Related Rules or Statutes
Wisconsin statutes and rules relating to the manufacture, distribution, and use of pesticides in Wisconsin are set forth in ss. 94.67 to 94.71, Stats., and chs. ATCP 29 and 30, Wis. Admin. Code. Waste management is governed by ch. 289, Stats., and ch. NR 500, Wis. Admin. Code. The manufacture, distribution and dispensing of prescription drugs falls under the authority of the Pharmacy Examining Board. See ch. 450, Stats. “Veterinary prescription drugs” is defined in s. 453.02 (11), Stats. The Uniform Controlled Substances Act sets standards for prescription drugs that are “controlled substances,” pursuant to ch. 961, Stats. On April 8, 2014, 2013 Wisconsin Act 198 was published, which in part authorizes a political subdivision or a designee to operate a drug disposal program, effective July 1, 2015. Wisconsin clean sweep projects that collect unwanted prescription drugs will need to follow requirements in this statute. Plain Language Analysis
Under the clean sweep program, DATCP distributes grants to counties and other local governments to assist in funding their hazardous waste collection events and permanent waste collection sites. The clean sweep program was established in 1990 to provide financial assistance to Wisconsin counties to collect unwanted agricultural pesticides. In 2004, the program expanded to provide grants to local governments to collect household hazardous wastes such as acids, flammable chemicals, mercury, lead paint, and solvents. In 2007, Wis. Act 20 was enacted, which authorized the department to include the funding of county, municipal, and regional planning commission programs to collect unwanted prescription drugs, which include controlled substances, analgesics, anti-inflammatory drugs, antibiotics, gastrointestinal drugs, and antihistamines. DATCP implemented a pilot prescription drug program to develop standards for issuing grants related to collection of unwanted prescription drugs, and those standards are now incorporated into this rule.
Other changes in the rule are designed to improve the operational and administrative efficiency of the program for the department and local governments that participate in the “clean sweep” program. Since 1990, the program has matured and several current requirements are no longer needed. At the same time, the needs of the grant recipients have changed. These rule revisions address these changes and reflect the current state of hazardous waste collection in Wisconsin.
Rule Content
This rule amends ch. ATCP 34 relating to the clean sweep program. The following provides a summary of the rule changes by section topic: Section on the Purpose of the Rule
The establishment of procedures for making grants to local governments to dispose of unwanted prescription drugs will be added to the “Purpose” section of the rule.
Section on Definitions
The term “unwanted prescription drug” is added and includes Schedule II to V controlled substances, and nonprescription drug products. It also includes prescribed and over–the-counter veterinary drugs. The definition specifically excludes chemotherapy drugs, trace chemotherapy waste, infectious waste, and products that contain elemental mercury like thermometers. The unwanted prescription drug must come from a place where the individual, a member of the individual’s household, an in-home hospice service, or an adult family home serving fewer than five adult members manages the use of the unwanted prescription drug.
When local governments first decided to collect pesticide and household wastes, they often held one- or two-day collection “events.” Since then, many local governments have expanded to multiple collections or have established permanent collection sites that offer convenience for local residents. The rule removes the term “event” and refers to a clean sweep project as a “collection.”
A “temporary collection” means a clean sweep project that collects hazardous waste five days or less in a calendar year. A “continuous collection” means a clean sweep project that collects chemicals on six or more days in a calendar year. Initially, comments during DATCP listening sessions on the clean sweep program showed a desire to broaden the gap in time periods between temporary and continuous collections, DATCP did amend these definitions in the initial hearing draft. However, comments received during the rule’s public hearings indicated that there was no benefit to be gained by the proposed change in definitions. In fact, some collection projects would be unable to stay at a continuous collection level, which would ability of local governments to serve their communities because temporary collections must request lower funding levels. Therefore, DATCP’s proposed change to broaden the gap between “temporary” and “continuous” collections was removed from the proposed final rule.
Section on Grants to Counties and Municipalities
Drug Drop Boxes. Currently, clean sweep grant funds cannot be used to purchase permanent equipment. However, a large expense associated with the collection of unwanted prescription drugs is a drug drop box. These drop boxes are a secure place for residents to dispose of their unwanted prescription and veterinary drugs. The boxes typically are located within law enforcement agencies and are designed in such a way that drugs cannot be removed except by authorized personnel. The rule would allow a local government to request funds for the direct costs associated with the purchase and installation of a drug drop box.
Disposal of Dual-Hazardous Waste. This rule will allow counties and municipalities to request reimbursement for the disposal of delivery devices that contain medication such as epinephrine auto-injectors (an example is an EpiPen® ) or prefilled syringes. Disposal costs for sharps such as needles or lancets would remain ineligible for reimbursement.
Eligible Costs: Direct Costs related to the collection and disposal of unwanted prescription drugs were specified within the hearing draft. In the final draft, some modifications were made to specify eligibility of the collection and disposal of mercury-containing devices under a household hazardous waste collection.
Prohibited Uses: Prohibited uses of grant funds is expanded to include infectious waste, hypodermic needles and lancets, personal care products, and oxygen-containing devices. Section on Grant Applications
Grant Solicitation Announcements. This rule expands the methods of soliciting applications for clean sweep grant funds beyond just written announcements.
Grant Fund Amounts. Wis. Admin. Code ch. ATCP 34 states that the department shall offer no less than $400,000 for farm chemical waste collection and not less than $200,000 for household hazardous waste collection. In recent years, the demand for the collection and disposal of household hazardous waste has outpaced agricultural pesticides and farm chemical waste. Also, with the statutory addition of grants for unwanted prescription drug collections in 2008, a different allocation of funds among the collection grants is now required. The new statutory language requires the department to offer a minimum of two-thirds of the available funds for household hazardous waste under s. 93.57, Stats. This rule reflects the change in statutory requirements and eliminates the conflict between rule and statute. This change is also supported by the data collected from clean sweeps in recent years. The demand for household hazardous waste disposal is increasing while the demand for agricultural waste disposal is declining. Household waste disposal demand is outpacing agricultural demand by about a 16:1 margin, based on 2013 collection data.
Grant Applications. The current rule requires that grant applications be submitted on a form provided by the department. To keep up with changing and available technology such as electronic or web-based applications, the rule specifies that future applications will be submitted in a manner designated by DATCP.
Required Information in Applications. Because of the gap between grant submittal and acceptance and the possibility that a grant may not be funded, this rule specifies that applicants no longer have to provide specific dates, locations and facilities for collections. The department will gather that information after grants are awarded. The rule also removes the requirement that an applicant describe its plans for collecting, handling and disposing of chemical waste. Clean sweep collections are not new and local governments and waste haulers have developed much experience since 1990. Finally, because multi-government collections are quite common as a way to reach more residents and gain efficiencies with collections, applicants no longer need to describe the role of each government participant under this rule.
Section on Evaluating Grant Applications
Evaluation of Eligible Applications. Under this rule, the department will modify the criteria used to assess clean sweep grant applications. Early in the program’s history, applicants were encouraged to collect farm and household waste and determine what chemicals were of concern in their areas. Now the majority of applicants are experienced project coordinators familiar with local needs and available resources. For some, it is impractical to collect more than one waste type because there is no need. Because of the experience of the local government coordinators and their staff, evaluating an application based on its safety and suitability is no longer necessary. Coordination across multiple governments is encouraged and points are awarded for these types of collections, but it is no longer necessary to place a priority on such coordination.
Section on Grant Awards
Farm Waste and Household Waste. This proposed section reflects the changes in the statute for grant awards and removes the discrepancy between statue and rule. The current rule states that the department will annually award grants totaling at least $400,000 for farm chemical waste, while the statute directs that the department to offer a minimum of two-thirds of the available funds for household hazardous waste. This rule corrects the discrepancy by taking into consideration the current appropriation under s. 20.115 (7) (va), Stats. Section on Grant Contracts
Hazardous Waste Contract. This rule removes the requirement that the written contract between the department and the clean sweep grant recipient include the recipient’s contract with its hazardous waste contractor. The department has found that the information provided in the grant applications is sufficient to make awards.
Limited Funding. Should the amount of grant funds available be insufficient to cover the awarded grants, the department has the ability to cancel one of more of the grants at itsdiscretion.
Section on Collecting Waste Pesticides from Very Small Quantity Generators (VSQGs)
Generally, a “VSQG” is an individual or business who generates limited quantities of waste pesticides and can include certain hardware stores, farm supply stores, cooperatives, municipalities, or commercial pesticide applicators. This proposed section removes the requirement that a county must collect the license status of a VSQG licensed under ch. ATCP 29. As long as the VSQG’s name and address is captured, the department can verify licensure, if necessary. Section on Hazardous Waste
Hazardous Waste Contractor. This proposed section incorporates unwanted prescription drug collection into the rule. It also removes the requirement that hazardous waste contractors selected by grant recipients attend a training session provided by the department. This was a necessary requirement in the early days of the program but is no longer needed since the program participants, including waste contractors, have gained experience and familiarity with the clean sweep program rules.
Section on Reports and Payments
Final Report. This proposed section allows for a 45-day extension on the final report deadline. Other required elements of the final report are consolidated within the rule. This proposed section removes the requirements to estimate future collection needs, the timing of collection and suggestions on how to collect chemical waste, which are considered no longer necessary with a mature program.
Comparison with Existing or Proposed Federal Statutes and Regulations
The United States environmental protection agency (EPA) administers the Resource Conservation and Recovery Act (RCRA), which includes regulations affecting the collection, movement, and disposal of hazardous agricultural and household waste. EPA has also adopted universal waste management rules under 40 CFR 273. Wisconsin’s “clean sweep” grantees and vendors must comply with all applicable RCRA and universal waste provisions. Prescription drugs that are controlled substances are regulated under the federal Controlled Substance Act (21 USC 801) and the Controlled Substances Import and Export Act (21 USC 951). On September 9, 2014, the federal drug enforcement administration published its final regulations on prescription drug disposal under the Secure and Responsible Drug Disposal Act of 2010, which took effect on October 9, 2014. Wisconsin’s prescription drug “clean sweep” program must comply with all these federal laws and regulations. Comparison with Rules in Adjacent States
The surrounding states of Illinois, Iowa, Michigan and Minnesota also collect unwanted pesticides, household hazardous waste or unwanted prescription drugs. The agencies involved, their funding sources, and distribution of funds vary greatly. Wisconsin is the only state that has one agency overseeing these various types of grants.
Illinois
Illinois offers a grant for agricultural and structural pesticide collections through the Illinois department
of agriculture. The Illinois environmental protection agency also offers four one-day collections for household hazardous waste and unwanted drugs, in addition to some county hosted events. Illinois’s Prescription Pill and Drug Disposal Fund provides reimbursement to law enforcement agencies for collection, transport and incineration of medicines collected from residential sources. Iowa
Iowa no longer holds household hazardous waste collection days and eliminated the award of grants to fund those one-day collections. Instead, the Iowa department of natural resources offers Regional Collection Centers (RCCs) that are open year-round. These RCCs take household waste but can also accept agricultural waste at their discretion. In addition to main RCCs, there are satellite RCC sites and mobile collections that contract with an RCC and travel within a county for collections. Iowa offers two kinds of funds: (1) reimbursement funds to cover operating expenses/disposal costs, and (2) establishment funds to help a county set up a permanent site. Unlike Wisconsin’s clean sweep program, Iowa allows its funds to be used to build permanent facilities.
Iowa also offers a pharmaceutical disposal program called TakeAway, in which patients or caregivers can bring unwanted or expired medicines to participating TakeAway pharmacies. The pharmacist will dispose of the returned medications (prescription drugs or over-the-counter products) into a waste bin specially designed to safely store discarded pharmaceutical products, along with their packaging. Once filled, the TakeAway system is sealed and shipped to a medication disposal facility where the system and its contents are incinerated at a waste-to-energy facility. Some participating pharmacies also sell TakeAway envelopes, pre-addressed, postage pre-paid large envelopes that can be taken into the home, filled with unused and expired medicine, and mailed through the United States postal service to the disposal facility. Controlled substances must go to law enforcement or one of the United State drug enforcement administration collections.
Michigan
Michigan offers a clean sweep program for agricultural pesticides through its department of agriculture & rural development (MDARD). The Michigan department of environmental quality covers household collections, supported by an EPA grant. No grants are given. MDARD will cover the cost of transportation and disposal costs of pesticides collected at household events.
Minnesota
Minnesota enters into cooperative agreements with counties to collect non-agricultural and agricultural waste pesticides. For those counties without a cooperative agreement, the Minnesota department of agriculture (MDA) holds collections. Agricultural pesticides are collected every other year and household hazardous wastes are collected each year. MDA pays supplies, transportation and disposal costs and $0.25/lb. for “reasonable overhead costs.” The Minnesota pollution control agency (MPCA) provides stipends to counties for household hazardous waste collections. Stipends cover about 10 percent of costs and are determined by different formulas. Minnesota does not offer drug grants. Collections, transportation and disposal are overseen by county law enforcement and the counties pay all associated costs.
Summary of Factual Data and Analytical Methodologies
To develop this rule, four listening sessions were held throughout Wisconsin. Participants included representatives from local government entities that are current and past grant recipients, many of whom manage county or municipal solid waste programs. Comments were also received from law enforcement agencies that administer unwanted prescription drug collections.
Fiscal Impact
There will be no fiscal impact from this rule revision. The amount of available grant funds will not change under this rule revision nor have eligibility requirements changed.
