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ft E A ~ United States ._.,,.., Environmental Protectior , Agency Region 6 - Enforcement & Compliance Assurance Division INSPECTION REPORT Inspection Date(s): Media Program: Regulatory Program(s) 10/29/2024 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: Inhance Technologies, LLC dba Advance Research Chemicals Inhance Technologies, LLC dba Advance Research Chemicals 5010 N Skiatook Rd Catoosa, OK 74015 5010 N Skiatook Rd Catoosa, OK 74015 Rogers 918-266-6789 Kelly McFadden VP of EHS kmcfadden@inhancetechnologies.com FRS Number: Identification/Permit Number: Media Identifier Number: NAICS: SIC: 110069447101 EPA Est. No. 72806-OK-1 n/a 325180 2819 Personnel participating in inspection: Justin Mullenix EPA Region 6 Kelly McFadden Inhance Technologies, LLC Robert Adams Inhance Technologies, LLC Life Scientist / Inspector VP of EHS Technical Fellow EPA Lead Inspector Signature/Date Mullenix, Justin Date: 2024.12.31 10:02:23 -06'00' Digitally signed by Mullenix, Justin Justin Mullenix Date Supervisor Signature/Date St UC key Troy Digitally signed by Stuckey, Troy I Date: 2025.01.13 09:51 :36 -06'00' H. Troy Stuckey, PhD Date 6ENFORM-019-R8.2 (02/12/2020) 1 Section I - INTRODUCTION Inhance Technologies, LLC dba Advance Research Chemicals Inspection Date 10/29/2024 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 an adulterated/contaminated pesticide, Azamax (EPA Reg. No. 71908-1-81268). FACILITY DESCRIPTION Inhance Technologies, LLC dba Advance Research Chemicals ("Advance Research Chemicals"), is a facility operating in Catoosa, Oklahoma whose parent company is headquartered at 22008 North Berwick Drive, Houston, Texas 77095. The company specializes in the production, distribution or sale of specialty chemicals including pesticides and generates an estimated $60 million in annual revenue according to sources available online. The Catoosa, Oklahoma facility is registered with the EPA as a pesticideproducing establishment under Establishment Number 72806-OK-1. Section II - OBSERVATIONS I, EPA Region 6 inspector Justin Mullenix, arrived at Advance Research Chemicals on October 29, 2024, at approximately 10:35 AM. Upon signing in at the facility, I met with Kelly McFadden, the facility's Vice President of Environmental Health and Safety. I explained the premise of FIFRA inspections to Ms. McFadden and asked if there was a conference room available. Ms. McFadden led me to a nearby conference room where we were then joined by Robert Adams, a Technical Fellow at the facility. I presented Ms. McFadden my federal credential and a Notice of Inspection which she signed (Appendix 1). I discussed in greater detail the purpose of the inspection, which was to follow up on a referral made by another EPA regional office regarding potential adulteration/contamination of a pesticide produced by Advance Research Chemicals. The pesticide, Azamax, was sampled by a state inspector in June of 2022 and found to be contaminated with trace amounts of the fungicide diphenylamine. In addition, the product's active ingredient, azadirachtin, was found to be at a higher concentration than the labeled amount. Ms. McFadden and Mr. Adams reviewed their company's records and determined that the Azamax production contract had been terminated in October of 2023. They inquired about the product's batch code which I was unable to provide. I asked how quality assurance is done at the facility regarding products such as Azamax. Ms. McFadden and Mr. Adams explained that their company was contracted to produce the Azamax by Parry America, Inc., the authorized agent of the product's registrant, Coromandel International Limited. Under the terms of the contract, Advance Research Chemicals acted as a toll manufacturer for Parry America, Inc., to produce a specified quantity of the product for a 2 Inhance Technologies, LLC dba Advance Research Chemicals Inspection Date 10/29/2024 specified period of time utilizing specified materials provided by both companies. I asked if a copy of the manufacturing agreement, bills of lading, batch sampling records, inventory records, etcetera, could be provided to me for review. Upon receiving permission by an attorney at Advance Research Chemicals, Ms. McFadden provided a physical copy of the manufacturing agreement, as well as a bill of materials and a contract termination letter. She also emailed me a copy of the Neemazal T/S 1.2% EC (EPA Reg. No. 71908-1) material safety data sheet. She informed me that the other requested records would be provided via email at a later time once they were collected. I provided a Confidential Business Information (CBI) notice and declaration form to Ms. McFadden which she then filled out and included with the provided documents. Ms. McFadden and Mr. Adams explained that most of the materials used in the production of Azamax were provided by Parry America, Inc. pursuant to the contract, and they did not believe that Avance Research Chemicals was to blame for the contamination; however, due to the period of time that had transpired since the termination of the manufacturing agreement, there was no longer any of the Azamax or its production materials left in inventory to review and/or sample to make a determination. I asked about the company's recordkeeping practices regarding production of pesticides, and it was explained that records are kept for at least 5 years. I informed Ms. McFadden that such records may be requested at a later time, and she agreed to provide them. I then completed a Receipt for Samples (Appendix 2) for the records collected during inspection. Copies of the Notice of Inspection and Receipt for Samples were then made and provided to Ms. McFadden for her records. No photographs were taken during the inspection. The inspection concluded at approximately 11:15 AM. Section III - AREAS OF CONCERN An area of concern identified during the inspection includes the potential distribution or sale of an adulterated/contaminated pesticide. Section IV - FOLLOW UP On October 29, 2024, at approximately 3:01 PM, Ms. McFadden emailed me a bill of lading, sample batch sheets, and an inventory record associated with Azamax. Section V - LIST OF APPENDICES Appendix 1 - Notice of Inspection Appendix 2 - Receipt for Samples Appendix 3 - MSDS for Neemazal T/S 1.2% EC CBI/Sensitive Appendices (not included in published version of the report) Appendix 4 - Parry America, Inc. Contract #1000433 Appendix 5 - Bill of Materials 3 Appendix 6 - Termination Letter Appendix 7 - Sample Batch Sheets Appendix 8 - Bill of Lading Appendix 9 - Inventory Records Inhance Technologies, LLC dba Advance Research Chemicals Inspection Date 10/29/2024 4 Inhance Technologies, LLC dba Advance Research Chemicals Inspection Date 10/29/2024 Appendix 1 Notice of Inspection &EPA United States Environmental Protection Agency United States ENVIRONMENTAL PROTECTION AGENCY Washington, DC 20460 Notice of Inspection Office of Enforcement and Compliance Assurance Facility Name AJ 11,. t11.(_ l.tSe.11 rc,h "5J,,t I0/2!1/'A {t:,, J;\T,t /T,tth11t,iu --r1,d1"'-1lo :lS' I Name of Facility Official J lht.t1 ;CA 15 J.J,/A. kt IIY ),\l tA J,( t t\ Facility Address ,o )t' ,-J Sk.,~ 10c K j_J.. lit-too$"' 1 0 K 7\.\ o)5" Title Vf r-l, 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 Inspection. 1 Facility Official 's Signature: ~ 1 Y l ~ 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) Routine Inspection ~ For Cause Inspection Violation Suspected: pe.S~; ,;Je.,, Additional Information: A J1-t l1 l,.t'""A. -t;P,'\ -A1-"-M ... K [[Pf\ l,.tj,N,, 7110~-l -bl2.bi) Name of Inspector ~Si;" /vf 11 ll er1; ,< Signature of Inspector ; d . . t ' ~ Title L:f~ 5t.iel"l-r,;-,-- Date I0/2'JI 2.1;z.1i Time lt:r r,o AJ.11 Address 120 I )""' s-1-. D"-\1~5 I TK 7,270 Note: The absence of a Facility Official's si gnature on this form does not invalidate this Notice of Inspection, or establish th at consent to the inspection was not provided or that the proper procedures were not followed. EPA Form 3540-2 (Rev. 07/09) Previous editions may be used until supply is exhausted 1-lnspector Copy 2-Facility Co py Inhance Technologies, LLC dba Advance Research Chemicals Inspection Date 10/29/2024 Appendix 2 Receipt for Samples oEPA United States Environmen tal Protection Agency United States ENVIRONMENTAL PROTECTION AGENCY Washington, DC 20460 Receipt for Samples Office of Enforcement and Compliance Assurance FacilityName l..,'1,ar1c.'- 7~t}t,1,le,1:~S d,I, A)...11~r1.u.. ~se4,-, ,_, l'1t,., , ~,. r' Facility Address ljo /0 JJ., k,i,doo ~ !.,d. c~-+oo s-. I () K 7 1-l O ls Name of Facility Official Kt 11i M. '- 1:,-J.J.,~ Title VP }-I~ Samples Collected (Assign sample number and describe fully (e.g. , product name, size, quantity, registration , establishment, lot, batch , model and/or serial numbers, etc.)) The following samples were collected by or on beh alf of the U.S. Environmental Protectio n Agency and receipt is hereby ac kn owledg ed pursuant to Section 9(a) of the Federal Insecticide, Fungicide, and Rodenticide Act (7 U.S.C. 136g). \o1 ~ 101 l-\ - o'I, 1 ~" 7 3 1 9 3 oo O IO l 7 7 I 3 - t' I - o I : /IA S() 5 Nee~~ z.14 I (l .., - 0 I -1J2; f r,..rry A~r;,,.. lu,-lrAct Jooe41;,1 (c I')- ,, -t:?1-o,: 8i'l}o-f 1'1rltri.,d~ (lBI)- 2fJ$ ~s ., ,... - CI - pl): ,~r M,.,,,,14-/ ,'," ~-&r (L8J) - Ifj 0 Duplicate samples ~ Duplicate samples A .d mount paI requested and provided not requested D Cash D Credit Card ~ No Charge Acknowledgement of Samples Collected: The undersigned acknowledges that the sam ples shown above were obta ined from pesticides or devices that we re p ac kaged, la be led and re leased for shipment. Facility Official Signature Name of Inspector Vu -f; r\ 5 Signature of Inspector Address / ZP ( E) N\ 5-/ , 1 p, Ila f 1 / )( 7 72 7 C Title l,i{e. 5litr,f; ff Date IO / 19 / 1_ ~ EPA Form 3540-3 (Rev. 07/ 09) Previous editions may be used until supply is exhausted 1-lnspecto r Copy 2-Fac il ity Copy Inhance Technologies, LLC dba Advance Research Chemicals Inspection Date 10/29/2024 Appendix 3 MSDS for Neemazal T/S 1.2% EC MATERIAL SAFETY DATA SHEET NEEMAZAL T/S 1.2% EC (AZADIRACHTIN BASED) SECTION I MANUFACTURER E.I.D PARRY (INDIA) LIMITED BIO PRODUCTS DIVISION THYAGAVALLI VILLAGE ALAPAKKAM VIA CUDDALORE 608 801 (INDIA) Tel: 0091 4142 270201/202 REGD.OFFICE: E.I.D PARRY (INDIA) LIMITED Dare House, Chennai SECTION II HAZARDOUS INGREDIENTS / IDENTITY INFORMATION Hazardous Components % Azadirachtin A & B 1.2 CAS No. 11141-17-6 95507-03-2 OSHA/PEL None known ACGIH/ TLV None known OTHER LIMITS RECOMMEN DED None known Other neem compounds, Aza-F, Aza-H, Aza-I, Salannin, Nimbin and Fatty acids etc. Other proprietary mixture and formulation compounds. Signature of the Preparer: 2.8 118855-02-0 134788-15-1 134788-16-2 992-20-1 5945-86-8 96.0 Not known Not known Not known Not known Not known For E.I.D PARRY (INDIA) LIMITED Not known Not known AUTHORISED SIGNATORY SECTION III PHYSICOCHEMICAL CHARACTERISTICS Appearance : Brown Viscous liquid Odour : Characteristic Neem Fragrant odour Solubility in water : Emulsifies with water Specific Gravity Melting Point Vapour Pressure : 0.98 : > 160 0 C for Technical grade product : 3.6 10-11 (hpa) Molecular Weight : 720 - Aza - A 662 - Aza - B Active Ingredients : Azadirachtin A Azadirachtin B Empirical Formula : C 35 H44 016 - Aza A C 33 H42 014 - Aza B Acidity : < 0.24% PH : 7 0.02 Corrosion Characteristics Viscosity Explodability : Non corrosive to HDPE containers : 281.4 mm2/S at 20 0 C 96.95 mm2/S at 40 0 C : Non explosive Boiling Point : Not established STABILITY AND REACTIVITY Conditions to avoid : Materials to avoid : Dangers of Product Decomposition : High temperature, sunlight Acids, alkalis and oxidising agents None SECTION IV Flash Point FIRE AND EXPLOSION DATA : > 171 0 C - No Fire & Explosion Hazard Flammable Limits : Not known Extinguishing Media : Polymer foam or carbon dioxide Special Fire Fighting Procedures : Wear protective clothing and face shields Unusual fire and explosion hazards : No hazard SECTION V REACTIVITY DATA Stability : Stable at ordinary conditions of use and storage Conditions to avoid : High temperature, open sunlight or highly illuminated places degrade the material Materials to Avoid : Acids, alkali or oxidizing agents. Hazardous Decomposition : No hazardous materials are produced Hazardous polymerization : Not occur SECTION VI HEALTH HAZARD DATA Mode of Entry Health Hazards: Acute Toxicity Acute &Chronic Toxicity (TGAC ) : Inhalation - yes Skin - yes Ingestion- yes : Acute oral - Rat LD 50 Not applicable (liquid) Acute Dermal -Rat LD 50 Not applicable (liquid) Acute Inhalation-Rat-LC50 Not applicable (liquid) Skin Irritation-Rabbit Mild Eye Irritation-Rabbit-No Irritation Skin Sensitization-Guinea Pig-No Sensitization : - Acute Oral-Rat-LD50>5000 mg/kg - Acute Dermal-Rat-LD50>2000 mg/kg - Acute Inhalation-Rat-LC50 > 0.10 mg/L - Skin Irritation-Rabbit-No Irritation - Eye Irritation-Slight - Skin Sensitization-Guinea Pig- Slight - Mutagenicity-Non Mutagenic - Carcinogenicty-Non Carcinogenic - Neurotoxicity-No Neurotoxicity(NOAEC 1000 mg/kg) - Developmental Toxicity- Rats-NOAEC-50 mg/kg/day - Dietary Toxicity- rats-NOAEC-100 ppm SIGN AND SYMPTOMS OF EXPOSURE Inhalation : Ingestion : Skin Contact : Eye Contact : Chronic Exposure : May be irritating to mucous membrane and excessive Exposure may result in drowsiness May cause drowsiness May cause mild irritation May cause mild irritation Chronic exposure may cause various implications EMERGENCY AND FIRST AID PROCEDURE Inhalation : Remove to fresh air Ingestion : Induce vomiting by gastric larvage, call physician Immediately Skin Contact : Wash skin with soap Eye Contact : Wash eyes with excessive water. Get medical attention if required SECTION VII ECOLOGICAL SAFETY Effect on Honeybees : Effect on Earthworms : Effect on Predators : Hazard to Soil Micro flora : Acute Daphnia Immobilization : Acute Fish Toxicity (Rinbow Trout) : Algal Inhibition test : Metabolism in Soil : Degradability in Water : Harmless Harmless (> 1000 mg/kg) Harmless Non hazardous EC 50 > 50 mg/l LC 50 = 440 mg/l (24 hrs) Non inhibitory, non stimulant Rapid Decomposition in Soil Readily Biodegradable in Water SECTION VIII PRECAUTIONS FOR SAFE HANDLING AND USE STEPS TO BE TAKEN IN CASE MATERIAL IS RELEASED OR SPILLED Flush the area with water. Do not allow water to contaminate surrounding area. Personnel in operation may wear protective clothing. WASTE DISPOSAL METHOD Do not contaminate water, food, or feed by storage or disposal. Disposal of containers in an approved disposal facility. Ensure compliance with local, state and federal regulations. PRECAUTIONS FOR HANDLING AND STORAGE Keep in a cool and dry place. Avoid direct sunlight. Open dumping is prohibited. Dispose containers in an approved waste facility. OTHER PRECAUTIONS Shipping Name : NEEMAZAL T/S 1.2% EC Shipping Containers Markings : NEEMAZAL T/S 1.2% EC Shipping Container Labels : NEEMAZAL T/S 1.2% EC Special Instructions : No special instruction on handling required Flammability : Non flammable Transport by Air : Safe for Air/Sea Transport SECTION IX CONTROL MEASURES Respiratory Protection : Use spraying clothings to avoid spray mist Direct contact Protective Gloves : Wear protective gloves Eye protection : Wear chemical safety goggles Ventilation Work Practices : Thorough ventilation is recommended in case of accidental spillage : Observe good personnel hygiene. Wash hands after usage of the product Regulatory Information SECTION X Designation : Eco-friendly Neem Based Liquid : Non Hazardous Material Information Origin SECTION XI E.I.D PARRY (INDIA) LIMITED BIO PRODUCTS DIVISION THYAGAVALLI VILLAGE ALAPAKKAM VIA CUDDALORE 608 801 (INDIA) Regd. Office: E.I.D Parry (India) Limited. 234, N.S.C Bose Road "Dare House" Post Box No.12 Chennai - 600 001 India The information contained herein is provided in good faith and is believed to be correct as of the date. However, E.I.D Parry (India) Limited makes no representation as to the comprehensives or accuracy of the information. It is expected that individuals receiving the information will exercise this independent judgment in deforming its appropriateness for a specific purpose. Accordingly, E.I.D Parry (India) Limited will not be responsible for damage of any kind resulting from the use of or reliance upon such information.