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DEC Enforcement Discretion Letter, 6 NYCRR Parts 360 and 373

The following is a letter from DEC Office of the General Counsel, Deputy Counsel, Scott W. Crisafuli, dated June 22, 2016

This is to advise you, that subject to the terms set forth in this letter, the New York State Department of Environmental Conservation ("DEC") will exercise its authority to utilize enforcement discretion with respect to certain provisions of 6 NYCRR Parts 360 and 373 (Part 360 and Part 373) relating to the disposal of household pharmaceuticals, including controlled substances. Since the collection of household pharmaceuticals includes controlled substances as well as non-controlled substances, for the purposes of this enforcement discretion, all collected pharmaceuticals must be managed as controlled substances.

There is scientific evidence that unused pharmaceuticals are entering New York State water supplies. There is also a threat of rising drug abuse related to the improper storage or disposal of unwanted or expired pharmaceuticals from households. This has led to growing demand for communities, pharmacies, and other entities to sponsor community household pharmaceutical collection events and for authorized collectors and law enforcement agencies to install permanent collection receptacles. The Department promotes the management of household pharmaceuticals through collection events and permanent receptacles as the preferred method for homeowners to properly manage unused or expired pharmaceuticals.

In addition to the enforcement discretion with respect to part 360 and Part 373 provided herein, household pharmaceuticals are also excluded from regulation as hazardous waste pursuant to the Resource Conservation and Recovery Act and 6 NYCRR 371.1 (e)(2)(i). This exclusion continues after the household pharmaceuticals have been collected at household pharmaceutical collection events ("Event(s)") and permanent household pharmaceutical collection receptacles ("Receptacle(s)").

With respect to Events, Part 360 does contain an exemption for a site used to collect household hazardous waste (HHW) as part of a cleanup day or similar event (6 NYCRR 360-1.7(b)(6)). Because many pharmaceuticals fall within the definition of HHW, and absent regulatory criteria specific to pharmaceuticals, 6 NYC RR 360-1.7(b )(6) has been used to implement the current household pharmaceutical collection program for Events. For Receptacles, Part 360 requires a permit since Receptacles fall within the definition of solid waste management facilities (6 NYCRR 360-1.2(158)).

Additionally, the final disposal of household pharmaceuticals collected from an Event or Receptacle requires disposal at a facility permitted under Part 373, if disposed of in New York State, to the extent that the pharmaceuticals collected include HHW. The Department has issued variances from Part 373 to allow disposal of the collected household pharmaceuticals at municipal waste combustion facilities permitted under Part 360 (if disposed in New York State).

On October 9, 2014, the United States Drug Enforcement Administration (DEA) promulgated regulations ("Controlled Substances Disposal Rule")1 authorizing household pharmaceutical users to transfer unwanted and unused pharmaceutical controlled substances to certain entities authorized by the DEA for safe, secure and responsible disposal. More specifically, the Controlled Substances Disposal Rule permits manufacturers, distributors, reverse distributors, narcotic treatment programs, hospitals/clinics with on-site pharmacies and retail pharmacies to obtain authorization from the DEA to voluntarily administer mail-back programs and to maintain Receptacles ("Authorized Collectors"). Subsequently on October 26, 2015, Public Health Law §3343-b was amended to allow DEA Authorized Collectors to collect controlled substances in New York, without the presence or control of law enforcement agencies.

Existing DEC regulations hinder the efficient implementation of the DEA's Controlled Substances Disposal Rule and the amendments to the state Public Health Law. Therefore, compliance with the requirements of the Controlled Substances Disposal Rule and Public Health Law §3343-b will not be considered a violation of the provisions of Part 360 and Part 373 cited in this letter. Events and Receptacles that comply with the Controlled Substance Disposal Rule and the Public Health Law is consistent with previously allowed events for the collection and disposal of pharmaceuticals. Enforcement discretion will not be applied to the disposal of an Authorized Collector's existing inventory or stock of pharmaceuticals which continues to be subject to all requirements of Part 360 and Part 373.

Collected household pharmaceuticals disposed in the state must be destroyed in a municipal waste combustion facility permitted under Part 360 or by another method approved by the DEC. A list of permitted municipal waste combustors located in New York State can be found at www.dec.ny.gov/chemical/23683.html.

The DEC will exercise this authority until either January 2, 2018 or a rule is promulgated that exempts such facilities from the permit or variance requirements of Part 360 and Part 373, whichever is earlier. This issue has been addressed in the proposed amendments to the Part 360 Series, with an express exemption for Events and Receptacles. All other provisions of 6 NYCRR Parts 360 and 373 remain in effect and will be enforced.

Thank you for your cooperation in this matter. If you have any questions, please call Melissa Treers, P.E. of the Division of Materials Management at (518) 402-8678.

1 21 Code of Federal Regulations (CFR) Parts 1300, 1301, 1304, 1305, 1307 and 1317 (79 Federal Register (FR) 53520-53570, September 9, 2014) [http://www.deadiversion.usdoj.gov/drug_disposal/].


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