[Federal Register Volume 76, Number 218 (Thursday, November 10, 2011)]
[Notices]
[Pages 70220-70223]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2011-29155]


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DEPARTMENT OF TRANSPORTATION

Pipeline and Hazardous Materials Safety Administration

[Docket No. PHMSA-2011-0294 (PDA-35(R)]


New Jersey Regulations on Transportation of Regulated Medical 
Waste

AGENCY: Pipeline and Hazardous Materials Safety Administration (PHMSA), 
DOT.

ACTION: Public notice and invitation to comment.

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SUMMARY: Interested parties are invited to comment on an application by 
the Healthcare Waste Institute (Institute) for an administrative 
determination as to whether Federal hazardous material transportation 
law preempts regulations of the New Jersey Department of Environmental 
Protection (NJDEP) which apply to the transportation of regulated 
medical waste in commerce, including the packaging of regulated medical 
waste for transportation; marking and labeling of containers of 
regulated medical waste offered for transportation or transported; the 
description of regulated medical waste on documents accompanying 
shipments of regulated medical waste and the use and retention of such 
documents; and the marking of vehicles which transport regulated 
medical waste.

DATES: Comments received on or before December 27, 2011 and rebuttal 
comments received on or before February 8, 2012 will be considered 
before an administrative determination is issued by PHMSA's Chief 
Counsel. Rebuttal comments may discuss only those issues raised by 
comments received during the initial comment period and may not discuss 
new issues.

ADDRESSES: The Institute's application and all comments received may be 
reviewed in the Docket Operations Facility (M-30), U.S. Department of 
Transportation, West Building Ground Floor, Room W12-140, 1200 New 
Jersey Avenue SE., Washington, DC 20590. The application and all 
comments are available on the U.S. Government Regulations.gov Web site: 
http://www.regulations.gov.
    Comments must refer to Docket No. PHMSA-2011-0294 and may be

[[Page 70221]]

submitted by any of the following methods:
     Federal eRulemaking Portal: Go to http://www.regulations.gov. Follow the online instructions for submitting 
comments.
     Fax: 1-(202) 493-2251.
     Mail: Docket Operations Facility (M-30), U.S. Department 
of Transportation, West Building Ground Floor, Room W12-140, 1200 New 
Jersey Avenue SE., Washington, DC 20590.
     Hand Delivery: Docket Operations Facility (M-30), U.S. 
Department of Transportation, West Building Ground Floor, Room W12-140, 
1200 New Jersey Avenue SE., Washington, DC 20590, between 9 a.m. and 5 
p.m., Monday through Friday, except Federal holidays.
    A copy of each comment must also be sent to (1) Alice P. Jacobson, 
Esq., Director, Healthcare Waste Institute, 4301 Connecticut Avenue 
NW., Suite 300, Washington, DC 20008, and (2) Mary Jo M. Aiello, 
Administrator, New Jersey Department of Environmental Protection, Solid 
and Hazardous Waste Management Program, Mail Code 401-02C, P.O. Box 
420, Trenton, NJ 08625-0420. A certification that a copy has been sent 
to these persons must also be included with the comment. (The following 
format is suggested: ``I certify that copies of this comment have been 
sent to Mses. Jacobson and Aiello at the addresses specified in the 
Federal Register.'')
    Anyone is able to search the electronic form of all comments 
received into any of our dockets by the name of the individual 
submitting the comment (or signing a comment submitted on behalf of an 
association, business, labor union, etc.). You may review DOT's 
complete Privacy Act Statement in the Federal Register published on 
April 11, 2000 (65 FR 19477-78), or you may visit http://www.regulations.gov.
    A subject matter index of hazardous materials preemption cases, 
including a listing of all inconsistency rulings and preemption 
determinations, is available through PHMSA's home page at http://www.phmsa.dot.gov. From the home page, click on ``Hazmat Safety 
Community,'' then on ``Regulations,'' then on ``Preemption Documents'' 
under ``Chief Counsel's Decisions.'' A paper copy of the index will be 
provided at no cost upon request to Mr. Hilder, at the address and 
telephone number set forth in FOR FURTHER INFORMATION CONTACT below.

FOR FURTHER INFORMATION CONTACT: Frazer C. Hilder, Office of Chief 
Counsel (PHC-2), Pipeline and Hazardous Materials Safety 
Administration, U.S. Department of Transportation, 1200 New Jersey 
Avenue SE., Washington, DC 20590; telephone No. (202) 366-4400; 
facsimile No. (202) 366-7041.

SUPPLEMENTARY INFORMATION:

I. Application for a Preemption Determination

    The Institute has applied to PHMSA for a determination whether 
Federal hazardous material transportation law, 49 U.S.C. 5101 et seq., 
preempts requirements in Subchapter 3A of Title 7, Chapter 26 of the 
New Jersey Administrative Code, on the transportation of regulated 
medical waste in commerce regarding:
     Packaging regulated medical waste for transport off-site, 
in Sections 7:26-3A.10 (segregation of sharps, fluids (greater than 20 
cc), and ``other'' regulated medical waste); 7:26-3A-11 (``oversized'' 
regulated medical waste that is ``too large to be placed in a plastic 
bag or standard container''); and 7:26-3A.27(g) (conditions when a 
transporter must comply with ``pre-transport'' requirements).
     Labeling and marking containers of regulated medical waste 
with additional information, in Sections 7:26-3A.14 and 7:26-3A.15, 
respectively, and 7:26-3A.28(c) (additional labeling by a ``subsequent 
transporter'' when ``regulated medical waste is handled by more than 
one transporter'').
     Preparation, use, and retention of a ``tracking form'' 
describing a shipment of regulated medical waste, in Sections 7:26-
3A.19, 7:26-3A.21, 7:26-3A.28, 7:26-3A.31 through 7:26-3A.34, 7:26-
3A.41, and (with respect to rail transporters) 7:26-3A-45 & 7:26-
3A.46.\1\
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    \1\ In its application, the Institute refers to Section 7:26-
3A.47 (``Alternative or innovative technology authorization''), but 
it seems clear that it meant to refer to Section 7:26-3A.46 (``Rail 
shipment tracking form requirements'').
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     Preparation and retention of ``exception reports,'' in 
Sections 7:26-3A.21, 7:26-3A.22, and 7:26-3A.36.
     Marking a motor vehicle used to transport regulated 
medical waste with additional information, in Section 7:26-3A.30.
    In summary, the Institute contends that these requirements are 
preempted because they are (1) not ``substantively the same as'' 
requirements in the Federal hazardous material transportation law or 
the Hazardous Materials Regulations (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. The Institute notes that certain non-Federal 
requirements on the transportation of medical waste have been found to 
be preempted in Preemption Determination (PD) No. 23(RF), 
``Morrisville, PA Requirements for Transportation of `Dangerous 
Waste,''' 66 FR 37260 (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 
(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.\2\ 
See also 49 CFR 173.134(a)(5).
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    \2\ In 1991, after a two-year demonstration program, the U.S. 
Environmental Protection Agency (EPA) decided not to regulate 
medical waste, so that medical waste is not a ``hazardous waste'' 
under the Resource Conservation and Recovery Act, 42 U.S.C. 6901 et 
seq. Id.
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II. Federal Preemption

    Section 5125 of 49 U.S.C. contains express preemption provisions 
relevant to this proceeding. As amended by Section 1711(b) of the 
Homeland Security Act of 2002 (Pub. L. 107-296, 116 Stat. 2320), 49 
U.S.C. 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.

    These two paragraphs set forth the ``dual compliance'' and 
``obstacle'' criteria that PHMSA's predecessor agency, the Research and 
Special Programs Administration, had applied in issuing inconsistency 
rulings prior to 1990, under the original preemption provision in the 
Hazardous Materials Transportation Act (HMTA). Public Law 93-633 
112(a), 88 Stat. 2161 (1975). The dual compliance and obstacle criteria

[[Page 70222]]

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 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:

    (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.\3\
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    \3\ Subparagraph (E) was editorially revised in Sec. 7122(a) of 
the Hazardous Materials Transportation Safety and Security 
Reauthorization Act of 2005, which is Title VII of the Safe, 
Accountable, Flexible, Efficient Transportation Equity Act: A Legacy 
for Users (SAFETEA-LU), Public Law 109-59, 119. Stat. 1891 (Aug. 10, 
2005). Technical corrections to cross-references in subsections (d), 
(e), and (g) were made in Public Law 110-244, Sec. 302(b), 122 Stat. 
1618 (June 6, 2008).

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).\4\
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    \4\ 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). See also 49 CFR 171.1(f) 
which explains that a ``facility at which functions regulated under 
the HMR are performed may be subject to applicable laws and 
regulations of state and local governments and Indian tribes.''
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    The 2002 amendments and 2005 reenactment of the preemption 
provisions in 49 U.S.C. 5125 reaffirmed Congress's long-standing view 
that a single body of uniform Federal regulations promotes safety 
(including security) in the transportation of hazardous materials. More 
than thirty years ago, when it was considering the HMTA, the Senate 
Commerce Committee ``endorse[d] the principle of preemption in order to 
preclude a multiplicity of State and local regulations and the 
potential for varying as well as conflicting regulations in the area of 
hazardous materials transportation.'' S. Rep. No. 1102, 93rd Cong. 2nd 
Sess. 37 (1974). When Congress expanded the preemption provisions in 
1990, it specifically found:

    (3) Many States and localities have enacted laws and regulations 
which vary from Federal laws and regulations pertaining to the 
transportation of hazardous materials, thereby creating the 
potential for unreasonable hazards in other jurisdictions and 
confounding shippers and carriers which attempt to comply with 
multiple and conflicting registration, permitting, routing, 
notification, and other regulatory requirements,
    (4) Because of the potential risks to life, property, and the 
environment posed by unintentional releases of hazardous materials, 
consistency in laws and regulations governing the transportation of 
hazardous materials is necessary and desirable,
    (5) In order to achieve greater uniformity and to promote the 
public health, welfare, and safety at all levels, Federal standards 
for regulating the transportation of hazardous materials in 
intrastate, interstate, and foreign commerce are necessary and 
desirable.

Public Law 101-615 2, 104 Stat. 3244. (In 1994, Congress revised, 
codified and enacted the HMTA ``without substantive change,'' at 49 
U.S.C. chapter 51. Public Law 103-272, 108 Stat. 745 (July 5, 1994).) A 
United States Court of Appeals has found 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).

III. Preemption Determinations

    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). A short period of time is allowed for filing of petitions 
for reconsideration. 49 CFR 107.211. 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).
    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, above, 
951 F.2d at 1581 n.10.
    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 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.

IV. Public Comments

    All comments should be directed to whether 49 U.S.C. 5125 preempts 
the New Jersey regulations on the transportation of regulated medical 
waste in commerce. Comments should specifically address the preemption 
criteria discussed in Part II above.


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    Issued in Washington, DC, on November 7, 2011.
Vanessa L. Allen Sutherland,
Chief Counsel.
[FR Doc. 2011-29155 Filed 11-9-11; 8:45 am]
BILLING CODE 4910-60-P