I 

112TH CONGRESS 

1ST SESSION H. R. 2939 

To provide for the disposal of drugs pursuant to national pharmaceutical 

stewardship programs, and for other purposes. 

IN THE HOUSE OF REPRESENTATIVES 

SEPTEMBER 15, 2011 

Ms. SLAUGHTER introduced the following bill; which was referred to the Committee on Energy and Commerce, and in addition to the Committee on 

Ways and Means, for a period to be subsequently determined by the 

Speaker, in each case for consideration of such provisions as fall within 

the jurisdiction of the committee concerned 

A BILL 

To provide for the disposal of drugs pursuant to national 

pharmaceutical stewardship programs, and for other purposes. 

1 Be it enacted by the Senate and House of Representa2 tives of the United States of America in Congress assembled, 

3 SECTION 1. SHORT TITLE. 

4 This Act may be cited as the ‘‘Pharmaceutical Stew5 ardship Act of 2011’’. 


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1 SEC. 2. NATIONAL PHARMACEUTICAL STEWARDSHIP PRO2 GRAMS. 

3 (a) REQUIRED PARTICIPATION.—Each manufacturer 

4 and brand owner of a drug marketed in the United States 

5 shall participate in— 

6 (1) the certified national pharmaceutical stew7 ardship program of the National Pharmaceutical 

8 Stewardship Organization; or 

9 (2) another certified national pharmaceutical 

10 stewardship program. 

11 (b) NATIONAL PHARMACEUTICAL STEWARDSHIP OR12 GANIZATION.— 

13 (1) ESTABLISHMENT.—There shall be estab14 lished in accordance with this section a nonprofit 

15 private corporation to be known as the National 

16 Pharmaceutical Stewardship Organization. The Or17 ganization shall not be an agency or instrumentality 

18 of the Federal Government, and officers, employees, 

19 and members of the board of the Organization shall 

20 not, by virtue of such service, be considered officers 

21 or employees of the Federal Government. 

22 (2) PURPOSE.—The purpose of the Organiza23 tion shall be to establish and, not later than 2 years 

24 after the date of the enactment of this Act, begin 

25 implementation of a certified national pharma26 ceutical stewardship program. 


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1 (3) BOARD OF DIRECTORS.—The Organization 

2 shall have a board of directors including representa3 tives of manufacturers and brand owners of drugs 

4 and public health stakeholders. The Administrator 

5 shall appoint the initial members of the board of di6 rectors. 

7 (4) BYLAWS.—The board of directors shall es8 tablish the general policies of the Organization for 

9 carrying out the purpose described in paragraph (2), 

10 including the establishment of the bylaws of the Or11 ganization. The board of directors shall ensure that 

12 the bylaws of the Organization include bylaws for 

13 the following: 

14 (A) Entering into contracts and agree15 ments with service providers and entities as 

16 necessary, useful, or convenient to provide all or 

17 portions of the national pharmaceutical stew18 ardship program of the Organization. 

19 (B) Taking any legal action necessary or 

20 proper for the recovery of an assessment for, on 

21 behalf of, or against manufacturers or brand 

22 owners of a drug participating in such program. 

23 (C) Performing such other functions as 

24 may be necessary or proper to carry out the 

25 purpose described in paragraph (2). 


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1 (D) Ensuring that the members of the 

2 board of directors serve without compensation, 

3 but are entitled to reimbursement (solely from 

4 the funds of the Organization) for expenses 

5 (other than meal or travel expenses) incurred in 

6 the discharge of their duties as members of the 

7 board of directors. 

8 (E) Ensuring that the Organization does 

9 not use any State or local government funds to 

10 carry out the purpose described in paragraph 

11 (2). 

12 (F) Allowing the Administrator— 

13 (i) to audit the activities of the Orga14 nization as the Administrator deems nec15 essary; and 

16 (ii) to access any facilities or property 

17 of the Organization as the Administrator 

18 deems necessary to conduct inspections or 

19 investigate complaints. 

20 (5) NONPROFIT STATUS.—In carrying out the 

21 purpose described in paragraph (2), the board of di22 rectors shall establish such policies and bylaws under 

23 paragraph (4) as may be necessary to ensure that 

24 the Organization maintains its status as an organi25 zation that— 


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1 (A) is described in subsection (c)(3) of sec2 tion 501 of the Internal Revenue Code of 1986; 

3 and 

4 (B) is, under subsection (a) of such sec5 tion, exempt from taxation. 

6 (6) CONTRIBUTIONS TO NATIONAL PHARMA7 CEUTICAL STEWARDSHIP ORGANIZATION NOT

8 TREATED AS CHARITABLE CONTRIBUTIONS.—A con9 tribution by a manufacturer or brand owner of a 

10 drug to the Organization or the Organization’s na11 tional pharmaceutical stewardship program shall not 

12 be treated as a charitable contribution for purposes 

13 of section 170 of the Internal Revenue Code of 

14 1986. 

15 (7) ARTICLES OF INCORPORATION.—The Ad16 ministrator shall ensure that the initial articles of 

17 incorporation of the Organization are properly filed 

18 not later than 60 days after the date of the enact19 ment of this Act. 

20 (c) PROGRAM REQUIREMENTS.—To be certified 

21 under subsection (f) or (g), a program shall meet each 

22 of the following: 

23 (1) The program is operated pursuant to an 

24 agreement among the manufacturers and brand 

25 owners of drugs participating in the program. 


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1 (2) Subject to subsection (d), the costs of the 

2 program are fully paid by such manufacturers and 

3 brand owners. 

4 (3) The program is developed with input from 

5 the public, including an opportunity for public com6 ment and at least one public hearing. 

7 (4) The program provides a system to facilitate 

8 the collection and disposal of any drug that— 

9 (A) is delivered to the program by an indi10 vidual in the United States; and 

11 (B) is household waste as defined under 

12 the implementing regulations of subtitle C of 

13 title II of the Solid Waste Disposal Act (42 

14 U.S.C. 6901 et seq.; commonly referred to as 

15 the ‘‘Resource Conservation and Recovery 

16 Act’’). 

17 (5) Collection and disposal of a drug through 

18 the program’s system (described in paragraph (4)) 

19 occurs in a manner that— 

20 (A) is safe and secure; 

21 (B) results in incineration of the drug in 

22 accordance with the hazardous waste inciner23 ation requirements under subtitle C of title II 

24 of the Solid Waste Disposal Act (42 U.S.C. 

25 6901 et seq.); 


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1 (C) protects patient information; 

2 (D) is accessible in every State, county, 

3 and city or town, including— 

4 (i) at least one collection site in every 

5 county of every State and one collection 

6 site in every city with a population of more 

7 than 10,000 individuals on an ongoing, 

8 year-round basis; or 

9 (ii) if collection is not feasible in a 

10 specific county or city, provision of prepaid 

11 mailing envelopes to individuals in such 

12 county or city for such collection and dis13 posal; and 

14 (E) in the case of a controlled substance, 

15 is consistent with section 302(g) of the Con16 trolled Substances Act (21 U.S.C. 822(g)). 

17 (6) The program shall not impose any fee on 

18 individuals for delivery or disposal of a drug through 

19 the program. 

20 (7) The program promotes the collection and 

21 disposal of drugs through the program. 

22 (8) The program ensures that options for col23 lection and disposal of drugs through the program 

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1 tailers, and health care practitioners including doc2 tors and other prescribers, including by— 

3 (A) maintaining a toll-free telephone num4 ber and a Web site publicizing such collection 

5 and disposal options; 

6 (B) preparing educational and outreach 

7 materials— 

8 (i) describing where and how to dis9 pose of drugs through the program; and 

10 (ii) addressing the risks of diversion 

11 of drugs and the importance of awareness 

12 about safe storage and disposal of drugs; 

13 and 

14 (C) providing such materials to phar15 macies, health care facilities, and other inter16 ested parties for dissemination. 

17 (9) The program— 

18 (A) annually evaluates the effectiveness of 

19 its educational and outreach activities under 

20 paragraph (7); and 

21 (B) at least every 4 years, includes in such 

22 evaluation— 

23 (i) the percentage of residents of the 

24 United States who are aware of the pro25 gram; and 


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1 (ii) the extent to which residents of 

2 the United States find the program to be 

3 convenient. 

4 (d) MECHANISM FOR TRANSFER OF COSTS AMONG

5 MANUFACTURERS AND BRAND OWNERS.—To be certified 

6 under subsection (f) or (g), a program shall include a 

7 mechanism that— 

8 (1) provides for receiving and transferring 

9 funds among all certified national pharmaceutical 

10 stewardship programs in such amounts as may be 

11 necessary to ensure that the manufacturers and 

12 brand owners of drugs participating in such pro13 grams bear the costs of such programs in proportion 

14 to the market shares of their respective drugs; and 

15 (2) is specified in a written agreement among 

16 all manufacturers and brand owners of drugs. 

17 (e) PROGRAM REPORTING REQUIREMENTS.— 

18 (1) IN GENERAL.—To be certified under sub19 section (f) or (g), a program shall agree to submit 

20 a report to the Environmental Protection Agency by 

21 not later than January 1st of the first calendar year 

22 following such certification, and annually thereafter. 

23 (2) CONTENTS.—Each report submitted by a 

24 program under paragraph (1) shall describe the proVerDate Mar 15 2010 00:10 Sep 17, 2011 Jkt 099200 PO 00000 Frm 00009 Fmt 6652 Sfmt 6201 E:\BILLS\H2939.IH H2939

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1 gram’s activities during the preceding calendar year, 

2 including at a minimum— 

3 (A) a specification of the amount, by 

4 weight, of drugs collected through the program, 

5 including the amount by weight from each col6 lection method used; 

7 (B) an identification of any safety or secu8 rity problems which occurred during collection, 

9 transportation, or disposal of drugs during the 

10 preceding calendar year and a description of the 

11 changes which have or will be made to policies, 

12 procedures, or tracking mechanisms to alleviate 

13 any such problems and to improve safety and 

14 security in the future; 

15 (C) a description of the educational and 

16 outreach activities under subsection (c)(8); 

17 (D) a description of how collected pack18 aging was recycled to the extent feasible, in19 cluding the recycling facility or facilities used; 

20 and 

21 (E) the total expenditures of the program 

22 and a statement on whether the program fore23 sees a need for adjustment of the total annual 

24 cost responsibility under subsection (d) of man25 ufacturers and brand owners participating in 


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1 the program as a result of changes in volumes 

2 of collected drugs or other costs. 

3 (3) PROCEDURES.—The Administrator shall es4 tablish procedures for reporting under this sub5 section not later than the date that is one year after 

6 the date of the enactment of this Act. 

7 (4) PUBLIC AVAILABILITY.—The Administrator 

8 shall make each report submitted under this sub9 section available to the public. 

10 (f) CERTIFICATION OF NATIONAL PHARMACEUTICAL

11 STEWARDSHIP ORGANIZATION’S PROGRAM.— 

12 (1) APPLICATION.—To seek certification of its 

13 program, the Organization shall submit an applica14 tion to the Administrator containing such informa15 tion as the Administrator may require. 

16 (2) CONSIDERATION BY ADMINISTRATOR.— 

17 Upon receipt of an application under paragraph (1), 

18 the Administrator— 

19 (A) shall consult with the Administrator of 

20 the Drug Enforcement Agency on the adequacy 

21 of the proposed program’s security measures 

22 for collection, transportation, and disposal of 

23 drugs, disposal systems, and mechanisms for 

24 secure tracking and handling; and 


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1 (B) within 90 days after receipt of the ap2 plication, shall— 

3 (i) certify the program if the Adminis4 trator determines it meets the require5 ments of this section; or 

6 (ii) reject the proposed program and 

7 provide a written explanation of the rea8 sons for such rejection. 

9 (3) RESPONSE TO REJECTION OF PROPOSED

10 PROGRAM.—If the Administrator rejects the Organi11 zation’s proposed program under paragraph 

12 (2)(B)(ii), the rejection shall be treated as final 

13 agency action, and the Organization may— 

14 (A) revise its proposed program and sub15 mit a new application under paragraph (1); or 

16 (B) seek judicial review of the rejection not 

17 later than 60 days after receiving notice of the 

18 rejection. 

19 (4) SOLICITATION OF PUBLIC COMMENT TO IN20 FORM PROGRAM UPDATES.— 

21 (A) IN GENERAL.—A certified national 

22 product stewardship program shall— 

23 (i) annually invite comments from 

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1 ernments, law enforcement personnel, and 

2 citizens on their satisfaction with the serv3 ices provided by the program; 

4 (ii) compile and submit the informa5 tion received through such comments to 

6 the Administrator; and 

7 (iii) use such information in devel8 oping updates and changes to the program. 

9 (B) USE BY ADMINISTRATOR.—The Ad10 ministrator shall use information submitted 

11 under subparagraph (A)(ii) in reviewing pro12 posed updates and revisions to certified national 

13 pharmaceutical stewardship programs. 

14 (C) GUIDANCE.—The Administrator shall 

15 issue guidance on the process for complying 

16 with this paragraph. 

17 (5) TERM OF CERTIFICATION; UPDATES.—The 

18 term of a certification under paragraph (2)(B)(i) 

19 shall be not more than 4 years. Not less than every 

20 4 years, a new application, including any relevant 

21 updates to the certified national pharmaceutical 

22 stewardship program, shall be submitted under para23 graph (1) and approved under paragraph (2)(B)(i) 

24 in order for a program’s certification under this sub25 section to remain in effect. 


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1 (6) CHANGES TO CERTIFIED PROGRAM.— 

2 (A) IN GENERAL.—Before making any sig3 nificant change to its certified national pharma4 ceutical stewardship program, the Organization 

5 shall seek and obtain approval for the change 

6 from the Administrator. Not later than 15 days 

7 after submission of a request for a change 

8 under the preceding sentence, the Adminis9 trator shall approve the change or reject the 

10 change and provide a written explanation of the 

11 reasons for the rejection. 

12 (B) CHANGES TO COLLECTION LOCA13 TIONS.—Not less than 15 days after making 

14 any change to a location for the collection of 

15 drugs through its certified national pharma16 ceutical stewardship program, the Organization 

17 shall inform the Administrator of the change. 

18 (7) SUBMISSION REQUIREMENTS.— 

19 (A) PUBLICATION.—Not later than 6 

20 months after the date of the enactment of this 

21 Act, the Administrator shall publish require22 ments for the submission of applications under 

23 paragraph (1) and requests for changes under 

24 paragraph (6), including requirements for the 

25 contents of such submissions. 


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1 (B) FAILURE TO PUBLISH.—If the Admin2 istrator fails to publish such requirements by 

3 the deadline specified in subparagraph (A), the 

4 requirements of this section applicable to manu5 facturers and brand owners of drugs shall none6 theless apply. 

7 (g) CERTIFICATION OF OTHER PROGRAMS.— 

8 (1) APPLICATION.—In lieu of participating in 

9 the certified national pharmaceutical stewardship 

10 program of the Organization, one or more manufac11 turers or brand owners of a drug may submit an ap12 plication to the Administrator seeking certification 

13 of a separate national pharmaceutical stewardship 

14 program. 

15 (2) GOVERNING PROVISIONS.—The provisions 

16 of subsection (f) shall apply with respect to an appli17 cation for certification of a program under para18 graph (1) to the same extent and in the same man19 ner as such provisions apply to an application for 

20 certification of a program by the Organization under 

21 subsection (e), except as follows: 

22 (A) The reference to 90 days in subsection 

23 (f)(2)(B) (relating to the period of the Adminis24 trator’s review of an application) shall be treat25 ed as a reference to 120 days. 


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1 (B) If the Administrator rejects the pro2 posed program, in lieu of submitting a new ap3 plication under paragraph (1) or seeking judi4 cial review of the rejection, the manufacturers 

5 or brand owners may choose to participate in 

6 the certified national pharmaceutical steward7 ship program of the Organization. 

8 (C) The references to 4 years in subsection 

9 (f)(5) (relating to the term of certification and 

10 to submission of a new application) shall be 

11 treated as references to 3 years. 

12 (h) PROCESS TO CHANGE DISPOSAL MECHANISM.— 

13 (1) PETITIONS.—On petition by any person, the 

14 Administrator may authorize a national pharma15 ceutical stewardship program to use, in lieu of the 

16 disposal technologies otherwise required by sub17 section (c)(5)(B), one of more other disposal tech18 nologies described in paragraph (2). 

19 (2) REQUIRED LEVELS OF PROTECTION.—The 

20 Administrator may authorize the use of a disposal 

21 technology under paragraph (1) only if the tech22 nology— 

23 (A) is proven, available, and consistent 

24 with Federal and State legal requirements; and 


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1 (B) provides equivalent environmental and 

2 human health protection in each, and superior 

3 environmental and human health protection in 

4 one or more, of the following areas: 

5 (i) Monitoring of any emissions or 

6 waste. 

7 (ii) Worker health and safety. 

8 (iii) Air, water, or land emissions con9 tributing to persistent, bioaccumulative, 

10 and toxic pollution. 

11 (iv) Overall impact to the environment 

12 and human health. 

13 (i) SUSPENSION OF PROGRAM.— 

14 (1) IMMINENT DANGER.—The Administrator 

15 may suspend, in whole or in part, the certification 

16 of any national pharmaceutical stewardship program 

17 if the Administrator determines that such action is 

18 necessary to protect the public from imminent dan19 ger. 

20 (2) FAILURE TO COMPLY.—If the Adminis21 trator determines that a national pharmaceutical 

22 stewardship is in violation of the requirements of 

23 this section, the Administrator— 


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1 (A) may issue a written warning to the 

2 program stating that the program is in violation 

3 of this section; and 

4 (B) if the program has not rectified each 

5 violation identified in such warning within 30 

6 days of receipt of such warning, may suspend, 

7 in whole or in part, the certification of the pro8 gram. 

9 (j) CIVIL PENALTIES.—Beginning on the date that 

10 is 2 years after the date of the enactment of this Act, 

11 a manufacturer or brand owner of a drug shall be liable 

12 for a civil penalty of not more than $50,000 for each cal13 endar day on which, as determined by the Administrator, 

14 the manufacturer or brand owner— 

15 (1) is not participating in a certified national 

16 pharmaceutical program; or 

17 (2) is in violation of its obligation to contribute 

18 to the costs of such a program under subsection 

19 (c)(2). 

20 (k) REGULATORY POWER.—The Administrator may 

21 adopt rules or guidance necessary to implement, admin22 ister, and enforce this section. The Administrator, in con23 sultation with the Secretary of Health and Human Serv24 ices, the Administrator of the Drug Enforcement Agency, 

25 the Director of National Drug Control Policy, and the 


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1 Commissioner of Food and Drugs, may include in such 

2 regulations or guidance any performance standards deter3 mined appropriate for implementing the program require4 ments specified in this section. 

5 (l) STATE, TRIBAL, AND LOCAL REGULATION.—This 

6 section does not preempt the authority of State, tribal, 

7 and local governments to impose more stringent require8 ments relating to the disposal of drugs. 

9 (m) REPORT TO CONGRESS.—By December 31, 

10 2016, the Environmental Protection Agency shall report 

11 to the appropriate committees of the Congress concerning 

12 the status of the national pharmaceutical stewardship pro13 grams under this section, including any recommendations 

14 for changes to this section. 

15 (n) SEVERABILITY.—If any provision of this section 

16 or the application of such provision to any person or cir17 cumstance is held to be unconstitutional, the remainder 

18 of this section, and the application of the provisions of 

19 such remainder to any person or circumstance, shall not 

20 be affected thereby. 

21 (o) DEFINITIONS.—In this section: 

22 (1) The term ‘‘Administrator’’ means the Ad23 ministrator of the Environmental Protection Agency. 

24 (2) The term ‘‘board of directors’’ means the 

25 board of directors of the Organization. 


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1 (3) The term ‘‘brand owner’’, with respect to a 

2 drug, means the holder of an approved application 

3 for the drug under section 505 of the Federal Food, 

4 Drug, and Cosmetic Act (21 U.S.C. 355). 

5 (4) The term ‘‘certified national pharmaceutical 

6 stewardship program’’ means a national pharma7 ceutical stewardship program with a certification in 

8 effect under subsection (f) or (g). 

9 (5) The term ‘‘controlled substance’’ has the 

10 meaning given to such term in section 102 of the 

11 Controlled Substances Act (21 U.S.C. 802). 

12 (6) The term ‘‘drug’’ has the meaning given to 

13 such term in section 201 of the Federal Food, Drug, 

14 and Cosmetic Act (21 U.S.C. 321) except that such 

15 term excludes any drug for which a take-back pro16 gram is in effect pursuant to a risk evaluation and 

17 mitigation strategy under section 505–1 of such Act 

18 (21 U.S.C. 355–1). 

19 (7) The term ‘‘Organization’’ means the Na20 tional Pharmaceutical Stewardship Organization es21 tablished in accordance with subsection (b). 

22 (p) FEES.—The Administrator may assess and col23 lect fees from manufacturers and brand owners of drugs 

24 to pay the administrative costs of carrying out this section. 

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1 facturers and brand owners in proportion to the market 

2 shares of their respective drugs. 

3 (q) AUTHORIZATION OF APPROPRIATIONS.— 

4 (1) IN GENERAL.—There is authorized to be 

5 appropriated to the Environmental Protection Agen6 cy $8,000,000 for fiscal year 2012 and each subse7 quent fiscal year to pay the administrative costs of 

8 carrying out this section, including the costs of certi9 fying, evaluating, and auditing national pharma10 ceutical stewardship programs under this section. 

11 (2) SOURCE OF FUNDS.—Amounts authorized 

12 to be appropriated pursuant to paragraph (1) shall 

13 be derived exclusively from amounts collected as civil 

14 penalties under subsection (j) or fees under sub15 section (p). 

16 SEC. 3. EDUCATION CAMPAIGN ON DRUG DISPOSAL; EVAL17 UATION OF NATIONAL PHARMACEUTICAL 

18 STEWARDSHIP PROGRAM. 

19 (a) EDUCATION AND OUTREACH CAMPAIGN.—Not 

20 later than 18 months after the date of the enactment of 

21 this Act, the Director of National Drug Control Policy, 

22 in consultation with the Secretary of Health and Human 

23 Services and the Administrator of the Environmental Pro24 tection Agency, shall establish and begin implementation 

25 of an education and outreach campaign— 


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1 (1) to increase awareness among members of 

2 the public regarding how drugs may be lawfully dis3 posed consistent with public safety, public health, 

4 and environmental protection through national phar5 maceutical stewardship programs under section 2 

6 and by other appropriate means; and 

7 (2) to link members of the public to the na8 tional and local educational and outreach activities 

9 conducted by such programs. 

10 (b) EVALUATION.— 

11 (1) IN GENERAL.—Not later than 2 years after 

12 the date of the enactment of this Act, and annually 

13 thereafter, the Director of National Drug Control 

14 Policy, in consultation with the Secretary of Health 

15 and Human Services and the Administrator of the 

16 Environmental Protection Agency, shall conduct an 

17 evaluation of the effectiveness of the national phar18 maceutical stewardship programs under section 2 

19 and submit a report to the Congress on the results 

20 of each such evaluation, including recommendations 

21 for improving the programs. 

22 (2) METRICS.—The evaluation under paragraph 

23 (1) shall address each of the following: 

24 (A) Access to national pharmaceutical 

25 stewardship programs under section 2. 


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1 (B) Awareness of such programs, including 

2 awareness of the risks of diversion of drugs and 

3 awareness of the importance of safe storage and 

4 safe disposal of pharmaceuticals. 

5 SEC. 4. COMMISSION ON DRUG DISPOSAL AND ITS PUBLIC 

6 SAFETY, PUBLIC HEALTH, AND ENVIRON7 MENTAL IMPACTS. 

8 (a) ESTABLISHMENT.—The Administrator of the En9 vironmental Protection Agency shall establish an inter10 agency commission, to be known as the Commission on 

11 Drug Disposal and its Public Safety, Public Health, and 

12 Environmental Impacts (in this section referred to as the 

13 ‘‘Commission’’). 

14 (b) MEMBERSHIP.—The members of the Commission 

15 shall include the following: 

16 (1) The Administrator of the Environmental 

17 Protection Agency. 

18 (2) The Director of the Centers for Disease 

19 Control and Prevention. 

20 (3) The Director of the National Institute of 

21 Environmental Health Sciences. 

22 (4) The Administrator of the Drug Enforce23 ment Administration. 

24 (5) The Commissioner of Food and Drugs. 

25 (6) The Secretary of Veterans Affairs. 


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1 (7) The Administrator of the Centers for Medi2 care & Medicaid Services. 

3 (8) The Director of National Drug Control Pol4 icy. 

5 (9) Any other Federal official with relevant ex6 pertise appointed or invited to serve on the Commis7 sion by the Administrator of the Environmental Pro8 tection Agency. 

9 (10) Such individuals with expertise in public 

10 health, public safety, or the environment as may be 

11 appointed to serve on the Commission by the Admin12 istrator of the Environmental Protection Agency. 

13 (11) Such State and local officials and other 

14 stakeholders as may be invited to serve on the Com15 mission by the Administrator of the Environmental 

16 Protection Agency. 

17 (c) DUTIES.—The Commission shall— 

18 (1) provide a forum for academic, govern19 mental, and other experts, as appropriate, to develop 

20 a strategy to— 

21 (A) prevent the entry of drugs into the Na22 tion’s water supply and environment consistent 

23 with current public safety standards; and 


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1 (B) protect public health and promote pub2 lic safety by reducing diversion and the risk of 

3 abuse and accidental overdose; and 

4 (2) not later than 2 years after the date of the 

5 enactment of this Act, and annually thereafter, de6 velop and submit to the Congress such a strategy. 

7 (d) STRATEGY.— 

8 (1) CONTENTS.—The strategy required by sub9 section (c) shall— 

10 (A) assess risk hazards and strategies for 

11 reducing the risks associated with misuse of 

12 prescription drugs, including diversion, over13 dose, and accidental poisoning; 

14 (B) address all sources of contamination, 

15 including development, manufacturing, disposal, 

16 and metabolic processing; 

17 (C) include recommendations on minimum 

18 environmental standards for disposing of drugs 

19 by incineration and any other means deter20 mined appropriate by the Administrator of the 

21 Environmental Protection Agency; and 

22 (D) be designed to inform the regulations 

23 and guidance of the Environmental Protection 

24 Agency. 


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1 (2) CONSIDERATION.—In preparing the strat2 egy required by subsection (c), the Commission shall 

3 take into consideration the analysis and rec4 ommendations in the report under section 5. 

5 (e) TERMINATION.—The Commission shall terminate 

6 on the date that is 5 years after the date of the enactment 

7 of this Act. 

8 SEC. 5. REPORT ON DRUG BYPRODUCTS IN THE NATION’S 

9 WATER SUPPLY. 

10 (a) IN GENERAL.—Not later than 1 year after the 

11 date of the enactment of this Act, the Comptroller General 

12 of the United States shall submit a report to the Congress 

13 on drugs and drug byproducts in surface and ground 

14 water in the United States. 

15 (b) CONTENTS.—At a minimum, the report under 

16 subsection (a) shall include— 

17 (1) an analysis of— 

18 (A) the quantity and distribution of drugs 

19 and drug byproducts in surface and ground 

20 water in the United States; 

21 (B) the risks for humans and the environ22 ment associated with the presence of drugs and 

23 drug byproducts in such water; and 


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27 

•HR 2939 IH

1 (C) the current efforts of Government 

2 agencies to prevent the entry of drugs and drug 

3 byproducts into the water supply; 

4 (2) recommendations for actions by the Govern5 ment in order to prevent the entry of drugs and 

6 drug byproducts into the ground and surface waters 

7 of the United States; and 

8 (3) recommendations for additional research on 

9 drugs and drug byproducts in surface and ground 

10 water in the United States, including a budget for 

11 such research. 

Æ 


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