The Texas Commission on Environmental Quality (TCEQ) recently approved adoption of the US EPA 40 CFR Part 266 Subpart P regulations for Hazardous Waste Pharmaceuticals to be incorporated into existing Texas law under 30 TAC Chapter 335 – Industrial Solid Waste and Municipal Hazardous Waste. The proposed rule changes were published in the Texas Register for public comment (which ended on August 30, 2021). The expected adoption date for this rule is January 2022.
The change in the Texas regulation was required to retain its EPA authorization to administer the federal Resource Conservation and Recovery Act (RCRA) after the EPA promulgated the new Hazardous Waste Pharmaceuticals regulations on February 22, 2019. When amendments are made to the federal rule, Texas must adopt those changes to maintain its RCRA authorization and avoid complicated compliance requirements for its regulated community.
The Subchapter P rule sets out new standards for healthcare facilities for the management of hazardous pharmaceutical wastes. Once incorporated into Texas law, small and large quantity generators of this type of waste will be required to comply with the new standards, as opposed to complying with the requirements of 40 CFR Part 262 for hazardous waste generators. Hazardous waste pharmaceuticals are those that are specifically listed (P- and U-listed wastes) in 40 CFR Part 261 Subpart D, or which exhibit one or more of the hazardous characteristics defined in 40 CFR Part 261 Subpart C. Subpart P does not apply to healthcare facilities that are very small quantity generators (VSQGs), or to other hazardous and non-hazardous waste generated by healthcare facilities, although VSQG’s can decide to opt into Subpart P to manage their wastes. Note that VSQG healthcare facilities not participating in Subpart P will need to prove their VSQG status if audited. Healthcare facilities can also opt into the program to manage all their pharmaceutical wastes as hazardous waste, to save costs on training, sorting practices and disposal.
The table below indicates waste classifications that will be subject to the rule.
Note: Under this new rule, hazardous waste pharmaceuticals do not have to be counted as hazardous waste for the purposes of determining the facility’s waste generation status.
Table 1. Applicability of Subpart P and Part 262 Generator Category for Healthcare Facilities
Texas healthcare facilities that will be regulated by this rule when adopted include:
- Supermarkets and grocery stores
- Pharmacies (including mail-order pharmacies)
- Warehouse clubs and supercenters
- Outpatient care centers
- Hospitals
- Clinics at industrial facilities
- Doctor and dentist offices (including optician and chiropractic offices)
- Nursing care and assisted living facilities
- Veterinary facilities (clinics and hospitals)
- Ambulatory care centers
- Reverse distributors (including forward distributors, third party logistics providers, and pharmaceutical manufacturers).
The definition of Hazardous Waste Pharmaceuticals includes:
- Prescription pharmaceuticals
- Some over the counter drugs and dietary supplements
- Contaminated clean up materials
- Contaminated personal protective equipment
- Non-empty containers that held pharmaceuticals
Key elements of the new rule include:
- Prohibition on the dumping or flushing of hazardous waste pharmaceuticals into municipal sanitary systems (POTWs);
- Establishes EPA policies on the regulatory status of unsold retail items, household hazardous wastes, and non-prescription pharmaceuticals
- Sets the point of generation at the healthcare facility once a decision is made to dispose of a pharmaceutical or send to a reverse distributor
- Exempts over-the-counter nicotine replacement therapies
- Notification requirement within 60 days of rule adoption for individual facilities
- Employee training for proper waste handling and emergency procedures
- Labeling and container management requirements
- Accumulation time limits for healthcare facilities and reverse distributors
- New standards for definition of “RCRA empty” for containers that held regulated pharmaceuticals
- Elimination of duplicative regulation for pharmaceuticals that are also subject to Drug Enforcement Agency requirements.
With these RCRA hazardous waste regulation changes, increased regulatory oversight and scrutiny of the healthcare and hospital industry in Texas may be coming. Now is a great time to ensure your facility is proactively managing its waste compliance risks. Healthcare facilities often struggle with meeting regulatory compliance requirements related to RCRA, given the hundreds if not thousands of wastes and waste streams that may be generated in a typical healthcare facility.
Braun Intertec is a full-service environmental consulting and engineering firm that has established itself as a key provider for regulatory environmental permitting and compliance services and we have the specific hazardous waste, pharmaceutical waste and environmental program compliance experience and expertise to support your RCRA compliance needs.
For more information on the proposed rule, see the link: www.tceq.texas.gov/rules/prop.html. Contact us using the form to the right of this page if you have any questions.
