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OPPT CDR Submission Coordinator Mailcode: 7407M October 2 1 , 2014

Office ofChemical Safety and Pollution Prevention U.S. Environmen tal Protection Agency 1200 Pennsylvania Avenue, N.W. Washington, D.C
. 20460 Re: Petition for Partial Exemption of Biodiesel Product s Dear Sir or Madam: 

# Ra, .i 'J> Sv 

# CT 2 2 2014 OfP T CBIC Control Number 

# 362346

The Biobased and Renewabl e Products Advocacy Group (BRAG®) 1 sub mits this petition to amend the Chemica l Data Reporting (CDR) partially exempted chemica l list at 40 C.F.R. Section 71 1. 6(b)(2)( iv). Spec ifi cally, BRAG petitions to add " b iodiesel " as a chemical category for partial exemption with t he following c hemicals and associated Chemical Abstracts Service Regi stry Numbers (CASRN) included:
• Ta ll ow, Methyl Ester: CASRN 61788-61-2;
• Soy Oi l, Methyl Ester: CASRN 67784-80-9;
• Fatty acids, com-oi l , 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 a nd to work collectively to address them. BRAG tackles regulatory hindrances related to commerc ialization 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.orgOPPT C DR Submission Coordinator Octobe r 21, 20 14 Page 2 Background The U.S. Environmental Protection Agency (EPA) maintain s two lists of partially exempted chem ical s for which manufacturers are exempt from reporting the processing and us e inf onnation r equired b y 40 C .F .R. Section 711.15(b )( 4). One list of partially exempted chemicals is found at 40 C
. F.R. Sec tion 711.6(b)(2)(iv) , hereafter referred to as the (b)(2) List. EPA has s tated that CDR processing and u se information for chemicals on this list is of "low curren t interest." EPA has estab lished a formal petition pr ocess for amending the (b )(2) Li st in which EPA will issue a written response t o the pet ition within 1 20 day s of receipt. Th e petition process e nable s s takeholders to add che mi ca ls to the { b )(2) List, but only after EPA ha s reviewed re levant inf o rmation , including pote nti a l toxicity data , and determined there is lo w c urrent interest in the processing and use info rmatio n fo r that sub s tance. The other list, found at 4 0 C
.F.R. Section 7 11. 6(b)(l), referred to as the ( b )( l ) List , co n sists prim ari ly of petroleum process streams tha t were exempted v ia a rulemaking process based o n pr oposals s ubmitted by the American Petroleum Institute (API). In t he final rule ad d in g t he petr o leum process exemption, EPA stat ed t he follow in g:

2 The bas is for this exemption is not becau se these s tream s are of kn o wn low toxicity. EPA believes that the chemical s te rmed " petroleum process streams" for purpo ses of rURA are often toxicologically active. However , thes e chemicals are frequently processed at the site where t hey are produ ce d in vessels which are des igned to minimize lo sses and, coincidentall y, th e potential for releases and exposure. In many cases , th e flammabl e nature of th ese products requires that they also be tran s p o rted , pro cesse d, and sto red in we ll controlled vesse ls. For these reasons, EPA b elieves worker exposur e to the chem ica ls termed "petroleum process s treams" for purpo ses o f IURA is dimini shed and thus full IURA ex po sure-related reporting is not warranted a t this time
. 2 There is no specified p e tition process to amend the (b)( l ) List.

68 Fe d
. 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 lo w 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 th e (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 add ing biodiesels to the (b)(l) List is necessary to ensure equitable regulatory treatm ent of chemic a l 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 i s proceeding with a request for a rulemaking to add biodiese l to the (b)(l) List via a Sect ion 21 citizen's petition, the reality i s that final EPA response under this approach could take many months, if not years, to proceed to complet i on. Because timing is critical, BRAG is also submitting this petitio n 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 Submi ss ion Coordinator O ct o be r 21 , 2014 Page4
Petition Eleme n ts As id entified in 40 C .F.R. Section 711.6(b)(2)(ii) , EPA i s required to co n s ider the following inf o rmati on in determining whether a parti a l exe mption sho uld apply:

(A) Whether the c hemi ca l sub s tance qualifie s or has qualified i n past IUR co lle ctions for the reporting of the information described in § 711.15(b)(4). (B) Th e ch emical sub stance's chemi c al and phys ical properties or poten ti al fo r persistence , bioac cumu lati o n , health effects , or environmental effec ts (cons idered indep endently or toge the r ). ( C) The information needs of EP A, othe r Federal agenc i es , Tribes, States , and local go vernme nts, a s w e ll as members of the public. (D) The av ai la bil ity of other compl eme ntary ri s k s creening information. (E) The availability of comparab le process ing a nd use information. (F) W hether the potential ri sks of the c hemi ca l s ubstance a r e ade quate ly manage d
. Information on each of these considerations is provided below
.

{00620. 002 / 1 1 1 I 00 1 3984 2. DOC 7}OPPT CDR Submission Coordinator October 21, 2014 Page 5 Qualificationfor Previous CDR Reporting Based on information derived from the EPA Chemical Data Access Too l (CDAT, available at http :// java.epa.go v/oppt chemical searcl:!L) , all of the chemicals in this petition qualified for reporting under the 2012 CDR. Public information on national production vo lum es and number of reporting entities is as follows:
• Tallow, Methyl Ester: CASRN 61788-61-2 National Production Volume: 418,370,092 pounds, wi t h 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
• F atty 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 t he chemi cals and potential toxicity concerns , specific exposure controls and worker protections are in place to minimiz e potential releases. Because s imilar 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 env ironmental effects derived from registration dossiers for the {00620.002 I Ill I 00139842.DOC 7}OPPT CDR Submission Coordina tor October 21, 2014 Page 6 European Registration, Evaluation, Authorization and Restriction of Chemicals (REACH) program and othe r publicly available sources is provided in Appendix 1
. The petitioners note that EPA has additional in formation for health and safety of biodi esel on its webs ite (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, Fat es 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.pd f)
. 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 Cooperat i on and Development (OECD) Cooperative Chemicals Assessment Meeting (CoCAM) in Oc tober 2014. Information Needs of EPA , Other Agencies, and Public Wi th the ongoing government dialogue concerning biofuels , including biodiesel, there is and will continue to be significant interest in b iodiese l substances and th i s level of interest will result in identification of inform ation needs. Nonetheless, t he screening l evel process and use inf ormation 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 Comparab le Processing and U se 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 --Ri sk sc reening conducted under Section 5 n ew 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 {00620
. 002 I Il l I 00 139842.DOC 7 }OPPT CDR Submission Coordina tor 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 biodiese l un der CDR is not necessary for EPA, other agencies, or the general public, as relevant informat ion collection and reporting already occurs under other federal programs. Information on the production and use of biodiesel i s currently collected, maintained, and publicly reported by the U.S. Energy Information Admin i stration (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 -u sers. There are also other reports on biofuels, including
. b iodiesel, 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 vesse l s. These process controls to reduce potential for releases and exposures are simi lar to tho se implemented for the petroleum process streams listed at (b)(l), for which EPA determined full CDR reporting was not warranted. BRAG members loo k forward to the opportunity to respond to any questions that EPA may have regarding this petition and to EPA's response to the petit i on request. Please call me at 443-964-4653 or e-mai l me at kroberts@bc-cm
. com for further information or to schedu le a meeting.

Attachment

{00620.002 / III / 00139842.00C 7} Sincerely, 

# / ·' ?7/ /!L

## r~**o/f 7;:;0~;**  Kathleen M. Roberts BRAG Executive D i rectorFrom: (202) 557·3800 Or ig i n I D: AUKA Ka t

h l een M. Roberts BERGESON & CAM P BE LL , P

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