May 10, 2004 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: 0574.12 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). 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 § 8( b) Inventory), must provide a premanufacture notice ( PMN) 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 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, 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.

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. May 10, 2004 2 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 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.

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. EPA uses this authority to take follow up action on new or existing chemicals that may not present an unreasonable risk in their original uses but may present an unreasonable risk should other uses occur that may result in different and/ or higher exposures to human beings or the environment. EPA determines that a new use is significant by examining the specific circumstances of each case.

A SNUR 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. May 10, 2004 3 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.

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.

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 testmarketing 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. May 10, 2004 4 ( 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:

° 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 peelapart 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. May 10, 2004 5 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 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.

Copies of TSCA section 5 and of 40 CFR Parts 700, 720, 721 ( excepting Subpart E), 723 and 725 are attached. 40 CFR Part 721, Subpart E, Significant New Uses for Specific Chemical Substances, which consumes nearly 200 pages in the Code of Federal Regulations, is not attached due to its volume. However, Subpart E ( 40 CFR 721.225 through 40 CFR 721.9973) is accessible on the Internet at http:// www. access. gpo. gov/ nara/ cfr/ waisidx_ 03/ 40cfr721_ 03. html or from the US Government Printing Office's " E CFR" prototype site at http:// www. gpoaccess. gov/ ecfr/.

2( b) Use/ Users of the Data TSCA gives EPA authority to regulate the manufacture or import of chemical substances that may present an unreasonable risk of injury to health or the environment from their manufacture, processing, distribution in commerce, use or disposal. 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.

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. May 10, 2004 6 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 Notice of Commencement results in EPA adding that substance to the TSCA Inventory.

EPA requires the use of a specific form ( EPA Form No. 7710 56) for Notices of Commencement of chemical substances. 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 standard reporting form also reduces EPA processing time for NOCs.

To facilitate EPA's ability to regulate new substances efficiently and expeditiously, EPA considers essential the capability to promulgate Significant New Use Rules ( SNURs) for new chemical substances without first issuing a TSCA section 5( e) consent order for the substance. Since the reporting requirements and provisions of a non section 5( e) SNUR apply also to the original PMN submitter, only one EPA action is required instead of two; fewer EPA resources are necessary and efficiency is gained as a non section 5( e) SNUR is more efficient than a combination of consent order and SNUR to regulate new chemical substances. May 10, 2004 7 EPA publishes in the Federal Register information summarizing the content of each notice, including the generic class 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 testmarketing 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 may be published in various EPA documents or other publications, e. g., Chemicals in Progress Bulletin, support documents for TSCA section 5 rulemakings.

The recordkeeping requirements for PMNs, MCANs, 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 Prevention, Pesticides and Toxic Substances, and in the Office of Enforcement and Compliance Assurance ( OECA), and Core TSCA Regional Coordinator Inspectors. In particular, staff of the New Chemicals Branch 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. OPPTS employees in the Regional Offices and OECA employees in Headquarters and in the Regions use TSCA section 5 data for compliance monitoring and enforcement purposes.

3 NON DUPLICATION, CONSULTATIONS AND OTHER COLLECTION CRITERIA 3( a) Non Duplication EPA is the only federal agency that regularly collects information on new chemical substances used for purely industrial applications. ( In instances where chemical substances with industrial applications also have drug or cosmetic uses, the Food and Drug Administration would have concurrent jurisdiction.) Therefore, the information submitters provide in a PMN or MCAN cannot be obtained elsewhere. However, data previously submitted to EPA need not be resubmitted if the following conditions are met: the data were submitted with no claims of confidentiality and the PMN ( or other TSCA section 5 notice) identifies the office or person to whom the data were submitted and May 10, 2004 8 the date of the submission.

3( b) Public Notice Required Prior to ICR Submission to OMB In proposing to renew this ICR, EPA provided a 60 day public notice and comment period that ended on February 13, 2004 ( 68 FR 69677, December 15, 2003 ). EPA received no comments during the comment period.

3( c) Consultations Since 1983, EPA has received hundreds of public comments from industry, public interest groups, trade unions and other governmental agencies on various aspects of the TSCA section 5 rules. Early in the Program, persons commented on the final PMN rule and notice form, and the clarification of polymers and revisions to four stayed provisions of the PMN regulation, particularly the R& D exemption. Industry comments to the PMN rule led to staying of various sections of the PMN rule and clarification of other sections. All these issues were resolved with the issuance of final revisions in April 1986.

The Agency reviewed and modified its standard recordkeeping requirements associated with various SNUR reporting triggers when issuing the final General Provisions for New Chemical Followup ( Generic SNUR) in July 1989. These more flexible recordkeeping provisions resulted from comments received by the Agency during public meetings with representatives of the Conservation Foundation, the Natural Resources Defense Council, the Chemical Manufacturers Association, the Chemical Specialties Manufacturers Association, the Synthetic Organic Chemicals Manufacturer's Association and individual chemical companies. In 1993 and 1995, EPA held several public meetings for the general public to discuss in detail the four PMN Rule Amendments that were published in March 1995. In December 1989 and June 1993 the biotechnology rule was discussed in public meetings of the Biotechnology Science Advisory Committee before the final biotechnology rule was published in 1997.

In addition, EPA has held various public meetings with interested parties. In June 1983, EPA officials held a two day seminar attended by 450 industry representatives. Discussions centered on PMN review procedures and clarification of PMN requirements. EPA has also held several seminars that included sessions on TSCA section 5 in February and May 1986 and May 1987, and participated in industry sponsored seminars ( e. g., American Chemistry Council and the Synthetic Organic Chemicals Manufacturers Association, " Living With TSCA" seminar series in April 1989, October 1990, October 1992, April 1994, October 1995, April 1997, November 1998, March 2001, March 2002, and April 2003).

EPA has arranged or actively participated in a number of scientific meetings and symposia of immediate relevance to the PMN program. Among the programs for which EPA has made substantial contributions ( often in collaboration with others) are the following: " Safer Chemicals Through Molecular Design," EPA sponsored, Crystal City, VA, 1983; " SAR and Toxicity Assessment," American Chemical Society, Gaithersburg, MD, 1984; workshop on " The Application of the Techniques of Computational Biological Chemistry to Environmental Problems," EPA Office of Research and Development, Research Triangle Park, NC, 1984; symposium on " Assessment for May 10, 2004 9 Potential Developmental Toxicants," EPA sponsored, at the 1985 Teratology Society Meeting in Calloway Gardens, GA.

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 or to arrange for the generation of data that otherwise are not available to the PMN program. These meetings have involved issues of hazard assessment ( health and environmental), exposure analysis ( occupational, environmental, consumer) and economics. Industry groups that have established an ongoing dialogue with EPA over the past several years include DETO/ ETAD ( an association of dyestuff manufacturers), acrylate manufacturers and pyridine manufacturers/ users. A workshop in April 1990 discussed the chemical category of epoxides with the Chemical Manufacturers Association and other industry, environmental and trade union organization representatives.

Finally, in renewing this information collection, EPA contacted a number of organizations to request their review of and comments on this ICR. The names of the organizations and the respective staff person at each organization EPA contacted, along with each person's telephone number and email address, are listed below.

American Chemical Society David Schutt 202 872 4477 d_ schutt@ acs. org American Chemistry Council, Inc. Larry Rampy 703 741 5855 larry_ rampy@ americanchemistry. com Biotechnology Industry Organization Brent Erickson 202 962 9200 berickson@ bio. org Consumer Specialty Products Association D. Christopher Cathcart 703 907 7600 ccathcart@ cspa. org Environmental Council of the States Steve Brown 202 624 3661 ceppstein@ sso. org Independent Petroleum Association of America Lee Fuller 202 857 4722 lfuller@ ipaa. org Synthetic Organic Chemical Manufacturers Association Jim Cooper 202 721 4100 copperj@ socma. com VA Department of Environmental Quality  FOSTTA Harry Gregori 804 698 4374 hegregori@ deq. state. va. us Working Group on Community Right to Know Paul Orum 202 234 8494 orum@ crtk. org In the end, none of the persons contacted chose to respond to EPA's solicitation for comments, with the exception of Mr. Harry Gregori of the Virginia Department of Environmental May 10, 2004 10 Quality. Mr. Gregori's response was simply to inform EPA that, since his organization was not a respondent to the information collection but rather a user of information that resulted from the information collection, he declined to offer any substantive comments on the information collection. A copy of Mr. Gregori's response appears as Attachment I to this document.

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 typically submit a PMN, SNUN, or MCAN at least 90 days prior to anticipated manufacturing or distribution of the substance for nonexempt 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.

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 fiveyear 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 § 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 May 10, 2004 11 720.87( 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 providing the public with as much information as possible.

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 NAICS 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:

° the common or trade name, chemical identity and molecular structure of the chemical in question;

° the categories or proposed categories of use of the chemical; May 10, 2004 12 ° an 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;

° a description of the byproducts resulting from the manufacture, processing, use or disposal of the chemical;

° an 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 ° the manner or method of the disposal of the chemical.

In addition, the submitter must provide any test data in the submitter's possession that indicates 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.

To facilitate the review of chemicals, EPA has developed a PMN reporting form ( EPA Form 7710 25, copy attached). 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. The submitter will be able to provide information in a format of his or her own choosing.

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 are not currently required to use the PMN form May 10, 2004 13 or any other prescribed reporting form. However, 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 test marketing activity, including its length and how it can be distinguished from full scale commercial production and research and development.

The Agency retains the right to 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:

1. For the low volume exemption ( LVE) ( 40 CFR 723.50( 1)), submitters are required to submit their exemption on the PMN form 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. The low exposure/ low release exemption ( LoREX) ( 40 CFR 723.50( 2)) encourages the use of pollution prevention practices through the development of manufacturing, processing and use techniques that minimize exposure to workers, May 10, 2004 14 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.

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.

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.

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.

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 non exempt commercial manufacture or importation of a new chemical begins. Required reporting information includes the following: May 10, 2004 15 ° the specific chemical identity of the chemical, and a generic chemical name if the specific name is considered confidential;

° the premanufacture notice number assigned by EPA;

° the date manufacture or importation commenced;

° the address of the site where manufacture commenced;

° the 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 ° a clear indication 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). 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 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.

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 May 10, 2004 16 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 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 May 10, 2004 17 limitations; and ( 9) documentation of compliance with disposal and release to water limitations.

( ii) 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;  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;  files and stores submissions;  proposes and implements regulatory action as appropriate; and  conducts site and record inspections and performs related compliance monitoring functions.

5( b) Collection Methodology and Management EPA encourages but does not require the submission of premanufacture notices and other submissions by electronic means ( see 40 CFR 720.40). EPA believes electronic submission reduces the reporting burden on industry, because it is intended to reduce both the cost and the time required to enter, review, edit and transmit the data. Electronic submission may also improve data quality because it facilitates correcting incorrect data or adding omitted data. There is no other new technology applicable to the collection of this information that would minimize the collection burden, nor has EPA been able to identify a more efficient, less expensive or more flexible means of obtaining the required data.

Respondents are able to submit TSCA section 5 notices electronically, using the " e PMN" May 10, 2004 18 form available at the New Chemicals website ( https:// cdx. epa. gov/ ssl/ pmn/ download. asp). The form uses Adobe Acrobat software that allows submitters to complete and save the form electronically, but then print it and mail it to EPA as hard copy as they have always done. About 15 20% of TSCA section 5 notices are submitted on this form. This was the first phase of an e PMN project that is to be followed with submitters being able to submit the form electronically via diskettes with a hard copy signature page.

The Agency is currently developing a data entry tool using technology that will allow pure electronic submittal of TSCA section 5 data. This technology will work with DOS as well as UNIXbased computers and uses XML technology for more efficient data transmittal. This approach will be designed so that data can be submitted using portable media, such as a CD ROM. However the proposed solution can easily be scaled to enable eventual submission of data over the Internet. The Agency contemplates in time receiving electronic TSCA section 5 notices via the Internet once security issues have been resolved and industry's preferences have been determined. No matter what electronic media the Agency decides upon, however, paper submissions will always be accepted.

Additionally, to aid persons subject to this information collection, OPPT has set up a TSCA Hotline that provides information regarding TSCA regulatory requirements. When Hotline staff are unable to answer questions regarding TSCA section 5, the questions are referred to OPPT staff for appropriate resolution.

5( c) 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 nonfinancial 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 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. May 10, 2004 1 The PMN submission information presented below is based on the " OPPT New Chemicals Annual Report;" U. S. EPA/ OPPT; October 2002 ( hereinafter referred to as OPPT, 2002). PMN burden data are from the " Regulatory Impact Analysis of Amendments to Regulations for TSCA Section 5 Premanufacture Notifications;" U. S. EPA/ OPPT/ Economics, Exposure and Technology Division/ Regulatory Impacts Branch; September 9, 1994; ( hereinafter referenced as " RIA, 1994a"). The information on biotechnology submissions is from " Regulatory Impact Analysis of Regulations on Microbial Products of Biotechnology;" U. S. EPA/ OPPT/ Economics, Exposure and Technology Division; January 21, 1997; ( hereinafter referenced as " RIA, 1997a").

19 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 prenotice 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. Prenotice communication coordinators respond to other pre notice inquiries that may pertain to the full scope of the TSCA section 5 regulations.

5( d) 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 Burden and cost calculations are based on the assumption that EPA will receive approximately 1,450 TSCA Section 5 notices each year, based on the average number of notices received for years 2000, 2001, and 20021 ( see Table 1). The trend since FY 1994 has been a significant decline in the number of TSCA section 5 notices received, from 2,645 in FY 1994, to 1,471 in FY 2002. Amendments to the PMN rule in 1995 eliminated the PMN requirement for eligible polymers, broadened the low volume exemption, and introduced the low release/ low exposure exemption. The overall effect of these amendments has been a significant decline in the submission of notices in general and of full PMNs in particular. In addition to chemical PMNs, this analysis covers submissions of Bona Fide claims, Microbial Commercial Activity Notices ( MCANs), TSCA Experimental Release Applications ( TERAs), and Tier I and II exemption applications, as required by the 1997 Microbial Products of Biotechnology rule.

6( a) Estimating Respondent Burden The burden to respondents includes: 1) reporting burden for submission of PMNs, SNUNs, exemption notices, and biotechnology notices; 2) reporting burden associated with implementation of TSCA Section 5( e) consent order restrictions such as the use of exposure controls and/ or performing toxicity testing; and 3) recordkeeping burden associated with notice submissions, consent orders, exposure controls and toxicity testing. May 10, 2004 20 6( b) Burden Hours Associated with Reporting As shown in Table I, the total respondent reporting burden associated with this information collection is estimated to total 160,037 hours. This burden estimate is calculated by multiplying the hours of reporting burden times the revised number of each type of notice that EPA expects to receive and summing across the notice types.

The hours for respondent reporting burden for a full PMN submission is estimated to range between 95 and 114 hours ( RIA, 1994), with an average respondent burden of 105 hours. This burden applies also to the submission of SNUN, LVE, and LoREX submissions since each of these notices requires the submission of a complete PMN form. The respondent burden for submission of a TME is estimated to average 98 hours ( RIA, 1994).

The respondent burden for an MCAN is estimated to range between 71 and 533 hours, with an average of 302 hours. The respondent burden for a TERA is estimated to range between 91 and 950 hours, with an average of 522. The respondent burden for a Tier I or Tier II exemption is estimated to range between 13 and 215 hours, with an average of 114 ( RIA, 1997).

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 SNURs, which are relatively few. Current data suggest the Agency expects to receive approximately 8 SNUNs annually ( OPPT, 2002).

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 only one bona fide notice is expected to be submitted annually.

Based on a review of submission data for 2000  2002, on average, Low Volume Exemptions and LoREX exemptions are expected to account for roughly 32% of submissions, or about 463 notices annually. Further, test market exemptions ( TME) are expected to average 7 applications per year, or less than 1% of all TSCA Section 5 notices ( OPPT, 2002).

The various exemptions available to submitters since the 1995 amendments have significantly reduced the need for consent order development and post notice data review. EPA data indicate that such consent orders and post notice data reviews will amount to roughly 2% ( 26/ 1450) of the total estimated 1,450 TSCA Section 5 notices ( OPPT, 2002). Based on historical data, EPA estimates 26 cases would be subject to either test data or non testing TSCA Section 5( e) burden with 12 cases requiring test data, and 14 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 May 10, 2004 21 lab burden.

Table 1 on the following page displays the overall respondent reporting burden.

Table I Reporting Burden Type of Notice Avg. Annual Responses Reporting Hours / Response Avg. Annual Burden PMNs 980 105 102,900 Exemptions TME 7 98 686 LVE / LoREX 463 105 48615 Polymer1 0 2 0 MCAN 1 302 302 TERA 2 522 1044 Tier I & II 30 114 3420 SNUN 8 105 840 5( e) Test 12 155 1860 Non Testing 5( e) Burden 14 25 350 Bona Fide 1 20 20 Total Respondent Reporting Burden Hours 160,037 Average Annual Responses computed as the average number of notices filed over 2000, 2001, and 2002 based on OPPT, 2002. 1 Since the 1995 amendments, polymer exemptions are no longer submitted. The exemption is included in this memo for consistency with prior ICRs.

6( c) Burden Hours Associated with Recordkeeping As shown in Table II, the respondent recordkeeping burden associated with this information collection is estimated to total 3,754 hours. This burden estimate is calculated by multiplying the estimated burden associated with each type of submission ( RIA, 1994), by the estimated number of submissions for each notice and summing across notice types. Once the respondent presents information in an initial TSCA Section 5 submission, the burden for maintaining or updating these records is minimal. The Agency assumes an aggregate annualized recordkeeping burden of two hours for each PMN, SNUN, exemption submission, or biotech submission. This is based on the recordkeeping burden associated with essential technical requirements, such as records that demonstrate that the first commercial batch of polymer manufactured for commercial purposes under the exemption met certain eligibility criteria. Such recordkeeping requirements allow the Agency substantially to eliminate all other data and reporting requirements associated with the polymer exemption. Recordkeeping burden for 5( e) testing and May 10, 2004 22 non testing burden are 35 and 25 hours, respectively ( RIA, 1994)

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

Table II Respondent Recordkeeping Burden Type of Notice Avg. Annual Responses Hours for Recordkeeping Avg. Annual Burden PMN 980 2 1,960 Exemptions TME 7 2 14 LVE / LoREX 463 2 926 Polymer 0 4 0 MCAN 1 2 2 TERA 2 2 4 Tier I & II 30 2 60 SNUN 8 2 16 5( e) Test 12 35 420 Non Testing 5( e) Burden 14 25 350 Bona Fide 1 2 2 Total Respondent Recordkeeping Burden Hours 3,754 Average Annual Responses computed as the average number of notices filed over 2000, 2001, and 2002 based on OPPT New Chemicals Annual Report, 2002.

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 $ 34,348,733, as presented in Table III below.

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. May 10, 2004 23 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 average cost per notice was calculated by summing each of the three cost components identified above for each type of notice. The average cost per notice was then multiplied by the expected number of notice submissions and summed across notice types to obtain the total industry cost. Table III below outlines the total average cost calculations for the various types of notice submissions and presents the total respondent cost estimate. May 10, 2004 24 Table III Total Respondent Cost Calculation Notice Average Annual Number of Responses Total Burden ( reporting + recordkeeping) and Wage Rate by Labor Category Labor Costs1 Delay Costs2 Fees3 Total Avg.

Costs Per Notice4 Total Respondent Cost Managerial Technical Clerical Hrs Wage($) Hrs Wage($) Hrs Wage($)

PMN 980 18 $ 57.60 75 $ 44.75 14 $ 24.71 $ 4,739 $ 19,416 $ 2,500 $ 26,655 $ 26,121,900 TME 7 17 $ 57.60 70 $ 44.75 13 $ 24.71 $ 4,433 $ 0 $ 0 $ 4,433 $ 31,031 LVE / LoREX 463 18 $ 57.60 75 $ 44.75 14 $ 24.71 $ 4,739 $ 9,773 $ 0 $ 14,512 $ 6,719,056 Polymer 0 0 $ 57.60 0 $ 44.75 0 $ 24.71 $ 0 $ 0 $ 0 $ 0 $ 0 MCAN 1 65 $ 57.60 224 $ 44.75 15 $ 24.71 $ 14,139 $ 19,416 $ 2,500 $ 36,055 $ 36,055 TERA 2 129 $ 57.60 380 $ 44.75 15 $ 24.71 $ 24,806 $ 0 $ 0 $ 24,806 $ 49,612 Tier I & II 30 23 $ 57.60 88 $ 44.75 5 $ 24.71 $ 5,386 $ 0 $ 0 $ 5,386 $ 161,580 SNUN 8 18 $ 57.60 75 $ 44.75 14 $ 24.71 $ 4,739 $ 19,416 $ 2,500 $ 26,655 $ 213,240 5( e) Test Data 12 38 $ 57.60 130 $ 44.75 22 $ 24.71 $ 8,550 $ 0 $ 73,6505 $ 82,200 $ 986,400 Non Testing 5( e) Burden 14 10 $ 57.60 25 $ 44.75 15 $ 24.71 $ 2,065 $ 0 $ 06 $ 2,065 $ 28,910 Bona Fide 1 5 $ 57.60 12 $ 44.75 5 $ 24.71 $ 949 $ 0 $ 0 $ 949 $ 949 Total Respondent Costs $ 34,348,733 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 RIA, 1994, updated to March 2003$ using Bureau of Labor Statistics Producer Price Index data for chemical and allied products 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 costs 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. May 10, 2004 25 Baseline respondent wage rates used to support the calculation of average cost per submission were obtained from the U. S. Bureau of Labor Statistics' March, 2003 Employer Costs for Employee Compensation for Private Industries, Manufacturing Industries, White collar occupations for managerial, technical, and clerical labor categories. The baseline wage for each labor category was multiplied by a loading factor computed for each category to determine the loaded average hourly wage. Loading factors for benefits are calculated separately for each labor category by dividing the benefits percentage of total compensation by the wage percentage of total compensation for each occupational group. An additional loading factor of 17 percent is applied for overhead. The final loading factor is thus calculated as: ( 1 + benefits loading factor + .17 overhead factor). The baseline wage for each labor category is then multiplied by its respective loading factor to obtain the loaded hourly wage rate. The loaded hourly labor rates for the different labor categories used in calculation of respondent labor cost are as follows: managerial  $ 57.60; technical  $ 44.75; clerical  $ 24.71.

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 of were computed using the midpoint of the low and high delay cost estimates presented in the 1994 RIA, inflated to March 2003 dollars using the Bureau of Labor Statistics' Producer Price Index data for Chemical and Allied Products industry.

The explicit costs or fees used to calculate the average cost per submission were taken from the 2000 ICR and have not been adjusted.

For PMNs and SNUNs, the average cost to respondents, including the standard user fee of $ 2,500, is estimated to be $ 26,655. The submission costs for low volume exemptions and low release/ low exposure exemptions is estimated to average $ 14,512. The cost for submission of test market exemptions is estimated to average $ 4,433.

As noted above, the amended PMN rule has place stricter requirements for submission of a bona fide notice, with submission expected to average about one a year. The average cost for Bona fide notices under the amended rule are estimated to be $ 949.

For biotech submissions, the average cost of submitting an MCAN is $ 36,055, including a user fee of $ 2,500; the average cost for a TERA is $ 24,806; and the average for a Tier I or Tier II exemption is $ 5,386.

Submitters required to perform 5( e) testing will incur an average of $ 8,550 in labor costs, plus lab fees averaging $ 73,650, for a total of $ 82,200. Non Testing 5( e) burden costs average $ 2,065.

The total respondent burden hours and costs therefore is the sum of reporting hours and recordkeeping hours, and the total costs for all expected notice submissions. Total respondent burden hours is 163,791 ( 160,037 reporting hours + 3,754 recordkeeping hours). As noted above, total respondent costs based on the expected number of TSCA Section 5 notice submissions are $ 34,348,733. 6( e) Estimating Agency Cost May 10, 2004 2 For a description of the calculation of extramural cost, see footnote 7 of figure 2.

26 EPA's costs associated with this information collection are estimated to total $ 7,307,840, as presented in Table IV below. Costs to the government include: 1) initial review of PMN substances ( after which the majority of cases are dropped from further regulatory review), 2) comprehensive reviews on a minority of chemicals, during which the Agency conducts a more through evaluation of the potential risks associated with manufacturing, processing, use and disposal of the PMN substance 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 average Agency cost per notice was computed by multiplying the Agency labor hours for each notice, as reported in the RIA, 1994, by the Agency labor cost per hour for a fully loaded GS 13, step 5 employee in the Washington D. C. area, plus updated extramural costs for contractor support2. The average cost per notice was then multiplied by the expected number of notice submissions and summed across notice types to obtain the Total Agency Cost.

Agency wage rate data used to calculate labor costs were gathered from the U. S. Office of Personnel Management Salary Table 2003 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 2003 loaded wage rate of $ 125, 221 per year ( PMN ICR, 2000). The final hourly wage 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.

Agency unit costs for review of full PMN notices are estimated to average $ 4,681. The costs for review of SNUNs are expected to total $ 4,670. The average cost to the Agency for a test market exemption review is estimated to be $ 6,540.

Agency costs associated with the polymer exemption are assumed to be $ 0 as these exemptions are no longer submitted. The costs to the Agency for Bona fide notices, based on data provided in the RIA, 1994, are expected to total $ 187.

Agency unit costs for LVE/ LoREX reviews average $ 1,911.

For biotech submissions, Agency costs average $ 64,020 per MCAN, $ 88,560 per TERA, and $ 11,220 for a Tier I or II exemption petition.

Agency costs to review 5( e) test data are estimated at $ 90,000 and non testing 5( e) costs are estimated at $ 3,900 per case.

Finally, the Agency estimates that tracking and validating fees cost the Agency approximately $ 40,000 per year.

Table IV Total Agency Cost Calculations May 10, 2004 27 Type of Notice Average Annual Number of Responses Agency Labor Hours Wage Rate Labor Costs6 Extramural Costs7 Total Avg.

Costs8 Total Agency Costs PMN 980 641 $ 60 $ 3,840 $ 841 $ 4,681 $ 4,587,380 TME 7 1092 $ 60 $ 6,540 $ 0 $ 6,540 $ 45,780 LVE / LoREX 463 221 $ 60 $ 1,320 $ 591 $ 1,911 $ 884,793 Polymer 0 0 $ 60 $ 0 $ 0 $ 0 $ 0 MCAN 1 1,0673 $ 60 $ 64,020 $ 0 $ 64,020 $ 64,020 TERA 2 1,4763 $ 60 $ 88,560 $ 0 $ 88,560 $ 177,120 Tier I or II 30 1873 $ 60 $ 11,220 $ 0 $ 11,220 $ 336,600 SNUN 8 641 $ 60 $ 3,840 $ 830 $ 4,670 $ 37,360 5( e) Test Data 12 1,5004 $ 60 $ 90,000 $ 0 $ 90,000 $ 1,080,000 Non Testing 5( e) Burden 14 655 $ 60 $ 3,900 $ 0 $ 3,900 $ 54,600 Bona Fide 1 21 $ 60 $ 120 $ 67 $ 187 $ 187 User Fee ( tracking and validation costs) $ 40,000 $ 7,307,840 1 RIA, 1994.

2 ICR, 2000.

3 RIA, 1997.

4 Estimated to be similar to TERA review.

5 Estimated to be similar to PMN / SNUN review.

6 Labor costs calculated as labor hours times Agency wage rate. Wage rate based on salary taken from Salary Table 2003 DCB, U. S. Office of Personnel Management.

7 Extramural costs for contractor support. RIA, 1994, updated to March 2003$ using BLS Producer Price Index for Chemical and Allied Products.

8 Agency labor costs plus extramural costs. May 10, 2004 28 6( f) Reasons for Change in Burden This request reflects a decrease in the total estimated burden of 20,817 hours ( from 184,608 hours to 163,791 hours) in the total estimated respondent burden from that currently in the OMB inventory. This decrease represents an adjustment in the number of annual submissions to reflect EPA's experiences since the most recent ICR. The decrease in the number of submissions per year is largely associated with the polymer and other exemptions implemented under the 1995 amendments.

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 average 102.1 hours per response, and to require 3.4 hours of recordkeeping per response. According to the Paperwork Reduction Act, " burden" means the total time, effort, or financial resources expended by persons to generate, maintain, retain, or disclose or provide information to or for a Federal agency. For this collection it includes the time needed to review instructions; develop, acquire, install and utilize technology and systems for the purposes of collecting, validating, and verifying information, processing and maintaining information, and disclosing and providing information; adjust the existing ways to comply with any previously applicable instructions and requirements; train personnel to be able to respond to a collection of information; search data sources; complete and review the collection of information; and transmit or otherwise disclose the information. 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. OPPT 2003 0065, which is available for public viewing at the Pollution Prevention and Toxics Docket in the EPA Docket Center ( EPA/ DC), EPA West, Room B102, 1301 Constitution Ave., NW, Washington, DC. The EPA Docket Center 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 Reading Room is ( 202) 566 1544 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 EPA Dockets ( EDOCKET) at http:// www. epa. gov/ edocket. Use EDOCKET 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 No. OPPT 2003 0065 and OMB control number 2070 0012 in any correspondence. May 10, 2004 28 Attachment A Toxic Substances Control Act Section 5 ( 15 U. S. C. 2604) May 10, 2004 Sec. 2604.  Manufacturing and processing notices ( a) In general ( 1) Except as provided in subsection ( h) of this section, no person may  ( A) manufacture a new chemical substance on or after the 30th day after the date on which the Administrator first publishes the list required by section 2607( b) of this title, or ( B) manufacture or process any chemical substance for a use which the Administrator has determined, in accordance with paragraph ( 2), is a significant new use,

unless such person submits to the Administrator, at least 90 days before such manufacture or processing, a notice, in accordance with subsection ( d) of this section, of such person's intention to manufacture or process such substance and such person complies with any applicable requirement of subsection ( b) of this section. ( 2) A determination by the Administrator that a use of a chemical substance is a significant new use with respect to which notification is required under paragraph ( 1) shall be made by a rule promulgated after a consideration of all relevant factors, including  ( A) the projected volume of manufacturing and processing of a chemical substance, ( B) the extent to which a use changes the type or form of exposure of human beings or the environment to a chemical substance, ( C) the extent to which a use increases the magnitude and duration of exposure of human beings or the environment to a chemical substance, and ( D) the reasonably anticipated manner and methods of manufacturing, processing, distribution in commerce, and disposal of a chemical substance.

( b) Submission of test data ( 1)( A) If ( i) a person is required by subsection ( a)( 1) of this section to submit a notice to the Administrator before beginning the manufacture or processing of a chemical substance, and ( ii) such person is required to submit test data for such substance pursuant to a rule promulgated under section 2603 of this title before the submission of such notice, such person shall submit to the Administrator such data in accordance with such rule at the time notice is submitted in accordance with subsection ( a)( 1) of this section. ( B) If  ( i) a person is required by subsection ( a)( 1) of this section to submit a notice to the Administrator, and ( ii) such person has been granted an exemption under section 2603( c) of this title from the requirements of a rule promulgated under section 2603 of this title before the submission of such notice,

such person may not, before the expiration of the 90 day period which begins on the date of the submission in accordance with such rule of the test data the May 10, 2004 submission or development of which was the basis for the exemption, manufacture such substance if such person is subject to subsection ( a)( 1)( A) of this section or manufacture or process such substance for a significant new use if the person is subject to subsection ( a)( 1)( B) of this section. ( 2)( A) If a person  ( i) is required by subsection ( a)( 1) of this section to submit a notice to the Administrator before beginning the manufacture or processing of a chemical substance listed under paragraph ( 4), and ( ii) is not required by a rule promulgated under section 2603 of this title before the submission of such notice to submit test data for such substance, such person shall submit to the Administrator data prescribed by subparagraph ( B) at the time notice is submitted in accordance with subsection ( a)( 1) of this section.

( B) Data submitted pursuant to subparagraph ( A) shall be data which the person submitting the data believes show that  ( i) in the case of a substance with respect to which notice is required under subsection ( a)( 1)( A) of this section, the manufacture, processing, distribution in commerce, use, and disposal of the chemical substance or any combination of such activities will not present an unreasonable risk of injury to health or the environment, or ( ii) in the case of a chemical substance with respect to which notice is required under subsection ( a)( 1)( B) of this section, the intended significant new use of the chemical substance will not present an unreasonable risk of injury to health or the environment. ( 3) Data submitted under paragraph ( 1) or ( 2) shall be made available, subject to section 2613 of this title, for examination by interested persons. ( 4)( A) ( i) The Administrator may, by rule, compile and keep current a list of chemical substances with respect to which the Administrator finds that the manufacture, processing, distribution in commerce, use, or disposal, or any combination of such activities, presents or may present an unreasonable risk of injury to health or the environment. ( ii) In making a finding under clause ( i) that the manufacture, processing, distribution in commerce, use, or disposal of a chemical substance or any combination of such activities presents or may present an unreasonable risk of injury to health or the environment, the Administrator shall consider all relevant factors, including  ( I) the effects of the chemical substance on health and the magnitude of human exposure to such substance; and ( II) the effects of the chemical substance on the environment and the magnitude of environmental exposure to such substance. ( B) The Administrator shall, in prescribing a rule under subparagraph ( A) which lists any chemical substance, identify those uses, if any, which the Administrator determines, by rule under subsection ( a)( 2) of this section, would constitute a significant new use of such substance. ( C) Any rule under subparagraph ( A), and any substantive amendment or repeal of such a rule, shall be promulgated pursuant to the procedures May 10, 2004 specified in section 553 of title 5, except that ( i) the Administrator shall give interested persons an opportunity for the oral presentation of data, views, or arguments, in addition to an opportunity to make written submissions, ( ii) a transcript shall be kept of any oral presentation, and ( iii) the Administrator shall make and publish with the rule the finding described in subparagraph ( A).

( c) Extension of notice period The Administrator may for good cause extend for additional periods ( not to exceed in the aggregate 90 days) the period, prescribed by subsection ( a) or ( b) of this section before which the manufacturing or processing of a chemical substance subject to such subsection may begin. Subject to section 2613 of this title, such an extension and the reasons therefor shall be published in the Federal Register and shall constitute a final agency action subject to judicial review. ( d) Content of notice; publications in the Federal Register ( 1) The notice required by subsection ( a) of this section shall include  ( A) insofar as known to the person submitting the notice or insofar as reasonably ascertainable, the information described in subparagraphs ( A), ( B), ( C), ( D), ( F), and ( G) of section 2607( a)( 2) of this title, and ( B) in such form and manner as the Administrator may prescribe, any test data in the possession or control of the person giving such notice which are related to the effect of any manufacture, processing, distribution in commerce, use, or disposal of such substance or any article containing such substance, or of any combination of such activities, on health or the environment, and ( C) a description of any other data concerning the environmental and health effects of such substance, insofar as known to the person making the notice or insofar as reasonably ascertainable. Such a notice shall be made available, subject to section 2613 of this title, for examination by interested persons. ( 2) Subject to section 2613 of this title, not later than five days ( excluding Saturdays, Sundays and legal holidays) after the date of the receipt of a notice under subsection ( a) of this section or of data under subsection ( b) of this section, the Administrator shall publish in the Federal Register a notice which  ( A) identifies the chemical substance for which notice or data has been received; ( B) lists the uses or intended uses of such substance; and ( C) in the case of the receipt of data under subsection ( b) of this section, describes the nature of the tests performed on such substance and any data which was developed pursuant to subsection ( b) of this section or a rule under section 2603 of this title.

A notice under this paragraph respecting a chemical substance shall identify the chemical substance by generic class unless the Administrator determines that more specific identification is required in the public interest. ( 3) At the beginning of each month the Administrator shall publish a list in the Federal Register of May 10, 2004 ( A) each chemical substance for which notice has been received under subsection ( a) of this section and for which the notification period prescribed by subsection ( a), ( b), or ( c) of this section has not expired, and ( B) each chemical substance for which such notification period has expired since the last publication in the Federal Register of such list. ( e) Regulation pending development of information ( 1) ( A) If the Administrator determines that  ( i) the information available to the Administrator is insufficient to permit a reasoned evaluation of the health and environmental effects of a chemical substance with respect to which notice is required by subsection ( a) of this section; and ( ii)( I) in the absence of sufficient information to permit the Administrator to make such an evaluation, the manufacture, processing, distribution in commerce, use, or disposal of such substance, or any combination of such activities, may present an unreasonable risk of injury to health or the environment, or ( II) such substance is or will be produced in substantial quantities, and such substance either enters or may reasonably be anticipated to enter the environment in substantial quantities or there is or may be significant or substantial human exposure to the substance,

the Administrator may issue a proposed order, to take effect on the expiration of the notification period applicable to the manufacturing or processing of such substance under subsection ( a), ( b), or ( c) of this section, to prohibit or limit the manufacture, processing, distribution in commerce, use, or disposal of such substance or to prohibit or limit any combination of such activities. ( B) A proposed order may not be issued under subparagraph ( A) respecting a chemical substance ( i) later than 45 days before the expiration of the notification period applicable to the manufacture or processing of such substance under subsection ( a), ( b), or ( c) of this section, and ( ii) unless the Administrator has, on or before the issuance of the proposed order, notified, in writing, each manufacturer or processor, as the case may be, of such substance of the determination which underlies such order.

( C) If a manufacturer or processor of a chemical substance to be subject to a proposed order issued under subparagraph ( A) files with the Administrator ( within the 30 day period beginning on the date such manufacturer or processor received the notice required by subparagraph ( B)( ii)) objections specifying with particularity the provisions of the order deemed objectionable and stating the grounds therefor, the proposed order shall not take effect. ( 2)( A) ( i) Except as provided in clause ( ii), if with respect to a chemical substance with respect to which notice is required by subsection ( a) of this section, May 10, 2004 the Administrator makes the determination described in paragraph ( 1)( A) and if  ( I) the Administrator does not issue a proposed order under paragraph ( 1) respecting such substance, or ( II) the Administrator issues such an order respecting such substance but such order does not take effect because objections were filed under paragraph ( 1)( C) with respect to it,

the Administrator, through attorneys of the Environmental Protection Agency, shall apply to the United States District Court for the District of Columbia or the United States district court for the judicial district in which the manufacturer or processor, as the case may be, of such substance is found, resides, or transacts business for an injunction to prohibit or limit the manufacture, processing, distribution in commerce, use, or disposal of such substance ( or to prohibit or limit any combination of such activities). ( ii) If the Administrator issues a proposed order under paragraph ( 1)( A) respecting a chemical substance but such order does not take effect because objections have been filed under paragraph ( 1)( C) with respect to it, the Administrator is not required to apply for an injunction under clause ( i) respecting such substance if the Administrator determines, on the basis of such objections, that the determinations under paragraph ( 1)( A) may not be made. ( B) A district court of the United States which receives an application under subparagraph ( A)( i) for an injunction respecting a chemical substance shall issue such injunction if the court finds that  ( i) the information available to the Administrator is insufficient to permit a reasoned evaluation of the health and environmental effects of a chemical substance with respect to which notice is required by subsection ( a) of this section; and ( ii)( I) in the absence of sufficient information to permit the Administrator to make such an evaluation, the manufacture, processing, distribution in commerce, use, or disposal of such substance, or any combination of such activities, may present an unreasonable risk of injury to health or the environment, or ( II) such substance is or will be produced in substantial quantities, and such substance either enters or may reasonably be anticipated to enter the environment in substantial quantities or there is or may be significant or substantial human exposure to the substance.

( C) Pending the completion of a proceeding for the issuance of an injunction under subparagraph ( B) respecting a chemical substance, the court may, upon application of the Administrator made through attorneys of the Environmental Protection Agency, issue a temporary restraining order or a preliminary injunction to prohibit the manufacture, processing, distribution in commerce, use, or disposal of such a substance ( or any combination of such activities) if the court finds that the notification period applicable under subsection ( a), ( b), or ( c) of this section to the manufacturing or processing of such substance May 10, 2004 may expire before such proceeding can be completed. ( D) After the submission to the Administrator of test data sufficient to evaluate the health and environmental effects of a chemical substance subject to an injunction issued under subparagraph ( B) and the evaluation of such data by the Administrator, the district court of the United States which issued such injunction shall, upon petition dissolve the injunction unless the Administrator has initiated a proceeding for the issuance of a rule under section 2605( a) of this title respecting the substance. If such a proceeding has been initiated, such court shall continue the injunction in effect until the effective date of the rule promulgated in such proceeding or, if such proceeding is terminated without the promulgation of a rule, upon the termination of the proceeding, whichever occurs first. ( f) Protection against unreasonable risks ( 1) If the Administrator finds that there is a reasonable basis to conclude that the manufacture, processing, distribution in commerce, use, or disposal of a chemical substance with respect to which notice is required by subsection ( a) of this section, or that any combination of such activities, presents or will present an unreasonable risk of injury to health or environment before a rule promulgated under section 2605 of this title can protect against such risk, the Administrator shall, before the expiration of the notification period applicable under subsection ( a), ( b), or ( c) of this section to the manufacturing or processing of such substance, take the action authorized by paragraph ( 2) or ( 3) to the extent necessary to protect against such risk. ( 2) The Administrator may issue a proposed rule under section 2605( a) of this title to apply to a chemical substance with respect to which a finding was made under paragraph ( 1)  ( A) a requirement limiting the amount of such substance which may be manufactured, processed, or distributed in commerce, ( B) a requirement described in paragraph ( 2), ( 3), ( 4), ( 5), ( 6), or ( 7) of section 2605( a) of this title, or ( C) any combination of the requirements referred to in subparagraph ( B).

Such a proposed rule shall be effective upon its publication in the Federal Register. Section 2605( d)( 2)( B) of this title shall apply with respect to such rule.

( 3)( A) The Administrator may  ( i) issue a proposed order to prohibit the manufacture, processing, or distribution in commerce of a substance with respect to which a finding was made under paragraph ( 1), or ( ii) apply, through attorneys of the Environmental Protection Agency, to the United States District Court for the District of Columbia or the United States district court for the judicial district in which the manufacturer, or processor, as the case may be, of such substance, is found, resides, or transacts business for an injunction to prohibit the manufacture, processing, or distribution in commerce of such substance. May 10, 2004 A proposed order issued under clause ( i) respecting a chemical substance shall take effect on the expiration of the notification period applicable under subsection ( a), ( b), or ( c) of this section to the manufacture or processing of such substance. ( B) If the district court of the United States to which an application has been made under subparagraph ( A)( ii) finds that there is a reasonable basis to conclude that the manufacture, processing, distribution in commerce, use, or disposal of the chemical substance with respect to which such application was made, or that any combination of such activities, presents or will present an unreasonable risk of injury to health or the environment before a rule promulgated under section 2605 of this title can protect against such risk, the court shall issue an injunction to prohibit the manufacture, processing, or distribution in commerce of such substance or to prohibit any combination of such activities. ( C) The provisions of subparagraphs ( B) and ( C) of subsection ( e)( 1) of this section shall apply with respect to an order issued under clause ( i) of subparagraph ( A); and the provisions of subparagraph ( C) of subsection ( e)( 2) of this section shall apply with respect to an injunction issued under subparagraph ( B). ( D) If the Administrator issues an order pursuant to subparagraph ( A)( i) respecting a chemical substance and objections are filed in accordance with subsection ( e)( 1)( C) of this section, the Administrator shall seek an injunction under subparagraph ( A)( ii) respecting such substance unless the Administrator determines, on the basis of such objections, that such substance does not or will not present an unreasonable risk of injury to health or the environment. ( g) Statement of reasons for not taking action If the Administrator has not initiated any action under this section or section 2605 or 2606 of this title to prohibit or limit the manufacture, processing, distribution in commerce, use, or disposal of a chemical substance, with respect to which notification or data is required by subsection ( a)( 1)( B) or ( b) of this section, before the expiration of the notification period applicable to the manufacturing or processing of such substance, the Administrator shall publish a statement of the Administrator's reasons for not initiating such action. Such a statement shall be published in the Federal Register before the expiration of such period. Publication of such statement in accordance with the preceding sentence is not a prerequisite to the manufacturing or processing of the substance with respect to which the statement is to be published. ( h) Exemptions ( 1) The Administrator may, upon application, exempt any person from any requirement of subsection ( a) or ( b) of this section to permit such person to manufacture or process a chemical substance for test marketing purposes  ( A) upon a showing by such person satisfactory to the Administrator that the manufacture, processing, distribution in commerce, use, and disposal of such substance, and that any combination of such activities, for such purposes will not present any unreasonable risk of injury to health or the environment, and ( B) under such restrictions as the Administrator considers appropriate. May 10, 2004 ( 2)( A) The Administrator may, upon application, exempt any person from the requirement of subsection ( b)( 2) of this section to submit data for a chemical substance. If, upon receipt of an application under the preceding sentence, the Administrator determines that  ( i) the chemical substance with respect to which such application was submitted is equivalent to a chemical substance for which data has been submitted to the Administrator as required by subsection ( b)( 2) of this section, and ( ii) submission of data by the applicant on such substance would be duplicative of data which has been submitted to the Administrator in accordance with such subsection,

the Administrator shall exempt the applicant from the requirement to submit such data on such substance. No exemption which is granted under this subparagraph with respect to the submission of data for a chemical substance may take effect before the beginning of the reimbursement period applicable to such data. ( B) If the Administrator exempts any person, under subparagraph ( A), from submitting data required under subsection ( b)( 2) of this section for a chemical substance because of the existence of previously submitted data and if such exemption is granted during the reimbursement period for such data, then ( unless such person and the persons referred to in clauses ( i) and ( ii) agree on the amount and method of reimbursement) the Administrator shall order the person granted the exemption to provide fair and equitable reimbursement ( in an amount determined under rules of the Administrator)  ( i) to the person who previously submitted the data on which the exemption was based, for a portion of the costs incurred by such person in complying with the requirement under subsection ( b)( 2) of this section to submit such data, and ( ii) to any other person who has been required under this subparagraph to contribute with respect to such costs, for a portion of the amount such person was required to contribute.

In promulgating rules for the determination of fair and equitable reimbursement to the persons described in clauses ( i) and ( ii) for costs incurred with respect to a chemical substance, the Administrator shall, after consultation with the Attorney General and the Federal Trade Commission, consider all relevant factors, including the effect on the competitive position of the person required to provide reimbursement in relation to the persons to be reimbursed and the share of the market for such substance of the person required to provide reimbursement in relation to the share of such market of the persons to be reimbursed. For purposes of judicial review, an order under this subparagraph shall be considered final agency action.

( C) For purposes of this paragraph, the reimbursement period for any previously submitted data for a chemical substance is a period  ( i) beginning on the date of the termination of the prohibition, imposed under this section, on the manufacture or processing of such substance by the person who submitted such data to the Administrator, and May 10, 2004 ( ii) ending  ( I) five years after the date referred to in clause ( i), or ( II) at the expiration of a period which begins on the date referred to in clause ( i) and is equal to the period which the Administrator determines was necessary to develop such data, whichever is later. ( 3) The requirements of subsections ( a) and ( b) of this section do not apply with respect to the manufacturing or processing of any chemical substance which is manufactured or processed, or proposed to be manufactured or processed, only in small quantities ( as defined by the Administrator by rule) solely for purposes of  ( A) scientific experimentation or analysis, or ( B) chemical research on, or analysis of such substance or another substance, including such research or analysis for the development of a product, if all persons engaged in such experimentation, research, or analysis for a manufacturer or processor are notified ( in such form and manner as the Administrator may prescribe) of any risk to health which the manufacturer, processor, or the Administrator has reason to believe may be associated with such chemical substance. ( 4) The Administrator may, upon application and by rule, exempt the manufacturer of any new chemical substance from all or part of the requirements of this section if the Administrator determines that the manufacture, processing, distribution in commerce, use, or disposal of such chemical substance, or that any combination of such activities, will not present an unreasonable risk of injury to health or the environment. A rule promulgated under this paragraph ( and any substantive amendment to, or repeal of, such a rule) shall be promulgated in accordance with paragraphs ( 2) and ( 3) of section 2605( c) of this title. ( 5) The Administrator may, upon application, make the requirements of subsections ( a) and ( b) of this section inapplicable with respect to the manufacturing or processing of any chemical substance ( A) which exists temporarily as a result of a chemical reaction in the manufacturing or processing of a mixture or another chemical substance, and ( B) to which there is no, and will not be, human or environmental exposure. ( 6) Immediately upon receipt of an application under paragraph ( 1) or ( 5) the Administrator shall publish in the Federal Register notice of the receipt of such application. The Administrator shall give interested persons an opportunity to comment upon any such application and shall, within 45 days of its receipt, either approve or deny the application. The Administrator shall publish in the Federal Register notice of the approval or denial of such an application.

( i) '' Manufacture'' and '' process'' defined For purposes of this section, the terms '' manufacture'' and '' process'' mean manufacturing or processing for commercial purposes May 10, 2004 Attachment B 40 CFR Part 700 May 10, 2004 40 CFR Protection of Environment CHAPTER I ENVIRONMENTAL PROTECTION AGENCY ( CONTINUED)

SUBCHAPTER R  TOXIC SUBSTANCES CONTROL ACT PART 700  GENERAL Subparts A B [ Reserved]

Subpart C  Fees § 700.40 Purpose and applicability. ( a) Purpose. The purpose of this subpart is to collect fees from manufacturers, importers, and processors who submit notices and applications to EPA under section 5 of the Toxic Substances Control Act ( 15 U. S. C. 2604) to defray part of EPA's cost of administering the Act.

( b) Applicability. This subpart applies to all manufacturers, importers, and processors who submit certain notices and applications to EPA under section 5 of the Act.

§ 700.41 Radon user fees. User fees relating to radon proficiency programs authorized under the Toxic Substances Control Act appear at 40 CFR part 195.

[ 59 FR 13177, Mar. 18, 1994]

§ 700.43 Definitions. Definitions in section 3 of the Act ( 15 U. S. C. 2602), as well as definitions contained in § § 704.3, 720.3, and 725.3 of this chapter, apply to this subpart unless otherwise specified in this section. In addition, the following definitions apply:

Consolidated microbial commercial activity notice or consolidated MCAN means any MCAN submitted to EPA that covers more than one microorganism ( each being assigned a separate MCAN number by EPA) as a result of a prenotice agreement with EPA.

Consolidated premanufacture notice or consolidated PMN means any PMN submitted to EPA that covers more than one chemical substance ( each being assigned a separate PMN number by EPA) as a result of a prenotice agreement with EPA ( See 48 FR 21734).

Exemption application means any application submitted to EPA under section 5( h)( 2) of the Act.

Exemption notice means any notice submitted to EPA under § 723.175 of this chapter.

Final product means a new chemical substance ( as " new chemical substance" is defined in § 720.3 of this chapter) that is manufactured by a person for distribution in commerce, or for use by the person other than as an intermediate. May 10, 2004 Intermediate premanufacture notice or intermediate PMN means any PMN submitted to EPA for a chemical substance which is an intermediate ( as " intermediate" is defined in § 720.3 of this chapter) in the production of a final product, provided that the PMN for the intermediate is submitted to EPA at the same time as, and together with, the PMN for the final product and that the PMN for the intermediate identifies the final product and describes the chemical reactions leading from the intermediate to the final product. If PMNs are submitted to EPA at the same time for several intermediates used in the production of a final product, each of those is an intermediate PMN if they all identify the final product and every other associated intermediate PMN and are submitted to EPA at the same time as, and together with, the PMN for the final product.

Joint submitters means two or more persons who submit a section 5 notice together.

Microbial commercial activity notice or MCAN means any notice for microorganisms submitted to EPA pursuant to section 5( a)( 1) of the Act in accordance with subpart D of part 725 of this chapter.

Person means a manufacturer, importer, or processor.

Premanufacture notice or PMN means any notice submitted to EPA pursuant to section 5( a)( 1)( A) of the Act in accordance with part 720 of this chapter or § 723.250 of this chapter.

Section 5 notice means any PMN, consolidated PMN, intermediate PMN, significant new use notice, exemption notice, exemption application, any MCAN or consolidated MCAN submitted under section 5 of the Act.

Significant new use notice means any notice submitted to EPA pursuant to section 5( a)( 1)( B) of the Act in accordance with part 721 of this chapter.

Small business concern means any person whose total annual sales in the person's fiscal year preceding the date of the submission of the applicable section 5 notice, when combined with those of the parent company ( if any), are less than $ 40 million.

[ 53 FR 31252, Aug. 17, 1988, as amended at 62 FR 17931, April 11, 1997]

§ 700.45 Fee payments.

( a) Persons who must pay fees. Persons submitting a section 5 notice to EPA shall remit for each such notice the appropriate fee identified in paragraph ( b) of this section in accordance with the procedures in paragraph ( e) of this section.

( b) Fees. Persons shall remit fee payments to EPA as follows:

( 1) Small business concerns. Small business concerns shall remit a fee of $ 100 for each section 5 notice submitted.

( 2) Others. Persons other than small business concerns shall remit fees according to the type of May 10, 2004 section 5 notice as follows:

( i) Premanufacture notices and consolidated premanufacture notices. Persons shall remit a fee of $ 2,500 for each PMN or consolidated PMN submitted.

( ii) Intermediate premanufacture notices. Persons shall remit a fee of $ 1,000 for each intermediate PMN. However, for the PMN for the final product the person shall submit the fee in paragraph ( b)( 2)( i) of this section.

( iii) Significant new use notices. Persons shall remit a fee of $ 2,500 for each significant new use notice submitted.

( iv) Exemption applications. Persons shall remit a fee of $ 2,500 for each exemption application submitted under section 5( h)( 2) of the Act.

( v) Exemption notices. Persons shall remit a fee of $ 2,500 for each exemption notice submitted under § 723.175 of this chapter.

( vi) MCAN and consolidated MCAN. Persons shall remit a fee of $ 2,500 for each MCAN or consolidated MCAN submitted.

( c) No fee required. Persons are exempt from remitting any fee for submissions under § § 720.38, 723.50, and subparts E, F, and G of part 725 of this chapter.

( d) Joint submitters. Joint submitters of a section 5 notice are required to remit the appropriate fee identified in paragraph ( b) of this section for each section 5 notice regardless of the number of joint submitters for that notice. To qualify for the fee identified in paragraph ( b)( 1) of this section, each joint submitter of a section 5 notice must qualify as a small business concern under § 700.43.

( e) Remittance procedure. ( 1) Each remittance under this section shall be in United States currency and shall be paid by money order, bank draft, or certified check drawn to the order of the Environmental Protection Agency.

( 2) Each remittance shall be sent to the Environmental Protection Agency, HQ Accounting Operations Branch ( PM 226), P. O. 360399M, Pittsburgh, PA 15251 6399, ATTN: TSCA User Fee.

( 3) Persons who submit a section 5 notice shall place a unique identifying number, which must include the letters " TS" followed by a combination of 6 numbers ( letters may be substituted for some numbers), on the front page of each section 5 notice submitted. The same identifying number and the submitter's name must appear on the corresponding fee remittance under this section. If a remittance applies to more than one section 5 notice, the person shall include the name of the submitter, the identifying number for each section 5 notice to which the remittance applies, and the amount of the remittance which applies to each notice. Any remittance not having the identifying name and number described above will be returned to the remitter. May 10, 2004 ( 4)( i) Each person who remits the fee identified in paragraph ( b)( 1) of this section for a PMN, consolidated PMN, intermediate PMN, or significant new use notice shall write or type the words, " The company named in part 1, section A is a small business concern under 40 CFR 700.43 and has remitted a fee of $ 100 in accordance with 40 CFR 700.45( b)." under " CERTIFICATION" on Page 2 of the Premanufacture Notice for New Chemical Substances ( EPA Form 7710 25 ( 4 26 83)).

( ii) Each person who remits the fee identified in paragraph ( b)( 1) of this section for an exemption application under section 5( h)( 2) of the Act shall include the words, " Each company identified in this application is a small business concern under 40 CFR 700.43 and has remitted a fee of $ 100 in accordance with 40 CFR 700.45( b)." in the exemption application.

( iii) Each person who remits the fee identified in paragraph ( b)( 1) of this section for an exemption notice under § 723.175 of this chapter shall include the words, " Each company identified in this notice is a small business concern under 40 CFR 700.43 and has remitted a fee of $ 100 in accordance with 40 CFR 700.45( b)." in the certification required in § 723.175( i)( 1)( x) of this chapter.

( iv) Each person who remits the fee identified in paragraph ( b)( 1) of this section for a MCAN for a microorganism shall include the words, " The company identified in this notice is a small business concern under 40 CFR 700.43 and has remitted a fee of $ 100 in accordance with 40 CFR 700.45( d)," in the certification required in § 725.25( b) of this chapter.

( 5)( i) Each person who remits a fee identified in paragraph ( b)( 2) of this section for a PMN, consolidated PMN, intermediate PMN, or significant new use notice shall write or type the words, " The company named in part 1, section A has remitted the fee specified in 40 CFR 700.45( b)." under " CERTIFICATION" on page 2 of the Premanufacture Notice for New Chemical Substances ( EPA Form 7710 25 ( 4 26 83)).

( ii) Each person who remits the fee identified in paragraph ( b)( 2) of this section for an exemption application under section ( 5)( h)( 2) of the Act shall include the words, " Each company identified in this application has remitted a fee of $ 2,500 in accordance with 40 CFR 700.45( b)." in the exemption application.

( iii) Each person who remits the fee identified in paragraph ( b)( 2) of this section for an exemption notice under § 723.175 of this chapter shall include the words, " Each company identified in this notice has remitted a fee of $ 2,500 in accordance with 40 CFR 700.45( b)." in the certification required in § 723.175( i)( 1)( x) of this chapter.

( iv) Each person who remits a fee identified in paragraph ( b)( 2) of this section for a MCAN for a microorganism shall include the words, " The company identified in this notice has remitted the fee specified in 40 CFR 700.45( b)," in the certification required in § 725.25( b) of this chapter.

( f) Fee refunds. EPA will refund any fee paid for a section 5 notice whenever the Agency determines:

( 1) That the chemical substance that is the subject of a PMN, intermediate PMN, exemption May 10, 2004 application, or exemption notice is not a new chemical substance as of the date of submission of the notice.

( 2) In the case of a significant new use notice, that the notice was not required.

( 3) The notice is incomplete under either § 720.65( c) or 725.33, of this chapter.

( 4) That as of the date of submission of the notice: the microorganism that is the subject of a MCAN is not a new microorganism; nor is the use involving the microorganism a significant new use.

[ 53 FR 31252, Aug. 17, 1988, as amended at 54 FR 21429, May 18, 1989; 58 FR 34204, June 23, 1993; 62 FR 17932, April 11, 1997]

§ 700.49 Failure to remit fees.

EPA will not consider a section 5 notice to be complete unless the appropriate certification under § 700.45( e) is included and until the appropriate remittance under § 700.45( b) has been sent to EPA as provided in § 700.45( e) and received by EPA. EPA will notify the submitter that the section 5 notice is incomplete in accordance with § § 720.65( c) and 725.33 of this chapter.

[ 62 FR 17932, April 11, 1997] May 10, 2004 Attachment C 40 CFR Part 720 May 10, 2004 40 CFR Protection of Environment CHAPTER I ENVIRONMENTAL PROTECTION AGENCY ( CONTINUED)

SUBCHAPTER R  TOXIC SUBSTANCES CONTROL ACT PART 720  PREMANUFACTURE NOTIFICATION Subpart A  General Provisions Sec. 720.1 Scope. 720.3 Definitions. Subpart B  Applicability 720.22 Persons who must report. 720.25 Determining whether a chemical substance is on the Inventory. 720.30 Chemicals not subject to notification requirements. 720.36 Exemption for research and development. 720.38 Exemptions for test marketing.

Subpart C  Notice Form 720.40 General. 720.45 Information that must be included in the notice form. 720.50 Submission of test data and other data concerning the health and environmental effects of a substance. 720.57 Imports.

Subpart D  Disposition of Notices 720.60 General. 720.62 Notice that notification is not required. 720.65 Acknowledgment of receipt of a notice; errors in the notice; incomplete submissions; false and misleading statements. 720.70 Notice in the FEDERAL REGISTER. 720.75 Notice review period. 720.78 Recordkeeping.

Subpart E  Confidentiality and Public Access to Information 720.80 General provisions. 720.85 Chemical identity. 720.87 Categories or proposed categories of uses of a new chemical substance. 720.90 Data from health and safety studies. 720.95 Public file.

Subpart F  Commencement of Manufacture or Import 720.102 Notice of commencement of manufacture or import.

Subpart G  Compliance and Inspections May 10, 2004 720.120 Compliance. 720.122 Inspections.

Authority: 15 U. S. C. 2604, 2607, and 2613.

Source: 48 FR 21742, May 13, 1983, unless otherwise noted.

Subpart A  General Provisions § 720.1 Scope. This part establishes procedures for the reporting of new chemical substances by manufacturers and importers under section 5 of the Toxic Substances Control Act, 15 U. S. C. 2604. This part applies to microorganisms only to the extent provided by part 725 of this chapter. The rule defines the persons and chemical substances subject to the reporting requirements, prescribes the contents of section 5 notices, and establishes procedures for submitting notices. The rule also establishes EPA policy regarding claims of confidentiality for, and public disclosure of, various categories of information submitted in connection with section 5 notices.

[ 48 FR 21742, May 13, 1983, as amended at 58 FR 34204, June 23, 1993; 62 FR 17932, April 11, 1997]

§ 720.3 Definitions.

( a)( 1) For the purposes of this part, the terms cosmetic, device, drug, food, and food additive have the meanings contained in the Federal Food, Drug, and Cosmetic Act, 21 U. S. C. 321 et seq., and the regulations issued under it. In addition, the term " food" includes poultry and poultry products, as defined in the Poultry Products Inspection Act, 21 U. S. C. 453 et seq.; meats and meat food products, as defined in the Federal Meat Inspection Act, 21 U. S. C. 60 et seq.; and eggs and egg products, as defined in the Egg Products Inspection Act, 21 U. S. C. 1033 et seq.

( 2) The term pesticide has the meaning contained in the Federal Insecticide, Fungicide, and Rodenticide Act, 7 U. S. C. 136 et seq. and the regulations issued under it.

( 3) The terms byproduct material, source material, and special nuclear material have the meanings contained in the Atomic Energy Act of 1954, 42 U. S. C 2014 et seq. and the regulations issued under it.

( b) Act means the Toxic Substances Control Act, 15 U. S. C. 2601 et seq.

( c) Article means a manufactured item ( 1) which is formed to a specific shape or design during manufacture, ( 2) which has end use function( s) dependent in whole or in part upon its shape or design during end use, and ( 3) which has either no change of chemical composition during its end use or only those changes of composition which have no commercial purpose separate from that of the article and that may occur as described in § 720.36( g)( 5), except that fluids and particles are not considered articles regardless of shape or design.

( d) Byproduct means a chemical substance produced without a separate commercial intent during May 10, 2004 the manufacture, processing, use, or disposal of another chemical substance or mixture.

( e) Chemical substance means any organic or inorganic substance of a particular molecular identity, including any combination of such substances occurring in whole or in part as a result of a chemical reaction or occurring in nature, and any chemical element or uncombined radical, except that " chemical substance" does not include: ( 1) Any mixture. ( 2) Any pesticide when manufactured, processed, or distributed in commerce for use as a pesticide. ( 3) Tobacco or any tobacco product. ( 4) Any source material, special nuclear material, or byproduct material. ( 5) Any pistol, firearm, revolver, shells, or cartridges. ( 6) Any food, food additive, drug, cosmetic, or device, when manufactured, processed, or distributed in commerce for use as a food, food additive, drug, cosmetic, or device.

( f) Commerce means trade, traffic, transportation, or other commerce ( 1) between a place in a State and any place outside of such State, or ( 2) which affects trade, traffic, transportation, or commerce between a place in a State and any place outside of such State.

( g) Customs territory of the United States means the 50 States, Puerto Rico, and the District of Columbia.

( h) Director means the Director of the EPA Office of Pollution Prevention and Toxics.

( i) Distribute in commerce means to sell in commerce, to introduce or deliver for introduction into commerce, or to hold after introduction into commerce.

( j) EPA means the U. S. Environmental Protection Agency.

( k) Health and safety study or study means any study of any effect of a chemical substance or mixture on health or the environment or on both, including underlying data and epidemiological studies, studies of occupational exposure to a chemical substance or mixture, toxicological, clinical, and ecological, or other studies of a chemical substance or mixture, and any test performed under the Act. Chemical identity is always part of a health and safety study.

( 1) Not only is information which arises as a result of a formal, disciplined study included, but other information relating to the effects of a chemical substance or mixture on health or the environment is also included. Any data that bear on the effects of a chemical substance on health or the environment would be included.

( 2) Examples include:

( i) Long and short term tests of mutagenicity, carcinogenicity, or teratogenicity; data on behavioral disorders; dermatoxicity; pharmacological effects; mammalian absorption, distribution, metabolism, and excretion; cumulative, additive, and synergistic effects; acute, subchronic, and chronic effects; and structure/ activity analyses. May 10, 2004 ( ii) Tests for ecological or other environmental effects on invertebrates, fish, or other animals, and plants, including: Acute toxicity tests, chronic toxicity tests, critical life stage tests, behavioral tests, algal growth tests, seed germination tests, plant growth or damage tests, microbial function tests, bioconcentration or bioaccumulation tests, and model ecosystem ( microcosm) studies.

( iii) Assessments of human and environmental exposure, including workplace exposure, and impacts of a particular chemical substance or mixture on the environment, including surveys, tests, and studies of: Biological, photochemical, and chemical degradation; air, water, and soil transport; biomagnification and bioconcentration; and chemical and physical properties, e. g., boiling point, vapor pressure, evaporation rates from soil and water, octanol/ water partition coefficient, and water solubility.

( iv) Monitoring data, when they have been aggregated and analyzed to measure the exposure of humans or the environment to a chemical substance or mixture.

( v) Any assessments of risk to health and the environment resulting from the manufacture, processing, distribution in commerce, use, or disposal of the chemical substance.

( l) Importer means any person who imports a chemical substance, including a chemical substance as part of a mixture or article, into the customs territory of the United States. " Importer" includes the person primarily liable for the payment of any duties on the merchandise or an authorized agent acting on his or her behalf. The term also includes, as appropriate:

( 1) The consignee. ( 2) The importer of record. ( 3) The actual owner if an actual owner's declaration and superseding bond has been filed in accordance with 19 CFR 141.20; or ( 4) The transferee, if the right to draw merchandise in a bonded warehouse has been transferred in accordance with subpart C of 19 CFR part 144. ( See " principal importer.")

( m) Impurity means a chemical substance which is unintentionally present with another chemical substance.

( n) Intermediate means any chemical substance that is consumed, in whole or in part, in chemical reactions used for the intentional manufacture of another chemical substance( s) or mixture( s), or that is intentionally present for the purpose of altering the rates of such chemical reactions.

( o) Inventory means the list of chemical substances manufactured or processed in the United States that EPA compiled and keeps current under section 8( b) of the Act.

( p) Known to or reasonably ascertainable by means all information in a person's possession or control, plus all information that a reasonable person similarly situated might be expected to possess, control, or know.

( q) Manufacture means to produce or manufacture in the United States or import into the customs territory of the United States. May 10, 2004 ( r) Manufacture or import for commercial purposes means:

( 1) To import, produce, or manufacture with the purpose of obtaining an immediate or eventual commercial advantage for the manufacturer or importer, and includes, among other things, " manufacture" of any amount of a chemical substance or mixture:

( i) For commercial distribution, including for test marketing.

( ii) For use by the manufacturer, including use for product research and development or as an intermediate.

( 2) The term also applies to substances that are produced coincidentally during the manufacture, processing, use, or disposal of another substance or mixture, including byproducts that are separated from that other substance or mixture and impurities that remain in that substance or mixture. Byproducts and impurities without separate commercial value are nonetheless produced for the purpose of obtaining a commercial advantage, since they are part of the manufacture of a chemical substance for commercial purposes.

( s) Manufacture solely for export means to manufacture or import for commercial purposes a chemical substance solely for export from the United States under the following restrictions on activities in the United States:

( 1) Distribution in commerce is limited to purposes of export or processing solely for export as defined in § 721.3 of this chapter. ( 2) The manufacturer or importer, and any person to whom the substance is distributed for purposes of export or processing solely for export ( as defined in § 721.3 of this chapter), may not use the substance except in small quantities solely for research and development in accordance with § 720.36.