Page 1 o f 8 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. T his 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 n eeds 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 outw eighed 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 possib le 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 sub mitting 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 reque sting 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 amend ment 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 processingPage 2 o f 8 and use information...” and is also “based on the Agency’s current need for collecting IURA processing and use information ” (6 8 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

conside rations 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; HP V 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 s pecific 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, hea lth 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.Page 3 o f 8 Canola oil (CASRN 120962

- 03

- 0). The peti tioner 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 she et, 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 ed ible 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 nontar get 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 aquati c 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 requir ements 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 cha racterize 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 ac tive 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 ar e 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 g ranted 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.Page 4 o f 8 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 o nly 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 t he 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 pancre as 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 info rmation 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 th at “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/m 3 for total exposu re and 5 mg/m 3 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 tro pical fish and coral to vegetable

derived 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 respiratoryPage 5 o f 8 irritation. Exposure to acacia gum oil has been associated with occupational asthma and dermatitis [ACGIH 1991].

Based upon the information summarized above, the petition r eview 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 memb ers 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 gro up 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 H AP, 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 pet ition 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 struc turally 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

ex posure 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 e xemption 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 mini mal 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 wi thin 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 stat ed, “The TSCA

regulated 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.Page 6 o f 8 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 m anufacture

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 als o 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 pe tition 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 ques tions 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 E PA, 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.syrr es.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/scrip ts/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 a t 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) C hallenge 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.pdfPage 7 o f 8 U.S. EPA. 2004 Edition of the Drinking Water Standards and H ealth 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.htmlPage 8 o f 8 List of Acronyms

ACGIH American Conference of Governmental Industrial Hygienists

AEGL Acute Exposure Guideline L evel

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

EH C 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 S afe

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 Intern ational 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 O ECD 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