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 andHeckman 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 of your petition

requesting that 41 chemical substances, listed below by CAS registry number and TSCA

Inventory chemical name, be exempted from the reporting of processing and use information

under the Inventory Update Reporting (IUR) rule (See 40 CFR 710.46(b)(2)(iv)). For the

reasons explained below, one chemical is not required to 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-propanetricarboxylic acid, 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-propanetricarboxylic acid, 2-hydroxy-, tripotassium salt

vitamin E

butanedioic acid, hydroxylecithins, soya

proteins, soybean

fatty acids, vegetable-oil

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'0<;7 contains at least 50% recycled fiber

.
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, C16-18 and C18-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 of the 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 collected through

the IUR rule, will be used by EPA to support activities which are essential to achieving this goal.

In conjunction with available hazard data, the IUR information will be used to support risk

screening, assessment, priority setting, and management activities, as appropriate. The

information collected under the IUR rule 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,

chemicalsubstances are included on this list only if EPA has determined that there is low current

interest in the processing and use information for that substance.

Regarding proteins, soybean (CASRN 9010-10-0), in our May 17,2004, initial

acknowledgment of your petition1,EPA stated that this chemical is exempt from reporting under

the IUR rule because it is a polymer (see 40 CFR 71O.46(a)(I)).Additionally, starch, oxidized

IPleasenote that the May 17thletter replaced a letter dated May 4th,which was mistakenly mailed

to you. Ms. Martha Marrapese was informed by telephone of the retraction of the 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 if their composition is intended to contain all polymeric molecules. However, if their

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 if any are, indeed, polymers. The review of these

chemicals has been suspended pending notification that they do not meet the 40 CFR

710.46(a)(l) definition of polymer. Please also see the discussion below concerning low volume

chemicalsubstances.

As explained in the preamble to the rule, in making its determination about whether there

is low current interest in gathering processing and use 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 of the considerations [specified in the rule] and/or [additional]

considerations...tomake an informed decision" (68 FR 848,855 (January 7, 2003)). EPA has

evaluated your petition in light of these considerations, using the information provided in your

petition and other information, as described in the attached petition 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 either the lack of previous IUR reporting for

those substances or for the reporting of volumes well below 300,000 pounds. In a follow-up

letter dated July 26, 2004, you requested that we continue our review of those substances as there

is the chance, some time in the possible future, that these substances will be used for a TSCA use

in sufficient volume 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 of making 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-propanetricarboxylic acid, 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

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In 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, if these three substances are determined to not meet the polymer

definition provided in an earlier paragraph, their TSCA-related production volumes are not

expected to meet or exceed the 300,000 pound threshold required to report the IUR processing

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). If the level of interest in

the IUR processing and use information for this chemical substance changes, EPA will

reevaluate the decision to include it in the partial exemption.

Regarding xylitol (CASRN 87-99-0);soybean meal (CASRN 68308-36-1); fats and

glyceridic oils, vegetable (CASRN 68956-68-3); and canola oil (CASRN 120962-03-0),EPA has

determined that processing and use information for these four chemicals appears to be of low

current interest at this time and will initiate rulemaking necessary to add them to the list of

chemicals partially exempt from reporting under 40 CFR 710.46(b)(2). The final listing decision

is pending, based on possible responses to the publication of the rule. Additionally, if the level

of interest in the IUR processing and use information for these chemical substances changes,

EPA will reevaluate the decision to include them in the partial exemption.

The remaining sixteen of your petition substances, listed below, are part of the HPV

Challenge Program or are potential program additions. As discussed iJlthe document,

"Methodology Used for the Initial Selection of Chemicalsfor the Inventory Update Rule

Amendments(IURA) 'Low Current Interest' Partial Reporting Exemption," EPA considersthe

IUR processing and use information for HPV chemicals to be of current interest, as it will be

used with the hazard-screening information, generated by the HPV sponsors, to support risk

screening and other important activities as appropriate, in support of protecting human health and

the environment. Additionally, the IUR processing and use information for these chemicals will

be used as part of an overall database, allowing the Agency to comparatively identify potential

exposure- and risk-related scenarios, or in other uses 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-propanetricarboxylic acid, 2-hydroxypropanoic acid, 2-hydroxy-, ethyl ester

2-butenedioic acid (2E)-

D-gluconic acid, monosodium salt

benzoic acid, sodium salt

butanedioic acid, hydroxy4
8030-77-0

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, C16-C18

fatty acids, C16-18and C18-unsatd.,Me esters

fatty acids, soya

soaps, stocks, soya, acidulated

soaps, stocks, acidulated

Thus, after considering the totality of information available during the review of your

petition, EPA identified current interest in the IUR processing and use information for these

sixteen chemicals and is denying your petition. The enclosed five reports further explain the

Agency's review of your petition.

Additional information concerning your petition can also be found in EPA's docket

number EPA-HQ-OPPT-2004-0071. Please contact Susan Sharkey at 202-564-8789 or

sharkey.susan@epa.gov with any questions.

Sincerely,

~A,~

Cliarles M. Auer, Director

Office of Pollution Prevention and Toxics

Enclosures (5)

1. IUR Petition Review Report for:

57-48-7 D-fructose

68-04-2 1,2,3-propanetricarboxylic acid, 2-hydroxy-, trisodium salt

77-92-9 1,2,3-propanetricarboxylic acid, 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

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3. 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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