Review Report for Soybean Oil, Me Ester (CASRN 67784-80-9) Partial Exemption

January 2015

Biobased and Renewable Products Advocacy Group (BRAG)

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

Summary of Decision: The U.S. Environmental Protection Agency (hereinafter “EPA” or the 

“Agency”) has determined that there is a low current interest in the processing and use 

information collected under the Chemical Data Reporting (CDR) rule (see 40 CFR Part 711) for

Soybean oil, Me ester (CASRN 67784-80-9). 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 little readily 

available human health and environmental information for Soybean oil, Me ester;

however, EPA’s Office of Pesticide Programs’ (OPP) tolerance exemption for analog 

chemicals and the presence of Soybean oil, Me ester on the low risk lists for Canada’s

Domestic Substances List (DSL) categorization program and EPA’s Design for the 

Environment (DfE) Safer Chemical Ingredients List (SCIL) 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: The petitioner provided little evidence of the availability of 

complementary risk screening information for this chemical; however, OPP’s tolerance 

exemption and reassessment, which provide evidence for human health, and Canada’s

DSL categorization of “not inherently toxic to aquatic organisms” lead EPA to believe 

that ecotoxicology 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 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 Soybean oil, Me ester 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 
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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 Soybean oil, Me ester (CASRN 

67784-80-9) be added to the 40 CFR 711.6(b)(2)(iv) list of specific chemical substances that are 

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

to report 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 Soybean oil, Me ester 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 

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 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.

 

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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The petitioner referenced information concerning Soybean oil, Me ester 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 Soybean oil, Me ester (CASRN 67784-80-9) was reported in the

2012 CDR and provided public information on production volume. EPA reviewed the 2012 

CDR data for Soybean oil, Me ester and found that 23 sites reported domestically manufacturing 

and/or importing Soybean oil, Me ester with a nationally aggregated production volume of

3,094,877,961 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 Soybean oil, Me ester is non-hazardous or nontoxic, but instead referred to exposure controls that would be in place to limit exposure. 

Nevertheless, as noted above, EPA reviewed additional 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, Soybean oil, Me ester is not a registered chemical under 

REACH. The petitioner noted that the National Toxicology Program (NTP) had prepared a 

summary of data for this chemical and 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 

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 
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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. In a reassessment of a tolerance exemption under the Food Quality 

Protection Act (FQPA) for analog chemicals similar in structure and constituents to Soybean oil, 

Me ester, OPP concluded that these chemicals are expected to have poor absorption by all routes 

(oral, inhalation, and dermal), with little risk anticipated from possible degradation products.3

OPP’s analysis 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. 

For Soybean oil, Me ester, NTP conducted genetic toxicity studies in vitro in Salmonella, and in 

mouse micronucleus assays; the results were negative.4,5 The Agency’s New Chemicals Program 

reviewed the toxicity of analog chemicals that are similar in structure and constituents to 

Soybean oil, Me ester, and determined that it was a low risk to human health. Additionally, the 

chemical is listed as a solvent on DfE’s SCIL, with a yellow designation for health hazards.6

NTP has conducted genetic toxicity studies in vitro in Salmonella and in mouse micronucleus 

assays and the results were negative.

7,8 EPA’s New Chemicals Program reviewed the toxicity of 

analog chemicals that are similar in structure and constituents to Soybean oil, Me ester, and 

determined that it was a low risk to human health. Based on the available information, EPA has a 

relatively low level of concern regarding the potential for Soybean oil, Me ester to have effects 

on human health.

Environmental Effects. There are no readily available environmental toxicity data for Soybean 

oil, Me ester. However, it is listed on Canada’s DSL as having low ecotoxicity concerns. It is 

also listed on DfE’s SCIL, with a yellow designation for potential hazards. The Agency’s New 

Chemicals Program reviewed the toxicity of analog chemicals similar in structure and 

constituents to Soybean oil, Me ester, and determined 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 concern regarding the potential for 

Soybean oil, Me ester to have effects on the environment.

Environmental Fate. There are no readily available environmental fate data for Soybean oil, Me 

ester. 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 

 

3 U.S. EPA, 2006. FQPA Reassessment Action: Reassessment of Fifteen Exemptions from the Requirement of a 

Tolerance for Twelve Poorly Absorbed Chemicals, June 1, 2006.

4 http://tools.niehs.nih.gov/cebs3/ntpViews/?studyNumber=002-02448-0002-0000-2 Accessed 12/9/2014.

5 http://tools.niehs.nih.gov/cebs3/ntpViews/?studyNumber=002-02448-0001-0000-1 Accessed 12/9/2014.

6 http://www.epa.gov/dfe/saferingredients.htm Accessed 12/9/2014.

7 http://tools.niehs.nih.gov/cebs3/ntpViews/?studyNumber=002-02448-0002-0000-2 Accessed 12/9/2014.

8 http://tools.niehs.nih.gov/cebs3/ntpViews/?studyNumber=002-02448-0001-0000-1 Accessed 12/9/2014.
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similar in structure and constituents, and therefore suitable analogs. 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 biodegradable.9 Soybean oil, Me ester is also listed under 

Canada’s DSL as having uncertain persistence, but not bioaccumulating. Overall, the available 

data and information indicate that soybean oil, Me ester is readily biodegradable and not likely to 

be persistent in the environment.

There is little readily available human health and environmental information for Soybean oil, Me

ester. 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 risk is in 

agreement with the general conclusions of low risk that Canada and DfE have reached respecting 

this chemical substance. These determinations carry 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 Soybean oil, 

Me ester on the low risk lists for Canada DSL’s and DfE’s SCIL 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 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 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 respects 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.

 

9 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.
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The petitioner noted that Soybean oil, Me ester has been evaluated as part of 

DfE’s SCIL. However, a screening status decision for a chemical substance is not inherently 

indicative that risk screening information is available for the substance. While EPA has access to 

the assessment that resulted in the listing of Soybean oil, Me ester as a solvent on the SCIL, this 

assessment is not publicly available. Soybean oil, Me ester is listed with a yellow triangle due to 

hazard concerns.

As EPA noted above, under 40 CFR 180.910, Methyl esters of fatty acids derived from edible 

fats and oils are approved for use as an inert ingredient in pesticides applied to crops, both preand post-harvest. A 2006 FQPA reassessment document10 for Methyl esters of fatty acids derived 

from edible fats and oils recommended maintaining such an exemption. Though FQPA 

reassessment documents generally include hazard and exposure assessments, in this case, 

ecotoxicology was not reviewed. OPP in its InertFinder identifies CASRN 67784-90-9 as 

associated with the chemical name Methyl esters of fatty acids derived from edible fats and oils.

Overall the petition provided little evidence that complementary risk screening information is 

available for Soybean oil, Me esters. Although risk screening determinations are publicly 

available for Soybean oil, 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 DSL 

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 concludes that the partial availability of information relevant to Consideration D is

sufficient to weigh moderately in favor of partially exempting Soybean oil, Me ester 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.

 

10 U.S. EPA, 2006. FQPA Reassessment Action: Reassessment of Fifteen Exemptions from the Requirement of a 

Tolerance for Twelve Poorly Absorbed Chemicals, June 1, 2006.
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Nonetheless, EPA found that recent processing and use information for analogs of Soybean oil, 

Me ester was already available under the REACH program and that it 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, solvents for cleaning, 

surface active agents, and intermediates. The following consumer and commercial uses were also 

identified: fuels and related products, personal care products. 

Though EPA recognizes that the ECHA database does not specify the amounts of Soybean oil, 

Me ester for each use, when considered in combination with the other substance-specific 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 Soybean 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 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 manufactured and processed using “continuous closed 

systems” and are 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 
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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.