vised inventory. In addition, section 15(2) 

### oftheAct asIt relates to rectlon 5(a) (I) (A) will not be applied to persons who procesa or use for a commercial purpose chemical substances not on the inventory until 

## after publication of the revised Inventory. (c) Personsnotsubject to theinitial inventory. Persons who have only pro- cessed or used a chemical substance for

a commercial purpose arenot subjectto the Initial inventory requirements. 

## §710.4 Scope oftheinventory.

(a) Chemical substances subjct to these regulations.Only chemical substances which are manufactured, imported, or processed "for a commercial purpose," as defined in §710.2, are subjecttotheseregulations. (b) Naturallyoccurringchemicalsubstances automatically included. 

## Any chemical substancewhichisnaturallyoc- curringand (1) whichis (I) unprocessed

or () processed only by manual, me- chanical, orgravitational means; bydissolution in water; by flotation; or by heating solely to removewater; or (2) whichisextracted frbm airbyany means, shall automaticaily be included in the inventory under the category "Naturally Occurring Chemical Substances." Examples of such substances
are: raw agricultural commodities, wa- ter,air, natural gas,and crude oil; and rocks,ores, andminerals. (c) Substancesexcluded by definition

orsection8 (b) of TSCA. The following substances are excluded from theinventory:

(1) Any substance which is not con- sidered a "chemical substance" as pro- vided in subsection 3(2) (B) of the Act and in the definiticn of "chemical substance"in §710.2(h) ; (2) Any mixture as defined in §710.2 (q);

Nors.-Achemical ubstancethat Ismanu- factured as part of a mixture is subject to these reporting regulations. This exclusion applies only to the mixture and not to the chemical substances ofwhich themixture is conprised. The term "mixture- Includes alloys, Inorganic glasses. cerami, frits, and cemen%, Including Portland cement.



## (3) Any chemipal substance which is manufactured, Imported, or processed solely in small quantities for research and development as defined in §710.2 (y); and

(4) Anychemical substancenotmanu- factured, processed or imported for a commercial purpose since January 1, 1975.

(d) Chemical substances excluded fromtheinventory.Thefollowing chemIcalsubstancesareexcluded fromtheinventory. Although they are considered to be manufactured or processed for a commercial purpose for the purpose of section 8 oftheAct, they arenot manu- factured orprocessed fordistribution in

commerce as chemical substancesperse and have no commercial purpose separate from the substance, mixture, or ar- ticleofwhich they maybea part.

Norm.-In addition, chemical substances excluded here will not be subject to premanufacture notification under section 5 of theAct. 

## ,1) Any impurity. (2) Anybyproductwhich hasnocom- mercial purpose.

Nor -A byproductwhichhas commercial value onlyto municipal orprivate organiza- 

## tionswho (I) burnit asa fuel, (i) "dispose of It as a waste. Including In a Landi or for enriching coil. or (1in) extract component 

## chemical substances which have commercial value,

## maybereported forthe inventory,but 

## will notbe subjecttopremanufacturing no- tifIcation under section 5 ofthe Act if not Included, (3) Anychemical substancewhichre- sults from a chemical reaction that

occurs incidental to exposure ofanother chemical substance,mixture,orarticleto environmental factors such as air,moisture,microbial organisms,orsunlight.

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

occurs incidental to storage of another chemical substance, mixture, or article.

(5) Any chemical substance whichresults from a chemical reaction that oc-
curs upon end use of other chemical substances, nixtures, or articles such as adhesives, paints, miscellaneous cleansers or other housekeeping products, fuels and fuel additives, water softening and treatment agents, photographic, films, batteries, matches, and safety flares, and which is not itself manu- factured for distribution in commerce
or for use as an intermediate. (6) Anychemical substance whichre- sults from a chemical reaction that oc-
curs upon use of curable plastic orrubber molding compounds, inks, drying oils, metal finishing compounds, adhesives, or paint; or other chemical

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## RULES AND REGULATIONS

substances formed during manufacture of an article destined for the marketplace without further chemical change of the chemical substance except for those chemical changes that may occur
as described elsewhere inthis §710.4(d).

(7) Any chemical substance which re- sults from a chemical reaction that oc-
curs when (i)a stabilizer, colorant, odorant, antioxidant, filler, solvent,car- rier, surfactant, plasticizer, corrosion inhibitor, antifoamer or de-foamer, dispersant, precipitation inhibitor, binder, emulsifier, de-emulsifier, dewatering agent, agglomerating agent, adhesion promoter, flowmodifier, pH neutralizer, sequesterant, coagulant, flocculant, fire retardant, lubricant, chelating agent, or quality control reagent functions as intended or (ii) achemical substance, solely intended toimpart a specificphysicochemical characteristic, functions as intended.

(8) Chemicalsubstances which arenot Intentionally removed from the equipment in which they weremanufactured.

NOTE.-See note to definition of "intermediate" at §710.2(n) for explanation of "equipment in which itwas manufactured." 

## §710.5 How toreport.

(a) Generalinstructions. (1) Except forsmallmanufacturers or smallimporters, any person who is required to re- port under §710.3(a) (1) or (2) shall follow the reporting procedures ofpara- graphs (b), (c), and (d)of this sec- tion. (2) Any person who reports under §710.3(a) (3) shall follow the reporting procedures of paragraphs (b), (c), (d) (1) and (d) (3) ofthis section. In addition, the Agency encourages these per-
sonsto report in accordance with para- graphs (d) (2) and (d) (4) of this sec- tion.A trade association or other agent may report aggregated production data under paragraph (d) (4) of this section, (3) Any person who is required to report under §710.3(a) (1) or (2) and who is a small manufacturer or smallImporter as defined in -§ 710.2 shall follow the reporting procedures of paragraphs (b), (c), and (d) (1) and (3) of this section except that -uch person is exempt from reporting production volume (for quantities less than 100,000 pounds) andsite information. (4) Anyperson whoreports under sec- tion 710.3(b) shall follow the reporting procedures of paragraphs (b), (c), and (d) (1) ofthissection.

(b) Reporting the identity of a chemicalsusbtance. (1) Any person re- porting under these regulations should first read and carefully follow the re- porting instructions, "Reporting for the Chemical Substance Inventory," pub- lished by and available through EPA. (2) Toreport a chemical substance, a person should first consult the TSCA Candidate List of Chemical Substances and any amendment to the Candidate List. For assistance inusing the Candidate List, consult the "Guide to the Use of the TSCA CandidateList ofChemical Substances." (3) All persons required to report except "small manufacturers and importers" mustuse a separate Form A, B,

or C to report chemical substances for each site. Small manufacturers and importersmay reportseveralchemical substances manufactured at different sites

ononeform,as appropriate. (4) To report a chemical substance found in the Candidate List, or in an amendment to the list, a person must complete, sign, and submit EPA inventoryreportFormA (EPAFormNo. 7710- 3A). All forms, A through D, have OMB No. 1585 77011. (5) To report achemical substancenot found in the Candidate List, or in an amendment to the list, but for which there is a Chemical Abstracts Service (CAS) Registry Number, a person must complete, signandsubmitEPAinventory reportFormB (EPAFormNo. 7710-3B). (6) To report a chemical substance whichisnotfound inthe CandidateList,

or in an amendment to the list, and for which there is no known CAS Registry Number, a person must complete, sign, and submit EPA inventory report Form C (EPA Form No. 7710-3C). Persons must describe chemical substances on Form C as specifically as possible,in ac- cordance with the instructions published by EPA, "Reporting for the Chemical Substance Inventory."

(7) -To report a chemical substance whose chemical identity is"claimed tobe confidential, a person must complete, 

## sign, and submit EPA inventory report Form C (EPA Form No. 7710-3C). In addition, he mustsubstantiate the claim that thechemical identity isconfidential atthe'time he submits the form toEPA, in accordance with Instructions published in "Reporting for the TSCA Inventory" and section 710.7.

NoT.--The reporting instructions afso describe a reporting Form D (EPA Form No. 7710-3D). This is for additional voluntary reports which may be submitted by anypersonwho manufactures trademarked products comprised of ch6mical substances and is not

a substitute for any of the reports required by these regulations.



## - (c) Reportingpolymers. (1) To report

a polymer a person mustlist in the description of the polymer composition at 

## least those monomers used at greater than two percent (by weight) in the manufacture ofthepolymer. (2) Those monomers used at two percent (byweight) orlessinthemanufacture ofthe polymer may be included as part of the description of the polymer composition.

Noz.-TEhe "percent (by weight)" of a
monomer is the weight of the monomer ex- pressed as a percentage of the weight of the porymeric chemical substance manufactured. 

## (d) Reportingotherinformationcon- cerning a chemical substance. (1) For purposes of the initial inventory, designate whether the person manufactures and/orimports the chemical substance. For purposes of the revised inventory, designate whether the person processes and/or imports the chemical substance.

(2) Report thie site(s) at which the person manufactures and/orimports the chemical substance. The site, as defined in §710.2(w), forImportersIs theirbusi-

ness address.

(3) Designate whether the person manufactures andprocesses thechemical substances only within a site and does not distribute the chemical substance,

orany mixture orarticle containing that substance, for commercial purposes outsidethatsite.

NOTE.-This requirement does not apply toimporters.

(4) Reporttheamount ofthe chemical substance which the person manufactured at each site and/orImported during calendar year 1977. For each substance, report the digit (e.g., 0 through 9) which corresponds to the appropriate volume range,according tothe following table. Enter "N" in the space provided for production amounts If the person didnot manufacture or import the substance during calendar year 1977. Small manufacturers or Importers, as defined in §710.2(x), should enter 

## "1X" In the space provided for production amounts ofless than 100,000 pounds (45,400 kilograms). If a small manufacturer or importer reportsthese production amounts, thatperson shall enterboth "X"andthe appropriate digits (e.g., XO, Xl, or X2). For other production ranges, do not Include an "X" (e.g., 3 through 0), Trade associations or other agents should en- ter "A" in the space provided for pro- duction amounts. If trade associations

or agents report production volumes, they should enter both "A" and the appropriate digits (e.g., A2 or AG).

(0) Lessthan 1,000 pounds; Less than 454 kilograms.



## (1) 1,000 to 10,000 pounds; 4.4 to 4,540 kilograms.

(2) 10,000 to 100,000 pounds; 4,540 to 45,400kilograms.

(3) 100.000 to 1million pounds; 45,400 to 454.000kilograms.

(4) 1millionto 10 millionpounds; 454,000 to 4.54millionkilograms.



## (6) 10 million to 50 million pounds; 4.54 million to 22.7 million kilograms. (6) 50 million to 100 million pounds: 22.7 million to 45.4 million kilograms,

(7) 

## 100millionto500mllionpounds: 

## 45.4 -millionto 227 million kilograms. (8) 500 million to 

## 1 billion pounds: 237 million to 454 million kilograms.

(9) over 1billion pounds; over 454 million kilograms.



## (A) Trade associations or other agents. (e) Importers. (1) Any Importer who reports a chemical substance for the inventory may authorize the foreign supplier of the Imported chemical substance(s) to reporttoEPA onhisbehalf, if both the foreign supplier and the importer sign the declarations provided on the reporting forms. A foreign supplier may authorize an agent to act In his behalf. (2) Theimporter has theultimate re- sponsibility forreporting all Information required by this Part and for the com- pleteness and truthfulnessofsuch information. If certain Information is not or cannot be provided by the foreign sup- plier or his duly authorized agent, It must be provided by the importer.

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## RULES AND REGULATIONS

(f) Tradeassociations orotheragents. (1) A trade association or other agent may report onbelalfof anypersonwho is notrequired -toreport for the initial inventory under §710.3 (a)(1) and (a) (2). Accordingly, a trade association or other agent may report on behalf of a manufacturer or importer of a chemical substance whochooses toreport un- der §710.3(a) (3), or any processor or
user ofa chemical substance, oranyimporter of a chemical substance as part of a mixture or an article who chooses toreport under §710.3(b).

(2) For every chemical substance re- ported by a trade association or other agent under this section, at least one manufacturer, importer or processor musthave cei-tified tothat agent, andbe able to document toEPA, in accordance with §710.1(c). that the chemical substance was manufactured, imported, or processed foracommercial purposesince January 1,1975. 

## §710.6

-

## When toreport.

(a) All reports for the initial inventory shall be submitted by May 1, 1978. (b) All reports concerning chemical substances which are manufactured or imported for a commercial purpose for the first time during the period from May 1, 1978 tothe effective dateofpremanufacture notification requirements shallbe submitted when suchmanufacturing or importation begins. (c) All reports for the revised inventory shall be submitted within 210 days after publication of the initial inventory

. 

## §710.7 Confidentiality.

(a) A manufacturer, importer, or processor mayclaim that fora particular chemical substance any or all ofthe following items of information.submittedunder thisPartare entitledtoeonifdential treatment: (1) Company name, (2) Site.

- 

## (3) The'specific chemical identity. (4) Whetherthechemicalsubstance is manufactured, imported, orprocessed. (5) Whether the chemical substance is manufactured and processed only within one site and not distributed for commercial purposesoutside that site. (6) The quantity manufactured, imported, orprocessed. (b) Anyclaims ofconfidentiality must accompany the information at the time it is submittedtoEPA. The claimsmust appear on theform onwhich theinformation is submitted to EPA and in the

manner prescribed on theform. In addition, any claims of confidentiality must be substantiated at the time the information is submitted to EPA in the

manner specified in the form instructions. (c) Anyinformation thatisCoveredby

a claim made as specified will be disclosed by EPA only to the extent permitted by, andby means Of, the proce- dures set forth in this section and in Part 2 ofthis Title (41 FR 36902). (d) If no claim accompaniesinformation atthe time it issubmitted toEPA, the information may be made public byEPA without further notice to the submitter.Failure to provide substantiation ofany claim asserted on the forms will be considered awaiver of the claim and will result in a determination that the information Is not entitled to confidentialtreatment. (e) (1) A claim of confidentiality may beassertedconcerning thespecificchemicalIdentity ofaparticular chemical substance. This claim may be asserted by any submitter who believes that inclusion ofthe specific chemical Identity on the inventory would reveal the trade secret fact that the particular chemical substance is manufactured or processed for commercial purposes. (2) If asubmitter assertssuch a claim thesubmitter must (I) Report the specific chemical Identity.

(I) Propose a generic chemical name which is only as generic asnecessary to protect the confidential Identity of the particularchemical substance, (Wii)Provide a detailed, written substantiation of the claim as specified in the reportinginstructions, (1v) Agree that EPAmay disclose toa person with a bona fide intent tomanu- facture the substance (as defined in paragraph (g) of this section) the fact that the particular chencal substance is includedin theinventory forpurposes of TSCA section 5(a) (1) (A) premanufacturenotification, and

(v) Have available, and agree to furnish toEPA upon request, for theparticular chemical substance, either an X-ray diffraction pattern (inthe caseof inorganic substances) or a mass spectrum for the particular chemical substance (in the case of most other substances), a sample of the substance in its purest form, an elemental analysis, any additional or alternative spectra, or other data that may be required to re- solve uncertainties with respect to the Identity of the substance. Failure to meet any ofthese fiverequirements will be considered a waiver ofthe claim and will result in inclusion ofthe particular chemical Identity on the inventory. () (1) If a submitter asserts that the identity of a particular chemical substance should not be included on the inventory, the submitter has met the fiverequirements specified Inparagraph (e) ofthissection, and the EPA General Counsel has made a determination, in "accordancewithPart2 ofthis Titlethat the particular chemical identity should not appearon theinventory because inclusion wour disclose a trade secret, EPA will publish a generic chemical

name in an appendix to the inventory rather than place the specific chemical identity on the inventory. Publication ofa generic name in the appendix does
notcreate a categoryforpurposes ofthe inventory.Anyperson proposingtomanufacture asubstance included inthe appendix under a genericname must submit notice under section 5(a)(1) (A) of the Act unless specifically exempted by EPA (seeparagraph (g) ofthissection). (2) EPA will examine the generic chemical nameproposed by the submitterclaimingconfidentiality. (i)If EPA determines thatthegeneric

name proposed by the submitter assertIngthe claimis onlyasgeneric asneces- sary to protect the confidential identity of the particular chemical substance, EPAwillplace thatgenericname onthe inventory.

(iI) If EPA determines that the genericname proposedby the submitter asserting theclaim Ismore generic than necessary to protect the confidential Identity, EPA will ask the submitter to submit further proposed generic names.

(iii) If EPA does not agree with the further proposed generic names, EPA will choose a generic name that EPA determines is only as generic as neces- sary toprotect the confidential identity. EPA will give 30 days notice of this choice to the submitter asserting the claim. After the end of the 30-day periodEPAwill placethe chosen generic

narne on the inventory. fg)(1) If theparticular chemical substance a person is proposing to manu- facture isnotincluded on the inventory by specific name but does fall within

one of the generic chemical names in the appendix entitled "Confldentiaidentities," thepersonmayaskEPAwheth-

er the specific substance Is included on the inventory. EPAwill answer such an inquiry only ifEPA determines thatthe person has a bona Me intent to manu- facture the substance. (2) In order to establish a bonaJlde intenttomanufacture thespecificchemical substance the person proposing to manufacture the chemical substance mustsubmittoEPA: (I) A signed statement thatthatper-
son intends to manufacture the substance for commercial purposes (ID A description ofthe research and development activities hehas conducted to date and the purposes forwhich the substance will bemanufactured, (ill) An elemental apalysis, (iv) Either anX-ray diffraction pattern (in the case of inorganic substances) oramass spectrum (inthecase ofmostother substances) oftheparticular chemical substance, (v) A sample of the substance in its purest form, ifrequested, and (vi) Any additional or alternative spectra, or other data that may be required toresolve uneertainities withre- spectto theIdentityofthechemical substance.

(3) (1) Upon receipt of the informationspecifiedinparagraph (g) (2) ofthis section, EPA may require the submitter who asserted the confidentiality claim foraspecific chemical substance within thegeneric nameto submittoEPA: (A) Either anX-ray diffraction pattern or a mass or alternative spectrum forthesubstance, (B) An elemental analysis ofthe substance, (C) A sample of the substance in its purestform, ifrequested, and (D) Any additional spectral or other data thatmay berequired toresolveunFEDERAL REGISTER, VOL 42, NO. 247--FRIDAY, DECEMBER 23, 1977 

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certainties with respect to the identity ofthesubstance. (ii) Failure to submit any of the information required by EPA under this pargraph (g) (3) will be construed as a waiver of the submitter's confidentiality claim, and EPA will place the specific chemical identity on theinventory without further notice to the submitter. (4) EPAwillcompare the information submittedbythe proposedmanufacturer under paragraph (g) (2) of this section with the information submitted under paragraph'(g) (3) ofthis section. (5) If (1) the comparison of the elemental analyses and either the X-ray diffraction patterns or mass or alternative spectra is sufficiently similar to be consistent with a presumption that the chemical substances are the same, and (i) comparison of anyofthe other submitted information affirms this pre- sumption, EPA will tell the person pro- posing to -manufacture the particular chemical substance that the particular chemical substance -is included on the inventory and, therefore, that premanu- facture notification isnot required. (6) If (I) the comparison ofeither the X-ray diffraction patterns or the mass
or alternative spectra is not sufficiently similar tobe consistent with apresumptionthat thechemical substances arethe same, and (ii) comparison of the other information affirms this conclusion,EPA will tell the person proposing to manu- facturethe particular substancethat the information submitted does not support
a conclusion that the substance is in-- cluded on the inventory, and, therefore, that premanufacture notification is re- quired.



## (7) A disclosure to a person with a bonafide intent to manufacture a par- ticular chemical substance will not be considered apublic disclosure. § 710.8 Effectivedate.

These regulations shall take effect on January 1, 1978,

APPENDIX A-SIGN'ICANT COMIMENTS AND RESPONSES 

## Over 400 comments were received in re- sponse to the notices ofproposed rulemaking published in the FEDERAL REGISTER on March 

### 0, August 2, and October 3, 1977. Thefollo,0- ing summarizes and responds to the sig- nificant issues raised in these comments. Comments which concern problems specific tooneparticular companywere not generally included in these comments. These com- ments were referred to EPA's Industry Assistance Office for directreply.
CONTENTS
Overall Approachto theseReportingRules. 

## Comments 1-12.

WhiC hPersons areSubjectto theseRegula- tions. Manufacturers, comments 13-17; Importers, comments 18-23; Definition ofSmall Manufacturer or Importer, comments 24-27; Processors, comment 28.

Chemical Substances Manufactured or ProcessedFor a CommercialPurpose.Comments 29-30.

Exclusions to the Definition of Chemical Substances.Mixtures, comments 31-36; Pesticides and Foods, Food Additives, Drugs. Cosmetics and Devices, comments 37-42.

Chemical Substances Excluded from the 

## inventory.Small Quantities for Research and 

## RULES AND REGULATIONS

Development, comments 43-51; Byproducts, comments 52-55; Articles, comments 56-60; Impurities, comment 61.

ChemicalSubstances Includedin the Inventory. Comments 62-63; Test Marketing, comments 64-66; Intermediates, comments 67-71; Naturally Occurring Substances, comments 72-74.

Inventory ReportingProcedures.General.
comment 76: Reporting of Polymers, comments 77-82; Inventory Reporting Forms, comments 83-87.

When To Report.Comments 88-92. Confidentiality.Comments 93-103.

OVERALL APPROACHTO THESEREPO4TING RULES

Comment 1: Reporting under these first reporting rules should not only be for the purpose of compiling the inventory required by section 8(b), but also to establish a base line of information for further regulatory action under TSCA. Failure to gather site, production, use, impurity, byproduct, disposal, and worker exposure information in a comprehensive manner precludes a systematic approach to the regulation of chemicals.

Response: The Administrator agrees, in part, with this comment. The August 2, 1977, reproposal expanded the purpose of these regulations as proposed on March 9, 1977. These final regulations are similar to those proposed on August 2nd.

In deciding the scope of these first section 8(a) reporting requirements, EPA considerdd not only the interest of compiling

an inventory of chemical substances as required by TSCA section 8(b), but also the need for obtaining sufficient information for monitoring chemical substances in the environment and setting Agency priorities for implementing other provisions of TSCA. The .kgency decided that initial reporting requirements should at least establish a profile of the chemical industry, Including sites where chemicals are being manufactured and the relative quantities in which they are produced or imported into the United States. With this information, EPA will be able to estimate the potential exposure to chemical substances for control, and preventive actions. For example, plant site information will be useful in identifying possible sources of hazardous chemicals, especially in an emergency. Data on the quantities of chemical substances manufactured for a commercial purpose will enable EPA and other agencies to select substances for priority attention fron among the tens of thousands of chemicals In commerce.

The Agency will not be requiring use, impurity, byproduct, disposal, or worker exposure information in these regulations. The Administrator has determined that this information is notnow necessary for all chemical substances manufactured for a commercial purpose, and that the additional burden to industry and consequent delay in publication of the inventory would not be Justified. EPA intends, under the authority of section 8(a), to require this additional information on a smaller number of chemicals in order to assess their potential risks in depth. These requirements will be directed at manufacturers and processors of the chemical substances to enable the Agency to build a more complete profile on these chemicals which are of concern.

Comment 2: EPA's proposed approach would require unnecessarily burdensome and needlessly duplicative reporting. EPA should compile and publish a list of chemical substances from government, industry, and other sources, and allow manufacturers and trade associations to report any chemiCal substances not included.

Response: The Administrator disagrees with this comment. The Agency reviewed existing lists of chemical substances and 

### found them inadequate In several respects. First, many existing lists contain chemical substances which are not eligible for Inclusion on the TSCA inventory, Second, in existing lists, many of the entries are in broad categories or use groups (such as "optical brighteners") which would be Inappropriate for the purposes of compiling a list of discrete chemical substances manufactured or processed for a commercial purpose In the United States. Third, existing lists would not permit EPA to identify the basia manufacturers of a chemical substance, The purposes of TSCA, accordingly, would not be met if EPA were simply to publish currently available lists as the inventory of chemical substances and permit manufacturers to re- port any substance not included.

EPAis Interestedin minimizing theburden of reporting for the inventory. Accordingly, the Agency has published a Candidate List of Chemical Substances which Includes those substances we have reason to believe have been manufactured or processed In the United States. For any chemical substance included on the Candidate List.reporting for the inventory Is greatly simplified. By FEDERAL REGIsTER notice dated April 28, 1977 (42 FR 21639) and July 8, 1977 (43 PR 35183), the Agency announced the availability of the Candidate List in hard copy and computer readable tape. EPA plans to supplement the Candidate List with at least

one additional list of substances. EPA will

announce the availability of any additional list In the FEDERAL REGISTER. By FEDERAL REGIsTER notice dated April 12, 1977 (42 PR 19298) the Agency published a proposed Guide to the Use of the Candidate List. This Guide will be republished with some changes to assist persons reporting for the Inventory. This document and any supplement to the Candidate List will be available from EPA at the address listed above.

In a further effort to minimizo duplicative reporting to the extent consistent with the needs of the Agency, §710,5(f) of these final regulations permits all manufacturers

or importers not required to report by § 7103 (a) (1) and (2) to report chemical substances through a trade assoclatlon or other agent, Further, any person Who processes a chemical substance is only Subjeet to the revised inventory. These policies should eliminate a great amount of duplicative report- .Ing.

Comment 3: Manufacturers should be re- quired to report chemical substances manu- factured for a commerical purpose by plant siterather than by company headquarters.

Response: The Administrator agrees with this comment. The March 9, 1977 proposal would only have required manufacturers to report chemical substances by company headquarters. As part of the decision to require reporting of Information which will give the Administrator a profile of whore chemicals are being manufactured, the August 2, 1977 reproposal would require reporting by plant site. These final regulations continue this requirement, The Agency intends to use this Information to monitor for potential exposure and identify possible

sources of hazardous chemicals In an energency.

Comment 4: EPA has failed to demon- strate that production volume data are necessary to compile the Inventory, and It Is unclear how EPA Intends to use this additional Information. In emergencies, EPA needs to knowwhere a chemical Is produced, not the exact quantity. The delay In publishing the inventory Is not Justified,by the Information to be gained by requiring more detailed data.

Response: Production volume Information is not being required to publish the Inventory under section 8(b). This Information Is

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## RULES AND REGULATIONS

being required under the general authority of section 8(a) of the Act, to require submission of information necessary for administrationof7 CA.

EPA intends to use theproduction volume data to help set priorities for Implementing TSCA.In particular, EPA will initiate subsequent phases for reporting on chemical ,substances selected in part on the basis of their productionvolume. Section 710.5(d) (4) requires reporting of production In fairly broad ranges. (See comment 6.) Because manufacturers should know generally how much of a chemical substance they manu- facture on an annual basis. EPA does not anticipate that this requirement will significantlydelay reporting. CombiningreportIng ofproduction with reporting of chemical substance Identities is far more efficient, in terms of time and resources both for EPA and the industry, than requiring separate reporting.Saving manymonths ofaddltional effort clearly justifies the few months of delay in the publication of the initial Inventory.

Comment 5: Production volume data are available elsewhere, notably from trade as- ,sociationsand other governmental agencies. EPA alsohas authorityunder Air and Water Acts togather the data.

Response: The production data available to EPA from other sources are inadequate in-several respects. Other government agen- ces. such as the International Trade ConemIsson, believe they are not permitted, by statute, to disclose confidential production detwto EPA. Further, these data are often collected for groups of chemical substances, and not for discrete chemical substances. While EPA has gathered certain data for several hundred chemical substances under its other authorities, these substances repre- sent only a fraction ofthoseEPA anticipates will be reported for the inventory. Only by collecting production information along with the chemical Identities as they are reported for the inventory will EPA be as- sured of having a comprehensive indication ofproduction for these substances.

Comment6:Several commenters suggested that production volume data should be re- ported in broad ranges because statistical analysis showsthat aggregate totals willprovide enough accuracy forEPA to set relative priorities. Others recommended that production volume data should be reported to one or two significant figures or to within a specified percentage.

Response: Asprovided In §710.5(d) (4),the Administrator hasdetermined thatreporting of production Tolume in ranges is adequate for the purposes of these regulations. The ranges established bythese regulations arein terms of powers often, except in the upper volumes where the difference between the lower and upper limits of the ranges would 

### be too great. In subsequent section 8(a) re- porting requirements, when the Agency has identified a particular interest in a chemical, the Administrator may request production volume information with greater specificity.

Comment 7: Total production volume information for a company shouldbe required, rather than site specific Information.

Response: The Administrator disagrees with this comment. In order to establish an adequate profile of the chemical industry and properly assign agency resources, particularly the agency's regional resources,pro- duction information is necessary on a site specific basis.

Comment 8: Production volume Information on intermediates, raw materials, and byproducts should not be required.



### Response: Section 710.5(d) (4) of these regulations will require reporting of produc- tion volume Information on intermediates. As discussed in response to comment 67below, the term "intermediate" has been defined to include only those chemical sub- stances that are Intentionally removed from the equipment in which they are manu- factured. The Agency expects that a manu- facturer will be able to estimate the range of production volume of the intermediatcs whichhe Isolates In thismanner.

Undertheseregulations, manufacturers are not required to report the Identity ofpurchased raw materials or byproducts which have no commercial value. Accordingly, a manufacturer would not be required to re- port the production volume of these sub- stances.

Comment 9: EPAshould not set Its prlorities on the basis ofproduction volume alone.

Response: EPA recognizes that priorltis under T CA cannot be set on the basis of any single factor. The production data obtained under these regulations will be only

one factor In selecting chemical cubstances for attention. Production volume information is Important because It gives someindication ofthe potential forhuman and environmental exposure. OtherInformation such

as the toxicity of the subatance, Its uses, and byproducts will. as appropriate, also be considered In assigning relative priorities to substances for testing and other regulatory actions.

Comment 10: EPA should not require a designation of those chemical substances that are site-limited. This Information uiy be confidential and any use of such a -ub- stance for commercial purposes outside the 

## manufacturing sito isnot necessarily a "sig- nificant new use" for thepurpose of TSCA section 5(a)(1) (B).

RESPONSE: Section 710.5(d) (3) will re- quire designation of these chemical sub- stances which are minufactured and processed within a alte and are not distributed for a commercial purpose outside the site. The information will be used by EPA and other agencies to Identify thee chemical substances which may have little exposure to the general environment.

Section 710.7 of these regulations recog- nizes that the fact thata particular chemical substance is "site limited" may be claimed

as confidential. If a claim of confidentiality Is asserted It will be handled In accordance with the Agen~y's businezs confidentiality regulations. 40CPR Part2.

EPA has not decided exactly how it will propose to define "signiflcant new use" for the purposes of notification under section 5(a) (1) (B). The comments which we have received arequiteextensive onthis point and correctly emphasize the various considerations set forth In section 5(a) (2). EPA Intends to take Into account all these con- Biderations prior to Ising a proposed rule under section 5(a) (2).

Comment I: Compilation of production volume and site data will be a time-consuming and expensive procedure since many companies will have to consult production batch sheets and Inventories. This burden is greatly increased by requiring the reporting of Isolatable intermediates.

Response: In preparing the final regulations,EPA has attempted to reduce the burden ofreporting to industry while obtaining important information. As discussed In re- sponse to comment6, theseregulations would require reporting In fairly broad ranges of the production of chemical aub3tances. Further, as discussed In response to comment 67, EPA has revised Its definition of "intermediate" to exclude "isolatable intermediates", or those which "could be Isolated," but are not. These amendments should greatly reduce the potential reporting burden to industry. Moreover, the burdens of compiling the production and site Information required by these regulations has been considered In establishing the definition of "small manufacturer" under these regulations. As discumsed in greater detail in respouse to comment 24, small manufacturers

are not required to submit this information.

Comment 12: Certain industries may find it more convenient to report their chemicals In units other than pounds. Cubic feet for
g and barrels for petroleum products are two examples.Further, manufacturers should be able to report in metric units.

Response: In order to simplify reporting andto enableEPA toprocesstheInformation in a timelyfashion, It is very important that manufacturers report production volumes according to theranges established by §710.- 5(d)(4). EPA-expects manufacturers who normally deal In otherunits of measurement to beable to convert to the specified ranges. The table of ranges is provided in both pounds and kilogramsto facilitate reporting by persons using the metric system. In instances where manufacturers cannot determine the actual welght of a chemical substance, a best estimate should be made.

wrecH P=s SAosa SUBJXCr TO

Manufacturers

Comment13: EPA wil lose valuableinformation by not requiring all chemical manufacturers to report for the inventory. There

are many chemical manufacturers outside of SIC groups 28 and 2911 and EPA will not be able to locate these potential sources of hazardous chemicals. The Agency does not have the discretion to exempt some chemIcal manufacturers from the reporting obilgatlon.

Response: The Administrator interprets section 8(a) of the statute as giving EPA broad discretion to determine the manufacturers who shall be subject to any reporting rule.

By directing these reporting requirements
to manufacturers substantially engaged in producing chemical products of the types described under SIC 23 or 2911 theAgency is focusing on that segment of the industry which is ofprimary concern under TSCA. By narrowing the population of manufacturers required to respond from a possible 225,0C0 establ'hments who may be engaged in processing chemical substances to approximately 8,400 establishments engaged in manufacturing chemicl substances, EPA will dramatically reduce potential duplication ofreporting and still create a data base which is comprehensive with respect to principal chemical manufacturers. EPA expects the Initial inventory to contain over 95% of the chemical substancesmanufactured and proces-sed fora commercalpurpose in theUnited States.

In response to this comment. however, in order to increase the reliability of the data base which the Agency wil generate. EPA has expanded the category of manufacturers who must report, in two respects. First, 

### §710.3(a) (1) (1)(B) requires manufacturers who have produced one million or more poundsofa reportable chemical substance(s)
at a plant site toreport concerning allchemIcal substances manufactured at that site during 1977. This criterion applies whether

or not the manufacturing establishment would be included In SIC Code 23 or 2911. Second §710.3(a) (1) (il) requires all manufacturers to report-concerning any chemical substance that they manufactured at one plant site in quantities equal to or greater than 100,000 pounds during calendar year 1977.

The Agency, accordingly, will receive reportingonallthe chemical substances manuJactured at plants included in the chemical andallied productssector ofthe industryand at the plants of the largest manufacturers in the other sectors. In addition, the data ba-e will include at least all chemical subFEDERAL REGISTER, VOL 42, NO. 247--FRIDAY, DECEMBER 23, 1977 

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## RULES AND REGULATIONS

stances produced in quantities equal to or greater than 100,000 pounds annually at any plant site.

Comment 14: Since any manufacturer whose chemical substance is not included in the initial inventory will be 'required to comply with the premanufacture notification requirements of section 5(a) (1) (A), manufacturers outside SIC groups 28 and 2911 will still be forced to report their chemicals to

ensure that they are included onthe inventory. Thus EPA's efforts to reduce duplicative reporting will not be successful.

Response: The Administrator believes that these regulations will reduce duplicative reporting. Those manufacturers who are not required by §710.3(a) (1) or (2) to report chemical substances have several options for ensuring the chemical substances they man- ufacture are included on theinventory. First, they can report individually. Second, these manufacturers can rely on their knowledge that another manufacturer is reporting the chemical substance. Or, third, as provided in § 710.5(f), they can ensure that the chemical substances are reported by a trade association

or other group. Thus, the inventory reporting burden on these persons will be minimized and the 'number of reports submitted to the Agency will be greatly reduced.

Comment 15: EPA should clarify by notice In the FEDERAL REGISTER or by directmailing, exactly who is Included in SIC groups 28 and 2911.

Response: The Agency intends by direct mail to notify those persons included on the Dun and Bradstreet list of SIC Code 28 or 2911 manufacturers, as well asothers who are included on EPA's mailing list, concerning these reporting regulations. Moreover, EPA has decided for administrative and legal rea-
sons not to rely on the designations of SIC groups that the Bureau of Census assigns to all manufacturers. Instead, §7103(a) (1) of these regulations sets forth independent criteria for reporting for these regulations. Manufacturers should be able to determine for themselves whether the reportingrequire- ments are applicable to them. The proposed criteria should encoinpass atleastthose man- ufacturers in SIC groups 28 and 2911, as designated by the Bureau of Census. Any manufacturer meeting the criteria of §710.3(a) (1) is subject to thege regulations regardless of whetherhe has been assigned to SIC group 28

or2911 bythe Buerau of Census and whetho' he receives a letter from this Agency

Comment16: Trade associatiois should let non-member firms add to any list of manufactured chemicals.

Response: In allowing trade associations to report, the reguations do not stipulate that the persons for whom the trade associations may report are actual members of that association. Section 710.5(f) ofthese regulations only requires that for every chemical sub- stance reported by a trade association at least

one manufacturer, importer, or processor must have certified to that trade asso iation, and be able to document to EPA, that the chemical substance was manufactured, imported, or processed In accordance with these regulations.

Comment 17: A company which contracts with another company to manufacture a chemical substance for a commercial purpose should be allowed to report that chemical substance for the inventory.

Response: The Administrator agrees with this comment. EPA recognizes that there are companies who contract with other com- panies to ma~nufacture chemical substances for commercial purposes. The company who actually manufactures the substance Is, 'of
course, responsible for reporting any chemical substance manufactured during calendar year 1977, in accordance with §710.3(a) (1). In addition, the manufacturer mayreport for the inventory under §710.3(a) (3) The company who has contracted for manufacture of the chemical substance may also report for the Initial Inventory, if he has reason to believe that the manufaoturer hasno intention of reporting the substance. For example, the manufacturer mayno longer bein businessor may not have manufactured the substance since January 1, 1977, and does not intend tocontinue manufacturing the chemicalsubstance. If the contractor reports for the Inventory he must be able to certify that the chemical substance was manufactured since January 1, 1975, and provide the address of the manufacturing site. Importer

Comment 18: Importers and foreign suppliers should be permitted to appoint a mu- tually agreeable agent to report for the inventory. It is unfair to hold small importers liable for reporting the chemicals manufactured by a large international corporation.

Response: Section 710.5(e) of these regulations provides that an importer required to report chemical substances may authorize

a foreign manufacturer, or an agent of a foreign manufacturer, to report on the importer's behalf. Because the jurisdiction of TSCA reaches the importer and not the foreign manufacturer, EPA must hold the importer liable. An importer Is free, however, to take whatever legal measures are necessary In contracts with the foreign supplier to protect himself from penalties. Whatever conditions the Importer and reporting agent agree to, however, are outside the purview of these regulations.

In addition, the reporting instructions re- ferred to in §710.5(b), "Reporting for the TSCA Inventory," willprovide that importers may report certain information directly to EPA and request a foreign manufacturer or his agent to supply other information. Thus,

an importer could arrange that he would send directly to EPA the trade name of the imported chemical substance andthe amount imported, and that a foreign manufacturer

or his agent would submit the specific chemical identity of the trade name substance. Tne Agency expects such arrangements to be useful in the event some information is a confidential trade secret.

Comment 19: Standard-Industrial Classification (SIC) codes should be used todetermine which importers are required to re- port. EPA should insure that importers are not required to report under § 710.3(a) (1) and should clarify the "site" for importers for the purposes of these regulations.

Response: The Administrator agrees in part with this comment. EPA has revised the final regulations to require reporting by importers concerning all chemical substances imported if (1) thirty percent or more of the weight of the products imported con- sists of products of the types described under-SIC28 or 2911, or (2) the totalpounds of reportable chemical substances imported equals one million or more pounds. In addition, importers must report any chemical substance imported during calendar year 1977 in quantities equal to or greater than 10D,000 pounds. These requirements parallel those under §710.3(a) (1) for domestic man- ufacturers. An importer, however, is not required to report under §710.3(a) (1); he Is required to report under §710.3 (a) (2).

As defined in § 710.2(w), the' business address of an importer will be considered his site for the purposes of these regulations. Importers need not specify the port of entry for importation of a chemical substance.

Comment20:If EPAallows mixtureswhich contain substances not on the inventory to be imported, foreign competitors will have

an unfair advantage. EPA should require premanufacture notification of now chemical substances imported as partsof mixtures.

Response: The Administrator agrees with this comment. On October 3, 1977. EPA published in the FEDERAL REGIsrta a supplemental notice (42 FR 53804) addressing the applicability of these regulations and promanufacture notification requirements to Importers of chemical substances an part of mixtures. Since an importer of a mixture Is also importing the component chemical substance in the mixture, such an Importet would be subject to the premanufacturo no- tification requirements with respect to all

new chemical substances. Accordingly, although Importers of chemical substances s part of mixtures are not required to report for compilation of the inventory, they should

ensure that the chemical substance3 they import are included on the inventory. As provided in §§710.3(a)(3) and 710.3(b), they may report either during the reporting period for the initial inventory or the reporting period for the revised Inventory. And, as provided In 9710.5(f), they may re- port through a trade association or other agent. The premanufacture notification requirements of section 5(a) (1) (A) will not be applied to importers of chemical substances as part of mixtures until 30 days after publication of the revised Inventory, At that time, no person will be permitted to import any mixture containing a "now chemical substance" except in accordance with TSCA section 5. Please refer to the October 3, 1977 notice for a discussion of the legal and policy considerations supporting this decision.

Comment 21: Importers of chemical substances as part of articles should not be re- quired to report for the inventory and should not be subject to premanufacturo notification.

Response: The Administrator agrees that importers of chemical substances as part of articles should not be required to report for the inventory, and is reviewing whether any importers of articles should be subject to premanufacture notification requirements, Sections 710.3(a) (3) and,710.3(b) provide, however, that Importers of a chemical substance as part of an article may report for the Initial and revised inventory.

The October 3, 1977 supplemental notice 

### (42 PR 53804) in the PlDE3AL MaEio=sT 

### discussed-the applicability of these regulations, and premanufacturo notification requirements to importers of chemical substances

as part of articles. Persons who Import articles also "import" the component chemical substances. Thus, as discussed in response to comment 20, the importer could be subject to the premanufacturo notification requirements with respect to all now chemical substances comprising the article. However, for reasons discussed in greater detail In the October 3, 1977 notice, the Administrator does not presently intend the premanufacture notification requirements of section 5(a) (1) (A) to be applied to the importation of all articles that contain a new chemical substance. As discussed in response to comment 22, EPA will carefully consider the economic and international ramifications of any premanufacture notification requirements that may be applied to chemical substances imported as part of articles, In the interim, EPA will not consider persons who import chemical substances as part of articles or who process or use such articles to be In violation of section 5(a) (1) (A). If upon re-evaluation, the Administrator determines that these requirements should be applied
to importers of chemical substances imported as parts of some or all articles, or to Importers of selected chemical substances Imported as parts of.articles, a proposed notice will be published for further public comment. Such change in policy would be finalFEDERAL REGISTER, VOL 42, NO. 247-FRIDAY, DECEMBER 23, 1977 

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## RULES AND REGULATIONS

Ised before publication of the initial Inventory so that any affected parties may report during the reporting period for the revised inventory.

Chemical substances or mixtures which are imported within articles, such as in drums. barrels, or other containers used forpurposes

- of transportation or containment, are con-

sidered to be chemical substances imported in bulk and are subject to these reporting requirements. Chemical substances or mix- tures will be considered to be imported as
a part of an article, if the substance or mixture is notintended to be removed from that article and has no end use or commer- cial purposes separate from the article of which it is" a part. Importers may report these chemical substances but are not re- quired to do so. For example, transformer fluids in transformers, lighter fluids In cigarette lighters, and crankcase oil in auto- mobiles are not intended to beremoved from the articles of which they are a part and .have no commercial purpose separate from these articles. Accordingly, these chemical substances need not be reported.These same chemical substances, however, if imported in drums, cans, or other containers, must be reported asrequired bythese regulations.

The Agency will exercise its authority to regulate the import of chemical substances which are part of articles (as well as imported in bulk and in mixtures) under sec- tion 6 or other authorities of the Act, as necessary to protect against unreasonable risks of injury to health and the environ- ment. This might, for example, Include prohibiting, limiting, or, in other ways, re- stricting the import of such chemical substances.

Comment 22: Importers of chemical sub- stances as part of an article have an unfair competitive advantage over domestic manu- facturers because they can introdurce new chemical substances into domestic markets without complying withpremanufacture no- tification requirements. This policy should be changed so that substances which are manufactured domestically at a site solely to be included in an article would not be considered pommercial substances per se. Thus they would not be reported for the Inventory and would not be subject to premanufacture notification.

Response: The Administrator disagrees with this comment. EPA recognizes that the reporting requirements are not Identical for importers and domestic manufacturers of chemical substances as part of an article, but EPA has tried to equalize the burdens of complying with these regulations, as directed bythe Act.With respect to therequire- ments for premanufacture notification. EPA will assess the Impact ofthose requirements
over the next several months as they are developed.

Under §7104(d) ofthese regulations some chemical substances manufactured as part of an article which have no commercial purpose separate from the article of which they

are a part, are excluded from the Inventory and premanufacture notification require- ments. To exclude from the inventory other chemical substances manufactured for a commercial purpose which are subsequently incorporated in an article would create an unacceptable loophole and not fulfill the purposes of the TSCA inventory. The domestic manufacturer of a chemical substance who also manufactures an article Is only required to report the chemical substance(s) he actually manufactures. EPA does not believe that this is an unreasonable burden. If undersubsequent regulations the Agencyimposes certain requirements on domestic manufacturers of chemical substances whichare incorporated as parts of articles, in general the Agency will impose the same requirements on importers of those chemical substances.

Comment 23: In developing premanufacture requirements under section 5. EPA should tako into account foreign manufacturers whose6 application for a patent for

a new chemical substance with a foreign governmentmaybe jeopardized by premanufacture notification under TSCA.

Response: If a foreign government willnot award a patent for a chemical subs-tance whose Identity has been disclosed, even to another government under a provision such

as the premanufacture notification requirements of TSCA. persons should take this into account and apply for the patent prior,
to the Importation ofthechemical substance intothe United States. DefinitionofSmall Mfanulecturcr or Importer

Comment 24: The definition of "small manufacturer or Importer" proposed byEPA is unduly restrictive and ought tobe revised.

Response: The Administrator agrees with this comment. The definition of the term "small manufacturer or importer" at 1710.2 (x) has been revised to mean a "manufacturer or Importer whose total annual salcs is lessthan $5 million, based upon the manufacturer's or Importer's latest complete fiscal year as of January 1, 1978. except that no manufacturer or importer is a 'small manufacturer or Importer' with respect to any chemical substance which such person manufactured or imported in quantitel greater than 100.000 pounds during calendar year 19771

This definition Is different In several respects from the definition of "small manu- facturer orimporter" which was proposed on August 2, 1977. In the first place, EPA has deleted the criterion based on the number of plant sites. It had been proposed that a manufacturer would bea smallmanufacturer if he had only one plant site. The Admlnistrator has determined that for the purposes of these regulations.,such a criterion would have little meaning. The one plant site criterion had little relation toburden on the small manufacturer. It also provided very little benefit to EPAbecause veryfew manu- facturers who meet the other criteria will have more than one plant site.

In the second place, whereas the August proposal would have defined as a "small manufacturer or importer" a person with total sales of less than $100.000. these final regulations consider a 'small manufacturer

or importer" a person who, In part,has total annual sales ofless than 65 million, based on the manufacturers' or importers' latest fiscal year as ofJanuary 1.1978. The Agency re- ceived extensive comments that the $100,000 figure was unreasonably low, and has agreed that It should be substantially Increased.

And, In the third place, these regulations provide that no person Is a "small manufac- turer or Importer" withrespect to anychemical substance produced In quantities greater than 100.000 pounds annually. The August proposal had provided that a person would be a small manufacturer if he had no more than 2,000 pounds annual production of a chemical substance. The Agency has established this criterion for the definition of the term "small manufacturer or Importer" based on Its need for information onchemlcals produced in substantial quantitles.

It is important to emphasize that in ac- cordance "with section 8(a) (3) of 7SCA. small manufacturers and importers are not exemptfromreporting Information necessary for compilation of the Inventory. Accordinely, under these regulations, small manu- facturers and importers who are required to report (§ 710.3(a) (1) and (2)) must report 

# 64583

at least (1) thL-identities of the chemical substances, and (2) whether theymanufacture. process, or Import the substance. Reporting of the chemical identities Is neces- sary to publish the list required under section 8(b). In order to enforcethese inventory reporting regulations, manufacturers, and Importers must Indicate whether they do manufacture or Import the substance.

Under thee regulations "small manufacturers" are also required to report whether the chemical substance Ismanufactured and prccezz:ed only within one site and not dst-lbuted outside thatsite.The Administrator 

### has determined that this Is very important for utility of the inventory and that the burden ofreporting this additional Informa

### tion by manufacturers i- neglIble. Spe- cifically. EPA may want to use thisinformation. I.e. which chemical substances are now "site-limited". for purposes of requiring notification under section 5(a) (1) (B) prior
to distribution of such substances outside the manufacturing site.

Small manufacturers and Importers are exempt from reporting the production volume and site Information that win be required by thence regulations. As is discussed In response to comments 1 through 12. this Information is being required pursuant to the general reporting authority of section 8(a) to obtain sufficient information to implement the prov1-ons of TSCA. In defining "small manufacturer or importer" EPA has attempted to balance the burdens to manufacturers and importers of submitting this Information against the value of that information tothe Agency.

TheAdministrator has determined thatre- ouiring production and site information from all manufacturers and Importers other than "small nnufacturers and Importers"

as defined In these regulations, will notpresent anunreasonable burden. Forthosefirms with approximately $5 million in sales, the .ots of reportlng will range from about 0.6 nercent of annual profits (for reporting for the Inventory alone) to about 1.2 percent (for alsoreporting productvolume and Identity of substances manufactured by site). These figures assume a 6 percent profit-rate. For example, a firm with $5 mililon in sales and $300,000 In profits (6 percent) would have to spend about $3.500 (1.2 percent of 9300.000) to comply with these regulations. The above costs would decrease as the size of the flrdi increases.

The firms generally most impacted are these with the largest number of chemicals to report. Those firms with less than $5million in sales mustreport production volume by siteforchemicals manufactured in quantitles in excess of 100.000 pounds. The costs to these firms will fall between 0.6 and 1. 'percent of profits, or between the costs of reporting for the inventory alone and the
costs ofreporting all requiredinformation.

In analyzing the costs of reporting. EPA examined the costs to those required to report under section 710.3. The bulk of reepondents wouldfall in SICgroup 28. Chemicais and Allied Products, or SIC 2911, PetroleumRefining. Theremaining resoondents

are those who arenot classified as SIC 28 or 2911 firms but who have at least one site from which thirty percent or more ofproducts distributed are of the type described by SrC 28 or 2911. or who either manufacture

a total of one million or more pounds of renortable chemical substances or manufacture one or more chemical substance in quantities of 100.000 pounds or greater. The costs per chemical of reporting for these additional firms would besimlar tothe costs estimated for the SIC 28 and 2911 flims. However, the costs as a percentage of sales wouldbe smallerbecause chemical salesarea relatively smaller portion oftheir totalsales.

FEDERAL REGISTER, VOL 42, NO. 247-FRIDAY, DECEMBER 23, 1977



### HeinOnline -- 42 Fed. Reg. 64583 1977

# 64584

In estimating the number of firms required to report by these rules, EPA started with the firms classified as primarily producers of SIC 28 and 2911 products. 'This number was then reduced to account for those firms within SIC 28 and 2911 who are notmanufacturers (i.e., processors) andthose who e primary products are not covered by TSCA (e.g., SIC 283. Drugs and SIC 2879, Pesticides). Firms whose major products are not in SIC28 or 2911 but which had significant chemical manufacturing activities were also examined and included in the analysis. The total number of firms expected to be required to report is estimated to be approximately 6400.

This definition of small manufacturer will exemptapproximately 78percent ofthe firms required to report from complete reporting ofproduction and site information, Though the number offirms defined as small s significant, they account for lessthan 5percent of the sales and 6percent of employment.

EPAhas consulted with theSmall Business Administration (SBA) in developing this definition of "small manufacturer or importer." The SBA suggested that EPA define

as a "small manufacturer or importer" a company with 100 employees or less. Such

a definition would exempt a slightly larger percent of firms; it would be ecfuivalent to exempting companies whose total annual sales are approximately $6.8 million. These final rules substantially reduce the burden of reporting by requiring reporting only for intermediates which are actually isolated (see comment 67) and by requiringreporting of production volumes in broad ranges (see .comment 6). Based on these changes, EPA believes that the definition of "small manufacturer or importer" In these reaulations is adequate to prevent unreasonable burdens

on chemical mnanufacfurers. The SBA

concurs.

Further analysis of the costs associated with this definition of "small manufacturer" is contained in the report, "Analysis of Options for Definition of Small Business and Estimated Cost of the Initial Section 8(a) Reporting Requirements", prepared by Arthur D. Little, Inc. and included in the rulemaking record.

Comment 25: Several commenters suggested that EPA should define "'small manufacturer or importer" in terms ofproduction volume and total annual sales; other commenters suggested that the term should be defined In terms of manufacturing sites. number of employees, assets, or value of sale3 per chemical.

Response: The Administrator considered the utility of each of these parameters and,

as is discussed in response to comment 24, has decided to rely on total annual sales and production volume.

The total annual sales of a manufacturer

or importer are generally known and, therefore, use of this criterion would require no additional calculations. In addition, the value of sales gives a good Indication of the ability ofthe company to bear the reporting 'burden. Generally the larger the sales, the larger the staff employed by the firm, and the more resources the company will have available to report to the Agency.

Production volume gives a goodindication of the potential for human and environmental exposure. Accordingly, these regulations

use this crterion in conjunction with the sale3 criterion. However. a manufacturer or importer with total annual sales of less than 45million dollarsonly must report production volumes for those chemical substances produced in quantities greater than 100,000 pounds. Informatlon on chemicals producedin such quantities hasgreatervalue to theAgency.

AS discussed in response to comment 24, the Administrator had determined that a cri

## RULES AND REGULATIONS

terlon on number of manufacturing sites would have little meaning for the purposes of this regulation. It has no relation to cost or burden on a company and the additional information gained by EPA by Including this criterion would be minimal since very few firms that satisfy the other criteria of the definition would have more than one plant site.

The numberofemployees ofamanufacturer or importer may'be useful a parameter for determining the burdens of a reporting requirement. However, it is not as good a

measure as sales of the ability to bear the burden ofreporting. This is particularly true since there are significant variations in dollar sales per employee in various segments ofthe chemical industry 'reflecting a substantial difference in the abilities of various firms to bear the burden of reporting. Over the entire industry, annual sales per employee is about $68,000, varying from $45,000 in SIC 2816, Inorganic Pigments to over $225,000 in SIC 2911, Petroleum Refining.

Criteria based on assets or value of sales
per chemical are also not included in these regulations. The value of assets would provide an indication of the size of a firm. However, the components oftotal assets are complex and the information is not generally available to the public. Further, assets may not bear any relationship to a company's ability to absorb these reporting costs. Value of salesper chemical produced mightprovide

a good measure of a company's ability to bear reporting costs; however, this criterion would require a company to make a determination as to whether it was a "small manufacturer or importer" with respect to every chemical manufactured. This would be an unnecessary burden.

Comment 26: Including a volume ofproduction limit as part of the definition of "small manufacturer or importer" is consistent with the Act and will give EPA at least a rough estimate of the quantities of chemicals produced.

•Response: As discussed in comment 24, in determining an appropriate definition of "small manufacturer or importer," EPA considered the value of and need for this Information with respect to the costs to manufacturers and importers of submitting the information. Production data are to be used primarily in. decisions concerning prioritization of Agency actions and allocations of Agency resources. Because of this, the Agency's need for the information grows as production volume increases, thusjustifying

an increased burden to small businesses who produce large quantities of chemical substances. EPA is requiring reporting of production volumes In excess of 100,000 pounds from all companies. Under these final regulations,reporting production volumes should
not be burdensome, especially for those substances manufactured in substantial quantities.

Comment 27: EPA should defi~e the term "small manufacturer" without respect to whether a manufacturer is owned or controlled by another company. A manufacturer who meets the basic criterion should be considered a "small manufacturer," even if the manufacturer's company is owned or controlled by another company.

Response: The Administrator disagrees with this comment. The legislative history of TSCA makes it clear that in considering what manufacturers and processors qualify

as "small manufacturers and processgrs," the Administrator must consider whether the
company Is owned or controlled by another
company and applythe factorsfor determining "small manufacturers or processors" to both companies. H. Rep. No, 94-1341, 94th Cong.,2nd Sess. 5 (1976). Proces3ors


### Comment 28:EPA does not have the discretion to prevent processors of chemical substances (including manufacturers of a mixture or article containing the chemical substance) from reporting for the Initial Inventory.

Response: EPA interprets section 8(a) of the statute as providing broad discretion to determine which persons shall be subject to any reporting rule. Section 710,3(o) provides that the processors are not subject to the initial inventory. They may report chemical substances not included on the Initial inventory during the reporting period for the revised inventory,

Theseregulationsprovide that persons who will be subject to the premanufacture notiflcation requirements *of section 6(a) (1) (A) of the Act are subject to the initial Inventory.Therequirements ofsection 5(a) (1) (A) only apply to manufacturers and importers ofchemical substances, procemors ofchemical substances are not required to give promanufacture notification on new chemical substances. Therefore, proceszorsare not subject to the initial inventory

If processors were subject to the initial inventory,the Agency expects that thenum- ber of respondents would increase ten-fold, Moreover, the Agency expects the list of chemical substances reported by manufacturers and importers to contain over 96 percent of the chemical substances which are manufactured or processed for a commercial purvose in theUnited States.Accordingly, by makingprocessors and usersofchemicalsubstances subject to only the revised inventory, the Agency will avoid duplicative roporting and substantial delays in publica' tion of the inventory. The Agency will not Process any reports submitted for the initial inventory by processors or users ofchemical substances.

-

it Is a prohibited act under section 16(1) ofTSCA for a person to use for a commer- cial purpose a chemical substance which he had reason to know was manufactured in violation of section 5. The Agency has an- nounced, however, that section 15(2) with respect to section 5(a) (1) (A)will not be aunlled to persons who process or use a chemical substance for a commercial pur-
nose until Publication ofthe revised Inventory. Therefore. by reportina during the re- 'porting -Period for the revised Inventory€ Processors ofchemical substanceo will beable toprotect themselvesfromprosecutionunder the statute.

CHEMICAL SUBSTANCES MANrACrutlrD on

rROCESSED FOP. A COMMERCIAL PUEPOSV


### Comment 29: The definition of the term "manufacture for a commercial purpose." should be modified to exclude the manufacture ofa chemical substance In small quantities forresearch and development.

Response: The Administrator disagrees with this comment, Chemical substances which are manufactured for research and development are "manufactured for com- mercial purposes" within the meaning of TSCA and are appropriately included under this definition. However, if these substances

are produced solely In small quantities for research and development they are speciflcally excluded from the inventory under sec- tion 8(b), and are exempt from the promanufacture notification requirementS of section 5(a)by section 5(h) (3) oftheAct.

Comnent30:Commercial biological preparations such as yeasts, bacteria, and fungi should not be considgred "chemical substances" under TSCA.

Response: The Administrator disagrees with this comment. The term chemical substance is defined to mean "any organic or Inorganic substance ofa particular molecuFEDERAL REGISTER, VOL. 42, NO. 247-FRIDAY, DECEMBER 23, 1977

HeinOnline -- 42 Fed. Reg. 64584 1977lar Identity including any combination * * occurring in nature." This definition does
not exclude life forms which may be manufactured for commercial purposes and nothIng In the legislative history would suggest otherwise.

EXCLUSIONS TO THE DEFINTION Op CHErmIAL SUasD&CES

Mixtures
Comment 31: EPA should clarify that manufacturers, not processors, have the responsibility for reporting the component chemical substances of a mixture.

Response: EPA believes that these regulations clarify that only manufacturers of chemical substances must report for the initial inventory. In fact, processors are not -subject to the initial inventory. Processors, including manufacturers of mixtures, may report for the "revised" inventory.

Comment 32: Multi-nutrient "mixed fertilizers" that could have been prepared by physically 'blending dry products such as urea, superphosphate and potash, should be considered mixtures, regardless of whether they are produced by physically mixing or by a method that involves a chemical reaction, such as by combining liquid ammonlum phosphate and granulating with potash.

Response: Te Administrator agrees with this comment and will consider multinutrient "mixed fertilizers" as mixtures of the ingredients beIng mixed.

Comment 33: Manufacturers of alloys including steel, glasses, ceramics, enamels, Portland cement, and similar combinations of chemical substances should not be required to report for the inventory.

Response: The Administrator agrees with this comment. Alloys. inorganic glasses, ceramics, frits, and cements, Including Portland cement, are mixtures under TSCA; manufacturers ofthese products are not required to report them. However, as stated in a note at §710.4(c), the exclusion ofthese products applies only to the mixture and
notto the chemical substances ofwhich the mixture Is comprised. Thus, the metals in the case of alloys, or oxides in the case of glasses and ceramics, and any additives or components other than impurities, should be included on the inventory. The manufacturers of themetals, oxides, and additives wouldbe responsible for reporting them.

Comment 34: "Hydrates" and "hydrated ions" should be considered "mixtures."

Response: The Administrator agrees with this comment and has defined the term "mixture" to include 'hydrates." Hydrated formsof chemical substances are accordingly exempt from the inventory. The anhydrous chemical substances, however, should be Included. Thus the manufacturer of hydrated copper sulfate, CuSo, (H.O),. would report that anhydrous form, CuSO4, for the nventory. As clarified in the preamble to the March 9 regulations, this provision does not apply to theproduct of discrete chemical reactions in which either water or a solvent Is

a reactant, e.g., water reacting with an ester to form an acid and an alcohol. Similarly, metal hydroxides formed by the reactions of metal oxides with water are not considered to be hydrates.

Comment35: If a person combines two or

more chemical substances toproduce a "mixture." -the person should be considered a "Mahufacturer of themiture," not a "processorofa chemicalsubstance."

Response:- The Administrator disagrees -with this comment. A person who combines two chemical substances to produce a mixture," ttge person should be considered a turer of the mixture" or a "processor ofthe chemical substance." For the purposes of these regulations, regardless of how such 

## RULES AND REGULATIONS

a person is characterized, he may only re- port during the reporting period for the re- vised Inventory.

The Agency recognizes that the Congress in section 8(a) established adifferent standardfor requiring reporting and retention of Information on mixtures than on chemical substances. EPA does not intend to require reporting on mixtures from either their manufacurers or processors when information concerning the chemical substances which comprise the mixture Is adequate for the Agency's purposes.

Comment 36: The definition of the term "mixture"should be expanded toinclude (1) incidental reaction products, (2) some chemical substances, (3) chemical substances which are the result of a chemical reaction that occurs upon use of certain chemical substances, such as curable plastic

orrubber molding compounds, or othersubstances which are formed during the manu- facture of an article, and (4) chemical substances which occur es the result of a chemical reaction when specified substances including, for example, a stabilizer, colorant,or antioxdant, function as Intended, or when a chemical substance which is solely intended to impart specific phyrlco-chemcal characteristics, functions as intended.

Response: The Administrator disagrees that the substances encompassed within this comment are "mixtures" within themeaning ofTSCA.EPAbelieves that each ofthe reac- tion products Is a "chemical substance" for thr purposes ofTSCA and that thechemical substance is manufactured or processed for

a commercial purpose within the meaning ofsection 8 of theAct. However. in keeping with the legislative history of the Act, 

## §710.4(d) excludes all these substances from the inventory because they are not manufactured for distribution in commerce
-as chemical substances per scand have no commercal purposes separate fromthe mixtureor article ofwhich they may be a part. Inaddition, they are not subjecttothe premanufacture notification requirements of section 5. The Administrator may In thefuture Impose a section 8(a) reporting rule as to these substances. In addition, the provisions of sections 8(c), 8(d) and 8(e) are applcable to these substances.

The term "mixture" under TSCA has. a meaning which Is diffcrent from its usual meaning In some respects. Many compositions commonly considered to be mixtures

are "chemical substances" rather than "mixtures" for purposes of these regulations.

A combination of two or more chemical substances is Itself a "chemical substance" for purposes of these regulations unless It falls within the specific definition of the term "mixture." In general, a combination of two or more chemical substances Is a "mixture" If they have been combined by actuallymixing them together.

If, however, the combination occurs In nature, it is a "chemical substance" and is not a "mixture." If, further, the combination Is prepared by a chemical reaction. It Is a "chemical substance" and not a 'ltixture," unless the combination could actually havebeen manufacturedfor commercial purposes at this time without a chemical reaction e.g., by mixing Its separate componehtswith each other.

No r-Hydrates and hydrated Ions are treatedseparately, andare discussed In comment34. PesticidesandFoods,FoodAdditices, Drugs, CosmeticsandDevices Comment 37: Various commenters stated that a substance should be excluded from TSCA If It Ia Intended for use solely as a pesticide, food,foodadditive, drug,cosmetic,

ordevice. 

## 64585

Response: The Adminstrator agrees with these comments. Pesticides are regulated under theFederal Insecticide, Fungicide and Rodenticde Act (FIFRA), as amended. 7 USC 136 et seq. Foods, food additives, drugs, cosmetics, and devices are regulated under the Federal Food, Drug and Cosmetic Act (PDIA). 21 USC 321 et seq. If the manufacturing. processing, distribution, or use of

a substance Isregulated under either FIFRA

or FFDCA. the substance would not be subject to regulation under TSCA Insofar as It is actually manufactured, processed or distributed in commerce for use as a pesticide. fond. food additive, drug, cosnetic or device. If a substance has multiple uses only some of which are regulated under FIFRA or FFDCA, the manufacture, processing, distribution, and use of the substance for the remaining uses would come within the jurtadlction of TSCA. In cases where a substance Is manufactured, processed, or distributed for undifferentiated uses, the substance will be presumed to be subject to TSCA for the purposes ofthese regulations. EPA recognizes that the interrelationship of TSCA, FIFRA, and FFDCA is complex and that jurisdictional Issues need further exploration In light of the various types of regulatory situations that may arise and the Congressional Intent of avoiding both dual jurisdiction and regulatory gaps. EPA believes that an appropriate resolution has been made In this particular Instance.

Comment38:Asubstance shouldbeconsidered a pesticide at the time that an appllcation for an experimental usepermit or an application for registration Is submitted.

Response: The Administrator agrees with this comment. If a manufacturer, processor,
or distributor of a substance expects to receivo benefit In pest control from Its use, It would be considered a pesticide within the meaning ofFIFRA. Submiion ofan appllcaton for anexperimental usepermit (FIFRA) section 5. 40 CFR Part 172) or an application for regIstration (FIFRA) section 3. 40 CFRPart 162) will be evidence thatthe substance is a "pesticide" within the meaning ofFIFRA. Prior to this stage, the substance will be presumed to be a chemical substance within the meaning ofTSCA. Therefore, any particular substance will first be subject to the provisions of TSCA and then, the provisions ofFIFRA.

Implementation of this approach will not pose an unreasonable burden on registrants of pesticide products. The substance will be considered a "chemical substance" under TSCA atthe -esearchanddevelopment stage. A.suming that the substance is only producedin small quantitiesforresearch anddevelopment (as definedin these rules), under the exemption of section 5(h) (3), the TSCA premanufacturo notification requirements would notapply.TheAdministrator couldrequire that all persons engaged in experimentation. research or analysis ofthe substance banotified ofanyrisktohealthw4uchmaybe associatedwiththe substance.Thisis entirely in keeping with thepurposes ofTSCA.

In addition, the Administrator could take regulatory action on the substance under TSCA sections 4. 6 or 7, and could require reporting under section 8(a) (1) (B). The Agency recognizes theimportance ofresearch? and development and does not intend to impede such innovation unneceszarly. Chemicas in the research and development stage

are generally handledbytechnically qualified
persons andonlyin small quantities. Accordingly. although the Agency may take regulatory action (including labelling and disposal requirements) in order to regulate inadvertent mishandling of research chemicals by an untrained person and inadvertent exposure to the environment of the research chemical, submission of test data and extenasve regulation of the uses of the substance



### FEDERAL REGISTER, VOL 42, NO. 247--FIDAY, DECEMBER 23, 1977

HeinOnline -- 42 Fed. Reg. 64585 1977

## RULES AND REGULATIONS

would normally be limited to situations involving significant exposure. In the case of a research chemical which becomes a pesticide, these latter areas of concern would be addressed under FIFRA.

Comm .t 39: Various commenters maintained thatraw materials, Intermediates, and inert ingredients produced or used In the manufacture of a pesticide should be considered "pesticides" and excluded from regulation underTSCA. Othercommenters argued that raw materials and intermediates produced orused in themanufacture of a pesticide are not "pesticides," are not covered under FIFRA, and should be regulated under TSCA.

Response: The A-dmlnistrator agrees that

raw materials, intermediates and inert ingredients produced or used in the manufac- ture of a pesticide are substances or mixtures which can be regulated under TSCA.

In order to beconsidered a pesticide, a substance must be intended for use as a pesticide.Raw materials, intermediates, and inert ingredients produced or used in the manufacture of a pesticide are not themselves regulated under F'IFRA (unless they happen to be pesticides themselves) and, therefore, are subject to TSCA. The pesticide regulations
at40 CFR 162.4 are consistent with this view. A manufacturing useproduct is considered a pesticide, (40 CPA 162.4(b) (3)); an Intermediate substance intended for the production of a pesticide product bychemical reaction with other substances Is not considered

r. pesticide, (40 CFR 162.4(c) (6)).

The legislative history of TSCA also supports this view. TSCA was enacted to provide' protection from harmful chemicals where legal authority was previously Inadequate, cumbersome or Inefficient. Congress intended to avoid the possibility that the risks from a chemical would not be subject
to regulation. S. Rep. No. 94-698, 94th Cong., 2d Eess. 5 (1976). H. Rep. No. 94-1341, 94th Cong.. 2d Seas. 6 (1976). In addition, Senator Allen of the Senate Committee on Agriculture and Forestry in attempting to conform the language of TSCA to that ofFIFRA specifically addressed the interface between 

### FIFRAand TSCAstating: "* * * any chemical or toxic substance would first be subject
to the provisions of (TSCA) andyet when it becomes a component of a pesticide, it would be subject to FIFRA. In many instances the manufacturer and registrant of the compo- nent Is also themanufacturer andregistrant of the pesticide." Committee on nterstate and Foreign Commerce. 94th Cong., 2d Sess., Legislative History of the Toxic Substances Control Act232 (1976). Araw material, intermediate, or inert ingredient which is not Itself a pesticide would, accordingly, be a chemicalsubstance within thejurisdiction of TSCA; It would come within thejurisdiction of FIFl.RA when it becomes a component of

a pe3ticide product.

The manufacturer, processor, or distributor of the'chemlcal substance who does not also maufacture, process or distributea pesticide product will not be subject to the dtal jurisdiction of TSCA and FIFRA. That person will only be subject to TSCA. The manufactarer, processor, and distributor of the

oraw material, intermediate, or inert ingredi-

ent who also manufactures the pesticide product will besubject to thejurisdictioi of both acts. TSCA and its legislative history contemplates this, and EPAhas no discretion
to reach a different result since a raw material, Intermediate, or inert ingredient (which is not itself a pesticide) cannot be regulated under FIFRA until It becomes a component of a pesticide product. As a matter ofpolicy, however, EPA does not Intend to impose duplicative requirements on these substances. Comment 40. A substance should be considered a food, food additive, drug, cosmetic

or device at the time that the Food and Drug Administration (FDA) regulates the, substance.

Response: The Administrator agrees with this comment. As soon as the FDA regulates

a product, its manufacture, processing, or distribution in commerce solely for a FDA regulated use will be excluded from thejurisdiction of TSCA. The FDA gives as examples of such points in time: when an application for exemption for an investigational use of

a new drug Is submitted (FFDCA 505(a); 21 CFR Part 312); when an application for exemption for Investigational use of a new animal drug Is submitted (FFDCA 512(a); 21 CFP Part 511); and when an application for exemption for investigational use of a device is submitted (FFDCA 520(g): 21 CFR Part 812, as proposed, 41 FR 35282, August 20, 1976).-

Comment41: Intermediates and catalysts intended solelyfor usein theproduction ofa food, food additive, drug, cosmetic, or device

are excluded from regulation under TSCA.

Response: The Administrator agrees with this comment. The definitions of the FFDCA provide that chemical substances which are intended for use as a component of a food, food additive, drug, cosmetic, or device are encompassed within the meaning of such terms, respectively. The FDA considers intermediates and catalysts to be such components. Therefore, they are subject to regulation under the FFDCA. Any such substance is excluded from regulation under TSCA insofar as it is actually manufactured processed or distributed in commerce solely for

usein theproduction of afood, food additive, drug, cosmetic or device.

Comment 42: Substances which are approved foruse bythe Food andDrugAdministration as foods or food additives, should be excluded from further regulation under TSCA even when used for commercial (nonfood) uses.

Response: As discussedin response to comment 37, if a substance has multiple utes only some ofwltich areregulated under the FPDCA, the manufacturing, processing, distribution, and use of the substance for the remaining uses comeswithin thejurisdiction of TSCA. Under these regulations, that sub- .stance should be reported for the inventory.

EPA does not intend to impose duplicative requirements on manufacturers and processors subject to regulation under another Federal authority. Accordingly,EPA will consult with FDA or any other Federal agency,
as appropriate, prior to taking regulatory action on substances which are alsoregulated under other authorities.

CHESICAL SSBSTANCES EXCLUDED FROM THE INVENTORY 

### SmallQuantities forResearchand Development - , Comment 43: The exemption for "small quantities for research and developmeht", should include small quantities used for quality control testing and for development of a chemical substance or product.

Response: 'Mhe Administrator agrees, in part, with this comment. Chemicals used for quality control testing and for the development of a product are considered "small quantities for researbh and development" if they fall within the definition provided in §710.2(y). Specifically, they must be manufactured orprocessedin quantities no greater than reasonably necessary for such purposes and, after publication of the revised inventory, they must beused by, or directly under the supervision of "technically qualified individual(s)." a term defined In § 710.2(aa). Substances can be "small quaftities for re

### search and development" evenif theyare distributedIncommerce.

Comment 44: Numerical limits should be Included in thedefinitionofsmallquantities for research and development.

Response: The Administrator considered establishing upperlimits forsmall quantities forresearch and development andfound that different values might have to be assigned for various groups of substances depending upon their physical/cl~emical characteristics and intended uses.For example, many plastics and fibers are commonly produced in 100,000 pound quantitiea during the develop- mental phase, while additives or minor uso substances may be manufactured in a few thousandpounds or letsforresearch and developmentpurposes.After compilationofthe inventory,.the Agency will consider developing a schedule of quantities to define small quantities for different chemical substances and different purposes.

Forthese reportingrequirements, however, EPA will in large part rely on the qualitative testcontained inthedefinition at 1710.- 2(y). In response to this comment, as provided In a note to the definition, If a substance is manufactured or imported in quantities ofless thanone thousand pounds, annually, It will be presumed to be for re- search and development purposes. Ifaman- ufacturer wishes to report for Inclusion on the inventory a chemical substance which Is manufactured for commercial purposes In quantities ofless than one thousand pounds, annually,he mustbeable to certify that the substance Is used forpurposes otherthan for research and development. After the publi- cation of the revised inventory, in order to qualify as a "small quantity for research or development." these quantities must be used by, or directly under the supervision of, a technically qualified individual.

Comment 45: The exemption for "small quantities" should notextend toresearch or analysis of chemical substances for the development of a product. The exemption should applyonly toresearch In a laboratory and not to situations where production workersare exposed.

Response: The Administrator disagrees with this comment. The legislative history of the Act makes clear that Congress Intended the exemption for "small quantities" to extend to chemical substances in the developmental period and notonly toresearch chemicals In a laboratory. H.R.Rep, No.04- 1341, 94th Cong., 2d Bess. 29-30 (1076). TI e Coneress contemplated that during the re- search and development phase, a chemical substance would be within the control of technically qualified individuals who would Puoreciate the risks from exposure to the substanceandbe abletominimize suchrisk

. Theregulationsprovide that acompound will only qualify for the "small quantities" ex- emotionifit Is usedby, ordirectly under the suoervision of, technically qualified individual(s). The Agency expects this requirement to provide workers inthe development ofa product thesame protections as workers in the laboratory. In addition, section 5(h) (3) of the Act specifically provides that in order for a substance to be exempted from the requirements ofpremanufacture notification, all persons handling the chemical substance for the manufacturer or proces-
sor must be notified of any risk to health which the manufacturer, processor or the Administrator has reason to believe may be associatedwith it.

Comment 46: The exemption for "small quantities" should not extend to chemical substances distributed in commerce.

Response: The Administrator disagrees with thiscomment. Congressrecognized that

FEDERAL REGISTER, VOL. 42, NO. 247-FRIDAY, DECEMBER 23, 1977 

# 64586

HeinOnline -- 42 Fed. Reg. 64586 1977

## RULES AND REGULATIONS

a manufacturer may notbe able to evaluate fully a potential-product in house. So long

as the research and evaluation of the sub- stance is conducted by or under the direct supervision of persons technically qualidee
to analyze and evaluate the physlcal.'chemical. and performance characteristics of the substance, the Congress Intended the ex- -emptionto apply.H.R. Rep. No. 94-1341, 94th Cong.,2d Sess.30 (1976).

Comment 47: After the effective date of the premanufacture notification requirements, EPA should require all research and development chemicals to be labeled rather than require a "certification of use" statement by a customer upon each sale.

Response: The Agency recognizes that it maybe unnecessarily burdensome to require customers to certify upon each sale (or even annually) that the chemical substances they purchase are for research and develop- ment only. EPA is considering imposing a labeling requirement on allresearch and development chemicals (such as 'Tor Research And Development Use Only") and requiring distributors of such chemicals to include
statements In their catalogs and sales literature detailing the restrictions on use.

Comment 48: EPA should clarify the responsibilities under these r~gulations ofpersons who manufacture or import "chemical substances solely in small quantities for re- search and development.

Response: Chemical substances manufactured, imported, or processed solely in small quantities for research and development as defined at §710.2(y) are excluded from reportlng for the inventory under § 710.4(c) (3). As discussed above, if a person manufactures or imports a chemical substance in quantities of less than one thousand pounds annually, the substance is presumed to be for research and development. In such a case, in order to report the substance a manufacturer or importer must be able to certifythatthe substance is being used for purposes other than research and development.

With respect to quantities greater than

one thousand pounds, manufacturers and importers 'are not required to obtain certification from their customers concerning the intended use of such chemicals. However, unless a manufacturer or importer knows that a customer is using a chemical substance for other than research purposes, he should not report that chemical substance. The special reporting period after publication of the initial inventory is ex-. uressly to provide an opportunity for people
to supplemeqt the initial Inventory with chemicalsubstances which are manufactured

or processed for commercial purposes but which were not reported by manufacturers

or importers. The customers of a company selling primarily research chemical sub- stances could report any chemical substance that belongs on the inventory at that time.

Comment 49: The provision that small quantities for research and development
must be used by, or directly under the supervision of a technically qualified individual, should be deleted.

Response: The Administrator disagrees with this comment. As discussed in response to comments 43.44.45, and 46 above. Congress clearly intended research and develop- ment chemicals, that are exempted from the inventory and from premanufacture notification requirements, to be used only by, or under the supervision of technically quallfied individuals.

Comment 50: Professional certification should be added as a factor which would establish-that a person is "technically quail-. fled."

Response: EPA believes that this factor is already included in the definition of technically qualified individual. EPA presumes that professional certification Would be based on the education, training, or experi-

ence of the Individual. Accordingly, it would be redundant to Include professional certification as a separate factor. Persons could cite their professional qualifications as evidence of being a "technically qualified Individual."

Comment 51: Can the responsibilities included within the definition of "technically qualified individual" be delegated to more than one person?

Response: The Agenqy recognizes that

some manufacturers may designate an individual other than the person actually conducting or directly supervising the research

or development as the person responsible for making safety assessments and clearances with respect to the procurement, storage, use, and disposal of the chemical substance. Such responsibilities can be delegated, so long asall phases of the research and development of a product are conducted, or directly supervised by a person who because of his education, training, or experience, or a combination of these factors, is capable of appreciating the health and environmental risks associated with the chemical substance.

For example, one person may be responsible for analyzing the properties ofa chemical substance used as a glue to back a rug, while a second person may have responsibility for determining how to dispose of the rug samples that contain the experimental glue. Similarly, there may be a duly authorized Individual responsl6le for pro- curement of research chemical substances who is different from the technically qualilfied individuals who conduct the experiments with those chemical substances. So long aseach ofthese persons Isprofessionally qualified, the "technically qualified individual" definition will be fulfilled. Byproduct3

Comment52:All byproducts should be required to be reported for the inventory.

Response: The Administrator disagrees with this comment. As a matter of policy, the Agency has decided that byproducts 'which have no commercial purpose should not be reported for the inventory. And. as Is discussed in response to comment 54, byproducts which have some commercial value

are not required to be reported for the inventory. Insofar as these wastes are hazardous,EPAintends torequire reporting ofthem under the Resource Conservation and Recovery Act (Pub. L. 94-580) next spring, or under 'SCA Eection 8(a) (2) during subsequentphases ofreporting. Moreover theprovisions ofTSCA sections 8(e), 8(d), and 8(e)

are applicable to byproducts and the Agency will use the authorities of TSCA sections 4. 6, and 7 toprevent and reduce anyunreasonable risks posed by byproducts.

Comment53: The definition of byproduct in the March 9.1977, proposal is confusing. Chemical substances formed as a result of secondary chemical reactions.Including thos that occur uoon end-use or In storage, are not "byproducts."

Response: EPA recognizes that the definition of byproduct In the March 9 proposal

was confusing. The August 2 proposal and these final regulations (§710.2(g)) have re- defined "byproduct" to include only those chemical substances produced without Fepa- rate commercial intent during the mnnufacture or processing of other chemical substancesormixtures.

The legislative history of TSCA makes clear that these secondary chemical substances arenot tobe subjectto the Inventory and premanufacture notification require- ments because they are not manufactured for commercial purposes per se. S. Rep. No. 9t-98, 94th Cong. 2d Ses. 19 (1976). Accordingly, section 710A (d)(2) of these regulations excludes these substances from these recuirements.

Comment 54: Should slags which have

some commercial value and that are byproducts in themanufacture ofanother substance be reported for the Inventory?

Response: Sactlon 710.4(d) (2) of these regulations provides that byproducts that have come specifickinds ofcommercial value may be reported forthe inventory, although there Is no requirement that they be soreported. Byproducts that have no commercial value may not be reported for the Inventory.

Comment 55: Persons who extract component chemical substances from byproducts shouldnotberequiredto reportthosechemical substanccs.

Response: The Administrator agrees with this comment. Persons who recover chemical substances frombyproducts ofthemanufacture or processing of other chemical substances, mixtures, or articles would beprocessors of the chemical substances and need
not report for the Inventory. There Is no requirement that these persons report any chemical substance which is extracted or separated from a byproduct, Including by

means ofheat or a chemical reaction, if the chemical substance that Is recovered Is actually present in the byproduct orwas an intermediate used in the manufacture of the byproduct, and If also, to the best of the knowledge of the person recovering the substance, the manufacturer of the substance Is reporting the substance for inclusion on theinventory.

Articles

Comment 56: Can articles bereported for the Inventory?

Response: Articles as defined at §7102(f) will not be included on the inventory. The inventory is a list of chemical substances manufactured or processed for a commercial
purpose in theUnited States. Chemical substances ofwhich articles are comprised can., however, be reported fortheinventory.

Comment 57: What are the reporting requirement3 with respect to manufactured Items containing fluidsorparticles?

Response: The definitlon of "article" at 1710.2 excludes fluids and particles regardless ofshape or design. Accordingly, all fluids and particles will either be a "mixture" or "chemical substance" for the purposes of TSCA. Any fluid orparticle which is a chemical substance should be reported for theinventory. See alsoresponse to comment21.

Comment 58: The definition of "article" should be modified to include products such

as films and batteries which undergo chemIcalchanges duringtheirenduses.

Response: The Administrator agrees with this comment and has amended clause 3 of the definition to include within the meaning of "article" a manufactured item "which either has no change of chemical composttIQnduringIts end-use oronlythose changes In composition which have no commercial purpose separate from the article of which It is a part and that may occur as described in 1710.4(d)(5)." The provision In 1710A is an exclusion for chemical substances which are the result of reactions thatmay occurupon end-use of otherchemical substances, mixtures, or articles. Under thisrevised approach, batteries,photographic films, matches, flares, ablative nose cones, brake linings, and other such products are considered "articles.'

Comment 59: Fibers, filaments, and whiskers should be considered articles.

Response: As defined in 17102(f), fibrous materials may be considered articles If (1) their end-use functions depend in whole or



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in part upon their shape or design and (2) they are functional in their end-use without a change of chemical composition except for changes that have no commercial purpose separate from the articles of which they are a part.If a person shapes a chemical sub tance Into a filament or fiber,he would be a processor of that substance. The chemical substance -would be reportable by the manufacturer. The filament or fiber or whisker would be an article and could not be reported. However, if that fibrous material

was Intended to be used as an intermediate in the manufacture of another chemical substance, it would not be considered an article. It would be considered a chemical substance (or mixture). Particles are not articles whether they are round or asymmetric. If a whisker or other fibrous mate- rial may be used as a particle in its subsequent processing, It would not be considered

anarticle.

'Comment60: Chemical substances used in the finishingprocess ofan article should not be excluded from the inventory. Dyes and fire retardants are two examples of substances which should be reported.

Response: The Administrator agrees with this comment. There has been some confusion over the intent of the exclusion in 1710.6(d) (6) of these regulations. The ex- clusion is for chemical substances that are not manufactured for distribution In commerce as chemical substances per so and have no commercial purpose separate from the mixture or article of which they may bepart.

Dyes and fireretardants are chemical substances, manufactured for distribution in

commerce as chemical substances, and there-. fore do have a separate commercial purpose. These substances should be reporter, by their manufacturers for inclusion on the inventory. The exclusion in §710.4(d) (6) is for chemical substances formed when the dye or fire retardant reacts with fibers of a garment or other article upon end-use of those substandes by a processor. These reac- tion products must not be reported.
Impurities
Comment 61: Chemical substances should be listed on the inventory with respect to theirImpurities.

Response: The Administrator disagrees with this comment. The Agency has detPrmined that as a matter of policy, this firstinventory should not distinguishamong chemical substances which are identical ex- cept with respect to their impurities. The Agency recognizes the potential hazards of

some Impurities and intends to use the alternative authorities of sections 4, 6, 7, and 8 to prevent and reduce any unreasonable risks posed by impurities. In addition, in the future EPA may revise the inventory to take impurities of a chemical substance into account.
CHEMICAL SUBSTANCES INCLUDED IN THE
INVENTORY Comment62: Since customer demand runs In cycles, some provision should be made to allow companies to report chemical substances which they manufactured for a commercial purpose more than three years ago and plan to produce again.

Response. TheAdministrator agrees in part with this comment. Section 8(b) of TSCA provides that a chemical substance may not be included on the Inventory if it was not manufactured or processed withinthreeyears before the effective date ofthese regulations. Accordingly, § 710.3(a) (3) (i) of these regulations, provides that if a person manufactured a substance for a commercial purpose before January 1, 1975, he may still report 

## RULES AND REGULATIONS

the substance for the inventory if he certifies that the substance was processed after January 1, 1975. If a manufacturer neither manufactured a chemical substance nor can certify that the substance was processed within the past three years, he may not report the substance for the inventory, even If he plans to produce It again in the future. If the substance is not reported for the inventory by the manufacturer or by another manufacturer or processor, manufacturers will have tosubmitpremanufacture notification on the substance 90 days before manufacturing it again.

Comment 63: Manufactures should be able to report chemical substances manufactured since July 1,1974, as provided in the March 9, 1977, proposal.

Response: The Administrator disagrees with this comment. The July 1, 1974, date

was included in the March 9, 1977, proposal onthe assumption that finalInventory reporting rules would be prondulgated by July 1977. Section 8(b) of TSCA clearly providesthat the inventory maynotinclude any chemical substance which was not manufactured or processed within 3 years of the effective date ofthese rules.As discussed in response to comment 62, a manufacturer may report a substance for the Inventory if it was manufactured beforeJanuary 1, 1975, solong

as it was processed after January 1, 1975.

TestMarketing

Comment 64: The Administrator has no authority to exclude chemical substances presentlyundergoing testmarketingfrom the Initial inventory.

Response: Any chemical substance which is manufactured or imported for test mar- keting purposes Is eligible for inclusion on theinventory.This is made clearbythe definition of the term "manufacture or import 'for commercial purposes' 1 at §710.2(p). Af- ter the effective date of the premanufacture notification requirements of section 5(a) (1) (A), a manufacturer may not test market a
new chemical substance without first either providing the premanufacture notification required by that section or obtaining an exemption from the requirement under section5(h) (1) ofthe Act.

Comment 85: The critical factor in distinguishing the "development phase" of a product from its "test marketing" phase is thatthe latterphase contemplates a sale.The word "sale" must be ncluded in the definition of "test marketing" because accepted and ordinary usage of thephrase Involves the sale of a product underpractical competitive conditions.

Response: The Administrator does not agree with this comment. Sale of a product does not always distinguish its development phase from its test marketing phase. The Congress itselfrecognized that "the fact that the other industrial user maypay the costs forthe substance does not necessarily signal the end of the development period." H.R. Rep. No. 94-1341, 94th Cong, 2d Sess. 30 (1976).

For the purposes of these regulations, re- search and development activity will be differentiated from test-marketing primarily by the greater degree of control maintained by the manufacturer and the greater technical qualifications of those handling and supervising the use of the substance during the research and development phase. Distribution of the product during the test marketing phase generally removes the product, its use, and its disposal from the direct supervision of the manufacturer. (See response to comments 43-51.)

Comment66: EPAshouldplace restrictions

on both the population andgeography which may be'exposed to products In test marketing and should require labeling of products to Indicate potential hazards. Response: The Administrator has authority under section 5(h) (1) to impose sueh restrictions on test marketing of a chemical substance as are necessary prior to exempting the chemical from thepremanufacture,notification requirements. In addition, the Administrator will use the authorities of sections 4. 6, and 7 of the Act to prevent unreasonable risks to man and the environment. Intermediates

Comment 67: The term "Intermediate" should exclude intermediates that are merely "isolatable", and are never encountered In the environment. The Identification ofthese intermediates will often require highly trained chemists and will significantly Increase the costs of complying with the reporting requirements.

Response: The Adnlnistrator agrees with this comment and the definition of "Intermediate" at §710.2(n) has been amended accordingly. Chemical substances which are not removed from the equipment in which they are manufactured are not considered "Intermediates" for the purposes of there regulations and are excluded from the Inventory by §710.5(d) (8). EPA will require notification under section 5 for any chemical substance which is not on the Inventory and which, after the date of the premanufacturo notification requirements, Is Isolated, or Intentionally removed from the equipment in which It was manufactured. Amanufacturer
may, however, apply for an exemption from thisrequirement under section 5(h) (5) Ifthe intermediate exists temporarily and there Lq
no, and will not be any, human or environ- .mental exposure. Chemical substances eXcluded from the Inventory by §710.4(d) (8)

are considered to be manufactured or processed for a commercial purpose for the purposes of section 8 of the Act.

Comment 68: The definition of "intermediate" In the March 9, 1977 proposed regulations is more descriptive of an "impurity." An "Intermediate" should refer to a chemical substance that is both created and totally consumed during the chemical reaction process. This description would provide a meaningful distinction between an "intermediate." a "byproduct," and tm "impurity."

Response: The Administrator agrees In part with this comment and has substantially revised the definition of "intermediate." The purpose of the definitions under these regulations is tO clarify which chemical substances are Included and which arc excluded from the Inventory. The Administrator does not agree that the term "Intermediate" should be restricted to chemical substances that are totally consumed in chemical reaction processes. A chemical substance may be an intermediate and also appear later as a byproduct or ao an impurity. In such circumstances, the substance should bL reported for the Inventory,

Under these definitions, the essential difference between a byproduct and an Intermediate Is that the Intermediate is consumed, in whole or In part, In a chemical reaction used for the Intentional manufacture of other chemical substances, or Is intentionally present for the purpose of altering the rate of such reaction(s). A byproduct may be formed and then consumed in whole or In part during the reaction squence but is not an "ntermediate" unless it Is consumed in whole or In part in chemical reactions used for the intentionalmanufacture of other chemical substance3 or Is Intended to alter the rate of such reactions.

Impurities are defined as chemical substances which are unintentionally present with another chemical substance, While intermediates often appear as trace impurities in a final product, they are In general disFEDERAL REGISTER, VOL 42, NO. 247-FRIDAY, DECEMBER 23, 1977



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## RULES AND REGULATIONS

tinguished from impurities in that they

serve an intentional purpose In a reaction
sequence.

Comment 69: Chain transfer agents or
cross linking agents used in the manufacture of polymers should be considered intermediates.

Response: The Administrator agrees with this comment, Cross linking agents and chaintransfer agents which are used in the manufacture of polymers are considered to be processed for commercial purposes and should be included on the inventory. The processor who buys such substances for use In the manufacture of polymers need not report such substances. However, he should

ensure that the substances are included on the initial inventory or report these substances during the special reporting period for the revisedinventory.

Section 710.5(c) requires listing In the description of a polymer at least those mon-
omers used at greater than two percent (by weight) in the manufacture of thepolymer. In a similar fashion, a manufacturer would list, as partof the polymer description, those

cross linking, chain transfer and other reactive agents which are present at greater than two percent (by weight) in the manufacture of the polymer. Additives such as plasticizers and emulsifiers which are only entrained in the polymer are considered to be components of a mixture and should not be considered to be components ofthe polymer. See response to comments 77-82 on reportingofpolymers.

Comment 70:In the manufacture of poly-
mers, there are literally thousands of intermediates deliberately present in the reaction sequence. The process may be interrupted, occasionally, for examination and testing,at which point chemically reacted substances

are removed. Such substances should not be considered "intermediates" for the purposes -of these regulations and should not be re- portedfor theinventory. I Response: The Administrator agrees, In part, with this comment. If a chemical substance satisfies the definition of "Intermediate" at §710.2(n) of theseregulations, for the purposes of these regulations, it Is an intermediate. However, an intermediate may also fall within the exclusion from these regulations at § 710.4(c) (3) for "small quantitles for research and development." If an "intermediate" is a "small quantity for research and development" it is excluded from the inventory. Hence the removal of small quantities of a chemical substance from the equipment in-whlch it was manufactured does not make that chemical substance a reportable "intermediate" if the amount removed is used solely for testing or research purposes described In §710.2(y).

Comment 71: The inclusion of "intentionallypresent catalysts" underthe definition of intermediates in the March 9 proposal is confusing.

Response: The Administrator agrees With this comment and has revised the term "intermediate" at §710.2(n) to include "any chemical substance which is intentiallypres- ent for the purpose of altering the rate of (such) chemicalreaction(s) ." Thisdefinition ofthe term "intermediate" is consistent with

common usage. It considers "catalysts" as "intermediates". Naturally Occurring Substances,

Comment 72: Which of thefollowing sub- stances would be considered "naturally oc- curring substances." and therefore be excluded from the reporting requirements: natural latex; "natural rubber"; enzymes; and calcinateid clays?

Response: Thenatural latexobtained from certain trees is considered a naturally oc- curring substance. However, the "natural rubber" which is formed after chemical coagulants are added to the latex would not be considered in the category of "naturally occurring substances". Thus. Importers of "natural rubber" must report under these regulations. Enzymes are notincluded In this category unless they were extracted from nature only by the means described in 1710.4 (b). And, calcinated clays which are formed by heating naturally occurring clay are not Included In thiscategory because such beating is not done solely to remove water.

Comment 73: The category of "naturally occurring substances" should be expanded to include those substances which are extracte from other naturally occurring substances using any solvent. not Just water.

Response: The Administrator disagrees with this comment. EPA has decided that the category should contain only those substances which are removed from nature es- sentially by natural means. Using water to extract a chemical substance from a nat- urally occurring substance Is considered a natural means of removal. Using other sol- vents is not considered a natural means of removal.

Comment 74: The category for naturally occurring substances should include substances that are processed by electrostatic

means.

Response: The Administrator agrees with this comment.In an electrostatic ceparation. small particles are removed from a liquid

or gas stream. The process I- e.sentially analogous to a filtration or gravitational separation. Substances which are procesed by this means fall within the naturally occurring substances category.

Comment 75: How does EPA intend to regulate naturally occurring chemical substances which may be harmful?

Response: The Agency will use the authorities contained in sectlon 8(a) of the statute to require reporting on a celective basis from manufacturers and processors of naturally occurring chemical substances. In addition, the Agency will use the authorities of sections4. 6.and 7ofTSCA toIdentify and regulate any unreasonable risks to health or the environment presented by naturally occurring' chemical substances.

INVNTORY RiEPOaro PnCEDWUIES
Comment 76: EPA should form a group whichcan help Industryanswer speciflc questions concerning illing out the reporting forms. Responses should be available within 10 days and signed by an authorized Individual.

Response: The Office of Industry Assistance in the Office of Toxic Substances and the staffsofthe Agency's Regional offices will beprepared to answer specific questions concerning the inventory reporting requirements.EPA will makeevery effort to respond
to inquiries as quickly as posible. ReportingofPolymers

Comment 77:Polymers shouldbe required to be identified with respect to their constituent monomers present at grediter than
two percent with the option of reporting these monomers presentatlessthan twopercent. All monomers used In the manufacture of the polymer should be reported for the Inventory. 'Response: The Administrator agrees with this comment. Section 710.5(d) ofthe regulations is written to accomplish this result.

Comment 78: Some commenters argued thatpolymers shouldbe required to be Identified with respect to the constituent mono-
mers present at greater than five percent. Other commenters argued that every constituent monomer of a polymer should be reported.

Response: The Administrator disagrees with these commehts. In the Interest ofhaying an inventory that accurately reflects the identities ofthe polymers In commerce. EPA felt that requiring reporting of only these constituent monomers present at five percent or greater would be unsatisfactory. On the other hand, since every monomer must be identified on the inventory even though
not reported as part of a.specific polymer, EPA did not believe it was essential to require reporting of each polymerwith respect to all of Its constituent monomers. Moreover. EPA recognizes important advantages in requiring manufacturers of polymers to identify only those monomers present at two percent or more.

First, the principal Identities of many polymers thatmighthavebeen claimed tobe confidential Ifrequired to be fully disclosed will be included on the Inventory. Further. It Is sometimes difficult to distinguish what chemical substances present at less than two percent in a polymer would be appropriately considered a reportable monomer or merely

an Impurity. Finally, small variations among polymers due to minor process changes, for example, will not be subject to premanufaclure notiication provided; the polymer dces
not contain a new chemical substance.

EPA recognizes that for the purpose of evaluating potential toxicity, the proposed description of polymers Is Insufhclent EPA intends to obtain detailed information with respect to specific claszes of polymers under section 8(a). In addition, EPA will consider po=sible refinement of description of polymers for purposes of the Inventory in the future. However, because potential toxicity may be dependent on properties such as rolubillty molecular weightdistribution, and crystallinity, it is unlikely that even with further revisions, the listing of monomers would be sufficient to indicate the relative potential toxicity ofthe polymers.

Finally these regulations do not exempt from the inventory any chemical substance which Is manufactured for commercial purposes as a monomer, regardless of its percentage use in the manufacture ofpolymers. Additives which are not intended to be part ofpolymeric chemical substances should not be reported as part of the description of polymers, but should be included separately

on the inventory as chemical substances.

Comment 79: Some numerical molecular weight should be determined for purposes ofdistinguishing reactive andrelativelynonreactive polymers and copolymers. Above a certain specified molecular weight, relatively non-reactive polymers should not be listed individually, but only the monomers that comprise these polymers in various combinations should be listed. Below that weght. each polymer or copolymer should be listed separately with respect to its constituent



### monomers.

Response: TheAdministrator believes that such an approach should be investigatedWhileit Is notfeasible to adopt such an approach for the present Inventory, EPA may revise the Inventory accordingly once an appropriate test method is adopted to ensure consistency in measuring polymerweights.

Comment 80: Any, chemical substance known as a polymer shouldbe excluded from the inventory,providedthateach constituent

monomer and precursor chemical Isreported.

Response: The Administrator does not agree with theproposal to excludereporting ofall polymers.EPA doesrecognize, however, that non-volatile or Inert polymers above

scme particular average molecular weight could perhaps be handled differently. As mentioned In response to comment 79 above, EPA intends to investigate distinguishing .polymers on.the basis of their average molecular weight and possibly modifying the inventoryin the future.

Comment 81: How should the weight ofa

monomer be calculated and what is meant

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by a monomer present at a certain "weight percent" ofa polymer?

Response For purpose of the inventory reporting requirements, the percent (by weight) of a monomer is the weight of the

monomer charged into the reactor and not the weight incorporated into the polymer. The weight of the monomer should be expressed as a percentage of the weight of the polymeric chemical substance manufactured.

Comment 82 If a polymer listed on the inventory contains five monomers, for example, a new polymer with four of those five monomers should not be considered a "new chemical substance" for the purposes of section 5(a) (1) (A).

Response: The Administrator disagrees with thit comment. If someone created a polymer that contained fifty different monomers which were added in insignificant quantities merely to include them, as part of that reported polymer, a manufacturer could then create thousands of polymeric combinations based on those fifty monomers without reporting them for the inventory or submitting premanufacture notification.
Irmentory Reporting Forms

Comment 83: All forms should begin with

a certification to the effect that "to the best of my knowledge and belief. I certify that

.

Response: The Administrator agrees with this comment and has modified the forms accordingly.

Comment 84: It should not be necessary
to report both chemical names and Chemical Abstracts Service (CAS) numbers on Form B.

Response: The reason that EPA requires a manufacturer to report both a chemical

name and the Chemical Abstract Service Registry number on Form B is to ensure that a manufacturer has reported correctly. If EPA required only reporting of the sevendigit CA$ numbers, EPA would have no

means to check whether a manufacturer correctly reported that number.

Commr t 85: It should be possible to fill

out all forms on computer print-out or tape.

Response: Manufacturers may report chemical substances that have cAs registry numbers by computer print-out or tape. Instructions forreportine in this manner are included in the instruction booklet accompanying the formn. I Comment 86: The instructions for reporting should make clear that complex, undefined chemical substances may be reported by describing the reaction process used to manufacture the substances.

Response: EPA recognizes that if is often difficult to describe complex reaction products whose composition is, variable or un

### known. Many of these substances are commonly described by generic terms such as coal tar, shellac, or vegetable extracts. For purposes of the inventory, manufacturers should report as specifically as possible. using generic terms and a description of the method used ,in the final reaction sequence to produce the reported:substunce. EPA will publish detailed instructions in "Reporting for the TSCA Inventory."

CommeOnt 67: Form D is an excellent Idea which will be very useful for processors and other; who buy trademarked chemicals who

, composition is unknown to them. It should be updated frequently.

Response: EPA encourages manufacturers who report for the initial inventory to inelude on Form D the trademarks, whether registere'd or not, by which chemical substances reported for the inventory ar known. A manufacturer may report a trademark. for a product which is a chemical Pubstance, a mixture or an article containing a chemical substance. As provided In-the 

## RULES AND REGULATIONS

instructions to Fomn D.a manufacturer who chooses to report,.must certify that allthe chemical substances which comprise the trademarked product have been reported for the inventory, either by him or by someone else.

EPArecognizes that processors and users of chemical substances do not always know the identities of the substances they purchase and thus, may have difficulty determining whether or not the chemical substances they purchase are included on the inventory Processors could individually request suppliers to certify that the substances they sell

are included on the inventory. The Agencr hopes to ease this burden somewhat by proriding manufacturers who sell their products under a trademark an opportunity to certify that the chemical substances contained in the particular trademarked product have been reported for the inventory. Any false certification would subject amanufacturer to criminal penalties under 18 U.S.C. 1001.

The usefulness of the trademark list is. however. limited. EPA recognizes that the composition of any particular trademark product may vary over time. Further, the Agency is not now requiring manufacturers who choose toreport their trademarks tolink the product name with specific chemical substances. Accordingly. the Agency will not be able to verify the accuracy of the trademark list.

Bemuse ofthe limited utility of the trademark list,the Agency does not now Intendto update it. The list is designed,to assist processors and users in reporting for the revised inventory. The Agency will be studying the continuing problem presented by the fact that persons in the chemical industry do not always know the identity of the substances they purchase.

WHEN TO REPORT

Comment88: MLantufacturers and processors need more than 90days to report all the information required by thesa regulations.

Response: The Administrator agrees with thiscomment. Section 710.6(a) provides manufasturers and Importersuntil May I, 1978to report for the initial inventory. Section710.6 (c) provides processors and users of chemical substances 210 days to report for the revised inventory.The Agencyencourages personsreporting for the inventory to sta'mor their submissions throughout thereporting period

so that they can be processed in a timely

manner.

Comment 89: A manufacturer should be able to add new chemicals to the inventory anytime prior tothe startof premanufacture notification.

Response: The Administrator agrees with this comment. Section 710.6(b) provides this authority. A manufacturer or importer of a chemical substance in bulkmay report a new chemical substance until 30 days after publicalion of the initialinventory.An importer of

,chemical substance as part of a mixture or article may report a new chemical substance for the inventory until 30 days after publication of the revised inventory.

Comment90: Anufacturers and importers of chemical substances should be allowed to report for therevised Inventory.Premanufacture notification should notbegin until after publication of the revised inventory.

Response:- The Administrator disagrees with this comment. Postponement of promanufacture notification until after publication of the revised inventory would delay the effectiveness ofthis provision of the Act for an unacceptable period of time. The revised inventory may not be published until November 1979 orlater.

Comment 91' Thd Administrator should provide by regulation that failure to report for Inclusion in the inventory for "good 

### cause" will not subject the manufacturer to the premanufaoture notification requlromentsofsection 5(a) (1) (A)

Response: The Administrator disagrec with this comment. Such a provision is not appropriate for these Inventory reporting regulations, EPA doe3 recoonlzo, however, that given the large volume of information that is to be compiled and transmitted, It I inevitable that there may be some clerical or technical errors made in reporting chemical substances for the inventory, Accordinrly. the note at 9710.1(b) of these regulations provides that as a matter of traditional Agency policy, EPA does not intend to concentrate its enforcement efforts on Insignificant clerical errors in reporting. instead. EPA will give priority to bringing enforcement actions against persons who (1)report false information, (2) report for Inclusion on the inventory chemical substance3 Which are excluded under § 710.4(c) of theze retulations, (3) fall to report, or (4) fail to maintain records documenting reported Information.

Comment 92: In asessing any penalty on

a manufacturer, the impa.cts on procezors and users of the chemical substance(s) should beconsidered.

Response: The Administrator agrems with this comment. Section 16(R) (2) (B) of th Act provides that in assejsing any penalty the Administrator must tahe Into account several factors. In assessing a civil penalty against a manufacturer, the Administrator

as a matter of policy will consider the effoot ofthe action on permous who prom-.:J and mae that chemical substance.

CONVIDENTVLArrv identityo/ ChemicalSubstanc

Comment 93: Some chemical Identittca are entitled to confidential treatment f0 purposes of the TSOA inventory. Any ubmitter should be allowed to claim that any chemnocal identity is confidential for the Inventory.

Response: The Administrator agriec With this comment. The general approach EPA will take to confidentiality of specific chemlcal Identities for purposes of the inventory is set out in the preamble and 9710.7 of these regulations. In choosing this approch EPA had to balance the competing concerns of section 14 and seotons 8(a) and 5(b). The reasons for taking thiG approach follow,

The inventory is a list of chemical hubstances manufactured (including lmported)

or proczssed for a commercial purpoe, Mtny chemical substances have been doveloped and synthesized for which no commorcial purpose hasbeen found. The fact that someone has found a commercial purpose for t particular chemical substance may be a confidential trade secret. Placement of the specific chemical Identity on the Inventory would announce that fact to potential competitors who might be able to narrow their research activities. Thi3 problem would ho further compounded If the chemical substance were newly synthesized and known only to the person reporting It to EPA or If the substance were patentable, in which

case inclusion on the Inventory might constitute a publication and limit the pergon's patent rights.

Were there no requirement in section 8(b) of TSCA to publish a list of chemical substances manufactured and processed for commercial purpose, there Is no doubt that the fact that certain substances are manufactured or processed for commercial purposes would be confidential under traditional trade secrets law and case law under the Freedqm of Information Act fourth eiemption (5 U.S.C. 652(b) (4)). Section 14(a) of TSOA states that any information reported
to EPA under TSCA that is exempt from disclosure under 5 U.S.C. 552(b) (4) may not

FEORAL REGISTER, VOL 42; NO. 247--4RIDAY, DECEMBER 23, 1977



### HeinOnline -- 42 Fed. Reg. 64590 1977

## RULES AND REGULATIONS

be disclosed except In five situations specfied&in section 14 (a) and (b). Standing alone section 14 would, accordingly, seem to require that EPAnot disclose the fact that a particular chemical substance is manufactured or processed for commercial purposes if that fact would be exempt from disclosure under 5 U.S.C. 552(b) (4). However, section 14 is part of a larger statutory scheme In TSCA.

Section 8(b) requiresEPA to publish a list of 'eachchemical substance which is manu- factured or processed in the United States. Such list shall include each chemical sub- stance which any person reports, under section 5 or subsection (a) of this section. is manufactured or processed in the United States" (emphasis added). The Inventory Is intended to inform the public which chemical substances are being manufactured or processed in the United States for commer- cialpurposes. With this knowledge, thepublic would know the chemical substances to which they may be exposed and would be able to take an active participatory role in EPA actions under TSCA. This s clearly contemplated in sections 20 and 21 of TSCA that provide for citizens' civil actions and citizens' petitions. The inventory also has a regulatory purpose.It defines what is a "new chemical substance" for purposes of section 5(a) (1)(A). A "new chemical substance" is any substance that is not included In the inventory. If a chemical substance s a new chemical substance no person may manufacture it without first submitting to EPA a 90-day premanufacture notice, during which time the person may not manufacture the

new chemical substance.If EPAhas promulgated a testing rule under section 4ofTSCA, the delay period before manufacture might be significantly extended.

Were there no section 14 requirement in TSCA, EPA wouldpublish a list ofall chemical substances manufactured or processed in the United States for commercial purposes without provision for claiming confidentiality. Thepublic would know all chemical substances to which It may be exposed and would be able to participate fully under sections 20 and 21 of TSCA. Any person proposing td manufacture a chemical substance'would be able to look at the inventory and determine whether the chemical substance .was an existing chemical substance with a commercial purpose. If the substance appeared on the list,there would be no premanufacture-notiflcation requirements under section 5(a) (1) (A). If the sub- stance did not appear on the list,theperson would know.jt was a "new chemical substance." The Agency could conduct its investigation of all chemical substances in open public forums. However, were EPA to publish all chemical substances reported to EPA on the inventory, some persons submitting the inf~rmation would suffer com- petitive harm when the fact that certain chemical substances have a commercial purpose was published.

Were EPA to give full effect to section 14 and publish a list of only those chemical substances for which the fact of manufacture or processing for commercial purposes
was not confidential, the public would have

no information about those particular confidential chemical substances to which it may be exposed. The Agency would have to conduct its investigation of some chemical substances fn camera..A manufacturer proposing to manufacture a chemical substance that did not appear on the list would not know whether the substance was a new chemical substance. Therefore, the manu- facturer would be forced to give premanufacture notification under section 5(a) (1) (A). If, in fact, the chemical substance had been reported for the inventory list, and, therefore, wasnot a new chemical substance, this new manufacturer would be placed at

a competitive disadvantage by having to delay manufacture at least 90 days.

EPA has adopted the approach set out In §710.7 of these regulations to balance the

concerns of section 14 with those of sections 8(b) and 5(a). In choosing this approach. EPA looked to TSCA for guidance. It Is clear that Congress intended section 5(a) (1) (A) premanufacture notification to apply only to chemical substances which are not currently manufactured for a commercial purpose. Congress created the section 8(b) Inventory for the express purpose of determining this class of chemical substances. Congress did not seem to contemplate that the fact that certain chemical substances are manufactured or processed for commercial purposes would be claimed as confidential. Congress was clear In section *14that confidentiality should be preserved
to the maximum extent practicable without Impairing the regulatbry scheme of TSCA. The approach EPA has adopted preserves confidentiality to the maximum extentpracticable while allowing the section 8(b) inventory to perform Its regulatory function for purposes ofsection 5(a) (1) (A), premanufacture notification.

EPA will allow any manufacturer or processor submitting information to EPA under thisrule to claim that a particular chemical substance should not be included on the inventory of chemical substances because the fact thatthe chemical substance s man- ufactured or processed for commercial purposes in the United States is a confidential trade secret. EPAwill make a final confidentiality determination in accordance with the procedures in 40 CFR Part 2, Subpart B, If the fact that a particular chemical substance is manufactured or processed for a commercial purpose in the United States iconfidential, a generic chemical name will be included in an appendix to the Inventory; if It Is not confidential, after 30 days notice to the submitter, the chemical Identity w1il be included on the inventory. If any pe Mon re- ports a particular Identity and does not claim It as confidential EPA will place the Identity onthe Inventory.

Section 710.7(e) provides that a person claiming confidentiality for the specific chemical identity must provide a proposed generic chemical name to EPA. The proposed generic name must be onlyas generic as necessarytoprotect the identityoftheparticular chemical substance. Pursuant to I710.7(f), EPA will review the proposed generic name. If the proposed generic name Is not acceptable to EPA, EPA will consult with the submitter concerning alternative names. EPA may choose a name proposed by the submitter or a name proposed by EPA. In the latter case, EPA will notify the submitter 30 days in advance of publishing the final choice, during which timethe submitter may seek ajudicial remedy.

Placement of the generic name In the appendix to the inventory will cerve two purposes. First, the public will know the generic types of confidential chemical substances to which It may be exposed. The public will be able to use this knowledge to participate In accordance with sections 20 and 21. Second, a manufacturer who is proposing to manufacture a substance not Included on the inventory by name will be able to see whether the substance Is described by one ofthe generic names. If It is not,It Is a "new chemical substance," and the manufacturer must submit notices under section 5(a) (1) (A) at least 90 days priorto manufacture. If the substance does fall within one of the generic names, the manufacturer could come to EPA. show a tona fide intent to manufac- turethe substance, and be Informed whether the specific proposed substance was Included

on the Inventory. If It was, the manufacturer would be able to begin manufacture without delay. If It was not, it would be a "new chemical substance," and the manufacturer would have to submit notice under section 5 at least 90 days prior to manufacture. No person may manufacture a substance within a generic nameunless EPAhas notified the person that the particular substance is included in the Inventory.



### To determine whether or not such a man- ufacturer has a bona fide intent tomanufacture the proposed chemical substance, EPA will require the manufacturer to submit a statement ofpretent Intent to manufacture the particular chemical substance, including

a descriptionofthe research anddevelopment activities to date and the purpose ofmanufacture. In addition.EPA will require an elemental analysis, either an X-ray diffraction pattern ofthe substance (for inorganic substances) or a mass or alternative spectrum of the substance (for other substances), and
any additional spectra or data. Including a sample of the substance in its purest form, that may beretlulred toresolve uncertainties with respect totheidentity ofthe substance. At thetime such an Inquiry is received, EPA will contact the original submitter and ask for an elemental analysis andeithera mass or alternative spectrum or an X-ray diffractio pattern ofthe substance. Further, additional spectraor data mayberequiredtoresolve uncertainties withrespect tothe identityofthe substance. EPA may require a.sample ofthe substnce in Its purest form for compariso with that submittedbythe Inquiring manufacturer. Section 710.7(e) pro-Ades that any peon aserting a claim of confidentiality mut agree to make such information availabletoEPAupon requestandmustagree that EPA may disclose the fact that the specific chemical substance is ncluded onthe inventory to a manufacturer with a bonafide Intent to manufacture the substance. (Failure
to to aZree orto furnish requested data reEults in waiver of the claim of confIdenti

### ality.)

If EPA determines that the manufacturer has a bona fide Intent to manufacture the substance, EPA will disclose whether the substance In question is on the inventory. EPA cientists will compare the technical data submitted by the inquirer with that prepared by the manufacturer of the confidential chemical substance to determine whether the data from bothEources aresufficiently similar to be consistent with a presumption that the chemical substazces are thecame. If EPA determines thatthe mannfacturer'has not shown a tona fide intentto manufacture the substance.EPAwill notdisclose whether the substance is onthe Inventory. The manufacturer will then have the choice of supplying further Information to EPAtochowboa fide Intentto manufacturer the substance or of submitting premanufacture notification under section 5(a) (1) (A).

This approach will place some burden on manufacturers to come to EPA to show a bona fide Intent to manufacture. However. this burden s less than the burden of section 5(a) (1) (A) premanufacture notification. Anymanufacturer whodoes have a bona fide Intentto manufacture a particularsubstance should know the information required to 

### show thatintenttoEPA. This approach will diccourage fishing expeditions by persons without a bona fide intent to manufacture and thereby protect trade secrets from disclosure to competitors. EPA dos not view disclosure to a bona fide nianufacturer to be a disclsure In violation of section 14. The trade secret that I- being kept confidentlal is that the particular chemical substance is manufactured or precesed for commercial purposes in the United States by anyone. If the Inquiring manufacturer shows a bona fide intentto manufacture the particular substance, the manufacturer al

### FEDERAL REGISTER, VOL 42, NO. 247-FRIDAY, DECEMBER 23, 1977 

## 64591

HeinOnline -- 42 Fed. Reg. 64591 1977

## RULES AND REGULATIONS

ready knows that it can be manufacture, for a commercial purpose. Telling the man. ufacturer that the substance is on the in. ventory does not reveal anything except tha'

someone else already found a commerca purpose for the substance.

Maintaining specific chemical Identities a confidential for purposes of the Inventor, has Impacts beyond those on sections 8(b] and 5(a). It is conceivable that the Agence will decide to direct a section 4 testing rub to a confidential chemical, that the Agencl will decide to promulgate a section 5(a) (21 significant new use rule on a confidentisa chemical, that the Agency will decide to pro. mulgate a section 8 reporting rule on a con. fidential chemical, and that proceedings un- der section 20 and 21 of the Act may pertair to confidential chemicals. The Agencyintend, to honor the confidentiality of specificchemical identities to the extent practicable with- out Impairing the Agency's abilityto perform Its duties under TSCA. This means that EPA may have to balance confidentiality with other TSICAneeds at future timesunder othez rules. TSCA section 14 (a) and (b) directs the Administrator to disclose information otherwise entitled to confidential treatment in certain circumstances. The Agency intends to rely onthese authorities to the fullest ex- tent provided bylaw.

A determination that an identity is confidential forpurposes of theInventory maybe reviewed if new facts suggest that confidential treatment is no longer appropriate. Comment 94: Requiring substantiation at the time of submission of a claim that the Identity of a chemical substance should not be placyd on the Inventory is overly burden-

some. Such substantiation should only bere- quired when necessary to respond to aFreedom ofInformation Act request.

Response: The Administrator disagrees with this comment. The requirement in TSCA section 8(b) that the Agency publish

an inventory of chemical substances re- quires the Agency to make individual final determinations on the entitlement of the identity of a particular chemical substance to confidential treatment under the test of 5 U.S.C. 552(b) (4) before publication of the initial Inventory. Under the procedures of 40 CFR Part 2, Subpart B, this determination is made on-the basis of the substantiation of that claim provided by the person asserting the claim. In order for EPA to re- view, prior to publication of the initial inventory. IIl claims that the identity of a chemicaltubstance is entitled to trade se- cret protection, substantiation of the claim must b: submitted when the claim is as- serted. Failure to submit substantiation of such a claim will be a waiver of the claim.

Comment 95: The statements for sub. stantiating a claim for confidentiality on proposed Form C are too restrictive. A com- pany must be allowed to state for Itself the basis of its claim of confidentiality.

Response: The Administrator agrees with this comment. Any submiltter claiming that the identity of a particular chemical sub- stance should not be included on the inventory must substantiate that claim. The substantiation must be in the form of a let- ter attached to Form C stating the submitter's basis for Its claim of confidentiality,and addressing a list of questions specified in the Form C instructions. The burden for substantiating a 'claim that the particular chemical identity should not appear in the inventory is greater than that for substantiating other confidentiality claims under the Inventory because of the increased burden that will be placed on the public and future manufacturers under section 5(a), Ir not knowing all of the specific chemical IdentiI ties reported for the inventory. Accordingly

- companies should be very careful in claimIng that specific identities- are entitled tc confidential treatment. I Comment 96: EPA should accept the gethe generic chemical name is too broad oi

s misleading request the submitter to modify 7 the generic name. EPA should not substitute I its judgment. EPA should not substitute it,
y judgment for that of the submitter. Response: The Administrator disagrees with this comment. Submitters will have an interest in submitting the broadest generic L names possible. Since-EPA is balancing competing considerations of confidentiality, the public's right to know, and the Interests of manufacturers under section 5(a), EPA must take an active rolein choosing a generic name that Is only generic enough to protect the trade secret identity.

If EPA agrees with the generic chemical

name proposed by the submitter and the chemical identity has been found to be confidential for purposes of the inventory. EPA will place the proposed generic name in an appendix to the inventory. If EPA believes that the generic name Is too general so that It will not serve the purpose of Informing the public and future manufacturers under section 5(a). EPA will consult with the submitter concerning more restrictive names. If EPA and the submitter areunable to agreeon the generic name. EPA will choose a generic
name, notify the'submitter of the choice at least 30 days before inclusion on the inventory. The submitter may seek a judicial remedy under section 14. Unless a court Intervenes, after the end of the notice period, EPA will place the generic name on the list.

Link ofCompanyNameto ChemicalIdentity

Comment 97: The fact that a certain company manufactures a particular chemical substance-may be a confidential trade secret. EPA should not publish company names on the inventory.

Response: The Administrator agrees with this comment. Section 710.7(a) permits a manufacturer, importer, orprocessor toclaim that the link between the name of the manufacture. Importer, or processor with a particular chemical substance Is entitled to con- fidential treatment. The-8(b) Inventory will consist only of a list of chemical substances reported to EPA. It will not include any information concerning which companies re- ported the chemical substances. A claim that

a particular chemical Identity should not appear on the inventory (see comment 92) should not be made if the only confidential trade secret is the link between the company name and chemical identity.

If a claim of confidentiality is asserted re- garding the link of company name with a particular chemical substance, it will be disclosed by EPA only to the extent permitted by, and by means of the procedures set forth In 40 CFR Part 2, Subpart B.

Production data

Comment98: Site specific production data may be a confidential trade secret.

Response: Section 710.7(a) recognizes that production data may be entitled to con- fidential treatment and permits persons re- porting production volumes to the Agency to assert a claim of confidentiality. Section 710.5(d) (4). of these final regulations re- quires companies to report broad production ranges, rather than the more specificproduction volumeswhich would have been required by the August 2, 1977 propbsed rules. This should eliminate the need for many claims of confidentiality.

Comment 99: Does EPA plan to publish asgregates of data from the inventory, espe- cially confidential data? If so. in what way will EPA protect the confidential data? * Response: EPA is considering alternative W

ays of publishing aggregates of production and other data submitted for chemical substances. However, before EPA publishes any

- aggregation that includes data that have

r beenclaimed as confidential. EPA willdevelop aggregation procedures designed to protect P the confidentiality of the underlying data and will publish these procedure for public
comment.
NationalSecurity Information

Comment 100: Some Information requirel by these regulations may be entitled to confidential treatment because of national security reasons. How will EPA handle =turtions of confidentiality on these groundg?

Response: Section 22 of TSCA states that EPA "shall waive compliance with any provision of this Act upon a request and dotermInation by the President thatthe requested waiver is necessary In the interest of national defense." The President has, not requested that any walver be granted with regard to the Inventory regulations. Accordingly, any person subject to the reporting requirements of these regulations must report any substance subject to these regulationm

even if that substance is being made for national defense purposes. Production for national defense purposes is a commercial purpose as defined In these regulations, Any person reporting under these regullItlons
must report all information required to be reported concerning sites, production, etc., regardless of whether that informatlon relates to national defense.

If a person required to report under these regulations would be reporting information that 

### iS or may be classified as national defense information under Executive Order 11652, that person should not report to CAB Instead, the person must contact Kenneth Olsen, Office of Toxic Substances. EPA. 401, M Street, SW., Washington, D.C. 20460, by letter stating that the person may be required to report classified information to EPA under these regulations. Do not report the classified Information to EPA
at that time. EPA will tend the person a letter with specific instructions how to proceed. This will include forwarding the information to the particular Systems program office that is managing the particular work. involved. The systems program office will examine the specific Information and mark It with the appropriate classification, The information will then be sent to EPA where it Will be kept in a special system senarate from the remainder of the inventory Information. EPA will have art office with personnel authorized toreceive and use classified Information.

Please note, if the information in question is also considered to be confidential business information by the personsubmitting it, that person must assert all claims ofbusiness confidentiality at the time the information is submitted to EPA In accordance with these regulations and the Instructions on the forms.
Freedc;m of InformationRequests

Comment 101: How will EPA handle Freedom of Information Act requests for the confidential Information submitted under these regulations?

Response: EPA will allow submitters to claim any item ofinformation submitted to EPA under this rule as confidential. The re- porting forms are designed to allow all con- fidentiality claims to be made by checking boxes on the forms. In addition, the certification statement has been,written to allow

a submitter to substantiate all claims of confidentiality, except chemical identity, on the reporting form. By using this approach, EPA intends tominimize the need to goback

•FEDERAL REGISTER, VOL 42, NO. 247-FRIDAY, DECEMBER 23, 1977 

## 64592

HeinOnline -- 42 Fed. Reg. 64592 1977to specificsubmitters to require them to substatlate confidentiality claims.This willenable EPA to deal more effectively with the anticipated large volume of Freedom of Information Act requests that will be received under TSCA.

.

All information submitted under these rules will be computerized. All confidential information (except confidential Identities) wil be specially coded If a claim of confidentiality vs made and substantiated at the time of submission.

WhenEPAreceives FOIS requests,EPAwi
prepare a computer print out of the nonconfidential information requested; that Information will be disclosed to the requester. The computer will then print out the requepted confidential information. The requester will receive an initial denial of the request for any confidential Information in accordancedwith the procedures In 40 CFR Part 2, Subpart B. EPA wi then make a final confidentiality determination, inform the requester of the decision, give 30 days notice to the submitter if the -determination is that the Information is not entitled to confidential treatment, and then disclose any non-confidential information.

EPA will not have computer access capability until at least 6 to 8 months after the end of the initial reporting period. During that period the Agency will be processing submitted information. The actual forms submitted to EPA will not be filed in a retrievable form. If EPA receives FOIArequests prior to the end ofthe processing period it will be virtually impossible tosearch for the requested Information. Consequently, EPA requests that FOIA requesters refrain from making FOTArequestsforinventory information until the end of the processing period.

In some cases, whien responding to FOIA requests. EPA will be forced to give uninformative denials.If a requester asks a question in such a waythat t6 answer the request would reveal confidential information. EPA will answer the request in the following fashion: "Your request Is denied either because the records yourequest are entftled to confidential treatment under 5 U.S.C. 552(b) (4) and EPA may not disclose them under section 14 of TSCA, or because no such records exist.' The requester will have a final EPA denial and will be able to go to a Federal districtcourt toseek furtherreview. Whe -confidential information will be protected, pendingthisreview. Confidentiality Procedures andSecurity

- Comment 102: How will EPA determine

the entitlement of information to confidentialtreatment; whatprocedures willit follow
to ensure that confidential information is
notdisclosed?

- Response: The Agency's business confidentiality regulations are contained at 40 CPR Part 2, Subpart B. These regulations willbe amended to take into account specific modifications required by TSCA section 14. such as the extension of the notice period to 30 days. The basic approach for determining confidentiality will not change.

EPA has estabillhed a Task Force to recommend procedures to the Administrator to provide for the security of confidential Information submitted to EPA under TSCA. TheTaskForce will work quicklyso thatEPA will have procedures adopted by April 30, 1978. the end ofthe inventory reporting period. The Task Force will hold several public -neetings andwill publish proposals forpublice,comment. The final security procedures will be published.A more detailed discussion of the work of the Task Force appeared in 

## RULES AND REGULATIONS

the FlEDEum E mxs-, 42 FR 57984, November7.1977. Access to Confldentt l Informationby States

Comment 103: EPA should allowaccess to confidential Information by the states.

Response: EPA does not have generar au- .thority to disclose confident'l TECA Information to. the States. Section 14(a) lists the parties to whom confidential information may be disclosed. In certain circumstances, EPA may discloce confidential In

# 64593

formation to otherFederal agencies, to CA contractors, when relevant to a proceeding under TSCA. or when necesary to protect health or the environment against an unreasonable risk of injury. Accordnglb confidentlal information may only be disclosed
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