Document NGNYo6XxZbnEwkEZD6OOoDnZD
ft E A ~ United States
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Environmental Protection
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Agency
Region 6 - Enforcement & Compliance Assurance Division
INSPECTION REPORT
Inspection Date(s): Media Program : Regulatory Program(s)
07/24/2025 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:
Exfluor Research Corporation Exfluor Research Corporation 2350 Double Creek Drive Round Rock, TX, 78664 Same Same Williamson (512) 310-9044 Eric Bierschenk (512) 310-9044
Head of Engineering
FRS Number: Identification/Permit Number: Media Identifier Number:
NAICS:
SIC:
110017613322
N/A N/A
325998 - All other miscellaneous chemical product & preparation manufacturing
N/A
Personnel participating in inspection:
David Riley
US EPA Region 6 (ECDST)
Tim Juhlke
Exfluor Research Corporation
Tyson Railey
Exfluor Research Corporation
Tom Bierschenk
Exfluor Research Corporation
Tyler King
Exfluor Research Corporation
Han-Chao Wei
Exfluor Research Corporation
Eric Bierschenk
Exfluor Research Corporation
Kurt Jacquin
Exfluor Research Corporation
Dawn Ulbricht
Exfluor Research Corporation
Inspector Vice President Head of Sales & Marketing Vice President Senior Research Chemist Head of Research & Development Head of Engineering Environmental, Health, & Safety Manager Head of Quality
EPA Lead Inspector Signature/Date
r)J!t,D~~
John David Riley
-
9/24/25
Date
Supervisor Signature/Date
/~/
Gerardo Acosta
Digitally signed by GERARDO ACOSTA Date: 2025.09.2612:21 :05 -05'00'
Date
6ENFORM-020-R8.2 (02/12/2020)
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Section I - INTRODUCTION
Exfluor Research Corporation Inspection Date 07/24/2025
PURPOSE OF THE INSPECTION
The purpose of this inspection is to evaluate Exfluor Research Corporation's {Exfluor) Round Rock, TX facility 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 2020 to the present.
EPA initially reviewed information from ChemView and the Chemical Information System, which showed that Exfluor had previously submitted Low Volume Exemptions {LVE) and Notices of Activity {NOA) for various fluorinated hydrocarbons. Regarding LVEs, certain categories of new low-volume chemical substances are exempt from full premanufacture notice {PMN) review under section 5 of TSCA. Regarding NOAs, the 2016 amendments to TSCA required the EPA to designate chemical substances on the Chemical Substance Inventory as either "active" or "inactive" in U.S. commerce. This involved reporting from entities that domestically manufactured, imported, or processed a listed chemical substance for nonexempt commercial purposes during a specified period.
The facility was selected for an inspection based on reviews of additional EPA information sources, as well as no record of prior TSCA inspections at the facility. This is the only Exfluor location.
I, David Riley of US EPA Region 6, contacted the facility via phone on 7/8/2025 and left a message regarding the scheduling of the inspection. That afternoon, I was emailed by Eric Bierschenk, Head of Engineering for Exfluor, with potential dates, eventually deciding on 7/24/2025. On 7/10/2025, I had a Teams call with Mr. Bierschenk and company representatives to discuss the focus ofthe inspection. A list of information to prepare for review was emailed to Mr. Bierschenk on 7/11/2025. [Appendix 1].
INSPECTION ENTRY & OPENING CONFERENCE
I arrived at the facility at approximately 8:40am on 7/24/2025. I drove through the parking lot to view the grounds and returned to park near the lot entrance on Double Creek Drive. I was greeted by a representative of FluoroMed LP, which occupies Building A of the campus. I was escorted to Building D
2
Exfluor Research Corporation Inspection Date 07/24/2025
of the campus at 8:55am to meet with Exfluor. In a conference room, I presented my inspector credentials to company representatives and informed them that the inspection would involve a review and discussion of the facility's products and manufacturing process. At that time, Dr. Tim Juhlke, Vice President, signed the Notice of Inspection [Appendix 2].
Exfluor representatives proceeded with a presentation involving some of the information requested in my email of 7/11/2025, which is described in the following section. We also discussed the request in more detail to determine what would be sufficient for my review.
COMPANY HISTORY & FACILITY DESCRIPTION
Exfluor was established in 1984 to develop a commercially viable method for conversion of hydrocarbons to fluorocarbons using elemental fluorine. In the 1980s, efforts were concentrated on contract research for the development of aerospace and defense materials such as lubricants, fluids, and coatings; however, the company eventually transitioned into the manufacture of specialty fluorinated chemicals in small to bulk quantities. The company website {https://exfluor.com) highlights certain "top products" with Chemical Abstracts Service Registry Number {CASRN), including:
1H,1H,4H,4H-Perfluoro-1,4-butanediol, 97%; CASRN 425-61-6 Perfluoro-3,6,9-trioxaundecane-l,ll-dioic acid; 98%, CASRN 55621-18-6 Perfluorodecalin, 90%; CASRN 306-94-5 Perfluoro-3,6,9-trioxatridecanoic acid, 98%; CASRN 330562-41-9 Perfluoro-3,6-dioxadecanoic acid, 98%; CASRN 137780-69-9 Perfluoro-3,6,9-trioxadecanoic acid, 98%; CASRN 151772-59-7 Octafluoroadipoyl fluoride, 98%; CASRN 37881-62-2 Perfluoro-3,6-dioxaoctane-1,8-dioic acid, 98%; CASRN 55621-21-1 Perfluoro-3,6-dioxaheptanoic acid, 98%; CASRN 151772-58-6 Dimethyl perfluorosuccinate, 98%; CASRN 356-36-5
In 1994, Exfluor purchased its current site and began expanding in 2012. Exfluor occupies buildings B, C, and D of the campus. Building A is occupied by FluoroMed, a separate company co-founded by Exfluor in 1996 to produce fluorinated hydrocarbons for medical applications. Exfluor does provide FluoroMed with fluorine and certain chemical intermediates.
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Section II - OBSERVATIONS
Exfluor Research Corporation Inspection Date 07/24/2025
DISCUSSION
Company representatives provided the following information for my review:
1. Confidential process flow diagrams of various product chemical families, indicating those with CASRNs on the public TSCA inventory, chemical substances with LVEs, and other identifying information. After discussing the number of chemical substances manufactured by the facility over the past five years, it was agreed to provide diagrams of those that were manufactured in the greatest amounts for that period. I will follow up with the company for any questions on other products.
2. A table of chemical substances manufactured over the past five years, with reactants, dates, batch amounts, and special uses {e.g., research & development, medical, export only).
3. A table of raw materials from domestic suppliers {some other raw materials are imported).
Hard copies of Safety Data Sheets and company TSCA compliance procedures were made available for my review on-site.
I discussed the Chemical Data Reporting rule briefly with company representatives, relative to the small amounts of chemical substances manufactured annually.
FACILITY TOUR
At 10:45am, I was led on a tour of the facility, focusing on an existing, active production area {Building B) and a new area under development with offices, labs, and production {Building D). The company fabricates its own manufacturing equipment. The company is in the process of constructing a new waste water treatment area, with a goal of no waste water discharge and returning clean water to various processes. The tour concluded at 11:45am, and participants returned to the conference room.
FACILITY DOCUMENTATION
No requested documents were collected at the time of the inspection. Mr. Bierschenk said that he would review the information presented during the discussion for additional CBI; if not considered as such, it would be emailed to me. Company representatives would prepare additional information to be claimed as CBI and submit that through the EPA's Central Data Exchange {CDX) service.
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Section Ill - AREAS OF CONCERN
Exfluor Research Corporation Inspection Date 07/24/2025
No areas of concern were observed at the time.
CLOSING CONFERENCE
At 11:50am, I began a closing conference with all present, indicating that I would follow up with the facility company contacts regarding any questions. I also stated that an inspection report would be finalized in approximately two months. Exfluor representatives stated that they would compile the information requested in Appendix 1 and submit it by either email or CDX. The Notice of Proprietary/Confidential Business Information [Appendix 3] was signed by Dr. Juhlke. The TSCA Notice of Inspection and TSCA CBI Notice were then photocopied, and the originals were returned to me. I exited the facility at 12:05pm.
Facility and company representatives were very cooperative throughout the inspection process.
Section IV - FOLLOW UP
Mr. Bierschenk emailed some non-confidential information on 7/24/25. Other confidential information was submitted through CDX on 7/24 and 7/25, 2025.
Section V - LIST OF APPENDICES
Appendix 1- Inspection Notification Email Appendix 2 - Notice of Inspection Appendix 3 - TSCA CBI Notice
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Exfluor Research Corporation Inspection Date 07/24/2025
Appendix 1 Inspection Notification Email
Riley, David
From: Sent: To: Subject: Attachments:
Riley, David Monday, July 14, 2025 10:25 AM eric.bierschenk@exfluor.com Core TSCA Inspection of Exfluor Research Corporation TSCA Enforcement Communications Quick Reference Guide.docx
Hello Eric,
Thank you for contacting me regarding that information - - my apologies for the delay. Here is the specific information related to the upcoming inspection. I, as a representative of the EPA's Region 6 office, will conduct an inspection of the Exfluor Research Corporation facility at 2350 Double Creek Drive, Round Rock, on July 24th, beginning at 9:00 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. The in-person portion of the inspection will involve a facility tour and discussion. Please prepare some initial information for the site visit related to the company/facility background, manufacturing processes, and a site map. I don't plan on taking up an entire day - - only 3 or so hours.
Outside of the site visit, any of the more detailed information below should be provided within four weeks from today (8/11/2025) as one or more electronic files in a form that allows EPA to readily retrieve and utilize the information using commercially available software. If none of the requested information is subject to claims of confidential business information (CBI) by Exfluor, please email the information directly to me. Do Not Email CBI. If Exfluor will make claims of CBI on any of the requested information, please use the attached instructions for submission of that information through the Central Data Exchange (CDX). Under Step 9, choose "Inspection Communication Request". Note: if the steps outlined in the CDX attachment are not working, please let me know.
The EPA has 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 online at: https ://www.epa.gov/compliance/small-business-resources-information-sheet.
If you have any questions concerning the inspection or the requested information, or if additional time is needed to compile the information, please contact me 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 calendar years 2020 through 2024, and for 2025 up to today's date, unless otherwise specified. If some items are 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.
1
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. 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) . Detailed 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) by the facility, as well as any intermediates both non-isolated and isolated. 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 name; 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, a non-isolated intermediate, or an 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 #
2
[Use a separate per shipment (in row for each bs) manufacture]
Item #4: Prepare a spreadsheet of the raw materials (including mixtures) acquired from domestic suppliers that were used or processed by the facility. 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. 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-subject-tsca-section- 12bexport-notification-O.
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)/(fl
3
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 record.keeping requirements in 40 C.F.R. 720.78; 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:
~ASRNor Name of IEPA Accession llecipient
I#
Recipient's Address
Quantity per shipment (in bs)
~ms, shipping label and/or
~itten 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 Record.keeping and reporting under Section 8(a) and (b) including those for Chemical Data Reporting (CDR); o For CDR, provide a sample calculation of the volumes reported for the 2024 CDR rule, including facility sources used. TSCA Sections 8(c), 8(d), and 8(e) o Documentation of allegations subject to TSCA Section 8(c) record.keeping. Provide OSHA Injury & Illness Record.keeping 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
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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 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.
Sincerely,
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
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Exfluor Research Corporation Inspection Date 07/24/2025
Appendix 2 Notice of Inspection
&EPA United States Environme ntal Protection
Ag ency
United States
ENVIRONMENTAL PROTECTION AGENCY
Washington, DC 20460
Notice of Inspection
Office of Enforcement and Compliance Assurance
1. Investigation Identification
3. Facility Name
Date
Inspection Number DaUy Seq. Numbe, I X f(v.o, Re .,('"'rv\... c~q:,t,t,li\o ./'
!Jul 24, 2025 11 1
111 of 1
I
I
2. Inspector's Address 1200 Elm Street, Suite 500, Dallas, TX 75270
4. Facility Address
2350 -povh 1~ c~~rk.. 'Dr-~
Rov-" J Qoc..,k , ~ 7-166~
For Internal EPA Use. Copies may be provided to the recipient as acknowledgment 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
ra-?.anufactured, processed, stored or held before or after their distribution in commerce (including records, files, papers, rocesses, 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):
D A. Financial Data
D D. Personnel Data
D B. Sales Data
D E. Research Data
D C. Pricing Data
The nature and extent of inspection of such data specified in A through Eabove is as follows:
Inspector's Signature
~b~
Name IJohn David Riley
Title !Environmental Scientist
~
--
Recipient's Signature
--/,, :H: a.f'P- ~'-'
~ //
I Name I lintofl.y_ hk/ke
I Date I1-fi ~{_is ITitle I Vi c.e fry~~+
I
IDate I1 /2s- l
EPA Form 77403 (Rev. 2/16)
1-lnspector Copy 2-Facility Copy
Exfluor Research Corporation Inspection Date 07/24/2025
Appendix 3 TSCA CBI Notice
&EPA United States Environmental Protection Agency
UNITED STATES ENVIRONMENTAL PROTECTION AGENCY Notice for Toxic Substances Control Act (TSCA) Inspections
NOTICE REGARDING PROPRIETARY/CONFIDENTIAL BUSINESS INFORMATION (CBI) SUBMITTED 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 (PBI). 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 of your business may be CBI, EPA requests that a representative of your 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. If you have questions about this Notice, you or a representative of your 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: htt s://www.e a. ov/com liance/cbi-noticeinformation-collected-durin -e a-ins ections-or-other-com liance-monitorin
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 htt s://echo.e a. ov. Also, EPA may be required by law to release the information to the public.' For example, the FOIA requires the disclosure of Agency records that have been requested by a FOIA request unless that information falls within a FOIA exemption. However, EPA does not release information claimed as CBI to the public in response to a FOJA 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 of TSCA CBI claims. 15 U.S.C. 2613(g). Information that you claim as CBI 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 fo rth 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 10-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 ofasserting 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 htt s://www.e a. ov/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 lfyour 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 I0-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 I0-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 I0-calendar day period begins on Wednesday. If the IO-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 you may not submit only a document\\ ith the CBI blacked out or remmed (a "'sanitized copy ...) . EPA treats the sanitized copy as a publicly available document.
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(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 10-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: htt s://www.e a. ov/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.
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&EPA UNITED STATES ENVIRONMENTAL PROTECTION AGENCY
United States
PROPRIETARY/CONFIDENTIAL BUSINESS INFORMATION NOTICE
Environmental Protection Agency
FOR TSCA INSPECTIONS
Facility:
Facility Address:
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Facility Representative with authority to make a CBI claim (print name & title):
Jimo~Y, JuJd Jee
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Inspection Number:
1_ C ) f
Signature: Phone/email: ri,, i e.f''Sc.h.cllk@e:~.fiuor.
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EPA Inspector (print): J L.~ J:>~": J 12:\~6"
Address: [mailing or courier address appropriate for inspector and/or inspector's Document Control Officer]
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Date: -=rL2c,/v
Phone: 'll'I- 66t---+-i~-g
Email:
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X 1 have received this Notice and DO NOT make any CBI claim on the documents and information I have 1 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 iriformation 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 I 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 materiallyfalse , fictitious, or fraudulent statement or representation is subject to criminal penalty pursuant to 18 US.C. ,$ 1001.
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Part B of this Notice explained how to identify infonnation claimed as CBI. You or the inspector may use this box to _st and generally describe any CBI claims. For clarity, please be as specific as possible.
Ex le: Internal layout of facility.
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(Revised: January 2021)
Attach additional sheets, if needed.
Original to EPA I Copy to Facility
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