# I I

28736 Federal Register / VOL 58, No. 92 / Friday, May 14, 1993 / Notices {,

ENVIRONMENTALPROTECTiON AGENCY
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RIM2070-AC3t

TSCA Sactfon 4(a)(l)(B) Final Statement of PotIcy; C2ftarta for EvaluaWg Substantial Productl~ Subetantlat Relaaaa, and Substantial

or Slgniflcant Human Expouura

AGENCY:

Environmental protection Agency (EPA), ACTION: Final Statement ofpo]icv.

SUMMARY:

EPA is articulating standards” and criteria formaking findings itwill

usein implementing its authority under the Toxic Substances Control Act (TSCA) aectfon 4(a)(l)(B)(i). Under this policy, EPA will use as guidance threshold amounts to make “substantial” production, reiease, and” human exposure findings under TSCA section 4(a)(l)(B). However, EPA may also make.such findings in situations where the quantitative numerical thresholds are not met ifadditional fwtors exist, EPA will continue to develop and refine the criteria as its experience with chemical substances and mixtures (chemicals) considered for testing evolves, particularly wi”&wgmd tothe findings of“significant” human exposure, forwhich EPA is not establishing a minimum numerical threshold in this notice, This notice also addresses 8peciflc issues related to EPA’s existing cumene test ru]e (July27, 1988,53 FR28195), FM FURTNER

INFORMATION

CONTACT Susan % Hwen, Director, En*L-onmental Asbistrmce Division (TS 799), Offim ofPollution Prevention and rxxics, rrn. E-543B, 401 M St., SW., Washingtori, DC 20480, telephone: [202) 554-1404, TDD (202] 554-0551. SUPPLEMENTARY

INFORMATKM: Electronic Availability This document is available as an electronic fileon “The Federrd Bulletin Board at 9a.m. on the date ofpublication in the Faderaf Register. By modem dia] [202) 512-1387

or call (2o2) 512-1530 for disks or paper copies. This fileis also available in Postscript. WordPerfect and ASCII. EPA is articulating guidelines for findingthat “a chemical substance or mixture isorwill be produced in substantial quantities, end [1)it entera or may reasonably he anticipated to enter the environment insubstantial quantities, or (IIIthere’is or may be significant orsubstantial human exposure to such asubstance or mixture,” under TSCA section 4(e)(l) (B)(i]. In Chemicaf Manufacturers

,.. . .’

-. :..

., ... - -,. Association v. Environmental Protection Agen
, 899 F.2d 344 (5th Cir, 1990), the F%ICircuit

CourtafA~ti(the “Court”) remanded to EPA erule issued pursuant to 4(a)(l)(B) forcumene testing and required EPA toarticulate mitena forthe findings EPA made inthe

cumene test ruhr(53 FR28195, July 27, 1988). EPA hSS decided to use this opportunity to articulate criteria for making 011findingsunder aect50n 4(a)(l)(B)(i) ofTSCA. This notice dam not address how EPA wfll setpriorftiet.for testingor how EPA will determine thes cffictasts to be performed. Rather, t& notkxraddmasas

one element inEPA’s process for selecting appropriate candidate frfr testing

— i.e, how EPA will determine whether the chemical is Or will be “produced Insubstantial quantities,” whetfwr it “enters ormay maaonably be anticipated to enter theenvironmwt jn substantial quantititis,” and wlmther there is or may be ‘“significaritor ~ substantial human exposure,” as used in TSCA aedion 4(a)(l)(B)(i).
T.Introduction
A. Remand On April 12,1990, theFifth Circuit Court ofAppeals remanded to EPA the TSCA section 4test rule forcumene based on achrd]engetotbe ruleby the C&mid Manufacturers Assrxiation (CM/l). CMA V. EPA, 899 F.2d 344 (5th Cir. 1990) ~%ereinafter %umena decision”). The Court generally upheld EPA’s factual fipdings inthenda as beingsupported by substantial evidenra butinstructed the Agency to “’articulate the standards ofcritmia on thebaais of which itfound the quantities ofcumene enterfng the environmentfrom the faciIitieain question to he ‘substantial’.” 899 F.2d at 360, Inthis notice, EPA is articulating standards and criterfaitwill

use in making findingsunder section 4(a)(l)(B)(i) ofTSCA. Additionally, EPA is responding t~ the instructions bythe Court ~arding the application ofsuch criteria ;0the cumena rule.
B. Background Congress enacted TXA togiveEPA the authority to assess and prevent unreasonable risks gasociated with the manufacture, processing, distribution in commerce, use, ordisposal ofchemicals through avariety ofregulatory means. ” 15 !_!.s.C 26oI. etseq. Thisauthority includes, among other thin= tha authority to require chemical taiting to develop data forrtsk sssessmtrrrt, H LJ.S.C.2603, and theauthority

~ ~ chemicals ifnecessary to prwwnf unreasonable risks. 15 U,S.C. 2605. A principal tenetunderlying TSCA is that “adequate data should be developed with respect to the effectofchemical substances and mixtures on health and the environment and that the development ofsuch datashould bethe

res onsibility ofthose who manufacture 1 an those who process such chemical substances and mixtures.” 15U.S.C. 2601(b)(l). See ChemicaJ Manufacturers Association v, EPA, 059 F.2d 977,980 (D.C. Cir. 1988) (hereinafter “EHA decision”), To accomplish this goal; EPA has established aprogram forthe testing ofchemicals. EPA must make findings under either section 4(a)(l)(A) (“A” finding) or 4(a)(l)(B) (“B” finding) ofTSCA before testing may herequired ofa manufacturer or processor. Boti’the “-A” and ““B’.’

findings under TSCA section 4(a)(l) require the Administrator to find that “there are insufficient data and experience upon which the effects ofthe manufactlw, distribution in commerce, processing, uyr, or djsposal ofsuch stibstance ormixture or any combination ofsuch sctiviiies on health

or the environment can reasonably be determined or predicted,” and that “testing ofsuch substance or mixtum wfth respect to such effects is necessary to develop such data.’* 15U.S.C. 2603[a)(l)(A)(ii)+ iii) and 2603(a) (l)(13)(ii)-(iii).
. To require tinting under section 4(ti)[I)(A) d TSCA the .%dministrator mturtfind that “the manufacture, distribution in commerce, processing,
use, or disposal ofIS

chemical substance

ormixture, or that any combination of such activities, may present an unreasonable risk ofinjury to health or the environment” (emphasis added), h theEHA decision, tho Court found this provision to require EPA to establish a “more than theoretic-l basis” forfinding thatthe chemical may pmsant an unreasonable risk, but that EPA could establish existence and amount of human expusure to the chemical on the basis ofinference drawn from circumstrmces undar which the chemical is manufactured and procassed, 859 F.2d at991. This interpretation ofthe statute “prevents a z testing rule based on little more than scientific curiosity, yet allows the. .Agen.cyto act when an existing

i pos ibility ofharm raises reasona~le,

an legitimate cause f~i concern,” Ausfmont U.S.A. v. E~A, 838 F.2d 93. 97 (3rd Cir. 1988). In contrast toTSCA section 4(a)(l)(k,’ under TSCAsaction 4(a)(l)(B), thereis

no risk-based criterion la satisfy, Sea 899 F.2d at 347, n.d (cumene decision). According to tha legislative historyi tits:.

~--‘“

~~ provisions ofTSCA “saction4(a)(ll(B)(i)-. ~.

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,. . ... ..,..~..Federal Register I Vol. 58, No. 92 / Friday, May 14, 1993 ) Notices 28737

there are certain situations in which teeth should be conducted even J thou there is an absence of information indicating that the substance or mixture per se may be hazardous,” H. Conf. Rept. 1679, 94th Cong., 2d seas. (1976), at 61, reprinted in A Legislative History of the Toxic Substances Control Act (Comm. Print 1976) (“Leg. Hist.”) at 674; and H, Conf. Rept, 1341, 94th “Cong., 2d S6ss. (1976), at 18, reprinted in Leg. Hist,, at 425. Thus, under section 4(a)(l)(B) ofTSCA, EPA can act even in the absence of information that the chemicol maybe hazardous. Section 4(a)(l)(B)(i) requires the Administrator to find that “a chemical substance ormixture is or will be produced in substantial quantities, and (I)it enters m may reasonably be antidpatod to enter the environment in substantial quantities, or (II) there is or may be significant or substantial human

ex osure to such substance or mixture. ” fhis poIicy statement sets out EPA’s interpretation of section 4(afil)(B)(i) of TSCA. This notice is not intended to

~ address EPA’s preliminary policy decisions for selectin chemicals as t potential candidates or testing. Likewise, it is not intendad to iiddress findings made under TSCA sections 4(a)(l) (B)(ii) or (iii), or the scope of testing that may eventually ‘beimposed by EPA. It is only intended to articulate the standards and criteria EPA wil} use in implementing its authority to make findings under TSCA section 4(a)(l)(B)(i). To this end, FiFA”published in the Federal Register on July 15, 1991 (56 FR 32294), its proposed statement of policy regarding section 4(a)(l)(B)(i) of TSCA. EPA uested comments on its

? construction o the phrasea “produced in substantial quantities,” “enters or m“ayreasonably be anticipated to enter the environment in substantial qu@ities,” and ‘“isor may be significant or substantial human exposure” as used in section 4(a)(l)(B)(i) ofTS(X.

“’ C. The “B”Policy section 4(a)($)(B)(i) ofTSCA requires the Admirdstrator to find that a chemical substagce or mixture is or WiII be produced in tyhtantial quantities, and “(I) it entem,or may reasonably be anticipated to enter the environment in substantial quiytities, or (If)there is or may W@nificaqt or substantial human expwuy to such substance or mixture,” to impoag testing requirements. However, TSCA does not define the statute is silent or ambiguous on a particular issue, deference is accorded to any reasonable interpretation consistent with the statutory purpose. Chevron USA, Inc. v. EPA, 467 US. 837, 842-$44, (19@; A?RIX V. EPA, 907 F.2d 1146,1153 (D.C Cir. 1990). The Fifth Circuit Court ofAppeals recognized this prind le when reviewing the cumene
r test rue. Acc&din to the Court, where

% TSCA and its Iegis tive history provide

no definition ofa term such as ‘ “substantial,” “Con~ iS d~m~ to have implicitly delegated to the EPA the power to define or inte rat

w? ‘substantial,’ and we “1sustain the Agency’s interpretation as long as it is rational and consistent with the statutory scheme and legislative
:%JK?&%K%!h%i,yhpmi.

● ● ● no definition orgroup of crite;a can beestablished which will function like amathematical ibrmula, so that forevery %iven

satoffactsaspecific, proctictable,answer till always be forthcoming. Roommustbeleftforthe exerciseofjudgment. Id. af359. Clearly, there is nothing in the ‘statutory language or legklative hiitory that restricts the Agency’s allowed interpretation of“substantial” or “siWificat” to considemtion of particular quantities ofor other evidence relating to production, release,

or exposure. In fact, Congress provided

a list of factors which may w may not be considered by EPA in making TSCA seilion 4(a)(l)(B)(i) findings. H. Rept. 1341, 94th Cong., 2d sass. (?976), at 18, reprinted in Leg. Hist., at 425. SW also

cumene decision, 899 F.2d at 356, n.16 (“Morecver, the quoted hmguage in H. Rept. 1341 ● ● * is permissive and expansive in respect to what the EPA may consider and when it may require testin under section 4(a)(l)(B) ● ●

### ● “). 1“ In Mstatement ofpolicy, WA is exercising its discretion by articulating quantitative thresholds to serve as guidance in making findings of “substantial” production, releasej and human exposure. “Significant” human exposure findings till be made on a case-by-case basis. As explained in the proposed policy statement (56 k ‘ 32294), it is EPA’s belief that EPA may make findings under section 4(a)(l)(B)(i) of TSCA based on quantitative thresholds. However, EPA doea not intend to limit itself to the use ofthese criteria in making “B” findings and

reserves the ability to consider other. facto= on a case-by-case basis. Such an interpretation is consistent with the developing adequate data with respect to chemicals and making the development of that data the responsibility of chemical manufacturers and processors. Il. Raapense to Public Comments
A. Smrunory
EPA received written comments on the proposed statement ofpolicy ffom the Chemical Manufacturers Association (cMA), the Epoxy Resin Systems Task Group ofThe Sodety ofthe Plastics Industry, Inc. (SPI), the Monsanto Company, the Ecological and Toxicological Association ofthe Dyestuffa Manufacturing Industry (ETAD), the Callery Chemical Company. the Halogenated Solvents Industry Alliance (IISW), the GAP chemicals ““ Corporation (GAF), the BASF Corporation (BASF], the Arco Chemical Company (ACQ, the U.S. Department of Labor’s Occupational Safety and Health Administration (DOIJOSHA), and the U.S. Department of Health and Human Service’s FJational Institute for Occupational Safety and Heahh (HHS/ MOSH) (Refs. 1-9). CMA’S Acetone and Ketones panels, Oxo Process Panel, CUinenu Panel, Cyclohex&ie Panel, and Hwmmethylena Diiosocyanate Panel, and the Die’hyl Ether Manufacturers Task Group (Refs. IO-15) also submitted comments which supported, in general, the comments submittttd by CMA. These commenters),

are collectively referred to as “cMA” hereafter in this notice. comments

. submitted !)ythose groups which are specific to a proposed test rule for a specific chemical will be addressed, as appropriate, in the 5na1 rule for that specific chemical. Those rules will be published in the fotum. The comment, periods were reopened for proposed test rules fo~Office ofDrinking Water Chemicals (55 FR 21393, Miiy 24, i990), Cyclohextie (52 FR 19090, May ZO, 1987), 1,6-Hexamet.hylene, Diisocyanate [54 FR 21240, my 17, 1989), and Nmethylp~olidone (55 FR 11398, March 28, ,1990); See 56 FR 32292 (JU]y 15,

, 1991). A summary of tha Commenw.. received on the TSCA section 4(a)(l)(B) proposed statement ofpolicy is included in the following Uniti ILB. -ILG.; along with BPA’s responsea to.. comments. .- B. Scope of Testing
CMA and other cornmentera havti ~, ‘ expfessed the con”iwm that, #ven me. criteria articulated in this notice,-. .‘.

-28738 Federal Register / Vol. 58, No. 92 I Friday, May 14, 1993 / Notices

misinterpreted the intended and actual scope of this policy. The “B” licy is K not intended to be, nor will it used

as an automatic trigger to testing. Nothing in tlds policy will require EPA to immediately review any of the chemical substances currently in
commerce, Rather, this policy statement sets out EPA’s inte rotation of the findinga it must a under section 4(a)(l)(B)(i] and the general factors EPA will consider in evaluating se@ion 4(a)(l)(B)(i)’s applicability in specific

cases. This pnlmy statement is not intended to function as a tool for setting testing priorities. Testing riorities will ! be set by BFA’s ongoinge C@ in developing a Master Teatin List. This t%e list was made available to “ EPA’s Chemicala-i.n-ProgreSS #&!&in (@e, 1990). See ahw 58 FR 42055 (Aug. 26, 1891) for further inibrrnation, Many respondents, including CMA, have indicated their tacit au port for the J thrashoId criteria articula in this policy noti~ so long as “B” findings aremadeordyineu portofrules

ml requiring only tie

~~ level or “baseline testing” of chemical substances (tit 1).
~ 0PPOS9S utilizatkm ofthe “B” policy criteria, and ind@ use ofEPA’s section 4(a)(l)(B) testing authority for any other level of testing. On the policy as a whole, CMA commented that EPA% proposed criteria under TSCA saction 4(a)(l)(B)(i) are reasonable as a basis for requiring screening testa such as the Screening ‘ bformation Dab’ Set (SIDS) utilized by the Ormmizstion for Economic ‘$ Coope&tion and Development (OECD) for high reduction volume

~ chemi c$?

. CMA stated, “EPA’S proposed ‘B’ criteria would provide a suitable basis for sekting substances for such screening tests’” (Ref. 1). CMA proposed that, if scrwning studies reveal tlw

r ential for adverse effects, then EPA cndd add the chemicnl to a subsequent proposed rule under the SiihOTity of

~ -on 4(a)(l)(A)~ tie “may present” findin

. CMA proposed f that, in the absenca o toxicity concerns, EPA should require additional testing only if it concludes that exposure is “unusually great.’! CMA argued that
mw rigOTOUS

“B” criteria; which teke into accopnt all must be develo such high exposure substances for additional testing.

~ stated that it would not oppose EPA*s critefia ifthpy

wera incn ted into the @red

r ‘“ approadt eicribed above. CMA would environmental releases, the Agency should limit rules supported by such findings to chemical tisteand environmental eftbcta testing” (Ref. 1). EPA believes that any linkage between the particular numerical threshold criteria articulated in this policy statement, or the particular findings made under TSCA section 4(a)(l)(B)(i), and the nature and scope of testing to be required once such a finding has beexi made, is misplaced, and indeed, based on a misinterpretation ofthe scope ofEPA’s testing authority under section 4 of TSCA.

. TSCA section 4[a) states (a)TESTINGREQ~.-If the Administratorfindsthet- [l)(A)(i) themanufactum,distributionin commerce, pr_uaa, Or-Ofa chemical substanceormixtnra, orthatwy combinationofsuch actlvitias, maypresent
anunreasonableriskoftnjurytohealthorthe environment, (ii) thereareinsufiiciant&ts and experienceuponwhichthaeffectsofsuch msnufiwtura,distributiontncouunerca, PmCXISSin&

use,ordhpoaat ofsuch substance ormixturaor ofsny~wntiti activitiesonimaithortheenvironmentcan reasonablybadeterminedorpredicted, and (iii)testingofsuchsubstanceormixture withraspecttosucheft%cts tanamssaryto devalopsuchdetIN

m (B)(i) achemical aubstencaormixturs isor will beproducedinsuMantM quantities, and [I)itentersosMSySWSO06biy & anticipatedtoentertheenvironmentin substantialquantitiesor (IIIthereisormay bssignificantorsubstantialhumansxpoaure tosuchSubstanceorrnbdum, [ii) thereareinsufficientdataand experienceuponwhich theeffectsofthe manufacture,distributionincommerce, processin~ use, ordiapoaatofauch substance

ormixture orofsny combination ofauh activitiesonhealthmthaanvtronmantcan reasonablyhad6tenninadorprsd!ct~ and (iii)testingofsuchauMance ormixturu withr8specttosucheffectsisnecessaryto cievalopsuch ds@ and ● ● ● theAdminikntrx shallbyrulerequirathat testingbeconductedonsuchaubataoceor mixturetodevelopdatawithrespectto the healthand environmentale- forwhich themisaninsufficiencyofdataand experienceandwhich amrelevanttoa determinatirin

thatthemsnufactum, distributionincommerce, prOcassin&use, or disposalofsuchsubstmca ormixture, orthat SOy combinationofsuch tlcthitim does or doesnotpresent anummmna& risk of injurytohealthorthaenvironment. 15U.S.C 2603(a) (amphasiaadded).
The final paragraph of section 4(a) sets out EPA’s authority to uire testing ? once the Agency has ma e the findings under section 4(a)(l)fA) or (B).The directive ofthis final paragraph clearly relates to the “data insufficiency” and ?+g isnecessa&’ fh&igs of ,,- z , sections 4(a)(l)(A)(ii) and (iii) &d (B)(ii) and (iiik it bears no dependence on or other relationship to the findings under either subsection 4(a)(l)(A)(i) or (B)(i), Thus, once the Administrator has made a finding under TSCA section 4(a)(l)(A)(i) that a subatanca may present an unreasonable risk, or under TSCA section 4(a)(l](B)(i) that a. substance is or will be produced in substantial quantities and may either enter the environment in substantial quantities or that there maybe substantial or significant human

ure to the substanca, the ~’nistrator may require any t~” of testing necessary to address unanswered questions about the effects ofthe substance. EPA need not limit the scope of testing required to the factual bases for the section 4(a)(l)(A)(i) or (B)(i) findings. Essentially, under TSCA section 4(a)(l)(B), EPA may require health effects testing even if it haa only made

a finding that there is or may be substantial entry into the environment ofa substance, ‘or7 uire environmental effects testing even i it has only made

a finding that there is or may ha substantial or si ificant human

r exposure to a su stance. Clauses (I) and (II) of section 4(a)(l)(B)(i) cm. be interpreted as mutually exclusive. See ‘

cumene decision, 899 F.2d at 357 n, 19. Either finding is sufficient to require testing, so long as EPA finds that data relavant to a d~termination ofwhether

a substance does or doea not present an unreasonable risk of injury to health or the envii-onment are insufficient end that testing is necessary to develop such data. It is the interrelationship of the e,xisting data set and numerous other substance-specific parameters, which

ure evaluated under subsections (ii) and (iii) of section 4(a)(l)(B), that determines the specific testing requirements, ifany, for a articular substance.

x EP notes, however, that while it has the authority to require testing for any health and environmental etlacts once it has made a finding under either section 4(a)(l)(A)(i) or (B)(i) of TSCA, the Act does. not compel EPA to require testing ofall health or environmental effects endpointa in all cases. Rather, once EPA has decided that it will require testing, EPA must also determine what data are sufficient and what testing is necessay in each particular case in promulgating specific testing requirements. In addition, once EPA has decided to require testing, EPA also considers, among other factors, “the relative costs ofthevarious test

protocols ● “’end the reasonably foreseeable availability ofthe facilities and personnel needed to

- perforin the testing required tinder tiff ;-. ~:. :.,, -. ., —.———.—- —- --------

Fedtd Reg&ter } Vol. 58, K@. 92 / Friday, May 14, 19931 F&Xicea 2tW39

rule.” TWA section 4(b)(l), 15 

## U.s.c thattheadatingdataadp=tind 2603(b)(l). sufficasaabasiaforkm~ Furthermore% if COmzmaabad ypredict thattherewilthanohealthorenvimnmeatal intended that &e W“g.requ& under ~@W *
~ --kw PIWXS@ section @a)f@)@)be dated to whether etc.)oftbachmnkxd, than affirmaths the findings ambaaedma information .

about human exposure or environmental rebaae, it is MM* to conclude that Congress wudcl beve used tbe word ‘OF fnstaad Of’’aud” when directing the Admfnistmtorta require testing “to develop data with respect to the health and environmental effects ● **” in tbe fine} pemgreph of section 4[&).However, the explicii choice oftbe word “and” b this final paragraph indicates tlmt congress authorized EPA ~reqwire health md envirorr~@ ffff%eta testing independent ofthe beak forcm(A)fi) or (B)fi}finding. Indeed, EPA has consistently interpreted the “testing is necaaaary” underTSGA sections 4(a)(l)@)(iii}d (B)(W) temearr that BFAmay requira any haekb or en ‘ ~efktat6atingbwhick&&

m inmffkkmt andvshkh H% balkmea are “capableofdaveAoping tbe~’ information“ & 4S FR 46510. 48s30 (July 18,1980~

EPA’s broad mandate torequire testing is tdso refkacted in the legislative history of T.SCA. sea H. Ropt. 1341, 94th Con& 2d Seas. (?97@, at 3-6. replintad in 1+ HiaL at 411+14. The breadtb of TSCAfa authority ta require testing is most apparant in TSCA section 4[a)(l)@) which, according to the Conference Report on TSC& authorizes FPA to r&@re tasting “even though theie is an absence of information indicating that the substance or mixtuM per se may ba hzerdous.” H. Conf. Rept. 167s 94th Gong., 2d Seas. (1976), at 6~ reprinted in Leg. fist. et 674. see also H. Rept. 1341, 94th Gong.. Zd

~ (1976L at I& reprinted in Leg. Wt. at 425. FinaQ. urn

the cumeme decision, the Court supported EPA’s interpretation mgarding.the relationship between the findin&Lunder TSCA SUh6SCtiOD 4(a)(l)(B)@ard subsections 4(8)(l)@)@] and (iiik A tln~undar $ackirm 4~)(l)(B)(i) does notelona

just@ ate+orrkm. Itintuit SKSO betbundrmdersacffon4(aJfl~B)(i~ that ‘therew inso.fB6i9nt

dataand axprfaDm u~wkfkh theafibcteof thernenufectum Fcm evidenceand5dfngs ofrfakofsuchin@ry athypotheticaltmdcityhrveKs undersectton 4(a)(l)(BHi) arenotmcaaary toprovldu.e nsxusbstween re@riag taotfng under

s- 4faXll(Et)and

~ ~== rbrhaalkhaadtia~

899 F.2d et 354-i55 (em&eeia in original). Ghremthat T!YX section

& 4(a)(l)[B)@ vesEPA aukhority to -h tastfng wan J&! information that e suhatmce is hszardous,ktiareaaoti -ti speci&&atinfJlA9 b@&*&@ the datainanf6~d_k

nec --waactiom 7 4(a)(l)(B land @i) mtkettbau to the mkmmmtd rolhaaeorlmmen :xPO- ffnd&rnad#lmdHSCA” 1

- 4(e)[lB~).
C SMktOrlt&rfhhti”oxr. EPA@opeedavaKmofl

- poumkas a threahnid level for findin~ of “SUbStaDtiS~ prodwtfon.” 56

~ 3229& Aa an aharnative to &ie threshold. EPA dfcftad comments on the adoption oftheTSCA section 5{eJ New Charn.kd Pr6gmrn’s axpowm—

. baaed aubatantfd production tbmaboId (i.G.,2z0,000 pounds)or some higher threshold (56 FR 32299). Both CMA and SETcommented ‘that EFA”aproposed production threshoki fs

a reasonable interpretation of “’substantial produ@”on” under TSCA section 4(a)(1)@) (Refis. 1 and 2]. However, according to CM& “[wJhiIe EPA’s approach is a reasonable cm% a pmktion thraabw of 2.2rniuion pounds wcmki bUpM&mbbS toachkve consistency

~ Ep#s
~~ under TSCA section 4 and the t3ECD HEWExisting Chemical Tasting Program” [ReE 1). CMA noted that for “pwpoawldmqscartahl

-~ types Gfstub EPA abo uses 2.2 million pounds 8s a pmductiork volume triggerinftsnevscheuliti~ un(irKTscA eactfcm5”wl}. wM quntitiae equal to Orgrester than

%%r<LYi%?%$ pofiCy,

-~ $-q tbad t4WtfIl$ (e.g., bioassay, Certafrt ~yk~&~h*

consumer lforthos8chem#cda @&~ amouBt30fur&Mm-e gmebm howevar, the substantial

~ considering t-under aecticm 5(e)@](A)@)@K)

ia ZQOOO

_ &f. 16~ EPAdieqyo&Wti~~V threshold woukkho amorereaaom& approach for the initieh threahoki under TSCAaectirm A’llMQHPV threshold was~ ~ different ~Q&& P’Waed tbreaboid h “auba&&d P~ “ Countrfes (h”&!!&-*i* countries) devebpad

~ fnvontorioa Oflrl?v Cbernfcala manuf&tured or imported into&air co@ri&3. Tbase in~ wmerged into a cOmpmhenafve fnventhry maintained by tbe OEQ and is called the OECD Ra 

# r~vf+~~’l?~. which incI es a.11

chermcaf,s (twaiudmg polymers and petrrdeum fiactioraa] reported in any member coun in 3 eXC6S6 Of~O~a tOM8S (~ “ OR pounds] and all chemfcalae k two or more countrfes in axcess Oflma tomes (2.2 miIlion pounds). Hencg the OECD HPV prwluti”on volume threshold ofZ.Zmillion mmde waa la conceived merdy to gui the generation ofnational invenkuieg which when combined would ykhf an intro-national list Ofhigh produm”olr volume chemicda. R was aaaurgad by 3ECD that the ‘on volume alone muidbeas cient hdi6ator OF @antial exposure such that the OECWs
., Xogram on misting Chemfcars has ‘mead since 1966 on the chemicals Ound on theorem F . The TSCA section 4 e)(l)(B~i~= ~f substantial

~ ie not ?he sob inding EPA must make to ttiro, 3 esting. Tlwthmaholdf#l

- cm pounds set fbrthbyBPA h ft.ls~.:- statement Ofpolicy f5s PR.32z94]hon0

- ofaewsd ffdings EPA ~EN&~ L..28740 Federal Register / Vol. 58, No. 92 I Friday, May 14, 1993 I Notices

chemicals and which is the only timer for entry into that program sho~ld

~ determinative of the threshold chosen for “substantial production” under TSCA section 4(a)(l)(B)(i). GAP, 13ASF,and ACC objected to the proposed threshold on two grounds. First, the proposed threshold value will involve subjecting 95 percent ofU.S. chemical production (on a total volume basis-n ercent on number of chemicals L is) to potential testing. They argue that because the threshold will encompass such a large percentage ofchemical production, the threshold reflects an incorrect interpretation of section 4(a)(l)(B) (Ref. 7). As previously explained, EPA has broad discretion in defining “substantial” and could choose a quantitative threshold at any point along a wide spectrum when consfb-uing the meaning of “substantial production.” For instance, if one were I to create a chart ranking fkom lowest to highest the aggregate production for all substances on the TSCA Irnmntory, EPA could interpret the term “produced in substantial quantities” narrowly to

1’ ap ly only to substances produced in

vo umes at the extreme top end ofthe chart. EPA could also choose to adopt

abroader interpretation, finding all chemical production to be substantial unless it fell below a value at the extreme low end ofthe chart, EPA has proposed a production figure in between the two extremes. The 1 million pound threshold for production

narrows the “univmse” of chemicals potentially subject to 

## ‘rscA section 4 testing under TSCA section 4(a)(l)(B) to 11 percent of the TSCA Inventory. Since that small percentage of the I.nventorj accounts for 95 percant of to!al chemical production, it i6reasonable to use this information as abasis for making a finding of“substemtial production” for substances producad in excess ofthat threshold. GAF, BASF, and A(X alsa commented that the 1 million pound threshold “will impose an unfair economic burden on chemical manufacturers and processors that could stifle technological innovation” (Ref. 7). This comment (which is unsupported by any empirical data) also appears to reflect a misunderstanding ofthe scope ofthis policy statement. Neither the “B” policy nor any

Earticular numerical threshold set forth erein institutes an automatic trigger for testing. Furthermore, this policy statement does not address the amount particular production volume threshold to believe based on a lower threshold would have any economic im act. Y alone that EPA would be overwhelmed, EPA does, however, careful y es Callery Chemical Company believes, consider the Potential economic imDacts bv adoDtion ofthe TSCA section 5 and tbe valui of testing data for all “ section 4 test rules. For each chemical subject to testing, EPA conducts an analysis which estimates the costs of testing. In addition, EPA considers any comments received on the economic effects ofproposed testin requirements f when developing 5a.1 m es under section 4, and may revise testing requirements when res ondents 7 demonstrate that the m e would impose excessive economic burdens or would stifle technological innovation. The consideration ofeconomic impacts is particularly important for chemical testing

decisions because EPA’s purpcse in using section 4 is to obtain data for use in risk assessment and, where necessary, risk management activity. EPA recognizes that ifthe te~ting it requires on a substance under section 4 imposes an unfair or excesiive burden, the likely result ofthe section 4 rule would be to drive the chemical from the market, rather than to produce test data, To insure that test data are received, EPA must be concerned with any significant adverse economic impacts associated with section 4 test rules. Economic considerations are therefore wei! integrated into EPA’s testing decisions. In response to EFA’s alternative threshold proposal for the substantial production criterion (zz0,000 pounds) used in the review ofnew chemical substances under section 5 ofTSCA, Cane Chemical Company stated,

x [a]t isthresholdproduction level, the publicationofproduction quantitieswill not onlyrevealextremelysensitivemnfidential businessinformationbutwill clearly overwhelmtheAgencywithworkthatit came! handle(Ref.5).

EPA belimms that adopting the threshold of subatan~ai production used in the review ofnew chemical substances under section 5{e) ofTSCA is inappropriate at this time, although for different reasons. Callery Chemical Company’s concern about public disclosure of sensitive business information is addressed elsewhere in this notice (Unit 11.F.ofthis notice). EPA recognizes that the number of chemicals which could be considered as potential testing candidate under

- section 4 ofTSCA would be greater if the lower threshold value ofZZ0,000 &esh61d value for substantial

- production. Nevertheless, for the

reasons set forth above and in the pm osed policy, EPA will adopt the 1

r mil ion pound threshold for “substantial production” under section 4(a)(l)(B)(i) ofTSCA,
D. Substantial Release Ifthe criterion for “substantial production” is met, then at least one of

~ three additional findings under TSCA section 4(a)(l)(B)(i) must also be made i before testing is required, The first”of 1

these findings is that the substance “enters or may reasonably be anticipated to enter the environment in substantial quantities” under TSCA section 4(a)(l)(B)(i)(I). EPA refers to this finding as “substantial release” and proposed that a value of 1 million pounds per year release orreleaae of 10 percent or moie oftotal production i volume, whichever is lower, be established as the threshold value for “substantial mlaase.” As an alternative to this threshold, EPA solicited comments on the adoption of a tied
, threshold, such as 100,000 pounds or 1 mi]lion pounds (56 FR ~2296). Ch4A, HSIA, and SPI disagree with EPA’s interpretation that “enters the environment in substantial quantities”

a uates with “substantial” release.

ase cornmenters contend-that I?PA must consider not simpl the total

r poundage released but a so other factors ‘ that address the potential for human andor environmental exposure such as the chemical’s persistence in the environment and its likely or estimated concentrations in various environmental media (Refs. 1, 2 and 6). EPA disagrees with the commented argumants regarding what information EPA must consider when making a finding under TSCA section 4(a)(l) (B)(i)(~. In 9ffect, CM.A attempts to import the “exposure” component of clause (II) of iection 4(a)(l)(B)(i) into clause (1).However, as indicated by the “
~ word “or” between the two clauses, ‘- clauses (I) and (II) of section 4(a)(l)(B)(i)

- can be interpreted as being mutually ‘ exclusive, While EPA ma , ifit chooses,
, “ J make a finding under bo claw {I)and I C16UW(II), a finding udder either clausal”

~ ~ done, COupkd with findings mder,,

- J. ~. .4(a)(l)(B)(ii) and (iii), is sufficient to ‘.,>’ -., , pounds were adopted. However,
~ ‘“wma~estm’e” “o”‘“

- ‘;’””” ‘“ ““”’”’”: “-’~“’“ A belleves that lt is reasonabl~ to’ 1“ subatanthd production is only one of the

~~ ibterpret @on.4(a)(l)(B)(i)(I) ~iY@i&iri&~. .::’.,~::!”
-‘ oftesting to be required for chemicals findinga that EPA must ma@ h-order to, that any meeting the “B!?fhdinga criteria, so it : pro ose chemical testing under sectiom ~. distribution imcomm !

- ~ ~~~..not powble.to deter@ne whether +;2.. d.o .T~~:~fo~,.thmwkuo reasoww use

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Federal Registsr i Vol. 58, No. 92 f Friday, May 14, ‘1993 / Notices 28741

is, pei se, “entry” ofthat substance inta themwirormxmt, irrespective of the substance’s subetquent persistence or concentration in the environment. TSCA explicitly uses different term% “enters” jn c~us~ (I], wd “~~” in clause (II). There is rLothinS h the statute ,grlegislative history that clearly indicates thet cliause (1)nectwja@ embraces u incorporates n “expcmm” companent. or e dwetkmad or persistence requirement. Moreovar, in the cumene decisiom the Court explicitly rejected CMA’s argument that EPA must incmrpmete a“persistmx” compcmfmt in making a aectfon 4(e)fl)fB)(i)(l) finding. See BSW F.2d at 355-35& end rr. 15-16. Far these
reasons, EPA ?@ieve6 that its intirpretatfa of t?mphrase “enters ~kos environment” as encompassing any ~’ralease” ta the environment is a reasonable reed@ of section 4(a)(IJ@)@(I). (3MA 131so

commented that BPAshould clarify that, as in section 313 ofEPCRA,the only releases on which a“’B” finding will b based arerehmsas toairor wataIbeyondsiteboundark Releasesor transferstotmahnant

and waste disposd facilities raise entirdy different exposure considerations and stmukt not be taken fnto account in makhg “6” findings (Ref.I).

EPA dfse~ with ~%’ characterization tithe scope ofthe term “rakse” in ERR% end as the Agency is using that tom ir.r

its interpretation of TSCA ssctibn 4[a)(l)(B]fi)[x). Contrsry to CMA”sessortforr, EPCRA does not limit th6t- “lWk#’ on~ to ~lea~ to “air orwater beyond site boundaries. ” Rather, %ekese” fs broadly defined in EPCRA *“err 329(8),42 

## U.s.c. 1lo’48@), es Spi& km- pumping. pouring. emitting, emptytng, &schs@ng, injecting, ~ping, Ie%ching,dMJll#irl& ordisposing mto the envirmuoen
.$imikdy, EPGRA section 329[2k 42 

## U.s.c. lmm(zk defines the term

2 IJenvimment” ~d to include water, air, and land the interrelationship A&A exists amung and hetwean water, ~and kind and all living thi~.

,... .. ..f:.,..
,,
An i&h&J1’&t& of Inventory, the &mcy is limited toe consideration ofthose effects which would occur “at concentration levels that are reasonably lfkely to exist beyond facility site boundaries as a result ofccmtinuow or blsquently recurring releesa” TM limitation applies only in thfa instance, end does not epply to or modify any ather cJause ofEPCXA section 313. Theref~ CMA’s attempt to limit the scope of the term “release” under EPCR& sod to relate this limitation to r+asea considered under TSCA, i~baee&tE MCWCMM.

Mtbr “r&arw” Mr

t“ ia defined in “enters @a snvironrnsn T!SCM.As explained shave, EPA believes that it ia meeanahle to interpret clause (I) ofsection 4(e)[l)@(f) ofthe Act to encarn

r any relearn of the substance tti ‘gn~nt. F~ P~ ~ti @icY. end consistent with the deffnitian of “wIv-@” k TSCF+ “enters the ~v~~nt” ~r swtion 4(a)(l) (B](i) includes WY raleaaea to “water, sir, and lend” that result from ar may mesOnaM ybe anticipated to result from the manufact~ pracesdn~ distribution in commerc% use or disposal af a &amicel substance or mixture, regardlsaa oftlm

source or nature cdthe rdaese. Furthermcim, TSCA’S scope is nat limited to conaidaretian ofordy relaesas from a site or transfikra to treatment and waste disposeI facilities. Xather, TSCA is intanded ta bmedl

. address the genend uncertainty elmut the effects of the manufsctu.re, pmcassi% distibutitm in co~ use or disposal cdRchemicaf subst~ or mixtu.?e. SPI com.n’wn~ that EPA’s reposed L 1 mi!liou pound rdeese thres d and the m’oposed akerniitive 10 percent of production vah,trrmthreahol~ were “arbitray” end that ‘“EPA does not provide any suppart fbrthe sekwtion of 10percent ofthe roducticm vohrne

f’ other than it wou d seem to he a sizeble number. Absent any frame ofrefiirence such as expos~ or pr~ in the environmen~ such a number is no 16ss Valid tbanlpementmw-t” (&& 2). EPAdise@a&k~s~Lk choosing the Lmffmn paurid threshoId value to repmat@ %ubs@W” * EPA was guided b~ the same considerations tlutvvere used to det~ the threshold value for “subst~~,” p~@~ frl ChOOSing the poundage thmshoI&EFA used the account far 99 percent of the total reperted release on the TRI by vahune. Clearly, the small percentage of ‘IN chemicals that exceed the selected poundage tWwsfmId accounts fiMtho vast majont oftotal TIUreleaaea It is

z reasonabk+ or EPA to use that information os a basis far focusing its attent&m on chemida r&aaed in

excess af that thmahnW. In additiu as stated in the Y posed pdky statement [56 FR 32296, the

La ementege threshold has bean propa6ed U=-EPA is&O can~m~ ~ut cbemicd roiessea that area aizdde percentage ofthe production voh.une of that chemical. EPA believes that when such e sisabk percentage ofa ) chemical’s pmdti”on vcduma is reiaas.od. that IoIease shmakl be considered ‘-’aubetantial” for timt aemi~ auhmco. ‘fhfsdmshald tilI allow EPA tha flexibility to requige testing ofck@mic& W’th production volumes equal to or greater than 1 million pounds per yeer, b~ with relaeamofleaathm l.tiu

- ,, per year,
E. Substantirdund S;gnfjbnt Human Exposure EPA proposed thef ‘Wsubmtid expusure” means expasum to @ numbers ofpeopIe (s6 FR 3229?]. and set out the foIIowfng numerid tbresh@s for a finding of ““suhdentiel exposure’*: 1400 warkers, laconsu~ endfor 100,000 persane in the general population. EPA propose& that “’significant exposure”ra%m to the nature ofthe mposura. A finding of “sign&ant exposure” wauhf genandly be made where the numericeI threshold for numbers ofparsons exposed for “substantial expoenre” is not met, but the nature of the expasti is sufficiently direct. large ar pmIongecf. However. EPAmaymakeafi& thatihamism

Y may be tJotb significant .uman expwwm and substmtiaf humaa e number ofpeopIa emtiti$ thresholds sot fixth in this pcdicyend the nature ofthe e~ fSSISO significant es Set farthfhti

an alternative to these solicited comments an tha adc@iau M. ‘. either the TSCA sectffm !3(e]~;;,-
.,, Chemical Program’sexp~baaed ,; .:”: critaria far” SubAMi&’erld : ,. ‘l.

### k28742 Federal Register I Vol. 58, No. 92 I Friday, May 14, 1993 f Notices

proposal’” that would result in testing compounds for which fewer than 1,000 workera era exposed” (Ref. 9). OSHA agmad with EPA that, for TSCA PT oaas, the proposed definitions for “SU stantial” human exposure and ‘ “significant” human exposure set reasonable criteria for determining if ! testing is required when toxicity ata

are absent or incomplete. Accordingly, “OSHA believes that ex osure of 1,000 F workers to a chemical o unknown toxicity represents adequate impetus to require testirm” [Ref. 8). In addition. OSHA stated bat the proposed

- distinction between “substantial” humqn exposure and “significant”

~human exposure is appropriate (Ref. 8). 1. Substantial human exposure. CMA, SPI, Mons.dnto, ~AD, HSIA, GAP, BASF, and ACC submitted comments that questioned the definitions and rationaleunderlying the proposed criteria. A common comment was that EPA had not provided sufficient ratimiale to justifj the pro oeed Cf numerical thresholds for etermining “substantial” human exposure, EPA disagrees with the commenters’ suggestion that EPA did not provide sufficient rationale for the numeric thresholds chosen to guide “aubstantiql” human exposure findings. As articulated in the proposed policy statement (56 FR 32297), EPA chose numeric thresholds to characterize “substantial” human exposure because it is EPA’s belief that TSCA section 4(a)(l)(B) was intended to address situations where large numbers of people may be ex sad to a chemical

r substance and lit e or no hazard data exists to indicate whether or not that chemical subsfUnce may present an unreasonable risk. EPA has based its thresholds for workera on experience gained through case-byase analysis of existinR substances. Fwthermore. accor&g to the Nationai Occupational Bxposum Survey (NOES) date (Ref. 18),

an avern e of 650 workera am d potenti y expoaad to a chemical substance produced in a quantity of 1 million unda. In other words, for a
s chemi p@xiucad in a quantity of 1 million pounds, it 1srelatively

~ uncommon that as many as 1,000 workera wmdd be exposed, Given this analyaisand its experience ofcaae-by-

.c+ amdygjs ofe~ding chemical exposure over the @ire; EPA believes thatit haareasonably interpreted %ndwtantial humim exbosure” under

.. determination of substantial human exposure, they did not specifically argue that these thresholds were unreaeonabIe, nor did they provide any specific alternative criteria or rationale. The different numeric thresholds for worker, consumer, and general population exposure are EPA’s attem t $ to reflect the inherent differences in e probable exposure scenarios for particular categories ofindividuals, As stated in the pro sad policy statement,

ral’O “workers gene ly are exposed on a
mom routine or direct basis than
consumers, and coneumem are generally exposed on a more direct basis than the general public” (56 FR 32297, July 15, 1991). EPA has decided to apply a differential equal to one order of magnitude betwean the worker,
consumer, and general po ulation & thresholds, EPA believes is ap roach 1 is reasonable and sufficient m acts &’ the inherent differences in e probable exposure acenm”oa for each of the categories of individuals, Both OSHA (Ref. 8) and NIOSH (Raf. 9) supported the basis for the distinction between substantial exposure to workers,
consumers, and the general population, EPA recognizes that this a preach, tl which is consistent with e Fifth Circuit’s cumene dadsion, integrates to

some extent *&econcepts of “substantial” and “significant” in determining what constitutes

f “subetantia “ human exposure. 899 F.2d at 356, n. 17 (cumene decision); and 56 FR 32297-32298 Uldy 15, 1991). Although commenters generally criticized EPA’s rationale for choosing the numeric thresholds articulated in the proposed policy statemon!, none of the comments offered fmy specific alternative thresholds for making a section 4(a)(l) (B)(i)(II) finding. Many comments expreseed the view that EPA must consider certain chemical specific factors to make a “substantial” human

e oaura finding. L and other commentera objected to EPA’s threshold approach for determining “substantial” exposure because it is baaed solely on numbers of people exposed and doea not take into account the hyaical and biological

r properties o a chemical, the manner of its usa and release, the level, frequency, and duration of exposure, nor any available relevant exposure data. CMA argues that EPA’should “make prudent but realistic assumptions about the exposure leveIa that would be of regulatory concerh iftesting ‘ demonstrates adverse effects” (Ref. 1). EPA believes that CMA’s comments’ 1

I 1 TSCA’S statutory hmework and purposes. As explained above in Unit L, TSCA was enacted to ensure that, given the exposure ofhumans and the environment to a large number of chemical substances andmixturas with

Lotentially harmful effects, there wouId effective regulation of commerce in such substances. TSCA section 2(a), 15 U.S.C. 2601(a). Since the potential effects of many chqmical substances in

commerce are not known, the policy provisions ofTSCA rdlect Congress’ intent that: sdequate data should ha developed with EEz::r$k%?g:k%”:nt andthatthedevelopmentofsuchdata shouldbetherasponaibilityofthosewho msnufscruraand thosewhoprocesssuch [substances].

TSCA section 2(b)(l), 15 U.S,C. 2601(b)(l). Section 4 ofTSCA provides EPA the authority to require such testing.

In effect, by urging EPA to make “assumptions about the exposure levels that would be ofregulatory concern if testing demonstrates adverse effects,” CMA argues that EPA must make an affirmath;e finding +&ata chemical i substance would pose aii unreasonable risk ofinjury at some hypothetical levels of toxicity and exposure in order’ to require testing under section 4(a)(l)(B) ofTSCA. This contention was explicitly rejected by the Court in the

cumene decision, 899 F.2d at 354-355. Further, in contrast to the TSCA section 4(a)(l)(A) risk-based criterion and the TSCA section 6 risk5anefit analysis, a finding under TSCA section 4!ti)(l)(B) requirea no risk anaIysis. See 899 F,2d at 354 (cumene decision); and 859 F.2d at 979, and 984-988 (EHA decision). Additionally, as both exposure and hward are factors used to determine whe*Aer a chemical may pose
arisk, without the necessary hiuard information, making “prudent but realistic assumptions about the exposure levels that would be of f regulatory conc8m if testing

. . demonstrates adverse effects” would be

a meaningless exercise. The utility of the frequency, duration, and levels of”’ exposure is limited when EPA is acting’ in the absence of information about the hazard of the chemi~ substance in question, Given the statutory framework DfTSCA, its Legislative history, tind the

case law interpreting the section 4 testing provisions, WA dckis rqt believe

.

,:-”-- I that it is required to undertake the type ,“ : ofdetailed ex@ure aneIysi@g@.:; ~’
upon it by

~ and oth~responderitti’. ~’‘,: in making &ti”T~:’~o&+32Ww:>$j>i,:~; ::,~<: ;

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-=, Federal Register / Vol. 58, No. 92 / Friday, May 14, 1993 / Notices 28743
4(a)(l)(B)(i)(X) “substantial” human exposure finding. Although EPA is not nquired to consider the factors enumerated above in making afinding of “substantial” human exposure, EPA did, as amatter ofpolicy, offir forconsideration in the pmpoaed policy statement an alternative set ofhuman exposure criteria, baaed on the TSCA aqction 5(e) New Chemicals program human exposure guidelines Which incorporated some ofthese factors (56 FR3229%323oo, Ju]y 15, 1991). However, despite an explicit invitation for comments addressing the merit and feasibility ofapplying these guidelines in the context of aect$on 4test rules,

none ofthe commen”ta addressed the specific numerical values and other factors outlined in EPA’s proposed alternative thresholds, Comments on the alternative thresholds expre~d only the general view that. the section 5(e) criteria should not be applied to review ofexisting chemimls under section 4(a)(l)(B). (Refs. 1 and 2). Furthermore, EPA solicited comments on adopting “some other criteria than the criteria proposed herein by EPA” and “the supporting rationale” for such criteria, yet received no comments offering any alternative thresholds or other specific

su estions or rationales. & spite EPA’s attempt to elicit more specific comments, most commentera addressed only the general concept of the proposed thresholds. For example, CMA argued that “Congress clearly axpectad EPA to demonstrate a pattern ofunusual] large or widespread

L exposure w ‘ch differentiate the test substance ikom typical chemicals in commercial use” (Raf. 1]. Baaed on this @mgument,QUA suggested that EPA develop an analysis ofvariations in
, human exposure potential within the universe ofcommercially produced chemicals. Such an analysis would provide a baais for,’’low”, “me&u’t, and “high” exposure chemicals. For exa,mplo,

- stated that EPA had made no effort to determine whether there are many or few chemicals to WhfCh @]- 1;000 workem

~ “ exp.os@.Wi@out such en ana]ysisl CMA arguqi, one carpet conclude that exposure.ta 1,.000.workers is large or small fo! typical Chemic@s in Household Solvent Products: A National Usage Survey, EPM3TS 560/5-87+05; and the System for Tracking the Inventory ofChemicals (STIC) Database, U.S. Consumer Product Safety Commission (CPSC) 1988. CMA also stated that about 400 substances have been screened under TSCA section 4 and that EPA’s R.Ml (Risk ManagementI) process has resulted in a systematic review of available exposure information for a growing number of existing chemicals (Ref. 1)0 As explained above, EPA disagrees with commentera’ fimdamental premise that the Agency is reqidred to undertake

an analysis of typical expbaures ofall chemical substances currently in

. commercial production in order to support its interpretation ofthe term “nb~~a])g under don 4(a](l)(B)(i)(~ ofTSCA, or that such an approach was mandated by Congress. Neither the plain language ofTSCA nor the legislative history % uire EPA to undertake the kind ofe austive analysis urged upon it by QUA and other respondents to support findings under TSCA section 4(a)(l)(B)(i). In short, the coat ofgenerating the exposure information necessary for this type ofanalysis may well exceed the coat oftesting, and is not appro nate for f a decision to require testing un er section 4 ofTSCA.

. EPA notes, however, that it does not ignore all ofthese factors in making d~sions to requh testing under SOCtiOII 4 ofTSCA. For each mdMsncespecific rulemaking under section 4, EPA must determine whather there is sufficient ‘“data and e erienm” upon

? which to “reasonably etmrnine or predi& the heal+h and environmental effects ofa chemical substance, and whether testing of such substance is “necessary to develop such data.” in making these determinations, the Agency has always, and will continue to examine all available and relevant {

1 

# I
i 1 ( 1 t
4
s

a

i

u

s

,, CMA at thfs time, the potential sources ofinformation identified bv CMA

information concerning the subst&ce in question; including the physical and biologkal properties ofthe substance, the,mammr ofits use and release, the ~evpl.fi’eq@rwy, &d du.iation of

~~ mposure, and any available relevant

;j/~ \
!1! ‘i ‘ ; ,1 1~1 ‘i];

i ~l~il

‘~ /

,.. < *> .:.,:, y.. ;
-,. ;’, present a number ofprobl&m~f&n&

an analysis due to the limited scope of their coverage. These limitations differ from database to database, and include the number ofchemicals covered, limited overlap betwean the databases, the specific data included in each database or information source, ixnpraciae date concerning current production ofa given substance, gaps in exposure, use and release information, and differences in the quality of data and the basis for each estimated parameter. For example, the NOES database developed by NIOSH contains information on more than 4,~ ‘ chemicals. This database contains useful information on the approximate number ofworkera tentkdly exposed,

P the irumber of fema e workers potentially exposed, the approxinmte number of facilities in th9 industry handling the chemical, and the industry Standard Industrial Code (SIC) where the chemical is found. However, by itself, the data- is insufficient to fully charactariza the potential worker exposures because the database does not contain information ofthe frequency, duration, or the levels ofworkers’ exposures. Due to these limitations, EPA doea not believe that it is possible to develop an analysis ofthe variations in
tnrman exposure potential for the entire universe ofchemicals. However, in the :ontaxt ofa substa.nca-s~fic wlem-kking, EPA will carefully consider he human exposure scenario. Once lgain, EPA invites interested parties to mbmit for EPA’s consideration all Ivailable and relevant information luring the notice and comment period

or each substan~s~fic rulemtig inder TSCA section 4.

1 Z. Signi icont humon exposure. CM& upporte by SPI, agreed with EPA that exposure can be considered significant’ where the otential exposed

t population is not large ut the conditions ofexpo~ are unique and
create unusually great concern about the substance’s pot@ial for adve~ effects” (Refs. 1 and 2). OSHA alm ‘. agreed and stated,

~ [i]faworker is axposaddiractiy (i.e.,by

~ inhalation) oron aroutine orepisodic basis, itisreasonable to detarmipe that asignificant human exposure exists, even iffewerthan 1000workers am exposed (Ref.8). ‘“.. However, CMA~HSIA and &hem’.”

.

### I b

28744 Federal Register / Vol. 58, No. 92 I Friday, May 14, 1993 / Notices



### I

I

1

I generically deiine criteria that it will employ in making a-finding of “significant” human exposure under TSCA section 4(a)(l)(B)(i)(II). Should EPA make such a finding in a subatanc& specific ruhmdin~ it will My explain the bases for that tindin at that time. % CMAslaostatedthet Ahasnot adequately &tined or explained the term “direct exposure” and how it relates to “significant” exposure (Ref. 1). A “direct” exposure IIUlybe charac@hd es having a cleerl identifiable or likely source ofL chemical, an exposure ~~ybrom the

source to the receptor E eXpSCtWi, with reasonable c8rtaint y, to result in the potential for exposure, end

an exposure route that will or,- reamnablybemqwtedtomaultin intaka/uptake by the receptor. For these
reasons, it is reasonable to conclude that in inatancea wham exposure is “direct”, EPAmay consider the ekpoaum to be “significant” under TSCA section exposure scenarios suggested by CMA would have much utili

. However. EPA will examine, among 0%er factors, the criteria suggested by CMA and others in the context of substance-specific rulemekings under TSCA section 4. including the manner ofuse, the chemical specific physical rom end whether for the affectJ L puletion the

~ would hlVOkl concentrations or is frequent nr prolonged. Also, in response to en earlier suggestion tim commentertk EPA did propose, as en ahernative to the proposed section 4(a)(l)(B) criteria fix “significant; exposure, adopting the qualitative and quantitative “substsntia~ and “significant” exposure guidelines used to mvjew new chemical substances under section 5[e) ofTSCA (56 FR32299): The_ section 5(e) criteria do include some consMeration of frequency, duration end magnitude ofexpoaum for workers, and consideration ofmagnitude of exposure for the general pulstion.

r The section 5(e) criteria or consumer exposure era quelkstive only. These criteria were developdd baaed on experience esaeasing the exposures associated with thousends ofnew chemicals with limited, but known, uses and exposure settings. However, es explained above, none ofthe commenters were in favor ofEPA adopting the TSCA wction 5(e) human exposure criteria. In’summary. forthepurpose of determ” ‘ Y Whather there isormsybe “subetantia “ oxposura under T= section ~a)[l)@)(i)(U~ EPA will utilize the numerical thresholds of 1,000 wark~ 10@OO

commune% andhr 100,000 persons in the general population. A finding of “significant” expoaum @l genefilly be made on a rxwe-by~se basis+ taking ihto considerstio% among other factors, the

manner of use, substance specific physiud properties, concentration levels, and the duration aod fnsquepcy ofthe exposure tothe a&stance. Itis irnpo~nt tqnote that TSCA section 4 is an information gathering tooi oniy andthdtpl scesnolirnitsona chemical substance’s menufimture+”
p~ distribiition in mmn.Wrce

~ w. Giverlthe limited pl+pOse @XA section 4(aL @ requiriitadn~ and because thammtheratimmay be-%ubstantidw or.’%igdficant” human ex@sursi hlcmiy Ono-of several findings, EPArnyat&&@@@re_

EkJA,A bdev@hetthecritede9at.forthhemin F. Other ksues
I. Categories. EPA proposed that it would apply the generic numerical
thresholds for most substances considered for action under TSCA section 4(a)(l)(B). Insome cases, however, where the thresholds are not met, EPA proposed that it may consider “additional factors”’ on a case-by-case basis for reeking findings. An example of such a case mentioned by EPA in the proposed policy *8 chemics!

- categories. CMA, supported by SFI, believes that categories should bnarrowiy defined.

In(WA’Sjudgament, thermlj categorythat would be.suitablefora ‘B’ findingwooldbe

onewhosememberspowamed sidlsr chemical stndums endwerethemfim likdy tohavechely dated kdth

~ ., environmentaleffects[Ref.1).

EPA dmuld in im lamenting its policy

r under aoction 4[a) I)(B) of TSCA, presmve the flexibility to consider additional end mitigating hctors on a ‘ case-by-case bssia Monsento supports the “substantial” and “significant”

e osure criteria es bedmmksbut “ ‘ b~eve that othes thctora, on a case- ‘ specific bask may,,nead ewduetion. For example, CMA stated that where there

are no other Micatnm OfauMantM. exposure other than that a ch&nicaL ““

a pears in human sdi P&-mEP~. L ould COIlSid8T that L tie reflectkiof backgmmd Ieveb’in ‘ environmen~ a met@oMproduct of enother Compounli or qdeaq! fkan *

.:. induatrhismimaa
~ l)ifn#uch 6;,:. -. ,:, Situatiom-’=%g-$,+ -,, ‘:”

.tider -q@)(l)(’Bl.Of=’wo@~

.{.{ *..

. ..s.-’;:?.’.. ,:i-.,...: : ,:.. not be juati&& ~.,m@~~f,~:,,>:~..> ~.+++ :.. ;~,: ,f. .,$

.. ”.,

.. . .,., :.. @‘: ‘

. ‘ .:.. -.-,.

. ‘+:...,’..

. :++”=+::?: ‘“

.-*?+..’.W-
...,..,. . -:<* ‘:’:-”.,! “‘. -!..’ ?.9 .ig.~:fi;’.~;::’?.’::?:%qi;;g \ :;. ,+:?-;:~.yl

,....,. ,. .. .. ~ ; “:,

- ,, . ‘‘.- >L%q’,-z,. .,!:.
:.. .:,.., ‘ .,-...

.’.,.

..... ““::.

~.”. “’’’’”:’ ‘“”:: .’”;‘z:’~gy::: :- .$.-.

, $:<;>.::e.

,. :,-- /,.+..

. .- .-’.’ .$.+ .’.,“*. ~:. .: “, CMA dso .gomments that ‘ *

re resantetives from a category could be Y seected lorteating. obviating theneed to test each end every member ofthe

‘Bl%esnot&ee with the commentere that categories must, by necessity, be limited to chemicals with similar structures or toxicxdogicsl properties. However. EPA does agree

. that chemicals with simiiar structures or toxicological properties COU!Lin ce@ain instances, be grouped togather and referred to collectively as a category. Additionally, after consideration ofall relevant chemical specific -parameters, EPA may propose cdegory findings on
a Cese-byw basis, and will solicit comments on this decision in the

c SFf3CifiC PTO test rule. This is the approach nintheproposed teatrlde for glycidois (56 FR 57144, November 11, 1991). 2.Additional or nu”tigatingfcctors. CMA Monsanto and others stated that

# 1 . . ..—.— ...... . ...... ..

Federal Register / VOL 58, No. 92 I Friday, May 14, 1993 I Notices 28745

EPA agrees with the respondents that in implementing this poli Tm’ should preserve the flembl lty to consider certain variables on a case-bycase basis. Furthermore, in implementing section 4(a)(l)(B) of TsCA, EPA intends to use the criteria articulated in this policy statement as guidelines to retain the flexibility to consider all relevant ,variables in making findings under section 4(a)(l)(B) of TSCA. As stated in the proposed statement ofpolicy, EPA intends to

- utilize the generic thresholds for most chemical substances conddered for action under TSCA section 4(a)(ll(B1. In

some cases, however, wherq the thresholds are not met, EPA may consider “’additional factors” on a caseby-case basis to make findings. EPA’s authority to use this flexible approach was recognized by the Gourt in its decision regarding the cumene test rule. The Gourt stated that EPA’s definition need not be piecise

— it need not “function like a mathematical fo~ula.” 899 F.2d at 359. On the other hand, them may be some instances when a chemical substance meets the criteria articulated under TSGA section 4(a)(l)(B)(i), but where testing under TSCA section 4(a)(l)(B) will not be required bectmse EPA finds under subsection (ii) or subsection (iii) of section 4(a)(l](B], respectively, that deta

are sufficient to reasonably determiae or predict the effects ofthe manufacture, process, distribution, use, or disposal of the chemical or that testing is not necessary. Monsanto, GAF, BASF, and AGG stmngl support the use of

; “mitigating actors” tojustify not requiring testing for those chemicals that meet the section 4(a)(l)(B)(i) criteria for which tha available data are sufficient to reasmmbly determine or predict the effects of the manufacture, process, distribution, use or disposal of the chemical end/or that testing is not necessary. 3. Confidential business information. Callerj Chemical Company is concerned that an BPA finding under TSCA section 4(a)(l)(B)(i) that a chemical maybe produced in substantial quantities may result in disclosure ofconfidential business information (CM) and “could provide valuable marketing information to competitors and potential .cam@itora without justification” (Ref. 5). EPA does not bdieve that disclosing
to the publjc the fact that at least I million fiunds ofa chemical substance’ EPA would not be disclosing specific information regarding any particular manufacturer’s production. Should su~
a statement affect a single manufacturer,

as might be the case with specialty chemicals, EPA does not believe that a statement that production volume is at least 1 million pounds would dtscIose sufficient information to be considered

a disclosure ofinformation which might be entitled to confidential treatment. Furtlmrmom, TSCA sectton 14(a)(4) authorizes the disclosure ofinformation which otherwise might be entitled to. confidential treatmimt when relevant in

an proceeding under TSCA, including [ m emaking, provided that disclosure is made in such a manner as to preserve confidentiality to the extent practicable without impairing the proceeding. See 40 CFR 2.306 (1991). EPA believes that by disdosing only that a substance is or will be produced in voIumes of 1 million pounds per ear or greetet,

{ confidentiality wou dbe preserved to the extent practicable while still making findings under section 4(a)(l)(B). However, EPA will make this decision

on a case-by-case basis, in accordance with 40

~ 2.306, ifsuch situations arise.
G. Beyond Scope Respondents raised several issues which em beyond the scope ofthis policy statament. The issues relate to the usa of structure activity relationships (SAR), exclusion of polymers, tiered testing schemes, end testing priorities under ‘TSCAsection 4(a)(l)(B). 1. Structun3 activity relationships. Monsanto believes that “[t]lie ‘B’policy shouId recognize and authorize tbe use ofstructure activity relationships (SAR) when evaluating the testing needs and priorities for substantial production chemicals” (Ref. 3). Monsanto commented that a huge number oftheir high production volume chemicals are produced as intermediates end then later converted to neutral salts to facilitate handling end shippin ;kmost ofthese cases, the salt an% interniediate itself have essentially the

same toxicological priorities. Thereforei by testing and evaluating one substance, the other chemical can be evaluated using SAIL Monsanto’s comment is hot releva& to a discussion af TS(X a&tion 4(a){l)(B)(i). Rather, whether SAR will be a fac$or iq determining,the “test@g

II f3ttdSmid. Drioritiea for substantial :‘ mattti “-,..

, l(l](B)(ii) ’~: 2. Polymer exclusion. Monsanto

commented ~at polymer exemptions should be recognized by BPA under this ‘ policy, because “[polymers represent a special class ofchemical subsfences that needs se mete consideration under the prop osel ‘B’policy” (Ref, 3). Monsanto nated that a number ofpolymer substances are biologically benign and, therefore, do not represent substantial health or environmental concern.@ support of this pcwition, Monsanto I noted that exemption pmce@res are

“provided for in the review ofnew .” ‘,
~ chemical substances imder TSCA ..’ ‘,, “I /,,.,! sectiorI 5. Likewise, the OBCD HFV program did not include polymers on the Representative List. Monsanto believes a similar

w ofpolymer. exemptiim should offered under the. section 4(a)(l)(B) policy. Again, Monsanto’s concerns relate”

z&$$Y;&X$7%LY& section 4[a)(l)(B)(i). EPA believes that in the absendb ofany submitted data, it is difficult to address the manufiwturers’

concern. Polymers do not have a welldefined composition, and there may be

a need to test same lower molecular weight polymers or oIi@omers which may have potential for health or environmental effects; Therefore, it would be premature for EPA to suggest that ablanket exemption from testing for polymers may be appro nate. To / data, BPA has not propose “orrequired testing ofa polymeric compound under TSCA. 3. Tiered testing. Monsan!o commented that EPA should adopt a tiered testing approach to evaluating

~ chemical substances. BPA believes that determination of whether tiered testing is appropriate generally must be made on a ~bycase basis. I@A recognizes that incorporating a tiered testing scheme in

a test mle can generate pridirninsry data relatively uickly with mincir Sxperiseii

7 Howcwer, m a rehtiyely well ‘, characterised chemical substance; it is” likely that a tiered tasting approqch.
,., would not be appraptiata. h other; ‘--, ~. instances, if the scientific M6retiireVLl contains information which strougly’

~ suggests that the chemical ii used ti ‘a way that would tilt in ‘tid&pmad, ‘ worker OFcorymmer expasur6 (e.g:, -a ~:,~ solvent USO)l

“ihep i! i~ less like& that a‘: prelimin~ q@rnOiN woulitdih$+;.”

- the kigd of da~, toaiippo@d’d@dtiv& answqr needed ftisu@-*des@ad- ‘“’; expo-”. Tl@ eitomatlc~ l’:’:. ;~j :@,:$E-

~ . inwr@retioD of iitie&d @ink.sd28746 Federal Ilwiater / Vol. 58, No. 92 / Fridav, Mav 14, 1993 / Notices

4. Teti”ng priorities. CMA commented that, in addition to adopting the 2.2 million pound threshold for substantial production, EPA should adopt atiered, sequential process for identifying data needs on all hi~ production volume (HPV) chernkds. ‘b CMA’s opinion, EPA should group I-WVchem_kala into categories and establish priorities for the review of each chemical. “ OnceoveraIltestingprioritieshavebeen

, set, individualhigh vohnne chemicals shouldbereviewedto determinewhether theywarrantaninitial setofmmeningtests comparable to those in the 0M2) screening Information DataSet (SDS) battery (Ref. 1).

EPA clearly articulated in the proposed statement ofpolicy and in Unit I. ofthis final notice that iasuas related to how EPA establishes testing priorities and how EPA makes Endings under wbsections (ii) and (iii) of section 4(a~l)(B) ofTSCA would not be addressed in this statement of @icy. V atsome future point in time, EPA decides that adoption of a tasting program such as that proposed by CMA would be beneficial in the gathering of data on existing +emicsl substanctm EPA will clearly articulate that policy and the underlying rationale in a notice.
III. Final pohy A, Substantial Production
EPA is establishing a threshokl value of 1 million pounds, aggregate production volume ofthe substance per year for all manufacturari, as the substantial production thrashold. This threshold currently represents only 11% ofthe entire universe ofchemical substances potentially subject to testing under TSCA section 4, yet accounts for 95% oftotal chemical production by volume. For the reasons articulated in the proposed statement ofpolicy (s6 Fil 32294) and Unit 11.C ofthis notice, EPA believes a threshold value of 1 million pounds is a reasonable interpretation of the phrase “produced in substantial quantities” in TSCA section 4(a)(l)(B)[i). B, Subdantial Release
EPA is establishing a threshold value of 1 million pounds ofrelease to the erivimnment from all sources per yew
or release equal to or greater than 10 percent-of production volume per ear,
r whichever is lower, as the thrasho d for substantial release. In choosing the 1 million pound thmshoid valw to mpmseut “substantial” release, EPA wed the TRI as a guide in judging the “substantial” nature ofthat amount of release. EPA has determined that 37 percent ofthe chemicals listed on the TRl have releases of 1 million pounds

or greater and that these releases represent over 99 pament ofthe total reported release an the TRI by volume. Clearly, the small percentage ofTRI

- chemicals that exceed the poundage threshold accounts for the vast majority oftotal TRI rehmsas. The percentage threshold reflects EPA’s concern about chemical releases that era a sizable percentage of the production volume ofthat chemical.

~ EPA believes that when such a sizable percentage ofa chemical’s production

- volume is released, that release should be considered “substantial” for that chemical substance. For the reasons articulated in the proposed stateinent of policy (56 FR 322&t) end in Unit I.I.D. of this notice, EPA belie~es that this is

a reasonable interpretation ofthe phrase “enters the environment in substantial quantities” in TSCA section 4(a)(l)(B)(i)(I).
C.Substantial and Significant Human Exposure
EPA is establishing the crittia in Table I ofthis Unit for “substantial” and “significant” exposure. As articulated in the proposed policy statement, EPA chose numeric thresholds to characterize “substantial” human exposure because it is EPA’E belief that TSCA section 4(a)(l)(B) was intended to address situations where large numbers ofpeople may ~ @osed to a chemical substance and little orno hazard data exists to indidate whe~,er or not that chemical substance may prixwnt

an unreasonable risk. EPA based its ‘ thresholds for workers on experience gained through ~by-case analysis of existing chemicals. The different numeric thresholds for worker, consumers, and general population are EPA’s attempt to reflect the inherent differences in the probable

. exposure scenarios for particular categories of individuals. EPA decided to apply a differential equal to one orbr ofmagnitude between the worker,
consumer, and general population thrasholas. For tha masons articulated in the proposed statement of policy (56 FR 32294) and Unit ILE. ofthis notice, EPA believes that these criteria are a reasonable interpretation of the phrase “significant or substantial human exposure” in TSCA section 4(a)(l)(B) (i)(Ii).

T= 1 .— TSCA Section ~a)(l ){B)(i) Human Exposure Criteria Guidelines

suiletEnttai 

### Significflflt
Ganarsd popuiatkm

... 100,OOO

pea- <l~,~memhe-md~ywma-ewe-~s.

* (knswwa

. . . . . . . . . . . .. . 10,OOOpao- <lO,OOOpaopia exposed &oredkacUyoran aroutine wapiaadkbaaia.

* 

### Wodwra

.................... <1,000 workers expoaed nwed&acttyoron aroutineof episcdkbasia.

D. Aliditional Factors
EPA will apply the generic numerical thresholds for mast substances considered for testing under TSCA ‘ section 4(a)(l)@l In same cases, however, where the thresholds era not met, it maybe more appropriate to use.
a case-by-case a preach for making

f. findings by app ymg o@er considerations. For the reasons articulat@ hi the proposed statement of pO~ (56 FR 32296) and Unit ILF.2. of

I this notice, EPA may consider

-- . . /-

,-- . “additional factors” fw making findings ofthe chemical and/or tit testing isxmt / for substan~s which do not meat the nace-.

-- ...-. :’. numerical thresholds articulated herein for evaluating existing chemicals under ~. ~~ T- R~e fir ~e

.. ‘.:.

.. -,,,, _...Federal Register ) Vol. 58, No. 92 I Friday, May 14, 1993 / Noticos 28747

consideration under TSCA section 4. Baaad on the available data, BPA found under TSCX section 4(a)(l)(B)(i) that

cunume is “produced in substantial quantities and that it enters the environment in substantial quantities,
with the potential for resulting substantial human exposure to cumene from its manufacture, proceaain~ use and dispoaa.L” EPA also made the requisite findings under TSCA section 4(a)(l)(B)(ii) and (iii) (53 FR 28200, July 27, 1986). =A’s findin@ were challenged by the Chemical Me.rp~~ -~tion

~ ~ “. EPA, 899 F:2d 344 (5th Cir. 19901 The Court remended the rule requiring EPA to: articulatethestandardsorcriteriaonthe basisofWhich it found the quantities Of

.
cumena entering tha environment &omthe facilitiesJoquestiontobe“’substantist” and thehumanexposurepotentially resultingto be““substantial.”

899 F.2d at 360~ The Court tiu-ther instructed BPA to: . articulatewhetheri~”respactive~SCA section4(a)(l)(B)(i)] clause (1)and clause (II) findings~nthecumenerole] each constitute, alone, anindependentandsufficientbasisfor itstestingrequirements,orwhether, onthe

other hand, its teeting requirements rest only

on the clau.ms (I)and (II)findings jointly ●● •. The WA Audi further indicate whether its tlndings under either clause (1)orclause (11)

areto any extent dependent on its !h@ which we have disapproved, concerning entry into the aquatic environment; end, if so, shall reconsider its clause ~ and (U) findings in the light ofourreferenced ruiing.

Id. at 36o, n. 22. Finally, the Court directed EPA to ccnsider new studies to be presented by

~ on remand “unless they would not be material to any of the EPA’s criteria relied on for the testing.” Id. at 360-361. On remand the @rnene Panel of U submitted both specific studies and general comments on the cumene tinal test rule. The test rule remained in effect, and test data was submitted to EPA in response tctherule.

~ BPA has addressed some of the Court’S instructions conr+erning EPA’s statutory authority and the Cumane Panel’s generic comments regarding the

‘ “B” policy (Raf. 12) in Unit IL of this notice. Specific comments on cumene and EP&s review ofremand evidence

* addraaaed in this 

## unitiv.

B. SUbst@~ Pmdudion disputed. For the reasons ‘ hcuasadin Unit 11.C. of this notice, EPAbelieves that this level ofproduction clearly qualifies as “subatantiaI production” under section 4(a)(l)(B)(i) ofTSCA. The level ofcumene reduction reportad in

b the final rule we exceeds the “substantial production” threshold articulated in this notice.
C. Substantial Release
In support of tie final test rule; EPA found that cumene isreleased to the environment in substantial uantities baaed on en estimated 3 & “onpounds per year of fhgitive emfaaions ofcumene to the atmosphere from manufacturin~
Pmcasaing, and use activities. The Court upheld the validity ofBPA’s estimate. 899 F.2d at 352-353. To a lesser extent, BPA also noted in i-hefinal mle that

cumene wes released h unspecified quantities to the aquatic environment. Because BPA was unable to estimate with reasonable certainty the magnitude ofthis release, EPA did not rely on this release in calculating human exposure; nonetheless, EPA did believe that there

was a potential for human exposure as
aresult ofrelease of ‘kumane to aquatic environments. The Cumene Panel commented that EPA lacks an adequate basis for finding that cumene “enters the environment in substantial

8uentities.” Specifically, the Panel ia@aed with EPA’s equeting “~bst~tial m]~” tith “entem tie environment in substtitisl qusntiti~.” The Panel stated, [tlheAgencyhasmadenoefforttoanalyze theextensiveevidencein ‘h record regardingthepersistenceanddistributionof

cumeneintheenvironmentortorelate

cumenereleaselevelstohumanexposure patterns(Ref. 12).

As discussed in Unit ILD. ofthis notice, EPA rejects the premise that “efiter the envimruneni in twktantiaj “ quantities,” as used in section 4(a)(l)(B)(i)(I) ofTSCA, be defined to include a determination of “persistence in the environment ofthose substantial quantities.” The (hut in the cumane case, 899 F.2d at 355-356, found that EPA is not obliged to follow CMA’s construction ofTSCA section 4. The Panel also raised this issue in their comments on the final rule for
cumane, asserting tba~ considering the short half-life ofcumene iq the atmosphere, there is no reason to believe thah except forpopulationa viry close to the plant, there is any general pOpUkit.iOIIexposure to cumtma. EPA

mse that the hrdflife ofcumene, ‘“ ongoing manufacturing and processing activities would be expected to be distributed over a large portion ofthe communities near manufacturing end processing facilities depending on the prevailing atmospheric conditions. Thuthe Panel has not provided BPA with a convincing rationale to refute EPA’s finding that cumene “enters the environment in substantial quantities”

or that there is not “substantial human exposure.” Rather, the Panel has only demonstretad that persistence, one of many chemicrd-spacific parameters EPA considers in evaluating a @unical, may beoflimited importance when ccmsiderqd with other factow such es the manufact;~ and processing Scenario.
D. Substantial Hurnaz fiposu~

. “ The Panel commented thaL even if the release of cumene imuld be equated to “substantial” environmental entry, EPA would not be justified in requiring human health effects testing unless it.

were to make a finding of “substantial human exposure.” Once again, the Panel is attempting to link the type oftesting required to the bases forthe TSCA section 4(a)(l)(B)(i) findin

. EPA doea not believe this to be f a vali interpretation of section 4(a) of TSCA. Furthermore, EPAbelie% as, stated in Unit 11.B. of thig notice, that clauses (I) and m ofTSCA section 4(a)(l)[B)(i) can be interpreted as independent. In partkukw, although EPA made findings for cumene under both clauaea (I) end 01), BPA believes a finding under either clause alone constitutes en independent and sufficient basis for the testing &red. T In support of its final rule, BP found that there may be datantial human exposure to cumene baaed on the expomre potential to approximately 13.5 million people living in the vidtity of cumene mandkturing and processing fimilitiea. EPA believes that .a majority of the people -would be exposed es aresult of fi.@ive emissions ofcumene to the atmosphere. The majority ofcumene manufacturing and processing facilities are concentrated in

a few large metropolitan emw The Court in the cumene case; 899 F.2d at 353, found that the ndemaking record adequately supported BPA’s finding. However, WhSI)

~ briefed its

~ $t submitted a monitoring atu@rti

-- pB3ViOUSljI submitted es comments M the rule, that relateato the preeerbof

- many chemicals, including cume~ in the Houston Ship

~ &@&s.
,287#1 Federal Register f Vol. 58, No. 92 I Friday, May 14, 1993 I Notices

either the “inters the environment in substantial quantities” or “substantial human expostwe” findings of section 4(a)(l)(B)(i). Theremand evidence presented by the petitioners tndicataa that such exposure does not existbecause cumane levels am not elevated even at short dlstancas fromthe

cumene plants (Refi12).

As instructed by the Court on remend, EPA has reviewed the study submitted by CMA. In general, EPA’s review (Rd 20) concluded that the study supporta the conclusions of its authors. However, the study dted by the Cnmene Panel does not show, nor was it designed to show, the monitored environmental concentration from manufacturing and procesd!ng facilities. The study’s introduction states: Mine underlyinggoalofthe monitoring P-~ toProvjdemember6rms with accurateambientairqualitymeasurements and technical data forbatter understanding dr.quality concerns in the Houston Ship Channel ama [Ref.19).

There am seven sites where monitorin devices are maintained

i dcpvnwin from the Houston Ship Channel. One.site only monitors meteorology and any accidental rqhsea. TM site is the northeksternmost site and does not monitor for any organic compound. The study states that the prevailing wind direction is from the southeast (Ref. 21). Therefore, the monitoring sites are up~d from d} but one of the cumene manufacturing rmd processing sites and

are gathering data on curnene emissions from refineries and other unknown Sourc$la. There is one manufacturing facility sited in the monitorin array. However,

%0 the bdlity appears to at least 5 miles from the closest downwind monitoring site. Additionally, it is not clear from
this study whether the detected environmental concentrations were detected at the closest downwind monitoring sites. The monitoring array is either upwind from all the other

~+e rn~tict@ng and processing sites or is over 30 miles away from those sites. At thatdiatance, the facilities would have to release e~mely large amounts ofcumene per minute to read detectable levels in the monitoring array..Therefore, it is unlikely that the data a@urately assass the level of cumenepresent in close proximity to the facility.’ ...’

-.The Cwhene Panel submitted ~ddit@ml information on modelling perforrhed at the’Champlin Refining and Chaicabtllcilityirl corpus Cbristi, Champlin modelled point source air emissions from barges loading cumene. Annual emissions ofcumene from these loading operations wem estimated to be 23,000 pounds. However, there am shortcomings with the methodology employed in the study. For modelling purposes, Champlin divided the annual oint

J source release estimate by the to number of minutes in a year to derive the source term (mass mleasa per minute). Champlin should have divided the annual point source release estimate by the total number of minutes per ear in which barge loading

J occurred to erive a more realistic

source term for modelling potenthd air concentrations. Based on a 1990 joint effort between EPA and the American Oil Company on the mhing industry, EPA estimates that tha capadty ofan intercnastal barge or tanker ranges from 2.5 million to 70 million gallons. Based

on sn.aesumed 1 day ftll rate and a 10 million galion bargehnker capadty, the entire capacity ofproduction at the Chsmplin facility could be loaded in 7 days. Ifthe cumene emissions were assumed to be released over a period of 7 days rather than 365 days, the source

term (input) would be raised by a factor of 50. Additionally, C&unplin used typical to better than average meteorological conditions of stability class C and a windspeed of 12 miles per hour in the modelling exercise, A more conservative, yet still realistic, set of meteorologic conditions 

### wouid be a stability class ofD and a windspeed of 5 miles per hour. Therefore, EPA believes th6 resulting ambient concentrations ofcumene from the Champlin modelling exercise underestimate the ambient concom.rstion of cumene resulting from miaases at the Chsmplin facility. Furthermore, EPA’s review ofthe study indicates that the study does not shed any light on the number ofpeople potentially exposed to cumene, rather it ia only conmmed with determining a level of cumene in the area ofthe Houston Ship Channel. Therefore, the study does not relate to whether EPA could make asubstantial human exposure finding. Another section ofthe remand evidence submitted by CMA consisted ofmodeling shidies of ambient air concentrations ofcumene that ma araf’ result from emissions ffom sev
cumene manufacturing sites. Althou@ all studies used the EPA industrial Source Complex Long Term (ISCLT) air dispersion modid, the level ofdetail concerning methods and assumptions used VSliOd fiorn studv to studv, thUS inhibiting EPA’s abili~y to ade@ately ’
~

,, “.. ., i’, .:; :- ,. ,T,.
,, “’,:- ; ., ... :“ ‘...’,>,
.,. ,:,,.:

.. review the studies. Each ofthe studies is briefl discussed below. L Mode hng of cumene emissions from two Georgia Gulf Corporation facilities,

one in Plaquemine, Louisiana, and the other in Pasadena, Texas, were performed using “adjusted”

~ section 313 release data for reporting year 1987 (Ref. 23). The rstiona]e to justify the procedure used to adjust the EPCRA section 313 release data and to justify the meteorological assumptions used for modeling air dispersion were not sufficiently detailed to enable an adequate EPA review ofthe study. The study describirig the modelling of

curnene emissions from a Kcch Refining Company facility (Ref. 24) provided sufficient details on methods and assumptions to SI1OW

for an ad uate 3 EPA review. This modelling stu y also purported using 1987 EPCRA section 313 release data. However, the annual releases used in the study, 1,971 pounds, show a large unexplained discrepancy with the 19,500 pounds of

cumene emissions actually reported under EP~ section 313. Modelling studies for the Shell Oil Company Deer Park, Texas, facility (Ref. 25) and Texaco’s El Dorado facility (Ref. 26) were also submitted. However, supporting data on tbe mdmds and
, assumptions used in the studies were not sufficiently detailed to enable an adequate EPA review ofthe studies. The remand evidence was accompanied by an affidavit from Marvin B. Hertz, an industry consultant, supporting the uw of ambient air monitoring data rather than the mass emission data from the ~ section 313 Toxic Release Inventory (TM) (Ret 27). EPA recognizes that tiie use of ambient tir monitoring data, when performed correctly, plays arole in any exposure assessment, and thus, in risk assessment. However, it is very difficult to nerfcnn any risk assessment when ‘

---–- the hazards ofthe cmmpound are either not known or not we}l characterized. For this reason, and the reasons articulated in Unit 11.E.of this notic6,

~ EPA does not depend on human exposure at a particular “level” in determining “exposure” under TSCA section 4(a)(l)(B)(i). Finally, the Cumene Panel stated that testing submitted pursuant to the final test rule confirms that cumene does not present arisk. Moreover, the Panel objected to EPA’s reference to a TSCA section 6(e) submission, which indicated cataract formation in rats exposed to cumene vapors? @s ap ~. - example ofthe benefits of testing a ,. “.
~,.. chemical titheabsen~ of @ard data.’.. “:

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Federal Regf8ter I Vol. 58, No. 92 I Friday, May 14, 1993 I Notices 28749

Panel has u~etien a follow-up subchronic study.

on June 17,1992, ut.iking data submittti b ~ponse to the cumene test rule, EPA held an RMl disposition, for cumene to determine whether to take risk management action on the chemical (Rbfs. 28 and 29). EPA determined that sufficient information for hazard assessment is available and supports a iow concern, When the hazard information was considered in conjunction with available exposure information, EPA determined that

cumene presents a relatively low risk to h- health, and has discontinued review of this chemical at this time. Therefore, EPA doea not believe any further testing of curnene is neceaemy at this time.


# v.Public Record
A. Suppoti”ng Documentation

EPA has established a record f& this policy under TSCA section 4, docket number 0PPTS47002K, which is available for inspection Monday through Friday, excluding legal holidays, in Rm. ET-ClO2, 401 M St., SW., Washington, DC., 20480 from 8

a.m. to 12 noon and from 1 p.m. to 4 p.m. This record includes basic information considered by EPA in developing this policy. his record includes the following information: (1) Interagency memoranda, comments, and proposals. (2) Reports-published and unpublished data. (3) Chemical Manufacturers Association v. EPA, 8S9 F.2d 344 (5th 

# Cir$ 1990),
B. References (1)TheChemical Manufactumra Association. CommentsOnEPA’sTSCA section4(E)(1)(B) proposedStatementof Policysubmittedtothe TSCA Public Docket Office, USEPA (September 17, 1991). (2) EPoxy RaainSystemsTeskGroupof Thesociety ofthePlastics Industry, Inc. Comments on EPA’sTSCA section 4[a)[l)[B)

. .. .. . proposed Statement ofPolicy submitted to the TSCA Public Docket Office. USEPA (September 17, 1991),

. (3) Mon~@ Company. Comments on 6A’s TSCA section 4(a)(l)(B) Pro sad

r StatementofPolicy subrnimto eTSCA PublicDocketOffke. USEPA (September 12.

.. Iwl); .< :

,.. .,. ? ‘ (4) Ecological and Toxicological Association ofthe Dyestuffs Manufacturing Industry. Comments on EPA’ssection 4(a)(l)(B) Proposed Statement ofPolicy submitted to the TSCA Public Docket Office, USEPA (September 17, 1991). (5) Caky ChemicalCompany.Comments
onEPA’ssection4(a)(l)(B) proposed StatementofPolicysubmittedtotheTSCA PublicDocketOffice,USEPA (September 18, 1991). (6)Helogenatad Solvents Industry Alliance. Commentson~A’s section 4(al(ll(B) ProposedStatementofPolicy submittedtotheTSCAPublicDocketOffice, USBPA(September19, 1991). (7) GAPChemicalsCorporation,BASF Corporation,ahdARCOt2mmicafCompany. CommentsonEPA’ssection4 [a)(l)(B) ProposedStatementofPolicy submittedto TSCAPublicInformationOffice,iJSEPA (S9pt6mber17, ?S91) (6) U.S. DepartmentofI.dor, Oc&@ionel SaYaty andHeidtbAdministration. Comments
onEPA’ssection 4(a)(l)(B) Prbpoaed Statement ofPolicy submitted toTSCA Public Docket Office, USEPA (October 7, 1991). (9) U.S. Department ofHealth and HumM services, National Institute forOccupational safety and Health. Comments on EPA’s section 4(a)(l)(B) proposed Statement of Policy submitted toTSCA Public Docket Of!lce, USEPA (September 17, 1991). (10) CMA’sAcetone and Ketones Panel. Comments on EPA’ssection 4(a)(l)(B) proposed Statement ofPolicy submitted ti TSCA Public Information Office, USEPA (September 17, 1991). (11) CMA’s0.0 Proce9s Pane!. Comments

on EPA’ssection 4(a)(l)(B) proposed Statement ofPolicy submitted to TSCA Public Information Office, USEPA (September 17, 1991). (12) CMA’sCumentj mnel. ~mmen~ on EPA’ssection 4(a)(l)(B) Proposed Statement ofPolicy submitted toTSCA Public Information Office, USEPA (September 17, 1991). (13) CMA’SCyclobexane Panel. Comments

on EPA’ssection 4(a)(l)(B) proposed Statement ofPolicy submitted to TSCA Public Information Office, USEPA (September 17, 1091). (14) CMA’sHexamethylene Dikwcysnate Panel. Qunrnents on EPA’ssection 4(a)(l) (B] proposed Statement ofPolicy submitted to TSCXPublic Information Office, USEPA (September 12, 1991). (15) Diethyl EtherManufacturers Task Group. Comments on EPA’s section 4(a)(l)(B) Pmposad Statement ofPolicy submitted to TSCAPublic Information Office, IJSEPA [September1$ 1991).. (16)USEPA.Implementationproposal; “New@emicsls &poaure-Bssad Findi~”

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..... ..-., .... . .,

. ..’. ,.:. ... ., letterfrom Charles L E~ to Geraldine V. Cox (Chemical Manufacturers Association), ,Offica ofToxic Substances, USEPA (September 22, 1966). (17) Organization fir Economic Cooperation and Development. “OECD’s Workon Investigation ofHigh Production Voliune Chemicals.” Document 3, May 1991. (18) U.S. Department ofHealthsod Human Services, NationalInstituteforOccupational Safetyand Health. National(lcxmpational ExposureStudy (NOES,1988). (19) Radian Corp. A Method forAssessing Community Expoaur9 to selected Volatile Indicator Compounds (July20, 1988). (CMA exhibits for remand evidence). , (20) USEPA.Review ofEvidence Submitted by CMA on Jlemand ofCumene Test Rule. Washington, Ml Office of Pollution Prevention and Toxica, USEPA (April, 1992). (21) Radian Corp. Volatile Indicator Compound Measurement ResMtairom the Houston Regional Monitoring Network, Phase IV(July20, 1966). (CMAexbiblts for remandevidence). (22) Champlin Refining Company. AU Modelling ofCumene Releases atCluunplin Refining Company (October 14, 1966). (CMA exhibits forremand evidence). (23) GeorgiaGulfCorporation, KC and ISCLTAir Modelling Results from Georgia GulfCorporation Facilities (December 16, 1986) (CMAexhibits forremand evidence]. (24) Koch Refining Company. Air Mndelling Results horn K&b Refining Company Facility (October 20, 1988) (CMA exhibits forremand evidence). (25) Shell Oil Company. AiI Modelling Results from SheIl DeerParkFacility (Undated) [CMAexhibita forremand evidence). (26) StarResearch. Air Modelling Results fromTexaco’s El Dorado Facility (Sapternbm 30, 1988) (CMAexhibits forremand evidence). (27) Hertz, Man-in A. Affidavit on Use of Monitoring Dataversus Mass Emission Dats (CMAexhibits forrwmandevidence). (28) USEPA. Regulatory Management-1 (RMl) Summary forCurnane. Washington, DC:Offhx ofPollution Prevention and Toxics, USEPA (January10, 1991). (29) USEPA. Regulatory Management-1 (RMl) Sum-nary forCumene. Washington,

- IX: Office ofPollution Prevention sod Toxics, USEPA (june 17, 1992).

Dated: May 5, 1993.
Victor J.Kimm, ActingAssistantAdministratorfor Prevention,Pesticidesand ToxicSubstances. [FR Dec. 93-11496 Filed 5-13-93; 8:45 SOI] r$n.lmo’cOoE

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