**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: Recordkeeping and Reporting Requirements for Allegations**  **of Significant Adverse Reactions to Human Health or the Environment** 
**EPA ICR No.: 1031.10 OMB Control No.: 2070** 
**- 0017**  **1(b) Short Characterization**  Section 8(c) of the Toxic Substances Control Act (TSCA), 15 U.S.C. 2607(c), P.L. 94

- 469, requires that “any

person who manufactures (including imports), processes, or distributes in commerce an y chemical substance or mixture” must keep “records of significant adverse reactions to health or the environment, as determined by the Administrator by

rule, allege d to have been caused b y the substance or mixture.” TSCA is available on the Internet at http://epw.senate.gov/tsca.pdf

. EPA promulgated 40 CFR 717, “Allegations that Chemical Substances Cause Significant Adv erse Reactions to Health or the Environment; Subpart A

-- Recordkeeping and Reporting,” on August 22, 1983 (48 FR 38178) (40 CFR 717 is available on the Internet through EPA’s TSCA section 8(c) webpage at http://www.epa.gov/opptintr/chemtest/pubs/sect8c.html ). 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 “signifi cant adverse reactions” alleged to have been caused b y such substances or mixtures. The rule also prescribes the conditions under which a firm must submit or make the records available to a dul y designated representative of the Administrator. TSCA secti on 8(c) requires that allegations of adverse reactions to the health of employ ees be kept for thirty y ears, and all other allegations be kept for five years. The total economic burden imposed by TSCA section 8(c) on the regulated community is estimated at 23,650 hours per respondent with an associated cost of $1,562,535 (13,951 respondents). The total estimated respondent burden has increased slightly (0.5%) as a reflection of the higher number of firms at 13,951 compared to 13,521 in the I CR most recent ly approved by OMB.**2 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 b y 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 compan y files or require reporting o f 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. Copi es 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 anal ys is. 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. In formation 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 mix tures 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 an y 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 affects 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

- ye ar and 30

- ye ar recordkeeping feature of the statute.**3 NON** 
**- DUPLICATION, CONSULTATIONS AND OTHER COLLECTION** 

**CRITERIA 3(a)**  **Non**
**- Duplication** 
In formation 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 inj ury 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 forma l 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 employ ees be kept for 30 y ears, and all other relevant allegations be kept for 5 years. There are not an y 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 n or does any other government program have direct authority to access such information. If an y 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 employ ee 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 onl y 5 years (see 29 CFR part 1904 for recording and reporting requirements for occupational injuries and illnesses under the Occupational Safet y and Health Act of 1970), then a cop y of that OSHA record must be included in the allegation record. **3(b) Public Notice R**  **equired Prior to ICR Submission to OMB** In proposing to renew this I CR, EPA provided a 60

- day public notice an d comment period that ended on December 27, 2011 (76 FR 66061, October 25, 2011 ). EPA received no comm ents during the comment period. **3(c) Con**  **sultations** Prior to proposing the TSCA section 8(c) rule, EPA held information meetings with the following groups:

• Oil, Chemical, and Atomic Workers Union

• AFL/CIO

• Environmental Defense Fund

• American Textile Manufacturing Association

• Chemical Manufacturers Association

• Chemical Specialty Manufacturers Association

• Rubber Manufacturers Association

• National Congress of Petroleum Retailers

• National Association of Chain DrugstoresDuring the public comment period, EP A received 160 comments from a wide variet y of

groups including the Chemical Manufacturers Association (now called the American Chemistry Council), American Petroleum Institute, chemical manufacturers and processors, chemical industry representatives, and environmental and labor organizations. In addition, EPA held public meetings on the proposed rule in Washington, D.C., Newark, New Jersey , and Houston, Texas. In promulgating the final TSCA section 8(c) rule, EPA contacted Allied Chemical, American Cyanamid, Monsanto, Proctor and Gamble, Stauffer Chemical, and Union Carbide to obtain industry

estimates on the number of expected allegations and company indirect costs. In addition, the TSCA section 8(c) final rule concept was reviewed b y the Administr ator’s Toxic Substance Advisory

Committee, which was composed of representatives of business and environmental groups. Since promulgation, provisions of the final rule have been thoroughl y discussed in briefings with representatives of the chemical industry . Also, certain aspects of the rule were subsequently

modified via notice and comment rulemaking based upon recommendations by members of the industry

and after full consideration of comments from representatives of industry , labor groups, environmental groups, and the general public. OPPT has provided continuing interpretive guidance to interested parties whenever the need has arisen. In July

of 1986, OPPT conducted a seminar for industry representatives on TSCA that included information exchange regarding TSCA section 8(c). Another such industry seminar was conducted in 1990. TSCA section 8(c) has also been discussed at a variet y of other seminars and meetings with industry

. Additionally , under 5 CFR 1320.8(d)(1), OMB requires agencies to consult w ith potential ICR respondents and data users about specific aspects of ICRs before submitting an ICR to OMB for review and approval. In accordance with this regulation, EPA submitted questions to nine parties via email. The individuals and/or organizatio ns contacted were: Robert Kiefer , Director Regulatory

& Technical Affairs robert_kiefer@americanchemistry .com American Chemistry

Council Washington, D.C. 2002 Ernie Rosenberg, President and CEO erosenberg@cleaninginstitute.org American Cleaning Institute Washington, D.C. 20005 Doug Fratz, Vice President of Scientific and Technical Affairs dfratz@cspa.org Consumer Specialty

Products Association Washington, D.C. 20006Daniel Newton, Manager

Government Relations newtond@socma.com Society of Chemical Manufacturers & Affiliates Washington, DC 20036 William McL in, President and CEO bill@aafa.org Asthma & Allergy

Foundation of America Landover, MD 20785 Nsedu Obot Witherspoon, E xecutive Director nobot@cehn.org Children's Environmental He alth Network Washington, DC 20002 Robert Denison, Senior Scientist rdenison@edf.org Environmental Defense Washington, D.C. 20009 Kenneth A. Cook, President ken@ewg.org Environmental Working Group Washington, D.C. 20009 Thomas Neltner, Food Additi ves Project D irector tneltner@pewtrusts.org Food Additives Campaign / Pew Health Group / The Pew Charitable Trusts Washington, D.C. 20004 EPA received no responses to its solicitation for consultations. A copy of EPA’s consultation e

- mail to the above nine potential respondents is included in Attachment 3. **3(d) Effects of Less Frequent Collection**  Currently , EPA uses its authority to col lect information pursuant to the TSCA section 8(c) rule sparingl y. Currently , EPA anticipates issuing infrequent requests (less than 2 per ye ar) for TSCA section 8(c) reporting. However, reporting requests may occur more frequently because individual noti ces or letters containing such TSCA section 8(c) requests may be clustered in the same ye ar. 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 b y OP PT or when a chemical not under assessment b y 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 requ ire records submission onan 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 se ction 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 ye ars. 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 y ears from the date such reactions were first reported or known to the person maintaini ng the record. An y other record of such adverse reactions (e.g., to the environment, non

- employ ees) is required to be retained for a period of 5 y ears. 40 CFR part 717 incorporates these record retention provisions authorized by TSCA. **3(f) Confidential**  **ity** 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.

**4 THE RESPONDENTS AND THE INFORMATION REQUESTED**  **4(a) Respondent NAICS Codes**  Respondents affected b y this collection activity are mainly

NAICS categories 325 and 32411 ( Chemicals and Allied Products Manufacturers and Petroleum Refining , respectivel y). **4(b) Information Requested**  (i) Data Items Records maintained pursuant to 40 CFR Part 717 must consist of the following: a. The original allegation as rece ived. 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, articl e, company process or operation, or site discharge.4. A description of the alleger (e.g., emplo yee, 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 an y self initiated investigation with respect to an allegation. EPA does not require such investigation under the section 8(c) rule.) d. Copies of an y 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

. (ii) 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 sub

ject to the rule must record significant reactions alleged to have been caused b y substances or mixtures that they manufacture, import, or process. These firms must establish a recordkeeping s ys tem for such allegations and monitor incoming complaints to d etermine if they meet the criteria for filing. Allegations that are filed must be retained for 30 y ears if they are employ ee related and for 5 y ears for all other t ypes/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 usuall y 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 c ited 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 wi th 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 readil y retrievable b y 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 n otice 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 an y relevant records of significant adv erse reactions alleged to have been caused by thesubstance 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.

**5 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 authorit y o f 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 re sponses will be staff of the Chemical Information and Testing Branch (CITB) of the Chemical Control Division (CCD), the Director of CCD and the Director of the Office of Pollution Prevention and Toxics (OPPT). (For more information about the Chemical Test ing Program, go to: http://www.epa.gov/oppt/chemtest/index.html.) 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 assessi ng 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 identifie d 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 day s 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 subje ct 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 section 8(a) of TSCA, Congress did not include a specific exemption of small businesses in TSCA section 8(c). This rule does not exempt sm all 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 adversel y affected b y products, emissions, etc.,produced or created b y firms of all siz es.

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 specificall y eliminated most distributors and effectivel y limits th e 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 report ing 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.

**6 ESTIMATING THE BUR** **DEN 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 compl y with a TSCA section 8(c) reporting are assumed to include revi ew 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. **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 b y EPA, include estimating the number of affected firms and employees, the number of allegations, and number of reports requested b y 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 tota l 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) IC R burden anal ys i s, EPA utilizes Census’ County Business Patterns database to determine numbers of firms/plants and their employ ment. The anal ys is entails computing the average number of employ ees per firm. 1

1 EPA has used this methodology from 2006 forw ard because the data source is publically available, making theThe first step is to gather information on the number of firms and employ ees 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 substance s. The most recent dataset available is from 2008. The number of employ ees per firms is calculated using employ ment figures from County Business Patterns for those firms that fall under NAI CS 325 or NAICS 32411. Data from County Business Patterns show that compared to the previous ICR renewal, the number of firms and the number of employees have both decreased slightly , resulting in about a 2% decrease in average number of employ ees per firm. Current estimates using 2008 Census data are provided in Tab le 1.
**Table 1. Numbers of Firms and Em ployees for NAICS 325 and 32411, for**  **2008 Number of Firms** * **Total Number of Employees** * **Average Number of Employees per Firm**  13,951 876,091 63

* Excludes most government employees, railroad employees, and self

- employ ed persons. Source: US Census Bureau. 2008 County Business Patterns. Release Date: 8/1 7/2010. 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 man y 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 I CR, the consensus opinion of the firms contacted is that recordable TSCA section 8(c) allegations are likel y to be made b y 0.5 percent of the employ ees at an average firm. Additionall y, and per the 1983 ICR, EPA assumes that the rate of allegations made b y the general public would be about one

- third the employee allegation rate. Based on the average number of emplo ye es per firm, the estimated annual number of allegations per firm is presented below in Table 2. The total number of allegations is calculated b y multiplying the total number of firms (13,951) b y the average annual number of allegations per firm (.42), for a total of 5,841 allegations per ye ar.

analysis more trans parent. In the program’s initial ICR burden analysis, EPA used Dun’s Market Identifiers (DMI) from a Dun and Bradstreet database (se e U.S. EPA, “Comparison of Data Sources for Characterizing Manufacturers and Processors,” Draft Report, Prepared by Centaur Associates, Inc under EPA contract No. 68

- 02

- 3980, Washington, DC; November 6, 1986)

.**Table 2. Estimated Total Number of Allegations per Year**  **for 2012**
**- 2015** 

**Firms Avg. Number of** 

**Employees Average Annual # of**  **Allegations per Firm Total**  **Allegations Employee**  **Public Total**  13,951 63 0.31 0.10 0.42 5,841 Estimate of the Number of Reports Requested b y EPA EPA’s long

- term experience shows that onl y 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 I CR. To date, onl y two reporting notices have been issued under TSCA section 8(c) 2 and these two notices covered two chemicals and two chemical categories. A total of 31 reports have been r eceived under TSCA section 8(c). 3 , 4 This represents an average of onl y about 1.1 reports per year since the rule was promulgated in 1983. 5 Estimated Wage Rates Loaded wage rates for technical, managerial, and clerical personnel are der ived using a standard methodology

for the TSCA

- regulated community . Wage rate data are obtained from the regularl y 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 2011, for manufacturing industries. 6 The cost of fringe benefits (paid leave, insuran ce 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 analy ses for two major rulemakings. 7 See Table 3 below for calculation details.

2 U.S.EPA. “Chemical on Reporting Rules Database (CORR),” CCD and CSB, June 1990; and U.S.EPA. “Chemical on Reporting Rules Database (CORR): Update,” CCD and CSB; October 31, 1992. 3 U.S.EPA. [Untitled Computer Printout], IMD; June 3, 1992. 4 Sherlock, Scott, Information Management Division. Phone conversation with Wendy Hoffman based upon “TSCA Reports to Congress for EPA Fiscal Years 1992

- 93;” August 1994. 5 In comparison to the estimate of over 5800 allegations, it appears that the allegations rate used to estimate total allegations in Table 2 is overstated. How ever, given potentials for higher counts of allegations, EPA retain s the existing methodology, whic h provides for a large contingency in additional burden . Moreover, the total burden for this information collection is relatively small despite the use of an overstated estimate for total allegations. 6Employer Costs for Employee Compensation Supplementary Tables: December 2006

-Mach 2011 , US Bureau of Labor Statistics, June 8, 2011 (pp 17,18,20) (http://www.bls.gov/ncs/ect/sp/ecsuphst.pdf, accessed July 13, 2011)

. 7 For methodology, s ee: Wage Rates for Economic Analyses of the Toxics Release Inventory Progr am (U.S.EPA/OEI/EAD/ASB, June 10, 2002) and the Revised Economic Analysis for the Amended Inventory Update Rule: Final Report (U.S. EPA/OPPT/EETD/EPAB. August 2002.**Table 3: Loaded Industry Wage Rates (March, 2011)**

**EPAB Labor Category**  **Data Sources d**  **Date Wage**  **Fringe Benefit**  **Fringes as**

**% wage Over** 
**- head** 

**% wage b**  **Fringe +**

**overhead factor**  **c Loaded** 

**Wages a**  (A) (B) (C)

=(B)/(A) (D) (E)

=(C)+(D)+1 (F)

=(A)*(E)

**Managerial** BLS ECEC, Private

**Manufacturing industries**  , “Mgt, Business, and Financial” Mar

- 11 $43.11 $20.51 47.58% 17% 1.65 $70.95

**Professional/ Technical**  BLS ECEC, Private

**Manufacturing industries**  , “Professional and related“ Mar

- 11 $37.31 $16.77 44.95% 17% 1.62 $60.42

**Clerical** BLS ECEC, Private

**Manufacturing industries,**  “Office and Ad ministrative Support” Mar

- 11 $17.61 $10.85 61.61% 17% 1.79 $31.45

**Notes:**

a Wage data are rounded to the closest dollar figure in this table; however, in calculations using these numbers for this report, unround ed values were used.
b An overhead rate of 17% was used based on assumptions in Wage Rates for Economic Analyses of the Toxics Release Inventory Program (Rice, 2002), and the Revised Economic Analysis for the Amended Inventory Update Rule: Final Report (EPAB, 2002).

c An inflation factor of “1” means wage data were not escalated to reflect inflation. d Source: Employer Costs for Employee Compensation Supplementary Tables: December 2006

-Mach 2011, US Bureau of Labor Statistics, June 8, 2011 (pp 17,18,20) (http://www.bls.gov/ncs/ect/sp/ecsuphst.pdf, accessed July 13, 2011). Unit 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 4 using the wage rates referred to above. i. Unit Recordkeeping Burden and Cost Based on the original TSCA section 8( c) anal ys is, EPA estimates that a firm’s TSCA section 8(c) coordinator will spend 2 to 3 hours to determine the status of an allegation. 8 For the purposes of this anal ys is, it is assumed that 3 hours are needed. This level of effort will occur for all all egations received. If the allegation is found to be recordable, the coordinator completes a form, has it ty

ped, 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 $264.05.

8 U.S.EPA. “Economic Analysis of TSCA Section 8(c) Significant Adverse Reaction Recordkeep ing Rule, OTS/ETD/RIB.” January 1983.ii. Unit Reporting Burden a nd Cost

Based on the original TSCA section 8(c) anal ys is, EPA estimates that a management level compan y official will spend one hour reviewing the Federal Register notice or letter from EPA to determine whether the compan y m anufactures (including imports ) or processes substances subject to the reporting requirement. Technical personnel would then spend an estimated two hours conducting a search of the compan y’s TSCA section 8(c) files for an y relevant allegation records. Once the file search is complet e, EPA estimates that a managerial employee would spend two hours preparing a transmittal letter and other explanatory material to accompan y the allegation records. An upper

level management official would spend an additional two hours reviewing these mat erials. 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 $507.04.
iii. Unit Federal Register Notice Review Burden and Cost Based on the original TSCA section 8(c) anal ys is, 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 Federa l Register notice review is $17.74. **Table 4. Unit Respondent Burden and Cost Estimates**

**Activity Clerical** 

**Hours Technical** 

**Hours Manager** 

**Hours Total** 

**Hours Total Cost**  Recordkeeping, per allegation 0.5 0 3.5 4 $264.05 Reporting, per report 1 2 5 8 $507.04 Federal Register notice review, per notice 0 0 0.25 0.25 $17.74

Total Industry

Burden and Cost Estimates for Burden and Cost are summarized in Table 5 b y activit y, and are thereafter presented in more detail.**Table 5. Summary of Total Industry Burden and Cost** 

**Activity Unit** 

**Burden, Hours**  **Unit**

**Cost Applicable # and Unit**  **# Firms**  **Burden,**

**Hours Cost**  Recordkeeping, per allegation 4 $264.05 5,841 Allegations per year N/A 23,362 $1,542,196 Reporting, per report 8 $507.04 1.1 Reports per year N/A 9 $542 Federal Register Notice review, per Notice 0.25 $17.74 0.08 Notices per year per firm 13,951 279 $19,796
**Total Burden/Cost 23,650**  **$1,562,535** i Total Recordkeeping Burden and Cost The unit burden for recordkeeping is multiplied by the total number of allegations. Total annual recordkeeping burden is 23,362 hours. The unit cost for recordkeeping of $264.05 is multiplied by the average annual number of allegations per firm. This figure is then multiplied by

the number of firms. Total annual recordkeeping cost is $1,542,196. ii. Total Reporting Burden and Cost EPA assumes that 1.1 TSCA section 8(c) reports will be required annuall y, based on the 31 reports received in the 27

–ye ar history of the rule (31÷27 = 1.1). Total reporting burden hour is 1.1 reports x 8 hours per report (from Unit Reporting Burden and Co sts), or 9 hours. The cost of submitting these reports is determined by multiplying the annual number of reports by the unit reporting cost of $507.04. Total annual reporting cost is $542. iii. Total Federal Register Notice Review Burden and Cost Histo rically , the Agency

has published an average of only 0.08 notices each y ear since 1983, as EPA has published only two notices to date. Given this rate, and a unit burden of .25 hours per notice, the total industry burden is 279 hours. The total cost to i ndustry of reviewing the Federal Register notices is estimated using the unit cost for Federal Register review at $17.74 and multiplying by

0.08 notices per y ear to obtain $19,796. iv. Total Industry Burden and Costs The total economic burden on the r egulated 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 23,650 hours with an associated cost of $1,562,535. These costs, shown in the table below, would be incurred in each of the three ye ars covered b y this ICR.**Table 6. Total Industry Burden and Cost** 

**Collection Activity Number of**  **Respondents Total Annual** 

**Burden ,**  **Hours Total Annual**  **Cost** Recordkeeping 13,951 23,362 $1,542,196 Reporting 1.1 9 $542 Federal Register Review 13,951 279 $19,796 **Total/Overall 13,951**  **23,650 $1,562,535**  Regulatory

Flexibility

Analy sis TSCA section 8(c) does not include a specific exemption for small businesses (annual parent compan y s ales of less than $40 million). The costs of TSCA section 8(c) for an average compan y are listed below. The costs for a small business can be expected to be less. **Table 7. Average Total Costs per Firm**

**Type of Cost Cost**  Average recordkeeping cost 110.54 a Reporting cost per firm 0.04 b Federal Register notice review cost per firm 1.42 c **Average total cost per firm $112.00** 

a Calculated as the average cost per allegation times the average number of allegations per year. Smaller firms with fewer em

ploy ees can expect fewer allegations, and thus lower costs. b Calculated as the total industry reporting costs divided by the total number of firms.

c Calculated as the total industry review costs divided by the total number of firms. The average annual recordkeeping, reporting, and review costs to an average firm are $112. A firm would have to have less than $10,000 in annual sales for these costs to amount to 1 percent of annual sales. Based on information from previous I CRs, an average small f irm can be expected to have greater than $10 million in annual sales. Therefore, these requirements do not appear to impose a significant burden on small firms. **6(c) 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 $5 8 , 698 . This figure is based on activities identified in the 1986 and 1989 I CRs. Costs are estimated based on wages and salaries in 2011 GS

- schedule. 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 Registerprinting costs, do cument control, and document review. Annual costs to EPA are derived based

on an anal ys is of the cost of performing these various activities. The various factors that contribute to EPA costs include:

• Each ye ar, general administration of the rule involve s 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 by th e Environmental Assistance Division (EAD) in OPPT.

• 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.

• EPA previously

estimated that a maximum of six industry

- wide reporting notices involving a total of 100 chemicals would be developed each year. However, to date only two notices involving two chemicals and two chemical categories have been issued. EPA al so estimated that the notices would generate a maximum 500 reports per year. To date, however, a total of onl y 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 y ear an d an average of only 1.3 reports received. EPA expects that reporting activity under TSCA section 8(c) will remain at this low level during the period covered b y this ICR renewal. EPA costs associated with reporting have been adjusted to reflect this lar ge decrease in the level of expected activity. L abor 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 ru le 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 b y the office directl y requesting the information as well a s by the Chemical Information and Testing Branch (CITB) of the Chemical Control Division (CCD). EPA will incur costs related to the above activities in each of the three ye ars covered b y the I CR. The following table provides the projected annual burden and the associated annual costs to the government for activities related to TSCA section 8(c).**Table 8. Annual Burden and Cost to the Federal Government**

**Activity Hourly Wage**  **Burden Hours Annual Cost**  Administrative maintenance $68.26/$94.88 a 288 $21,788 Education/Outreach $57.41 b 240 $13,778 Compliance monitoring $57.41 b 400 $22,963 Develop reporting notices $57.41 b 1.1 $63 Document control functions $57.41 b 0.75 $43 Notice review, referral and data entry $57.41 b 1.1 $63 **Totals 931**  **$58,698**

a This activity is estimated to require 208 hours at the GS

- 13 level and 80 hours at the GS

- 15 level. The 2011 base hourly wage for a GS

- 13, Step 1 is $42.66, plus 60 percent overhead and benefits yields a total hourly rate of $ 68.26; The 2011 base hourly wa ge for a GS

- 15, Step 1 is $59.30, plus overhead and benefits yields a total hourly rate of $94.88. b The estimated total cost to the EPA of a full time employee (FTE) at a GS 12, Step 1 level The 2011 base hourly wage for a GS

- 1 2 , Step 1 is $ 35

. 88 , plus 60 percent overhead and benefits yields a total hourly rate of $57.41. Source: OPM 2011 hourly rate table for the Washington

- Baltimore

- North ern Virginia Locality Pay Area. **6(e) Reasons for Change in Burden**  There is an increa se of 114 hours (from 23,536 hours to 23,650 hours) in the total estimated respondent burden compared with that identified in the I CR currently approved b y OMB. This increase reflects EPA's estimate of a greater number of potential respondents affected by the reporting requirement. The total estimated respondent burden has increased slightl y ( 0 .5%) as a reflection of the higher number of firms at 13,951 compared to 13,521 in the I CR most recentl y approved by OMB. As shown in Table 5, over 87% of the burden hours are attributed to recordkeeping for allegations. The number of allegations follows directl y from the number of firms, in accord with the allegation rate of .42 allegations per firm (see Table 2 for details on allegations rate). This change is an adj ustment. **6(f) Burden Statement**  The annual public burden for this collection of information, which is approved under OMB Control No. 2070

- 00 17 , is estimated to range between approximately 1 minute and 8 hours per response , depending upon the ty pe(s) of activity

that a respondent must complete. 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 display s a current and va lid 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. The Agency

has est ablished a public docket for this I CR under Docket ID No. EPA

- HQ

OPPT

- 2011

- 0699 , which is available for online viewing at www.regulations.gov, or in personviewing at the EPA Docket Center (EPA/DC), EPA West, Room 3334, 1301 Constitution Ave.,

NW, Washingt on, 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 holiday s. 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. You may submit comments regarding the Agency 's need for this information, the accuracy of the provided burden estimates and an y suggested methods for minimizing respondent burden, including the use of automated collection techniques. Submit your comments, referencing Docket ID No. EPA

- HQ

- OPPT

- 2011

- 0699 and OMB Control No. 2070

- 0017 , to (1) EPA online using www.regulations.gov (our preferred method), or b y mail to: Document Control Office (DCO), Office of Pollution Prevent ion and Toxics (OPPT), Environmental Protection Agency , Mail Code: 7407T, 1200 Pennsylvania Ave., NW, Washington, D.C. 20460, and (2) OMB b y mail to: Office of Information and Regulatory Affairs, Office of Management and Budget (OMB), Attention: Desk Offi cer for EPA, 725 17th Street, NW, Washington, DC 20503.