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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 JimWillis, 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 fromthe 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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# C 3a13 5sUNITED 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 notspecified by test rule Dear Mr. Olsen: OFFICE OF PREVENTION, PESTICIDES AND TOXIC SUBSTANCES

This letter concerns thefinal 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 4test 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 thetest rule. Following is a list ofthose tests and the guidelines concerned. 

### Test Test Guideline Test Guideline Follow Rq,uired by Rule OctanoUwater partition coefficient OECD 117 799.6755 Inherent Biodegradation ASTM E 1279 ASTM1625 or ISO9888 Reproduction/Developmental 870 .3550 799

.9355 Toxicity Screening Test Thetest rule required that testing be conducted according to specific guidelines. Under 40 CFR790

.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 ofthe test standards. At this point, you must provide an explanation to EPAofwhy the guidelines specified by thetest 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 explanationto EPA .

Internet Address (URL) " httpJ/www .epe.gov RoeYOI"Reeyalablt 9 Prhil~d withVapefable 00 8amd Inks on Rooyobd Paper (Nlkdmum50% Postcornuner eon0ont)Aresponse 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 EPAwill then review

your response and the studies, decide ifthe studies were properly conducted, and decide whether the studies provide the information theAgency was seeking when it required the tests. Failure to provide an adequate explanation may result in enforcement action under 40 CFR790

.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 RomanDEPARTMENT OF THE ARMY US ARMY CENTER FOR HEALTH PROMOTIONAND 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 andToxic 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 OECDand 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. Ifthe Environmental Protection Agency finds issue with the citation, a protocol amendment may be in order to change the method citation, if required. Theexperimental data conducted in our laboratories suggested a very slow and minimal saturation of 1,3-Pentaerythritol tetranitrate in sterile water at room temperature

. Giventhis outcome, American Society for.Testing and Materials Method 1279 (Biodegradation by a ShakeFlask Die-Away Method) was substituted for 1625 or ISO9888 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 forTesting 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

## 2- (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 ofwatersolubility, 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 ofthe 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