common violations observed at biotech facilities and cers ......2017/07/25 · • delete outdated...

Common Violations Observed at Biotech Facilities and CERS Reporting Tips

Louise NortonEnvironmental Health Specialist IIIDEH, Hazardous Materials DivisionEPIC+ SeminarJuly 25, 2017

OVERVIEW

Top 10 Most Cited Violations CERS Common MistakesInventory Reporting Tips &

Reminders

TRENDS IN VIOLATIONS CITED

Out of 440 inspections conducted at San Diego’s Biotech/R&D facilities in the last fiscal year 2016-2017,

These are the top violations cited:

Top 10 Violations Cited2016-2017

1 Chemical inventory incomplete or not submitted in CERS HM

2 HMBP not certified annually as complete and accurate in CERS. HM

3 Initial/annual employee training not conducted or no records for 3years HM

4 Failed to properly label/date hazardous waste container and/or tank HW

5 Site map not submitted in CERS or not sufficient HM

6 Failed to obtain and/or maintain an active EPA ID HW

7 Primary containers accumulating MW not labeled with generator's label MW

8 Facility Permit not obtained for hazardous materials HM

9 Failed to properly close hazardous waste container(s) HW

10 Emergency contact not provided or current HM & HW

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Hazardous Materials Business Plan Violations

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Hazardous Waste Violations

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Labeling Violations

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TOP 10 VIOLATION CATEGORIES

• Hazardous Materials Business Plan

• Hazardous Waste and Medical Waste Labeling

• Other Hazardous Waste Violations

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TOP 10 VIOLATION CATEGORIES:

Hazardous Materials Business Plan • Site Map

• Employee Training

• Emergency Response/Contingency Plan

• CERS and Inventory Reporting

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ANNUAL HMBP SUBMITTAL• The entire Hazardous Materials Business Plan (HMBP) is required to

be submitted annually pursuant to CA HSC Chapter 6.95 section 25508(a)(1)(A):

• Facility Information, • Hazardous Materials Inventory and Site Map, and • Emergency Response/Contingency and Training Plans

• Re-certify within 12 months of the last submittal and/or within 30 days of a change to your HMBP

• Delete outdated or multiple copies of documents

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SITE MAP NOT UPDATEDEmergency Response /Spill Response Equipment Locations• On January 1, 2015, Senate Bill 1261 became effective resulting in changes to

the California Health & Safety Code (HSC), Chapter 6.95, Article 1, which governs requirements for the Hazardous Material Business Plan (HMBP).

• Site maps are required to contain locations of emergency response/spill response equipment.

• For detailed information and guidance see this link on our HMD webpage: http://www.sandiegocounty.gov/content/dam/sdc/deh/hmd/pdf/hmbp/hm-952%20(02-16)%20HMBP.pdf

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http://links.govdelivery.com/track?type=click&enid=ZWFzPTEmbXNpZD0mYXVpZD0mbWFpbGluZ2lkPTIwMTYwMjE3LjU1MzM0OTAxJm1lc3NhZ2VpZD1NREItUFJELUJVTC0yMDE2MDIxNy41NTMzNDkwMSZkYXRhYmFzZWlkPTEwMDEmc2VyaWFsPTE2ODEyNzg0JmVtYWlsaWQ9am9obi5taXNsZWhAc2Rjb3VudHkuY2EuZ292JnVzZXJpZD1qb2huLm1pc2xlaEBzZGNvdW50eS5jYS5nb3YmdGFyZ2V0aWQ9JmZsPSZtdmlkPSZleHRyYT0mJiY=&&&100&&&http://www.sandiegocounty.gov/content/dam/sdc/deh/hmd/pdf/hmbp/hm-952%20(02-16)%20HMBP.pdf

SITE MAP NOT UPDATEDStandard information missing

North orientation, adjacent streets, storm and sewer drains, access and exit points, emergency shutoffs, evacuation staging areas, and hazardous material handling/storage areas.

Map not legible/symbols not clear

Ensure only the most current copy is uploaded in CERS; load all site map pages in CERS as one complete document (pdf recommended).

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Employee training is required annually AND employee training documentation (3 years worth) maintained for:

• Facilities subject to HMBP • Large quantity hazardous waste generators

Training Records• Training records shall be documented electronically or by hard

copy and made available:• HMBP for at least 3 years (HSC 25505 (a)(4))• HW, kept until closure of facility for current employees and at least

3 years for former employees (22 CCR 66265.16)

EMPLOYEE TRAINING PLAN AND TRAINING RECORDS

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• Developed to unify• Emergency Response plan(hazardous materials) and• Contingency plan (hazardous waste)

• This template can also be used to satisfy:• HMBP employee training description [HSC §25505(a)(4)]• HW employee training description [22 CCR 66262.34(d)(2), 22 CCR 66265.16]

• Revised in March 2017• Emergency Communication• Emergency Coordinator information

Template and instructions available at: http://www.calepa.ca.gov/cupa/bulletins/Also available in CERS: http://cers.calepa.ca.gov/business/templatesforms

14CONSOLIDATED EMERGENCY RESPONSE/CONTINGENCY PLAN

http://www.calepa.ca.gov/cupa/bulletins/

http://cers.calepa.ca.gov/business/templatesforms


Inventory and CERS Reporting

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CERS fields commonly misunderstood or incorrectly reported:

• Maximum Daily Amount should not be less than largest container size

• Report shell capacity of container, not amount stored in it

• State Waste Code• Required for all wastes except medical or universal waste

• Hazardous Materials Type: Pure, Mixture, Waste

• “Units” should match the “physical state” in which it is stored• Exceptions: EHS subject to EPCRA reported in pounds

INVENTORY REPORTING IN CERS

*Note: some exceptions apply to Hazardous Waste in below threshold quantities

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Reporting Compressed Gases

Threshold quantities for compressed gases ≥1000 CF:• Carbon dioxide• Inert gases: nitrogen, air, helium, argon, etc

Units and physical state (exception: EHS)• Cryogenic (liquefied) gas are reported in

CERS in gallons • Propane-Report in gallons

INVENTORY REPORTING IN CERS17

Reporting Hazardous Materials below threshold quantities:

• Reporting a material below reportable quantities is not required

• You may leave it on the inventory, but be advised it will be a billable item on your permit

INVENTORY REPORTING IN CERS18

UPDATED LOCAL REPORTING REQUIREMENTS IN CERS

• San Diego County Ordinance was updated regarding local reporting requirements as per instruction from the September 2014 CalEPAbulletin

• Generators are to required to report hazardous waste and medical waste in CERS that they routinely produce, including those below HMBP threshold values.

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San Diego County Code SEC. 68.904(a) CERS REPORTING for Hazardous Waste Below HMBP Thresholds

At a Minimum, the following information should be included:1. Common name of the waste2. Maximum amount in storage at any one time3. Annual waste amount4. Physical state of the waste5. Unit of measure6. Federal hazard categories for hazardous waste

INVENTORY REPORTING IN CERS

INVENTORY REPORTING IN CERS: LOCAL REPORTING REQUIREMENTS

As per SD County Ordinances

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Lab processing/sequencing machines generating hazardous waste• Example: HPLC machine, MiSeq machine, extraction • Many discharge liquid waste to sewer or have solid cartridges• Generator is responsible for making a waste determination and check if

Industrial Discharge permit required

Labpack waste

Episodic waste generation and reporting• Rule of thumb is when the waste is/was generated in the past 3 years and is

expected to be generated/ accumulated again, then report that reoccurring waste in CERS inventory.

• HMD does not require reporting if it is a one-time only waste (like asbestos abatement at a bldg.)

WASTE REPORTING AT RESEARCH FACILITIES

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Liquid biohazardous waste (bleached and sewered)• Remember to report in Medical Waste Management Plan• Also add in CERS as a waste stream!

Medical Waste Management Plan (MWMP)• Please use updated version on the website• MW streams reported on MWMP should match

CERS waste reporting

MEDICAL WASTE REPORTING23

Template on our HMD Forms Webpage!

http://www.sandiegocounty.gov/content/sdc/deh/hazmat/hmd_forms.html

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Container Labeling:

Hazardous Waste & Medical Waste

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HAZARDOUS WASTE VIOLATION: 22 CCR 12 66262.34(f); 66262.34(a)(2), 66262.34(a)(3)

All Hazardous Waste containers accumulating waste need to be labeled with the with the following:

• words "Hazardous Waste", • Name and address of the generator, • Physical and chemical characteristics of the Hazardous Waste, • Starting accumulation date

HAZARDOUS WASTE CONTAINER LABELING

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Satellite hazardous waste needs a complete label too!

MAKE SURE ALL INFORMATION IS LEGIBLE AND COMPLETELY FILLED OUT

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MEDICAL WASTE CONTAINERS REQUIRE GENERATOR LABEL: SDCC 68.1205Primary containers accumulating Medical Waste need to be labeled with the generator's name, address, and phone number. Applies to all medical waste containers

MEDICAL WASTE CONTAINER LABELING

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Other Common Hazardous Waste

Violations

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• Businesses that generate hazardous waste must obtain an EPAidentification number in order to ship a hazardous waste offsitefor treatment or disposal.

• Ensure that your EPA ID number is current! Common violation cited is for an expired number or not obtaining a new number when required

• EPA ID numbers are site specific and owner specific. You need a new number if you move locations and/or change business owners

EPA ID NUMBERS32

• Whether a Federal or California EPA ID number is needed depends on the type and quantity of waste generated

• If a business generates more than 1 kilogram of RCRA acutelyhazardous waste per month or more than 100 kilograms (27gallons) of other RCRA waste per month, then facility must obtain a U.S. EPA ID Number. (CAR, CA, CAD, etc)

• If a business generates RCRA hazardous waste in amounts belowthe federal EPA ID Number requirements or generates non-RCRAhazardous wastes (California only), facility is required to obtain aCalifornia ID Number. (CAL, etc)

DO I NEED A US EPA ID # OR A CALIFORNIA EPA ID#?

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• Businesses with California ID numbers must complete an annual information verification form to keep their number active

• Annual ID number Verification Questionnaire – Generators, transporters, and facilities that are authorized to generate, store, transport, treat, and dispose of hazardous waste are required to annually verify their ID number information per Health & Safety Code section 25205.16(b).

• DTSC FAQ page at:http://www.dtsc.ca.gov/IDManifest/upload/eVQ_FAQs.pdf

CALIFORNIA EPA ID NUMBERS34

http://www.dtsc.ca.gov/IDManifest/upload/eVQ_FAQs.pdf

66265.173(a); 40 CFR 262.34 (d)(2); 265.173; 22 CCR 66262.34(d)(2) SQG and LQG

• Containers must be kept closed except while adding or removing waste

• Open funnels are NOT closed containers!

• Containers need tight fitting lids

OPEN HAZARDOUS WASTE CONTAINERS

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Organic solvent hazardous waste left open.

Container of ethidium bromide waste was missing a lid and missing the hazardous waste label

OPEN CONTAINER HOLDING A WASTE SOLVENT MIXTURE (TFA, ACETONITRILE, METHANOL, ETHANOL, ISOPROPYL

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REMEMBER! REGULATORY GUIDANCE IS AVAILABLE

Helpful Resources on HMD’s Web Page:• HMD Forms:

http://www.sandiegocounty.gov/content/sdc/deh/hazmat/hmd_forms.html• HMD Guidance Documents:

http://www.sandiegocounty.gov/content/sdc/deh/hazmat/hmd_publications.html

• CERS information: http://www.sandiegocounty.gov/content/sdc/deh/hazmat/hmd_cers.html

DTSC Publications and Guidance Documents:http://www.dtsc.ca.gov/PublicationsForms/

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http://www.sandiegocounty.gov/content/sdc/deh/hazmat/hmd_forms.html

http://www.sandiegocounty.gov/content/sdc/deh/hazmat/hmd_publications.html

http://www.sandiegocounty.gov/content/sdc/deh/hazmat/hmd_cers.html

http://www.dtsc.ca.gov/PublicationsForms/

Questions?Louise Norton

[email protected]

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mailto:[email protected]