McCarthy, Sweeney & Harkaway, P.C. — Hazardous Materials Safety Interpretation

Page 1US Departmens of transportation 400 Sevenn Steer SW Washungion, DC 20350 Research and Special Programs Administration NOV 1 6 2000 Mr. Lawrence W. Bierlein Ref. No. 00-0263 McCarthy, Sweeney & Harkaway, P.C. Suite 600 2175 K Street, N.W. Washington, D.C. 20037 Dear Mr. Bierlein: This is in response to your September 22, 2000 letter regarding selective testing variations for packagings under the Hazardous Materials Regulations (HMR, 49 CFR Parts 171 to 180). Your request concerned the applicability of the selective testing variations found in § 178.601(g) to a packaging for a material that is toxic by inhalation. As provided by § 173.226(c), a material that is toxic by inhalation in Hazard Zone A may be packaged in a combination packaging consisting of an inner packaging system and an outer packaging. The inner packaging system consists of an impact resistant inner receptacle packed within a leak-tight packaging. This combination packaging in turn is packed within the outer packaging. Both the inner packaging system and the outer packaging must conform to the performance test requirements of subpart M of part 178. You ask if an inner packaging system which has been tested to packing group 1 performance level may utilize the variations provided in § 178.601(g). If the inner packaging system is tested in accordance with the requirements in subpart M of Part 178 and marked in accordance with § 178.503 as a UN standard packaging, then you may use the variations provided in § 178.601(g). If the inner packaging system has not been marked as a UN standard packaging, there is no provision for variations of inner packagings. I hope this satisfies your request. Sincerely, Director, Office of Hazardous Materials Standards#

Page 2"' • NOV 1 6 2000 Mr. Lawrence W. Bierlein Ref. No. 00-0263 McCarthy, Sweeney & Harkaway, P.C. Suite 600 2175 K Street, N. W. Washington, D.C. 20037 Dear Mr. Bierlein: This is in response to your September 22, 2000 letter regarding selective testing variations for packagings under the Hazardous Materials Regulations (HMR, 49 CFR Parts 171 to 180). Your request concerned the applicability of the selective testing variations found in § 178.601(g) to a packaging for a material that is toxic by inhalation. As provided by § 173.226(c), a material that is toxic by inhalation in Hazard Zone A may be packa in a combination packaging consisting of an inner packaging system and an outer packaging. The packaging system consists of an impact resistant inner receptacle packed within a leak-tight packag This combination packaging in turn is packed within the outer packaging. Both the inner packagin system and the outer packaging must conform to the performance test requirements of subpart M o part 178. You ask if an inner packaging system which has been tested to packing group 1 performa level may utilize the variations provided in § 178.601(g). If the inner packaging system is tested in accordance with the requirements in subpart Mi of Part 1' and marked in accordance with § 178.503 as a UN standard packaging, then you may use the vanations provided in § 178.601(g). If the inner packaging system has not been marked as a UN standard packaging, there is no provision for variations of inner packagings. I hope this satisfies your request. Sincerely, Edward T. Mazzullo Director, Office of Hazardous Materials Standards OFFICIAL FRE COPY#

Page 3SEP-22-0017.22 09/9/00 FROM WUULIVUS PAGE FACSIMILE COVER SHEET U.S. DEPARTMENT OF TRANSPORTATION RESEARCH AND SPECIAL PROGRAMS ADMINISTRATION • OFFICE OF HAZARDOUS MATERIALS ENFORCEMENT. "¡ester Region" 820 Beat Tavera Road, Sulic 306 West Treaton, New Jersey 08628 TELEPHONE: (609) 989-2256 BAX: (609) 989-2277 3 Date: 2/7/00 _ Time:_ _ Nuraber of Pages (actuding Cover Soot. Iocatica: ALL -PAK: Pax Number (716) 633-7745 Frora: CHRIS MICHALSIC/ Commenis: PER OUR BRONE "COURSATION, TINCLOSTS PURSE FIND THE FUT BEFING TATIARRD. BE ME PEASE CAL ME LE YOU BAVE AY MOPITIONDL QUESTIONS SERMINE IN TUS EXIT INITELNE.#

Page 4SEP-22-00 08/07/00 17.21 11:58 YAN GUN VOK LEAS FROM. PACE. 6 U5 Departnaik Otice of Hazardous B2D BACE TAvaro Ra, Sta. 306 of Transportation. Materials Entorcament Special Prograstis Research and Eastam Region (003)989-2258 West Trenton, N/ 08528 Fax B09 S8a 22T7 Administration SOCIT BRIEFING "(Fais document is not a ilnal roport., Date: 2/2/00 Report control #: 0042/03/ ompany taro: - ALL PAKiNG sddress: 4225 GENESSE ST, BUEFALO, NY 14225 HANE O8 INDIVIDUAIS RECBIVING IRISIONO: Names - RAY NATT Natas ritic:. Titla: 5121(C). Tuls exit brialing addresser orly the sioss noted, and it 13 sot & Ilnding of Iblo 1a6 been a compllanca inspootion, carductad in accordanca vita Titla 49 V.S.C. Scotion general compliance in any othor dinax conorad by too Hazardous Matarials Regulations that vexe subject to tha Laspection. "Duriag the courRo of the inspectios the folloriar probable violationa of 49 CTS and/on. quality control itoas nato rotod: PROBABLE VIOLATIONS: section: Explanation: 17860162) 8173.222/67(2) CERTIFYNG. PACINGES AIMAKTING THE UN SENNOBRE FOR PIM SHIPMANES, NHEN THE PROPITR DESIGN QUALITICATION TESTING WAS NOT- CONDUCTTO.. section: Ixplanation: 178.503(4118) FAILURE TO LUE JAT NAMIR AND SOURTUS OR AUTMORIZEN SYMBOL IN. IME IN CERFIFIGATION FOR PACHGES. (TENAFE 'S CERTIFICATION USED ON jA NÃN SIESIGN. NOT TÁSTRA SY TRN-TE). U.S.D.O.T ARSPNOENO Exhibit l. Report 8.#

Page 5SEP-22-00 17,22 FROM. ит. 03/07/00 -FIXXXLXXX PACE nda desament in rot a final report. hap dean and an erotions noted ate eated pet the finalizing the report. Probable yiolation(S) nay be renoved ox others nay ba added during this revicu. Is addition, quality control iters nay. be ravised to becore probable volations during this ravier. Upon deterination that a probable violatios axiats, the Associate adminiatzator for Hazardous Matorials gafety, is authorizca to imposc certaini sanctions, inaluding warning letters, complianco ordaza; and civ!! cout actions, including Injunctive ox erstinal proccedings, may be initiated. Istle 49 U.S.C. Sactione 5123 and 5124 provido lox civil and' oxininal penáltias lor violation of the Hazardous Matoxials Regulations. a civil penalty of not zore than $27,500, but not less taan $250, pa tan Office of chief Coursal of the Research end Sprolal Programs violation say be imposed througu administrative proccedings initirted b Administration. When a cximinal. violation has been deterained by a cout, a fine, or imprisonment Lox not tore than 5 years, or both, ray be imposod ror cach violation. or sarotions imposed. Documentation of corroative action submittad in waiting to the inspector within 30 days or the inspection' nay be considerca for mitigation should penalty. Iorever, any documanted corxective action vould not aliminate or the 'sanation inposed rasult in the issuanca oi a notico propoting a civil graclude the initlation of a civil penalty procceding, a finding of violation, or assessment or a civll penalty. " . 10 Régional Fairnesa Boards were establíshed tó receíve coments fron small Tho Snall Business and Agricultural Regulatory Enforcoment ombudasan and businesses about fedcral agency onforcerent activities. The Ombudsman will annually evaluate these activities and rate each agency's rasponsiveness activities of the Rescarch and Specíal Progzans Adainistration, call 1-888- to small business. "It you wish to cornent on the inspeation and xelated REG-ENIR (1-888-736-3247). I certify that I raceived tha abova briefing as it' appears on this lora. with its contents. 2peсtо(3) signatura of Representativo (5) 917/00 Date Date x Reports. Erbibit It Page - of#

Page 6SEP-22-00 17.20 FROM. ID. PAGE 2 • LAw Offices LAWRENCE W. BICALEN MCCARTHY, SWEENEY & HARKAWAY, P.C. FACSIMLE JOHN M. CUTLER, Je DOUGLAS MI. CANTER SUITE 600 (202) 393-5721 STEVEN J, KAUSH ANDREW P. GOLOSTEN 2175K STREET, N.W. E-Mat HARVEY LI RETER RICHARO D, LIEBERMAN WASHINGTON, D. C. 20037 MSH@MSMACCOM (202) 393-5710 HTT///WWW.MSHPC.COM WEBSITE Or COUNSEL DANIEL S. SWEENEY Johnsen September 22, 2000 2173.226(c) 2118.601 Packaging Mr. Chris Michalski Office of Hazardous Materials Enforcement Research & Special Programs Administration Testina Deo Bear Tave road, Suite 306 90-0265 West Trenton, NJ 08628 Re: All-Pak; September 9 Exit Briefing Dear Mr. Michalski: Thank you for the opportunity to respond to the September 9, 2000, exit briefing you sent to Ray Watt of All-Pak (copy attached). As noted in your telephone conversations with Mr. Watt, I believe there is a difference of opinion on the proper interpretation of the regulations and, by copy of this letter, I am asking Mr. Mazzullo to look at the issue. All-Pak manufactures combination packaging for use by shippers of TIH materials under the rule applicable to them in 49 CFR 173.226(c). I first would like to note that you allege a violation of this Part 173 provision by All-Pak, and I suggest that as a packaging manufacturer the appropriate citation against the company, if any, would be under Part 178, not Part 173. The shipper is advised under Section 173.226(c) that, for combination packagings, "both the inner packaging system and the outer packaging must conform to the performance rest requirements of Subpart Ml of Part 178 of this subchapter, at tbe Packing Group I performance level." Subpart M of Part 178 is entitled "Testing of Non-Bulk Packagings and Packages," and it covers Sections 178.600-609. Thus, it includes not only Section 178.601(c)(2), which you cite, but Section 178.601(g), which describes selective testing#

Page 7SEP-22-00 17,20 FROM. ID» PAGE 3 :" variations. As I understand it, you contend that Section 178.601(g) is inapplicable, and that is our point of difference that I ask Mir. Mazzullo to address. The situation is that All-Pak manufactures, marks, and sells a packaging for TIH shippers. This is a combination packaging consisting of the inner receptacle holding the product, a leak-tight absorbent pouch inner roceptacle, a removable-head canister, a plastic bag, and padding within an outer fiberboard box. This packaging has been third- party tested by Ten-E Packaging. One of All-Pak's customers, Dow Agro, had filled packages of this type in storage in the field. Their own people discovered that the metal removable head canister inside the filled packaging was rusting and they wanted to change it, in the field, to a unit that was not subject to such corrosion. A plastic removable head canister was considered for this purpose. All-Pak identified a suitable plastic removable head canister of similar design 1o the metal unit. The company believed it would be sufficient, but before determining that this was an acceptable substitute, All-Pak performed cold drop resting on this inner canister. The results confirmed All-Pak's expectations. At the same time, All-Pak contacted Ten-E for subsequent testing of the completed packaging but the employee in charge of this project died befure this work was completed. While we acknowledge that prudence would have had All-Pack test this eclaming as a violation of the regulations as saying that failure 10 have this testing Specifically, Section 178.601(g)(1) provides a selective testing variation under which additional testing is nos required. • The conditions of this variation arc important. First, the inner packagings of a combination packaging must be of similar design to the tested inner packagings. Here it was not the inner that was changed but insicad an intermediate open-head packaging holding two inner receptacles, the bottle and the pouch. Ihe canister was of similar dimensions as the replaced unit. Second, the material of construction of the inner packagings (glass, plastic, melal, etc.) offers resistance to impact and stacking forces equal to or greater than that of the originally tested inner packaging. The intermediate removable-head unit, by All-Pak's own drop testing and their substantial knowledge of the dynamics of combination packaging, had this strength. To respond to your concems, All-Pak since has confirmed this fact through Ten-E but, in our view, such confirmation was not required. A copy of the Ten-E retest report will he sent to you by the company under separare cover. Third, the inner packagings had to have the same or smaller sized openings and the closure was of similar design. The innermost packaging unit and the inner receptacle (pouch) were unchanged, With regard to the removable-head canister, both units are removable head drums and, in fact, the plastic unit with a clip-on feature is more secure than the tested metal cover.#

Page 8SEP-22-00 17,21 FROM. 1D. PAGE 4 Fourth, cushioning must take up void spaces, and the expanded polystyrene pads do this. Fifth, the inner packaging orientation must be the same, and it was. Sixth, the gross mass must not exceed that originally tested, and it did not. Under Selective Testing Variation 1, therefore, which is an integral part of Suopart M of Part 178, All-Pak did not have to test the plastic intermediate unit at all. The company did perform some tests to bolster their own expectations and subsequently All-Pak had Ten-E re- perform all the tests, but we do not agree with your characterization in the Exit Briefing that All-Pak's actions constitured "probable violations." You make a second allegation, that the marking on the packaging was not changed. As noted above, your contention only carries weight if one concludes that Variation 1 is inapplicable and, we submit, nothing in the regulations confirms your view on this point. In conclusion, a customer was faced with an urgent problem with packaging already filled in the field. All-Pak worked with that customer to fashion a solution to that problem. Variation 1 envisions changes to tested packagings without retesting, under certain conditions. All-Pak met those conditions. Subsequent testing by Ten-E verifies that the company's conclusions with regard to this change were valid, and that no safety issuc is involved. Therefore, we ask that you not proceed with this invessigation or any subsequent penalty claim. Please contact me if you have any questions on this letter or our reading of the applicable regulations. Sincerely, awrence W. Biericin cc: Edward I. Mazzullo, Director Office of Hazardous Materials Standards Ray Watt, All-Pak#