Document 93oLoDdbwXkz8JxbxNLEvzoMp

ft E A ~ United States .._..,~ Environmental Protectior ,,. Agency Region 6 - Enforcement & Compliance Assurance Division INSPECTION REPORT Inspection Date(s): Media Program: Regulatory Program(s) 10/31/2024 Pesticides FIFRA Company Name: Facility Name: Facility Physical Location: (city, state, zip code) Mailing address: (city, state, zip code) County/Parish: Facility Phone Number Facility Contact: Kemin Industries, Inc. dba Bio-cide International, Inc. Bio-cide International 2650 Venture Dr Norman, OK 73069 2650 Venture Dr Norman, OK 73069 Cleveland 405-329-5556 Don Jacques I l Reg. Affairs Mgr. Don.jacques@kemin.com FRS Number: Identification/Permit Number: Media Identifier Number: NAICS: SIC: 110002130015 EPA Est. No. 9804-OK-1 n/a 325612 2819, 2899, 2992, 5999, 5084 Personnel participating in inspection: Justin Mullenix EPA Region 6 Don Jacques Bio-cide International, Inc. Kristie Krafka Kemin Industries, Inc. Jill Hyda Kemin Industries, Inc. Life Scientist / Inspector Reg. Affairs Mgr. VP Reg. Affairs & QA Associate Reg. Affairs Dir. EPA Lead Inspector Signature/Date Mu IIen .IX Just1 n Digitally signed byMullenix,Justin , Date: 2024.11.21 13:46:24 -06'00' Justin Mullenix Date Supervisor Signature/Date Stuckey Troy Digitally signedby Stuckey, Troy 1 Date: 2024.11 .2114:07:41-06'00' H. Troy Stuckey, PhD Date 6ENFORM-019-R8.2 (02/12/2020) 1 Section I - INTRODUCTION Kemin Industries, Inc. dba Bio-cide International, Inc. / Bio-cide International Inspection Date 10/31/2024 PURPOSE OF THE INSPECTION This for-cause scheme producer establishment inspection was conducted pursuant to the Federal, Insecticide, Fungicide, and Rodenticide Act (FIFRA) Section 8, 7 U.S.C. 136f, and Section 9(a), 7 U.S.C. 136g(a), to evaluate compliance with FIFRA and the regulations thereunder. The inspection occurred for-cause for suspected distribution or sale of misbranded antimicrobial pesticides including those registered under EPA Registration Numbers 9804-1, 9804-3, and 9804-9. FACILITY DESCRIPTION Bio-cide International, Inc. ("Bio-cide International"), located at 2650 Venture Drive, Norman, Oklahoma 73069, is a subsidiary of Kemin Industries, Inc. ("Kemin"), headquartered at 1900 Scott Avenue, Des Moines, Iowa 50317. Bio-cide International, which specializes in stabilized chlorine dioxide and acidified sodium chlorite disinfectant products, was purchased by Kemin, a global biotechnology company, on or around May 2021. The Bio-cide International facility is registered as a pesticide producing establishment pursuant to FIFRA Section 7, 7 U.S.C. 136e, under EPA Establishment Number 9804-OK-1. According to EPA records, it primarily produces its own products that are registered under EPA Company Number 9804. Section II - OBSERVATIONS I, EPA Region 6 inspector Justin Mullenix, arrived at Bio-cide International at approximately 9:30AM. I entered the facility and explained the purpose of my visit to an employee who then contacted Don Jacques, Regulatory Affairs Manager of Bio-cide International. Mr. Jacques and I proceeded to a conference room where I further explained the purpose of the inspection. Mr. Jacques requested that additional staff of Kemin be included on our meeting virtually. Kristie Krafka, Vice President of Regulatory Affairs and Quality Assurance, and Jill Hyda, Associate Regulatory Affairs Director, were patched in virtually. During this time, I prepared a Notice of Inspection which I presented to Mr. Jacques for signature along with my federal credential. With all parties present for the meeting, I explained the for-cause nature of the inspection, citing a tip or complaint received by EPA Region 6 regarding potential distribution or sale of misbranded antimicrobial pesticides by Bio-cide International, including those registered under EPA Registration Numbers 9804-1, 9804-3 and 9804-9. I presented information obtained from the tip or complaint along with information obtained from the Bio-cide International company website (URL: https://www.bio-cide.com) to substantiate these areas of concern. The representatives of Kemin / Bio-cide International acknowledged the areas of concern but explained that the information that I cited was in the process of being updated or eliminated following the purchase of Bio-cide International by Kemin. The 2 Kemin Industries, Inc. dba Bio-cide International, Inc. / Bio-cide International Inspection Date 10/31/2024 representatives also explained that administrative processes were taking place with EPA Headquarters regarding the transfer of company ownership. I requested that the company provide records with respect to the above-mentioned products, including current labeling and distribution or sales records. The representatives of Kemin / Bio-cide International agreed to provide these records but explained that it would take time to collect them. I agreed to provide up to 30 days for the collection and transfer of the records and agreed to follow up with the company via email with an electronic transfer link. I then provided information on Confidential Business Information and Small Business Resources, and Mr. Jacques made a copy of the Notice of Inspection for his records. No documentary or physical samples were collected during the inspection. The inspection concluded at approximately 11:00AM. Section III - AREAS OF CONCERN An area of concern identified during the inspection includes the potential distribution or sale of misbranded antimicrobial pesticides as specified above. Section IV - FOLLOW UP On November 1, 2024, I sent an email message and electronic file transfer link to Mr. Jacques via the GoAnywhere Web Client. Mr. Jacques replied to the email on November 8, 2024, to request clarification on the records requested. I responded to Mr. Jacques on November 11, 2024. Section V - LIST OF APPENDICES Appendix 1 - Notice of Inspection 3 Kemin Industries, Inc. dba Bio-cide International, Inc. / Bio-cide International Inspection Date 10/31/2024 Appendix 1 Notice of Inspection 4 &EPA United States Environmental Protection Ag en cy United States ENVIRONMENTAL PROTECTION AGENCY Washington, DC 20460 Notice of Inspection Office of Enforcement and Compliance Assurance Facility Address ?.bSo Vt,-rh,.rt.. Or-. 1 Nc,.-M~"', DK 73 Ob't Name of Facility Official Title By my signature, I represent that I am an owner, operator or agent in charge of the facility being inspected, and attest that the EPA, Designated State or Political Subdivision Employee or Officer identified on this form presented his or her credentials prior to issuing this Notice of lnspe )f Facility Official's Signature: Authority for Inspection For the purpose of inspecting and obtaining samples of any pesticides or devices packaged, labeled and released for shipment, and samples of any containers or labeling for such pesticides or devices, in places where pesticides or devices are held for distribution or sale [FIFRA 9(a) (7 U.S.C. 136g)]; and for the purpose of inspecting and obtaining copies of those records specified in FIFRA 8 (7 U.S.C. 136f) and 40 C.F.R. Part 169. Reasons for Inspections (Check applicable boxes) D Routine Inspection IEf' For Cause Inspection Violation Suspected: Additional Information: - EpA. k.J . >.J '1 $ . 9~ Cl\ _., \ / ~ b D~ - ? I ~ \ 0 \\ - i Name of Inspector Date \ O) 3) / 1o .2 '-\ Title L: Address EPA Reg ion 6, 1201 E lm St, D allas, TX 75270 Time Note: The absence of a Facility Official's signature on th is form does not invalidate this Notice of Inspection, or establish t hat consent to the inspection was not provided or that the proper procedures were not followed . EPA Form 3540-2 (Rev. 07/09) Previou s editions may be used until supply is exhausted 1-lnspector Copy 2-Fa cility Copy