April 23, 2003 Supporting Statement for a Request for OMB Review under the Paperwork Reduction Act 1 IDENTIFICATION OF THE INFORMATION COLLECTION 1( a) Title and Number of the Information Collection Title: Notification of Chemical Exports  TSCA Section 12( b)

EPA ICR No. 0795.11 OMB Control No. 2070 0030 1( b) Short Characterization Section 12( b)( 2) of the Toxic Substances Control Act states, in part, that any person who exports or intends to export to a foreign country a chemical substance or mixture for which submission of data is required under section 4 or 5( b), or for which a rule, action or order has been proposed or promulgated under section 5, 6, or 7, shall notify the EPA Administrator of such export or intent to export. The Administrator in turn will notify the government of the importing country of EPA's regulatory action with respect to the substance.

On December 16, 1980, EPA promulgated a rule at 40 CFR Part 707, Subpart D that provided final guidance for section 12( b) ( 45 FR 82844). This final rule requires exporters to submit an annual notice for each country to which a chemical subject to section 12( b) requirements is exported. On July 27, 1993 ( 58 FR 40238), EPA issued a final rule, which amended the December 16, 1980 rule, for chemicals subject to section 4 test rules by requiring exporters to submit a one time notice to EPA for export of a section 4 chemical to a particular country, instead of annual notification. There are no changes in reporting requirements for sections 5, 6 and 7 of TSCA.

The export notice must include five easily ascertainable items: the name and address of the exporter, the name of the chemical, the country of import, the date of export or intended export, and the section of TSCA under which EPA has taken action ( 4, 5, 6 or 7). There are currently over 1,000 substances or categories of substances that have been regulated or proposed to be regulated under the applicable sections of TSCA.

1( c) Potential Future EPA Actions Affecting this Information Collection The purpose of this section is to identify EPA actions that are anticipated to occur during the collection period that could affect the information requirements and burden. Of course, should any of these anticipated actions impact this ICR, EPA will follow appropriate procedures to amend this ICR, as appropriate.

On October 9, 1998, EPA announced the High Production Volume Chemical ( HPV) Challenge Program. The HPV Program is a key element of the Chemical Right to Know ( Chem Page 2 RTK) initiative announced on the eve of Earth Day 1998. The Chem RTK initiative challenges government, industry and the environmental community to develop aggressive strategies that will rapidly fill the gaps in our understanding about the potential health and environmental effects associated with chemicals used widely in our communities and make this information easily accessible to the public.

The HPV Challenge Program is a major new voluntary chemical testing effort created to ensure that a complete set of baseline health and environmental effects screening data on thousands of HPV industrial chemicals is made available to the public. Industry groups have committed to sponsor to compiling the basic information for 2,100 of the 2,800 HPV chemicals. HPV chemicals are defined as those that are manufactured in, or imported into, the United States in amounts exceeding 1 million pounds per year.

For those chemicals not selected by companies for voluntary testing, EPA will promulgate test rules, using the testing authorities contained in section 4 of TSCA. EPA proposed rulemaking for 37 of the HPV chemicals on December 26, 2000. At the time of this rulemaking, EPA expects to publish a final rule for approximately 25 of these chemicals during the fourth quarter of FY 2003. The chemicals included in the final rulemaking will be subject to section 12( b) export notification requirements. EPA anticipates that this will result in an increase of the information collection burden for section 12( b) that is presented in this ICR. The calculation for the increased burden will likely be a straightforward multiplication of number of chemicals not currently subject to section 12( b) requirements by the average number of hours and associated cost.

Additionally, EPA proposed a TSCA section 4 test rule for 47 chemicals of interest to OSHA on June 9, 1999. EPA expects to publish the final rule during the third quarter of FY 2003. The chemicals included in the final rulemaking will be subject to the section 12( b) export notification requirements. EPA anticipates that this will result in an increase of the information collection burden for section 12( b) that is presented in this ICR. The calculation for the increased burden will likely be a straightforward multiplication of number of chemicals not currently subject to section 12( b) requirements by the average number of hours and associated cost.

The Office of Pollution Prevention and Toxics ( OPPT) recently developed a new centralized publicly available database and website for chemical substances subject to TSCA section 12( b) export notification requirements ( see " Current List of Chemical Substances Subject to TSCA Section12( b) Export Notification Requirements" at http:// www. epa. gov/ opptintr/ chemtest/ main12b. htm). In addition, chemical substances subject to TSCA section 4 actions " sunset" after a specific period of time ( see " Sunset Date/ Status of TSCA Section 4 Testing, Reimbursement, and Reporting Requirements and TSCA Section 4 Triggered TSCA Section 12( b) Export Notification Requirements" at http:// www. epa. gov/ opptintr/ chemtest/ sunset. htm). EPA believes that this activity, long recommended by industry, will help to reduce the information collection burden for section 12( b) export notification that is presented in this ICR. At present, however, EPA has not attempted to calculate a related reduction in burden at this time.

In order to further facilitate consideration of improvements to the TSCA section 12( b) Page 3 export notification program, EPA intends to hold a Public Meeting in the fourth quarter of FY2003, and will invite interested parties to participate in developing amendments to the current TSCA section 12( b) regulation. EPA initiated a similar process when it found that there was a reasonable basis for amending TSCA section 8( d) regulations that it believes was quite successful in streamlining that reporting requirement.

2 NEED FOR AND USE OF THE COLLECTION 2( a) Need/ Authority for the Collection TSCA section 12( b)( 2) requires exporters to submit a notice for each country to which a chemical subject to section 12( b) requirements is exported. Specifically, section 12( b)( 2) states, in part, that any person who exports or intends to export to a foreign country a chemical substance or mixture for which submission of data is required under section 4 or 5( b), or for which a rule, action or order has been proposed or promulgated under section 5, 6, or 7, shall notify the EPA Administrator of such export or intent to export. The Administrator in turn will notify the government of the importing country of EPA's regulatory action with respect to the substance. See Attachment 1 for exact language of TSCA section 12( b), 15 U. S. C. 2611( b)( 2).

Regulations implementing the statutory mandate in TSCA section12( b) appear in 40 CFR Part 707, Subpart D, and include the following additional provisions:

( a) No notice of export will be required for articles, except PCB articles, unless the Agency so requires in the context of individual section 5, 6, or 7 actions.

( b) Any person who exports or intends to export polychlorinated biphenyls ( PCBs) or PCB articles, for any purpose other than disposal, shall notify EPA of such intent or exportation under section 12( b). PCBs and PCB articles have the definitions published in 40 CFR 761.3.

( c) Any person who would be prohibited by a section 5 or 6 regulation from exporting a chemical substance or mixture, but who is granted an exemption by EPA to export that chemical substance or mixture, shall notify EPA under section 12( b) of such intent to export or exportation.

( d) An exporter will be subject to possible enforcement action ( including penalties) for not complying with the applicable provisions of section 12( b).

The full text of 40 CFR part 707 is provided in Attachment 2.

2( b) Use/ Users of The Data As required by TSCA section 12( b), the Administrator will use the information collected under this ICR to furnish the required notice to the government of the importing country. The importing country typically uses the information provided to ensure that chemicals imported into their country comply with their laws and regulations. Page 4 3 NON DUPLICATION, CONSULTATIONS, AND OTHER COLLECTION CRITERIA 3( a) Non Duplication The exporter submits one notice to EPA. There is no duplication of this mandate or collection activity, and no alternate sources for the Agency to obtain the information necessary to satisfy the statutory mandate.

The Agency carefully considered alternatives to imposing a notification requirement on the chemical exporters, but no alternate sources were identified. Prior to promulgating the section 12( b) rule, EPA considered the possibility of using export data gathered by the Bureau of the Census in lieu of imposing notification requirements in a section 12( b) rule. However, several problems with the Census data continue to make such an approach impractical. These problems include, among others, the fact that Census data are often not chemical specific; Census exempts certain shipments and exporters that are not exempt from section 12( b) notifications; and Census data would not be available for up to eight weeks following export, a delay that would prevent EPA from providing an importing government the timely notice required by section 12( b).

In addition, the Agency's activities are not duplicative of any other agency's actions. Importing countries do not receive such notifications from any other sources.

3( b) Public Notice Required Prior to ICR Submission to OMB Prior to submission of the request to renew the approval for this ICR, EPA provided a 60 day public notice and comment period that ended on October 18, 2002 ( 67 FR 53792, August 19, 2002). EPA received four comments during that comment period, i. e., comments from Kokopelli Chemists, Inc.; the Proctor & Gamble Co.; the Color Pigments Manufacturers Association, Inc.; and the American Chemistry Council ( ACC). The following is a brief summary of those comments and EPA's response. ( Copies of the comments are included in Attachment 3.)

One commentor ( P& G) applauded EPA's publication of the TSCA section 12( b) Sunset Table on an EPA website. P& G also suggested that to facilitate compliance, the Agency should consider developing an Internet accessible " export compendium" of country/ chemical notifications for section 4 and section 5 chemicals. Although this comment is unrelated to estimating the burden imposed by export notification requirements imposed under TSCA section 12( b), EPA will consider this comment in future Agency efforts to lessen the burden associated with compliance under TSCA section 12( b) and avoid unnecessary duplication. It is important to note that EPA's OPPT has responded to previously expressed concerns regarding clarification of chemicals subject to TSCA section 12( b) and has issued a comprehensive list of all chemicals that are subject to the current section 12( b) regulation found at 40 CFR 707. This list is available at http:// www. epa. gov/ opptintr/ chemtest/ main12b. htm; hard copies of the list are also available through the TSCA Hotline ( 202 554 1404). EPA is making every effort to ensure that the list is kept as accurate and up to date as possible in order for it to continue to serve as an effective, complementary compliance tool for use by industry and others. Page 5 All of the commenters suggested that EPA exempt from the TSCA section 12( b) export notification requirements de minimus ( 1%) quantities, impurities, byproducts, R & D chemicals, and/ or establish a cutoff of 55 gallons or less of the chemical or 100 pounds, whichever measure applies, below which no section 12( b) notification would be required. Although EPA is not fully persuaded about the magnitude of the burden reduction which commentors say would result from such an exemption, EPA believes that it is reasonable to review the current TSCA 12( b) export notification requirements and consider industry's suggestions, as well as input from all other interested parties. EPA intends to review this TSCA reporting requirement in parallel with the ongoing U. S. Congressional deliberations regarding legislative implementation and ratification of the Rotterdam Convention on Prior Informed Consent, which is currently underway.

Two commenters complained that EPA

s burden estimate did not accurately reflect the total time, effort, or financial resources expended by persons to generate or provide the required information to EPA. EPA reviewed the estimates provided in the ICR and does not believe that the estimated burden provided is unreasonable or warrants any significant adjustments. The commenters appear to base this conclusion on the improper inclusion of activities and related burden that are not attributable to this activity. It is important to note that the burden estimate provided by EPA is intended to provide a reasonable average burden, rather than an accounting of actual burden. An individual company may experience more or less burden, based on many factors and circumstances specific to that company. For example, the commenters consider the burdens borne by a company related to identifying and tracking of multiple chemical substances and mixtures for which a TSCA section 12( b) notification is required. However, the identification and tracking of chemical substances is not in and of itself a burden imposed by TSCA section 12( b). Further, TSCA section 12( b) does not require companies to identify and track chemicals and mixtures. Rather it only requires that a company notify EPA of its export, or intent to export, for those chemical substances and mixtures upon which EPA has taken certain actions under TSCA sections 4, 5, 6, or 7 and which are " known to be" present in a shipment intended for export. Also, section 12( b) does not require a company to undertake any analysis in determining whether or not a chemical substance or mixture is present in a shipment to be exported. Exporters are only responsible for section 12( b) requirements for chemicals whose presence in an exported shipment is " reasonably ascertainable." Recognizing that knowledge of shipments is an indispensable element of routine commercial activities, EPA does not believe that the burden associated with export notification under TSCA section 12( b) should be expanded to include an estimate of the time required for checking orders for potential section 12( b) notifications, whether or not the notification is in fact required; i. e., developing a burden estimate based on shipments of chemicals checked to determine that export notices are not required.

In order to further facilitate the discussions on improving the export notification program, EPA would like to hold a Public Meeting and will invite interested parties to participate in developing amendments to the current TSCA section 12( b) regulation. EPA initiated a similar process when it found that there was a reasonable basis for amending TSCA section 8( d) that it believes was quite successful in streamlining that reporting requirement.

3( c) Consultations Page 6 Prior to proposing guidance for the submission of section 12( b) notices, EPA held informal meetings with the Manufacturing Chemists Association ( now American Chemistry Council), and with representatives of the Swedish, Canadian and British governments. Twelve comments were received from exporters, environmental groups and foreign governments during the public comment period for the proposal. We also met with members of the American Chemistry Council to discuss section 12( b) requirements and the possible need for some changes to the rule. Additionally, EPA consulted with industry during the preparation of this ICR, focusing in particular upon the Terms of Clearance specified in the last OMB approval of this ICR. The results of those consultations are included as Attachment 4.

3( d) Effects of Less Frequent Collection If the collection of information was conducted less frequently, the regulatory requirements would not be met.

3( e) General Guidelines This information collection is necessary to implement statutory requirements of section 12( b) of TSCA and is consistent with the requirements of 5 CFR 1320.6.

3( f) Confidentiality The respondent may claim all or part of a notice confidential. EPA will disclose information that is covered by a claim of confidentiality only to the extent permitted by, and in accordance with, the procedures in TSCA and 40 CFR Part 2. However, notwithstanding any claim of confidentiality, the foreign government of the importing country will be notified of the export of the substance( s) in question.

3( g) Sensitive Questions This section is not applicable. The information requested is not sensitive in nature.

4 THE INFORMATION COLLECTED AGENCY ACTIVITIES, COLLECTION METHODOLOGY, AND INFORMATION MANAGEMENT 4( a) Agency Activities The activities routinely conducted by EPA related to the receipt and processing of section 12( b) export notices include the following:

o review export notices for compliance; o respond to follow up inquiries from foreign governments; o consult with companies on complying with section 12( b) rule; o act as liaison between foreign governments and companies to seek additional information on exports; o log in notices for tracking/ reporting; Page 7 o prepare letters with supporting documents to foreign governments.

4( b) Collection Methodology and Management The collection methodology is event based, i. e., the respondent's decision to export a chemical subject to TSCA section 12( b). With the exception of section 4 chemicals, an exporter must submit, on an annual basis, one TSCA section 12( b) notice for each country to which a chemical subject to section 12( b) is exported. For section 4 chemicals, an exporter must only submit a TSCA section 12( b) notice for the first export or intended export to a particular country. The section 12( b) notice must be postmarked within seven days after the respondent accepts a definite contractual obligation or no later than the date of export.

TSCA section 12( b) export notifications are received by EPA's Environmental Assistance Division ( EAD) in OPPT. The contractor run TSCA Assistance and Information Service ( TAIS B also known as the TSCA Hotline), processes all of the TSCA section 12( b) export notifications and prepares the letters and related materials used to notify appropriate foreign governments of the export of the specific TSCA regulated chemicals to their country in accordance with the mandate in TSCA section 12( b) and the regulations at 40 CFR part 707, Subpart D.

The following is a brief overview of the Agency's handling and tracking process for these notices:

1) All incoming notices are received in OPPT's Confidential Business Information Center ( CBIC) which is managed by OPPT's Information Management Division ( IMD).

2) The CBIC sends the information to appropriate IMD staff to determine if the information is Confidential Business Information ( CBI) or not. IMD then sends the information with the CBI determination back to the CBIC.

3) The CBIC sends all notifications ( CBI or non CBI) to TAIS for processing.

4) TAIS records the company and chemical information, enters it into the database, and prepares the notification letter and explanatory materials ( e. g., Federal Register Notice, TSCA section 5( e) consent order). For CBI packages, TAIS sends the CBI packages back to the CBIC and the CBIC then sends the notification and explanatory information to the embassy/ foreign authority of the country to which the subject chemical is being exported. For non CBI packages, TAIS sends the notification and explanatory information to the embassy/ foreign authority.

5) If the receiving country requests further information, the request comes directly to EAD. EAD sends the request to TAIS. TAIS obtains and/ or generates the needed information, and sends the package back to EAD for formal signature and transmittal to the requesting country's embassy or authority.

The Export Notification Tracking System ( ENTS), which is maintained by TAIS, currently houses approximately 162,000 records, dating back to 1989. The ENTS database is modified daily with new, incoming records of chemical exports to foreign countries. Updates also Page 8 incorporate regulatory changes affecting the chemicals that are subject to EPA's TSCA section 12( b) export notification rule at 40 CFR 707.

EPA is currently in the process of developing and implementing an optional electronic data reporting system for the ease of respondents, which could result in a significant burden reduction. The projected reporting system is designed to be a user friendly interface for parties engaged in reporting under TSCA sections 4, 5, 8, and 12( b). Thus, the submission of information to EPA will be less expensive, faster, and more efficient once this technology is fully applied.

4( c) Small Entity Flexibility TSCA section 12( b) does not exempt small businesses. However, most reporting has been by large companies, because they do most of the exporting. In any case, the burden on any exporter is minimal, because it should take no more than one half hour to prepare a section 12( b) notice and mailing costs are minimal.

4( d) Collection Schedule In general, there are basically two collection schedules related to the TSCA section 12( b) export notification requirements, i. e., a one time collection and an annual collection. On an annual basis, excluding section 4 chemicals, an exporter must submit only one section 12( b) notice for each country to which a chemical subject to section 12( b) is exported. For section 4 chemicals, an exporter must only submit one section 12( b) notice for the first export or intended export to a particular country.

If the collection of information was conducted less frequently, the statutory requirements would not be met.

5 THE RESPONDENTS AND THE INFORMATION REQUESTED 5( a) Respondents/ NAICS Codes Respondents to this collection are exporters of chemical substances, which are mostly chemicals companies classified under NAICS Codes 325 and 32411.

5( b) Information Requested ( i) Data Items Respondents are required to include the following information in their export notification:

( 1) the name and address of the exporter; ( 2) the name of the chemical; ( 3) the country of import; ( 4) the date of export or intended export; and ( 5) the TSCA section 4, 5, 6 or 7 action that triggers the notice. Page 9 ( ii) Respondent Activities In providing the required section 12( b) export notification, the Respondent ( exporter) is likely to engage in the following activities:

( 1) Compile and maintain a list of chemical products manufactured by the company that are also subject to a TSCA section 4, 5, 6 or 7 action ( e. g., compare list of their chemicals with EPA's list of TSCA section 12( b) chemicals);

( 2) Check this list against outgoing orders to determine if a product/ chemical on the list is expected to be exported to a customer outside of the U. S.;

( 3) If it is, identify whether a 12( b) notice is required ( e. g., is it the first shipment to that country this year?); and ( 4) If product/ chemical is on the list and a 12( b) notice is required, complete the required export notice and forward it to EPA within the required time period.

6 ESTIMATING THE BURDEN AND COST OF THE COLLECTION The purpose of this analysis is to determine the incremental cost to industry and to the EPA associated with export reports that are submitted to the Agency under the TSCA section 12( b) reporting requirements.

6( a) Estimating Respondent Burden The burden to respondents of this information collection activity comprises the time required to perform the steps outlined in section 3 of this document.

Most companies comply by compiling a list of products exported by the company that are subject to section 12( b) reporting. Each outgoing order is checked to see if the chemical or product is on the list and, depending on the chemical, whether it is the first shipment to the importing country or the first shipment of the calendar year to that country. If so, a completed form letter is sent to EPA. In most cases the entire process is computerized.

Compile List. Since this information collection activity has been in place for twenty years, most respondents will have already developed a list of their products subject to section 12( b) reporting. Respondents need only check for new regulations promulgated and any new products exported by the company. Updating the list is estimated to take an average of one hour of technical time ( which may also include some proportion of legal time). This could vary depending on the number of products from two hours per year up to two hours per month of technical time ( which may also include some proportion of legal time). This will vary depending on the number of products exported by the company and the number of their products subject to section 12( b).

The number of submitters per year who report under section 12( b) has increased over time, rising from around 160 in 1991 to 430 in 2000. Based on this trend, we estimate that there Page 10 will be a further increase in the number of submitters to around 500 in the near future years. This is an increase from the estimate in the previous ICR analysis, which had projected around 350 submitters. Of these 500 submitters, we estimate that 400 companies are near the lower estimate of 2 hours per year, and 100 companies are near the upper estimate of 24 hours per year. Compiling the list for all respondents is estimated to take 3200 hours ( 2 hours x 400 firms plus 24 hours x 100 firms), or an average of 6.4 hours per firm. Around 100 of these companies will be filing notices under TSCA section 12( b) for the first time and thus could be incurring higher costs for this task.

Write or Revise Letter. Companies that export chemicals subject to section 12( b) reporting must prepare an export notice to send to EPA. Time for initial preparation of the export notice probably varies depending on whether the company has prior experience with this program, but this step is estimated to take an average of one hour of technical time ( which may also include some proportion of legal time) per year for each company subject to section 12( b) reporting. Many of the notifications received by EPA are for repeat submissions from a company. Most of the repeat submissions received by the Agency are computer generated form letters, and it is assumed that no additional time is required to prepare letters for repeat submissions. Thus we estimate a total of 500 hours ( 1 hour x 500 firms = 500 hours) per year in letter writing or revising.

Checking Orders and Send Notices. The 500 companies that export chemicals subject to section 12( b) reporting must check outgoing shipments against the list of their products described above. Where the shipment is for a section 12( b) chemical and, depending on the chemical, if it is the first shipment to the importing country or the first shipment of the calendar year to that country, a form letter notifying EPA is printed out. This whole process is estimated to take an average one half hour of clerical time per notice.

The annual number of submitted notices has varied substantially over time, but without any obvious trend. The number has been consistently in the range of 5,000 to 10,000 submissions, with a peak of 10,000 in 1997, but with more recent years being in the 7,000 range. We therefore estimate that the number of notices in near future years will average about 7,500. This is a reduction from the estimate in the previous ICR, where we had previously incorrectly projected an increase to 11,000 over that 1997 peak. For 500 firms, that indicates an average of 15 notices per year firm. Total time will be 3,750 hours ( 7,500 x .5 hour each). Page 11 TABLE 1: ANNUAL AVERAGE BURDEN PER RESPONDENT FACILITY BURDEN HOURS ACTIVITY TECHNICAL CLERICAL TOTAL Compile list 6.4  6.4 Write letter 1.0  1.0 Check order and send notice  7.5 7.5 Total 7.4 7.5 14.9 TABLE 2: ANNUAL AGGREGATE BURDEN BURDEN HOURS ACTIVITY TECHNICAL CLERICAL TOTAL Compile list 3,200  3,200 Write letter 500  500 Check order and send notice  3,750 3,750 Total 3,700 3,750 7,450 Average burden hours per notice 0.493 0.5 .993 It is estimated that the annual number of notices to be submitted for 2002 to 2004 will be 7,500 ( a reduction from the projected 11,000 submissions in the previous ICR). Estimating that the number of respondents will be 500, the average number of notices submitted per respondent will be 15.

6( b) Estimating Respondent Cost The costs to respondents is based on the time needed to complete the tasks listed in section 3, the hourly cost of labor at appropriate levels ( labor rates), the number of facilities affected, and the number of reports generated. There are also costs for mailing. There are no specific capital or miantenance/ operational costs associated directly with this information collection activity.

Labor rates, including overhead costs, are $ 98.34 for management time, $ 72.89 for technical time, and $ 29.39 for clerical time, based on current labor market estimates produced in this office.

Companies will also incur a cost of $ 9.62 per export notice to send the letter to EPA via registered mail ($ 7.50 for registered mail, $ 1.75 for a return receipt, and $ 0.37 postage). Aggregate annual costs for mailing will be $ 72,150 ($ 9.62 x 7,500). Page 12 TABLE 3: ANNUAL COST PER RESPONDENT FACILITY ( WITH 15 NOTICES)

ANNUAL COST ACTIVITY TECHNICAL CLERICAL TOTAL Compile list $ 466.50  $ 466.50 Write letter $ 72.89  $ 72.89 Check order and send notice  $ 220.42 $ 220.42 Mailing cost $ 144.30 Total $ 145.78 $ 220.42 $ 904.11 TABLE 4: ANNUAL AGGREGATE RESPONDENT COST ANNUAL COST ACTIVITY TECHNICAL $ 72.89/ hr CLERICAL $ 29.39/ hr TOTAL PRESENT VALUE*

Compile list $ 233,248  $ 233,248 $ 654,963 Write letter $ 36,445  $ 36,445 $ 102,338 Check order and send notice  $ 110,212 $ 110,212 $ 309,475 Mailing cost   $ 72,150 $ 202,597 Total $ 269,693 $ 110,212 $ 452,055 $ 1,269,373 * Present value for 3 years at a 7% discount rate.

6( c) Estimating Agency Burden and Costs Agency unit costs are based on past section 12( b) analyses, including the previous ICR, and on recent contacts with EAD/ OPPT and with an EPA contractor's office. EPA's cost estimates are based on past experience with these activities. The Agency cost can be divided into three parts: receiving and processing incoming notices, preparing and mailing notifications to importing countries, and responding to requests for information and clarification from companies and importing countries. The allocation of burden hours and costs among these three parts is not exact, but the analysis below is reasonably accurate in terms of the overall burden estimate and the approximate allocation of that burden among these tasks.

In the first task, notices are received from firms that intend to export a product covered by this rule, the forms are checked for completeness, and the submissions are logged into a document control system. Based on conversations with the workers responsible for this task, about ten submissions can be processed per hour. EPA projects that an average of 7,500 submissions will be received per year over the period covered by this ICR, requiring approximately 750 hours of Page 13 contractor support. This work is currently done by contractor staff with a fully loaded cost to EPA of approximately $ 20.00 per hour and thus is projected to cost $ 15,000 per year over the period of this ICR.

In the second task, workers prepare letters of notification which are subsequently reviewed and sent out to importing countries. Not all notices submitted require that a notification be sent out. Based on conversations with EPA and contractor employees, this work varies considerably depending on the circumstances of any particular chemical, but averages approximately 35 minutes per notification. Recent experience has been approximately 1,700 notifications per year. Assuming a similar rate in the future would project a total of approximately 1000 hours. This work is currently done by contractor staff with a fully loaded cost to EPA of approximately $ 20.00 per hour and thus is projected to cost $ 20,000 per year over the period of this ICR.

The cost of EPA's mailing a notification can vary from $ 2.00 to $ 15.00, depending on whether it is sent to an embassy in the US or to an overseas destination, and depending on whether the notice is registered. Mailing cost was estimated in 1998 to average approximately $ 4.50 per notification, but postal rates have subsequently increased. Assuming a 50% increase in postal rates, EPA projected an average mailing cost of $ 6.75 and a total annual mailing cost of $ 11,475.

The burden described above covers the routine tasks of handing both incoming notices and outgoing notifications. The totals above also include a certain amount of time spent responding to routine requests for information, since data are not available to separate this out from the other tasks. Based on conversations with EAD staff, the work of responding to non routine requests for information and clarification from industry and importing countries, assisting the contractor staff in handling non routine issues, and handling other tasks associated with the section 12( b) program can be expected to require about 20% of the time of a GS 13 EPA employee, or roughly 400 hours per year. Following the 2002 federal employee wage scale, and assuming an additional 60% to cover overhead benefits etc., that represents an annual cost of approximately $ 21,000.

TABLE 5: ESTIMATED COSTS FOR THE FEDERAL GOVERNMENT ANNUAL COST PRESENT VALUE *

Processing of notices from companies $ 15,000 $ 42,120 Processing of notifications to importing countries $ 20,000 $ 56,160 EPA staff time, responding to information requests, etc. $ 21,000 $ 58,968 Mailing cost of notifications $ 11,475 $ 32,222 Total $ 67,475 $ 189,470 * Present value calculated for 3 years at a 3% discount rate. Page 14 6( d) Total Burden and Costs to Industry The total estimated industry burden associated with this collection, as noted in Table 2, is estimated to be 7,450 hours annually. The associated cost, as noted in Table 4, is estimated to be $ 452,055 annually.

6( e) Bottom Line Burden Hours and Cost Tables ( i) Respondent Tally Annual Respondent Burden: 7,450 hours.

Annual Respondent Costs: $ 452,055.

( ii) The Agency Tally Annual Agency Costs: $ 67,475.

6( f) Reasons for Change in Burden There is a decrease of 2,950 hours ( from 10,400 hours to 7,450 hours) in the total estimated respondent burden compared with that identified in the information collection previously approved by OMB. The above analysis shows about a 30% decrease in the estimated number of notices sent to EPA, a 40% increase in the number of firms sending notices, and about a 15% increase in labor wage rates in comparison to the estimates for the previous ICR. These factors in combination result in about a 30% decrease in projected burden hours and a 4% increase in burden cost to responding firms. These numbers reflect our experience, which shows more reporting firms but fewer notices per firm than anticipated over the past several years.

6( e) Burden Statement The annual public burden for this collection of information is estimated to be about one hour per response. According to the Paperwork Reduction Act, " burden" means the total time, effort, or financial resources expended by persons to generate, maintain, retain, or disclose or provide information to or for a federal agency. For this collection it includes the time needed to review instructions; develop, acquire, install and utilize technology and systems for the purposes of collecting, validating, and verifying information, processing and maintaining information, and disclosing and providing information; adjust the existing ways to comply with any previously applicable instructions and requirements; train personnel to be able to respond to a collection of information; search data sources; complete and review the collection of information ; and transmit or otherwise disclose the information. An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB control number. The OMB control number for this information collection appears above. In addition, the OMB control numbers for EPA's regulation, after initial display in the final rule, are listed in 40 CFR part 9. Page 15 To comment on the Agency's need for this information, the accuracy of the provided burden estimates, and any suggested methods for minimizing respondent burden, including the use of automated collection techniques, EPA has established a public docket for this ICR under Docket ID No. OPPT 2002 0048, which is available for public viewing at the EPA Docket Center ( EPA/ DC), EPA West, Room B102, 1301 Constitution Ave., NW, Washington, DC. The EPA Docket Center Public Reading Room is open from 8: 30 a. m. to 4: 30 p. m., Monday through Friday, excluding legal holidays. The telephone number for the Reading Room is ( 202) 566 1744, and the telephone number for the Pollution Prevention and Toxics Docket is ( 202) 566 0280. An electronic version of the public docket is available through EDOCKET at http:// www. epa. gov/ edocket. Use EDOCKET to submit or view public comments, access the index listing of the contents of the public docket, and to access those documents in the public docket that are available electronically. Once in the system, select " search," then key in the docket ID number identified above. Also, you can send comments to the Office of Information and Regulatory Affairs, Office of Management and Budget, 725 17th Street, NW, Washington, DC 20503, Attention: Desk Office for EPA. Please include OMB Control No. 2070 0030 in any correspondence.

ATTACHMENTS:

[ NOTE: Unless otherwise noted, an electronic copy of the attachment is available in the electronic version of the public docket available through EDOCKET at http:// www. epa. gov/ edocket. Once in the system, select " quick search," then indicate that you'd like to search by Docket and key in the following docket ID number: OPPT 2002 0048. Search the docket index for the document by the title provided below. If you have any difficulties, please contact the technical person listed in the Federal Register notice announcing the submission of this ICR to OMB for review and approval.]

Attachment Document # 1 The Statute: Toxic Substances Control Act, Section 12( b)  15 U. S. C. 2611( b)( 2) [ The electronic copy for this attachment is available as part of the electronic copy of the ICR's Supporting Statement.]

# 2 The Regulation: Chemical Imports and Exports, 40 CFR 707, Subpart D [ The electronic copy for this attachment is available as part of the electronic copy of the ICR's Supporting Statement.]

# 3 Public Comments Received During Public Notice and Comment Period [ Available only in paper in the public docket.]

# 4 EPA Activities in Response to Terms of Clearance From Last OMB Approval [ The electronic copy for this attachment is available as part of the electronic copy of the ICR's Supporting Statement.] ATTACHMENT 1 The Statute: Toxic Substances Control Act, Section 12( b)

15 U. S. C. 2611( b)( 2)

[ The electronic copy for this attachment is available as part of the electronic copy of the ICR's Supporting Statement.] Sec. 2611.  Exports * * *

( b) Notice ( 5) If any person exports or intends to export to a foreign country a chemical substance or mixture for which the submission of data is required under section 2603 or 2604( b) of this title, such person shall notify the Administrator of such exportation or intent to export and the Administrator shall furnish to the government of such country notice of the availability of the data submitted to the Administrator under such section for such substance or mixture.

( 6) If any person exports or intends to export to a foreign country a chemical substance or mixture for which an order has been issued under section 2604 of this title or a rule has been proposed or promulgated under section 2604 or 2605 of this title, or with respect to which an action is pending, or relief has been granted under section 2604 or 2606 of this title, such person shall notify the Administrator of such exportation or intent to export and the Administrator shall furnish to the government of such country notice of such rule, order, action, or relief ATTACHMENT 2 The Regulation: Chemical Imports and Exports 40 CFR 707, Subpart D [ The electronic copy for this attachment is available as part of the electronic copy of the ICR's Supporting Statement.] Code of Federal Regulations  40 CFR part 707 ( As of July 1, 2000)

TITLE 40 PROTECTION OF ENVIRONMENT CHAPTER I ENVIRONMENTAL PROTECTION AGENCY ( CONTINUED)

PART 707  CHEMICAL IMPORTS AND EXPORTS § 707.20 Chemical substances import policy.

( a) Scope. ( 1) This statement addresses the policy of the Environmental Protection Agency ( EPA) on importation of chemical substances, mixtures, and articles under section 13 of the Toxic Substances Control Act ( TSCA; 15 U. S. C. 2601 et seq.). In particular, it addresses aspects of the regulation promulgated by the United States Customs Service ( Customs), Department of the Treasury ( 19 CFR 12.118 through 12.127, and 127.28 [ amended]) to implement section 13 of TSCA, 15 U. S. C. 2612. Section 13 requires the Secretary of the Treasury to refuse entry into the Customs territory of the United States of a chemical substance, mixture, or article if it does not comply with rules in effect under TSCA, or if it is offered for entry in violation of TSCA or rules or orders under TSCA.

( 2) In addition to this statement of policy, EPA will continue, as necessary, to address problems associated with imports in rulemaking and other actions under individual sections of TSCA, i. e., sections 4, 5, 6, 7, 8, and 12. Sections 5, 6, and 7 apply directly to imports subject to the section 13 requirements. Section 12 may apply to export of a shipment that is refused entry under section 13. Importers may have obligations under sections 4 and 8; section 4 and 8 requirements for importers would not apply to individual chemical shipments and thus are not included under section 13 requirements. Interested persons should refer to the records of these individual rulemaking actions for specific information and guidance.

( b) Objectives. ( 1) TSCA is intended to be comprehensive, and assure protection of health and the environment from unreasonable risks associated with chemicals whether the chemicals are imported or produced domestically. This intent is manifested by the inclusion of importation in the Act's definition of the term " manufacture": "[ M] anufacture means to import * * *, produce, or manufacture" ( 15 U. S. C. 2602( 7)). Thus, importers are responsible for insuring that chemical importation complies with TSCA just as domestic manufacturers are responsible for insuring that chemical manufacture complies with TSCA.

( 2)( i) The section 13 rule requires importers to sign the following statement for each import of chemical substances subject to TSCA: " I certify that all chemical substances in this shipment comply with all applicable rules or orders under TSCA and that I am not offering a chemical substance for entry in violation of TSCA or any applicable rule or order under TSCA." The certification will document that, in accordance with TSCA, the importer has taken the necessary steps to insure compliance.

( ii) The section 13 rule requires importers of chemicals not subject to TSCA ( e. g., pesticides) to certify that compliance with TSCA is not required. Importers must certify this by signing the statement: " I certify that all chemicals in this shipment are not subject to TSCA." This is appropriate when a chemical import is not clearly identified as a pesticide or other chemical not subject to TSCA. ( 3) The United States is involved in a major effort toward international harmonization in the control of chemicals. At such time as international agreement is reached on this issue, EPA would be prepared to modify its policy if necessary. EPA believes that its international harmonization efforts in the control of chemicals will protect health and the environment while fulfilling its obligations under the Trade Agreements Act of 1979.

( c) The section 13 rule  ( 1) General certification. ( i) The rule promulgated under section 13 of TSCA by Customs, in consultation with EPA, implements the requirement of section 13 that chemical substances, mixtures, or articles not in compliance with TSCA, or whose importation is not in compliance with TSCA, shall be denied entry into the customs territory of the United States. The rule requires that importers certify by a statement, on the entry document or invoice, that any shipment of a chemical substance subject to TSCA, imported in bulk or as part of a mixture, complies with TSCA, and that it is not offered for entry in violation of TSCA or any rule or order under TSCA, or that the chemicals imported are not subject to TSCA.

( ii) The certification applies to TSCA sections 5, 6, and 7.

( iii) EPA expects that this certification will be based upon actual knowledge of the importer in most cases. However, EPA realizes that sometimes importers may not have actual knowledge of the chemical composition of imported mixtures. In these cases, the importer should attempt to discover the chemical constituents of the shipment by contacting another party to the transaction ( e. g., his principal or the foreign manufacturer). This person may be able to identify the components of the mixture, or at least state that the substances comply with TSCA. The greater the effort an importer makes to learn the identities of the imported substances and their compliance with TSCA, the smaller his chance of committing a violation by importing a noncomplying shipment. If a shipment is ultimately determined to have violated TSCA, the good faith efforts of the importer to verify compliance, as evidenced by documents contained in his files, may obviate or mitigate the assessment of a civil penalty under section 16 of TSCA.

( 2) EPA enforcement. ( i) EPA and Customs will monitor chemical imports to determine if shipments and their import comply with the certification requirements and the substantive mandates of TSCA. Customs will refuse entry to any shipment until such time as the certification is properly submitted. Customs will also detain a shipment if there are reasonable grounds to believe that such shipment or its import violates TSCA or regulations or orders thereunder. A violative shipment must either be brought into compliance, exported, destroyed, or voluntarily abandoned within the time periods prescribed in 19 CFR 12.124 of the section 13 rule.

( ii) When EPA determines that a shipment should be detained, EPA will identify the reasons for the detention and the necessary actions for an importer to bring the shipment into compliance with TSCA. If EPA has given this information to Customs before the district director issues the detention notice, the information will become part of the detention notice. The importer should contact one of the following EPA regional offices for guidance as to the proper procedures to correct any deficiencies in the shipment.

Region I  John F. Kennedy Federal Building, Boston, MA 02203 ( 617 223 0586)

Region II  26 Federal Plaza, New York, NY 10278 ( 201 321 6669)

Region III  Curtis Building, 6th and Walnut Streets, Philadelphia, PA 19106 ( 215 597 7668) Region IV  345 Courtland Street, NE., Atlanta, GA 30365 ( 404 881 3864)

Region V  77 West Jackson Boulevard, Chicago, IL 60604 ( 312 353 2291)

Region VI  1201 Elm Street, Dallas, TX 75270 ( 214 767 2734)

Region VII  324 East 11th Street, Kansas City, MO 64106 ( 816 374 3036)

Region VIII  1860 Lincoln Street, Denver, CO 80295 ( 303 837 3926)

Region IX  215 Fremont Street, San Francisco, CA 94105 ( 415 974 8119)

Region X  1200 Sixth Avenue, Seattle, WA 98101 ( 206 442 2871)

( iii) If Customs detains or refuses entry of a shipment ( other than for failure to make the general certification) and the importer takes measures necessary to bring the shipment into conformity with the requirements of TSCA, EPA officials will reassess the shipment to determine its current compliance status. When a shipment is no longer in violation, EPA will notify the district director and the importer. The district director will then release the shipment. This notice will also serve as a determination to permit entry under 19 CFR 12.123( c) if a shipment is brought into compliance before the 19 CFR 12.123( c) decisionmaking process has been completed. If compliance is achieved after a 19 CFR 12.123( c) determination ( adverse to the importer) has been made, the EPA notice to the district director will serve as a reversal of the decision to refuse entry.

( 3) EPA assistance. Assistance in determining whether a chemical shipment is in compliance with TSCA can be obtained from the Director, Environmental Assistance Division ( 7408), Office of Pollution Prevention and Toxics, U. S. Environmental Protection Agency, Room E 543B, 1200 Pennsylvania Ave., NW., Washington, DC 20460, Telephone: ( 202) 554 1404, TDD: ( 202) 544 0551.

[ 48 FR 55464, Dec. 13, 1983, as amended at 60 FR 34463, July 3, 1995; 62 FR 1834, Jan. 14, 1997]

§ 707.60 Applicability and compliance.

( a) Section 12( b) of the Toxic Substances Control Act requires any person who exports or intends to export a chemical substance or mixture to notify the Environmental Protection Agency of such exportation to a particular country if any of the following actions have been taken under the Act with respect to that chemical substance or mixture:

( 1) Data are required under section 4 or 5( b),

( 2) An order has been issued under section 5,

( 3) A rule has been proposed or promulgated under section 5 or 6, or ( 4) An action is pending, or relief has been granted under section 5 or 7.

( b) No notice of export will be required for articles, except PCB articles, unless the Agency so requires in the context of individual section 5, 6, or 7 actions. ( c) Any person who exports or intends to export polychlorinated biphenyls ( PCBs) or PCB articles, for any purpose other than disposal, shall notify EPA of such intent or exportation under section 12( b). PCBs and PCB articles have the definitions published in § 761.3 of this title respectively.

( d) Any person who would be prohibited by a section 5 or 6 regulation from exporting a chemical substance or mixture, but who is granted an exemption by EPA to export that chemical substance or mixture, shall notify EPA under section 12( b) of such intent to export or exportation.

( e) Failure to comply with section 12( b) as set forth in these rules will be considered a violation of section 15( 3) of the Toxic Substances Control Act, and will subject the exporter to the penalty, enforcement, and seizure provisions of sections 16 and 17 of the Toxic Substances Control Act.

§ 707.63 Definitions.

The definitions set forth in the Toxic Substances Control Act, section 3, apply for this part. In addition, the following abbreviations and definitions are provided for purposes of this rule:

( a) EPA means the Environmental Protection Agency.

( b) Exporter means the person who, as the principal party in interest in the export transaction, has the power and responsibility for determining and controlling the sending of the chemical substance or mixture to a destination out of the customs territory of the United States.

( c) Regulated chemical means any chemical substance or mixture for which export notice is required under § 707.60.

( d) TSCA means the Toxic Substances Control Act.

§ 707.65 Submission to agency.

( a) Exporters must notify EPA of their export or intended export of each regulated chemical in accordance with the following:

( 1) The notice must be in writing;

( 2)( i) The notice must be for the first export or intended export to a particular country in a calendar year when data are required under section 5( b), an order has been issued under section 5, a rule has been proposed or promulgated under section 5 or 6, or an action is pending or relief has been granted under section 5 or 7.

( ii) The notice must be for the first export or intended export to a particular country when data are required under section 4.

( 3) The notice must be postmarked within seven days of forming the intent to export or on the date of export, whichever is earlier. A notice of intent to export must be based on a definite contractual obligation, or an equivalent intra company agreement, to export the regulated chemical.

( b) If the EPA action that prompts the notice is a proposed rule, the requirement to submit export notices to EPA shall begin thirty days after publication of the action in the Federal Register. ( c) Notices shall be marked " Section 12( b) Notice" and sent to the Document Control Office ( 7407), Office of Pollution Prevention and Toxics, U. S. Environmental Protection Agency, Room G 099, 1200 Pennsylvania Ave., NW., Washington, DC 20460.

[ 45 FR 82850, Dec. 16, 1980, as amended at 53 FR 12522, Apr. 15, 1988; 58 FR 40242, July 27, 1993; 60 FR 34463, July 3, 1995]

§ 707.67 Contents of notice.

The notice to EPA shall include:

( a) The name of the regulated chemical as it appears in the section 4, 5, 6, or 7 action. If a category is regulated, the name of the individual regulated chemical within that category, as well as the category, must be given. The name shall be that which appears in Volume I of the EPA Chemical Substance Inventory, or its supplements, if the chemical appears there.

( b) The name and address of the exporter.

( c) The country ( countries) of import.

( d) The date( s) of export or intended export.

( e) The section ( 4, 5, 6, or 7) of TSCA under which EPA has taken action.

§ 707.70 EPA notice to foreign governments.

( a)( 1) Notice by EPA to the importing country shall be sent no later than 5 working days after receipt by the TSCA Document Processing Center of the first annual notification for each regulated chemical when data are required under section 5( b), an order has been issued under section 5, a rule has been proposed or promulgated under section 5 or 6, or an action is pending or relief has been granted under section 5 or 7.

( 2) Notice by EPA to the importing country shall be sent no later than 5 working days after receipt by the TSCA Document Processing Center of the first notification for each regulated chemical when data are required under section 4.

( b) Notices shall:

( 1) Identify the regulated chemical.

( 2) Summarize the regulatory action taken, or indicate the availability of data under section 4 or 5( b) of TSCA.

( 3) Identify an EPA official to contact for further information.

( 4) Include a copy of the pertinent Federal Register notice.

( c) Notices shall be sent to the country's ambassador in Washington, DC, or other official designated by the foreign government, and to the United States Department of State. [ 45 FR 82850, Dec. 16, 1980, as amended at 58 FR 40242, July 27, 1993]

§ 707.72 Termination of reporting requirements.

( a) The reporting requirements of subpart D of this part are terminated for certain specific chemical substances and mixtures as set forth in this paragraph.

( 1) When data required under part 766 of this chapter have been submitted to EPA for a specific chemical substance produced by a specific process, and the data show no positive test result as defined in § 766.3 of this chapter, reporting is no longer required by persons who export or intend to export that substance produced by that process.

( 2) [ Reserved]

( b) [ Reserved]

[ 52 FR 21437, June 5, 1987]

§ 707.75 Confidentiality.

( a) A person may assert a claim of confidentiality for any information which is submitted to EPA in a notice.

( b) Any claim of confidentiality must accompany the information at the time it is submitted to EPA. In the notice, the submitter must clearly identify the information that is claimed confidential by marking the specific information on each page with a label such as " confidential business information", " proprietary", or " trade secret".

( c) Notwithstanding any claim of confidentiality, information outlined in § 707.70 will be included in the EPA notice to the foreign government. With this exception, EPA will disclose information that is covered by a claim of confidentiality asserted in accordance with this section only to the extent permitted by, and in accordance with, the procedures set forth in TSCA and part 2 of this chapter.

( d) If a person does not assert a claim of confidentiality for information at the time a notice is submitted to EPA, the Agency may make the information public, including placement in a public file, without further notice to the person. ATTACHMENT 3 Public Comments Received During Public Notice and Comment Period [ Available only in paper in the public docket.] ATTACHMENT 4 EPA Activities in Response to Terms of Clearance From Last OMB Approval [ The electronic copy for this attachment is available as part of the electronic copy of the ICR's Supporting Statement.] 2 EPA Activities in Response to Terms of Clearance From Last OMB Approval At the time OMB last approved this information collection, OMB included certain Terms of Clearance with its approval that it directed EPA to address at the time of the next request for OMB approval ( i. e., the submission of this ICR).

In a " Notice of Office of Management and Budget Action," dated January 31, 2000, OMB included the following Terms of Clearance:

" OMB acknowledges that EPA is taking into consideration comments suggesting modification of existing regulatory requirements for purposes of reducing the burden associated with reporting impurities, byproducts, R and D chemicals, and certain concentrations of other chemicals. OMB also acknowledges EPA's response to commenters' requests for clarification of the following: 1) TSCA Section 12( b) export notification requirements apply to chemical substances and mixtures, not to products of a particular state or mixture; and 2) Section 12( b) export notification requirements do not apply to proposed TSCA Section 4 rules.

" Before resubmission of this ICR for renewal, the Agency will report to OMB on the status of potential amendments to the TSCA Section 12( b) rule. The agency should include in this report an analysis of the burden associated with collecting information on exported impurities, byproducts, R and D chemicals, and certain concentrations of PCBs, and also a discussion of the usefulness of these data. While OMB appreciates EPA's refinement of burden estimates based on recent agency experience, OMB encourages EPA to confirm Agency estimates of burden per respondent, taking into consideration comments received on this ICR submission and also during both potential future Section 12( b) stakeholder meetings and/ or rulemakings."

During preparation of the current renewal request for this information collection, EPA engaged in specific consultations with a selected number of respondents to address these Terms of Clearance. As a part of these consultations, the Eastern Research Group, Inc. (" ERG") asked nine companies about their experiences with the reporting burden associated with chemicals present as byproducts or impurities. A summary of the responses they received follows, along with a copy of the sample letter they used.

As discussed in the ICR renewal request, commenters again asked the Agency to consider revising TSCA section 12( b) and the implementing regulations to exclude reporting of de minimus ( 1%) quantities, impurities, byproducts, R & D chemicals, and/ or establish certain other exclusions to eliminate reporting burden under TSCA section 12( b). Although, based on the responses summarized below, EPA is not fully persuaded about the magnitude of the burden reduction which commentors say would result from such exclusions, EPA believes that it is reasonable to review the current TSCA section 12( b) export notification requirements and consider industry's suggestions, as well as input from all other interested parties. EPA intends to review this TSCA reporting requirement in parallel with the ongoing U. S. Congressional deliberations regarding legislative implementation and ratification of the Rotterdam Convention on Prior Informed Consent, which is currently underway. In addition, to further facilitate a broader discussion on improving the export notification program, EPA intends to hold a Public Meeting in the fourth quarter of FY2003, and will invite all interested parties to participate in developing amendments to the current TSCA section 12( b) regulation. EPA initiated a similar 3 process when it found that there was a reasonable basis for amending TSCA section 8( d) regulations that it believes was quite successful in streamlining that reporting requirement. Such an effort, however, should be considered separately from this ICR. The purpose and coverage of this ICR continues to be the collection activity mandated by TSCA section 12( b), as implemented by the regulations in 40 CFR part 707, Subpart D. 1 See memo dated July 9, 1999, " TSCA Section 12( b) burdens," to Joe Callahan OPPT/ EETD/ EPAB, from Andrea Desilets and Jeff Cantin, ERG, Inc. MEMORANDUM Date: November 22, 2002 From: Dina Metivier and Jeff Cantin To: Joseph Callahan, OPPT/ EETD/ EPAB Subject: TSCA Section 12( b) Burden Update This memo summarizes responses we have received on the questions posed to a sample of companies that have previously submitted TSCA Section 12( b) export notifications to EPA. The companies were chosen based on their inclusion in a randomly selected sample used for a similar task in 1999.1 We contacted nine companies and spoke with or have received faxed or e mailed responses from five companies thus far. It is possible we will receive additional responses today or into next week, in which case we will fax or e mail the responses directly to you.

Table 1 highlights the key ratios you expressed interest in for the 12( b) ICR. Companies are listed in the order which their information was received.

Table 2 contains the companies' detailed responses to our questions, with companies again listed in the order which their information was received. More detail may be found in the telephone log sheets, where unsolicited comments from several companies are also listed. These log sheets will be provided separately at your request. Please contact Dina at ( 781) 674 7301 or Jeff at ( 781) 674 7315 if you have any questions. Table 1. Summary of 12( b) Data BASF Eastman A. W. Chesterton Bayerh FMC Products 1,040a 1,000f 300 5,000 500e Exported products 340b 500 300 25,000c 500e Products subject to 12( b) 340b 75i 15 25,000d 8 12( b) notices generated 170 Varies 10 75 20 12( b) notices due to impurities 153g Several 0 71 0 Percent of products exported 32.7% 50.0% 100.0% 100.0% j 100.0%

Percent of exported products requiring 12( b) notification 50.0% 15.0% k 3.3% 2.0% j 1.6%

Percent of exported products requiring 12( b) notification due to impurities 94.1% Varies 0.0% 95.0% 0.0%

a Number of new products reviewed yearly for applicability of 12( b) requirements. b Reflects number of exported products reviewed for 12( b). c Number of shipments per year, containing a variety of products. d Number of shipments reviewed, but not necessarily subject to the 12( b) notification requirements. e Actual response was " 500+ total products." f Actual response was " More than 1,000." g Actual response was " Most 12( b) triggers are for components, and in turn, most of these are impurities." ERG used 90% of the number of 12( b) notices as an estimate. h This company provided ranges for all answers. The midpoint of each range was used to provide estimates in this table. See Table 2 for actual responses. i Answer provided was a range. Midpoint of range was used to produce point estimate. See Table 2 for exact response. j Assumes that all unique products are exported ( 5,000 products) within the 25,000 shipments. k Based on the number of products subject to 12( b) divided by the number of exported products. May be more than the number of exported products ultimately requiring notification. Table 2. Detailed Company Responses to 12( b) Burden Questionnaire Question Respondent BASF Eastman A. W. Chesterton Bayer FMC 1. How do you respond to 12( b) when the chemical in question is present as an impurity or residual in your final product? Check supplier MSDS's for 12( b)

components. Will flag 12( b) chemicals if listed by supplier. Known impurities ( incl.

those in research samples) are reported in accordance with Section 12( b) Does not apply All known impurities are reported. All components, down to less than 1% of final product, are reviewed/ reported.

2. Do you check for instances where 12( b) requirements may be triggered by impurities? If the supplier indicates all components of product ( incl.

impurities) then any 12( b) impurities will automatically be flagged. Do not hunt for impurities if not notified of their existence by suppliers. Most impurities or residual solvents are known and thus reported. Company will not hunt for potential impurities. Yes Yes. Based on analytical data compiled for product specifications and customer notification. Do not look specifically for impurities.

3. No. of times 12( b) is triggered by impurities? Most 12( b)

chemicals at BASF are components of final products, and a large number of these are from impurities within the components of the final mixtures. Several times per year this is the case. None 95% of the 12( b)

chemicals encountered are low level impurities. Unknown 4. Total no. of products? > 100,000 ( Approx. 1,040 are new products must be reviewed for applicability of 12( b) each year) > 1,000 300 4,000 6,000 unique products 500+ Table 2. Detailed Company Responses to 12( b) Burden Questionnaire 5. No. products exported yearly? 340a > 500 ( at least half of all products manufactured) 300 20,000 30,000 shipments w/ mixture of unique products. 500+ ( all)

6. No. exported products subject to 12( b) yearly? 340 > 50 to 100 ( regardless of whether notification is ultimately required) 15 20,000 30,000 shipments per year w/ mixture of unique products are reviewed for 12( b). 8 7. No. of 12( b) notices sent to EPA yearly? 170 Varies greatly from year to year. 10 50 100 20 a Refers to total number of exported products reviewed for 12( b), regardless of whether notifications were ultimately needed. May not reflect total number of exported products.

b Total number of export shipments reviewed via computerized tracking system. 2 See 64 Fed. Reg. 2486 ( January 14, 1999). Dear Sir/ Madam:

We are helping the U. S. Environmental Protection Agency update their Information Collection Request ( ICR) burden statement for the export notification requirements of section 12( b) of the Toxic Substances Control Act ( TSCA). 2 We are speaking with a few selected companies that must comply with these regulations in order to better understand the paperwork burdens and costs that they face. We'd appreciate the opportunity to go over the questions listed below with you.

We would also like to collect some specific data that will help EPA understand the reporting burden associated with chemicals present as byproducts or impurities. The data you provide will not appear in any public documents, and will only be aggregated with information gathered from a number of other companies.

( 7) How do you respond to the 12( b) requirements in a case where the chemical triggering the requirements appears in your exported product only as the result of raw material impurity or manufacturing byproduct ( i. e., the 12( b) chemical is not an intended component of your final product)?

( 8) Do you check for instances where 12( b) requirements are triggered by unintended components of your final product, as described above?

( 9) In a typical year, how many times is 12( b) triggered by unintended components of your final product?

The following general questions are to place your answers from above into perspective with your entire 12( b) burden.

( 10) In a typical year, what is the number of products you manufacture?

( 11) In a typical year, how many of these products do you export?

( 12) In a typical year, of those products you export, how many are subject to 12( b)?

( 13) In a typical year, how many 12( b) notices are sent to EPA?

Thank you for your time Dina M. Metivier Research Analyst ( 781) 674 7301 Eastern Research Group, Inc., is conducting this research under EPA Contract Number: 68 W 02 077. The EPA contact is Joe Callahan ( 202 564 8793) with the Office of Pollution Prevention and Toxics, Economic and Policy Analysis Branch.