Review Report for Fatty Acids, C14-18 and C16-18-unsatd., Me esters (CASRN 67762-26-9) Partial Exemption

January 2015

Biobased and Renewable Products Advocacy Group (BRAG)

Docket Identifier: EPA-HQ-OPPT-2014-0809

Summary of Decision : The U.S. Environmental Protection Agency (hereinafter “EPA” or the “Agency”) has determined that there is a lo w current interest in the processing and use

information collected under the Chemical Data Reporting (CDR) rule (see 40 CFR Part 711) for Fatty acids, C14-18 and C16-18- unsatd., Me esters (C ASRN 67762-26-9). This determination is based on the totality of information available for the chemical substance, including an evaluation

of one or more of the considera tions listed in 40 CFR 7l1.6(b)(2)(ii). In the case of this particular chemical substance, the consid erations were as follows:

 Consideration A: Current CDR information sugge sts that at least one site would have a production volume sufficient to trigger the ne ed to report processing and use information under the 2016 CDR (25,000 pound threshold);

 Consideration B: The petitioner did not addr ess this consideration. There are no readily available data for Fatty acids, C14-18 and C16-18-unsatd., Me esters. Analog data

indicated a low concern for environmental fate. EPA’s Office of Pesticide Programs’ (OPP) tolerance exemption for analog chemi cals and the presence of Fatty acids, C14-18 and C16-18-unsatd., Me esters on the low risk list for the Organisation for Economic Cooperation and Development’s (OECD) High Production Volume (HPV) program weigh moderately in favor of establ ishing a partial exemption;

 Consideration C: The petitioner did not charact erize the particular information needs it expected to arise, nor substa ntiate its general expectation the CDR information would not be relevant; however, the availability of r ecent processing and use information for this chemical on the website of the European Ch emicals Agency (ECHA) weighs moderately in favor of establishing a partial exemption;

 Consideration D: The petitioner provided no evidence that complementary risk screening information is available for Fatty acids, C14-18 and C16-18-unsatd., Me ester; however, for the analog CASRN 67762-38-3, OPP’s tole rance exemption and reassessment, which provide evidence of the suppor ting assessment for human health, and Canada’s Domestic Substances List (DSL) determination that the analog was neither persistent nor bioaccumulative, and “not inherently toxic to aquatic organisms” leads EPA to believe that ecotoxicology is not a concern. The part ial availability of information for analog chemicals weighs moderately in favor of partially exempting Fatty acids, C14-18 and C16-18-unsatd., Me ester from CDR reporting;

 Consideration E: The petitioner did not substantiate its claim that information on processing and use information collected under CDR would be available from other sources. However, the availability of recent processing and use information for this chemical on the ECHA website weighs in favor of granting the partial exemption; and2  Consideration F: The petitioner’s limited discussion of ongoing risk management weighs marginally in favor of the partial exemption.

A direct final rule to add Fatty acids, C14- 18 and C16-18-unsatd., Me es ters to the list of chemical substances partially exempt from re porting CDR processing and use information in 40 CFR 711.6(2)(b)(iv) will be published in the Fede ral Register. If EPA receives adverse public

comment on the addition of this chemical substa nce to the list, EPA will withdraw the direct final rule before the listing becomes effective. Additionally, 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 listi ng 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 Bi obased and Renewable Products Advocacy Group (BRAG) 1 (hereinafter the “petitioner”), reques ting that Fatty acids, C14-18 and C16-18- unsatd., Me esters (CASRN 67762-26-9) 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 industria l 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 prom ulgated 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 exem ption is not itself a determina tion of the potential risks of a chemical. This partial exemption is solely intend ed 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 co llecting IURA processing and use information.” 2
Additionally, the preamble states, “[i]n determinin g 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 considera tions not identified below, to make an informed decision.” The considerations used by EPA in re viewing this petition an d an analysis of how

those considerations relate to Fatty acids, C14-18 and C16-18- unsatd., Me esters are set forth

below.

Discussion: EPA considered information submitte d with the petition, as well as other information including, but not limited to: whethe r the petitioned chemical substance is listed on the Emergency Planning and Co mmunity Right to Know Act, Section 313 list of Toxic Chemicals and thus is reportabl e to the Toxics Release Inventory; 2012 CDR submissions for the chemical substance; evaluations available thr ough EPA’s Integrated Risk Information System,

1 CDR Partial Exemption Petition (Oct ober 21, 2014) (Hereinafter “The Pe tition”); From: BRAG, Managed by B&C ® Consortia Management,
LLC.; To: OPPT CDR Submission Coordinator, U.S. Environmenta l Protection Agency; Re: “Petition for Partial Exemption of Biodie sel Products (7 pp.), with shipping label attachment.

2 Federal Register Volume 68, Issue 4 (January 7, 2003) p. 848 - 906. http://www.gpo.gov/fdsys/pkg/FR- 2003-01-07/pdf/02-32909.pdf

Accessed: 8/08/2013.3 the International Agency for Research on Cancer, OECD’s HPV Screening Information Data Set program, or EPA’s HPV Challenge Program. EPA also considered whether the substance is subject to other regulatory pr ograms administered by EPA and ot her information researched by EPA to supplement the petition.

The petitioner referenced information concerni ng Fatty acids, C14-18 and C16-18-unsatd., Me esters from a variety of sources and linked it to specific considerations cited in 40 CFR 711.6(b)(2)(ii).

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

The petitioner indicated that Fatty acids, C14-18 and C16-18-unsatd., Me esters (CASRN 67762- 26-9) was reported in the 2012 CDR and provide d public information on production volume. EPA reviewed the 2012 CDR data for Fatty aci ds, C14-18 and C16-18-unsatd., Me esters and found that 11 sites reported domestically manuf acturing and/or importing Fatty acids, C14-18 and C16-18-unsatd., Me esters with a nationally aggregated production volume of 1 billion – 5

billion lbs. in 2011.

EPA has concluded that at leas t one manufacturing site woul d likely have a production volume sufficient to trigger the need to report pr ocessing and use information under the 2016 CDR (25,000 lb threshold). Thus, EPA conc ludes that the other considera tions are ripe for evaluation.

Consideration B: The chemical substance’s ch emical and physical properties or potential for persistence, bioaccumulation, health effects, or environmental effects (c onsidered independently or together).

The petitioner claimed that it was not advocatin g that Fatty acids, C14-18 and C16-18-unsatd.,

Me esters is non-hazardous or non- toxic, but instead referred to exposure controls that would be in place to limit exposure. Nevertheless, as not ed above, EPA reviewed information for this consideration in making its decision. The petitioner provide d some data on physical and chemical properties and human health and environm ental effects, but did not provide the studies to support these results. Instea d, the petitioner noted that in formation is available from registration dossiers for the European Registrati on, Evaluation, Authorization and Restriction of Chemicals (REACH) program and other sources . Fatty acids, C14-18 and C16-18-unsatd., Me esters has a full REACH registration. The petitio ner also referred to ot her websites but did not explain how the information on those websites speci fically related to the considerations for the partial exemptions.

The information provided by the petitioner wa s insufficient, by itself, to review this consideration; EPA decided to review additional s ources of data relevant to this consideration. However, EPA did not have access to studies providing supporting data in the REACH registration dossiers. The peti tion request covered the followi ng six substances: Fatty acids, tallow, Me esters (CASRN 61788-61-2); Soybean oil, Me ester (CASRN 67784-80-9); Fatty acids, canola oil, Me esters (CASRN 129828-16-6); Fatty acids, corn oil, Me esters (CASRN 515152-40-6); Fatty acids, C16-18 and C18-unsatd., Me esters (CASRN 67762-38-3); and Fatty4 acids, C14-18 and C16-18-unsatd., Me este rs (CASRN 67762-26-9). The alkyl chain compositions of these six substances are fairly si milar, with the only differences in alkyl chain sizes being generally one carbon number (such as the presence or absence of saturated C14 chains or C16-unsaturated chains). The main di fferences between the tallow, corn, canola, and soybean oil sources are in the re lative percentages among the alkyl chains in common, especially

the relative amounts of saturated (largely palmitic, stearic) vers us unsaturated (largely oleic, linoleic) chains. The two alkyl range-named substances, where the alkyl ranges are C16-18 and

C18-unsaturated in one case and C14-18 and C16-18- unsaturated in the other, cover qualitatively the alkyl chains found in the four natural source -named substances in the petition; however, the two alkyl range-named substances could have any percentages of the individual chains named in the range. Based on these considerations, a nd for the purposes of this assessment, EPA

considered these six substances to be analogs of each other.

Human Health Effects. There are no readily available human health toxicity data for Fatty acids, C14-18 and C16-18-unsatd., Me esters . It is listed as a low priority for assessment as an HPV chemical by OECD. The Agency’s New Chemical s Program reviewed the toxicity of analog

chemicals similar in structure and constituents to Fatty acids, C16-18 and C18-unsatd., Me esters, and determined they were a low risk to human health. In a reassessment of a tolerance exemption under the Food Quality Protection Act (FQPA) for analog chemicals that are similar

in structure and constituents to Fatty acids, C14-18 and C18-uns atd., Me esters, OPP concluded that these chemicals are expected to have poor absorption by a ll routes (oral, inhalation, and dermal), with little risk anticipat ed from possible degradation products. 3 OPP determined that there is a reasonable certainty that no ha rm to any population subgroup will result from aggregate exposure to these chem icals and recommended that the tolerance exemptions for food and nonfood pesticide uses be maintained. The available information for Fatty acids, C14-18 and C16-18-unsatd., Me esters leads EP A to have a relatively low leve l of concern regarding this chemical substance’s potential for effects on human health.

Environmental Effects. There are no readily availa ble environmental toxicity data for Fatty acids, C14-18 and C16-18-unsatd., Me esters . It is listed as a low priority for assessment as a HPV chemical by OECD. EPA’s New Chemicals Program reviewed the toxicity of analog chemicals

that are similar in structure and constituents to Fatty acids, C14-18 and C16-18-unsatd., Me esters, and determined that they were a low ri sk to the environment. Based on the available information for Fatty acids, C14-18 and C16-18- unsatd., Me esters, EPA has a relatively low level of concern regarding this chemical substance’s potential for effects to the environment.

Environmental Fate. Neat Rapeseed oil (NR) and Neat, Soybean oil (N S) as well as their modified products Rape Ethyl Es ter (REE), Rape Methyl Ester (R ME), and Soyate Ethyl Ester (SEE) appear to be similar in their structure and constituents, and, therefore, suitable analogs for biodiesels. Test data on the analogs appear to indicate low persiste nce of biodiesel in water. The

maximum CO 2 evolution from flasks in tests on the analogs ranged from 75.95 to 88.49% in 28 days, seeming to indicate that bi odiesels are readily biodegradable 4 . Available information

3 U.S. EPA, 2006. FQPA Reassessment Action: Reassessment of Fifteen Exemptions from the Requirement of a Tolerance for Twelve Poorly Abso rbed Chemicals, June 1, 2006.

4 Zhang, X., Peterson, C., Reece, D., Haws, R., & Moller, G. (1998). Biodegradability of biodiesel in the aquatic

environment. Transactions of the ASAE

, 41 (5), 1423-1430.5 indicates that Fatty acids, C14- 18 and C16-18-unsatd., Me esters are readily biodegradable and not likely to be persistent in the environment.

There is no readily available hum an health and environmental in formation for Fatty acids, C14- 18 and C16-18-unsatd., Me esters. However, base d on the fact that analog chemicals are expected to have poor absorption, OPP was able to maintain a FQPA tolerance exemption. OPP’s conclusion of low risk is in agreement w ith the general conclusi ons of low risk that Canada and OECD have reached respecting this chemical substance, as evidenced by the chemical substance’s presence on the DSL and OECD lists. Canada’s DSL determination that the chemical substance was neither persistent nor bioaccumulative and “not inherently toxic to aquatic organisms” also carries some weight in EPA’s assessment of its own current interest in collecting further processing and use information re lating to this chemical substance. Thus, the tolerance exemption for analog chemicals and th e presence of Fatty acids, C14-18 and C16-18- unsatd., Me esters on the low risk lists fo r Canada’s DSL and the OECD HPV weighs moderately in favor of esta blishing a partia l exemption.

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 with the ongoing governme nt interest in biofue ls, including biodiesel, there is and will continue to be significant intere st in biodiesel substances and this level of

interest will result in identification of info rmation needs. The petitioner believes that the screening level process and use information co llected under CDR will likel y be of little use

within this debate and that information is being collected under other programs.

The petitioner did not characteri ze the particular information ne eds it expected would arise relating to biofuels, and thus c ould not substantiate its general expectation that the type of processing and use information collected under CDR would not be relevant to such information

needs.

However, recent processing and use information for this chemical is already available to government agencies and the public on the ECHA website. Although the uses of this chemical substance in Europe may not be exactly the same as those in the United States, they are likely to be similar. EPA is not currently aware of a ny respects in which the European data on the processing and use of this chemical substance would be inadequate for its foreseeable

information needs. This combination of circ umstances weighs moderately in favor of establishing a partial exemption for this chemical substance.

Consideration D: The availability of othe r complementary risk screening information.

The petitioner provided no information on the availabi lity of risk screening information for Fatty acids, C14-18 and C16-18-unsatd., Me esters.

EPA notes that CASRN 67762-38-3 is sufficiently similar in composition to allow read-across of information to Fatty acids, C14-18 and C16-18- unsatd., Me esters. The petitioner noted that Fatty acids, C16-18 and C18-unsat d., Me ester (CASRN 67762-38-3) has been evaluated as part6 of EPA’s Design for the Environment (DfE) Safer Chemical Ingredients List (SCIL). However, a screening status decision for a chemical subs tance is not inherently indicative that risk screening information is available for the s ubstance. While EPA has access to the assessment

that resulted in the lis ting of Fatty acids, C16- 18 and C18-unsatd., Me este r as a solvent on DfE’s SCIL, this assessment is not publicly available. Fatty acids, C16-18 and C18-unsatd., Me ester is listed on DfE’s SCIL with a yellow triangle due to hazard concerns.

As noted above, under 40 CFR 180.910, Methyl esters of fatty acids derived from edible fats and oils are approved for use as an inert ingredient in pesticides applied to crops, both pre- and postharvest. A 2006 FQPA reassessment document 5 for Methyl esters of fatty acids derived from edible fats and oils recommended maintaining such an exemption. Though FQPA reassessment documents generally include hazard and exposure assessments, in this case, ecotoxicology was

not reviewed. OPP in its InertFinder identifies the analog CASRN 67762-38-3 as associated with the chemical name Methyl esters of fatty acids derived from edible fats and oils.

The petition provided no evidence that complementar y risk screening information is available for Fatty acids, C14-18 and C16-18- unsatd., Me ester. Although risk screening determinations are publicly available for the analog Fatty acids , C16-18 and C18-unsatd., Me ester (CASRN 67762- 38-3), the supporting assessments for these determ inations are not readily available. OPP’s tolerance exemption and reassessment provide ev idence of the supporting assessment for human health of the analog CASRN 67762-38-3, but not for ecotoxicology. However, Canada’s DSL determination that the analog CASRN 67762-38-3 wa s neither persistent nor bioaccumulative and “not inherently toxic to aquatic organisms” leads EPA to believe that ecotoxicology is not a concern for Fatty acids, C14-18 and C16-18-unsatd., Me ester.

EPA concluded that the partial av ailability of information relevant to Consideration D for analog chemicals weighs moderately in favor of part ially exempting Fatty acids, C14-18 and C16-18- unsatd., Me ester from CDR reporting.

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

The petitioner stated that collec ting information on processing and use of biodiesel under CDR is not necessary for EPA, other agencies, or the ge neral public, as relevant information collection and reporting already occurs under other federal programs. The petitioner referred to the monthly biodiesel production repor t from the U.S. Energy Inform ation Administration (EIA) and indicated that EPA and the U.S. Department of Agriculture (USDA) al so generate reports on
biofuels.

The petitioner did not substantiate its claim th at the kind of processing and use information

collected under CDR would alrea dy be available in ot her reports about biodiesel prepared by EPA, EIA, and USDA, nor did the petitioner addre ss the observations EPA has already made about the non-equivalence of EIA reporting and CDR reporting. See 68 FR 873-74 (2003). EPA

notes that a chemical substance used as biodiesel may also have uses other than as fuel, which would not necessarily be discussed in a re port focused on the energy uses of biodiesel.

5 U.S. EPA, 2006. FQPA Reassessment Action: Reassessment of Fifteen Exemptions from the Requirement of a Tolerance for Twelve Poorly Abso rbed Chemicals, June 1, 2006.7 Nonetheless, EPA found that processing and us e information for Fatty acids, C14-18 and C16- 18-unsatd., Me esters was available under the REACH program and that it was sufficiently comparable to CDR processing and use inform ation. Data from the non-confidential 2012 CDR database identified the following industrial uses: fuels and fuel additives. The following

consumer and commercial uses were also identified: fuels and related products.

Though EPA recognizes that the ECHA database doe s not specify the amounts of Fatty acids, C14-18 and C16-18-unsatd., Me esters for each use, when considered in combination with the other substance-specific factor s that weigh in favor of gran ting a partial re porting 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 particularly problematic.

EPA believes that other recent processing a nd use information available from ECHA is sufficiently comparable to CDR processing and use information to favor granting a partial reporting exemption for this chemical substa nce. While the ECHA information may not be completely representative of use in the United Stat es, EPA concluded in this case (in view of all relevant considerations) that the ECHA inform ation is a reasonable surrogate indicator of possible United States processing and use.

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

The petitioner generally indicate d that the manufacturing and pro cessing of Fatty acids, C14-18 and C16-18-unsatd., Me esters uses continuous closed systems, and that regulations also require transport and storage to occur in well-control led vessels. Collectively, these controls reduce potential for releases and exposures similar to those implemented for the petroleum process streams listed at 711.6 (b)(1), for which EPA dete rmined full CDR reporting was not warranted.

EPA notes that chemical intermediates manuf actured and processed using “continuous closed systems” and never isolated are already from exempt from CDR pursuant to 40 CFR 711.10 and 40 CFR 720.30(g)(8). Respecting chemical substa nces that are manufactured and processed using continuous closed systems, and then isol ated for transport and storage, the closed conditions of pre-isolation ma nufacture and processing has li mited bearing on whether EPA would have an interest in post-isolation pro cessing and use of the chemical substance.

The petitioner also alluded to unspecified regulati ons that require transport and storage to occur in “well-controlled” vessels. Many chemical s ubstances are transported and stored in wellcontrolled vessels, and the alleged care with wh ich a particular chemical substance is being stored and transported has limited bearing on wh ether EPA would have an interest in the processing and use of the chemical substance af ter it has been stored and transported.

EPA acknowledges that the factor s cited by the petiti oner under Consideration F were also

factors that EPA cited at the time it establis hed the partial exempti on for petroleum process streams. 68 FR 853-54 (2003). However, the petitio ner fails to consider the full history of the petroleum process stream exemption, which documents additional considerations beyond those8 noted in this petition. For example, in proposi ng the exemption EPA noted the sheer magnitude of ongoing manufacturing for petroleum process st reams, observing that such manufacture was already responsible for approximately a quarter of all IUR reports at the time. See 64 FR 46785 (1999). In subsequent decisions whether partic ular chemical substances qualified for the petroleum process stream exemption, EPA has take n still other considerations into account. See 70 FR 75061-62 (2005). Because the potentially rele vant issues for a (b)(1) listing decision are broader than those cited in the petitioner’s argument by analogy, EPA regards petitioner’s

observations under Consideration F as carrying only marginal weight.

At the same time, EPA is unaware of any c ountervailing evidence that ongoing efforts or regulations to manage the poten tial risks of this chemical substance are inadequate. Thus, overall, EPA regards Consideration F as weighing ma rginally in favor of establishing a partial exemption for this chemical substance.