UNITED STATES ENVIRONMENTAL PROTECTION AGENCY WASHINGTON, D.C. 20460

JAN 

## 3 1 2006

OFFICE OF PREVENTION, PESTICIDES AND TOXIC SUBSTANCES Mr. Herbert Estreicher, Esq. Ms. Martha E. Marrapese, Esq. Keller and Heckman LLP 1001 G Street, N.W. Suite 500 West Washington, DC 20001

RE: Petition for Partial Exemption from Inventory Update Reporting Requirements

Dear Mr. Estreicher and Ms. Marrapese:

The Environmental Protection Agency (EPA) has completed review ofyour petition requesting that 41 chemical substances, listedbelow by CAS registry number and TSCA Inventory chemical name, be exempted from the reporting ofprocessing and use information underthe Inventory Update Reporting (IUR) rule (See 40 CFR 710.46(b)(2)(iv)). For the

reasons explainedbelow, one chemical is not requiredto report and four other chemicals may not need to report under the IUR, the petition for five chemicals is granted, and the petition for the remaining 31 is denied.

50-21-5 56-81-5 57-48-7 64-17-5 68-04-2 77-92-9 87-78-5 87-99-0 97-64-3 110-17-8 527-07-1 532-32-1 866-84-2 1406-18-4 6915-15-7 8030-76-0 9010-10-0 61788-66-7 propanoic acid, 2-hydroxy1,2,3-propanetriol (identified as glycerin in the petition) D- fructose ethanol 1,2,3-propanetricarboxylicacid, 2-hydroxy-, trisodium salt 1,2,3-propanetricarboxylic acid, 2-hydroxy- mannitol xylitol propanoic acid, 2-hydroxy-, ethyl ester 2-butenedioic acid (2E)- (also identified as fumaric acid in the petition) D-gluconic acid, monosodium salt benzoic acid, sodium salt 1,2,3-propanetricarboxylicacid, 2-hydroxy-, tripotassium salt vitamin E butanedioic acid, hydroxylecithins, soya proteins, soybean fatty acids, vegetable-oil

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.65996-62-5 67701-03-5 67762-38-3 68308-36-1 68308-50-9 68308-51-0 68308-53-2 68308-87-2 68334-29-2 68412-29-3 68424-10-2 68425-24-1 68512-26-5 68513-95-1 68525-86-0 68584-86-1 68607-87-4 68607-88-5 68918-03-6 68956-68-3 68990-86-3 70084-94-5 120962-03-0 starch, oxidized fatty acids, C16-C18 fatty acids, C 16-18 and C 18-unsatd.,Me esters soybean meal fatty acids, com-oil fatty acids, cottonseed-oil fatty acids, soya cottonseed, flour fats and glyceridic oils, vegetable, winterized starch, hydrolyzed cottonseed meal
soaps, stocks, soya, acidulated starch, 2-hydroxyethyl ether, base-hydrolyzed soybean, flour
com flour starch, acid-hydrolyzed, 2-hydroxypropyl ether soaps, stocks, acidulated protein hydrolyzates, soya soybean oil, winterized fats and glyceridic oils, vegetable soaps, stocks, cottonseed-oil, acidulated proteins, soy, enzyme-modified canola oil

The overarching goal ofthe Toxic Substances Control Act (TSCA) is to protect human health and the environment from risks associated with the manufacturij1g,processing, and use of chemicals. Information on processing and use, and other exposure-related data collectedthrough the IURrule, will be used by EPA to support activities which are essential to achieving this goal. In conjunctionwith available hazard data, the IUR information will be used to support risk screening, assessment, priority setting, and management activities, as appropriate. The informationcollected under the IURrule will provide EPA with data to gauge potential exposuresto chemical substances with increased accuracy and, because exposure scenarios can change significantly over time, with more currency.

Manufacturers of chemicals listed at 40 CFR 710.46(b) are exempt from reporting the processing and use information required by 40 CFR 71O.52(c)(4). As described in the rule, chemical substances are included on this list only ifEPA has determined that there is low current interest inthe processing and use information forthat substance.
Regarding proteins, soybean (CASRN 9010-10-0), in our May 17,2004, initial acknowledgmentofyour petition1,EPA statedthat this chemical is exempt from reporting under the IURrule because it is a polymer (see 40 CFR 71O.46(a)(I)). Additionally, starch, oxidized

IPleasenote that the May 17th letter replaced a letter dated May 4th,which was mistakenly mailed to you. Ms. Martha Marrapese was informedby telephone ofthe retraction ofthe May 4thletter. 2(CASRN 65996-62-5); starch, hydrolyzed (CASRN 68412-29-3); starch, 2-hydroxyethyl ether, base-hydrolyzed (CASRN 68512-26-5); and starch, acid-hydrolyzed, 2-hydroxypropyl ether (CASRN 68584-86-1) may also be polymers. These four substances would be considered polymeric iftheir composition is intended to contain all polymeric molecules. However, iftheir intended composition includes some non-polymeric material, EPA would not view the substances as polymeric, and they would not be excluded from IUR reporting. Please review this definition and these substances to determine ifany are, indeed, polymers. The review ofthese chemicalshas been suspended pending notification that they do not meet the 40 CFR 710.46(a)(l) definition ofpolymer. Please also see the discussion below concerning low volume chemical substances.

As explained in the preamble to the rule, in making its determination about whether there is low current interest in gathering processing anduse information with respect to a chemical substance, "EPA will look to the specific circumstances surrounding the chemical in question, and may use one or more ofthe considerations [specifiedin the rule] and/or [additional] considerations...tomake an informed decision" (68 FR 848,855 (January 7, 2003)). EPA has evaluatedyour petition in light ofthese considerations, using the information provided in your petition and other information, as described in the attachedpetition review report.
Regarding the fifteen substances listed below, EPA notified you in a May 17, 2004, letter that the Agency was suspending their review due to eitherthe lack ofprevious IUR reporting for those substances or forthe reporting ofvolumes well below 300,000 pounds. In a follow-up letter datedJuly 26, 2004, you requested that we continue ourreview ofthose substances as there is the chance, some time in the possible future, that these substances will be used for a TSCA use in sufficientvolume to trigger IUR processing and use reporting. EPA has revisited the issue, and is denying the petition for these fifteen chemicals. The Agency qyestions the public policy value ofmaking partial exemption decisions on chemicals for which there is no basis to believe that the 300,000 pound trigger volume will be met.

50-21-5 87-78-5 866-84-2 1406-18-4 68308-50-9 68308-51-0 68308-87-2 68334-29-2 68424-10-2 68513-95-1 68525-86-0 68607-88-5 68918-03-6 68990-86-3 70084-94-5 propanoic acid, 2-hydroxymannitol 1,2,3-propanetricarboxylicacid, 2-hydroxy-, tripotassium salt vitamin E fatty acids, corn-oil fatty acids, cottonseed-oil cottonseed, flour fats and glyceridic oils, vegetable, winterized cottonseed meal soybean, flour
corn flour protein hydrolyzates, soya 

### soybeanoil,winterized

. soaps, stocks, cottonseed-oil, acidulated proteins, soy, enzyme-modified

3In addition, the following three substances, describe above as possible polymers, also have past production volumes well below 300,000 pounds: starch, oxidized (CASRN 65996-62-5); starch, hydrolyzed (CASRN 68412-29-3); and starch, acid-hydrolyzed, 2-hydroxypropyl ether (CASRN 68584-86-1). Therefore, ifthese three substances are determined to not meet the polymer definitionprovided in an earlier paragraph, their TSCA-relatedproduction volumes arenot expectedto meet or exceed the 300,000 pound threshold required to report the IURprocessing and use information. Like the fifteen substances above, the petitions for these three substances would be denied.

Regarding 1,2,3-propanetriol (CASRN 56-81-5), in response to a different petition, EPA published a direct final rule adding this chemical to the partial exemption list of chemical substances at 40 CFR 710.46(b) on October 17,2005 (70 FR 60217). Ifthe level ofinterest in the IURprocessing and use information for this chemical substance changes, EPA will reevaluatethe decision to include it inthe partial exemption.
Regarding xylitol (CASRN 87-99-0); soybeanmeal (CASRN 68308-36-1); fats and glyceridic oils, vegetable (CASRN 68956-68-3); and canola oil (CASRN 120962-03-0),EPA has determinedthat processing anduse information forthese four chemicals appears to be oflow current interest atthis time and will initiate rulemakingnecessary to add them to the list of chemicalspartially exempt from reporting under40 CFR 710.46(b)(2). The final listing decision is pending, based on possible responses to the publication ofthe rule. Additionally, ifthe level ofinterestin the IUR processing and use information forthese chemical substances changes, EPA will reevaluatethe decision to include them in the partial exemption.

The remaining sixteen of yourpetition substances, listed below, are part ofthe HPV ChallengeProgram or are potential program additions. As discussed iJlthe document, "Methodology Used forthe Initial Selection of Chemicals for the Inventory Update Rule Amendments (IURA) 'Low Current Interest' Partial Reporting Exemption," EPA considers the IURprocessing anduse information forHPV chemicals to be of current interest, as it will be used with the hazard-screening information, generatedby the HPV sponsors, to supportrisk screening and other important activities as appropriate, in support ofprotecting human health and the environment. Additionally, the IURprocessing anduse information for these chemicals will be used as part of an overall database, allowing the Agency to comparatively identify potential exposure- andrisk-related scenarios, or in otheruses as further described in the petition review report.

57-48-7 64-17-5 68-04-2 77-92-9 97-64-3 110-17-8 527-07-1 532-32-2 6915-15-7 D-fructose ethanol 1,2,3-propanetricarboxylic acid, 2-hydroxy-, trisodium salt 1,2,3-propanetricarboxylicacid, 2-hydroxypropanoic acid, 2-hydroxy-, ethyl ester 2-butenedioic acid (2E)- D-gluconic acid, monosodium salt benzoic acid, sodium salt butanedioic acid, hydroxy48030-77-0 61788-66-7 67701-03-5 67762-38-3 68308-53-2 68425-24-1 68607-87-4 lecithins, soya fatty acids, vegetable-oil fatty acids, C 16-C18 fatty acids, C 16-18and C18-unsatd.,Me esters fatty acids, soya soaps, stocks, soya, acidulated soaps, stocks, acidulated

Thus, after considering the totality ofinformation available during the review ofyour petition, EPA identified current interest in the IUR processing and use information forthese sixteen chemicals and is denying yourpetition. The enclosed five reports further explainthe Agency's review ofyour petition.

Additional information concerning yourpetition can also be found in EPA's docket numberEPA-HQ-OPPT-2004-0071. Please contact Susan Sharkey at 202-564-8789 or sharkey.susan@epa.govwith any questions.
Sincerely, 

# ~A,~
Cliarles M. Auer, Director Office ofPollution Prevention and Toxics

Enclosures (5) 1. IUR Petition Review Report for: 57-48-7 D-fructose 68-04-2 1,2,3-propanetricarboxylicacid, 2-hydroxy-, trisodium salt 77-92-9 1,2,3-propanetricarboxylicacid, 2-hydroxy97-64-3 propanoic acid, 2-hydroxy-, ethyl ester 110-17-8 2-butenedioic acid (2E)- 527-07-1 D-gluconic acid, monosodium salt 532-32-1 benzoic acid, sodium salt 6915-15-7 butanedioic acid, hydroxy8030-76-0 lecithins, soya 61788-66-7 fatty acids, vegetable-oil 67762-38-3 fatty acids, C16-18 and CI8-unsatd., Me esters 68425-24-1 soaps, stocks, soya, acidulated 68607-87-4 soaps, stocks, acidulated

2. IUR Petition Review Report for: 64-17-5 ethanol

53. IUR Petition Review Report for: 67701-03-5 fatty acids, C16-C18 68308-53-2 fatty acids, soya

4. IUR Petition Review Report for: 56-81-5 1,2,3-propanetriol

5. IUR Petition Review Report for: 87-99-0 xylitol 68308-36-1 soybean meal 68956-68-3 fats and glyceridic oils, vegetable 120962-03-0 canola oil

cc: Docket number EPA-HQ-OPPT-2004-0071

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