- 1

- **Supporting Statement for a Request for OMB Review under**

**The Paperwork Reduction Act (1**  **st FR Notice, July 2011)** 
**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**  **(TSCA Section 8(c))**
**EPA ICR No.: 1031.10 OMB Control No.: 2070** 
**- 0017**  **1(b) Short Characterization** 
Section 8(c) of the Toxic Substances Control Act (T SCA), 15 U.S.C. 2607(c), P.L. 94

- 469 (TSCA is available on the I nternet at http://epw.senate.gov/tsca.pdf ), requires that “an y 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, alleged to have been caused by the substance or mixture.” EPA promulgated 40 CFR 717, “Allegations that Chemical Substances Cause Significa nt Adverse 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/sec t8c.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 “significant adverse reactions” alleged to have been caused b y such su bstances 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 section 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 y ears. The total economic burden imposed by TSCA section 8(c) on the regulated community is estimated at 23, 65 0 hours with an associated cost of $1,5 62,535 (13,951 respondents). The total estimated respondent burden has increased slightl y (.5%) as a reflection of the higher number of firms at 13,951 compared to 13,521 in the I CR most recently approved by

OMB.- 2

-

**2 NEED FOR AND USE OF THE COLLECTION**  **2(a) N**  **eed/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 administr ation 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 c ompan y 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 C FR 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 confi dential 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 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 mi crofiched 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 fo rmation 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 alread y under assessment by 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 atten tion 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 prem anufacture 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

-

**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, a nd all other relevant allegations be kept for 5 y ears. There are 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 do es any

other government program have direct authority to access such information. If an y records or reports relating to the allegation are required b y another agency , then copies of those records or reports must be maintained in the TSCA section 8(c) alle gation record. For example, if an employ ee allegation results in a requirement for the firm to record the case on Occupational Safet y and Health Administration (OSHA) Form 301, or equivalent form, which must be maintained by

the firm for onl y 5 ye ars (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 Requir**  **ed Prior to ICR Submission to OMB** Prior to submission to OMB, this I CR will be made available to the public for comment through a Federal Register notice. The public will have 60 day s to provide comments. Any comments received will be given considerati on when completing the supporting statement that is submitted to OMB. **3(c) Consultations**  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- 4

-

• National Association of Chain Drugstores

• During the public comment period, EPA received 160 comments from a wide variet y of groups including the Chemical Manufacturers Association (now called the American Chemistry Council), American Petroleum I nstitut e, chemical manufacturers and processors, chemical industry representatives, and environmental and labor organizations. I n 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 C yan amid, Monsanto, Proctor and Gamble, Stauffer Chemical, and Union Carbide to obtain industry

estimates on the number of expected allegations and company indirect cost s. In addition, the TSCA section 8(c) final rule concept was reviewed b y the Administrator’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 conduct ed 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 w ith industry

. •

• Under 5 CFR 1320.8(d)(1) OMB requires agencies to consult with potential I CR respondents and data users about specific aspects of I CRs before submitting an original or renewal I CR OMB for review and approval. In accordance with this regula tion, EPA will pursue additional consultations with interested parties during the development of the renewal of this collection. **3(d) Effects of Less Frequent Collection**  Currently , EPA uses its authority to collect information pursuant to the TSCA sec tion 8(c) rule sparingl y. Currently , EPA anticipates issuing infrequent requests (less than 2 per y ear) for TSCA section 8(c) reporting. However, reporting requests may occur more frequently

because individual notices or letters containing such TSCA secti on 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 by

OPPT or when a chem ical 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 require records submission on an as - needed ba sis in order to gather relevant information related to such matters. TSCA section 8(c) allegation records are part of such related information.- 5

-

**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 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 employ ees for a period of 30 y ears from the date such reactions were first reported or known to the person maintaining 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) Confidentiality**  Respondents may

assert a claim of b usiness 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 inc lude 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 received. b. An abstract of the allegation an d 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., emplo yee, neighbor), including age and sex, if ascertainable.- 6

- 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 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 subject to the rule must record significant reactions alleged to have been caused b y substances or mixtures that they manufacture, import, or process. Th ese firms must establish a recordkeeping s ys tem 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 y ears if they are employ ee related and for 5 y ears f or 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 deter

mine 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, i t 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 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 notice in the Federal Register . Respondents are responsible for monitoring the Federal Register for such notices. Whenever feasible, EPA will also not ify 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 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 m ail it with a cover letter to EPA. The company should note that they

have submitted such- 7

-

records to EPA so that future duplicative reporting will not occur.

**5 THE INFORMATION COLLECTED** 
**- AGENCY ACTIVITIES, COLLECTION**  **METHODOLOGY, AND INFORMATION MANAGEM ENT**  **5(a) Agency Activities**  OPPT is the primary

user of the information gathered under the authorit y of this rule. I n addition, information may be gathered for other EPA program offices/regions, and other Federal or state health or environmental agenci es. EPA personnel involved in monitoring recordkeeping, initiating reporting requests, and reviewing responses will be staff of the Chemical Information and Testing Branch (CITB) of the Chemical Control Division (CCD), the Director of CCD and the Directo r of the Office of Pollution Prevention and Toxics (OPPT). (For more information about the Chemical Testing Program, go to: http://www.epa.gov/oppt/chemtest/index.html.) As OPPT receives submissions, they will be logged in and reviewed for confidential ity 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 day s as outlined in the regulation. Neither the rule nor EPA requires the use of any particular met hodology

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 r egulatory information. When Hotline staff 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 small manufacturers (including importers) or processors of chemicals from its provisions. This is due to EPA’s belief that workers, plant neighbors and consu mers may be adversel y affected b y products, emissions, etc., produced or created b y firms of all sizes.- 8

-

However, the TSCA section 8(c) rule was written to concentrate the recordkeeping and reporting burdens on those firms generally associated with the ma instream chemical industry

. EPA specificall y eliminated most distributors and effectivel y 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 comprom ising 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 o f 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 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 compl y with a TSCA section 8(c) reporting are assumed to include review of the Federal Register for no tices 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**  Steps required to estimate burden associated with th e 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 employ ees, the number of allegations, and number of reports re quested 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 total burden estimates for the industry r eporting 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 base s 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 the analysis more transparent. In the program’s initial ICR burden analysis, EPA used Dun’s Market Identifiers (DMI) from a Dun and Bradstreet databas e (se e U.S. EPA, “Comparison of Data Sources for Characterizing Manufacturers- 9

-

The 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 (Petro leum 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 2008. The number of employ ees per firms is calculated using emplo ym ent 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 a bout a 2 % decrease in average number of employ ees per firm. Current estimates using 2008 Census data are provided in Table 1.
**Table 1. Numbers of Firms and Em ployees for NAICS 325 and 32411, for**  **2008 Number of Firms** * **Tot al 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 employ ees 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 assume s that the rate of allegations made b y the general public would be about one

- third the employ ee 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 multiply ing the total number of firms (13,951) b y t he average annual number of allegations per firm (.42), for a total of 5,841 allegations per ye ar. **Table 2. Estimated Total Number of Allegat ions**  **per Year for 2012** 
**- 2015**  **Firms Avg. Number of** 

**Employees Average Annual # of Allegations per Firm**  **Total Allegations**  **Employee Public**  **Total**
and Processors,” Draft Report, Prepared by Centaur Associates, Inc under EPA contract No. 68

- 02

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

.- 10

-

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 b y this I CR. To date, onl y two reporting notices have been issued under TSCA s ection 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
L oaded wage r ates for technical, managerial, and clerical personnel are derived 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 ana ly ses for two major rulemakings. 7 See Table 3 below for calculation details.

2 U.S.EPA. “Chemical on Reporting Rules D atabase (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. Pho ne 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, which 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. 6 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)

. 7 For methodology, s ee: Wage Rates for Economic Analyses of the Toxics Release Inventory Program (U.S.EPA/OEI/EAD/ASB, June 10, 2002) and the Revised Economic Analysis for the Amende d Inventory Update Rule: Final Report (U.S. EPA/OPPT/EETD/EPAB. August 2002.- 11

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**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 repor t, unrounded 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 al legations received. If the allegation is found to be recordable, the coordinator completes a form, has it ty

ped , and checks it for accuracy . This require s 0.5 hours of clerical time and an additional 0.5 hours of managerial time. Assuming that all alleg ations 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 Recordkeeping Rule, OTS/ETD/RIB.” January 1983.- 12

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ii. Unit Reporting Burden an d 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 complete , EPA estimates that a managerial employ ee 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 mate rials. 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 $50 7.04.
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 Federal 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 I ndustry

Burden and Cost Estimates for Burden and Cost are summarized in Table 5 b y activit y, and are thereafter presented in more detail.- 13

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**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 multiply ing the annual number of repo rts by the unit reporting cost of $507.04. T otal annual reporting cost is $5 42

. 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 industry of reviewing the Federal Register notices is estimated using the unit cost for Federal Register review at $17. 74 and multiply ing by

0.08 notices per y ear to obtain $19, 796

. iv. Total Industry Burden and Costs The total econo mic 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 23, 65 0 hours with an associated cost of $1,5 62,535 . Thes e costs, shown in the table below, would be incurred in each of the three ye ars covered b y this ICR.- 14

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**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. Sm aller firms with fewer employees can expect fewer allegations, and thus low er 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 firm 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 f irms. **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.- 1 5

-

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 ass ociated 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 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 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 by the Environmental Assistance Division (EAD) in OPPT.

• Compliance monitoring costs primarily involve the costs of the TSCA section 8(c) portion of inspection c arried 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 t he 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).- 16

-

**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 increase 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 respon dents affected by the reporting requirement. The total estimated respondent burden has increased slightl y (.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 b y OMB. As shown in Table 5, over 87% of the burden hours are attributed to recordkeeping for allegations. The number of allegations follows directly 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 adjustment. **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 average about **23,650** hours per response with the burden ranging between appr oximately 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 in formation unless it display s 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 instrumen t or form, if- 17

-

applicable. The Agency

has established 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 person viewing at the EPA Docket Center (EPA/DC), EPA West, Ro om 3334, 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 holiday s. The telephone number for the Reading Room is (202) 566

- 1744, and the tele phone 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 burd en, including the use of automated collection techniques. Submit y our 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 Prevention and Toxics (OPPT), Environmental Protection Agency , Mail Code: 7407T, 1200 Pennsy lvania 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 Officer for EPA, 725 17th Street, NW, Washington, DC 20503.- 18

- **EPA ICR No. 1031.10; OMB Control No. 2070**
**- 0017** 

**ATTACHMENT 1**
**Toxic Substances Control Act Section 8(c)**  **15 USC 2607(c)**- 19

-

US Code as of: 01/23/00 Sec. 2607. Reporting and retention of information
* * * (c) Records Any person who manufactures, processes, or distributes in commerce any chemical substance or mixture shall maintain 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. Records of such adverse reactions to the health of employ ees shall be retained for a period of 30 y ears from the date such re actions were first reported to or known by the person maintaining such records. An y other record of such adverse reactions shall be retained for a period of five ye ars from the date the information contained in the record was first reported to or known by the person maintaining the record. Records required to be maintained under this subsection shall 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. Upon request of an y duly

designated representative of the Administrator, each person who is required to maintain records under this subsection shall perm it the inspection of such records and shall submit copies of such records.- 20

- **EPA ICR No. 1031.10; OMB Control No. 2070**
**- 0017** 

**ATTACHMENT 2 Records and Reports of Allegations that Chemical Substances Cause S**  **ignificant Adverse Reactions to Health or the Environment** 

**40 CFR 717**- 21

- TI TL E 40

-- PROTECTION OF ENVIRONMENT
CHAPTER I

-- ENVIRONMENTAL PROTECTION AGENCY (CONTINUED)
PART 717

-- RECORDS AND REPORTS OF ALLEGATIONS THAT CHEMI CAL SUBSTANCES CAUSE SI GNI FI CANT ADVERSE REACTI ONS TO HEAL TH OR THE ENVIRONMENT

-- Table of Contents Subpart A

-- General Provisions Sec. 717.1 Scope and compliance. Section 8 (c) of the Toxic Substances Control Act (TSCA) requires manufacturers, processors, and distributors of chemical substances and mixtures:

(a) To keep “records of significant adverse reactions to health or the environment, as determined b y the Administrator by rule, alleged to have been caused by the substance or mixture.” (b) To “permit inspection and submit copies of such records,” upon request of any designated representative of the Administrator. This rule implements section 8(c) o f TSCA. It describes the records to be kept and prescribes the conditions under which certain firms must submit or make the records available to a dul y designated representative of the Administrator. Sec. 717.3 Definitions. The definitions set f

orth in section 3 of TSCA and the following definitions apply to this part: (a) 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.

(b) Firm or compan y means an y person, that is subject to this part, as defined in Sec. 717.5. (c)(1) Known human effects means a commonly recognized human health effect of a particular substance or mixture as described either in :

(i) Scientific articles or publications abstracted in standard reference sources. (ii) The firm’s product labeling or material safety data sheets (MSDS). (2) However, an effect is not a “known human effect” if it: (i) Was a significan tly

more severe toxic effect than previousl y described. (ii) Was a manifestation of a toxic effect after a significantl y shorter exposure period or lower exposure level than described.

(iii) Was a manifestation of a toxic effect b y an exposure ro ute different from that described. (d) Manufacture or process means to manufacture or process for commercial purposes.

(e)(1) Manufacture for commercial purposes means to import, produce, or manufacture with the purpose of obtaining an immediate or eventual commercial advantage for the manufacturer, and includes, among other things, such “manufacture” of any amount of a chemical substance or- 22

-

mixture: (i) For distribution in commerce, including for test marketing. (ii) For use b y the ma nufacturer, including use for product research and development, or as an intermediate.

(2) Manufacture for commercial purposes also applies to substances that are produced coincidentally

during the manufacture, processing, use, or disposal of another substance or mixture, including both by products that are separated from that other substances or mixture and impurities that remain in that substance or mixture. Such by products and impurities may , or may not, in themselves have commercial value. They ar e nonetheless produced for the purpose of obtaining a commercial advantage since they are part of the manufacture of a chemical product for a commercial purpose.

(f) Person includes any

individual, firm, company , corporation, joint venture, partnershi p, sole proprietorship, association, or any other business entity , any State or political subdivision thereof, and any department, agency , or instrumentally of the Federal Government. (g) Process for commercial purposes means the preparation of a chemical substance or mixture, after its manufacture, for distribution in commerce with the purpose of obtaining an immediate or eventual commercial advantage for the processor. Processing of an y amount of a chemical substance or mixture is included. I f a chemical substance or mixture containing impurities is processed for commercial purposes, then those impurities are also processed for commercial purposes.

(h) Retailer means a person who distributes in commerce a chemical substance, mixture, or article to ultimate purchasers who are not commercial entities.

(i) Significant adverse reactions are reactions that may indicate a substantial impairment of normal activities, or long

- last ing or irreversible damage to health or the environment.

(j) Site means a contiguous propert y unit. Property divided onl y b y a public right

- of

way is considered one site. There may be multiple manufacturing, processing, or distribution activities occurring within a single site.

(k) Substance means a che mical substance or mixture unless otherwise indicated. Sec. 717.5 Persons subject to this part. (a) Manufacturers. (1) All manufacturers of chemical substances are subject to this part except as provided in Sec. 717.7(a). If manufacture of a che mical substance occurs at any site owned or controlled b y a firm then that firm is subject to this part.

(2) A manufacturer must collect: (i) An y allegation identifying a chemical substance it manufactures and any allegation identify ing the opera tions in the manufacture of any chemical substance it manufactures. (ii) Any allegation identify ing an y of its own processing or distribution in commerce activities with respect to any chemical substance it manufactures. (iii) Any allegation iden tify ing emissions, effluents, or other discharges from activities described in this paragraph.

(iv) An y allegation identifying a substance produced coincidentally during processing, use, storage or disposal of a chemical substance it manufactures.

(3) For the purpose of this part, owned or controlled means ownership of 50 percent or more of a firm’s voting stock or other equit y rights, or the power to control the management and- 23

-

policies of that firm.

(b) Processors. (1) A person who processes chemical substances, who is not also a manufacturer of those chemical substances, is subject to this part if (i) the person processes chemical substances to produce mixtures, or (ii) the person repackages chemical substances or mixtures. (2) As a pro cessor subject to this part such person must collect:

(i) An y allegation identifying an y mixture it produces and distributes in commerce and any allegation identify ing an y chemical substance or mixture it repackages and distributes in commerce.

( ii) Any allegation identify ing an y of its own further processing or distribution in commerce activities of the products described in paragraph (b)(2)(i) of this section.

(iii) Any allegation identify ing emissions, effluents, or other discharges from a ctivities described in this paragraph.

(iv) An y allegation identifying a substance produced coincidentally during the processing, use, storage or disposal of the products described in paragraph (b)(2)(i) of this section. (c) SIC code. SIC codes a pplicable to this part are published in Standard I ndustrial Classification Manual

-- 1972 and the 1977 Supplement. This manual and supplement may be obtained from the U.S. Government Printing Office, Washington, D.C. 20402

-- stock number 4101

- 0006 and stock n umber 003

- 005

- 0170

- 0 respectivel y. Where there is a conflict between the SI C code use of a term and the definition of that term in this part, the definition in this part applies. [48 FR 38187, Aug 22, 1983, as amended at 50 FR 46769, Nov. 13, 1985]
S ec. 717.7 Persons not subject to this part. (a) Manufacturers. (1) Persons or site activities are exempt from this part if the means by which they

manufacture a chemical substance solely involves mining or other solely extractive functions, e.g., t hose companies or sites within a compan y whose sole function is to mine mineral ores, extract petroleum or natural gas, quarry non - metallic minerals (including extraction of salts from seawater or brines), mine or otherwise extract coal, or separate gases from the atmosphere. This exemption may include, but is not necessaril y limited to, firms engaged in activities as described in SIC Division B

-- Mining and SIC Code 2813

-- Industrial Gases. (2) A person is not subject to this part if the chemical substa nces that person causes to be produced are limited to:

(i) Chemical substances that result from chemical reactions that occur incidental to exposure of another chemical substance, mixture, or article to environmental factors such as air, moisture, microbial organisms, or sunlight.

(ii) Chemical substances that result from chemical reactions that occur incidental to storage or disposal of other chemical substances, mixtures, or articles. (iii) Chemical substances that result from chemical r eactions that occur upon end use of other chemical substances, mixtures, or articles such as adhesives, paints, miscellaneous cleaners or other housekeeping products, fuel additives, water softening and treatment agents, photographic films, batteries, matc hes, or safet y flares, and that are not themselves manufactured- 24

-

or imported for distribution in commerce for use as chemical intermediates.

(iv) Chemical substances that result from chemical reactions that occur upon use of curable plastic or rubber m olding compounds, inks, dry ing oils, metal finishing compounds, adhesives, or paints, or other chemical substance formed during the manufacture of an article destined for the marketplace without further chemical change of the chemical substance.

(v) C hemical substances that result from chemical reactions that occur when (A) a stabilizer, colorant, odorant, antioxidant, filler, solvent, carrier, surfactant, plasticizer, corrosion inhibitor, antifoamer or defoamer, dispersant, precipitation

- inhibitor, binder, emulsifier, deemulsifier, dewatering agent, agglomerating agent, adhesion promoter, flow modifier, pH adjuster, sequestrant, coagulant, flocculant, fire retardant, lubricant, chelating agent, or qualit y control reagent functions as intended, or (B) a chemical substance, which is intended solely to impart a specific ph ys icochemical characteristic, functions as intended.

(b) [Reserved] (c) Sole distributors. A person solel y engaged in the distribution of chemical substances is exempt from th is part, unless such person is also a manufacturer or processor subject to this part. For example, a “distributor” who repackages chemical substances or mixtures is considered to be a processor and, thus, is not a sole distributor. Sole distributors may in clude, but are not limited to, those firms that distribute chemical substances as described in the wholesale trade SI C codes 5161

-- Chemicals and Allied Products, 5171

-- Petroleum Bulk Stations and Terminals, and 5172

-- Petroleum and Petroleum Products Wholes alers, Except Bulk Stations and Terminals.

(d) Retailers. A person who is a retailer is exempt from this part unless such person is also a manufacturer or a processor subject to this part. [48 FR 38187, Aug 22, 1983, as amended at 50 FR 46770, Nov. 13, 1985] Sec. 717.10 Allegations subject to this part. (a) Allegations subject to this part are those allegations received on or after November 21, 1983 by

persons subject to this part. (b) Allegations subject to this part are those that: (1) Are submitted either in writing and are signed by the alleger, or are submitted orally . I n the case of an oral allegation, the firm must transcribe the allegation into written form, or it must inform the alleger that such allegation may be subjec t to this part and request that the alleger submit such allegation to the firm in writing and signed.

(2) Implicate a substance that caused the stated significant adverse reaction by one of the following:

(i) Naming the specific substance. ( ii) Naming a mixture that contains a specific substance. (iii) Naming an article that contains a specific substance. (iv) Naming a company

process or operation in which substances are involved. (v) Identify ing an effluent, emission, or other discharge from a site of manufacturing, processing or distribution of a substance.

(c) Allegations subject to this part may be made to a firm by

any person, such as an employ ee of the firm, individua l consumer, a neighbor of the firm’s plant, another firm on behalf- 25

-

of its employ ees or an organization on behalf of its members.

(d) EPA intends that firms should, to the maximum practical extent, provide allegers with information regarding the ultima te disposition of their allegations. For example, firms could provide a brief notice to the alleger stating that a record was created under this part based upon their allegation, or that a record was not created and briefl y explain the reasons why not. Sec. 717.12 Significant adverse reactions that must be recorded. (a) Except as provided in paragraph (b) of this section, significant adverse reactions to human health that must be recorded include but are not limited to:

(1) Long

- lasting or irreversible damage, such as cancer or birth defects. (2) Partial or complete impairment of bodily functions, such as reproductive disorders, neurological disorders or blood disorders.

(3) An impairment of normal activitie s experienced by all or most of the persons exposed at one time.

(4) An impairment of normal activities which is experienced each time an individual is exposed. (b) Firms are not required to record significant adverse reactions that are known hum an effects as defined in Sec. 717.3(c).

(c) Except as provided in paragraph (d) of this section, significant adverse reactions to the environment that must be recorded, even if restricted to the environs of a plant or disposal site, include but are no t limited to: (1) Gradual or sudden changes in the composition of animal life or plant life, including fungal or microbial organisms, in an area.

(2) Abnormal number of deaths of organisms (e.g., fish kills). (3) Reduction of the reproductiv e success or the vigor of a species. (4) Reduction in agricultural productivity , whether crops or livestock. (5) Alterations in the behavior or distribution of a species. (6) Long lasting or irreversible contamination of components of the ph ys ical environment, especially

in the case of ground water, and surface water and soil resources that have limited self

- cleansing capability

. (d) Firms are not required to record a significant adverse reaction to the environment if the alleged cause o f that significant adverse reaction can be directl y attributable to an accidental spill or other accidental discharge, emission exceeding permitted limits, or other incident of environmental contamination that has been reported to the Federal Government un der an y applicable authorit y. [48 FR 38187, Aug. 22, 1983, as amended at 49 FR 23183, June 5, 1984; 58 FR 34204, June 23, 1993] Sec. 717.15 Recordkeeping requirements. (a) Establishment and location of records. A firm subject to this part sha ll establish and maintain records of significant adverse reactions alleged to have been caused by chemical substances or mixtures manufactured or processed by the firm. Such records shall be kept at the firm’s headquarters or at any other appropriate locat ion central to the firm’s chemical operations.- 26

- (b) Content of records. The record shall consist of the following: (1) The original allegation as received. (2) An abstract of the allegation and other pertinent information as follows: (i) The name and address of the plant site which received the allegation. (ii) The date the allegation was received at that site. (iii) The implicated substance, mixture, article, compan y process or operation, or site discharge. (iv) A descript ion of the alleger (e.g., “compan y employ ee,” “individual consumer,” “plant neighbor”). If the allegation involves a health effect, the sex and y ear of birth of the individual should be recorded, if ascertainable.

(v) A description of the alleged heal th effect(s). The description must relate how the effect(s) became known and the route of exposure, if explained in the allegation.

(vi) A description of the nature of the alleged environmental effect(s), identify ing the affected plant and/or animal s pecies, or contaminated portion of the ph ys ical environment.

(3) The results of an y self

- initiated investigation with respect to an allegation. (EPA does not require persons subject to this part to investigate allegations received, and no provision of this part shall be construed to imply that EPA recommends, en courages or requires such investigation.) (4) Copies of an y further required records or reports relating to the allegation. For example, if an employ ee allegation results in a requirement for the firm to record the case on Occupational Safet y and He alth Form 101 or appropriate substitute (see 29 CFR part 1904 for requirements under the Occupational Safety and Health Act of 1970), a copy of that OSHA record must be included in the allegation record.

(c) File structure. Records must be retrievable by the alleged cause of the significant adverse reaction, which cause may be one of the following: (1) A specific chemical identity

. (2) A mixture. (3) An article. (4) A compan y process or operation. (5) A site emission, effluent or other discharge. (d) Retention period. Records of significant adverse reactions to the health of employ ees shall be retained for a period of 30 y ears from the date such reactions were first reported to or known b y the person maintaining such record s. This provision requires persons subject to this part to retain for 30 y ears an employ ee health related allegation, arising from any employ ment related exposure, whether or not such allegation was submitted by or on the behalf of that recordkeeper’s own employ ee. Any other record of significant adverse reactions shall be maintained for a period of five ye ars from the date the information contained in the record was first reported to or known by the person maintaining the record. (e) Transfer of records. (1) If a firm ceases to do business, the successor must receive and keep all the records that must be kept under this part.

(2) If a firm ceases to do business and there is no successor to receive and keep the records for the prescribed period, these records must be transmitted to EPA. See Sec. 717.17(c) for the address to which such records must be sent. [48 FR 38187, Aug. 22, 1983, as amended at 49 FR 23183, June 5, 1984; 58 FR 34204, June 23, 1993]- 27

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Sec. 717.17 Inspe ction and reporting requirements. (a) Inspection. Firms must make records of allegations available for inspection by any duly designated representative of the Administrator. (b) Reporting. Each person who is required to keep records under this part must submit copies of those records to the Agency as required by

the EPA Administrator or appropriate designee. EPA will notify those responsible for reporting b y letter or will announce an y such requirements for submitting copies of records b y a noti ce in the Federal Register. Such letter or notice will be signed b y t he Administrator or appropriate designee, and will specify which records or portion of records must be submitted. The reporting period will be specified b y the letter or notice but in no case will such reporting period be less than 45 days from the date of the letter or the effective date of the notice.

(c) How to report. When required to report, firms must submit copies of records (preferabl y b y certified mail) to the Document Contro l Office (7407), Office of Pollution Prevention and Toxics, U.S. Environmental Protection Agency , Room G

- 099, 401 M St., SW., Washington, DC., 20460, ATTN: 8(c) Allegations. [48 FR 38187, Aug. 22, 1983, as amended at 49 FR 23183, June 5, 1984; 52 FR 200 84, May 29, 1987; 53 FR 12523, Apr. 15, 1988; 58 FR 34204, June 23, 1993; 60 FR 34464, July 3, 1995] Sec. 717.19 Confidentiality

. (a) An y person submitting copies of records may assert a business confidentiality claim covering all or part of the submitted information. Any information covered by

a claim will be disclosed by

EPA onl y as provided in procedures set forth at part 2 of this title. (b) If no claim accompanies a document at the time it is submitted to EPA, the document will be place d in an open file available to the public without further notice to the respondent.

(c) To asset a claim of confidentiality for information contained in a submitted record, the respondent must submit two copies of the document.

(1) One cop y must be complete. In that cop y, the respondent must indicate what information, if an y, is claimed as confidential b y marking the specific information on each page with a label such as “confidential,” “proprietary ,” or “trade secret” and briefly state the basis of the claim. (2) If some information is claimed as confidential, the respondent must submit a second cop y of the record. The second cop y must be complete, except that all information claimed as confidential in the first cop y must be deleted.

(3) The first cop y will be for internal use b y EPA. The second cop y will be placed in an open file to be available to the public.

(4) Failure to furnish a second cop y when information is claimed as confidential in the first copy will be considered a presumptive waiver of the claim of confidentiality . EPA will notify the respondent by

certified mail that a finding of a presumptive waiver of the claim of confidentiality

has been made. The respondent will be given 30 day s from the date of receipt of n otification to submit the required second cop y. If the respondent fails to submit the second cop y within the 30 day s, EPA will place the first copy in the public file.- 28

-