Review Report for Fatty Acids, C16-18 and C18-unsatd., Me esters (CASRN 67762-38-3) 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, C16-18 and C18-uns atd., Me esters (CASRN 67762- 38-3). This determination is based on the totality of information on the chemical substance, including an evaluation of one or

more of the considerations lis ted in 40 CFR 7l1.6(b)(2)(ii):

 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. A review of analog

chemicals concluded that the an alogs were not expected to be a hazard for human health and the environment. This conclusion, whic h is in agreement with EPA’s Office of Pesticide Programs’ (OPP) Food Quality Pr otection Act (FQPA) reassessment and the general conclusions of low risk that Canada reached respecting Fatty acids, C16-18 and C18-unsatd., Me esters carries some weight in EPA’s assessment of its own current interest in collecting further processing and use information relating to this chemical substance. Thus, the low concern for an alog chemicals and Canada’s Domestic Substances List (DSL) determinations wei ghs moderately in favor of establishing 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 European Chemicals Agency (ECHA) website weigh moderately in favor of establishing a partial exemption;

 Consideration D: The petitioner provided little evidence of the availability of complementary risk screening information fo r this chemical; howev er, OPP’s tolerance exemption and reassessment, which provide evidence for human health considerations, and Canada’s DSL categorizati on of “not inherently toxic to aquatic organisms” lead

EPA to believe that ecotoxicol ogy is not a concern and weigh moderately in favor of the partial exemption;

 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; and

 Consideration F: The petitioner’s limited discussion of ongoing risk management weighs marginally in favor of the partial exemption.2 A direct final rule to add Fatty acids, C16-18 and C18-unsatd., Me es ters to the list of chemical substances partially exempt from reporting CD R processing and use information in 40 CFR 711.6(2)(b)(iv) will be published in the Federa l 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”), reque sting that Fatty acids, C16-18 and C18- unsatd., Me esters (CASRN 67762-38-3) 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 Fa tty acids, C16-18 and C18-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, the International Agency for Research on Can cer, the Organisation fo r Economic Co-operation and Development’s High Production Volume (HPV) Screening Information Data Set program, or EPA’s HPV Challenge Program. EPA also considered whether the substance is subject to other

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 regulatory programs administered by EPA a nd other information researched by EPA to supplement the petition.

The petitioner referenced information concer ning Fatty acids, C16-18 and C18-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, C16-18 and C18-unsatd., Me esters (CASRN 67762-38- 3) was reported in the 2012 CDR and provided public information on production volume. EPA reviewed the 2012 CDR data for Fatty acids, C 16-18 and C18-unsatd., Me esters and found that 15 sites reported domestically manufacturing an d/or importing Fatty acids, C16-18 and C18- unsatd., Me esters with a nationally aggregat ed production volume of 602,936,770 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 concludes the other considerati ons 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 it was not advocating that Fatty acids, C16-18 and C18-unsatd., Me esters is non-hazardous or non-toxic, but instead referred to exposure contro ls that would be in place to limit exposure. Nevertheless, as noted above, EPA re viewed information for this consideration in making its decision. The petitioner provided some data on physical and chemical properties and human health and environmental effects, but di d not provide studies to support these results. Instead, the petitioner noted that information is available from registration dossiers for the European Registration, Evalua tion, Authorization and Restri ction of Chemicals (REACH) program and other sources. Fatty acids, C16- 18 and C18-unsatd., Me esters has a full REACH registration. The petitioner also referred to other websites but did not explain how the information on those websites specifically rela ted 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 Fatty 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, and4 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, C16-18 and C18-unsatd., Me esters. The Agen cy’s New Chemicals Program reviewed the toxicity of analog chemicals that are similar in structure and constituents to Fatty acids, C16-18 and C18-unsatd., Me esters, and determined that they were a low risk to human health. In a

reassessment of a tolerance exem ption under FQPA for analog chemicals similar in structure and constituents to Fatty acids, C16-18 and C18- unsatd., Me esters, OPP concluded that these chemicals are expected to have poor absorption by all routes (oral, inhala tion, and dermal), with little risk anticipated from possible degradation products. 3 OPP determined there is a reasonable certainty that no harm to any population subgroup will result from aggregate exposure to these

chemicals and recommended that the tolerance exemptions for food and nonfood pesticide uses be maintained. This chemical is listed as a solvent on EPA’s Design for the Environment (DfE) Safer Chemical Ingredients List (SCIL) and is code yellow for health hazards. The available information on Fatty acids, C16-18-unsatd., Me esters leads EPA to have a relatively low level 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, C16-18 and C18-unsatd., Me esters. It is listed on Canada’s DSL categoriz ation program as “not inherently toxic to aquatic orga nisms.” It is also listed on Df E’s SCIL, with a yellow designation for potential hazards to the environment. EPA’ s New Chemicals Program reviewed the toxicity of analog chemicals similar in structure and c onstituents to Fatty acids, C16-18 and C18-unsatd., Me esters, and determined they were a low ri sk to the environment, with predicted low persistence and low bioaccumulation potential. Based on the available information, EPA has a relatively low level of concern regarding the po tential for Fatty acids, C16-18 and C18-unsatd.,

Me esters to have effects on 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 structures an d constituents and, therefore, suitable analogs for biodiesels. Test data on the analogs appear to indicate that there is low persistence 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 th at biodiesels are readily biodegradable 4

.

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 Fatty acids, C16-18 and C18-unsat d., Me esters are listed on Canada’s DSL as having low persistence and no bioaccumulation in the envi ronment. Based on the available information, Fatty acids, C16-18 and C18-unsatd., Me esters appear to be r eadily biodegradable and are not likely to be persistent in the environment.

A review of analog chemicals concluded that the analogs were not expected to be a hazard for

human health and the environment. This conclu sion, which is in agreement with OPP’s FQPA reassessment and the general conclu sions of low risk that Canada reached respecting Fatty acids, C16-18 and C18-unsatd., Me esters carries some we ight in EPA’s assessment of its own current interest in collecting further processing and use in formation relating to this chemical substance. Thus, the low concern for analog chemicals and Ca nada’s DSL determinations weigh moderately

in favor of establishi ng a partial 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 n eeds 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 noted that Fatty acids, C16-18 and C18-unsatd., Me esters has been evaluated as part of DfE’s SCIL. However, a screening stat us decision for a chemical substance is not inherently indicative that risk screening inform ation is available for the substance. While EPA

has access to the assessment that resulted in the listing of Fatty acids, C16-18 and C18-unsatd., Me esters as a solvent on the SCIL, this assessmen t is not publicly available. Fatty acids, C16-18 and C18-unsatd., Me esters is listed with a yellow triangl e due to hazard concerns.

As EPA noted above, under 40 CFR 180.910, Methyl es ters of fatty acids derived from edible fats and oils are approved for use as an inert ingr edient in pesticides ap plied to crops, both pre-6 and post-harvest. 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 haza rd and exposure assessments, in this case, ecotoxicology was not reviewed. OPP in its InertFinder identifies CASRN 67762-38-3 as associated with the chemical name Methyl esters of fatty acids derived from edible fats and oils.

Overall the petition provided litt le evidence that complementary risk screening information is available for Fatty acids, C16-18 and C18- unsatd., Me esters. A lthough risk screening determinations are publicly avai lable for Fatty acids, C16-18 and C18-unsatd., Me esters, the supporting assessments for these determinations are not readily available. OPP’s tolerance exemption and reassessment provide evidence of the supporting assessment for human health, but not for ecotoxicology. However, Canada’s DS L determination that this chemical substance was neither persistent nor bioaccumulative, and “ not inherently toxic to aquatic organisms” leads EPA to believe that ecotoxicology is not a concern for this substance.

EPA concluded that the partial av ailability of information relevant to Consideration D weighs moderately in favor of partially exempting Fa tty acids, C16-18 and C18-unsatd., Me esters 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 peti tioner referred to the monthly biodiesel production report from the U.S. Energy Information 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 biod iesel may also have uses other than as fuel, which would not necessarily be discussed in a report focused on the energy uses of biodiesel.

Nonetheless, EPA found that processing and us e information for Fatty acids, C16-18 and C18- unsatd., Me esters was available under the REAC H program and was sufficiently comparable to CDR processing and use information. Data fr om the non-confidential 2012 CDR database identified the following industrial uses: fuels a nd fuel additives, solvents for cleaning, surface active agents, intermediates, lubricants and lubricant additives, and processing aids. The following consumer and commercial uses were also identified: fuels and related products, plastic and rubber products, and non-TSCA uses.

5 U.S. EPA, 2006. FQPA Reassessment Action: Reassessment of Fifteen Exemptions from the Requirement of a Tolerance for Twelve Poorly Absorb ed Chemicals, June 1, 2006.7 Though EPA recognizes that the ECHA database doe s not specify the amounts of Fatty acids, C16-18 and C18-unsatd., Me esters for each use, wh en considered in combination with the other substance-specific factors that we igh in favor of granting a par tial reporting exemption (e.g., the evidence that the potential human health effect s and/or environmental effects would be low) EPA does not regard the lack of use-by-use vol ume 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 concludes 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, C16-18 and C18-unsatd., Me esters uses continuous closed systems, and that re gulations also require transport and storage to occur in well-control led vessels. Collectively, these controls reduce potential for release 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 petitione r fails to consider the full history of the petroleum process stream exemption, which documents additional considerations beyond those 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 are8 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 potential risks of this chemical substa nce are inadequate. Thus overall EPA regards Consideration F as weighing marginally in favor of establis hing a partial exemption

for this chemical substance.