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OPPT CDR Submission Coordinator 

Mailcode: 7407M 

October 21, 2014 

Office of Chemical Safety and Pollution Prevention 

U.S. Environmental Protection Agency 

1200 Pennsylvania Avenue, N.W. 

Washington, D.C. 20460 

Re: Petition for Partial Exemption of Biodiesel Products 

Dear Sir or Madam: 

Ra,.i 'J> Sv 

CT 2 2 2014 

OfPT 

CBIC Control Number 

362346 

The Biobased and Renewable Products Advocacy Group (BRAG®) 1 submits this 

petition to amend the Chemical Data Reporting (CDR) partially exempted chemical list at 40 

C.F.R. Section 71 1.6(b)(2)(iv). Specifically, BRAG petitions to add "biodiesel" as a chemical 

category for partial exemption with the following chemicals and associated Chemical Abstracts 

Service Registry Numbers (CASRN) included: 

• Tallow, Methyl Ester: CASRN 61788-61-2; 

• Soy Oil, Methyl Ester: CASRN 67784-80-9; 

• Fatty acids, com-oil, Me esters: CASRN 515152-40-6; 

• Fatty acids, Cl6-18 and CIS-unsaturated, Me esters: CASRN 67762-38-

3; and 

• Fatty acids, Cl4-l8 and Cl6-18-unsaturated, Me esters, CASRN 67762-

26-9. 

BRAG provides a platform !or organizations engaged in biobased chemistries to identify 

regulatory barriers for their unique products and to work collectively to address them. 

BRAG tackles regulatory hindrances related to commercialization of biobased products 

and works to improve public awareness of the benefits of these products. 

{00620.002 / III / 00139842.DOC 7} 

2200 Pennsylvania Ave, N.W. Suite lOOW 

Washington, D.C. 20037 

{202) 833-6580 

www.braginfo.org 
OPPT CDR Submission Coordinator 

October 21, 20 14 

Page 2 

Background 

The U.S. Environmental Protection Agency (EPA) maintains two lists of partially 

exempted chemicals for which manufacturers are exempt from reporting the processing and use 

infonnation required by 40 C.F .R. Section 711.15(b )( 4). 

One list of partially exempted chemicals is found at 40 C.F.R. Section 

711.6(b)(2)(iv), hereafter referred to as the (b)(2) List. EPA has stated that CDR processing and 

use information for chemicals on this list is of "low current interest." EPA has established a 

formal petition process for amending the (b )(2) List in which EPA will issue a written response 

to the petition within 120 days of receipt. The petition process enables stakeholders to add 

chemicals to the {b )(2) List, but only after EPA has reviewed relevant information, including 

potential toxicity data, and determined there is low current interest in the processing and use 

information for that substance. 

The other list, found at 40 C.F.R. Section 711.6(b)(l), referred to as the (b)(l) 

List, consists primarily of petroleum process streams that were exempted via a rulemaking 

process based on proposals submitted by the American Petroleum Institute (API). In the final 

rule adding the petroleum process exemption, EPA stated the following: 

2 

The basis for this exemption is not because these streams are of 

known low toxicity. EPA believes that the chemicals termed 

"petroleum process streams" for purposes of rURA are often 

toxicologically active. However, these chemicals are frequently 

processed at the site where they are produced in vessels which are 

designed to minimize losses and, coincidentally, the potential for 

releases and exposure. In many cases, the flammable nature of 

these products requires that they also be transported, processed, 

and stored in well controlled vessels. For these reasons, EPA 

believes worker exposure to the chemicals termed "petroleum 

process streams" for purposes of IURA is diminished and thus full 

IURA exposure-related reporting is not warranted at this time. 

2 

There is no specified petition process to amend the (b)( l) List. 

68 Fed. Reg. 848 (Jan. 7, 2003). 

(00620.002/111 I 00 l39842.DOC 7} 
OPPT CDR Submission Coordinator 

October 21,2014 

Page 3 

Biodiesel is used in conjunction with or as a replacement for petroleum-derived 

diesel fuel (CASRN 68334-30-5) and diesel fuel number 2 (CASRN 68334-30-5), both of which 

are included on the (b)(l) List. Similar to currently exempted products included in the (b)(1) 

List, the biodiesel products in this petition are not of known low toxicity and can be 

toxicologically active. Notwithstanding, biodiesel products are a specific group of substances 

that are treated similarly to the petroleum products included in the (b)( 1) List due to the 

conditions of manufacture and the properties and uses of the substances. Just like petroleum 

products, the biodiesel products included in this petition are transported, processed, and 

maintained in vessels to minimize losses that result in a low potential for release and exposure. 

Similar to the conclusions reached by EPA for the currently exempt petroleum products on the 

(b)(l) List, worker exposure to the listed biodiesel products for purposes of CDR is diminished 

and full CDR reporting is not warranted. 

BRAG believes that adding biodiesels to the (b)(l) List is necessary to ensure 

equitable regulatory treatment of chemical substances of comparable release and exposure 

potential, and to avoid EPA providing regulatory relief to one subset of diesel products over 

another -- even though both meet the decision conditions identified by EPA in its final 

rulemaking to amend the (b)(l) List. Indeed, given EPA's stated objectives and interest in 

sustainable technologies in general, and ongoing programs that engage biodiesel producers in 

particular, the actions outlined in this petition are appropriate. 

For the reasons listed above, BRAG believes it would be more appropriate to 

petition for biodiesel to be added to the (b)(l) List. As noted, however, there is no petition 

process to amend the (b)(l) List. While BRAG is proceeding with a request for a rulemaking to 

add biodiesel to the (b)(l) List via a Section 21 citizen's petition, the reality is that final EPA 

response under this approach could take many months, if not years, to proceed to completion. 

Because timing is critical, BRAG is also submitting this petition to amend the 

(b)(2) List, recognizing that EPA is required to respond to the petition request within 120 days. 

(00620.002 I Ill I 00139842.DOC 7} 
OPPT CDR Submission Coordinator 

October 21 , 2014 

Page4 

Petition Elements 

As identified in 40 C.F.R. Section 711.6(b)(2)(ii), EPA is required to consider the 

following information in determining whether a partial exemption should apply: 

(A) Whether the chemical substance qualifies or has qualified 

in past IUR collections for the reporting of the information 

described in § 711.15(b)(4). 

(B) The chemical substance's chemical and physical properties 

or potential for persistence, bioaccumulation, health effects, 

or environmental effects (considered independently or 

together). 

(C) The information needs of EPA, other Federal agencies, 

Tribes, States, and local governments, as well as members 

of the public. 

(D) The availability of other complementary risk screening 

information. 

(E) The availability of comparable processing and use 

information. 

(F) Whether the potential risks of the chemical substance are 

adequately managed. 

Information on each of these considerations is provided below. 

{00620.002 / 111 I 00 139842. DOC 7} 
OPPT CDR Submission Coordinator 

October 21, 2014 

Page 5 

Qualification for Previous CDR Reporting 

Based on information derived from the EPA Chemical Data Access Tool (CDA T, 

available at http://java.epa.gov/oppt chemical searcl:!L), all of the chemicals in this petition 

qualified for reporting under the 2012 CDR. Public information on national production volumes 

and number of reporting entities is as follows: 

• Tallow, Methyl Ester: CASRN 61788-61-2 

National Production Volume: 418,370,092 pounds, with nine companies 

reporting 

• Soy Oil, Methyl Ester: CASRN 67784-80-9 

National Production Volume: 3,094,877,961 pounds, with 23 companies 

reporting 

• Fatty acids, com-oil, Me esters: CASRN 515152-40-6 

National Production Volume: WITHHELD, with one company reporting 

• Fatty acids, C16-18 and CIS-unsaturated, Me esters: CASRN 67762-38-3 

National Production Volume: 602,936,770 pounds, with 15 companies 

reporting 

• Fatty acids, CI4-18 and Cl6-18-unsaturated, Me esters: CASRN 67762-

26-9 

National Production Volume: 1,000,000,000 - 5,000,000,000 pounds, 

with 11 companies reporting. 

Physical/Chemical Properties and Health/Environmental Effects 

Petitioners are not advocating that the subject chemicals are non-hazardous or 

non-toxic. Because of the nature of the chemicals and potential toxicity concerns, specific 

exposure controls and worker protections are in place to minimize potential releases. Because 

similar exposure controls and worker protection approaches were sufficient for EPA to determine 

petroleum process streams in the (b)(l) List should receive partial reporting exemptions, the 

same rationale for partial reporting exemption should be applied to the chemicals listed in this 

petition. 

A ·compilation of available information related to the physical and chemical 

properties and health and environmental effects derived from registration dossiers for the 

{00620.002 I Ill I 00139842.DOC 7} 
OPPT CDR Submission Coordinator 

October 21, 2014 

Page 6 

European Registration, Evaluation, Authorization and Restriction of Chemicals (REACH) 

program and other publicly available sources is provided in Appendix 1. The petitioners note 

that EPA has additional information for health and safety of biodiesel on its website (Biofuels 

Compendium -- Biodiesel -- Handling, see http://www.epa.gov/oust/altfue1s/biohndl.htm), as 

well as a presentation "Biofuels in the Environment: A Review of Behaviors, Fates and Effects 

& Remediation Techniques," on its Office of Solid Waste and Emergency Response website (see 

http://www.epa.gov/osweroel/docs/oil/fss/fss09/hollebonebiofuels.pdf). A summary of data for 

Soy Oil, Methyl Ester (CASRN 67784-80-9) was prepared for the National Toxicology Program 

(see http:/ /ntp.niehs.nih. gov/ntplhtdocs/chem backgroundlexsumpdflmethylsoyate 508 .pd!). 

Petitioners further note that a category related to the substances in this petition was the subject of 

international review under the Organization for Economic Cooperation and Development 

(OECD) Cooperative Chemicals Assessment Meeting (CoCAM) in October 2014. 

Information Needs of EPA, Other Agencies, and Public 

With the ongoing government dialogue concerning 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. Nonetheless, the screening level 

process and use information collected under CDR will likely be of little use within this debate. 

Moreover, information can and is being collected under other programs. (See Ava labil~ty of 

Comparable Processing and Use Information below.) 

Availability of Complementary Risk Screening Information 

EPA has access to risk screening information for the subject chemicals as follows: 

• Tallow, Methyl Ester: CASRN 61788-61-2 -- Screened under the 

categorization of the Canadian Domestic Substances List (DSL) 

• Soy Oil, Methyl Ester: CASRN 67784-80-9 -- Risk screening conducted 

as part of the Design for the Environment (DfE) program under Safer 

Chemical Ingredients for Use in DfE-Labeled products 

• Fatty acids, com-oil, Me esters: CASRN 515152-40-6 --Risk screening 

conducted under Section 5 new chemical review 

• Fatty acids, C16-18 and CIS-unsaturated, Me esters: CASRN 67762-38-3 

-- Risk screening conducted under Safer Chemical Ingredients for Use in 

DfE-Labeled Products 

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OPPT CDR Submission Coordinator 

October 21 , 2014 

Page7 

• Fatty acids, C14-18 and C16-18-unsaturated, Me esters: CASRN 67762-

26-9 

Availability of Comparable Processing and Use Information 

The collection of 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. Information on the production and 

use of biodiesel is currently collected, maintained, and publicly reported by the U.S. Energy 

Information Administration (EIA). EIA issues a monthly biodiesel production report that 

provides data on the U.S. biodiesel industry, including plant locations, production volumes, and 

sales of biodiesel to end-users. There are also other reports on biofuels, including. biodiesel, 

generated by EPA and the U.S. Department of Agriculture (USDA). 

Management of Potential Risks 

The manufacture and processing of these substances uses continu()us closed 

systems, and regulations require transport and storage to occur in well-controlled vessels. These 

process controls to reduce potential for releases and exposures are similar to those implemented 

for the petroleum process streams listed at (b)(l), for which EPA determined full CDR reporting 

was not warranted. 

BRAG members look forward to the opportunity to respond to any questions that 

EPA may have regarding this petition and to EPA's response to the petition request. Please call 

me at 443-964-4653 or e-mail me at kroberts@bc-cm.com for further information or to schedule 

a meeting. 

Attachment 

{00620.002 / III / 00139842.00C 7} 

Sincerely, 

/ ·' ?7/ /!L r~o/f 7;:;0~; 

Kathleen M. Roberts 

BRAG Executive Director 
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Kathleen M. Roberts 

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