1 Supporting Statement for a Request for OMB Review under the Paperwork Reduction Act 1. IDENTIFICATION OF THE INFORMATION COLLECTION l( a) Title of the Information Collection TITLE: Chemical Specific Rules, Toxic Substances Control Act Section 8( a)

EPA ICR No.: 1198.07 OMB Control No: 2070 0067 1( b) Short Characterization This information collection request requires OMB's approval for the continued collection of chemical specific information under section 8( a) of the Toxic Substance Control Act ( TSCA). TSCA section 8( a) authorizes the Administrator of the EPA to promulgate rules that require persons who manufacture, import or process chemical substances and mixtures, or who propose to manufacture, import, or process chemical substances and mixtures, to maintain such records and submit such reports to EPA as may be reasonably required. Information that may be collected under TSCA section 8( a) includes, but is not limited to, chemical names, categories of use, production volume, byproducts of chemical production, existing data on deaths and environmental effects, exposure data, and disposal information. These data are collected by the Office of Pollution Prevention and Toxics ( OPPT) and may be used by other EPA offices and/ or Federal agencies to ensure knowledge of specific practices that may affect human health and the environment.

There may be circumstances when EPA may require different information than is readily available or information that is different from that available through existing regulatory information collection tools, like the TSCA section 8( a) Preliminary Assessment Information Rule ( PAIR) which is discussed in another ICR under a different OMB control number. EPA promulgated PAIR on June 22, 1982 ( see 40 CFR Part 712). Whenever a substance is added to the PAIR, manufacturers and importers of the substance are required to complete a PAIR report form. The PAIR report requests a very limited amount of information on listed chemicals regarding activities occurring over a specific time period.

Any chemical covered by TSCA for which OPPT, other EPA Offices or another Federal agency has a reasonable need for information, and which cannot be satisfied via readily available sources or by use of PAIR, is a proper potential subject for a chemical specific TSCA section 8( a) rulemaking. For instance EPA may wish to ask detailed questions in regard to how industry oversees the use and production of a chemical. These specific monitoring capabilities could allow EPA to react to change in market conditions that may warrant a change in EPA's regulatory strategy. 2 Therefore, EPA could promulgate a TSCA section 8( a) rule to gather this information by requesting that current or potential manufacturers, importers or processors of the substance provide chemicalspecific information.

EPA's OPPT, other EPA Offices and/ or other Federal agencies will generally be the primary groups for which information will be collected. However, to the extent that reported information is not considered to be confidential business information ( CBI), environmental groups, environmental justice advocates, state and local government entities and other members of the public will have access to this information for their own use.

Rather than requiring respondents to submit information on reporting forms such as those used for PAIR, EPA has in the past allowed individual firms to choose the reporting means and format that is best suited to their recordkeeping resources. EPA believes that for TSCA section 8( a) chemical specific rules, this allowance keeps reporting costs low.

Total annual cost of a rule varies depending upon the number of chemicals per rule and the number of respondents per chemical. Based on the recent past usage of chemical specific TSCA section 8( a) rules and expected future usage, EPA assumes that it will promulgate one TSCA section 8( a) chemical specific rule with four respondents ( notices) per year for the three year duration of the ICR ( see Section 6( b), below). The maximum total annual number of burden hours for respondents range from 134 hours to 594 hours per TSCA section 8( a) chemical specific rule. The maximum cost associated with the promulgation of a TSCA section 8( a) chemical specific rule is $ 5,729 to $ 25,288. However, the cost per respondent varies with the type of chemical specific information requested, and subsequently, the tasks required to comply with a TSCA section 8( a) chemical specific rule. Because all respondents may not have to provide information on all data items listed ( see Sections 3 and 6( b), below), the ranges presented above are maximums. Assuming that all respondents do not have to complete all tasks identified to comply with a TSCA section 8( a) chemical specific rule, total annual reporting costs to all respondents range from $ 2,822 to $ 11,702 per rule.

2. NEED FOR AND USE OF THE COLLECTION 2( a) Need/ Authority for the Collection Generally, EPA may need chemical specific information under TSCA section 8( a) to evaluate the potential for adverse human health and environmental effects caused by the manufacture, importation, processing, use or disposal of identified chemical substances and mixtures. Additionally, EPA may use TSCA section 8( a) information to assess the need or set priorities for testing and/ or further regulatory action.

The information required in TSCA section 8( a) chemical specific rules can be custom tailored to aid in achieving EPA's goals of protecting human health and the environment. Information collected may vary depending on the substance, its current and potential uses and EPA's concerns 3 about potential human or environmental risks caused by exposures to the substance. Promulgated TSCA section 8( a) rules may require persons manufacturing, importing or processing the chemical substance to report to EPA on specific information such as: a chemical's composition, byproducts, quantity produced, employee exposure and environmental release. Persons have in the past also been required to notify EPA of a management decision to initiate the manufacturing, importing, or processing of a chemical substance or mixture.

The legal authority for this information collection is TSCA section 8( a), U. S. C. 2607( a). TSCA section 8( a) chemical specific rules have been codified at 40 CFR 704, subpart B.

2( b) Use/ Users of the Data EPA will use the information obtained through the TSCA section 8( a) reporting rules to satisfy specifically identified data needs. The information collected will be relevant to risk identification, all stages of risk assessment, and/ or control action functions. Receipt of TSCA section 8( a) information may also give the Agency an opportunity to work with the respondent, if necessary, to minimize exposure risks associated with specific uses. Generally, a specific information collection request would be made by the Chemical Control Division, Chemical Management Division, or the Chemical Screening and Risk Assessment Division in OPPT. However, other regulatory agencies and departments, such as Occupational Safety and Health Administration ( OSHA), the Food and Drug Administration ( FDA), and other members of the Interagency Testing Committee ( ITC) may also present a need for and subsequently use TSCA section 8( a) data to, for example, assess worker or consumer exposures.

An example of a use of a TSCA section 8( a) chemical specific rule that was key in affecting a benefit to human health was 1,1 aminoundecanoic acid ( 1,1 AA). From submitted TSCA section 8( e) " substantial risk" reports, EPA discovered that 1,1 AA is a carcinogen in one sex of one rodent species ( male rat), and that exposure is limited to workers producing the nylon in which the chemical is an ingredient. The manufacturer was contacted to obtain exposure data for this chemical. From this contact EPA learned: ( 1) 1,1 AA was imported and converted into nylon by one company and there was no domestic manufacture; ( 2) 1,1 AA was handled and transferred in a closed system and all 1,1 AA was converted during the reaction to produce nylon. Consequently, because of limited exposure potential, 1,1 AA was dropped from further review. However, concern would arise if 1,1 AA were to be manufactured domestically because of the greater likelihood for worker exposure. To alert EPA to domestic manufacture, on May 28, 1987, OPPT promulgated a TSCA section 8( a)/ 5 ( SNUR) rule for 1,1 AA ( 52 FR 19860) . Users of TSCA section 8( a) chemical specific data rarely make a judgment based solely on the content of the TSCA section 8( a) information received but rather use the TSCA section 8( a) chemical specific information as part of the larger risk management strategy. 1,1 AA TSCA section 8( a) information would be instrumental in affecting a benefit to human health if a company were to begin to manufacture the substance. 4 3. NON DUPLICATION, CONSULTATION, AND OTHER COLLECTION CRITERIA 3( a) Non Duplication Section 8( a)( 2) of TSCA states, " To the extent feasible, the Administrator shall not require any reporting which is unnecessary or duplicative." The reporting requirements of TSCA section 8( a) rules only require information that EPA believes will assist in a reasoned evaluation of the human health and environmental effects of chemical substances and mixtures. This information is unlikely to be duplicative since, ( 1) EPA estimates that each rule will generate only a few notices, ( 2) the information required by the TSCA section 8( a) rule is unique to the manufacturer, importer or processor ( e. g., the proposed date of production or importation, the amount produced or imported, the chemical composition, and uses of the chemical substance or mixture), and ( 3) EPA thoroughly checks other public and unpublished sources to see if the required data may already be available. Finally, once EPA became aware of a source of substantially similar information, for example via comments on a proposed rule, EPA would not continue with the information collection.

3( b) Public Notice Required Prior to ICR Submission to OMB Prior to submission to OMB, this ICR will be made available to the public for comment through a Federal Register notice. The public will have 60 days to provide comments. Any comments received will be given consideration when completing the supporting statement that is submitted to OMB.

3( c) Consultations EPA has not published a proposed or final TSCA section 8( a) chemical specific information gathering rule for more than fifteen years and, therefore, has received no comments since that time. EPA has received comments on the use of TSCA section 8( a) reporting rules through published Federal Register notices. Various organizations responded to EPA's request for comments during the 1985 to 1988 ICR period. For example, the Agency originally proposed a SNUR for 4,4,1 methylenebis ( 2 chloroaniline) ( MBOCA) but public comments received in July and August of 1986 on the proposed SNUR suggested that a TSCA section 8( a) rule would be more appropriate. This suggestion was followed, reducing the burden on the public since the TSCA section 8( a) rule exempted small manufacturers, whereas the proposed SNUR would not have had this exemption.

Also, after receiving public comment on the proposed SNUR/ 8( a) rule for 1,1 aminoundecanoic acid ( July 22, 1986), the proposed definition of the term " enclosed process" was modified to account for possible releases through emergency pressure relief, thus expanding the number of processes that would be considered " enclosed" and lessening compliance costs.

The Natural Resources Defense Council ( NRDC) has also responded to several TSCA section 8( a) chemical specific rules. The NRDC is a national nonprofit environmental organization dedicated to the protection of human health and the environment. The NRDC generally urges EPA to adopt a more extensive, detailed set of information requirements. 5 3( d) Effects of Less Frequent Collection Generally companies are required to report only once under a TSCA section 8( a) reporting rule. EPA may consider requiring reporting on an annual, semiannual, monthly or other basis if the Administrator deems this necessary to protect human health and the environment. EPA tailors each rule to meet chemical specific data requirements, thus reducing the potential for too frequent data collections.

3( e) General Guidelines This information collection activity is necessary to implement the statutory requirements of section 8( a) of TSCA and is consistent with the requirements of 5 CFR 1320.6.

3( f) Confidentiality Submitters may designate information as confidential, trade secret or proprietary. EPA has implemented procedures to protect any confidential, trade secret or proprietary information from disclosure. These procedure comply with EPA's confidentiality regulation, 40 CFR Part 2, Subpart B.

3( g) Sensitive Questions This section is not applicable. TSCA section 8( a) reporting rules do not include any questions of a sensitive nature.

4. THE RESPONDENTS AND THE INFORMATION REQUESTED 4( a) Respondents/ North American Industrial Classification System ( NAICS) Codes Respondents affected by this collection activity primarily include those businesses that fall under NAICS codes 325, Chemical Manufacturers and Processors, and 324110, Petroleum Refineries.

4( b) Information Requested 4( b)( i) Data Items Section 8( a) of TSCA specifically lists a wide range of data items that may be required by EPA, including information on use, production volume, exposure, and health and safety. Data items requested of manufacturers, importers, or processors of certain chemicals vary with each collection request, but will not repeat information previously requested in the PAIR or other information gathering tools. Some data items requested under TSCA section 8( a) chemical specific rules in the 6 past include: notification and description of changes in the end use of identified substances and mixtures, information on planned manufacturing and on site processing, and notification of changes to the method of manufacturing the substance ( see 40 CFR subpart B).

An example of a past TSCA section 8( a) chemical specific rule is one issued on 4,4,1 methylenebis ( 2 chloroaniline) ( MBOCA). It required persons who propose to manufacture MBOCA to notify EPA of that intent and to submit information on their planned manufacturing and on site processing activities. The rule also required persons who are manufacturing MBOCA to notify the Agency if they propose to alter their manner or method of manufacturing the substance.

4( b)( ii) Respondent Activities Activities a respondent may be required to perform as a result of TSCA section 8( a) chemicalspecific rule are as follows:

9 to 29.5 Hours of Managerial Labor  Identify listed chemicals;  Assign principal technical contact person;  Identify by product;  Review marketing data;  Research the date of the initiation of manufacture or importation of the chemical;  Research occupational exposure, environmental release, health and environmental data, disposal methods; and  Process, compile, and review information for accuracy, substantiate a claim of confidential business information.

17.5 to 98 Hours of Technical Labor  Identify chemical and trade name and chemical composition;  Identify by product;  Describe use of chemical;  Report quantity manufactured or imported;  Research workplace exposures, environmental releases, health and environmental data, and disposal methods; and  Provide occupational description.

7 to 21 Hours of Clerical Labor  Format research on occupational exposures, environmental releases, health and environmental data;  Format attachments; and  Prepare notice. 7 Recordkeeping Estimate TSCA section 8( a) chemical specific rules may contain recordkeeping requirements. The recordkeeping estimate is rough, but it is reasonably related to the maximum reporting burden. EPA estimates that recordkeeping will account for approximately five percent of the reporting burden, or a maximum of 12 hours ( see Table 2.)

5. THE INFORMATION COLLECTED  AGENCY ACTIVITIES, COLLECTION METHODOLOGY AND INFORMATION MANAGEMENT 5( a) Agency Activities Inventory For any TSCA section 8( a) chemical specific rule the Agency would have to perform a number of tasks. They are:

Industry/ Public Assistance ( answering questions regarding rule)

Data Processing and System Support Personnel

Storage and Distribution

Compliance Monitoring 5( b) Collection Methodology and Management An improved information technology to minimize burden of a TSCA section 8( a) chemicalspecific rule has not been found. EPA has not been able to identify a more efficient, less expensive, or more flexible means of obtaining the required data, than the one currently being used. To the extent data is not CBI, all information collected is made available to the public through the public docket office. At the present time, EPA is not requiring firms to submit this information on one standard reporting form. Reporting facilities will be able to choose the format that best suits their reporting resources. TSCA section 8( a) chemical specific rules typically require one time reporting. As future data needs arise, EPA will consider the use of electronic or other types of reporting methods. EPA believes the flexibility already allowed in the reporting structure significantly eases burden.

5( c) Small Entity Flexibility Section 8( a) of TSCA generally exempts small manufacturers and processors. However, under TSCA section 8( a)( 3), EPA may require small manufacturers and processors to report or keep records if the substance or mixture is subject to a rule proposed or promulgated under TSCA sections 4, 5( b)( 4), or 6 or with respect to which relief has been granted pursuant to a civil action brought under sections 5 or 7 of TSCA. All respondents to TSCA section 8( a) chemical specific rules, including small businesses, are granted flexibility in their reporting methods. 8 5( d) Collection Schedule TSCA section 8( a) chemical specific rules are generally one time collections of specific information, usually regarding one chemical substance. Proposed TSCA section 8( a) chemicalspecific rules request comments. The comments are then addressed and incorporated as appropriate in the final rule, which specifies the reporting deadline. Generally, EPA requires that information be reported no sooner than 30 days after the effective date of a final rule.

6. ESTIMATING THE BURDEN AND COST OF THE COLLECTION 6( a) Estimating Respondent Burden Wage rates including fringe benefits and overhead for three broad categories of labor ( managerial, technical, and clerical) were used in this analysis. The labor categories and methods for estimating loaded wage rates were developed during previous studies. The basis for estimating wage rates for these purposes is the Bureau of Labor Statistics ( BLS) December 2002 wage data for comparable labor categories in all goods producing private industries ( released March 18, 2003). The managerial wage rates are taken from the BLS data for the executive, administrative, and managerial occupational group. The technical wage rates are taken from BLS data for the professional specialty and technical occupational group. The clerical wage rates are taken from the BLS data for the administrative support ( including clerical) occupational group. Based on that BLS data, the average hourly wage rates are $ 33.09 for managerial personnel, $ 27.00 for technical personnel, and $ 14.89 for clerical personnel, all in December 2002 dollars.

The benefits and overhead loading factors are calculated from the BLS data on the cost of benefits, with 17 percent of the average wage added for overhead. The overhead factor of 17 percent is based on information provided by the chemical industry and chemical industry trade associations. The loaded hourly wage rates are $ 53.27 for managerial personnel, $ 43.34 for technical personnel, and $ 23.96 for clerical personnel, all in 2002 dollars, as shown in Table 1.

Table 1: Loaded Hourly Wage Rates by Labor Category Labor Category December 2002 Average Wages December 2002 Benefits and Overhead Loading Factor December 2002 Loaded Hourly Rate Managerial $ 33.09 1.610 $ 53.27 Technical $ 27.00 1.605 $ 43.34 Clerical $ 14.89 1.609 $ 23.96 Sources: U. S. Environmental Protection Agency, 2002. Wage Rates for Economic Analyses of the Toxics Release Inventory Program. Cody Rice, Analytical Support Branch, Office of Environmental Information. June 10, 2002. U. S. Department of Labor, Bureau of Labor Statistics, 2003. Employer Costs for Employee Compensation Historical Listing ( Quarterly), 2002. March 18, 2003. 9 This ICR maintains the assumption of the previous ICR that an average of four notices per year are submitted in response to one section 8( a) chemical specific rule per year. Current labor rates and burden hours used to calculate cost to respondents are listed below.

Labor Category Burden Hours Hourly Rate Managerial 9 to 29.5 $ 53.27 Technical 17.5 to 98 $ 43.34 Clerical 7 to 21 $ 23.96 6( b) Estimating Respondent Costs The following are the tasks that managers, technical, and clerical personnel are expected to perform in preparing a notice. However, as discussed at the end of this section and presented in Table 2, not all respondents are likely to be required to perform all tasks under each labor category. Therefore, the ranges of labor hours presented below for each labor category ( i. e., 9 to 29.5 hours for managers), are the maximums, and are based on the assumption that all tasks are performed for each notice.

Managerial Labor 1. Manufacturer identifies listed chemicals; 2. Assign principal technical contact person; 3. Identify by product; 4. Review marketing data; 5. Research the date of the initiation of manufacture or importation of the chemical; 6. Research occupational exposure, environmental release, health and environmental data, disposal methods; and 7. Process, compile, and review information for accuracy, substantiate a claim of confidential business information.

In performing these tasks, managerial labor hours have been estimated to range from 9.5 to 29.5 hours per TSCA section 8( a) chemical specific rule. At $ 53.27 per hour for management labor times the range of hours predicted, [$ 53.27 x ( 9.5 to 29.5)], the range of cost for management work is $ 506 to $ 1,571 per notice resulting from a TSCA section 8( a) chemical specific rule. With an average of four notices per year for the three year ICR period, the range of costs per year for managerial labor is [ 4 x ($ 506 to $ 1,571)] = $ 2,024 to $ 6,286.

Technical Labor 1. Identify chemical and trade name and chemical composition; 2. Identify by product; 3. Describe use of chemical; 4. Report quantity manufactured or imported; 10 5. Research occupational exposures, environmental releases, health and environmental data, and disposal methods; and 6. Provide occupational description.

In performing these tasks, technical labor hours have been estimated to range from 17.5 to 98 hours per notice resulting from a TSCA section 8( a) chemical specific rule. At $ 43.34 per hour for technical labor, times the range of hours predicted, ($ 43.34 x [ 17.5 to 98]), a range of cost for technical work is estimated to be $ 758 to $ 4,247 per notice resulting from a TSCA section 8( a) chemical specific rule. With four notices per year for a three year period, the range of annual costs for technical labor is [ 4 x ($ 758 to $ 4,247)] = $ 3,034 to $ 16,989.

Clerical Labor 1. Format research on occupational exposure, environmental releases, health and environmental data; 2. Format attachments; and 3. Prepare Notice.

In performing these tasks, clerical labor has been estimated to range from 7 to 21 hours per notice resulting from a TSCA section 8( a) chemical specific rule. At $ 23.96 per hour for clerical labor, times the range of hours predicted, ($ 23.96 x [ 7 to 21]), the range of cost for clerical work is estimated to be $ 168 to $ 503 per notice resulting from a TSCA section 8( a) chemical specific rule. With four notices per TSCA section 8( a) chemical specific rule, the range of costs per year for clerical labor is [ 4 x ($ 168 to $ 503)] = $ 671 to $ 2,013.

The cost to a respondent for filing a TSCA section 8( a) notice depends upon the various tasks performed. These tasks could include gathering the required data, preparing and submitting the TSCA section 8( a) notice, and possibly keeping records. Based on promulgated TSCA section 8( a) rules, EPA estimates that each respondent will submit one notice per TSCA section 8( a) chemicalspecific rule. EPA anticipates issuing one TSCA section 8( a) rule per year and expects to receive an average of four notices per year.

The cost to a respondent for submitting a TSCA section 8( a) notice is a function of the number of hours and the hourly labor costs for the individuals developing and preparing the notice. The annual estimated range of cost to the respondent is $ 1,432 ($ 506 + $ 758 + $ 168) to $ 6,322 ($ 1,571 + $ 4,247 + $ 503) per notice, and $ 5,729 to $ 25,288 per TSCA section 8( a) chemical specific rule ( above estimates multiplied by four, the number of notices expected per rule.) However, as mentioned above, these figures are likely to overstate the true cost because not all respondents may be required to supply information regarding each activity. Thus, the average actual cost to the respondent will be lower than the $ 1,432 to $ 6,322 per notice estimate calculated above. The estimated frequency of each activity, along with total respondent cost and burden calculations, is presented in Table 2. The total cost to all respondents of reporting under a TSCA section 8( a) chemical specific rule is estimated to range from $ 2,822 to $ 11,701 per year. On a per respondent 11 basis, the annual cost is estimated to range from $ 705 to $ 2,925 per notice, based on four notices per year.

Table 2. Total Annual Respondent Burden and Costs Associated with Preparing and Filing a TSCA Section 8( a) Notice Activity Managerial Hours $ 92.33/ hr Technical Hours $ 68.35/ hr Clerical Hours $ 27.24/ hr Notices Per Year Annual Burden Hours Annual Costs Manufacturer ID and Principal Technical Contact 1  4 4 4  16 $ 213 $ 852 Chemical and Trade Name 1  4 3 3  12 $ 130 $ 520 Chemical Composition 0.5  2 4 2  8 $ 87 $ 347 Byproduct ID 1 1  4 2 4  10 $ 193 $ 453 Use Description 1  4 4 4  16 $ 173 $ 693 Quantity Manufactured or Imported 1  4 4 4  16 $ 173 $ 693 Marketing Data 1  2 2 2  4 $ 107 $ 213 Date of Initiation of Manufacture or Importation 0.5 4 2 $ 107 Occupational Exposure 1  4 2  16 1  3 2 8  46 $ 328 $ 1,957 Environmental Release 1  4 1  8 1  3 2 6  30 $ 241 $ 1,263 Occupational Description 1  10 1 1  10 $ 43 $ 433 12 Health and Environmental Data 2  8 8  40 1 3 1 11  51 $ 477 $ 2,232 Disposal Methods 1  2 1  6 1 2  8 $ 97 $ 367 Attachments 2  6 1 2  6 $ 48 $ 144 Preparation of Notice 1  3 4 4  12 $ 96 $ 288 Managerial/ Legal Review of Submission 1  4 4 4  16 $ 213 $ 852 Recordkeeping 1  3 4 4  12 $ 96 $ 288 TOTAL 9.5  29.5 17.5  98 7  21 67  275 $ 2,822  $ 11,702 6( c) Estimating Agency Burden and Cost The Agency has developed the following burden hour estimates for activities related to promulgating a section 8( a) Chemical Specific rule.

Activity Burden o Industry/ Public Assistance 0.1 FTE ( answering questions regarding the rule) o Data processing and systems support personnel 0.2 FTE o Storage and Distribution 0.1 FTE o Compliance monitoring 0.1 FTE Total FTEs 0.5 FTE The Office of Pollution Prevention and Toxics bases its burden hour and labor cost estimates on prior experience in gathering and processing information associated with other information collections. EPA has not promulgated a TSCA section 8( a) chemical specific rule in the past 12 years. Because Agency activities involve a team approach, the Agency has used a composite burden hour estimate containing workers at various GS levels and calculated hourly costs based upon the wage rate for a GS 12 Step 1. The year 2003 annual salary for a GS 12 Step 1 is $ 57,421. The cost for .5 FTE, based on a full time work year of 2,080 hours, is $ 28,710 ( the hourly wage rate is $ 27.61 13 x 1,040 hours). Incorporating an overhead and benefits factor of .6 yields an annual, fully loaded cost of $ 45,937 to the Agency of promulgating and supporting a TSCA section 8( a) chemical specific rule.

6( d) Bottom Line Burden Hours and Costs The following table displays the annual burden and costs borne by respondents and EPA, respectively, associated with preparing, filing and reviewing a notice resulting from a TSCA section 8( a) chemical specific rule.

Table 3. Annual Burden and Cost of a TSCA Section 8( a) Chemical Specific Rule Annual Burden Hours Annual Costs Industry 67 to 275 $ 2,822 to $ 11,702 Agency 1,040 $ 45,937 6( e) Reasons for Change in Burden The current request for renewal estimates a total annual burden to respondents of 275 hours, which is unchanged from the previous ICR renewal.

EPA anticipates issuing one TSCA section 8( a) chemical specific rule per year with an average of four respondents submitting notices per rule. EPA may promulgate more than one TSCA section 8( a) chemical specific rule per year over the next three years. If EPA does this, the Agency will submit a technical amendment to OMB to reflect the change in estimated burden to the regulated industry and the government.

6( f) Burden Statement The public burden for this collection of information is estimated to average 68.8 hours per response ( one quarter of the maximum annual burden of 275 hours for four notices). Of the 68.8 hours, 65.8 hours are associated with reporting tasks such as reviewing instructions, gathering the data needed, and completing and reviewing the collection of information. The remaining three hours are associated with recordkeeping. 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. This includes the time needed to review instructions; develop, acquire, install, and utilize technology and systems for the purposes of collecting, validating, and verifying 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; and transmit or otherwise disclose the information. An Agency may not conduct or sponsor such a request, and a person or facility is not required to respond to a collection of information unless it displays a currently valid OMB control number. The OMB control numbers for EPA's regulations in title 40 of the CFR, after appearing in 14 the Federal Register, are listed in 40 CFR part 9 and included on the related collection instrument or form, if applicable.

Send comments on the Agency's need for this information, the accuracy of the provided burden estimates, and any suggested methods for minimizing respondent burden, including through the use of automated collection techniques, to the Director, Collection Strategies Division, U. S. Environmental Protection Agency ( Mail Code 2822T), 1200 Pennsylvania Ave., NW., Washington, D. C. 20460. Include the OMB control number identified above in any correspondence. Do not submit the completed form or requested information to this address. The actual information or form should be submitted in accordance with the instructions accompanying the form, or as specified in the corresponding regulations. ATTACHMENT 1 Toxic Substances Control Act Section 8( a)

15 USC 2607 Sec. 2607. Reporting and retention of information ( a) Reports ( 1) The Administrator shall promulgate rules under which  ( A) each person ( other than a small manufacturer or processor) who manufactures or processes or proposes to manufacture or process a chemical substance ( other than achemical substance described in subparagraph ( B)( ii)) shall maintain such records, and shall submit to the Administrator such reports, as the Administrator may reasonably require, and ( B) each person ( other than a small manufacturer or processor) who manufactures or processes or proposes to manufacture or process  ( i) a mixture, or ( ii) a chemical substance in small quantities ( as defined by the Administrator by rule) solely for purposes of scientific experimentation or analysis or chemical research on, or analysis of, such substance or another substance, including any such research or analysis for the development of a product, shall maintain records and submit to the Administrator reports but only to the extent the Administrator determines the maintenance of records or submission of reports, or both, is necessary for the effective enforcement of this chapter. The Administrator may not require in a rule promulgated under this paragraph the maintenance of records or the submission of reports with respect to changes in the proportions of the components of a mixture unless the Administrator finds that the maintenance of such records or the submission of such reports, or both, is necessary for the effective enforcement of this chapter. For purposes of the compilation of the list of chemical substances required under subsection ( b) of this section, the Administrator shall promulgate rules pursuant to this subsection not later than 180 days after January 1, 1977. ( 2) The Administrator may require under paragraph ( 1) maintenance of records and reporting with respect to the following insofar as known to the person making the report or insofar as reasonably ascertainable: ( A) The common or trade name, the chemical identity, and the molecular structure of each chemical substance or mixture for which such a report is required. ( B) The categories or proposed categories of use of each such substance or mixture. ( C) The total amount of each such substance and mixture manufactured or processed, reasonable estimates of the total amount to be manufactured or processed, the amount manufactured or processed for each of its categories of use, and reasonable estimates of the amount to be manufactured or processed for each of its categories of use or proposed categories of use. ( D) A description of the byproducts resulting from the manufacture, processing, use, or disposal of each such substance or mixture. ( E) All existing data concerning the environmental and health effects of such substance or mixture. ( F) The number of individuals exposed, and reasonable estimates of the number who will be exposed, to such substance or mixture in their places of employment and the duration of such exposure. ( G) In the initial report under paragraph ( 1) on such substance or mixture, the manner or method of its disposal, and in any subsequent report on such substance or mixture, any change in such manner or method. To the extent feasible, the Administrator shall not require under paragraph ( 1), any reporting which is unnecessary or duplicative. ( 3) ( A) ( i) The Administrator may by rule require a small manufacturer or processor of a chemical substance to submit to the Administrator such information respecting the chemical substance as the Administrator may require for publication of the first list of chemical substances required by subsection ( b) of this section. ( ii) The Administrator may by rule require a small manufacturer or processor of a chemical substance or mixture  ( I) subject to a rule proposed or promulgated under section 2603, 2604( b)( 4), or 2605 of this title, or an order in effect under section 2604( e) of this title, or ( II) with respect to which relief has been granted pursuant to a civil action brought under section 2604 or 2606 of this title, to maintain such records on such substance or mixture, and to submit to the Administrator such reports on such substance or mixture, as the Administrator may reasonably require. A rule under this clause requiring reporting may require reporting with respect to the matters referred to in paragraph ( 2). ( B) The Administrator, after consultation with the Administrator of the Small Business Administration, shall by rule prescribe standards for determining the manufacturers and processors which qualify as small manufacturers and processors for purposes of this paragraph and paragraph ( 1). ATTACHMENT 2 40 CFR 704 General Reporting and Recordkeeping Provisions for Section 8( a) Information Gathering Rules PART 704 REPORTING AND RECORDKEEPING REQUIREMENTS Table of Contents Subpart A General Reporting and Recordkeeping Provisions for Section 8( a) Information Gathering Rules Sec. 704.1 Scope.

( a) This part specifies reporting and recordkeeping procedures under section 8( a) of the Toxic Substances Control Act ( TSCA) for manufacturers, importers, and processors of chemical substances and mixtures ( hereafter collectively referred to as substances) that are identified in subpart B of this part. The reporting and recordkeeping provisions in subpart A of this part apply throughout this part unless revised in any other subpart. ( b) Subpart B of this part sets out chemical specific reporting and recordkeeping requirements under section 8( a) of TSCA.

[ 53 FR 51715, Dec. 22, 1988, as amended at 60 FR 31920, June 19, 1995]

Sec. 704.3 Definitions.

All definitions as set forth in section 3 of TSCA apply in this part. In addition, the following definitions are provided for the purposes of this part. Annual means the corporate fiscal year. 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 result from a chemical reaction that occurs upon end use of other chemical substances, mixtures, or articles; except that fluids and particles are not considered articles regardless of shape or design. Byproduct means a chemical substance produced without a separate commercial intent during the manufacture, processing, use, or disposal of another chemical substance( s) or mixture( s). CAS Number means Chemical Abstracts Service Registry Number. Coproduct means a chemical substance produced for a commercial purpose during the manufacture, processing, use, or disposal of another chemical substance or mixture. Customer means any person to whom a manufacturer, importer, or processor directly distributes any quantity of a chemical substance, mixture, mixture containing the substance or mixture, or article containing the substance or mixture, whether or not a sale is involved. Domestic means within the geographical boundaries of the 50 United States, including the District of Columbia, the Commonwealth of Puerto Rico, the Virgin Islands, Guam, American Samoa, the Northern Mariana Islands, and any other territory or possession of the United States. Enclosed process means a manufacturing or processing operation that is designed and operated so that there is no intentional release into the environment of any substance present in the operation. An operation with fugitive, inadvertent, or emergency pressure relief releases remains an enclosed process so long as measures are taken to prevent worker exposure to and environmental contamination from the releases. EPA means the United States Environmental Protection Agency. Import means to import for commercial purposes. Import for commercial purposes means to import with the purpose of obtaining an immediate or eventual commercial advantage for the importer, and includes the importation of any amount of a chemical substance or mixture. If a chemical substance or mixture containing impurities is imported for commercial purposes, then those impurities also are imported for commercial purposes. Import in bulk form means to import a chemical substance ( other than as part of a mixture or article) in any quantity, in cans, bottles, drums, barrels, packages, tanks, bags, or other containers, if the chemical substance is intended to be removed from the container and the substance has an end use or commercial purpose separate from the container. Importer means ( 1) any person who imports any chemical substance or any chemical substance as part of a mixture or article into the customs territory of the United States, and includes: ( i) The person primarily liable for the payment of any duties on the merchandise, or ( ii) An authorized agent acting on his behalf ( as defined in 19 CFR 1.11). ( 2) Importer also includes, as appropriate: ( i) The consignee. ( ii) The importer of record. ( iii) The actual owner if an actual owner's declaration and superseding bond have been filed in accordance with 19 CFR 141.20. ( iv) 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. ( 3) For the purposes of this definition, the customs territory of the United States consists of the 50 States, Puerto Rico, and the District of Columbia. Impurity means a chemical substance which is unintentionally present with another chemical substance. Intermediate means any chemical substance that is consumed, in whole or in part, in chemical reactions used for the intentional manufacture of other chemical substances or mixtures, or that is intentionally present for the purpose of altering the rates of such chemical reactions. 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. Manufacture means to manufacture for commercial purposes. Manufacture for commercial purposes means: ( 1) To import, produce, or manufacture with the purpose of obtaining an immediate or eventual commercial advantage for the manufacturer, and includes among other things, such    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) Manufacture for commercial purposes also applies to substances that are produced coincidentally during the manufacture, processing, use, or disposal of another substance or mixture, including both byproducts that are separated from that other substance or mixture and impurities that remain in that substance or mixture. Such byproducts and impurities may, or may not, in themselves have commercial value. They are nonetheless produced for the purpose of obtaining a commercial advantage since they are part of the manufacture of a chemical product for a commercial purpose. Manufacturer means a person who imports, produces, or manufactures a chemical substance. A person who extracts a component chemical substance from a previously existing chemical substance or a complex combination of substances is a manufacturer of that component chemical substance. Non isolated intermediate means any intermediate that is not intentionally removed from the equipment in which it is manufactured, including the reaction vessel in which it is manufactured, equipment which is ancillary to the reaction vessel, and any equipment through which the substance passes during a continuous flow process, but not including tanks or other vessels in which the substance is stored after its manufacture. Mechanical or gravity transfer through a closed system is not considered to be intentional removal, but storage or transfer to shipping containers    isolates'' the substance by removing it from process equipment in which it is manufactured. Own or control means ownership of 50 percent or more of a company's voting stock or other equity rights, or the power to control the management and policies of that company. A company may own or control one or more sites. A company may be owned or controlled by a foreign or domestic parent company. Parent company is a company that owns or controls another company. Person includes any individual, firm, company, corporation, joint venture, partnership, sole proprietorship, association, or any other business entity; any State or political subdivision thereof; any municipality; any interstate body; and any department, agency, or instrumentality of the Federal Government. Possession or control means in the possession or control of any person, or of any subsidiary, partnership in which the person is a general partner, parent company, or any company or partnership which the parent company owns or controls, if the subsidiary, parent company, or other company or partnership is associated with the person in the research, development, test marketing, or commercial marketing of the substance in question. Information is in the possession or control of a person if it is: ( 1) In the person's own files including files maintained by employees of the person in the course of their employment. ( 2) In commercially available data bases to which the person has purchased access. ( 3) Maintained in the files in the course of employment by other agents of the person who are associated with research, development, test marketing, or commercial marketing of the chemical substance in question. Process means to process for commercial purposes. Process for commercial purposes means the preparation of a chemical substance or mixture after its manufacture for distribution in commerce with the purpose of obtaining an immediate or eventual commercial advantage for the processor. Processing of any amount of a chemical substance or mixture is included in this definition. If a chemical substance or mixture containing impurities is processed for commercial purposes, then the impurities also are processed for commercial purposes. Processor means any person who processes a chemical substance or mixture. Production volume means the quantity of a substance which is produced by a manufacturer, as measured in kilograms or pounds. Propose to manufacture, import, or process means that a person has made a firm management decision to commit financial resources for the manufacture, import, or processing of a specified chemical substance or mixture. Site means a contiguous property unit. Property divided only by a public right of way shall be considered one site. There may be more than one plant on a single site. The site for a person who imports a substance is the site of the operating unit within the person's organization which is directly responsible for importing the substance and which controls the import transaction and may in some cases be the organization's headquarters office in the United States. Small manufacturer or importer means a manufacturer or importer that meets either of the following standards: ( 1) First standard. A manufacturer or importer of a substance is small if its total annual sales, when combined with those of its parent company ( if any), are less than $ 40 million. However, if the annual production or importation volume of a particular substance at any individual site owned or controlled by the manufacturer or importer is greater than 45,400 kilograms ( 100,000 pounds), the manufacturer or importer shall not qualify as small for purposes of reporting on the production or importation of that substance at that site, unless the manufacturer or importer qualifies as small under standard ( 2) of this definition. ( 2) Second standard. A manufacturer or importer of a substance is small if its total annual sales, when combined with those of its parent company ( if any), are less than $ 4 million, regardless of the quantity of substances produced or imported by that manufacturer or importer. ( 3) Inflation index. EPA shall make use of the Producer Price Index for Chemicals and Allied Products, as compiled by the U. S. Bureau of Labor Statistics, for purposes of determining the need to adjust the total annual sales values and for determining new sales values when adjustments are made. EPA may adjust the total annual sales values whenever the Agency deems it necessary to do so, provided that the Producer Price Index for Chemicals and Allied Products has changed more than 20 percent since either the most recent previous change in sales values or the date of promulgation of this rule, whichever is later. EPA shall provide Federal Register notification when changing the total annual sales values. Small quantities solely for research and development ( or " small quantities solely for purposes of scientific experimentation or analysis or chemical research on, or analysis of, such substance or another substance, including such research or analysis for the development of a product") means quantities of a chemical substance manufactured, imported, or processed or proposed to be manufactured, imported, or processed solely for research and development that are not greater than reasonably necessary for such purposes. Substance means either a chemical substance or mixture unless otherwise indicated. Test marketing means the distribution in commerce of no more than a predetermined amount of a chemical substance, mixture, article containing that chemical substance or mixture, or a mixture containing that substance, by a manufacturer or processor, to no more than a defined number of potential customers to explore market capability in a competitive situation during a predetermined testing period prior to the broader distribution of that chemical substance, mixture, or article in commerce. Total annual sales means the total annual revenue ( in dollars) generated by the sale of all products of a company. Total annual sales must include the total annual sales revenue of all sites owned or controlled by that company and the total annual sales revenue of that company's subsidiaries and foreign or domestic parent company, if any. TSCA means the Toxic Substances Control Act, 15 U. S. C. 2601 et seq.

[ 53 FR 51715, Dec. 22, 1988]

Sec. 704.5 Exemptions.

A person who is subject to reporting requirements for a substance identified in this part is exempt from those requirements to the extent that the person and that person's use of the substance is described in this section. This section is superseded by any TSCA section 8( a) rule that adds to, removes, or revises the exemptions described in this section.

( a) Articles. A person who imports, processes, or proposes to import or process a substance identified in this part solely as part of an article is exempt from the reporting requirements of this part with regard to that substance. ( b) Byproducts. A person who manufactures, imports, or proposes to manufacture or import a substance identified in this part solely as a byproduct is exempt from the reporting requirements of this part. ( c) Impurities. A person who manufactures, imports, processes, or proposes to manufacture, import, or process a substance identified in this part solely as an impurity is exempt from the reporting requirements of this part. ( d) Non isolated intermediate. A person who manufactures or proposes to manufacture a substance identified in this part solely as a non isolated intermediate is exempt from the reporting requirements of this part. ( e) Research and development. A person who manufactures, imports, processes, or proposes to manufacture, import, or process a substance identified in this part only in small quantities solely for research and development is exempt from the reporting requirements of this part. ( f) Small manufacturers and importers. Small manufacturers and importers are exempt from the reporting requirements of this part.

[ 53 FR 51717, Dec. 22, 1988]

Sec. 704.7 Confidential business information claims.

( a) Any person submitting a notice under this rule may assert a business confidentiality claim covering all or any part of the notice. Any information covered by a claim will be disclosed by EPA only to the extent and by means of the procedures set forth in part 2 of this title. ( b) If no claim accompanies the notice at the time it is submitted to EPA, the notice will be placed in an open file available to the public without further notice to the respondent. ( c) To assert a claim of confidentiality for data contained in a notice, the respondent must submit two copies of the notice. ( 1) One copy of the notice must be complete. In that copy the respondent must indicate what data, if any, are claimed as confidential by marking the specific information on each page with a label such as    confidential'',    proprietary'', or    trade secret''. ( 2) If some data in the notice are claimed as confidential, the respondent must submit a second copy. The second copy must be complete except that all information claimed as confidential in the first copy must be deleted. ( 3) The first copy of the notice will be for internal use by EPA. The second copy will be placed in an open file to be available to the public. ( 4) Failure to furnish a second copy of the notice when information is claimed as confidential in the first copy will be considered a presumptive waiver of the claim of confidentiality. EPA will notify the respondent by certified mail that a finding of a presumptive waiver of the claim of confidentiality has been made. The respondent has 15 days from the date of receipt of notification to submit the required second copy. Failure to submit the second copy will cause EPA to place the first copy in the public file. ( d) In submitting a claim of confidentiality, a person attests to the truth of the following four statements concerning all information which is claimed confidential: ( 1) My company has taken measures to protect the confidentiality of the information, and it intends to continue to take such measures. ( 2) The information is not, and has not been, reasonably obtainable without our consent by other persons ( other than government bodies) by use of legitimate means ( other than discovery based on a showing of special need in a judicial or quasi judicial proceeding). ( 3) The information is not publicly available elsewhere. ( 4) Disclosure of the information would cause substantial harm to our competitive position.

[ 48 FR 23420, May 25, 1983, as amended at 53 FR 51717, Dec. 22, 1988]

Sec. 704.9 Where to send reports.

Reports must be submitted by certified mail to the Document Control Office ( 7407), Office of Pollution Prevention and Toxics, U. S. Environmental Protection Agency, Room G 099, 401 M St., SW., Washington, DC., 20460, ATT: 8( a) Reporting.

[ 60 FR 34463, July 3, 1995]

Sec. 704.11 Recordkeeping.

Each person who is subject to the reporting requirements of this part must retain the following records for 3 years following the creation or compilation of the record.

( a) A copy of each report submitted by the person in response to the requirements of this part. ( b) Materials and documentation sufficient to verify or reconstruct the values submitted in the report. ( c) A copy of each notice sent by the person, return receipt requested, to that person's customers for the purpose of notifying their customers of the customer's reporting obligations under this part. ( d) All return receipts signed by the person's customers who received the notice described in paragraph ( c) of this section.

[ 53 FR 51717, Dec. 22, 1988, as amended at 58 FR 34204, June 23, 1993]

Sec. 704.13 Compliance and enforcement.

Violators of the requirements of this part may be subject to civil administrative penalties up to $ 25,000 per day of violation or criminal prosecution, as provided in sections 15 and 16 of TSCA. In addition, under section 17, EPA may seek judicial relief to compel submission of required information.

[ 53 FR 51717, Dec. 22, 1989]

Subpart B Chemical Specific Reporting and Recordkeeping Rules Sec. 704.25 11 Aminoundecanoic acid.

( a) Definitions. ( 1) 11 AA means the chemical substance 11 aminoundecanoic acid, CAS Number 2432 99 7. ( 2) Enclosed process means a process that is designed and operated so that there is no intentional release of any substance present in the process. A process with fugitive, inadvertent, or emergency pressure relief releases remains an enclosed process so long as measures are taken to prevent worker exposure to an environmental contamination from the releases. ( 3) Internal subunit means a subunit that is covalently linked to at least two other subunits. Internal subunits of polymer molecules are chemically derived from monomer molecules that have formed covalent links between two or more other molecules. ( 4) Monomer means a chemical substance that has the capacity to form links between two or more other molecules. ( 5) Polymer means a chemical substance that consists of at least a simple weight majority of polymer molecules but consists of less than a simple weight majority of molecules with the same molecular weight. Collectively, such polymer molecules must be distributed over a range of molecular weights wherein differences in molecular weight are primarily attributable to differences in the number of internal subunits. ( 6) Polymer molecule means a molecule which includes at least four covalently linked subunits, at least two of which are internal subunits. ( 7) Small processor means a processor that meets either the standard in paragraph ( a)( 7)( i) of this section or the standard in paragraph ( a)( 7)( ii) of this section. ( i) First standard. A processor of a chemical substance is small if its total annual sales, when combined with those of its parent company, if any, are less than $ 40 million. However, if the annual processing volume of a particular chemical substance at any individual site owned or controlled by the processor is greater than 45,400 kilograms ( 100,000 pounds), the processor shall not qualify as small for purposes of reporting on the processing of that chemical substance at that site, unless the processor qualifies as small under paragraph ( a)( 7)( ii) of this section. ( ii) Second standard. A processor of a chemical substance is small if its total annual sales, when combined with those of its parent company ( if any), are less than $ 4 million, regardless of the quantity of the particular chemical substance processed by that company. ( iii) Inflation index. EPA will use the Inflation Index described in the definition of small manufacturer set forth in Sec. 704.3, for purposes of adjusting the total annual sales values of this small processor definition. EPA will provide notice in the Federal Register when changing the total annual sales values of this definition. ( 8) Subunit means an atom or group of associated atoms chemically derived from corresponding reactants. ( b) Persons who must report. Except as provided in paragraph ( c) of this section, the following persons are subject to this section: ( 1) Persons who manufacture or propose to manufacture 11 AA: ( i) For use as an intermediate in the manufacture of polymers in an enclosed process when it is expected that the 11 AA will be fully polymerized during the manufacturing process, or ( ii) For use as a component in photoprocessing solutions. ( 2) Persons who import or propose to import 11 AA: ( i) For use as an intermediate in the manufacture of polymers in an enclosed process when it is expected that the 11 AA will be fully polymerized during the manufacturing process, or ( ii) For use as a component in photoprocessing solutions. ( 3) Persons who process or propose to process 11 AA: ( i) For use as an intermediate in the manufacture of polymers in an enclosed process when it is expected that the 11 AA will be fully polymerized during the manufacturing process, or ( ii) For use as a component in photoprocessing solutions. ( c) Persons not subject to this section. The following persons are not subject to this section: ( 1) Small manufacturers ( includes importers) as described in Sec. 704.3. ( 2) Small processors. ( 3) Persons described in Sec. 704.5. ( 4) Persons who, at any time during the 3 year period ending July 22, 1986, manufactured, imported, or processed 11 AA: ( i) For use as an intermediate in the manufacture of polymers in an enclosed process when it is expected that the 11 AA will be fully polymerized during the manufacturing process, or ( ii) For use as a component in photoprocessing solutions. ( d) What information to report. Persons identified in paragraph ( b) of this section must submit a Premanufacture Notice Form ( EPA Form 7710 25). ( e) When to report. ( 1) Persons who intend to manufacture, import, or process 11 AA for use as an intermediate in the manufacture of polymers in an enclosed process when it is expected that the 11 AA will be fully polymerized during the manufacturing process or for use as a component in photoprocessing solutions must notify EPA within 30 days after making a firm management decision to commit financial resources for the manufacturing, importing, or processing of 11 AA. ( 2) Persons who initiated manufacturing, importing, or processing of 11 AA for use as an intermediate in the manufacture of polymers in an enclosed process when it is expected that the 11 AA will be fully polymerized during the manufacturing process, or for use as a component in photoprocessing solutions during the time period between July 22, 1986 and July 13, 1987 must notify EPA by August 10, 1987. ( f) Recordkeeping. Persons subject to the reporting requirements of this section must retain documentation of information contained in their reports for a period of 5 years from the date of submission of the report. ( g) Where to send reports. Reports must be submitted by certified mail to the Document Control Office ( 7407), Office of Pollution Prevention and Toxics, U. S. Environmental Protection Agency, Room G 099, 401 M St., SW., Washington, DC., 20460, ATT: 11 AA Notification.

[ 52 FR 19864, May 28, 1987, as amended at 60 FR 16308, Mar. 29, 1995; 60 FR 34463, July 3, 1995]

Sec. 704.33 P tert butylbenzoic acid ( P TBBA), p tert butyltoluene ( P TBT) and p tert butylbenzaldehyde ( P TBB).

( a) Definitions. ( 1) P TBBA means the substance p tert butylbenzoic acid, also identified as 4( 1,1 dimethylethyl) benzoic acid, CAS No. 98 73 7. ( 2) P TBT means the substance p tert butyltoluene, also identified as 1( 1,1 dimethylethyl) 4 methylbenzene, CAS No. 98 51 1. ( 3) P TBB means the substance p tert butylbenzaldehyde, also identified as 4( 1,1 dimethylethyl) benzaldehyde, CAS No. 939 97 9. ( 4) Small processor means a processor that meets either the standard in paragraph ( a)( 4)( i) of this section or the standard in paragraph ( a)( 4)( ii) of this section. ( i) First standard. A processor of a chemical substance is small if its total annual sales, when combined with those of its parent company, if any, are less than $ 40 million. However, if the annual processing volume of a particular chemical substance at any individual site owned or controlled by the processor is greater than 45,400 kilograms ( 100,000 pounds), the processor shall not qualify as small for purposes of reporting on the processing of that chemical substance at that site, unless the processor qualifies as small under paragraph ( a)( 1)( ii) of this section. ( ii) Second standard. A processor of a chemical substance is small if its total annual sales, when combined with those of its parent company ( if any), are less than $ 4 million, regardless of the quantity of the particular chemical substance processed by that company. ( iii) Inflation index. EPA shall use the Inflation Index described in the definition of small manufacturer that is set forth in Sec. 704.3, for purposes of adjusting the total annual sales values of this small processor definition. EPA shall provide Federal Register notification when changing the total annual sales values of this definition. ( b) Persons who must report. Except as provided in paragraph ( c) of this section, the following persons are subject to the reporting requirements of this rule; a person may become subject to this rule more than once, for more than one substance or under more than one of the criteria listed in this paragraph ( b). ( 1) Persons who manufactured, imported, or processed P TBBA, P TBT, and/ or P TBB for commercial purposes during the person's latest complete corporate fiscal year prior to June 25, 1986. For purposes of this provision, processors of P TBBA, P TBT, and/ or P TBB shall include only those persons who processed the substances other than as non isolated intermediates. ( 2) Persons who commence manufacture or importation of P TBBA, P TBT, and/ or P TBB for commercial purposes after June 25, 1986. This provision is applicable to persons who cease manufacture or importation of P TBBA, P TBT, and/ or P TBB after June 25, 1986 and then subsequently resume manufacture or importation of the substance( s). ( 3) Persons who process P TBBA, P TBT, and/ or P TBB for commercial purposes in any way other than as a non isolated intermediate after June 25, 1986. ( c) Persons not subject to this rule. In addition to the persons described in Sec. 704.5, small processors, as defined in paragraph ( a)( 4) of this section, are not subject to this rule. ( d) Information to report. Persons subject to this rule as described in paragraph ( b) of this section shall report information to EPA as specified in this paragraph ( d). Respondents to this rule shall report all information that is known to or reasonably ascertainable by the person reporting. For purposes of importer reporting under this paragraph, a site is the operating unit within the person's organization which is directly responsible for importing the substance and which controls the import transaction. The import site may in some cases be the organization's headquarters office in the United States. ( 1) All manufacturers, importers, and processors specified in paragraph ( b) of this section shall report their name and headquarters address. ( 2) All manufacturers, importers, and processors specified in paragraph ( b) of this section shall report the name, address, and office telephone number ( including area code) of their principal technical contact. ( 3) All manufacturers, importers, and processors specified in paragraph ( b) of this section shall report the name and address of each site where P TBBA, P TBT, and/ or P TBB is manufactured, imported, or processed. ( 4) All manufacturers, importers, and processors specified in paragraph ( b)( 1) of this section only shall report the information described in this paragraph ( d)( 4). Respondents to this paragraph ( d)( 4) shall report separately for each substance that they manufacture, import, or process, and for each site at which they do so. However, if the information to be reported in response to this paragraph ( d)( 4) is the same for different sites, the respondent need not report separately for each site but need only notify EPA that the information is the same for each site. The information to be reported under this paragraph ( d)( 4) shall cover the respondent's latest complete corporate fiscal year prior to June 25, 1986. Respondents to this paragraph ( d)( 4) shall report the following information: ( i) The total quantity ( by weight) of P TBBA, P TBT, or P TBB manufactured, imported, or processed for commercial purposes per site. ( ii) A narrative description of the manufacturing, importing, or processing operation( s) involving P TBBA, P TBT, or P TBB at each site. ( iii) A narrative description of worker activities involving P TBBA, P TBT, or P TBB at each site, including the number of workers potentially exposed to each substance and, if applicable, the number of workers potentially exposed to more than one substance. ( iv) The potential routes of worker exposure to P TBBA, P TBT, or P TBB at each site ( e. g., inhalation, ingestion, dermal absorption). ( v) Available monitoring data from employee breathing zones with potential exposure to P TBBA, P TBT, or P TBB at each site, including a description of the method of monitoring, the number of samples taken, and the potential number of workers similarly exposed for each worker job category. Respondents to this paragraph ( d)( 4)( v) shall submit data showing a range of 8 hour time weighted averages ( TWAs), provided that the data are available in that form. Respondents also shall submit a calculated geometric mean of these data, with an explanation of the method by which the mean was derived. However, if the monitoring data are not available in the form of 8 hour TWAs, respondents shall submit raw sample data results and the duration time of sampling for each job category. ( vi) A narrative description of any personal protective equipment and/ or engineering controls used to prevent exposure to P TBBA, P TBT, or P TBB at each site. ( vii) A listing of the estimated quantities of P TBBA, P TBT, or P TBB released directly into air, water, or land from each site. ( viii) A narrative description of the times during the manufacturing, importing, or processing operations involving P TBBA, P TBT, or P TBB when environmental release occurs at each site. ( ix) A narrative description of any engineering controls used to prevent environmental release of P TBBA, P TBT, or P TBB at each site. ( x) A narrative description of all known end uses of any P TBBA, P TBT, or P TBB that is manufactured, imported, or processed by the respondent. The narrative need not include customer identity. ( xi) A narrative description of the methods used at each site for disposing of wastes generated during the manufacture, importation, or processing of P TBBA, P TBT, or P TBB, including the quantity and content of such wastes ( per site), the method of disposal, and an identification of the disposal site( s). ( 5) All manufacturers, importers, and processors specified in paragraph ( b) of this section shall report the information described in this paragraph ( d)( 5). Respondents to this paragraph ( d)( 5) shall report separately for each substance that they intend to manufacture, import, or process during the first 2 years following the date on which they become subject to this rule. The data reported under this paragraph ( d)( 5) shall cover that 2 year period. Respondents to this paragraph ( d)( 5) shall report separately for each site at which they intend to manufacture, import, or process each substance. Respondents need not comply with this paragraph ( d)( 5) if the information to be reported is identical to that reported by the respondent under paragraph ( d)( 4) of this section, provided that the respondent makes note of that fact to EPA. Respondents to this paragraph ( d)( 5) shall report the following information: ( i) An estimate of the total quantity ( by weight) of P TBBA, P TBT, or P TBB that the respondent intends to manufacture, import, or process for commercial purposes per site during each of the first 2 years following the date on which the respondent becomes subject to this rule. ( ii) A narrative description of the intended manufacturing, importing, or processing activities involving P TBBA, P TBT, or P TBB at each site during the first 2 years following the date on which the respondent becomes subject to this rule. The description shall include a summary of the intended manufacturing, importing, or processing operation( s); a summary of intended worker activities involving the substances, including an estimate of the number of persons anticipated to be exposed annually to P TBBA, P TBT, or P TBB ( per site) during the 2 year period, the anticipated routes of worker exposure to the substances ( e. g., inhalation, ingestion, dermal absorption); and a summary of any personal protective equipment and/ or engineering controls that the respondent intends to use to prevent exposure to the substances. ( iii) A narrative description of anticipated environmental releases of P TBBA, P TBT, or P TBB at each site from the manufacture, importation, or processing of these substances during the first 2 years following the date on which the respondent becomes subject to this rule. The narrative shall include the anticipated quantities of each substance released directly into air, water, or land, the anticipated routes of environmental release, and any intended engineering controls to be used to prevent environmental release of the substances. ( iv) A narrative description of all anticipated end uses or P TBBA, P TBT, or P TBB resulting from the respondent's manufacture, importation, or processing of the substances during the first 2 years following the date on which the respondent becomes subject to this rule. The summary need not include customer identity. ( v) A narrative summary of the anticipated disposal of wastes generated from the manufacture, importation, or processing of P TBBA, P TBT, or P TBB during the first 2 years following the date on which the respondent becomes subject to this rule. The summary shall include the anticipated quantity and content of such wastes ( per site), the intended method of disposal, and an identification of intended disposal site( s). ( e) When to report. Persons subject to this rule must submit the requisite information to EPA within 60 days of becoming subject to the rule under the standards set forth in paragraph ( b) of this section. ( f) Certification. Persons subject to this rule must attach the following statement to any information submitted to EPA in response to this rule:    I hereby certify that, to the best of my knowledge and belief, all of the attached information is complete and accurate.'' This statement shall be signed and dated by the company's principal technical contact. ( g) Recordkeeping. Persons subject to the reporting requirements of this section must retain documentation of information contained in their reports for a period of 5 years from the date of the submission of the report.

[ 51 FR 17339, May 12, 1986; 51 FR 18323, May 19, 1986, as amended at 52 FR 20083, May 29, 1987; 58 FR 34204, June 23, 1993]

Sec. 704.43 Chlorinated naphthalenes.

( a) Definitions. ( 1) Extent of chlorination means the percent by weight of chlorine. ( 2) Import means to import in bulk form or as part of a mixture. ( 3) Isomeric ratio means the relative amounts of each isomeric chlorinated naphthalene that composes the chemical substance; and for each isomer the relative amounts of each chlorinated naphthalene designated by the position of the chlorine atom( s) on the naphthalene. ( 4) Polychlorinated biphenyl means any chemical substance that is limited to the biphenyl molecule and that has been chlorinated to varying degrees. ( 5) Small manufacturer means a manufacturer ( including importers) who meets either paragraph ( a)( 5) ( i) or ( ii) of this section: ( i) A manufacturer of a chemical substance is small if its total annual sales, when combined with those of its parent company ( if any), are less than $ 40 million. However, if the annual production volume of a particular chemical substance at any individual site owned or controlled by the manufacturer is greater than 45,400 kilograms ( 100,000 pounds), the manufacturer shall not qualify as small for purposes of reporting on the production of that chemical substance at that site, unless the manufacturer qualifies as small under paragraph ( a)( 5)( ii) of this section. ( ii) A manufacturer of a chemical substance is small if its total annual sales, when combined with those of its parent company ( if any), are less than $ 4 million, regardless of the quantity of the particular chemical substance produced by that manufacturer. ( iii) For imported mixtures containing a chemical substance identified in paragraph ( b) of this section, the 45,400 kilograms ( 100,000 pounds) standard in paragraph ( a)( 5)( i) of this section applies only to the amount of the chemical substance in a mixture and not the other components of the mixture. ( 6) Waste means any solid liquid, semisolid, or contained gaseous material that results from the production of a chemical substance identified in paragraph ( b) of this section and which is to be disposed. ( b) Substances for which reports must be submitted.

 CAS registry number Chemical substance  90 13 1.......................... Naphthalene, 1 chloro 91 58 7.......................... Naphthalene, 2 chloro 1321 64 8........................ Naphthalene, pentachloro 1321 65 9........................ Naphthalene, trichloro 1335 87 1........................ Naphthalene, hexachloro 1335 88 2........................ Naphthalene, tetrachloro 1825 30 5........................ Naphthalene, 1,5 dichloro 1825 31 6........................ Naphthalene, 1,4 dichloro 2050 69 3........................ Naphthalene, 1,2 dichloro 2050 72 8........................ Naphthalene, 1,6 dichloro 2050 73 9........................ Naphthalene, 1,7 dichloro 2050 74 0........................ Naphthalene, 1,8 dichloro 2050 75 1........................ Naphthalene, 2,3 dichloro 2065 70 5........................ Naphthalene, 2,6 dichloro 2198 75 6........................ Naphthalene, 1,3 dichloro 2198 77 8........................ Naphthalene, 2,7 dichloro 2234 13 1........................ Naphthalene, octachloro 25586 43 0....................... Naphthalene, chloro 32241 08 0....................... Naphthalene, heptachloro 70776 03 3....................... Naphthalene, chloro derivatives.

( c) Persons who must report. ( 1) Persons who are manufacturing or importing a chemical substance identified in paragraph ( b) of this section on October 8, 1984. ( 2) Persons who propose to import a chemical substance identified in paragraph ( b) of this section on or after October 8, 1984. ( 3) Persons who manufacture a chemical substance identified in paragraph ( b) of this section after October 8, 1984. ( 4) A person is required to report only once for each chemical substance identified in paragraph ( b) of this section. ( d) Persons exempt from reporting. ( 1) Small manufacturers. ( 2) Persons described in Sec. 704.5. ( e) What information to report. Persons described in paragraph ( c) of this section must notify EPA of current or prospective manufacture or import. The notice must include, to the extent that it is known to or reasonably ascertainable by the person making the report, the following information: ( 1) Company name and address. ( 2) Name, address, and telephone number of the principal technical contact. ( 3) For chemical substances proposed to be imported, the proposed date of import. ( 4) A description of the use( s) or intended use( s) for the chemical substance. ( 5) A description of the isomeric ratio and extent of chlorination of the chemical substance and the impurity level of polychlorinated biphenyls. ( 6) The quantity ( by weight) manufactured or imported within 12 months prior to October 8, 1984, if any, and the estimated quantity ( by weight) to be manufactured or imported for the first 3 years following the date of the report or the date of the intended start of import whichever occurs later. ( 7) The number of persons exposed to the chemical substance during manufacture, import, processing, distribution in commerce, use, and disposal. ( 8) If a manufacturer's waste contains one or more of the chemical substances identified in paragraph ( b) of this section, the manufacturer must: ( i) Provide the quantity ( by weight) of the chemical substances identified in paragraph ( b) of this section present in the waste, ( ii) Identify the constituents of the waste and their concentrations, ( iii) State the rate of waste generation as a percentage of production volume, ( iv) Describe where in the manufacturing process the waste is generated, and ( v) Describe the method for disposal of the waste. ( f) When to report. ( 1) Persons who are manufacturing or importing a chemical substance identified in paragraph ( b) of this section on October 8, 1984 must notify EPA by November 6, 1984. ( 2) Persons who propose to import a chemical substance identified in paragraph ( b) of this section on or after October 8, 1984 must notify EPA by November 6, 1984, or 15 days after making the management decision described in Sec. 704.3, whichever is later in time. ( 3) Persons who manufacture a chemical substance identified in paragraph ( b) of this section after October 8, 1984 must notify EPA within 30 days after the initial date of manufacture.

[ 49 FR 33653, Aug. 24, 1984; 49 FR 45133, Nov. 15, 1984; 50 FR 1215, Jan. 10, 1985; 51 FR 19839, June 3, 1986; 52 FR 20083, May 29, 1987. Redesignated at 53 FR 51717, Dec. 22, 1988]

Sec. 704.45 Chlorinated terphenyl.

( a) Definitions. ( 1) Chlorinated terphenyl means a chemical substance, CAS No. 61788 33 6, comprised of chlorinated ortho, meta, and paraterphenyl. ( 2) Extent of chlorination means the percent by weight of chlorine for each isomer ( ortho, meta, and para). ( 3) Isomeric ratio means the ratios of ortho, meta, and parachlorinated terphenyls. ( 4) Polychlorinated biphenyl means any chemical substance that is limited to the biphenyl molecule that has been chlorinated to varying degrees. ( 5) Small manufacturer means a manufacturer ( importers are defined as manufacturers under TSCA) who meets either of the following standards under this rule: ( i) First standard. A manufacturer of an existing chemical substance is small if its total annual sales, when combined with those of its parent company ( if any), are less than $ 40 million. However, if the annual production volume of a particular chemical substance at any individual site owned or controlled by the manufacturer is greater than 45,400 kilograms ( 100,000 pounds), the manufacturer shall not qualify as small for purposes of reporting on the production of that chemical substance at the site, unless the manufacturer qualified as small under paragraph ( a)( 5)( ii) of this section. ( ii) Second standard. A manufacturer of an existing chemical substance is small if its total annual sales, when combined with those of its parent company ( if any), are less than $ 4 million, regardless of the quantity of chemicals produced by that manufacturer. ( b) Persons who must report. Except for small manufacturers and as provided in Sec. 704.5, the following persons are subject to the rule: ( 1) Persons who manufacture or propose to manufacture chlorinated terphenyl. ( 2) Persons who import ( importers) or propose to import chlorinated terphenyl as a chemical substance in bulk or as part of a mixture. ( c) What information to report. Persons subject to this rule as described in paragraph ( b) of this section must notify EPA of current or proposed manufacture or import of chlorinated terphenyl. The notice must include, to the extent that it is known to the person making the report or is reasonably ascertainable, the following information: ( 1) Company name and address. ( 2) Name, address, and telephone number of principal technical contact. ( 3) A description of the use( s) or intended use( s) for chlorinated terphenyl. ( 4) A description of the isomeric ratio and extent of chlorination of the chlorinated terphenyl and the impurity level of polychlorinated biphenyls. ( 5) The quantity ( by weight) manufactured or imported within 12 months prior to the effective date of the rule, if any, and the estimated quantity ( by weight) to be manufactured or imported for the first three years following the date of the report or the date of the intended start of production, whichever occurs later. ( 6) The proposed date for the initiation of manufacturing or importation of chlorinated terphenyl, if appropriate. ( d) When to report. Persons who are manufacturing or importing chlorinated terphenyl on the effective date of the rule must notify EPA within 30 days of the effective date of the rule. Persons who propose to manufacture or import chlorinated terphenyl must notify EPA within 15 days after making the management decision described in Sec. 704.3    Proposed to manufacture or import''.

[ 49 FR 11184, Mar. 26, 1984, as amended at 49 FR 32068, Aug. 10, 1984; 50 FR 2048, Jan. 15, 1985; 52 FR 20083, May 29, 1987. Redesignated at 53 FR 51717, Dec. 22, 1988; 58 FR 34204, June 23, 1993]

Sec. 704.95 Phosphonic acid, [ 1,2 ethanediyl bis[ nitrilobis ( methylene)]] tetrakis ( EDTMPA) and its salts.

( a) Substances for which reporting is required. The chemical substances for which reporting is required under this section are:  CAS No. Chemical name  1429 50 1. Phosphonic acid, [ 1,2 ethanediyl bis[ nitrilobis( methylene)]] tetrakis ( EDTMPA) 15142 96 8. Phosphonic acid, [ 1,2 ethanediyl bis[ nitrilobis( methylene)]] tetrakis, hexasodium salt 34274 30 1. Phosphonic acid, [ 1,2 ethanediyl bis[ nitrilobis( methylene)]] tetrakis, potassium salt 57011 27 5. Phosphonic acid, [ 1,2 ethanediyl bis[ nitrilobis( methylene)]] tetrakis, ammonium salt 67924 23 6. Cobaltate ( 6), [[[ 1,2 ethanediylbis [ nitrilobis( methylene)]] tetrakis[ phosphonato]] ( 8)], pentapotassium hydrogen, ( OC 6 21) 67969 67 9. Cobaltate ( 6), [[[ 1,2 ethanediylbis [ nitrilobis( methylene)]] tetrakis [ phosphonato]] ( 8) N, N', O, O'', O'''', O''''''], pentasodium hydrogen, ( OC 6 21) 67989 89 3. Cuprate ( 6), [[[ 1,2 ethanediylbis [ nitrilobis( methylene)]] tetrakis [ phosphonato]] ( 8)], pentapotassium hydrogen, ( OC 6 21) 68025 39 8. Cobaltate ( 6), [[[ 1,2 ethanediylbis [ nitrilobis( methylene)]] tetrakis [ phosphonato]] ( 6) N, N', O, O'', O'''', O''''''], pentaammonium hydrogen, ( OC 6 21) 68188 96 5. Phosphonic acid, [ 1,2 ethanediylbis [ nitrilobis( methylene)]] tetrakis, tetrapotassium salt 68309 98 8. Cadmate ( 6), [[[ 1,2 ethanediylbis [ nitrilobis( methylene)]] tetrakis [ phosphonato]] ( 8)], pentapotassium hydrogen, ( OC 6 21) 68901 17 7. Phosphonic acid, [ 1,2 ethanediylbis [ nitrilobis( methylene)]] tetrakis, octaammonium salt 68958 86 1. Nickelate ( 6), [[[ 1,2 ethanediylbis [ nitrilobis( methylene)]] tetrakis [ phosphonato]] ( 8)], pentaammonium hydrogen, ( OC 6 21) 68958 87 2. Nickelate ( 6), [[[ 1,2 ethanediylbis [ nitrilobis( methylene)]] tetrakis [ phosphonato]] ( 8)], pentapotassium hydrogen, ( OC 6 21) 68958 88 3. Nickelate ( 6), [[[ 1,2 ethanediylbis [ nitrilobis( methylene)]] tetrakis [ phosphonato]] ( 8)], pentasodiumhydrogen, ( OC 6 21)

( b) Persons who must report. Unless exempt as provided in Sec. 704.5, reports must be submitted by: ( 1) Persons who manufacture or import any of the substances identified in paragraph ( a) of this section. ( 2) Persons who propose to manufacture or propose to import any of the substances identified in paragraph ( a) of this section. For the purposes of importer reporting under this section, an import site is the operating unit within the person's organization which is directly responsible for importing the substance and which controls the import transaction; the import site may in some cases be the organization's headquarters office in the United States. ( c) What information to report. Persons identified in paragraph ( b) of this section must report to EPA, for each of the substances identified in paragraph ( a) of this section, the following information to the extent known to or reasonably ascertainable by them. ( 1) Initial Report: ( i) Name and Chemical Abstracts Service Registry Number of the substance for which the report is submitted. ( ii) Company name and headquarters address. ( iii) Name, address, and telephone number of the principal technical contact. ( iv) The total quantity ( by weight in pounds) of the substance manufactured or imported for the person's most recently completed corporate fiscal year. ( v) A description of the commercial uses of the substance during the person's most recently completed corporate fiscal year, including the production volume for each use. ( vi) The estimated quantity ( by weight in pounds) of the substance proposed to be manufactured or imported in the person's current corporate fiscal year. ( vii) A description of the intended commercial uses of the substance during the person's current corporate fiscal year, including the estimated production volume for each use. ( 2) Follow up Report: ( i) Name and Chemical Abstracts Service Registry Number of the substance for which the report is submitted. ( ii) Company name and headquarters address. ( iii) Name, address, and telephone number of the principal technical contact. ( iv) The estimated quantity ( by weight in pounds) of the substance proposed to be manufactured or imported in the person's current corporate fiscal year. ( v) A description of the intended commercial uses of the substance during the person's current corporate fiscal year, including the estimated production volume for each use. ( d) When to report. ( 1) Persons specified in paragraph ( b)( 1) of this section who are manufacturing or importing the substance as of December 5, 1988 must submit an initial report described in paragraph ( c)( 1) of this section by January 3, 1989. ( 2) Persons specified in paragraph ( b)( 2) of this section must submit an initial report within 30 days after making the management decision described in Sec. 704.3 or by January 3, 1989, whichever is later. ( 3) Persons specified in paragraph ( b) of this section, who submitted a report described in paragraph ( c)( 1) of this section, must submit a follow up report described in paragraph ( c)( 2) of this section within 30 days of making the management decision, described at Sec. 704.3, to do either of the following events: ( i) Manufacture or import the substance in a quantity 50 percent greater than the quantity reported in the most recently submitted report. ( ii) Manufacture or import the substance for a use not reported for that substance in any previous report. ( e) Certification. Persons subject to this section must attach the following statement to any information submitted to EPA in response to this section:    I hereby certify that, to the best of my knowledge and belief, all of the attached information is complete and accurate.'' This statement must be signed and dated by the company's principal technical contact. ( f) Recordkeeping. Persons subject to the reporting requirements of this section must retain documentation of information contained in their reports for a period of 5 years from the date of the submission of the report.

[ 53 FR 41337, Oct. 21, 1988, as amended at 58 FR 34204, June 23, 1993]

Sec. 704.102 Hexachloronorbornadiene.

( a) Definitions. ( 1) Endrin means the pesticide 2,7: 3,6 Dimethano naphth[ 2,3 b] oxirene, 3,4,5,6,9,9 hexachloro 1a, 2,2a, 3,6,6a, 7,7a octahydro, ( 1aalpha, 2beta, 2abeta, 3alpha, 6alpha, 6abeta, 7beta, 7aalpha), CAS Number 72 20 8. ( 2) HEX BCH means the chemical substance 1,2,3,4,7,7 hexachloronorbornadiene, CAS Number 3389 71 7. ( 3) Isodr in means the pest icide 1,4: 5,8 Dimethanonaphthalene, 1,2,3,4,10,10 hexacholoro 1,4,4a, 5,8,8a hexahydro, ( 1alpha, 4alpha, 4abeta, 5beta, 8beta, 8abeta), CAS Number 465 73 6. ( 4) Small business means any manufacturer, importer, or processor who meets either paragraph ( a)( 4)( i) or ( ii) of this section: ( i) A business is small if its total annual sales, when combined with those of its parent ( if any), are less than $ 40 million. However, if the annual manufacture, importation, or processing volume of a particular chemical substance at any individual site owned or controlled by the business is greater than 45,400 kilograms ( 100,000 pounds), the business shall not qualify as small for purposes of reporting on the manufacture, importation, or processing of that chemical substance at that site, unless the business qualifies as small under paragraph ( a)( 4)( ii) of this section. ( ii) A business is small if its total annual sales, when combined with those of its parent company ( if any), are less than $ 4 million, regardless of the quantity of the particular chemical substance manufactured, imported, or processed by that business. ( iii) For imported and processed mixtures containing HEX BCH, the 45,400 kilograms ( 100,000 pounds) standard in paragraph ( a)( 4)( i) of this section applies only to the amount of HEX BCH in a mixture and not the other components of the mixture. ( 5) 8 hour time weighted average means the cumulative exposure for an 8 hour work shift computed as follows:

C< INF> a</ INF> T< INF> a</ INF>+ C< INF> b</ INF> T< INF> b</ INF>+ . . . C< INF> n</ INF> T< INF> n</ INF> E =

8 Where: E is the equivalent exposure for the working shift. C< INF> i</ INF> is the concentration ( i. e., parts per million) during any period of time ( T< INF> i</ INF>) where the concentration remains constant. T< INF> i</ INF> is the duration in hours of the exposure at the concentration C< INF> i</ INF>.

( 6) Year means corporate fiscal year. ( b) Persons who must report. ( 1) Reports must be submitted by: ( i) Persons who are manufacturing, importing, or processing HEX BCH for use as an intermediate in the production or isodrin or endrin on or after January 2, 1986; and ( ii) Persons who propose to manufacture, import, or process HEX BCH for use as an intermediate in the production of isodrin or endrin, on or after January 2, 1986. ( 2) Persons described in paragraph ( b)( 1) of this section who engage or propose to engage in more than one activity ( i. e., manufacture and processing) must report the information required in paragraph ( d) separately for each activity. ( c) Persons exempt from reporting. ( 1) Small businesses. ( 2) Persons described in Sec. 704.5( a) and ( c). ( d) Information to report. ( 1) Initial reports must include, to the extent that it is known to or reasonably ascertainable by the person reporting, the following information: ( i) Company name and address. ( ii) Name, address, and telephone number of the principal contact. ( iii) Name and address of plant sites where HEX BCH is or is proposed to be manufactured, imported, or processed, noting for each plant site which activity takes or would take place at each site. ( iv) If applicable, the intended date for initiating the manufacture, import, or processing of HEX BCH. ( v) If applicable, the actual quantity ( by weight) of HEX BCH manufactured, imported, or processed during the most recently concluded year. ( vi) The estimated quantity ( by weight) of HEX BCH to be manufactured, imported, or processed each year during the first 3 years following the date of the report or the date of the intended start of manufacture, import, or processing, whichever occurs later. ( vii) For each year described in paragraphs ( d)( 1) ( v) and ( vi) of this section: the number or expected number of employees exposed to HEX BCH during the manufacture, import, processing, distribution in commerce, use, and disposal; the routes of exposure; and the 8 hour time weighted average of exposure. ( viii) If employees are exposed or expected to be exposed to HEX BCH, state for each reported route of exposure, whether personal protective equipment is used or expected to be used, and a description of the personal protective equipment. ( ix) The actual or anticipated quantity, content, method of disposal, and disposal site of any wastes generated or expected to be generated during the manufacture, importation, or processing of HEX BCH. ( 2) Subsequent reports must provide, to the extent known to or reasonably ascertainable by the person reporting, the information in paragraph ( d)( 1) of this section and a statement explaining why the subsequent report is required. ( e) When to report. ( 1) Persons who are manufacturing, importing, or processing HEX BCH on January 2, 1986, must submit an initial report to EPA by February 3, 1986. ( 2) Persons who propose to manufacture, import, or process HEX BCH on or after January 2, 1986, must submit an initial report to EPA by February 3, 1986, or 30 days after making the management decision described in Sec. 704.3 " Propose to manufacture, import, or process," whichever is later in time. ( 3) Persons described in paragraph ( b) of this section, who have submitted a report described in paragraph ( d) of this section, must submit a subsequent report within 30 days of any of the following events. Based on the most recently submitted report: ( i) The manufacture, importation, or processing of HEX BCH begins at a plant site different than that reported pursuant to paragraph ( d)( 1)( iii) of this section. ( ii) The actual quantity ( by weight) of HEX BCH manufactured, imported, or processed in a given year is greater than or equal to 200 percent of the estimated value for that year reported pursuant to paragraph ( d)( 1)( vi) of this section. ( iii) The total number of employees exposed to HEX BCH is greater than 130 percent of the projected value reported pursuant to paragraph ( d)( 1)( vii) of this section. ( iv) The route of exposures to HEX BCH differs from that reported pursuant to paragraph ( d)( 1)( vii) of this section. ( v) The actual 8 hour time weighted average exposure for any activity exceeds the projection reported pursuant to paragraph ( d)( 1)( vii) of this section by more than 100 percent. ( vi) The method of disposal or disposal site reported pursuant to paragraph ( d)( 1)( ix) of this section has changed. ( vii) Three years have passed since the most recent submission of a report and the person is still engaged in the manufacture, importation, or processing of HEX BCH. ( f) Certification of review. Each person who submits a report under this section must for 3 years following the submission date of the most recent submission, review their activities at the end of each year to determine whether any reportable event specified in paragraph ( e)( 3) of this section has occurred. If a review shows that none of these events has occurred, the person is required to certify this fact in writing. ( g) Recordkeeping. Any person subject to the reporting requirements of this section must: ( 1) Retain documentation of information contained in their reports. This documentation must be maintained for a period of 3 years from the date of the submission of the report; and ( 2) Retain the certification required by paragraph ( f) of this section for 3 years from the date of its creation.

[ 50 FR 47536, Nov. 19, 1985, as amended at 52 FR 20083, May 29, 1987. Redesignated at 53 FR 51717, Dec. 22, 1988; 58 FR 34204, June 23, 1993]

Sec. 704.104 Hexafluoropropylene oxide.

( a) Definitions. ( 1) " HFPO" means the chemical substance hexafluoropropylene oxide, CAS Number 428 59 1. [ Listed in TSCA Inventory as oxirane, trifluoro( trifluoromethyl)] ( 2) " Enclosed process" means a process that is designed and operated so that there is no intentional release of any substance present in the process. A process with fugitive, inadvertent, or emergency pressure relief releases remains an enclosed process so long as measures are taken to prevent worker exposure to and environmental contamination from the releases. ( 3) " Small processor" means a processor that meets either the standard in paragraph ( a)( 3)( i) of this section or the standard in paragraph ( a)( 3)( ii) of this section. ( i) First standard. A processor of a chemical substance is small if its total annual sales, when combined with those of its parent company, if any, are less than $ 40 million. However, if the annual processing volume of a particular chemical substance at any individual site owned or controlled by the processor is greater than 45,400 kilograms ( 100,000 pounds), the processor shall not qualify as small for purposes of reporting on the processing of that chemical substance at that site, unless the processor qualifies as small under paragraph ( a)( 3)( ii) of this section. ( ii) Second standard. A processor of a chemical substance is small if its total annual sales, when combined with those of its parent company ( if any), are less than $ 4 million, regardless of the quantity of the particular chemical substance processed by that company. ( iii) Inflation index. EPA will use the Inflation Index described in the definition of " small manufacturer" that is set forth in Sec. 704.3 for purposes of adjusting the total annual sales values of this small processor definition. EPA will provide Federal Register notification when changing the total annual sales values of this definition. ( b) Persons who must report. Except as provided in paragraph ( c) of this section, the following persons are subject to this section: ( 1) Persons who manufacture or propose to manufacture HFPO for use as an intermediate in the manufacture of fluorinated substances in an enclosed process. ( 2) Persons who import or propose to import HFPO for use as an intermediate in the manufacture of fluorinated substances in an enclosed process. ( 3) Persons who process or propose to process HFPO as an intermediate in the manufacture of fluorinated substances in an enclosed process. ( c) Persons not subject to this rule. The following persons are not subject to this rule: ( 1) Small processors. ( 2) Persons described in Sec. 704.5 ( a) through ( d). ( 3) Persons who have already submitted to EPA a completed copy of the Preliminary Assessment Information Manufacturer's Report ( EPA Form 7710 35, as described at Sec. 712.28 of this chapter) for HFPO are not required to report under this section with respect to activities previously reported on. ( d) What information to report. Persons identified in paragraph ( b) of this section must submit a Premanufacture Notice Form ( EPA Form 7710 25). ( e) When to report. ( 1) Persons who are manufacturing, importing, or processing, or who propose to manufacture, import, or process HFPO for use as an intermediate in the manufacture of fluorinated substances in an enclosed process as of December 10, 1987, must report by February 8, 1988. ( 2) Persons who propose to manufacture, import, or process HFPO for use as an intermediate in the manufacture of fluorinated substances in an enclosed process after December 10, 1987, must report within 30 days after making a firm management decision to commit financial resources for the manufacturing, importing, or processing of HFPO. ( f) Recordkeeping. Persons subject to the reporting requirements of this section must retain documentation of information contained in their reports for a period of 5 years from the date of submission of the reports. ( g) Where to send reports. Reports must be submitted by certified mail to the Document Control Office ( 7407), Office of Pollution Prevention and Toxics, U. S. Environmental Protection Agency, Room G 099, 401 M St., SW., Washington, DC., 20460, ATTN: HFPO Reporting.

[ 52 FR 41299, Oct. 27, 1987, as amended at 58 FR 34204, June 23, 1993; 60 FR 16308, Mar. 29, 1995; 60 FR 31920, June 19, 1995; 60 FR 34463, July 3, 1995]

Sec. 704.175 4,4' methylenebis( 2 chloroaniline) ( MBOCA).

( a) Substance subject to reporting. The chemical substance 4,4' methylenebis( 2 chloroaniline) ( CAS No. 101 14 4) is subject to reporting under this section. The substance also is identified as 4,4' methylenebis( 2 chlorobenzenamine) and MBOCA. ( b) Persons who must report. Except as provided in paragraph ( c) of this section, the following persons are subject to this rule. ( 1) Persons who propose to manufacture MBOCA in the United States on or after June 2, 1986. ( 2) Persons who are manufacturing MBOCA in the United States as of June 2, 1986. ( 3) Persons manufacturing MBOCA in the United States on or after June 2, 1986 who propose to change their manner or method of manufacturing the substance from a manner or method of manufacturing that previously was reported under this section. ( c) Persons not subject to this rule. The following persons are exempt from the reporting requirements of this section: ( 1) Persons who import MBOCA into the customs territory of the United States and do not otherwise manufacture the substance in the United States. ( 2) Persons who complied with the requirements of this section prior to June 2, 1986 and received written notification of compliance from EPA. ( d) What information to report. Persons who are subject to this rule as described in paragraph ( b) of this section must report information to EPA by completing the following parts of the notice form contained in appendix A to part 720 of this chapter: Parts I. A., I. B., I. C. 1., I. C. 3., and II. A.; also, part III as appropriate. Persons subject to the requirements of this section also must submit a narrative description of any processing and packaging of MBOCA that occurs at the manufacturing plant site, including the number of workers potentially exposed to MBOCA during on site processing and packaging of MBOCA and a description of any personal protective equipment and/ or engineering controls that would be used to prevent release of and exposure to MBOCA during on site processing and packaging. Persons subject to the requirements of this section are not required to submit information on processing or use of MBOCA away from the manufacturing plant site. Respondents to this rule shall report all information that is known to or reasonably ascertainable by the person reporting. ( e) When to report. ( 1) Persons specified in paragraph ( b)( 1) of this section must report by July 2, 1986 or within 30 days after making a firm management decision to commit financial resources for the manufacture of MBOCA, whichever is later in time. ( 2) Persons specified in paragraph ( b)( 2) of this section must report by July 2, 1986. ( 3) Persons specified in paragraph ( b)( 3) of this section must report within 30 days of making a firm management decision to commit financial resources to change their manner or method of manufacturing the substance from a manner or method of manufacturing that previously was reported under this section.

[ 51 FR 13223, Apr. 18, 1986, as amended at 52 FR 20083, May 29, 1987; 58 FR 34204, June 23, 1993]