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Interpretation Response #15-0152 ([DiSorb Systems, Inc] [Mr. Ted McLaughlin])

Below is the interpretation response detail and a list of regulations sections applicable to this response.

Interpretation Response Details

Response Publish Date:

Company Name: DiSorb Systems, Inc

Individual Name: Mr. Ted McLaughlin

Location State: PA Country: US

View the Interpretation Document

Response text:

February 17, 2016

Mr. Ted McLaughlin
Chief Executive Officer
DiSorb Systems, Inc.
1800 West Indiana Avenue
Philadelphia, PA  19132

Reference No.: 15-0152

Dear Mr. McLaughlin:

This letter is in response to you and your staff’s e-mails and telephone calls, your July 23, 2015 letter, and the October 14, 2015 meeting that you, Steve Savad (President, DiSorb Systems, Inc.), and Ed Krisiunas (MT(ASCP) MPH, President, WNWN International, LLC) attended with several Pipeline and Hazardous Materials Safety Administration (PHMSA) staff members at the Department of Transportation headquarters in Washington, DC.  Specifically, you requested clarification on how the Hazardous Materials Regulations (HMR; 49 CFR Parts 171-180) apply to the absorbent gel your company manufactures for use in suction canisters and with other liquid wastes described as “UN 3291, Regulated medical waste, n.o.s., 6.2 (infectious substance), Packing Group (PG) II” (RMW).  We have paraphrased your questions and answered them below.

Q1. Do the HMR permit suction canisters containing RMW to be transported with their contents in a liquid state?  

A1. The answer is yes, provided the completed package meets the HMR requirements for transporting liquid RMW (e.g., see §§ 172.24, 173.24a, 173.24b, 173.197 (a), (b) and (e)(2)).

Q2. If suction canisters that contain the liquid contents we described earlier are placed in a larger container, can that larger container be placed in transportation without a sufficient amount of absorbent material inside the outer packaging to solidify the liquid contents of the suction canisters if they leak or break?  

A2. The HMR specifically require packages that contain inner packagings of Division 6.2 liquids include sufficient amounts of absorbent and cushioning material between the inner and outer packagings to absorb, not solidify, the entire liquid contents (see §§ 173.27(e)(1), 173.196(a)(4), 173.197(c)(2) and (e)(1), 173.199(b)(2)).  Further, the HMR require that absorbent material in a hazardous materials packaging must not be capable of either reacting dangerously with the contents of the inner packaging or having its protective properties significantly weakened in the event of leakage (see §§ 173.24(b)(2) and (d)(e), and 173.24a(a)(3)).  However, please note the HMR do not specifically prohibit absorbent material from solidifying liquid Division 6.2 contents, provided the solidified contents do not adversely affect the safe transport of the material (e.g., by compromising the performance of the packaging).

Q3. I understand that under § 173.197(e)(2) liquids, such as blood, are authorized in RMW packagings that cannot exceed 5 gallons per inner packaging.  Therefore, if a one-gallon size liquid suction canister that contains product in a liquid state is placed directly into a red bag in a non-bulk package, do the contents of the suction canister need to be converted into a solid state, or does it need to be packaged with absorbent material?  Should the canister be placed in a red bag by itself with absorbent material?  

A3. Your understanding is correct that under § 173.197(e)(2) RMW liquids, such as blood that meets the definition of a Division 6.2 material, are authorized in inner packagings that cannot exceed 19 L (5 gallons).  However, the HMR do not require the liquid contents of a suction canister to be converted into a solid physical state.  Section 173.197(e)(2) requires that inner packagings placed in Large Packagings, wheeled carts, and bulk outer packagings are rigid and conform to applicable provisions in 49 CFR Part 173, Subpart B.  The 19-L inner packaging limit does not exist under § 173.197(b) which permits non-bulk, United Nations standard packagings to contain up to 450 L (119 gallons) of liquid per inner packaging.  Further, under § 173.134(c), RMW may be placed in packagings that comply with 29 CFR 1910.1030 bloodborne pathogen packagings, which permit use of a red bag as an inner packaging in a combination packaging, provided the packaging also complies with §§ 173.24 and 173.24a, is transported by private or contract carrier, or is transported by a private or contract carrier used exclusively to transport certain RMW.  

Q4. Can a large amount of liquid in its own inner packaging (e.g., a suction canister) be transported in a non-bulk package of RMW under § 173.24a(c)(2)?  Does § 173.24a(c)(2) limit the quantity of liquid per package to one ounce?

A4. Section 173.24a(c)(2) permits a non-bulk packaging that contains inner non-bulk packagings of Division 6.2 materials to contain only three types of additional hazardous materials:  1) refrigerants authorized under the HMR; 2) anticoagulants used to stabilize blood or plasma; or 3) small quantities of Class 3 (flammable liquid), Class 8 (corrosive), Class 9 (miscellaneous), or other materials in PG II or III that are used to stabilize or prevent the degradation of the Division 6.2 sample.  This section also limits these stabilizer/preservative materials to 30 mL (1 ounce) or 30 g (1 ounce) or less per each inner packaging, and the total amount of stabilizer/preservative to 4 L (1 gallon) or 4 kg (8.89 pounds) per completed package.

Q5. If liquid blood is acceptable in a bulk package, does the absence of the subject “liquids in a non-bulk package” suggest that liquids are not authorized in a non-bulk package?  

A5. The answer is no, the HMR require that a package authorized to contain liquid hazardous materials must comply with the applicable provisions for the quantity and type of that material.  

Q6. What does “absorbent material” mean under the HMR?  

A6.   The HMR do not define “absorbent material.”  However, as this term is used in
§§ 171.8 (outer packaging), 173.6(a)(4), 173.196(a)(4), 173.197(c)(2) and (e)(1), 173.199(b)(2) and (d)(1), and 178.609(d)(4) and (i)(3)(v), it is the opinion of this Office that “absorbent material” means a material that physically soaks up or takes in and retains liquid during transportation.  

Q7. Does DiSorb’s absorbent gel meet the HMR’s definition of an absorbent material?  If not, what actions must DiSorb take for PHMSA to authorize it as an absorbent material under the HMR?  

A7. The answer is yes, provided it performs as described in Answer A6.

I hope this information is helpful.  Please contact us if we can be of further assistance.


T. Glenn Foster
Chief, Regulatory Review and Reinvention Branch
Standards and Rulemaking Division

172.24, 173.24a, 173.24b, 173.197 (a), (b) and (e)(2), 173.27(e)(1), 173.196(a)(4), 173.197(c)(2) and (e)(1), 173.199(b)(2), 173.24(b)(2) and (d)(e), and 173.24a(a)(3), 173.134(c), 173.24, 173.24a(c)(2), 171.8, 173.6(a)(4), 173.196(a)(4), 173.197(c)(2) and (e)(1), 173.199(b)(2) and (d)(1), and 178.609(d)(4) and (i)(3)(v)

Regulation Sections

Section Subject
173.134 Class 6, Division 6.2-Definitions and exceptions
173.196 Category A infectious substances
173.196 Category A infectious substances
173.197 Regulated medical waste
173.197 Regulated medical waste