January 17, 2017
IDENTIFICATION OF THE INFORMATION COLLECTION
1(a) Title of the Information Collection
TITLE: TSCA Section 8(b) Reporting Requirements for TSCA Inventory Notification (Active-Inactive) Requirements
EPA ICR No: 2517.01 OMB Control No.: 2070-[new]
1(b) Short Characterization
This information collection request addresses the TSCA section 8(b) reporting and recordkeeping requirements associated with chemical substances on the TSCA Chemical Substance Inventory, as briefly outlined below.1
The Environmental Protection Agency (EPA) manages the Toxic Substances Control Act (TSCA) Chemical Substance Inventory (“Inventory”) under TSCA section 8(b). TSCA section 8(b) specifically requires that EPA compile and keep current a list of chemical substances manufactured or processed for commercial purposes in the United States. In 1977, EPA promulgated a rule published in the Federal Register issue of December 23 of that year under TSCA section 8, to compile the TSCA Chemical Substance Inventory from chemical substances that had been in commerce since January of 1975. Since compiling the initial TSCA Inventory, TSCA section 5 requires that any person who proposes to manufacture (includes import) a “new chemical,” i.e., a chemical not listed on the TSCA Inventory, must provide a premanufacture notice (PMN) or an exemption application to the Agency at least 90 days prior to commencing manufacture of that chemical. The Agency regularly adds new chemical substances that have completed new chemical review requirements pursuant to TSCA section 5(a) and that have been manufactured or processed for non-exempt commercial purpose. EPA maintains the TSCA Inventory as the authoritative list of all the chemical substances reported to the Agency for inclusion on the Inventory.
TSCA section 8(b), as amended in June of 2016 by the Frank R. Lautenberg Chemical Safety for the 21st Century Act, requires additional responsibilities of EPA in maintaining the TSCA Inventory (see Attachment A). EPA shall designate chemical substances on the Inventory as “active” or “inactive” in U.S. commerce based on whether they were manufactured (includes imported) or processed during the 10-year time period ending June 21, 2016, the day before the enactment of the Frank R. Lautenberg Chemical Safety for the 21st Century Act. TSCA section 8(b)(4) requires the Agency to promulgate a rule by June 22, 2017, which requires manufacturers (includes importers) to notify the Agency, by not later than 180 days after the date on which the final rule is published in the Federal Register, of each chemical substance on the TSCA Inventory that was manufactured for a nonexempt commercial purpose during the 10-year period. If EPA receives any notices for a chemical substance on the TSCA Inventory, the Agency must designate the chemical substance as active on the Inventory. If EPA receives no notices for a chemical substance on the TSCA Inventory, the Agency must designate the chemical substance as inactive.
Subsequent to TSCA section 8(b)(4) reporting, TSCA section 8(b)(5) requires persons that intend to manufacture or process chemical substances for non-exempt commercial purpose that are designated as inactive on the TSCA Inventory to notify EPA prior to the date that the chemicals are manufactured or processed. Upon receiving such notification, the Agency must change the designation of the reported substance from inactive to active.
The Government Paperwork Elimination Act (GPEA, Pub. L. 105-277) requires that, when practicable, federal organizations use electronic forms, electronic filings, and electronic signatures to conduct official business with the public. EPA’s Cross-Media Electronic Reporting Regulation (CROMERR) (70 FR 59848, October 13, 2005) provides that any requirement in Title 40 of the Code of Federal Regulations to submit a report directly to the Agency can be satisfied with an electronic submission that meets certain conditions once the Agency publishes a notice that electronic document submission is available for that requirement.
In light of GPEA and CROMERR, EPA published on January 5, 2010, a final rule entitled “TSCA Section 5 Premanufacture and Significant New Use Notification Electronic Reporting; Revisions to Notification Regulations” (75 FR 773) amending the TSCA section 5 notification regulations to phase out paper-based submissions and facilitate the introduction and use of electronic reporting. In addition, EPA published on December 4, 2013, a final rule entitled “Electronic Reporting Under the Toxic Substances Control Act” (78 FR 72818) which extended the TSCA section 5 electronic reporting requirements to certain documents relating to TSCA section 5 notices submitted to the Agency prior to April 6, 2010 (i.e., the effective date of the “TSCA Section 5 Premanufacture and Significant New Use Notification Electronic Reporting; Revisions to Notification Regulations”). These actions require manufacturers and processors of TSCA chemical substances to use the Internet, through EPA’s Central Data Exchange (CDX), to submit TSCA section 5 notices to the Agency. These include Premanufacture Notices (PMNs) (40 CFR 720), Significant New Use Notices (SNUNs) (40 CFR 721), exemption applications and notices (40 CFR 720 and 723.50), biotechnology notices for genetically modified microorganisms (40 CFR 725), Notices of Commencement of Manufacture or Import (NOCs) (40 CFR 720.102) and other support documents. The rule required under TSCA section 8(b)(4)(A) will extend TSCA electronic reporting requirements to documents submitted under the requirements of TSCA sections 8(b)(4)(A)(i) and 8(b)(5)(B)(i). These include Notices of Activity (NOAs) (40 CFR 710) which include an NOA form A for TSCA section 8(b)(4)(A)(i) reporting, to commence June 22, 2017, and an NOA form B for subsequent reporting under TSCA section 8(b)(5)(B)(i) (see Attachments B, C, and D).
EPA introduced CDX reporting in two phases over a two-year period. From April 6, 2010 through April 6, 2011, the Agency allowed submissions via CDX, optical disc, and paper. Regardless of the delivery method, the Agency required that all submissions be generated with new electronic-PMN “e-PMN” computer software. As of April 6, 2011, paper submissions were no longer accepted for any new notices and support documents (including NOCs). Disc-based submissions (e.g., CDs and data DVDs) for all new notices and support documents were no longer accepted as of April 6, 2012. As of April 6, 2012, all submitters are required to submit electronically via CDX using the e-PMN software. As of March 4, 2014 (i.e., the effective date of the “Electronic Reporting Under the Toxic Substances Control Act” regulations), all submitters are required to submit NOCs and all support documents via CDX using the e-PMN software. The Agency incorporated this phased approach because it allowed submitters to gain experience in using the e-PMN software and the submission delivery system. See epa.gov/opptintr/newchems/epmn/epmn-index.htm for information on e-PMN reporting and the use of CDX.
In addition, EPA published a direct final rule entitled “TSCA Section 5 Premanufacture and Significant New Use Notification Electronic Reporting” on July 20, 2015, which provides the user community with new methods for accessing the e-PMN software, new procedures for completing the electronic-PMN (e-PMN) and other forms, changes to the CDX registration process, adds the requirement to submit “bona fide intents to manufacture” electronically, and changes to the procedure for notifying EPA of any new manufacturing site of a chemical substance for which an exemption was granted by the Agency under 723.50. These changes were intended to further streamline and reduce the administrative costs and burdens of TSCA section 5 notifications for both industry and EPA. EPA believes that submitters now have sufficient experience in using the electronic software and system, and coupled with the recent changes to streamline the electronic reporting process, the Agency is requiring submitters to submit NOAs electronically via CDX using the e-NOA software, effective June 22, 2017.
TSCA section 8(b), 15 U.S.C. 2607, requires EPA to compile and keep current the TSCA Inventory, the list of chemical substances manufactured or processed in the United States. TSCA sections 8(b)(4) and 8(b)(5), as amended by the Frank R. Lautenberg Chemical Safety for the 21st Century Act, require additional responsibilities of the Agency in maintaining the TSCA Inventory; specifically, the Agency is to designate chemical substances on the Inventory as “active” or “inactive” in U.S. commerce. TSCA section 8(b)(4)(A)(i) requires EPA to promulgate a rule by June 22, 2017, which requires manufacturers to notify the Agency, by not later than 180 days after the date on which the final rule is published in the Federal Register, of each chemical substance on the TSCA Inventory that was manufactured for a nonexempt commercial purpose during the 10-year period ending on June 21, 2016, the day before the date of enactment of the Frank R. Lautenberg Chemical Safety for the 21st Century Act. TSCA section 8(b)(4)(A)(ii) requires the Agency to designate a chemical substance on the Inventory as an active substance if the Agency receives notice for that substance under clause (i). TSCA section 8(b)(4)(A)(iii) requires the Agency to designate chemical substances on the Inventory for which no notices are received under clause (i) as inactive substances.
TSCA section 8(b)(5)(A) requires EPA to maintain active and inactive designations for chemical substances on the TSCA Inventory. TSCA section 8(b)(5)(B)(i) requires persons that intend to manufacture or process chemical substances for non-exempt commercial purpose that are designated on the Inventory as inactive to notify the Agency prior to the date that these chemicals are reintroduced into U.S. commerce. Upon receiving such notification, TSCA section 8(b)(5)(B)(iii) requires the Agency to change the designation of the substance from inactive to active.
Copies of TSCA section 8(b) and of 40 CFR part 710 are available in the public docket established for this ICR under docket identification number EPA-HQ-OPPT-2016-0426 and are available for online viewing at www.regulations.gov (also see Attachments A and B). The regulations may also be viewed online at the National Archives and Records Administration’s Electronic CFR Website.
TSCA requires EPA to compile and keep current the TSCA Inventory, the list of chemical substances manufactured or processed in the United States for non-exempt commercial purposes, and to designate substances on the Inventory as active or inactive in U.S. commerce. To designate chemical substances as active or inactive, the Agency needs to conduct a retrospective collection of data on the commercial activity of each substance on the Inventory. Because a company may at any time in the future, after the retrospective data collection, reintroduce into U.S. commerce a chemical substance designated as inactive on the Inventory, the Agency also needs to conduct forward-looking collection of data for such substances in order to be notified when a substance’s commercial activity is about to change from inactive to active. Information collection is also essential to the Agency for compliance purposes. The information requirements for NOA reporting will assist in identifying cases where submitters have mistakenly reported chemical substances based on their commercial activity status in the U.S. Finally, information collection will support EPA’s responsibilities in routinely publishing non-confidential Inventory data.
EPA requires the use of two specific reporting forms, a Form A (EPA Form No. XXXX) and a Form B (EPA Form No. XXXX), for NOAs submitted for chemical substances on the TSCA Inventory in accordance with 40 CFR 710 (see Attachments B, C, and D). The use of a standard form for commercial activity reporting leads to greater efficiency by assisting EPA in providing uniformity in recording data in EPA databases and on the Inventory, and by providing manufacturers a format to assure that required information is not inadvertently omitted in their submissions.
The recordkeeping requirements for NOAs are necessary for EPA compliance and enforcement purposes. As part of its compliance program, EPA conducts inspections to review the records of TSCA section 8(b) submitters to ensure that the information submitted in notices is correct and that submitters provided notices for chemical substances in U.S. commerce during the time periods specified under TSCA section 8(b).
Users of these data are EPA employees located primarily in the Office of Pollution Prevention and Toxics (OPPT) within the Office of Chemical Safety and Pollution Prevention (OCSPP). In particular, management and staff of existing chemicals programs within the various Divisions of OPPT will use this information to inform existing chemical prioritization. OCSPP employees in the Regional Offices, employees in the Office of Enforcement and Compliance Assurance (OECA) in Headquarters and in the Regions, and Core TSCA Regional Coordinator Inspectors may use these data for compliance monitoring and enforcement purposes.
3(a) Non-Duplication
EPA manages the TSCA Chemical Substance Inventory under TSCA section 8(b). The Inventory is the Agency's comprehensive list of confidential and non-confidential chemical substances manufactured or processed in the United States. EPA is the only federal agency that regularly collects information on chemical substances listed on the TSCA Inventory. Therefore, the information submitters provide in an NOA cannot be obtained elsewhere.
In proposing this new ICR, EPA provided a 60-day public notice and comment period that ended on [insert date], 2017 [insert citation and date]. EPA received comments from [insert] during the comment period. Copies of the comments received and EPA’s response to the comments are included as Attachment E.
EPA has been regularly engaged in a continuing series of joint EPA/industry/public interest group meetings to exchange information related to TSCA programs in general (which includes the TSCA Inventory), and more recently has begun engaging in similar meetings to exchange information related to specific new requirements required by TSCA as amended in 2016. These recent meetings included EPA public meetings and meetings with individual companies, and may include upcoming professional meetings (e.g., the annual Global Chem Conference).
Additionally, under 5 CFR 1320.8(d)(1), OMB requires agencies to consult with potential ICR respondents and data users about specific aspects of ICRs before submitting an ICR to OMB for review and approval. In accordance with this regulation, EPA will be submitting questions to eight parties via email. The individuals to be contacted are:
Mike Walls, Vice President
Regulatory and Technical Affairs
American Chemistry Council, Inc.
Ernie Rosenberg, President and CEO
American Cleaning Institute
Derek Swick, MPP Senior Policy Advisor
Regulatory and Scientific Affairs
American Petroleum Institute
Brigid Klein, Vice President and General Counsel
Consumer Specialty Products Association
Lee O. Fuller, Vice President of Government Relations
Independent Petroleum Association of America
Jim Cooper
Vice President Petrochemicals
American Fuel and Petrochemical Manufacturers
William Carteaux, President
Society of the Plastics Industry, Inc.
Bill Allmond, Director Government Relations
Society of Chemical Manufacturers and Affiliates
Formerly the Synthetic Organic Chemical Manufacturers Association (SOCMA)
Comments were received as a result of early consultations from five organizations: the American Chemistry Council, the American Petroleum Institute, the Biotechnology Innovation Organization, the Color Pigments Manufacturers Association, and the Environmental Defense Fund. A copy of EPA’s consultation e-mail to the above eight potential respondents is included in Attachment F.
The information collection includes retrospective reporting from manufacturers that is mandated under TSCA section 8(b)(4). The information collection also includes the subsequent forward-looking collection of notifications that is mandated under TSCA section 8(b)(5). The deadlines associated with retrospective reporting and subsequent forward-looking notifications are specified by statute. Delaying collection would limit EPA’s ability to meet its obligations under TSCA section 8(b)(4) and manufacturers and processors’ ability to meet their obligations under TSCA section 8(b)(5). Manufacturers must submit an NOA for chemical substances in U.S. commerce during the time period specified under TSCA section 8(b)(4); the timing of forward-looking notifications is determined by submitters’ statutory obligations to submit such notifications under TSCA section 8(b)(5). Information is provided to the Agency on an as-needed basis, according to the retrospective reporting requirements to collect data on active chemical substances, i.e., chemical substances on the TSCA Inventory that were active in U.S. commerce during the 10-year time period ending on June 21, 2016. Subsequent forward-looking reporting would only be required for inactive substances, i.e., chemical substances on the Inventory for which EPA received no notice during the retrospective reporting period, that are intended to be reintroduced into U.S. commerce at a date after the retrospective submission period closes. As subsequent forward-looking notification occurs over time changing designations from inactive to active, fewer notification are expected.
This collection of information is consistent with all OMB guidelines under 5 CFR 1320.6 except with respect to the maintenance of records by respondents for more than three years. EPA believes a five-year recordkeeping requirement is needed to carry out an effective program. The five-year recordkeeping requirement is consistent with the five-year statute of limitations under 28 U.S.C. 2462 held applicable to all Agency enforcement actions, including administrative proceedings under TSCA. See 3M Company vs. Browner, 17 F.3d 1453 (DC Cir. 1994). Therefore, EPA requires respondents to retain records for more than three years.
The information required in an NOA may be considered by the submitter to be a trade secret, proprietary, or confidential business information (CBI). However, TSCA mandates that EPA require the submission of such information because it is essential for maintaining the individual chemical substance listings on the TSCA Inventory. Because unique, individual chemical substances are listed on the Inventory, the Agency requires specific chemical identity information for each listing to properly maintain on the TSCA Inventory.
Additionally, the Agency is required by TSCA section 8(b) to routinely publish non-confidential data on each chemical substance on the TSCA Inventory. Congress included this provision to provide the public with information on chemical substances in U.S. commerce. The Agency’s policies allow public involvement while preserving CBI. TSCA section 14(a) prohibits, except in limited circumstances, the disclosure of trade secret information. Under 40 CFR part 2, when the specific chemical identity data are claimed confidential, the Agency requires the submitter to provide generic descriptions for inclusion in Federal Register notices and the publications of the TSCA Inventory. Persons will be reporting chemical identity information in NOAs based on a list of TSCA Inventory chemical substances posted in EPA’s Substance Registry System. This list does not contain confidential chemical identity information. Persons will therefore report the specific chemical identity for non-confidential substances on the Inventory, which includes a Chemical Abstracts Service Registry Number (CASRN) and Chemical Abstracts (CA) Index name. Confidential substances on the Inventory will be reported by their non-confidential chemical identifiers, which includes the generic chemical name and an EPA-assigned accession number. Although no confidential chemical identity information will be included in NOAs, persons are required to certify and substantiate requests to maintain existing claims of confidentiality for chemical substances listed on the confidential portion of the TSCA Inventory.
The 2016 amendments to TSCA include new provisions that impact procedures for how CBI claims can be made and the Agency’s obligations to review and make determinations concerning the validity of the claims. Persons submitting NOAs that claim reported information CBI must follow the general requirements of TSCA section 14 for making such claims, as modified by the specific provisions under TSCA section 8(b). TSCA section 14(c) requires that submitters claiming CBI must provide a specific statement attesting to the basis for the CBI claims. TSCA also requires that all submissions containing information claimed as CBI also must include substantiations in support of the CBI claims. With the exception of requests to maintain existing CBI claims for chemical identity (as stated in TSCA section 8(b)), substantiations are required at the time of notification.
Based on its experience, EPA expects that information included in NOAs, specifically submitter information (company name and contact information), will likely be claimed CBI. The Agency has developed an elaborate system to prevent unauthorized disclosure of CBI. This system includes procedures for logging material in and out of the Confidential Business Information Center (CBIC) at EPA headquarters, procedures for photocopying and transmitting CBI, and a stand-alone CBI local area computer network. These procedures apply to CBI provided by submitters as well as CBI generated by EPA staff in the course of their review. Access to CBI is restricted to persons who need the information for their work. No one is allowed access to CBI without first undergoing instruction on procedures for handling CBI. Special procedures have been instituted to restrict access to computerized CBI. These procedures are detailed in the “TSCA CBI Protection Manual,” October 2003. EPA believes these procedures protect CBI while providing the public with as much information as possible.
Any information being sent via CDX is transmitted using secure technologies to protect CBI. The EPA-provided reporting application, termed e-NOA, encrypts submissions using a Federal Information Processing Standards (FIPS)-compliant encryption module. The encryption module employs a public key algorithm which converts readable text into encrypted text. This public key is downloaded from CDX to the e-NOA software, and the corresponding private key is sent to EPA’s Chemical Information System (CIS). The encryption remains while the submission is transmitted via CDX to CIS. The file can be decrypted only with the CIS private key when it has reached its final destination. The CIS is the only party that possesses the private key, which converts the encrypted text back into readable text.
The same protection will occur for all correspondence going back to the submitter. The CIS and e-NOA software are also provided with a set of public and private keys, so that correspondence containing any potential CBI will remain encrypted during transmission via CDX and can be opened only by the submitter within the e-NOA software.
Information requirements under TSCA section 8(b) do not include questions of a sensitive nature.
This information collection affects companies that manufacture or process chemical substances. These companies are typically found in NAICS major groups 325 (Chemical Manufacture) and 324 (Petroleum and Coal Products). The per-response reporting unit, or unit of analysis, is “notices.” A given notice typically submitted by a single firm may pertain to a single or multiple chemical substances.
Data Items - Reporting Requirements
Retrospective Notices of Activity - Under 40 CFR 710, manufacturers are required to notify the Agency by submitting a Notice of Activity (NOA) for chemical substances on the TSCA Inventory that were manufactured for non-exempt commercial purposes during the 10-year period ending on June 21, 2016. Processors may notify the Agency by submitting a Notice of Activity (NOA) for chemical substances on the TSCA Inventory that were processed for non-exempt commercial purposes during the 10-year period. Required information includes the following:
Chemical identity of the substance;
Date range that the chemical substance was in U.S. commerce during the 10-year period ending June 21, 2016;
Type of commercial activity (manufacture, importation, and/or processing);
Name of the submitting company;
Name and address of the authorized official for the submitting company who will be signing the NOA;
Name and telephone number of a technical contact person;
Clear indication of what information, if any, is to be considered CBI; and
Substantiation of CBI claims.
NOAs must be submitted to EPA using the NOA Form A (EPA Form XXXX). Submitters are required to submit electronically using the e-NOA software to generate a finalized submission using Form XXXX. Manufacturers must provide the NOA to the Agency no later than 180 calendar days after June 22, 2017. Processors may provide the NOA to the Agency no later than 360 calendar days after June 22, 2017. Substantiation of a CBI claim for specific chemical identity must be provided at a time to be determined by a rule that the Administrator is required to promulgate no later than one year after the date the Agency compiles the list of active substances (8(b)(4)(B)(iii)). Substantiation of CBI claims for all other data elements must be provided at time of notification.
Forward-looking Notices of Activity - Under 40 CFR 710, manufacturers and processors are required to notify the Agency by submitting a Notice of Activity (NOA) for inactive chemical substances on the TSCA Inventory that are to be reintroduced into U.S. commerce for non-exempt commercial purposes after June 22, 2016 (i.e., after the period addressed by retrospective reporting). Required information includes the following:
Chemical identity of the substance;
Date that the chemical substance is to be reintroduced into U.S. commerce;
Type of commercial activity (manufacture, importation, and/or processing);
Name of the submitting company;
Name and address of the authorized official for the submitting company who will be signing the NOA;
Name and telephone number of a technical contact person;
Clear indication of what information, if any, is to be considered CBI; and
Substantiation of CBI claims.
NOAs must be submitted to EPA using the NOA Form B (EPA Form XXXX). Submitters are required to submit electronically using the e-NOA software to generate a finalized submission using Form XXXX. Manufacturers and processors must provide the NOA to EPA prior to reintroducing a chemical substance into U.S. commerce but not more than 30 days prior. Substantiation of a CBI claim for specific chemical identity must be provided by not later than 30 days after the notice is submitted (8(b)(5)(B)(ii)(II)), but may be provided at the time of submission. Substantiation of CBI claims for all other data elements must be provided at time of notification.
Data Items - Recordkeeping Requirements
Under 40 CFR 710, submitters must keep documentation of information in a TSCA section 8(b) notice for five years from the date of submitting the notice.
Respondent Activities
In responding to the reporting and recordkeeping requirements outlined in this document, respondents will engage in the following activities:
Read regulatory requirements and provisions;
Determine which provisions are applicable to their activities;
Gather information necessary to meet the requirements;
Substantiate any claims of CBI;
Register with CDX;
Use the e-NOA software;
Submit information to EPA, as necessary;
Comply with any restrictions EPA may impose upon completion of review of their submission; and
Maintain any necessary records.
5(a) Agency Activities
From EPA’s perspective, the organizing reporting unit is a “notice.” A given notice typically submitted by a single firm pertains to a single chemical substance or multiple chemical substances. In processing TSCA section 8(b) notices, the Agency will perform the following activities:
Review NOA submissions;
Analyze submissions for confidentiality and provide appropriate protection for confidential data;
Acknowledge receipt of submissions and notify respondents of any submission errors or deficiencies;
File and store submissions to Agency data systems;
Update the TSCA Inventory based on notices received;
Provide technical assistance to respondents; and
Conduct site and record inspections and perform related compliance monitoring functions.
Data items, including recordkeeping requirements
Data items are approved under OMB Control Number 2070-XXXX.
Respondent Activities - Register with EPA’s CDX and Complete the Electronic Signature Agreement
EPA is providing two different variations of the e-NOA software, one with encryption and one without encryption. The e-NOA software with encryption, available on EPA’s CDX website, accommodates electronic submission through CDX. The e-NOA software without encryption is available through EPA’s TSCA New Chemicals Program website. Both variations of the e-NOA software are available free of charge as Internet downloads. The e-NOA software without encryption is also available on optical discs provided by the Agency upon request.
To register in CDX, the CDX registrant (also referred to as “Electronic Signature Holder” or “Public/Private Key Holder”) downloads two forms: the Electronic Signature Agreement and the Verification of Company Authorizing Official form. Registration enables CDX to perform two important functions: authentication of identity and verification of authorization. Within the “Electronic Signature Agreement” form, the Authorized Official (AO) agrees to certain CDX security conditions. On the “Verification of Company Authorizing Official” form, the AO designates himself/herself as the AO and attests to the completeness and accuracy of the submitted information.
There is a third form generated by CDX that the AO needs to fill out if the AO wants to authorize other persons to submit support documents on his or her behalf, including a paid employee of the company, an outside consultant for the company, or an authorized representative agent for the company. This form is entitled, “Authorization and Verification for Submitter by Company Authorizing Official.” On this form, the AO designates various persons to submit support documents on his or her behalf, and attests to the completeness and accuracy of the submitted information. Persons designated by the AO to submit on his or her behalf must also sign this form along with the Electronic Signature Agreement form, in order to be “linked” to the AO by EPA and therefore be able to submit support documents via CDX on the AO’s behalf.
When these forms are received, EPA activates the submitter's registration in CDX and sends an e-mail notification confirming registration.
Respondent Activities - Use the e-NOA Software to Prepare TSCA section 8(b) Notices
In all cases, respondents use the e-NOA software to:
generate the submission materials for TSCA section 8(b) notices, including forms (i.e., the NOA Form A XXXX and the NOA Form B XXXX); and,
populate the submission materials with the relevant information.
Respondent Activities - Finalize and Submit
Respondent activities to finalize and submit TSCA section 8(b) notices depend on the chosen submission method. The e-NOA software requires users to complete a finalization process before preparing the information for submission to EPA. During the finalization step, the e-NOA software checks that all legally required information is included and provides warnings for certain kinds of missing, incomplete or incorrect data.
Using e-NOA Software to Submit Electronically to EPA via CDX
After the e-NOA finalization step is complete, the e-NOA software prompts respondents to log-in to CDX. Respondents simply transmit the information to EPA online by clicking on the e-NOA software’s “send” button.
All NOA forms must be generated using the e-NOA software and submitted electronically via CDX. The data being transmitted electronically via CDX are encrypted to protect CBI. The software works with Windows, Macs, Linux, and UNIX-based computers, using XML for efficient data transmittal to Agency data systems. The Agency requires all TSCA section 8(b) notices to be submitted electronically via CDX.
An electronic signature is required for TSCA section 8(b) notices submitted to the Agency via CDX. Electronic signatures are granted as part of the CDX user-registration process.
All e-NOA software users need to perform the “finalization” step in generating a document. During the “finalization” step, the e-NOA software checks that all legally required information is included, provides warnings where necessary, and saves data in a read-only format acceptable to the Agency. TSCA section 8(b) notices in which data have not undergone the
“finalization” step are determined incomplete. This step is necessary to allow for an accurate and efficient transfer of data to EPA data systems. The word, “finalized,” is in the file name and the name ends with “tsca.” The “finalized” file (folder) contains the CBI and non-CBI data in XML format that are non-editable. The CBI and non-CBI attachments are also in this folder in their native format. Attachments must be submitted in one of EPA’s approved formats for the Agency to be able to open the files.
All information sent via CDX is transmitted securely to protect CBI. Furthermore, if anything in the submission has been claimed CBI, a sanitized copy of the notice must be provided by the submitter. The e-NOA software facilitates the creation of this sanitized non-CBI version, eliminating the need for the submitter to do this manually. It also allows submitters to share a draft notice within their company during the creation of a notice and to save a copy of the final file for future use. A “Profiler,” available in the software, also allows for certain information to be kept on file by the submitter to avoid the burden associated with re-entering the same information into a new form.
The Agency also benefits from receiving electronic submissions. Data systems are populated electronically, minimizing the potential for human error. Agency personnel are also able to communicate efficiently with submitters electronically. Because companies register with EPA to submit their data electronically to the Agency via CDX, the Agency in turn communicates electronically with submitters via CDX. The electronic means of communication provides significant time and resource efficiencies for both parties.
Additionally, to aid persons subject to this information collection, OPPT has set up a TSCA Hotline that provides information regarding TSCA regulatory requirements. When TSCA Hotline staff members are unable to answer questions regarding TSCA section 8(b), the questions are referred to OPPT staff for appropriate resolution.
The reporting and recordkeeping requirements associated with TSCA section 8(b) are applicable to all affected entities, regardless of size of business. However, EPA provides specialized assistance to respondents, particularly to small entities. TSCA section 26(d) established the TSCA Assistance Office, now known as the Environmental Assistance Division (EAD), to provide technical and other non-financial assistance to manufacturers and processors of chemical substances. This office has established a TSCA Hotline to assist small businesses complying with TSCA rules. It provides material such as copies of Federal Register notices, advisories, and other information on request.
Moreover, EPA has taken certain steps to minimize for all respondents the reporting burden associated with complying with this collection. For example, the information technology used by EPA includes chemical substances on the TSCA Inventory in EPA Substance Registry System. This list allows submitters to select their reportable chemical substances from the list rather than manually entering each substance. Additionally, submitters are able to report multiple chemical substances in one session; upon completion of a session, each chemical substance will be transmitted in one NOA submission.
Finally, EPA provides the services of TSCA Inventory and other personnel to assist persons with reporting questions and notice preparation prior to submission. TSCA Inventory personnel routinely respond to TSCA section 8(b) inquiries that pertain to the full scope of TSCA section 8(b) regulations.
Does not apply. Submission of information under this collection is on an as-needed basis, initiated by the submitters.
This analysis presents the burden and cost estimates for affected entities, and covers submissions of Notices of Activity (NOAs). Table 1 provides a list of general activities required for compliance with the regulation by manufacturers (including importers) and processors. Table 1 also provides a cross-walk of the related Information Collection category that corresponds to each activity. Burden and cost calculations are based on the assumption that EPA will receive approximately 4,692 NOA submissions during Start-Up Reporting in the first year, and 20 NOA submissions annually for each year of Forward-looking Reporting. For both Start-Up and Forward-looking Reporting, the typical submission is assumed to include seven chemicals.
Table 1. Cross-Walk between Industry Activities and Related Information Collections
Activity |
Description |
Related IC(s) included in this ICR Renewal |
Preparation and Submission of Reports |
Staff must collect all of the information, required by submissions. This ICR covers the NOAs submitted during Start-Up Reporting and for Annual Forward-looking Reporting. The information must be gathered, reviewed, and submitted to EPA. This activity involves any research necessary to identify the correct information and the act of completing the submission review. |
Prepare and Submit Report, and Maintain Records |
Recordkeeping |
Respondents must keep records supporting their submissions (technical and clerical burden). |
Prepare and Submit Report, and Maintain Records |
CDX Registration |
The information collection requires that submitters register with CDX in order to submit electronic records and completing an Electronic Signature Agreement form, including a CROMERR certification, which is signed, dated, and submitted electronically back to EPA. |
CDX Registration Activities |
This section presents the burden of this information collection activity to respondents in terms of the time required for facility personnel to perform the activities outlined in Section 3 of this document. The overall unit burden experienced by firms is estimated by combining activity-level unit burdens at the appropriate scale (e.g. per firm or per chemical) to produce estimates for unit burden per submission, by firm. This section details the activity-level unit burdens grouped by type of activity. For additional details see the Burden and Cost Report for the Proposed Rule: TSCA Inventory Notification Requirements (EPA, 2016). Note that there are two types of reporting within the ICR period. Start-Up Reporting occurs within the first year, and Forward-looking Reporting occurs during the last two years.
The required activities are described below. Table 2 provides the detailed estimates.
Submitter Information includes Authorized Official Name and Address and Technical Contact Name and Address.
CBI Designations for Submitter Information are part of the submission.
NOA Certification is a required component of the NOA submission.
Certifier e-mail Address with certification and e-signature, respondents are also required to provide an email address.
5A and 6A Non-CBI Chemical Name and Chemical Identity: For non-CBI chemicals, the NOA submitter is required to submit the TSCA Inventory Chemical Name and Chemical Abstract Services Registry Number (CASRN). The submitter locates this information during the electronic submission via access to SRS.
5B and 6B CBI Chemical Name and Chemical Identity: For CBI chemicals, the NOA submitter is required to submit the Generic Chemical Name. CBI chemical identities consists of an Accession Number and generic name. The submitter locates this information during the electronic submission via access to SRS.
CBI Designation for Chemical Name and Chemical Identity is part of the submission.
Manufacture, Import and/or Process Designations (per chemical).
Date Range or Start Date (per chemical): For submissions received during Start-Up Reporting the date range will be reported; for submissions received during Forward-looking Reporting, only Start Date will be reported. This information is needed by EPA for purposes of validating/verifying the NOA, and consequently avoiding processing of invalid notices, thereby increasing the reliability of the activity designations on the TSCA Inventory. For date range, the activity would require submitters to refer to company records in order to identify the necessary and relevant information.
CBI Designations for Manufacture, Import and/or Process designation and Date Range (or Start Date) are part of the submission.
Chemical Identity CBI Status Declaration involves selecting one of two conditions: to maintain the CBI claim or to not maintain the CBI claim for the specific chemical identity on the TSCA Inventory.
Upfront CBI Substantiation for Chemical Identity (Applies for Certain Submissions) As part of the NOA, submitters may provide upfront chemical identity CBI substantiation under certain circumstances. The chemical identity CBI substantiation questions are as follows:
What harmful effects to your competitive position, if any, or to your supplier's competitive position, do you think would result from the identity of the chemical substance being disclosed in connection with reporting under this part? How could a competitor use such information? Would the effects of disclosure be substantial? What is the causal relationship between the disclosure and the harmful effects?
How long should confidential treatment be given? Until a specific date, the occurrence of a specific event, or permanently? Why?
Has the chemical substance been patented? If so, have you granted licenses to others with respect to the patent as it applies to the chemical substance? If the chemical substance has been patented and therefore disclosed through the patent, why should it be treated as confidential?
Has the identity of the chemical substance been kept confidential to the extent that your competitors do not know it is being manufactured for a commercial purpose by anyone?
Is the fact that the chemical substance is being manufactured for a commercial purpose available to the public, for example in technical journals, libraries, or State, local, or Federal agency public files?
What measures have been taken to prevent undesired disclosure of the fact that the chemical substance is being manufactured for a commercial purpose?
To what extent has the fact that this chemical substance is manufactured for commercial purposes been revealed to others? What precautions have been taken regarding these disclosures? Have there been public disclosures or disclosures to competitors?
Does this particular chemical substance leave the site of manufacture in any form, e.g., as product, effluent, emission? If so, what measures have been taken to guard against the discovery of its identity?
If the chemical substance leaves the site in a product that is available to the public or your competitors, can the chemical substance be identified by analysis of the product?
For what purpose do you manufacture the chemical substance?
Has EPA, another Federal agency, or any Federal court made any pertinent confidentiality determinations regarding this chemical substance? If so, please attach copies of such determinations.
Note that chemical identity upfront CBI substantiation only affects a portion of NOA submissions, and only applies under the specific circumstances in which a submitter seeks to maintain the chemical identity CBI claim. Additionally, requirements differ according to reporting period: for Start-Up Reporting the CBI substantiation is not included in the NOA submission, but instead submitted later in accord with the Review Plan Rule. For Forward-looking Reporting, the upfront CBI substantiation may optionally be included in the NOA submission, or alternately may be provided 30 days after the NOA submission.
Upfront CBI Substantiation for non-Chemical Identity Data Elements as a Group (applies for certain submissions) As part of the NOA, submitters may provide upfront CBI substantiation for non-chemical identity data elements. This burden is considered for the collection of data elements because the practice of claiming these items (e.g., company name, location, dates of manufacture) is, in effect, to make a claim on the confidentiality of the connection between the information of the data element(s) and the non-confidential chemical identity. The non-chemical identity CBI substantiation questions are as follows:
For what period of time do you request that the information be maintained as confidential, e.g., until a certain date, until the occurrence of a specified event, or permanently? If the occurrence of a specific event will eliminate the need for confidentiality, please specify that event.
Information submitted to EPA becomes stale over time. Why should the information you claim as confidential be protected for the time period specified in your answer to question #1?
What measures have you taken to protect the information claimed as confidential? Have you disclosed the information to anyone other than a governmental body or someone who is bound by an agreement not to disclose the information further? If so, why should the information be considered confidential?
Is the information contained in any publicly available material such as the Internet, publicly available databases, promotional publications, annual reports, or articles? If so, specify which.
Is there any means by which a member of the public could obtain access to the information? Is the information of a kind that you would customarily not release to the public?
Has any governmental body made a determination as to the confidentiality of the information? If so, please attach a copy of the determination.
For each item or category of information claimed as confidential, explain with specificity why release of the information is likely to cause substantial harm to your competitive position. Explain the specific nature of those harmful effects, why they should be viewed as substantial, and the causal relationship between disclosure and such harmful effects. How could your competitors make use of this information to your detriment?
Do you assert that the information is submitted on a voluntary or a mandatory basis? Please explain the reason for your assertion. If you assert that the information is voluntarily submitted information, please explain whether the information is the kind that would customarily not be released to the public.
Whether you assert the information as voluntary or involuntary, please address why disclosure of the information would tend to lessen the availability to EPA of similar information in the future.
If you believe any information to be (a) trade secret(s), please so state and explain the reason for your belief. Please attach copies of those pages containing such information with brackets around the text that you claim to be (a) trade secret(s).
Explain any other issue you deem relevant.
Note that non-chemical identity upfront CBI substantiation only affects a portion of NOA submissions, and is required during both Start-Up and Forward-looking Reporting.
In Table 2, activity burdens are combined to produce unit burdens associated with submissions for a number of reporting conditions. For firms submitting an NOA for one chemical (i.e., Processors during Phase II of Start-Up Reporting), the nominal single-chemical submission estimates apply for either Start-Up or Forward-looking Reporting. For firms submitting an NOA with multiple chemicals, it is assumed that on average there are seven chemicals per firm submission. Therefore, the estimates for “Start-Up Typical Average Unit Burden per Firm” and “Annual Forward-looking Unit Burden per Firm” are on the basis of seven chemicals per submission. Note that the average burdens do not include CDX registration and e-Signature, as these activities coincide with a different unit of analysis (per registration) and constitute only a small part of the overall burden estimate.
Table 2. Unit Burden for Start-Up and Annual Forward-looking Conditions
Activity |
Unit of Analysis |
Clerical
Burden (hours) |
Technical
Burden (hours) |
Managerial
Burden (hours) |
Total
Burden (hours) |
CDX REGISTRATION 1 |
Registration |
0.000 |
0.180 |
0.000 |
0.180 |
CDX e-SIGNATURE 1 |
Registration |
0.000 |
0.350 |
0.000 |
0.350 |
RULE FAMILIARIZATION |
Firm |
0.000 |
2.000 |
2.000 |
4.000 |
COMPLIANCE DETERMINATION (Without Review of "Active Status" List) |
Firm |
0.000 |
0.500 |
0.000 |
0.500 |
COMPLIANCE DETERMINATION (Review of "Active Status" List Only) |
Chemical |
0.000 |
0.083 |
0.000 |
0.083 |
|
|||||
FORM COMPLETION FOR NOMINAL SINGLE-CHEMICAL SUBMISSION |
|||||
(1) Submitter Authorized Official Name, Company Name, and Mailing Address and Technical Contact Name and Telephone Number |
Firm |
0.000 |
0.010 |
0.004 |
0.014 |
(2) Technical Contact Name and Telephone Number |
Firm |
|
|
|
Included in (1) above |
(3) NOA Certification |
Submission |
0.000 |
0.000 |
0.500 |
0.500 |
(4) Certifier E-mail |
Submission |
0.000 |
0.017 |
0.000 |
0.017 |
(5) Chemical Name 2 |
Chemical |
0.000 |
0.083 |
0.000 |
0.083 |
(6) Chemical Identify 2 |
Chemical |
|
|
|
Included in (5) above |
(7) CBI Designations for Chemical Name and Chemical Identity |
Chemical |
|
|
|
Estimated at zero |
(8) Manufacture, Import, and/or Process Designations |
Chemical |
0.000 |
0.002 |
0.000 |
0.002 |
(9) Start-Up: Date Range of Manufacture, Import, and/or Process (Start-Up Period) |
|
0.000 |
0.944 |
0.000 |
0.944 |
--- OR --- |
Chemical |
|
|
|
OR |
Forward-looking: Start Date of Manufacture, Import, and/or Process (Annual Forward-looking Period) |
|
0.000 |
0.017 |
0.000 |
0.017 |
(10) CBI Designations for Manufacture, Import, and/or Process; and Date Range |
Chemical |
|
|
|
Estimated at zero |
(11) Chemical Identity CBI Status Declaration: maintain or not maintain claim of confidentiality of the specific chemical identity on the TSCA Inventory |
Chemical |
0.000 |
0.002 |
0.000 |
0.002 |
(12) Upfront CBI substantiation for Chemical Identity 3 |
Chemical |
0.000 |
0.035 |
0.018 |
0.053 |
Activity |
Unit of Analysis |
Clerical
Burden (hours) |
Technical
Burden (hours) |
Managerial
Burden (hours) |
Total
Burden (hours) |
(13) Upfront CBI Substantiation for non-Chemical Identity data elements as a group 4 |
Chemical |
0 |
0.400 |
0.200 |
0.600 |
Date and Time Stamps |
Submission |
|
|
|
System-Generated |
SINGLE CHEMICAL SUBMISSION FORM COMPLETION, Start-Up Period |
0.000 |
1.493 |
0.722 |
2.215 |
|
SINGLE CHEMICAL SUBMISSION FORM COMPLETION, Forward-looking Period |
0.000 |
0.566 |
0.722 |
1.288 |
|
RECORDKEEPING |
|
|
|
|
|
Per NOA Submission, Start-Up and Annual Forward-looking Periods |
Firm |
0.125 |
0.000 |
0.000 |
0.125 |
START-UP TOTAL, Unit Burden for Nominal Single Chemical |
|
|
|
6.923 |
|
ANNUAL FORWARD-LOOKING TOTAL, Unit Burden for Nominal Single Chemical (Note: No Rule Familiarization) |
1.996 |
||||
|
|||||
AVERAGE UNIT BURDEN ACCORDING TO MULTI-CHEMICAL SUBMISSION |
|||||
Start-Up Period |
|
|
|
|
|
Rule Familiarization |
|
0.000 |
2.000 |
2.000 |
4.000 |
Compliance Determination |
|
0.000 |
1.081 |
0.000 |
1.081 |
Form Completion |
|
0.000 |
10.289 |
2.030 |
12.319 |
Typical Average Unit Burden per Firm without Recordkeeping 5 |
|
|
|
|
17.400 |
Recordkeeping |
|
0.125 |
0.000 |
0.125 |
0.125 |
TOTAL, Typical Average Unit Burden per Firm 5 |
|
|
|
|
17.525 |
Annual Forward-looking Period |
|
|
|
|
|
Rule Familiarization |
|
N/A |
N/A |
N/A |
|
Compliance Determination |
|
0.000 |
1.081 |
0.000 |
1.081 |
Form Completion |
|
0.000 |
3.800 |
2.030 |
5.830 |
Average Annual Forward-looking Unit Burden per Firm without Recordkeeping 5 |
|
|
|
|
6.911 |
Recordkeeping |
|
0.125 |
0.000 |
0.000 |
0.125 |
TOTAL, Average Annual Forward-looking Unit Burden per Firm 5 |
|
|
|
|
7.036 |
General Note |
|||||
Sources for unit burden estimates are drawn from various Economic Analyses and ICR Supporting Statements. Additionally, Agency BPJ was employed to finalize results. For further detail, see Section 4.6 of Burden and Cost Report for the Proposed Rule: TSCA Inventory Notification Requirements (EPA, 2016). |
|||||
Footnotes |
|||||
1 New CDX registrations and e-signatures are expected due to: (1) firms that have not had experience with CDX, and (2) personnel turnover in firms that have experience with CDX. |
|||||
2 The composite of 0.083 hours, or about 5 minutes reported here is the result of the assessment that providing CBI chemical identity and chemical name (accession number plus generic name) requires 0.083 hours, and that providing non-CBI chemical identity and chemical name (CASRN and TSCA Inventory name) requires 0.083 hours. Also note that 3% of CDR 2012 chemicals are reported as having CBI chemical identities (EPA, 2014b). |
|||||
3 This unit burden is assumed to apply to only 3% of submissions, given that 3% of CDR 2012 chemicals are reported as having CBI chemical identities (EPA, 2014b). Therefore the value shown in the table is 3% of the full value unit burden per chemical reported in the Burden and Cost Report for the Proposed Rule: TSCA Inventory Notification Requirements (EPA, 2016) at 1.160 hours of technical labor; 0.610 hours of managerial labor. The estimate per chemical in this table is considered to be overstated because upfront substantiation is only applicable to certain submissions during the Annual Forward-looking period. |
|||||
4 This unit burden is assumed to apply to 50% of submissions, the assumed incidence rate for submissions in which the connection between the chemical identity and the company information, date range, etc. is claimed to be confidential. Therefore the value shown in the table is 50% of the full value unit burden per chemical reported in the Burden and Cost Report for the Proposed Rule: TSCA Inventory Notification Requirements (EPA, 2016) at 0.800 hours of technical labor; 0.400 hours of managerial labor. |
|||||
5 An average firm is expected to report seven chemicals per submission, as similarly observed for CDR 2012 as chemicals per site reported (Ballard, 2014). |
|||||
For total industry burden and cost by activity and reporting period, see Table 7 of this document in Section 6(d).
Estimation of unit industry cost involves combining the unit industry burden identified in Section 6(a) with wage data obtained for December 2015 from the BLS (2016) and converted from raw wage rate and benefit data to loaded wage rates. Table 3 presents the resultant loaded wage rates for managerial, professional/technical, and clerical staff.
Table 3. Industry Wage Rates (2015 Dollars)
Labor Category |
Data Series a |
Date |
Wage |
Fringe Benefit |
Fringes as % Wage |
Overhead % wage b |
Fringe + Overhead Factor c |
Hourly Loaded Wages |
(a) |
(b) |
(c) =(b)/(a) |
(d) |
(e)=(c)+(d)+1 |
(f)=(a)×(e) |
|||
Managerial |
BLS ECEC, Private Manufacturing industries, “Mgt, Business, and Financial” |
Dec-15 |
$48.66 |
$24.25 |
50% |
17% |
1.67 |
$81.18 |
Professional / Technical |
BLS ECEC, Private Manufacturing industries, “Professional and related“ |
Dec-15 |
$44.06 |
$24.34 |
55% |
17% |
1.72 |
$75.89 |
Clerical |
BLS ECEC, Private Manufacturing industries, “Office and Administrative Support” |
Dec-15 |
$19.91 |
$10.37 |
52% |
17% |
1.69 |
$33.66 |
Footnotes a Source: Employer Costs for Employee Compensation Historical Supplementary Tables: December 2006 – June 2016 (BLS, 2016). b An overhead rate of 17% is used based on assumptions in Wage Rates for Economic Analysis of the Toxics Release Inventory Program (Rice, 2002), and the Revised Economic Analysis for the Amended Inventory Update Rule: Final Report (EPA, 2002). c The inflation factor of “1” in the formula for calculating the fringe + overhead factor means wage data are not escalated to reflect inflation. |
||||||||
Industry unit costs are presented below in Table 4, in similar fashion to the industry unit burdens provided in Table 2.
Table 4. Unit Cost for Start-Up and Annual Forward-looking Conditions
Activity |
Unit of Analysis |
Clerical
Cost (2015$) |
Technical
Cost (2015$) |
Managerial
Cost (2015$) |
Total Cost (2015$) (a) + (b) + (c) |
CDX REGISTRATION 1 |
Registration |
$0.00 |
$13.66 |
$0.00 |
$13.66 |
CDX e-SIGNATURE 1 |
Registration |
$0.00 |
$26.56 |
$0.00 |
$26.56 |
RULE FAMILIARIZATION |
Firm |
$0.00 |
$151.78 |
$162.36 |
$314.14 |
COMPLIANCE DETERMINATION (Without Review of "Active Status" List) |
Firm |
$0.00 |
$37.95 |
$0.00 |
$37.95 |
COMPLIANCE DETERMINATION (Review of "Active Status" List Only) |
Chemical |
$0.00 |
$6.30 |
$0.00 |
$6.30 |
|
|
|
|
|
|
FORM COMPLETION FOR NOMINAL SINGLE-CHEMICAL SUBMISSION |
|
|
|
|
|
(1) Submitter Authorized Official Name, Company Name, and Mailing Address and Technical Contact Name and Telephone Number |
Firm |
$0.00 |
$0.76 |
$0.32 |
$1.08 |
(2) Technical Contact Name and Telephone Number |
Firm |
|
|
|
Included in (1) above |
(3) NOA Certification |
Submission |
$0.00 |
$0.00 |
$40.59 |
$40.59 |
(4) Certifier E-mail |
Submission |
$0.00 |
$1.29 |
$0.00 |
$1.29 |
(5) Chemical Name 2 |
Chemical |
$0.00 |
$6.30 |
$0.00 |
$6.30 |
(6) Chemical Identity 2 |
Chemical |
|
|
|
Included in (5) above |
(7) CBI Designations for Chemical Name and Chemical Identity |
Chemical |
|
|
|
Estimated at zero |
(8) Manufacture, Import, and/or Process Designations |
Chemical |
$0.00 |
$0.15 |
$0.00 |
$0.15 |
(9) Start-Up: Date Range of Manufacture, Import, and/or Process (Start-Up Period) |
|
$0.00 |
$71.64 |
$0.00 |
$71.64 |
--- OR --- |
Chemical |
|
|
|
OR |
Forward-looking: Start Date of Manufacture, Import, and/or Process (Annual Forward-looking Period) |
|
$0.00 |
$1.29 |
$0.00 |
$1.29 |
(10) CBI Designations for Manufacture, Import, and/or Process; and Date Range |
Chemical |
|
|
|
Estimated at zero |
(11) Chemical Identity CBI Status Declaration: maintain or not maintain claim of confidentiality of the specific chemical identity on the TSCA Inventory |
Chemical |
$0.00 |
$0.15 |
$0.00 |
$0.15 |
(12) Upfront CBI Substantiation for Chemical Identity 3 |
Chemical |
$0.00 |
$2.66 |
$1.46 |
$4.12 |
(13) Upfront CBI Substantiation for non-Chemical Identity data elements as a group 4 |
Chemical |
$0.00 |
$30.36 |
$16.24 |
$46.60 |
Date and Time Stamps |
Submission |
|
|
|
System-Generated |
SINGLE CHEMICAL SUBMISSION FORM COMPLETION, Start-Up Period |
|
$0.00 |
$113.31 |
$58.61 |
$171.92 |
SINGLE CHEMICAL SUBMISSION FORM COMPLETION, Annual Forward-looking Period |
|
$0.00 |
$42.96 |
$58.61 |
$101.57 |
RECORDKEEPING |
|
|
|
|
|
Per NOA Submission, Start-Up and Annual Forward-looking Periods |
Firm |
$4.21 |
$0.00 |
$0.00 |
$4.21 |
START-UP TOTAL, Unit Cost for Nominal Single Chemical |
$534.52 |
||||
ANNUAL FORWARD-LOOKING TOTAL, Unit Cost for Nominal Single Chemical (Note: No Rule Familiarization) |
$464.17 |
||||
|
|
|
|
|
|
AVERAGE UNIT COST ACCORDING TO MULTI-CHEMICAL SUBMISSION |
|
|
|
|
|
Start-Up Period |
|
|
|
|
|
Rule Familiarization |
|
$0.00 |
$151.78 |
$162.36 |
$314.14 |
Compliance Determination |
|
$0.00 |
$82.05 |
$0.00 |
$82.05 |
Form Completion |
|
$0.00 |
$780.87 |
$164.81 |
$945.68 |
Typical Average Unit Cost per Firm in Start-Up Period 5 |
|
|
|
|
$1,341.87 |
Recordkeeping |
|
$4.21 |
$0.00 |
$0.00 |
$4.21 |
TOTAL, Typical Average Unit Cost per Firm 5 |
|
|
|
|
$1,346.08 |
Annual Forward-looking Period |
|
|
|
|
|
Rule Familiarization |
|
N/A |
N/A |
N/A |
|
Compliance Determination |
|
$0.00 |
$82.05 |
$0.00 |
$82.05 |
Form Completion |
|
$0.00 |
$288.42 |
$164.81 |
$453.23 |
Average Unit Cost per Firm in Annual Forward-looking Period 5 |
|
|
|
|
$535.28 |
Recordkeeping |
|
$4.21 |
$0.00 |
$0.00 |
$4.21 |
TOTAL, Average Annual Forward-looking Unit Cost per Firm 5 |
|
|
|
|
$539.49 |
General Note |
|||||
Sources for Unit Burden estimates are drawn from various Economic Analyses and ICR Supporting Statements. Additionally Agency BPJ was employed to finalize results. For further detail, see Section 4.6 of Burden and Cost Report for the Proposed Rule: TSCA Inventory Notification Requirements (EPA, 2016). |
|||||
|
|||||
Footnotes |
|||||
1 New CDX registrations and e-signatures are expected due to: (1) firms that have not had experience with CDX, and (2) personnel turnover in firms that have experience with CDX. |
|||||
2 The composite of 0.083 hours, or about 5 minutes reported here is the result of that assessment that providing CBI chemical identity and chemical name (accession number plus generic name) requires 0.083 hours, and that providing non-CBI chemical identity and chemical name (CASRN and TSCA Inventory name) requires 0.083 hours. See Appendix B for further detail and reference. Also note that about 3% of CDR 2012 chemicals are reported as having CBI chemical identities (EPA, 2014b). |
|||||
3 This unit burden is assumed to apply to only 3% of submissions, given that 3% of CDR 2012 chemicals are reported as having CBI chemical identities (EPA, 2014b). Therefore the value shown in the table reflects 3% of the full value associated with the unit burden per chemical reported in the Burden and Cost Report for the Proposed Rule: TSCA Inventory Notification Requirements (EPA, 2016) at 1.160 hours of technical labor; 0.610 hours of managerial labor. The estimate per chemical in this table is considered to be overstated because upfront substantiation is only applicable to certain submissions during the Annual Forward-looking period. 4 This unit burden is assumed to apply to 50% of submissions, the assumed incidence rate for submissions in which the connection between the chemical identity and the company information, date range, etc. is claimed to be confidential. Therefore, the value shown in the table reflects 50% of the full value associated with the unit burden per chemical reported in the Burden and Cost Report for the Proposed Rule: TSCA Inventory Notification Requirements (EPA, 2016) at 0.800 hours of technical labor; 0.400 hours of managerial labor. |
|||||
5 An average firm is expected to report seven chemicals per submission, as similarly observed for CDR 2012 as chemicals per site reported (Ballard, 2014). |
|||||
The implementation of EPA capacity to receive and process NOAs will involve new costs in the Start-Up year and on a Forward-looking basis. EPA will implement new software and integration with CDX to facilitate form submission and processing. Additionally, the CISS database must be expanded to incorporate the new type of submission. Last, new tasks will be added to manage NOA submissions and take care of routine TSCA inventory maintenance.
Forward-looking new agency costs associated with the information collection are associated with the following tasks:
Reviewing NOA submissions;
Analyzing submissions for confidentiality and providing appropriate protection for confidential data;
Acknowledging receipt of submissions and notifying respondents of any submission errors or deficiencies;
Filing and storage of submissions to Agency data systems;
Updating the TSCA Inventory based on notices received;
Providing technical assistance to respondents; and
Conducting site and record inspections and performing related compliance monitoring functions.
Estimates of Agency labor required to complete Start-Up and Forward-looking tasks are discussed in Section 4.6 of the Burden and Cost Report for the Proposed Rule: TSCA Inventory Notification Requirements (EPA, 2016). Agency burden is combined with wage data in Table 5. to estimate Agency cost, as shown in Table 6
Table 5. Agency Wage Rate (2016 Dollars)
Labor Category |
Data Source for Wage Information |
Wage ($/hour) |
Fringe Benefit |
Fringes as % wage |
Overhead as % wage |
Fringe + Overhead Factor c |
Loaded Wage ($/hr) |
(a) |
(b) |
(c) = (b) / (a) |
(d) |
(e) = (c) + (d) + 1 |
(f) = (a) * (e) |
||
EPA staff |
Annual federal staff cost: OPM Washington-Baltimore-Northern Virginia, DC-MD-PA-VA-WV area, GS-13 Step 5 pay rates a |
$50.04 |
Included in 60% overhead |
N/A |
60% b |
1.6 |
$80.06 |
Footnotes a Source: Salaries & Wages for the locality of Washington-Baltimore-Arlington (OPM, 2016). b The 60 percent fringes-and-overhead rate is from Instructions for Preparing ICRs (EPA, 2009). c The inflation factor of “1” in the formula for calculating the fringe + overhead factor means wage data are not escalated to reflect inflation. |
|||||||
Table 6. Agency Burden and Cost for IT and Inventory Publication
Activity |
Burden |
Labor Cost |
Non-Labor Cost |
Total Cost (2016$) |
Start-Up Reporting Period |
|
|
|
|
CDX and CISS Expansion |
2 FTE |
$333,050 |
$185,000 |
$518,050 |
Management of NOA Submissions |
7.70 hours × 4,692 submissions |
$2,892,440 |
$0 |
$2,892,440 |
TSCA Inventory Setup |
2 FTE |
$333,050 |
$100,000 |
$433,050 |
TOTAL Start-Up Period Costs |
|
|
|
$3,843,540 |
Annual Forward-looking Reporting Period |
||||
CDX and CISS |
0.5 FTE |
$83,262 |
$10,000 |
$93,262 |
Management of NOA Submissions |
7.70 hours × 20 submissions |
$12,329 |
$0 |
$12,329 |
TSCA Inventory Maintenance |
0.5 FTE |
$83,262 |
$10,000 |
$93,262 |
TOTAL Annual Forward-looking Costs |
|
|
$198,853 |
|
General Notes |
||||
|
||||
|
||||
|
||||
Total industry burden and cost are estimated by combining industry unit burdens from Table 2 and industry unit costs from Table 4 with affected universe counts, as derived in the Burden and Cost Report for the Proposed Rule: TSCA Inventory Notification Requirements (EPA, 2016).2 Total burden and total costs are then aggregated for all firms in the affected universe. Total industry burden and cost are presented in Table 7.
Table 7. Total Industry Burden and Cost by Activity and Reporting Period
Reporting Group |
Unit Burden (Hours per Firm) |
Unit Costs (2015$) |
Rule Familiarization (Number of Firms) |
Submission Respondents (Number of Firms) |
Total Burden (Hours) |
Total Costs (2015$) |
PHASE I START-UP: RETROSPECTIVE REPORTING FOR MANUFACTURERS AND IMPORTERS (APPROXIMATELY JUN-DEC 2017) |
|
|
|
|||
Rule Familiarization |
4.000 |
$314.14 |
5,804 |
|
23,216 |
$1,823,269 |
Compliance Determination |
1.081 |
$82.05 |
|
4,227 |
4,569 |
$346,825 |
Form Completion |
12.319 |
$945.68 |
|
4,227 |
52,072 |
$3,997,389 |
Recordkeeping |
0.125 |
$4.21 |
|
4,227 |
528 |
$17,796 |
Total Phase I Start-Up 1 |
|
|
|
4,227 |
80,385 |
$6,185,279 |
PHASE II START-UP: RETROSPECTIVE REPORTING PERIOD FOR PROCESSORS (APPROXIMATELY JAN-JUN 2018) |
|
|
|
|
||
Group 1 – Additional Manufacturers and Importers Reporting (After Phase I) |
||||||
Rule Familiarization |
4.000 |
$314.14 |
365 |
|
1,460 |
$114,661 |
Compliance Determination |
1.081 |
$82.05 |
|
365 |
395 |
$29,948 |
Form Completion |
12.319 |
$945.68 |
|
365 |
4,496 |
$345,173 |
Recordkeeping |
0.125 |
$4.21 |
|
365 |
46 |
$1,537 |
Group 1 Subtotal 1 |
|
|
|
365 |
6,397 |
$491,319 |
Group 2 - Processors |
|
|
|
|
|
|
Rule Familiarization |
4.000 |
$314.14 |
161,550 |
|
646,200 |
$50,749,317 |
Compliance Determination |
0.583 |
$44.25 |
|
100 |
58 |
$4,425 |
Form Completion |
2.215 |
$171.92 |
|
100 |
222 |
$17,192 |
Recordkeeping |
0.125 |
$4.21 |
|
100 |
13 |
$421 |
Group 2 Subtotal 2 |
|
|
|
100 |
646,493 |
$50,771,355 |
Total Phase II Start-Up |
|
|
|
465 |
652,890 |
$51,262,674 |
CDX Registration and e-Signature (Phase I and II Combined) 3 |
0.530 |
$40.22 |
|
469 |
249 |
$18,863 |
TOTAL START-UP REPORTING |
|
|
|
4,692 |
733,524 |
$57,466,816 |
ANNUAL FORWARD-LOOKING REPORTING (APPROXIMATELY POST JUN 2018) |
|
|
|
|
|
|
Rule Familiarization |
N/A |
N/A |
|
|
|
|
Compliance Determination |
1.081 |
$82.05 |
|
20 |
22 |
$1,641 |
Form Completion |
5.831 |
$453.30 |
|
20 |
117 |
$9,065 |
Recordkeeping |
0.125 |
$4.21 |
|
20 |
3 |
$84 |
TOTAL ANNUAL FORWARD-LOOKING REPORTING 1 |
|
|
|
20 |
142 |
$10,790 |
General Note Total industry burden and cost are estimated by combining unit burdens (Table 2) and costs (Table 4) with estimates of the potentially affected universe (as determined in Section 3 and Table 2 of Burden and Cost Report for the Proposed Rule: TSCA Inventory Notification Requirements (EPA, 2016). |
||||||
|
||||||
Footnotes |
||||||
1 Assumes the average firm includes seven chemicals per submission, similar to characteristics of the general response universe, as observed in CDR 2012 in chemicals per site reported (Ballard, 2014). |
||||||
2 Assumes the average firm includes one chemical per submission, given the nature of the submission. |
||||||
3 Total reflects assumption that the number of CDX registrations is 10% of the count of affected firms in the Start-Up period. |
||||||
The following table displays the annual burden and costs borne by respondents and EPA associated with submitting and processing NOAs as a result of this information collection.
Table 8. Annual Burden and Cost of the TSCA Inventory Notification Requirements
|
Annual Burden Hours |
Annual Costs |
Industry |
||
Total Start-Up reporting (for one year) |
733,524 |
$57,466,816 |
Total Forward-looking reporting |
142 |
$10,790 |
Agency |
||
Total Start-Up reporting (for one year) |
44,448 |
$3,843,540 |
Total Forward-looking reporting |
2,234 |
$198,853 |
This is a new data collection activity resulting from the Frank R. Lautenberg Chemical Safety for the 21st Century Act, which requires additional responsibilities of EPA in maintaining the TSCA Inventory. As such, the change being implemented in this ICR period is the addition of new burden and cost, as presented in Table 8.
The industry burden for this collection of information is estimated to average 17.525 hours per typical response during the Start-Up year and 7.036 hours per response for annual Forward-looking Reporting. In both cases, the average submission by a firm contains seven chemicals. Burden is defined in 5 CFR 1320.3(b). An Agency may not conduct or sponsor such a request and a person or facility is not required to respond to a collection of information unless it displays a currently valid OMB control number. The OMB control numbers for EPA’s regulations in title 40 of the CFR, after appearing in the Federal Register, are listed in 40 CFR part 9 and included on the related collection instrument or form, if applicable.
The Agency has established a public docket for this ICR under Docket ID No. EPA-HQ-OPPT-2016-0426, which is available for online viewing at http://www.regulations.gov, or in-person viewing at the Pollution Prevention and Toxics Docket in EPA Docket Center (EPA/DC). EPA/DC Public Reading Room is located in the William Jefferson Clinton (WJC) West Building, Room 3334, 1301 Constitution Ave., N.W., Washington, DC. EPA/DC Public Reading Room is open from 8:30 a.m. to 4:30 p.m., Monday through Friday, excluding legal holidays. The telephone number for EPA/DC Public Reading Room is (202) 566-1744, and the telephone number for the Pollution Prevention and Toxics Docket is (202) 566-0280.
You may submit comments regarding the Agency's need for this information, the accuracy of the provided burden estimates and any suggested methods for minimizing respondent burden, including the use of automated collection techniques. Submit your comments, referencing Docket ID No. EPA-HQ-OPPT-2016-0426 and OMB Control No. 2070-New, to (1) EPA online using http://www.regulations.gov (our preferred method), or by mail to: Pollution Prevention and Toxics Docket, Environmental Protection Agency Docket Center (EPA/DC), Mailcode: 28221T, 1200 Pennsylvania Ave., N.W., Washington, DC 20460, and (2) OMB by mail to: Office of Information and Regulatory Affairs, Office of Management and Budget (OMB), Attention: Desk Officer for EPA, 725 17th Street, N.W., Washington, DC 20503.
Ballard, D. (2014). Email from Darryl Ballard to Laura Nielsen. January 13, 2014. ACE ITDS CDR Analysis, Revised.
BLS. (2016). Employer Costs for Employee Compensation Historical Supplementary Tables: December 2006 - June 2016. Retrieved from http://www.bls.gov/ncs/ect/sp/ecsuphst.pdf.
EPA. (2002). Revised Economic Analysis for the Amended Inventory Update Rule: Final Report. Retrieved from https://www.regulations.gov/document?D=EPA-HQ-OPPT-2014-0650-0011.
EPA. (2009). ICR Handbook: EPA's Guide to Writing Information Collection Requests under the Paperwork Reduction Act of 1995. Retrieved from https://www.pdffiller.com/10247637--ICR-Handbook---Environmental-Protection-Agency-.
EPA. (2014a). 2012 Chemical Data Reporting Results: Comparison between 2006 and 2012 submission periods, from https://www.epa.gov/chemical-data-reporting/2012-chemical-data-reporting-results#compare
EPA. (2014b). Chemical Data Reporting Fact Sheet: Chemicals Snapshot. Retrieved from https://www.epa.gov/sites/production/files/2014-11/documents/2nd_cdr_snapshot_5_19_14.pdf.
EPA. (2015). Supporting Statement for a Request for OMB Review under the Paperwork Reduction Act: Premanufacture Review Reporting and Exemption Requirements for New Chemical Substances and Significant New Use Reporting Requirements for Chemical Substances. Retrieved from http://www.regulations.gov/document?D=EPA-HQ-OPPT-2014-0735-0016.
EPA. (2016). Burden and Cost Report for the Proposed Rule: TSCA Inventory Notification Requirements.
OPM. (2016). Pay & Leave: Salaries & Wages: Salary Table 2016-DCB, from www.opm.gov/policy-data-oversight/pay-leave/salaries-wages/salary-tables/16Tables/html/DCB_h.aspx
Rice, C. (2002). Wage Rates for Economic Analysis of the Toxics Release Inventory Program. Retrieved from https://www.regulations.gov/document?D=EPA-HQ-OPPT-2014-0650-0005.
Williamson, T. (2016). Email from Tracy Williamson to Cody Rice and Laura Nielsen. October 26, 2016. RE: INV rule - internal resources.
ATTACHMENTS TO THE SUPPORTING STATEMENT
Attachments to the supporting statement are available in the public docket established for this ICR under docket identification number EPA-HQ-OPPT-2016-0426. These attachments are available for online viewing at www.regulations.gov or otherwise accessed as described in Section 6(f) of the supporting statement.
Attachment A: 15 U.S.C. 2607 - Section 8(b) of the Toxic Substances Control Act. Also available online at the U.S. House of Representatives’ U.S. Code website
Attachment B: 40 CFR part 710. Also available online at the National Archives and Records Administration’s Electronic CFR website
Attachment C: EPA Form XXXX – Notice of Activity Form A. Also available online at http://epa.gov/oppt/newchems/pubs/NOAA.htm
Attachment D: EPA Form XXXX - Notice of Activity Form B. Also available online at http://epa.gov/oppt/newchems/pubs/NOAB.pdf
Attachment E: Public Comments Received and EPA Responses
Attachment F: Copy of Consultations Message Sent by EPA to Potential Respondents
Attachment X: Instruction Manual for TSCA Section 8(b) Reporting. Also available online at http://www.epa.gov/oppt/newchems/pubs/tscaman2.pdf
1 Burden and Cost Report for the Proposed Rule: TSCA Inventory Notification Requirements, Docket No. EPA–HQ–OPPT–2016-0426
2 See Section 3 and Table 2 of the reference document. The number of firms is based on the number of firms in the affected universe that must undergo rule familiarization as well as the subgroup of those firms that actually submit responses to EPA.
| File Type | application/vnd.openxmlformats-officedocument.wordprocessingml.document |
| File Title | Supporting Statement for a Request for OMB Review under |
| Author | Flora Chow |
| File Modified | 0000-00-00 |
| File Created | 2021-01-23 |