Review Report for Fatty Acids, Canola Oil, Me Esters (CASRN 129828-16-6) 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, canola oil, Me es ters (CASRN 129828-16-6). This determination is based on the totality of information available for the chemical substance, including an evaluation of one or

more of the considerations listed in 40 CFR 7l1.6(b)(2)(ii). In the cas e 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 in formation for Fatty acids, canola oil, Me esters. However, a review of analog chemi cals concluded that the analogs were not expected to be a hazard for human health and the environmen t. This conclusion, which is in agreement with the genera l conclusions of low risk th at Canada reached respecting Fatty acids, canola oil, Me esters, carries so me weight in EPA’s assessment of its own current interest in collecting further pro cessing and use information relating to this chemical substance. Thus, the low concern for analog chemicals and Canada’s Domestic Substances List (DSL) determinations weigh mo derately 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 expectati on that CDR information would not be relevant; however, the availability of recent processing and use information for analog chemicals on the European Chemi cals Agency (ECHA) website weighs moderately in favor of establ ishing a partial exemption;

 Consideration D: Overall the pe titioner provided little eviden ce that complementary risk screening information is available for Fatty acids, canola oil, Me esters; however, the listing of the substance on the Toxic S ubstances Control Act Inventory without restrictions following a premanufacture notice (PMN) review and Canada’s DSL determinations of low priority provide evidence of a low hazard concern for this chemical and lead EPA to conclude that the partial avai lability of information is sufficient to weigh moderately in favor of partially exempting Fa tty acids, canola oil, Me esters 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 other2 sources; however, the availability of recent processing and use information for analog chemicals 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.

A direct final rule to add Fatty acids, canola oil, 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 be published in the Federal Register. If EPA receives adverse public comment on the addition of this chemical substance to the list, EP A will withdraw the direct final rule before the listing becomes effective. Additionally, if the le vel 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, ca nola oil, Me esters (CASRN 129828-16-6) be added to the 40 CFR 711.6(b)(2)(iv) li st of specific chemical substances that are exempt from the re porting requirements of 40 CFR 711.15(b)(4) ( i.e. , exempt from requirements to report industrial pro cessing 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, canola oil, 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

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

The petitioner referenced information concerning Fatty acids, canola oil, 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, can ola oil, Me esters (CASRN 129828-16-6) was reported in the 2012 CDR and provi ded public information on production volume. EPA reviewed the 2012 CDR data for Fatty acids, canola oil, Me esters and found that 2 sites reported domestically manufacturing and/or importing Fatty acids, canola oil, Me esters with a nationally aggregated production volume that was over 25,000 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, canola o il, Me esters is nonhazardous or non-toxic, but instead referred to expos ure controls 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 did not provide the studies to support 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, canola oil, Me esters is not a registered chemical under REACH. The petitioner also refe rred to other websites but did not explain how the information on those websites specifically 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. The petition request covered th e following six substances: Fa tty 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 six4 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 found

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, canola oil, Me esters. However, EPA’s New Chemicals Program reviewed the toxicity of analog chemicals similar in

structure and constituents to Fatt y acids, canola, Me esters, and determined they were a low risk

to human health. The chemical is listed as lo w for human health priorities on Canada’s DSL. Based on the available information, EPA has a re latively low level of concern regarding the potential for Fatty acids, canola oil, Me es ters to have effects on to human health.

Environmental Effects. There are no available envi ronmental toxicity data for Fatty acids, canola oil, Me esters. EPA’s New Chemicals Program revi ewed the toxicity of an alog chemicals that are similar in structure and constituents to Fatty acid s, canola oil, Me esters, and determined 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 concern regarding the potential for Fatty acids, canola oil, 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 structure and 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 3

.

Fatty acids, canola oil, Me esters are listed on Canada’s DSL as having low persistence and no

bioaccumulation in the environment. The availabl e information indicates that Fatty acids, canola oil, Me esters are readily biode gradable and not likely to be persistent in the environment.

There is no readily available human health and environmental info rmation for Fatty acids, canola oil, Me esters. However, a review of analog chemicals concluded that the analogs were not expected to be a hazard for hu man health and the environment. This conclusion, which is in agreement with the general conclusions of low ri sk that Canada reached respecting Fatty acids, canola oil, Me esters, carries some weight in EP A’s assessment of its own current interest in collecting further processing and use information re lating to this chemical substance. Thus, the

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

environment. Transactions of the ASAE

, 41 (5), 1423-14305 low concern for analog chemicals and Canada’s DS L determinations weigh 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 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 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 respect in which European data on the proc essing and use of this chemical substance would be inadequate for its foreseeable information needs. This combination of circumstances weighs moderately in favor of establishing a partia l exemption for this chemical substance.

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

The petitioner noted that EPA has access to risk sc reening information for Fatty acids, canola oil, Me esters through the Section 5 new chemical re view conducted for this substance, but did not reference the relevant risk screening informa tion, and PMN submissions are not generally made available to the public. At the time that EPA reviewed the PMN submission, EPA did not place any restrictions on the substance. A Notice of Commencement was received and Fatty acids, canola oil, Me esters was liste d on the TSCA Inventory in 2007. EPA notes that while Canada’s DSL categorization determined that Fatty acids, canola oil, Me esters were a low priority for additional assessment, this determination was not presented as the result of an assessment of

available data.

Overall the petition provided litt le evidence that complementary risk screening information is available for Fatty acids, canola oil, Me este rs. Although risk screening determinations are publicly available for Fatty acid s, canola oil, Me esters, the supporting assessments for these determinations are not readily av ailable to the public. The listi ng of the substance on the TSCA Inventory without restrictions following PMN review and Canada’s DSL determinations of low priority provide evidence of a lo w hazard concern for this chemical.6 EPA concludes that the partial availability of information relevant to Consideration D is sufficient to weigh moderately in favor of partia lly exempting Fatty acids, canola oil, 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 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.

Nonetheless, EPA found that processing and use information for analogs of Fatty acids, canola oil, Me esters was already available under th e REACH program and was sufficiently comparable to CDR processing and use information. Data from the non-confidential 2012 CDR database identified the following industrial uses: fuels a nd fuel additives. The following consumer and

commercial uses were also identi fied: fuels and related products.

Though EPA recognizes that the ECHA database doe s not specify the amounts of Fatty acids, canola oil, Me esters for each use, when consid ered in combination with the other substancespecific factors that affect a partial reporting ex emption (e.g., the eviden ce that the potential

human health effects and/or environmental effect s 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, canola oil, Me esters uses continuous closed systems, and that regulations also require transport and storage to occur in well-controlled vessels. Collectively, these controls reduce potential for7 release and exposures similar to those implemen ted for the petroleum process streams listed at 711.6 (b)(1), for which EPA determined fu ll CDR reporting was not warranted.

EPA notes that chemical intermediates that are manufactured and processed using “continuous closed systems” and never isolated are alr eady from exempt from CDR pursuant to 40 CFR 711.10 and 40 CFR 720.30(g)(8). Respecting chemical substances that are manufactured and processed using continuous closed systems, and then isolated for transport and storage, the closed conditions of pre-isol ation manufacture and processing would seem to have limited bearing on whether EPA would have an interest in post-isolation processing 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 seems to have limited bear ing on whether EPA would have an interest in the processing and use of the chemical substan ce after it has been st ored 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 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 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.