In March 2008, the Associated Press (AP) reported that a sizable amount and array of pharmaceuticals were detected in drinking water in 24 major metropolitan areas around the U.S., affecting the drinking supplies of at least 41 million Americans. The drugs detected include antibiotics, anti-convulsants, anti-depressants, steroids, and sex hormones. Indeed, the U.S. Environmental Protection Agency (EPA) has identified more than 100 individual pharmaceutical and personal care products in drinking water. As part of its ongoing investigation of these trace concentrations of drugs in drinking water, the AP also recently reported that approximately 271 million pounds of pharmaceuticals released into the waterways were legally released from manufacturing facilities.

While this figure seems large, consumers are undeniably the biggest contributors to the contamination. Prescription and over-the-counter drug products, as well as personal care products, are “released” by consumers into the environment in a number of ways, including excretion from the human body, routine ablutions, and common disposal habits, such as flushing them down the toilet, pouring them down the drain, or throwing them out in the garbage.

The AP investigation has heightened awareness of the issue of drugs in the water, triggering a number of actions and proposals on the national, state, and local levels. In the U.S. Congress, Sen. Kirsten Gillibrand (D-NY) has proposed requiring that the EPA conduct a two-year study to identify pharmaceutical and personal care products in the waterways, their sources, and methods of controlling them, including specific consideration of drugs that enter through human excretion, manufacturing, and other sources. Similar language has already passed in the House through the effort of Rep. Melissa Bean (D-IL).

While the proposed language supports EPA studying the issue, more onerous propositions are appearing in state congresses. At least five states have taken up legislation proposing industry-financed collection systems for unwanted drugs. Florida, Maine, Minnesota, Oregon, and Washington are each considering bills that would extend producer responsibility for unused pharmaceutical products through disposal.

Florida

Both the Florida House of Representatives and Senate are considering bills relating to pharmaceutical take-back programs. While the House bill proposes a pilot program in two counties, the Senate version would require drug manufacturers who sell prescription or proprietary drugs in Florida to establish a take-back program that accepts and disposes of pharmaceuticals turned in by consumers by July 1, 2011. The take-back program would be required to accept drugs presented by consumers, including long-term care facilities and hospice/home health programs; to accept drugs sold in the state regardless of manufacturer; to offer take-back services at no cost to the consumer; to be convenient and adequate to consumers in both rural and urban areas; to dispose of collected drugs by incineration or hazardous waste disposal; and to provide outreach and education to consumers regarding the availability of the program. The bill permits manufacturers to operate either individual or collective programs, requires a program plan be submitted initially and annually thereafter to the state for approval, permits fee collection by the state, and authorizes fines for violations.

Maine

The proposed legislation in Maine would, beginning January 1, 2010, require drug manufacturers – including those selling the drug on behalf of the physical manufacturer and those importing drugs – to participate in a program for the disposal of unwanted drugs. Manufacturers would be required to participate in a collective program unless specifically authorized to administer an independent program. The manufacturer would be responsible for submitting its proposed program to operate and finance the collection, transportation, and recycling or disposal of unwanted drugs; for paying all administrative and operational costs associated with the program; and for implementing the described program without charging a fee at the time of sale or collection of the product. An independent program must meet these requirements, and must also accept drugs from any manufacturer. The take-back program would be required to include, at a minimum, the use of prepaid mailing envelopes addressed to the Maine Drug Enforcement Agency (Agency), performance goals, including recovery goals for the first three years of the program, and a handling and disposal system that includes a public education effort and communications strategy. In addition, the program must be convenient and adequate to serve both urban and rural areas. The pending legislation would require disposal at a hazardous waste incinerator licensed with the state. With respect to enforcement, non-compliant manufacturers would be subject to civil penalties, and would be publicly identified as non-compliant on an Agency website. The program is to be paid for by the Unused Pharmaceu-tical Disposal Program Fund, including grants or contributions of money, fines and penalties under the proposal, or other things of value.

Minnesota

The proposed Minnesota Safe Drug Disposal Act of 2009 would mandate participation by drug producers and drug wholesalers in a product stewardship program operated by drug producers to collect and dispose of unwanted products from residential generators beginning January 1, 2012. Producers would be required to operate a product stewardship program approved by the state, independently or in conjunction with other producers, or to contract with a stewardship organization to execute such responsibility. All costs for the program would be borne by the producer. Each program must accept all unwanted products regardless of who produced them; must include public outreach; must describe the methods for collection including the locations of collection sites and mail-back program resources and an explanation of how the collection system will be convenient and adequate to both urban and rural residents; must describe tracking mechanisms through final disposal; and must describe its associated public education effort and outreach activities, including a website publicizing the collection locations and program operations and a toll-free number. Program submissions for state approval would be required by January 1, 2011, with required review and updates to program plans at least every four years. Producers would be required to submit an annual report describing the program’s activities. Administration of the program by the state would be funded by fees paid by producers. Enforcement provisions provide for substantial penalties up to and including $10,000 per day fines for non-participation.

Oregon

Proposed Oregon legislation would require manufacturers, either individually or with other manufacturers, to operate an approved pharmaceutical take-back program that would accept prescription and non-prescription drugs from consumers, including long-term care facilities and home health programs, regardless of manufacturer, at no cost to the consumer. The program, designed to be convenient and adequate to both rural and urban consumers, would permit disposal by incineration or hazardous waste disposal. The bill would also require an education and outreach program, and plan approval by the state. Within its program plan submitted to the state, a manufacturer must specify the steps it will take to coordinate with other manufacturers to minimize consumer confusion about different take-back programs, among other things. The state-run review of the take-back program plans, which would require annual renewal, would be paid for by industry fees. In addition, the bill provides for civil penalties. Manufacturers would be required to be covered by an approved program by July 1, 2011, with the requirement for plan submissions becoming effective January 1, 2010.

Washington

In the state of Washington, both the Senate and House are considering legislation requiring participation, beginning January 1, 2012, in a product stewardship program for unwanted products from residential sources by every producer of a prescribing or non-prescription drug sold in or into the state. The program, which can be administered individually or in conjunction with other producers or by a stewardship organization under contract, must be approved by the state, must be paid for by the producer, and must be accept all unwanted product regardless of who produces it. Plans submitted for evaluation by the state must describe and include collection mechanisms, with particular emphasis on location in each county and all cities with at least 10,000 people; transportation and disposal system; secure tracking and handling; maximization of packaging recycling; and public education efforts and outreach activities, including a toll-free number and website to publicize collection options. Programs would be required to dispose of collected products at hazardous waste facilities. Producers would be required to submit initial plans by January 1, 2011, update plans every four years thereafter, and submit annual reports describing the program’s activities beginning on or before June 30, 2013. The bill authorizes the use of fees for administering activities considered under the bill, and provides enforcement penalties up to and including $10,000 per day fines for non-participation.

If enacted, the bills purport to make drug manufacturers responsible for the pharmaceuticals they produce from cradle-to-grave. As stated in the Washington bill, the legislature specifically finds the producers of drugs to be “the best entity to provide and finance the product stewardship program.” The breadth of exposure of the AP investigation results, the growing concern over “pharm parties,” and the potential for accidental overdose attributed to the presence of unwanted, unused drug products, in conjunction with the gap in federal on-the-ground action, suggests that the potential for state activity in this area is great.

Gary C. Messplay is a partner in the Washington, D.C. office of Hunton & Williams LLP, where he is co-chair of the law firm’s Food and Drug Practice. Colleen Heisey is an attorney in the firm’s Food and Drug Practice.