 Review Report for Soybean Oil, Epoxidized (CASRN 8013-07-8) Partial Exemption
                        
                                 October 2014
                                       
              The National Oilseed Processors Association (NOPA)
                   Docket Identifier:  EPA-HQ-OPPT-2014-0347
Summary of Decision:  The U.S. Environmental Protection Agency (hereinafter "EPA" or the "Agency") has determined that there is a low current interest in the processing and use information collected under the Chemical Data Reporting (CDR) rule (see 40 CFR Part 711) for Soybean oil, epoxidized (CASRN 8013-07-8).  This determination is based on the totality of information on the chemical substance, including an evaluation of the considerations listed in 40 CFR 7l1.6(b)(2)(ii): 1) Consideration A: Current CDR information suggests that at least one site would have a production volume sufficient to trigger the need to report processing and use information for the 2016 CDR (25,000 pound threshold); 2) Consideration B: EPA considered the information from the Organization of Economic Cooperation and Development (OECD) U.S.-sponsored Screening Information Data Set (SIDS) Initial Assessment Report (SIAR) and the Food and Drug Administration's (FDA) Generally Recognized As Safe (GRAS, 21 CFR 172.723) designation sufficient for informing potential human health concerns for epoxidized soybean oil. Based on the information provided by the OECD SIAR, and EPA's Office of Pesticide Program's (OPP) Federal Insecticide, Fungicide and Rodenticide Act (FIFRA) tolerance exemptions for use both pre and post-harvest and on animals (40 CFR 180.910 and 930), EPA has determined that Soybean oil, epoxidized is of low potential hazard to the environment. For environmental fate, EPA determined that Soybean oil, epoxidized is readily biodegradable and is not expected to persist in the environment. Soybean oil, epoxidized has a low potential for bioconcentration or bioaccumulation in aquatic organisms; 3) Consideration C: EPA is not aware of any currently existing unmet information needs for CDR processing and use information for this chemical substance; 4) Consideration D: EPA determined that the petition did not provide evidence that complementary risk screening information is available for Soybean oil, epoxidized in its discussion under Consideration D; however, the OECD SIAR prepared by EPA provides evidence of a risk screening determination for epoxidized soybean oil; 5) Consideration E: Comparable processing and use information is available in the European Chemical Agency's (ECHA's) database, and although it is for use of products in Europe and not the United States, it provides an indication of uses that may occur in the United States; and 6) Consideration F: EPA is unaware of any specific actions that have already been taken by other agencies or authorities to manage risks relating to this substance.  

A direct final rule to add Soybean oil, epoxidized, to the list of chemical substances partially exempt from reporting CDR processing and use information in 40 CFR 711.6(2)(b)(iv) will be published in the Federal Register. The final listing is pending, based on possible adverse responses to the Federal Register notice. If the level of interest in the CDR processing and use information for this chemical substance were to change after final listing, EPA may reevaluate the listing and pursue amendment of the listing as appropriate. 

Persons submitting information in accordance with the CDR rule can still report processing and use information even if a chemical substance is partially exempt, so that their chemical substances may be considered for safer substitute analyses.

Background:  EPA received a petition from the National Oilseed Processors Association (NOPA) (hereinafter the "petitioner"), requesting that Soybean oil, epoxidized be added to the 40 CFR 711.6(b)(2)(iv) list of specific chemical substances that are exempt from the reporting requirements of 40 CFR 711.15(b)(4) (i.e., exempt from requirements to report industrial processing and use and commercial/consumer use information).  The chemical substances already included on this "partial exemption" list are substances for which EPA has previously determined that there is a low current interest in the CDR processing and use information.  However, as stated in the preamble to the Inventory Update Reporting Amendments (IURA) rule promulgated on January 7, 2003, "...the need for processing and use information under IURA 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 assessment of the need for collecting IURA processing and use information."  Additionally, the preamble states, "[i]n determining whether there is low current interest in IUR 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 Soybean oil, epoxidized are set forth below.

Discussion:  EPA considered information submitted with the petition, as well as other information including, but not limited to:  whether the petitioned chemical substance is listed on the Emergency Planning and Community Right to Know Act (EPCRA), Section 313 list of Toxic Chemicals and thus is reportable to the Toxics Release Inventory (TRI); 2012 CDR submissions for the chemical substance; evaluations available through the EPA's Integrated Risk Information System (IRIS), the International Agency for Research on Cancer (IARC), the OECD's High Production Volume (HPV) SIDS program, or the EPA's HPV Challenge Program; whether the substance is subject to other regulatory programs administered by EPA or other federal agencies; and other information researched by EPA to supplement the petition.

The petitioner provided information concerning Soybean oil, epoxidized from a variety of sources and linked it to specific considerations cited in 40 CFR 711.6(b)(2)(ii).

Consideration A:  Whether the chemical qualifies or has qualified in past IUR collections for the reporting of the information described in 40 CFR 711.15(b)(4).

The petitioner provided information to show that Soybean oil, epoxidized was reported for the 2012 CDR.  EPA reviewed the 2012 CDR data for Soybean oil, epoxidized and found that 18 sites reported domestically manufacturing and/or importing Soybean oil, epoxidized with a nationally aggregated production volume of 148,763,647 pounds in 2011.  

EPA has concluded that at least one manufacturing site would likely have a production volume sufficient to trigger the need to report processing and use information for the 2016 CDR (25,000 pound threshold). Thus, EPA concludes that the other considerations are ripe for evaluation.

Consideration B:  The chemical substance's chemical and physical properties or potential for persistence, bioaccumulation, health effects, or environmental effects (considered independently or together).

The petitioner referred to the 2006 U.S.-sponsored OECD SIAR (with shared partnership with the International Council on Chemical Associations (ICCA) for epoxidized oils and derivatives) to support the Soybean oil, epoxidized (ESBO; CASRN 8013-07-8) petition.  Soybean oil, epoxidized is an epoxidized (6.8-7.1%) fatty acid ester derived from epoxidation at most or all of the points of unsaturation (double bonds between carbon atoms) in soybean oil fatty acid chains. ESBO is primarily composed of C18 acids, with linoleic (49-57%), oleic (26-36%), and linolenic (1-2%) acids constituting the major unsaturated fatty acid components.  Saturated fatty acid components constitute about 14% of the soybean oil mixture.  Soybean oil, epoxidized is a triglyceride (in which the alcohol portion of the molecule is glycerol).  Soybean oil, epoxidized may be produced by oxidation of soybean oil with hydrogen peroxide.

EPA sponsored the OECD SIAR  for epoxidized oils and derivatives category, which included Soybean oil, epoxidized(CASRN 8013-07-8) and concluded that the chemicals in the category did not present a hazard to human health or the environment Soybean oil, epoxidized is listed as having an exemption from the requirement of a tolerance as an inert ingredient in pesticide formulations when used on pre-and post- crop harvests (40 CFR 180.910) and on animals (40 CFR 180.930).  In concluding that the tolerance is safe, EPA conducts a human health risk assessment and ecological effects assessment and makes a determination of safety for the pesticide chemical residue.  EPA considered OPP's tolerance exemptions for Soybean oil, epoxidized while assessing its hazard to human health and the environment.

EPA also took into account the inclusion of Soybean oil, epoxidized as GRAS according to FDA regulation at 21 CFR 172.723, where it is listed as a direct food additive permitted for use as a halogen stabilizer in brominated soybean oil not to exceed one percent.  Soybean oil, epoxidized is also classified as a plasticizer when migrating from food-packaging material as listed by the FDA at 21 CFR 181.27 as a specific prior-sanctioned food ingredient.  


Human Health Effects. For human health effects, the petitioner summarized the findings in the 2006 SIAR document. Based on the information provided by the U.S. sponsored OECD SIAR, EPA has determined that Soybean oil, epoxidized is of low potential hazard to human health.

Environmental Effects. For ecological toxicity, the petitioner summarized the findings in the 2006 SIAR document. Based on the information provided by the U.S. sponsored OECD SIAR, EPA has determined that Soybean oil, epoxidized is of low potential hazard to the environment.

Environmental Fate. The petitioner referred to the 2006 SIAR for information on the physical properties of epoxidized soybean oil., Soybean oil, epoxidized was found to be readily biodegradable (79% biodegradation in 28 days)is expected to not be persistent in the environment, and bioaccumulation is expected to be limited by the molecular size of Soybean oil, epoxidized. 

EPA believes that the decisions made in the OECD SIAR, and EPA's OPP tolerance exemption are  supported by FDA's acceptance of the GRAS designation and provide sufficient evidence to address human health and environmental toxicity concerns for epoxidized soybean oil.  Taken together, this information is sufficient to weigh in favor of partially exempting Soybean oil, epoxidized from CDR reporting based on human health and environmental concerns covered under Consideration B. 

Consideration C:  The information needs of EPA, other federal agencies, tribes, states, and local governments, as well as members of the public.

The petitioner stated that it was unaware of any unmet information needs of EPA, other federal agencies, tribes, states, local governments, or members of the public in light of FDA regulatory clearances available for Soybean oil, epoxidized in food applications and the extensive data published on the ECHA website.  The petitioner also noted that Soybean oil, epoxidized has not been the subject of information collection requirement by EPA under the Toxic Substances Control Act (TSCA) (other than CDR), the Interagency Testing Committee (ITC), or the Agency for Toxic Substances and Disease Registry (ATSDR). 

EPA is not aware of any currently existing unmet information needs respecting the processing and use of Soybean oil, epoxidized and agrees that processing and use information for this chemicals is otherwise available to government agencies and the public on the ECHA website. Although the uses in Europe noted in ECHA information may not be exactly the same as the uses in the United States, EPA believes they can provide an indication of potential uses on which to base further analysis, should the chemical substance be of interest (for a detailed summary of specific uses see Consideration E). Overall, EPA regards Consideration C as weighing in favor of establishing a partial exemption for this chemical substance.

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

The petitioner included a table which provided the status of the petitioned substance under the European Union's Registration, Evaluation and Authorization of Chemicals (REACH) registration, status under the voluntary EPA HPV Challenge Program, and status as a pesticide inert ingredient.  However, no discussion was provided linking the status to the availability of recent risk screening information.  Therefore, it is unclear how this table relates to Consideration D, the availability of other complementary risk screening information.  EPA notes that the fact that the petitioned substance was not present on the REACH exemption list, was registered under REACH, could have an ICCA HPV sponsorship, and is not listed as a low risk pesticide inert provides no evidence of the availability of risk screening information. The indication that there is not a low risk inert listing is outdated and in contradiction with the statement under Consideration B that Soybean oil, epoxidized is approved for use as an inert ingredient in pesticides. Actually, under 40 CFR 180.910, Soybean oil, epoxidized is approved for use as an inert ingredient in pesticides applied to crops, both pre- and post-harvest, and under 40 CFR 180.930, Soybean oil, epoxidized is approved for use as an inert ingredient in pesticides applied to animals.  Additionally, the petitioner does not mention under Consideration D that EPA prepared the OECD SIAR for the epoxidized oils category, which included epoxidized soybean oil.  The conclusion of the SIAR was that members of the epoxidized oils category do not possess properties indicating a concern for hazard to human health or the environment.

EPA determined that the petitioner did not provide evidence that complementary risk screening information is available for Soybean oil, epoxidized in its discussion under Consideration D. However, the 2006 OECD SIAR prepared by EPA, the FDA GRAS status, and EPA's OPP tolerance exemptions provide evidence of risk screening determinations for Soybean oil, epoxidized. Overall, EPA concluded that the availability of information relevant to Consideration D weighs in favor of partially exempting Soybean oil, epoxidized from CDR reporting.

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

The petitioner asserted that processing and use of Soybean oil, epoxidized is well characterized and that TSCA-regulated exposures are comparable to, or less significant than, the food-use exposures associated with these substances, which have already been shown to be "safe."  While the petitioner indicated that Soybean oil, epoxidized is predominantly used in food, this is not a use subject to TSCA.  Under Consideration B, the petitioner noted that Soybean oil, epoxidized is used as a plasticizer in PVC for a wide range of applications.  Under Consideration C, the petitioner referenced the extensive data available on the ECHA website.  

The uses in the ECHA database are for the European Union and indicate that Soybean oil, epoxidized may be used in adhesives and sealants, coatings and paints, fillers, finger paints, lab chemicals, lubricants and greases, plant protection products, and polymer preparations.  Data from the non-confidential 2012 CDR database identified the following industrial uses: adhesives and sealants, non-pesticidal agricultural chemicals, functional fluids, intermediates, lubricants and additives, plasticizes, and processing aids in petroleum production.  The following consumer and commercial uses were also identified:  floor coverings and plastic and rubber products.

On balance, EPA agrees that other recent processing and use information, available from ECHA is sufficiently comparable to CDR processing and use information to favor granting a partial reporting exemption for this chemical substance.  While the ECHA information may not be completely representative of use in the United States, EPA concluded in this case (in view of all relevant considerations) that the ECHA information is a reasonable surrogate indicator of possible United States processing and use.  EPA also recognizes that the ECHA database does not specify the amounts of Soybean oil, epoxidized to each use.  But when considered in combination with the other substance-specific factors that weigh in favor of granting a partial reporting exemption (e.g., the evidence that the potential human health effects and/or environmental effects would be low) EPA does not regard the lack of use-by-use volume information as sufficient to affect the decision.

Consideration F: Whether the potential risks of the chemical substance are adequately managed by EPA or another agency or authority.

The petitioner generally indicated that the manufacturing and use of Soybean oil, epoxidized primarily falls within the jurisdiction and authority of the FDA.  The petitioner also stated that EPA, the Occupational Safety and Health Administration (OSHA), the National Institute for Occupational Safety and Health (NIOSH), and the Consumer Product Safety Commission (CPSC) regulate the manufacture and use of epoxidized soybean oil. However, the petitioner did not specifically identify which uses of Soybean oil, epoxidized are regulated by the foregoing governmental bodies or regulations, except for the FDA regulations at 21 CFR 172.723 for use as a halogen stabilizer in brominated soybean oil (direct food additive), and 21 CFR 181.27 for use as a plasticizer, and EPA's inert pesticide exemptions at 40 CFR 180.910 and 180.930.  

Overall, although the petition included the general claim that this substance is already "controlled adequately under other regulatory regimes," it did not identify how any particular agency or authority was managing risk relating to this substance, or how such risk management actions should bear on EPA's level of current interest in processing and use information.

As noted above, EPA has approved Soybean oil, epoxidized for use as an inert ingredient in pesticides applied to pre- and post-harvest crops and to animals.  EPA is unaware of any specific actions that have already taken by other agencies or authorities to manage risks relating to this substance.  However, given the evidence that the potential human health effects and/or environmental effects would be low, EPA does not assume that this substance would likely be the subject of risk management actions in the future.  Thus, in this case, EPA believes this consideration weighs neither in favor of nor against adding the substance to the CDR partial exemption list.



