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Supporting Statement for a Request for OMB Review under

The Paperwork Reduction Act

1 IDENTIFICATION OF THE INFORMATION COLLECTION

1(a) Title of the Information Collection

TITLE: Premanufacture Review Reporting and Exemption Requirements for 

New Chemical Substances and Significant New Use Reporting 

Requirements for Chemical Substances

EPA ICR No: 0574.17 OMB Control No.: 2070-0012

1(b) Short Characterization

This information collection request addresses the TSCA section 5 reporting and 

recordkeeping requirements associated with the new chemicals review and regulatory program, 

as briefly outlined below.

The Environmental Protection Agency (EPA) administers the New Chemicals Program 

under section 5 of the Toxic Substances Control Act (TSCA) (see Attachment A). TSCA section 

5 requires that any person who proposes to manufacture (which includes import) a “new 

chemical” (i.e., a chemical not listed on the TSCA section 8(b) Inventory) must provide a 

premanufacture notice (PMN) or an exemption application to EPA at least 90 days prior to 

commencing manufacture of that chemical. EPA considers certain genetically engineered 

microorganisms to be chemical substances for purposes of the notification requirements found in 

TSCA section 5; the 90-day notice for microorganisms is a Microbial Commercial Activity 

Notice (MCAN).

Under TSCA section 5, EPA is authorized to determine that a use of a chemical substance 

is a significant new use and promulgate a significant new use rule (SNUR). In certain instances, 

persons may opt to pursue that use, in which case they must submit a notice and undergo a 

review. For such circumstances, TSCA section 5 requires a significant new use notice (SNUN) 

from any person who proposes to manufacture or process a chemical for a use that is determined 

by EPA to be a “significant new use.” Note that the scope of this ICR does not include reporting 

of estimates for respondent activities associated with SNURs, except for instances in which a 

SNUN is submitted. For more information on new and existing chemical SNURs, see a recent 

EPA Economic Analysis for new chemical SNURs issued under 40 CFR 721 Subpart D 

expedited process1and the Supporting Statement for “TSCA Section 5(a)(2) Significant New 

Use Rules for Existing Chemicals Information Collection Request”

2

Furthermore, TSCA section 5 authorizes EPA to regulate the manufacture, processing, 

distribution in commerce, use or disposal of new chemical substances. Using the PMN or MCAN

information submitted to the Agency, EPA evaluates the health and environmental effects of new 

 

1 Economic Analysis for the Significant New Use Rule on Certain Chemical Substances, Docket No. EPA–HQ–

OPPT–2015–0220.

2 EPA ICR No. 1188.11 OMB Control No. 2070-0038.
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chemical substances. On the basis of its review, EPA may take regulatory action with respect to 

the manufacture of a new chemical substance or with respect to a substance’s proposed new use

to ensure adequate protection of human health and the environment. If EPA takes no action 

within the 90-day review period for PMNs (or 30 or 45 days for PMN exemption applications), 

the PMN submitter is free to manufacture (which includes import) the new substance, or to 

manufacture or process the substance for a new use. EPA requires that the submitter of a PMN or 

MCAN inform EPA when non-exempt commercial manufacture of the substance in question 

actually begins by submitting a Notice of Commencement (see Attachment I).

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 EPA 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 EPA 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), Test Market Exemption 

Applications (TMEAs) (40 CFR 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 725), Notices of 

Commencement of Manufacture or Import (NOCs) (40 CFR 720.102) and other support 

documents (e.g., correspondence, amendments and test data) (see Attachments C, D, E and F).

The Agency 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, EPA 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. Note that the final 

CDX and e-PMN software amendments to the PMN notification requirements in 40 CFR 720 
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also apply to the SNUN requirements in 40 CFR 721.25(a). 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) form, 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 EPA under 723.50. These changes (to be effective on January 19, 

2016) are intended to further streamline and reduce the administrative costs and burdens of 

TSCA section 5 notifications for both industry and EPA.

2 NEED FOR AND USE OF THE COLLECTION

2(a) Need/Authority for the Collection

TSCA section 5(a)(1), 15 U.S.C. 2604, requires manufacturers (which includes 

importers) of new chemical substances to submit to the Administrator of EPA a premanufacture 

notice (PMN) of intent to manufacture a new chemical substance at least 90 days before 

manufacture begins. TSCA section 5(a)(1) also requires notification from any person who 

proposes to manufacture or process a chemical substance for a use that EPA has by rule (i.e, a 

SNUR) determined to be a significant new use. The notice must include, insofar as known to or 

is reasonably ascertainable by the submitter, information described in TSCA section 8(a)(2) (e.g., 

chemical identity, use and exposure data), plus test data and descriptions of other data related to 

the effects on health and the environment of the manufacture, processing, use, distribution in 

commerce and disposal of the new chemical substance. EPA reviews the information to evaluate 

the health and environmental effects of the new chemical substance. On the basis of the review, 

EPA can take further regulatory action under TSCA sections 5(e) and 5(f), if warranted, to 

ensure adequate protection of human health and the environment. If EPA takes no action at the 

end of 90 days, the submitter is free to manufacture the new chemical substance.

TSCA section 5, as interpreted in EPA’s Microbial Products of Biotechnology; Final 

Regulation under the Toxic Substances Control Act; final rule published at 62 FR 17910 (April 

11, 1997), authorizes EPA to regulate “new” genetically engineered microorganisms. According 

to the 1997 final rule, “new” microorganisms are those that, through deliberate human 

intervention, contain genetic material from dissimilar source organisms. Specifically, 

“intergeneric microorganisms” are those formed by either the deliberate combination of genetic 

material from organisms classified in different taxonomic genera or constructed with synthetic 

genes that are not identical in DNA that would be derived from the same genus as the recipient 

microorganism. Manufacturers of these new microorganisms must submit to EPA a microbial 

commercial activity notice (MCAN) at least 90 days before manufacturing begins. These 

microorganisms are subject to the same potential regulatory controls as new chemical 

substances.

TSCA section 5(d)(1)(B) requires premanufacture notices to include all test data in the 

submitter’s possession or control and TSCA section 5(d)(1)(C) requires PMN submitters to 
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provide other data on environmental or health effects that are known to or reasonably 

ascertainable by the submitter. These requirements are described in 40 CFR 720.50.

TSCA section 5(e) authorizes EPA to regulate the manufacture, processing, distribution 

in commerce, use or disposal of a new substance pending development of data sufficient to 

evaluate the health and environmental effects of the substance. EPA may take action under 

TSCA section 5(e) if the Agency determines that the information available is insufficient to 

evaluate the substance and that the substance either (1) may present an unreasonable risk of 

injury to health or the environment or (2) will be produced in substantial quantities and may be 

released to the environment in substantial quantities or there may be significant or substantial 

human exposure to the chemical. EPA’s actions often involve negotiation of a TSCA section 5(e) 

Consent Order to prohibit or limit activities associated with manufacture, processing, distribution 

in commerce, use and disposal of the new chemical. TSCA section 5(e) Consent Orders can 

typically include requirements for exposure or release mitigation, testing, labeling and hazard 

communication, and recordkeeping.

3

Significant New Use Rules (SNURs) are authorized under TSCA section 5(a)(2). 

Regulations providing details on EPA’s SNUR authority were promulgated at 40 CFR part 721 

on July 27, 1989 and at 40 CFR part 725 subparts H-K on April 11, 1997. Because TSCA section 

5(e) Consent Orders are only binding on the original PMN submitter that manufactured the 

substance, EPA may promulgate a SNUR under TSCA section 5(a)(2) that mimics the Consent 

Order to bind all other manufacturers and processors of former new chemicals to the terms and 

conditions contained in the Consent Order. EPA also uses this authority to take follow up action 

on new or existing chemicals that may not present an unreasonable risk in their original uses but 

may present an unreasonable risk should other uses occur that may result in different and/or 

higher exposures to human beings or the environment. EPA determines that a new use is 

significant by examining the specific circumstances of each case.

A SNUR requires notification to EPA of proposed new uses, provides EPA an 

opportunity to review the proposed new use and, if necessary, regulate the activity before it 

occurs. Once a use is determined to be a “significant new use,” a person must submit a 

Significant New Use Notice (SNUN) to EPA at least 90 days before that person may

manufacture or process a chemical substance for that use. The same reporting requirements that 

apply to PMNs also apply to SNUNs, and EPA has the same authorities under TSCA section 5(e) 

and 5(f) to regulate the SNUR chemical during the notice review period.

A SNUR requires notification to EPA of proposed new uses, provides EPA an 

opportunity to review the proposed new use and, if necessary, regulate the activity before it 

occurs. Once a use is determined to be a “significant new use,” a person choosing this 

compliance option must submit a Significant New Use Notice (SNUN) to EPA at least 90 days 

before that person may manufacture or process a chemical substance for that use. The same 

reporting requirements that apply to PMNs also apply to SNUNs, and EPA has the same 

authorities under TSCA section 5(e) and 5(f) to regulate the SNUR chemical during the notice 

 

3 Additionally, under TSCA section 5(f), EPA may regulate a new chemical substance if there is a reasonable basis 

to conclude that the manufacture, processing, distribution in commerce, use or disposal of the new substance will 

present an unreasonable risk of injury to health or the environment before EPA can promulgate a rule to regulate the 

chemical under TSCA section 6.
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review period.

Note that the scope of this ICR renewal does not include estimates for respondent 

activities associated with SNURs, except for conditions specific to a SNUN submission. For 

more information on new and existing chemical SNURs, see a recent Economic Analysis for 

new chemical SNURs issued under 40 CFR 721 Subpart D expedited process (Docket No. EPAHQ-OPPT-2015-0220) and the Supporting Statement for “TSCA Section 5(a)(2) Significant 

New Use Rules for Existing Chemicals” Information Collection Request (EPA ICR No. 1188.11

OMB Control No. 2070-0038).

4

EPA may also grant certain exemptions from the PMN, SNUN, and MCAN requirements 

of TSCA section 5, including the following. These exemption rules reduce reporting 

requirements, thereby providing relief to submitters from the burdens of the full PMN reporting 

requirements.

(i) Test-Marketing Exemption (TME)

Under TSCA section 5(h)(1), persons may apply for an exemption from the requirements 

of TSCA section 5 for test-marketing purposes. EPA may grant the exemption if it finds that the 

test-marketing activities described by the applicant will not present an unreasonable risk of 

injury to health or the environment. The applicant must provide the information necessary to 

make this finding and EPA must grant or deny the exemption within 45 days. If EPA grants the 

exemption, it may impose appropriate restrictions on the test-marketing activities. See 40 CFR 

720.38 and 725.370.

(ii) Research and Development Exemption (R&D)

TSCA section 5(h)(3) exempts from PMN reporting small quantities of chemical 

substances manufactured only for research and development purposes. Persons using this 

exemption must have their research overseen by a technically qualified individual and must 

notify any person involved in the research of any risk. See 40 CFR 720.36. Small quantities of 

genetically modified microorganisms manufactured solely for research and developmental 

purposes are also exempt when additional criteria are met as described in 40 CFR 725.235, 

activities conducted inside a structure, and 40 CFR 725.238 and 239, activities conducted outside 

a structure.

(iii) TSCA Section 5(h)(4) Exemptions

TSCA section 5(h)(4) authorizes EPA to exempt any person from the provisions of 

TSCA section 5 if EPA determines that the chemical substance will not present an unreasonable 

risk of injury to health or the environment when manufactured, processed, distributed, used or 

disposed of under the exemption. To date EPA has promulgated four rules under this section for 

chemical substances and three exemptions for microbial products of biotechnology:

 

4 EPA implements SNURs in two different ways, depending on the manner by which the chemical was listed on the 

TSCA Inventory. New chemicals are chemicals that are submitted to EPA via PMN, and that subsequently get on 

the TSCA Inventory upon commencement of manufacturing or import. Existing chemicals are chemicals that are 

already listed on the TSCA Inventory, and, therefore, “existing chemical SNURs” are generally written to require 

notice for significant new uses for chemicals that are already in commerce.
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 Low Volume Exemption (LVE) - This exemption applies to substances manufactured 

in quantities of 10,000 kilograms or less per year; submitters may request that EPA 

evaluate their exemption at a lower production volume level, to which the submitter 

would be legally bound. See 40 CFR 723.50.

 Low Release/Low Exposure (LoREX) - This exemption applies to certain chemical 

substances that meet strict human exposure and environmental release criteria to 

ensure that these substances will not present an unreasonable risk. See 40 CFR 

723.50.

 Polymer Exemption - This exemption applies to polymers that comply with certain 

chemical characterizations and that therefore will not present an unreasonable risk of 

injury to health or the environment. See 40 CFR 723.250.

 Instant Photographic Film Articles Exemption - This exemption applies to chemical 

substances used in or for the manufacture or processing of instant photographic and 

peel-apart film articles. See 40 CFR 723.175.

 TSCA Experimental Release Application (TERA) - This exemption applies to 

research and development activities that result in intentional environmental releases 

of microorganisms. EPA may grant the exemption if it finds that the activities 

described by the applicant will not present an unreasonable risk of injury to health or 

the environment. The applicant must provide the information necessary to make this 

finding and EPA must grant or deny the exemption within 60 days. If EPA grants the 

exemption, it may impose appropriate restrictions on the activities described in the 

notice. See 40 CFR 725.250.

 Tier I Exemption - This exemption applies to certain microorganisms subject to 

physical containment and control technologies. EPA has developed specific criteria 

for the host microorganism, introduced genetic material, and containment technology 

to ensure that the microorganism will not present an unreasonable risk. See 40 CFR 

725.400.

 Tier II Exemption - This exemption applies to the same microorganisms subject to a 

Tier I exemption without specified physical containment and control technologies. 

EPA may grant the exemption if it finds that the physical containment and control 

technologies described by the applicant will control releases of and exposure to the 

microorganism such that the microorganism will not present an unreasonable risk of 

injury to health or the environment. The applicant must provide the information 

necessary to make this finding and EPA must grant or deny the exemption within 45 

days. If EPA grants the exemption, it may impose appropriate restrictions on the 

activities described in the notice. See 40 CFR 725.428.

Finally, under TSCA section 26(b), EPA requires manufacturers and processors to pay

fees for PMNs, MCANs, certain PMN exemption applications and notices, and SNUNs 

submitted under TSCA sections 5(a) and (h) to help defray the cost of administering TSCA. EPA 

must take into account a submitter’s ability to pay the fee and the cost of reviewing the submitted 
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data. TSCA section 26(b) provides for maximum fees of $100 for small business concerns and 

$2,500 for other PMN submitters. The rule requires a limited amount of additional information to 

be submitted with the PMN or MCAN form. See 40 CFR 700, Attachment B.

The PMN form includes a User Fee Payment Identity Number field to enable the Agency

to match more easily a particular user fee with a particular notice submission. The required User 

Fee Payment Identity Number can be a check number, a wire transfer number, or a “Pay.gov” 

transaction number used to transmit the user fee.

Copies of TSCA section 5 and of 40 CFR parts 700, 720, 721 (except subpart E), 723 and 

725 are available in the public docket established for this ICR under docket identification 

number EPA-HQ-OPPT-2014-0735 and are available for online viewing at 

www.regulations.gov. (Also see Attachments B, C, D, E and F, respectively.) The regulations 

may also be viewed online at the National Archives and Records Administration’s Electronic 

CFR Website.

2(b) Use/Users of the Data

TSCA gives EPA authority to regulate the manufacture (which includes import), 

processing, distribution in commerce, use or disposal of a new chemical substance if EPA 

determines that if the Agency determines that the information available is insufficient to evaluate 

the substance and that the substance either: (1) may present an unreasonable risk of injury to 

health or the environment from its manufacture, processing, distribution in commerce, use or 

disposal or (2) may be produced in substantial quantities and may be released to the environment 

in substantial quantities or there may be significant or substantial human exposure to the 

chemical. To make a reasoned evaluation of the risk associated with such chemicals, EPA needs 

data on each chemical’s structure and properties, manufacturing process, worker exposure, 

environmental release, production volume, potential industrial, commercial, and consumer use, 

and test data related to the substance. EPA needs sufficient information so as to identify

substances with analogous chemical structures and properties, with similar manufacturing 

processes and with similar uses. The Agency reviews available data to evaluate the toxicity of 

the chemical and the potential risk resulting from human and environmental exposure to the 

substance. If EPA is considering regulation of the chemical, the Agency also evaluates the 

benefits of the substance to determine what regulatory action, if any, to take.

On the basis of its initial review, EPA eliminates the majority of new chemical 

substances from further review. EPA may (1) identify a number of chemical substances for more 

detailed evaluation for which additional exposure or toxicological data may be needed; (2) 

identify some substances for follow-up reporting on their commercial development; and (3) 

select a limited number for immediate regulatory action. Through this process, EPA minimizes 

the burden on both the Agency and industry by requiring detailed information only on those 

substances that may present unreasonable risk or injury to health or the environment or that may

be released to the environment in substantial quantities or for which there may be significant or 

substantial human exposure to the chemical.

A chemical is considered to be a “new” chemical if it is not listed in the TSCA section 

8(b) Inventory of chemicals manufactured or processed in the United States. The Inventory

includes both public and confidential information. Chemicals appear in the public portion of the 
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Inventory by name if the company manufacturing the chemical does not claim the name of the 

chemical to be confidential. Chemicals whose names are claimed confidential are identified in 

the public portion of the Inventory by an accession number and a generic name. The specific 

chemical name of a confidential chemical appears only in the confidential portion of the 

Inventory, which is not available to the public.

A company that intends to manufacture a chemical substance that does not appear by a 

specific name in the public portion of the Inventory may inquire of EPA whether the substance is 

included in the confidential portion of the Inventory (i.e., to determine whether the substance 

would be considered new and therefore subject to the TSCA section 5 notice requirements). 

Similarly, a person who intends to manufacture or process a chemical substance which is 

described by a generic chemical name in a SNUR, may ask whether their substance is subject to 

the requirements of the SNUR. EPA will respond to such an inquiry only if the Agency 

determines that the company has a “bona fide” intent to manufacture or import the substance. 

Reporting provisions found at 40 CFR 720.25, 721.11 or 40 CFR 725.15 require additional 

information from a submitter so as to encourage the submission only of bona fides that reflect 

serious intent.

EPA requires submitters of PMNs and bona fides to provide a specific chemical identity

for the substance for which a notice is made, based on a Chemical Abstracts (CA) Index name or 

a CA preferred name. This requirement reduces delays caused by incorrect or ambiguous 

chemical identity, expedites the Agency’s ability to perform Inventory searches, and saves 

Agency resources spent on naming submitters’ substances.

Since a company’s initial intention to manufacture a substance or microorganism may

change after making a PMN or MCAN submission, EPA requires companies to notify the 

Agency when manufacture (which includes import) begins by submitting a Notice of 

Commencement (NOC) (see 40 CFR 720.102 and 725.190). Submitters specify in the NOC

whether commencement occurred via domestic manufacture or importation and the address of 

the site(s) of first manufacture. This information is essential to the Agency as a compliance 

mechanism. The information requirements for NOC reporting also assist in identifying cases in 

which submitters have mistakenly reported the wrong case number in the NOC, or erroneously 

listed a substance that is very different from that which they intended to commence manufacture. 

In addition, the reporting requirements provide submitters an opportunity to update information 

that may no longer be correct or appropriate as reported in the notice. Finally, the NOC results in 

EPA adding that substance to the TSCA Inventory.

EPA requires the use of a specific reporting form (EPA Form No. 7710-56) for NOCs

submitted for new chemicals in accordance with 40 CFR 720.102 (see Attachment I). Although 

submission of an NOC is also required for new microorganisms, a specific reporting form is not 

required to be used; however, the required contents of such an NOC are described in 40 CFR 

725.190. The use of a standard form for new chemicals leads to greater efficiency by assisting 

EPA in readily identifying the type of notice, providing uniformity in recording responses in 

EPA databases, and providing manufacturers a format to assure that important information is not 

inadvertently omitted in their submissions. Before EPA required the use of a standard NOC 

form, a significant number of NOCs created difficulty because they were not recognized by the 

Agency as a NOC or they contained confusing, missing or unnecessary information. These 

problems resulted in a waste of time and resources for both submitters and EPA personnel who 
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must prepare or review these notices. The required use of a standard reporting form also reduces 

EPA processing time for NOCs.

On a monthly basis, EPA publishes in the Federal Register information summarizing the 

content of each PMN and test market exemption application received, including the specific or 

generic name of the chemical substance and the proposed use(s), as required by TSCA section 

5(d)(2). This monthly publication also includes a list of the PMNs for which EPA has received 

NOCs.

In order to be responsive to inquiries from Congress, the press and the public, EPA also 

periodically compiles certain information such as the number of notices submitted and their 

disposition.

The recordkeeping requirements for PMNs, MCANs, exemption applications, SNUNs 

and SNURs are necessary for EPA enforcement purposes. As part of its enforcement program, 

EPA conducts inspections to review the records of TSCA section 5 submitters to ensure that the 

information submitted in the notice was correct, that the submitter did not begin manufacture or 

processing before the review period expired, and that, for PMN chemicals or MCAN 

microorganisms, the notice of commencement was submitted when domestic manufacture or 

import began. The Agency also inspects manufacturers’ or processors’ chemical substances 

subject to SNURs to ensure that they are not doing so in violation of the SNUR. The 

recordkeeping requirements for exemptions are necessary for enforcement purposes as well. EPA 

conducts inspections to ensure that the information submitted in the aforementioned applications 

is true and that the person holding the exemption is complying with any restrictions EPA 

imposed when it granted the exemption.

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), and in the Office of Enforcement and Compliance Assurance (OECA), and Core 

TSCA Regional Coordinator Inspectors. In particular, staff of the New Chemicals Program 

within the various Divisions of OPPT use this information to review and evaluate the health and 

environmental effects of new chemicals and significant new uses of chemicals, and to 

recommend and implement regulatory actions if warranted. OCSPP employees in the Regional 

Offices and OECA employees in Headquarters and in the Regions use TSCA section 5 data for 

compliance monitoring and enforcement purposes.

3 NON-DUPLICATION, CONSULTATIONS AND OTHER COLLECTION 

CRITERIA

3(a) Non-Duplication

EPA is the only federal agency that regularly collects information on new chemical 

substances used for purely industrial applications. (In instances where chemical substances with 

industrial applications also have drug or cosmetic uses, the Food and Drug Administration would 

have concurrent jurisdiction.) Therefore, the information submitters provide in a PMN or 

MCAN cannot be obtained elsewhere. However, data previously submitted to EPA need not be 

resubmitted if the following conditions are met: the data were submitted with no claims of 
Page 10 of 37

confidentiality and the PMN (or other TSCA section 5 notice) identifies the office or person to 

whom the data were submitted and the date of the submission.

3(b) Public Notice Required Prior to ICR Submission to OMB

In proposing to renew this ICR, EPA provided a 60-day public notice and comment 

period that ended on June 29, 2015 (80 FR 23543, April 28, 2015). EPA received comments 

from the American Chemistry Council, the Society of Chemical Manufacturers and Affiliates, 

and the American Petroleum Institute during the comment period. Copies of the comments 

received and EPA’s response to the comments are included as Attachments K and L, 

respectively.

3(c) Consultations

For several years EPA has been engaged in a continuing series of joint 

EPA/industry/public interest group meetings to facilitate the identification and exchange of 

critical information related to the TSCA New Chemicals Program. These meetings include 

numerous “pre-notice” meetings with individual companies, presentations and delivery of 

training courses at professional meetings (including the annual Global Chem Conference), and 

active participation in the OECD Clearing House on New Chemicals.

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 submitted questions to nine 

parties via email. The individuals contacted were:

Mike Walls, Vice President

Regulatory and Technical Affairs

American Chemistry Council, Inc.

mike_walls@americanchemistry.com

Ernie Rosenberg, President and CEO

American Cleaning Institute

erosenberg@cleaninginstitute.org

Derek Swick, MPP

Senior Policy Advisor

Regulatory and Scientific Affairs

American Petroleum Institute

swickd@api.org

Brigid Klein, Vice President and General Counsel

Consumer Specialty Products Association

bklein@cspa.org

John Carroll, Chair

Enzyme Technical Association 

Director, Regulatory Affairs
Page 11 of 37

Novozymes North America

john@novozymes.com

Lee O. Fuller, Vice President of Government Relations

Independent Petroleum Association of America

lfuller@ipaa.org

Jim Cooper

Vice President Petrochemicals

American Fuel and Petrochemical Manufacturers

jcooper@afpm.org

William Carteaux, President

Society of the Plastics Industry, Inc.

wcarteaux@plasticsindustry.org

Bill Allmond, Director

Government Relations

Society of Chemical Manufacturers and Affiliates Formerly the Synthetic Organic 

Chemical Manufacturers Association. (SOCMA)

allmondb@socma.com

Although no comments were received directly as a result of these consultations, formal 

comments were received from three of these organizations as a result of the public notice in the 

Federal Register: the American Chemistry Council, the Society of Chemical Manufacturers and 

Affiliates, and the American Petroleum Institute. A copy of EPA’s consultation e-mail to the 

above nine potential respondents is included in Attachment J.

3(d) Effects of Less Frequent Collection

The frequency of the submission of information under TSCA section 5 is not under the 

Agency’s control. Manufacturers of new chemical substances must submit a PMN, SNUN, or 

MCAN at least 90 days prior to anticipated manufacturing or distribution of the substance for 

non-exempt commercial use. Submissions of exemption applications must be submitted within 

45 or 30 days prior to anticipated manufacturing or distribution of the substance for non-exempt 

commercial use. Information is provided to EPA on an as-needed, on-occasion basis, initiated 

by submitters. Subsequent reporting would only be required if EPA determined that a specific 

use of a substance constituted a significant new use. Less frequent collection would mean 

submitters not being required to provide data at all. However, without such data, EPA would be 

unable to administer the TSCA new chemical review requirements and would be unable to carry

out its statutory mandate to protect the public from unreasonable risks to health and the 

environment.

3(e) General Guidelines

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 
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five-year recordkeeping requirement is consistent with the five-year statute of limitations under 

28 U.S.C. 2462 held applicable to all EPA enforcement actions, including administrative 

proceedings under TSCA. See 3M Company v. Carol Browner and EPA, 17 F.3d (DC Cir.1994).

In addition, a five-year retention period comports with certain recordkeeping requirements 

imposed by the Occupational Safety and Health Administration and helps to keep these 

requirements consistent with one another, thereby avoiding different timing of reporting 

obligations. Therefore, the Agency requires respondents to retain records for more than three 

years.

3(f) Confidentiality

Much of the required premanufacture information 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 

providing a basis to determine unreasonable risk. EPA cannot draw conclusions or make 

assumptions concerning toxicological effects and potential risks without examining 

physicochemical structure, methods of production, byproducts, potential uses, exposure data, etc. 

The Agency is required by TSCA section 5(d)(2) to publish a Federal Register notice that 

identifies the chemical substance, lists its uses or intended uses and describes test data. Congress 

included these provisions to allow active public participation in the review process.

The Agency’s policies allow public involvement while preserving confidentiality. TSCA 

section 14(a) prohibits, except in limited circumstances, the disclosure of trade secret 

information. TSCA section 14(d) allows disclosure of health and safety studies, including 

underlying data, unless these studies disclose confidential process or mixture information. Under 

40 CFR 720.85 and 720.87 (See also 40 CFR part 2), when the specific chemical identity or use 

data are claimed confidential, the Agency requires the submitter to provide generic descriptions 

for inclusion in Federal Register notices and the public file. Additionally, the submitter must 

provide a “sanitized” copy of all health and environmental effects data, with confidential 

information deleted, for placement in the public docket. Within the Agency, only personnel with 

the required clearance may handle TSCA CBI.

Based on its experience, EPA expects that most information included in TSCA section 5 

notices will be CBI. EPA 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 submitted by manufacturers 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 confidential business information 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 e-PMN software encrypts PMN submissions using a Federal Information Processing 

Standards (FIPS)-compliant encryption module. The encryption module employs a public key
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algorithm which converts readable text into encrypted text. This public key is downloaded from 

CDX to the e-PMN software, and the corresponding private key is sent to EPA’s New Chemical 

System (NCS). The encryption remains while the submission is transmitted via CDX to NCS. 

The file can be decrypted only with the NCS's private key when it has reached its final 

destination. The NCS is the only party that possesses the private key, which converts the 

encrypted text back into readable text.

The same thing will occur for all correspondence going back to the submitter. The NCS 

and e-PMN software are also provided with a set of public and private keys, so that 

correspondence containing any potential confidential business information will remain encrypted 

during transmission via CDX and can be opened only by the submitter within the e-PMN 

software.

3(g) Sensitive Questions

Information requirements under TSCA section 5 do not include questions of a sensitive 

nature.

4 THE RESPONDENTS AND THE INFORMATION REQUESTED

4(a) Respondents/NAICS Codes

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 (related) chemical substances.

4(b) Information Requested

(i) Data Items - Reporting Requirements

Premanufacture Notices - Premanufacture notices required by TSCA section 5 must 

include certain information to the extent known to or reasonably ascertainable by the submitter. 

This information is defined in TSCA section 8(a)(2) and 40 CFR 720.45. Specific information 

includes the following:

 Common or trade name, chemical identity and molecular structure of the chemical in 

question;

 Categories or proposed categories of use of the chemical;

 Estimate of the total amount of such chemical to be manufactured or processed, 

including the amount to be manufactured or processed for each use category;

 Description of the byproducts resulting from the manufacture, processing, use or 

disposal of the chemical;
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 Estimate of the total number of individuals who will be exposed to the chemical in 

their places of employment, and the duration of such exposure; and

 Manner or method of the disposal of the chemical.

In addition, the submitter must provide any test data in the submitter’s possession that 

indicate the environmental or health effects of the chemical, and a description of any other data 

known to the submitter concerning the environmental or health effects of the chemical. The 

specific information requirements are spelled out in 40 CFR part 720, on the PMN reporting 

form itself, and in the Instruction Manual (see Attachment H).

To facilitate the review of chemicals, EPA has developed a PMN reporting form (EPA 

Form 7710-25; see Attachment G). This form is required for reporting new chemicals under 

TSCA section 5(a)(1) and is also required for submitting Significant New Use Notices (SNUNs). 

By supplying the information specified in the form, submitters do not incur the burden of 

providing information unnecessary for EPA’s review. Therefore, use of the form lessens the 

burden on companies by reducing uncertainty, minimizing the need for additional contact with 

EPA, and allowing companies to establish procedures for meeting reporting requirements.

EPA has limited the level of detail of information required in the PMN form to that 

necessary for EPA to conduct an initial review of a chemical. However, submitters may include 

additional or optional information in their notices that they believe EPA should consider in its 

review. For example, submitters may identify pollution prevention techniques being employed 

by the submitter that may be relevant to the Agency’s risk assessment. EPA encourages 

submitters to provide information on the benefits of the new substance in comparison to existing 

chemical substances, information on the substitutes, and any additional information available to 

them on waste management techniques.

The existing PMN form is not appropriate for reporting of new microorganisms in 

MCANs since the form was designed with traditional chemical substances in mind. EPA has 

developed a “Points to Consider” guidance document to assist submitters in providing to EPA 

the information necessary for EPA to make assessments of new microorganisms under TSCA 

section 5 (see http://www.epa.gov/oppt/biotech/pubs/pdf/ptcbio.pdf). The submitter will be able 

to provide information in a format of his or her own choosing. After the effective date of the ePMN rule (April 6, 2010), submitters of MCANs are required to use the e-PMN software to 

generate a finalized “header” sheet, called EPA Form 6300-07, TSCA Biotechnology Notice for 

Online Submissions. The form requires contact data, the addition of any attachments, and a 

signature page.

The e-PMN form also includes a 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 is required and may be a check number, a wire transfer number, or 

a “Pay.gov” transaction number used to transmit the user fee. This information is presently in the 

submitter’s possession.

Another information element on the PMN form is optional and consists simply of the email addresses for the principals listed on the Submitter Identification section of the PMN form. 
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This information helps facilitate electronic communications with the proper point of contact from 

the submitting entity.

Exemption Applications - Applications for exemptions from premanufacture or microbial 

commercial activity notice requirements have additional information requirements, as follows:

 Test-Marketing Exemption (TME) (40 CFR 720.38)

Test-marketing exemption applicants were not required to use the PMN form or 

any other prescribed reporting form prior to April 6, 2010, the effective date of the ePMN final rule. Since April 6, 2010, TME submitters have been required to use the ePMN software to generate finalized submissions using either Form 7710-25 or a cover 

letter and attached information. The test-marking exemption rule states that applicants 

should provide the following information: (1) all existing health and environmental 

effects data on the chemical or a discussion of toxicity based on structure-activity

relationships and relevant data on chemical analogues; (2) the maximum quantity of the 

chemical substance that the applicant will manufacture for test-marketing purposes; (3) 

the maximum number of persons who may be provided the chemical substance during 

test-marketing; (4) the maximum number of persons who may be exposed to the chemical 

substance as a result of test-marketing, including information regarding the duration and 

route of such exposure; and (5) a description of the test-marketing activity, including its 

length and how it can be distinguished from full-scale commercial production and 

research and development. The Agency retains the right to determine that an application 

contains insufficient information to make an evaluation. Any person who receives a testmarketing exemption must retain documentation of any information in the exemption 

application and documentation of their compliance with any restrictions imposed by EPA 

when it granted the application. This information must be retained for five years from the 

final date of manufacture or import under the exemption.

 Research and Development Exemption (R&D) (40 CFR 720.36)

A manufacturer using this exemption must notify all persons in its employ, or to 

whom it distributes the chemical substance and who are involved in any way in the 

research, of any risk to health associated with the chemical substance.

 TSCA section 5(h)(4) Exemptions

1. For the low volume exemption (LVE) (40 CFR 723.50), submitters are required to 

submit their exemption on the PMN form (generated using the e-PMN software) to 

ensure that the Agency has adequate information to make a determination that these 

substances will not present an unreasonable risk. Statements describing exposure and 

release controls, site, and use in an exemption application are legally binding and 

enforceable.

2. For the low exposure/low release exemption (LoREX) (40 CFR 723.50), submitters 

are required to submit their exemption on the PMN form (generated using the e-PMN 

software). The LoREX exemption encourages the use of pollution prevention practices 

through the development of manufacturing, processing and use techniques that minimize 
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exposure to workers, consumers, the general public and the environment. As with the low 

volume exemption, site, use, exposure and release controls identified in the notice are 

binding.

3. The polymer exemption rule (40 CFR 723.250) requires the submission of a postmanufacture report to EPA. A simple one-page annual report is required to be submitted 

to the Agency no later than January 31 of the year subsequent to initial manufacture 

under the terms of the exemption. The report must include company identity information 

including the name and telephone number of a technical contact and the number of 

exempt substances for which manufacture commenced during the preceding year. These

reports are not subject to the electronic reporting requirements of the e-PMN rule.

4. Instant photographic film articles exemption notices (under 40 CFR 723.175) must, 

at a minimum, identify the manufacturer and the new chemical substance. Applicants 

must submit an exemption notice when manufacture begins and comply with certain 

requirements to limit exposure to the chemical. Applicants must retain certain records for 

30 years from the final date of manufacture. These exemption notices are not subject to 

the electronic reporting requirements of the e-PMN rule.

5. A TSCA experimental release application (TERA) (under 40 CFR 725.250) applies 

to research and development activities that result in intentional environmental releases of 

new microorganisms. Applicants are required to include adequate information in their 

exemption application so that the Agency can make a determination as to whether the 

microorganism will present an unreasonable risk. Submitters must follow the conditions 

described in the TERA as well as any conditions of EPA’s TERA approval.

6. Tier I exemption (40 CFR 725.424) - This exemption applies to certain new 

microorganisms subject to physical containment and control technologies. EPA has 

developed specific criteria for the host microorganism, introduced genetic material, and 

containment technology to ensure that the microorganism will not present an 

unreasonable risk. Applicants must notify EPA 10 days before manufacture, certifying 

compliance with the exemption criteria and include the site of manufacture or import.

7. Tier II exemption (40 CFR 725.428) - This exemption applies to the same 

microorganisms subject to a Tier I exemption; however, the applicant must provide 

adequate information on its proposed physical containment and control technologies in 

order for EPA to evaluate the exemption. If EPA grants the exemption, it may impose 

appropriate restrictions on the activities described in the notice.

After the effective date of the e-PMN rule (April 6, 2010), submitters of biotechnology

notices (i.e., MCANs, TERAs, Tier I exemptions, and Tier II exemptions) are required to use 

the e-PMN software to generate a finalized “header” sheet, called EPA Form 6300-07, TSCA 

Biotechnology Notice for Online Submissions. The form requires contact data, the addition of 

any attachments, and a signature page.

Notices of Commencement - Under 40 CFR 720.102 and 725.190, EPA requires 

companies to notify the Agency by submitting a Notice of Commencement (NOC) when nonexempt commercial manufacture (including importation) of a new chemical begins. Required 

reporting information includes the following:
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 Specific chemical identity of the chemical, and a generic chemical name if the 

specific name is considered confidential;

 Premanufacture notice number assigned by EPA;

 Date that manufacture commenced;

 Address of the site where manufacture commenced;

 Name and address of the submitting company, the name of the authorized official 

signing the NOC, the name and telephone number of a technical contact person; and

 Clear indication of what information, if any, is to be considered confidential.

For traditional chemicals regulated under 40 CFR part 720, NOCs must be submitted to 

EPA using the NOC form (EPA Form 7710-56). Since the effective date of the e-PMN rule, 

submitters are required to use the e-PMN software to generate a finalized submission using Form 

7710-56. The submitter must provide the NOC to EPA on, or no later than 30 calendar days 

after, the day manufacture (including importation) began. The existing NOC form is not 

appropriate for reporting of new microorganisms since the form was designed with traditional 

chemical substances in mind. Thus, under 40 CFR 725.190 the submitter may provide 

information in a format of his or her own choosing when reporting an NOC for a new 

microorganism.

Bona Fides - To determine whether a chemical substance is on the confidential portion of 

the TSCA Inventory, submitters of bona fide inquiries under 40 CFR 720.25 and 40 CFR 725.15 

are required to provide the specific chemical identity of the substance in question, a signed 

statement that the submitter intends to manufacture that substance, a description of the research 

and development activity conducted on that substance, a description of the intended use of the 

substance, infrared spectrum data to identify the substance, the estimated date on which the 

company intends to submit a PMN, the address of the facility where manufacturing or processing 

will occur, and a description of the manufacturing process. A similar procedure is followed for 

companies wishing to obtain confidential information for a SNUR, including chemical identity,

and terms of the SNUR (see 40 CFR 721.11).

To determine whether a microorganism is on the confidential portion of the TSCA 

Inventory, submitters of bona fide inquiries under 40 CFR 725.15 are required to provide the 

taxonomic designations, pertinent genotypic and phenotypic information, a signed statement that 

the submitter intends to manufacture that microorganism, a description of the research and 

development activity conducted on that substance, a description of the intended use of the 

substance, and an indication of whether a related microorganism was previously reviewed by 

EPA to the extent known by the submitter. At this time, bona fides are not subject to the e-PMN 

rule electronic reporting requirements. However, when the direct final rule published on July 20, 

2015, becomes effective on January 19, 2016, electronic reporting of bona fides will be 

mandatory.
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User Fees - The TSCA section 26(b) rule (at 40 CFR part 700) that requires 

manufacturers and processors to pay fees for PMNs, MCANs, certain PMN exemption 

application notices, and SNUNs submitted under TSCA sections 5(a) and (h), requires a limited 

amount of additional information to be submitted with the section 5 notice. This information 

includes certification that the firm is a “small business concern” (if applicable), a certification 

statement that the submitter remitted the appropriate fee, and the placement of corresponding 

identifying numbers both on the PMN form and the fee remittance.

(ii) Data Items - Recordkeeping Requirements

Under 40 CFR 720.78(a), TSCA section 5 notice submitters must keep the following data 

for five years from the date of commencement of manufacture or processing: documentation of 

information in the notice (e.g., sources of information provided in the notice); production volume 

for the first three years of production; the date of commencement, plus documentation of this 

information; and “other data” described in the notice, as required by 40 CFR 720.50(b).

Recordkeeping requirements under SNURs require persons who manufacture or process a 

substance subject to significant new use reporting to maintain records indicating their 

compliance with certain methods of manufacture or processing. Some Significant New Use 

Rules do not require recordkeeping. Rather, recordkeeping requirements apply only to those 

SNURs for which compliance can only be monitored by recordkeeping or SNUR notice 

submission under TSCA section 5(a)(2). For example, upon occasion EPA will determine that a 

specific set of exposure controls will adequately mitigate risks to workers by a specific chemical 

substance. In such cases EPA may determine, by rule, that the failure to utilize such controls 

constitutes a significant new use. However, those persons employing the controls identified in 

the SNUR are not required to report to EPA. In order to demonstrate to EPA inspectors or to 

purchasers of the chemical substance that they are properly employing worker exposure controls 

(to avoid SNUR notification requirements), manufacturers or processors will likely maintain 

some record of their compliance. In instances such as those described above, EPA would request 

that records be kept documenting the establishment and implementation of procedures to ensure 

that employees use applicable personal protective equipment, and that employees are informed 

of the hazards associated with the chemical substance and are trained in the use of protective 

equipment. These records aid inspectors in EPA’s compliance monitoring program during their 

visits to plants where substances subject to SNUR requirements are manufactured or processed. 

EPA does not consider recordkeeping that indicates compliance with a SNUR to be burdensome. 

Information contained in these records is not submitted to EPA. Therefore, the costs of keeping 

such records should be minimal.

There are also recordkeeping requirements for persons subject to consent orders 

containing exposure controls. Depending on the facts of each case, submitters must keep records 

in connection with the use of the exposure controls including one or more of the following: (1) 

documentation of manufacture volumes of the PMN substance, with associated dates of 

manufacture; (2) documentation of the names and addresses of all persons outside the site of 

manufacture to whom the submitter directly sells or transfers the substance, with associated dates 

of transfer; (3) documentation of the establishment and implementation of personal protective 

equipment program; (4) documentation of chemical protective clothing imperviousness testing; 

(5) documentation of the hazard communication program; (6) copies of labels; (7) copies of 

material safety data sheets; (8) documentation of compliance with industrial, commercial and 
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consumer use limitations; and (9) documentation of compliance with disposal and release to 

water limitations.

(iii) 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 confidential business information;

 Register with CDX;

 Use the e-PMN 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 THE INFORMATION COLLECTED--AGENCY ACTIVITIES, COLLECTION 

METHODOLOGY AND INFORMATION MANAGEMENT

5(a) Agency Activities

From the Agency’s perspective, the organizing reporting unit is “notices.” A given notice 

typically submitted by a single firm may pertain to a single or multiple (related) chemical 

substances, but to the Agency involves similar burden according to notice.

In connection with administering the TSCA section 5 new chemical review and 

regulatory program, EPA performs the following activities:

 Reviews PMN/MCAN submissions;

 Analyzes submissions for confidentiality and provides appropriate protection for 

confidential data;

 Files and stores submissions to Agency data systems;

 Proposes and implements regulatory action as appropriate;

 Scan paper-based section 5 submissions to create electronic data for inclusion in 

Agency data systems;

 Acknowledges receipt of submissions and notifies respondents of any submission 

deficiencies;

 Provides technical assistance to respondents; and

 Conducts site and record inspections and performs related compliance monitoring 

functions.
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5(b) Information Requested

(i) Data items, including record keeping requirements

With the exceptions of the e-PMN software and the minor revisions to the PMN form that 

were incorporated into that software in 2010, that is, the required User Fee Payment Identity

Number, optional E-mail address for Principal Contacts, and software-generated format for 

Biotech notices (EPA Form 6300-07, TSCA Biotechnology Notice for Online Submissions), the 

data items currently approved under OMB Control Numbers 2070-0012 and 2070-0038 are 

otherwise unchanged.

(ii) Respondent Activities

Register with EPA’s CDX and Complete Electronic Signature Agreement

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, accommodates electronic submission through CDX. The e-PMN software without 

encryption is available through EPA’s TSCA New Chemicals Program website. Both variations 

of the e-PMN software are available free of charge as Internet downloads. The e-PMN 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 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 are received, EPA activates the submitter's registration in CDX and 

sends an e-mail notification confirming registration.

(iii) Use the e-PMN Software to Prepare TSCA Section 5 Notices

In all cases, respondents use the e-PMN software to:
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 generate the submission materials for TSCA section 5 notices, including forms (i.e., the 

PMN form (EPA Form 7710-25), the NOC (EPA Form 7710-56) and the TSCA 

Biotechnology Notice for Online Submissions (EPA Form 6300-07)) as well as 

submission materials that do not require a standardized form or format; and,

 populate the submission materials with the relevant information.

There are no required or official forms for certain TSCA section 5 notices, such as LVE 

modifications, LoREX exemption modifications, and TMEAs. For biotechnology notices, no 

EPA-approved forms exist. To allow for electronic submission of these notices using the e-PMN 

software, submitters do the following:

(1) For exemption modifications, submitters 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 checks the “TMEA” box on page 1 of the e-PMN form, 

and either fills out the form or attaches a cover letter to the body of the submission 

containing the information required by 40 CFR 720.38.

(3) Biotechnology notices have their own menu option. Instead of selecting 

“Premanufacture Notice,” a submitter selects “Biotech,” which prompts the software 

to present the submitter a header page with choices of biotech notices, and space to 

fill in contact information. The e-PMN software populates this information in a new 

form entitled, “TSCA Biotechnology Notice for Online Submissions” (EPA Form 

6300-07). The additional information may be submitted as an attachment(s).

Notice Type Use of e-PMN Software

PMN Form 7710-25 generated and finalized by e-PMN software.

Low Volume 

Exemption (LVE)

Form 7710-25 generated and finalized by e-PMN software.

Test Market Exemption 

Application (TMEA)

e-PMN software to generate finalized submission either using 

7710-25 or cover letter and attached information.

NOC e-PMN software to generate finalized submission using Form 

7710-56.

Biotechnology

Notices

e-PMN software to generate finalized “header” sheet (EPA 

Form 6300-07, TSCA Biotechnology Notice for Online 

Submissions) with contact data, add attachment with notice 

information, include signature page.

Modifications to 

Previous Notices

EPA Form 7710-25 generated and finalized by e-PMN 

software. Fill in pages 1, 2, and 3 of the Form, plus either 

applicable pages of Form, cover letter, or attachment.

Support

Documents

e-PMN software to generate finalized “header” sheet 

identifying reason for submission and contact data.
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Finalize and Submit

A respondent’s activities to finalize and a submit TSCA section 5 notices depend on the 

chosen submission method. The e-PMN software requires users to complete a finalization 

process before preparing the information for submission to EPA. During the finalization step, the 

e-PMN software checks that all legally required information is included and provides warnings 

for certain kinds of missing, incomplete or incorrect data.

Using e-PMN Software to Submit Electronically to EPA via CDX 

After the e-PMN finalization step is complete, the e-PMN software prompts respondents 

to log-in to CDX. Respondents simply transmit the information to EPA online by clicking on the 

e-PMN software’s “send” button.

5(c) Collection Methodology and Management

The electronic Adobe Acrobat version of the PMN form is no longer available to PMN 

submitters. All PMN forms must be generated using the e-PMN software and submitted 

electronically via CDX. The Thick Client version of the e-PMN software is available as a free 

internet download. 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 more efficient data transmittal to Agency data systems that once was performed manually.

Currently the Agency requires all section 5 notices and NOCs to be submitted electronically via 

CDX. 

An electronic signature is required for TSCA section 5 notices submitted to the Agency

via CDX. Electronic signatures are granted as part of the CDX user-registration process.

All e-PMN software users need to perform the “finalization” step in generating a 

document. During the “finalization” step, the e-PMN 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. Section 5 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 the 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.

The electronic submission software is changing the way that companies now interact with 

the Agency with many of its submissions. Electronic communication reduces the reporting 

burden on industry because it will reduce both the cost and the time required to enter, review, 

edit and transmit data to the Agency. The electronic submission software improves data quality

by facilitating data correction and validation by highlighting fields with omitted data prior to 

submission. The protection of encrypted TSCA CBI data and the generation of an electronic 

Copy of Record that is returned to the submitter are other critical advantages of submitting data 

electronically through CDX.
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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-PMN 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 that were 

populated manually are now populated electronically, reducing the potential for human error that 

exists when data are entered by hand. Agency personnel are also able to communicate more 

efficiently with submitters electronically, compared to using U.S. mail.

Because companies register with EPA to submit their data electronically to the Agency

via CDX, the Agency in turn will be able in the future to communicate electronically with 

submitters via CDX. Some examples of routine communications from EPA that could go through 

CDX include the Acknowledgment Letter (acknowledging receipt of a submission), and the 

Incomplete Letter (stating why a submission has been declared incomplete). Usually, these 

communications are sent through the mail. An electronic means of communication provides 

significant time and resource savings 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 5, the questions 

are referred to OPPT staff for appropriate resolution.

5(d) Small Entity Flexibility

The reporting and recordkeeping requirements associated with TSCA section 5 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. In addition, “small business concerns” submit a 

reduced fee of $100 (rather than $2,500) for each TSCA section 5 notice submitted pursuant to 

the user fee regulation at 40 CFR 700.45(a)(1).

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 bibliographic databases that reference scientific literature and databases 

containing previously submitted chemical information. These databases allow EPA to exempt 

submitters from needlessly providing already-published data or resubmitting previously

submitted information (unless the previously submitted information was claimed confidential).
Page 24 of 37

Also, as discussed above, EPA has issued several TSCA section 5 exemption rules that 

reduce PMN reporting requirements thereby providing relief to submitters from the burden of 

responding to the full PMN/MCAN requirements.

Finally, EPA provides the services of pre-notice communications coordinators and other 

personnel to assist persons in a comprehensive manner for purposes of notice preparation prior to 

submission. For instance, for new chemical substances a PMN submitter may, upon consultation 

with the pre-notice communication coordinator, prepare one “consolidated notice” for two or 

more chemical substances if they are similar in physicochemical structure and use and share 

common test data or other information. Pre-notice communication coordinators respond to other 

pre-notice inquiries that may pertain to the full scope of the TSCA section 5 regulations.

5(e) Collection Schedule

Does not apply. Submission of information under this collection is on an as-needed, onoccasion basis, initiated by the submitters.

6 ESTIMATING THE BURDEN AND COST OF THE COLLECTION

This analysis covers submissions of PMNs, SNUNs, MCANs, and associated exemption 

applications: test-marketing exemption (TME), research and development exemptions (R&D), 

low volume exemption (LVE), low exposure/low release exemption (LoREX), instant 

photographic film articles exemption, TSCA Experimental Release Applications (TERAs), and 

Tier I and II exemption applications. It also covers submission of Notices of Commencement 

(NOCs) and Bona Fide notifications, and the burden associated with implementation of TSCA 

section 5(e) consent order restrictions. Since the last renewal of this ICR, phase-in of the e-PMN 

rule has been completed, reducing the burden hours on submitters. To comply with the 

regulation, manufacturers (including importers) must complete the activities listed in Table 1. 

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 2,100 TSCA section 5 notices each year, based on the average annual 

number of notices submitted to EPA between Fiscal Year FY 2009 and FY 2014 (Table 2).
Page 25 of 37

Table 1: Cross-Walk between Industry Activities and Related Information Collections (ICs)

Activity Description Related IC(s) included in this 

ICR Renewal

Preparation and 

Submission of 

Reports

Staff must collect all of the information, required by 

whichever submission they are making. This ICR 

covers PMNs, SNUNs, MCANs, the associated 

exemption applications, NOCs, Bona Fide claims, or 

TSCA section 5(e) consent orders. The information 

must be gathered, reviewed, and submitted to EPA. 

This involves any research necessary to identify the 

correct information and the act of completing the 

submission review (technical and managerial burden),

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 Before submitting a TSCA section 5 notice, new 

submitters must register with CDX. In addition, 

respondents must complete an Electronic Signature 

Agreement form, which is signed, dated, and 

submitted electronically back to EPA.

CDX Registration Activities

6(a) Estimating Respondent Burden

The burden to respondents includes: (1) reporting burden for submission of PMNs, 

SNUNs, MCANs, exemption notices, and implementation of TSCA section 5(e) consent order 

restrictions such as the use of exposure controls and/or performing toxicity testing; (2) 

recordkeeping burden associated with notice submissions, consent orders, exposure controls and 

toxicity testing; and (3) burden associated with CDX registration activities.

6(b) Burden Associated with Reporting

The total respondent reporting and third-party notification burden associated with this 

information collection is estimated to total 101,448 hours. This burden estimate is calculated by 

multiplying the number of each type of notice that EPA expects to receive by the corresponding 

hours of reporting burden and summing across the notice types (see Table 2).

Number of Notices. The number of notices expected to be submitted annually is for each 

of the submission types is found in Table 2. Expected numbers are based on the average number 

of submissions EPA received between FY 2009 and FY 2014 rounded up to the nearest whole 

number, unless otherwise noted. 

 PMNs: Prior to the 1995 amendments to the PMN rule, 70 to 80 percent of all TSCA 

section 5 notices were full PMN submissions. Since the amendments of 1995, the 

increase in exemptions has significantly changed this distribution: between FY 2009 and 

FY 2014 approximately 35 percent of the TSCA section 5 notices discussed in this ICR 

were for full PMN submissions. Including only PMNs and LVE/LoREX/TME exemption 

applications in this calculation indicates that full PMNs account for about 60 percent of 

notifications. Based on the most recent data available, EPA believes it will receive 

approximately 591 PMN submissions annually.

 SNUNs: EPA expects few persons to submit significant new use notices (SNUNs), based 

on historical data. Current data suggest the Agency expects to receive approximately 7
Page 26 of 37

SNUNs per year.

 MCANs: Based on FY 2009 – FY 2014 data, EPA estimates it will receive approximately

10 MCAN submissions per year.

 TMEs: TMEs are expected to average 5 applications per year, or less than 1 percent of all 

TSCA section 5 notices.

 LVE and LoREXs: On average, LVE and LoREX exemptions are expected to account for 

about 385 notices each year.

 Polymers Exemptions: Based on FY 2010 – FY 2013 data, polymer exemptions are 

expected to be submitted for approximately 292 chemicals each year.

 R&D Exemptions: Firms are not required to submit any data to EPA to meet the R&D 

exemption; however, they must meet certain procedural requirements. EPA assumes that 

approximately 200 chemicals will meet the requirements for this exemption each year.

 Instant Photographic Film Article: Submissions of instant photographic film articles 

exemption notices are rare. EPA has not received any such notifications in many years 

and does not expect to receive any such notices over the next several years. However, this 

analysis conservatively assumes that 1 exemption will be submitted per year.

 Bona Fides: EPA estimates it will receive approximately 170 Bona Fide Intent to 

Manufacture or Import notifications per year.

 TSCA section 5(e) Consent Orders: The various exemptions available to submitters 

since the 1995 amendments have significantly reduced the need for consent order 

development and post-notice data review. Historical EPA data indicate that such consent 

orders and post-notice data reviews will amount to roughly 2 percent of the total of 

TSCA section 5 notices. Based on historical data, EPA estimates 33 cases would be 

subject to TSCA section 5(e) consent order restrictions burden, with 14 cases requiring 

test data, and 19 non-testing TSCA section 5(e) cases.

NOCs: Based on FY 2009 – FY 2014 data, the Agency estimates it will receive 

approximately 404 Notices of Commencement of Manufacture or Import each year.

Burden hours. The e-PMN rule reduces the burden hours on submitters by eliminating 

several hours, mainly clerical hours, from the paper submission process. Burden reduction 

resulted from eliminating the time and expense associated with preparing and mailing hardcopy 

notices. Paper submissions of section 5 notices were no longer accepted after April 6, 2011, and 

notices submitted on optical discs were no longer accepted after April 6, 2012. Burden hours for 

each type of notice were estimated in previous analyses, as described below and summarized in 

Table 2.

 PMNs, SNUNs, LVEs and LoREXs: The hours for respondent reporting burden for a full 

electronic PMN submission is expected to average 91.68 respondent burden hours. This 

burden applies also to SNUN, LVE, and LoREX submissions because each of these 
Page 27 of 37

notices requires the submission of a complete PMN form.

 MCANs: The respondent burden for an MCAN is estimated to average of 288.2 hours.

 TMEs: The respondent burden for submission of a TME is estimated to average 86.2 

hours.

 TERAs: The respondent burden for a TERA is estimated to average 507.2 hours.

 Tier I or Tier IIs: The respondent burden for a Tier I or Tier II exemption is estimated to 

average 110.2 hours.

 Polymer Exemptions: The respondent burden for submission of a polymer exemption 

post-manufacture annual report is estimated to average 2.25 hours.

 R&D Exemptions: The respondent burden to meet the procedural requirements for an 

R&D exemption is estimated to average 2.50 hours.

 Instant Photographic Film Article: The minimum amount of information that is required 

to be contained in an exemption notification for instant photographic film articles is the 

identity of the manufacturer and the new chemical substance. The burden associated 

with preparing and submitting this type of exemption notification is 0.5 hours.

 Bona Fides: The respondent burden for submission of a bona fide notice is estimated to 

average 20 hours.

 TSCA section 5(e) Consent Orders: The respondent burden for consent orders ranges 

from 21 to 151.5 hours per submission, depending on whether or not testing data are

submitted. For TSCA section 5(e) consent orders where testing data are submitted, EPA 

assumes testing is contracted out to a laboratory and burden associated with testing 

requirements represents the time that personnel from the submitting firm would spend 

overseeing the testing.

 NOCs: The respondent burden for submission of a NOC is estimated to be 0.6 hours.
Page 28 of 37

Table 2. Reporting Burden

Type of Notice Average Annual 

Responses1

Average Reporting 

Hours per Response

Average Annual 

Burden

PMN1

591 91.68 54,183

SNUN1

7 91.68 642

MCAN110 288.2 2,882

Exemptions: 0

TME15 86.2 431

LVE/LoREX1

385 91.68 35,297

TERA11 507.2 507

Tier I and II11 110.2 110

Polymer2292 2.25 657

Research & Development3

200 2.50 500

Instant Photographic Film Articles31 0.5 0.5

Bona Fide1170 20 3,400

5(e) Test114 151.5 2,121

Non-Testing 5(e) 119 25 475

NOC1404 0.6 242

Total 2,100 101,448

1 Based on the average number of submissions EPA received between FY 2009 and FY 2014, rounded up to the nearest whole 

number.

2 Based on the average number of submissions EPA received between FY 2010 and FY 2013, rounded up to the nearest whole 

number.

3 Based on EPA professional judgment and industry data.

6(c) Burden Associated with Recordkeeping

The total respondent recordkeeping burden associated with this information collection is 

an estimated 2,250 hours (Table 3). This burden estimate is calculated by multiplying the 

estimated recordkeeping burden associated with each type of submission, by the estimated 

number of submissions for each notice and summing across notice types. All recordkeeping 

burden estimates are taken from the Economic Analysis of the Premanufacture Notification 

Electronic Reporting Final Rule (EPA, 2009). It should be noted that there is no recordkeeping 

burden associated with submitting a full electronic PMN SNUN, LVE, or LoREX submissions 

because the burden estimate of 91.68 hours per form already includes the burden associated with 

recordkeeping.5

Once a respondent presents information in an initial TSCA section 5 submission, the 

burden for maintaining or updating these records is minimal. The recordkeeping burden for 

several TSCA section 5 submissions have decreased due to the implementation of the e-PMN 

rule, which was finalized in 2010. EPA assumes an aggregate annualized recordkeeping burden 

of one hour for each PMN, SNUN, MCAN, exemption submission, or biotech submission under 

this new rule. This estimate is based on the recordkeeping burden associated with essential 

technical requirements, such as records that demonstrate that the first commercial batch of a 

 

5 As stated in the 1994 Regulatory Impact Analysis of Amendments to Regulations for TSCA section 5 

Premanufacture Notifications, the burden estimates for PMN submissions include the time “maintaining a file of the 

submission” (p. III-13). Because SNUNs, LVE, and LoREX are assumed to have the same burden as PMN 

submissions, the recordkeeping burden is also included in the reporting burden for these submissions. 
Page 29 of 37

chemical manufactured for commercial purposes under the exemption met certain eligibility

criteria. The recordkeeping burden estimates for 5(e) testing and non-testing burden are 17.5 and 

25 hours, respectively.

The overall respondent recordkeeping burden is displayed below in Table 3.

Table 3. Respondent Recordkeeping Burden

Type of Notice

Average 

Annual 

Responses

Hours for Recordkeeping1

Average 

Annual 

Burden

PMN 591 0 0

SNUN 7 0 0

MCAN 10 1 10

Exemptions:

 TME 5 1 5

 LVE/LoREX 385 0 0

 TERA 1 1 1

 Tier I and II 1 1 1

 Polymer 292 3.5 1,022

 Research & Development 200 0.5 100

 Instant Photographic Film

 Articles 1 0.25 0.3

Bona Fide 170 2 340

5(e) Test 14 17.5 245

Non-Testing 5(e) 19 25 475

NOC 404 0.125 50.8

Total 2,100 2,250

1 Average recordkeeping hours per response

6(d) Burden Associated with CDX Registration

As part of EPA’s electronic reporting requirements, submitters of TSCA section 5 notices 

are required to register and submit information electronically with EPA’s Central Data Exchange 

(CDX) system. EPA estimates that companies submitting section 5 notices for the first time 

would incur a one-time burden to complete CDX registration activities, obtain a CDX electronic 

signature, and set up a Pay.gov ID account. The total burden associated with CDX registration is 

approximately 2.80 hours per company. EPA assumes each company will register five 

employees, resulting in a per-employee burden of 0.66 hours. This per-employee burden includes 

0.18 hours for CDX registration, 0.35 hours for submitting and then verifying electronic 

signature agreements, and 0.13 hours for setting up a Pay.gov account. In fiscal year 2013, a 

total of 392 new registrants, 303 TSCA-Authorized Officials (AO) and 89 TSCA-Support 

Registrants (SR), were approved via CDX for all TSCA section 5 activities, resulting in a total 

annual burden of 259 hours (Table 4).

EPA estimates that about 10 percent of new CDX registrations will be due to employee 

turnover, based on data provided in the Cross-Median Electronic Reporting Rule (CROMERR) 

ICR (EPA, 2011). Therefore, approximately 30 new Authorized Officials and 9 new Support 

Registrants will replace previously registered CDX users each year. The burden associated with 

new CDX registration activities is the same regardless of whether the registrant is new or 

replacing an existing employee. As a result, burden is not estimated separately for each type of 
Page 30 of 37

registrant.

Table 4. Burden Associated New CDX Registration Activities

CDX 

Registration 

Burden 

(Hours)

CDX ESignature 

Burden 

(Hours)

EPayment 

(Pay.gov 

ID 

account)

(Hours)

Total 

Burden for 

CDX 

Registration 

Activities, 

(Hours)

Annual 

Number of 

New CDX 

Registrants

Total Annual 

Burden for 

CDX 

Registration

(Hours)

0.18 0.35 0.13 0.66 392 258.72

6(e) Estimating Total Burden

Table 5 below contains the total annual respondent burden for all submissions and 

activities covered under this ICR. The total annual burden is estimated to be approximately

103,956 hours (101,448 reporting hours + 2,250 recordkeeping hours + 259 CDX registration 

hours).

Table 5. Total Annual Respondent Burden Calculation

Type of Notice

Average 

Annual 

Responses

Managerial

Hours

Technical

Hours

Clerical 

Hours

Total 

Labor 

Hours

Total Burden

PMN 591 18 73.68 0 91.68 54,183

SNUN 7 18 73.68 0 91.68 642

MCAN 10 65 223.7 0.5 289.2 2,892

Exemptions:

TME 5 17 69.7 0.5 87.2 436

LVE/LoREX 385 18 73.68 0 91.68 35,297

TERA 1 129 378.7 0.5 508.2 508

Tier I and II 1 23 87.7 0.5 111.2 111

Polymer 292 1.25 2.25 2.25 5.75 1,679

R&D 200 0 2.75 0.25 3 600

Film Articles 1 0 0.75 0 0.75 0.75

Bona Fide 170 6 15 1 22 3,740

5(e) Test 14 38.8 121.45 8.75 169 2,366

Non-Testing 5(e) 19 19.5 18 12.5 50 950

NOC 404 0 0.6625 0.0625 0.725 293

New CDX Registration1392 0.132 0.528 0 0.66 259

Total 103,956

1Based on the 2009 Economic Analysis of the Premanufacture Notification Electronic Reporting Final Rule, EPA assumes that 

20 percent of CDX registrants will be managerial employees and 80 percent will be technical employees. Therefore, the per 

employee registrations burden is split between managerial and technical hours using a 20/80 ratio. 

6(f) Estimating Respondent Cost

Respondents to TSCA section 5 reporting requirements experience costs associated with 

(1) reporting, (2) recordkeeping, and (3) compliance with exposure controls and testing 

requirements included in TSCA section 5(e) orders, when EPA takes regulatory action. The 

respondent costs associated with this information collection are estimated to total $36,764,017

(Table 6).
Page 31 of 37

Respondent costs for all submissions consist of three components: (1) labor costs, 

calculated by multiplying the estimated burden hours associated with each submission type by 

the appropriate labor rate; (2) delay costs, estimated as the cost of the delayed receipt of profits 

by chemical manufactures as a result of the submission review process, and (3) explicit costs, 

such as user fees or lab testing fees.

In order to estimate total respondent cost associated with TSCA section 5 submissions, an 

average cost per notice was first calculated for each type of notice. The cost for each notice type 

was calculated by summing each of the associated cost components, and then multiplying by the 

expected number of notice submissions. The total industry cost was calculated by summing the 

costs across notice types. Table 6 outlines the average cost calculations for the various types of 

notice submissions and presents the total respondent cost estimate.

Wages for managerial, professional/technical, clerical and production labor were taken 

from the Bureau of Labor Statistics (BLS) Employer Costs for Employee Compensation (ECEC) 

data, for December 2014, for manufacturing industries. The cost of fringe benefits such as paid 

leave and insurance, specific to each labor category, are taken from the same ECEC series. 

Fringe benefits as a percent of wages are calculated separately for each labor category. For 

example, for December 2014, the average wage rate for professional/technical labor was $42.19,

the average fringe benefit was $22.86. Fringe benefits as a percent of wages were $22.86/$42.19, 

or approximately 54.2 percent.

An additional loading factor of 17 percent is applied to wages to account for overhead. 

This approach is used for consistency with Office of Pollution Prevention and Toxics economic 

analyses for two major rulemakings: Wage Rates for Economic Analyses of the Toxics Release 

Inventory Program (2002), and the Revised Economic Analysis for the Amended Inventory 

Update Rule: Final Report (2002). This overhead loading factor is added to the benefits loading 

factor, and the total is then applied to the base wage to derive the fully loaded wage. For 

example, the December 2014 fully loaded wage for professional/technical labor is $42.19 × 

(1+0.541835 + 0.17) = $72.22.

As noted above, delay costs reflect the cost of the delayed receipt of profits by chemical 

manufactures as a result of the submission review process. Industry delay costs used to calculate 

the average cost per submission were computed using the midpoint of the low and high delay

cost estimates (1993 dollars) as presented in the “Regulatory Impact Analysis of Amendments to 

Regulations for TSCA section 5 Premanufacture Notifications” (1994), and inflated to 2014

dollars using the Bureau of Labor Statistics’ Producer Price Index data for the Chemical 

Manufacturing industry.

The EPA fees (explicit costs) used to calculate the average cost per submission were 

taken from the 2011 ICR and have not been adjusted, as fees have remained constant. Laboratory

testing costs were inflated to $2014 using the Bureau of Labor Statistics (BLS) Employment 

Cost Index (ECI) series for private industry White Collar Workers.
Page 32 of 37

Table 6. Total Respondent Cost Calculation

Type of Notice

Average 

Annual 

Responses

Total Burden (reporting + recordkeeping) and Wage Rate 

by Labor Category Labor 

Costs1

Delay 

Costs2 Fees3

Avg. Cost 

Per 

Notice4

Total 

Respondent 

Cost Managerial Technical Clerical 6

Hours Wage($) Hours Wage($) Hours Wage($)

PMN 591 18 $80.22 73.68 $72.22 0 $31.26 $6,765 $31,929 $2,500 $41,195 $24,346,102

SNUN 7 18 $80.22 73.68 $72.22 0 $31.26 $6,765 $31,929 $2,500 $41,195 $288,363

MCAN 10 65 $80.22 223.7 $72.22 0.5 $31.26 $21,386 $31,929 $2,500 $55,816 $558,157

Exemptions:

TME 5 17 $80.22 69.7 $72.22 0.5 $31.26 $6,413 - - $6,413 $32,067

LVE/LoREX 385 18 $80.22 73.68 $72.22 0 $31.26 $6,765 $16,072 - $22,837 $8,792,219

TERA 1 129 $80.22 378.7 $72.22 0.5 $31.26 $37,715 - - $37,715 $37,715

Tier I and II 1 23 $80.22 87.7 $72.22 0.5 $31.26 $8,195 - - $8,195 $8,195

Polymer 292 1.25 $80.22 2.25 $72.22 2.25 $31.26 $333 - - $333 $97,266

R&D 200 0 $80.22 2.75 $72.22 0.25 $31.26 $206 - - $206 $41,285

Film Articles 1 0 $80.22 0.75 $72.22 0 $31.26 $54 - - $54 $54

Bona Fide 170 6 $80.22 15 $72.22 1 $31.26 $1,596 - - $1,596 $271,308

5(e) Test 14 38.8 $80.22 121.45 $72.22 8.75 $31.26 $12,158 - $144,287 $156,444 $2,190,222

Non-Testing 5(e) 19 19.5 $80.22 18 $72.22 12.5 $31.26 $3,255 - - $3,255 $61,846

NOC 404 0 $80.22 0.6625 $72.22 0.0625 $31.26 $50 - - $50 $20,120

New CDX 

Registration 392 0.132 $80.22 0.528 $72.22 0 $31.26 $49 - - $49 $19,099

Total $36,764,017

1 Labor costs are calculated by multiplying burden hours by the wage rate for each labor category and summing across labor categories.

2 Delay costs calculated using the average of low and high estimates from “Regulatory Impact Analysis of Amendments to Regulations for TSCA section 5 Premanufacture Notifications” 

September 9, 1994 (RIA, 1994), updated to $2014 using Bureau of Labor Statistics Producer Price Index data for the chemical manufacturing industry. MCANs are assumed to have the 

same delay costs as PMNs.

3 User fees charged by EPA, except where noted. These were assumed to remain constant since ICR, 2000.

4 Average cost per notice is the sum of labor costs, delay costs and fees.

5 This figure is for a representative testing regimen consisting of 835.3110 (ready biodegradability), 850.1010, 850.1075, 850.5400 (aquatic base set), and OECD 407 (28-day repeated 

dose), based on an analysis of average costs for 277 testing cases and inflated to $2014 using the Bureau of Labor Statistics (BLS) Employment Cost Index (ECI) series for private 

industry White Collar Workers

6 While companies incur costs for control equipment, such costs are outside the scope of this ICR
Page 33 of 37

6(e) Estimating Agency Cost

The Agency costs associated with this information collection are estimated to total 

$6,365,397 (Table 7). Costs to the government include: (1) initial review of PMN substances 

(after which the majority of cases are dropped from further regulatory review), and (2) 

comprehensive reviews on a minority of chemicals, during which the Agency conducts a more 

thorough evaluation of the potential risks associated with manufacturing, processing, use and 

disposal of PMN substances including, if necessary, taking regulatory action under TSCA 

sections 5(e) or 5(f).

In order to determine the total cost for the Agency, an average cost was first computed 

for each type of notice. The Agency cost per notice was computed by multiplying the Agency

labor hours for each notice, as reported in various sources, by the current Agency labor cost per 

hour for a fully loaded GS-13, step 5 employee in the Washington D.C. area, and then adding 

updated extramural costs for contractor support. The average cost per notice was then multiplied 

by the expected number of notice submissions and summed across notice types to obtain the total 

Agency cost.

Agency wage rate data used to calculate labor costs were gathered from the U.S. Office

of Personnel Management Salary Table 2014-DCB, for a GS-13, step 5, employee in the 

Washington, D.C. area. A loading factor of 1.6 was applied to the base rate to arrive at the 2014

loaded wage rate of $164,691 per year. The hourly wage rate was computed by dividing the 

loaded wage by 2,080 hours, the hours associated with a full time employee. This loaded hourly 

wage was used in calculations of Agency cost.
Page 34 of 37

Table 7. Total Agency Cost Calculation

Type of Notice

Average 

Annual 

Responses

Agency 

Labor 

Hours1

Hourly 

Wage 

Rate

Labor 

Costs2

Extramural 

Costs3

Avg. Cost 

Per Notice4

Total 

Agency 

Burden

Total Agency 

Cost6

PMN 591 53.3 $79.18 $4,220 $987 $5,208 31,500 $3,077,749

SNUN 7 53.3 $79.18 $4,220 $987 $5,208 373 $36,454

MCAN 10 886 $79.18 $70,153 - $70,153 8,860 $701,535

Exemption:

TME 5 90 $79.18 $7,126 - $7,126 450 $35,631

LVE/LoREX 385 18 $79.18 $1,425 $703 $2,129 6,930 $819,497

TERA 1 1,225.00 $79.18 $96,996 - $96,996 1,225 $96,996

Tier I and II 1 155 $79.18 $12,273 - $12,273 155 $12,273

Polymer 292 1 $79.18 $79 - $79 292 $23,121

R&D 200 - $79.18 - - $0 0 $0

Film Articles 1 1 $79.18 $79 - $79 1 $79

Bona Fide 170 2 $79.18 $158 $149 $307 340 $52,180

5(e) Test 14 1,245.00 $79.18 $98,579 - $98,579 17,430 $1,380,107

Non-Testing 5(e) 19 65 $79.18 $5,147 - $5,147 1,235 $97,787

NOC 404 1 $79.18 $79 - $79 404 $31,989

New CDX Registration 392 - $79.18 - - - - -

Total 69,195 $6,365,397

1Economic Analysis of the Premanufacture Notification Electronic Reporting Final Rule (2009).

2 Labor costs calculated as labor hours multiplied by Agency wage rate. Wage rate based on salary taken from Salary Table 2014-DCB, U.S. Office of Personnel 

Management.

3 Extramural costs for contractor support. Values taken from RIA, 1994 (except for SNUN value, taken from “Burden Cost Analysis Supporting the Information 

Collection Request Renewal for TSCA Section 5 Premanufacture Notifications,” August 15, 2003) and updated to $2014 using the Bureau of Labor Statistics 

(BLS) Employment Cost Index (ECI) series for private industry White Collar Workers.

4 Agency labor costs plus extramural costs.
Page 35 of 37

6(f) Reasons for Change in Burden

This renewal reflects a decrease in the total estimated respondent burden of 13,220 hours 

(from 117,176 hours to 103,956 hours) from that currently in the OMB inventory. This decrease 

is mainly the result of a decrease in the number of annual PMN, SNUN, TME, LVE/LoREX,

TERA, Tier I and II, and NOC submissions (from 1,603 submissions to 1,394 submissions),

reflecting the most recent EPA data available. The change is augmented by corrections to errors 

found in the previous ICR – mainly rounding errors and errors associated with recordkeeping 

burden for some submissions.

Table 8. Summary of the Change in Burden

Burden Change

Starting Burden 117,162

Change due to Adjustments -13,205

Change due to correcting rounding errors from previous ICR -634

Change resulting from removing the additional recordkeeping 

burden estimates for PMNs, SNUNs, LVEs, and LoREXs -1,146

Change resulting from adding CDX registration burden for new 

submitters 259

Change due to decrease in the annual number of PMN, SNUN, 

TME, LVE/LoREX, TERA, Tier I and II, and NOC submissions -16,057

Change due to increase in the annual number of MCANs, 

Polymer Exemptions, Bona Fides, 5(e) Testing and non-5(e) 

Testing activities

4,372

Change due to Program Changes 0

Total 103,956

Note: Totals may not be exact due to rounding.

6(g) Burden Statement

The annual public burden for this collection of information, which is approved under 

OMB Control No. 2070-0012, is estimated to range between 0.725 hours and 508 hours per 

response depending upon the type of response. Burden is defined in 5 CFR 1320.3(b). An agency

may not conduct or sponsor, and a person is not required to respond to, a collection of 

information unless it displays a currently valid OMB control number. The OMB control number 

for this information collection appears above. 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-HQOPPT-2014-0735, which is available for online viewing at www.regulations.gov, or in-person 

viewing at the Pollution Prevention and Toxics Docket in the EPA Docket Center (EPA/DC). 

The EPA/DC Public Reading Room is located in the West William Jefferson Clinton Bldg., 

Room 3334, 1301 Constitution Ave., N.W., Washington, DC. The 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 the EPA/DC Public Reading Room is (202) 566-1744, and the 

telephone number for the Pollution Prevention and Toxics Docket is (202) 566-0280.
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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-2014-0735 and OMB Control No. 2070-

0012, to (1) EPA online using 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.
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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-2014-0735. 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. 2604 - Section 5 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 700 - General. Also available online at the National 

Archives and Records Administration’s Electronic CFR website

Attachment C: 40 CFR part 720 - Premanufacture Notification. Also available online 

at the National Archives and Records Administration’s Electronic CFR 

website

Attachment D: 40 CFR part 721 (excluding subpart E) - Significant New Uses Of 

Chemical Substances. Also available online at the National Archives and 

Records Administration’s Electronic CFR website

Attachment E: 40 CFR part 723 - Premanufacture Notification Exemptions. Also 

available online at the National Archives and Records Administration’s

Electronic CFR website

Attachment F: 40 CFR part 725 - Reporting Requirements And Review Processes 

For Microorganisms. Also available online at the National Archives and 

Records Administration’s Electronic CFR website

Attachment G: EPA Form 7710-25 - Premanufacture Notice. Also available online at 

http://epa.gov/oppt/newchems/pubs/pmnforms.htm

Attachment H: Instruction Manual for TSCA Section 5 Reporting. Also available 

online at http://www.epa.gov/oppt/newchems/pubs/tscaman2.pdf

Attachment I: EPA Form 7710-56 - Notice of Commencement of Manufacture or 

Import. Also available online at 

http://epa.gov/oppt/newchems/pubs/noc2.pdf

Attachment J: Copy of Consultations Message Sent by EPA to Potential Respondents

Attachment K: Public Comments Received

Attachment L: EPA Response to Public Comments