Food Products Association — Hazardous Materials Safety Interpretation

Page 1Guidance Relative to the Classification of Corrosive Materials Based on recent revisions to the U.S. Hazardous Materials Regulations (HMR; 49 CFR Parts 171- 180) of in vitro skin corrosion testing protocols, the Pipeline and Hazardous Materials Safety Administration’s (PHMSA) Office of Hazardous Materials Safety is working to ensure that all information relevant to the use of such test methods is available immediately to stakeholders via its website. The attached guidance issued in conjunction with a Final Rule published in the Federal Register on January 19, 2011 [76 FR 3308] under Docket No. PHMSA-2009-0126 (HM-215K) is the most currently available and is provided for the benefit of all concerned parties.#

Page 2srobinson on DSKHWCL6B1PROD with MISCELLANEOUS Federal Register / Vol. 76, No. 12 / Wednesday, January 19, 2011 / Rules and Regulations 3333 overpack. Additionally, an overpack containing packages of excepted quantities is not required to be marked with the word ‘‘OVERPACK.’’ Section 173.4b Section 173.4b prescribes the requirements for de minimis quantities of hazardous materials offered for transportation and transported by all modes, domestic or international. Consistent with the international standards, PHMSA is adding a new paragraph (b) to except non-infectious specimens (e.g., museum specimens) preserved with small amounts of certain Class 3 (flammable liquid) materials for scientific purposes from the requirements of the HMR. This amendment is consistent with previous interpretations we have issued on this matter indicating these specimens do not pose a risk to safety during the course of transportations. One commenter (AVMA) expressed support for the adoption of this exception as essential to the conduct of professional work of veterinarians. Therefore, in this final rule, we are adopting the exception from full regulation under the HMR for non- infectious specimens preserved with small amounts of certain Class 3 (flammable liquid) material for scientific purposes. Section 173.25 Section 173.25 prescribes the requirements for certain authorized packagings and overpacks. Consistent with the international standards, PHMSA is requiring an overpack containing packages of limited quantity material marked with the new limited quantities marking required by this final rule (see the Section 172.315 discussion) to be marked with the word ‘‘OVERPACK’’ if the markings are not visible, in addition to all other required package markings. This mark is an indication that the packages contained within the overpack are in accordance with the HMR. Additionally, for excepted quantities (see the Section 173.4a discussion) where the required package markings are not visible inside an overpack, the excepted quantities marking must also be placed on the overpack. An overpack containing packages of excepted quantities is not required to be marked with the word ‘‘OVERPACK.’’ Section 173.27 Section 173.27 prescribes the general requirements for packaging offered or intended for air transportation. In this final rule, PHMSA is amending paragraph (f) by adding a new Table 3 that outlines the requirements for limited quantities intended for air transportation consistent with the 2011– 2012 ICAO Technical Instructions, where appropriate. See the limited quantity, consumer commodity and ICAO Technical Instructions alignment NPRM comment discussion in Section III.A.5 of this rule. Section 173.40 Section 173.40 specifies the general packaging requirements for toxic materials packaged in cylinders. PHMSA is amending paragraph (c)(1) concerning closure requirements by requiring the valve connections on UN Specification cylinders to be made by a taper thread or some other means in accordance with ISO Standard 10692– 2:2001. Section 173.58 Section 173.58 outlines the assignment of class and division for new explosives. Based on a recommendation from comments provided by IME, we are revising paragraph (a)(5) to include a reference to the Type 6(d) test for determination of Division 1.4S classification for consistency with the adoption of the new test. Section 173.59 Section 173.59 provides definitions of explosive terms that are intended for information only. The UN Committee of Experts (COE) recently defined the term ‘‘phlegmatized’’ to meaning the addition of a substance to an explosive to enhance its safety in handling and transport. One commenter indicated support for adoption of the proposed definition of ‘‘phlegmatized,’’ therefore, in this final rule PHMSA is adopting the definition in the HMR as proposed. Section 173.63 Section 173.63 specifies packaging exceptions for limited quantities of certain Division 1.4S explosive articles authorized for reclassification and transport as ORM–D material. Prior to offering for transportation by aircraft, ‘‘Cartridges, power devices, ORM–D– AIR’’ (UN0323), must have been successfully tested in accordance with the new UN Test Series Type 6(d) test beginning July 1, 2011. See the Section 172.102, Special Provision 347 discussion. This requirement is a condition for the continuation of a Division 1.4S classification and for reclassification to ORM–D for limited quantities of such articles intended for transportation by international highway, rail and vessel and domestic vessel effective January 1, 2012. Limited quantities of such articles approved as Division 1.4S prior to January 1, 2012, may continue to be reclassed as ORM– D and offered for domestic highway and rail transportation only until January 1, 2014. Section 173.120 Section 173.120 defines Class 3 (flammable liquid) material. PHMSA is revising paragraph (c) to add new testing methods for determining the flash point of a liquid. See Section 171.7 for a listing of materials incorporated by reference pertaining to § 173.120. Section 173.121 Section 173.121 prescribes the packing group assignment for flammable liquids. The HMR do not specify a test method for determining the boiling point of a liquid which may be necessary for liquids with very low flash points. PHMSA is revising paragraph (a) to add new testing methods for determining the boiling point of a liquid. See Section 171.7 for a listing of materials incorporated by reference pertaining to § 173.121. Section 173.124 Section 173.124 defines Class 4 material. For consistency with a revision adopted in the UN Model Regulations, PHMSA is amending the definition of ‘‘self-heating’’ in § 173.124(b)(2) of the HMR to read: ‘‘Self-heating of a substance is a process where the gradual reaction of that substance with oxygen (in air) generates heat. If the rate of heat production exceeds the rate of heat loss, then the temperature of the substance will rise which, after an induction time, may lead to self-ignition and combustion.’’ Section 173.137 Section 173.137 establishes test criteria and packing group assignments for Class 8 (corrosive) material. Since 1993, PHMSA has authorized under the terms of a special permit (i.e., DOT–SP 10904) an in vitro test method (available commercially as Corrositex®) as an alternative form of testing to that specified in the HMR, which is based on live animal test results, to determine the corrosivity of certain materials. Materials authorized for analysis using the alternative test method include acids (and their derivatives), acyl halides, alkylamines and polyalkylamines, bases, chlorosilanes, metal halides, and oxyhalides. The UN COE recently recognized and adopted in vitro test methods in the UN Model Regulations as an alternative form of testing to that specified in OECD Guideline for Testing of Chemicals, Number 404, ‘‘Acute Dermal Irritation/ VerDate Mar<15>2010 18:10 Jan 18, 2011 Jkt 223001 PO 00000 Frm 00027 Fmt 4701 Sfmt 4700 E:\FR\FM\19JAR3.SGM 19JAR3#

Page 3srobinson on DSKHWCL6B1PROD with MISCELLANEOUS 3334 Federal Register / Vol. 76, No. 12 / Wednesday, January 19, 2011 / Rules and Regulations Corrosion.’’ The following alternative in vitro test methods include OECD Guidelines for the Testing of Chemicals: • No. 430, ‘‘In Vitro Skin Corrosion: Transcutaneous Electrical Resistance Test (TER)’’ (2004); • No. 431, ‘‘In Vitro Skin Corrosion: Human Skin Model Test’’ (2004); and • No. 435, ‘‘In Vitro Membrane Barrier Test Method for Skin Corrosion’’ (2006). A positive test result under in vitro methods 430 and 431 may be used to determine corrosivity for transportation purposes but cannot be used to determine the PG assignment. A negative result for corrosivity under in vitro methods 430 and 431 can preclude further testing to determine PG assignment using method 404, the current OECD Guideline involving in vivo testing, or method 435, the newly adopted OECD Guideline involving in vitro testing. Based on the adoption of three new OECD guidelines for the in vitro testing of materials for corrosivity in the UN Model Regulations and through encouragement from PETA to adopt these new test methods in a petition for rulemaking (P–1550), we proposed to adopt such guidelines as matter incorporated by reference (IBR) in §§ 171.7 and 173.137 of the HMR. In response to our proposal to incorporate several in vitro test methods for determination of corrosivity, PHMSA has received over 900 comments supporting the proposal, including a comment from PETA. We received no opposition. Therefore, we are adopting the OECD Guideline Test Nos. 430, 431, and 435, and revising Test No. 404 as proposed. Further, PETA urged PHMSA to facilitate access to DOT–SP 10904 through our Web site until such a time that this final rule becomes effective, and requested that PHMSA remove letters of interpretation that they believe recommend the use of in vivo testing even though alternative in vitro testing is available. With regard to PETA’s additional requests, they are beyond the scope of this rulemaking. However, we note that in prior correspondence with PETA, PHMSA has indicated that information about DOT–SP 10904 can be obtained by entering ‘‘Corrositex’’ in the search feature of the PHMSA Office of Hazmat Safety Web site. Also, the special permit may be accessed by entering ‘‘10904’’ in the search feature on our special permits Web site or by conducting a group number search. We agree with PETA that non-live animal testing should be used where available and encourage shippers to use the in vitro test methods to determine the classification of a material as corrosive and assignment of a packing group. We also remind shippers that historical data may also be used to classify a material in accordance with § 173.136(c). Thus, in this final rule we are revising § 173.136(a) to codify the authorization to use in vitro test methods and to highlight the availability of classifying a material based on historical data. Sections 173.150, 173.151, 173.152, 173.153, 173.154 and 173.155 Sections 173.150 through 173.155 prescribe the exceptions for certain Class 3, 8 and 9 and Division 4.1, 4.2, 4.3, 5.1, 5.2, 6.1 hazardous materials under the HMR. In this final rule, PHMSA is revising each of these sections to recognize the UN Model Regulations and IMDG Code package quantity limits for the highway, rail, and vessel transportation of limited quantities. No limited quantity limits decrease and two increase slightly to maintain alignment with the international standards for transport by other than aircraft. Additionally, the packaging provisions for ‘‘Polyester resin kits’’ are removed from § 173.152, as proposed, and placed in new § 173.165 for clarity. When PHMSA lowered the quantity limits for Division 6.1 (poisonous) materials of PG II (primary or subsidiary) authorized as a limited quantity in a final rule published under Docket HM–215G (70 FR 34065, June 13, 2005), it did not authorize the labeling exception for such packages when intended for transportation by highway, rail and vessel, nor did it authorize renaming and reclassification as ‘‘Consumer commodity, ORM–D’’ for such materials. In this final rule, except for transportation by aircraft, we are authorizing the labeling exception for packages of limited quantity material with a Division 6.1, PG II primary or subsidiary hazard and, until December 31, 2013, we are authorizing renaming and reclassification as ‘‘Consumer commodity, ORM–D’’. Additionally, until December 31, 2012, a consumer commodity as defined in § 171.8 in effect on October 1, 2010 may continue to be packaged, reclassed and marked ‘‘ORM–D–AIR’’ either in accordance with the new Table 3 of § 173.27(f) or §§ 173.150 through 173.155 and 173.306, as applicable. PHMSA fully believes this eventual alignment with international standards will improve clarity, promote regulatory compliance, reduce employee training costs and enhance safety overall. Section 173.161 Section 173.161 prescribes packaging requirements for chemical kits and first aid kits containing small amounts of hazardous materials. In this final rule, PHMSA is editorially revising the section. In addition, PHMSA is authorizing transport of dry ice in accordance with § 173.217 in packaging authorized under this section when used as a refrigerant for the contents of a kit. Section 173.165 A new section 173.165 is added to prescribe packaging and other requirements for ‘‘Polyester resin kits, UN3269’’ formerly contained in § 172.102, special provision 40 and § 173.152(b)(4) of the HMR. This amendment is intended to provide clarification of existing requirements while also harmonizing the HMR with international standards. Section 173.167 A new section 173.167 is added to indicate authorized materials and quantity limits for articles and substances that may be described as ‘‘ID8000, Consumer commodity,’’ when intended for transportation by all modes of transport provided all or some of the transportation is by aircraft. Such articles and substances eligible for classification or reclassification to Class 9 are Class 2 materials (non-toxic aerosols only), Class 3 materials (Packing Group II and III only), Division 6.1 (Packing Group III only), UN/ NA3077, UN/NA3082, and UN3175, provided such materials do not have a subsidiary risk and are authorized aboard a passenger-carrying aircraft. Inner and outer packaging quantity limits are based on Packing Instruction Y963 of the 2011–2012 ICAO TI. Specification outer packagings are not required under the conditions prescribed in this section. Additionally, the pressure differential capability of the inner packagings of a combination packaging intended to contain liquids is reduced from 95 kPa to 75 kPa for materials offered for transportation and transported by aircraft under the provisions of this section. Section 173.220 Section 173.220 provides exceptions from regulation under the HMR for the transport of internal combustion engines, self-propelled vehicles, mechanical equipment containing internal combustion engines, and battery-powered vehicles or equipment. This section is revised to include engines, vehicles, and equipment powered by fuel cells consistent with VerDate Mar<15>2010 18:10 Jan 18, 2011 Jkt 223001 PO 00000 Frm 00028 Fmt 4701 Sfmt 4700 E:\FR\FM\19JAR3.SGM 19JAR3#