New Jersey Regulations on Transportation of Regulated Medical Waste, 75672-75676 [2013-29604]
Download as PDF
75672
Federal Register / Vol. 78, No. 239 / Thursday, December 12, 2013 / Notices
Estimated Average Burden per
Response: 60 minutes.
Estimated Total One-Time Burden:
2,155 hours.
ADDRESSES: Interested persons are
invited to submit written comments on
the proposed information collection to
the Office of Information and Regulatory
Affairs, Office of Management and
Budget. Comments should be addressed
to the attention of the Desk Officer,
Department of Transportation/FAA, and
sent via electronic mail to oira_
submission@omb.eop.gov, or faxed to
(202) 395–6974, or mailed to the Office
of Information and Regulatory Affairs,
Office of Management and Budget,
Docket Library, Room 10102, 725 17th
Street NW., Washington, DC 20503.
Public Comments Invited: You are
asked to comment on any aspect of this
information collection, including (a)
Whether the proposed collection of
information is necessary for FAA’s
performance; (b) the accuracy of the
estimated burden; (c) ways for FAA to
enhance the quality, utility and clarity
of the information collection; and (d)
ways that the burden could be
minimized without reducing the quality
of the collected information. The agency
will summarize and/or include your
comments in the request for OMB’s
clearance of this information collection.
Issued in Washington, DC, on December 6,
2013.
Albert R. Spence,
FAA Assistant Information Collection
Clearance Officer, IT Enterprises Business
Services Division, AES–200.
[FR Doc. 2013–29686 Filed 12–11–13; 8:45 am]
BILLING CODE 4910–13–P
DEPARTMENT OF TRANSPORTATION
Pipeline and Hazardous Materials
Safety Administration
[Docket No. PHMSA–2011–0294 (PD–35(R)]
New Jersey Regulations on
Transportation of Regulated Medical
Waste
Pipeline and Hazardous
Materials Safety Administration
(PHMSA), DOT.
ACTION: Notice of administrative
determination of preemption.
maindgalligan on DSK5TPTVN1PROD with NOTICES
AGENCY:
Applicable Federal Requirements:
Federal hazardous material
transportation law, 49 U.S.C. 5101 et
seq., and the Hazardous Materials
Regulations (HMR), 49 CFR parts 171–
180.
Modes Affected: All transportation
modes
VerDate Mar<15>2010
16:45 Dec 11, 2013
Jkt 232001
Federal hazardous material
transportation law preempts the
following requirements in the New
Jersey Administrative Code (N.J.A.C.)
because the requirements are not
substantively the same as the
requirements in the HMR:
1. N.J.A.C. 7:26–3A.10(a) that
generators must separate into different
containers before transport sharps,
fluids (greater than 20 cc), and other
regulated medical waste;
2. N.J.A.C. 7:26–3A.11(d) which
allows a generator to ship oversized
medical waste without placing it in a
packaging as required by the HMR;
3. N.J.A.C. 7:26–3A.14 that the words
‘‘Medical Waste’’ or ‘‘Infectious Waste’’
must be labeled on the outside of the
package when there is untreated
regulated medical waste;
4. N.J.A.C. 7:26–3A:15 that each
‘‘generator shall mark each individual
container of regulated medical waste in
accordance with all applicable Federal
regulations. . . . ,’’ and that the markings
must include details of the transporter’s
name, the date of shipment, the
intermediate handler’s name, and other
specific information;
5. N.J.A.C. 7:26–3A.19 and those
provisions in 7:26–3A.31 which require
the use of a specific ‘‘tracking form’’ to
accompany shipments of regulated
medical waste that are prescribed for
either the generator or the transporter;
6. N.J.A.C. 7:26–3A.28 that, when
transferring between transporters, each
transporter must place a water resistant
tag below the generator’s marking on the
outer surface of the container with the
transporter’s name, solid waste
registration number, and date of receipt;
and
7. N.J.A.C. 7:26–3A.30 which requires
that a vehicle used to transport
regulated medical waste must have: 1)
the name of the transporter; 2) the New
Jersey Department of Environmental
Protection (NJDEP) solid waste
transporter registration number; and 3)
either the words ‘‘Medical Waste’’ or
‘‘Infectious Waste’’ on two sides and the
back of the cargo-carrying body.
8. N.J.A.C. 7:26–3A.45, to the extent
that it requires rail transporters to
comply with the transporter
requirements of 7:26–3A.28 and 7:26–
3A.30.
9. N.J.A.C. 7:26–3A.46 which requires
a specific tracking form to accompany
shipments of regulated medical waste
for rail transporters.
Federal hazardous material
transportation law does not preempt the
following requirements because they do
not create an obstacle in complying with
the HMR.
SUMMARY:
PO 00000
Frm 00130
Fmt 4703
Sfmt 4703
1. N.J.A.C. 7:26–3A.21(a)(1) to the
extent that it requires the generator to
retain a copy of the shipping paper for
at least three years from the date the
regulated medical waste was accepted
by the transporter;
2. N.J.A.C. 7:26–3A.21(a)(2) to the
extent that it requires the generator to
retain a copy of any exception report for
at least three years after the day the
exception report was submitted;
3. N.J.A.C. 7:26–3A.22 to the extent
that it requires the generator of
regulated medical waste to file an
exception report with the state when a
transporter and/or destination facility
notifies the generator of any discrepancy
between the shipment as accepted by
the initial transporter and delivered to
the destination facility;
4. N.J.A.C. 7:26–3A.32 to the extent
that it requires the transporter to deliver
the entire quantity of regulated medical
waste to the proper party listed on the
tracking form;
5. N.J.A.C. 7:26–3A.33 to the extent
that does not require a particular form
to be used to consolidate the multiple
shipments;
6. N.J.A.C. 7:26–3A.34 to the extent
that it requires that the transporter of
regulated medical waste to retain a copy
of the shipping paper for at least three
years from the date the regulated
medical waste was accepted by the next
party; and
7. N.J.A.C. 7:26–3A.41 to the extent
that it requires intermediate handlers
and destination facilities to certify that
they had received the listed regulated
medical waste.
FOR FURTHER INFORMATION CONTACT:
Alisa Chunephisal, Office of Chief
Counsel, Pipeline and Hazardous
Materials Safety Administration, U.S.
Department of Transportation, 1200
New Jersey Avenue SE., Washington,
DC 20590–0001 (Tel. No. 202–366–
4400).
SUPPLEMENTARY INFORMATION:
I. Application
The Healthcare Waste Institute
(Institute) has applied to PHMSA for a
determination whether Federal
hazardous material transportation law,
49 U.S.C. 5101 et seq., preempts
requirements in the N.J.A.C. on the
transportation of regulated medical
waste in commerce regarding packaging,
labeling and marking of containers, use
of a specific ‘‘tracking form,’’
submission of ‘‘exception reports,’’ and
marking of transport vehicles.
In summary, the Institute contends
that these requirements are preempted
because they are (1) not ‘‘substantively
the same as’’ requirements in the
E:\FR\FM\12DEN1.SGM
12DEN1
maindgalligan on DSK5TPTVN1PROD with NOTICES
Federal Register / Vol. 78, No. 239 / Thursday, December 12, 2013 / Notices
Federal hazardous material
transportation law or the HMR, 49 CFR
parts 171–180, on the transportation of
regulated medical waste, or (2)
otherwise an ‘‘obstacle’’ to
accomplishing and carrying out Federal
hazardous material transportation law
and the HMR, as the NJDEP
requirements are enforced and applied.
On November 10, 2011, PHMSA
published a notice in the Federal
Register inviting interested persons to
comment on the Institute’s application.
77 FR 39567. The only comment was
submitted by the American Trucking
Associations, Inc. (ATA). ATA echoes
the position of the Institute that New
Jersey’s tracking form, marking, and
labeling requirements fall within the
‘‘enumerated ‘covered subjects’’’ that
‘‘requires that the state regulation be
‘substantively the same as’ the federal
requirements.’’ ATA also states that
‘‘requiring different labels and marking
for hazardous materials packagings and
motor vehicles in transportation creates
an unworkable situation [and] . . .
motor carriers cannot be expected to
modify package and vehicle markings
and labels depending upon the states or
municipalities they travel through.’’
ATA opines that ‘‘New Jersey’s use of a
unique hazardous materials shipping
paper impacts safety by creating
potential confusion for motor carriers
and emergency responders. Moreover,
the use of unique hazardous material
shipping papers by states and
municipalities creates a compliance
nightmare for motor carriers.’’
In a June 8, 2012 telephone
conversation, staff attorneys in the New
Jersey Department of Law and Public
Safety advised an attorney in my office
that the New Jersey regulations dated
from 1989 when the U.S. Environmental
Protection Agency (EPA) conducted a
two-year demonstration program, which
expired in 1991. See the discussion in
Preemption Determination (PD) No.
23(RF), ‘‘Morrisville, PA Requirements
for Transportation of ‘Dangerous
Waste,’ ’’ 66 FR 37260–61 (July 17,
2001), decision on petition for
reconsideration, 67 FR 2948 (Jan. 22,
2002), and PD–29(R), ‘‘Massachusetts
Requirements on the Storage and
Disposal of Infectious or Physically
Dangerous Medical or Biological
Waste,’’ 69 FR 34715, 34717 (June 22,
2004). As explained in those decisions,
DOT regulates the transportation of
regulated medical waste as a Division
6.2 hazardous material. PD–23(RF), 66
FR at 37260–61; PD–29(R), 69 FR at
34717. See also 49 CFR 173.134(a)(5).
However, New Jersey’s regulations
appear to treat regulated medical waste
in a manner similar to hazardous waste
VerDate Mar<15>2010
16:45 Dec 11, 2013
Jkt 232001
subject to the Resource Conservation
and Recovery Act, 42 U.S.C. 6901 et seq.
I. Federal Preemption
A United States Court of Appeals has
found that uniformity was the
‘‘linchpin’’ in the design of the Federal
laws governing the transportation of
hazardous materials. Colorado Pub. Util.
Comm’n v. Harmon, 951 F.2d 1571,
1575 (10th Cir. 1991). Section 5125 of
Title 49 U.S.C. contains express
preemption provisions. Section 5125(a)
provides that a requirement of a State,
political subdivision of a State, or
Indian tribe is preempted—unless the
non-Federal requirement is authorized
by another Federal law or DOT grants a
waiver of preemption under § 5125(e)—
if
(1) complying with a requirement of the
State, political subdivision, or tribe and a
requirement of this chapter, a regulation
prescribed under this chapter, or a hazardous
materials transportation security regulation
or directive issued by the Secretary of
Homeland Security is not possible; or
(2) the requirement of the State, political
subdivision, or tribe, as applied or enforced,
is an obstacle to accomplishing and carrying
out this chapter, a regulation prescribed
under this chapter, or a hazardous materials
transportation security regulation or directive
issued by the Secretary of Homeland
Security.1
Subsection (b)(1) of 49 U.S.C. 5125
further provides that a non-Federal
requirement concerning any of the
following subjects is preempted—unless
authorized by another Federal law or
DOT grants a waiver of preemption—
when the non-Federal requirement is
not ‘‘substantively the same as’’ a
provision of Federal hazardous material
transportation law, a regulation
prescribed under that law, or a
hazardous materials security regulation
or directive issued by the Department of
Homeland Security: 2
(A) the designation, description, and
classification of hazardous material.
(B) the packing, repacking, handling,
labeling, marking, and placarding of
hazardous material.
1 These two paragraphs set forth the ‘‘dual
compliance’’ and ‘‘obstacle’’ criteria which are
based on U.S. Supreme Court decisions on
preemption. Hines v. Davidowitz, 312 U.S. 52
(1941); Florida Lime & Avocado Growers, Inc. v.
Paul, 373 U.S. 132 (1963); Ray v. Atlantic Richfield,
Inc., 435 U.S. 151 (1978).
2 To be ‘‘substantively the same,’’ the non-Federal
requirement must conform ‘‘in every significant
respect to the Federal requirement. Editorial and
other similar de minimis changes are permitted.’’
49 CFR 107.202(d). Additional standards apply to
preemption of non-Federal requirements on
highway routes over which hazardous materials
may or may not be transported and fees related to
transporting hazardous material. See 49 U.S.C.
5125(c) and (f).
PO 00000
Frm 00131
Fmt 4703
Sfmt 4703
75673
(C) the preparation, execution, and use of
shipping documents related to hazardous
material and requirements related to the
number, contents, and placement of those
documents.
(D) the written notification, recording, and
reporting of the unintentional release in
transportation of hazardous material.
(E) the designing, manufacturing,
fabricating, inspecting, marking, maintaining,
reconditioning, repairing, or testing a
package, container, or packaging component
that is represented, marked, certified, or sold
as qualified for use in transporting hazardous
material.
Under 49 U.S.C. 5125(d)(1), any
person (including a State, political
subdivision of a State, or Indian tribe)
directly affected by a requirement of a
State, political subdivision or tribe may
apply to the Secretary of Transportation
for a determination whether the
requirement is preempted. The
Secretary of Transportation has
delegated authority to PHMSA to make
determinations of preemption, except
for those concerning highway routing
(which have been delegated to the
Federal Motor Carrier Safety
Administration). 49 CFR 1.53(b).
Section 5125(d)(1) requires notice of
an application for a preemption
determination to be published in the
Federal Register. Following the receipt
and consideration of written comments,
PHMSA publishes its determination in
the Federal Register. See 49 CFR
107.209(c).
Preemption determinations do not
address issues of preemption arising
under the Commerce Clause, the Fifth
Amendment or other provisions of the
Constitution, or statutes other than the
Federal hazardous material
transportation law unless it is necessary
to do so in order to determine whether
a requirement is authorized by another
Federal law, or whether a fee is ‘‘fair’’
within the meaning of 49 U.S.C.
5125(f)(1). A State, local or Indian tribe
requirement is not authorized by
another Federal law merely because it is
not preempted by another Federal
statute. Colorado Pub. Util. Comm’n v.
Harmon, 951 F.2d at 1581.
In making preemption determinations
under 49 U.S.C. 5125(d), PHMSA is
guided by the principles and policies set
forth in Executive Order No. 13132,
entitled ‘‘Federalism’’ (64 FR 43255
(Aug. 10, 1999)), and the President’s
May 20, 2009 memorandum on
‘‘Preemption’’ (74 FR 24693 (May 22,
2009)). Section 4(a) of that Executive
Order authorizes preemption of State
laws only when a statute contains an
express preemption provision, there is
other clear evidence Congress intended
to preempt State law, or the exercise of
State authority directly conflicts with
E:\FR\FM\12DEN1.SGM
12DEN1
75674
Federal Register / Vol. 78, No. 239 / Thursday, December 12, 2013 / Notices
the exercise of Federal authority. The
President’s May 20, 2009 memorandum
sets forth the policy ‘‘that preemption of
State law by executive departments and
agencies should be undertaken only
with full consideration of the legitimate
prerogatives of the States and with a
sufficient legal basis for preemption.’’
Section 5125 contains express
preemption provisions, which PHMSA
has implemented through its regulations
and which PHMSA applies in making
administrative preemption
determinations.
maindgalligan on DSK5TPTVN1PROD with NOTICES
III. Discussion
A. Packaging and Segregation
Requirements
The Institute raises concerns with two
provisions which (1) allow generators to
ship oversized medical waste without a
packaging or container and (2) require
generators to separate sharps, fluids
(greater than 20 cc), and other regulated
medical waste.
The HMR authorize the following
packagings for the transportation of
regulated medical waste: (1) UN
standard non-bulk packagings
conforming to the requirements of 49
CFR part 178 at the Packing Group II
performance level; (2) large packagings
constructed, tested, and marked in
accordance with the requirements of
part 178 provided the waste is
contained in inner packagings
conforming to the requirements of
paragraph (e) of § 173.197; and (3) nonspecification bulk packaging such as a
wheeled cart or bulk outer packaging
(BOP) provided the waste is contained
in inner packagings conforming to the
requirements of paragraph (e) of
§ 173.197. In addition, regulated
medical waste transported by a private
or contract carrier is excepted from the
specific packaging requirements of
§ 173.197, if packaged in a rigid nonbulk packaging conforming to the
general packaging requirements of
§§ 173.24 and 173.24a and packaging
requirements specified in 29 CFR
1910.1030, provided the material does
not include a waste concentrated stock
culture of an infectious substance.
Sharps containers must be securely
closed to prevent leaks or punctures.
Thus, in all cases, the HMR require that,
regardless of size, regulated medical
waste may be transported only in a
closed packaging or container.3
3 In
the preamble to its August 14, 2002 final rule
making ‘‘Revisions to Standards for Infectious
Substances,’’ PHMSA’s predecessor agency, the
Research and Special Programs Administration,
responded to a comment that it had proposed to
‘‘permit regulated medical waste to be transported
in large open-top, roll-off containers. This is not the
case. The non-specification bulk packagings
VerDate Mar<15>2010
16:45 Dec 11, 2013
Jkt 232001
In comparison, New Jersey’s
regulations are less prescriptive than the
HMR. First, N.J.A.C. 7:26–3A.5 defines
‘‘oversized regulated medical waste’’ as
‘‘medical waste that is too large to be
placed in a plastic bag or standard
container,’’ without defining the term
‘‘standard container.’’ More importantly,
N.J.A.C. 7:26–3A.11(d) explicitly allows
‘‘oversized regulated medical waste’’ to
be transported without any form of
packaging or containment, in stark
contrast to the authorized bulk
packagings required in § 173.197.
The HMR also contain specific
packaging requirements for sharps and
liquids. 49 CFR 173.197(b) and (e)(3),
respectively, provide that: ‘‘A non-bulk
packaging used as a sharps container
must be puncture-resistant for sharps
and sharps with residual fluid as
demonstrated by conducting the
performance tests in part 178. . . .
Sharps containers must be securely
closed to prevent leaks or puncture in
conformance with the instructions
provided by the packaging
manufacturer.’’ Moreover, ‘‘[s]harps
transported in a Large Packaging, Cart,
or BOP must be packaged in a punctureresistant inner packaging (sharps
container).’’ As for liquids,
§ 173.197(e)(2) requires that:
Liquid regulated medical waste or clinical
waste or (bio) medical waste transported in
a Large Packaging, Cart, or BOP must be
packaged in a rigid inner packaging
conforming to the provisions of subpart B of
this part. Liquid materials are not authorized
for transportation in inner packagings having
a capacity of greater than 19 L (5 gallons).
The HMR do not provide a quantity
exception. In contrast, the N.J.A.C. 7:26–
3A.10(a) ‘‘requires generators to separate
regulated medical waste into different
containers before transport, i.e., sharps,
fluids (greater than 20 cc), and other
regulated medical waste.’’ Moreover,
N.J.A.C. 7.26–3A.11(d) provides that the
packages or containers for sharps must
be puncture resistant while the packages
for fluids (quantities greater than 20
cubic centimeters) in packaging or
containers must be break-resistant and
tightly lidded or stoppered.
Because N.J.A.C. 7:26–3A.10(a) and
N.J.A.C. 7:26–3A.11(d) cover ‘‘the
packing, repacking, [and] handling . . .
of hazardous material’’ and they are not
substantively the same as the HMR,
these regulations are preempted.
B. Labeling and Marking Requirements
The HMR require that an
‘‘INFECTIOUS SUBSTANCE’’ label
authorized for the transportation of RMS must be
closed with a lid or closure to prevent intrusion of
water into the packaging or release of contents from
the packaging.’’ 67 FR 53118, 53125.
PO 00000
Frm 00132
Fmt 4703
Sfmt 4703
must be affixed on packages that contain
regulated medical waste unless the
packaging is marked with the
‘‘BIOHAZARD’’ marking and is being
transported by a private or contract
carrier. 49 CFR 172.400(a), 172.432, and
173.134(c)(1)(i). The ‘‘INFECTIOUS
SUBSTANCE’’ label is a white panel
with black text. 49 CFR 172.432. The
HMR do not differentiate when a label
is needed based on whether there is
treated or untreated medical waste nor
do they define untreated medical waste.
N.J.A.C. 7:26–3A.5, however, defines
‘‘untreated regulated medical waste’’ as
waste ‘‘that has not been treated to
substantially reduce or eliminate its
potential for causing disease.’’ N.J.A.C.
7:26–3A:14 requires that only a
container of untreated regulated
medical waste must have the label
‘‘Medical Waste,’’ ‘‘Infectious Waste,’’ or
display the universal biohazard symbol
on the outside of the container. The
N.J.A.C. 7:26–3A.14 requirement is not
substantively the same as the HMR and
therefore is preempted.
Additionally, the HMR require that
the inner packagings authorized for
large packagings, carts, and bulk outer
packagings containing regulated
medical waste ‘‘must be durably marked
or tagged with the name and location
(city and state) of the offeror, except
when the entire contents of the Large
Packaging, Cart, or BOP originates at a
single location and is delivered to a
single location.’’ 49 CFR 173.197(e).
Moreover, the markings for the outer
packaging for regulated medical waste
of non-bulk packages and bulk packages
require only the proper shipping name
and UN identification number while the
inner packaging for non-bulk packages
is required to only be marked with the
‘‘BIOHAZARD’’ symbol. 49 CFR 172.301
and 172.304. Bulk packagings that
contain infectious substances must be
marked with an orange panel containing
the UN identification number and the
‘‘BIOHAZARD’’ symbol. 49 CFR 172.323
and 172.332.
However, New Jersey requires that all
packages containing treated regulated
medical waste must to be marked in
accordance with N.J.A.C. 7:26–3A:15.
According to N.J.A.C. 7:26–3A.5,
‘‘treated regulated medical waste’’
means ‘‘regulated medical waste that
has been treated to substantially reduce
or eliminate its potential for causing
disease, but has not yet been
destroyed.’’ New Jersey’s 7:26–3A:15
requires that each ‘‘generator shall mark
each individual container of regulated
medical waste in accordance with all
applicable Federal regulations. . . .,’’
and also requires additional markings
such as the transporter’s name, the date
E:\FR\FM\12DEN1.SGM
12DEN1
Federal Register / Vol. 78, No. 239 / Thursday, December 12, 2013 / Notices
of shipment, the intermediate handler’s
name. Thus, because 7:26–3A:15
requires additional markings that the
HMR does not, it is not substantively
the same and therefore preempted.
Further, N.J.A.C. 7:26–3A.28 requires
that each transporter place a water
resistant tag below the generator’s
marking on the outer surface of the
container when transferring between
transporters with the transporter’s
name, solid waste registration number,
and date of receipt. The HMR do not
require such markings or labels;
therefore, N.J.A.C. 7:26–3A.28 is
preempted.
maindgalligan on DSK5TPTVN1PROD with NOTICES
C. Tracking Form Requirements
The HMR require that any person
offering a hazardous material must
provide a shipping paper describing the
material by:
• The identification number, the
proper shipping name, the hazard class,
and the packing group of the material,
49 CFR 172.202(a)(1)–(4);
• Total quantity of the material
covered by one description, 49 CFR
172.202(c);
• Emergency response telephone
number, 49 CFR 172.604; and
• Shipper’s certification that the
material is ‘‘properly classified,
described, packaged, marked and
labeled and are in proper condition for
transportation . . .’’ 49 CFR
172.204(a)(1).
However, except for shipments of
hazardous waste for which the EPA
hazardous waste manifest is required
(see 49 CFR 172.205), a hazardous
material shipping paper need not be in
any specific form or format, nor must it
be signed by the transporter or recipient
of the shipment. In contrast, N.J.A.C.
7:26–3A.19 and 7:26–3A.31 require the
use of a specific ‘‘tracking form’’ for
shipments of regulated medical waste,
which must be prepared in accordance
with the instructions found in these
regulations. These regulations for use of
the tracking form also differentiate
between ‘‘NJ Treated’’ versus ‘‘NJ
Untreated’’ medical waste (which the
HMR do not) and further require that
the transporter and destination facility
sign the tracking document.
As explained in ‘‘Massachusetts
Requirements on the Storage and
Disposal of Infectious or Physically
Dangerous Medical or Biological
Waste,’’ a requirement that the
transporter sign the shipping paper is
preempted since it is not substantively
the same as the federal requirement.
Because New Jersey’s tracking form
requires a signature not required by the
HMR, it is not substantively the same as
VerDate Mar<15>2010
16:45 Dec 11, 2013
Jkt 232001
the requirements of the HMR, and is
preempted.4
Additionally, N.J.A.C. 7:26–3A.33
allows a transporter to consolidate
multiple shipments of waste to a new
tracking form. The HMR does not have
a specific regulation about consolidation
of shipments onto a new tracking form.
Insofar as N.J.A.C. 7:26–3A.33 does not
require a particular form to be used to
consolidate the multiple shipments, it is
not preempted by the HMR.
N.J.A.C. 7:26–3A.21(a)(1) requires that
the generator of the regulated medical
waste keep a copy of the tracking form
for at least three years from the date
waste is accepted by the transporter and
7:26–3A.34 requires the same of the
transporter from the date the waste is
accepted by the next party. On the other
hand, Federal hazardous material
transportation law and the HMR require
an offeror of a hazardous material to
retain a copy of the shipping paper for
two years, and a carrier to retain a copy
of the shipping paper for one year. 49
U.S.C. 5110, 49 CFR 172.201(e),
177.817(f).5 I do not find that
requirements specifying the time period
for which an offeror or transporter must
retain a copy of the shipping documents
to be within the scope of the
‘‘preparation, execution, and use of
shipping documentation’’ or
‘‘requirements related to the number,
contents, and placement of those
documents’’ in 49 U.S.C. 5125(b)(1)(C).
Nor is there information to show that
the longer retention period in N.J.A.C.
7:26–3A.21(a)(1) and 7:26–3A.34 is any
obstacle to accomplishing the shorter
retention periods in the HMR. The fact
that the State’s requirement is more
stringent does not, by itself, appear to
constitute an obstacle for the offeror and
transporter meeting the two-year and
one-year retention periods in the HMR,
respectively. Therefore, as applied to
requirements to retain copies of
shipping papers, N.J.A.C. 7:26–
3A.21(a)(1) and 7:26–3A.34 are not
preempted.
4 The Institute takes issue with N.J.A.C. 7:26–
3A.45 and 7:26–3A.47 in its application. We believe
that the Institute meant to cite 7:26–3A.45 and
7:26–3A.46 since those both relate to rail
transporters while 7:26–3A.47 pertains to
alternative or innovative technology authorization.
Since N.J.A.C. 7:26–3A.45 and 7:26–3A.46 are
similar in substance to the regulations pertaining to
highway transporters discussed in this section, they
are also preempted. Additionally, we read the
intent of N.J.A.C. 7:26–3A.32 and 7:26–3A.41 as
ensuring that the hazardous materials reach the
intended recipient on the shipping document; to
that extent, these provisions are not preempted.
5 A person who offers a hazardous waste for
transportation must retain a copy of the shipping
paper for three years. 49 CFR 172.201(e).
PO 00000
Frm 00133
Fmt 4703
Sfmt 4703
75675
D. Exception Reports
N.J.A.C. 7:26–3A.22 requires the
generator of the waste to file an
exception report with the state when a
transporter and/or destination facility
fails to return a signed copy of the
tracking form to the generator while
N.J.A.C. 7:26–3A.21(a)(2) requires the
generator to retain a copy of all
exception reports submitted for at least
three years after the day the exception
report was submitted. The Institute
asserts that the regulations ‘‘create
confusion because shippers may think
that an exception report relieves them of
failure to have a shipping paper on file.’’
The HMR do not provide a parallel
requirement. While these requirements
relate to transportation of the regulated
medical waste, they apply to the
generator of the waste and not the
transporter. There is not sufficient basis
to show that New Jersey’s regulations
confuse shippers into thinking that they
are not required to retain a copy of the
shipping paper as required by 49 CFR
172.201(e). The HMR clearly describe
the recordkeeping requirements of the
shipping papers without any
contingencies. New Jersey cannot
require a specific tracking form as
discussed above, but the requirements
to submit and retain the exception
report in 7:26–3A.21(a)(2) and 7:26–
3A.22 do not appear to create an
obstacle in complying with the HMR.
Therefore, these requirements are not
preempted.
E. Marking a Motor Vehicle With
Additional Information
The HMR require that each selfpropelled commercial motor vehicle
(CMV) be marked with the legal name
or a single trade name of the motor
carrier operating the self-propelled
CMV. 49 CFR 390.21 (as incorporated in
the HMR by 49 CFR 177.804(a)).
Additionally, the HMR require two
types of markings for the outside of a
vehicle depending on whether the
regulated medical waste is contained in
packaging which is bulk or non-bulk. 49
CFR 172.332 and 172.336 require that
vehicles containing non-bulk packages
of a single hazardous materials with an
aggregate gross weight of the hazardous
material is 4,000 kg (8,820 pounds) or
more to be marked with the
identification number on either orange
panels or on a plain white square-onpoint display configuration having the
same outside dimensions as a placard.
In accordance with 49 CFR 172.323(b),
when a bulk packaging contained in or
on a transport vehicle or freight
container is marked with a
‘‘BIOHAZARD’’ marking which is not
E:\FR\FM\12DEN1.SGM
12DEN1
75676
Federal Register / Vol. 78, No. 239 / Thursday, December 12, 2013 / Notices
maindgalligan on DSK5TPTVN1PROD with NOTICES
visible, then the transport vehicle or
freight container must be marked on
each side and each end with a
‘‘BIOHAZARD’’ marking.
In contrast, N.J.A.C. 7:26–3A.30
requires that the vehicles that transport
regulated medical waste have: (1) The
name of the transporter; (2) the NJDEP
solid waste transporter registration
number; and (3) either the words
‘‘Medical Waste’’ or ‘‘Infectious Waste’’
on two sides and the back of the cargocarrying body. The N.J.A.C. marking
requirement is not substantively the
same as the HMR and is therefore
preempted.
IV. Ruling
Federal hazardous material
transportation law preempts the
following requirements in the New
Jersey Administrative Code (N.J.A.C.)
because the requirements are not
substantively the same as the
requirements in the HMR:
1. N.J.A.C. 7:26–3A.10(a) that
generators must separate into different
containers before transport sharps,
fluids (greater than 20 cc), and other
regulated medical waste;
2. N.J.A.C. 7:26–3A.11(d) which
allows a generator to ship oversized
medical waste without placing it in a
packaging as required by the HMR;
3. N.J.A.C. 7:26–3A.14 that the words
‘‘Medical Waste’’ or ‘‘Infectious Waste’’
must be labeled on the outside of the
package when there is untreated
regulated medical waste;
4. N.J.A.C. 7:26–3A.15 that each
‘‘generator shall mark each individual
container of regulated medical waste in
accordance with all applicable Federal
regulations. . . . .’’ and that the markings
must include details of the transporter’s
name, the date of shipment, the
intermediate handler’s name, and other
specific information;
5. N.J.A.C. 7:26–3A.19 and those
provisions of 7:26–3A.31 which require
the use of a specific ‘‘tracking form’’ to
accompany shipments of regulated
medical waste that are prescribed for
either the generator or the transporter;
6. N.J.A.C. 7:26–3A.28 that, when
transferring between transporters, each
transporter must place a water resistant
tag below the generator’s marking on the
outer surface of the container with the
transporter’s name, solid waste
registration number, and date of receipt;
and
7. N.J.A.C. 7:26–3A.30 which requires
that a vehicle used to transport
regulated medical waste must have: (1)
The name of the transporter; (2) the
NJDEP solid waste transporter
registration number; and (3) either the
words ‘‘Medical Waste’’ or ‘‘Infectious
VerDate Mar<15>2010
16:45 Dec 11, 2013
Jkt 232001
Waste’’ on two sides and the back of the
cargo-carrying body.
8. N.J.A.C. 7:26–3A.45 to the extent
that it requires rail transporters to
comply with the transporter
requirements of 7:26–3A.28 and 7:26–
3A.30.
9. N.J.A.C. 7:26–3A.46 which requires
a specific tracking form to accompany
shipments of regulated medical waste
for rail transporters.
Federal hazardous material
transportation law does not preempt the
following requirements because they do
not create an obstacle in complying with
the HMR.
1. N.J.A.C. 7:26–3A.21(a)(1) to the
extent that it requires the generator to
retain a copy of the shipping paper for
at least three years from the date the
regulated medical waste was accepted
by the transporter;
2. N.J.A.C. 7:26–3A.21(a)(2) to the
extent that it requires the generator to
retain a copy of any exception report for
at least three years after the day the
exception report was submitted;
3. N.J.A.C. 7:26–3A.22 to the extent
that it requires the generator of the
regulated medical waste to file an
exception report with the state when a
transporter and/or destination facility
notifies the generator of any discrepancy
between the shipment as accepted by
the initial transporter and delivered to
the destination facility;
4. N.J.A.C. 7:26–3A.32 to the extent
that it requires the transporter to deliver
the entire quantity of regulated medical
waste to the proper party listed on the
tracking form;
5. N.J.A.C. 7:26–3A.33 to the extent
that does not require a particular form
to be used to consolidate the multiple
shipments;
6. N.J.A.C. 7:26–3A.34 to the extent
that it requires that the transporter of
the regulated medical waste to retain a
copy of the shipping paper for at least
three years from the date the regulated
medical waste was accepted by the next
party; and
7. N.J.A.C. 7:26–3A.41 to the extent
that it requires intermediate handlers
and destination facilities to certify that
they had received the listed regulated
medical waste.
V. Petition for Reconsideration/Judicial
Review
In accordance with 49 CFR
107.211(a), any person aggrieved by this
decision may file a petition for
reconsideration within 20 days of
publication of this decision in the
Federal Register. A petition for judicial
review of a final preemption
determination must be filed in the
United States Court of Appeals for the
PO 00000
Frm 00134
Fmt 4703
Sfmt 4703
District of Columbia or in the Court of
Appeals for the United States for the
circuit in which the petitioner resides or
has its principal place of business,
within 60 days after the determination
becomes final. 49 U.S.C. 5127(a).
This decision will become PHMSA’s
final decision 20 days after publication
in the Federal Register if no petition for
reconsideration is filed within that time.
The filing of a petition for
reconsideration is not a prerequisite to
seeking judicial review of this decision
under 49 U.S.C. 5127(a).
If a petition for reconsideration is
filed within 20 days of publication in
the Federal Register, the action by
PHMSA’s Chief Counsel on the petition
for reconsideration will be PHMSA’s
final action. 49 CFR 107.211(d).
Issued in Washington, DC on December 2,
2013.
Vanessa L. Allen Sutherland,
Chief Counsel.
[FR Doc. 2013–29604 Filed 12–11–13; 8:45 am]
BILLING CODE 4910–60–P
DEPARTMENT OF TRANSPORTATION
Surface Transportation Board
[Docket No. FD 35787]
Mark W. Dobronski and Susan K.
Dobronski—Acquisition of Control
Exemption—Adrian & Blissfield Rail
Road Company, Charlotte Southern
Railroad Company, Detroit Connecting
Railroad Company, Lapeer Industrial
Railroad Company and Jackson &
Lansing Railroad Company
Mark W. Dobronski and Susan K.
Dobronski (Applicants), both
noncarriers, have filed a verified notice
of exemption under 49 CFR 1180(d)(2)
to indirectly control Adrian & Blissfield
Rail Road Company (ADBF), a Class III
railroad, and ADBF’s four Class III
railroad subsidiaries: Charlotte Southern
Railroad Company (CHS), Detroit
Connecting Railroad Company (DCON),
Lapeer Industrial Railroad Company
(LIRR), and Jackson & Lansing Railroad
Company (JAIL).
Applicants state that they control
Ferrovia, L.L.C. (Ferrovia), also a
noncarrier and a limited liability
company, which, until very recently,
owned 50 percent of ADBF. On
November 15, 2013, two minority
shareholders of ADBF were required by
court order to sell their outstanding
shares back to ADBF. As a result,
Ferrovia now owns 58.33 percent of the
outstanding shares of ADBF and
therefore directly controls ADBF and
indirectly controls CHS, DCON, LIRR,
E:\FR\FM\12DEN1.SGM
12DEN1
Agencies
[Federal Register Volume 78, Number 239 (Thursday, December 12, 2013)]
[Notices]
[Pages 75672-75676]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2013-29604]
-----------------------------------------------------------------------
DEPARTMENT OF TRANSPORTATION
Pipeline and Hazardous Materials Safety Administration
[Docket No. PHMSA-2011-0294 (PD-35(R)]
New Jersey Regulations on Transportation of Regulated Medical
Waste
AGENCY: Pipeline and Hazardous Materials Safety Administration (PHMSA),
DOT.
ACTION: Notice of administrative determination of preemption.
-----------------------------------------------------------------------
Applicable Federal Requirements: Federal hazardous material
transportation law, 49 U.S.C. 5101 et seq., and the Hazardous Materials
Regulations (HMR), 49 CFR parts 171-180.
Modes Affected: All transportation modes
SUMMARY: Federal hazardous material transportation law preempts the
following requirements in the New Jersey Administrative Code (N.J.A.C.)
because the requirements are not substantively the same as the
requirements in the HMR:
1. N.J.A.C. 7:26-3A.10(a) that generators must separate into
different containers before transport sharps, fluids (greater than 20
cc), and other regulated medical waste;
2. N.J.A.C. 7:26-3A.11(d) which allows a generator to ship
oversized medical waste without placing it in a packaging as required
by the HMR;
3. N.J.A.C. 7:26-3A.14 that the words ``Medical Waste'' or
``Infectious Waste'' must be labeled on the outside of the package when
there is untreated regulated medical waste;
4. N.J.A.C. 7:26-3A:15 that each ``generator shall mark each
individual container of regulated medical waste in accordance with all
applicable Federal regulations. . . . ,'' and that the markings must
include details of the transporter's name, the date of shipment, the
intermediate handler's name, and other specific information;
5. N.J.A.C. 7:26-3A.19 and those provisions in 7:26-3A.31 which
require the use of a specific ``tracking form'' to accompany shipments
of regulated medical waste that are prescribed for either the generator
or the transporter;
6. N.J.A.C. 7:26-3A.28 that, when transferring between
transporters, each transporter must place a water resistant tag below
the generator's marking on the outer surface of the container with the
transporter's name, solid waste registration number, and date of
receipt; and
7. N.J.A.C. 7:26-3A.30 which requires that a vehicle used to
transport regulated medical waste must have: 1) the name of the
transporter; 2) the New Jersey Department of Environmental Protection
(NJDEP) solid waste transporter registration number; and 3) either the
words ``Medical Waste'' or ``Infectious Waste'' on two sides and the
back of the cargo-carrying body.
8. N.J.A.C. 7:26-3A.45, to the extent that it requires rail
transporters to comply with the transporter requirements of 7:26-3A.28
and 7:26-3A.30.
9. N.J.A.C. 7:26-3A.46 which requires a specific tracking form to
accompany shipments of regulated medical waste for rail transporters.
Federal hazardous material transportation law does not preempt the
following requirements because they do not create an obstacle in
complying with the HMR.
1. N.J.A.C. 7:26-3A.21(a)(1) to the extent that it requires the
generator to retain a copy of the shipping paper for at least three
years from the date the regulated medical waste was accepted by the
transporter;
2. N.J.A.C. 7:26-3A.21(a)(2) to the extent that it requires the
generator to retain a copy of any exception report for at least three
years after the day the exception report was submitted;
3. N.J.A.C. 7:26-3A.22 to the extent that it requires the generator
of regulated medical waste to file an exception report with the state
when a transporter and/or destination facility notifies the generator
of any discrepancy between the shipment as accepted by the initial
transporter and delivered to the destination facility;
4. N.J.A.C. 7:26-3A.32 to the extent that it requires the
transporter to deliver the entire quantity of regulated medical waste
to the proper party listed on the tracking form;
5. N.J.A.C. 7:26-3A.33 to the extent that does not require a
particular form to be used to consolidate the multiple shipments;
6. N.J.A.C. 7:26-3A.34 to the extent that it requires that the
transporter of regulated medical waste to retain a copy of the shipping
paper for at least three years from the date the regulated medical
waste was accepted by the next party; and
7. N.J.A.C. 7:26-3A.41 to the extent that it requires intermediate
handlers and destination facilities to certify that they had received
the listed regulated medical waste.
FOR FURTHER INFORMATION CONTACT: Alisa Chunephisal, Office of Chief
Counsel, Pipeline and Hazardous Materials Safety Administration, U.S.
Department of Transportation, 1200 New Jersey Avenue SE., Washington,
DC 20590-0001 (Tel. No. 202-366-4400).
SUPPLEMENTARY INFORMATION:
I. Application
The Healthcare Waste Institute (Institute) has applied to PHMSA for
a determination whether Federal hazardous material transportation law,
49 U.S.C. 5101 et seq., preempts requirements in the N.J.A.C. on the
transportation of regulated medical waste in commerce regarding
packaging, labeling and marking of containers, use of a specific
``tracking form,'' submission of ``exception reports,'' and marking of
transport vehicles.
In summary, the Institute contends that these requirements are
preempted because they are (1) not ``substantively the same as''
requirements in the
[[Page 75673]]
Federal hazardous material transportation law or the HMR, 49 CFR parts
171-180, on the transportation of regulated medical waste, or (2)
otherwise an ``obstacle'' to accomplishing and carrying out Federal
hazardous material transportation law and the HMR, as the NJDEP
requirements are enforced and applied.
On November 10, 2011, PHMSA published a notice in the Federal
Register inviting interested persons to comment on the Institute's
application. 77 FR 39567. The only comment was submitted by the
American Trucking Associations, Inc. (ATA). ATA echoes the position of
the Institute that New Jersey's tracking form, marking, and labeling
requirements fall within the ``enumerated `covered subjects''' that
``requires that the state regulation be `substantively the same as' the
federal requirements.'' ATA also states that ``requiring different
labels and marking for hazardous materials packagings and motor
vehicles in transportation creates an unworkable situation [and] . . .
motor carriers cannot be expected to modify package and vehicle
markings and labels depending upon the states or municipalities they
travel through.'' ATA opines that ``New Jersey's use of a unique
hazardous materials shipping paper impacts safety by creating potential
confusion for motor carriers and emergency responders. Moreover, the
use of unique hazardous material shipping papers by states and
municipalities creates a compliance nightmare for motor carriers.''
In a June 8, 2012 telephone conversation, staff attorneys in the
New Jersey Department of Law and Public Safety advised an attorney in
my office that the New Jersey regulations dated from 1989 when the U.S.
Environmental Protection Agency (EPA) conducted a two-year
demonstration program, which expired in 1991. See the discussion in
Preemption Determination (PD) No. 23(RF), ``Morrisville, PA
Requirements for Transportation of `Dangerous Waste,' '' 66 FR 37260-61
(July 17, 2001), decision on petition for reconsideration, 67 FR 2948
(Jan. 22, 2002), and PD-29(R), ``Massachusetts Requirements on the
Storage and Disposal of Infectious or Physically Dangerous Medical or
Biological Waste,'' 69 FR 34715, 34717 (June 22, 2004). As explained in
those decisions, DOT regulates the transportation of regulated medical
waste as a Division 6.2 hazardous material. PD-23(RF), 66 FR at 37260-
61; PD-29(R), 69 FR at 34717. See also 49 CFR 173.134(a)(5). However,
New Jersey's regulations appear to treat regulated medical waste in a
manner similar to hazardous waste subject to the Resource Conservation
and Recovery Act, 42 U.S.C. 6901 et seq.
I. Federal Preemption
A United States Court of Appeals has found that uniformity was the
``linchpin'' in the design of the Federal laws governing the
transportation of hazardous materials. Colorado Pub. Util. Comm'n v.
Harmon, 951 F.2d 1571, 1575 (10th Cir. 1991). Section 5125 of Title 49
U.S.C. contains express preemption provisions. Section 5125(a) provides
that a requirement of a State, political subdivision of a State, or
Indian tribe is preempted--unless the non-Federal requirement is
authorized by another Federal law or DOT grants a waiver of preemption
under Sec. 5125(e)--if
(1) complying with a requirement of the State, political
subdivision, or tribe and a requirement of this chapter, a
regulation prescribed under this chapter, or a hazardous materials
transportation security regulation or directive issued by the
Secretary of Homeland Security is not possible; or
(2) the requirement of the State, political subdivision, or
tribe, as applied or enforced, is an obstacle to accomplishing and
carrying out this chapter, a regulation prescribed under this
chapter, or a hazardous materials transportation security regulation
or directive issued by the Secretary of Homeland Security.\1\
---------------------------------------------------------------------------
\1\ These two paragraphs set forth the ``dual compliance'' and
``obstacle'' criteria which are based on U.S. Supreme Court
decisions on preemption. Hines v. Davidowitz, 312 U.S. 52 (1941);
Florida Lime & Avocado Growers, Inc. v. Paul, 373 U.S. 132 (1963);
Ray v. Atlantic Richfield, Inc., 435 U.S. 151 (1978).
Subsection (b)(1) of 49 U.S.C. 5125 further provides that a non-
Federal requirement concerning any of the following subjects is
preempted--unless authorized by another Federal law or DOT grants a
waiver of preemption--when the non-Federal requirement is not
``substantively the same as'' a provision of Federal hazardous material
transportation law, a regulation prescribed under that law, or a
hazardous materials security regulation or directive issued by the
Department of Homeland Security: \2\
---------------------------------------------------------------------------
\2\ To be ``substantively the same,'' the non-Federal
requirement must conform ``in every significant respect to the
Federal requirement. Editorial and other similar de minimis changes
are permitted.'' 49 CFR 107.202(d). Additional standards apply to
preemption of non-Federal requirements on highway routes over which
hazardous materials may or may not be transported and fees related
to transporting hazardous material. See 49 U.S.C. 5125(c) and (f).
(A) the designation, description, and classification of
hazardous material.
(B) the packing, repacking, handling, labeling, marking, and
placarding of hazardous material.
(C) the preparation, execution, and use of shipping documents
related to hazardous material and requirements related to the
number, contents, and placement of those documents.
(D) the written notification, recording, and reporting of the
unintentional release in transportation of hazardous material.
(E) the designing, manufacturing, fabricating, inspecting,
marking, maintaining, reconditioning, repairing, or testing a
package, container, or packaging component that is represented,
marked, certified, or sold as qualified for use in transporting
hazardous material.
Under 49 U.S.C. 5125(d)(1), any person (including a State,
political subdivision of a State, or Indian tribe) directly affected by
a requirement of a State, political subdivision or tribe may apply to
the Secretary of Transportation for a determination whether the
requirement is preempted. The Secretary of Transportation has delegated
authority to PHMSA to make determinations of preemption, except for
those concerning highway routing (which have been delegated to the
Federal Motor Carrier Safety Administration). 49 CFR 1.53(b).
Section 5125(d)(1) requires notice of an application for a
preemption determination to be published in the Federal Register.
Following the receipt and consideration of written comments, PHMSA
publishes its determination in the Federal Register. See 49 CFR
107.209(c).
Preemption determinations do not address issues of preemption
arising under the Commerce Clause, the Fifth Amendment or other
provisions of the Constitution, or statutes other than the Federal
hazardous material transportation law unless it is necessary to do so
in order to determine whether a requirement is authorized by another
Federal law, or whether a fee is ``fair'' within the meaning of 49
U.S.C. 5125(f)(1). A State, local or Indian tribe requirement is not
authorized by another Federal law merely because it is not preempted by
another Federal statute. Colorado Pub. Util. Comm'n v. Harmon, 951 F.2d
at 1581.
In making preemption determinations under 49 U.S.C. 5125(d), PHMSA
is guided by the principles and policies set forth in Executive Order
No. 13132, entitled ``Federalism'' (64 FR 43255 (Aug. 10, 1999)), and
the President's May 20, 2009 memorandum on ``Preemption'' (74 FR 24693
(May 22, 2009)). Section 4(a) of that Executive Order authorizes
preemption of State laws only when a statute contains an express
preemption provision, there is other clear evidence Congress intended
to preempt State law, or the exercise of State authority directly
conflicts with
[[Page 75674]]
the exercise of Federal authority. The President's May 20, 2009
memorandum sets forth the policy ``that preemption of State law by
executive departments and agencies should be undertaken only with full
consideration of the legitimate prerogatives of the States and with a
sufficient legal basis for preemption.'' Section 5125 contains express
preemption provisions, which PHMSA has implemented through its
regulations and which PHMSA applies in making administrative preemption
determinations.
III. Discussion
A. Packaging and Segregation Requirements
The Institute raises concerns with two provisions which (1) allow
generators to ship oversized medical waste without a packaging or
container and (2) require generators to separate sharps, fluids
(greater than 20 cc), and other regulated medical waste.
The HMR authorize the following packagings for the transportation
of regulated medical waste: (1) UN standard non-bulk packagings
conforming to the requirements of 49 CFR part 178 at the Packing Group
II performance level; (2) large packagings constructed, tested, and
marked in accordance with the requirements of part 178 provided the
waste is contained in inner packagings conforming to the requirements
of paragraph (e) of Sec. 173.197; and (3) non-specification bulk
packaging such as a wheeled cart or bulk outer packaging (BOP) provided
the waste is contained in inner packagings conforming to the
requirements of paragraph (e) of Sec. 173.197. In addition, regulated
medical waste transported by a private or contract carrier is excepted
from the specific packaging requirements of Sec. 173.197, if packaged
in a rigid non-bulk packaging conforming to the general packaging
requirements of Sec. Sec. 173.24 and 173.24a and packaging
requirements specified in 29 CFR 1910.1030, provided the material does
not include a waste concentrated stock culture of an infectious
substance. Sharps containers must be securely closed to prevent leaks
or punctures. Thus, in all cases, the HMR require that, regardless of
size, regulated medical waste may be transported only in a closed
packaging or container.\3\
---------------------------------------------------------------------------
\3\ In the preamble to its August 14, 2002 final rule making
``Revisions to Standards for Infectious Substances,'' PHMSA's
predecessor agency, the Research and Special Programs
Administration, responded to a comment that it had proposed to
``permit regulated medical waste to be transported in large open-
top, roll-off containers. This is not the case. The non-
specification bulk packagings authorized for the transportation of
RMS must be closed with a lid or closure to prevent intrusion of
water into the packaging or release of contents from the
packaging.'' 67 FR 53118, 53125.
---------------------------------------------------------------------------
In comparison, New Jersey's regulations are less prescriptive than
the HMR. First, N.J.A.C. 7:26-3A.5 defines ``oversized regulated
medical waste'' as ``medical waste that is too large to be placed in a
plastic bag or standard container,'' without defining the term
``standard container.'' More importantly, N.J.A.C. 7:26-3A.11(d)
explicitly allows ``oversized regulated medical waste'' to be
transported without any form of packaging or containment, in stark
contrast to the authorized bulk packagings required in Sec. 173.197.
The HMR also contain specific packaging requirements for sharps and
liquids. 49 CFR 173.197(b) and (e)(3), respectively, provide that: ``A
non-bulk packaging used as a sharps container must be puncture-
resistant for sharps and sharps with residual fluid as demonstrated by
conducting the performance tests in part 178. . . . Sharps containers
must be securely closed to prevent leaks or puncture in conformance
with the instructions provided by the packaging manufacturer.''
Moreover, ``[s]harps transported in a Large Packaging, Cart, or BOP
must be packaged in a puncture-resistant inner packaging (sharps
container).'' As for liquids, Sec. 173.197(e)(2) requires that:
Liquid regulated medical waste or clinical waste or (bio)
medical waste transported in a Large Packaging, Cart, or BOP must be
packaged in a rigid inner packaging conforming to the provisions of
subpart B of this part. Liquid materials are not authorized for
transportation in inner packagings having a capacity of greater than
19 L (5 gallons).
The HMR do not provide a quantity exception. In contrast, the
N.J.A.C. 7:26-3A.10(a) ``requires generators to separate regulated
medical waste into different containers before transport, i.e., sharps,
fluids (greater than 20 cc), and other regulated medical waste.''
Moreover, N.J.A.C. 7.26-3A.11(d) provides that the packages or
containers for sharps must be puncture resistant while the packages for
fluids (quantities greater than 20 cubic centimeters) in packaging or
containers must be break-resistant and tightly lidded or stoppered.
Because N.J.A.C. 7:26-3A.10(a) and N.J.A.C. 7:26-3A.11(d) cover
``the packing, repacking, [and] handling . . . of hazardous material''
and they are not substantively the same as the HMR, these regulations
are preempted.
B. Labeling and Marking Requirements
The HMR require that an ``INFECTIOUS SUBSTANCE'' label must be
affixed on packages that contain regulated medical waste unless the
packaging is marked with the ``BIOHAZARD'' marking and is being
transported by a private or contract carrier. 49 CFR 172.400(a),
172.432, and 173.134(c)(1)(i). The ``INFECTIOUS SUBSTANCE'' label is a
white panel with black text. 49 CFR 172.432. The HMR do not
differentiate when a label is needed based on whether there is treated
or untreated medical waste nor do they define untreated medical waste.
N.J.A.C. 7:26-3A.5, however, defines ``untreated regulated medical
waste'' as waste ``that has not been treated to substantially reduce or
eliminate its potential for causing disease.'' N.J.A.C. 7:26-3A:14
requires that only a container of untreated regulated medical waste
must have the label ``Medical Waste,'' ``Infectious Waste,'' or display
the universal biohazard symbol on the outside of the container. The
N.J.A.C. 7:26-3A.14 requirement is not substantively the same as the
HMR and therefore is preempted.
Additionally, the HMR require that the inner packagings authorized
for large packagings, carts, and bulk outer packagings containing
regulated medical waste ``must be durably marked or tagged with the
name and location (city and state) of the offeror, except when the
entire contents of the Large Packaging, Cart, or BOP originates at a
single location and is delivered to a single location.'' 49 CFR
173.197(e). Moreover, the markings for the outer packaging for
regulated medical waste of non-bulk packages and bulk packages require
only the proper shipping name and UN identification number while the
inner packaging for non-bulk packages is required to only be marked
with the ``BIOHAZARD'' symbol. 49 CFR 172.301 and 172.304. Bulk
packagings that contain infectious substances must be marked with an
orange panel containing the UN identification number and the
``BIOHAZARD'' symbol. 49 CFR 172.323 and 172.332.
However, New Jersey requires that all packages containing treated
regulated medical waste must to be marked in accordance with N.J.A.C.
7:26-3A:15. According to N.J.A.C. 7:26-3A.5, ``treated regulated
medical waste'' means ``regulated medical waste that has been treated
to substantially reduce or eliminate its potential for causing disease,
but has not yet been destroyed.'' New Jersey's 7:26-3A:15 requires that
each ``generator shall mark each individual container of regulated
medical waste in accordance with all applicable Federal regulations. .
. .,'' and also requires additional markings such as the transporter's
name, the date
[[Page 75675]]
of shipment, the intermediate handler's name. Thus, because 7:26-3A:15
requires additional markings that the HMR does not, it is not
substantively the same and therefore preempted.
Further, N.J.A.C. 7:26-3A.28 requires that each transporter place a
water resistant tag below the generator's marking on the outer surface
of the container when transferring between transporters with the
transporter's name, solid waste registration number, and date of
receipt. The HMR do not require such markings or labels; therefore,
N.J.A.C. 7:26-3A.28 is preempted.
C. Tracking Form Requirements
The HMR require that any person offering a hazardous material must
provide a shipping paper describing the material by:
The identification number, the proper shipping name, the
hazard class, and the packing group of the material, 49 CFR
172.202(a)(1)-(4);
Total quantity of the material covered by one description,
49 CFR 172.202(c);
Emergency response telephone number, 49 CFR 172.604; and
Shipper's certification that the material is ``properly
classified, described, packaged, marked and labeled and are in proper
condition for transportation . . .'' 49 CFR 172.204(a)(1).
However, except for shipments of hazardous waste for which the EPA
hazardous waste manifest is required (see 49 CFR 172.205), a hazardous
material shipping paper need not be in any specific form or format, nor
must it be signed by the transporter or recipient of the shipment. In
contrast, N.J.A.C. 7:26-3A.19 and 7:26-3A.31 require the use of a
specific ``tracking form'' for shipments of regulated medical waste,
which must be prepared in accordance with the instructions found in
these regulations. These regulations for use of the tracking form also
differentiate between ``NJ Treated'' versus ``NJ Untreated'' medical
waste (which the HMR do not) and further require that the transporter
and destination facility sign the tracking document.
As explained in ``Massachusetts Requirements on the Storage and
Disposal of Infectious or Physically Dangerous Medical or Biological
Waste,'' a requirement that the transporter sign the shipping paper is
preempted since it is not substantively the same as the federal
requirement. Because New Jersey's tracking form requires a signature
not required by the HMR, it is not substantively the same as the
requirements of the HMR, and is preempted.\4\
---------------------------------------------------------------------------
\4\ The Institute takes issue with N.J.A.C. 7:26-3A.45 and 7:26-
3A.47 in its application. We believe that the Institute meant to
cite 7:26-3A.45 and 7:26-3A.46 since those both relate to rail
transporters while 7:26-3A.47 pertains to alternative or innovative
technology authorization. Since N.J.A.C. 7:26-3A.45 and 7:26-3A.46
are similar in substance to the regulations pertaining to highway
transporters discussed in this section, they are also preempted.
Additionally, we read the intent of N.J.A.C. 7:26-3A.32 and 7:26-
3A.41 as ensuring that the hazardous materials reach the intended
recipient on the shipping document; to that extent, these provisions
are not preempted.
---------------------------------------------------------------------------
Additionally, N.J.A.C. 7:26-3A.33 allows a transporter to
consolidate multiple shipments of waste to a new tracking form. The HMR
does not have a specific regulation about consolidation of shipments
onto a new tracking form. Insofar as N.J.A.C. 7:26-3A.33 does not
require a particular form to be used to consolidate the multiple
shipments, it is not preempted by the HMR.
N.J.A.C. 7:26-3A.21(a)(1) requires that the generator of the
regulated medical waste keep a copy of the tracking form for at least
three years from the date waste is accepted by the transporter and
7:26-3A.34 requires the same of the transporter from the date the waste
is accepted by the next party. On the other hand, Federal hazardous
material transportation law and the HMR require an offeror of a
hazardous material to retain a copy of the shipping paper for two
years, and a carrier to retain a copy of the shipping paper for one
year. 49 U.S.C. 5110, 49 CFR 172.201(e), 177.817(f).\5\ I do not find
that requirements specifying the time period for which an offeror or
transporter must retain a copy of the shipping documents to be within
the scope of the ``preparation, execution, and use of shipping
documentation'' or ``requirements related to the number, contents, and
placement of those documents'' in 49 U.S.C. 5125(b)(1)(C). Nor is there
information to show that the longer retention period in N.J.A.C. 7:26-
3A.21(a)(1) and 7:26-3A.34 is any obstacle to accomplishing the shorter
retention periods in the HMR. The fact that the State's requirement is
more stringent does not, by itself, appear to constitute an obstacle
for the offeror and transporter meeting the two-year and one-year
retention periods in the HMR, respectively. Therefore, as applied to
requirements to retain copies of shipping papers, N.J.A.C. 7:26-
3A.21(a)(1) and 7:26-3A.34 are not preempted.
---------------------------------------------------------------------------
\5\ A person who offers a hazardous waste for transportation
must retain a copy of the shipping paper for three years. 49 CFR
172.201(e).
---------------------------------------------------------------------------
D. Exception Reports
N.J.A.C. 7:26-3A.22 requires the generator of the waste to file an
exception report with the state when a transporter and/or destination
facility fails to return a signed copy of the tracking form to the
generator while N.J.A.C. 7:26-3A.21(a)(2) requires the generator to
retain a copy of all exception reports submitted for at least three
years after the day the exception report was submitted. The Institute
asserts that the regulations ``create confusion because shippers may
think that an exception report relieves them of failure to have a
shipping paper on file.'' The HMR do not provide a parallel
requirement. While these requirements relate to transportation of the
regulated medical waste, they apply to the generator of the waste and
not the transporter. There is not sufficient basis to show that New
Jersey's regulations confuse shippers into thinking that they are not
required to retain a copy of the shipping paper as required by 49 CFR
172.201(e). The HMR clearly describe the recordkeeping requirements of
the shipping papers without any contingencies. New Jersey cannot
require a specific tracking form as discussed above, but the
requirements to submit and retain the exception report in 7:26-
3A.21(a)(2) and 7:26-3A.22 do not appear to create an obstacle in
complying with the HMR. Therefore, these requirements are not
preempted.
E. Marking a Motor Vehicle With Additional Information
The HMR require that each self-propelled commercial motor vehicle
(CMV) be marked with the legal name or a single trade name of the motor
carrier operating the self-propelled CMV. 49 CFR 390.21 (as
incorporated in the HMR by 49 CFR 177.804(a)). Additionally, the HMR
require two types of markings for the outside of a vehicle depending on
whether the regulated medical waste is contained in packaging which is
bulk or non-bulk. 49 CFR 172.332 and 172.336 require that vehicles
containing non-bulk packages of a single hazardous materials with an
aggregate gross weight of the hazardous material is 4,000 kg (8,820
pounds) or more to be marked with the identification number on either
orange panels or on a plain white square-on-point display configuration
having the same outside dimensions as a placard. In accordance with 49
CFR 172.323(b), when a bulk packaging contained in or on a transport
vehicle or freight container is marked with a ``BIOHAZARD'' marking
which is not
[[Page 75676]]
visible, then the transport vehicle or freight container must be marked
on each side and each end with a ``BIOHAZARD'' marking.
In contrast, N.J.A.C. 7:26-3A.30 requires that the vehicles that
transport regulated medical waste have: (1) The name of the
transporter; (2) the NJDEP solid waste transporter registration number;
and (3) either the words ``Medical Waste'' or ``Infectious Waste'' on
two sides and the back of the cargo-carrying body. The N.J.A.C. marking
requirement is not substantively the same as the HMR and is therefore
preempted.
IV. Ruling
Federal hazardous material transportation law preempts the
following requirements in the New Jersey Administrative Code (N.J.A.C.)
because the requirements are not substantively the same as the
requirements in the HMR:
1. N.J.A.C. 7:26-3A.10(a) that generators must separate into
different containers before transport sharps, fluids (greater than 20
cc), and other regulated medical waste;
2. N.J.A.C. 7:26-3A.11(d) which allows a generator to ship
oversized medical waste without placing it in a packaging as required
by the HMR;
3. N.J.A.C. 7:26-3A.14 that the words ``Medical Waste'' or
``Infectious Waste'' must be labeled on the outside of the package when
there is untreated regulated medical waste;
4. N.J.A.C. 7:26-3A.15 that each ``generator shall mark each
individual container of regulated medical waste in accordance with all
applicable Federal regulations. . . . .'' and that the markings must
include details of the transporter's name, the date of shipment, the
intermediate handler's name, and other specific information;
5. N.J.A.C. 7:26-3A.19 and those provisions of 7:26-3A.31 which
require the use of a specific ``tracking form'' to accompany shipments
of regulated medical waste that are prescribed for either the generator
or the transporter;
6. N.J.A.C. 7:26-3A.28 that, when transferring between
transporters, each transporter must place a water resistant tag below
the generator's marking on the outer surface of the container with the
transporter's name, solid waste registration number, and date of
receipt; and
7. N.J.A.C. 7:26-3A.30 which requires that a vehicle used to
transport regulated medical waste must have: (1) The name of the
transporter; (2) the NJDEP solid waste transporter registration number;
and (3) either the words ``Medical Waste'' or ``Infectious Waste'' on
two sides and the back of the cargo-carrying body.
8. N.J.A.C. 7:26-3A.45 to the extent that it requires rail
transporters to comply with the transporter requirements of 7:26-3A.28
and 7:26-3A.30.
9. N.J.A.C. 7:26-3A.46 which requires a specific tracking form to
accompany shipments of regulated medical waste for rail transporters.
Federal hazardous material transportation law does not preempt the
following requirements because they do not create an obstacle in
complying with the HMR.
1. N.J.A.C. 7:26-3A.21(a)(1) to the extent that it requires the
generator to retain a copy of the shipping paper for at least three
years from the date the regulated medical waste was accepted by the
transporter;
2. N.J.A.C. 7:26-3A.21(a)(2) to the extent that it requires the
generator to retain a copy of any exception report for at least three
years after the day the exception report was submitted;
3. N.J.A.C. 7:26-3A.22 to the extent that it requires the generator
of the regulated medical waste to file an exception report with the
state when a transporter and/or destination facility notifies the
generator of any discrepancy between the shipment as accepted by the
initial transporter and delivered to the destination facility;
4. N.J.A.C. 7:26-3A.32 to the extent that it requires the
transporter to deliver the entire quantity of regulated medical waste
to the proper party listed on the tracking form;
5. N.J.A.C. 7:26-3A.33 to the extent that does not require a
particular form to be used to consolidate the multiple shipments;
6. N.J.A.C. 7:26-3A.34 to the extent that it requires that the
transporter of the regulated medical waste to retain a copy of the
shipping paper for at least three years from the date the regulated
medical waste was accepted by the next party; and
7. N.J.A.C. 7:26-3A.41 to the extent that it requires intermediate
handlers and destination facilities to certify that they had received
the listed regulated medical waste.
V. Petition for Reconsideration/Judicial Review
In accordance with 49 CFR 107.211(a), any person aggrieved by this
decision may file a petition for reconsideration within 20 days of
publication of this decision in the Federal Register. A petition for
judicial review of a final preemption determination must be filed in
the United States Court of Appeals for the District of Columbia or in
the Court of Appeals for the United States for the circuit in which the
petitioner resides or has its principal place of business, within 60
days after the determination becomes final. 49 U.S.C. 5127(a).
This decision will become PHMSA's final decision 20 days after
publication in the Federal Register if no petition for reconsideration
is filed within that time. The filing of a petition for reconsideration
is not a prerequisite to seeking judicial review of this decision under
49 U.S.C. 5127(a).
If a petition for reconsideration is filed within 20 days of
publication in the Federal Register, the action by PHMSA's Chief
Counsel on the petition for reconsideration will be PHMSA's final
action. 49 CFR 107.211(d).
Issued in Washington, DC on December 2, 2013.
Vanessa L. Allen Sutherland,
Chief Counsel.
[FR Doc. 2013-29604 Filed 12-11-13; 8:45 am]
BILLING CODE 4910-60-P