Daily Rules, Proposed Rules, and Notices of the Federal Government
You may be affected by this action if you manufacture, import, or process chemical substances for commercial purposes that are subject to TSCA. Potentially affected entities may include, but are not limited to:
• Manufacturers, importers, and processors of chemical substances or mixtures (NAICS codes 325 and 324110, e.g., chemical manufacturing and processing and petroleum refineries).
This listing is not intended to be exhaustive, but rather provides a guide for readers regarding entities likely to be affected by this action. Other types of entities not listed in this unit could also be affected. The North American Industrial Classification System (NAICS) codes have been provided to assist you and others in determining whether this action might apply to certain entities. To determine whether you or your business may be affected by this action, you should carefully examine the applicability provisions in 40 CFR parts 700, 720, 721, 723, and 725 for TSCA section 5-related obligations. If you have any questions regarding the applicability of this action to a particular entity, consult the technical person listed under
EPA is issuing these amendments pursuant to TSCA section 5, 15 U.S.C. 2604. The amendments are to the TSCA Section 5 Premanufacture and Significant New Use Notification regulations and related provisions. This final rule was proposed in the
The Government Paperwork Elimination Act (GPEA) (Public Law 105-277 (44 U.S.C. 3504)) requires Federal agencies to provide for the:
1. Option of electronic maintenance, submission, or disclosure of information, when practicable as a substitute for paper.
2. Use and acceptance of electronic signatures, when practicable. EPA’s Cross-Media Electronic Reporting Regulation (CROMERR) (40 CFR part 3), published in the
In light of GPEA and CROMERR, EPA is issuing these amendments to require manufacturers (including importers) and processors of TSCA chemical substances to use the Internet, through EPA’s CDX, to submit TSCA section 5 notices and related documents to the Agency. These include PMNs (40 CFR part 720), Significant New Use Notices (SNUNs) (40 CFR part 721), Test Market Exemption Applications (TMEAs) (40 CFR part 720), Low Volume Exemption notices (LVEs) (40 CFR 723.50), Low Exposure/Low Release Exemption (LoRex) notices (40 CFR 723.50), biotechnology notices for genetically modified microorganisms (40 CFR part 725), Notices of Commencement of Manufacture or Import (NOCs) (40 CFR 720.102), and other support documents (e.g., correspondence, requests for suspensions of the notice review period, amendments, and test data).
The Agency is introducing CDX reporting in three phases over a 2-year period. During the first year following the effective date of this final rule, the Agency will allow submissions via CDX, optical disc (CD or DVD), and paper. Regardless of the method of submission, EPA will require that all submissions be generated using the new electronic-PMN (e-PMN) software. One year after the effective date of this final rule, paper submissions will no longer be accepted for any new notices and support documents (including NOCs), though optical discs may continue to be used. Two years after the effective date of this final rule, optical discs will no longer be accepted, and all submitters must submit the notices and support documents identified in Table 1 of Unit III.I. via CDX. The phased approach allows submitters to gain experience in using the e-PMN software and the submission delivery system.
EPA is also amending the TSCA section 5 User Fee regulations at 40 CFR 700.45 to add a new User Fee Payment Identity Number field to the PMN form. This new field will enable the Agency to more easily match a particular user fee with its notice submission. The second new information element on the amended PMN form will be optional and consist simply of the e-mail address for the Authorized Official (AO) submitting the notice listed on the “Submitter Identification” section on page 3 of the PMN form. EPA is also removing the required Agent signature block field on page 2 of the form.
Section 5(a)(1)(A) of TSCA requires persons to notify EPA at least 90 days before manufacturing a new chemical substance for commercial purposes (under TSCA manufacture includes import). Section 3(9) of TSCA defines a “new chemical substance” as any substance that is not on the TSCA Inventory of Chemical Substances compiled by EPA under section 8(b) of TSCA. Section 5(a)(2) of TSCA authorizes EPA to determine that a use of a chemical substance is a “significant new use.” EPA must make this determination by rule after considering all relevant factors, including those listed in TSCA section 5(a)(2). Once EPA determines that a use of a chemical substance is a significant new use, TSCA section 5(a)(1)(B) requires persons to submit a notice to EPA at least 90 days before manufacturing or processing the chemical substance for that use. GPEA requires Federal agencies to provide for the:
1. Option of electronic maintenance, submission, or disclosure of information, when practicable as a substitute for paper.
2. Use and acceptance of electronic signatures, when practicable.
Currently, TSCA section 5 submissions must be sent to EPA on paper through the U.S. mail or delivered by courier. Submitters are able to use electronic means to generate hard copies for certain TSCA section 5 notices, using the PMN form available on EPA's TSCA New Chemicals Program website (
If the submitter marks anything on the PMN form as CBI, then the submitter must submit one version of the form containing the CBI and another version of the form without CBI. The latter version is referred to as the sanitized or non-CBI version and is required for the public docket.
Upon receipt at EPA, paper submissions are assigned a “mail received” number, which is used to identify the submission until an official document control number (DCN) is generated, which does not occur until EPA verifies that the notice is complete. Once the mail information is captured, the submission is sent for prescreening. During prescreening, the submission is checked for completeness using criteria listed at 40 CFR 720.65. If the notice does not pass prescreening, EPA declares the original notice “Incomplete” and notifies the submitter that information is missing or incorrect, and that the submitter must correct the package and provide a new submission to EPA. If a new notice is not submitted, EPA will return the user fee.
After a successful prescreening, EPA generates a DCN and barcode for the submission. EPA also generates a DCN and barcode for the non-CBI version of a CBI submission and places the non-CBI version in the public docket. The original CBI submission is then kept in a hard copy case file folder in a TSCA CBI storage area for reference. Any supporting documents for the CBI submission are also assigned DCNs and barcodes, and placed in the hard copy case file folder.
This unit provides a detailed description of EPA’s electronic reporting software, the changes to the reporting process, the benefits of electronic reporting to both industry and EPA, and how EPA is phasing-in the electronic reporting.
EPA’s CDX is the point of entry on the Environmental Information Exchange Network (Exchange Network) for environmental data submissions to the Agency. CDX provides the capability for submitters to access their data through the use of web services. CDX enables EPA and participating program offices to work with stakeholders-including State, tribal, and local governments and regulated industries-to enable streamlined electronic submission of data via the Internet. For more information about CDX, go to
EPA has developed e-PMN software for use in preparing and submitting PMNs and other TSCA section 5 notices and support documents electronically to the Agency. EPA is providing two different variations of the e-PMN software, one with encryption and one without encryption. The e-PMN software with encryption, available on EPA’s CDX website (
The e-PMN software works with Windows, Macs, Linux, and UNIX-based computers, using Extensible Markup Language (XML) specifications for more efficient data transmittal across the Internet. The e-PMN software operates using the Java 6 programming language, which can be downloaded free from
The e-PMN software includes features intended to be helpful for preparing PMNs and other notices using the PMN form, such as SNUNs. A validation mechanism alerts users when a field on the form, required by regulation, is either missing information or contains certain kinds of potentially incorrect information. For example, if “use” information is claimed CBI, then the e-PMN software indicates that the form is not complete unless the submitter has provided both specific use information on the CBI version of the form and generic use information on the non-CBI version of the form. The e-PMN software includes header pages for biotechnology notices (i.e., Microbial Commercial Activity Notices (MCANs), TSCA Experimental Release Applications (TERAs), TMEAs, and Tier I or Tier II Exemption Requests), support documents, and attachments—any document not submitted on the PMN form itself—that identify submitters and the nature of their communications.
Guidance documents developed by EPA for TSCA section 8(a) Inventory Update Rule (IUR) reporting via CDX are available at
The change to phase-out paper-based submissions in favor of CDX reporting, including use of the e-PMN reporting software, is in concert with broader government efforts to move to modern, electronic methods of information gathering. The use of CDX for submission of TSCA section 5 notices and support documents is consistent with GPEA, that requires Federal agencies to provide for the:
1. Option of electronic maintenance, submission, or disclosure of information, when practicable as a substitute for paper.
2. Use and acceptance of electronic signatures, when practicable.
The e-PMN software and electronic submission via CDX will change the way that companies interact with the Agency regarding many TSCA section 5 submissions. Companies will register with EPA to submit their data electronically to the Agency via CDX and the Agency will benefit from
Agency personnel will also be able to communicate more efficiently with submitters electronically, compared to using U.S. mail or courier services. PMN electronic reporting software allows for more efficient data transmittal, and the software’s validation mechanism should help industry users submit fewer incomplete notices, which ultimately will save EPA and industry processing resources and reduce transaction times. EPA believes the adoption of electronic communications will reduce the reporting burden on industry by reducing both the cost and the time required to review, edit, and transmit data to the Agency (See Unit V. for more detail.). It also will allow submitters to share a draft notice within the 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, will also allow for certain information to be kept on file by the submitter to avoid re-entering the same information into a new form.
Please note that although submitters will be able to communicate to EPA via CDX after the effective date of this final rule, the capacity will not initially be available for EPA to communicate back to submitters via CDX at the time this final rule becomes effective (except for e-mails related to CDX registration and copy of record notifications). Two examples of routine communications from EPA that are planned to be sent via CDX rather than the U.S. mail are the “Acknowledgement Letter” (acknowledging receipt of a notice) and the “Incomplete Letter” (stating why a notice has been declared incomplete by EPA). EPA will continue sending these letters by paper until approximately 1 year after the effective date of this final rule. EPA will issue a document in the
All information sent by the submitter via CDX will be transmitted securely to protect CBI. Furthermore, if anything in the submission has been claimed CBI, a non-CBI copy of the notice must be provided by the submitter. The new e-PMN software will facilitate the creation of this non-CBI version, eliminating the need for the submitter to do this manually.
EPA is amending the PMN form in order to collect two new information elements. First, 40 CFR part 700 requires submitters to pay a fee when they submit PMNs, MCANs, certain PMN exemption application notices, and SNUNs to the Agency. The amended PMN form will include a new User Fee Payment Identity Number field to enable the Agency to match more easily a particular user fee with a particular notice submission. A User Fee Payment Identity Number will be required and may be a check number, a wire transfer number, or a “Pay.gov” transaction number used to transmit the user fee electronically. The second new information element on the amended PMN form will be optional and consist simply of the e-mail addresses for the AO or AOs listed on the Submitter Identification section on page 3 of the PMN form. The e-mail address will enable the Agency to contact the submitter through e-mail, facilitating communications related to the submission.
EPA is also removing the required Agent signature block field on page 2 of the PMN form. On the existing PMN form, if a manufacturer/importer subject to the notice requirements in 40 CFR part 720 designates an agent to submit the form pursuant to 40 CFR 720.40(e), both the manufacturer/importer and the agent must sign the form. EPA is removing the requirement that agents sign the PMN form because few agents have submitted forms in the past, and the Agent signature block is rarely used by the Agency. Eliminating the second signature also simplifies development of the e-PMN form. Note that a form submitted by an agent will still have to be signed by the manufacturer/importer’s AO (an electronic signature if submitted via CDX), and the agent’s name and contact information will still be provided on page 3 of the PMN form. The AO remains responsible for false or misleading statements in the notice.
The e-PMN software will allow users to print paper copies for internal company use. The printed version of the amended e-PMN form will have the same general look of the current paper PMN form, i.e., containing the same fields (with the modifications to the form discussed in Unit III.D.) and the same pagination. However, fields have been expanded to make more room for submitter information, resulting in a larger total number of pages, and realigned to make the form easier to scan. Persons who choose to submit PMNs on paper during the first year after the effective date of this final rule will be required to use the new e-PMN software to generate the paper form for each PMN or other TSCA section 5 notices they submit. EPA is requiring use of the new paper form because the Agency has incorporated into the form many scanning efficiencies for the electronic capturing of data that will be lost if a blank PMN form is printed, photocopied, and used for another submission.
In order to submit TSCA section 5 notices via the Internet, submitters will have to register with EPA’s CDX and use the e-PMN software to prepare a data file for submission through CDX.
EPA has established a 90-day time-frame between the publication date and effective date of this final rule. Companies can use this time to register with CDX so they are prepared to submit notices to EPA via CDX on the effective date of this final rule.
The e-PMN software guides users through the process of creating a PMN submission on their computers. Once a user completes the relevant data entry, the software will validate the submission by performing basic error checks and making sure all the required fields are completed, allow the user to create and save the submission for company records, and prompt users to choose a submission method.
In order to submit electronically to EPA via CDX, submitters of all TSCA section 5 documents must first register with CDX. One must register either as:
1. An AO of a company who can send all types of TSCA section 5 documents to EPA via CDX or
2. Someone authorized by the AO to send TSCA section 5 supporting documents to EPA via CDX. Note, however, that AOs are the only persons allowed to send TSCA section 5 notices and Letters of Support to EPA via CDX.
There are two ways that joint submissions can be submitted to EPA via CDX. The first way is for each joint submitter to fill out his or her portion of the submission in separate notice forms. These forms are linked to each other within EPA via a common identifying number—a “TS” number (See regulatory text language in 40 CFR 700.45(e)(3).)—which both companies are required to develop together and put on their respective forms. The second way is for one of the joint submitters to provide supporting information in a Letter of Support. Both will require the AOs of the joint submitting companies to register in order to submit to EPA via CDX.
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 AO agrees to certain CDX security conditions. On the “Verification of Company Authorizing Official” form, the AO designates himself or 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 Section 5 Notice Support 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 described in Unit III.F. are received, EPA activates the submitter’s registration in CDX and sends him or her an e-mail notification. Submitters will need to complete and sign these forms only once.
Yes. EPA will ensure secure transmission of PMN data sent from the user’s desktop through the Internet via the Transport Layer Security (TLS) 1.0 protocol. TLS 1.0 is a widely used approach for securing Internet transactions, and is endorsed by the National Institute of Standards and Technology (NIST) for protecting data sent over the Internet. See NIST Special Publication 800-52, “Guidelines for the Selection and Use of Transport Layer Security (TLS) Implementations,”
In addition, e-PMN software supports EPA’s CROMERR requirements, as described under 40 CFR part 3, by enabling the submitter to electronically sign, encrypt, and submit submissions which EPA subsequently provides back to the submitter as an unaltered copy of record. This assures the submitter that the Agency has received exactly what the submitter sent to EPA. The current version of the e-PMN encrypts using Federal Information Processing Standards (FIPS)-validated RSA BSAFE Crypto-J. EPA may incorporate other encryption modules into future versions of e-PMN. Information submitted via CDX is processed within EPA by secure systems certified for compliance with FIPS.
Yes. EPA is providing two different variations of the e-PMN software, one with encryption and one without encryption. The e-PMN software with encryption, available on EPA’s CDX website (
The e-PMN software without encryption, available through EPA's TSCA New Chemicals Program website (
The e-PMN software, both with and without encryption, produce identical e-PMN files; however, only by registering through CDX can the e-PMN software with encryption (containing the application program interface to encrypt submissions) be downloaded and used for sending files to EPA via CDX. Users of the e-PMN software without encryption do not have to register with CDX. The e-PMN software without encryption can be used to create a paper PMN form for submission during the first year after the effective date of this final rule, or to create a PMN file that
The variations of the e-PMN software, both with and without encryption, are accessible through EPA's TSCA New Chemicals Program website (
If and when EPA makes changes to the e-PMN software, an automatic download of the updated software will be triggered when a submitter opens their existing variation of the software (i.e., the with and without encryption variations). Submitters will then be required to validate their submissions with this new version before submitting to EPA. e-PMN software installed from optical discs will not automatically be updated with new versions of the software. However, EPA will keep a list of all submitters that request optical discs. If major revisions to the software are made during the first two years after the effective date of the final rule, EPA will notify these submitters of the availability of the updated software.
Yes. On the effective date of this final rule, submitters must use the e-PMN software to generate TSCA section 5 notices, NOCs, and support documents regardless of whether they are submitted via CDX, on optical disc, or in paper form (40 CFR part 720.3 defines “support documents” as materials and information submitted to EPA in support of a TSCA section 5 notice, including but not limited to, correspondence, amendments, and test data. The term “support documents” does not include orders under TSCA section 5(e) (either consent orders or orders imposed pursuant to TSCA section 5(e)(2)(B))). EPA will not accept paper submissions that use either the old version of the paper PMN form or the amended form filled in by hand or typewriter. The Agency will make available free Internet downloads or, upon request, optical discs that contain the version of e-PMN software lacking encryption. All e-PMN software users, regardless of how a document is submitted, must undergo a “finalization” step in generating a document. During the finalization step, the e-PMN software checks that all required fields contain information and provides warnings for certain kinds of missing, incomplete, or incorrect data. Notices submitted on paper or optical disc containing data which have not undergone finalization will be declared “Incomplete” by EPA. This step is necessary to allow for an accurate and efficient transfer of data from an optical disc or a paper form to the EPA data systems, and also enables the generation of a non-CBI version.
Anyone submitting the paper form generated using the e-PMN software must submit the notice to the Agency via U.S. mail or a courier service. The paper form must be hand signed on page 2. If the submitter makes any CBI claims, the original submission needs to include both the CBI version and a non-CBI version.
Optical discs must be submitted with an original hand-signed hard copy of page 2 (Certification page) and a hard copy of page 3 (a copy of page 3 is needed for contact information in the event that the optical disc is not readable). Optical discs must be delivered only by courier service, to avoid damage to the disk from the Agency’s mail screening equipment.
Certain TSCA section 5 notices such as LVE modifications, LoREX modifications, TMEAs, and biotechnology notices currently have no required or official forms. In order to allow for electronic and paper submission of these notices using the e-PMN software and CDX, the Agency is requiring the following:
1. For exemption modifications, submitters must use the e-PMN form by checking the “modification” box on page 1, filling in contact information on page 3, and including the previous exemption number and chemical identity information. A submitter may send a cover letter with the new revisions to the original exemption notice or the pertinent pages of the e-PMN form.
2. For a TMEA, the submitter will check the “TMEA” box on page 1 of the e-PMN form, and either fill out the form or attach a cover letter for the submission containing the information required by 40 CFR 720.38.
3. Biotechnology notices (Form 6300-07) will have their own menu option. Instead of selecting “Premanufacture Notice,” a submitter will select “Biotechnology,” which will prompt the software to present a header page to the submitter with choices of biotechnology notices, and space to fill in contact information. The information required by 40 CFR part 725 must be submitted as an attachment(s).
The notices listed in Unit III.I.1.-3. must undergo the “finalization” step (See Unit III.H.). An exemption submission on an optical disc must be accompanied by a complete signed hard copy of page 2 and a complete hard copy of page 3 of the e-PMN form for contact information in case the optical disc is not readable. The TMEA will only need a complete page 3. The optical discs for both types of submissions will need to be delivered by courier to the Agency to avoid damage to the optical disc from the Agency's mail screening equipment. If submitted by paper, the forms must be generated using the e-PMN software and sent to the Agency. For biotechnology notices, a signed hard copy of a biotechnology certification must accompany the optical disc. The printed form must follow the same procedures: Use the e-PMN software to generate a finalized “header” sheet with contact data, add an attachment with notice information, and include a signature page.
The submission process for completing the various notice and document types is summarized in Table 1 of this unit. After the effective date of this final rule, all of these notices must be prepared using the new e-PMN software.
Depending upon how a notice is submitted, the following submission requirements and delivery methods must be used:
The Agency is introducing electronic reporting in three phases. In the first phase, the Agency is allowing the submission of TSCA section 5 notices and support documents via CDX, on optical disc, and on paper. All submissions (whether submitted via CDX, on optical disc, or on paper) must be generated using the new e-PMN software.
In the second phase, occurring 1 year after the effective date of this final rule, paper submissions will no longer be accepted for any new notices and support documents (including NOCs). In the third phase, at the end of the second year after the effective date of this final rule, optical disc submissions for all new notices and support documents will no longer be accepted. Thereafter, EPA will accept TSCA section 5 notices and support documents only through CDX. TSCA section 5 notices and support documents not submitted in the appropriate manner as set forth in 40 CFR parts 720, 721, and 725 will be considered invalid by EPA and returned to the submitter.
Note that NOCs and support documents whose original notices were submitted before the effective date of this final rule will still need to be mailed as hard copy to the Agency. This is necessary because, although the notices received after implementation of the new system will be entered into the newly created EPA database, notices submitted before the effective date of this final rule will only exist in EPA’s “legacy” database, i.e., the database used prior to the effective date of this final rule, and so a subsequent support document will not be able to be linked up with its parent notice within EPA’s new database. The phase-in schedule for submissions is displayed in Table 2 of this unit.
No. After careful consideration, the Agency has concluded that the overall benefits from everyone using the e-PMN software and submission through CDX exceed those associated with maintaining a multi-optioned reporting approach (Ref. 3). The Agency recognizes that there is the potential for costs and burden associated with predictable or unanticipated technical difficulties in electronic filing or with conversion to an electronic CDX reporting format. However, EPA expects that reduced reporting costs to submitters will ultimately exceed the transition costs and that any transition difficulties will be mitigated by:
1. The phase-in periods.
2. EPA’s planned outreach and training sessions prior to the effective date of this final rule. The Agency has allowed ample time between the date of publication and the effective date of this final rule for submitters to install and become proficient with the e-PMN software.
3. EPA’s technical support following the effective date of this final rule.
At this time, the Agency does not have electronic reporting capability for all TSCA section 5-related notices (i.e.,
The Agency received comments from three persons on the proposed rule. Copies of all comments received are available in the public docket for this action. The comments received on the proposed rule did not result in EPA making significant changes to the final rule. A discussion of the comments germane to the rulemaking and the Agency’s responses follow:
• Whether the proposed 2-year phase-in period following the effective date of the final rule, during which time paper and/or optical disc submissions would be accepted, is reasonable or necessary to allow sufficient time to transition to the new Internet-based method.
• Did industry have information that could further inform EPA’s estimate regarding burden. For example, EPA asked whether submitters intended on submitting notices via CDX as soon as it becomes available, or if not, when during the 2-year phase-in period would they expect to begin using CDX?
The public comments overwhelmingly supported the 2-year phase-in period following the effective date of the final rule. Commenters agreed that the 2-year phase-in period is reasonable and necessary to allow sufficient time for transition to the new electronic reporting method.
Although, EPA did not receive any comments directly related to its burden estimate, EPA did receive positive feedback on the proposed electronic submittal system. Commenters strongly supported the Agency’s effort to move to electronic methods of information gathering. Commenters agreed with the Agency’s statements that this change will allow for more effective and efficient reviews of TSCA section 5 notices and that the changes will improve communication with submitters. One commenter appreciated aspects of the e-PMN software such as the ability of the e-PMN software to check for completeness of a PMN submission and create non-CBI versions of notices. Another commenter was pleased to see the addition of the new User Fee Payment Identity Number field to track payments.
• Registered in CDX.
• Authorized by the AO in CDX to submit documents onthe client’s behalf.
EPA will be using a two-tiered approach for registration and submission of PMNs. The first tier is the company AO, who, for the purposes of EPA’s CROMERR and this final rule, is the person who certifies and signs the notice. The second tier will be comprised of persons designated and authorized by the company’s AO to submit supporting documents.
The AO has the ability to submit all documents on the company’s behalf via CDX. During CDX registration, all AOs will be required to fill out two forms: The “Electronic Signature Agreement” form in which the AO agrees to certain CDX security conditions and the “Verification of Company Authorizing Official” form in which the AO designates himself or 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. This form is entitled, “Authorization and Verification for Section 5 Notice Support 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 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. Note, that a client, or company, can have multiple AO’s.
The approach described in Unit IV.4. was discussed in the preamble of the proposed rule. To clarify the different responsibilities of the AO and persons designated to submit support documents on the AO’s behalf, EPA has added regulatory text at 40 CFR 720.40(e)(3)(i) and (ii).
The Agency’s evaluation of the economic impact of this final rule is present in a document entitled “Economic Analysis of the Amendments to TSCA Section 5 Premanufacture and Significant New Use Notification Requirements Final Rule” (Ref. 3), a copy of which is available in the docket and is briefly summarized in this unit. EPA estimates
In its economic analysis for the final rule (Ref. 3), EPA estimated cost and burden savings at the industry level, at the individual company level, and on a per-form basis. Estimates presented in this unit are for all TSCA section 5 notices; estimates for PMNs separately can be found in the economic analysis.
At the industry level for all TSCA section 5 notices, EPA estimates a net total burden decrease of 14,972 hours in the first year of the final rule, 15,700 hours in the second year of the final rule, and 16,178 hours in the third year of the final rule. Industry savings are estimated at 16,187 hours per year for subsequent years of the final rule. At the company level for all TSCA section 5 notices, EPA estimates an average net total burden decrease of 50.4 hours in the first year of the final rule, 51.2 hours in the second and third years of the final rule, and 50.4 hours per year for subsequent years of the final rule.
At the industry level for all TSCA section 5 notices, EPA estimates a net cost savings of $379,271 in the first year of the final rule, $424,863 in the second year of the final rule, and $457,066 in the third year of the final rule. Industry savings are estimated at $457,628 per year for subsequent years of the final rule. When taking into account the lower total number of TSCA section 5 notices expected during this 3-year Information Collection Request (ICR) period in addition to savings attributable to the final rule, the average annual reduction in industry costs is $5.7 million. At the company level for all TSCA section 5 notices, EPA estimates an average cost savings of $1,352 in the first year of the final rule, $1,396 in the second and third years of the final rule, and $1,352 in subsequent years of the final rule.
EPA estimates that the Agency also will experience a reduction in both burden and cost to administer the TSCA section 5 premanufacture notification program as a result of the final rule. Specifically, EPA expects to experience a net burden reduction of 4,521 hours in the first year of the final rule, a reduction of 9,042 hours in the second year of the final rule, and a reduction of 13,563 hours in the third and subsequent years of the final rule. The Agency expects to experience a net savings of $214,377 in the first year of the final rule, a net savings of $586,108 in the second year of the final rule, and a net savings of $1,057,838 in the third and subsequent years of the final rule.
EPA recognizes that information and feedback received during the 2-year phase-in period, along with experience gained during this phase-in period, can be used to further improve the use of the new Internet-based reporting mechanism. This information will also inform the Agency’s estimates, which will be reflected in the ICR, which EPA must complete every 3 years under the Paperwork Reduction Act (PRA), 44 U.S.C. 3501
The following is a listing of the documents referenced in this preamble that have been placed in the public docket for this final rule under docket ID number EPA-HQ-OPPT-2008-0296, which is available for inspection as specified under
1. EPA. TSCA Section 5 Premanufacture and Significant New Use Notification Electronic Reporting; Revisions to Notification Regulations; Proposed Rule.
2. EPA. Cross-Media Electronic Reporting; Final Rule.
3. EPA. Economic and Policy Analysis Branch, Office of Pollution Prevention and Toxics (OPPT). Economic Analysis of the Amendments to TSCA Section 5 Premanufacture and Significant New Use Notification Requirements Final Rule. July 13, 2009.
4. EPA. Regulatory Impacts Branch, OPPT. Regulatory Impact Analysis of Amendments to Regulations for TSCA Section 5 Premanufacture Notifications. September 9, 1994.
5. EPA. Supporting Statement for a Request for OMB Review Under The Paperwork Reduction Act. Information Collection Request (ICR): New Information Collection Activities Related to Electronic Submission of Certain TSCA Section 5 Notices EPA ICR No. 2327.02. OMB Control No. 2070-0173.
This action is not a “significant regulatory action” under the terms of Executive Order 12866, entitled
The information collection requirements contained in this final rule have been submitted for OMB approval under the Paperwork Reduction Act (PRA), 44 U.S.C. 3501
This rule-related ICR covers amendments to existing reporting and recordkeeping programs that are approved under OMB control numbers 2070-0012 and 2