The proposed rule amendments are intended to allow flexibility in the management of hazardous waste pharmaceuticals by regulating such waste as universal waste in Florida, and to clarify standards applicable to handlers of hazardous waste ...  


  • RULE NO: RULE TITLE
    62-730: HAZARDOUS WASTE
    62-730.186: Universal Pharmaceutical Waste
    PURPOSE AND EFFECT: The proposed rule amendments are intended to allow flexibility in the management of hazardous waste pharmaceuticals by regulating such waste as universal waste in Florida, and to clarify standards applicable to handlers of hazardous waste pharmaceuticals. The new rule does not require generators to manage hazardous waste pharmaceuticals as universal waste, and does not require reverse distributors to become handlers of hazardous waste pharmaceuticals. The new rule does not impose any new regulatory requirements. It merely allows a less stringent management option for persons who generate hazardous waste pharmaceuticals and for reverse distributors who choose to accept hazardous waste pharmaceuticals.
    SUMMARY: This rule establishes requirements for handlers of hazardous waste pharmaceuticals. It includes definitions; prohibitions; notification; waste and container management; labeling; accumulation time limits; employee training; response to releases; off-site shipments; record-keeping; and conditions related to handlers who are reverse distributors.
    SUMMARY OF ESTIMATED REGULATORY COSTS: No Statement of Estimated Regulatory Cost was prepared.
    Any person who wishes to provide information regarding a statement of estimated regulatory costs, or provide a proposal for a lower cost regulatory alternative must do so in writing within 21 days of this notice.
    SPECIFIC AUTHORITY: 403.061, 403.151, 403.704, 403.72, 403.721 FS.
    LAW IMPLEMENTED: 120.52, 120.54, 403.061, 403.151, 403.704, 403.72, 403.721 FS.
    A HEARING WILL BE HELD AT THE TIME, DATE AND PLACE SHOWN BELOW:
    TIME AND DATE: October 26, 2006, 9:00 a.m.
    PLACE: Conference Room A, 3900 Commonwealth, Tallahassee, Florida
    Pursuant to the provisions of the Americans with Disabilities Act, any person requiring special accommodations to participate in this workshop/meeting is asked to advise the agency at least 48 hours before the workshop/meeting by contacting: DEP Bureau of Personnel Services at (850)245-2511 If you are hearing or speech impaired, please contact the agency using the Florida Relay Service, 1(800)955-8771 (TDD) or 1(800)955-8770 (Voice).
    THE PERSON TO BE CONTACTED REGARDING THE PROPOSED RULE IS: Julie Rainey, Environmental Manager; Hazardous Waste Regulation; Mail Station 4560, Department of Environmental Protection, 2600 Blair Stone Road, Tallahassee, Florida 32399-2400, (850)245-8713; julie.c.rainey@dep.state.fl.us.

    THE FULL TEXT OF THE PROPOSED RULE IS:

    62-730.186  Universal Pharmaceutical Waste

    (1)  The requirements of this section apply to:

    (a)  “Hazardous waste pharmaceuticals” (as defined in paragraph 62-730.186(4)(e), F.A.C.) while they are managed in Florida: and

    (b)  Large and small quantity handlers of universal pharmaceutical waste as defined in paragraphs 62-730.186(4)(f) and (l), F.A.C., including persons who handle universal pharmaceutical waste on an infrequent or episodic basis, as well as those who handle such waste routinely or periodically.

    (2)  The requirements of this section do not apply to:

    (a)  Pharmaceuticals that are not hazardous waste;

    (b)  Pharmaceuticals that have not been discarded and that are:

    1.  Returned with a reasonable expectation of credit through the pharmaceutical reverse distribution system to a manufacturer, wholesaler or reverse distributor, in accordance with an agreement or policy of the manufacturer, due to an oversupply, expiration of the recommended shelf life, a manufacturer recall, a shipping error or damage to the exterior packaging;

    2.  Donated to a charitable organization as described in the Internal Revenue Code and permitted pursuant to the requirements of subsection 64F-12.023(1), F.A.C.; or

    3.  Sold to persons who resell and do not discard the pharmaceuticals;

    (c)  Pharmaceuticals that are biomedical waste as defined in section 403.703, Florida Statutes (F.S.);

    (d)  Spill residues, cleanup materials, and media that are contaminated with pharmaceuticals as the result of a spill or discharge; and

    (e)  Raw materials or ingredients used in the manufacture of pharmaceuticals.

    (3)  Hazardous waste pharmaceuticals are considered to be universal waste in Florida when managed in accordance with this section.  Hazardous waste pharmaceuticals not managed as universal waste in accordance with this section shall be managed in accordance with Chapter 62-730, F.A.C., and shall be disposed of at a permitted hazardous waste treatment, storage or disposal facility.

    (4)  Definitions.  As used in this section:

    (a)  “Consumer packaging” means the packaging that surrounds or encloses a container, in a form intended or suitable for a healthcare or retail venue, or rejected during the manufacturing process as long as it is enclosed in its bottle, jar, tube, ampule, or package for final distribution to a healthcare or retail venue.

    (b)  “Container” means the receptacle, such as a bottle, jar, tube, or ampule, into which a pharmaceutical is placed, packaged for transport and/or transported and intended for distribution or dispensing to an ultimate user, and does not include any element of a pharmaceutical that is intended to be absorbed, inhaled or ingested.

    (c)  “Distribute” means to deliver a pharmaceutical by means other than by administering or dispensing.

    (d)  “Distributor” means a person who distributes.

    (e)  “Hazardous waste pharmaceutical” means a “non-viable” “pharmaceutical” [as defined in paragraphs 62-730.186(4)(i) and 62-730.186(4)(h), F.A.C., respectively] that exhibits a characteristic as described in 40 CFR Part 261, Subpart C [as adopted in subsection 62-730.030(1), F.A.C.] or is listed hazardous waste pursuant to 40 CFR Part 261, Subpart D [as adopted in subsection 62-730.030(1), F.A.C.]  If the waste formulation includes a commercial chemical product listed in Subpart D as the sole active ingredient, then the entire formulation is considered a hazardous waste pharmaceutical, unless excluded by 40 CFR 261.3(g) [as adopted in subsection 62-730.030(1), F.A.C.]. A pharmaceutical becomes a waste when it is no longer “viable” (as defined in paragraph 62-730.186(4)(n), F.A.C.); when a decision is made to discard the pharmaceutical; or when the pharmaceutical is abandoned as described in 40 CFR 261.2(b) [as adopted in subsection 62-730.030(1), F.A.C.]  A pharmaceutical does not meet the definition of a “solid waste” under 40 CFR 261.2 and is considered product as long as it is viable, a decision to discard it has not been made, and it is not abandoned as described in 40 CFR 261.2(b).  Pharmaceuticals that are produced by a pharmaceutical manufacturer without reasonable expectation of sale, returned or delivered without a reasonable expectation of credit to a manufacturer, wholesaler, reverse distributor or any type of waste broker, are non-viable and are discarded.  Non-viable pharmaceuticals that are hazardous waste may be handled as universal waste under this rule.

    (f)  “Large quantity handler of universal waste” means a “universal waste handler” [as defined in 40 CFR 273.9 (as adopted in subsection 62-730.185(1), F.A.C.)] that, at any time:

    1.  Accumulates 5,000 kilograms or more total of universal waste (batteries, pesticides, thermostats, lamps, or pharmaceuticals, calculated collectively), or

    2.  Accumulates universal pharmaceutical waste consisting of more than one kilogram total of pharmaceuticals listed in 40 CFR 261.33(e) [as adopted in subsection 62-730.030(1), F.A.C.] as acute hazardous waste (“p-listed wastes”). The designation as a large quantity handler of universal waste is retained through the end of the calendar year in which the universal waste, identified in subparagraphs 1. and 2. of paragraph 62-730.186(4)(f), F.A.C., is accumulated.

    (g)  “Manufacturer” means a person who prepares, derives, manufactures, or produces a pharmaceutical.

    (h)  “Pharmaceutical” means a manufactured chemical product that is intended to be inhaled, ingested, injected, or topically applied for use in the diagnosis, cure, mitigation, treatment, therapy, or prevention of disease or injury in humans or other animals.

    (i)   “Non-viable” means a pharmaceutical that cannot be sold, returned to the manufacturer, wholesaler or reverse distributor with a reasonable expectation of credit, or donated to a charitable organization.  Pharmaceuticals that are obviously "waste-like", such as partial intravenous formulations; partial vials used in the preparation of intravenous (IV) formulations; outdated samples; other outdated items repackaged at the pharmacy; partial vials or vials used on the unit and not emptied (such as insulin and epinephrine dispensing devices); partial ointments, creams and lotions;  partial inhalants; partial containers that are not empty as defined in 40 CFR 261.7 [as adopted in subsection 62-730.030(1), F.A.C.]; patient's personal medications that have been left at the hospital; filled finished products that are rejected during the manufacturing process, so long as they are in their consumer package (such as bottle, jar, tube, or ampule), do not support a reasonable expectation of credit and therefore are non-viable pharmaceuticals.

    (j)  “Pharmaceutical reverse distribution system” means the established practice of shipping expired or other unsaleable pharmaceutical products from pharmacies, medical practitioners, over-the-counter pharmaceutical retailers, and pharmaceutical wholesalers to pharmaceutical reverse distributors and then to manufacturers with the intent of receiving credit.  These items may be shipped directly to manufacturers depending on manufacturer return policies.

    (k)  “Reverse distributor” means a person engaged in the reverse distribution of pharmaceuticals who:

    1.  Operates a warehouse licensed by the Department of Health Bureau of Statewide Pharmaceutical Services under Chapter 499, F.S., as a reverse distributor; and

    2.  Has management systems in place to ensure compliance with applicable requirements of 40 CFR Parts 260 through 273 [as adopted in sections 62-730.021 and 62-730.183, and subsections 62-730.020(1), 62-730.030(1), 62-730.160(1), 62-730.170(1), 62-730.180(1) & (2), 62-730.181(1), 62-730.185(1), and 62-730.220(1), F.A.C.] and Chapter 62-730, F.A.C.

    NOTE:  The Federal Drug Enforcement Administration has registration requirements for  persons engaged in the reverse distribution of pharmaceuticals who handle controlled substances in Schedules II through V promulgated under United States Code, Title 21, Section 812

    (l)  “Small quantity handler of universal waste” means a “universal waste handler” [as defined in 40 CFR 273.9 (as adopted in subsection 62-730.185(1), F.A.C.)] that does not:

    1.  Accumulate 5,000 kilograms or more total of universal waste (batteries, pesticides, thermostats, lamps or pharmaceuticals, calculated collectively); or

    2.  Accumulate universal pharmaceutical waste consisting of more than one kilogram total of pharmaceuticals listed in 40 CFR 261.33(e) [as adopted in subsection 62-730.030(1), F.A.C.] as acute hazardous waste (“p-listed wastes”).

    (m)  “Universal waste” means any of the following hazardous wastes that are subject to the universal waste requirements of 40 CFR Part 273 [as adopted in subsection 62-730.185(1), F.A.C.], Chapter 62-730, F.A.C., or Chapter 62-737, F.A.C.: batteries as described in 40 CFR 273.2; pesticides as described in 40 CFR 273.3; thermostats as described in 40 CFR 273.4; lamps as described in 40 CFR 273.5; mercury-containing devices as described Chapter 62-737, F.A.C.; and pharmaceuticals as defined in paragraph 62-730.186(4)(e), F.A.C.

    (n)  “Viable” means a pharmaceutical can be sold, returned to the manufacturer, wholesaler or reverse distributor with a reasonable expectation of credit, or donated to a charitable organization meeting the definition in the Internal Revenue Code and permitted in accordance with subsection 64F-12.023(1), F.A.C.

    (o)  “Wholesaler” means a person who sells or distributes for resale any pharmaceutical as defined in paragraph 62-730.186(4)(e), F.A.C., to any entity other than the ultimate user.

    (5)  A large or small quantity handler of universal pharmaceutical waste (“handler”) is prohibited from:

    (a)  Disposing of universal pharmaceutical waste; and

    (b)  Diluting or treating universal pharmaceutical waste, except when responding to releases as described in subsection 62-730.186(10), F.A.C., or when managing waste as described in subsection 62-730.186(7), F.A.C.

    (6)  A handler shall notify the Department in writing and receive an EPA Identification Number before accumulating universal pharmaceutical waste or offering such waste for transport.  A handler of hazardous waste that has already notified the Department of its hazardous waste management activities and obtained an EPA Identification Number is not required to renotify under this section.  Notification shall include:

    (a)  The handler’s name and mailing address;

    (b)  The name and business telephone number of the person at the handler’s site to contact regarding universal pharmaceutical waste management activities;

    (c)  The address or physical location of the universal pharmaceutical waste management activities;

    (d)  A list of all the types of universal waste managed by the handler (e.g., batteries, pesticides, thermostats, lamps, pharmaceuticals); and

    (e)  A statement indicating the handler status and the amount in kilograms of each universal waste the handler expects to accumulate at one time.

    (7)  A handler shall implement proper universal pharmaceutical waste management activities that include the following:

    (a)  A handler shall contain any universal pharmaceutical waste that shows evidence of leakage, spillage, or damage that could cause leakage under reasonably foreseeable conditions.  A handler shall manage universal pharmaceutical waste in a way that prevents releases of any universal pharmaceutical waste or component of a universal pharmaceutical waste to the environment.  The universal pharmaceutical waste shall be contained in one or more of the following:

    1.  A container that remains closed (except when adding or removing waste), is structurally sound and compatible with the pharmaceutical, and that lacks evidence of leakage, spillage, or damage that could cause leakage under reasonably foreseeable conditions;

    2.  A container that does not meet the requirements of subparagraph 62-730.186(7)(a)1., F.A.C., provided the unacceptable container is overpacked in a container that does meet the requirements; and

    3.  A tank that meets the requirements of 40 CFR Part 265 Subpart J [as adopted in subsection 62-730.180(2), F.A.C.], except for 40 CFR 265.197(c), 265.200 and 265.201.

    (b)  A handler shall clearly label containers and tanks accumulating waste pharmaceuticals with the phrase “universal pharmaceutical waste” or “universal waste pharmaceuticals,” and with specific hazardous waste codes applicable to the universal pharmaceutical waste in the container or tank.

    (c)  A handler may conduct the following activities as long as the innermost container of each individual pharmaceutical remains intact and closed, and marked with the applicable hazardous waste code:

    1.  Sorting or mixing individual pharmaceuticals in one outer container, as long as the pharmaceuticals are compatible;

    2.  Disassembling packages containing several pharmaceuticals into individual pharmaceuticals; and

    3.  Removing pharmaceuticals from consumer packaging.

    (d)  A handler of universal pharmaceutical waste may generate solid waste as a result of the activities in paragraph 62-730.186(7)(c), F.A.C., of this subsection. A handler of universal pharmaceutical waste that generates solid waste shall determine whether the solid waste is hazardous waste identified in 40 CFR Part 261 Subpart C or D [as adopted in subsection 62-730.030(1), F.A.C.].  If the solid waste is a hazardous waste, it shall be managed in compliance with all applicable requirements of Chapter 62-730, F.A.C.  The handler is considered the generator of the hazardous waste and is subject to 40 CFR Part 262 [as adopted in subsection 62-730.160(1), F.A.C.].  If the solid waste is not hazardous waste, the handler may manage the waste in any way that is in compliance with applicable federal, state and local solid waste regulations.

    (e) 1.  A reverse distributor who meets the definition of “universal waste handler” in 40 CFR 273.9 [as adopted in subsection 62-730.185(1), F.A.C.] shall meet the requirements for “handlers” in subsections 62-730.186(6) through (12), F.A.C., of this section.

    2.  A reverse distributor shall:

    a.  Begin the process of distinguishing viable pharmaceuticals from universal pharmaceutical waste or hazardous waste within 14 days of receipt of a complete shipment of returns from a handler, and in no event more than 21 days from the receipt of the first installment of a partial shipment;

    b.  Complete the universal pharmaceutical waste or hazardous waste identification process within 21 days of receipt of the complete shipment, and in no event more than 30 days from receipt of the first installment of a partial shipment; and

    c.  Keep a record of each shipment of returns by any method that clearly demonstrates the date on which the shipment was received and the date on which the reverse distributor determined the universal pharmaceutical waste or hazardous waste status of all items in the shipment.

    (8)  The following are accumulation time limits and verification practices for handlers of universal pharmaceutical waste:

    (a)  A small quantity handler of universal waste may accumulate universal pharmaceutical waste for no longer than one year from the date the universal pharmaceutical waste were generated, unless the requirements of paragraph 62-730.186(8)(c), F.A.C., are met.

    (b)  A large quantity handler of universal waste may accumulate universal pharmaceutical waste for no longer than 6 months from the date the universal pharmaceutical wastes are generated, unless the requirements of paragraph 62-730.186(8)(c), F.A.C., are met.

    (c)  A handler may accumulate universal pharmaceutical waste for a longer period of time than specified in paragraphs 62-730.186(8)(a) and (b), F.A.C., if such activity is solely for the purpose of accumulation of such quantities of universal pharmaceutical waste as are necessary to facilitate proper recovery, treatment or disposal.  However, the handler bears the burden of proving that the extended accumulation time is solely for these purposes.

    (d)  A handler shall be able to demonstrate the accumulation time for the universal pharmaceutical waste.  The handler may make this demonstration by:

    1.  Placing the universal pharmaceutical waste in a container and marking or labeling the container with the earliest date that any universal pharmaceutical waste in the container became a waste;

    2.  Marking or labeling each individual item of universal pharmaceutical waste (e.g., each individual pharmaceutical container or package) with the date it became a waste;

    3.  Maintaining an inventory system on-site that identifies the date each universal pharmaceutical waste became a waste;

    4.  Maintaining an inventory system on-site that identifies the earliest date that any universal pharmaceutical waste in a group of universal pharmaceutical wastes, or a group of containers of universal pharmaceutical wastes, became waste; or

    5.  Using any other method which clearly demonstrates the length of time the universal pharmaceutical wastes have been accumulating from the date they became a waste.

    (9)  A handler shall ensure that all employees handling or managing universal pharmaceutical waste successfully complete a program of classroom instruction or on-the-job training.

    (a)  The training shall ensure that all employees are thoroughly familiar with proper waste management procedures relevant to their responsibilities during normal facility operations and emergencies.  The training shall include response to releases as required by subsection 62-730.186(10), F.A.C.

    (b)  Employees working at a handler’s facility on [effective date] shall successfully complete the training program required in paragraph 62-730.186(9)(a), F.A.C., within three months after the effective date.  Employees hired or assigned after [effective date] shall successfully complete the training program within three months after the date of their employment at or assignment to the handler’s facility.  These employees shall not work unsupervised until they have completed the training requirements.

    (c)  Employees shall take part in an annual review of the initial training required in paragraph 62-730.186(9)(a), F.A.C., and the handler shall ensure that the annual review is available to the employees.

    (d)  A handler shall document the training given to each employee.  The documents shall include the employee’s name, signature, date of hire or assignment, date of training, and type of training.  The training documents shall be kept at the handler's place of business for at least three years.

    (10) A handler shall immediately contain all releases of universal pharmaceutical waste (including spills that occur indoors).  A handler shall determine whether any material resulting from a release is hazardous waste.  A handler shall manage any such hazardous waste in compliance with the requirements of 40 CFR Parts 260 through 272 [as adopted in sections 62-730.021, and 62-730.183, and subsections 62-730.020(1), 62-730.030(1), 62-730.160(1), 62-730.170(1),  62-730.180(1) & (2),  62-730.181(1), and 62-730.220(1), F.A.C.].  The handler is considered the generator of the material resulting from the release and shall manage the material in compliance with 40 CFR Part 262 [as adopted in subsection 62-730.160(1), F.A.C.]. Material resulting from the release of universal pharmaceutical waste may not be managed as universal pharmaceutical waste.

    (11) Off-site shipments of universal pharmaceutical waste shall meet the following requirements:

    (a)  A handler is prohibited from sending or taking universal pharmaceutical waste to a place other than to a handler who has notified the department pursuant to subsection 62-730.186(6), F.A.C, a reverse distributor, a destination facility as defined in 40 CFR 273.9 [as adopted in subsection 62-730.185(1), F.A.C.], or a foreign destination in accordance with the requirements of paragraph 62-730.186(11)(j), F.A.C.

    (b)  A reverse distributor is prohibited from taking or sending universal pharmaceutical waste to a place other than a destination facility that is permitted pursuant to 40 CFR Parts 264 [as adopted in subsection 62-730.180(1), F.A.C.] and 270 [as adopted in subsection 62-730.220(1), F.A.C.] for treatment, storage or disposal of hazardous waste, or a foreign destination in accordance with the requirements of paragraph 62-730.186(11)(j), F.A.C.

    (c)  If a handler self-transports universal pharmaceutical waste off-site, the handler becomes a universal waste transporter for those self-transportation activities and shall comply with the transporter requirements of 40 CFR Part 273 Subpart D [as adopted in subsection 62-730.185(1), F.A.C.] while transporting the universal pharmaceutical waste.

    (d)  A handler that intends to transport a universal pharmaceutical waste that meets the definition of hazardous materials in 49 CFR Parts 171 through 180 shall comply with the applicable Department of Transportation regulations in 49 CFR Parts 172 through 180.  The handler shall package, label, mark and placard the shipment, and prepare proper shipping papers, in accordance with these Department of Transportation regulations.  Handlers are advised to consult 49 CFR 172.101 for a list of hazardous materials and a table summarizing shipping requirements.

    (e)  A handler that transports a universal pharmaceutical waste to a reverse distributor must provide the reverse distributor with written information sufficient to allow the reverse distributor to make knowledgeable decisions about the safe handling and proper disposal of the universal pharmaceutical waste.

    (f)  Prior to sending a shipment of universal pharmaceutical waste to a destination facility, the originating handler shall ensure that the destination facility agrees in writing to receive the shipment. One agreement to accept universal waste from a handler can cover more than one shipment.

    (g)  If a handler sends a shipment of universal pharmaceutical waste to a destination facility and the shipment is rejected by the destination facility, the originating handler shall either:

    1.  Receive the waste back when notified that the shipment has been rejected; or

    2.  Agree with the destination facility on a alternate destination facility to which the shipment will be sent.

    (h)  If a destination facility receives a shipment containing hazardous waste that is labeled universal pharmaceutical waste but is not in fact universal pharmaceutical waste, the destination facility shall immediately notify the Department of the mislabeled shipment and provide the name, address, and telephone number of the originating handler.  The destination facility shall handle the hazardous waste in accordance with the requirements of Chapter 62-730, F.A.C.

    (i)  If a destination facility receives a shipment of non-hazardous, non-universal waste pharmaceuticals, the destination facility may manage the waste pharmaceuticals in any way that is in compliance with applicable federal, state and local solid waste regulations.

    (j)1. A handler who sends universal pharmaceutical waste to a foreign destination which is one of the following designated member countries of the Organization for Economic Cooperation and Development (OECD): Australia, Austria, Belgium, Denmark, Finland, France, Germany, Greece, Iceland, Ireland, Italy, Japan, Luxembourg, Netherlands, New Zealand, Norway, Portugal, Spain, Sweden, Switzerland, Turkey, and United Kingdom, is subject to the requirements of 40 CFR Part 262 Subpart H [as adopted in subsection 62-730.160(1), F.A.C.].

    2.  A handler who sends universal pharmaceutical waste to a foreign destination other than those listed in subparagraph 62-730.186(11)(j)1., F.A.C., must:

    a.  Comply with the requirements applicable to a primary exporter in 40 CFR 262.53, 262.56(a)(1) through (4), (6), and (b), and 262.57 [as adopted in subsection 62-730.160(1), F.A.C.];

    b.  Export such universal pharmaceutical waste only upon consent of the receiving country and in conformance with the EPA Acknowledgement of Consent as defined in 40 CFR 262.51 [as adopted in subsection 62-730.160(1), F.A.C.]; and

    c.  Provide a copy of the EPA Acknowledgement of Consent for the shipment to the transporter who transports the shipment for export.

    (k)  This section applies to hazardous waste pharmaceuticals only while they are managed in Florida.  Handlers are advised to meet the regulatory requirements of the receiving state when hazardous waste pharmaceuticals are shipped out of state.

    (12) A handler shall keep a record of each shipment of universal pharmaceutical waste sent to a reverse distributor, destination facility, or foreign destination.  The record shall consist of a written receipt, manifest, bill of lading or other written documentation.  A handler shall retain the records at its place of business for at least three years from the date of shipment.  The record for each shipment of universal pharmaceutical waste shall include the following information:

    (a)  The name and address of the reverse distributor, destination facility or foreign destination to which the universal pharmaceutical wastes were sent;

    (b)  The quantity of universal pharmaceutical waste sent; and

    (c)  The date the shipment of universal pharmaceutical waste left the handler’s facility.

    (13) This section constitutes state authorization for reverse distributors to manage hazardous pharmaceutical waste from conditionally exempt hazardous waste generators (CESQGs) and authorization for CESQGs to ensure delivery of their hazardous waste pharmaceuticals to a reverse distributor, pursuant to 40 CFR 261.5(f)(3)(iii) and 40 CFR 261.5(g)(3)(iii) [as adopted in subsection 62-730.030(1), F.A.C.].

    Specific Authority 403.061, 403.151, 403.704, 403.72, and 403.721, F.S. Law Implemented 120.52, 120.54, 403.061, 403.151, 403.704, 403.72, and 403.721, F.S. History-New            .


    NAME OF PERSON ORIGINATING PROPOSED RULE: Tim Bahr, Environmental Administrator, Hazardous Waste Regulation, Department of Environmental Protection
    NAME OF SUPERVISOR OR PERSON WHO APPROVED THE PROPOSED RULE: Mary Jean Yon, Division, Division of Waste Management, Department of Environmental Protection
    DATE PROPOSED RULE APPROVED BY AGENCY HEAD: September 1, 2006
    DATE NOTICE OF PROPOSED RULE DEVELOPMENT PUBLISHED IN FAW: May 2, 2003

Document Information

Comments Open:
9/15/2006
Summary:
This rule establishes requirements for handlers of hazardous waste pharmaceuticals. It includes definitions; prohibitions; notification; waste and container management; labeling; accumulation time limits; employee training; response to releases; off-site shipments; record-keeping; and conditions related to handlers who are reverse distributors.
Purpose:
The proposed rule amendments are intended to allow flexibility in the management of hazardous waste pharmaceuticals by regulating such waste as universal waste in Florida, and to clarify standards applicable to handlers of hazardous waste pharmaceuticals. The new rule does not require generators to manage hazardous waste pharmaceuticals as universal waste, and does not require reverse distributors to become handlers of hazardous waste pharmaceuticals. The new rule does not impose any new ...
Rulemaking Authority:
403.061, 403.151, 403.704, 403.72, 403.721 FS.
Law:
120.52, 120.54, 403.061, 403.151, 403.704, 403.72, 403.721 FS.
Contact:
Julie Rainey, Environmental Manager; Hazardous Waste Regulation; Mail Station 4560, Department of Environmental Protection, 2600 Blair Stone Road, Tallahassee, Florida 32399-2400, (850)245-8713; julie.c.rainey@dep.state.fl.us.
Related Rules: (1)
62-730.186. Universal Pharmaceutical Waste