[Federal Register Volume 67, Number 239 (Thursday, December 12, 2002)]
[Notices]
[Pages 76443-76448]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 02-31339]


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DEPARTMENT OF TRANSPORTATION

Research and Special Programs Administration

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


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

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

ACTION: Public notice and invitation to comment.

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SUMMARY: Interested parties are invited to submit comments on an 
application by the Medical Waste Institute for an administrative 
determination whether

[[Page 76444]]

Federal hazardous materials transportation law preempts requirements of 
the Commonwealth of Massachusetts concerning regulations on the storage 
and disposal of infectious or physically dangerous medical or 
biological waste.

DATES: Comments received on or before January 27, 2003, and rebuttal 
comments received on or before March 12, 2003, will be considered 
before an administrative ruling is issued by RSPA's Associate 
Administrator for Hazardous Materials Safety. Rebuttal comments may 
discuss only those issues raised by comments received during the 
initial comment period and may not discuss new issues.

ADDRESSES: The application and all comments received may be reviewed in 
the Dockets Office, U.S. Department of Transportation, Room PL-401, 400 
Seventh Street, SW., Washington, DC 20590-0001. The application and all 
comments are also available on-line through the home page of DOT's 
Docket Management System, at ``http://dms.dot.gov.''
    Comments must refer to Docket No. RSPA-02-13481 and may be 
submitted to the docket either in writing or electronically. Send three 
copies of each written comment to the Dockets Office at the above 
address. If you wish to receive confirmation of receipt of your written 
comments, include a self-addressed, stamped postcard. To submit 
comments electronically, log onto the Docket Management System Web site 
at http://dms.dot.gov, and click on ``Help'' to obtain instructions. 
You may also sign up on the DOT's DMS ``List Serve'' at this Web site. 
This service will automatically notify you when certain documents are 
put into a docket that is of interest to you.
    A copy of each comment must also be sent to (1) Alice P. Jacobsohn, 
Esq., Director, Public Affairs and Industry Research, Medical Waste 
Institute, 4301 Connecticut Avenue, NW., Suite 300, Washington, DC 
20008, and (2) Howard S. Wensley, M.S., C.H.O., Director, Commonwealth 
of Massachusetts, Executive Office of Health and Human Services, 
Department of Public Health, Division of Community Sanitation, 305 
South Street, Jamaica Plain, MA 02130-3597. 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 Ms. Jacobsohn and Mr. Wensley at the 
addresses specified in the Federal Register.'')
    A list and subject matter index of hazardous materials preemption 
cases, including all inconsistency rulings and preemption 
determinations issued, are available through the home page of RSPA's 
Office of the Chief Counsel, at ``http://rapa-atty.dot.gov.'' A paper 
copy of this list and 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 the Chief 
Counsel, Research and Special Programs Administration (Tel. No. 202-
366-4400), U.S. Department of Transportation, Washington, DC 20590-
0001.

SUPPLEMENTARY INFORMATION:

I. Application for a Preemption Determination

    The Medical Waste Institute (the ``Institute'') has applied for a 
determination that Federal hazardous material transportation law, 49 
U.S.C. 5101 et seq., preempts requirements contained in Title 105 of 
the Code of Massachusetts Regulations (CMR) Section 480.000 et seq. 
applicable to the storage and disposal of ``infectious or physically 
dangerous medical or biological waste.'' In its application, the 
Institute challenges packaging, labeling, and manifesting requirements 
for this waste that it states are not substantially the same as 
requirements in the HMR. The test of the Institute's application is set 
forth in Addendum A to this notice.
    Packaging. The Institute asserts that Massachusetts' storage 
requirements in 105 CMR 480.100 provide that storage containers must be 
``rodent-proof'' and ``fly-tight'' without defining these standards, 
which are not contained in the HMR, and which could be shown only by 
additional, different testing. The Institute also states that, with one 
exception, Massachusetts' requirements do not distinguish between 
materials stored purely for on-site treatment and those stored in 
preparation for transport and disposal off-site: certain wastes must be 
stored in ``a non-permeable three mil or greater polyethylene bag (or 
equivalent which is securely sealed to prevent leaks'' but that, under 
105 CMR 480.200, wastes must be ``placed in a second three mil bag if 
they are to be transported off-site for disposal.''
    Labeling. The Institute alleges that, unlike the HMR, 105 CMR 
480.300 requires (1) a special label to be used on containers of 
``sharp wastes,'' and (2) a label with the name, address, and telephone 
number of the generator on ``every container or bag of waste that has 
not been rendered infectious and which will be transported off the 
premises of the waste generator.'' The Institute asserts that these 
differences may confuse emergency responders and users of packaging, 
and that interstate shipments may be frustrated if a transporter must 
stop at the State border and re-label packages.
    Manifest. The Institute asserts that Massachusetts requires a 
specific manifest form which is not required in the HMR. The Institute 
states that the manifest requirements in 105 CMR 480.500 cover items 
that fall outside the HMR's definition of hazardous waste, including 
blood and blood products, pathological waste, cultures and stocks of 
infectious agents and associated biologicals, sharps, biotechnological 
by-product effluents, and contaminated animal carcasses, body parts, 
and bedding. It refers to PD-23(FR), Morrisville, PA Requirements for 
Transportation of ``Dangerous Waste,'' 66 RR 37260 (July 17, 2001), 
decision on petition for reconsideration, 67 FR 2948 (Jan. 22, 2002), 
where RSPA explained that regulated medical waste is not a ``hazardous 
waste'' regulated by the Environmental Protection Agency (EPA) under 
the Resource Conservation and Recovery Act (RCRA), 42 U.S.C. 6901 et 
seq. In PD-23(RF), RSPA concluded that a local requirement to carry a 
hazardous waste manifest on a truck transporting medical waste is not 
``substantively the same as'' requirements in the HMR ``because the HMR 
does not require the use of any specific form for shipments of 
regulated medical wastes (or other hazardous materials that are not 
hazardous wastes).'' 66 FR at 37265.
    The Institute also notes that definitions in 105 CMR 480.010 may 
not be consistent with revised provisions in the HMR that become 
effective on February 14, 2003, as issued in the final rule in Docket 
No. RSPA-98-3971 (HM-226), Hazardous Materials: Revisions to Standards 
for Infectious Substances, 67 FR 53118 (Aug. 14, 2002), corrections, 67 
FR 54967 (Aug. 27, 2003), 67 FR 57635 (Sept. 11, 2002).

II. Federal Preemption

    Section 5125 of Title 49 U.S.C. contains several preemption 
provisions that are relevant to the Institute's application. Subsection 
(a) provides that--in the absence of a waiver of preemption by DOT 
under 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 or a 
regulation issued under this chapter is not possible; or

[[Page 76445]]

    (2) The requirement of the State, political subdivision, or 
Indian tribe, as applied or enforced, is an obstacle to the 
accomplishing and carrying out this chapter or a regulation 
prescribed under this chapter.

    These two paragraphs set forth the ``dual compliance'' and 
``obstacle'' criteria which RSPA 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 
section 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, that is not 
``substantively the same as'' a provision of Federal hazardous material 
transportation law or a regulation prescribed under that law, is 
preempted unless it is authorized by another Federal law or DOT grants 
a wavier of preemption:

    (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)
    These preemption provisions in 49 U.S.C. 5125 carry out Congress's 
view that a single body of uniform Federal regulations promotes safety 
in the transportation of hazardous materials. In 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 it amended the HMTA in 1990, Congress 
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 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 law 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 101-614 Sec.  2, 104 Stat. 3244. A Federal Court of Appeals 
has found that uniformity was the ``linchpin'' in the design of the 
HMTA, including the 1990 amendments that expanded the original 
preemption provisions. Colorado Pub. Util. Comm'n v. Harmon, 951 F.2d 
1571, 1575 (10th Cir. 1991). (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.)

III. Preemption Determinations

    Under 49 U.S.C. 5125(d)(1), any directly affected person may apply 
to the Secretary of Transportation for a determination whether a State, 
political subdivision or Indian tribe 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(d). 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 to another 
Federal law or whether a fee is fair. 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 principals and policies set forth in Executive Order 
No. 13132, entitled ``Federalism.'' 64 FR 43255 (Aug. 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.

IV. Public Comments

    All comments should be limited to whether 49 U.S.C. 5125 preempts 
the Massachusetts requirements challenged by the Institute. Comments 
should specifically address the preemption criteria detailed in Part 
II, above, and set forth in detail the manner in which these 
requirements are applied and enforced, including but not limited to:
    (1) What are the differences between Massachusetts' packaging 
requirements and the HMR packaging requirements?
    (2) What do the requirements for a ``rodent proof'' and ``fly-
tight'' container mean?
    (3) Are Massachusetts' packaging, labeling, and manifesting 
requirements ``substantively the same as'' the requirements in the HMR?
    (4) Do Massachusetts' packaging, labeling, and manifesting 
requirements ``present an obstacle'' to accomplishing and carrying out 
Federal hazmat law and the HMR?
    (5) Are any of Massachusetts' requirements ``authorized by another 
Federal law''?

    Issued in Washington, DC on December 6, 2002.
Robert A. McGuire,
Associate Administrator for Hazardous Materials Safety.

Addendum A

National Solid Wastes Management Association
4301 Connecticut Avenue, NW., Suite 300, Washington, DC 20008, 800-
424-2869
    Application of the Medical Waste Institute for a Preemption 
Determination as to

[[Page 76446]]

Massachusetts' Regulations on the Storage and Disposal of Infectious 
or Physically Dangerous Medical or Biological Waste
    In accordance with Title 49 of the Code of Federal Regulations 
(CFR), Part 107, Subsection C, the Medical Waste Institute 
(Institute) is submitting this application for a preemption 
determination requesting that certain sections of the Massachusetts 
Code be found in violation of federal transportation law.
    Anyone with questions about this application, may contact Alice 
Jacobsohn at 202-364-3724 (phone), 202-364-3792 (fax), or 
[email protected] (e-mail).

    Submitted By:

Alice P. Jacobsohn, Esq.
Director, Public Affairs and Industry Research.

August 30, 2002.

Table of Contents

A. List of Massachusetts requirements for which the preemption 
determination applies --------
B. Each requirement of the HMR for which the state regulations are 
being compared --------
C. Explanation of why the state regulations should be preempted ----
----
D. Explanation of how the applicant is affected by the 
commonwealth's regulations --------
E. Conclusion --------

A. List of Massachusetts Requirements for Which the Preemption 
Determination Applies

    Each of the regulations is detailed in full below. The specific 
text at issue in this application is highlighted by the use of 
capital letters.

1. Title 105 of the Code of Massachusetts Regulations (CMR) Section 
480.010 Definition of Infectious or Physically Dangerous Medical or 
Biological Waste \1\
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    \1\ The Institute believes that Massachusetts regulations found 
in 105 CMR 480.010 that include definitions for terms used in the 
Commonwealth's medical waste provisions may now be in violation of 
the HMR under the revised rules published on August 14, 2002 (67 
Fed. Reg. 53117; HM-226). We do not take issue with those terms in 
this application for preemption because the federal rules are new. 
However, we hope that the commonwealth will review these provisions 
soon and make appropriate adjustments.
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    Waste which because of its characteristics may: cause, or 
significantly contribute to an increase in mortality or an increase 
in serious irreversible or incapacitating reversible illness; or 
pose a substantial present potential hazard to human health or the 
environment when improperly treated, stored, transported, disposed 
of, or otherwise managed.
    The following types of waste are identified and defined as 
infectious or physically dangerous medical or biological waste, and 
shall be subject to the requirements of 105 CMR 480.000:
    (a) Blood and Blood Products: Discarded bulk human blood and 
blood products in free draining liquid state; body fluids 
contaminated with visible blood; and materials saturated/dripping 
with blood.
    (b) Pathological Waste: Human anatomical parts, organs, tissues 
and body fluids removed and discarded during surgery or autopsy, or 
other medical procedures and specimens of body fluids and their 
containers.
    (c) Cultures and Stocks of Infectious Agents and Associated 
Biologicals: All discarded cultures and stocks of infectious agents 
and associated biologicals, biotechnological by-product effluents, 
cultures of specimens from medical and pathological laboratories, 
cultures and stocks of infectious agents from research laboratories, 
wastes from the production of biologicals, and discarded live and 
attenuated vaccines intended for human use.
    (d) Contaminated Animal Carcasses, Body Parts and Bedding: The 
contaminated carcasses and body parts and bedding of all research 
animals known to be exposed to pathogens.
    (e) Sharps: Discarded medical articles that may cause puncture 
or cuts, including but not limited to all used and discarded 
hypodermic needles and syringes, pasteur pipettes, broken medical 
glassware, scapel blades, disposable razors, and suture needles.
    (f) Biotechnological By-Product Effluents: Any discarded 
preparations made from genetically altered living organisms and 
their products.

2. 105 CMR 480.020 When Waste is Subject to 105 CMR 480.000

    (a) Once material becomes waste, as defined in 105 CMR 480.010, 
such material shall remain waste and shall be subject to the 
requirements of 105 CMR 480.000 unless and until it has been both 
labeled in compliance with 105 CMR 480.300 and disposed of in 
compliance with 105 CMR 480.200 as applicable.
    (b) The requirements of 105 CMR 480.000 shall not apply to waste 
which is contained in a mixture which, due to the presence of other 
materials, is subject to regulation as a hazardous or radioactive 
waste.

3. 105 CMR 480.100 Storage

    (a) WASTE GENERATIONS SHALL CONTAIN AND STORE MEDICAL WASTE AT 
ALL TIMES IN LEAK PROOF, RODENT PROOF, FLY-TIGHT CONTAINERS WHICH 
ENSURE THAT NO DISCHARGE OR RELEASE OF SUCH WASTE OCCURS AND THAT NO 
ODOR OR OTHER NUISANCE IS CREATED.
    (b) All onsite storage of containers of waste shall be held in 
an area away from general traffic flow patterns, preferably in a 
room identified for this purpose. The manner of storage shall 
restrict access or contact with such waste to authorized persons 
only. SHARPS SHALL BE SEGREGATED FROM OTHER WASTES AND AGGREGATED IN 
LEAK PROOF, RIGID, PUNCTURE-RESISTANT, SHATTERPROOF CONTAINERS 
IMMEDIATELY AFTER USE.
    (c) WASTES OTHER THAN FREE DRAINING BLOOD AND BLOOD PRODUCTS, 
SHARPS AND BIOTECHNOLOGY BY-PRODUCT EFFLUENTS SHALL BE PLACED IN A 
NON-PERMEABLE THREE MIL OR GREATER POLYETHYLENE BAG (OR EQUIVALENT) 
WHICH IS SECURELY SEALED TO ELIMINATE LEAKS. FREE DRAINING BLOOD AND 
BLOOD PRODUCTS AND BIOTECHNOLOGY BY-PRODUCT EFFLUENTS SHALL BE 
STORED AT ALL TIMES IN LEAK PROOF CONTAINERS THAT ARE SECURELY 
SEALED.

4. 105 CMR 480.200 Disposal

    (C) Blood Saturated Materials, Cultures, and Stocks of 
Infectious Agents and Associated Biologicals, Dialysis Waste and 
Laboratory Waste
    (2) Disposed of on-site at an approved incinerator facility, OR 
PLACED IN A SECOND 3 MIL BAG FOR TRANSPORT TO AN APPROVED 
INCINERATION FACILITY OFF-SITE.
    (E) Pathological waste and contaminated animal carcasses shall 
be disposed of at an approved incineration facility or by interment, 
provided however, that liquid pathological waste may also be 
disposed in accordance with 105 CMR 480.200(A) and discarded teeth 
and tissue may also be disposed of in accordance with 105 CMR 
480.200(C)(1). THESE WASTES SHALL BE PLACED IN A SECOND THREE MIL 
BAG IF THEY ARE TO BE TRANSPORTED OFF-SITE FOR DISPOSAL.

5. 105 CMR 480.300 LABELING

    (A) EVERY CONTAINER OR BAG OF WASTE WHICH HAS NOT BEEN RENDERED 
NONINFECTIOUS SHALL:
    (2) IN THE CASE OF SHARP WASTES, BE DISTINCTIVELY LABELED TO 
INDICATE THAT IT CONTAINS SHARP WASTE CAPABLE OF INFLICTING 
PUNCTURES OR CUTS.
    (B) EVERY CONTAINER OR BAG OF WASTE WHICH HAS NOT BEEN RENDERED 
NONINFECTIOUS AND WHICH WILL BE TRANSPORTED OFF THE PREMISES OF THE 
WASTE GENERATOR SHALL IN ADDITION TO THE REQUIREMENTS OF 105 CMR 
480.300(A):
    BEAR A LABEL WHICH STATES THE NAME, ADDRESS AND TELEPHONE NUMBER 
OF THE GENERATOR. THE LABEL SHALL BE AFFIXED IN A MANNER WHICH 
ENSURES THAT IT CANNOT BE EASILY REMOVED.

6. 105 CMR 480.500 MANIFESTS

    (A) GENERATORS SHALL PREPARE MANIFESTS BEFORE SHIPPING WASTE 
WHICH HAS NOT BEEN RENDERED NONINFECTIOUS OFF-SITE. THE MANIFEST IS 
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. THE GENERATOR SHALL APPOINT A 
DESIGNEE TO PREPARE, SIGN AND MAINTAIN SUCH MANIFESTS.
    (B) THE MANIFEST MUST INCLUDE THE FOLLOWING INFORMATION:
    (1) DESCRIPTION OF WASTE TO BE SHIPPED;
    (2) TOTAL QUANTITY OF WASTE; AND
    (3) TYPE OF CONTAINER IN WHICH WASTE IS TRANSPORTED.
    (C) A GENERATOR SHALL DESIGNATE ON THE MANIFEST THE ADDRESS OF 
THE SITE TO WHICH THE WASTE IS TO BE

[[Page 76447]]

DELIVERED AND SIGN IT. THE TRANSPORTER OF THE WASTE OR AN AGENT OF 
THE TRANSPORTER SHALL SIGN THE MANIFEST TO INDICATE THAT THE 
TRANSPORTER HAS RECEIVED THE WASTE AND WILL COMPLY WITH THE 
GENERATOR'S TRANSPORTATION INSTRUCTIONS. WHEN THE WASTE ARRIVES AT 
THE APPROVED OFF-SITE DISPOSAL FACILITY, AND HAS BEEN DISPOSED OF, 
THE DISPOSAL FACILITY OWNER OR AGENT SHALL SIGN THE MANIFEST AND 
RETURN THE ORIGINAL TO THE GENERATOR.
    (D) IF THE GENERATOR DOES NOT RECEIVE THE MANIFEST FROM THE 
DISPOSAL FACILITY WITHIN 30 DAYS AFTER SHIPMENT OF WASTE BY THE 
GENERATOR, THE GENERATOR SHALL REPORT THIS FACT TO THE DEPARTMENT OF 
PUBLIC HEALTH.
    (E) THE GENERATOR SHALL MAINTAIN A COPY OF THE MANIFEST BOTH AS 
INITIALLY SENT OUT AND AS RETURNED BY THE DISPOSAL FACILITY FOR A 
PERIOD OF THREE YEARS.
    (F) IN THE ABSENCE OF ANY RESTRICTION CONCERNING INDIVIDUALS WHO 
ARE AUTHORIZED TO TRANSPORT WASTE, INCLUDING BUT NOT LIMITED TO 
THOSE IMPOSED BY BOARDS OR THE DEPARTMENT OF ENVIRONMENTAL 
PROTECTION, GENERATORS WHO TRANSPORT THEIR OWN WASTE SHALL FOLLOW 
THE MANIFEST REQUIREMENTS SET FORTH IN 105 CMR 480.500.

B. Each Requirement of the HMR for Which the State Regulations Are 
Being Compared

    Under 49 CFR Sec.  107.202(a), a state regulation that is not 
substantively the same as any provision of federal hazardous 
material transportation law concerning the following subjects is 
preempted:
    1. Designation, description, and classification of hazardous 
material;
    2. Packing, repacking, handling, labeling, marking, and 
placarding of hazardous material; and
    3. Preparation, execution, and use of shipping documents 
pertaining to hazardous material and requirements related to the 
number, content, and placement of those documents.
    In addition, under 49 CFR Sec.  107.202(b), a state regulation 
is preempted if, as applied or enforced, it is an obstacle to 
accomplishing and carrying out the federal hazardous material 
transportation law or regulation.
    The Institute asserts that Massachusetts' requirements are in 
conflict with the federal hazardous material transportation rules 
found in:
    [sbull] 49 CFR Sec. Sec.  172.200 et seq. Shipping papers
    [sbull] 49 CFR Sec. Sec.  172.300 et seq. Marking
    [sbull] 49 CFR Sec. Sec.  172.400 et seq. Labeling
    [sbull] 49 CFR Sec.  173.24 General requirements for packagings 
and packages
    [sbull] 49 CFR Sec.  173.24a Additional general requirements for 
non-bulk packagings and packages
    [sbull] 49 CFR Sec.  173.134 Class 6, Division 6.2--Definitions, 
exceptions and packing group assignments
    [sbull] 49 CFR Sec. Sec.  178.600 et seq. Testing of non-bulk 
packagings and packages

C. Explanation of Why the State Regulations Should Be Preempted

1. Packaging Requirements

    When Congress enacted the Hazardous Materials Transportation 
Act, it intended to create one system of commerce for the transport 
of hazardous materials throughout the United States. Congress found 
that preemption was necessary to avoid the potential for 
unreasonable hazards created by multiple and conflicting 
requirements in other jurisdictions. Shippers 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. 
See Pub. L. 101-615 Sec. Sec.  2(3) and 2(4), 104 Stat. 3244 (Nov. 
16, 1990) (preemption provisions found in 49 U.S.C. Sec.  5125(c)).
    In 105 CMR 480.100, Massachusetts established several packaging 
requirements that are not substantively the same as the U.S. 
Department of Transportation's (DOT) Hazardous Materials Regulations 
(HMR) found in 49 CFR. As applicable to storage incidental to 
transportation, the packaging requirements in 105 CMR 480.100(b) 
include requirements that the HMR do not. For example, the CMR 
requires that containers be rodent proof and fly-tight. The HMR does 
not require testing or other proof to ensure that a container is 
rodent proof and fly-tight. A laboratory or self-tester of the 
performance tests required by the HMR cannot use those tests to 
certify that the containers will meet Massachusetts' requirements. 
Different tests would be required. We can speculate that a container 
tested to HMR standards for infectious substances may also be rodent 
and fly proof, but this is not certain and the performance tests in 
49 CFR Sec.  178.600 et seq. were not designed for that purpose.
    The Massachusetts' storage requirements do not distinguish 
between materials stored purely for on-site treatment and disposal 
and those stored in preparation for transport and disposal off-site. 
In fact, interpretation letters from the commonwealth do not make 
this distinction (see Appendix A) and provisions in 105 CMR 480.200 
that reference to off-site treatment require a ``second * * * bag'' 
before transport, implying a first packaging found in the storage 
provisions.
    In addition, both 105 CMR 480.100 and 480.200 require the use of 
three mil or greater polyethylene (or equivalent) bags. The HMR does 
not require this type of packaging. The requirements in 49 CFR 
Sec. Sec.  173.24, 173.24a, 173.196, and 173.197 include significant 
detail on packaging requirements, none of which refers to three mil 
or greater polyethylene (or equivalent) bags. Instead, the HMR 
allows 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.

2. Labeling Requirements

    Massachusetts' labeling requirements in 105 CMR 480.300 are not 
substantially the same as the labeling and marking requirements 
found in HMR--49 CFR Sec. Sec.  172.400, 172.301, 172.332, and 
172.336. The HMR does not require a special label to be used on 
sharps containers nor does it require a label to indicate 
information about the generator. The Institute does not take issue 
in this application with the intent of Massachusetts regulations. 
The problem occurs when states or localities require their own and 
different labeling requirements. This confuses users of packaging 
and emergency responders. To comply with Massachusetts regulations, 
transporters would have to stop at state borders and re-label each 
package or hope that federal and other state enforcement officers 
would look the other way when they see a Massachusetts label on a 
package. The conflict is an obstruction to commerce, the very 
problem Congress aimed to resolve in the Hazardous Materials 
Transportation Act.

3. Manifesting

    The manifesting requirements in 105 CMR 480.500 conflict with 
the HMR's shipping paper requirements in 49 CFR Sec.  172.200. 
Manifesting in the HMR is required for hazardous waste not hazardous 
materials and is part of the HMR because of the relationship between 
the U.S. Environmental Protection Agency's (EPA) regulations under 
the Resource Conservation and Recovery Act and transportation 
requirements under the HMR.
    The DOT already concluded in its Notice of administrative 
determination of preemption--Morrisville, PA Requirements for 
Transportation of ``Dangerous Waste'' (PD-23) (July 17, 2001; 66 FR 
37260, at 37265) \2\ that manifesting by state and local governments 
for other than hazardous waste is in conflict with the HMR. The CMR 
manifesting requirements apply to blood and blood products; 
pathological waste; cultures and stocks of infectious agents and 
associated biologicals; contaminated animal carcasses, body parts, 
and bedding; sharps; and biotechnological by-product effluents. 
Setting aside differences in definitions for these terms between the 
CMR and HMR, none of these items fall within the definition of 
hazardous waste under the HMR or any other federal agency, i.e., 
EPA.
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    \2\ This determination was appealed on the grounds that the DOT 
did not have jurisdiction to make a determination; however, the DOT 
did not change its opinion in the final decision and further 
discussion on manifesting was not provided. The detailed discussion 
found in DOT's determination is not repeated in this application.
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D. Explanation of How the Applicant Is Affected by the Commonwealth's 
Regulations

    The Institute, a policy-making group within the National Solid 
Wastes Management Association, represents companies that transport 
regulated medical waste and infectious substances, assist shippers 
in complying with hazardous material packaging requirements, and 
manufacture and distribute packaging used to transport regulated 
medical waste and infectious substances. When state transportation 
requirements are in conflict with federal transportation laws, 
Institute members are placed in a difficult position. They are 
subject to enforcement actions where they cannot show compliance. 
This, in

[[Page 76448]]

turn, jeopardizes their relationship with existing and potential 
customers. In addition, many state permit requirements include a 
company's compliance record; thus, an untenable position on 
compliance may prevent a company from conducting business.

E. Conclusion

    Congress passed a law to avoid the precise problems created by 
the CMR. For purposes of intra and interstate transportation, 
Congress mandated a national system whereby generators, shippers, 
transporters, emergency responders, enforcement officers, and the 
public would all follow the same protective rules.
    The Commonwealth of Massachusetts has the same opportunity as 
the Institute and all other living in the United States to file a 
petition for rulemaking with the DOT to make changes to the HMR. In 
fact, Massachusetts could have filed comments on the advanced notice 
of proposed rulemaking and notice of proposed rulemaking that led to 
the revised infectious substance rule published on August 14, 2002.
    The Institute continues to offer its services to states to 
ensure appropriate rules for the management of medical waste. We 
make the same offer to Massachusetts in revising the CMR to reflect 
federal requirements.

Appendix A

The Commonwealth of Massachusetts

February 28, 2000

Paul Hartman,
Stericycle, Inc., 369 Park East Drive, Woonsocket, RI 02895
    Dear Mr. Hartman: It has come to my attention that my letter to 
you relative to acceptable equivalency to the required 3.0 mil red 
plastic bags did not contain sufficient information. The following 
equivalency statement should eliminate any questions.
    The equivalency to the 3.0 mil is a bag meeting ASTM D 1709-85 
and ASTM D 959-80 standards. 1709-85 is the Dart Impact Resistance--
165 grams and the 959-80 is the load drop test, requiring a 125 
pound load to be dropped from a four foot height, five times without 
rupturing.

 Sincerely,

Howard S. Wensley, M.S., C.H.O.,
Director.

[FR Doc. 02-31339 Filed 12-11-02; 8:45 am]
BILLING CODE 4910-60-M