I

I

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

{,

ENVIRONMENTALPROTECTiON

AGENCY

IOPPW-47002K FRL44WM]

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 of po]icv.

SUMMARY: EPA is articulating standards”

and criteria for making findings it will

use in 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 if additional

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

to the findings of “significant” human

exposure, for which 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 (July 27,

1988,53 FR28195),

FM FURTNERINFORMATION CONTACT

Susan % Hwen, Director,

En*L-onmental Asbistrmce Division (TS

799), Offim of Pollution 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 file on “The

Federrd Bulletin Board at 9 a.m. on the

date of publication in the Faderaf

Register. By modem dia] [202) 512-1387

or call (2o2) 512-1530 for disks or paper

copies. This file is also available in

Postscript. WordPerfect and ASCII.

EPA is articulating guidelines for

finding that “a chemical substance or

mixture is or will be produced in

substantial quantities, end [1)it entera or

may reasonably he anticipated to enter

the environment in substantial

quantities, or (IIIthere’is or may be

significant or substantial human

exposure to such a substance 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),

theF%ICircuitCourtafA~ti(the

“Court”) remanded to EPA e rule

issued pursuant to 4(a)(l)(B) for cumene

testing and required EPA to articulate

mitena for the findings EPA made in the

cumene test ruhr (53 FR 28195, July 27,

1988). EPA hSS decided to use this

opportunity to articulate criteria for

making 011findings under aect50n

4(a)(l)(B)(i) of TSCA.

This notice dam not address how EPA

wfll set priorftiet.for testing or how EPA

will determine thes cffictasts to be

performed. Rather, t& notkxraddmasas

one element in EPA’s process for

selecting appropriate candidate frfr

testing — i.e, how EPA will determine

whether the chemical is Or will be

“produced In substantial quantities,”

whetfwr it “enters or may maaonably be

anticipated to enter the environmwt 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, the Fifth Circuit

Court of Appeals remanded to EPA the

TSCA section 4 test rule for cumene

based on a chrd]enge to tbe rule by 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 in the nda as

being supported by substantial evidenra

but instructed the Agency to “’articulate

the standards of critmia on the baais of

which it found the quantities of cumene

enterfng the environment from the

faciIitiea in question to he ‘substantial’.”

899 F.2d at 360, In this notice, EPA is

articulating standards and criterfa it will

use in making findings under section

4(a)(l)(B)(i) of TSCA. Additionally, EPA

is responding t~ the instructions by the

Court ~arding the application of such

criteria ;0 the cumena rule.

B. Background

Congress enacted TXA to give EPA

the authority to assess and prevent

unreasonable risks gasociated with the

manufacture, processing, distribution in

commerce, use, or disposal of chemicals

through a variety of regulatory means. ”

15 !_!.s.C 26oI. et seq. This authority

includes, among other thin= tha

authority to require chemical taiting to

develop data for rtsk sssessmtrrrt, H

LJ.S.C.2603, and the authority ~ ~

chemicals if necessary to prwwnf

unreasonable risks. 15 U,S.C. 2605. A

principal tenet underlying TSCA is that

“adequate data should be developed

with respect to the effect of chemical

substances and mixtures on health and

the environment and that the

development of such data should be the

res onsibility of those who manufacture

an1 those who process such chemical

substances and mixtures.” 15 U.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 a program for the

testing of chemicals.

EPA must make findings under either

section 4(a)(l)(A) (“A” finding) or

4(a)(l)(B) (“B” finding) of TSCA before

testing may he required 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 of the

manufactlw, distribution in commerce,

processing, uyr, or djsposal of such

stibstance or mixture or any

combination of such sctiviiies on health

or the environment can reasonably be

determined or predicted,” and that

“testing of such substance or mixtum

wfth respect to such effects is necessary

to develop such data.’* 15 U.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 of ISchemical substance

or mixture, or that any combination of

such activities, may present an

unreasonable risk of injury to health or

the environment” (emphasis added), h

the EHA decision, tho Court found this

provision to require EPA to establish a

“more than theoretic-l basis” for finding

that the chemical may pmsant an

unreasonable risk, but that EPA could

establish existence and amount of

human expusure to the chemical on the

basis of inference drawn from

circumstrmces undar which the

chemical is manufactured and

procassed, 859 F.2d at 991. This

interpretation of the statute “prevents a z

testing rule based on little more than

scientific curiosity, yet allows the.

.Agen.cy to act when an existing

i

pos ibility of harm 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 to TSCA section 4(a)(l)(k,’

under TSCA saction 4(a)(l)(B), there is

no risk-based criterion la satisfy, Sea

899 F.2d at 347, n.d (cumene decision).

According to tha legislative historyi tits:. ~--‘“ ~~

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

.,, ,

. .,>.. --- ~..: ..-. >.,. $> ,,.. ,.:. -’ .-. ... ,, . . .,, <.> ,“. -z

,, . . . ...-. ,.,’? :.”./. ,. . ... ..,..~..
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) of TSCA,

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 or mixture 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. ”

f his 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

potential candidates tor 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 ‘be imposed

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 ‘“is or may be

significant or substantial human

exposure” as used in section

4(a)(l)(B)(i) of TS(X.

“’ C. The “B” Policy

section 4(a)($)(B)(i) of TSCA 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 of Appeals recognized this

prind le when reviewing the cumene

test rue.r Acc&din to the Court, where

TSCA and its Iegis %tive history provide

no definition of a term such as ‘

“substantial,” “Con~ iS d~m~ to

have implicitly delegated to the EPA the

power to define or inte rat

‘substantial,’ and we w?“ 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 or group of

crite;a can be established which will

function like a mathematical ibrmula, so that

for every %ivensat of facts a specific,

proctictable,answer till always be

forthcoming. Room must be leftforthe

exercise of judgment.

Id. af 359.

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 of or 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) ● ● ●“).

In 1“M statement of policy, 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 of these

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 of policy ffom

the Chemical Manufacturers Association

(cMA), the Epoxy Resin Systems Task

Group of The Sodety of the Plastics

Industry, Inc. (SPI), the Monsanto

Company, the Ecological and

Toxicological Association of the

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 !)y those 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 of Drinking 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 of policy 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

not intended to be, nor will it K 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

list was made available to t%e “

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

thrashoId criteria articula J in this

policy noti~ so long as “B” findings

aremadeordyineu portofrules

requiring only tie ml ~~ level or

“baseline testing” of chemical

substances (tit 1). ~ 0PPOS9S

utilizatkm of the “B” policy criteria,

and ind@ use of EPA’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

that, in the absenca of 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 if thpy

wera incn ted into the @red

‘“ approadt r eicribed above. CMA would

environmental releases, the Agency

should limit rules supported by such

findings to chemical tiste and

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 of the scope of EPA’s

testing authority under section 4 of

TSCA. .

TSCA section 4[a) states

(a) TESTINGREQ~.-If the

Administratorfinds thet-

[l)(A)(i) the manufactum, distribution in

commerce, pr_uaa, Or-Ofa

chemical substanceor mixtnra, or that wy

combination of such actlvitias, may present

an unreasonablerisk of tnjury to health or the

environment,

(ii) there are insufiiciant &ts and

experience upon which tha effects of such

msnufiwtura,distributiontn couunerca,

PmCXISSin&use, or dhpoaat of such substance

ormixturaor ofsny~wntiti

activities on imaithor the environment can

reasonablyba determinedor predicted, and

(iii) testing of such substanceor mixture

with raspect to such eft%ctsta namssary to

devalop such detINm

(B)(i) a chemical aubstencaor mixturs is or

will be produced in suMantM quantities,

and [I) it enters os MSySWSO06biy&

anticipated to enter the environment in

substantialquantitiesor (IIIthere is or may

bs significantor substantialhuman sxpoaure

to such Substanceor rnbdum,

[ii) there are insufficientdata and

experience upon which the effectsof the

manufacture, distributionin commerce,

processin~ use, or diapoaatofauch substance

or mixture or ofsny combination of auh

activities on health m tha anvtronmant can

reasonablyha d6tenninad or prsd!ct~ and

(iii) testingof such auMance or mixturu

with r8spect to such effects is necessary to

cievalopsuch ds@ and ● ● ●

the Adminikntrx shall by rule requira that

testing be conducted on such aubataoceor

mixture to develop data with respectto the

health and environmentale- for which

them is an insufficiencyof data and

experience and which am relevant to a

determinatirinthat the msnufactum,

distributionin commerce, prOcassin&use, or

disposal of such substmca or mixture, or that

SOycombination of such tlcthitim does or

does not present an ummmna& risk of

injury to health or tha environment.

15 U.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 of this final paragraph clearly

relates to the “data insufficiency” and

?+g is necessa&’ 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 of the

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

of a substance, ‘or

7

uire environmental

effects testing even i it has only made

a finding that there is or may ha

substantial or si ificant human

exposure to a sur 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 of whether

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, if any,

for a articular substance.

EPx 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

of all 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

of the various testprotocols ● “’end the

reasonably foreseeable availability of the

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). suffica saabasiaforkm~

Furthermore% if COmzmaabad

y predict

that there wilt ha no health or envimnmeatal

intended that &e W“g.requ& under ~@W * ~ --kw PIWXS@

section @a)f@)@) be dated to whether etc.) of tba chmnkxd, than affirmaths

the findings am baaed mainformation

.

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%etatesting

independent of the beak for cm(A)fi) or

(B)fi} finding. Indeed, EPA has

consistently interpreted the “testing is

necaaaary” under TSGA sections

4(a)(l)@)(iii}d (B)(W) temearr that

BFAmay requira any haekb or

en~efktat6atingbwhick&& ‘

m inmffkkmt andvshkh H% balkmeaare

“capableof daveAopingtbe ~’ 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. urnthe cumeme decision, the

Court supported EPA’s interpretation

mgarding.the relationship between the

findin&L under TSCA SUh6SCtiOD

4(a)(l)(B)@ard subsections

4(8)(l)@)@] and (iiik

A tln~undar $ackirm4~)(l)(B)(i) does

not elona just@ a te+orrkm. It intuitSKSO

be tbundrmder sacffon 4(aJfl~B)(i~ that

‘therew inso.fB6i9ntdata and axprfaDm

u~wkfkh the afibcteof thernenufectum Fcm

evidence and 5dfngs ofrfak of such in@ry

at hypothetical tmdcity hrveKsunder sectton

4(a)(l)(BHi) are not mcaaary toprovldu.e

nsxusbstween re@riag taotfngunder

s- 4faXll(Et)and ~ ~== rbrhaalkhaadtia~

899 F.2d et 354-i55 (em&eeia in

original). Ghrem that T!YX section

&

4(a)(l)[B)@ vesEPA aukhority to

-h

tastfngwan J&!

information that e suhatmce is

hszardous,ktiareaaoti -ti

speci&&atinfJlA9 b@&*&@

the datainanf6~d_k

nec --waactiom

4(a)(l)(B 7 land @i) mtkettbau to the

mkmmmtd rolhaaeorlmmen

:xPO- ffnd&rnad#lmdHSCA” 1

- 4(e)[lB~).

C SMktOrlt&rf hhti”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”a proposed 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

which incIr~vf+~~’l?~. es a.11chermcaf,s (twaiudmg

polymers and petrrdeum fiactioraa]

reported in any member coun in

eXC6S6 Of~O~a tOM8S (~ 3 “ 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 of Z.Z million mmde waa

conceived merdy to gui la the

generation of national 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~=

~fsubstantial ~ ie not ?he sob

inding EPA must make to ttiro,

esting. Tlwthmaholdf#l 3 - 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 of U.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

of chemical 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 of the

chart. EPA could also choose to adopt

a broader interpretation, finding all

chemical production to be substantial

unless it fell below a value at the

extreme low end of the 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 ‘rscAsection 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 i6 reasonable to use this

information as a basis for making a

finding of “substemtial production” for

substances producad in excess of that

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 of the scope

of this policy statement.

Neither the “B” policy nor any

E

articular 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 of the 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 of proposed testin requirements

when developing 5a.1 mf es under

section 4, and may revise testing

requirements when res ondents

demonstrate that the m7e would impose

excessive economic burdens or would

stifle technological innovation.

The consideration of economic

impacts is particularly important for

chemical testingdecisions 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 if the

te~ting it requires on a substance under

section 4 imposes an unfair or excesiive

burden, the likely result of the 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 of new chemical

substances under section 5 of TSCA,

Cane Chemical Company stated,

[a]tx is threshold production level, the

publication of production quantitieswill not

only reveal extremely sensitive mnfidential

business informationbut will clearly

overwhelm the Agency with work that it

came! handle (Ref. 5).

EPA belimms that adopting the

threshold of subatan~ai production used

in the review of new chemical

substances under section 5{e) of TSCA

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.of this notice).

EPA recognizes that the number of

chemicals which could be considered as

potential testing candidate under -

section 4 of TSCA would be greater if

the lower threshold value of ZZ0,000

&esh61d value for substantial -

production. Nevertheless, for the

reasons set forth above and in the

pm osed policy, EPA will adopt the 1

mil rion pound threshold for

“substantial production” under section

4(a)(l)(B)(i) of TSCA,

D. Substantial Release

If the 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 of total 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

poundage released but arso 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 , if it chooses, , “

make a finding under bo J 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” A belleves that “o”‘“ lt is reasonabl~ - ‘;’”””‘“ ““”’”’”: to’ 1““-’~“’“

subatanthd production is only one of the ~~ibterpret @on.4(a)(l)(B)(i)(I) ~iY@i&iri&~..::’. ,~::!”

-‘ of testing 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

~ :(J. ~,~.J:kij;.&j T

;;;::;* -&+ ;,,,.+:Y:;:‘::. ‘-‘ ?.- “c -“:: “ ‘:‘:”’,- .(.~::.~:. ‘..“:::~:::j’.~:!*;;;:j. f;%i:; “ ; ::.’ ~K;$,+“

j#.. .,. ..;:.:.. . ..$ . . . . . .

T.., ...>,,, —~’

. . . &G. . .. . . . . . . . , , -, . . ...= :7- ,.. . ., ! 9 .~ ..+.., ;:,3, .--:. ,.4, .:,..J ;. . :+7-.,,. ..:,,.%

,..<:2.. 1..’.. -4’....:, . . .

,; ..’.. . . . . . . . . ~ , .

,% :: ;.”” ,. . ..~..- ,~, “.., ., .. A,. >/ ,. : .,, . :.l .,..-<.+ ... ,- -, -, : ~< ,\ .:, ,. :( .,< ., /... -. -.

,.

‘k:’’-:.,,’’:,:. .,’’ .,, :....., ‘ . . . . . ‘, -’ ~ - . . . “, - . . . . . -’. : ,. ,’: ,

,. ..;,

,, .’> ,, . !,. .=-. .,x,;:-~: : ,. ~--, :... -..

,..
I

. ........... . ..

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

is, pei se, “entry” of that 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 ,gr legislative history that clearly

indicates thet cliause (1) nectwja@

embraces u incorporatesn “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 BSWF.2d at

355-35& end rr. 15-16. Far these

reasons, EPA ?@ieve6 that its

intirpretatfa of t?m phrase “enters ~kos

environment” as encompassing any

~’ralease” ta the environment is a

reasonable reed@ of section

4(a)(IJ@)@(I).

(3MA 131socommented that

BPAshould clarify that, as in section 313

of EPCRA,the only releases on which a “’B”

finding will b based are rehmsas to air or

wataI beyond site boundark Releasesor

transfersto tmahnantand 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 of the term

“rakse” in ERR% end as the Agency

is using that tom ir.rits interpretation of

TSCA ssctibn 4[a)(l)(B]fi)[x). Contrsry to

CMA”s essortforr, EPCRA does not limit

th6 t- “lWk#’ on~ to ~lea~ to

“air or water 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&or disposing

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 of those effects which

would occur “at concentration levels

that are reasonably lfkely to exist

beyond facility site boundaries as a

result of ccmtinuow or blsquently

recurring releesa” TM limitation

applies only in thfa instance, end does

not epply to or modify any ather cJause

of EPCXA 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

“enters @a snvironrnsn t“ ia defined in

T!SCM.As explained shave, EPA

believes that it ia meeanahle to interpret

clause (I) of section 4(e)[l)@(f) of the

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 of tlm

source or nature cd the 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 cd Rchemicaf subst~ or

mixtu.?e.

SPI com.n’wn~ that EPA’s reposed

1 mi!liou pound rdeese thres L d and

the m’oposed akerniitive 10 percent of

production vah,trrm threahol~ were

“arbitray” end that ‘“EPA does not

provide any suppart fbr the sekwtion of

10 percent of the roducticm vohrne

other than it wou f’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 L mffmn 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 of total TIU releaaea It is

reasonabk+ zor 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 of the 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 of ck@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 of peopIe (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 of the mposura. A finding of

“sign&ant exposure” wauhf genandly

be made where the numericeI threshold

for numbers of parsons exposed for

“substantial expoenre” is not met, but

the nature of the expasti is sufficiently

direct. large ar pmIongecf. However.

EPAmaymakeafi& thatihamism

may be tJotb significant Y .uman expwwm

and substmtiaf humaa e

number of peopIa emtiti$

thresholds sot fixth in this pcdicyend

the nature of the e~ fS SISO

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

P

T

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

workers to a chemical oFunknown

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

numerical thresholds for Cfetermining

“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

substance and litr 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

potenti d y expoaad to a chemical

substance produced in a quantity of 1

million unda. In other words, for a

chemi s p@xiucad in a quantity of 1

million pounds, it 1s relatively ~

uncommon that as many as 1,000

workera wmdd be exposed, Given this

analyaisand its experience of caae-by-

. c+ amdygjs of e~ding chemical

exposure over the @ire; EPA believes

thatithaareasonably 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 of individuals, As

stated in the pro sad policy statement,

“workers gene ral’Oly 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

is reasonable and sufficient m 1 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,

which is consistent with tl e Fifth

Circuit’s cumene dadsion, integrates to

some extent *&econcepts of

“substantial” and “significant” in

determining what constitutes

“subetantia f “ 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

properties or 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 if testing ‘

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 of humans and the

environment to a large number of

chemical substances andmixturas with

L

otentially 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 of TSCA rdlect Congress’

intent that:

sdequate data should ha developed with

EEz::r$k%?g:k%”:nt

and that the development of such data

should be the rasponaibilityof those who

msnufscrura and those who process such

[substances].

TSCA section 2(b)(l), 15 U.S,C.

2601(b)(l). Section 4 of TSCA provides

EPA the authority to require such

testing.

In effect, by urging EPA to make

“assumptions about the exposure levels

that would be of regulatory 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 of injury at some hypothetical

levels of toxicity and exposure in order’

to require testing under section

4(a)(l)(B) of TSCA. 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

a risk, 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 ,“ :

of detailed ex@ure aneIysi@g@.:; ~’

upon it by ~ and oth~responderitti’. ~’‘,:

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

.“ --- ...

,:,:.

. J:--f,1:<~,,;’.;,,‘+;:,:.;q;:%% . ‘ ‘.,;,.,.,.

., ..-: . ,....,~”-, .“*’~,,.,,w-

:, z., , .... -~..$,,;f~.,t*}:

,, .... ~. ...’.. .+:,l<.,::>*.
I

..—..--------------

-=,

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 a finding of “substantial”

human exposure, EPA did, as a matter

of policy, offir for consideration in the

pmpoaed policy statement an

alternative set of human exposure

criteria, baaed on the TSCA aqction 5(e)

New Chemicals program human

exposure guidelines Which

incorporated some of these factors (56

FR 3229%323oo, Ju]y 15, 1991).

However, despite an explicit invitation

for comments addressing the merit and

feasibility of applying these guidelines

in the context of aect$on 4 test rules,

none of the 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

of existing 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

of unusual] large or widespread

exposure wL‘ch differentiate the test

substance ikom typical chemicals in

commercial use” (Raf. 1]. Baaed on this

@mgument,QUA suggested that EPA

develop an analysis of variations in ,

human exposure potential within the

universe of commercially 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 of Chemicals (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 of all

chemical substances currently in .

commercial production in order to

support its interpretation of the term

“nb~~a])g under don

4(a](l)(B)(i)(~ of TSCA, or that such an

approach was mandated by Congress.

Neither the plain language of TSCA nor

the legislative history

%

uire EPA to

undertake the kind of e 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 of generating the

exposure information necessary for this

type of analysis may well exceed the

coat of testing, and is not appro nate for

f a decision to require testing un er

section 4 of TSCA. .

EPA notes, however, that it does not

ignore all of these factors in making

d~sions to requh testing under

SOCtiOII4 of TSCA. 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 of a 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

of information identified bv CMA

information concerning the subst&ce in

question; including the physical and

biologkal properties of the substance,

the,mammr of its use and release, the

~evpl. fi’eq@rwy, &d du.iation of ~~

mposure, and any available relevant

;j/~\

!1!

; ,1‘i‘

1~1 ‘i];

i

~l~il

‘~

/

,..<

*>

.:.,:,

y..;

-,.

;’,

present a number of probl&m~f&n&

an analysis due to the limited scope of

their coverage. These limitations differ

from database to database, and include

the number of chemicals covered,

limited overlap betwean the databases,

the specific data included in each

database or information source,

ixnpraciae date concerning current

production of a 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 of workera tentkdly exposed,

the irumber of fema Pe 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 of the frequency,

duration, or the levels of workers’

exposures. Due to these limitations, EPA

doea not believe that it is possible to

develop an analysis of the variations in

tnrman exposure potential for the entire

universe of chemicals. However, in the

:ontaxt of a 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

population tis not large ut the

conditions of expo~ 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]f a worker is axposaddiractiy (i.e., by ~

inhalation) or on a routine or episodic basis,

it is reasonable to detarmipe that a significant

human exposure exists, even if fewer than

1000 workers 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 of L

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 of use, the

chemical specific physical rom

end whether for the affect J

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)

of TSCA (56 FR32299): The_

section 5(e) criteria do include some

consMeration of frequency, duration

end magnitude of expoaum for workers,

and consideration of magnitude of

exposure for the general pulstion.

The section 5(e) criteria ror consumer

exposure era quelkstive only. These

criteria were developdd baaed on

experience esaeasing the exposures

associated with thousends of new

chemicals with limited, but known, uses

and exposure settings. However, es

explained above, none of the

commenters were in favor of EPA

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@OOcommune% 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

of the exposure to the a&stance. It is

irnpo~nt tq note 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). In some 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’S judgament, the rmlj category that

would be.suitable for a ‘B’ findingwoold be

one whose members powamed sidlsr

chemical stndums end were themfim likdy

to have chely dated kdth ~ .,

environmental effects [Ref.1).

EPA dmuld in im lamenting its policy

under aoction 4[a)rI)(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

reflectkiof backgmmd Ieveb’in tie ‘

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

seected Y lorteating. obviating theneed

to test each end every member of the

‘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!L in ce@ain

instances, be grouped togather and

referred to collectively as a category.

Additionally, after consideration of all

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”tigating fcctors.

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

should preserve the flembl Tm’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 of policy, 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 of the 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” to justify 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 of confidential

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 of a 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 of information which might

be entitled to confidential treatment.

Furtlmrmom, TSCA sectton 14(a)(4)

authorizes the disclosure of information

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 {d be 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, if such situations

arise.

G. Beyond Scope

Respondents raised several issues

which em beyond the scope of this

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

of structure activity relationships (SAR)

when evaluating the testing needs and

priorities for substantial production

chemicals” (Ref. 3). Monsanto

commented that a huge number of their

high production volume chemicals are

produced as intermediates end then

later converted to neutral salts to

facilitate handling end shippin ; kmost of these 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

IIf3ttdSmid. 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 of chemical subsfences that

needs se mete consideration under the

prop osel ‘B’ policy” (Ref, 3). Monsanto

nated that a number of polymer

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 of new .” ‘,~

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

of polymer.

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 of any 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 a blanket exemption from testing

for polymers may be appro nate. To

data, BPA has not propose / “orrequired

testing of a 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

Howcwer, 7m 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 ii tie&d @ink.sd
28746 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 a tiered,

sequential process for identifying data

needs on all hi~ production volume

(HPV) chernkds. ‘b CMA’s opinion,

EPA should group I-WV chem_kala into

categories and establish priorities for the

review of each chemical. “

Once overaIl testing priorities have been ,

set, individual high vohnne chemicals

shouldbe reviewed to determine whether

they warrant an initial set of mmening tests

comparable to those in the 0M2) screening

Information Data Set (SDS) battery (Ref. 1).

EPA clearly articulated in the

proposed statement of policy and in

Unit I. of this 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) of TSCA would not be

addressed in this statement of @icy. V

at some 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 of the substance per

year for all manufacturari, as the

substantial production thrashold. This

threshold currently represents only 11%

of the entire universe of chemical

substances potentially subject to testing

under TSCA section 4, yet accounts for

95% of total chemical production by

volume. For the reasons articulated in

the proposed statement of policy (s6 Fil

32294) and Unit 11.C of this 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 of release to the

erivimnment from all sources per yew

or release equal to or greater than 10

percent-of production volume per ear,

whichever is lower, as the thrasho rd 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 of that amount of

release. EPA has determined that 37

percent of the chemicals listed on the

TRl have releases of 1 million pounds

or greater and that these releases

represent over 99 pament of the total

reported release an the TRI by volume.

Clearly, the small percentage of TRI -

chemicals that exceed the poundage

threshold accounts for the vast majority

of total TRI rehmsas.

The percentage threshold reflects

EPA’s concern about chemical releases

that era a sizable percentage of the

production volume of that chemical. ~

EPA believes that when such a sizable

percentage of a 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 of the 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 of this 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 of people may ~ @osed

to a chemical substance and little or no

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

of magnitude between the worker,

consumer, and general population

thrasholas. For tha masons articulated

in the proposed statement of policy (56

FR 32294) and Unit ILE. of this 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

Ganarsdpopuiatkm... 100,OOOpea- <l~,~memhe-md~ywma-ewe-~s.

*

(knswwa ....... ....... 10,OOOpao- <lO,OOOpaopiaexposed &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

findings by app f.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 of the 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:

articulate the standards or criteria on the

basisof Which it found the quantities Of .

cumena entering tha environment &omthe

facilities Jo question to be “’substantist”and

the human exposure potentially resulting to

be ““substantial.”

899 F.2d at 360~ The Court tiu-ther

instructed BPA to:

.

articulate whether i~”respactive ~SCA

section 4(a)(l)(B)(i)] clause (1)and clause (II)

findings~n the cumene role] each constitute,

alone, an independent and sufficientbasis for

its testing requirements, or whether, on the

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)or clause (11)

are to 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 of our referenced 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 of remand evidence

* addraaaed in this unitiv.

B. SUbst@~ Pmdudion

disputed. For the reasons hcuasadin ‘

Unit 11.C. of this notice, EPAbelieves

that this level of production clearly

qualifies as “subatantiaI production”

under section 4(a)(l)(B)(i) of TSCA. The

level of cumene 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 is released to the

environment in substantial uantities

baaed on en estimated 3 & “on pounds

per year of fhgitive emfaaions of cumene

to the atmosphere from manufacturin~

Pmcasaing, and use activities. The Court

upheld the validity of BPA’s estimate.

899 F.2d at 352-353. To a lesser extent,

BPA also noted in i-he final mle that

cumene wes released h unspecified

quantities to the aquatic environment.

Because BPA was unable to estimate

with reasonable certainty the magnitude

of this 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

a result of release of ‘kumane to aquatic

environments. The Cumene Panel

commented that EPA lacks an adequate

basis for finding that cumene “enters

the environment in substantial

8

uentities.” Specifically, the Panel

ia@aed with EPA’s equeting

“~bst~tial m]~” tith “entem tie

environment in substtitisl qusntiti~.”

The Panel stated,

[tlhe Agency has made no effortto analyze

the extensive evidence in ‘h record

regardingthe persistence and distributionof

cumene in the environment or to relate

cumene release levels to human exposure

patterns (Ref. 12).

As discussed in Unit ILD. of this

notice, EPA rejects the premise that

“efiter the envimruneni in twktantiaj “

quantities,” as used in section

4(a)(l)(B)(i)(I) of TSCA, be defined to

include a determination of “persistence

in the environment of those 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 of TSCA section 4.

The Panel also raised this issue in

their comments on the final rule for

cumane, asserting tba~ considering the

short half-life of cumene iq the

atmosphere, there is no reason to

believe thah except for populationa viry

close to the plant, there is any general

pOpUkit.iOIIexposure to cumtma. EPA

mse that the hrdflife of cumene, ‘“

ongoing manufacturing and processing

activities would be expected to be

distributed over a large portion of the

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

be of limited 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 of testing required to the

bases for the TSCA section 4(a)(l)(B)(i)

findin . EPA doea not believe this to be

a vali f interpretation of section 4(a) of

TSCA. Furthermore, EPA belie% as,

stated in Unit 11.B. of thig notice, that

clauses (I) and m of TSCA 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.

In support of its final rule, BPT 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 -wouldbe

exposed es a result of fi.@ive emissions

of cumene to the atmosphere. The

majority of cumene 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).

The remand evidence presented by the

petitioners tndicataa that such exposure does

not exist because cumane levels am not

elevated even at short dlstancas from the

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:

Mineunderlying goal of the monitoring

P-~ to Provjde member 6rms with

accurate ambient air quality measurements

and technical data for batter understanding

dr.quality concerns in the Houston Ship

Channel ama [Ref. 19).

There am seven sites where

monitorin devices are maintained

dcpvnwin i 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,

the bdlity appears to %0 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 of cumene 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 of cumene 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

occurred to J erive a more realistic

source term for modelling potenthd air

concentrations. Based on a 1990 joint

effort bet ween EPA and the American

Oil Company on the mhing industry,

EPA estimates that tha capadty of an

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 of production at the

Chsmplin facility could be loaded in 7

days. If the 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 of D and a windspeed of

5 miles per hour. Therefore, EPA

believes th6 resulting ambient

concentrations of cumene from the

Champlin modelling exercise

underestimate the ambient

concom.rstion of cumene resulting from

miaases at the Chsmplin facility.

Furthermore, EPA’s review of the

study indicates that the study does not

shed any light on the number of people

potentially exposed to cumene, rather it

ia only conmmed with determining a

level of cumene in the area of the

Houston Ship Channel. Therefore, the

study does not relate to whether EPA

could make a substantial human

exposure finding.

Another section of the remand

evidence submitted by CMA consisted

of modeling shidies of ambient air

concentrations of cumene that ma

result from emissions ffom sevaraf’

cumene manufacturing sites. Althou@

all studies used the EPA industrial

Source Complex Long Term (ISCLT) air

dispersion modid, the level of detail

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 of the studies

is briefl discussed below.

Mode Lhng 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 of the 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 SI1OWfor an ad uate

EPA review. This modelling stu3 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 of the 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 a role in any

exposure assessment, and thus, in risk

assessment. However, it is very difficult

to ‘nerfcnn ---–- any risk assessment when

the hazards of the 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 a risk. 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? @sap ~. -

example of the benefits of testing a ,. “. ~,..

chemical titheabsen~ of @ard data.’.. “: . .
1

..

. .

,.. -<>. -... .. ....... .. . ..

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) The Chemical Manufactumra

Association. Comments OnEPA’s TSCA

section 4(E)(1)(B) proposed Statement of

Policy submitted to the TSCA Public Docket

Office, USEPA (September 17, 1991).

(2) EPoxy RaainSystems Tesk Group of

The society of the Plastics Industry, Inc.

Comments on EPA’s TSCA section 4[a)[l)[B)

. .. .. .

proposed Statement of Policy 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

Statementof Policy subrnimto r e TSCA

PublicDocketOffke. USEPA (September 12. ..

Iwl); .< :

,..

.,. ?

‘ (4) Ecological and Toxicological

Association of the Dyestuffs Manufacturing

Industry. Comments on EPA’s section

4(a)(l)(B) Proposed Statement of Policy

submitted to the TSCA Public Docket Office,

USEPA (September 17, 1991).

(5) Caky Chemical Company. Comments

on EPA’s section 4(a)(l)(B) proposed

Statement of Policy submittedto the TSCA

Public DocketOffice, USEPA (September 18,

1991).

(6) Helogenatad Solvents Industry

Alliance. Comments on ~A’s section

4(al(ll(B) Proposed Statement of Policy

submittedto the TSCA Public DocketOffice,

USBPA(September19, 1991).

(7) GAP ChemicalsCorporation, BASF

Corporation, ahd ARCOt2mmicaf Company.

Comments on EPA’s section 4 [a)(l)(B)

Proposed Statement of Policy submittedto

TSCAPublic InformationOffice, iJSEPA

(S9pt6mber17, ?S91)

(6) U.S. Departmentof I.dor, Oc&@ionel

SaYatyand HeidtbAdministration. Comments

on EPA’s section 4(a)(l)(B) Prbpoaed

Statement of Policy submitted to TSCA

Public Docket Office, USEPA (October 7,

1991).

(9) U.S. Department of Health and HumM

services, National Institute for Occupational

safety and Health. Comments on EPA’s

section 4(a)(l)(B) proposed Statement of

Policy submitted to TSCA Public Docket

Of!lce, USEPA (September 17, 1991).

(10) CMA’s Acetone and Ketones Panel.

Comments on EPA’s section 4(a)(l)(B)

proposed Statement of Policy submitted ti

TSCA Public Information Office, USEPA

(September 17, 1991).

(11) CMA’s 0.0 Proce9s Pane!. Comments

on EPA’s section 4(a)(l)(B) proposed

Statement of Policy submitted to TSCA

Public Information Office, USEPA

(September 17, 1991).

(12) CMA’s Cumentj mnel. ~mmen~ on

EPA’s section 4(a)(l)(B) Proposed Statement

of Policy submitted to TSCA Public

Information Office, USEPA (September 17,

1991).

(13) CMA’SCyclobexane Panel. Comments

on EPA’s section 4(a)(l)(B) proposed

Statement of Policy submitted to TSCA

Public Information Office, USEPA

(September 17, 1091).

(14) CMA’s Hexamethylene Dikwcysnate

Panel. Qunrnents on EPA’s section 4(a)(l) (B]

proposed Statement of Policy submitted to

TSCX Public Information Office, USEPA

(September 12, 1991).

(15) Diethyl Ether Manufacturers Task

Group. Comments on EPA’s section 4(a)(l)(B)

Pmposad Statement of Policy submitted to

TSCA Public Information Office, IJSEPA

[September1$ 1991)..

(16) USEPA.Implementationproposal;

“New @emicsls &poaure-Bssad Findi~”

.,.

. . . .. ..-.,

..... .,

. ..’.

,.:. ... .,

letter from Charles L E~ to Geraldine V.

Cox (Chemical Manufacturers Association),

,Offica of Toxic Substances, USEPA

(September 22, 1966).

(17) Organization fir Economic

Cooperation and Development. “OECD’s

Work on Investigation of High Production

Voliune Chemicals.” Document 3, May 1991.

(18) U.S. Department of Health sod Human

Services, National Institute for Occupational

Safety and Health. National(lcxmpational

Exposure Study (NOES,1988).

(19) Radian Corp. A Method for Assessing

Community Expoaur9 to selected Volatile

Indicator Compounds (July 20, 1988). (CMA

exhibits for remand evidence). ,

(20) USEPA. Review of Evidence

Submitted by CMA on Jlemand of Cumene

Test Rule. Washington, Ml Office of

Pollution Prevention and Toxica, USEPA

(April, 1992).

(21) Radian Corp. Volatile Indicator

Compound Measurement ResMta irom the

Houston Regional Monitoring Network,

Phase IV (July 20, 1966). (CMA exbiblts for

remandevidence).

(22) Champlin Refining Company. AU

Modelling of Cumene Releases at Cluunplin

Refining Company (October 14, 1966). (CMA

exhibits for remand evidence).

(23) Georgia Gulf Corporation, KC and

ISCLTAir Modelling Results from Georgia

Gulf Corporation Facilities (December 16,

1986) (CMA exhibits for remand evidence].

(24) Koch Refining Company. Air

Mndelling Results horn K&b Refining

Company Facility (October 20, 1988) (CMA

exhibits for remand evidence).

(25) Shell Oil Company. AiI Modelling

Results from SheIl Deer Park Facility

(Undated) [CMA exhibita for remand

evidence).

(26) Star Research. Air Modelling Results

from Texaco’s El Dorado Facility (Sapternbm

30, 1988) (CMA exhibits for remand

evidence).

(27) Hertz, Man-in A. Affidavit on Use of

Monitoring Data versus Mass Emission Dats

(CMA exhibits for rwmandevidence).

(28) USEPA. Regulatory Management-1

(RMl) Summary for Curnane. Washington,

DC:Offhx of Pollution Prevention and

Toxics, USEPA (January 10, 1991).

(29) USEPA. Regulatory Management-1

(RMl) Sum-nary for Cumene. Washington, -

IX: Office of Pollution Prevention sod

Toxics, USEPA (june 17, 1992).

Dated: May 5, 1993.

Victor J. Kimm,

Acting Assistant Administrator for

Prevention,Pesticides and Toxic Substances.

[FRDec. 93-11496 Filed 5-13-93; 8:45 SOI]

r$n.lmo’cOoEwm—60—F