Review Report for Fatty Acids, C16-18 and C18-unsatd., Me esters (CASRN 67762-38-3) 

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, C16-18 and C18-unsatd., Me esters (CASRN 67762-38-3). This determination is 

based on the totality of information on the chemical substance, including an evaluation of one or 

more of the considerations listed in 40 CFR 7l1.6(b)(2)(ii): 

 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. 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 EPA’s Office of 

Pesticide Programs’ (OPP) Food Quality Protection Act (FQPA) reassessment and the 

general conclusions of low risk that Canada reached respecting Fatty acids, C16-18 and 

C18-unsatd., 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 weighs 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 European Chemicals Agency (ECHA) website weigh 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 considerations, 

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 this 

chemical 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. 
2

A direct final rule to add Fatty acids, C16-18 and C18-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, C16-18 and C18-

unsatd., Me esters (CASRN 67762-38-3) 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, C16-18 and C18-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, 

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 

 

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

regulatory programs administered by EPA and other information researched by EPA to 

supplement the petition. 

The petitioner referenced information concerning Fatty acids, C16-18 and C18-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, C16-18 and C18-unsatd., Me esters (CASRN 67762-38-

3) was reported in the 2012 CDR and provided public information on production volume. EPA 

reviewed the 2012 CDR data for Fatty acids, C16-18 and C18-unsatd., Me esters and found that 

15 sites reported domestically manufacturing and/or importing Fatty acids, C16-18 and C18-

unsatd., Me esters with a nationally aggregated production volume of 602,936,770 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 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, C16-18 and C18-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 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, C16-18 and C18-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 

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 
4

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, 

C16-18 and C18-unsatd., Me esters. The Agency’s New Chemicals Program reviewed the 

toxicity of analog chemicals that are similar in structure and constituents to Fatty acids, C16-18 

and C18-unsatd., Me esters, and determined that they were a low risk to human health. In a 

reassessment of a tolerance exemption under FQPA for analog chemicals similar in structure and 

constituents to Fatty acids, C16-18 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 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. This chemical is listed as a solvent on EPA’s Design for the Environment (DfE) 

Safer Chemical Ingredients List (SCIL) and is code yellow for health hazards. The available 

information on Fatty acids, 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, 

C16-18 and C18-unsatd., Me esters. It is listed on Canada’s DSL categorization program as “not 

inherently toxic to aquatic organisms.” It is also listed on DfE’s SCIL, with a yellow designation 

for potential hazards to the environment. EPA’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 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, C16-18 and C18-unsatd., 

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 structures 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 biodegradable4. 

 

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

Fatty acids, C16-18 and C18-unsatd., Me esters are listed on Canada’s DSL as having low 

persistence and no bioaccumulation in the environment. Based on the available information, 

Fatty acids, C16-18 and C18-unsatd., Me esters appear to be readily biodegradable and are not 

likely to be persistent in the environment. 

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 OPP’s FQPA 

reassessment and the general conclusions of low risk that Canada reached respecting Fatty acids, 

C16-18 and C18-unsatd., 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 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 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 noted that Fatty acids, C16-18 and C18-unsatd., Me esters 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 Fatty acids, C16-18 and C18-unsatd., 

Me esters as a solvent on the SCIL, this assessment is not publicly available. Fatty acids, C16-18 

and C18-unsatd., Me esters 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 pre- 
6

and post-harvest. 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 CASRN 67762-38-3 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 Fatty acids, C16-18 and C18-unsatd., Me esters. Although risk screening 

determinations are publicly available for Fatty acids, C16-18 and C18-unsatd., 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 concluded that the partial availability of information relevant to Consideration D weighs 

moderately in favor of partially exempting Fatty acids, C16-18 and C18-unsatd., 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 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. 

Nonetheless, EPA found that processing and use information for Fatty acids, C16-18 and C18-

unsatd., Me esters was 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, solvents for cleaning, surface 

active agents, intermediates, lubricants and lubricant additives, and processing aids. The 

following consumer and commercial uses were also identified: fuels and related products, plastic 

and rubber products, and non-TSCA uses. 

 

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

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

C16-18 and C18-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 concludes 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, C16-18 

and C18-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 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 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 

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 
8

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.