[Federal Register: December 12, 2002 (Volume 67, Number 239)]
[Notices]
[Page 76443-76448]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr12de02-141]
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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
alicej@envasns.org (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