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Supporting Statement for a Request for OMB Review under

The Paperwork Reduction Act

(1st 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 (TSCA), 15 U.S.C. 2607(c), P.L. 94-

469 (TSCA is available on the Internet at http://epw.senate.gov/tsca.pdf), requires that “any 

person who manufactures (including imports), processes, or distributes in commerce any 

chemical substance or mixture” must keep “records of significant adverse reactions to health or 

the environment, as determined by the Administrator by rule, alleged to have been caused by the 

substance or mixture.”

EPA promulgated 40 CFR 717, “Allegations that Chemical Substances Cause Significant 

Adverse Reactions to Health or the Environment; Subpart A -- Recordkeeping and Reporting,” 

on August 22, 1983 (48 FR 38178) (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 “significant 

adverse reactions” alleged to have been caused by such substances or mixtures. The rule also 

prescribes the conditions under which a firm must submit or make the records available to a duly 

designated representative of the Administrator.

TSCA section 8(c) requires that allegations of adverse reactions to the health of 

employees be kept for thirty years, and all other allegations be kept for five years.

The total economic burden imposed by TSCA section 8(c) on the regulated community

is estimated at 23,650 hours with an associated cost of $1,562,535 (13,951 respondents). The 

total estimated respondent burden has increased slightly (.5%) as a reflection of the higher 

number of firms at 13,951 compared to 13,521 in the ICR most recently approved by OMB. 
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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 by statute. The TSCA section 8(c) reporting and recordkeeping requirements are of 

central importance in the administration of TSCA section 8 as a whole. Without the ability to 

administer these paperwork requirements, EPA would not be able to meet its obligation under 

TSCA. 

Since the statute does not contain an automatic reporting provision, EPA must either 

inspect company files or require reporting of records that relate to specific substances of concern 

in order to obtain and use information about allegations of significant adverse reactions. EPA’s 

authority to inspect and require such reporting is codified in 40 CFR 717.17. EPA will review 

relevant TSCA section 8(c) records in connection with its TSCA chemical assessment activities.

All studies submitted to EPA will be verified and the contents of the submissions 

recorded and inspected for the inclusion of confidential business information. Copies of the 

documents will then be prepared for inclusion in EPA’s public docket and distributed, as 

appropriate and based on the associated chemical identity, to program offices at EPA and/or to 

other federal agencies for scientific analysis. A coding form will be completed to capture certain 

descriptive information such as identity, document control number, confidentiality indicator, 

document title, document date, receipt date and chemical identity. The document will be 

microfiched and stored for archival purposes.

2(b) Use/Users of the Data

By using the TSCA section 8(c) reporting authority, EPA can examine such records 

whenever a chemical is discovered to present possible risks to human health or the environment. 

Information contained in the TSCA section 8(c) allegation records will have several uses. The 

information collected will be used on a case-specific basis to evaluate suspected adverse health 

or environmental effects of a chemical substance or mixture already under assessment by OPPT. 

Most of these substances will be “existing” chemicals, e.g., chemicals for test rule consideration, 

substances that are the subjects of TSCA section 8(e) notices of substantial risk, or substances or 

mixtures brought to the attention of OPPT by other EPA programs, other government agencies, 

industry, or the public. However, TSCA section 8(c) reports also may be required on “new” 

chemicals as one means of monitoring for any suspected or potential hazards identified during 

the premanufacture notification (PMN) review period.

On a case-specific basis, requiring reporting of TSCA section 8(c) records will also serve 

as a discovery function. It will help identify trends of adverse 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-year and 30-year recordkeeping feature of the statute.
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3 NON-DUPLICATION, CONSULTATIONS AND OTHER COLLECTION 

CRITERIA

3(a) Non-Duplication

Information recorded and reported on alleged adverse effects on health or the 

environment is specific for compliance with the TSCA section 8(c) rule. Records required to be 

maintained under this rule include records of consumer allegations of personal injury or harm to 

health, reports of occupational disease or injury, and reports or complaints of injury to the 

environment submitted to the manufacturer, processor, or distributor in commerce from any

source. Allegation means a statement, made without formal proof or regard for evidence, that a 

chemical substance or mixture has caused a significant adverse reaction to health or the 

environment. TSCA section 8(c) requires that allegations of adverse reactions to the health of 

employees be kept for 30 years, and all other relevant allegations be kept for 5 years. 

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 does any other government program have direct authority to access such information. 

If any records or reports relating to the allegation are required by another agency, then copies of 

those records or reports must be maintained in the TSCA section 8(c) allegation record. For 

example, if an employee allegation results in a requirement for the firm to record the case on 

Occupational Safety and Health Administration (OSHA) Form 301, or equivalent form, which 

must be maintained by the firm for only 5 years (see 29 CFR part 1904 for recording and 

reporting requirements for occupational injuries and illnesses under the Occupational Safety and 

Health Act of 1970), then a copy of that OSHA record must be included in the allegation record.

3(b) Public Notice Required Prior to ICR Submission to OMB

Prior to submission to OMB, this ICR will be made available to the public for 

comment through a Federal Register notice. The public will have 60 days to provide comments. 

Any comments received will be given consideration when completing the supporting statement 

that is submitted to OMB.

3(c) Consultations

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
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• National Association of Chain Drugstores

• During the public comment period, EPA received 160 comments from a wide variety 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 by 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 thoroughly 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 variety of other 

seminars and meetings with industry.

•

• Under 5 CFR 1320.8(d)(1) OMB requires agencies to consult with potential ICR 

respondents and data users about specific aspects of ICRs before submitting an original or 

renewal ICR OMB for review and approval. In accordance with this regulation, 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 section 8(c) rule 

sparingly. Currently, EPA anticipates issuing infrequent requests (less than 2 per year) for TSCA 

section 8(c) reporting. However, reporting requests may occur more frequently because 

individual notices or letters containing such TSCA section 8(c) requests may be clustered in the 

same year. The information will be collected on a case-specific basis to evaluate suspected 

adverse health or environmental effects of a chemical substance or mixture already under 

assessment by OPPT or when a chemical not under assessment by OPPT is discovered to present 

possible risks to human health or the environment. For example, chemical disasters are 

obviously unpredictable and OPPT must reserve the capability to require records submission on 

an as-needed basis in order to gather relevant information related to such matters. TSCA section 

8(c) allegation records are part of such related information.
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3(e) General Guidelines

The record retention provisions of TSCA section 8(c) and 40 CFR part 717 exceed the

Paperwork Reduction Guidelines (5 CFR 1320.6) in that they require respondents to maintain 

records other than health, medical, or tax records, for more than three years. TSCA section 8(c) 

authorizes EPA to require persons (i.e., manufacturers (including importers), processors, or 

distributors) to maintain records of adverse reactions to the health of employees for a period of 

30 years from the date such reactions were first reported or known to the person maintaining the 

record. Any other record of such adverse reactions (e.g., to the environment, non-employees) is 

required to be retained for a period of 5 years. 40 CFR part 717 incorporates these record 

retention provisions authorized by TSCA.

3(f) Confidentiality

Respondents may assert a claim of business confidentiality with respect to all or part of 

an allegation submission. Such submissions will be handled in accordance with the provisions at 

40 CFR Part 2.

3(g) Sensitive Questions

This section is not applicable. The information does not include responses to questions of 

a sensitive nature.

4 THE RESPONDENTS AND THE INFORMATION REQUESTED

4(a) Respondent NAICS Codes

Respondents affected by this collection activity are mainly NAICS categories 325 and 

32411 (Chemicals and Allied Products Manufacturers and Petroleum Refining, respectively).

4(b) Information Requested

(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 and other pertinent information as follows:

1. The name and address of the plant site that received the allegation.

2. The date the allegation was received at that site.

3. The implicated substance, mixture, article, company process or operation, or

 site discharge.

4. A description of the alleger (e.g., employee, neighbor), including age and sex,

 if ascertainable.
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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 any further required records relating to the allegation (e.g., records required

 under OSHA).

Each person who is required to keep records under this part must submit copies of those 

records to EPA as required by the Administrator or appropriate designee. EPA will notify those 

responsible for reporting by letter or will announce any such requirements by notice in the 

Federal Register.

(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 by 

substances or mixtures that they manufacture, import, or process. These firms must establish a 

recordkeeping system for such allegations and monitor incoming complaints to determine if they

meet the criteria for filing. Allegations that are filed must be retained for 30 years if they are 

employee related and for 5 years for all other types/sources of allegations.

Firms subject to the rule must keep their TSCA section 8(c) records at company

headquarters or at a site central to their chemical operations. A multi-site company will usually 

require the responsible official at the individual plant site to forward potentially recordable 

TSCA section 8(c) allegations to a designated TSCA coordinator at their operations 

headquarters. Depending on the size of the company, such allegations will be reviewed by a 

committee to determine if the allegations relate to the company’s product, operations, or 

discharges. If so, the effects cited in the allegation are compared against the rule’s definition and 

examples of “significant adverse reaction.” If the allegation meets this test, it is recorded. The 

actual allegation record is to be comprised of an abstract of the allegation along with a record of 

any company-initiated investigation and other pertinent documents. The rule does not require 

further investigation. EPA requires that allegations be filed so that they may be readily 

retrievable by the alleged “cause” of the reaction. EPA does not, however, require a specific 

form under this rule.

Firms subject to this rule must maintain an awareness of their reporting requirements. A 

reporting requirement will take the form of a letter directed to selected respondents or it will be a 

notice in the Federal Register. Respondents are responsible for monitoring the Federal Register

for such notices. Whenever feasible, EPA will also notify those companies that can be identified 

with the production, importation or processing of a substance or mixture in question. 

Respondents then must determine if they manufacture or process the chemical substance or 

mixture. If so, they must conduct a search of their TSCA section 8(c) files to determine if there 

are any relevant records of significant adverse reactions alleged to have been caused by the 

substance or mixture. If such records are present, they must make a photocopy of those records 

and mail it with a cover letter to EPA. The company should note that they have submitted such 
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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 authority of this rule. In 

addition, information may be gathered for other EPA program offices/regions, and other Federal 

or state health or environmental agencies.

EPA personnel involved in monitoring recordkeeping, initiating reporting requests, and 

reviewing responses will be staff 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 Testing 

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 

assessing the substances of concern. Non-confidential versions of the submissions will be placed 

in a public docket and will be available for review by other government agencies and the public.

5(b) Collection Methodology and Management

EPA has not identified a more efficient, less expensive or more flexible means of 

obtaining the required data. At present there is no new technology applicable to the collection of 

this information that would minimize the collection burden.

Any reporting requirements will have a minimum reporting schedule of forty-five days as 

outlined in the regulation. Neither the rule nor EPA requires the use of any particular 

methodology or technology for the retention or transmittal of TSCA section 8(c) records.

To aid persons subject to this information collection, OPPT has set up a TSCA Hotline 

that provides information regarding TSCA section 8(c) reporting as well as other regulatory

information. When Hotline staff 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 consumers may be adversely affected by products, emissions, etc., 

produced or created by firms of all sizes.
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However, the TSCA section 8(c) rule was written to concentrate the recordkeeping and 

reporting burdens on those firms generally associated with the mainstream chemical industry. 

EPA specifically eliminated most distributors and effectively limits the number of processors 

subject to the rule. By doing so, EPA has eliminated a large number of small businesses from 

the purview of the rule without compromising its objectives.

5(d) Collection Schedule

If EPA publishes in the Federal Register a reporting requirement relating to a chemical 

substance or mixture, or requests such reporting by letter, then manufacturers (including 

importers) and processors of such substance or mixture must submit a copy of relevant allegation 

records in their files. TSCA section 8(c) reporting requirements will be developed on an asneeded 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 comply with a TSCA section 8(c) 

reporting are assumed to include review of the Federal Register for notices regarding specific 

chemicals, recording pertinent information on allegations and storing such records, and reporting 

allegations to EPA when required.

6(a) Estimating Respondent Burden and Cost

Steps required to estimate burden associated with the activities of (1) maintaining records 

of significant adverse effects, and (2) submitting copies of allegation records when required by

EPA, include estimating the number of affected firms and employees, the number of allegations, 

and number of reports requested by EPA. Unit estimates of burden for the various activities are 

also required. These unit estimates are then coupled with the number of allegations, reports, and 

Federal Register notice reviews to develop total burden estimates for the industry reporting 

community.

Estimates of costs require estimation of wage rates for personnel who are expected to 

participate in TSCA section 8(c) activities. These, coupled with the burden hours associated 

with the various tasks, provide the bases for industry cost estimates.

Estimate of the Number of Firms

As in the previous TSCA section 8(c) ICR burden analysis, EPA utilizes Census’ County 

Business Patterns database to determine numbers of firms/plants and their employment. The 

analysis entails computing the average number of employees per firm.1

 

1 EPA has used this methodology from 2006 forward 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 database (see U.S. EPA, “Comparison of Data Sources for Characterizing Manufacturers 
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The first step is to gather information on the number of firms and employees from the 

Bureau of the Census’s County Business Patterns for NAICS code 325 (Chemical and Allied 

Products) and NAICS code 32411 (Petroleum Refining and Related Industries). EPA chose 

those NAICS codes to define the firms that manufacture (including import) and process chemical 

substances. The most recent dataset available is from 2008. 

The number of employees per firms is calculated using employment figures from County 

Business Patterns for those firms that fall under NAICS 325 or NAICS 32411. Data from 

County Business Patterns show that compared to the previous ICR renewal, the number of firms 

and the number of employees have both decreased slightly, resulting in about a 2% decrease in 

average number of employees per firm. Current estimates using 2008 Census data are provided 

in Table 1.

Table 1. Numbers of Firms and Employees 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-employed persons.

Source: US Census Bureau. 2008 County Business Patterns. Release Date: 8/17/2010.

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 many comments about the Agency’s estimate of the 

number of allegations. In response to these comments, EPA contacted a number of firms to 

develop a consensus estimate. According to the 1983 ICR, the consensus opinion of the firms 

contacted is that recordable TSCA section 8(c) allegations are likely to be made by 0.5 percent of 

the employees at an average firm. Additionally, and per the 1983 ICR, EPA assumes that the rate 

of allegations made by the general public would be about one-third the employee allegation rate. 

Based on the average number of employees per firm, the estimated annual number of allegations 

per firm is presented below in Table 2. The total number of allegations is calculated by 

multiplying the total number of firms (13,951) by the average annual number of allegations per 

firm (.42), for a total of 5,841 allegations per year.

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

 

and Processors,” Draft Report, Prepared by Centaur Associates, Inc under EPA contract No. 68-02-3980, 

Washington, DC; November 6, 1986).
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13,951 63 0.31 0.10 0.42 5,841

Estimate of the Number of Reports Requested by EPA

EPA’s long-term experience shows that only a very limited amount of reporting has been 

required under TSCA section 8(c); this is not expected to change during the period covered by 

this ICR. To date, only two reporting notices have been issued under TSCA section 8(c)2and 

these two notices covered two chemicals and two chemical categories. A total of 31 reports have 

been received under TSCA section 8(c).

3,4

This represents an average of only 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 derived using a 

standard methodology for the TSCA-regulated community. Wage rate data are obtained from the 

regularly updated Bureau of Labor Statistics (BLS) Employer Costs for Employee Compensation 

Supplementary Tables.

Wages and fringe benefits for managerial, professional/technical, and clerical labor are

taken from the BLS Employer Costs for Employee Compensation (ECEC) data for March 2011, 

for manufacturing industries.6The cost of fringe benefits (paid leave, insurance and other items) 

specific to each labor category is taken from the same BLS series. 

An additional loading factor of 17 percent is applied to wages to account for overhead. 

This approach is consistent with OPPT practice, as established in economic analyses for two 

major rulemakings.7See 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. However, given potentials for higher counts of allegations, EPA retains 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, see: 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 Amended Inventory Update 

Rule: Final Report (U.S. EPA/OPPT/EETD/EPAB. August 2002.
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Table 3: Loaded Industry Wage Rates (March, 2011)

EPAB Labor 

Category Data Sourcesd Date

Wage Fringe 

Benefit

Fringes 

as % 

wage

Overhead % 

wageb

Fringe + 

overhead 

factorc

Loaded 

Wagesa

(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 

Administrative 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, 

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) analysis, EPA estimates that a firm’s TSCA 

section 8(c) coordinator will spend 2 to 3 hours to determine the status of an allegation.8 For the 

purposes of this analysis, it is assumed that 3 hours are needed. This level of effort will occur for 

all allegations received. If the allegation is found to be recordable, the coordinator completes a 

form, has it typed, and checks it for accuracy. This requires 0.5 hours of clerical time and an 

additional 0.5 hours of managerial time. Assuming that all allegations are recordable, a total of 4 

hours are expended per allegation (3.5 hours managerial plus 0.5 hours clerical). Storage costs 

for the allegations are believed to be negligible. The unit cost per allegation is $264.05.

 

8

U.S.EPA. “Economic Analysis of TSCA Section 8(c) Significant Adverse Reaction Recordkeeping Rule, 

OTS/ETD/RIB.” January 1983.
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ii. Unit Reporting Burden and Cost

Based on the original TSCA section 8(c) analysis, EPA estimates that a management 

level company official will spend one hour reviewing the Federal Register notice or letter from 

EPA to determine whether the company manufactures (including imports) or processes 

substances subject to the reporting requirement.

Technical personnel would then spend an estimated two hours conducting a search of the 

company’s TSCA section 8(c) files for any relevant allegation records. Once the file search is 

complete, EPA estimates that a managerial employee would spend two hours preparing a 

transmittal letter and other explanatory material to accompany the allegation records. An upperlevel management official would spend an additional two hours reviewing these materials. One 

hour of clerical labor would be required to prepare and mail the response. A total of eight hours 

is expended per report (five managerial hours, two technical hours and one clerical hour). The 

unit cost for reporting, per report, is $507.04.

iii. Unit Federal Register Notice Review Burden and Cost

Based on the original TSCA section 8(c) analysis, EPA estimates that 0.25 hour of 

managerial labor would be required to review each Federal Register notice (see Table 4). The 

unit cost for Federal Register notice review is $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 by activity, and are thereafter 

presented in more detail.
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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 annually, based on the 

31 reports received in the 27–year 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 Costs), 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

Historically, the Agency has published an average of only 0.08 notices each year since 

1983, as EPA has published only two notices to date. 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 multiplying by 0.08 notices per year to obtain $19,796.

iv. Total Industry Burden and Costs 

The total economic burden on the regulated community imposed by TSCA section 8(c) is 

the sum of the three components identified above (recordkeeping, reporting, and Federal Register

notice review) and estimated at 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 years covered by this ICR.
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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 Analysis

TSCA section 8(c) does not include a specific exemption for small businesses (annual 

parent company sales of less than $40 million). The costs of TSCA section 8(c) for an average 

company 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 employees 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 ICRs, 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 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 $58,698. This figure is based on activities identified in the 1986 

and 1989 ICRs. Costs are estimated based on wages and salaries in 2011 GS-schedule.
-15-

Annual costs to EPA associated with the recordkeeping portion of the rule include 

general administration of the rule, education and outreach activities, and compliance monitoring. 

Costs associated with reporting involve preparation of reporting notices, Federal Register

printing costs, document control, and document review. Annual costs to EPA are derived based 

on an analysis of the cost of performing these various activities. The various factors that 

contribute to EPA costs include:

• Each year, general administration of the rule involves approximately one-tenth of a staff 

specialist’s time plus approximately one week’s time each for two management personnel 

at the branch, division and OPPT Office Director’s level.

• Education and outreach activities will include ongoing rule support by the 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 

also estimated that the notices would generate a maximum 500 reports per year. To date, 

however, a total of only 31 reports have been received. Based on historical data, over the 

life of the rule an average of only 0.08 notices have been issued per year and an average 

of only 1.3 reports received. EPA expects that reporting activity under TSCA section 

8(c) will remain at this low level during the period covered by this ICR renewal. EPA 

costs associated with reporting have been adjusted to reflect this large decrease in the 

level of expected activity. Labor involved in developing the reporting notices will 

require decision meetings and either the development of letters, separate Federal Register

notices, or the insertion of boilerplate segments in other rule preambles.

• Time will be required to process submissions based upon reporting requirements and to 

review them for confidentiality considerations.

• The Federal Register notices will be reviewed by the office directly requesting the 

information as well as by 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 years covered by 

the ICR. 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 a288 $21,788 

Education/Outreach $57.41 b240 $13,778 

Compliance monitoring $57.41 b400 $22,963 

Develop reporting notices $57.41 b1.1 $63 

Document control functions $57.41 b0.75 $43 

Notice review, referral and data 

entry

$57.41 b1.1 $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 wage 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-12, 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-Northern 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 ICR currently approved by 

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 slightly (.5%) 

as a reflection of the higher number of firms at 13,951 compared to 13,521 in the ICR most 

recently 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 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. 2070-0017, is estimated to average about 23,650 hours per response

with the burden ranging between approximately 1 minute and 8 hours per response depending 

upon the type(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 displays a current and valid OMB control number. The OMB 

control numbers for EPA’s regulations in title 40 of the CFR, after appearing in the Federal 

Register, are listed in 40 CFR part 9 and included on the related collection instrument or form, if 
-17-

applicable.

The Agency has established a public docket for this ICR under Docket ID No. EPA-HQOPPT-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, Room 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 holidays. The telephone number for the 

Reading Room is (202) 566-1744, and the telephone number for the Pollution Prevention and 

Toxics Docket is (202) 566-0280. You may submit comments regarding the Agency's need for 

this information, the accuracy of the provided burden estimates and any suggested methods for 

minimizing respondent burden, including the use of automated collection techniques.

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 by mail to: Document Control Office (DCO), Office of Pollution Prevention and 

Toxics (OPPT), Environmental Protection Agency, Mail Code: 7407T, 1200 Pennsylvania Ave., 

NW, Washington, D.C. 20460, and (2) OMB by 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 employees shall be 

retained for a period of 30 years from the date such reactions were first reported to or known by

the person maintaining such records. Any other record of such adverse reactions shall be retained 

for a period of five years 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 any duly designated representative of the Administrator, each person who is required 

to maintain records under this subsection shall permit the inspection of such records and shall

submit copies of such records.
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 EPA ICR No. 1031.10; OMB Control No. 2070-0017

ATTACHMENT 2

Records and Reports of Allegations that Chemical Substances Cause Significant Adverse 

Reactions to Health or the Environment

40 CFR 717
-21-

TITLE 40--PROTECTION OF ENVIRONMENT

CHAPTER I--ENVIRONMENTAL PROTECTION AGENCY (CONTINUED)

PART 717--RECORDS AND REPORTS OF ALLEGATIONS THAT CHEMICAL 

SUBSTANCES CAUSE SIGNIFICANT ADVERSE REACTIONS TO HEALTH 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 by 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) of 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 duly designated representative of the Administrator.

Sec. 717.3 Definitions.

 The definitions set forth 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 company means any 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 significantly more severe toxic effect than previously described.

 (ii) Was a manifestation of a toxic effect after a significantly shorter exposure period or 

lower exposure level than described.

 (iii) Was a manifestation of a toxic effect by an exposure route 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 by the manufacturer, including use for product research and development, 

or as an intermediate.

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

coincidentally during the manufacture, processing, use, or disposal of another substance or 

mixture, including both byproducts that are separated from that other substances or mixture and 

impurities that remain in that substance or mixture. Such byproducts and impurities may, 

or may not, in themselves have commercial value. They are nonetheless produced for the 

purpose of obtaining a commercial advantage since they are part of the manufacture of a 

chemical product for a commercial purpose.

 (f) Person includes any individual, firm, company, corporation, joint venture, 

partnership, 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 any amount of a 

chemical substance or mixture is included. If 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-lasting or irreversible damage to health or the 

environment.

 (j) Site means a contiguous property unit. Property divided only by a public right-ofway is considered one site. There may be multiple manufacturing, processing, or distribution 

activities occurring within a single site.

 (k) Substance means a chemical 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 chemical substance occurs at any site 

owned or controlled by a firm then that firm is subject to this part.

 (2) A manufacturer must collect:

 (i) Any allegation identifying a chemical substance it manufactures and any allegation 

identifying the operations in the manufacture of any chemical substance it manufactures.

 (ii) Any allegation identifying any of its own processing or distribution in commerce 

activities with respect to any chemical substance it manufactures.

 (iii) Any allegation identifying emissions, effluents, or other discharges from activities 

described in this paragraph.

 (iv) Any 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 equity 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 processor subject to this part such person must collect:

 (i) Any allegation identifying any mixture it produces and distributes in commerce and 

any allegation identifying any chemical substance or mixture it repackages and distributes in 

commerce.

 (ii) Any allegation identifying any 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 identifying emissions, effluents, or other discharges from activities 

described in this paragraph.

 (iv) Any 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 applicable to this part are published in Standard Industrial 

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 number 003-005-0170-0 respectively. Where there is a conflict between the 

SIC 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]

Sec. 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., those companies or sites within a company 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 necessarily 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 substances 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 reactions 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, matches, or safety 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 molding compounds, inks, drying 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) Chemical 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 quality 

control reagent functions as intended, or (B) a chemical substance, which is intended solely to 

impart a specific physicochemical characteristic, functions as intended.

 (b) [Reserved]

 (c) Sole distributors. A person solely engaged in the distribution of chemical 

substances is exempt from this 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

include, but are not limited to, those firms that distribute chemical substances as described in the 

wholesale trade SIC codes 5161--Chemicals and Allied Products, 5171--Petroleum Bulk Stations 

and Terminals, and 5172--Petroleum and Petroleum Products Wholesalers, 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. In 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 subject 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) Identifying 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 

employee of the firm, individual consumer, a neighbor of the firm’s plant, another firm on behalf 
-25-

of its employees 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 ultimate 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 briefly 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 activities 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 human 

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 not 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 reproductive 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 physical 

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 of that significant adverse reaction can be directly 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 under any 

applicable authority.

[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 shall 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 location 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, company process or operation, or site 

discharge.

 (iv) A description of the alleger (e.g., “company employee,” “individual consumer,” 

“plant neighbor”). If the allegation involves a health effect, the sex and year of birth of the 

individual should be recorded, if ascertainable.

 (v) A description of the alleged health 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), identifying the 

affected plant and/or animal species, or contaminated portion of the physical environment.

 (3) The results of any 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, encourages or requires such 

investigation.)

 (4) Copies of any further required records or reports relating to the allegation. For 

example, if an employee allegation results in a requirement for the firm to record the case on 

Occupational Safety and Health 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 company process or operation.

 (5) A site emission, effluent or other discharge.

 (d) Retention period. Records of significant adverse reactions to the health of 

employees shall be retained for a period of 30 years from the date such reactions were first 

reported to or known by the person maintaining such records. This provision requires persons 

subject to this part to retain for 30 years an employee health related allegation, arising from any

employment related exposure, whether or not such allegation was submitted by or on the behalf 

of that recordkeeper’s own employee. Any other record of significant adverse reactions shall be 

maintained for a period of five years 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]
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Sec. 717.17 Inspection 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 by letter or will announce any such 

requirements for submitting copies of records by a notice in the Federal Register. Such letter or 

notice will be signed by the Administrator or appropriate designee, and will specify which 

records or portion of records must be submitted. The reporting period will be specified by 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 

(preferably by certified mail) to the Document Control Office (7407), Office of Pollution 

Prevention and Toxics, U.S. Environmental Protection Agency, Room G-099, 401 M St., SW., 

Washington, DC., 20460, ATTN: 8(c) Allegations.

[48 FR 38187, Aug. 22, 1983, as amended at 49 FR 23183, June 5, 1984; 52 FR 20084, 

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) Any 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 only 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 placed 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 copy must be complete. In that copy, the respondent must indicate what 

information, if any, is claimed as confidential by 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 copy of the record. The second copy must be complete, except that all information 

claimed as confidential in the first copy must be deleted.

 (3) The first copy will be for internal use by EPA. The second copy will be placed in 

an open file to be available to the public.

 (4) Failure to furnish a second copy 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 days from the date of receipt of 

notification to submit the required second copy. If the respondent fails to submit the second copy 

within the 30 days, EPA will place the first copy in the public file.
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