Partners in Compliance, Inc. — Hazardous Materials Safety Interpretation

Page 1U.S. Department of Transportation 400 Seventh Street, S.W. Special Programs Research and Washington, D.C. 20590 Administration JAN 1 2 1988 Mr. Jay Johnson Partners in Compliance, Inc. 1 100 Dominion Drive Suite 102 Morrisville, NC 27560 Dear Mr. Johnson: This is in response to your letter of July 28, 1997, and August 11, 1997 telephone conversation with Ms. Eileen Edmonson of my staff asking if multiple primary packagings of a Division 6.2 material must be separated by a material that is both cushioning and capable of absorbing their entire contents. The answer is no. Section 173.196(a)(1)(iii) requires that multiple primary packagings of a Division 6.2 material be wrapped individually by a material, absorbent or non-absorbent, sufficient to ensure contact between the receptacles is prevented and the packaging complies with the performance tests in § 178.609. However, this section does require that material sufficient to absorb the entire liquid contents of the inner packagings be placed between the primary and secondary packagings. : You stated the current design for your packaging has each primary receptacle surrounded with an absorbent foam that prevents contact between the receptacles. You questioned whether separating these packagings with fiberboard or plastic dividers and placing an absorbent strip at the bottom of the secondary packaging would fulfill the requirements in § 173.196. Provided the packaging meets the performance tests required in § 178.609, this configuration would be acceptable. However, please be aware that these performance tests require the packaging to be dropped on its bottom, top, sides, and corner, cold-conditioned and immersed in water with no leakage from the primary receptacle. Placing the absorbent material only at : the bottom of the packaging may prove insufficient to meet these criteria. Thank you for inquiry. If we can assist you further, please let us know. Sincerely, : it Genifer Kar Hattie L. Mitchell, Chief Exemptions and Regulations Terminations Office of Hazardous Materials Standards#

Page 2• • U.S.Department of Transportation -on seven SC 559 Research and Administration Special Programs APR 9 IC93 Mr. Barry Sibley Environmental Packaging Systems Ltd. 1 Research Drive Dartmouth, N.S. Canada B2Y 4M9 Dear Mr. Sibley: This is in response to your February 18 telefax to Mr. James Jones, and packaging you described for the shipment of infectious substances and additional information dated March 3, 1993, concerning the suitability of the diagnostic specimens. packaging and a fiberboard outer packaging. The packaging you described consists of a plastic inner New packaging requirements for infectious substances are not mandatory within the United States until January 1, 1994. your packaging does not meet the requirements for packagings for infectious From the information you presented, Edition of the United Nations Recommendations on the Transport of Dangerous substances specified in 49 CFR 173.196 and 178.609 and the Seventh Revised Goods for the following reasons: First, paragraph 173.196(a) (11) (and UN 6.13. (a)(11I)) requires that absorbent material be placed between the primary and secondary receptacles, enough to absorb the entire liquid contents of all primary receptacles. The absorbency test result noted in your test report from Nova Scotia Research Foundation corporation shows an absorbency of 50 ml. One of the packages tested contained 14 "Vacutainers" of 5 ml capacity each. The 70 ml liquid contents is more than the absorbent material is capable of absorbing. Second, the testing requirements of 49 CFR 178.609 (and UN 6.14.3 and 6.14.4) for a plastic inner packaging in a fiberboard outer packaging include two drop tests. For the first drop test, the packaging (assembled as for shipment) 50+/-2 percent relative humidity. There is no indication in the test report that the immersion was conducted. For the second drop, the packaging must be condítioned in an atmosphere of -18°C or less for at least 24 hours. There is no indication in the test report that this cold conditioning was performed. : A packaging used to transport infectious substances after January 1, 1994 must There is an exception from these requirements in paragraph 173.196 (h) for comply with all other applicable requirements of 49 CFR 173.196 and Part 178. certain diagnostic specimens.#

Page 3is stated above, the requirements for infectious substances contained in §$ 173.196 and 178.609 are not mandatory until January 1, 1994. Voluntary compliance with the new requirements is currently authorized. January 1, 1994, packagings for infectious substances which are "etiologic September 30, 1990) must meet the requirements of 49 CFR 173.387 (of the same agents, " as defined in 49 CFR 173.386 (of the of the regulations in effect on packaging meets those requirements. From the information presented in your letter, it appears that your You also asked whether your company would qualify for an "M" number to place on the outer packaging. UN packaging, part of the marking is an indication of the country authorizing If your packaging will be certified and marked as a allocation of the mark. manufactured and marked in the United States. The "M" numbers issued by our The letters "USA" may only be marked on a packaging Office of Hazardous Materials Exemptions and Approvals are only issued for packagings manufactured and marked in the United States. Sincerely, -... I la 1 7i Mazzill Director edward 1. Office of Hazardous Materials Standards#

Page 4: Edmansas PARTNERS IN COMPLIANCE. INC. File: 173.19610)01) (ind 100 Dominion Drive, Suite 102, Morrisville, NC 27560 Phone: 919-468-0333 FaX: 919-408-0311 SC: 300, July 28, 1997 Edward T. Mazzullo Director, Office of Hazardous Materials Standards U.S. Department of Transportation Research & Special Programs Administration DHM-10, Room 8100 ashington, DC 20590-000 0 Seventh Street, ST SUBJECT: Request for Interpretation 49 CFR, Section 173.196(a)(1)(iüi) an absorbent material must be placed between the primary receptacle and the secondary packaging. If multiple-primary receptacles are placed in a single secondary packaging they must be wrapped individually to ensure that contact between them is prevented. The absorbent material, such as cotton wool, must be sufficient to absorb the entire contents of all primary receptacles. Partners In Compliance, Inc. is committed to compliance with the regulations governing the transportation of hazardous materials. We are currently developing a packaging system for the transport of infectious substances. Each individual primary receptacle will be surrounded in an absorbent foam rack that protects and prevents contact. Based on a conversation with Helen Engrum of the DOT/RSPA and our understanding of the regulations, multiple primary receptacles placed in a single secondary packaging must be individually surrounded by material that is both absorbent and cushioning to prevent breakage or leakage and control movement. We feel that the use of corrugate or plastic dividers to separate primary receptacles with an absorbent strip at the bottom of the secondary packaging does not meet the requirements for individual wrapping stated in the regulations. Please respond with your concurrence/non-concurrence. Sincerely, Partners In Compliance, Inc.#

Page 5TELEPHONIC CONVERSATION RECORD Specialist Receiving Call: Eileen Edmonson ROUTING Date of Call: 8/11/97 SYMBOL INT Person (s) Contacted: Mr. Jay Johnson Their Organization: Partners in Compliance, Inc Date of Incoming Letter: 7/28/97 words): Mr. Johnson is designing an infectious Specific Subject (including section #'s and key substance packaging. 173.196 (a) (1) (lii) was instructing him to wrap He wanted to know if § each primary packaging with an absorbent material that would simultaneously separate each primary packaging to prevent damage and absorb its entire contents. letter Summary: On August 7, 1997, I faxed Mr. Johnson a related 4/9/93) we did on absorbent material for infectious substance Environmental Packaging Systems Ltd., packagings as an example of the type of information we needed Johnson called me on August 11 and stated he has only begun to about his packaging to provide him with a response. design his packaging and, as a result, has no drawing or test results to send me. I told him that the dividers between the primary receptacles did not have to meet the absorbent criteria in § wished to design it that way. I prevent the inner packagings from being damaged. I told him however he designed the packaging, it would have to pass the performance tests located in § 178.609. He requested this response in writing. Comments for Further Action: I drafted the response on August 11, 1997, and forwarded it for review. specialist signature: Gillen & Edmanen Date: 8/11/97#

Page 6• FFICE OF HAZARDOUS MATERIALS STANDARD 'ORRESPONDENCE TRACKING SHEEL DATE COMPANY SPECIALIST 07/28/97 PARTNERS IN COMPLIANCE INC /FROM: JAY JOHNSON EDMONSON RECEIVED: DUE: ASSIGNED: 08/07/97 SUBJECT 09/04/97 173.196 SIGNED: COMMENTS: SUMMARY: COMPLEXITY: H M L SIGNATURE: DRAFTS:#