Interpretation Response #06-0267 ([Healthcare Support Services] [Lisa Hardesty, MA, CHCC, HEM ])
Below is the interpretation response detail and a list of regulations sections applicable to this response.
Interpretation Response Details
Response Publish Date:
Company Name: Healthcare Support Services
Individual Name: Lisa Hardesty, MA, CHCC, HEM
Location State: MI Country: US
View the Interpretation Document
Response text:
Jan 23, 2007
Lisa Hardesty, MA, CHCC, HEM Reference No. 06-0267
Healthcare Support Services
14593 North Barton Lake Drive
Vicksburg, MI 49097
Dear Ms. Hardesty:
This is in response to your November 17, 2006 e-mail and recent telephone conversations with a member f my staff asking how to transport Division 6.2 (infectious) and non- infectious pathological wastes preserved in a 10% buffered formalin solution tinder the Hazardous Materials Regulations (HMR; 49 CFR Parts 171-180). You state different hospitals around the United States offer these wastes for transport mixed with formalin containing various concentrations of formaldehyde up to but not exceeding 10 % described herein as "10% buffered formalin." You also state the wastes exhibit corrosive and toxic characteristics and are subject to the hazardous waste manifest requirements of the U.S. Environmental Protection Agency (EPA). I have paraphrased your questions and answered them in the order provided.
Q1. Is a 10% buffered formalin solution considered a hazardous material under the HMR? If sc, does § 173.24a(c)(2)(iii) apply to a formalin solution placed in an inner packaging with a Division 6.2 material that meets the definition for a regulated medical waste?
Al. As provided in § 173.22 of the HMR, it is the shipper"s responsibility to properly class a hazardous material. This Office does not perform that function. However, it is our opinion that formalin containing 10% formaldehyde placed in an inner packaging with non-hazardous material meets the definition for a Class 9 (miscellaneous) material and should be described as "IJN 3334, Aviation regulated liquid, n.o.s. (formaldehyde), 9" for transportation by aircraft, or "NA 3082, Other regulated substances, liquid, n.o.s. (formaldehyde), 9, PG III" for dome transportation in all modes. See § 172.202(b). Formalin containing less that 10% formaldehyde does not meet the definition for a hazardous material und the
HMR.
Class 9 formalin packaged with regulated medical waste (RMW) as a preservative or stabilizing material under the provisions of 173.24a(c)(2)(iii) must conform to the requirements in § 173.197 and the material must be described as "UN 3291, Regulated medical waste, n.o.s, 6.2, PG II." Section 173.24a(c) permits the transportation of more than one hazardous material in a non-bulk outer packaging
paragraph (c)(2), a packaging containing inner packagings of Division 6.2 material may also contain refrigerants, anticoagulants used to stabilize blood or plasma, or small quantities of Class 3, 8, 9 or other materials used to stabilize or prevent degradation of the sample provided the quantity of such materials does not exceed 30 mL or 30 g for each inner packaging and 4 L or 4 kg for each outer packaging.
Q2. Is a formalin solution that is subject to the EPA hazardous waste manifest requirement considered a hazardous material under the HMR?
A2. Yes. For purposes of the HMR, a hazardous waste is a material that is subject to the EPA hazardous waste manifest requirements in 40 CFR Part 262. Provided the material does not meet the definition for any other hazard class, a waste formalin solution may be described as "UN 3334, Waste aviation regulated liquid, n.o.s. (formaldehyde), 9" for transportation by aircraft, or "NA 3082, Waste other regulated substances, liquid, n.o.s. (formaldehyde), 9, PG III" for domestic transportation in all modes.
For a formalin solution meeting the definition for a hazardous waste under the HMR that is contained in the same inner packaging as RMW, the packaging must conform to :he requirements in § 173.197 and the material must be described as "UN 3291, : medical waste, n.o.s., 6.2, PG II." If the shipper determines that enough formalin is placed in the package such that 100 pounds of formaldehyde is present at a concentration by weight of 0.2 percent or 2000 ppm, its contents also meets the definition of a hazardous substance and must be described a "RQ, UN 3291, Regulated medical waste, n.o.s, (formaldehyde), 6.2, PG II."
Q3. Does the 30 mL limit for formalin in § 173.24a(c)(2)(iii) apply to RMW or all infectious substances?
A3. Yes. The 30 mL limit in § 173.24a(c)(2)(iii) applies to all infectious substances, including RMW. See answer Al above.
Q4. In a letter of interpretation your agency issued on April 10, 2003, (Reference No. 02-0292) you state the appropriate proper shipping name for biological samples preserved with a 10% buffered formalin solution transported by aircraft is "NA 3082, Other regulated substances, n.o.s. (formaldehyde), 9, PG III." Does the same proper shipping description apply to ground transportation?
A4. Yes, provided the biological samples or pathological materials packaged with the formalin solution do not meet the definition for a Division 6.2 material and the material is transported domestically. However, please note that on October 1, 1999, we added the proper shipping description "UN 3334, Aviation regulated liquid, n.o.s. (formaldehyde), 9" to the Hazardous Materials Table to align the HMR with international requirements for transporting hazardous materials (Docket No. HM-215C; 64 FR 10741 and 64 FR 44426). As stated in our July 13, 2001 letter of interpretation (Reference No. 01-0120), this is the preferred proper shipping name for 10% buffered formalin solutions that meet no other hazard class and are offered for domestic and international transportation by aircraft. See answer Al above.
I hope this information is helpful.
Sincerely
Hattie L. Mitchell, Chief
Regulatory Review and Reinvention
Office of Hazardous Materials Standards
173.24a(a)(2)(iii)
Jan 23, 2007
Lisa Hardesty, MA, CHCC, HEM Reference No. 06-0267
Healthcare Support Services
14593 North Barton Lake Drive
Vicksburg, MI 49097
Dear Ms. Hardesty:
This is in response to your November 17, 2006 e-mail and recent telephone conversations with a member f my staff asking how to transport Division 6.2 (infectious) and non- infectious pathological wastes preserved in a 10% buffered formalin solution tinder the Hazardous Materials Regulations (HMR; 49 CFR Parts 171-180). You state different hospitals around the United States offer these wastes for transport mixed with formalin containing various concentrations of formaldehyde up to but not exceeding 10 % described herein as "10% buffered formalin." You also state the wastes exhibit corrosive and toxic characteristics and are subject to the hazardous waste manifest requirements of the U.S. Environmental Protection Agency (EPA). I have paraphrased your questions and answered them in the order provided.
Q1. Is a 10% buffered formalin solution considered a hazardous material under the HMR? If sc, does § 173.24a(c)(2)(iii) apply to a formalin solution placed in an inner packaging with a Division 6.2 material that meets the definition for a regulated medical waste?
Al. As provided in § 173.22 of the HMR, it is the shipper"s responsibility to properly class a hazardous material. This Office does not perform that function. However, it is our opinion that formalin containing 10% formaldehyde placed in an inner packaging with non-hazardous material meets the definition for a Class 9 (miscellaneous) material and should be described as "IJN 3334, Aviation regulated liquid, n.o.s. (formaldehyde), 9" for transportation by aircraft, or "NA 3082, Other regulated substances, liquid, n.o.s. (formaldehyde), 9, PG III" for dome transportation in all modes. See § 172.202(b). Formalin containing less that 10% formaldehyde does not meet the definition for a hazardous material und the
HMR.
Class 9 formalin packaged with regulated medical waste (RMW) as a preservative or stabilizing material under the provisions of 173.24a(c)(2)(iii) must conform to the requirements in § 173.197 and the material must be described as "UN 3291, Regulated medical waste, n.o.s, 6.2, PG II." Section 173.24a(c) permits the transportation of more than one hazardous material in a non-bulk outer packaging
paragraph (c)(2), a packaging containing inner packagings of Division 6.2 material may also contain refrigerants, anticoagulants used to stabilize blood or plasma, or small quantities of Class 3, 8, 9 or other materials used to stabilize or prevent degradation of the sample provided the quantity of such materials does not exceed 30 mL or 30 g for each inner packaging and 4 L or 4 kg for each outer packaging.
Q2. Is a formalin solution that is subject to the EPA hazardous waste manifest requirement considered a hazardous material under the HMR?
A2. Yes. For purposes of the HMR, a hazardous waste is a material that is subject to the EPA hazardous waste manifest requirements in 40 CFR Part 262. Provided the material does not meet the definition for any other hazard class, a waste formalin solution may be described as "UN 3334, Waste aviation regulated liquid, n.o.s. (formaldehyde), 9" for transportation by aircraft, or "NA 3082, Waste other regulated substances, liquid, n.o.s. (formaldehyde), 9, PG III" for domestic transportation in all modes.
For a formalin solution meeting the definition for a hazardous waste under the HMR that is contained in the same inner packaging as RMW, the packaging must conform to :he requirements in § 173.197 and the material must be described as "UN 3291, : medical waste, n.o.s., 6.2, PG II." If the shipper determines that enough formalin is placed in the package such that 100 pounds of formaldehyde is present at a concentration by weight of 0.2 percent or 2000 ppm, its contents also meets the definition of a hazardous substance and must be described a "RQ, UN 3291, Regulated medical waste, n.o.s, (formaldehyde), 6.2, PG II."
Q3. Does the 30 mL limit for formalin in § 173.24a(c)(2)(iii) apply to RMW or all infectious substances?
A3. Yes. The 30 mL limit in § 173.24a(c)(2)(iii) applies to all infectious substances, including RMW. See answer Al above.
Q4. In a letter of interpretation your agency issued on April 10, 2003, (Reference No. 02-0292) you state the appropriate proper shipping name for biological samples preserved with a 10% buffered formalin solution transported by aircraft is "NA 3082, Other regulated substances, n.o.s. (formaldehyde), 9, PG III." Does the same proper shipping description apply to ground transportation?
A4. Yes, provided the biological samples or pathological materials packaged with the formalin solution do not meet the definition for a Division 6.2 material and the material is transported domestically. However, please note that on October 1, 1999, we added the proper shipping description "UN 3334, Aviation regulated liquid, n.o.s. (formaldehyde), 9" to the Hazardous Materials Table to align the HMR with international requirements for transporting hazardous materials (Docket No. HM-215C; 64 FR 10741 and 64 FR 44426). As stated in our July 13, 2001 letter of interpretation (Reference No. 01-0120), this is the preferred proper shipping name for 10% buffered formalin solutions that meet no other hazard class and are offered for domestic and international transportation by aircraft. See answer Al above.
I hope this information is helpful.
Sincerely
Hattie L. Mitchell, Chief
Regulatory Review and Reinvention
Office of Hazardous Materials Standards
173.24a(a)(2)(iii)