PRETREATMENT CORNERE-REPORTING

DENTAL RULE STATUS, Q & AHAZARDOUS WASTE PHARMACEUTICALS

VWEA Industrial Waste and Pretreatment Conference

Charlottesville, VA

March 5th, 2019

Deborah DeBiasi, Virginia State Coordinator for Pretreatment/WET

Electronic (E) Reporting• Phase 1 - DMRs must be submitted electronically starting December 21, 2016

• Biosolids/Sewage Sludge Annual Program Reports

• Phase 2 – Reports must be submitted electronically by December 21, 2020

• Notices of Intent to discharge (NOIs) under a general permit

• Notices of Termination (NOTs) of coverage under a general permit

• No Exposure Certifications (NOEs) under a stormwater general permit

• Low Erosivity Waivers (LEWs) under a stormwater general permit

• Concentrated Animal Feeding Operation (CAFO) Annual Program Reports

• Municipal Separate Storm Sewer System (MS4) Program Reports

• Pretreatment Program Annual Reports

• Sewer Overflow/Bypass Event Reports

• Clean Water Act (CWA) Section 316(b) Annual Reports

• Significant Industrial User (SIU) Bi-annual Compliance Reports in municipalities without approved pretreatment programs.

E Reporting

• https://www.epa.gov/compliance/npdes-ereporting-information-permittees-and-other-regulated-entities

• EPA developed a database for permittees to enter their data, which would then go directly to EPA. The data would be uploaded weekly to ECHO and be available to the public. As a delegated state for pretreatment, Virginia will not be using their system.

• DEQ is currently working toward developing an electronic database for permittees to enter pretreatment data that will upload to DEQ’s CEDS database, be verified before upload to EPA’s ICIS database, and finally to ECHO. We are planning on meeting the December 21, 2020 deadline.

E Reporting

Important things to remember!

• DEQ will be doing training when the system is ready.

• All entered data will ultimately be available to public. Make sure it is accurate! Dates and decimals matter!

• Make sure it is complete – all required elements are entered

• The requirements of E-Reporting are much more extensive than current annual report requirements. Implementation Technical Paper No. 7 for Pretreatment Data Elements on this page: https://www.epa.gov/compliance/data-entry-guidance-and-technical-papers

DENTAL RULE UPDATES

• Dental Effluent Guidelines published June 14, 2017 as 40 CFR part 441

• Dental offices are considered IUs of POTWs, NOT CIUs or SIUs,

• DEQ webpage for Dental Rule is https://www.deq.virginia.gov/DentalRule.aspx

• Dental offices that apply or remove amalgam must install amalgam separator and implement 2 BMPs

• Prohibit discharge of waste (or scrap).

• Prohibit use of line cleaners that may lead to dissolution of solid mercury from traps and lines.

• Dental offices must fill in and submit the Virginia Dental Rule Compliance fillable form to DEQ by the applicable date

• Data from forms is consolidated on a spreadsheet and made available to POTWs

• POTWs can also have copy of submitted form

DENTAL RULE UPDATES

• To date, I have received 28 usable forms, of which 9 offices use amalgam

• 5 forms were returned to dental office for edits, have not been resubmitted

• Continue to work with Virginia Dental Association for outreach

• POTWs should also try to contact dental offices in their jurisdictions

• Will continue to ask for quarterly updates to the list of

dental offices with Xray machines from VDH and

share with POTWs.

NOTE: List does NOT include military and federal

dental facilities

DENTAL RULE UPDATES – POTW RESPONSIBILITIES

• EPA FAQ for POTWs: https://www.epa.gov/sites/production/files/2018-05/documents/final_faqs_for_control_authorities_dental_category_final_rule_may_2018.pdf

• Dental dischargers are IUs only – not SIUs or CIUs unless designated as such by POTW

• Dental offices that use/remove amalgam should be identified and listed in Industrial Waste Surveys

• Not required to be listed in annual report

• Regulatory consequences for dental office non-compliance:

40 CRF Part 441 contains Pretreatment Standards and Requirements applicable to specific industrial users of a POTW (dental dischargers). Pursuant to Section 307(d) of the Clean Water Act, a failure to comply with such applicable standards and requirements would constitute a violation of the Clean Water Act and potentially therefore subject the industrial user, in this case the dental discharger, to federal civil and criminal penalties under Section 309 of the Clean Water Act, and to civil and criminal penalties under state and local law implementing the CWA pretreatment program.

DENTAL RULE UPDATES – RECENT Q & A’S • The Virginia Dental Rule Compliance form doesn’t require a wet signature. Is

this a problem? If there are concerns, do a site visit to verify information.

• Will DEQ be doing site visits to dental offices?- Not to dental offices that discharge to approved program POTWs

• Will DEQ require the POTWs to do site visits to dental offices? – No

• Should the POTW get the forms directly? – Please don’t confuse the dentists -Have the dental offices send their forms to DentalRule@deq.virginia.gov for consistency.

• What should the POTWs do about dental offices who missed their deadline for installing a separator or submitting the compliance form. My recommendation is to make them aware of the Dental Rule, and set new compliance dates if the applicable ones are past. If they don’t comply, then follow your ERP.

• Will DEQ be following up with POTW to see if all dental offices are compliant? – Probably not unless POTW is non-compliant for mercury – then yes.

HAZARDOUS WASTE PHARMACEUTICALS AND AMENDMENT TO PO75 LISTING FOR NICOTINE

• Published February 22, 2019 – effective date of prohibition is August 21, 2019

• https://www.epa.gov/hwgenerators/final-rule-management-standards-hazardous-waste-pharmaceuticals-and-amendment-p075

• FDA-approved OTC nicotine replacement therapies (patches, gums and lozenges) are no longer hazardous waste when discarded.

• All healthcare facilities subject to rule are prohibited from sewering hazardous waste pharmaceuticals - must be disposed of via reverse distributors.

Healthcare facilities as defined: wholesale distributors third-party logistics providers that serve as forward distributorsmilitary medical logistics facilities hospitalspsychiatric hospitals ambulatory surgical centers health clinics physicians’ offices optical and dental providers chiropractorslong-term care facilities ambulance servicesPharmacies long-term care pharmaciesmail-order pharmacies retailers of pharmaceuticalsveterinary clinics veterinary hospitals.

HAZ WASTE PHARMS RULE – POTW RESPONSIBILITY

9 VAC 25-31-800 F.2.c.

c. Notify industrial users identified under subdivision 2 a of this subsection, of applicable pretreatment standards and any applicable requirements under §§204(b) and 405 of the CWA and subtitles C and D of the Resource Conservation and Recovery Act (42 USC § 6901 et seq.). Within 30 days of approval pursuant to 9VAC25-31-800F 6, of a list of significant industrial users, notify each significant industrial user of its status as such and of all requirements applicable to it as a result of such status.

HAZARDOUS WASTE PHARMS CONTINUED

• A solid waste is considered hazardous waste if it meets a listing or exhibits a characteristic described in title 40 of the Code of Federal Regulations Part 261.

• There are approximately 30 commercial chemical products listed on the P and U hazardous waste lists that have pharmaceutical uses. As the P and U lists are based on chemical designations, this number does not completely represent the total number of brand name pharmaceuticals that may actually be listed hazardous wastes. For example, the following chemotherapy drugs, CTX, Cytotoxan, Neosar and Procytox, are all designated as a U058 hazardous waste for cyclophosamide.

• In addition, waste pharmaceuticals may also be hazardous because they exhibit one or more of the four characteristics of hazardous waste: ignitability, corrosivity, reactivity and toxicity. For example, solutions containing more than 24 percent alcohol exhibit the ignitability characteristic. Pharmaceuticals exhibiting the corrosivity characteristic are generally limited to compounding chemicals, including strong acids, such as glacial acetic acid, and strong bases, such as sodium hydroxide.

• Depending on the concentration in different pharmaceutical preparations, pharmaceuticals may also exhibit the toxicity characteristic because of the use of arsenic (D004), barium (D005), cadmium (D006), chloroform (D022), chromium (D007), lindane (D013), m-cresol (D024), mercury (D009), selenium (D010), and silver (D011).

HAZ WASTE PHARMS RULE - CONTINUED

• It is not necessary to modify a pretreatment program to incorporate this prohibition since it is a RCRA regulation revision, and not a CWA revision. However, it is recommended that POTWs add a Specific Prohibition for:

1. Bulk, expired, outdated or concentrated prescription or non-prescription drugs.

2. Hazardous waste pharmaceuticals or DEA controlled substances to the POTW by a healthcare facility or reverse distributor pursuant to 40 CFR Section 266.505 shall be prohibited.

to their legal authority – non substantial modification. (sic Curt McCormick)

• Slide presentation: https://clu-in.org/conf/tio/HazWastePharmaceuticals_021419/

Haz Waste Pharms Rule Resources

• EPA Training available: https://clu-in.org/conf/tio/HazWastePharmaceuticals/

• https://www.deq.virginia.gov/Programs/LandProtectionRevitalization/SolidHazardousWasteRegulatoryPrograms/HazardousWaste.aspx

• February 14, 2019, 1:00 PM - 2:30 PM ESTMarch 4, 2019, 1:00 PM - 2:30 PM ESTMarch 13, 2019, 1:00 PM - 2:30 PM EST

• https://www.pwaste.com/EPA-subpart-p