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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: 0574.15 OMB Control No.: 2070-0012

1(b) Short Characterization

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 or 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 or 

import of that chemical. Similarly, TSCA section 5 requires a significant new use notice 

(SNUN) from any person who proposes to manufacture, import or process a chemical for a use 

that is determined to be a “significant new use.” 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).

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

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

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

chemical substances. On the basis of its review, EPA may take regulatory action with respect to 

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

proposed new use. If EPA takes no action within the 90-day review period for PMNs (30 or 45 

days for PMN exemption applications), the submitter is free to manufacture or import the new 

substance, or to manufacture, import or process the substance for a new use. EPA requires that 

the submitter inform EPA when non-exempt commercial manufacture, processing or importation 

of the substance in question actually begins by submitting a Notice of Commencement.

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) (October 13, 2005; 70 FR 59848; FRL-7977-1) 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. 
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In light of GPEA and CROMERR, EPA published a final rule entitled, “TSCA Section 5 

Premanufacture and Significant New Use Notification Electronic Reporting; Revisions to 

Notification Regulations” (RIN 2070-AJ41) (75 FR 773) to amend the Toxic Substances Control 

Act (TSCA) section 5 Notification regulations and related provisions to phase-out paper-based 

submissions and facilitate the introduction and use of a new electronic reporting mechanism. 

This action enables, and eventually will require, manufacturers, importers, 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).

The Agency introduced CDX reporting in two phases over a two-year period. From 

April 6, 2010 (the effective date of the rule) 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 are 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 will no longer be accepted beyond the second year after the final 

rule’s effective date, April 6, 2012. After this, all submitters will be required to submit 

electronically via CDX using the e-PMN software. The Agency incorporated this phased 

approach because it allows 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 also apply to the SNUN requirements in 40 CFR 

721.25(a). 

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 above.

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 and importers of new 

chemical substances to submit to the Administrator of EPA a premanufacture notice (PMN) of 

intent to manufacture or import a new chemical substance at least 90 days before manufacture or 

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

manufacture, import or process a chemical substance for a use that EPA has by rule 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 
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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. If EPA takes no 

action at the end of 90 days, the submitter is free to manufacture or import 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. For the purposes of this 

policy, all microorganisms of different genera (intergeneric) are considered “new.” 

Manufacturers and importers of these new microorganisms must submit to EPA a microbial 

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

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

substances.

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

possession or control and TSCA section 5(d)(1)(C) requires submitters to 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 there 

may be significant or substantial human or environmental 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 the new chemical. TSCA section 5(e) Consent Orders typically include

exposure or release mitigation, testing, labeling and hazard communication, and record keeping.

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.

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 

or imported the substance, EPA may promulgate a SNUR under TSCA section5(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 
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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 allows EPA to receive reporting on such uses, review them and, if necessary, 

regulate the uses before they occur. Once a use is determined to be a “significant new use,” a 

person must submit a SNUN to EPA at least 90 days before that person may manufacture, 

process or import 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.

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 or imported 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:
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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 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 activities described in the notice. See 40 CFR 725.428.

Finally, under TSCA section 26(b), EPA requires manufacturers, importers and 

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

Significant New Use Notices (SNUNs) submitted under TSCA sections 5(a) and (h) to help 
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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 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.

The amended PMN form includes a new User Fee Payment Identity Number field to 

enable the Agency to match more easily a particular user fee with a particular notice submission. 

A User Fee Payment Identity Number is required that could 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 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 (http://ecfr.gpoaccess.gov).

2(b) Use/Users of the Data

TSCA gives EPA authority to regulate the manufacture or import of a new chemical 

substances if EPA determines that: (1) the substance may present an unreasonable risk of injury

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

disposal or (2) the substance may be produced in substantial quantities, and that there may be 

substantial or significant exposure/release. 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 vast 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 produced in substantial quantities, and may result in substantial or significant 

exposure/release.
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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 

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 or import 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). 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 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 or import a substance or 

microorganism may change after making a PMN or MCAN submission, EPA requires 

companies to notify the Agency when manufacture or importation 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 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 form (EPA Form No. 7710-56) for NOCs (see 

Attachment I). The form is not required for microorganisms. The use of a standard form 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 must prepare or review these notices. The required use of a 
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standard reporting form also reduces EPA processing time for NOCs.

EPA publishes in the Federal Register information summarizing the content of each 

notice, including the generic name of the chemical substance, the proposed uses and certain test 

data submitted with the notice, as required by TSCA section 5(d)(2). EPA publishes at the 

beginning of each month a list of PMN notices and polymer exemption applications that have 

been received, those that are still under review and those for which the review period has ended. 

This publication is mandated by TSCA section 5(d)(3). TSCA also requires EPA to publish a 

notice of receipt of a test-marketing application so that the public may comment, and another 

notice stating whether the application was granted or denied.

Periodically EPA compiles certain information such as the number of notices submitted 

and their disposition. This information is presented on EPA’s website. See 

http://www.epa.gov/oppt/newchems/tools/status1.htm and http://www.epa.gov/oppt/ar/.

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

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

MCAN microorganisms, the notice of commencement was submitted when 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 of 

the Chemical Control Division within 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 
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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 

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

Prior to submission to OMB, this ICR will be made available to the public for comment 

through a Federal Register notice. The public will have 60 days to provide comments. Any

comments received will be given consideration when completing the supporting statement that is 

submitted to OMB. 

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 Chems Conference), and 

active participation in the ORCD Clearing House on New Chemicals. 

In addition to the public notice and comment period required by the OMB regulations 

that implement the Paperwork Reduction Act (see Section 3(b) of this Supporting Statement), the 

OMB regulations, 5 CFR 1320.8(d)(1), also require agencies to consult with potential ICR 

respondents and data users about specific aspects of an ICR before the agency submits the ICR to 

OMB for review and approval. In accordance with this regulation and based on OCSPP

Regulatory Coordination Staff guidance, EPA will solicit comments from potential ICR 

respondents and data users with respect to the renewal of this ICR.

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. Submission of information thus is on an as-needed, on-occasion 

basis, initiated by respondents. 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 respondents not being required to submit data at all. However, without such data, 

EPA would be unable to administer the new chemical review requirements found in TSCA and 

would be unable to carry out its mandate to protect the public from unreasonable risks to health 

and the environment.
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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 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. 3M Company v. Carol Browner and EPA, 17F.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 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 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 and procedures for photocopying and 

transmitting CBI. 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 information while 
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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

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/NAIC Codes

This information collection affects companies that manufacture, process or import 

chemical substances. These companies are typically found in NAIC major groups 325 

(Chemical Manufacture) and 324 (Petroleum and Coal Products).

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 is 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;
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 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;

 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. However, after the effective date 

of the e-PMN 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.
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The amended e-PMN form also includes a new User Fee Payment Identity Number field 

to enable the Agency to match more easily a particular user fee with a particular notice 

submission. A User Fee Payment Identity Number will be required and may be a check number, 

a wire transfer number, or a “Pay.gov” transaction number used to transmit the user fee. This 

information is presently in the submitter’s possession

The second new information element on the amended PMN form is optional and consists 

simply of the e-mail addresses for the principals listed on the Submitter Identification section of 

the PMN form. This information will help 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 either using 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 or import 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 testmarketing 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 

declare that an application contains insufficient information to make an evaluation. Any

person who receives a test-marketing 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 or importer 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
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1. For the low volume exemption (LVE) (40 CFR 723.50(1)), 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(2)), 

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 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 

microorganisms. Applicants are required to include adequate information in their 

exemption so that the Agency can make a determination that the microorganism will not 

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 

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 or import, 

certifying compliance with the exemption criteria and include the site of manufacture or 

import.
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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 or importation of a new chemical begins. Required reporting 

information includes the following:

 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 manufacture or importation 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, Notices of Commencement 

must be submitted to EPA using the standard Notice of Commencement 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 or 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 are required to 

provide the specific chemical identity of the substance in question, a signed statement that the 

submitter intends to manufacture or import that substance, a description of the research and 

development activity conducted on that substance, a description of the intended use of the 
Page 16 of 34

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.

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 or import 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 ePMN rule electronic reporting requirements.

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

manufacturers, importers 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), notice submitters must keep the following data for five years 

from the date of commencement of manufacture, import, 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 
Page 17 of 34

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 and importation volumes of the PMN substance, with associated 

dates of manufacture or importation; (2) documentation of the names and addresses of all 

persons outside the site of manufacture or import 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 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

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;
Page 18 of 34

 Files and stores submissions including transfer of data submitted on optical disc 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.

5(b) Information Requested

(i) Data items, including record keeping requirements

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

form that were incorporated into that software, 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-PMNsoftware, 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 
Page 19 of 34

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 him or her an e-mail notification. 

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

In all cases, respondents use the e-PMN software to:

 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 and paper 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 fill out the form or attach a cover letter for 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).
Page 20 of 34

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.

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. 

Paper

After the e-PMN finalization step was complete, respondents would print submission 

materials using the e-PMN software, sign them as required, and deliver the submission to EPA 

via US Mail or courier.

Optical disc

After the e-PMN finalization step is complete, respondents prepare the data generated by

the e-PMN software in XML for transfer to an optical disc. With limited exception, discs will be 

submitted with an original signed hard copy of page 2 (Certification page) and a hard copy of 

page 3 (a copy of page 3 is needed for contact information in the event that the disc is not 

readable). A disc-based TMEA submission only needs to be accompanied by a hard copy of the 

completed page 3. For biotechnology notices, a signed hard copy of the biotech certification 

needs to accompany the disc. Discs need to be delivered only by courier service to avoid damage 

to the disk from the Agency’s mail screening equipment.
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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. The e-PMN software 

is available as a free internet download. The Agency makes available free optical discs 

containing the software. 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.

The Agency introduced the electronic submission software in two phases. The first year, 

the Agency allowed the submission of information for notices and support documents via CDX, 

optical disc, and using paper forms generated with the e-PMN software. All paper submissions 

were eliminated after April 6, 2011, for all new section 5 notices and support documents whose 

parent notices were submitted after the new system was implemented (April 6, 2010). Disc 

submissions generated using the e-PMN software will be eliminated April 6, 2012 (the end of the 

second year) for all new section 5 notices and support documents whose original notices were 

submitted after the new system was implemented. After April 6, 2012, only electronic 

submissions via CDX will be allowed for new section 5 notices and support documents whose 

related notices were submitted after the new system was implemented. Support documents 

whose parent notices were submitted before the new system was implemented will still need to 

be mailed as hard copy to the Agency. NOCs and support documents that are submitted to the 

Agency for review after implementation of CDX-based submissions, but that are related to 

section 5 notices that were submitted to the Agency for review before implementation of CDXbased submissions, will still be required to be submitted on paper; however, EPA is planning to 

revise this requirement in the future and enable submitters to provide them to the Agency

electronically. The Agency took this position because although the section 5 notices received 

after implementation of the new system will be entered into a newly created database, section 5 

notices submitted before promulgation of this rule will only exist in the “legacy” database, i.e., 

the database used prior to promulgation of this rule. This will similarly be the case for SNUNs 

and related support documents. Support documents that are submitted to the Agency for review 

after implementation of CDX-based submissions but that are related to SNUNs that were 

submitted to the Agency for review before implementation of CDX-based submissions will also 

still have to be submitted by paper. The Agency will prefer to allow everything to be submitted 

electronically; however, at this time the Agency does not have the resources to enter 

placeholders for old files in the new system to accommodate support documents and NOCs that 

will ultimately be submitted to the Agency for section 5 notices and SNUNs submitted prior to 

the effective date of this rule.
Page 22 of 34

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. 

However, since the Agency has no system for collecting official signatures for forms submitted 

on an optical disc, such as a CD, original signatures have to accompany the disc and any paper 

forms submitted during the phase-in period.

The Adobe electronic form that was in use for filling out the PMN form used a “header” 

page at the beginning of the PMN form. The “header” page asked for certain information for the 

purpose of adding or spawning additional pages requested by the submitter. In the new e-PMN 

software, there are header pages for support documents, and attachments that identify submitters 

and the nature of their communications. These header pages allow the software to identify and 

store data correctly in the Agency’s databases when submitted by paper.

Submitters are required to use the e-PMN software to generate section 5 notices and 

support documents regardless of whether they are submitted via CDX or delivered on a disc, or 

were submitted on paper. A notice may have been submitted on paper; however, for the notice 

to be declared complete, the entire PMN form must have been generated and “finalized” using 

the software. Disc submissions must be accompanied by an original, signed, hard copy of page 2

of the new e-PMN form (the Certification page), and page 3, (contact information in case the 

submitted disc is unreadable). All e-PMN software users, regardless of how a document is

submitted, need to undergo a “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 whose data have not undergone the 

“finalization” step are declared incomplete. This step is necessary to allow for an accurate and 

efficient transfer of data from an optical disc or a paper-based form 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 biggest difference between the old and new methods of data entry on the e-PMN 

form is the user interface. Data now are entered through a series of pages or screens on the 

computer as opposed to being entered on the form itself. Most screens represent a page of the 

printed e-PMN form. For those submitters who would like to see how their data look on the ePMN form once filled out, the new software allows the submitter to navigate between the e-PMN 

form and a PDF version. The PDF or printed version has the look of the original or current paper 

PMN form; however, submitters should not submit the PDF to the Agency because this

submission is in the wrong format and thus would be declared incomplete. Only the “finalized” 

read-only XML file folder is accepted by the Agency. 

The questions and pagination on the new e-PMN form are the same as on the old PMN 

form, except that fields on the print form have been expanded to make more room for submitter 

information, which results in the total number of pages being greater. Fields on the new print 

form have been realigned to make the form easier to scan. 
Page 23 of 34

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.

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 new 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 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 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, importers and 

processors of chemical substances. This office has established a hotline to assist small 

businesses complying with TSCA rules. It provides material such as copies of Federal Register
Page 24 of 34

notices, advisories, and other information on request. It also publishes the bi-monthly

Chemicals-in-Progress bulletin that identifies activities in EPA. 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 data bases that reference scientific literature and data bases 

containing previously submitted chemical information. These data bases allow EPA to exempt 

submitters from needlessly providing already-published data or resubmitting previously

submitted information (unless the previously submitted information was claimed confidential).

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 respondents.

6 ESTIMATING THE BURDEN AND COST OF THE COLLECTION

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

applications: test-marketing exemption (TME), low volume exemption (LVE), low exposure/low 

release exemption (LoREX), TSCA Experimental Release Applications (TERAs), and Tier I and

II exemption applications. It also covers submission of Bona Fide claims, and the burden 

associated with implementation of TSCA section 5(e) consent order restrictions. Since the 1995 

amendments, polymer exemptions are no longer submitted, and so are not included in this 

analysis. Since the last renewal of this ICR in 2007, phase-in of the e-PMN rule has begun, 

reducing the burden hours on submitters.

Burden and cost calculations are based on the assumption that EPA will receive 

approximately 1,968 TSCA section 5 notices each year, based on the latest estimate of annual 

notices submitted to EPA, based on the Economic Analysis of the Premanufacture Notification 

Electronic Reporting Final Rule (2009) (Table 1). 
Page 25 of 34

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; and (2) 

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

toxicity testing.

6(b) Burden Associated with Reporting

As shown in Table 1, the total respondent reporting and 3rd-party notification burden 

associated with this information collection is estimated to total 114,036 hours. This burden 

estimate is calculated by multiplying the hours of reporting burden by the number of each type of 

notice that EPA expects to receive and summing across the notice types. 

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

estimated according to data provided in the Economic Analysis of the Premanufacture 

Notification Electronic Reporting Final Rule (2009).

Prior to the 1995 amendments to the PMN rule, 70% to 80% of all TSCA section 5 

notices were full PMN submissions. Since the amendments of 1995, the increase in exemptions 

has not significantly changed this distribution. EPA expects few persons to submit significant 

new use notices (SNUNs). The number of SNUNs submitted is a function of the number of 

chemicals regulated under Significant New Use Rules, which are relatively few. Current data 

suggest the Agency expects to receive approximately 8 SNUNs annually.

The amendments also placed stricter control on bona fide claims, intended to establish 

bona fide intent. This was done in response to the steadily increasing number of bona fide 

notices submitted to EPA. The result of the amendments has been a significant reduction in bona 

fide submissions. Current EPA data suggest that 116 bona fide notices are expected to be 

submitted annually.

On average, LVE and LoREX exemptions are expected to account for about 419 notices 

annually. Further, TME are expected to average 8 applications per year, or less than 1% of all 

TSCA section 5 notices.

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% of the total TSCA section 5 notices. Based on historical data, EPA estimates 28

cases would be subject to TSCA section 5(e) consent order restrictions burden, with 12 cases 

requiring test data, and 16 non-testing TSCA section 5(e) cases. Testing is usually contracted 

out to a laboratory, thus the burden associated with testing requirements represents the time that 

personnel from the submitting firm would spend overseeing the testing, assumed to be 25% of 

the lab burden.
Page 26 of 34

The e-PMN rule reduces the burden hours on submitters by eliminating several hours, 

mainly clerical hours, of the paper submissions. Burden reduction resulted from eliminating the 

time and expense of preparing and mailing hardcopy notices. Paper submissions of Section 5 

notices will no longer be accepted after April 6, 2011 and notices submitted on optical discs will 

no longer be accepted after April 6, 2012.

Burden hours. Burden hours for each type of notice were estimated in previous 

analyses, as described below and summarized in Table 1.

 The hours for respondent reporting burden for a full electronic PMN submission is 

expected to average 92.2 respondent burden hours. This burden applies also to SNUN, 

LVE, and LoREX submissions since each of these notices requires the submission of a 

complete PMN form. 

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

 The respondent burden for submission of a TME is estimated to average 86.2 hours.

 The respondent burden for submission of a polymer exemption post-manufacture annual 

report is estimated to average 2 hours.

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

 The respondent burden for a Tier I or Tier II exemption is estimated to average 110.2

hours.

 The respondent burden for submission of a Notice of Commencement (NOC) is 

estimated to be 0.6 hours

 Submissions of instant photographic film articles exemption notices are incredibly 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, for the sake of this analysis, EPA 

assumes that 1 such exemption will be submitted per year. The minimum amount of 

information that is required to be contained in this exemption notification is 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.
Page 27 of 34

Table 1. Reporting Burden

Type of Notice

Average Annual 

Responses1

Average Reporting Hours 

per Response

Average Annual 

Burden

PMN 720 92.2 66384

SNUN 8 92.2 737.6

MCAN 3 288.2 864.6

Exemptions:

 TME 8 86.2 689.6

 LVE/LoREX 419 92.2 38631.8

 TERA 2 507.2 1014.4

 Tier I and II 3 110.2 330.6

 Polymer 17522 3504

 Research & Development 200 2.5 500

 Instant Photographic Film

 Articles 1 0.5 0.5

Bona Fide 116 20 2320

5(e) Test 12 151 1812

Non-Testing 5(e) Burden 16 25 400

NOC 443 0.6 265.8

Total Respondent Reporting Burden Hours

 

117,455 

1Economic Analysis of the Premanufacture Notification Electronic Reporting Final Rule (2009)

2Although the information requirements of the polymer exemption are expected to apply to 175 new polymers 

reports per year, EPA only expects to receive 29 post-manufacture annual reports per year

The total number of estimated annual responses of all types is 2,126.

6(c) Burden Associated with Recordkeeping

The total respondent recordkeeping burden associated with this information collection is 

an estimated 2,861 hours (Table 2). 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.

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 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 is based on the recordkeeping burden associated with essential technical requirements, 

such as records that demonstrate that the first commercial batch of chemical manufactured for 

commercial purposes under the exemption met certain eligibility criteria. The recordkeeping 

burden 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 2.
Page 28 of 34

Table 2. Respondent Recordkeeping Burden

Type of Notice

Average Annual 

Responses Hours for Recordkeeping

Average Annual 

Burden

PMN 720 1 720

SNUN 8 1 8

MCAN 3 1 3

Exemptions:

 TME 8 1 8

 LVE/LoREX 419 1 419

 TERA 2 1 2

 Tier I and II 3 1 3

 Polymer 175 4 700

 Research & Development 200 0.5 100

 Instant Photographic Film

 Articles 1 0.25 0.25

Bona Fide 116 2 232

5(e) Test 12 17.5 210

Non-Testing 5(e) Burden 16 25 400

NOC 443 0.125 55.375

Total Respondent Recordkeeping Burden Hours 2,861 

6(d) 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 $34,417,821 

(Table 3).

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 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 3 outlines the total average cost calculations for the various

types of notice submissions and presents the total respondent cost estimate.

Wages and fringe benefits 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 September 2010, 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 
Page 29 of 34

calculated separately for each labor category. For example, for September 2010, the average 

wage rate for professional/technical labor was $36.57; the average fringe benefit was $18.54. 

Fringe benefits as a percent of wages were $18.54/$36.57, or approximately 50.7 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 September 2010 fully loaded wage for professional/technical labor is $36.57 × 

(1+0.506973 + 0.17) = $61.32.

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 (2003 dollars) as presented in the “Regulatory Impact Analysis of Amendments to 

Regulations for TSCA section 5 Premanufacture Notifications” (1994), and inflated to 2010

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

Manufacturing industry. 

The explicit costs or fees used to calculate the average cost per submission were taken 

from the 2007 ICR and have not been adjusted.

The total respondent burden hours and costs is the sum of reporting hours and 

recordkeeping hours, and the total costs for all expected notice submissions. Total respondent 

burden hours are 120,316 (117,455 reporting hours + 2,861 recordkeeping hours). As noted 

above, total respondent costs based on the expected number of TSCA section 5 notice 

submissions are $34,417,821.

6(e) Estimating Agency Cost

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

$6,397,518 (Table 4). 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 
Page 30 of 34

Total Agency Cost.

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

of Personnel Management Salary Table 2010-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 2010

loaded wage rate of $161,446 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 31 of 34

Table 3. 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

Total 

Avg. 

Cost Per 

Notice4

Respondent 

Cost6

Managerial Technical

Hours Wage($) Hours Wage($)

PMN 720 18.0 70.16 75.2 61.32 5,874 25,058 2,500 33,432 24,071,144

SNUN 8 18.0 70.16 75.2 61.32 5,874 25,058 2,500 33,432 267,457

MCAN 3 65.0 70.16 224.2 61.32 18,308 25,058 2,500 45,866 137,599

Exemptions: - -

 TME 8 17.0 70.16 70.2 61.32 5,497 - - 5,497 43,979

 LVE/LoREX 419 18.0 70.16 75.2 61.32 5,874 12,613 - 18,487 7,746,113

 TERA 2 129.0 70.16 379.2 61.32 32,303 - - 32,303 64,606

 Tier I and II 3 23.0 70.16 88.2 61.32 7,022 - - 7,022 21,066

 Polymer 175 3.0 70.16 3 61.32 394 - - 394 69,027

 Research & Development 200 1.3 70.16 1.75 61.32 195 - - 195 39,002

 Instant Photographic Film

 Articles 1 0.0 70.16 0.75 61.32 46 - - 46 46

Bona Fide 116 6.0 70.16 16 61.32 1,402 - - 1,402 162,641

5(e) Test 12 38.8 70.16 129.75 61.32 10,675 - 132,9615143,636 1,723,632

Non-Testing 5(e) Burden 16 19.5 70.16 30.5 61.32 3,238 - - 3,238 51,814

NOC 443 0.0 70.16 0.725 61.32 44 - - 44 19,694

Total Respondent Cost

 

$34,417,821 

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 2010$ 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 Total average cost 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.

6 While companies incur costs for control equipment, such costs are outside the realm of this ICR.
Page 32 of 34

Table 4. Total Agency Cost Calculation

Type of Notice

Average Annual 

Responses

Agency Labor 

Hours1 Wage Rate

Labor 

Costs2

Extramural 

Costs3

Total Avg. Cost 

Per Notice4 Agency Cost

PMN 720 53.0 77.62 4,114 987 5,101 3,672,619

SNUN 8 53.0 77.62 4,114 982 5,096 40,767

MCAN 3 886.0 77.62 68,771 - 68,771 206,314

Exemptions: - -

 TME 8 90.0 77.62 6,986 - 6,986 55,886

 LVE/LoREX 419 18.0 77.62 1,397 703 2,100 879,967

 TERA 2 1,225.0 77.62 95,085 - 95,085 190,169

 Tier I and II 3 155.0 77.62 12,031 - 12,031 36,093

 Polymer 175 1.0 77.62 78 - 78 13,584

 Research & Development 200 - 77.62 - - - -

 Instant Photographic Film

 Articles 1 1.0 77.62 78 - 78 78

Bona Fide 116 2.0 77.62 155 80 235 27,288

5(e) Test 12 1,245.0 77.62 96,637 - 96,637 1,159,643

Non-Testing 5(e) Burden 16 65.0 77.62 5,045 - 5,045 80,725

NOC 443 1.0 77.62 78 - 78 34,386

Total Agency Cost $ 6,397,518 

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 2003-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 2005$ using Bureau of Labor Statistics 

Producer Price Index data for the chemical manufacturing industry.

4

 Agency labor costs plus extramural costs.
Page 33 of 34

6(f) Reasons for Change in Burden

This request reflects a decrease in the total estimated respondent burden of 34,006 hours 

(from 154,322 hours to 120,316 hours) from that currently in the OMB inventory. This decrease 

represents a re-estimate in the number of annual submissions to reflect EPA's experiences since 

the most recent ICR. The decrease in the number of annual submissions is largely associated 

with the finalization of the e-PMN rule in 2010. The decrease is an adjustment.

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 1.5 hours and 84.8 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.

To comment on 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, EPA has established a public docket for this ICR under 

Docket ID No. EPA-HQ-OPPT-2010-1011. The docket is available for public 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 EPA West Building, Room 3334, 1301 Constitution Ave., 

NW., 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. An electronic version of the public docket is available 

through the Federal Docket Management System (FDMS) at www.regulations.gov. Use FDMS 

to submit or view public comments, access the index listing of the contents of the public docket, 

and to access those documents in the public docket that are available electronically. Once in the 

system, select “search,” then key in the docket ID number identified above. Also, you can send 

comments to the Office of Information and Regulatory Affairs, Office of Management and 

Budget, 725 17th Street, NW, Washington, DC 20503, Attention: Desk Office for EPA. Please 

include the EPA Docket ID Number EPA-HQ-OPPT-2010-1011 and OMB Control Number 

2070-0012 in any correspondence.
Page 34 of 34

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-2010-1011. 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 - 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://epa.gov/oppt/newchems/pubs/pmnforms.htm

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