Supporting Statement for an Information Collection Request (ICR)
Under the Paperwork Reduction Act (PRA)
IDENTIFICATION OF THE INFORMATION COLLECTION
	1(a)	Title and Number of the Information Collection
		Title:	Recordkeeping and Reporting Requirements for Allegations of Significant Adverse Reactions to Human Health or the Environment
		EPA ICR No.: 1031.12
OMB Control No.: 2070-0017
Docket ID No.: EPA-HQ-OPPT-2015-0688
	1(b)	Short Characterization
	Section 8(c) of the Toxic Substances Control Act (TSCA), 15 U.S.C. 2607(c) (Attachment 1), requires that "any person who manufactures (including imports), processes, or distributes in commerce any chemical substance or mixture" must keep "records of significant adverse reactions to health or the environment, as determined by the Administrator by rule, alleged to have been caused by the substance or mixture." TSCA section 8(c) requires that allegations of adverse reactions to the health of employees be kept for thirty years, and all other allegations be kept for five years.
	EPA promulgated 40 CFR 717, "Allegations that Chemical Substances Cause Significant Adverse Reactions to Health or the Environment; Subpart A -- Recordkeeping and Reporting," on August 22, 1983 (48 FR 38178) (Attachment 2).  This rule became effective on November 21, 1983.  The rule requires manufacturers (including importers) and processors of chemical substances and mixtures to keep records of "significant adverse reactions" alleged to have been caused by such substances or mixtures.  The rule also prescribes the conditions under which a firm must submit or make the records available to a duly designated representative of the Administrator.
NEED FOR AND USE OF THE COLLECTION
	2(a)	Need/Authority for the Collection
	The recordkeeping and reporting activities associated with this collection of information are required by statute.  The TSCA section 8(c) reporting and recordkeeping requirements are of central importance in the administration of TSCA section 8 as a whole.  Without the ability to administer these paperwork requirements, EPA would not be able to meet its obligation under TSCA.  
	Since the statute does not contain an automatic reporting provision, EPA must either inspect company files or require reporting of records that relate to specific substances of concern in order to obtain and use information about allegations of significant adverse reactions.  EPA's authority to inspect and require such reporting is codified in 40 CFR 717.17.  EPA will review relevant TSCA section 8(c) records in connection with its TSCA chemical assessment activities.
	All studies submitted to EPA will be verified and the contents of the submissions recorded and inspected for the inclusion of confidential business information.  Copies of the documents will then be prepared for inclusion in EPA's public docket and distributed, as appropriate and based on the associated chemical identity, to program offices at EPA and/or to other federal agencies for scientific analysis. A coding form will be completed to capture certain descriptive information such as identity, document control number, confidentiality indicator, document title, document date, receipt date and chemical identity. The document will be recorded on microfiche and stored for archival purposes.
	2(b)	Use/Users of the Data
	By using the TSCA section 8(c) reporting authority, EPA can examine such records whenever a chemical is discovered to present possible risks to human health or the environment. Information contained in the TSCA section 8(c) allegation records will have several uses.  The information collected will be used on a case-specific basis to evaluate suspected adverse health or environmental effects of a chemical substance or mixture already under assessment by EPA's Office of Pollution Prevention and Toxics (OPPT).  Most of these substances will be "existing" chemicals, e.g., chemicals for test rule consideration, substances that are the subjects of TSCA section 8(e) notices of substantial risk, or substances or mixtures brought to the attention of OPPT by other EPA programs, other government agencies, industry, or the public.  However, TSCA section 8(c) reports also may be required on "new" chemicals as one means of monitoring for any suspected or potential hazards identified during the premanufacture notification (PMN) review period.
	On a case-specific basis, requiring reporting of TSCA section 8(c) records will also serve as a discovery function.  It will help identify trends of adverse effects across the industry that may not be apparent to any one company.  It will also serve as a long-term trend identification function because of the 5-year and 30-year recordkeeping feature of the statute.
NON-DUPLICATION, CONSULTATIONS AND OTHER COLLECTION CRITERIA
	3(a)	Non-Duplication
	Information recorded and reported on alleged adverse effects on health or the environment is specific for compliance with the TSCA section 8(c) rule.  Records required to be maintained under this rule include records of consumer allegations of personal injury or harm to health, reports of occupational disease or injury, and reports or complaints of injury to the environment submitted to the manufacturer, processor, or distributor in commerce from any source.  Allegation means a statement, made without formal proof or regard for evidence, that a chemical substance or mixture has caused a significant adverse reaction to health or the environment. TSCA section 8(c) requires that allegations of adverse reactions to the health of employees be kept for 30 years, and all other relevant allegations be kept for 5 years.  
	No other EPA programs or other agencies/departments that require this specific set of information on alleged adverse effects to be recorded and maintained for this retention period nor does any other government program have direct authority to access such information.  If any records or reports relating to the allegation are required by another agency, then copies of those records or reports must be maintained in the TSCA section 8(c) allegation record.  For example, if an employee allegation results in a requirement for the firm to record the case on Occupational Safety and Health Administration (OSHA) Form 301, or equivalent form, which must be maintained by the firm for only 5 years (see 29 CFR part 1904 for recording and reporting requirements for occupational injuries and illnesses under the Occupational Safety and Health Act of 1970), then a copy of that OSHA record must be included in the allegation record.
	3(b)	Public Notice Required Prior to ICR Submission to OMB
      As part of the renewal process, EPA will publish a notice in the Federal Register prior to submitting the ICR to OMB. Pursuant to 5 CFR 1320.8(d), any public comments received will be placed in the EPA docket, EPA-HQ-OPPT-2015-0688, for this action. 
	3(c)	Consultations
Under 5 CFR 1320.8(d)(1), agencies are required to consult with potential ICR respondents and data users about specific aspects of ICRs before submitting an original or renewal ICR to OMB for review and approval.  In accordance with this regulation, EPA will consult with representative stakeholders during the public comment period (see attachment 3 for list of potential questions).  EPA will submit questions to ICR respondents and data users via e-mail prior to submitting this ICR to OMB for review and approval.  
	3(d)	Effects of Less Frequent Collection
       Currently, EPA uses its authority to collect information pursuant to the TSCA section 8(c) rule sparingly. Currently, EPA anticipates issuing infrequent requests (less than 2 per year) for TSCA section 8(c) reporting.  However, reporting requests may occur more frequently because individual notices or letters containing such TSCA section 8(c) requests may be clustered in the same year.  The information will be collected on a case-specific basis to evaluate suspected adverse health or environmental effects of a chemical substance or mixture already under assessment by OPPT or when a chemical not under assessment by OPPT is discovered to present possible risks to human health or the environment.  For example, chemical disasters are obviously unpredictable and OPPT must reserve the capability to require records submission on an as-needed basis in order to gather relevant information related to such matters.  TSCA section 8(c) allegation records are part of such related information.
	3(e)	General Guidelines
 	The record retention provisions of TSCA section 8(c) and 40 CFR part 717 exceed the Paperwork Reduction Guidelines (5 CFR 1320.6) in that they require respondents to maintain records other than health, medical, or tax records, for more than three years.  TSCA section 8(c) authorizes EPA to require persons (i.e., manufacturers (including importers), processors, or distributors) to maintain records of adverse reactions to the health of employees for a period of 30 years from the date such reactions were first reported or known to the person maintaining the record.  Any other record of such adverse reactions (e.g., to the environment, non-employees) is required to be retained for a period of 5 years.  40 CFR part 717 incorporates these record retention provisions authorized by TSCA.
	3(f)	Confidentiality
 	Respondents may assert a claim of business confidentiality with respect to all or part of an allegation submission.  Such submissions will be handled in accordance with the provisions at 40 CFR Part 2.
	3(g)	Sensitive Questions
	This section is not applicable. The information does not include responses to questions of a sensitive nature.
THE RESPONDENTS AND THE INFORMATION REQUESTED
	4(a)	Respondent NAICS Codes
 	Respondents affected by this collection activity are mainly NAICS categories 325 and 32411 (Chemicals and Allied Products Manufacturers and Petroleum Refining, respectively).
	4(b)	Information Requested
Data Items
 	Records maintained pursuant to 40 CFR Part 717 must consist of the following:
 	a. The original allegation as received.
       b. An abstract of the allegation and other pertinent information as follows:
          1.  The name and address of the plant site that received the allegation.
          2.  The date the allegation was received at that site.
          3.  The implicated substance, mixture, article, company process or operation, or site discharge.
          4.  A description of the alleger (e.g., employee, neighbor), including age and sex, if ascertainable.
          5.  A description of the health effects, including explanation of how the effects became known and the route of exposure, if explained in the allegation.
 	c. The results of any self-initiated investigation with respect to an allegation.  EPA does not require such investigation under the TSCA section 8(c) rule.)
 	d. Copies of any further required records relating to the allegation (e.g., records required under OSHA).
 	Each person who is required to keep records under this part must submit copies of those records to EPA as required by the Administrator or appropriate designee.  EPA will notify those responsible for reporting by letter or will announce any such requirements by notice in the Federal Register.
Respondent Activities
 	Respondents must do two things: (1) maintain records of allegations of significant adverse reactions, and (2) submit copies of these allegation records when required by EPA.  Entities subject to the rule must record significant reactions alleged to have been caused by substances or mixtures that they manufacture, import, or process.  These firms must establish a recordkeeping system for such allegations and monitor incoming complaints to determine if they meet the criteria for filing.  Allegations that are filed must be retained for 30 years if they are employee-related and for 5 years for all other types/sources of allegations.
 	Firms subject to the rule must keep their TSCA section 8(c) records at company headquarters or at a site central to their chemical operations.  A multi-site company will usually require the responsible official at the individual plant site to forward potentially recordable TSCA section 8(c) allegations to a designated TSCA coordinator at their operations headquarters.  Depending on the size of the company, such allegations will be reviewed by a committee to determine if the allegations relate to the company's product, operations, or discharges.  If so, the effects cited in the allegation are compared against the rule's definition and examples of "significant adverse reaction."  If the allegation meets this test, it is recorded.  The actual allegation record is to be comprised of an abstract of the allegation along with a record of any company-initiated investigation and other pertinent documents.  The rule does not require further investigation.  EPA requires that allegations be filed so that they may be readily retrievable by the alleged "cause" of the reaction.  EPA does not, however, require a specific form under this rule.
 	Firms subject to this rule must maintain an awareness of their reporting requirements.  A reporting requirement will take the form of a letter directed to selected respondents or it will be a notice in the Federal Register.  Respondents are responsible for monitoring the Federal Register for such notices.  Whenever feasible, EPA will also notify those companies that can be identified with the production, importation or processing of a substance or mixture in question.  Respondents then must determine if they manufacture or process the chemical substance or mixture.  If so, they must conduct a search of their TSCA section 8(c) files to determine if there are any relevant records of significant adverse reactions alleged to have been caused by the substance or mixture.  If such records are present, they must make a photocopy of those records and mail it with a cover letter to EPA.  The company should note that they have submitted such records to EPA so that future duplicative reporting will not occur.
THE INFORMATION COLLECTED - AGENCY ACTIVITIES, COLLECTION METHODOLOGY, AND INFORMATION MANAGEMENT
	5(a)	Agency Activities
 	OPPT is the primary user of the information gathered under the authority of this rule.  In addition, information may be gathered for other EPA program offices/regions, and other Federal or state health or environmental agencies.
 	EPA personnel involved in monitoring recordkeeping, initiating reporting requests, and reviewing responses will be staff in the Office of Pollution Prevention and Toxics (OPPT).  
 	As OPPT receives submissions, they will be logged in and reviewed for confidentiality considerations.  Copies of submissions will be made available to offices within OPPT that are assessing the substances of concern.  Non-confidential versions of the submissions will be placed in a public docket and will be available for review by other government agencies and the public.
	5(b)	Collection Methodology and Management
 	EPA has not identified a more efficient, less expensive or more flexible means of obtaining the required data.  At present there is no new technology applicable to the collection of this information that would minimize the collection burden.
 	Any reporting requirements will have a minimum reporting schedule of forty-five days as outlined in the regulation.  Neither the rule nor EPA requires the use of any particular methodology or technology for the retention or transmittal of TSCA section 8(c) records.
 	To aid persons subject to this information collection, OPPT has set up a TSCA Hotline that provides information regarding TSCA section 8(c) reporting as well as other regulatory information.  When Hotline staff members are unable to answer questions regarding TSCA section 8(c), the questions are referred to OPPT/CCD staff for appropriate resolution.
	5(c)	Small Entity Flexibility
 	Unlike TSCA section 8(a), Congress did not include a specific exemption of small businesses in TSCA section 8(c).  This rule does not exempt small manufacturers (including importers) or processors of chemicals from its provisions.  This is due to EPA's belief that workers, plant neighbors and consumers may be adversely affected by products, emissions, etc., produced or created by firms of all sizes.
 	However, the TSCA section 8(c) rule was written to concentrate the recordkeeping and reporting burdens on those firms generally associated with the mainstream chemical industry.  EPA specifically eliminated most distributors and effectively limits the number of processors subject to the rule.  By doing so, EPA has eliminated a large number of small businesses from the purview of the rule without compromising its objectives.
	5(d)	Collection Schedule
 	If EPA publishes in the Federal Register a reporting requirement relating to a chemical substance or mixture, or requests such reporting by letter, then manufacturers (including importers) and processors of such substance or mixture must submit a copy of relevant allegation records in their files.  TSCA section 8(c) reporting requirements will be developed on an as-needed basis and could initially require only the submission of an abstract of the allegation record, which is generally one page in length, not the full allegation file.
ESTIMATING THE BURDEN AND COST OF THE COLLECTION
 	This section presents the estimates of the industry burden hours and costs associated with TSCA section 8(c) activities.  The specific action required to comply with a TSCA section 8(c) reporting are assumed to include review of the Federal Register for notices regarding specific chemicals, recording pertinent information on allegations and storing such records, and reporting allegations to EPA when required. Table 1 below, contains a cross-walk between the required activities and the related information collections.
Table 1: Cross-Walk between Industry Activities and Related Information Collections (ICs)
Activity
Description
Related IC(s)
Recordkeeping
Manufacturers, importers and processors of chemical substances or mixtures are required to maintain records of significant adverse reactions to health or the environment that are alleged to be caused by the substance or mixture, or alleged to be associated with its manufacture, processing, or distribution. Allegations that must be recorded include any statement of belief made by any person regarding a link between a particular company's product, process or emission and a significant adverse health or environmental effect. 
Prepare and maintain records
Reporting
If EPA has requested TSCA 8(c) records via a Federal Register notice or letter, respondents must find and submit the relevant data. They must also need to prepare and submit a transmittal letter and other explanatory material to accompany the allegation records. 
Prepare and submit records, a transmittal letter, and other relevant materials to EPA  
Federal Register notice review
Manufacturers, importers and processors of chemical substances or mixtures will need to review each Federal Register notice to see if EPA has requested any TSCA 8(c) record
Review Federal Register 
	6(a)	Estimating Respondent Burden and Cost
 	The steps required to estimate burden associated with the activities of (1) maintaining records of significant adverse effects, and (2) submitting copies of allegation records when required by EPA, include estimating the number of affected firms and employees, the number of allegations, and number of reports requested by EPA.  Unit estimates of burden for the various activities are also required.  These unit estimates are then coupled with the number of allegations, reports, and Federal Register notice reviews to develop total burden estimates for the industry reporting community.
 	Estimates of costs require estimation of wage rates for personnel who are expected to participate in TSCA section 8(c) activities.  These, coupled with the burden hours associated with the various tasks, provide the bases for industry cost estimates.
                Estimate of the Number of Firms
	As in the previous TSCA section 8(c) ICR burden analysis, EPA utilizes Census' County Business Patterns database to determine numbers of firms/plants and their employment. The analysis entails computing the average number of employees per firm.
 	The first step is to gather information on the number of firms and employees from the Bureau of the Census's County Business Patterns for NAICS code 325 (Chemical and Allied Products) and NAICS code 32411 (Petroleum Refining and Related Industries).  EPA chose those NAICS codes to define the firms that manufacture (including import) and process chemical substances. The most recent dataset available is from 2013.  
 	The number of employees per firms is calculated using employment figures from County Business Patterns for those firms that fall under NAICS 325 or NAICS 32411.  Data from County Business Patterns show that compared to the previous ICR renewal, the number of and employees decreased, resulting in about a 6% decrease the number of firms, and a 9% decrease in the number of employees, and a slight 3% decrease in average number of employees per firm. Current estimates using 2013 Census data are provided in Table 2.
Table 2.  Numbers of Firms and Employees for NAICS 325 and 32411, for 2013
                                Number of Firms*
                           Total Number of Employees*
                      Average Number of Employees per Firm
                                     13,160
                                    801,477
                                       61
 * Excludes most government employees, railroad employees, and self-employed persons.
 Source: US Census Bureau. 2013 County Business Patterns. Release Date: April 2015.
Estimate of the Number of Allegations of Significant Adverse Health Reactions
 	The total number of allegations is based upon the average number of employees per firm and the number of firms, multiplied by a standard annual allegation rate per firm. 
 	The Agency received numerous public comments following the issuance of the initial TSCA section 8(c) proposal, including many comments about the Agency's estimate of the number of allegations.  In response to these comments, EPA contacted a number of firms to develop a consensus estimate.  According to the 1983 ICR, the consensus opinion of the firms contacted is that recordable TSCA section 8(c) allegations are likely to be made by 0.5 percent of the employees at an average firm. Additionally, and per the 1983 ICR, EPA assumes that the rate of allegations made by the general public would be about one-third the employee allegation rate.  Based on the average number of employees per firm, the estimated annual number of allegations per firm is presented below in Table 3.  The total number of allegations is calculated by multiplying the total number of firms (13,160) by the average annual number of allegations per firm (.42), for a total of 5,527 allegations per year.
Table 3.  Estimated Total Number of Allegations per Year for 2016-2020
                                     Firms
                            Avg. Number of Employees
                    Average Annual # of Allegations per Firm
                               Total Allegations
                                        
                                        
                                    Employee
                                     Public
                                     Total
                                        
                                     13,160
                                       61
                                      0.31
                                      0.1
                                      0.42
                                     5,527
	Estimate of the Number of Reports Requested by EPA
 	EPA's long-term experience shows that only a very limited amount of reporting has been required under TSCA section 8(c); this is not expected to change during the period covered by this ICR. To date, only two reporting notices have been issued under TSCA section 8(c) and these two notices covered two chemicals and two chemical categories.  A total of 31 reports[,] have been received under TSCA section 8(c), an average of approximately 16 reports per notice. This represents an average of only about 1.1 reports per year since the rule was promulgated in 1983. EPA expects to issue one additional notice per year during the three year ICR collection period, and therefore, in light of past experience, EPA anticipates that it may receive an additional 16 reports annually.
Estimated Wage Rates
 	Loaded wage rates for technical, managerial, and clerical personnel are derived using a standard methodology for the TSCA-regulated community. Wage rate data are obtained from the regularly updated Bureau of Labor Statistics (BLS) Employer Costs for Employee Compensation Supplementary Tables.
      Wages and fringe benefits for managerial, professional/technical, and clerical labor are taken from the BLS Employer Costs for Employee Compensation (ECEC) data for March 2020, for manufacturing industries. The cost of fringe benefits (paid leave, insurance and other items) specific to each labor category is taken from the same BLS series. 
       An additional loading factor of 17 percent is applied to wages to account for overhead.  This approach is consistent with OPPT practice, as established in economic analyses for two major rulemakings. See Table 4 below for calculation details.
Table 4: Industry Wage Rates
                                  Labor Type
                                     Wage
                               Fringes as % Wage
                             Over-head % wage [a]
                         Fringe + Overhead Factor [b]
                               Loaded Wages [c]
                                       
                                      (a)
                                      (b)
                                      (c)
                                 (d)=(b)+(c)+1
                                   (a)x(d)
Professional / Technical
                                    $46.65
                                      50%
                                      17%
                                     1.67
                                    $77.78
Managerial
                                    $51.65
                                      44%
                                      17%
                                     1.61
                                    $83.28
Clerical
$20.54 
46%
17%
1.63
$33.57 
Footnotes:
[a] An overhead rate of 17% is used based on assumptions in Wage Rates for Economic Analysis of the Toxics Release Inventory Program (Rice, 2002), and the Revised Economic Analysis for the Amended Inventory Update Rule: Final Report (U.S. EPA, 2001).
[b] The inflation factor of "1" in the formula for calculating the fringe + overhead factor means wage data are not escalated to reflect inflation.
[c] Wage data are rounded to the closest cent in this analysis.
	6(b)	Unit Respondent Burden Hours and Costs
       Unit costs for each of the burdens associated with the TSCA section 8(c) requirements are calculated in this section and summarized in Table 5 using the wage rates referred to above.
                Unit Recordkeeping Burden and Cost 
 	Based on the original TSCA section 8(c) analysis, EPA estimates that a firm's TSCA section 8(c) coordinator will spend 2 to 3 hours to determine the status of an allegation. For the purposes of this analysis, it is assumed that 3 hours are needed.  This level of effort will occur for all allegations received.  If the allegation is found to be recordable, the coordinator completes a form, has it typed, and checks it for accuracy.  This requires 0.5 hours of clerical time and an additional 0.5 hours of managerial time.  Assuming that all allegations are recordable, a total of 4 hours are expended per allegation (3.5 hours managerial plus 0.5 hours clerical).  Storage costs for the allegations are believed to be negligible. The unit cost per allegation is $308.27. 
Unit Reporting Burden and Cost
	Based on the original TSCA section 8(c) analysis, EPA estimates that a management level company official will spend one hour reviewing the Federal Register notice or letter from EPA to determine whether the company manufactures (including imports) or processes substances subject to the reporting requirement.
 	Technical personnel would then spend an estimated two hours conducting a search of the company's TSCA section 8(c) files for any relevant allegation records.  Once the file search is complete, EPA estimates that a managerial employee would spend two hours preparing a transmittal letter and other explanatory material to accompany the allegation records.  An upper-level management official would spend an additional two hours reviewing these materials.  One hour of clerical labor would be required to prepare and mail the response.  A total of eight hours is expended per report (five managerial hours, two technical hours and one clerical hour). The unit cost for reporting, per report, is $605.53.
Unit Federal Register Notice Review Burden and Cost
 	Based on the original TSCA section 8(c) analysis, EPA estimates that 0.25 hour of managerial labor would be required to review each Federal Register notice (see Table 4).  The unit cost for Federal Register notice review is $20.82.
Summary Unit Respondent Burden Hours and Costs
Table 5.  Summary Unit Respondent Burden and Cost Estimates
                                    Activity
                                    Clerical
                                   Technical
                                   Managerial
                                     Total
 
                                     Hours
                                      Cost
                                    ($2020)
                                     Hours
                                      Cost
                                    ($2020)
                                     Hours
                                      Cost
                                    ($2020)
                                     Hours
                                      Cost
                                    ($2020) 
 Recordkeeping, per allegation
                                      0.5
                                    $16.79
                                       0
                                     $0.00
                                      3.5
                                    $291.48
                                       4
                                   $308.27 
 Reporting, per report
                                       1
                                    $33.57
                                       2
                                    $155.56
                                       5
                                    $416.40
                                       8
                                   $605.53 
 Federal Register notice review, per notice
                                       0
                                     $0.00
                                       0
                                     $0.00
                                     0.25
                                    $20.82
                                     0.25
                                    $20.82 
 Unit totals
                                      1.5
                                    $50.36
                                       2
                                    $155.56
                                     4,25
                                    $728.70
                                     12.25
                                    $934.62
	6(c)	Total Respondent Burden and Cost
       Estimates for burden and cost are summarized in Table 6 by activity, and are thereafter presented in more detail.
Table 6. Summary of Total Annual Respondent Burden and Cost
                                   Activity
                               Unit Burden Hours
                                   Unit Cost
                             Applicable # and Unit
                                    # Firms
                                  BurdenHours
                                     Cost
                         Recordkeeping, per allegation
                                       4
                                    $308.27
                                     5,527
                             Allegations per year
                                      N/A
                                    22,109
                                  $1,703,808
                             Reporting, per report
                                       8
                                    $605.53
                                      16
                               Reports per year
                                      N/A
                                      128
                                    $9,688
                  Federal Register Notice review, per Notice
                                     0.25
                                    $20.82
                                       1
                           Notices per year per firm
                                    13, 160
                                     3,290
                                   $273,991
                               Total Burden/Cost
                                    25,527
                                  $1,987,487
                Total Recordkeeping Burden and Cost
       The unit burden for recordkeeping is multiplied by the total number of allegations.  Total annual recordkeeping burden is 22,109 hours. The unit cost for recordkeeping of $308.27 is multiplied by the average annual number of allegations per year (5,527) and the total annual recordkeeping cost is $1,703,808.  
Total Reporting Burden and Cost
       Despite the infrequency with which the Agency actually publishes TSCA section 8(c) notices, EPA conservatively assumes that 16 TSCA section 8(c) reports will be submitted annually, in response to the publication of a single, assumed TSCA section 8(c) notice per year. The estimated number of 16 annual responses is based on the 31 reports received in response to the two TSCA section 8(c) notices published in the 27 - year history of the rule.  The estimated annual reporting burden hour is 16 reports x 8 hours per report (from Unit Reporting Burden and Costs), or 128 hours. The cost of submitting these reports is determined by multiplying the annual number of reports by the unit reporting cost of $605.53. The estimated total annual reporting cost is $9,688.
Total Federal Register Notice Review Burden and Cost
 	Historically, the Agency has published an average of only 0.08 notices each year since 1983, as EPA has published only two notices to date.  In light of that history, EPA conservatively assumes that it will publish a single, TSCA section 8(c) notice each year. Given this assumption, an estimated unit burden of 0.25 hours per notice, and an estimated 13,160 firms that will read the Federal Register notice to determine compliance obligations, the estimated annual industry burden is 3,290 hours.  The estimated annual cost to industry of reviewing the Federal Register notices is estimated using the unit cost for Federal Register review at $20.82 and multiplying by 13,160 firms reading 1 notice per year to obtain $273,991.
Overall Total Respondent Burden and Costs 
 	The total economic burden on the regulated community imposed by TSCA section 8(c) is the sum of the three components identified above (recordkeeping, reporting, and Federal Register notice review) and estimated at 25,527 hours annually with an associated annual cost of $1,987,487.  These costs, shown in the table below, would be incurred in each of the three years covered by this ICR.
Table 7. Overall Total Industry Burden and Cost
                              Collection Activity
                             Number of Respondents
                              Number of Responses
                          Total Annual Burden, Hours
                               Total Annual Cost
                                 Recordkeeping
                                    13,160
                                    13,160
                                    22,109
                                  $1703,808 
                                   Reporting
                                         16
                                         16
                                        128
                                       $9,688 
                            Federal Register Review
                                    13,160
                                    13,160
                                     3,290
                                    $273,991 
                                 Total/Overall
                                    13,160
                                    26,336
                                    25,527
                                  $1,987,487 
	6(d)	Average Burden and Cost per Respondent and per Response
 	Table 8 presents the average annual cost and burden per respondent. On average each firm will spend a total of 1.94 hours and $145.25 annually to complete TSCA 8(c) information collection activities.
Table 8.  Average Annual Cost and Burden per Respondent
                                    Activity
                                     Hours/
                                   Respondent
                                     Hours/
                                    Response
                                Cost/Respondent
                                 Cost/Response
                               Recordkeeping [a]
                                      1.68
                                      1.68
                                    $129.47
                                    $129.47
                                 Reporting [b]
                                      8.00
                                      8.00
                                    $605.53
                                    $605.53
                          Federal Register review [c]
                                      0.25
                                      0.25
                                      $20.82
                                      $20.82
                                    Average
                                      1.94
                                      0.97
                                    $151.02
                                      $77.86
 Notes: 
 a Calculated as the average cost (or hourly burden) per allegation times the average number of allegations per year.
 b Calculated as the total industry reporting costs (or total burden) divided 0by the total number of firms.
 [c] Calculated as the total industry review costs (or total burden) divided by the total number of firms.
	6(e)	Estimating Agency Burden and Cost
	The total annual cost to EPA for TSCA section 8(c) for each of the three years covered by this ICR is estimated to be $69,611.  This figure is based on activities identified in the 1986 and 1989 ICRs.  Costs are estimated based on wages and salaries in 2020 GS-schedule for the Washington-Baltimore-Northern Virginia Locality Pay Area, for GS-15, Step 1, GS-13, Step 1, and GS-12, Step 1 employees.  Wages include an additional 60 percent loading rate to account for overhead and benefits. 
 	Annual costs to EPA associated with the recordkeeping portion of the rule include general administration of the rule, education and outreach activities, and compliance monitoring.  Costs associated with reporting involve preparation of reporting notices, Federal Register printing costs, document control, and document review.  Annual costs to EPA are derived based on an analysis of the cost of performing these various activities.  The various factors that contribute to EPA costs include:
 Each year, general administration of the rule involves approximately one-tenth of a staff specialist's time plus approximately one week's time each for two management personnel at the branch, division and OPPT Office Director's level.
 Education and outreach activities will include ongoing rule support.
 Compliance monitoring costs primarily involve the costs of the TSCA section 8(c) portion of inspection carried out by regional personnel and other administrative costs for headquarters personnel to target and review results of such inspections.
 To date, a total of only 31 reports have been received.  Based on historical data, over the life of the rule an average of only 0.08 notices have been issued per year and an average of only 1.3 reports received.  EPA expects that reporting activity under TSCA section 8(c) will remain at low levels during the period covered by this ICR renewal.  EPA costs associated with reporting have been adjusted to reflect this large decrease in the level of expected activity.  Labor involved in developing the reporting notices will require decision meetings and either the development of letters, separate Federal Register notices, or the insertion of boilerplate segments in other rule preambles.
 Time will be required to process submissions based upon reporting requirements and to review them for confidentiality considerations.
 The Federal Register notices will be reviewed by the office directly requesting the information as well as by OPPT.
Table 9.  Annual Burden and Cost to the Federal Government
                                   Activity
                                   GS-Level
                          Loaded Hourly Wage ($2020)
                                 Burden Hours
                                  Annual Cost
Administrative maintenance
                                 GS-13, Step 1
                                    $78.70
                                      208
                                    $16,370

                                 GS-15, Step 1
                                    $109.40
                                      80
                                    $8,752

                                     Total
                                      288
                                    $25,122
Education/Outreach
                                 GS-12, Step 1
                                    $66.18
                                      240
                                    $15,883
Compliance monitoring
                                 GS-12, Step 1
                                    $66.18
                                      400
                                    $26,472
Develop reporting notices
                                 GS-12, Step 1
                                    $66.18
                                      16
                                     $1059
Document control functions
                                 GS-12, Step 1
                                    $66.18
                                       1
                                      $66
Notice review, referral and data entry
                                 GS-12, Step 1
                                    $66.18
                                      16
                                     $1059
                                    Totals
                                      961
                                    $69,611
	6(f)	Reasons for Change in Burden
	There is an increase in the total cost associated with this ICR as a result in an increase in the wage rate from $1,911,477 to $1,987,487.  This change is an adjustment.
      In addition, OMB has requested that EPA move towards using the 18-question format for ICR Supporting Statements used by other federal agencies and departments and is based on the submission instructions established by OMB in 1995, replacing the alternate format developed by EPA and OMB prior to 1995. EPA intends to update this Supporting Statement during the comment period to reflect the 18-question format, and has included the questions in attachment 4 to this Supporting Statement. In doing so, the Agency does not expect the change in format to result in substantive changes to the information collection activities or related estimated burden and costs. 
Table 10: Estimate of Changes in Annual Burden Hours from Previous ICR by Activity
                                       
                              Annual Burden Hours
Current OMB Inventory
                                    26,932
Change in Burden due to Adjustments
 
Changes in the number of firms and employees per firm
                                    -1,405
Change in Burden due to Program Changes
                                       0
Total Change in Burden
                                    -1,405
	6(g)	Burden Statement
      The annual public burden for this collection of information, which is approved under OMB Control No. 2070-0017, is estimated to average 0.97 hours per response. Burden is defined in 5 CFR 1320.3(b).  An agency may not conduct or sponsor, and a person is not required to respond to a collection of information unless it displays a current and valid OMB control number. The OMB control numbers for EPA's regulations in title 40 of the CFR, after appearing in the Federal Register, are listed in 40 CFR part 9 and included on the related collection instrument or form, if applicable.
      To comment on the Agency's need for this information, the accuracy of the provided burden estimates, and any suggested methods for minimizing respondent burden, including the use of automated collection techniques, EPA has established a docket for this ICR under Docket ID No. EPA-HQ-OPPT-2015-0688 which is available for public viewing online at http://regulations.gov. 
      Use the federal government wide electronic docket and comment system at www.regulations.gov to submit or view public comments, access the index listing of the docket contents, and to access those documents in the docket that are available electronically. Once in the system, select "advance search," then key in the docket ID number identified above. 
ATTACHMENTS
All the attachments listed below can be found in the docket for this ICR or using the hyperlink that is provided for the source documentation. The docket for this ICR is accessible electronically through http://www.regulations.gov using Docket ID Number: EPA-HQ-OPPT-2015-0688.
 Attachment 1		15 USC 2607(c) - TSCA section 8(c) - This attachment is available as part of the electronic copy of the ICR's Supporting Statement.
 Attachment 2 	40 CFR 717  -  Records and Reports of Allegations that Chemical Substances Cause Significant Adverse Reactions to Health or the Environment  -  This attachment is available as part of the electronic copy of the ICR's Supporting Statement.
 Attachment 3		Sample of Consultation Questions 
Attachment 4 	Example of 18-Question Format for Future ICR Supporting Statement
