# Food Products Association — Hazardous Materials Safety Interpretation

- **operation:** document
- **citation:** 05-0307
- **title:** Food Products Association — Hazardous Materials Safety Interpretation
- **source type:** guidance
- **agency:** Pipeline and Hazardous Materials Safety Administration
- **status:** guidance
- **official:** true
- **published on:** 2006-01-24
- **effective on:** Not available
- **summary:** 05-0307 response to Food Products Association concerning 173.137.
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- **markdown:** https://regulus.evalyn.ai/document/phmsa-interpretation-05-0307.md
- **app url:** https://regulus.evalyn.ai/document/phmsa-interpretation-05-0307
- **source url:** https://www.phmsa.dot.gov/sites/phmsa.dot.gov/files/legacy/interpretations/Interpretations/2005/050307%20Vitro%20Guidance%20PDF.pdf
**body:**

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Guidance 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.

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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/
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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
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