IUR Petition Review Report

April 17, 2005

CASRNs and TSCA Inventory Chemical Names:

67701-03-5 fatty acids, C16-C18

68308-53-2 fatty acids, soya

Petitioners and Petition Docket Numbers:

Keller and Heckman OPPT-2004-0071

The Soap and Detergent Association (SDA) OPPT-2004-0006

Note: The petitions contained additional chemicals. These additional 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 rule (IUR) (see 40 CFR Part 710) for fatty acids, C16-18 (CASRN 67701-03-5) and

fatty acids, soya (CASRN 68308-53-2). 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 two petitions requesting that fatty acids, C16-18 (CASRN 67701-

03-5) and fatty acids, soya (CASRN 68308-53-2) be added to the 40 CFR 710.46(b)(2)(iv) list of

specific chemical substances which 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 processing and use information.” (68 FR 855) 

Additionally, the preamble states, “In 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.” 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.

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

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

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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. 

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The petition from SDA (docket number OPPT-2004-0006) stated that these two chemicals are

included as part of larger categories under the OECD/ ICCA HPV Chemicals initiative in order

to help meet objectives of minimizing testing and costs and completing assessments earlier, and

to ensure the data summaries for the categories were as robust as possible. SDA further states

that the presence of the chemicals in the categories “does not imply a concern or high interest for

these substances, but rather that existing data for these substances could be used to support the

characterizations of other substances in the category.” The petitioner requested that these two

substances be granted a partial exemption on the basis that “HPV chemical program sponsorship

does not indicate an ongoing interest in processing and use data and that these substances should

not have been removed from the initial partial exemption list on that basis.” Despite the

statements in the SDA petition, none of these chemical substances were ever included on the

initial partial exemption list. Additionally, as discussed in the document “Methodology Used for

the Initial Selection of Chemicals for the Inventory Update Rule Amendments (IURA) ‘Low

Current Interest’ Partial Reporting Exemption,” because sponsorship under the HPV Challenge

Program will result in the availability of hazard screening information, EPA did not consider

these chemicals to be of low current interest for purposes of the reporting of IUR processing and

use information.

The petition from SDA did not link information furnished in the petition to specific

considerations cited in 40 CFR 710.46(b)(2)(ii), but provided general statements as described

previously. Such general statements alone are of limited use in establishing a rationale for

adding a chemical to the IUR partial exemption list.

The petition from Keller and Heckman (docket number OPPT-2004-0071) did link information

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

included in the discussion below.

Consideration A: Production volume.

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

production volume for each of the two substances of 300,000 pounds or greater.

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

bioaccumulation, health effects, or environmental effects.

The petition from Keller and Heckman included excerpts from the Kirk-Othmer Encyclopedia of

Chemical Technology to address Consideration B for these two substances. The excerpts from

Kirk-Othmer were for broad categories such as “Fats and Fatty Oils” and offered little

See the attached list of acronyms at the end of this report.

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information specific to the individual substances. The petition from the SDA did not address this

consideration.

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

governments, as well as members of the public.

The petition from Keller and Heckman reported that neither substance has been the subject of

information collection requirements by ATSDR or the ITC; the petition from the SDA did not

address this consideration. Both substances are part of EPA’s HPV Challenge Program. SDA

stated that the fact that these chemicals are sponsored does not indicate an ongoing interest in

processing and use data for these chemicals. However, EPA’s 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 the HPV Challenge Program. For this purpose, the IUR

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

complementing the HPV Challenge Program submission by providing EPA with exposurerelated information. IUR reporting is needed at least once and, potentially, periodically 2

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 include comparative exposure

analyses, identification of safer substitutes, or pollution prevention investigations.3

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

To address this consideration, the petition from Keller and Heckman noted that these two 

substances are similar to substances that are already partially exempt, differing in the

composition of the fatty acids. It was not clear how this similarity related to complementary risk

screening information.

Since both substances are included in the HPV Challenge Program and are sponsored through the

ICCA HPV Initiative (as described in the SDA petition), additional hazard data may become

available. However, effective risk screening and risk management require both exposure

information and hazard information. The availability of hazard information for these substances

coupled with the IUR processing and use information as an indicator of potential exposure will

facilitate a more effective screening of this and other substances based on either exposure or risk.

Risk is composed of hazard and exposure. In order to screen for potential risk in the U.S., both hazard

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data and exposure-related data relative to U.S. 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)

For additional information on uses of IUR processing and use information, see IURA Data Use Plan,

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located in EPA’s electronic docket OPPT-2002-0054, item number 0261.

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

The petition from Keller and Heckman indicated that the processing and use of these substances

is well-characterized, and included excerpts from the Kirk-Othmer Encyclopedia of Chemical

Technology. The excerpts, however, are from 1984, raising a concern for the timeliness and

usefulness of the exposure-related data presented therein. Since exposure scenarios change based

on uses and available technology, information quickly becomes outdated and of limited use. The

IUR information is needed to provide current processing and use data for the United States. 

Additionally, IUR data encompass information not included in the Kirk-Othmer Encyclopedia,

such as the relative importance of each use, and therefore the excerpts are not judged to provide

comparable processing and use data. For instance, the IUR collects data on the function of the

chemical in the industrial processing and use category, the NAICS code associated with the use,

the amount of the chemical going to each use category, 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 four 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.

The petition from Keller and Heckman indicated that EPA, NIOSH, OSHA, CPSC, and FDA all

regulate the manufacture and use of these petition substances, but did not provide information

specific to individual chemicals except for FDA regulations. The petition review group does not

consider that the FDA regulations cover issues under the purview of the other listed regulatory

agencies and therefore do not necessarily address all of the potential risks associated with the

chemical substance. Sufficient evidence to state that potential risks of the chemicals substances

are adequately managed was therefore not included in the petition. 

The SDA petition did not identify or discuss any risk management actions taken by EPA or

another agency or authority with respect to the petitioned chemical(s). The petition did not

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

light of any such risk management actions.

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) ToxFAQs (Frequently asked questions about contaminants found TM

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

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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/

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 HPV (High Production Volume) 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. 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

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