CDX Updates Based on Final Amendments to the New Chemicals Regulations under the Toxic Substances Control Act (TSCA)

CDX Updates Based on Final Amendments to the New Chemicals Regulations under the Toxic Substances Control Act (TSCA)

Docket: EPA-HQ-OPPT-2022-0902
RIN 2070-AK65
EPA ICR No. 1188.15

 

PRA Burden Statement

• •This collection of information is approved by OMB under the Paperwork Reduction Act, 44 U.S.C. 3501 et seq. (OMB Control No. 2070-0038). Responses to this collection of information are mandatory for certain persons who engage in the covered activities as specified in section 5 of the Toxic Substances Control Act and EPA implementing regulations (40 CFR parts 720 through 725). An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB control number. The public reporting and recordkeeping burden for this collection of information is estimated to be between 16.97 to 525.85 hours per response. Send comments on the Agency’s need for this information, the accuracy of the provided burden estimates and any suggested methods for minimizing respondent burden to the Director of the Information Engagement Division, Office of Mission Support, U.S. Environmental Protection Agency (2821T), 1200 Pennsylvania Ave., NW, Washington, D.C. 20460. Include the OMB control number in any correspondence. Do not send the completed form to this address. 

 

TSCA-10125

 

What is Being Added to TSCA 10125?

• •Type of release () this is already describes in the process description and should be clarified – With a dropdown option to select from transport/interim storage, disposal, equipment cleaning,  or other 

• •How often is the equipment cleaned? (for cleaning type of release) This should be clarified in process description it is already listed but states “note frequency if not used daily or per batch” – Input field specific to only selected type of release. 

• •What is used to clean the equipment? (for cleaning type of release) – Input field 

• •How is the chemical or the product containing the chemical transported from the site? (5 gallon pails, 55 gallon drum, rail car, tank truck, other) (for transport/interim storage type of release) this is in the process description section – With a dropdown option to select from -5 gallon pails, 55 gallon drum, rail car, tank truck, or other. 

• •Are the containers used to store/transport the chemical dedicated? (for transport type of release) this is already in process description at d(1) but may be clarified. - Yes/No radio button 

• •Is the cleaning and disposal of the transport containers under your control? (for transport type of release) – Yes/No radio button. 

• •For cleaning storage/transport containers, what is the cleaning method, frequency of cleaning, and amount released per cleaning? (for transport type of release) – Input field 

• •Clean Air Act operating permit numbers (for media release of air) This should be clarified in the releases section that only identifies releases to water…should be updated to environmental releases – Input field 

• •Is the site under a Leak Detection and Repair program (related to the monitoring and management of fugitive releases)? If so, please describe the program. What is this information used for?  Clarification of fugitive releases…this should be a line item in the testing information at 720.50 that identifies “Monitoring data and other test data related to human exposure to or environmental release of the chemical substance. – Input field 

• •NPDES permit numbers (for media release of water)– Input field. This is already in the form but not in Sites Controlled by others.  

• •If local or state ordinances will impact incineration facilities that will receive waste, describe. – Input field(Need clarification on where/how to implement.) 

 

TSCA-10107

 

What is Being Added to TSCA 10107?

• •Type of Release – With a dropdown option to select from transport/interim storage, disposal, equipment cleaning,  or other 

• •How often is the requirement cleaned? – With input field 

• •What is used to clean the equipment? – With input field 

• •How is the chemical or the product containing the chemical transported from the site? – With a dropdown option to select from 5 gallon pails, 55 gallon drum, rail car, tank truck, or other 

• •Are the containers used to store/transport the chemical dedicated? (for transport type of release) – With input field 

• •Is the cleaning and disposal of the transport containers under your control? (for transport type of release) – Dropdown with yes or no 

• •For cleaning storage/transport containers, what is the cleaning method, frequency of cleaning, and amount released per cleaning? (for transport type of release) – With input field 

• •Clean Air Act operating permit numbers (for media release of air) – With input field 

• • Is the site under a Leak Detection and Repair program (related to the monitoring and management of fugitive releases)? If so, please describe the program. – With input field 

• •If local or state ordinances will impact incineration facilities that will receive waste, describe. – With input field 

 

TSCA-10106

 

What is Being Added to TSCA 10106?

• •The identity, approximate weight, and entry point of all starting materials and feedstocks (including reactants, solvents, catalysts, etc.) – With input field. 

• •The identity, approximate weight, and entry point of all products, recycle streams, and wastes, including cleaning chemicals (note frequency if not used daily or per batch). – With input field 

• •Specify type of interim storage and transport containers – Input field or dropdown 

• •Identify by number the points of release; if releasing to two media at the same step, assign a second release number for the second medium. – With input field, possible auto numbering. 

 

TSCA-10105

 

What is Being Added to TSCA 10105?

• •The identity, approximate weight, and entry point of all starting materials and feedstocks (including reactants, solvents, catalysts, etc.) – Input field 

• •The identity, approximate weight, and entry point of all products, recycle streams, and wastes, including cleaning chemicals (note frequency if not used daily or per batch). – Input field 

• •Specify type of interim storage and transport containers. – Input field or dropdown 

• •Identify by number the points of release; if releasing to two media at the same step, assign a second release number for the second medium. – With input field, possible auto numbering. 

 

TSCA-10104

 

What is Being Added to TSCA 10104?

• •Submitter Operation Information Screen 

• •Pop-Up
  • On the Site selection pop-up: Add guidance on how to add sites to CDX account to populate drop-down list. 

• •Process Diagram
  • Add a Process Diagram
  • Add the following text: "Identifying required elements must be provided in either the text box or within the attached process diagram for the submission to be considered valid".
  A process description of each manufacture, processing, and use operation which includes a diagram of the major unit operations and chemical conversions, the identity and entry point of all feedstocks, and the points of release of the new chemical substance. 

 

TSCA-10005

 

TSCA-10005 (cont.)

 

TSCA-10005 (cont.)

 

What is Being Added to TSCA 10005?

• •Releases and exposure generated under an exemption (e.g., byproducts) – Input field 

• •Displayed with Byproduct as a stand alone page and as part of the environmental releases page.  

 

TSCA-9891

 

What is Being Added to TSCA 9891?

• •OECD use code – Dropdown with options similar data to CDR 2020 for Industrial Codes and Consumer Use Codes 

• •Detailed description of the types of products or articles that will incorporate the NCS substance (e.g., household cleaners, plastic articles). – Input field 

• •Description of how and where a potential product would be used (e.g., spray applied indoors, brushed on outdoor surface) including information regarding consumption rates, frequency and duration of use. – Input field  

 

TSCA-9052

 

TSCA-9052

 

What is Being Added to TSCA 9052?

• •Environmental Release and Disposal – You must make separate confidentiality claims for the release number and the amount of the new chemical substance released and other release and disposal information. Mark (X) the “Confidential” box next to each item you claim as confidential. 

• •(1) – Enter the number of each release point identified in the process description, part II, section A, subsection 1d(3). 

• •(2) – Mark (X) this column if entries in column (1) is confidential business information (CBI). 

• •(3) – Estimate the amount of the new substance released (a) directly to the environment or (b) into control technology (in kg/day or kg/batch). 

• •(4) – Mark (X) this column if entries in columns (3a) or (3b) are confidential business information (CBI). 

• •(5) – Identify the media (stack air, fugitive air (optional-see Instruction Manual), surface water, on-site or off-site land or incineration, POTW, or 

• •other (specify)) to which the new substance will be released from that release point. (specify)) to which the new substance will be released from 

• •that release point. 

• •(6) – Mark (X) this column if entries in column (5) is confidential business information (CBI). 

• •(7) – (a) Describe control technology, if any, and control efficiency that will be used to limit the release of the new substance to the environment. 

• •For releases disposed of on land, characterize the disposal method and state whether it is approved for disposal of RCRA hazardous waste. 

• •On a continuation sheet, for each site describe any additional disposal methods that will be used and whether the waste is subject to 

• •secondary or tertiary on-site treatment. (b) Estimate the amount released to the environment after control technology (in kg/day). 

• •(8) – Mark (X) this column if entries in columns (7(a)) or (7(b)) are confidential business information (CBI). 

• •(9) – Identify the destination(s) of releases to water. Please supply NPDES (National Pollutant Discharge Elimination System) numbers for direct 

• •discharges or NPDES numbers of the POTW (Publicly Owned Treatment Works). Mark (X) if the POTW name or NPDES # is confidential business 

• •information (CBI). 

 

TSCA-9050

 

What is Being Added to TSCA 9050?

• •In the Premanufacture Notice (PMN) form, the interest is in removing the ability to claim the Optional Pollution Prevention text box as CBI and adding text, and a new document type, letting users know that if they are going to claim the information CBI, they will need to attach a document. 

• •1. Remove the CBI checkbox 

• •2. Add this text: “In this section you may provide information not reported elsewhere in this form regarding your efforts to reduce or minimize potential risk associated with activities surrounding manufacturing, processing, use, and disposal of the chemical substance.” 

• •Information entered into the text field cannot be claimed CBI. To claim information provided as CBI, select the Attach Document button below, select the Optional                                  Pollution Prevention type from the drop-down and attach the CBI and corresponding sanitized version of the document explaining the Pollution Prevention activities. 

• • 3. Add "Optional Pollution Prevention" to the Type and Subtype drop-down in the Attachment window.  

 

TSCA-8399

 

What is Being Added to TSCA 8399?

• •If physical form is solid, provide moisture content (moisture content < 50% or blank will result in use of dust model) – Input field 

• •Type of worker exposure - Dropdown with options for dermal, inhalation, other, none, or unknown 

• •What kind of gloves limit worker exposure, if any (i.e., material composition, name/model number)? – Input field 

• •What kind of protective clothing and goggles limit worker exposure, if any (i.e., name/model number)? – Input field 

• •What kind of respirator limits worker exposure, if any (i.e., name/model number, cartridge type, assigned protective factor (APF))? – Input field  

• • Attach SDS or MSDS – Button to allow for upload of documentation. 

 

TSCA-8101

 

What is Being Added to TSCA 8101?

• •A.2 Occupational Exposure - Submitter Controlled Sites 

• •Add a CBI checkbox for Physical Form(s) (5) and % New Substance (5).  

 

TSCA-8098

 

What is Being Added to TSCA 8098?

• •Protective equipment in place, if any – Input field 

• •Engineering controls in place, if any – Input field 

• •Type of worker exposure – Dropdown with options dermal, inhalation, other, none, or unknown 

• •What kind of gloves limit worker exposure, if any (i.e., material composition, name/model number)? – Input field 

• •What kind of protective clothing and goggles limit worker exposure, if any (i.e., name/model number)? – Input field 

• •What kind of respirator limits worker exposure, if any (i.e., name/model number, cartridge type, assigned protective factor (APF))? – Input field 

 

TSCA-8097

 

What is Being Added to TSCA 8097?  

• •Site Information Screen 

• •Add additional text to the screen indicating that if the submitter is an importer interim storage sites are considered sites and should be reported, and that any new or amended data may affect the review period. 

• •Site Controlled Screens 

• •Add additional text to the screen indicating all known information must be provided. If information is not provided the Agency will complete the review with the understanding that data is not available or is NKRA. 

 

TSCA-8055

 

TSCA-8055 

 

TSCA-8055 (cont.)

 

TSCA-8055 (cont.)  

 

What is Being Added to TSCA 8055?

• •Provide particle size distribution analysis data if new chemical substance is manufactured as a particle  – Yes/No Radio button, with a button giving the option to attach document. 

• •If physical form is solid, provide moisture content   (moisture content < 50% or blank will result in use of dust  model) – Yes/No Radio button and input field. 

• •Adding Nanomaterials dropdown box 

• •Fate Properties Worksheet will be a new page and the corresponding screenshots show how the Fate Properties will be displayed. 

• • •Fate Properties dropdown will have the below options: 

• • • •Hydrolysis 

    • •Photolysis 

    • •Aerobic and anaerobic biodegradation 

    • •Atmospheric oxidation half-lives 

 

TSCA-8054

 

What is Being Added to TSCA 8054?  

• •Production Volume and Hazard/Safety Information Screen 

• •Section 5 SDS/MSDS Validation Requirements - (change #1) 

• •Add a check a box certifying the user does not have either an SDS or MSDS document to submit. 

• •If the box is not checked, user will be required to attach either a SDS or MSDS document. 

• •Production Information or Hazard Information must be selected before attaching a document. 

• •Overall screen instructional text - (change #2)
  (Add additional screen text emphasizing what information is needed and that "not providing all pertinent data could result in delays in EPA completing the risk assessment or impact the overall review timeline for the submission) 

• •Use Information Screen 

• •If a Consumer use is identified - (change #3)
  Add the following 3 text boxes 

• •"The types of product(s) or article(s)" 

• •"How and where the product(s)/article(s) will be used" 

• •"Additional use information (this to replace or be in addition to the existing text box)"
  (Improve instructional text to better describe what information is needed within each text response) 

• •If a Commercial use is identified - (change #4)
  Add the following 3 text boxes 

• •"The types of product(s) or article(s)" 

• •"How and where the product(s)/article(s) will be used" 

• •"Additional use information"
  (Add instructional text to better describe what information is needed within each text response) 

 

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