Page 1 of 8 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

- hydr oxy

97

- 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, hydroxy

8030

- 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 N umber: 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/consu mer 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 no t 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 coll ecting IURAPage 2 of 8 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 speci fic 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 petiti on 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 Chemica l 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 petiti on 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 seem s 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 cons ideration. 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.Page 3 of 8 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 “Hydro xy 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 ef fects 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 fu rther 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 t hat 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 exposure

related information. 2

2 Risk is composed of hazard and exposure. In order to screen for potential risk in th e 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, mayPage 4 of 8 include comparative exposure analyses, identification of safer substitu tes, 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 s hould 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 beca use 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 sub stances 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 che micals 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 situat ions by combining available hazard data with the IUR exposure

related information, thereby identifying new or revised exposure scenarios. Effective risk screening and risk management require both exposure information and hazard information. The availabil ity 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 ri sk. 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 Consi deration 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

scena rios 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.Page 5 of 8 may develop. EPA believes tracking these changes is important. The I UR 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 screenin g. 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 associate d 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 chemi cal 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

- propanetricarbo xylic 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 countr y 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 a nd 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 judgme nt 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.Page 6 of 8 Table 1: Chemical Names Also Used in Petition that Differ from TSCA Inventory Chemical Name s 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

- cit ric 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 butanedioi c 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 (C ASRN 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. Avail able 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 Confer ence 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) ToxFAQs TM (Frequently asked questions about contaminants found at hazar dous 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 Enfor cement 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 Can cer (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/Page 7 of 8 National Advisory Co mmittee 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 Enviro nment 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_an d_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. EP A

- 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) Permissibl e Exposure Limits (PELs), available at http://www.osha.gov/SLTC/pel/index.htmlPage 8 of 8 List of Acronyms
ACGIH American Conference of Governmental Industrial Hygienists AEGL Acute Exposure Guideline Level
ARB Air Resources Board ATSDR Ag ency 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 En vironmental 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 H igh 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
I RIS 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 R eporting 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 Chem icals 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