## IUR Petiti on Review Repor t April 17, 2005

CASRNs and TS CA Inventory Chem ical Nam es: 67701-03-5 fatty

acids, C16-C18 68308-53-2 fatty

acids, soya

P etitioner s and P etition Docket Num bers: Keller and He ckman OPPT-2004-0071 The Soap a

nd Deter g ent Association (SDA) OPPT-2004-0006 Note: The petitions contained additional chemicals. These additional chemic als are addressed in other petition review reports.

Summ ary of Decision: The pe tition review g roup re commends a de nial for this petition as EPA has a c urre nt interest in the proc essingand use infor mation collected unde r the Inventory Update Reportingrule (I

UR) ( see 40 CFR Part 710) for fatty acids, C16-18 (CASRN 67701-03-5) and fatty acids, soya (CASRN 68308-53-2) . This rec ommendation is based, in par t, on the deter mination by

the petition reviewg roup that there is a direc t application of the I UR proce ssing and use infor

mation to complement data c ollected by or identified f

or use unde r the HPV Challeng e Prog ram. See Considerations A, C, D, and E.
Background : EPA rec eived two pe titions reque sting that fatty acids, C16-18 (CASRN 67701- 03-5) a nd fatty acids, soya (CASRN 68308-53-2) be adde d to the 40 CFR 710.46(b)( 2)(iv) list of specific chemica l substances whic h are exempt from the repor ting of industrial proce ssing a

nd use and c ommercia l/consumer use infor mation require d by

40 CFR 710.52(c) (4). The chemica l substances inc luded on this “partial e x emption” list are substanc es for which EPA has pr eviously deter mined that there is a low curr ent intere st in the I UR proce ssing a nd use information. Howeve r, as state d in the prea mble to the amendment to the IUR rule promulg ated on January 7, 2003 (68 F R 854), “...the ne ed for proce ssing a

nd use information ... chang es over time. The inclusion of a che mical substance under this par tial exempti on is not based on the potential risks of a c hemical. This par

tial exempti on is solely

intended to provide a

tool to assistthe Ag ency in better ma nag ing the collection of pr ocessing and use infor

mation...” and is also “ba sed on the Ag ency ’s cur

rent ne ed for

collecting

IURA proce ssing a

nd use information.” (68 F R 855) Additionally , the pre amble states, “ In deter mining whe ther ther e is low curr ent intere st in I URA proce ssing a

nd use information related to a specific chemica l substance, EPA will look to the specific circ umstances surr ounding the chemica l in question, and may use one or

more of the considerations identified below, and/or c onsiderations not identified below, to make an informe d decision.” The considerations used by EPA in reviewingthis petiti on and an a naly sis of how those consider ations relate to the chemica ls identified in this petit ion are set forth be low.

Discussion : The pe tition review g roup consider ed information submi tted with the petitions, as well as other

information including(but not limi ted to): whethe r the pe tition s ubstance s are

Pag e 1 of 6

## included in TRI , I RI S, or I ARC; OECD HPV SI DS prog ram status; HPV Challeng e Prog ram

status; and their inclusion in other re g ulatory prog rams administere d by EPA. 1


## The pe tition from SDA (docket number OPPT-2004-0006) stated that these two che micals are included as pa

rt of lar g er c ateg ories under the OECD/ I CCA HPV Chemicals initi ative in orde r to help meet objec tives of minimiz ing te sting a nd costs and completingassessments ea rlier, a nd to ensure the data summarie s for the c ateg ories we re a s robust as possible. SDA further states that the pre sence of the c hemicals in the c ateg ories “doe s not impl y a conc ern or

high inter est for these substanc es, but rathe r that existi ngdata f or these substanc es could be used to support the char acte rizations of other substance s in the cate g ory .” The petitioner re quested that these two substances be g rante d a par tial exempti on on the basis that “HPV c hemical pr og ram sponsorship does not indicate a

n ong oing inter est in proce ssing a nd use data

and that these substances should not have be en re moved from the initial par tial exempti on list on t hat basis.” De spite the statements in the SDA petition, none of these chemica l substances we re e ver inc luded on the initial partial exempti on list. Addit ionally , as discussed in the doc ument “Methodolog y Used for the Initial Selection of Chemicals for the Inventory

Update Rule A mendments (IURA) ‘L ow Current Intere st’ Partial ReportingEx emption,” bec ause sponsorship unde r the HPV Challeng e Prog ram will result in the ava ilability of hazard sc ree ning inf

ormation, EPA did not consider these c hemicals to be of

low curr ent intere st for purpose s of the re porting of IUR proce ssing a nd use information. The pe tition from SDA did not l ink information furnished in the pe tition t o specific considerations cited in 40 CFR 710.46(b)(2) (ii), but provided g ener al statements as de scribed previously . Such g ener al statements alone are of limited use in establishing a rationale for addinga che mical to the I UR partial exemption lis t. The pe tition from Keller a nd Hec kman (doc ket number O PPT-2004-0071) did link information in their petition to specific c onsiderations cited in 40 CFR 710.46(b) (2)( ii). This information is included in the discussion below.

Consideration A: Production volume. The pe tition review g roup found that ther e wa s at least one site r eportingto the 2002 IUR with a production volume for

eac h of the two substanc es of 300,000 pounds or greater.
Consideration B: The substance’s che mical and physical properties or potential for persistence, bioaccumulation, health effec ts, or environmental effec ts. The pe tition from Keller a nd Hec kman included e x cer pts from the Kirk- Othmer Enc y clopedia of Chemical Tec hnology

to addre ss Consideration B f or these two substanc es. The e x cer pts from Kirk-Othmer

wer e for broad c ateg ories such a s “F ats and F atty Oils” and off

ere d littl e

S e e t h e a t t a c h e d l i s t o f a c r o n y m s a t t h e e n d o f t h i s r e p o r t

. 1 

## Pag e 2 of 6

## information spec ific to the individual substances. The petition from the SDA did not addre ss this

consideration.

Consideration C : The information needs of EPA, other fede ral agencies, tribes, states, and local governm ents, as well as members of the public. The pe tition from Keller a nd Hec kman re ported that ne ither substance has bee n the subject of information collec tion requireme nts by ATSDR or the I TC; the petition from the SDA did not addre ss this consideration. Both substanc es ar e par t of EPA’s HPV Challeng e Prog ram. SDA stated that the fa ct that these c hemicals a re sponsore d does not indicate a n ong oing inter est in proce ssing a

nd use data

for these chemica ls. Howeve r, EPA’s HPV Challeng e Prog ram see ks to collect a nd, wher e nec essar

y , develop a

scre ening -leve l hazard data set for c hemicals produc ed or imported in larg e quantities in the United States. EPA plans to scre en and, a s neede d, further assess che micals included unde r the HPV Challeng e Prog ram. F or this purpose, the IUR proce ssing a

nd use information is needed by EPA to put the hazard data into conte x t, complementingthe HPV Challeng e Prog ram submission by providingEPA with ex posurerelated information. IUR repor ting is nee ded at lea st once a nd, potentially , periodica lly 2 

## there afte r to more a ccur ately and re alistically

g aug e potential exposure and pr ovide information neede d for sc ree ning, a ssessing, a nd manag ing e x posures a nd risk. Other important use s of the repor ted information, eve n for low ha zard che micals, may include compa

rative e x posure analy ses, identification of safe r substitutes, or polluti on preve ntion investigations. 3



## Consideration D: The availabilit y of other com

plementary

risk scree ning informati on.
To addre ss this consideration, the petition from Ke ller and H eckma n noted that these two substances a

re similar to substance s that are alre ady partially exempt, differingin the composition of the fatty

acids. It was not clea

r how this simil arity

related to complementar

y risk
scre eninginformation.

Since both substances a

re inc luded in the HPV Challeng e Program a nd are sponsored through the I CCA HPV I nitiative (as desc ribed in the SDA pe tition), additional hazard data may become available . Howeve r, ef

fec tive risk scre eningand risk mana g ement re quire both exposure information and ha zard information. The a vailability

of hazard inf

ormation for the se substance s coupled with the IUR proce ssing a nd use information as an indicator of potential exposure will fac ilitate a more e ffe ctive scr eeningof this and other substanc es base d on either e x posure or risk.

R i s k i s c o m p o s e d o f h a z a r d a n d e x p o s u r e

. I n o r d e r t o s c r e e n f o r p o t e n t i a l r i s k i n t h e U

. S

. , b o t h h a z a r d 2 d a t a a n d e x p o s u r e
- r e l a t e d d a t a r e l a t i v e t o U

. S

. s i t u a t i o n s a r e n e e d e d

. E x p o s u r e i s b a s e d u p o n m a n u f a c t u r i n g , p r o c e s s i n g , a n d u s e s c e n a r i o s , a l l o f w h i c h c h a n g e o v e r t i m e a s t e c h n o l o g y a n d o t h e r s o c i e t a l e f f e c t s c h a n g e

. T h e
c h a n g i n g n a t u r e o f e x p o s u r e s c e n a r i o s m e a n s t h e p o t e n t i a l r i s k s a s s o c i a t e d w i t h a c h e m i c a l c a n a l s o c h a n g e , a n d t h e r e f o r e t h e c o l l e c t i o n o f e x p o s u r e
- r e l a t e d i n f o r m a t i o n o v e r t i m e i s f u n d a m e n t a l t o i d e n t i f

y i n g p o t e n t i a l r i s k s

. ( S e e 6 8 F R 8 4 8 , 8 5 2 f

o r f u r t h e r d i s c u s s i o n )

F o r a d d i t i o n a l i n f

o r m a t i o n o n u s e s o f I U R p r o c e s s i n g a n d u s e i n f o r m a t i o n , s e e I U

R A D a t a U

s e P l a n , 3 l o c a t e d i n E P A ’ s e l e c t r o n i c d o c k e t O P P T

- 2 0 0 2

- 0 0 5 4 , i t e m n u m b e r 0 2 6 1

. 

## Pag e 3 of 6

## Consideration E: The availabili ty of comparable proc essing and use information.

The pe tition from Keller a nd Hec kman indicated that the proce ssing a nd use of these substances is well-cha

rac terized, and include d excerpts from the K irk-Othmer Encyclopedia of

Chemical Tec hnology . The e x cer

pts, however , are from 1984, ra ising a conce rn for

the timeliness and usefulness of

the exposure-re lated data prese nted there in. Since exposure scena rios chang e base d on uses and available tec hnology , information quickly become s outdated and of limit ed use. The IUR information is neede d to provide cur rent proc essingand use data for the United States. Additionally , IUR data e ncompass informa tion not included in the Kirk-Othmer Encyclopedia, such as the r elative importanc e of e ach use , and ther efor e the e x cer pts are not judg ed to provide compar able pr ocessingand use data. For instance, the IUR collects data on the func tion of the chemica l in the industrial processingand use c ateg ory , the NAI CS code associated with the use, the amount of the c hemical g oing to e ach use cate g ory , and the number of potentially

exposed worke rs and the numbe r of sites assoc iated with ea ch use. F or commer cial and c onsumer uses, the IUR collects data

on the amount of the c hemical in var ious use cate g ories, the c oncentr ation of the c hemical in the use cate g ory , and the likelihood of inclusion in products intended f or children. F urthermor e, IUR information is updated eve ry four year s, is quantitative, and is specific to the United States.

Consideration F: W

hether the pote ntial risks for the che mical substance areadequately m anaged by EPA or another age ncy or authority. The pe tition from Keller a nd Hec kman indicated that EPA, NI OSH, OSHA, CPS C, and FD A all regulate the manuf

actur e and use of these pe tition s ubstance s, but did not provide information specific to individual chemicals except for FDAregulations. The petition reviewg roup does not consider that the FDAreg ulations cover issues unde r the purvie w of the othe r listed regulatory ag encie s and there fore do not nece ssarily addre ss all of the potential risks associated with the chemica l substance. Suffic ient evidenc e to state that potential risks of the chemica ls substances
are adequately

manag ed wa s theref

ore not include d in the petition. The SDA pe tition di d not identify or discuss any

risk manag ement ac tions taken by EPA or another ag ency or authority

with respec t to the petitioned chemica l(s). The pe tition di d not explain why

the downstrea

m proce ssing a

nd use information should be of low curr ent intere st in light of a ny such risk mana g ement ac tions.

Sou rce s Searc he d: ( Note: T hese sources are typi cally searched or reviewed to ga ther in format ion presented in the p etition review re po rt.)

Am erican Con f

erence of G overnm ental In du strial Hy gienists (A CG IH) ThresholdLim it V alues (TLV -TW A ). 2 00 3. A CG IH, Cincin nati OH. pp . 1 2-6 1.

A gency for Toxic Su bstances and Disease Registry (A TSDR) T oxFA Qs (Frequ ently aske d q uestion s abou t con tam inan ts found T M at hazardou s w aste sites). Available at http ://ww w .atsdr.cd c.gov/toxf

aq.h tm l

Calif orn ia A ir Resou rces Board List of T oxic A ir Co ntam inan t Fact Sh eets, av ailable at http ://arbis. arb.ca.gov/toxics/tac/toctbl. htm



## Pag e 4 of 6Calif orn ia EP A , Safe Drinking W ater and Toxic Enforcem ent Ac t o f 19 86 : List of chem icals known t o t he St ate to cause cancer or rep rod uctive toxicity . Listing as of Nov. 1 4, 20 03 . Av ailable at http ://ww w .oeh ha.ca.gov/prop 65 /CRNR_n otices/list_ changes/111 40 3lsta.h tm l

Intern ation al A gency

of Resea rch o n Can cer (IA RC) Overa ll Evaluatio ns o f Carcinogenicity

to Huma ns. A vailable at http ://m on ographs.i arc.f

r/m on oeval/crthall.ht m l
Interagency

Te sting Co m

m ittee (ITC) P riori ty

Te sting List. Av ailable at h ttp: //tsca-itc.sy rres.com /Chem icals/

Nation al A dvisory

Committee A cute Expo sure Guid eline Lev els (A EG Ls ). Av ailable at h ttp: //ww w .epa.gov/op pt/aegl/ind ex.htm Orga nisatio n for Eco no m ic Coo peration and Deve lop m ent (OECD) In tegra ted HP V Database, http ://cs3-h q.o ecd.org/scripts/h pv/ind ex.a sp
United Nation s Enviro nm ent P rogram m e (UNEP ) persistent organic po llut ants (P OP s), available at http ://ww w .chem .un ep.ch/p op s/defa ult. html

United Nation s Enviro nm ent P rogram m e (UNEP ) Ozone S ecre tariat, Su m m ary Con trol Measures, ava ilable at http ://ww w .un ep.o rg/ozon e/T reaties_and_ Ratif ication /2B_ m on treal_pro toco l.asp

U.S. EP A Clean Air A ct (CAA ) Hazardous Air P ollu tants (HAPs). Available in t he Clean Air A ct, section 11 2(b ), available at http ://ww w .epa.gov/air/caa/c aa112 .txt

U.S. EP A . E m erge ncy

P lann ing andComm

un ity Right-to -Kno w

A ct Section 31 3, Lis t o f

Toxic Chem icals. 20 01 . Off ice of Enviro nm ental In f

orma tion , EP A 26 0-B-0 1-0 01 , available at http:// w w w .epa.gov/tri/chem ical/chem list20 01 .pd f

U.S. EP A HP V (High P rod uctio n V olu m e) Challenge P rogram and V olu ntary

Chi ldren 's Chem ical Evaluation P rogram (V CCEP ) Web sites und er the EP A Chem ical Right-to -Kno w Ini tiative, h ttp: //ww

w .epa.gov/chem

rtk

U.S. EP A Int egra ted Risk Inform ation Sy stem (IRIS) Sub stance L ist. Available at http ://ww w .epa.gov/iris/sub st/ind ex.htm l

U.S. EP A . Natio nal Recomm ended Water Quality Criteria: 2 00 2. Of

f ice of W ater. EP A -82 2-R-0 2-0 47 . Av ailable at http ://ww w .epa.gov/w atersc ience/pc/revcom .pd f

U.S. EP A . 2 00 4 E diti on of the Drin king W ater Stand ards and Health Advisories. Off ice of W ater. EP A -82 2-R-0 4-0 05

. Available at http ://ww

w .epa.gov/w atersc ience/drin king/standards/d w standard s.pd f

U.S. EP A Su bstance Registry

Sy stem (SRS ). Av ailable at h ttp: //ww w .epa.gov/srs/

U.S. Occupation al Saf

ety and Health Adm inistratio n (OS HA ) P erm issible Expo sure Lim its (P ELs), av ailable at http ://ww w .osh a.gov/SL TC /pel/in dex.html



## Pag e 5 of 6

## List of A crony ms
ACGIH Am eric an Conf erence of Governm ental Indus trial Hygienis ts A EG L Ac ute Exposure G uideline Level A RB Ai r Res ources B oard A TSDR Agenc y for Tox ic S ubst ances and Dis ease Regis try CA A Clean A ir A ct CA SRN Chem ic al A bst ract S ervice Regis try Num ber CICA D Conci se Int ernational Chem ic al A ss ess m ent Docum ent CPS C Consum er P roduct S afet y Com m is si on EHC Environm ental Health Criteria EP A Environm ental Prot ect ion A gency EU European Union FDA Food and Drug Adm inis trat ion FFDCA Federal Food, Drug, and Cosm etic A ct FI FRA Federal Ins ect ic ide, Fungic ide, and Rodent ic ide A ct GRA S Generally Recogn ized as S afe HA P Hazardous Ai r P ollut ant HPV High P roduct ion V olum e HSDB Hazardous Subs tanc es Databank IA RC Int ernational A gency of Researc h on Cancer ICCA Int ernational Counc il of Chem ic al A ss oci ations IF CS Int ernational F orum on Chem ic al S afet y IP CS Int ernational P rogram m e on Chem ic al S afet y IRI S Int egrated Ris k Inform ation Sys tem IRP TC Int ernational Regis ter of Pot ential ly T ox ic Chem ic als ITC Int eragency Tes ting Com m itt ee IUCL ID Int ernational Unif orm Chem ic al I nform ation Databas e IUR Invent ory Update Reporting Rule IURA Invent ory Update Reporting Rule A m endm ent NA ICS North Am eric an I ndust ry Clas si fic ation Sys tem NIOS H Nationa l I nst itut e f or Oc cupat ional Saf ety an d Healt h OE CD Organis ation for Ec onom ic Cooperat ion an d Developm ent OE CD HP V SI DS or OE CD HP V SI DS pro gram OE CD/S IDS HP V Chem ic als P rogram m e

OP P Off ic e of P est ic ide P rogram s OP PT Off ic e of P ollut ion P revention and T ox ic s OS HA Oc cupat ional Saf ety an d Healt h A dm inis trat ion PE L Perm is si ble E x posure Lim it PO P Pers is tent Organi c Pol lutant SI A M SI DS Init ial As ses sm ent Meeting SI A P SI DS Init ial As ses sm ent Prof ile SI A R SI DS Init ial As ses sm ent Report SI DS Sc reening I nform ation Data Set SRS Subs tanc e Regis try S yst em TLV-TW A Thres hold L im it Val ue T im e-W eighte d A verage TRI Tox ic s Releas e I nventory TSCA Tox ic S ubst ances Cont rol A ct UNEP United Nations E nvironm ent Program m e VCCE P Vol untary Chi ldren’s Chem ic al E valuatio n P rogram



## Pag e 6 of 6