Review Report for Fatty Acids, C14-18 and C16-18-unsatd., Me esters 

(CASRN 67762-26-9) 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 

Fatty acids, C14-18 and C16-18-unsatd., Me esters (CASRN 67762-26-9). 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 are no readily 

available data for Fatty acids, C14-18 and C16-18-unsatd., Me esters. Analog data 

indicated a low concern for environmental fate. EPA’s Office of Pesticide Programs’ 

(OPP) tolerance exemption for analog chemicals and the presence of Fatty acids, C14-18 

and C16-18-unsatd., Me esters on the low risk list for the Organisation for Economic Cooperation and Development’s (OECD) High Production Volume (HPV) program 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 the CDR information would not 

be relevant; however, the availability of recent processing and use information for this 

chemical on the website of the European Chemicals Agency (ECHA) weighs moderately 

in favor of establishing a partial exemption; 

 Consideration D: The petitioner provided no evidence that complementary risk screening 

information is available for Fatty acids, C14-18 and C16-18-unsatd., Me ester; however, 

for the analog CASRN 67762-38-3, OPP’s tolerance exemption and reassessment, which 

provide evidence of the supporting assessment for human health, and Canada’s Domestic 

Substances List (DSL) determination that the analog was neither persistent nor 

bioaccumulative, and “not inherently toxic to aquatic organisms” leads EPA to believe 

that ecotoxicology is not a concern. The partial availability of information for analog 

chemicals weighs moderately in favor of partially exempting Fatty acids, C14-18 and 

C16-18-unsatd., Me ester 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 

sources. However, the availability of recent processing and use information for this 

chemical on the ECHA website weighs in favor of granting the partial exemption; and 
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 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, C14-18 and C16-18-unsatd., 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, C14-18 and C16-18-

unsatd., Me esters (CASRN 67762-26-9) 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 Fatty acids, C14-18 and C16-18-unsatd., 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 

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

 

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.
3

the International Agency for Research on Cancer, OECD’s 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, C14-18 and C16-18-unsatd., Me 

esters from a variety of sources and linked it to specific considerations cited in 40 CFR 

711.6(b)(2)(ii). 

Consideration A: Whether the 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, C14-18 and C16-18-unsatd., Me esters (CASRN 67762-

26-9) was reported in the 2012 CDR and provided public information on production volume. 

EPA reviewed the 2012 CDR data for Fatty acids, C14-18 and C16-18-unsatd., Me esters and 

found that 11 sites reported domestically manufacturing and/or importing Fatty acids, C14-18 

and C16-18-unsatd., Me esters with a nationally aggregated production volume of 1 billion – 5 

billion 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 concludes 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 that it was not advocating that Fatty acids, C14-18 and C16-18-unsatd., 

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 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 that information is available from 

registration dossiers for the European Registration, Evaluation, Authorization and Restriction of 

Chemicals (REACH) program and other sources. Fatty acids, C14-18 and C16-18-unsatd., Me 

esters has a full REACH registration. The petitioner also referred to other websites but did not 

explain how the information on those websites specifically 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. 

However, EPA did not have access to studies providing supporting data in the REACH 

registration dossiers. 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 
4

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 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. There are no readily available human health toxicity data for Fatty acids, 

C14-18 and C16-18-unsatd., Me esters. It is listed as a low priority for assessment as an HPV 

chemical by OECD. The Agency’s New Chemicals Program reviewed the toxicity of analog 

chemicals similar in structure and constituents to Fatty acids, C16-18 and C18-unsatd., Me 

esters, and determined they were a low risk to human health. In a reassessment of a tolerance 

exemption under the Food Quality Protection Act (FQPA) for analog chemicals that are similar 

in structure and constituents to Fatty acids, C14-18 and C18-unsatd., Me esters, 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 determined that 

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. The available information for Fatty acids, C14-18 and 

C16-18-unsatd., Me esters leads EPA to have a relatively low level of concern regarding this 

chemical substance’s potential for effects on human health. 

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

C14-18 and C16-18-unsatd., Me esters. It is listed as a low priority for assessment as a HPV 

chemical by OECD. EPA’s New Chemicals Program reviewed the toxicity of analog chemicals 

that are similar in structure and constituents to Fatty acids, C14-18 and C16-18-unsatd., Me 

esters, and determined that they were a low risk to the environment. Based on the available 

information for Fatty acids, C14-18 and C16-18-unsatd., Me esters, EPA has a relatively low 

level of concern regarding this chemical substance’s potential for effects to 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 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 biodegradable4

. Available information 

 

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

 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

indicates that Fatty acids, C14-18 and C16-18-unsatd., 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, C14-

18 and C16-18-unsatd., 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 risk is in agreement with the general conclusions 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 determination that the 

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, C14-18 and C16-18-

unsatd., 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 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 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 the 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 provided no information on the availability of risk screening information for Fatty 

acids, C14-18 and C16-18-unsatd., Me esters. 

EPA notes that CASRN 67762-38-3 is sufficiently similar in composition to allow read-across of 

information to Fatty acids, C14-18 and C16-18-unsatd., Me esters. The petitioner noted that 

Fatty acids, C16-18 and C18-unsatd., Me ester (CASRN 67762-38-3) has been evaluated as part 
6

of EPA’s Design for the Environment (DfE) Safer Chemical Ingredients List (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 Fatty acids, C16-18 and C18-unsatd., Me ester as a solvent on DfE’s 

SCIL, this assessment is not publicly available. Fatty acids, C16-18 and C18-unsatd., Me ester is 

listed on DfE’s SCIL with a yellow triangle due to hazard concerns. 

As 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 pre- and postharvest. A 2006 FQPA reassessment document5

 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 the analog CASRN 67762-38-3 as associated with 

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

The petition provided no evidence that complementary risk screening information is available for 

Fatty acids, C14-18 and C16-18-unsatd., Me ester. Although risk screening determinations are 

publicly available for the analog Fatty acids, C16-18 and C18-unsatd., Me ester (CASRN 67762-

38-3), 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 of the analog CASRN 67762-38-3, but not for ecotoxicology. However, Canada’s DSL 

determination that the analog CASRN 67762-38-3 was neither persistent nor bioaccumulative 

and “not inherently toxic to aquatic organisms” leads EPA to believe that ecotoxicology is not a 

concern for Fatty acids, C14-18 and C16-18-unsatd., Me ester. 

EPA concluded that the partial availability of information relevant to Consideration D for analog 

chemicals weighs moderately in favor of partially exempting Fatty acids, C14-18 and C16-18-

unsatd., 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 collection 

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. 

 

5

 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. 
7

Nonetheless, EPA found that processing and use information for Fatty acids, C14-18 and C16-

18-unsatd., Me esters was 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. 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, 

C14-18 and C16-18-unsatd., Me esters for each use, when considered in combination with the 

other substance-specific factors that weigh in favor of granting 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, C14-18 

and C16-18-unsatd., 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 releases 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 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 has 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 has 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 
8

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.