Review Report for Fatty Acids, Tallow, Me Esters (CASRN 61788-61-2) 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, tallow, Me esters (CASRN 61788-61-2) . This determination is based on the totality

of information available for the chemical substan ce, including an evaluation of one or more of

the considerations listed in 40 CF R 7l1.6(b)(2)(ii). In the case of this particular chemical substance, the considera tions 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 is no readily

available human health and environmental info rmation for Fatty acids, tallow, Me esters; however, EPA’s Office of Pesticide Programs’ (OPP) tolerance exemption for analog chemicals and the categorization of Fatty acids, tallow, Me es ters as low risk on Canada’s Domestic Substances List (DSL) and by the Organisation for Economic Co-operation and Development (OECD) High Production Volume (HPV) program weigh 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 analog chemicals on the website of the European Chemicals Agency (ECHA) weighs moderately

in favor of establishi ng 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 provides 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 analog chemicals on ECHA’s 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.

A direct final rule to add Fatty ac ids, tallow, Me esters to the list of chemical substances partially exempt from reporting CDR processing and use information in 40 CFR 711.6(2)(b)(iv) will be2 published in the Federal Register. If EPA recei ves adverse public comment on the addition of this chemical substance to the list, EPA will w ithdraw the direct final rule before the listing

becomes effective. Additionall y, if the level of interest in the CDR processing and use

information for this chemical substance were to change after final listi ng, EPA may reevaluate the listing decision and pursue amendm ent 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 Bi obased and Renewable Products Advocacy Group (BRAG) 1 (hereinafter “the petitioner”), requesti ng that Fatty acids, tallow, Me esters (CASRN 61788-61-2 be added to th e 40 CFR 711.6(b)(2)(iv) list of sp ecific chemical substances that are exempt from the reporti ng 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 promulgated on January 7, 2003, “...the need for processing and use information under IURA changes over time. The in clusion of a chemical substance under this partial exemption is not itself a determination of 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.” 2 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 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, tallow, 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 Cancer, OECD’s HPV Screening Information Data Set program, and 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.

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 petitioner referenced information concerning Fatty acids, tallow, Me esters from a variety of sources and linked it to specific consid erations 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 acid s, tallow, Me esters (CASRN 61788-61-2) was reported in the 2012 CDR and provided public information on production volume. EPA reviewed the 2012 CDR data for Fatty acids, tallow , Me esters and found that nine sites reported domestically manufacturing and/or importing Fatty acids, tallow, Me esters with a nationally aggregated production volume of 418,370,092 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 concluded that the other considerations ar e 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, tallow, Me esters is non-hazardous or non-toxic, but instead referred to exposure controls that would be in place to limit exposure. Nevertheless, as noted above, EPA reviewed info rmation for this consideration in making its decision. The petitioner provided some data on physical and chemical properties and human health and environmental effects, but did not pr ovide the studies to s upport these results. Instead, the petitioner note d generally that information is ava ilable from registration dossiers for the European Registration, Evaluation, Authoriz ation and Restriction of Chemicals (REACH) program and other sources. However, Fatty acids, tallow, Me esters is no t a registered chemical under REACH. 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 sour ces of data relevant to this consideration. The petition request covered the following six substances: Fatty acids, tallow, Me esters (CASRN 61788-61-2); Soybean oil, Me ester (CAS RN 67784-80-9); Fatty acids, canola oil, Me esters (CASRN 129828-16-6); Fatty acids, corn oil, Me esters (CAS RN 515152-40-6); Fatty acids, C16-18 and C18-unsatd., Me esters (C ASRN 67762-38-3); and Fatty acids, C14-18 and C16-18-unsatd., Me esters (CASRN 67762-26-9). Th e alkyl chain compositions of these six substances are fairly similar, with the only diffe rences in alkyl chain sizes being generally one carbon number (such as the presence or absence of saturated C 14 chains or C16-unsaturated chains). The main differences between the tallow, corn, canola, and soybean oil sources are in the relative percentages among the alkyl chains in common, especially the relative amounts of saturated (largely palmitic, stearic) versus unsatur ated (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 othe r, cover qualitatively the alkyl chains found4 in the four natural source-named substances in the petition; however, th e two alkyl range-named substances could have any per centages of the individual chains named in the range. Based on these considerations, and for the purposes of this assessment, EPA considered these six substances to be analogs of each other.

Human Health Effects. No human health data we re found for Fatty acids, tallow, Me esters. However, in a reassessment of a tolerance exemption under the Food Quality Protection Act (FQPA) for analog chemicals that are similar in st ructure and constituents to Fatty acids, tallow, Me esters, OPP concluded that these chemicals are expected to have poor absorption by all routes (oral, inhalation, and derm al), with little risk anticip ated from possible degradation products. 3 OPP concluded 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.

Additionally, Fatty acids, tallow, Me esters is listed as “low” for human health priorities by Canada’s DSL categorization program and is liste d as low priority for assessment in the OECD HPV program. Based on the available informati on, EPA has a relatively low level of concern regarding the potential for Fatty acids, tallow, Me esters to have effects on human health.

Environmental Effects. No enviro nmental toxicity data were f ound for Fatty acids, tallow, Me esters. Ecotoxicology was not included in the 2006 FQPA reassessment. This chemical is listed as “not inherently toxic to a quatic organisms” by Canada’s DSL categorization program and is a low priority for assessment in the OECD HPV program. EPA’s New Chemicals Program reviewed the toxicity of analog ch emicals that are similar in stru cture and constituents to Fatty acids, tallow, Me esters, and dete rmined that they were a low risk to the environment, with predicted low persistence, and low bioaccumulation potential. Based on the available information, EPA has a relatively low level of c oncern regarding the potential for Fatty acids, tallow, Me esters to have effects on the environment

Environmental Fate. There is no readily available information on the environmental fate of Fatty acids, tallow, Me esters. However, this chem ical is listed as not persistent and not bioacumulative by Canada’s DSL categorization program. Neat Rapeseed oil (NR) and Neat, Soybean oil (NS) as well as their modified pr oducts Rape Ethyl Ester (REE), Rape Methyl Ester (RME), and Soyate Ethyl Ester (SEE) appear to be similar in their structure and constituents, and therefore are suitable analogs for biodiesels. Test data on these analogs app ear to indicate that there is low persistence of biodi esel 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 biodiesels are readily biodegradable. 4

There is no readily available hum an health and environmental information for Fatty acids, tallow, Me esters. However, based 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

3 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.

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 risk is in agreement with 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 dete rmination that this 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 relating to this chemical substance. Thus, the tolerance exemption for analog chemicals and the presence of Fatty acids, tallow, Me esters on the low risk lists for Canada’s DSL and the OECD HPV weighs moderately in favor of establishing 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 analog chemicals that are similar in structure and constituents to this chemical is already av ailable to government agen cies 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 lik ely to be similar. EPA is not currently aware of any respects in which the European data on the processing and use of this chemical substance would be inadequate for its foreseeable informa tion needs. This combination of circumstances weighs moderately in favor of establishing a pa rtial exemption for this chemical substance.

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

The petitioner noted that Fatty ac ids, tallow, Me esters was scr eened under the categorization of Canada’s DSL. However, a screening status deci sion for a chemical substance is not inherently indicative that risk screening information is available for the substance. Canada’s DSL determination was not presented as the result of an assessment of available data.

While the OECD has also judged Fatty acids, tallow, Me esters to be a low priority for additional assessment, this judgement is listed without the supporting material leading to that

determination.

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 mainta ining such an exemption. FQPA reassessment documents generally include hazard and e xposure assessments, although in this case, ecotoxicology was not reviewed. OPP in its InertFinder identifies CASRN 61788-61-2 as associated with the chemical name Methyl esters of fatty acids derived from edible fats and oils (tallow is an edible fat).

Overall the petition provided litt le evidence that complementary risk screening information is available for Fatty acids, tallow, Me esters. Alt hough risk screening determ inations are publicly available for this chemical, the supporting assessments for these determinations are not readily available. OPP’s tolerance exemption and r eassessment provide evidence of the supporting assessment for human health, but not for ecotoxi cology. However, Canada’s DSL determination that this chemical substance was neither persiste nt nor bioaccumulative a nd “not inherently toxic to aquatic organisms” leads EPA to believe that ecotoxicology is not a concern for this

substance.

EPA concluded that the partial availability of information relevant to Consideration D is sufficient to weigh moderately in favor of partiall y exempting Fatty acids, tallow, 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 collecting 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 rule repor ting. 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 use information for analogs of Fatty acids, tallow,

Me esters was available under REACH and th at it was sufficiently comparable to CDR processing and use information. Data from th e non-confidential 2012 CDR database identified the following industrial uses: fuels and fuel a dditives, and solvent for cleaning. The following

consumer and commercial uses were also identifie d: fuels and related pr oducts and agricultural products.

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, tallow, Me esters for each use, when considered in combination with the other substance-specific factors that affect a partial reporting exemption (e.g., the evid ence that the potential human

health effects and/or environmental effects woul d be low) EPA does not regard the lack of useby-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, tallow,

Me esters uses continuous closed systems, and that regulations al so require transport and storage to occur in well-controlled vessels. Collectively, these controls reduce potential for release and exposures similar to those implemented for the petroleum process stream s listed at 711.6 (b)(1), for which EPA determined 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 711.6 (b)(1) listing decision8 are broader than those cited in the petitione r’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.