Document Z4Jm8RQXbNey3bovjpj9vGYGY

REPORT OF RCRA COMPLIANCE EVALUATION INSPECTION At BECTON DICKINSON AND COMPANY, HOLDREGE 1329 West Highway 6 Suite A Holdrege, NE 68949 (308) 995-6501 EPA Identification Number: NED047047543 On August 22, 2023 By U.S. ENVIRONMENTAL PROTECTION AGENCY Region 7 Enforcement & Compliance Assurance Division 1.0 INTRODUCTION At the request of the Enforcement and Compliance Assurance Division, I performed a Resource Conservation and Recovery Act (RCRA) compliance evaluation inspection (CEI) at Becton Dickinson And Company, Holdrege (Becton Dickinson), located in Holdrege, Nebraska, on August 22, 2023. I conducted the inspection under the authority of RCRA Section 3007(a), as amended. During the inspection, I collected the information necessary to determine compliance with the applicable regulatory and statutory requirements. This report and attachments present the results of the inspection. Based on the information obtained during the inspection, I inspected the facility as a Conditionally Exempt Small Quantity Generator (CESQG), small quantity handler of universal waste, and used oil generator. Becton Dickinson was last inspected for RCRA compliance on July 8 and 9, 2019, by the Nebraska Department of Environment and Energy (NDEE). Two potential findings or violations and four areas of concern were observed or cited as a result of the 2019 NDEE RCRA inspection. 2.0 PARTICIPANTS Becton Dickinson: Jason Sidel, Plant Manager Akua Asare, Environmental Compliance Specialist U.S. Environmental Protection Agency (EPA): Trevor Urban, Environmental Scientist, ECAD Timothy Evans, Life Scientist, ECAD (Lead Inspector) 3.0 INSPECTION PROCEDURES On August 22nd, at approximately 9:10 AM, Mr. Urban and I arrived at the building shared by Embecta and Becton Dickinson (See Attachment 1 for facility diagrams). A drive-by inspection was conducted on the north and southwest perimeter of the facility and no apparent issues were observed. Mr. Urban and I then proceeded into the facility building and met Jessie Powley, EHS Administrator for Embecta. Mr. Urban and I introduced ourselves, presented our business cards, and explained the purpose of our visit. Mr. Urban and I asked Ms. Powley if Akua Asare was available; Ms. Asare was listed as site contact on the Notification Acknowledgement/ Verification Report form (Attachment 5). Ms. Powley informed us that we were in the Embecta portion of a building shared with Becton Dickinson. Ms. Powley then contacted Ms. Asare, to let her know we were at the facility. After approximately 10 minutes Mr. Urban and I were greeted by Ms. Asare. Ms. Asare then escorted Mr. Urban and me to ta Becton Dickinson office area and conference room for the in briefing. Mr. Urban and I were introduced to Mr. Sidel, who joined us for the in briefing. I presented Ms. Asare and Mr. Sidel with my business card and I presented my EPA credentials. During the in-briefing, I presented Ms. Asare and Mr. Sidel with a copy of the RCRA Facility Access Information Sheet, March 2013, which provides inspection authority. I explained my need to collect accurate information and presented Ms. Asare and Mr. Sidel with a copy of Title 18 U.S. Code, Sections 1001 and 1002. As part of the in-briefing, Ms. Asare and Mr. Sidel were made aware of Becton Dickinson's confidentiality rights and informed that a Confidentiality Notice would be provided at the end of the inspection to make, or not to make, any claims. Ms. Asare and Mr. Sidel acted as the facility representatives during the on-site inspection activities. During the inspection, discussions consisted of wastes generated and waste management practices. Document photocopies were collected as inspection documentation (see Attachments 1-6). Mr. Urban and I conducted a visual inspection of the following areas: Staging/Recycling Area Universal Waste/Parts Washer Room Hazardous Waste Accumulation Room Production - Luer Lok and Molding EHS Clinic Warehouse - Sterilization JLL Maintenance Information collected during the inspection was documented in a bound field note logbook, on field sheets, and as discussed below. 2 At the conclusion of the inspection, Mr. Urban and I summarized recommendations with Ms. Asare and Mr. Sidel (see Section 4.7 of this report for additional information). I provided Mr. Sidel with a Confidentiality Notice (Attachment 2) which he signed as acknowledgement of receipt. Mr. Sidel made no confidentiality claims. I provided Mr. Sidel with a Receipt for Documents and Samples (Attachment 3), which Mr. Sidel signed as acknowledgement of receipt. The following inspection documents were provided to Becton Dickinson: Inspection Documents Confidentiality Notice Notice Regarding Proprietary/Confidential Business Information Submitted to or Collected by EPA In Connection with Inspections Receipt of Documents and Samples Documents Shared with Becton Dickinson (Provided by e-mail on August 22, 2023) 2019 NDEE Inspection Report 2019 NDEE Letter of Warning RCRAInfo generated Manifest Report I followed the inspection procedures discussed in the RCRA CEI Standard Operating Procedure (No. 2321.1E), unless noted differently. Any federal regulatory citations noted in this report are as adopted by reference in the authorized Nebraska regulations. 4.0 FINDINGS AND OBSERVATIONS 4.1 General Information/Facility Description and RCRA Status The Becton Dickinson facility in Holdrege, Nebraska assembles Eclipse needles and is a manufacturer of Luer Lok syringes. Manufacturing of Luer Lok syringes involves plastic injection molding of barrels and plungers, printing scale markings on barrels, assembly, packaging, and cobalt sterilization. Luer Lok syringes are manufactured in three sizes: 3, 5, and 10mL. Eclipse needles involve assembling a needle shield, safety shield, and cannula (needle), packaging, and cobalt sterilization. All Eclipse needle components are manufactured off-site. Rubber stoppers, which are attached to plungers, and packaging for all products are manufactured off-site. The hours of operation for the facility are 24 hours each day, seven days per week. The facility consists of storage for raw material, production areas, and product storage. See Attachment 2 for facility diagram and aerial photo). Becton Dickinson employs approximately 540-550 people. 3 Hazardous waste generated at the facility includes, but is not limited to: x Spent Next 3000 solvent x Spent Safety-Kleen Heavy Duty Lacquer Thinner x Spent ink x Aerosol can residual x Isopropyl alcohol and Next 3000-contaminated absorbent pigs, disposable wipes, and PPE x Mercury-containing equipment x Labpack waste x Universal waste lamps and batteries (Lithium Ion, NiCad, and Lead Acid) See Attachment 6 for additional information related to waste streams generated at the facility. 4.2 RCRA Status According to the RCRAInfo database, Becton Dickinson has notified as a Small Quantity Generator of D001, D003, D005, D006, D007, D008, D009, D018, D019, D021, D035, D039, D040 characteristic hazardous waste and F001, F002, F003, and F005 listed hazardous waste, last notifying on July 21, 2023. I provided Ms. Asare and Mr. Sidel with a Notification Acknowledgement/Verification Report form for review (Attachment 5). Mr. Sidel stated that his phone number had recently changed. I noted Mr. Sidel's new phone number in my bound field notebook. Based on the amount of known hazardous waste generated per month (less than 220 pounds) and accumulated onsite (less than 2,200 pounds), I inspected the facility as a CESQG. In addition, I inspected the facility as a small quantity handler of universal waste and a used oil generator. The facility's generator classification may change based upon impending elimination of manufacturing/production activities in October of 2023. 4.3 Previous Inspection and Related Findings Becton Dickinson was previously inspected by the NDEE on July 8 and 9, 2019. The 2019 NDEE inspection report (Attachment 4), included the following potential findings or violations: 1. Failure to post ''No Smoking" signs where there is a hazard from ignitable or reactive waste (Title 128, Chapter 16, 001.01 as referenced by Chapter 10, 004.01 AS). 2. Failure to prepare a manifest according to the instructions in the Appendix to 40 CFR, 262 (Title 128, Chapter 10, 002.0lA). In addition to the potential findings or violations listed, the following areas of concern were identified: 1. The person listed as the back-up emergency coordinator in the contingency plan will need to be updated once a replacement has been named as required by Title 128, Chapter 18,005.03. 2. The contingency plan did not describe the evacuation signals (e.g. bell, steady or wavering siren, visual flashing light, etc.) as required by Title 128, Chapter 18, 003.06. 4 3. It was not clear that the satellite accumulation drum for HFE waste in the Safety Products area met the requirements for satellite accumulation areas under Title 128, Chapter 10, 005.01. 4. Without additional explanation, it is unclear that training records provided via the C2C system meet the documentation requirements of Title 128, Chapter 19,004. 4.4 Changes Since Previous Inspection Changes that have occurred at the Becton Dickinson since the previous inspection include, but are not limited to: x Becton Dickinson and Embecta became two separate facilities at this location in April of 2021 (see Attachment 1 for facility diagram). Raw Material Use and Waste Streams x Next 3000 is no longer used as a carrier for silicone lubricant. x HFE is no longer used or generated as a waste (D001, D035, D039, and F005). x Titration waste is no longer generated by Becton Dickinson (D001, D022, D029, D038, and F005). x Off-specification isopropyl alcohol swabs are no longer generated. x Water-based ink is no longer used by Becton Dickinson. Personnel Changes x Ashley Reeves, EHS Manager left the company in September of 2021. x Shri Vani Sripada, Environmental Compliance Specialist left the facility in August of 2020. x Linda Freeland, Chief Custodian, JLL, retired in February of 2018. x Jason Sidel, Plant Manager, began in April of 2021. x Akua Asare, Environmental Compliance Specialist, replaced Shri Vani Sripada. 4.5 Waste Streams and Waste Management Information related to waste streams is listed in the Waste Stream Table (Attachment 6). 4.6 Records Review Uniform Hazardous Waste Manifests and Land Disposal Restriction (LDR) Notification Forms Prior to arriving at the facility, I had conducted an inspection of electronic manifests from August 2020 through June 2023, using RCRAInfo. I also reviewed four manifests dated July 20, 2023 through August 19, 2023; signed copies from the designated facility were not yet on file at the facility. 5 During the inspection, I reviewed the following LDR notification forms associated with hazardous waste generated at and shipped from the facility: x Waste Paint Related Material - D001, D018, D035, D039, D040, F003, and F005 x Waste Printing Ink - D001 and F003 x Waste Flammable Solids - F003 and F005 x Waste Aerosols - D001, D003, D005, D006, D007, D008, D035, D039, and D040 Aside from questionable waste codes (see Section 4.7), no other apparent issues were observed during review of manifests and LDR notification forms. Waste Determination Documentation During the inspection, Ms. Asare provided Mr. Urban and me with Safety Data Sheets (SDSs) for the following material used at the facility: x Screen and Pad Printing Ink x Cleaning Agent 30 L UR 1 x Isopropyl Alcohol 70% USP x Safety-Kleen Heavy Duty Lacquer Thinner Aside from questionable waste codes (see Section 4.7), no other apparent issues were observed during review of waste determination documentation SDSs. 4.7 Additional Observations Waste Determinations and Applicable Waste Codes - During review of waste determination documentation SDSs, Mr. Urban and I discussed waste codes associated with hazardous waste streams generated at Becton Dickinson facility. Based upon a review of SDSs for raw materials used at the facility, some waste codes did not appear to be applicable - in addition to correct waste codes, additional waste codes had been added on manifests for hazardous waste generated and shipped from the facility. Mr. Urban and I encouraged Ms. Asare and Mr. Sidel to go through SDSs to ensure waste codes listed on LDRs and uniform hazardous waste manifests are being accurately applied to hazardous waste generated at, and shipped from, Becton Dickinson. 5.0 SUMMARY I inspected Becton Dickinson as a CESQG of hazardous waste, small quantity handler of universal waste, and generator of used oil. No apparent preliminary findings were observed or cited. However, EPA post-inspection review of this report may change or add findings. 6 TIMOTHY Digitally signed by TIMOTHY EVANS EVANS Date: 2023.09.20 12:47:17 -05'00' __________________________ Timothy R. Evans Life Scientist ECAD/CB/RCRA, EPA Region 7 Whisnant, Digitally signed by Whisnant, Amber Amber Date: 2023.09.21 20:04:31 -05'00' __________________________ Amber Whisnant Section Chief ECAD/CB/RCRA, EPA Region 7 Attachments 1. Aerial Photo and Facility Diagram (3 pages) 2. Confidentiality Notice (1 page) 3. Document of Receipt (1 page) 4. July 8 and 9, 2019 NDEE RCRA Inspection Report (8 pages) 5. Notification Acknowledgement/Verification Report Form (2 pages) 6. Waste Stream Table (6 pages) 7