RCRA

PSSNY Owners Presentation By: James R. Schiffer and Debbi Barber June 2017

RCRAWhat is "RCRA"?• The Resource Conservation and Recovery Act (RCRA)

• Passed in 1976 ; amended and strengthened in 1984

• Regulations under the United States Environmental Protection

Agency established a regulatory framework for a "cradle -t o-

grave" hazardous waste management program

• The New York State Department of Environmental Conservation

(NYSDEC) is authorized to manage the RCRA hazardous waste

program in New York State

What is a RCRA hazardous waste?

The material must first meet the definition of

"solid waste"A solid, liquid or contained gaseous material that is:• Abandoned (thrown away)• "Inherently waste- like“• Discarded military munition• Recycled

What is a RCRA hazardous waste?

Is the solid waste specifically identified on one of five lists?:

• F-list : Manufacturing and industrial waste from non specific sources

(includes some spent solvent waste)

• K-list : Manufacturing and industrial source-specific waste

• U-list: Unused commercial chemical products

• P-list: Acute hazardous unused commercial chemical products

(Most Hazardous Pharmaceuticals fall under “P-Listed” Waste)

• B-list : PCB-containing solid waste ( 50 ppm)

- - -

How are Waste Generators

Regulated under RCRA?

What is a hazardous waste generator?

Defined as any entity, by site:

• Whose acts or processes generate a solid waste that is listed in the hazardous waste regulations

• Determined to be characteristically hazardous, or

• Otherwise identified as a hazardous waste

What is a hazardous waste generator?• Examples of typical hazardous waste generators include:

• Manufacturing operations

• Universities

• Hospitals

• Small businesses (such as auto repair shops and dry

cleaners)

• Pharmacies

• Retail stores (including food stores)

How are hazardous waste generators

regulated under RCRA?

Based the amount of hazardous waste generated in a calendar month and total quantity accumulated on-site

Three categories with increasing regulatory requirements/ responsibility:

• Conditionally exempt small quantity generators (CESQGs)

• Small quantity generators (SQGs)

• Large quantity generators (LQGs)

Conditionally Exempt Small Quantity

Generator (CESQG)• Generate:• < 100 kg (220 lbs)/month of hazardous waste• < 1 kg (2 .2 lbs)/month of acute hazardous waste

• Accumulate:• < 1,000 kg (2,200 lbs) of hazardous waste

• < 1 kg (2.2 lbs) of acute hazardous waste Regulatory

Requirements:• Hazardous waste determination• Storage quantity limits

•Ensure delivery to a facility for proper treatment and disposal of waste*******Most pharmacies will fall into this category********

Small Quantity Generator (SQG)

• Generate:

•>100 to <1,000 kg (220 to 2, 200 lbs)/month of hazardous

waste

•< 1 kg (2.2 lbs )/month of acute hazardous waste Accumulate:

• < 6,000 kg (13,200 lbs) of hazardous waste

• < 1 kg (2.2 lbs ) of acute hazardous waste

Small Quantity Generator (SQG) (cont'd)

• Hazardous waste determination

• Obtain EPA identification number

• On-site management requirements

• Storage time and quantity limits

• Emergency preparedness and prevention

• Hazardous waste manifests/LDRs

• Recordkeeping (3 years)

• Personnel training

Large Quantity Generator (LQG)

Generate:• > 1,000 kg (2,200 lbs)/month of hazardous waste• > 1 kg (2.2 lbs)/month of acute hazardous waste "'

Accumulate:

• > 6,000 kg (13,200 lbs) of hazardous waste• > 1 kg (2.2 lbs) of acute hazardous waste• Requirements (in addition to SQG Requirements):

• 90-day storage requirements• Written contingency plan

• Annual reports (required in NYS)

Hazardous Waste Disposal

•The final link in RCRA's " cradle-t o-grave" concept is a permitted

treatment, storage, and disposal facility (TSDF)

• Hazardous waste is transported to a TSDF by a permitted

transporter

• Hazardous waste shipments are tracked from the generator's facility

to the TSDF on a hazardous waste manifest that is signed by the

generator, transporter and TSDF

• The generator receives a copy of the signed manifest from the TSDF

to verify that the waste was delivered to the proper destination

facility

Hazardous Waste Disposal

•The final link in RCRA's " cradle-to-grave" concept is a permitted

treatment, storage, and disposal facility (TSDF)

• Hazardous waste is transported to a TSDF by a permitted

transporter

• Hazardous waste shipments are tracked from the generator's facility

to the TSDF on a hazardous waste manifest that is signed by the

generator, transporter and TSDF

• The generator receives a copy of the signed manifest from the TSDF

to verify that the waste was delivered to• the proper destination facility

What is a Universal Waste?

• Waste that meets the definition of hazardous waste but is

widely generated including :

• Spent lamps and bulbs (such as fluorescent, high intensity discharge,

neon, mercury vapor, high pressure sodium, metal halide)

• Spent batteries (such as lead acid, mercuric oxide, silver oxide, lithium,

nickel-cadmium [Ni-Cad])

• Recalled pesticides and pesticides from collection programs

• Mercury-containing equipment

Pharmaceutical waste

•Nicotine, warfarin, certain vaccines, some chemotherapy drugs

and other medications are listed hazardous waste (U- and P-

coded waste)

• Pharmaceuticals may also exhibit a characteristic of hazardous

waste:

• lgnitability - Flash point < 140° F, oxidizer or flammable gas

• Corrosivity - Strong acid or base

• Toxicity - Contains arsenic, barium, mercury, selenium, silver, lindane, or m-creso l

Pharmaceutical waste

•Hazardous waste pharmaceuticals that are "potentially

creditable" currently may be sent to a pharmaceutical reverse

distributor and do not need to be managed under the ordinary

RCRA hazardous waste regulations

•Hazardous waste pharmaceuticals that are not "creditable"

currently must be managed and transported off-site for proper

disposal in accordance with RCRA regulations

What are the Steps to Comply with RCRA ?

• Implement facility compliance plan• Implement site-specific compliance measures

• Develop and maintain a compliance binder

• Waste determinations

• Monthly hazardous waste generation rates

• Training records

• Hazardous waste manifests, LDRs and bills of lading

(SQGs and LQGs, recommended for CESQGs)

• Exception Reports (SQGs and LQGs)

• Annual Reports (LQGs)

What are the Steps to Comply with RCRA ?

Employee Training:

Conditionally Exempt Small Quantity Generators:• Formal RCRA training not required but employees must know how to manage hazardous waste to

maintain CESQG status

Small Quantity Generators:

• • RCRA training required for employees on proper waste handling and emergency procedures, relevant to their responsibilities during normal facility operations and emergencies

What are the Steps to Comply with RCRA ?

Large Quantity Generators:

• • Formal RCRA training required - Classroom or on the-job training required with annual updates

All:

• • Employees handling or managing universal waste must be informed of proper handling and emergency procedures

• • Employees preparing or signing waste manifests with DOT regulated materials must receive DOT hazmat training with updates every three years

Prohibition of discharging hazardouswaste pharmaceuticals to a sewer system

• All healthcare facilities and reverse

distributors are prohibited from

discharging hazardous waste

pharmaceuticals to a sewer system

connected to a publicly-owned

treatment works

What is a Universal Waste?

Waste that meets the definition of hazardous waste but is widely

generated including :

• Spent lamps and bulbs (such as fluorescent, high intensity discharge,

neon, mercury vapor, high pressure sodium, metal halide)

• Spent batteries (such as lead acid, mercuric oxide, silver oxide, lithium,

nickel-cadmium [Ni-Cad])

• Recalled pesticides and pesticides from collect ion programs

• Mercury-containing equipment

Hazardous Waste PharmaceuticalManagement

New draft federal " Sub part P" regulations propose streamlined

standards for management of hazardous waste pharmaceuticals

that apply to :

• Healthcare facilities, including:• Pharmacies• Retailers of over-t he-counter (OTC) medications

• Pharmaceutical reverse distributors

• Receive, evaluate and accumulate potentially "creditable" hazardous

waste pharmaceuticals

Management of Hazardous Waste

Pharmaceutical Residues in Empty

Containers• Entering into the NYS DEC RCRA agreement on or before May 1,

2017 allows pharmacies to abide by the EPA Proposed Rule “Sub Part P”

• Allows empty bottles, such as warfarin, to not be considered hazardous waste

• Dispensing bottle, vial or ampule ( 1 liter or 1,000 pills) or unit -dose container is considered empty and not regulated as hazardouswaste if:

• All pharmaceuticals have been removed using practices commonlyemployed

• Original manufacturer product packaging is destroyed to prevent further use

• of the container

Potential RCRA waste compliant vendors?

http://www.securedmedwaste.com

https://www.stericycle.com

http://www.db-eng.com/services/solid-waste-management/

https://www.bioservusa.com

http://www.sharpsinc.com/hazardous-waste

http://www.approvedmedwaste.com/ (In NYC)

QUESTIONS?