Report text available as:

  • TXT
  • PDF   (PDF provides a complete and accurate display of this text.) Tip ?

111th Congress                                            Rept. 111-618
                        HOUSE OF REPRESENTATIVES
 2d Session                                                      Part 1

======================================================================



 
                     SAFE DRUG DISPOSAL ACT OF 2010

                                _______
                                

 September 22, 2010.--Committed to the Committee of the Whole House on 
              the State of the Union, and ordered printed

                                _______
                                

 Mr. Waxman, from the Committee on Energy and Commerce, submitted the 
                               following

                              R E P O R T

                        [To accompany H.R. 5809]

      [Including cost estimate of the Congressional Budget Office]

  The Committee on Energy and Commerce, to whom was referred 
the bill (H.R. 5809) to amend the Controlled Substances Act to 
provide for take-back disposal of controlled substances in 
certain instances, and for other purposes, having considered 
the same, report favorably thereon with an amendment and 
recommend that the bill as amended do pass.

                                CONTENTS

                                                                   Page
Amendment........................................................     1
Purpose and Summary..............................................     3
Background and Need for Legislation..............................     3
Committee Consideration..........................................     4
Committee Votes..................................................     5
Committee Oversight Findings and Recommendations.................     5
New Budget Authority, Entitlement Authority, and Tax Expenditures     5
Statement of General Performance Goals and Objectives............     5
Constitutional Authority Statement...............................     5
Earmarks and Tax and Tariff Benefits.............................     6
Federal Advisory Committee Statement.............................     6
Applicability of Law to Legislative Branch.......................     6
Federal Mandates Statement.......................................     6
Committee Cost Estimate..........................................     6
Congressional Budget Office Cost Estimate........................     6
Section-by-Section Analysis of the Legislation...................     7
Changes in Existing Law Made by the Bill, as Reported............     8

                               Amendment

  The amendment is as follows:
  Strike all after the enacting clause and insert the 
following:

SECTION 1. SHORT TITLE.

  This Act may be cited as the ``Safe Drug Disposal Act of 2010''.

SEC. 2. DELIVERY OF CONTROLLED SUBSTANCES BY ULTIMATE USERS FOR 
                    DISPOSAL.

  (a) Regulatory Authority.--Section 302 of the Controlled Substances 
Act (21 U.S.C. 822) is amended by adding at the end the following:
  ``(g)(1) An ultimate user who has lawfully obtained a controlled 
substance in accordance with this title may, without being registered, 
deliver the controlled substance to another person for the purpose of 
disposal of the controlled substance if--
          ``(A) the person receiving the controlled substance is 
        authorized under this title to receive and dispose of the 
        controlled substance; and
          ``(B) the delivery and disposal takes place in accordance 
        with regulations issued by the Attorney General to prevent 
        diversion of controlled substances.
The regulations referred to in subparagraph (B) shall be consistent 
with the public health and safety. In developing such regulations, the 
Attorney General shall take into consideration the ease and cost of 
program implementation and participation by various communities. Such 
regulations may not require any entity to establish or operate a 
delivery or disposal program.
  ``(2) The Attorney General shall, by regulation, authorize long-term 
care facilities, as defined by the Attorney General by regulation, to 
deliver for disposal controlled substances on behalf of ultimate users 
in a manner that the Attorney General determines will provide effective 
controls against diversion and be consistent with the public health and 
safety.
  ``(3) If a person dies while lawfully in possession of a controlled 
substance for personal use, any person lawfully entitled to dispose of 
the decedent's property may deliver the controlled substance to another 
person for the purpose of disposal under the same conditions as 
provided in paragraph (1) for an ultimate user.''.
  (b) Conforming Amendment.--Section 308(b) of the Controlled 
Substances Act (21 U.S.C. 828(b)) is amended--
          (1) by striking the period at the end of paragraph (2) and 
        inserting ``; or''; and
          (2) by adding at the end the following:
          ``(3) the delivery of such a substance for the purpose of 
        disposal by an ultimate user, long-term care facility, or other 
        person acting in accordance with section 302(g).''.

SEC. 3. PUBLIC EDUCATION CAMPAIGN.

  The Director of National Drug Control Policy, in consultation with 
the Administrator of the Environmental Protection Agency, shall carry 
out a public education and outreach campaign to increase awareness of 
how ultimate users may lawfully and safely dispose of prescription 
drugs, including controlled substances, through drug take-back programs 
and other appropriate means.

SEC. 4. GAO REPORT.

  The Comptroller General of the United States shall--
          (1) collect data on the delivery, transfer, and disposal of 
        controlled substances under section 302(g) of the Controlled 
        Substances Act, as added by section 2; and
          (2) not later than 4 years after the date of the enactment of 
        this Act, submit findings and recommendations to the Congress 
        regarding use, effectiveness, and accessibility of disposal 
        programs.

SEC. 5. EPA STUDY OF ENVIRONMENTAL IMPACTS.

  (a) Study.--The Administrator of the Environmental Protection Agency 
(in this section referred to as the ``Administrator'') shall--
          (1) in consultation with relevant State and local officials 
        and other sources of relevant technical expertise, conduct a 
        study to--
                  (A) examine the environmental impacts resulting from 
                the ultimate disposal of controlled substances through 
                existing methods;
                  (B) taking into consideration such impacts, and the 
                ease and cost of implementation of drug take-back 
                programs and participation in such programs by various 
                communities, formulate appropriate recommendations on 
                the destruction or ultimate disposal of prescription 
                drugs, including controlled substances; and
                  (C) identify additional authority needed to carry out 
                such recommendations if the Administrator determines 
                that the Administrator's existing legal authorities are 
                insufficient to implement such recommendations; and
          (2) not later than 18 months after the date of the enactment 
        of this Act, submit a report to the Congress on the results of 
        such study.
  (b) Rule of Construction.--Nothing in this section shall be construed 
to affect the Administrator's authority under other provisions of law.

                          Purpose and Summary

    H.R. 5809, the ``Safe Drug Disposal Act of 2010'', was 
introduced by Representatives Jay Inslee (D-WA), Lamar Smith 
(R-TX), Bart Stupak (D-MI), and James P. Moran (D-VA) on July 
21, 2010. The bill was referred to the Committee on Energy and 
Commerce, and in addition to the Committee on the Judiciary.
    The legislation has two overriding goals:
     To allow individuals, as well as long-term care 
facilities on behalf of their patients, to deliver unused 
prescription drugs to an appropriate person for disposal 
purposes, as determined by the Attorney General.
     To enhance understanding of the environmental 
impacts of the disposal of unused medicines through existing 
methods.

                  Background and Need for Legislation

    The abuse of prescription medications is a growing public 
health concern in the United States. According to the 2010 
National Drug Control Strategy released by the White House, 
prescription drug abuse is the fastest growing drug problem in 
the United States.\1\ Several recent studies underscore this 
point:
---------------------------------------------------------------------------
    \1\Office of National Drug Control Policy, The 2010 National Drug 
Control Strategy, p. 29 (online at www.whitehousedrugpolicy.gov/
publications/policy/ndcs 10/ndcs2010.pdf).
---------------------------------------------------------------------------
     In a study released in July 2010, the Substance 
Abuse and Mental Health Services Administration (SAMHSA) found 
that between 1998 and 2008 there was a 400% increase in 
hospital admissions for those aged 12 and over reporting abuse 
of prescription pain relievers.\2\
---------------------------------------------------------------------------
    \2\Substance Abuse and Mental Health Services Administration, 
Substance Abuse Treatment Admissions Involving Abuse of Pain Relievers: 
1998-2008 (July 15, 2010) (online at oas.samhsa.gov/2k10/230/
230PainRelvr2k10Web.pdf).
---------------------------------------------------------------------------
     In a report published in June 2010, the Centers 
for Disease Control and Prevention (CDC) noted that emergency 
department visits associated with non-medical use of 
prescription controlled substances doubled between 2004 and 
2008, reaching a million visits.\3\
---------------------------------------------------------------------------
    \3\Centers for Disease Control and Prevention, Emergency Department 
Visits Involving Nonmedical Use of Selected Prescription Drugs--United 
States, 2004-2008 (June 18, 2010) (online at www.cdc.gov/mmwr/preview/
mmwrhtml/mm5923al.htm).
---------------------------------------------------------------------------
     In a 2008 study, SAMHSA found that youth between 
the ages of 12 and 17 abuse prescription drugs more often than 
cocaine, heroin, and methamphetamine combined.\4\ It also 
showed that the scale of the problem is vast: more than six 
million Americans used a prescription medication for nonmedical 
purposes in a one-month period. The study further found that 
70% of people who abuse prescription pain relievers obtained 
them from friends or relatives who had obtained them from a 
doctor.
---------------------------------------------------------------------------
    \4\Substance Abuse and Mental Health Services Administration, 
Results from the 2008 National Survey on Drug Use and Health, p. 15-30 
(online at www.oas.samhsa.gov/nsduh/2k8nsduh/2k8Results.pdf).
---------------------------------------------------------------------------
    Drug take-back programs are one way to help address this 
growing and serious problem. As noted, a major factor in the 
increasing trend of prescription drug abuse is the availability 
of such drugs in the home. These programs provide a means by 
which patients can safely dispose of their unused medicines. 
Such programs also decrease the amount of pharmaceuticals that 
might otherwise enter waterways via municipal waste water 
systems if such pharmaceuticals are flushed down the toilet.
    According to the Environmental Protection Agency, we know 
that pharmaceuticals have health effects at the therapeutic 
dose, but we do not know if there are effects to human health 
associated with long-term exposure to pharmaceuticals at much 
lower concentrations in drinking water. Some laboratory and 
other studies have demonstrated effects on fish and aquatic 
life of low-level exposure to pharmaceuticals. There are no 
known human health effects of low-level exposures to 
pharmaceuticals in drinking water in the general population, 
but EPA believes that more investigation is required to 
determine whether sensitive human populations (such as 
developing fetuses) are experiencing such effects.
    Under current law, the Controlled Substances Act (CSA) 
creates a barrier for many drug take-back programs. The CSA 
regulates controlled substances\5\ through a closed 
registration system designed to prevent diversion.\6\ Under 
this system, any entity other than the ``ultimate user'' (i.e., 
the patient who is prescribed a controlled pharmaceutical) who 
receives or distributes a controlled substance must be 
registered with the Drug Enforcement Administration (DEA). In 
other words, although patients do not have to be registered 
with DEA in order to receive a controlled substance, they 
cannot lawfully deliver a controlled substance to another 
entity for any purpose, including disposal of the drug.\7\
---------------------------------------------------------------------------
    \5\Controlled substances are those substances listed in the 
schedules of the CSA and 21 CFR 1308.11-1308.15, and generally include 
drugs that have a potential for abuse and physical and psychological 
dependence, such as narcotics, stimulants, depressants, anabolic 
steroids and hallucinogens.
    \6\Drug Enforcement Administration, Testimony for the Special 
Committee on Aging Hearing on Drug Waste and Disposal: When 
Prescriptions Become Poison, Statement of Joseph T. Rannazzisi, p. 3 
(June 30, 2010) (hereinafter, ``DEA Testimony'') (online at 
aging.senate.gov/events/hr223gk.pdf).
    \7\Id.
---------------------------------------------------------------------------
    Under current law as well, the only entities authorized to 
take possession of expired or otherwise unwanted controlled 
substances for the purpose of disposal are known as ``reverse 
distributors.'' Other registrants, such as pharmacies, may 
dispose of controlled substances already in their possession 
(for instance, if they are expired, damaged, or contaminated), 
but may not accept controlled substances from patients or any 
other person solely for the purpose of disposal.\8\
---------------------------------------------------------------------------
    \8\21 CFR 1300.01(b)(41).
---------------------------------------------------------------------------
    In January 2009, in response to growing concerns raised by 
individuals, interest groups, the healthcare industry, and the 
law enforcement community, DEA solicited public comments on the 
disposal of controlled substances dispensed to individual 
patients, as well as to long-term care facilities. Although DEA 
received numerous responses during the public comment period 
(which ended on March 23, 2009), the agency has stated it 
cannot move forward with a regulatory proposal in the absence 
of authorizing legislation.\9\
---------------------------------------------------------------------------
    \9\DEA Testimony, supra note 6, at 5.
---------------------------------------------------------------------------

                        Committee Consideration

    H.R. 5809, the ``Safe Drug Disposal Act of 2010'', was 
introduced by Representatives Inslee (D-WA), Smith (R-TX), 
Stupak (D-MI), and Moran (D-VA) on July 21, 2010, and referred 
to the Committee on Energy and Commerce, and subsequently to 
the Subcommittee on Health on the same day. The Subcommittee on 
Health conducted a legislative hearing on the bill and 
afterwards met in open markup session to consider H.R. 5809 on 
July 22, 2010. An amendment in the nature of a substitute 
(manager's amendment) by Representative Stupak was adopted by a 
voice vote. Subsequently, H.R. 5809 was favorably forwarded to 
the full Committee, amended, by a voice vote.
    On July 28, 2010, the Committee on Energy and Commerce met 
in open markup session and considered H.R. 5809 as approved by 
the Subcommittee. An amendment in the nature of a substitute 
(manager's amendment) offered by Representative Pallone (D-NJ) 
was adopted by a voice vote. Subsequently, the Committee 
ordered H.R. 5809 favorably reported to the House, amended, by 
a voice vote.

                            Committee Votes

    Clause 3(b) of rule XIII of the Rules of the House of 
Representatives requires the Committee to list each record vote 
on the motion to report legislation and amendments thereto. A 
motion by Mr. Waxman ordering H.R. 5809 reported to the House, 
amended, was approved by a voice vote. There were no record 
votes taken during consideration of this bill.

            Committee Oversight Findings and Recommendations

    In compliance with clause 3(c)(1) of rule XIII and clause 
2(b)(1) of rule X of the Rules of the House of Representatives, 
the oversight findings and recommendations of the Committee are 
reflected in the descriptive portions of this report, including 
the finding that drug take-back programs provide one means of 
addressing the growing and serious problem of prescription drug 
abuse.

   New Budget Authority, Entitlement Authority, and Tax Expenditures

    Regarding compliance with clause 3(c)(2) of rule XIII of 
the Rules of the House of Representatives, the Committee finds 
that H.R. 5809 would result in no new budget authority, 
entitlement authority, or tax expenditures or revenues.

         Statement of General Performance Goals and Objectives

    In accordance with clause 3(c)(4) of rule XIII of the Rules 
of the House of Representatives, the performance goals and 
objectives of the Committee are reflected in the descriptive 
portions of this report, including the goal of facilitating the 
delivery of unused prescription drugs to appropriate persons 
for disposal purposes, and enhancing scientific understanding 
of the environmental impacts of the disposal of unused 
medicines through existing methods.

                   Constitutional Authority Statement

    Pursuant to clause 3(d)(1) of rule XIII of the Rules of the 
House of Representatives, the Committee finds that the 
constitutional authority for H.R. 5809 is provided under 
Article I, section 8, clauses 3 and 18 of the Constitution of 
the United States.

                  Earmarks and Tax and Tariff Benefits

    H.R. 5809 does not contain any congressional earmarks, 
limited tax benefits, or limited tariff benefits as defined in 
clause 9(d), 9(e), or 9(f) of rule XXI of the Rules of the 
House of Representatives.

                  Federal Advisory Committee Statement

    The Committee finds that the legislation does not establish 
or authorize the establishment of an advisory committee within 
the definition of 5 U.S.C. App., section 5(b) of the Federal 
Advisory Committee Act.

             Applicability of Law to the Legislative Branch

    Section 102(b)(3) of Public Law 104-1 requires a 
description of the application of this bill to the legislative 
branch where the bill relates to terms and conditions of 
employment or access to public services and accommodations. 
H.R. 5809 contains no such provisions.

                       Federal Mandates Statement

    Section 423 of the Congressional Budget and Impoundment 
Control Act of 1974 (as amended by section 101(a)(2) of the 
Unfunded Mandates Reform Act, P.L. 104-4) requires a statement 
on whether the provisions of the report include unfunded 
mandates. In compliance with this requirement the Committee 
adopts as its own the estimates of federal mandates prepared by 
the Director of the Congressional Budget Office.

                        Committee Cost Estimate

    Pursuant to clause 3(d)(2) of rule XIII of the Rules of the 
House of Representatives, the Committee adopts as its own the 
cost estimate of H.R. 5809 prepared by the Director of the 
Congressional Budget Office pursuant to section 402 of the 
Congressional Budget Act of 1974.

               Congressional Budget Office Cost Estimate

    With respect to the requirements of clause (3)(c)(3) of 
rule XIII of the Rules of the House of Representatives and 
section 402 of the Congressional Budget Act of 1974, the 
Committee has received the following cost estimate for H.R. 
5809 from the Director of the Congressional Budget Office:
                                                    August 5, 2010.
Hon. Henry A. Waxman,
Chairman, Committee on Energy and Commerce,
House of Representatives, Washington, DC.
    Dear Mr. Chairman: The Congressional Budget Office has 
prepared the enclosed cost estimate for H.R. 5809, the Safe 
Drug Disposal Act of 2010.
    If you wish further details on this estimate, we will be 
pleased to provide them. The CBO staff contact is Mark 
Grabowicz.
            Sincerely,
                                              Douglas W. Elmendorf.
    Enclosure.

H.R. 5809--Safe Drug Disposal Act of 2010

    CBO estimates that implementing H.R. 5809 would cost about 
$2 million in fiscal year 2011 and less than $500,000 annually 
over the 2012-2014 period, from appropriated amounts. The bill 
would not affect direct spending or revenues; therefore, pay-
as-you-go procedures do not apply. H.R. 5809 contains no 
intergovernmental or private-sector mandates as defined in the 
Unfunded Mandates Reform Act and would impose no costs on 
state, local, or tribal governments.
    H.R. 5809 would require the Department of Justice (DOJ) to 
authorize long-term care facilities (such as nursing homes) to 
arrange for the appropriate disposal of certain controlled 
substances. Based on information from DOJ, CBO estimates that 
implementing the bill would not significantly affect the 
department's spending on drug control programs.
    In addition, H.R. 5809 would direct the Office of National 
Drug Control Policy to carry out a public outreach campaign 
relating to the safe disposal of prescription drugs. H.R. 5809 
also would require the Environmental Protection Agency (EPA) to 
conduct a study on the environmental impacts of disposing of 
controlled substances and would require the Government 
Accountability Office (GAO), within four years of the date of 
enactment, to prepare a report on implementation of the bill's 
provisions.
    Based on the costs of similar activities, CBO estimates 
that the public outreach campaign and the EPA study would cost 
about $1 million each in 2011 and the GAO report would cost 
less than $500,000 annually over the 2011-2014 period, from 
appropriated funds.
    On August 3, 2010, CBO transmitted a cost estimate for S. 
3397, the Secure and Responsible Drug Disposal Act of 2010, as 
reported by the Senate Committee on the Judiciary on July 29, 
2010. The two bills are similar, but S. 3397 did not require a 
public outreach campaign or any reports and we estimated that 
its implementation would have no significant cost to the 
federal government.
    The CBO staff contact for this estimate is Mark Grabowicz. 
The estimate was approved by Theresa Gullo, Deputy Assistant 
Director for Budget Analysis.

             Section-by-Section Analysis of the Legislation


Section 1. Short title

    Section 1 designates that the short title may be cited as 
the ``Safe Drug Disposal Act of 2010''.

Section 2. Delivery of controlled substances by ultimate users for 
        disposal

    Section 2 amends the Controlled Substances Act to permit an 
ultimate user who has lawfully obtained a controlled substance 
and who is not registered with the DEA to deliver that 
controlled substance to another person for the purpose of 
disposal if the person receiving the controlled substance is 
authorized to do so under the Act, and if the delivery and 
disposal takes place in accordance with regulations to be 
issued by the Attorney General to prevent diversion of 
controlled substances. In developing such regulations, the 
Attorney General is to consider both the ease and cost of 
program implementation and participation by various 
communities. The legislation prohibits the DEA from requiring 
any entity to establish a drug take back program.
    Section 2 also requires the Attorney General to issue 
regulations to authorize long-term care facilities to deliver 
for disposal controlled substances on behalf of ultimate users.
    In addition, Section 2 authorizes any person lawfully 
entitled to dispose of a decedent's property to deliver 
controlled substances belonging to that decedent to another 
person for the purpose of disposal.

Section 3. Public education campaign

    Section 3 requires the Director of National Drug Control 
Policy (ONDCP), in consultation with EPA, to carry out a public 
education and outreach campaign to increase awareness of drug 
take-back programs.

Section 4. GAO report

    Section 4 requires the Comptroller General to submit a 
report to Congress on the delivery, transfer, and disposal of 
controlled substances under the Controlled Substances Act (as 
amended by the legislation) that includes findings and 
recommendations regarding the use, effectiveness, and 
accessibility of drug disposal programs.

Section 5. EPA study of environmental impacts

    Section 5 requires the EPA administrator, in consultation 
with relevant state and local officials and other relevant 
experts, to conduct a study to:
     Examine the environmental impacts from the final 
disposal of controlled substances through existing methods.
     Consider the ease and cost of implementation of 
drug take-back programs, and participation in such programs by 
various communities.
     Make recommendations on the appropriate ways to 
dispose of prescription drugs.
     Identify additional authority needed to carry out 
such recommendations if the Administrator determines that 
existing legal authorities are insufficient to implement them.
    EPA is required to submit the results of the study to 
Congress within 18 months of the enactment of the legislation.

         Changes in Existing Law Made by the Bill, as Reported

  In compliance with clause 3(e) of rule XIII of the Rules of 
the House of Representatives, changes in existing law made by 
the bill, as reported, are shown as follows (existing law 
proposed to be omitted is enclosed in black brackets, new 
matter is printed in italic, existing law in which no change is 
proposed is shown in roman):

CONTROLLED SUBSTANCES ACT

           *       *       *       *       *       *       *



TITLE II--CONTROL AND ENFORCEMENT

           *       *       *       *       *       *       *



Part C--Registration of Manufacturers, Distributors, and Dispensers of 
Controlled Substances; Piperidine Reporting

           *       *       *       *       *       *       *



                      PERSONS REQUIRED TO REGISTER

  Sec. 302. (a) * * *

           *       *       *       *       *       *       *

  (g)(1) An ultimate user who has lawfully obtained a 
controlled substance in accordance with this title may, without 
being registered, deliver the controlled substance to another 
person for the purpose of disposal of the controlled substance 
if--
          (A) the person receiving the controlled substance is 
        authorized under this title to receive and dispose of 
        the controlled substance; and
          (B) the delivery and disposal takes place in 
        accordance with regulations issued by the Attorney 
        General to prevent diversion of controlled substances.
The regulations referred to in subparagraph (B) shall be 
consistent with the public health and safety. In developing 
such regulations, the Attorney General shall take into 
consideration the ease and cost of program implementation and 
participation by various communities. Such regulations may not 
require any entity to establish or operate a delivery or 
disposal program.
  (2) The Attorney General shall, by regulation, authorize 
long-term care facilities, as defined by the Attorney General 
by regulation, to deliver for disposal controlled substances on 
behalf of ultimate users in a manner that the Attorney General 
determines will provide effective controls against diversion 
and be consistent with the public health and safety.
  (3) If a person dies while lawfully in possession of a 
controlled substance for personal use, any person lawfully 
entitled to dispose of the decedent's property may deliver the 
controlled substance to another person for the purpose of 
disposal under the same conditions as provided in paragraph (1) 
for an ultimate user.

           *       *       *       *       *       *       *


                              ORDER FORMS

  Sec. 308. (a) * * *
  (b) Nothing in subsection (a) shall apply to--
          (1) * * *
          (2) the delivery of such a substance to or by a 
        common or contract carrier for carriage in the lawful 
        and usual course of its business, or to or by a 
        warehouseman for storage in the lawful and usual course 
        of its business; but where such carriage or storage is 
        in connection with the distribution by the owner of the 
        substance to a third person, this paragraph shall not 
        relieve the distributor from compliance with subsection 
        (a)[.]; or
          (3) the delivery of such a substance for the purpose 
        of disposal by an ultimate user, long-term care 
        facility, or other person acting in accordance with 
        section 302(g).

           *       *       *       *       *       *       *