FAA — Hazardous Materials Safety Interpretation

Page 1• Memorandum U.S. Department of Transportation Research and Special Programs Administration Date APR - 9 2004 Reply to Altn of Subject Definition of a Diagnostic Specimen From Edwildf Mazild, Director MRSPA Office of Hazardous Materials Safety Reference No. 03-0208 To: Bill Wilkening Manager, ADG-1, FAA This is in response to your memorandum requesting clarification on the definition of a diagnostic specimen under the Hazardous Materials Regulations (HMR; 49 CFR Parts 171-180). You stated under the Federal Aviation Administration's (FAA's) airworthiness requirements all diagnostic specimens are considered hazardous since some diagnostic specimens contain hazardous materials. You also stated certain air carriers are prevented from transporting hazardous materials under the FAA's airworthiness requirements. Your questions have been paraphrased and answered in the order provided. Q1: Are routine diagnostic specimens such as urine tests for drug screenings, blood tests for routine physicals, etc., taken from healthy individuals that are not suspected of containing a pathogen considered to be hazardous materials under the HMR? A1: The answer is no. Samples transported for routine testing and samples transported to investigate non-communicable diseases or conditions that are not known or suspected of being contaminated with an infectious substance do not meet the definition in under the HMR. § 173.134(a)(1) for a Division 6.2 (infectious) material and, therefore, are not regulated Q2: Is the wording "Diagnostic Specimen," as a regulated term of art, prohibited as a marking on shipments of specimens that are not classed as hazardous materials under § 172.303 or any other part of the HMR? A2: The answer is no. Section § 172.303(b)(3) permits a proper shipping name, such as "Diagnostic specimen," listed on the § 172.101 Table to be marked on a package containing a non-regulated material provided the marking does not include a UN or NA identification number. The intent of the provision is to provide shippers and transporters relief when using proper shipping names that also describe non-regulated materials.#

Page 2Edmonson $173.134 Debnition of Diagnostic Specimen U.S. Department 03-0208 Memorandum of Transportation • Federal Aviation Administration Subject: Diagnostic Specimens Date: August 15, 2003 From: FAA Office of Hazardous Materials Attn. of: Reply to To: Ed Mazzullo RSPA Office of Hazardous Materials Standards Dear Mr. Mazzullo, As you know, FAA airworthiness requirements prevent certain air operators from accepting hazardous materials. Therefore, we must clearly understand when a diagnostic specimen meets the definition of a hazardous material. Currently, because some diagnostic specimens contain considered hazardous materials. •hazardous materials, all diagnostic specimens are 49 CFR 173.134(a)(4) of the HMR defines a diagnostic specimen as "...any human or animal material, including excreta, secreta, blood and its components, tissue, and tissue fluids being transported for diagnostic or investigational purposes, but excluding live animals." The definition goes on to explain that specimens suspected of containing a Risk Group 4 pathogen must be classed as div 6.2 and assigned UN 2814 or UN 2900. Paragraph 173.134(b) makes the following clarification: "The following are not subject to the requirements of this subchapter as division 6.2 materials: ... (2) A diagnostic specimen known to contain or suspected of containing a micro-organism in Risk Group 1, or that does not contain a pathogen, or a diagnostic specimen in which the pathogen has been neutralized or inactivated so it cannot cause disease when exposure to it occurs. " Question 1 - Are routine diagnostic specimens from healthy individuals (e.g.; urine tests for drug screenings, blood tests for routine physicals, etc.) that are not suspected of containing a pathogen considered to be hazardous materials under the HMR? Question 2 - Is the term "Diagnostic Specimens" (as a regulated term of art) prohibited as a marking on shipments of specimens that are not classed as hazardous materials under 172.303 or any other part of the HMR?#

Page 3* 2 Question 3 - If a "non-hazardous" use of the term diagnostic specimen is not prohibited, specimens? how can air carriers identify the hazardous diagnostic specimens from the non-hazardous Thank you for your assistance. Bill wilbs Bill Wilkening, Manager, ADG-1#

Page 4Federal Register / Vol. 56, No. 245 / Friday, December 20, 1991 / Rules and Regulations 66133 tanks having a capacity of less than portable tanks in § 172.514, to portable § 173.29(d), for some time. which has been in the regulations, at are materials poisonous by inhalation as 3,785 L (1,000 gallons). RSPA also is revision of the cargo tank marking size accepting petitions recommending requirement to cover or obliterate the Another petitioner objected to the defined in $ 171.8. This revision the need in paragraph (a) for marking addresses HMAC's request to eliminate to require a 50 mm (2 inch) marking. marking (8 172.303(b)(2)) when moving marking required for cargo tanks in Accordingly, consistent with the 50 mm facilities, or to or from cleaning or repair an empty tank car from manufacturing "Inhalation Hazard" on packages liquids. containing lesser hazard Division 6.1 to specify a 50mm (2 inch) mark for § 172.328(b), paragraph (b)(3) is revised facilities. The petitioner said that, although the concept not to have the for marking the phrase "Inhalation One petitioner stated that the location cargo tanks and other bulk packages. tank car is noteworthy, strict adherence shipping name shown on a clean empty Hazard" on tank cars, as specified in associated with remarking bulk In order to relieve some of the burden on a tank car is a problem, or a poisonous liquid, is not appropriate. paragraph (a), for a Division 2.3 material recommending that RSPA permit empty, packages due to minor changes in clean tank cars, moving from tank car instead of locating the marking in The petitioner recommended that shipping names, RSPA is adding a new manufacturing facilities, or to or from packaging marked with a proper paragraph (f) stating that a bulk remain marked with the hazardous tank car cleaning or repair facilities, to the marking would better communicate association with the labels or placards, shipping name prior to October 1, 1991, material shipping name and the "inhalation hazard" to emergency words of the old mark are identical to does not have to be remarked if the key covering or obliterating the marking. identification number without securely association with the required shipping response personnel if it were located "in those currently specified in the § 172.101 RSPA is denying this petition. As with because the placard displays the name." The petitioner stated that "ANHYDROUS AMMONIA" need not Table. For example, a tank car marked the provision addressed in the previous provision previously found in paragraph, this is a long-standing symbol of the skull and crossbones), the pictorial representation of poison (i.e., be remarked "ANHYDROUS AMMONIA, LIQUEFIED:" § 173.29(d). RSPA believes covering of redundant. RSPA believes that locating placement of the required marking is stated that the requirements for Section 172.303. Several petitioners necessary to preclude confusion or markings on empty bulk packagings is proper shipping name, when one is this warning in association with a prohibited marking in paragraph (a), as unnecessary response on the part of . used generically, such as paint, ink or written, would prohibit the use of terms emergency responders. • located near labels or placards. required, is equally as visible as when recommended revision of requirementa Section 172.312. Several petitioners (a) to permit either location. A petitioner Therefore, RSPA is revising paragraph cotton, from being used in connection name is the same as the hazardous with a non-hazardous product, when the in paragraph (a)(2) for display of hazardous materials in non-bulk orientation markings on liquid questioned the need to permanently mark the word "POISON" on non-bulk can easily be solved if "or" is replaced product. They suggested that the matter plastic outer packagings, as specified in specify that the marking only packagings. They suggested that RSPA § 172.313(b), used as single or composite "shipping name" and "identification with "and" between the words "pictorially" conform to the ISO 780- packaging for materials in Division 6.1. 1985 standard, to allow for commonly basis for extending this provision to The petitioner stated that RSPA had no package containing a non-hazardous number." The effect would be that a packages containing hazardous used methods of orientation markings on toxicity, and that the provision should materials with a relatively low degree of product, whose name is the same as a with a UN or NA identification number, hazardous product, when not marked materials. They stated, for example, that the orientation marking shown in the Packing Groups I and II. RSPA be limited to materials in Division 6.1, prohibited marking provision. RSPA would not be in violation of the used and readily recognized and ICAO Technical Instructions is widely that each polyethylene packaging used disagrees. Currently, the HMR requires However, changing the conjunction to agrees in principle with petitioners. recommended that two additional understood. One petitioner meeting the definition of a poison be as an outside packaging for materiala name or the identification number, but "and" would permit either the shipping exceptions to the orientation marking included in paragraph (C) for requirements in paragraph (a) be "POISON" ($ 173.24(d)(4)). RSPA permanently marked with the word could lead to confusion. Instead, RSPA not both to appear on a package. This manufactured articles and when the top requirements to permanently mark the believes that extension of the paragraph (b) for those shipping names is providing an additional exception in or seal (e.g., a dry cell battery). The closure is similar to the bottom closure outer packagings used as a single or word "POISON" on non-bulk plastic which describe non-regulated materials. petitioner stated that in such cases the irrelevant or not applicable with respect orientation of the inner package is either composite packaging for materials in different reasons, to the exceptions Several petitioners objected, for requirement will help ensure that Division 6.1 is necessary. This provided in paragraphs (b)(1) and (b)(2). to the closures of the inner packagings. paragraph (a) is revised to require that RSPA agrees. Therefore, in § 172.312, foodstuffs are not packed in the same One petitioner objected to allowing non- drum or package with the poison to remain marked. The petitioner bulk packages, under certain conditions, "pictorially" conform to the ISO 780- the orientation marking only material. Therefore, the requirements in final rule. $ 172.313 will remain unchanged in the confusion on the part of carriers, believes that the exceptions may lead to added in paragraph (c) for orientation 1985 standard, and exceptions are were received regarding the requirement Section 172.320. Several petitions inspectors, enforcement officers, and requiring removal of marking, or emergency responders, and stated that sealed inner packagings and markings for liquids in hermetically- in $ 172.320 to mark packages with the manufactured articles. explosive contained therein. Products approval number (i.e., EX-number) of the covering the marking would present no of problems caused by this exception, burden to industry. RSPA is not aware paragraph (a) to clarify package marking Section 172.313. RSPA is revising those packages that are marked with that are not given EX-numbers and for requirements for gases and liquids that national stock numbers or product codes#

Page 566254 Federal Register / Vol. 56, No. 245/ Friday, December 20, 1991 / Rules and Regulations included in the proper shipping name for in § 173,115(c) of this subchapter), is not shipping name are.identical to those the material, the technical name shall be currently specified in the § 172.101 hermetically-sealed inner packagings. (5) A non-buik package with manner prescribed in paragraph (k) of entered on the shipping paper in the "ANHYDROUS AMMONIA" need not Table. For example, a tank car marked revised to read as follows: 41. In § 172.313, paragraph (a) is this section. be remarked "ANHYDROUS by inhalation (see § 171.8 of this (3) For materials which are poisonous AMMONIA, LIQUEFIED". 39. In § 172.303, the introductory text $ 172.313 Poisonous hazardous materials. Inhalation Hazard" and the words subchapter), the words "Poison- paragraph (b)(3) is added to read as of paragraph. (b) is republished, and. inhalation (see § 171,8 of this (a) For materials poisonous by "Zone A", "Zone B", "Zone C", or "Zone follows: subchapter), the package shall be. association with the required labels or marked "Inhalation Hazard" in for liquids, as appropriate, shall be D", for gases or "Zone A" or "Zone B" § 172.303 Prohibited marking. immediately following the shipping entered on the shipping paper * placards, as appropriate, or shipping (b) This section does not apply to. , of this subpart for size s. name, when required. (See § 172.302(b) be repeated if it otherwise appears in description. The word "Poison" need not (2) * * * (1) * * * the shipping description. subchapter. material not regulated under this a package when the name describes a (3) The marking of a shipping name on revised to read as follows: 42. In § 172.316, the section heading is § 172.203 [Amended] § 172.316 Packagings containing materials following changes are made: 37. In addition, in § 172.203, the revised, and paragraphs (c)(4) and (c)(5) 40. In $ 172.312, paragraph (a)(2) is classed as ORM-D. a. In paragraph (c)(2), in the second and "'PG" is removed both places it "g" is revised to read "6.1"; are added to read as follows: as follows:. 43. Section 172.320 is revised to read § 172.312 Liquid hazardous materials in § 172.320 Explosive hazardous materials. b. In paragraph (k) introductory text, non-bulk packagings. "PG" is removed both places it appears; (a) * * * paragraphs (b), (c), (d) and (e) of this (a) Except as otherwise provided in and the last sentence is revised to read orientation markings that conform 2) Legibly marked, with package section, each package containing a solid, 5.2, UN 3102 (dibenzoy) peroxide, For example, 'Organic peroxide type B, the EX-number for each substance, Class 1 material must be marked with pictorially to ISO Standard 780-1985, on 52-100%)' or 'Organic peroxide type E, package with the arrows pointing in the two opposite vertical sides of the article or device contained therein. solid, 5.2, UN 3108 (dibenzoyl peroxide, accordance with § 173.58(j) of this (b) Except for fireworks approved in correct upright direction. c. In paragraph (k)(1), in the second materials may be marked, in lieu of the subchapter, a package of Class 1 "'mixtures" both places it appears; and "compound!' is revised to read EX-number required by paragraph (a) of "PG" is removed both places it appears. this section, with a national stock "PG" is removed each place it appears. d. In paragraphs (k)(2) and (k)(4)(iii), number issued by the Department of required by regulations for commercial Defense or identifying information. • "§ 172.101(c)(12)" is revised to read e. In paragraph (k)(4)(ii), the reference explosives specified in 27 CFR part 55, if "§ 172.101(c)(11)". the national stock number or identifying sentence is revised to read "For I. In paragraph (k)(4)(iv), the last associated with the EX-number information can be specifically flammable, toxic, n.o.s., flash point less example: 'Carbamate pesticides, liquid, Class 1 materials are packed in the (c) When more than five different than 23°C (contains Xylene) 3, 6.1, UN same package, the package may be [b)(3) are revised, and a new paragraph 38. In § 172.302, paragraphs (b)(2) and numbers, national stock numbers, marked with only five of the EX- (t) is added to read as follows: product codes, or combination thereof. not apply if the EX-number, product (d) The requirements of this section do § 172.302 General marking requirements or bulk packagings code or national stock number of each explosive item described under a proper (b) association with the shipping shipping description is shown in (1) *** tanks with capacities of less than 3,785 L (2) 25mm (one inch) for portable description required by § 172.202(a) of this part. Product codes and national (1,000 gallons); and and other bulk packages. (3) 50mm (2.0 inches) for cargo tanks Package orientation specific EX-number assigned by the stock numbers must be traceable to the Associate Administrator for Hazardous October 1, 1991, in conformance to the (f) A bulk packaging marked prior to (c) * (b)* * * Materials Safety. ** (e) The requirements of this section do regulations of this subchapter in effect (4) Liquids contained in manufactured not apply to the following Class 1 remarked if the key words of the proper on September 30, 1991, need not be thermometers) which are leak-tight in al articles (e.g., alcohol or mercury ir materials: (1) Those being shipped to a testing orientations. agency in accordance with § 173.56(d) of this subchapter;#