    Review Report for Oils, Palm Kernel (CASRN 8023-79-8) Partial Exemption
                        
                                   May 2014

Coalition of Corn Refiners Association (CRA), the National Oilseed Processors Association (NOPA), and the Institute of Shortening and Edible Oils (ISEO)
                   Docket Identifier:  EPA-HQ-OPPT-2012-0221

Note: Supporting petition information for bentonite, acid-leached (CASRN 70131-50-9) and 1,3- propanediol (CASRN 504-63-2) are addressed in separate supporting review reports. 

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 oils, palm kernel (hereinafter referred to as "palm kernel oils") (CASRN 8023-79-8).  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 under the 2016 CDR (25,000 pound threshold); 2) Consideration B: EPA noted the similarity of palm kernel oils to coconut oils, which are already on the CDR partial exemption list, and the U.S. Food and Drug Administration (FDA) acceptance of the safety of palm kernel oils when used to prepare a cocoa butter substitute approved for use as a food additive.  Adequate data was unavailable on environmental toxicity; however, EPA noted the acceptance of coconut oils as an analog for palm kernel oils and the current presence of coconut oils on the CDR partial exemption list.  Concerning environmental fate, EPA determined from submitted data that palm kernel oils have the potential to biodegrade, will not be persistent in the environment, and have a low potential for bioconcentration or bioaccumulation in aquatic organisms based on modeling data; 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: The availability of complementary risk screening information was not clearly characterized in the petition for this chemical; 5) Consideration E: Other recent 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 palm kernel oils to the list of chemicals substances in 40 CFR 711.6(2)(b)(iv) will be published in the Federal Register.  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 decision 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 chemicals substances may be considered for safer substitute analyses.

Background:  EPA received a petition from Keller and Heckman on behalf of a coalition of the Corn Refiners Association (CRA), the National Oilseed Processors Association (NOPA), and the Institute of Shortening and Edible Oils (ISEO) (hereinafter the "petitioner"), requesting that palm kernel oils (CASRN 8023-79-8) 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 palm kernel oils 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, Section 313 list of Toxic Chemicals and thus is reportable to 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 Organisation for Economic Co-operation and Development's (OECD)'s High Production Volume (HPV) Screening Information Data Set (SIDS) program, or the EPA's HPV Challenge Program; whether the substance is subject to other regulatory programs administered by EPA; and other information researched by EPA to supplement the petition.

The petitioner provided information concerning palm kernel oils 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 that palm kernel oils (CASRN 8023-79-8) were reported in the 2006 IUR.  EPA reviewed the 2012 CDR data for palm kernel oils and found that three companies reported domestically manufacturing and/or importing palm kernel oils with a nationally aggregated production volume of between 50,000,000 and 100,000,000 lb 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 under the 2016 CDR (25,000 lb 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 major components of palm kernel oils (CASRN 8023-79-8) are saturated and unsaturated glycerides:  C12 (lauric) saturated alkyl chains (48%), C14 saturated alkyl chains (17%) and C18 unsaturated (oleic) alkyl chains with one double bond (15%).  The petitioner described glycerides, C8-18 and C18-unsaturated (CASRN 67701-28-4) as a substance identical to palm kernel oils.  EPA accepts glycerides, C8-18 and C18-unsaturated (CASRN 67701-28-4) as a suitable analogue for palm kernel oils because it includes the major saturated and unsaturated components of palm kernel oils esterified to a glycerol backbone.  The petitioner provided data summaries from ECHA's database for substances registered under the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH; Regulation European Commission (EC) No. 1907/2006) regulation for glycerides, C8-18 and C18-unsaturated (CASRN 67701-28-4).  

The petitioner inferred that palm kernel oils were similar to coconut oils (CASRN 8001-31-8), which are already included on the partial exemption list at 40 CFR 711.6(b)(2)(iv), and should therefore have the same partial exemption.  EPA agrees that palm kernel oils and coconut oils are similar because the alkyl chain length composition of palm kernel oils and the degree of unsaturation are quite similar to coconut oils, although coconut oils are somewhat richer in C8-10 chains (15%) than palm kernel oils (8%), and palm kernel oils have more unsaturated chain content (17%) than coconut oils (8%).  Notwithstanding these differences, EPA concluded that coconut oils (CASRN 8001-31-8) can be considered a valid analogue for palm kernel oils.

Human Health Effects. 
While EPA found the summaries referenced by the petitioner to be inadequate for evaluation of hazards, EPA took into account the inclusion of the similar coconut oils in the partial exemption list and its accepted use as a food additive.  The FDA at 21 CFR 172.861 permits a cocoa butter substitute from coconut oil, palm kernel oil, or both oils to be used as a food additive under specific conditions. EPA considered the safety determination made by FDA in listing palm kernel oil as a direct food additive sufficient for informing potential human health concerns and therefore considers palm kernel oils a low hazard to human health.

Environmental Effects. The ecotoxicity data in the ECHA dissemination database were limited and did not meet the EPA and OECD test guidelines.  EPA was unable to identify adequate substitute data on environmental toxicity.  Because of the inadequacy of the available ecological toxicity information, the environmental hazard of palm kernel oils could not be characterized.  However, EPA has accepted coconut oils as an analog for palm kernel oils.  In the partial exemption list established in 2003, EPA deemed coconut oils to be of low current interest based on its presence on a list of chemicals excluded from the HPV Challenge Program.  The list took into consideration chemical substances' "chemical and physical properties or potential for persistence, bioaccumulation, health effects, or environmental effects (considered independently or together)," and "the Agency was able to utilize these lists, along with the Agency's current knowledge and understanding of the individual chemical's structure, properties, indications of hazards and potential exposures, to inform its determination that there is a low current interest in the IURA processing and use information for these specific chemicals." Therefore, EPA considers the partial exemption of coconut oils as sufficient for inferring that palm kernel oils present a low hazard to the environment.

Environmental Fate. The petitioner submitted ECHA data summaries for glycerides, C8-18 and C18-unsaturated, which included information on the physical properties of palm kernel oils and a biodegradation summary on coconut oil-related substances. EPA determined that these data informed the potential for palm kernel oils to biodegrade and concluded that palm kernel oils will not be persistent in the environment.  The petitioner also reported an estimated bioaccumulation factor (BAF); however, the petitioner actually reported the estimated bioconcentration factor (BCF), not the bioaccumulation factor (BAF).  EPA accepted the BCF value and used the BCF/BAF model to predict a BAF value. EPA determined that the estimated BCF and BAF values suggest that palm kernel oils have a low potential for bioconcentration or bioaccumulation in aquatic organisms.  

Although the data provided by the petitioner on palm kernel oils and the analogues are limited or incomplete, EPA accepts FDA's determination that palm kernel oils may be used as a cocoa butter substitute food additive and the existing CDR partial exemption for coconut oils, a recognized analog of palm kernel oils, as sufficient evidence to address human health and environmental toxicity concerns.  EPA accepts that submitted biodegradation and bioconcentration data as well as modeled bioaccumulation data are sufficient to address environmental fate concerns.  Taken together, this information is sufficient to weigh in favor of partially exempting palm kernel oils 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 palm kernel oils (CASRN 8023-79-8) have not been the "subject of or considered for information collection requirements by EPA under TSCA (other than the TSCA IUR), the Interagency Testing Committee (ITC) or the Agency for Toxic Substances and Disease Registry (ATSDR).  Palm kernel oils "[have] not been nor [are they] the subject of any proposed or final regulation by the EPA."  The petitioner stated that they are not aware of any unmet information needs of the EPA, other federal agencies, tribes, states, local governments, or members of the public, in light of FDA regulatory clearances currently available for palm kernel oils which acknowledge that its safe use in food applications and the extensive data on the analogue glycerides, C8-18 and C18-unsaturated (CASRN 67701-28-4) published on the ECHA database.  The petitioner asserts that there is sufficient information available, and there have been no previous information requests.

EPA is not aware of any currently existing unmet information needs respecting the processing and use of palm kernel oils and agrees that recent processing and use information for all three chemicals is available to government agencies and the public on the ECHA website. Although the uses in Europe 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.  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 substances on the European Commission Annex II list of low risk substances, exemption determinations by the European Union for the REACH program, status under the voluntary EPA High Production Volume (HPV) Challenge Program and safety determinations for low toxicity pesticide inerts.  But, no discussion was provided linking the status to the availability of recent risk screening information.  Therefore, it is unclear why the petitioner believes this table relates to Consideration D, the availability of other complementary risk screening information.  EPA notes that the fact that the petitioned substances were not present on most of these lists provided no evidence of the availability of risk screening information nor were explanations given of the significance of the chemicals not being listed on the two European lists.  The petitioner indicated that palm kernel oils were sponsored through the Global HPV Initiative but provided no evidence that risk screening information is available through that program.  EPA notes that the chemical is listed by OECD as "unsponsored." 

EPA determined that the petition did not provide evidence that complementary risk screening information is available for palm kernel oils. However, 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 did not regard this consideration as sufficiently weighty to alter the overall weight of evidence in favor of establishing a partial reporting exemption for this chemical substance.


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

While the petitioner indicated that palm kernel oils are predominantly used in food (which is not a use subject to TSCA), the information they provided from the ECHA database indicated a broader range of uses. The petitioner asserted 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."  The petitioner included a list of uses obtained from ECHA's database.  

The uses in the ECHA database are for the European Union and indicate that palm kernel oils may have broader use in Europe than in the United States.  Data from the non-confidential 2012 CDR database identified the following industrial uses:  soap, cleaning compound, and toilet preparation manufacturing; food, beverage, and tobacco product manufacturing; and basic organic chemical manufacturing.  The following consumer and commercial uses were also identified:  laundry and dishwashing products as well as commercial use in other cleaning and furnishing products and non-TSCA uses.

As indicated under Consideration B, palm kernel oils and coconut oils are similar because the alkyl chain length composition of palm kernel oils and the degree of unsaturation are quite similar to coconut oils.  Coconut oils, which are already included on the list of partially exempt chemical substances at 40 CFR 711.6(b)(2)(iv), had an aggregated production volume on the 2012 CDR of between 250,000,000 and 500,000,000 lb while palm kernel oils had an aggregated production volume of between 50,000,000 and 100,000,000 lb.  

Overall, the relevance of Consideration E to the disposition of the petition was mixed.  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 palm kernel oils 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 sufficiently weighty to alter its overall decision to establish a partial reporting exemption for this substance.

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 palm kernel oils 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 palm kernel oils.  However, the petitioner did not specifically identify which uses of palm kernel oils are regulated by the foregoing governmental bodies or regulations, except for FDA [FDA Regulation at 21 CFR 172.861 - Multipurpose Additives (Based on the listing for Cocoa Butter Substitute from Coconut Oils, Palm kernel oils or Both, 85665-33-4)].  

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 any particular risk relating to this substance, let alone how such risk management actions should bear on EPA's level of current interest in processing and use information.

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 therefore 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.



