Document DGgwOG4mkdka4YxDO87BNye8a
UNITED STATES ENVIRONMENTAL PROTECTION AGENCY REGION III
Four Penn Center 1600 John F. Kennedy Boulevard Philadelphia, Pennsylvania 19103-2852
Via Electronic Mail
Brooke James, EHS Specialist Agilent Technologies, Inc. 2850 Centerville Road Wilmington, Delaware 19808 Brooke.james@agilent.com
RE: Request for Information Pursuant to Section 3007(a) of the Resource Conservation and Recovery Act, U.S.C. 6927(a), Regarding Generation and Management of Hazardous Waste by Agilent Technologies - Little Falls EPA ID No. DED984073163 Reference Number: C23-005
Dear Mr. James:
The U.S. Environmental Protection Agency, Region III ("EPA") is requesting to supplement information obtained during EPA Region 3's Compliance Evaluation Inspection ("CEI") of the Agilent Technologies - Little Falls facility, located at 2850 Centerville Road, Wilmington, Delaware, ("Agilent" or "the Facility") conducted on January 17, 2023 (report sent on 03/06/2023 - referred to as "EPA Inspection Report"). EPA is requesting this information pursuant to Section 3007(a) of the Resource Conservation and Recovery Act, 42 U.S.C. 6927(a), regarding generation and management of hazardous waste. EPA requires that you furnish to EPA, within thirty (30) calendar days of receipt of this letter, the information requested below, including documents responsive to such requests.
Section 3007(a) of the Resource Conservation and Recovery Act
For each and every request, if you have any reason to believe that there may be a person(s) who may be able to provide a more detailed or complete response to such request or provide additional responsive documents, then as a part of your response to such request, identify each such person and the additional information or documents which such person may be able to provide. Furthermore, for each and every response, if information or documents responsive to such request are not in your possession, custody or control, then as part of your response to such request, identify each person from whom such information or documents may be obtained.
Please provide a separate narrative response to each information request. Precede each answer with the number of the question or letter of the subpart of the request to which it corresponds. A request for documents shall be construed as a request for any and all documents maintained by you or in your custody, control, or possession or in the possession, custody or control of any employees or agents, relating to the matters described below. All copies of documents submitted to EPA in response to the following requests must be complete and legible.
Customer Service Hotline: 1-800-438-2474
As used herein, the term "document" means: writings (handwritten, typed or otherwise produced or reproduced) and includes, but is not limited to, any invoices, checks, receipts, bills of lading, weight receipts, tolls receipts, correspondence, offers, contracts, agreements, deeds, leases, manifests, licenses, permits, bids, proposals, policies of insurance, logs, books of original entry, minutes of meetings, memoranda, notes, calendar or daily entries, agendas, bulletins, notices, announcements, charts, maps, photographs, drawings, manuals, brochures, reports of scientific study or investigation, schedules, price lists, telegrams, teletypes, phonograph records, magnetic voice or video records, tapes, summaries, magnetic tapes, punch cards, recordings, discs, computer print outs, or other data compilations from which information can be obtained and translated.
All other terms used in this request for information that are defined in RCRA, 42 U.S.C. 6901 et seq., 40 C.F.R. Parts 260-266, 268, and 273 (1998 ed.), and the authorized State of Delaware Hazardous Waste Program, set forth in the Delaware Regulations Governing Hazardous Waste ("DeRGHW") Parts 260-279, and Parts 122 and 124., shall have the meanings set forth therein.
Please provide the information requested below:
Information Request
1. With respect to the used cotton swabs, contaminated with Opti-Fluor, generated by Agilent's electron capture detector ("ECD") quality control wipe test, please answer the following:
a. Please provide a detailed narrative describing any and all systems, agreements, and/or procedures (e.g. Standard Operating Procedure) Agilent has or had in place that show how Agilent manages the used cotton swabs, from the time the used cotton swabs are generated until they are shipped off-site. Please submit any and all supporting documentation (e.g. SOPs, manifests, bills of ladings).
b. Please state whether or not a "waste determination" and "LDR determination" has been made for the used cotton swabs.
c. If a "waste determination" was made for the used cotton swabs, state whether the waste determination was based on analytic results or on the generator's knowledge of the process that generated the waste. If the determination was based on analytical results, provide any and all documentation of such results. If the determination was based upon generator's knowledge, provide a narrative explanation of the scientific basis for such determination, and provide any supporting documentation.
d. Were the used cotton swabs determined to be "hazardous waste?" If so, please state the specific EPA Hazardous Waste Code(s) associated with such hazardous waste.
e. For the time period of January 1, 2022 up to the present, please (1) state the method of disposal for the used cotton swabs, and (2) submit copies of all bills of lading, manifests (hazardous and non-hazardous), shipping invoices, and LDR notices/certifications that have accompanied the off-site shipment of such wastes.
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2. According to email correspondence with Agilent on January 31, 2023, it was determined that Opti-Fluor waste would be treated as hazardous waste due to toxicity and corrosive characteristics. Please state the specific EPA Hazardous Waste Code(s) associated with the OptiFluor waste.
3. With respect to the oily fluid observed in EPA Inspection Report Photo #3, please answer the following:
a. What is the observed oily fluid?
b. Provide a detailed description of the process or processes that generated the oily fluid.
c. Does Agilent sample and analyze the oily fluid? If so, please provide a detailed narrative that describes Agilent sampling process and analytical methods used. Submit any and all laboratory analysis.
d. Please state whether or not a "waste determination" and "LDR determination" has been made for the oily fluid.
e. If a "waste determination" was made for the oily fluid, state whether the waste determination was based on analytic results or on the generator's knowledge of the process that generated the waste. If the determination was based on analytical results, provide any and all documentation of such results. If the determination was based upon generator's knowledge, provide a narrative explanation of the scientific basis for such determination, and provide any supporting documentation.
f. Was the oily fluid determined to be "hazardous waste?" If so, please state the specific EPA Hazardous Waste Code(s) associated with such hazardous waste.
4. With respect to the single use waste laboratory gloves ("glove waste"), please answer the following:
a. Provide a detailed description of the process or processes that generated the glove waste.
b. Please provide a detailed narrative describing any and all systems, agreements, and/or procedures (e.g. Standard Operating Procedure) Agilent has or had in place that show how Agilent manages the glove waste, from the time the glove waste is generated until it is shipped off-site. Please submit any and all supporting documentation (e.g. SOPs, manifests, bills of lading).
c. Does Agilent sample and analyze the glove waste? If so, please provide a detailed narrative that describes Agilent sampling process and analytical methods used. Submit any and all laboratory analysis.
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d. Please state whether or not a "waste determination" and "LDR determination" has been made for the glove waste.
e. If a "waste determination" was made for the glove waste, state whether the waste determination was based on analytic results or on the generator's knowledge of the process that generated the waste. If the determination was based on analytical results, provide any and all documentation of such results. If the determination was based upon generator's knowledge, provide a narrative explanation of the scientific basis for such determination, and provide any supporting documentation.
f. Was the glove waste determined to be "hazardous waste?" If so, please state the specific EPA Hazardous Waste Code(s) associated with such hazardous waste.
5. With respect to the used rags, utilized with IPA solution to clean super glue residues in the Quality Lab (see EPA Inspection Report section III.G. Quality Lab), please answer the following:
a. Provide a detailed description of the process or processes that generated the used rags.
b. Please provide a detailed narrative describing any and all systems, agreements, and/or procedures (e.g. Standard Operating Procedure) Agilent has or had in place that show how Agilent manages the used rags, from the time the used rags are generated until they are shipped off-site. Please submit any and all supporting documentation (e.g. SOPs, manifests, bills of lading).
c. Does Agilent sample and analyze the used rags? If so, please provide a detailed narrative that describes Agilent sampling process and analytical methods used. Submit any and all laboratory analysis.
d. Please state whether or not a "waste determination" and "LDR determination" has been made for the used rags.
e. If a "waste determination" was made for the used rags, state whether the waste determination was based on analytic results or on the generator's knowledge of the process that generated the waste. If the determination was based on analytical results, provide any and all documentation of such results. If the determination was based upon generator's knowledge, provide a narrative explanation of the scientific basis for such determination, and provide any supporting documentation.
f. Were the used rags determined to be "hazardous waste?" If so, please state the specific EPA Hazardous Waste Code(s) associated with such hazardous waste.
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The provisions of Section 3008 of RCRA, 42 U.S.C. 6928 authorize EPA to pursue penalties for failure to comply with Section 3007(a) of RCRA respectively. In addition, Section 3007(a) of RCRA, 42 U.S.C. 6928 authorizes EPA to pursue penalties for failure to respond adequately to an information request under Section 3007(a) of RCRA. In addition, providing false, fictitious, or fraudulent statements or representations may subject you to criminal penalties under 18 U.S.C. 1001. The information you provide may be used by EPA in administrative, civil, or criminal proceedings. Your response must include the following signed and dated certification:
I certify under penalty of law that I have personally examined and am familiar with the informing submitted in this and all attached documents and that based on my inquiry of those individuals immediately responsible for obtaining the information, I believe that the submitted information is true, accurate and complete.
Signature: Date: Name: Title:
____________________________ ____________________________ ____________________________ ____________________________
With regard to the Small Business Regulatory Enforcement and Fairness Act ("SBREFA"), please see the "Information for Small Businesses" memo, found at https://www.epa.gov/sites/production/files/2017-06/documents/smallbusinessinfo.pdf, which might be applicable to your facility. This enclosure provides information on contacting the SBREFA Ombudsman to comment on federal enforcement and compliance activities and also provides information on compliance assistance. As noted in the enclosure, any decision to participate in such program or to seek compliance assistance does not relieve your facility of its obligation to respond in a timely manner to an EPA request or other enforcement action, create any rights or defenses under law, and will not affect EPA's decision to pursue an enforcement action. To preserve your facility's legal rights, you must comply with all rules governing the administrative enforcement process. The Ombudsman and fairness boards do not participate in the resolution of EPA's enforcement actions. EPA has not made a determination as to whether or not your facility is covered by SBREFA.
Your Facility is entitled to assert a claim of business confidentiality covering any part or all of the information submitted, in a manner described in 40 C.F.R. 2.203(b). Information subject to a claim of business confidentiality will be made available to the public only in accordance with 40 C.F.R. Part 2, Subpart B. Unless a claim of business confidentiality is asserted at the time the requested information is submitted, EPA may make this information available to the public without further notice to your facility.
This request for information is not subject to review by the Office of Management and Budget pursuant to the Paperwork Reduction Act, 44 U.S.C. 3501-3520.
Please send your response electronically to:
Jeremy Dearden (3ED22) Dearden.jeremy@epa.gov
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U.S. Environmental Protection Agency Region III Four Penn Center 1600 John F. Kennedy Blvd. Philadelphia, PA 19103-2029
If you have any questions concerning this matter, please contact Mr. Dearden, Enforcement Officer, at (215) 814-5351 or dearden.jeremy@epa.gov.
Sincerely,
KAREN MELVIN
Digitally signed by KAREN MELVIN Date: 2023.04.13 16:13:55 -04'00'
Karen Melvin, Director Enforcement and Compliance Assurance Division
cc: Jeremy Dearden (3ED22) Pauline Belgiovane (3ED20) Karen J'Anthany, DNREC (karen.janthony@delaware.gov) Braden Case, Agilent Technologies (braden.case@agilent.com)
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