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IUR Petition Review Report

December 19, 2005

CASRNs and TSCA Inventory Chemical Names:

87-99-0 xylitol

68308-36-1 soybean meal 

68956-68-3 fats and glyceridic oils, vegetable

120962-03-0 canola oil

Petitioner and Petition Docket Number:

Keller and 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 has determined that, at this time, EPA has a 

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

Reporting (IUR) rule (see 40 CFR Part 710) for these four chemical substances, and therefore is 

recommending a grant for this petition. This recommendation is based upon the conclusions 

reached under Consideration B, that these four substances generally present a low risk of adverse 

human health or environmental effects, and Consideration C, that there are no identified, unmet 

information needs for the IUR processing and use information for these chemical substances. 

Although the petition did not address Considerations D, E, or F in sufficient detail, the petition 

review group determined that the conclusions from Considerations B and C outweighed the 

issues raised in the other considerations. 

A direct final rule to add these four chemicals to the list of chemicals in 40 CFR 710.46(b)(iv) 

will be published in the Federal Register (FR). The final listing decision is pending, based on 

possible responses to the FR notice. 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.

Please note that persons submitting information in accordance with the IUR rule can still report 

processing and use information even if a chemical is partially exempt, so that their chemicals 

may be considered for safer substitute analyses.

Background: EPA received a petition requesting that the four substances 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 
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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” (68 FR 855). 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 by the petitioner, 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

In its petition, Keller and Heckman provided information concerning these four chemical 

substances from a variety of sources and linked the information to specific considerations cited 

in 40 CFR 710.46(b)(2)(ii). Keller and Heckman also provided additional, more specific 

information in a supplemental submission dated November 18, 2004. 

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 four 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 the four substances. The summary 

information on physical and chemical properties and/or health and environmental effects 

contained in the excerpts implies that these four substances generally present a low risk of 

adverse human health or environmental effects. However, the excerpts did not pertain to the 

specific petition substances, but rather were for broad categories such as “Fats and Fatty Oils” 

and “Vegetable Oils.” The petitioner supplemented the excerpts with information specific to the 

individual substances, including the following:

 1

See the attached list of acronyms at the end of this report.
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Canola oil (CASRN 120962-03-0). The petitioner provided the following summary information 

on this substance, most of which was taken directly (often verbatim) from the EPA Technical 

data sheet supporting the registration of canola-based products as biopesticides under FIFRA 

(located at http://www.epa.gov/pesticides/biopesticides/ingredients/tech_docs/tech_011332.htm). 

The petitioner also referred the petition review group to this technical data sheet, and provided 

the Web address for it.

According to EPA’s Office of Pesticide Programs, canola oil “has low chronic toxicities.” 

In addition, FDA has granted “generally recognized as safe” (GRAS) status to low erusic 

acid rapeseed oil for use as an edible fat or oil in human food. Canola and low erusic 

acid rapeseed oil (<2.0% erusic acid) are essentially the same. The FDA issued a final 

rule in the Federal Register of December 29, 1998 (Vol. 53, No. 250, P. 52682) revising 

its regulations [21CFR184.1555(c)] to include canola oil as the alternate common and 

usual name for low erusic rapeseed oil. Canola oil is an edible substance that is readily 

metabolized by humans...EPA notes that “Although the Agency does not have toxicity 

test results for nontarget insects, fish, and other wildlife directly exposed to canola oil, 

numerous metabolic studies on the dietary effects and metabolism of canola in birds, 

mammals, and fish are reported in the literature. Ecological effects data for terrestrial 

and aquatic animals, and nontarget plants for canola were waived for the same reasons 

given above; principally, the low toxicity of the product, and its rapid degradation in the 

environment”...The Office of Pesticide Programs (OPP) has waived the generic data 

requirements for canola oil, except for certain technical chemistry information, in light of 

its low toxicity. Available literature indicates that this substance has low chronic 

toxicities...There is adequate information available from literature sources to characterize 

the toxicity of canola oil. These studies indicate that canola oil's nutritional and 

toxicological profiles are similar to those of other vegetable oils (50FR 3745, 3752) 

(Kramer et. al., 1983). Moreover, the available literature indicates that the use of this 

substance as a component of food is safe. Data available on soybean oil, discussed in 

Reregistration Eligibility Decision (RED): Flower and Vegetable Oils EPA 

738_R_93_031 December, 1993 also support the low toxicity of canola oil. There are no 

incident reports on file for low erucic acid canola oil. Canola oil has a non-toxic mode of 

action for the target pests. 

Acute toxicity data were submitted to OPP in support of the end-use product registrations 

for NEU1161, which contains the active ingredients: 89.5% canola oil and 0.5% 

pyrethrins. NEU1161 is classified as toxicity category IV (virtually non-toxic) for acute 

inhalation and primary eye toxicity. These data are considered adequate to support all 

three canola formulations that are registered with EPA: NEU1160 Vegetable Oil Spray, 

NEU1161, and NEU1161 RTU. It should be noted, however, that the NEU1160 and 

NEU1161 RTU products contain either no or substantially less pyrethrin, respectively, 

and are thus likely to have a lower acute toxicity than the NEU1161 product.

The petitioner noted that canola oil (CASRN 120962-03-0) degrades rapidly in the environment. 

The petitioner also referenced Section 408 of the FFDCA (63 FR 18326, April 15, 1998), which 

states that data waivers were granted for canola oil (CASRN 120962-03-0) because of its long 

history of use as an edible fat and oil in food without any indication of deleterious effects, its low 

toxicity, and its natural occurrence as an oil extracted from plants.
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Xylitol (CASRN 87-99-0). The petitioner provided the following summary information on this 

substance:

Acute toxicity endpoints for xylitol (CASRN 87-99-0) are all greater than 8 gm/kg – i.e., 

virtually non-toxic. Inhalation of aerosolized iso-osmotic xylitol (CASRN 87-99-0) was 

well-tolerated by naive and atopic mice, and by healthy human volunteers. Xylitol 

(CASRN 87-99-0) may be safely used in foods for special dietary uses, provided the 

amount used is not greater than that required to produce its intended effect. The only 

citation found that indicated any toxicity was to an existing E. coli C mutant strain. The 

petitioner noted that this toxicity is prevented by fructose in both wild-type and mutant 

strains. 

Soybean meal (CASRN 68308-36-1). The petitioner provided the following summary 

information on this substance:

Soybean meal (CASRN 68308-36-1) is considered safe as an animal feed. Although 

there are some reports in the literature that raw soybean meal (CASRN 68308-36-1) may 

cause some enlargement of the pancreas of growing chicks and rats, soybean meal 

(CASRN 68308-36-1) is heat treated before use to remove the constituents that may 

cause these effects.

Fats and glyceridic oils, vegetable (CASRN 68956-68-3). The petitioner provided the following 

summary information on this substance: 

The acute toxicity endpoint for an intravenous study on rabbits exposed to fats and 

glyceridic oils, vegetable (CASRN 68956-68-3) was 840 mg/kg. Studies on exposure to 

vegetable oil mist in manufacturing settings have shown that “vegetable oil mists seem to 

have little adverse effect on the lungs and do not produce significant organic disease or 

toxic effects when exposures are kept under reasonable control.” The OSHA PELs for 

‘vegetable oil mist’ are 15 mg/m3 for total exposure and 5 mg/m3 for the respirable 

fraction...According to USDA, “Vegetable oils have superb environmental credentials, 

such as being inherently biodegradable, having low ecotoxicity and low toxicity towards 

humans.” Two studies looking at exposures of tropical fish and coral to vegetablederived lubricants (VDL) and mineral-derived lubricants (MDL) showed that VDL was 

less toxic. Studies with sunflower oil and linseed oil resulted in longer degradation time 

for sunflower oil, but a study with VDL and MDL indicated significantly faster 

degradation of VDL.

The petitioner also provided the Web address for an Occupational Safety and Health Guideline 

for Vegetable Oil Mist 

(http://www.osha.gov/SLTC/healthguidelines/vegetableoilmist/recognition.html), which stated 

the following, with respect to human health hazard information:

Most vegetable oil mists are biologically inert and are, therefore, considered to be 

nuisance particulates. Vegetable oil mists seem to have little adverse effect on the lungs 

and do not produce significant organic disease or toxic effects when exposures are kept 

under reasonable control [ACGIH 1991]. Oils from certain plants such as castor bean, 

sesame, acacia, and cashew nut have caused occupational dermatitis and respiratory 
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irritation. Exposure to acacia gum oil has been associated with occupational asthma and 

dermatitis [ACGIH 1991].

Based upon the information summarized above, the petition review group concluded that these 

four substances generally present a low risk of adverse human health or environmental effects. 

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

governments, as well as members of the public.

Keller and Heckman stated in its petition that it was unaware of any unmet information needs 

and noted that none of these chemicals has been the subject of information collection 

requirement by ATSDR or the ITC. The petition review group noted further that none of these 

four substances is currently a TRI chemical, a member of the HPV Challenge Program, a POP, a 

Clean Air Act HAP, IARC-listed, IRIS-listed, featured on an ATSDR ToxFAQTM sheet, or 

undergoing OECD HPV SIDS review.

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

The petition addressed this consideration by stating that 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”), or because they are structurally similar to other chemicals that are already listed as 

partially exempt chemicals or to List 4A or 4B pesticide inerts. As stated in the petition, a 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 conclusion does not necessarily 

apply to other non-pesticidal uses of these chemicals. Also, structural similarity alone is not a 

sufficient rationale for including a chemical on the partial exemption list. Additionally, it is 

unclear how these statements by the petitioner relate to the main point of Consideration D, which 

is the availability of other complementary risk screening information. The petition review group 

determined that the minimal complementary risk screening information presented in the petition 

has little relevance to EPA’s decision to grant or deny this petition.

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

The petition indicated that the processing and uses of these substances are well-characterized, 

and included excerpts from the 1984 edition of Kirk-Othmer Encyclopedia of Chemical 

Technology to address this consideration. The petitioner, however, did not identify specific 

information within those excerpts that addresses Consideration E. The excerpts do contain some 

processing and use information; however, the Kirk-Othmer Encyclopedia is dated 1984, raising a 

concern about whether the information is still current. The petition also stated, “The TSCAregulated exposures associated with these substances are comparable to, or less significant than, 

the food use exposures...” but offers no support for this statement. The petition review group 

does not consider such unsupported statements as relevant to its decision-making process. 
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Consideration F: Whether the potential risks for the chemical substance are adequately 

managed by EPA or another agency or authority.

The petition indicated that EPA, NIOSH, OSHA, CPSC, and FDA all regulate the manufacture 

and use of the substances which are the subject of this petition. However, the petition, which 

contained 41 chemicals, did not specifically identify which chemicals were regulated by which 

agency or regulation, except for FDA.

The petition also did not explain why the downstream processing and use information should be 

of low current interest in light of these regulatory 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) 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/

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
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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