Managed by B&C® Consortia Management, L.L.C.

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2200 Pennsylvania Ave, N.W. Suite 100W (202) 833-6580

Washington, D.C. 20037 www.braginfo.org

November 5, 2014

Via Federal Express

OPPT CDR Submission Coordinator

Mailcode: 7407M

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:

The Biobased and Renewable Products Advocacy Group (BRAG®)

1 submits this 

letter as a supplement to its October 21, 2014, petition to amend the Chemical Data Reporting 

(CDR) partially exempted chemical list at 40 C.F.R. Section 711.6(b)(2)(iv). Specifically, 

BRAG wishes to amend the list of chemicals to be considered in the proposed “biodiesel” 

chemical category for partial exemption to include:

 Canola Oil, Methyl Ester: Chemical Abstracts Service Registry Number 

(CASRN) 129828-16-6

Petition Elements

As identified in 40 C.F.R. Section 711.6(b)(2)(ii), the U.S. Environmental 

Protection Agency (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 [Inventory Update Reporting] collections for the 

reporting of the information described in § 711.15(b)(4). 

 1 BRAG provides a platform for 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.
OPPT CDR Submission Coordinator

November 5, 2014

Page 2

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(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 Canola Oil, Methyl Ester, CASRN 129828-16-6, for each of these 

considerations is provided below.

Qualification for Previous CDR Reporting

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

available at http://java.epa.gov/oppt_chemical_search/), Canola Oil, Methyl Ester, CASRN 

129828-16-6 qualified for reporting under the 2012 CDR. The reported national production 

volume was withheld, with two companies reporting. 

Physical/Chemical Properties and Health/Environmental Effects

Petitioners are not advocating that the subject chemical for this amendment or the 

original chemicals listed in the October 21, 2014, petition 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 40 C.F.R. Section 711.6(b)(1), referred to as the (b)(1) List, should receive 

partial reporting exemptions, the same rationale for partial reporting exemption should be 

applied to the chemicals listed in this petition.
OPPT CDR Submission Coordinator

November 5, 2014

Page 3

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A compilation of available information related to the physical and chemical 

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

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

program and other publicly available sources is provided in Appendix 1, which was also 

included in the initial October 21, 2014, petition. 

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 Availability of Comparable Processing and Use 

Information below.)

Availability of Complementary Risk Screening Information

EPA has access to risk screening information for Canola Oil, Methyl Ester, CASRN 

129828-16-6 through the Section 5 new chemical review conducted on this substance.

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 Canola Oil, Methyl Ester, CASRN 129828-16-6 

and the other substances on the initial petition uses continuous 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 on the (b)(1) 

List, for which EPA determined full CDR reporting was not warranted. 
OPPT CDR Submission Coordinator

November 5, 2014

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Thank you for the opportunity to provide this supplement to the BRAG October 21, 

2014, petition. 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.

Sincerely,

Kathleen M. Roberts

BRAG Executive Director

Attachment
Canola Oil Methyl Ester Tallow Methyl Ester Soy Oil Methyl Ester Fatty acids, corn‐oil, Me esters

Fatty acids, C16‐18 and C18‐unsaturated,

Me esters

Fatty acids, C14‐18 and C16‐18‐unsaturated, Me

esters

CAS RN 129828‐16‐6 61788‐61‐2 67784‐80‐9 515152‐40‐6 67762‐38‐3 67762‐26‐9

Melting Point Approximately 10 o

C >= ‐16.92 <= 15.59 °C

From ‐16.92°C to +15.59°C

Tp= +6.29°C

Boiling Point >150 oC >200 oC at 760 mm Hg >= 344.7 <= 354.3 °C

The mean corrected boiling point values of the

test item (on 4 assays) are Tel = 344.7°C and Tp=

354.3°C

Vapor Pressure <1 mm Hg (at 20 o

C) <2 mm Hg

4.2 m Bar , or 420 Pa , at 25°C, and 3.6 m

Bar at 20°C

The vapor pressure is determinated to be 4.2 m

Bar , or 420 Pa , at 25°C, and 3.6 m Bar at 20°C

Partition Coefficient

Information to be presented at OECD

CoCAM 6 ‐‐ October 2014

Mean Log Pow for the 6 peaks of Esterol A

for 3 determinations are 2.7, 3.0 > 6.2. The

value of 6.2 is taken as definitive

Mean Log Pow for the 6 peaks of Esterol A for 3

determinations are 2.7, 3.0 > 6.2. The value of 6.2

is taken as definitive

Water Solubility Negligible Insoluble Insoluble (< 0.1 mg/L)

All replicates give the result of water solubility as

less than 0.023mg/L, which is the detection limit

of the analysis method

Density/Specific Gravity 0.882 0.874 0.884 0.8881 g/cm3

The mean relative density of the test item is

D(20°C/4°C)=0.8881 g/cm3

Viscosity (Kinematic, mm2/s at 40°C) 4.439 (Kinematic, mm2/s at 40°C) 4.824 (Kinematic, mm2/s at 40°C) 4.039 6.1 mPa*s at 20°C Dynamic viscosity is 6.1 mPa*s at 20°C

Flash Point 163 o

C >150 oC 218 oC 173°C +/‐ 1°C

Corrected at the pressure of 101.3kPa, flash

point of Esterol A was 173°C +/‐ 1°C

Acute Toxicity LD50: >17.4 g/kg b.w.

Not acute oral toxic, not considered dermal

toxic

Not considered to be an acute oral toxic; not

considered to be an acute dermal toxic

Repeated‐Dose Toxicity

Information to be presented at OECD

CoCAM 6 ‐‐ October 2014

No effect in Repeated dose oral toxicity for

a dose of until 1000 mg/kg/bw

No effect in Repeated dose oral toxicity for a

dose of until 1000 mg/kg/bw

Genetic Toxicity in vivo

Information to be presented at OECD

CoCAM 6 ‐‐ October 2014

No in vivo studies evaluating methyl

soyate for mutagenic effects were found in

the available literature

Methyl ester of fatty acids in chain length

from C6 to C20 does not show

chromosomal aberration on Chinese

Hamster bone‐marrow cells until a

concentration of 5000 mg/Kg

Methyl ester of fatty acids in chain length from

C6 to C20 does not show chromosomal

aberration on Chinese Hamster bone‐marrow

cells until a concentration of 5000 mg/Kg

Genetic Toxicity in vitro

Information to be presented at OECD

CoCAM 6 ‐‐ October 2014

No in vitro studies evaluating methyl

soyate for mutagenic effects were found in

the available literature

Does not induce chromosome aberrations

in cultured human lymphocytes.

Does not induce chromosome aberrations in

cultured human lymphocytes; does not show any

mutagenic activity in the bacterial reverse

mutation test on Salmonella typhimurium

strains; showed no evidence of mutagenic

activity in this bacterial system under test

condition employed; negative without metabolic

activation.

Reproductive Toxicity

Information to be presented at OECD

CoCAM 6 ‐‐ October 2014

No effect in Screening for reproduction for

a dose of until 1000 mg/kg/bw

Revealed no effect in Screening for reproduction

for a dose of until 1000 mg/kg/bw

Developmental Toxicity/Teratogenicity

Information to be presented at OECD

CoCAM 6 ‐‐ October 2014 Scientifically unjustified Scientifically unjustified

Skin Irritation

Information to be presented at OECD

CoCAM 6 ‐‐ October 2014 Not considered to be a skin irritant Not considered to be a skin irritant

Eye Irritation

Information to be presented at OECD

CoCAM 6 ‐‐ October 2014 Not considered to be an eye irritant Not considered to be an eye irritant

Skin Sensitization

Information to be presented at OECD

CoCAM 6 ‐‐ October 2014

Does not induce delayed contact

hypersensitivity in guinea‐pigs

Does not induce delayed contact hypersensitivity

in guinea‐pigs

Carcinogenicity

Information to be presented at OECD

CoCAM 6 ‐‐ October 2014

No 2‐year carcinogenicity studies of methyl

soyate in animals were identified in the

available literature. Data are available on

individual fatty acid esters.

No relevance to carcinogenic

effect/potential No relevance to carcinogenic effect/potential

Acute Toxicity to Aquatic Vertebrates LC 50: 2.18148 ‐ 4.88 mg/l LC50 1.1739 ‐ 2.22205 mg/l

In Fish exposed to an average measured

loading rate of 0.26 mg/L of Fatty acids,

C16 ‐C18 and C18 unsaturated , methyl

esters in diluition water (limit test), visible

abnormalities (loss of equilibrium, changes

in swimming behavior, respiratory

function, pigmentation, etc.) were not

observed.

WAF EC50 48h Brachydario rerio >= 100000 mg/l;

In Fish exposed to an average measured loading

rate of 0.26 mg/L of Fatty acids, C16 ‐C18 and C18

unsaturated , methyl esters in diluition water

(limit test), visible abnormalities (loss of

equilibrium, changes in swimming behavior,

respiratory function, pigmentation, etc.) were

not observed.

Acute Toxicity to Aquatic Invertebrates EC50: 006 mg/l

Information to be presented at OECD

CoCAM 6 ‐‐ October 2014

In the test conditions (solution saturated in

Esterol A, 48h exposure), Esterol A is not

toxic for Daphnids.

Validity criteria are partially fulfilled.

BUT it is important to notice that as the

concentration is below the detection limit

of the analytical method (0.13 mg/l), the

precise concentration with no observed

effect cannot be determined.

WAF EC50 48 Daphnia magna = 2504 mg/l; In the

test conditions (solution saturated in Esterol A,

48h exposure), Esterol A is not toxic for

Daphnids.

Validity criteria are partially fulfilled.

BUT it is important to notice that as the

concentration is below the detection limit of the

analytical method (0.13 mg/l), the precise

concentration with no observed effect cannot be

determined.

Chronic Aquatic Vertebrate Toxicity

Information to be presented at OECD

CoCAM 6 ‐‐ October 2014

Chronic Aquatic Invertebrate Toxicity

Information to be presented at OECD

CoCAM 6 ‐‐ October 2014

Toxicity to Terrestrial Plants

Information to be presented at OECD

CoCAM 6 ‐‐ October 2014

Toxicity to Soil Dwelling Organisms

Information to be presented at OECD

CoCAM 6 ‐‐ October 2014 Study scientifically unjustified

Toxicity to Non‐Mammalian Terrestrial Species

Information to be presented at OECD

CoCAM 6 ‐‐ October 2014

BRAG® CDR Partial Exemption Petition:  Substance Data Health Effects Information Environmental Effects Information Physical and Chemical Properties