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 low 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 esters (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 case of this particular chemical 

substance, the considerations were as follows: 

 Consideration A: Current CDR information suggests that at least one site would have a 

production volume sufficient to trigger the need to report processing and use information 

under the 2016 CDR (25,000 pound threshold); 

 Consideration B: The petitioner did not address this consideration. There is no readily 

available human health and environmental information 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 human health and the environment. This conclusion, which is 

in agreement with the general conclusions of low risk that Canada reached respecting 

Fatty acids, canola oil, 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 analog chemicals and Canada’s Domestic 

Substances List (DSL) determinations weigh moderately in favor of establishing a partial 

exemption; 

 Consideration C: The petitioner did not characterize the particular information needs it 

expected to arise, nor substantiate its general expectation that CDR information would 

not be relevant; however, the availability of recent processing and use information for 

analog chemicals on the European Chemicals Agency (ECHA) website weighs 

moderately in favor of establishing a partial exemption; 

 Consideration D: Overall the petitioner provided little evidence that complementary risk 

screening information is available for Fatty acids, canola oil, Me esters; however, the 

listing of the substance on the Toxic Substances 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 availability of information is sufficient to weigh 

moderately in favor of partially exempting Fatty 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 other 
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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, 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 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 Biobased and Renewable Products Advocacy 

Group (BRAG)1

 (hereinafter the “petitioner”), requesting that Fatty acids, canola oil, Me esters 

(CASRN 129828-16-6) be added to the 40 CFR 711.6(b)(2)(iv) list of specific chemical 

substances that are exempt from the reporting requirements of 40 CFR 711.15(b)(4) (i.e., exempt 

from requirements to report industrial processing and use and commercial/consumer use 

information). The chemical substances already included on this “partial exemption” list are 

substances for which EPA has previously determined that there is a low current interest in the 

CDR processing and use information. However, as stated in the preamble to the Inventory 

Update Reporting Amendments (IURA) rule promulgated on January 7, 2003, “...the need for 

processing and use information under IURA changes over time. The inclusion of a chemical 

substance under this partial exemption is not 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 considerations not identified below, to make an informed 

decision.” The considerations used by EPA in reviewing this petition and an analysis of how 

those considerations relate to Fatty acids, canola oil, Me esters are set forth below. 

Discussion: EPA considered information submitted with the petition, as well as other 

information including, but not limited to: whether the petitioned chemical substance is listed on 

the Emergency Planning and Community Right to Know Act, Section 313 list of Toxic 

Chemicals and thus is reportable to the Toxics Release Inventory; 2012 CDR submissions for the 

 

1 CDR Partial Exemption Petition (October 21, 2014) (Hereinafter “The Petition”); From: BRAG, Managed by B&C® Consortia Management, 

LLC.; To: OPPT CDR Submission Coordinator, U.S. Environmental Protection Agency; Re: “Petition for Partial Exemption of Biodiesel 

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.
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chemical substance; evaluations available through EPA’s Integrated Risk Information System, 

the International Agency for Research on Cancer, the Organisation for 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 and 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 chemical qualifies or has qualified in past IUR collections for the 

reporting of the information described in 40 CFR 711.15(b)(4).

The petitioner indicated that Fatty acids, canola oil, Me esters (CASRN 129828-16-6) was 

reported in the 2012 CDR and provided 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 least one manufacturing site would likely have a production volume 

sufficient to trigger the need to report processing and use information under the 2016 CDR 

(25,000 lb threshold). Thus, EPA concluded that the other considerations are ripe for evaluation. 

Consideration B: The chemical substance’s chemical and physical properties or potential for 

persistence, bioaccumulation, health effects, or environmental effects (considered independently 

or together). 

The petitioner claimed it was not advocating that Fatty acids, canola oil, Me esters is nonhazardous or non-toxic, but instead referred to exposure controls that would be in place to limit 

exposure. Nevertheless, as noted above, EPA reviewed 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 noted generally that information is available from registration dossiers for 

the European Registration, Evaluation, Authorization 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 referred 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 was insufficient, by itself, to review this 

consideration. EPA decided to review additional sources 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 (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 esters (CASRN 67762-26-9). The alkyl chain compositions of these six 
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substances are fairly similar, 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 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 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, 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 were 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 Fatty acids, canola, Me esters, and determined they were a low risk 

to human health. The chemical is listed as low for human health priorities on Canada’s DSL. 

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 to human health. 

Environmental Effects. There are no available environmental toxicity data for Fatty acids, canola 

oil, Me esters. EPA’s New Chemicals Program reviewed the toxicity of analog chemicals that are 

similar in structure and constituents to Fatty acids, 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 (NS) as well as their 

modified products Rape Ethyl Ester (REE), Rape Methyl Ester (RME), 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 CO2 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 biodegradable3. 

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

bioaccumulation in the environment. The available information indicates that Fatty acids, canola 

oil, Me esters are readily biodegradable and not likely to be persistent in the environment. 

There is no readily available human health and environmental information 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 human health and the environment. This conclusion, which is in 

agreement with the general conclusions of low risk that Canada reached respecting Fatty acids, 

canola oil, 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 

 

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), 1423-1430 
5

low concern for analog chemicals and Canada’s DSL 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 government interest in biofuels, including biodiesel, 

there is and will continue to be significant interest in biodiesel substances and this level of 

interest will result in identification of information needs. The petitioner believes that the 

screening level process and use information collected under CDR will likely be of little use 

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

The petitioner did not characterize the particular information needs it expected would arise 

relating to biofuels, and thus could 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 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 

any respect in which European data on the processing 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 partial exemption for this chemical substance. 

Consideration D: The availability of other complementary risk screening information. 

The petitioner noted that EPA has access to risk screening information for Fatty acids, canola oil, 

Me esters through the Section 5 new chemical review conducted for this substance, but did not 

reference the relevant risk screening information, 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 listed 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 little evidence that complementary risk screening information is 

available for Fatty acids, canola oil, Me esters. Although risk screening determinations are 

publicly available for Fatty acids, canola oil, Me esters, the supporting assessments for these 

determinations are not readily available to the public. The listing of the substance on the TSCA 

Inventory without restrictions following PMN review and Canada’s DSL determinations of low 

priority provide evidence of a low hazard concern for this chemical. 
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EPA concludes that the partial availability of information relevant to Consideration D is 

sufficient to weigh moderately in favor of partially exempting Fatty acids, canola oil, Me esters 

from CDR reporting. 

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

The petitioner stated that collecting information on processing and use of biodiesel under CDR is 

not necessary for EPA, other agencies, or the general public, as relevant information collecting 

and reporting already occurs under other federal programs. The petitioner 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) also generate reports on 

biofuels. 

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

collected under CDR would already be available in other reports about biodiesel prepared by 

EPA, EIA, and USDA, nor did the petitioner address 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 report 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 the 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 and fuel additives. The following consumer and 

commercial uses were also identified: fuels and related products.

Though EPA recognizes that the ECHA database does not specify the amounts of Fatty acids, 

canola oil, Me esters for each use, when considered in combination with the other substancespecific factors that affect a partial reporting exemption (e.g., the evidence that the potential 

human health effects and/or environmental effects would be low) EPA does not regard the lack 

of use-by-use volume information as particularly problematic. 

EPA believes that other recent processing and use information available from ECHA is 

sufficiently comparable to CDR processing and use information to favor granting a partial 

reporting exemption for this chemical substance. While the ECHA information may not be 

completely representative of use in the United States, EPA concluded in this case (in view of all 

relevant considerations) that the ECHA information is a reasonable surrogate indicator of 

possible United States processing and use. 

Consideration F: Whether the potential risks of the chemical substance are adequately managed 

by EPA or another agency or authority. 

The petitioner generally indicated that the manufacturing and processing 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 for 
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release and exposures similar to those implemented for the petroleum process streams listed at 

711.6 (b)(1), for which EPA determined full CDR reporting was not warranted. 

EPA notes that chemical intermediates that are manufactured 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 substances that are manufactured and 

processed using continuous closed systems, and then isolated for transport and storage, the 

closed conditions of pre-isolation 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 regulations that require transport and storage to occur 

in “well-controlled” vessels. Many chemical substances are transported and stored in wellcontrolled vessels, and the alleged care with which a particular chemical substance is being 

stored and transported seems to have limited bearing on whether EPA would have an interest in 

the processing and use of the chemical substance after it has been stored and transported. 

EPA acknowledges that the factors cited by the petitioner under Consideration F were also 

factors that EPA cited at the time it established the partial exemption for petroleum process 

streams. 68 FR 853-54 (2003). However, the petitioner 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 proposing the exemption EPA noted the sheer magnitude 

of ongoing manufacturing for petroleum process streams, 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 particular chemical substances qualified for the 

petroleum process stream exemption, EPA has taken still other considerations into account. See 

70 FR 75061-62 (2005). Because the potentially relevant 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 countervailing evidence that ongoing efforts or 

regulations to manage the potential risks of this chemical substance are inadequate. Thus, 

overall, EPA regards Consideration F as weighing marginally in favor of establishing a partial 

exemption for this chemical substance.