Review Report for Fatty Acids, Tallow, Me Esters (CASRN 61788-61-2) 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, tallow, Me esters (CASRN 61788-61-2). 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, tallow, Me esters; 

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

chemicals and the categorization of Fatty acids, tallow, Me esters as low risk on Canada’s 

Domestic Substances List (DSL) and by the Organisation for Economic Co-operation and 

Development (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 analog 

chemicals on the website of the European Chemicals Agency (ECHA) 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 provides 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 analog 

chemicals on ECHA’s 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, tallow, 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 
2

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, tallow, Me esters 

(CASRN 61788-61-2 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, tallow, 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, OECD’s HPV Screening Information Data Set 

program, and 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.
3

The petitioner referenced information concerning Fatty acids, tallow, 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, tallow, Me esters (CASRN 61788-61-2) was reported in 

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

CDR data for Fatty acids, tallow, Me esters and found that nine sites reported domestically 

manufacturing and/or importing Fatty acids, tallow, Me esters with a nationally aggregated 

production volume of 418,370,092 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, tallow, 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 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, tallow, 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 

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 
4

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, tallow, Me esters. 

However, 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, tallow, 

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 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. 

Additionally, Fatty acids, tallow, Me esters is listed as “low” for human health priorities by 

Canada’s DSL categorization program and is listed as low priority for assessment in the OECD 

HPV program. Based on the available information, EPA has a relatively low level of concern 

regarding the potential for Fatty acids, tallow, Me esters to have effects on human health. 

Environmental Effects. No environmental toxicity data were found for Fatty acids, tallow, Me 

esters. Ecotoxicology was not included in the 2006 FQPA reassessment. This chemical is listed 

as “not inherently toxic to aquatic organisms” by Canada’s DSL categorization program and is a 

low priority for assessment in the OECD HPV program. EPA’s New Chemicals Program 

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

acids, tallow, Me esters, 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 Fatty acids, 

tallow, Me esters to have effects on the environment 

Environmental Fate. There is no readily available information on the environmental fate of Fatty 

acids, tallow, Me esters. However, this chemical is listed as not persistent and not 

bioacumulative by Canada’s DSL categorization program. 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 are suitable analogs for biodiesels. Test data on these 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.4

There is no readily available human health and environmental information for Fatty acids, 

tallow, 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 

 

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

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 this 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, tallow, 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 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 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, tallow, Me esters was screened under the categorization of 

Canada’s DSL. However, a screening status decision for a chemical substance is not inherently 

indicative that risk screening information is available for the substance. Canada’s DSL 

determination was not presented as the result of an assessment of available data. 

While the OECD has also judged Fatty acids, tallow, Me esters to be a low priority for additional 

assessment, this judgement is listed without the supporting material leading to that 

determination. 

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. FQPA reassessment 

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

ecotoxicology was not reviewed. OPP in its InertFinder identifies CASRN 61788-61-2 as 

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

(tallow is an edible fat). 

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

available for Fatty acids, tallow, Me esters. Although risk screening determinations are publicly 

available for this chemical, 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 is 

sufficient to weigh moderately in favor of partially exempting Fatty acids, tallow, 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 rule 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, tallow, 

Me esters was available under REACH 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, and solvent for cleaning. The following 

consumer and commercial uses were also identified: fuels and related products and agricultural 

products. 

 

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, 

tallow, Me esters 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 useby-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, tallow, 

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 711.6 (b)(1) listing decision 
8

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.