[Federal Register Volume 69, Number 119 (Tuesday, June 22, 2004)]
[Notices]
[Pages 34715-34720]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 04-14075]


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DEPARTMENT OF TRANSPORTATION

Research and Special Programs Administration

[Docket No. RSPA-02-13481 (PD-29(R))]


Massachusetts Requirements on the Storage and Disposal of 
Infectious or Physically Dangerous Medical or Biological Waste

AGENCY: Research and Special Programs Administration (RSPA), Department 
of Transportation (DOT).

ACTION: Notice of administrative determination of preemption by RSPA's 
Associate Administrator for Hazardous Materials Safety.

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    Local Laws Affected: Title 105 Code of Massachusetts Regulations 
(CMR) 480.000 et seq.
    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: Highway and Rail.
SUMMARY: Federal hazardous material transportation law preempts the 
following requirements because they are not substantively the same as 
requirements in the Federal hazardous material transportation law and 
the HMR:
    (1) 105 CMR 480.100(a) that storage containers must be ``rodent 
proof'' and ``fly-tight'' when those containers are used for 
transporting medical waste in commerce, including preparing medical 
waste for transportation in commerce.
    (2) 105 CMR 480.200(C) that 3 mil bags must be used for waste that 
is transported off-site.
    (3) 105 CMR 480.200(E) that pathological waste and contaminated 
animal carcasses must be double-bagged in 3 mil bags when transported 
off-site for disposal.
    (4) 105 CMR 480.300(A) that a distinctive label must be used on a 
container of ``sharp wastes * * * to indicate that it contains sharp 
waste capable of inflicting punctures or cuts'' when those containers 
are used for transporting medical waste in commerce, including 
preparing medical waste transportation in commerce.
    (5) 105 CMR 480.300(B) that a label with the name, address, and 
telephone number of the generator must be placed on ``every container 
or bag of waste that has not been rendered noninfectious and which will 
be transported off the premises of the waste generator.''
    (6) 105 CMR 480.500(C) that the generator of medical waste must 
designate on a manifest the address of the delivery site, that the 
transporter and disposal facility must sign the manifest, and that the 
disposal facility must return the signed original to the generator.
    (7) 105 CMR 480.500(E) that the generator must retain more than one 
copy of the manifest, and retain a copy of the manifest for more than 
375 days after the material is accepted by the initial carrier.
    The following requirements are not preempted to the extent that 
they are applied and enforced in the same manner as requirements in the 
HMR:
    (1) 105 CMR 480.500(A) & (B) that the generator of medical waste to 
be transported in commerce must prepare a shipping paper or manifest 
that includes a description of the waste, the total quantity, and the 
type of container in which the waste is transported.
    (2) 105 CMR 480.500(C) that the generator of medical waste must 
sign the manifest.

FOR FURTHER INFORMATION CONTACT: Frazer C. Hilder, Office of the Chief 
Counsel, Research and Special Programs Administration, U.S. Department 
of Transportation, 400 Seventh Street, SW., Washington, DC 20590-0001 
(Tel. No. 202-366-4400).

SUPPLEMENTARY INFORMATION:

[[Page 34716]]

I. Background

    In this determination, RSPA considers requirements of the 
Massachusetts Department of Public Health (Mass-DPH) applicable to the 
storage and disposal of ``infectious or physically dangerous medical or 
biological waste.'' These requirements in 105 CMR 480.000 et seq. are 
in addition to, and appear to differ from, the requirements in the HMR 
for the transportation of infectious substances, including regulated 
medical waste. (Massachusetts appears to have two sets of State 
regulations applicable to these materials, because it has also adopted 
the ``highway related portions of the Federal Hazardous Materials 
Regulations'' in 49 CFR parts 171-180 ``as regulations of the Registry 
of Motor Vehicles governing * * * the transportation of hazardous 
materials upon the public ways of the Commonwealth of Massachusetts in 
both intrastate and interstate commerce.'' 540 CMR 14.03.)
    In its August 30, 2002 application, the Medical Waste Institute 
(the ``Institute'') applied for a determination that Federal hazardous 
material transportation law preempts certain packaging, labeling, and 
manifesting requirements for these waste materials on the ground that 
these requirements are not substantively the same as requirements in 
the HMR. The Institute specifically challenges requirements in:
    --105 CMR 480.100(a) that storage containers must be ``rodent 
proof'' and ``fly-tight'' without defining those standards, which are 
not contained in the HMR
    --105 CMR 480.200(C) & (E) that 3 mil bags must be used for waste 
that is transported off-site, and that pathological waste and 
contaminated animal carcasses must be double-bagged in 3 mil bags when 
transported off-site for disposal.
    --105 CMR 480.300(A) that a distinctive label must be used on a 
container of ``sharp wastes * * * to indicate that it contains sharp 
waste capable of inflicting punctures or cuts.''
    --105 CMR 480.300(B) that a label with the name, address, and 
telephone number of the generator must be placed on ``every container 
or bag of waste that has not been rendered noninfectious and which will 
be transported off the premises of the waste generator.''
    --105 CMR 480.500 for use of a ``manifest'' containing specified 
information as a ``tracking document designed to record the movement of 
waste from the generator through its trip with a transporter to an 
approved disposal facility and final disposal.''
    In a notice published in the Federal Register on December 12, 2002 
(67 FR 76443), RSPA invited interested persons to submit comments on 
the Institute's application and address specific issues including the 
differences between the packaging requirements in 105 CMR 480.100 & 
480.200 and the requirements in the HMR; the meaning of requirements 
for a ``rodent proof'' and ``fly-tight'' container; and whether the 
Massachusetts packaging, labeling, and manifesting requirements (i) are 
substantively the same as requirements in the HMR, (ii) present an 
obstacle to accomplishing and carrying out Federal hazardous material 
transportation law or the HMR, or (iii) are authorized by another 
Federal law. In response to that notice, Mass-DPH and the Maine 
Department of Environmental Protection (Maine-DEP) submitted comments. 
Essential Services Partnerships, LLC (ESP) and the Institute submitted 
rebuttal comments.

II. Federal Preemption

    As discussed in the December 12, 2002 notice, 49 U.S.C. 5125 
contains express preemption provisions that are relevant to this 
proceeding. 67 FR at 76444-45. As amended by Section 1711 of the 
Homeland Security Act of 2002 (Pub. L. 107-296, 116 Stat. 2319), 49 
U.S.C. 5125(a) provides that--in the absence of a waiver of preemption 
by DOT under Sec.  5125(e) or specific authority in another Federal 
law--a requirement of a State, political subdivision of a State, or 
Indian tribe is preempted 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 RSPA had applied in issuing inconsistency 
rulings prior to 1990, under the original preemption provision in the 
Hazardous Materials Transportation Act (HMTA). Pub. L. 93-633 Sec.  
112(a), 88 Stat. 2161 (1975). The dual compliance and obstacle criteria 
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 Secretary 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 design, manufacturing, fabricating, marking, maintenance, 
reconditioning, repairing, or testing of a packaging or a container 
represented, marked, certified, or sold as qualified for use in 
transporting hazardous material.
    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).
    The November 2002 amendments to 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. 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 that:
    (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

[[Page 34717]]

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.
    Pub. L. 101-615 Sec.  2, 104 Stat. 3244. (In 1994, Congress 
revised, codified and enacted the HMTA ``without substantive change,'' 
at 49 U.S.C. Chapter 51. Pub. L. 103-272, 108 Stat. 745.) 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).
    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 RSPA to make determinations of preemption, except for 
those that concern highway routing (which have been delegated to the 
Federal Motor Carrier Safety Administration). 49 CFR 1.53(b).
    Section 5125(d)(1) requires that notice of an application for a 
preemption determination must be published in the Federal Register. 
Following the receipt and consideration of written comments, RSPA will 
publish its determination in the Federal Register. See 49 CFR 107.209. 
A short period of time is allowed for filing of petitions for 
reconsideration. 49 CFR 107.211. Any party to the proceeding may seek 
judicial review in a Federal district court. 49 U.S.C. 5125(f).
    Preemption determinations do not address issues of preemption 
arising under the Commerce Clause, the Fifth Amendment or other 
provisions of the Constitution or under 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(g)(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), RSPA 
is guided by the principles and policies set forth in Executive Order 
No. 13132, entitled ``Federalism.'' 64 FR 43255 (August 10, 1999). 
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 that Congress intended to preempt State 
law, or the exercise of State authority directly conflicts with the 
exercise of Federal authority. Section 5125 contains express preemption 
provisions, which RSPA has implemented through its regulations.

III. Discussion

A. Federal Regulation of Medical Waste as a Hazardous Material, not as 
a Hazardous Waste

    For more than 30 years, DOT has regulated the transportation of 
medical waste as a hazardous material, as RSPA explained in PD-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). Because ``the majority of [medical] wastes 
are untreated and, thus, may potentially contain infectious substances, 
RSPA strongly believes that the public and transport personnel [should] 
be protected from the hazards of these materials during 
transportation.'' Id., quoting from 56 FR 66124, 66142 (Dec. 20, 1991). 
Except for a two-year demonstration project in five States, the U.S. 
Environmental Protection Agency (EPA) has not regulated medical waste 
and, in a March 24, 1989 final rule (54 FR12326), EPA confirmed that it 
``did not list infectious waste in the final rule'' listing hazardous 
wastes under the Resource Conservation and Recovery Act, 42 U.S.C. 6901 
et seq.
    The requirements in the HMR for transporting infectious substances, 
including regulated medical waste, were most recently revised in 2002 
and are based on the classification criteria for infectious substances 
in the ``risk group'' table of the World Health Organization. 67 FR 
53119 (Aug. 14, 2002); revision of effective date, 67 FR 54967 (Aug. 
27, 2002); correction, 67 FR 57635 (Sept. 11, 2002). In these 
revisions, RSPA defined ``regulated medical waste'' as

    a waste or reusable material known to contain or suspected of 
containing an infectious substance in Risk Group 2 or 3 and 
generated in the diagnosis, treatment, or immunization of human 
beings or animals; or the production or testing of biological 
products. Regulated medical waste containing an infectious substance 
in Risk Group 4 must be classed as Division 6.2, described as an 
infectious substance, and assigned to UN 2814 or UN 2900 as 
appropriate.

49 CFR 173.134(a)(5). This category clearly includes the ``infectious 
or physically dangerous medical or biological waste'' subject to the 
Massachusetts requirements in 105 CMR 480.000 et seq. The Institute 
does not ``take issue'' with the definition of ``infectious or 
physically dangerous medical or biological waste'' in 105 CMR 490.010 
but suggests that this definition may be preempted under 49 U.S.C. 
5125(b)(1)(A) to the extent that it is not substantively the same as 
the designation, description, and classification of ``regulated medical 
waste'' in the HMR.

B. Summary of Application and Comments

    In its application, the Institute contends that the challenged 
Massachusetts requirements are preempted because they are not 
substantively the same as requirements in the HMR. The Institute states 
that the HMR do not require ``testing or other proof to ensure that a 
container is rodent proof and fly-tight,'' and that the HMR do not 
require the use of 3 mil bags, but rather allow ``for a variety of 
packaging materials as long as the user can show that the packaging 
complies with the performance tests or requirements in the exceptions 
to the rules.'' The Institute states that the HMR do not require ``a 
special label to be used on sharps containers nor * * * a label to 
indicate information about the generator.'' The Institute also argues 
that ``manifesting by state and local governments for other than 
hazardous wastes is in conflict with the HMR,'' under RSPA's decision 
in PD-23(RF).
    The Institute notes that ``[s]hippers and carriers should not be 
confused by the rules regardless of where they are conducting business 
nor should they be required to stop at every town and state border to 
repackage, re-label, and prepare new shipping documents.'' In response 
to comments from Maine DEP, the Institute argues that ``stopping at 
every state border to repackage, re-label, and re-create shipping 
papers would not prevent terrorist activity, but would provide a clear 
opportunity for such activity.''

[[Page 34718]]

    Mass-DPH appears to accept the Institute's arguments with respect 
to the packaging and labeling requirements at issue. It states that it 
``is contemplating making changes in its regulations to assure its 
approach is better coordinated with applicable federal requirements,'' 
and it addresses only ``those questions that are relevant to the claim 
that RSPA should find that the Department's manifesting requirements 
are preempted.'' Mass-DPH states that its manifest requirements differ 
from those considered in PD-23(R) because it does not require a 
``specific form'' but rather that the generator prepare a ``tracking 
document'' that contains certain information, is signed by the 
generator, transporter, and disposal facility, and then is returned to 
the generator for retention for three years. Mass-DPH argues that, 
because its regulations do not ``extend or require the use of the 
Federal hazardous waste manifest,'' its manifest requirement is not 
preempted under the ``substantively the same as'' standard, and that, 
``because the use of the Federal hazardous waste manifest has not been 
extended to materials not defined as hazardous waste, * * * the 
Massachusetts requirement in no way presents ``an obstacle to carrying 
out Federal hazmat law or the HMR.'''
    In rebuttal comments, the Institute compares the specific 
requirements in 105 CMR 480.500 with the HMR. It notes that the 
requirement to include a ``description of the waste'' is not as 
specific as the requirements in 49 CFR 172.202, and that shippers 
(generators) appear to be omitting the packing group when they identify 
the ``type of container'' used. The Institute also states that the HMR 
(1) do not require a shipping paper to contain the address where a 
hazardous waste is to be delivered, (2) do not require the transporter 
or consignee to sign a shipping paper, (3) do not require the consignee 
to return a copy of the shipping paper to the offeror (generator), and 
(4) require an offeror to maintain a copy of the shipping paper (or an 
electronic image thereof) for 375 days, rather than copies ``as 
initially sent out and as returned by the disposal facility for a 
period of three years.''
    Maine-DEP comments that the Massachusetts packaging, labeling and 
manifest requirements do not present an obstacle to complying with 
Federal hazardous material transportation law and the HMR, because the 
``majority of these requirements are the responsibility of the 
generator of the medical waste and will not be a burden to the 
transporter.'' It states that these requirements ``have been put in 
place to protect public health and the environment,'' and that ``a 
valid argument has not been put forth to justify preempting these 
requirements for medical waste'' that ``has an inherent negative 
value.'' Maine-DEP also states that ``proper labeling, packaging, and 
manifest requirements for medical waste are consistent with the 
national effort to combat acts of bio-terrorism,'' and that it is 
important for emergency ``response personnel and regulatory inspectors 
be able to easily identify infectious medical waste.'' It asserts that 
``[r]equiring the generator to initiate a manifest is a prudent step 
toward managing medical waste.''
    ESP states that it has encountered ``discriminatory, arbitrary and 
capricious regulatory obstacles * * * stemming from conflicting 
adoption and interpretation'' of the regulations in 105 CMR 480.000 et 
seq. by the Massachusetts Department of Environmental Protection. While 
ESP states that the Mass-DPH regulations in ``105 CMR 480.000 et seq. 
are not inherently in conflict with the regulations of the DOT,'' ESP's 
greater concerns seem to be with the authority of ``each of the 350 
communities in Massachusetts to issue a permit, require a fee and 
require and conduct a vehicle inspection of Interstate Transportation 
haulers of [regulated medical waste] in the form of an `Offal Permit.' 
'' ESP states that a ``broader ranging federal preemption decision is 
needed from the DOT to provide public health regulators and hazardous 
material haulers with the ability to over come the solid waste 
permitting constraints and the `NIMBY' mentality that infects both the 
implementation and interpretation of solid waste regulations when they 
are used for solid waste regulators for RMW management in the United 
States.''

C. Packaging and Labeling Requirements

    The HMR provide that packagings used for the transportation of 
infectious substances must meet the general packaging requirements in 
subpart B of 49 CFR part 173 and also, in most cases, certain 
performance requirements in the HMR (such as a free-fall drop, 
stacking, leakproofness, water spray, or resistence to puncture by a 
steel rod, depending on the type of packaging and its contents). 49 CFR 
173.196, 173.197. There are also specific requirements for the inner 
packagings that may be used when regulated medical waste is shipped in 
a ``large packaging,'' a ``wheeled cart,'' or a ``bulk outer 
packaging.'' 49 CFR 173.197(e). Among these inner packaging 
requirements are:
    --Solid (or absorbed liquid) regulated medical waste may be placed 
in plastic film bags that (1) do not exceed 175 L (46 gallons), (2) are 
marked and certified as having passed specified standard test methods 
of the American Society of Testing and Materials for tear and impact 
resistance, and (3) are marked or tagged with the name and location of 
the offeror except when the entire contents of the large packaging, 
wheeled cart, or bulk outer packaging originates at a single location 
and is delivered to a single location.
    --Liquid regulated medical waste must be in a rigid inner packaging 
that is no larger than 19 L (5 gallons).
    --Inner containers for sharps must be puncture-resistant and, if 
larger than 76 L (20 gallons) must be capable of passing performance 
tests in the HMR at the Packing Group II performance level.
    However, there is no requirement in the HMR that packagings used to 
transport medical waste must be ``rodent proof'' or ``fly-tight.'' In 
addition, plastic film bags are not authorized as single or outer 
packagings for medical waste; as inner packagings, these bags must meet 
the tear and impact resistence tests, but they need not be 3 mil thick 
and no wastes need be ``double bagged.''
    The HMR require that a bulk packaging containing a regulated 
medical waste must be marked with the UN identification number of this 
material (UN3291) and the ``BIOHAZARD'' marking conforming to 29 CFR 
1910.1030(g)(1)(i) in the regulations of the Occupational Safety and 
Health Administration. 49 CFR 172.302(a), 172.323. A non-bulk packaging 
for regulated medical waste must be marked with the proper shipping 
name (``Regulated Medical Waste'') and UN identification number. 49 CFR 
172.301(a). The ``INFECTIOUS SUBSTANCE'' hazard warning label must also 
be affixed to the outer packaging, except when the transportation is by 
a private or contract carrier and the packaging is marked with the 
``BIOHAZARD'' marking. 49 CFR 172.400(a), 173.134(c)(1)(i). (There is 
no placard specified for infectious substances, including regulated 
medical waste.). But the HMR do not require a distinctive label on 
sharps containers and, while inner packagings for regulated medical 
waste ``must be durably marked or tagged with the name and location 
(city and state) of the offeror,'' 49 CFR 173.197(e), there is no 
requirement for the outer packaging to have a label with the name, 
address, and telephone number of the generator of the waste. Indeed, in 
its final rule on ``Security Requirements for Offerors and Transporters 
of Hazardous Materials,'' 68 FR 14510, 14512-13 (Mar. 25, 2003),

[[Page 34719]]

RSPA decided not to adopt its earlier proposal to require a hazardous 
material shipping paper to include the name and address of the 
consignor and consignee of the shipment.
    Accordingly, as applied to medical waste in transportation in 
commerce, or prepared for transportation in commerce, these packaging 
and labeling requirements in 105 CMR 480.100(a), 480.200(C) & (E), and 
480.300(A) & (B) are not substantively the same as requirements in the 
HMR and, accordingly, are preempted under 49 U.S.C. 5125(b)(1)(B).

D. Manifest Requirements

    The HMR provide that any person who offers an infectious substance, 
including regulated medical waste, for transportation in commerce must 
describe the material on a shipping paper that contains:
    --The proper shipping name, hazard class or division, 
identification number, and packing group of the material, in that 
sequence (49 CFR 172.202 (a)(1)-(4), (b));
    --the total quantity of the material (with an indication of the 
unit of measurement, except that the total quantity of a material in 
bulk packagings may be indicated by the number of packages, e.g., ``1 
cargo tank'') and the number and type of packages, before or after the 
previous description (49 CFR 172.202(a)(5)(c));
    --the telephone number, that is monitored at all times the material 
is in transportation, of a person who is either knowledgeable of the 
material and has comprehensive emergency response information for that 
material or who has immediate access to a person who possesses such 
knowledge and information (49 CFR 172.201(d), 172.604(a)(3)); and
    --a signed certification by the offeror that the material is 
``properly classified, described, packaged, marked and labeled, and . . 
. in proper condition for transportation according to the regulations 
of the Department of Transportation'' (49 CFR 172.204(a)(1)).
    As noted above, in a recent rulemaking, RSPA decided not to require 
the shipping paper to include the name and address of the consignor and 
consignee of the shipment. Moreover, there is no requirement in the HMR 
for the transporter or the consignee (delivery facility) to sign the 
shipping paper or for the delivery facility to return a copy of the 
shipping paper to the offeror. At present, the HMR also provide that 
the offeror and carrier of an infectious substance, including a 
regulated medical waste, must retain a copy of the shipping paper (or 
an electronic image thereof) for 375 days after the material is 
accepted by the initial carrier. 49 CFR 172.201(e), 174.24(b), 
177.817(f). (DOT has proposed an amendment to 49 U.S.C. 5110 to 
increase to three years the period for retaining shipping papers.)
    The requirements in 105 CMR 480.500(B) for the manifest to include 
a description of the waste, the total quantity, and the type of 
container in which the waste is transported, and the requirement in 105 
CMR 480.500(C) for the generator to sign the manifest, appear to be 
substantively the same as requirements in the HMR and, therefore, are 
not preempted under 49 U.S.C. 5125(b)(1)(C). To the extent that these 
requirements are applied or enforced in a different manner than the 
requirements in the HMR, as suggested in the Institute's rebuttal 
comments, these requirements may be preempted under 49 U.S.C. 
5125(a)(2) as an ``obstacle to accomplishing and carrying out'' the 
HMR.
    On the other hand, the requirements in 105 CMR 480.500(C) for the 
generator to designate the address of delivery site, for the 
transporter and disposal facility to sign the manifest, and for the 
disposal facility to return the signed original to the generator, and 
the requirement in 105 CMR 480.500(E) for the generator to retain more 
than one copy of the manifest, or to retain any copy for more than 375 
days after the material is accepted by the initial carrier, are not 
substantively the same as requirements in Federal hazardous material 
transportation law and the HMR and, accordingly, are preempted under 49 
U.S.C. 5125(b)(1)(C). If and when 49 U.S.C. 5110 is amended to increase 
to three years the retention period for shipping papers, that 
requirement in 105 CMR 480.500(C) will no longer be preempted (so long 
as the three-year retention period is applied in the same manner as 
specified in the Federal hazardous material transportation law and the 
HMR).

IV. Ruling

    Federal hazardous material transportation law preempts the 
following requirements because they are not substantively the same as 
requirements in the Federal hazardous material transportation law and 
the HMR:
    (1) 105 CMR 480.100(a) that storage containers must be ``rodent 
proof'' and ``fly-tight'' when those containers are used for 
transporting medical waste in commerce, including preparing medical 
waste transportation in commerce.
    (2) 105 CMR 480.200(C) that 3 mil bags must be used for waste that 
is transported off-site.
    (3) 105 CMR 480.200(E) that pathological waste and contaminated 
animal carcasses must be double-bagged in 3 mil bags when transported 
off-site for disposal.
    (4) 105 CMR 480.300(A) that a distinctive label must be used on a 
container of ``sharp wastes * * * to indicate that it contains sharp 
waste capable of inflicting punctures or cuts'' when those containers 
are used for transporting medical waste in commerce, including 
preparing medical waste transportation in commerce.
    (5) 105 CMR 480.300(B) that a label with the name, address, and 
telephone number of the generator must be placed on ``every container 
or bag of waste that has not been rendered noninfectious and which will 
be transported off the premises of the waste generator.''
    (6) 105 CMR 480.500(C) that the generator of medical waste must 
designate on a manifest the address of the delivery site, that the 
transporter and disposal facility must sign the manifest, and that the 
disposal facility must return the signed original to the generator.
    (7) 105 CMR 480.500(E) that the generator must retain more than one 
copy of the manifest, and retain a copy of the manifest for more than 
375 days after the material is accepted by the initial carrier.
    The following requirements are not preempted to the extent that 
they are applied and enforced in the same manner as requirements in the 
HMR:
    (1) 105 CMR 480.500(A) & (B) that the generator of medical waste to 
be transported in commerce must prepare a shipping paper or manifest 
that includes a description of the waste, the total quantity, and the 
type of container in which the waste is transported.
    (2) 105 CMR 480.500(C) that the generator of medical waste must 
sign the manifest.

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. Any party to this 
proceeding may seek review of RSPA's decision ``in an appropriate 
district court of the United States * * * not later than 60 days after 
the decision becomes final.'' 49 U.S.C. 5125(f).
    This decision will become RSPA's final decision 20 days after 
publication in the Federal Register if no petition for

[[Page 34720]]

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. 5125(f).
    If a petition for reconsideration is filed within 20 days of 
publication in the Federal Register, the action by RSPA's Associate 
Administrator for Hazardous Materials Safety on the petition for 
reconsideration will be RSPA's final action. 49 CFR 107.211(d).

    Issued in Washington, DC on June 15, 2004.
Robert A. McGuire,
Associate Administrator for Hazardous Materials Safety.
[FR Doc. 04-14075 Filed 6-21-04; 8:45 am]
BILLING CODE 4910-60-P