Document 3Xm70x3my6dQNrJjqVzQ7EME

ft E A ~ UnitedStates ......, Environmental Protection , Agency Region 6 - Enforcement & Compliance Assurance Division INSPECTION REPORT Inspection Date(s): Media Program: Regulatory Program(s) 03/28/2024 Toxic Substances Control Act (TSCA) New and Existing Chemicals (NEC) Program, also known as "Core TSCA" Company Name: Facility Name: Facility Physical Location: (city, state, zip code) Mailing address: (city, state, zip code) County/Parish: Facility Phone Number Facility Contact: SACHEM Incorporated SACHEM Cleburne 2311 Pipeline Road Cleburne, TX 76033 Same Same Johnson County (817) 202-3200 Katrice Harris 817-202-3228 (817) 202-3228 HSE Manager FRS Number: Identification/Permit Number: Media Identifier Number: NAICS: SIC: 110063183193 N/A N/A 325199 -All other basic organic chemical manufacturing N/A Personnel participating in inspection: David Riley US EPA Region 6 (ECDST) Katrice Harris SACHEM Inc Tom Mooney SACHEM Inc Uchenna Okpara SACHEM Inc Casey Tackett SACHEM Inc Paul Kamprath (online) SACHEM Inc Richard Engler (online) Bergeson & Campbell Inspector HSE Director EVP, HSSEE & Quality HSE Engineer Operations Manager VP, Global Supply Chain Scientist (Consultant for SACHEM) EPA Lead Inspector Signature/Date ?JltP~~ John David Riley 5/24/24 Date Supervisor Signature/Date H STUCKEY Digitally signed by H STUCKEY Date: 2024.05.24 11 :59:33 -05'00' H. Troy Stuckey Date 6ENFORM-020-R8.2 (02/12/2020) 1 SACHEM Incorporated Inspection Date 03/28/2024 Section I - INTRODUCTION PURPOSE OF THE INSPECTION The purpose of this inspection is to evaluate SACHEM Incorporated of Cleburne, Texas, for compliance with Sections 4, 5, 8, 12, and 13 of the Toxic Substances Control Act (TSCA), also referred to as the New and Existing Chemicals (NEC) program, or "Core TSCA". These Sections are as follows: 4 -Testing of Chemical Substances and Mixtures 5 - Manufacturing and Processing Notices 8 - Reporting and Retention of Information 12- Exports 13 - Entry into Customs Territory of the United States The inspection was conducted pursuant to Section 11 of TSCA. The Core TSCA program is not statedelegated; therefore, inspections are conducted by the EPA. This is a "neutral scheme" inspection covering the calendar years 2019 to the present. EPA initially reviewed information from its Chemical Information System, which showed SACHEM as a processor or manufacturer of chemical substances that were the subject of a TSCA Section 5(e) order. The Cleburne facility was selected for an inspection based on reviews of additional EPA information sources, as well as no record of prior TSCA inspections. I, David Riley of US EPA Region 6, initially contacted the company by phone on March 14, 2024, and left a message for Katrice Harris, HSE Director. I spoke with Ms. Harris later that day, and the inspection was scheduled for Thursday, March 28, at 10:00am. On March 15, I sent Ms. Harris an inspection notification email containing a list of information that the company should prepare for my review [Appendix l]. INSPECTION ENTRY & OPENING CONFERENCE I arrived at the facility at 9:50am on March 28, 2024. I entered the reception area and was met by Ms. Harris, who escorted me to a conference room. I presented my inspector credentials and a business card to those present and informed them that the inspection would involve a review and discussion of the information requested in Appendix 1. At that time, Ms. Harris signed the Notice of Inspection [Appendix 2]. COMPANY HISTORY & FACILITY DESCRIPTION SACHEM is a privately-held company based in Austin, TX. It grew out of Mooney Chemicals, which was founded in 1946. In 1984, Southwest Analytical Chemicals was acquired, and the Sachem Cleburne 2 SACHEM Incorporated Inspection Date 03/28/2024 facility was established in 1991. Since 1998, SACHEM has expanded its manufacturing and/or research & development into Japan, The Netherlands, China, Korea, and India. SACHEM develops and produces chemicals for use in various industries. They also perform some toll formulating, processing, and blending for other companies. SACHEM Incorporated is located at 2311 Pipeline Road in Cleburne, TX. The Cleburne facility manufactures various quaternary ammonium compounds which are used in organic synthesis, function as formulation components in etchants for integrated circuit manufacturing, or act as templates or structure directing agents in the production of zeolites: microporous, crystalline aluminosilicate materials commonly used as commercial adsorbents and catalysts. In 2020, the EPA and SACHEM entered into a TSCA Section S(e) Consent Order, regarding three chemicals for which premanufacture notices were submitted to the EPA. The consent order requires that SACHEM follow certain requirements for processing, manufacturing, distribution, releases to water, personal protective equipment, respirators, labeling, and recordkeeping. Section II-OBSERVATIONS DISCUSSION The inspection began with a review of company vision, history, and policies. FACILITY TOUR Mr. Tackett, Ms. Harris, and Mr. Okpara led me on a tour of the raw material storage area, process areas, and finished product storage areas. FACILITY DOCUMENTATION No documents were collected at the time of the inspection, as SACHEM was still in the process of compiling the information requested in the inspection notification email. It was agreed that SACHEM would keep me informed of their progress and submit the information via CDX later. Section Ill - AREAS OF CONCERN I observed no areas of concern at the time. Facility representatives were very cooperative prior to and during the inspection. 3 CLOSING CONFERENCE SACHEM Incorporated Inspection Date 03/28/2024 At 12:15pm, I conducted a closing conference with all present, indicating that I would follow up with any questions, and that an inspection report would be finalized in approximately two months. We discussed some modifications to the deliverables specified in the inspection notification email. The Notice of Proprietary/Confidential Business Information {Appendix 3] was signed by Ms. Harris, as well as the Receipt for Samples and Documents [Appendix 4]. The TSCA Notice of Inspection, TSCA CBI Notice, and Receipt for Samples and Documents were then copied, and the originals were returned to me. I exited the facility at 1:00pm. Section IV - FOLLOW UP I contacted Ms. Harris on 5/20/24 regarding the status of SACHEM submitting the information requested in the inspection notification email. That day, the information under Item 1 of the email (both CBI and sanitized versions) was submitted via CDX. Section V - LIST OF APPENDICES Appendix 1- Inspection Notification Email Appendix 2 - Notice of Inspection Appendix 3 - TSCA CBI Notice Appendix 4 - Receipt for Samples and Documents 4 SACHEM Incorporated (Cleburne) Inspection Date: 03/28/2024 Appendix 1 Inspection Notification Email Riley, David From: Sent: To: Subject: Riley, David Friday, March 15, 2024 3:14 PM kharris@sacheminc.com Core TSCA Inspection of SACHEM Inc., Cleburne, TX Ms. Harris, This email is regarding our phone call on March 14th. My apologies for not getting it to you earlier today. As discussed, I, as a representative of the EPA's Region 6 office, will conduct an inspection of the SACHEM Inc. facility at 2311 Pipeline Rd., Cleburne, TX on March 28th, beginning at 10:00 am. The inspection will be conducted pursuant to Section 1l(a) of the Toxic Substances Control Act (TSCA), 15 U.S.C. Section 2610(a) to determine compliance with TSCA Sections 4, 5, 6, 8, 12 and 13. Among the specific issues to be addressed are: Premanufacture Notices (PMNs) submitted by the facility, or requests for exemption from the PMN review process, including Low Volume Exemptions (LVEs), Test Marketing Exemptions (TMEs), Low Release and Low Exposure Exemptions (LoREX), and Polymer Exemptions (PEs). Notice of Commencements (NOCs), Bonafide Intent to Manufacture Letters, and Significant New Use Notices (SNUNs) submitted by the facility and any associated TSCA Section 5(e) or (f) Orders issued by the EPA. Research and development activities and procedures in effect at the facility, specifically as related to compliance with the requirements of a TSCA Research and Development (R&D) Exemption. Records maintained by the facility pursuant to TSCA Sections 8(a), (c), (d) and (e), including the 2020 Chemical Data Reporting (CDR) Rule report. Facility and/or Corporate Headquarters' operations and practices developed to ensure compliance with TSCA Sections 4, 5, 6, 8, 12 and 13. Manufacturing and process flow diagrams for each chemical substance that is manufactured at the facility. As mentioned over the phone, the in-person portion of the inspection will involve a facility tour and discussion. I don't plan on taking up an entire day - - only 3 or so hours. Any requested information should be provided as one or more electronic files in a form that allows EPA to readily retrieve and utilize the information using commercially available software. These electronic files must be submitted via EPA' s Central Data Exchange (CDX) Program Service titled "CSPP: Submissions for Chemical Safety and Pesticide Programs" under its drop-down "TSCA Enforcement and Compliance Communications" application. Click here to download a copy of the CSPP CDX Registration Guide. The requested information does not necessarily need to be provided before the inspection date. Additional time is available, and if that is the case, we can at least discuss the contents/formatting of that information during my visit. TSCA CBI Claims 1 Under Section 14(a) ofTSCA, 15 U.S.C. 2613(a), submitters may claim information submitted to the EPA under TSCA as CBI. TSCA CBI claims must be asserted and substantiated concurrently with the submission of the information, except for those types of information exempt under TSCA Section 14(c)(2). There are several procedural requirements that must be followed when asserting CBI claims in TSCA submissions. The authorized official submitting TSCA CBI claims must make several assertions as well as certify that information submitted to substantiate a TSCA CBI claim is true and correct, as required by Sections 14(c)(l)(B) and 14(c)(5) ofTSCA, 15 U.S.C. 2613(c)(l)(B) and (c)(5), and 40 C.F.R. 2.208. The certification statement in CDX will satisfy these requirements. If a specific chemical identity is claimed as TSCA CBI, a structurally descriptive generic name must be provided. General guidance for what to include in TSCA CBI substantiations, including several sample substantiation templates, are available here: https://www.epa.gov/tscacbi/what-include-cbi-substantiations#substantiationtemplates. If some or all information provided in response to this email is claimed to be TSCA CBI, please follow the directions below to ensure that the security and confidentiality of the information is maintained: Complete the certification statement that is incorporated into CDX. If you are unable to provide the identity of the chemical substances or mixtures because your suppliers or customers have a CBI claim on the products that were purchased domestically, imported or exported, please submit the suppliers/customers name and address for that product with your response. A second copy of any documents claimed as CBI must be provided with CBI claims redacted to include only that information that you are NOT claiming as CBI. The EPA developed an information sheet entitled "U.S. EPA Small Business Resources" to help applicable small businesses understand federal and state environmental laws and rights under the Small Business Regulatory Enforcement Fairness Act. The information sheet can be found on the internet at: https ://www.epa.gov/compliance/small-business-resources-information-sheet . If you have any questions concerning the inspection, or if additional time is needed to compile the information listed below, please contact David Riley at 214-665-7298 or riley.david@epa.gov. Thank you for your cooperation in this matter. The following information (Items 1 through 7) is requested for the last five calendar years from the date of this inspection email, unless otherwise specified. If some information is not applicable, please indicate. Requested Information Item #1: General Company Information. Provide information on the following: Brief company history of ownership and business. Corporate structure (including foreign and domestic parent companies). Listing of all U.S. facilities owned by the company, including subsidiaries, and their locations. Number of employees on the facility and corporate level. Shifts per workday, hours of operation, days per week. Gross annual sales on the facility and corporate level for the last two complete years or accounting cycles (note the fiscal cycle) rounded to at least three significant figures. Identifying information for the facility and U.S. parent company, including data universal numbering system (DUNS) number. Importer of Record ID for all sites that import into the U.S. that are owned by the U.S. parent company. 2  Scope of business, main North American Industry Classification System (NAICS) codes under which the site operates, and main industries that the company and site supply. Facility and/or corporate policies developed to ensure compliance with TSCA Sections 4, 5, 6, 8, 12, and 13. Section 6 policies relevant to PCB compliance are not requested at this time. Facility Permit IDs, including RCRA Hazardous Waste, TRI, NPDES, CAA, Air Emissions Inventory (EIS) . Site map of the facility Item #2: Process Flow Diagrams. Provide existing diagrams and the following information: Manufacturing and processing flow diagrams for substances manufactured at the facility, listing each raw material input and the resulting products (by Chemical Abstracts Service Registry Number (CASRN) or EPA Accession Number) for each step between the particular raw material and the commercial product, including intermediates, byproducts, and catalysts, that are part of the commercial production but are not intended for sale or distribution. Indicate all steps including on-site use, marketing, transfer, recycling, and waste disposal. Item #3: Prepare a spreadsheet of chemical substances that were manufactured (including those imported), as well as any intermediates both non-isolated and isolated, for products by the facility for the current calendar year and the past 8 calendar years. If a chemical substance is a hydrate under the definition of mixture pursuant to 40 C.F.R. 710.3, please include Chemical Abstracts Service Registry Number (CASRN) of both the hydrate and the anhydrous forms of the chemical substance. The spreadsheet should include the following information: 1. CASRN or the EPA Accession Number; 2. Chemical substance; 3. Dates of manufacture, including import; 4. Quantity manufactured per batch, including quantity imported per shipment and shipment number; 5. Whether the chemical substance is Manufactured or Imported, or both; 6. Indicate if the chemical is a byproduct, an impurity, or a non-isolated intermediate, and isolated intermediate, and a general description of use. If the chemical is identified as a byproduct or an intermediate, indicate in the process diagrams how it is produced; 7. HTS Code used if imported; and 8. Indicate if an R&D Exemption (R) or Polymer Exemption (PE) has been claimed. Please organize your response to Item #3 in a spreadsheet in tabular format: CASRNor PA ccession # anufacture eluding port) se a separate w for each anufacture uantity anufactured er atch/lmported er shipment (in bs) )/Polymer E) Item #4: 3 Prepare a spreadsheet of the raw materials (including mixtures) acquired from domestic suppliers that were used or processed by the facility for the current calendar year and the past 5 calendar years. The spreadsheet should include the following information: 1. CASRN or the EPA Accession Number; and 2. The supplier's name and address. Please organize your response to Item #4 in a spreadsheet in tabular format: CASRNor EPA Accession# Product Name l-\mount Supplier's received in CY name ~023 Supplier's address b the substance received for R&D purposes? (YIN) Item #5: Prepare a spreadsheet of chemical substances and the components of each mixture of the products that were exported from the United States by the facility for the current calendar year and the past 5 calendar years. List each unique CASRN only once and only if the chemical substance makes up one percent or greater of the volume of the product. The spreadsheet should include the following information: 1. CASRN or the EPA accession number for each chemical substance; 2. Export date; 3. Final destination (foreign country); 4. Section 12(b) export notice status, see 40 C.F.R. Part 707 Subpart D and https ://www.epa.gov/tsca-import-export-requirements/chemicals-subj ect-tsca-section-12bexport-notification-0. Please organize your response to Item #5 in a spreadsheet in tabular format: CASRN or EPA Accession Export date # Final destination Section 12(b) notice submitted? (YIN or NA) Item 6: Documentation Pursuant to TSCA Sections 5 and 6. Provide the following documents and information: TSCA Section 5{a) o List of PMNs and SNUNs submitted by your company or transferred to your company; o List ofNOCs submitted by your company; and o Records documenting compliance with any Significant New Use Rules. Please refer to 40 C.F.R. 721.125 to ensure submission to EPA of all required information. TSCA Section 5(e)/(f) o Records demonstrating compliance with TSCA Section 5(e)/(f) Orders. TSCA Section 5{h) o Research and development activities and procedures in effect at the facility, specifically as related to compliance with the requirements of a TSCA R&D Exemption. See recordkeeping requirements in 40 C.F.R. 720.78; 4 o Documentation of prudent laboratory practices and of the notification and evaluation of risks, where appropriate; and o Operating manuals or written procedures that are used by laboratory personnel to manage chemicals with unknown hazards. o Prepare a spreadsheet of chemical substances that the facility manufactured, processed or used under the TSCA R&D exemption for the current calendar year and the past 5 calendar years in tabular format. The list should include the following information for each chemical substance/component on an annual basis: i.CASRN or the EPA accession number for each chemical substance; ii.Names and addresses of those who received the R&D chemical; iii.Amount distributed per shipment to each addressee; and iv.Make available a copy of the Safety Data Sheet, shipping label and any written notice provided to the customers for each R&D chemical. Please organize your response to Item #6 in a spreadsheet in tabular format: (:ASRN or Name of ~PA Accession J{ecipient I# Recipient's !Address Quantity per shipment (in bs) SDS, shipping label and/or ,written notices provided 'YIN) TSCA Section 6 o Records demonstrating compliance with Section 6 rules. Please refer to 40 C.F.R. Part 751 to ensure submission to EPA of all required information. Item #7: Documentation Pursuant to TSCA Sections 4 and 8. Provide the following documents and information: Provide the certificate of analysis from a representative lot for each manufactured product that is used in commerce. TSCA Section 4 o Letters of intent to conduct testing and proof of data submittal, or requests for exemption from testing, for chemicals manufactured or used at the facility that are subject to an active TSCA Section 4 final test rule, Consent Agreement and/or test order. TSCA Sections 8(a) and 8(b) o Recordkeeping and reporting under Section 8(a) and (b) including those for CDR; o For CDR, provide a sample calculation of the volumes reported to 2020 CDR, including facility sources used. TSCA Sections 8(c), 8(d), and 8(e) o Documentation of allegations subject to TSCA Section 8(c) recordkeeping. Provide OSHA Injury & Illness Recordkeeping Forms 300, 300A, and 301; o A list of 8(d) health and safety studies submitted to EPA and copies of any known health and safety information that were not submitted to EPA. Section 8(d) as explained in 40 C.F.R. 716.3 includes any health and safety study of any effect of a chemical substance or mixture on health or the environment or on both, including but not limited to: Epidemiological or clinical studies; Studies of occupational exposure; In vivo and in vitro toxicological studies; and 5  Ecotoxicological studies. See: https://www.epa.gov/assessing-and-managingchemicals-under-tsca/data-development-and-information-collection-assessrisks#studies. o TSCA Section 8(e) substantial risk information not known to EPA or previously submitted to EPA by your company. The TSCA Section 8(e) information includes among other items: toxicity or exposure data, full reports, summarized results, limited studies (e.g., range-finding studies), preliminary results, and draft reports that constitute sufficient evidence for Section 8(e) reporting. Thank you, David Riley Inspector/Enforcement Officer Core TSCA, EPCRA 313 US EPA Region 6 (ECDST) 1201 Elm Street, Suite 500 Dallas, Texas 75270-2102 Phone: (214) 665-7298 e-mail: riley.david@epa.gov 6 SACHEM Incorporated (Cleburne) Inspection Date: 03/28/2024 Appendix 2 Notice of Inspection oEPA Uniled S!al eo Environmental Protoct io,.._ Agency United States ENVIRONMENTAL PROTECTION AGENCY Washington, DC 20460 Notice of Inspection Office of Enforcement and Compliance Assurance 1. Investigation Identification 3. Facility Name Date I I I IMar 28, 2024 Inspection Number 11 of 1 Daily Seq. Number 11 I I 5AtH~~ , ,I\(!,, 7 ~ 2. Inspector's Address 4. Facility Address EPA Region 6 omcc 1201 Elm Street, Suite 500, Dallas, Texas 75270 Z-3H P:jel;...., Rd- cl~bv..r-1\.e >--Y-~ :uo?>3 For Internal EPA Use. Copies may be provided to the recipient asacknowledgment of this notice. Reason for Inspection Under the authority of Section 11 of the Toxic Substances Control Act For the purpose of inspecting (including taking samples, photographs, statements and other inspection activities) an establishment, facility or other premises in which chemical substances or mixtures, articles containing same are anufactured, processed, stored or held before or after their distribution in commerce (including records, files, papers, ~ recesses, control and facilities) and any conveyances being used to transport chemical substance, mixtures or articles containing same in connection with their distribution in commerce (including records, files, papers, processes, controls and facilities) bearing on whether the requirements of the Act are applicable to the chemical substances, mixtures or articles, within, or associated with, such premise or conveyance have been complied with. D In addition, this inspection extends to (check appropriate blocks): DA. Financial Data D B. Sales Data D C. Pricing Data D D. Personnel Data D E. Research Data The nature and extent of inspection of such data specified in A through Eabove is as follows: / ~ _ ) Inspector's Signature Name !John David~ley Title !Env ironmental Scienti st ~ R~eci . '. Si natu , \ \l~, ~(____Q "'\,.._J . ~ I I Na~ ~ c . . e \ - \ - n r , ~ I Date I3 {1,i{i4 ITitle I \-\-'2:E:- bi~ ttt:r I Date I3/~cY-/ I EPA Form 77403 (Rev. 2/16) 1-lnspector Copy 2-Facility Copy SACHEM Incorporated (Cleburne) Inspection Date: 03/28/2024 Appendix 3 TSCA CBI Notice &EPA Unih)d St8:Ut$ Environment:JI P-101ue1io1) Aooncy UNITED STATES ENVIRONMENTAL PROTECTION AGENCY Notice for Toxic Substances Control Act (TSCA) Inspections NOTICE REGARDING PROPRIETARY/CONFIDENTIAL BUSINESS INFORMATION (CBI) SUBI\1ITTED TO OR COLLECTED BY EPA IN CONNECTION WITH INSPECTIONS AND OTHER COMPLIANCE MONITORING For information submitted to or obtained by the U.S. Environmental Protection Agency (EPA or Agency) during or after an inspection (or other compliance monitoring), regulated entities (e.g., businesses, facilities, etc.) may assert a confidentiality claim on information that it believes is a trade secret or as privileged or confidential commercial or financial information, which is protected under Exemption 4 of the Freedom of Information Act (FOIA) at 5 U.S.C. 552(b)(4). This type of information is commonly referred to as CBI or proprietary business information (PBl). For consistency purposes, the term CBI will be used within this document. Under section 14 ofTSCA, regulated entities (e.g., businesses, facilities, etc.) have a right to claim certain information submitted to the EPA in connection with an inspection (or other compliance monitoring) as CBI. 15 U.S.C. 2613. This document provides instructions for asserting a CBI claim, under TSCA, on the business information that you provided to EPA during or after its inspection based on the time limitations defined below. EPA is giving you this Notice so that you have the opportunity to request confidential treatment of your business information in order to ensure that EPA properly handles your business' CBI claims. If your business believes that any information that EPA will be viewing or collecting during the inspection ofyour business may be CBI, EPA requests that a representative ofyour business who has the authority to claim that information as CBI, read, fill out and sign this Notice. You must read and follow all instructions for properly giving EPA notice of your CBI claim. lfyou have questions about this Notice, you or a representative ofyour business with the authority to assert the CBI claim may request clarification from the EPA inspector or call the contact name that the inspector will give you with this Notice. EPA has also created a Questions and Answers document for this Notice that you may find helpful and is available at: https://www.epa.gov/compliance/cbi-noticeinformation-collected-during-epa-inspections-or-other-compliance-monitoring If a CBI claim does not accompany the information submitted to EPA, or is not submitted within 10 calendar days following an inspection, as described in Paragraph (A)(l)(b), below, then the Agency may make the information available to the public without further notice. For example, the Agency may make inspection reports available to the public, including through this website at https://echo.epa.gov. Also, EPA may be required by law to release the information to the public.1 For example, the FOIA requires the disclosure of Agency records that have been requested by a FOIA request unless that information falls within a FOTA exemption. However, EPA does not release information claimed as CBI to the public in response to a FOIA request. In addition, EPA is required under section 14 ofTSCA to routinely review (and approve or deny) all but some exceptional CBI claims for chemical identity, and a representative subset, comprising at least 25 percent, of other types ofTSCA CBI claims. 15 U.S.C. 2613(g). Information that you claim as CBT in accordance with TSCA section 14 will be held as such until the CBI claim is withdrawn, expires, or is denied by EPA, in accordance with TSCA section 14 and 40 C.F.R. Part 2, Subpart B. 1 Information covered by a CBI claim will be disclosed by EPA only to the extent of, and by means of, the procedures set forth in 40 C.F.R. Part 2, Subpart B (A) Procedures to claim confidential treatment/or information provided to EPA. (1) You may assert a CBI claim covering part or all of the information submitted to or obtained by EPA: (a) at the time of the inspection; (b) within IO-calendar days2 following the inspection for information submitted to or obtained by EPA during the inspection; or (c) at the time of submittal, if you submit information requested before or after the inspection. (2) If you fail to assert a CBI claim before an inspection, during an inspection, or within the IO-calendar day period following the inspection, the information may be made available to the public by EPA without further notice to the business. (3) EPA's CBI regulations are at 40 C.F.R. Part 2, Subpart B (sections 2.201-2.311). See https://www.ecfr.gov. (B) Method and time of asserting business confidentiality claim. (1) Under TSCA section 14(c), you are required to substantiate each CBI claim (with some exceptions, described in TSCA section 14(c)(2)), provide certain certification statements, and, for CBI claims concerning chemical identity, provide a structurally descriptive generic name. All of this information must be provided at the time the information claimed as CBI is submitted to EPA. More information on how to assert a claim under TSCA may be found at https://www.epa.gov/tsca-cbi. (2) A business that is submitting information to EPA may assert a business confidentiality claim by highlighting, bracketing, boxing, or circling the information claimed as CBI, and marking the page or document with language such as trade secret, proprietary, company confidential, PBL or CBI. You may also provide a "sanitized" or non-confidential version of the document, with all CBI removed to facilitate identification and handling of CBI by EPA.3 If your business requests confidential treatment only until a certain date or until a certain event happens, then please indicate this at the time your business makes its CBI claim. The Notice includes a box (page 4) that you or the inspector may use to list and generally describe the CBI claims; add an attachment if more space is needed. (3) For documents that EPA inspectors collect or copy during the inspection, a representative of the facility should provide a general description of information that is claimed as CBI in those documents when provided to the inspector. Substantiation, certification, and generic name(s) (when applicable) may be provided to EPA following the inspection, but must be received by EPA within 10 calendar days after the inspection. Similarly, assertions that photos taken by EPA include or may include CBI should be made at the time of the inspection by a representative of the facility. Such assertions should generally describe what is considered CBI by the business, for example, specific equipment or processes. Substantiation of these CBI claims must be provided within 10 calendar days following the inspection. CBI claims to documents and photos taken or collected during the inspection that are not substantiated within this 10-calendar day timeframe or are otherwise not complete according to TSCA section 14(c), will be considered by EPA to have been withdrawn. Substantiation should be directed to the address for the EPA inspector identified on the sheet attached to this notice. 2 The I 0-calendar day period begins on the day after an inspection concludes. For example, if the inspection of your business commenced on Monday and concluded on Tuesday, the IO-calendar day period begins on Wednesday. If the JO-calendar day period ends on a weekend day or a holiday your claim must be postmarked, or EPA contacted by telephone by the next business day . In certain instances EPA may find it necessary to disclose the information obtained during the inspection and not claimed as CBI before the I0-calendar day period expires, and as such, EPA may provide the affected business less than I0-calendar days following an inspection to assert a CBI claim. 3 You should indicate, but not black out, white out or remove, all CBI in the documents you submit to EPA so that the CBI remains visible for EPA to read. Only marking the document or page as confidential or the like is not sufficient to assert a proper CBI claim. In addition to submitting the document with legible CBI , you may also submit a copy of the document with the CBI blacked out or removed, but yo u may not submit only a document with the CBI blacked out or removed (a "sanitized copy."). EPA treats the sanitized copy as a publicly available document. 2 (C) Substantiation ofbusiness confidentiality claim. Unless the information is exempt from the substantiation requirement under TSCA section 14(c)(2), substantiation must be provided with TSCA CBI claims at the time they are asserted and submitted to the agency (but note the IO-calendar day period discussed in paragraph (B) for materials collected during an inspection). EPA has developed several submission type-specific and general templates that may be used to provide substantiation (use of the templates is recommended, but not required) and has provided additional guidance on what to include in a substantiation on the EPA TSCA CBI webpage: https://www.epa.gov/tsca-cbi The questions included in 40 C.F.R. 2.204(e)(4) and the substantive criteria at 40 C.F.R. 2.208 may also serve as a useful guide to what to include in a TSCA CBI substantiation. (D) Certain information not entitled to confidential treatment. Information that is publicly available at the time of inspection, or that is required to be disclosed to the public by law, is not entitled to confidential treatment and should not be claimed as CBI. While this is not a comprehensive list, the following types of information generally are not protected as CBI: information that is publicly available; information that was submitted to a federal, tribal, state or local government that was not claimed as CBI; information prohibited by law as CBI, such as effluent data, emissions data, or health and safety data in health and safety studies (see, e.g., TSCA section 14(b)). If a business makes a claim on any such information, EPA may make a determination under 40 C.F.R. 2.204(d)(2) that the information is clearly not entitled to confidential treatment. See Attachment A, Questions and Answers about this Notice, for some examples of what is and is not entitled to confidential treatment. 3 &EPA UNITED STATES ENVIRONMENTAL PROTECTION AGENCY United State PROPRIETARY/CONFIDENTIAL BUSINESS INFORMATION NOTICE Environmental Protection Agency FOR TSCA INSPECTIONS Facility: SP, GH Facility Address: 1..5 I \ Facility Representative with authority to make a CBI claim (print name & title): ~:c.e__ ~ if1S \t~I5\feCtcr Phone/email: i \l-J~- 3:;)~t EPA Inspector (print): Address: [mailing or courier address appropriate for inspector and/or inspector's Document Control Officer] Date: John David Riley Phone: 214-697-4546 Email: riley.david@epa.gov , / I I have received this Notice and DO NOT make any CBI claim on the documents and information I have V provided to EPA at this time. I understand that, within JO-calendar days ofthe date ofthis inspection, ifI determine that any ofthe documents and information I provided to EPA are CBI, I may send a written notice to the EPA inspector (address and email listed above) identifying the specific information I wish to claim as CBI I further understand that ifno CBI claim was made at the time ofthe inspection or within the 10-calendar day period following this inspection, the information may be made available to the public by EPA withoutfurther notice to the business. See 40 C.F.R. 2.203. I have received this Notice and DO make a CBI claim regarding the documents and information listed below I that l have provided to EPA. I hereby certify to the best ofmy knowledge and belie/that all information entered on this form is complete and accurate. I further certify that, pursuant to 15 U.S.C 2613(c), for all claims for confidentiality made with this submission, all information submitted to substantiate such claims is true and correct, and that it is true and correct that i. My business has taken reasonable measures to protect the confidentiality ofthe information; ii. I have determined that the information is not required to be disclosed or otherwise made available to the public under any other Federal law; iii. I have a reasonable basis to conclude that disclosure ofthe information is likely to cause substantial harm to the competitive position ofmy business; and iv. I have a reasonable basis to believe that the information is not readily discoverable through reverse engineering. Any knowing and willful materially fals e, fictitious, or fraudulent statement or representation is subject to criminal venally vursuant to 18 USC. 1001. 4 Part B of this Notice explained how to identify infonnation claimed as CBI. You or the inspector may use this box to list and generally describe any CBI claims. For clarity, please be as specific as possible. Example: Internal layout of facility. N~t\,,.;~. fv 6r slA b ,.,..,; tk d v:1,.. CD'){. J . (Revised: January 2021) Attach additional sheets, if needed. 5 Original to EPA I Copy to Facility SACHEM Incorporated (Cleburne) Inspection Date: 03/28/2024 Appendix 4 Receipt for Samples and Documents &EPA United States Environmenta l Protection Agency United States ENVIRONMENTAL PROTECTION AGENCY Washington, DC 20460 Receipt for Samples and Documents Office of Enforcement and Compliance Assurance - 1. Investigation Identification 2. Company Name Date Inspection No. Daily Seq. No. IMar 28, 2024 111 of 1 111 1 I 5ACH<:f\ l.l'c.., ' I 3. Inspector Address 4. Company Address EPA Region 6 Office I '2.3 I I f ;rr\,~ R.d ~ 1201 Elm Street, Suite 500, Dallas, Texas 75270 : Cl t bv,----. 1"1'l( -=,-6o'.53 I For internal EPA use. Copies of this form may be provided to recipient as acknowledgment of the documents and samples of chemical substances and/or mixtures described below collected in connection with the administration and enforcement of the Toxic Substances Control .Act. 1......... Receipt of Document(s) and/or Sample(s) Described is Hereby Acknowledged: No. ~ Description I ~ 11 I I l~ I II ~>(~ I "V:.. 11 ~Cr,/ I 11 II 11 II 11 Optional: Duplicate or Split Samples: Requested and Provided Inspector's Signature ~S:>~ ~~-.) / l) ~~ ~"\,,&_ .... ~ ~ I I I (',,._ I ~ Not Requested Claim~ L e _ J \ Signature '- ~ ~ Name IJohn David1liley Name ~ ; e , - e _ -\-( (~':> I Title !Environmental Scientist I Date I?>{'Li rL~ Title It\-::E .[),r-ff._fty- I Date 13/d~~ I EPA Form 7740-1 (Rev. 2/16) 1-lnspector Copy 2-Facility Copy