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 Soy bean 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 sit e 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 n ot 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 D omestic S ubstanc es L ist (DSL) categorization program and EPA’s Design for the Environment ( DfE ) Safer Chemical Ingredient s 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 rel e vant ; however, the availability of recent processing and use information for analog ch emicals on the European Chemicals Agency ( ECHA ) website weigh s moderately in favor of establishing a partial exemption ;

 Consideration D : The petitioner provided little evidence of t he availability of complementary risk screening information for this chemi cal; however, OPP’s tolerance exemption and re a ssessment , 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 i n favor o f the partial exemption;

 Consideration E : T he petitioner did n ot 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 weigh s 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 be2

published in the Federal Register. If EPA receives adverse public comme nt 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 subs tance 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 “ p etitioner”), requesting th at Soy bean 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 u se information. However, as stated in the preamble to the Inventory Update Reporting Amendments ( IUR A ) 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 o f 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 pr ocessing 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 proce ssing 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 Soyb ean 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 Commu nity Right to Know Act, Sect i on 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 Int egrated Risk Information System

, the Int ernational Agency for Research on Cancer , the Organis ation 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

re gulatory 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 E xemption 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

T he petitioner referenced information concerning Soybean oil, Me ester from a variety of sources and linked it to specific considerations cite d in 4 0 CFR 711 .6(b)(2)(i i ).

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 p etitioner indicated that Soybean oil, Me ester (CASRN 67784

- 80

- 9) w as 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 lb s. 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 CD R (25,000 lb threshold)

. Thus, EPA conclude d 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 non

toxic, but instead referred to exposure controls that would be in place to limit exposure. Nevertheless, as n oted above, EPA r eviewed additional information for this conside ration 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 thes e results. Instead, the petitioner noted generally that information is available from registration dossiers for the European Registration, Evaluation, Authorization and Restriction of Chemicals (REA CH) program and other sources. However, Soybean oil, Me e ster is not a registered chemical under REACH. The petitioner noted that the National Toxicology Program (NTP) had prepared a

s ummary of data for this chemical a n d 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 o f 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, M e esters (CASRN 129828

- 16

- 6); Fatty a cids, 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 simi lar, 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 unsat urated (largely oleic, linoleic) chains. The two4

alkyl range

- named substances, where the alkyl ranges are C16

- 1 8 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 percentag es of the individ ual 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 rout es (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 o n D fE ’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 S oybean oil, Me ester, and determined that it w as a low risk to human health. Based on the available information, EPA has a relatively low lev el of concern regarding the potential for S oybean oil, Me ester to have effects

on human health.

Environmental Effects

. There are no readily available environmental toxicity data for S oybean oil, Me ester. However, it is listed on C anada ’s DSL as ha ving 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 S oybean oil, Me ester, an d 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 S oybean 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 Meth yl 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 12/9/2014.5

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 CO 2 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 C anada ’s DSL as having uncertain persistence, but not bioaccumulating. Ov erall, 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 envir o nmental information for Soybean oil, Me
est er. However, based on the fact that analog chemicals are expected to have poor absorption, OPP was able to maintain a F QP A tolerance exemption. OPP’s conclusion of low risk is in agreement with the general conclusions of low risk that Canada and DfE have r eached respe cting this chemical substance. These determinations carry some weight in EPA’s assessment of its own current interest in collecting further processing and use information relati ng to this chemical substance. Thus, the tolerance exemption for an alog chemicals and the presence of S oybean 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 lev el 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 unde r other programs.

The petitioner did not ch aracterize 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 s ubstance 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 ris k 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

- 1430.6

The petitioner noted that Soybean oil, Me ester has been evaluated as part of D fE ’s SCIL . However, a screening status decision for a chemical substance is not inherently indicative that risk screening information i s 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

assessm ent 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 crop s, both pre

and post

- harvest. A 2006 F QP A reassessment document 10 for Methyl esters of fatty acids derived from edible fats and oils recommended maintaining such an exemption. Though F QP A reassessment documents generally include hazard and exposure assessments, in this case, ecotoxicology was not reviewed. OPP in its In ertFinder 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 availab le for Soybean oil, Me esters. Although risk screening determinations are publicly available for Soybean oil, Me esters, the supporting assessments for these determinat ions are not readily available. OPP ’s tolerance exemption and reassessment provide evidence of the
sup porting 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 ecotoxico logy 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

.

T he 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 coll ecting 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 p repared by EPA, EIA, and USDA, n or did the petitioner address the observations EPA has already made about the non

- equivalence of EI A 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 t he Requirement of a Tolerance for Twelve Poorly Absorbed Chemicals, June 1, 2006.7

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 wa s sufficiently comparable to CDR p rocessing 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 s ubstance

- 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 problem atic.

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 U nited S tates process ing and use

. Consideration F: Whether the potential risks of the chemical substance are adequately manage d by EPA or another agency or authority.

The petitioner generally indicated that the manufacturing and processing of Soybean oil , Me
esters uses co ntinuous 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 lis ted 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 r equire transport and storage to occur in “well

- controlled” vessels. Many chemical substances are transported and stored in well

controlled vessels, and the alleged care with which a particular chemical substance is being stored and transported seems to hav e 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 E PA 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 be yond those8

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). I n subsequent decisions whether particular chemical substances qualified for the petroleum process stream exemption, EPA has taken still other considerations into accoun t. 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 t his chemical substance.