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IUR Petition Review Report

December 20, 2005

CASRNs and TSCA Inventory Chemical Names:

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 C18-unsatd., Me esters

68425-24-1 soaps, stocks, soya, acidulated

68607-87-4 soaps, stocks, acidulated

Alternate Chemical Names Used in Petition: In addition to the TSCA Inventory chemical 

names listed above, the petition also referred to the chemicals using non-TSCA Inventory 

chemical names. Table 1 at the end of this report lists the alternate chemical names. 

Petitioner and Petition Docket Number:

Keller & Heckman EPA-HQ-OPPT-2004-0071

Note: This petition contained additional petition chemicals. These additional petition chemicals 

are addressed in other petition review reports.

Summary of Decision: The petition review group recommends a denial for this petition as EPA 

has a current interest in the processing and use information collected under the Inventory Update 

Reporting (IUR) rule (see 40 CFR Part 710) for the thirteen chemicals listed above. This 

recommendation is based, in part, on the determination by the petition review group that there is 

a direct application of the IUR processing and use information to complement data collected by 

or identified for use under the HPV Challenge Program. See Considerations A, C, D, and E.

Background: EPA received a petition requesting that the thirteen chemicals listed above be 

added to the 40 CFR 710.46(b)(2)(iv) list of specific chemical substances that are exempt from 

the reporting of industrial processing and use and commercial/consumer use information 

required by 40 CFR 710.52(c)(4). The chemical substances included on this “partial exemption” 

list are substances for which EPA has previously determined that there is a low current interest in 

the IUR processing and use information. However, as stated in the preamble to the amendment 

to the IUR rule promulgated on January 7, 2003 (68 FR 854), “...the need for processing and use 

information ... changes over time. The inclusion of a chemical substance under this partial 

exemption is not based on the potential risks of a chemical. This partial exemption is solely 

intended to provide a tool to assist the Agency in better managing the collection of processing 

and use information...” and is also “based on the Agency’s current need for collecting IURA 
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processing and use information” (68 FR 855). Additionally, the preamble states, “[i]n 

determining whether there is low current interest in IURA processing and use information related 

to a specific chemical substance, EPA will look to the specific circumstances surrounding the 

chemical in question, and may use one or more of the considerations identified below, and/or 

considerations not identified below, to make an informed decision.” Id. The considerations used 

by EPA in reviewing this petition and an analysis of how those considerations relate to the 

chemicals identified in this petition are set forth below.

EPA recently published revisions to the IUR rule, making certain clarifying changes to the 

petition requirements and considerations (70 FR 75059, December 19, 2005). Because this 

petition was submitted prior to the revisions rule publication, the original requirements and 

considerations were used in its evaluation. Petitions received after December 19, 2005, will be 

evaluated using the revised requirements and considerations.

Discussion: The petition review group considered information submitted with the petition, as 

well as other information including (but not limited to): whether the petition substances are 

included in TRI, IRIS, or IARC; OECD HPV SIDS program status; HPV Challenge Program 

status; and their inclusion in other regulatory programs administered by EPA.1

The petition provided information from publicly available sources such as the 1984 Kirk-Othmer 

Encyclopedia of Chemical Technology, government lists, and other sources. The petition linked 

the information to specific considerations cited in 40 CFR 710.46(b)(2)(ii). This information is 

included in the discussions below. 

 

Consideration A: Production volume.

The petition review group found that there was at least one site reporting in 2002 with a 

production volume of 300,000 pounds or greater for each of these chemicals.

Consideration B: The substance’s chemical and physical properties or potential for persistence,

bioaccumulation, health effects, or environmental effects.

The petition included excerpts from the 1984 Kirk-Othmer Encyclopedia of Chemical 

Technology to address this consideration for each of these thirteen substances. The petitioner, 

however, did not identify specific information within those excerpts which addresses 

Consideration B. The excerpts included summary information on physical and chemical 

properties and/or health and environmental aspects. Some information contained in these 

excerpts seems to indicate that these substances generally present a low risk of adverse human 

health or environmental effects.

Additionally, some of the Kirk-Othmer Encyclopedia of Chemical Technology excerpts 

contained very little information pertaining to this consideration. For example, the referenced 

excerpt for D-fructose (CASRN 57-48-7) contained no information on health or environmental 

 1

See the attached list of acronyms at the end of this report.
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effects other than a statement that “long-range studies of the effects of fructose feeding in 

humans have not been conducted” (Ref. 1). Furthermore, other referenced excerpts did not 

pertain to the specific petition substance, but rather a general group of substances. For example, 

for propanoic acid, 2-hydroxy-, ethyl ester (CASRN 97-64-3) the referenced excerpt was for 

“Hydroxy Carboxylic Acids” and it contained information mostly for lactic acid. It contained 

only a few sentences on the physical and chemical properties of propanoic acid, 2-hydroxy-, 

ethyl ester (CASRN 97-64-3) and no information on health or environmental effects specific to 

propanoic acid, 2-hydroxy-, ethyl ester (CASRN 97-64-3).

The petition review group also found that three of these chemicals, 1,2,3-propanetricarboxylic 

acid, 2-hydroxy- (CASRN 77-92-9), D-gluconic acid, monosodium salt (CASRN 527-07-1), and 

benzoic acid, sodium salt (CASRN 532-32-1), have undergone review in the OECD HPV SIDS 

program. The petition review group reviewed the SIAPs for these three chemicals, all of which 

indicated that these chemicals are considered of low priority for further work (within the OECD 

HPV SIDS program) (Refs. 2, 3, and 4). The SIAPs indicated that human health and 

environmental toxicity for these three substances are generally low; additionally, the SIAP for 

1,2,3-propanetricarboxylic acid, 2-hydroxy- (CASRN 77-92-9) indicated that irritation, in 

particular of the eyes but also of the respiratory pathways and the skin, is the major toxicological 

hazard presented by this chemical.

Consideration C: The information needs of EPA, other federal agencies, tribes, states, and local 

governments, as well as members of the public.

To address this consideration, the petition noted that none of these chemicals has been the 

subject of information collection requirements by ATSDR or the ITC. The petition also 

indicated that FDA regulatory clearances currently available for these petitioned substances 

acknowledge that their use in food applications is safe, and that many of these substances are 

similar in chemistry and use to substances already recognized as of low current interest for 

purposes of IUR. 

However, nine of these chemicals are included in the HPV Challenge Program. The HPV 

Challenge Program seeks to collect and, where necessary, develop a screening-level hazard data 

set for chemicals produced or imported in large quantities in the United States. EPA plans to 

screen and, as needed, further assess chemicals included under this program. Therefore, the IUR 

processing and use information is needed by EPA to put the hazard data into context, 

complementing the HPV Challenge Program submissions by providing EPA with exposurerelated information.2

 2

Risk is composed of hazard and exposure. In order to screen for potential risk in the United States, both hazard data 

and exposure-related data relative to United States situations are needed. Exposure is based upon manufacturing, processing, and 

use scenarios, all of which change over time as technology and other societal effects change. The changing nature of exposure 

scenarios means the potential risks associated with a chemical can also change, and therefore the collection of exposure-related 

information over time is fundamental to identifying potential risks. (See 68 FR 848, 852 for further discussion)

 The reporting of IUR processing and use information is needed at least 

once and, potentially, periodically thereafter to more accurately and realistically gauge potential 

exposure and provide information needed for screening, assessing, and managing exposures and 

risk. Other important uses of the reported information, even for low-hazard chemicals, may 
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include comparative exposure analyses, identification of safer substitutes, or pollution prevention 

investigations.3

The other four chemicals are on the 1994 IUR list of potential HPV Challenge Program 

additions. The IUR processing and use information is of current interest to assist in determining 

if these four chemicals should be included in the HPV Challenge Program. 

Consideration D: The availability of other complementary risk screening information.

To address this consideration, the petition stated that some of these petition chemicals should be 

partially exempt because they are classified as either 4A (“minimal risk inert ingredients”) or 4B 

(“inerts which have sufficient data to substantiate that they can be used safely in pesticide 

products”). As stated in the petition, listing as 4A or 4B indicates that these substances have 

been found to be safe when used in high exposure applications such as pesticide inert 

ingredients. This does not necessarily apply to other non-pesticidal uses of these chemicals.

The petition also pointed out that some of these petition chemicals are structurally similar to 

other chemicals that are already listed as partially exempt chemicals or List 4A or 4B pesticide 

inerts. Therefore, the petition states, these petition chemicals should also be included as partially 

exempt. EPA does not consider structural similarity alone to be a sufficient rationale for 

including a chemical on the partial exemption list. 

With the collection of IUR processing and use data for these chemicals, the United States will be 

able to identify domestic situations by combining available hazard data with the IUR exposurerelated information, thereby identifying new or revised exposure scenarios. Effective risk 

screening and risk management require both exposure information and hazard information. The 

availability of hazard information for these substances, coupled with the collection of IUR 

processing and use information as an indicator of potential exposure, will facilitate a more 

effective screening of these and other substances based on either exposure or risk. See 

Consideration E below for further discussion of the IUR exposure-related processing and use 

information.

Consideration E: The availability of comparable processing and use information.

The petition indicated that the processing and use of these substances is well-characterized, and 

included excerpts from the 1984 Kirk-Othmer Encyclopedia of Chemical Technology to address 

this consideration. The petitioner, however, did not identify specific information within those 

excerpts which addresses Consideration E. The excerpts do contain some processing and use 

information; the Kirk-Othmer Encyclopedia, however, is dated 1984, raising a concern for the 

timeliness of the information presented therein, which is at least 20 years old. Since exposure 

scenarios change based on uses and available technology, information quickly becomes outdated 

and of limited use. Because of this, the relative importance of each use may change or new uses 

 3

For additional information on uses of IUR processing and use information, see IURA Data Use Plan, located in EPA’s 

electronic docket EPA-HQ-OPPT-2002-0054, item number 0261. 
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may develop. EPA believes tracking these changes is important. The IUR provides current 

exposure-related processing and use information in the United States every five years. This 

facilitates tracking changes in use patterns and the identification of new exposure scenarios, 

which is an important component of risk screening. Additionally, the IUR contains some 

exposure-related data elements not provided in the Kirk-Othmer Encyclopedia of Chemical 

Technology, such as data on the function of the chemical in the industrial processing and use 

category, the NAICS code associated with the use, and the number of potentially exposed 

workers and the number of sites associated with each use. For commercial and consumer uses, 

the IUR collects data on the amount of the chemical in various use categories, the concentration 

of the chemical in the use category, and the likelihood of inclusion in products intended for 

children. Furthermore, IUR information is updated every five years, is quantitative, and is 

specific to the United States.

Consideration F: Whether the potential risks for the chemical substance are adequately 

managed by EPA or another agency or authority.

To address this consideration, the petition indicated that EPA, NIOSH, OSHA, CPSC, and FDA 

all regulate the manufacture and use of these substances; however, the petition did not explain 

why the downstream processing and use information should be of low current interest in light of 

these regulatory actions.

Other Considerations/Notes:

The petition review group found that the OECD HPV SIDS SIAPs for 1,2,3-propanetricarboxylic 

acid, 2-hydroxy- (CASRN 77-92-9), D-gluconic acid, monosodium salt (CASRN 527-07-1), and 

benzoic acid, sodium salt (CASRN 532-32-1) noted conclusions of a low priority for further 

work under OECD HPV SIDS. A designation of low priority for further work within the OECD 

HPV SIDS program means that no further hazard testing is needed to meet the purposes of 

OECD HPV SIDS at the time the review was completed. These judgments, however, do not 

determine the approach that an individual OECD member country must take in considering such 

chemicals. Rather, the OECD assessment is seen as a starting point for assessment by individual 

countries. In the United States case, it is a starting point for a screening-level risk assessment, 

for which IUR processing and use reporting provides screening-level exposure information. In 

the past there have been a number of chemicals identified by the OECD HPV SIDS program as a 

“low priority for further work,” but for which EPA wanted to make a confirmatory priority 

judgment based on risk - i.e., screening-level hazard information based on the OECD work plus 

screening-level exposure information based on the United States situation.
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Table 1: Chemical Names Also Used in Petition that Differ from

TSCA Inventory Chemical Names

CASRN TSCA Inventory Chemical Name Chemical Name 

Also Used in 

Petition

57-48-7 D-fructose levulose

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

trisodium salt

sodium citrate 

anhydrous

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

97-64-3 propanoic acid, 2-hydroxy-, ethyl ester ethyl lactate

110-17-8 2-butenedioic acid (2E)- fumaric acid

527-07-1 D-gluconic acid, monosodium salt sodium gluconate

532-32-1 benzoic acid, sodium salt sodium benzoate

6915-15-7 butanedioic acid, hydroxy- malic acid

Cited References

1) Keller &Heckman petition. Dated December 2003. Docket no. OPPT-2004-0071. Available at www.epa.gov/edocket

2) SIAP for D-gluconic acid, monosodium salt (CASRN 527-07-1). Dated April 2004. Available on the Web at http://cs3-

hq.oecd.org/scripts/hpv/index.asp

3) SIAP for benzoic acid, sodium salt (CASRN 532-32-1). Dated November 2001. Available on the Web at http://cs3-

hq.oecd.org/scripts/hpv/index.asp

4) SIAP for 1,2,3-propanetricarboxylic acid, 2-hydroxy- (CASRN 77-92-9). Dated January 2001. Available on the Web at 

http://cs3-hq.oecd.org/scripts/hpv/index.asp

Sources Searched:

(Note: These sources are typically searched or reviewed to gather information presented in the petition review report.)

American Conference of Governmental Industrial Hygienists (ACGIH) Threshold Limit Values (TLV-TWA). 2003. ACGIH, 

Cincinnati OH. pp. 12-61.

Agency for Toxic Substances and Disease Registry (ATSDR) ToxFAQsTM (Frequently asked questions about contaminants 

found at hazardous waste sites). Available at http://www.atsdr.cdc.gov/toxfaq.html

California Air Resources Board List of Toxic Air Contaminant Fact Sheets, available at 

http://arbis.arb.ca.gov/toxics/tac/toctbl.htm

California EPA, Safe Drinking Water and Toxic Enforcement Act of 1986: List of chemicals known to the State to cause cancer 

or reproductive toxicity. Listing as of Nov. 14, 2003. Available at 

http://www.oehha.ca.gov/prop65/CRNR_notices/list_changes/111403lsta.html

International Agency of Research on Cancer (IARC) Overall Evaluations of Carcinogenicity to Humans. Available at 

http://monographs.iarc.fr/monoeval/crthall.html

Interagency Testing Committee (ITC) Priority Testing List. Available at http://tsca-itc.syrres.com/Chemicals/
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National Advisory Committee Acute Exposure Guideline Levels (AEGLs). Available at http://www.epa.gov/oppt/aegl/index.htm

Organisation for Economic Cooperation and Development (OECD) Integrated HPV Database, http://cs3-

hq.oecd.org/scripts/hpv/index.asp

United Nations Environment Programme (UNEP) persistent organic pollutants (POPs), available at 

http://www.chem.unep.ch/pops/default.html

United Nations Environment Programme (UNEP) Ozone Secretariat, Summary Control Measures, available at 

http://www.unep.org/ozone/Treaties_and_Ratification/2B_montreal_protocol.asp

U.S. EPA. Clean Air Act (CAA) Hazardous Air Pollutants (HAPs). Available in the Clean Air Act, section 112(b), available at

http://www.epa.gov/air/caa/caa112.txt

U.S. EPA. Emergency Planning and Community Right-to-Know Act Section 313, List of Toxic Chemicals. 2001. Office of 

Environmental Information, EPA 260-B-01-001, available at http://www.epa.gov/tri/chemical/chemlist2001.pdf

U.S. EPA. High Production Volume (HPV) Challenge Program and Voluntary Children's Chemical Evaluation Program 

(VCCEP) Web sites under the EPA Chemical Right-to-Know Initiative, http://www.epa.gov/chemrtk

U.S. EPA. Integrated Risk Information System (IRIS) Substance List. Available at http://www.epa.gov/iris/subst/index.html

U.S. EPA. National Recommended Water Quality Criteria: 2002. Office of Water. EPA-822-R-02-047. Available at 

http://www.epa.gov/waterscience/pc/revcom.pdf

U.S. EPA. 2004 Edition of the Drinking Water Standards and Health Advisories. Office of Water. EPA-822-R-04-005. 

Available at http://www.epa.gov/waterscience/drinking/standards/dwstandards.pdf

U.S. EPA. Substance Registry System (SRS). Available at http://www.epa.gov/srs/

U.S. OSHA. Occupational Safety and Health Administration (OSHA) Permissible Exposure Limits (PELs), available at 

http://www.osha.gov/SLTC/pel/index.html
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List of Acronyms

ACGIH American Conference of Governmental Industrial Hygienists

AEGL Acute Exposure Guideline Level

ARB Air Resources Board

ATSDR Agency for Toxic Substances and Disease Registry

CAA Clean Air Act

CASRN Chemical Abstract Service Registry Number

CICAD Concise International Chemical Assessment Document

CPSC Consumer Product Safety Commission

EHC Environmental Health Criteria

EPA Environmental Protection Agency

EU European Union

FDA Food and Drug Administration

FFDCA Federal Food, Drug, and Cosmetic Act

FIFRA Federal Insecticide, Fungicide, and Rodenticide Act

GRAS Generally Recognized as Safe

HAP Hazardous Air Pollutant

HPV High Production Volume

HSDB Hazardous Substances Databank

IARC International Agency of Research on Cancer

ICCA International Council of Chemical Associations

IFCS International Forum on Chemical Safety

IPCS International Programme on Chemical Safety

IRIS Integrated Risk Information System

IRPTC International Register of Potentially Toxic Chemicals

ITC Interagency Testing Committee

IUCLID International Uniform Chemical Information Database

IUR Inventory Update Reporting Rule

IURA Inventory Update Reporting Rule Amendment

NAICS North American Industry Classification System

NIOSH National Institute for Occupational Safety and Health

OECD Organisation for Economic Cooperation and Development

OECD HPV SIDS or OECD 

HPV SIDS program OECD/SIDS HPV Chemicals Programme

OPP Office of Pesticide Programs

OPPT Office of Pollution Prevention and Toxics 

OSHA Occupational Safety and Health Administration

PEL Permissible Exposure Limit

POP Persistent Organic Pollutant

SIAM SIDS Initial Assessment Meeting

SIAP SIDS Initial Assessment Profile

SIAR SIDS Initial Assessment Report

SIDS Screening Information Data Set

SRS Substance Registry System

TLV-TWA Threshold Limit Value Time-Weighted Average

TRI Toxics Release Inventory

TSCA Toxic Substances Control Act

UNEP United Nations Environment Programme

VCCEP Voluntary Children’s Chemical Evaluation Program