An Act To Promote the Proper Disposal of Used Medical Sharps
Maine Legislature, Session 125, LD 1412
Committee: Environment and Natural Resources
Sponsors: INNES, CHIPMAN, DUCHESNE, RUSSELL, SANBORN
Amends: 38 MRSA §1319-O, 38 MRSA §1611

Legislative Document 
No. 1412 
H.P. 1038 
House of Representatives, April 6, 2011 
An Act To Promote the Proper Disposal of Used Medical Sharps 
Reference to the Committee on Environment and Natural Resources suggested and ordered 
printed. 
HEATHER J.R. PRIEST 
Clerk 
Presented by Representative INNES of Yarmouth. 
Cosponsored by Representatives: CHIPMAN of Portland, DUCHESNE of Hudson, RUSSELL 
of Portland, SANBORN of Gorham. 
Be it enacted by the People of the State of Maine as follows: 
Sec. 1.  38 MRSA §1319-O, sub-§3, ¶F is enacted to read: 
F.  A generator of sharps is not required to dispose of them by shredding. As used in 
this paragraph, "sharps" has the same meaning as in paragraph E. 
Sec. 2.  38 MRSA §1611 is enacted to read: 
§1611.  Medical sharps 
1.  Definitions.  As used in this section, unless the context otherwise indicates, the 
following terms have the following meanings. 
A.  "Manufacturer" means a person or entity that: 
(1)  Has a physical presence in the United States and causes a medical sharp to be 
manufactured or has legal ownership of the brand, brand name or cobrand under 
which a medical sharp is sold; 
(2)  Imports a medical sharp branded or manufactured by a person or entity that 
has no physical presence in the United States; or 
(3)  Sells at wholesale a medical sharp and does not have legal ownership of the 
brand or brand name, but elects to fulfill the manufacturer's responsibilities for 
that medical sharp. 
"Manufacturer" does not include a compounding pharmacy or pharmacist who 
compounds a prescribed drug for an individual and uses a medical sharp as a delivery 
system or a retailer that puts its store label on a medical sharp unless the retailer 
imports the medical sharp directly from a person that has no physical presence in the 
United States. 
B.  "Medical sharp" means a hypodermic needle, pen needle, intravenous needle, 
lancet and other device that is used to penetrate the skin for the delivery of 
medications. 
C.  "Program" means a stewardship program established by a manufacturer or in 
conjunction with other manufacturers pursuant to this section for the collection, 
handling, transportation, treatment and disposal of unwanted medical sharps. 
D.  "Program plan" means a plan developed by a manufacturer to operate a program. 
E.  "Residential source" includes single-family and multifamily residences and other 
locations where unwanted medical sharps are generated outside of the health care 
setting.  "Residential source" does not include a hospital, clinic or pharmacy or a 
business such as a physician's or veterinary office or any other location identified by 
the department that may generate unwanted medical sharps in the course of its 
business. 
F.  "Sharps collection center" means a site that provides medical sharps users with 
secure collection containers and accepts unwanted medical sharps from a residential 
source for proper disposal. 
G.  "Sharps collection container" means a container specifically designed for holding 
unwanted medical sharps that meets the requirements of the federal Occupational 
Safety and Health Administration and the federal Department of Transportation and 
is marked with the international biohazard symbol. 
H.  "Stewardship organization" means a corporation, nonprofit organization or other 
legal entity created or contracted by a manufacturer or group of manufacturers to 
implement a program. 
I.  "Unwanted medical sharp" means a medical sharp that its user no longer wants or 
that has been abandoned or discarded or is intended to be discarded by the user. 
J.  "Wholesaler" means a person or entity that buys a medical sharp for resale and 
distribution to a person or entity other than a consumer but that does not have legal 
ownership of the brand or brand name. 
2.  Disposal ban.  After July 1, 2013, a person may not knowingly place a medical 
sharp in the solid waste for disposal in a solid waste disposal facility as defined in section 
1303-C, subsection 30. 
3.  Manufacturer responsibility.  A manufacturer shall participate in a program, 
individually or in conjunction with other manufacturers, for the collection, handling, 
transportation, treatment and disposal of unwanted medical sharps. A manufacturer that 
operates a program independently or that participates in a program with other 
manufacturers shall ensure that the program operates in compliance with the provisions of 
this section, in accordance with the approval issued by the department under subsection 6 
and in compliance with all applicable state and federal law, rules and regulations. 
A.  By July 1, 2012, a manufacturer shall submit to the department a program plan 
individually or in conjunction with other manufacturers through a stewardship 
organization. 
B.  Before initiating sales of medical sharps in the State after July 1, 2012, a 
manufacturer shall submit a program plan or join a program approved under 
subsection 6. 
C.  A manufacturer or stewardship organization whose program plan has been 
approved under subsection 6 shall begin operating the program within 90 days of 
obtaining approval from the department or by January 1, 2013, whichever is sooner. 
D.  At least every 4 years, a manufacturer or stewardship organization must update its 
program plan and submit the updated plan to the department for review and approval. 
E.  For each program plan submitted under paragraph A and annual report submitted 
under subsection 8, a manufacturer or stewardship organization shall pay the 
department a processing fee as follows: 
(1)  A fee of $1,000 for each manufacturer represented in a program plan and 
report; or 
(2)  A fee of $10,000 for a program plan and report submitted on behalf of 10 or 
more manufacturers. 
Processing fees collected by the department pursuant to this paragraph must be 
deposited in the Maine Environmental Protection Fund established in section 351. 
F.  A manufacturer or stewardship organization shall pay all the administrative and 
operational costs associated with implementation of a program, including the cost of 
the collection, transportation, management and disposal of the unwanted medical 
sharps and the related packaging.  Sharps collection containers must be considered 
part of program costs and must be supplied on an ongoing basis and free of charge to 
sharps collection centers. 
G.  A manufacturer or stewardship organization may not charge a fee at the time of 
collection for the management of unwanted medical sharps. 
4.  Program requirements.  A program must: 
A.  Provide for collection of unwanted medical sharps generated by residential 
sources.  The collection system must be convenient and adequate to serve the needs 
of residents in both urban and rural areas; 
B.  Establish sharps collection centers in the following types of locations that 
volunteer to participate and agree to follow state guidelines and rules for sharps 
management: medical facilities such as hospitals and community clinics, pharmacies, 
locations that provide public transportation, public parks and municipal facilities such 
as fire or police stations; 
C.  Provide for transporting, handling, treatment and disposal of unwanted medical 
sharps from all manufacturers; 
D.  Provide for management of medical sharps as biomedical waste at a licensed 
biomedical waste disposal or treatment facility; 
E.  Include a public education and communications strategy that includes educational 
and outreach information and materials provided at no cost to consumers, 
pharmacies, health care facilities and other interested parties.  The public education 
and communications strategy must: 
(1)  Promote the use of the program and the proper disposal of unwanted medical 
sharps so that collection options are widely understood by consumers, 
pharmacists, retailers of medical sharps and health care practitioners, including 
doctors and other prescribers; and 
(2)  Provide a toll-free telephone number and publicly accessible website where 
information regarding collection options and locations is made available; and 
F.  Identify performance standards that include the number of collection locations and 
the amount by weight of unwanted medical sharps collected and describe target goals 
for each component of the program under this subsection over the life of the program. 
5.  Plan requirements.  A program plan submitted to the department under 
subsection 3 must: 
A.  List all manufacturers participating in the program and the manufacturers' contact 
information; 
B.  List the biomedical waste disposal or treatment facilities and transporters, and 
their contact information, to be used to collect and destroy the unwanted medical 
sharps; 
C.  Describe how the unwanted medical sharps are tracked from collection to final 
disposal and the policies and procedures to be followed to ensure that safety and 
security are maintained; 
D.  Describe the financing mechanism for the program and delineate any activities 
necessary to implement the program that are not funded by the program and identify 
who will be responsible for those costs.  If the manufacturer is financing the program 
through payment to a stewardship organization, any assessment imposed by the 
manufacturer through its sales chain must reflect the manufacturer's actual program 
costs and must not be described at wholesale or retail as a tax or government-imposed 
fee.  Any information provided to the consumer about the assessment must clearly 
state that it is imposed by the manufacturer and may not identify the assessment as, or 
imply that the assessment is, a tax or government-imposed fee or mandate; and 
E.  Include a description of how the program will meet the requirements under 
subsection 4. 
6.  Program review and approval.  The department shall review each program plan 
submitted pursuant to subsection 3 in consultation with the Department of Health and 
Human Services. 
A.  If the department is satisfied that a program plan is complete and that a program 
complies with the requirements of this section, the department shall issue an approval 
or an approval with conditions. 
B.  If a program is rejected, the department shall provide the applicant with the 
reasons for rejecting the program in writing. 
C.  The department shall provide expedited review and approval for a program plan 
submitted by a manufacturer or a stewardship organization if it has entered into a 
contractual agreement with a statewide hospital association for dissemination of 
sharps collection containers and the collection and disposal of medical sharps from 
residential sources using the infrastructure of a statewide hospital association. 
D.  The decision of the department under this subsection is a final decision and may 
be appealed to the board pursuant to section 341-D, subsection 4. 
7.  Program modification.  Except as provided in this subsection, a program must be 
operated in compliance with the approval issued by the department under subsection 6. 
A.  A manufacturer or stewardship organization may make substantive changes to the 
manner in which a program is operated only upon submission of a written application 
for modification to and issuance of written notice of approval by the department.  The 
manufacturer or stewardship organization operating a program may request a 
substantive change to the previously approved program plan at any time. 
B.  An additional manufacturer may join a stewardship organization and participate in 
its program if the manufacturer or stewardship organization operating the program 
provides the department with an updated manufacturer participant list within 15 days 
after the additional manufacturer begins participation in the program. 
C.  If a manufacturer withdraws from a program operated by a stewardship 
organization or discontinues a program operated independently, the manufacturer 
shall provide notice to the department within 15 days prior to taking action and a 
statement explaining the manufacturer's plans for complying with this section. 
8.  Program reports.  A manufacturer or stewardship organization shall provide 
program reports as follows. 
A.  By February 1, 2014, and annually thereafter, the manufacturer or stewardship 
organization shall submit to the department 2 copies of a written annual report in a 
format prescribed by the department and covering the previous calendar year.  The 
program report must include: 
(1)  A list of manufacturers participating in the program and their contact 
information; 
(2)  A list of the biomedical waste disposal or treatment facilities used, the 
location of those facilities and the weight of unwanted medical sharps treated at 
each facility; 
(3)  Documentation verifying collection and disposal of the unwanted medical 
sharps; 
(4)  A statement of whether policies and procedures for transporting and 
disposing of unwanted medical sharps, as established in the program plan, were 
followed and a description of noncompliance with those policies and procedures, 
if any; 
(5)  A statement of whether any safety or security problems occurred during 
collection, handling, transportation, treatment or disposal of unwanted medical 
sharps and, if so, what changes are proposed for policies, procedures or tracking 
mechanisms to improve safety and security in the future; 
(6)  A description of the public education effort and communications strategy 
required under subsection 4, paragraph E; 
(7)  A list of active sharps collection centers and locations; and 
(8)  Any other information that the department or the Department of Health and 
Human Services may reasonably require. 
B.  By August 1, 2014, and annually thereafter, the manufacturer or stewardship 
organization shall submit to the department a midyear data report of the amount, by 
weight, of unwanted medical sharps collected during the 6-month period covering 
January to June. 
9.  Enforcement.  If the department determines that a program is not being managed 
in accordance with this section or other applicable state rules or if the department 
determines that there is an imminent danger to the public or the environment: 
A.  The department may amend the approval of the program by clarifying terms or 
conditions to ensure full implementation of the program or suspend or cancel the 
approval of the program. Except as provided in paragraph B, at least 15 days prior to 
amending, suspending or canceling an approval, the department shall inform the 
manufacturer or stewardship organization of the action and provide the manufacturer 
or stewardship organization an opportunity to respond; and 
B.  If the department determines that it is necessary in order to protect the public or 
the environment from imminent danger, the department may immediately amend, 
suspend or cancel the approval of a program without giving the manufacturer or 
stewardship organization an opportunity to be heard, but shall provide an opportunity 
to be heard through proceedings consistent with Title 5, chapter 375, subchapter 4 
within 15 days after the date on which the department takes action. 
10.  Penalties.  After January 1, 2013, a manufacturer that is not in compliance with 
this section is subject to civil penalties under section 349.  By June 1, 2013, the 
department shall list on its publicly accessible website manufacturers that are 
participating in approved programs and manufacturers that have been identified as being 
not in compliance with this section.  All penalties collected for violations of this section 
must be deposited into the Maine Environmental Protection Fund established in section 
351. 
11.  Wholesaler responsibility.  By February 1, 2013, and annually thereafter, a 
wholesaler of medical sharps sold in the State shall report to the department the name and 
contact information for each manufacturer whose medical sharps the wholesaler sold or 
distributed within the State during the previous calendar year.  Information reported 
under this subsection is confidential and may not be disclosed by the department except 
that the department may share that information with the Department of Health and 
Human Services. 
12.  Pharmacy responsibility.  A pharmacy licensed to operate in the State under 
Title 32, chapter 117 shall make available to its customers the educational information 
and materials provided free of charge by the Department of Health and Human Services, 
the manufacturers or the stewardship programs. 
13.  Voluntary participation.  A hospital, medical clinic, pharmacy, public 
transportation location, public park, municipal facility or other approved site may 
volunteer to be a sharps collection center at any time.  Volunteer sites must agree to abide 
by collection procedures issued by the department as well as state rules applicable to 
medical sharps management.  If the location is a hospital or medical facility, it must keep 
medical sharps accepted from residential sources separate from those generated in the 
course of business.  Sharps collection centers must be provided with free sharps 
collection containers and written information to give to medical sharps users. 
14.  Anticompetitive conduct.  A stewardship organization that manages a program 
pursuant to this section is immune from state laws relating to antitrust, restraint of trade, 
unfair trade practices and other regulation of trade and commerce for the limited purpose 
of establishing and operating a program for residential sources.  The activities of the 
organization that comply with the provisions of this section may not be considered to be 
in restraint of trade, a conspiracy or a combination thereof or any other unlawful activity 
in violation of any provision of Title 10. 
15.  Rules.  The department may establish rules to implement this section.  Rules 
adopted pursuant to this subsection are routine technical rules as defined in Title 5, 
chapter 375, subchapter 2-A. 
SUMMARY 
This bill requires a manufacturer of medical sharps to participate in a program, 
individually or in conjunction with other manufacturers, for the collection, handling, 
transportation, treatment and disposal of unwanted medical sharps. It also provides that 
an entity that uses medical sharps is not required to dispose of them by shredding.