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Dyno Nobel Americas 

Document Control Office (DCO) (7407M) 09 SEP - I AM 6 : Of 

Office of Pollution Prevention and Toxics (OPPT) 

Environmental Protection Agency 

1200 Pennsylvania Ave., NW. 

Washington, DC 20460-0001 

ATTN : TSCA Section 4 

Date 19 August 2009 

Dyno Nab*t 

DYNO NOBEL INC. 

2650 Decker Lake Blvd . 

Suite 300 

Salt Lake City, Utah 

84119 USA 

Telephone: 801-364:4800 

Fax: 801-328-6452 

www.dynonobel .com 

Re: Studies conducted according to test guidelines not specified by test rule 

Jim Willis, Director: 

Upon receipt of your letter dated July 13, 2009, Dyno Nobel Inc (DNI) reviewed the project file and it is 

with regret that we confirmed your findings . We understand EPA's position with regards to this matter. 

DNI will take measures to prevent any recurrence if the company is required to conduct testing in 

accordance with future test rules. 

As required by the July 13th letter, DNI contacted the laboratory that performed the testing to obtain the 

requested explanation as to why the guidelines specified by the test rule were not used and a rationale 

for using the guidelines that were used . The US Army Center for Health Promotion and Preventive 

Medicine responded in correspondence to DNI dated August 19, 2009. 

We respectfully submit the attached letter from the laboratory for your review . 

Please do not hesitate to contact me if there are any questions, comments or concerns. 

Regards 

Neal Olsen 

DNI Environmental Affairs Manager 

Phone: +1 801 .328.6425 

e-mail : neal.olsenCaD-am .dynonobel .com 

cc: Catherine Roman 

iJSEPA 

1200 Pennsylvania Ave., NW, 7405M 

Washington, DC 20460 

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UNITED STATES ENVIRONMENTAL PROTECTION AGENCY 

WASHINGTON, D.C. 20460 

JUL 13 2o 

Mr. Neal Olsen 

Environmental Affairs Manager 

Dyno Nobel Inc. 

2650 Decker Lake Boulevard, Suite 300 

Salt Lake City, Utah 84119 

RE: Studies conducted according to test guidelines not specified by test rule 

Dear Mr. Olsen: 

OFFICE OF 

PREVENTION, PESTICIDES AND 

TOXIC SUBSTANCES 

This letter concerns the final test reports which you submitted for 1,3-Propanediol, 2,2-

bis[(nitrooxy)methyl]-, dinitrate (ester) (CAS No.78-11-5), aka PETN, in response to the TSCA 

section 4 test rule entitled "Testing of Certain High Production Volume Chemicals" (71 FR 

13708, March 16, 2006). Your submission indicated that the test guidelines followed for several 

tests were not the test guidelines required by the test rule . Following is a list of those tests and 

the guidelines concerned. 

Test 

Test Guideline Test Guideline 

Follow R q,uired by Rule 

OctanoUwater partition coefficient OECD 117 799.6755 

Inherent Biodegradation ASTM E 1279 ASTM 1625 or ISO 9888 

Reproduction/Developmental 870.3550 799.9355 

Toxicity Screening Test 

The test rule required that testing be conducted according to specific guidelines . Under 

40 CFR 790.55 (attached), EPA's approval is needed before guidelines not specified by the test 

rule may be used. If you believe the guidelines specified by the teat rule were not appropriate for 

your chemical, you must follow the procedures in 40 CFR 790.55 and submit an application for 

modification of the test standards. At this point, you must provide an explanation to EPA of why 

the guidelines specified by the test rule were not used and a rationale for using the guidelines that 

were used. If you believe that the alternate test guidelines were acceptable substitutes, you must 

justify that in your explanation to EPA. 

Internet Address (URL) " httpJ/www .epe.gov 

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A response is needed by August 21, 2009. Your response must be submitted to the 

address in 790.5(b) (attached) . Please cc to: 

Catherine Roman 

USEPA 

1200 Pennsylvania Ave., NW, 7405M 

Washington, DC 20460 

EPA will then review your response and the studies, decide if the studies were properly 

conducted, and decide whether the studies provide the information the Agency was seeking when 

it required the tests. Failure to provide an adequate explanation may result in enforcement action 

under 40 CFR 790.59 (attached). If you have any questions concerning this matter, please 

contact Catherine Roman at 202-564-8172 . 

Sincerely, 

'~ Jim Willis, Director 

Chemical Control Division 

Attachment 

cc: Renee Kesrney/ Docket No. EPA-HQ-OPPT-2005-0033 

Catherine Roman 
DEPARTMENT OF THE ARMY 

US ARMY CENTER FOR HEALTH PROMOTION AND PREVENTIVE MEDICINE 

5158 BLACKHAWK ROAD 

ABERDEEN PROVING GROUND MD 21010-6W3 

August l9, 2009 

Health Effects Research Program 

Mr. Neal Olsen 

Environmental Affairs Manager 

Dyno Nobel Incorporated 

2650 Decker Lake Boulevard, Suite 300 

Salt Lake City, Utah 84119 

Dear Mr. Olsen: 

This letter is in reference to three specific studies conducted by the United States Army 

Center for Health Promotion and Prevention Medicine as requested by Dyno Nobel to fulfill test 

guidelines required by the United States Environmental Protection Agency Office of Prevention, 

Pesticides and Toxic Substances for 1,3-Pentaerythritol tetranitrate (PETN, CAS No. 78-11-5; 71 

FR 13708, March 16, 2006). The enclosed letter dated July 13, 2009 finds that three guidelines 

used were not those mentioned in the test rule . 

Test methods ,used for the determination of the OctanoUwater partition coefficient (OECD 

117 vis 799.6755) and for the Reproductive/Developmental Toxicity Screening Test (870.3550 

vis 799.9355.) are identical to those required in the test rule. Both the OECD and OPPTS 

methods are cited in the reports since they are more widely available. We respectfully suggest 

that the Environmental Protection Agency review these harmonized methods with those outlined 

in the test rule. If the Environmental Protection Agency finds issue with the citation, a protocol 

amendment may be in order to change the method citation, if required. 

The experimental data conducted in our laboratories suggested a very slow and minimal 

saturation of 1,3-Pentaerythritol tetranitrate in sterile water at room temperature. Given this 

outcome, American Society for. Testing and Materials Method 1279 (Biodegradation by a ShakeFlask Die-Away Method) was substituted for 1625 or ISO 9888 for the following reasons: 

(a) American Society for Testing and Materials 1279 allowed for analytical determination 

of 1,3-Pentaerythritol tetranitrate concentration over time. 

(b) American Society for Testing and Materials 1279 used a sensitive, less bioactive 

media (i .e . pond water) to provide information relative to environmental releases . 

(c) Availability for the apparatus prescribed by American Society for Testing and 

Materials 1625 and bioreactive component (i.e. activated sludge) was unknown. 

Readiness thru Health 
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(d) Important laboratory and occupational health issues associated with working with 

activated sludge and associated bioreactors. 

The data from utilization of American Society for Testing and Materials 1279 showed that 

bioreactivity exceeded that of water solubility, an outcome that was determined through the use 

of this method. These data are relevant in understanding the environmental and disposal issues 

associated with releases . 

We hope this explanation provides sufficient information in satisfying the conditions of the 

test rule : Please let us know if further assistance is required. Point of contact for this effort is 

Dr. Mark S. Johnson. 

Sincerely, 

Glenn J. Leach 

Acting Director of Toxicology 

Enclosure