Page 1 of 6 IUR Petition Review Report December 28, 2005

CASRN and TSCA Inventory Chemical Name:

64

- 17

- 5 ethanol

Petitioners and Petition Docket Numbers:

Keller & Heckman EPA

- HQ

- OPPT

- 2004

- 0071 BASF Corporation EPA

- HQ

- OPPT

- 2004

- 0044 Note: The petitions contained additional chemicals. The additional chemicals are addressed in other petition review reports.

Summary of Decision: The petition review group recommends a denial for these petitions as

EPA has a curre nt interest in the processing and use information collected under the Inventory Update Reporting (IUR) rule ( see 40 CFR Part 710) for ethanol (CASRN 64

- 17

- 5). This recommendation is based, in part, on the determination by the petition review group that th ere 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 ethanol (CASRN 64

- 17

- 5) 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 substanc es 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 promulg ated 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 so lely 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, “[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 these petitions and an analysis of how those considerations relate to the

chemicals id entified in these petitions 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 these petitions were submitted prior to the revisions rule publication, the original requirements and considerations were used in their evaluation. Petitions received after December 19, 2005, will be evaluated using the revised requirements and considerations.Page 2 of 6 Discussion: The petition review group considered information submitted with the petitions, as well as other information including (but not limited to): whether the petition substance is included in TRI, IRIS, or IARC; OECD HPV SIDS program status; HPV Challenge Program

status; an d the petition chemical’s inclusion in other regulatory programs administered by EPA. 1

The petition from the BASF Corporation stated that the inclusion of ethanol (CASRN 64

- 17

- 5) in the HPV Challenge Program, which includes the submission or development of a robust summary/dossier and test plan, warrants inclusion of this chemical in the partial exemption. The petition did not address any of the considerations cited in 40 CFR 710.46(b)(2)(ii), and only provided a general citation to the HPV Challenge Pr ogram submission for this chemical. General citations alone are of limited use in establishing a rationale for adding a chemical to the IUR partial exemption list.

The petition from Keller & Heckman furnished 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 discussion 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 this chemical.

Consideration B: The substance’s chemical and physical proper ties or potential for persistence, bioaccumulation, health effects, or environmental effects.

The petitions included excerpts on ethanol (CASRN 64

- 17

- 5) from the 1984 Kirk

- Othmer Encyclopedia of Chemical Technology and HPV Challenge Program robust summaries on ethanol (CASRN 64

- 17

- 5). The excerpts from the Kirk

- Othmer Encyclopedia of Chemical Technology included a summary of the chemical’s physical and chemical properties as well as information on health and safety considerations wit h regard to ethanol (CASRN 64

- 17

- 5), including the following:

Ethanol is flammable. Vapor concentrations of this chemical can be explosive and liquid ethanol can react vigorously with oxidizing materials. Exposure to concentrations of 5000

– 10,000 ppm results in irritation of the eyes and mucous membranes of the upper respiratory tract and, if continued for an hour or more, may result in stupor or drowsiness. The chemical is oxidized completely to carbon dioxide and water in the body,

and thus it is n ot a cumulative poison.

The HPV Challenge submission (Ref. 1) provides a summary of screening

- level hazard data such as physical

- chemical data, environmental fate, ecotoxicity, and health endpoints. The EPA

1 See the attached list of acronyms at the end of this report.Page 3 of 6 comments on the HPV Challenge submission stat ed that all SIDS

- level data needs were satisfied

for all of the SIDS

- level testing endpoints. The HPV Challenge submission data indicate that ethanol (CASRN 64

- 17

- 5) has the potential to cause repeated

- dose, reproductive, and/or developmental toxicity, an d that it possesses a low order of acute toxicity and ecotoxicity (Ref. 1).

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 & Heckm an reported that ethanol (CASRN 64

- 17

- 5) has not been the subject of information collection requirements by ATSDR or the ITC; the petition from the BASF Corporation did not address this consideration. This chemical is part of EPA’s 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 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 exposure

- related information. 2 Repor ting 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 r isk. 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 comp lementary risk screening information.

The petition from Keller & Heckman referred EPA to the HPV Challenge Program submission as a potential source of complementary risk screening information on ethanol (CASRN 64

- 17

- 5) and also noted that ethanol (CASRN 6 4

- 17

- 5) is a 4B pesticide inert. The referenced HPV Challenge submission contains certain hazard information, as described in Consideration B. However, effective risk screening and risk management require both exposure information and

hazard information. The availability of hazard information for this substance, 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 e xposure or

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 ba sed upon manufacturing, processing, and use scenarios, all of which change over time as technology and other societal effects change. The changing nature of exposur e scenarios means the potential risks associated with a chemical can also change, and there fore the collection of exposure

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

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

electronic docket EPA

- HQ

- OPPT

- 2002

- 0054, item number 0261.Page 4 of 6 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 from Keller & Heckman indicated th at the processing and use of ethanol (CASRN

64

- 17

- 5) is well

- characterized, and included an excerpt from the 1984 Kirk

- Othmer Encyclopedia of Chemical Technology. The Kirk

- Othmer excerpt contains the following processing and use information:

The main us es for ethanol are as an intermediate in the production of other chemicals, and as a solvent. It is a key raw material in the manufacture of drugs, plastics, polishes, perfumes, and cosmetics. The fastest

growing solvent use of ethanol is in cleaning pre parations and liquid detergents.

The petition review group recognizes that 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 u se may change or new uses may develop. EPA believes tracking these changes is important. The IUR rule provides current exposure

- related processing and use information in the United States every five years. This facilitates tracking changes in

use patter ns and the identification of new exposure scenarios, which is an important component of risk screening.

Additionally, the IUR rule contains some exposure

- related data elements not provided in the

1984 Kirk

- Othmer Encyclopedia of Chemical Technology, su ch 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 u ses, the IUR rule 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 ever y 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.

The petition from the BASF Corporation did not addr ess this consideration; the petition from Keller & Heckman indicated that EPA, NIOSH, OSHA, CPSC, and FDA all regulate the manufacture and use of ethanol (CASRN 64

- 17

- 5). Neither petition explained why the downstream processing and use information should b e of low current interest in light of any risk management actions.

Cited Reference: 1) HPV Challenge Program submission for ethanol (CASRN 64

- 17

- 5). Dated 2001. Available on

- line at http://www.epa.gov/chemrtk/ethanol/c12981tc.htmPage 5 of 6 Sources Searched: (No te: 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 TM (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 Con taminant 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/

National Advisory Committee Acute Exposure Guideline Levels (AEGLs). Available at http://www.epa.gov/oppt/aegl/index.htm

Organisation for Eco nomic 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/chem rtk

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 Regi stry 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.htmlPage 6 of 6 List of Acronyms

AC GIH 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 C oncise 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 Internatio nal 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 Testin g 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 Saf ety 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 Safet y 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 Substan ce 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