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

**The Paperwork Reduction Act**

**1 IDENTIFICATION OF THE INFORMATION COLLECTION**

**1(a) Title and Number of the Information Collection**

**Title: Recordkeeping and Reporting Requirements for Allegations of
Significant Adverse Reactions to Human Health or the Environment (TSCA
Section 8(c))**

**EPA ICR No.: 1031.09 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 (see Attachment 1), requires that "any person who
manufactures (including imports), processes, or distributes in commerce
any chemical substance or mixture" must keep "records of significant
adverse reactions to health or the environment, as determined by the
Administrator by rule, alleged to have been caused by the substance or
mixture."

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) (see
Attachment 2). This rule became effective on November 21, 1983. The rule
requires manufacturers (including importers) and processors of chemical
substances and mixtures to keep records of "significant adverse
reactions" alleged to have been caused by such substances or mixtures.
The rule also prescribes the conditions under which a firm must submit
or make the records available to a duly designated representative of the
Administrator.

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.

**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 of 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.

**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

-   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 over the last 15 years.

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. It would be irresponsible and contrary
to the intent of TSCA to arbitrarily limit the number of collections
available to EPA under TSCA section 8(c). 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. If EPA were limited to only two such
actions per year, it would prevent the Agency from exercising its
responsibility under the law. The information will be collected on a
case-specific basis to evaluate suspected adverse health or
environmental effects of a chemical substance or mixture already under
assessment by OPPT or when a chemical not under assessment by OPPT is
discovered to present possible risks to human health or the environment.
For example, chemical disasters are obviously unpredictable and OPPT
must reserve the capability to require records submission on an
as-needed basis in order to gather relevant information related to such
matters. TSCA section 8(c) allegation records are part of such related
information.

**3(e) General Guidelines**

The record retention provisions of TSCA section 8(c) and 40 CFR part 717
exceed the Paperwork Reduction Guidelines (5 CFR 1320.6) in that they
require respondents to maintain records other than health, medical, or
tax records, for more than three years. TSCA section 8(c) authorizes EPA
to require persons (i.e., manufacturers (including importers),
processors, or distributors) to maintain records of adverse reactions to
the health of employees for a period of 30 years from the date such
reactions were first reported or known to the person maintaining the
record. Any other record of such adverse reactions (e.g., to the
environment, non-employees) is required to be retained for a period of 5
years. 40 CFR part 717 incorporates these record retention provisions
authorized by TSCA.

**3(f) Confidentiality**

Respondents may assert a claim of business confidentiality with respect
to all or part of an allegation submission. Such submissions will be
handled in accordance with the provisions at 40 CFR Part 2.

**3(g) Sensitive Questions**

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

**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.

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]{.underline}.

\(ii\) Respondent Activities

Respondents must do two things: (1) maintain records 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]{.underline}. Respondents are responsible for monitoring the
[Federal Register]{.underline} for such notices. Whenever feasible, EPA
will also notify those companies that can be identified with the
production, importation or processing of a substance or mixture in
question. Respondents then must determine if they manufacture or process
the chemical substance or mixture. If so, they must conduct a search of
their TSCA section 8(c) files to determine if there are any relevant
records of significant adverse reactions alleged to have been caused by
the substance or mixture. If such records are present, they must make a
photocopy of those records and mail it with a cover letter to EPA. The
company should note that they have submitted such records to EPA so that
future duplicative reporting will not occur.

**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/opptintr/chemtest/index.htm>.)

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 been able to identify 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.

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]{.underline} a reporting
requirement relating to a chemical substance or mixture, or requests
such reporting by letter, then manufacturers (including importers) and
processors of such substance or mixture must submit a copy of relevant
allegation records in their files. TSCA section 8(c) reporting
requirements will be developed on an as-needed basis and could initially
require only the submission of an abstract of the allegation record,
which is generally one page in length, not the full allegation file.

**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]{.underline} 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 these activities
include estimating the number of affected firms and employees, the
number of allegations, and number of reports. Unit estimates of burden
for the various activities are also required. These unit estimates are
then coupled with the number of allegations, reports, and notice reviews
to develop total burden estimates for the industry.

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 basis for industry cost estimates.

[Estimate of the Number of Firms]{.underline}

For previous TSCA section 8(c) ICR analyses, EPA investigated potential
data sources of numbers of firms/plants and their employment and parent
company sales to estimate the number of firms subject to TSCA section
8(c) requirements. EPA initially concluded that a Dun and Bradstreet
database, Dun's Market Identifiers, (DMI), provided the most complete
and timely data.[^1] The DMI data base contains employment data for each
of a firm's plants as well as parent firm sales data. However, for the
previous and current ICR renewals, EPA used publicly available data from
the Bureau of the Census to allow for transparency in its analyses.

The first step in the analysis was 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). The most recent
dataset available is from 2005. EPA chose those NAICS codes to define
the firms that manufacture (including import) and process chemical
substances.

The number of employees for these firms was 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 has risen very
slightly, while the number of employees has fallen by approximately four
percent.

The following table presents the number of firms and employees for 2005:

**Table 1. Numbers of Firms and Employees for NAICS 325 and 32411 for
2005**

  ----------------------- ------------------------ -----------------------
  **Number of Firms**     **Total Number of        **Average Number of
                          Employees**              Employees per Firm**

  13,521                  871,709                  64
  ----------------------- ------------------------ -----------------------

[Estimate of the Number of Allegations of Significant Adverse Health
Reactions]{.underline}

The total number of allegations was 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 was that recordable TSCA section 8(c) allegations are likely
to be made by 0.5 percent of the employees at an average firm.

For the 1983 ICR, EPA assumed 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. The total number of
allegations is calculated by multiplying the total number of firms
(13,521) by the average annual number of allegations per firm (.43), for
a total of 5,814 allegations per year.

**Table 2. Estimated Total Number of Allegations for 2005**

  ----------- ------------- -------------- ------------ ------------ ---------------
  **Firms**   **Avg. Number **Average                                **Total
              of            Annual \# of                             Allegations**
              Employees**   Allegations                              
                            per Firm**                               

                            **Employee**   **Public**   **Total**    

  13,521      64            0.32           0.11         0.43         5,841
  ----------- ------------- -------------- ------------ ------------ ---------------

[Estimate of the Number of Reports]{.underline}

For previous TSCA section 8(c) ICR analyses, EPA estimated that it would
issue a maximum of six industry-wide notices per year requiring
reporting on a maximum of 100 chemicals. The Agency estimated that an
average of approximately five firms per chemical would actually be
subject to reporting, resulting in the submission of an industry-wide
total of 500 reports. However, to date, only a very limited amount of
reporting has been required under TSCA section 8(c), and 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)[^2] and
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 1.3 reports per year
since the rule was promulgated in 1983.

[Estimated Wage Rates]{.underline}

The basic methodology used to derive loaded wage rates for technical,
managerial, and clerical personnel is described more fully in *Wage
Rates for Economic Analysis of the Toxics Release Inventory Program*.^7^
These rates differ from those used in previous versions of the TSCA 8(c)
ICR, and represent a more accurate picture of industry wages, based on
public information.

In March 2004, BLS began using the North American Industry
Classification System (NAICS) codes instead of the Standard Industrial
Classification (SIC) System, and the Standard Occupational
Classification (SOC) system instead of the Occupational Classification
System (OCS). The following table shows the crosswalk between old and
new occupational titles.

  ------------------------ ----------------------- -----------------------
  **EPAB Labor Category**  **BLS Old Title (OCS)** **BLS New Title (SOC)**

  Managerial               Executive,              Management, business,
                           administrative, and     and financial
                           managerial              

  Professional/Technical   Professional specialty  Professional and
                           and technical           related

  Clerical                 Administrative support, Office and
                           including clerical      administrative support
  ------------------------ ----------------------- -----------------------

Wages and fringe benefits for managerial, professional/technical, and
clerical labor were taken from the Bureau of Labor Statistics (BLS)
*Employer Costs for Employee Compensation* (ECEC) data for September
2007, for manufacturing industries.[^5] The cost of fringe benefits
(paid leave, insurance and other items) specific to each labor category
is taken from the same BLS series.

An additional loading factor of 17 percent is applied to wages to
account for overhead. This approach is used for consistency with OPPT's
economic analyses for two major rulemakings.[^6] This overhead loading
factor is added to the benefits amount, and the total is then applied to
the base wage to derive the fully loaded wage. The fully loaded wage for
technical labor, for example, is \$33.25 + \$16.54 + (33.25 x .17) =
\$55.44. Fully loaded wages for managerial and clerical labor were
calculated in a similar manner (see Table 3).

[Unit Burden Hours and Costs]{.underline}

Unit costs for each of the burdens associated with the TSCA section 8(c)
requirements are calculated in this section using the wage rates
presented above (see Table 4).

**Table 3. Derivation of Loaded Hourly Wage Rates**

+------+--------------------+----+-----+------+-------+------+-----+
| **L  | **Data Sources**   | *  |     |      | **Ove | **   | **  |
| abor |                    | *W |     |      | rhead | Frin | Loa |
| Ca   |                    | ag |     |      | as %  | ge + | ded |
| tego |                    | es |     |      | of    | Over | W   |
| ry** |                    | a  |     |      | W     | head | age |
|      |                    | nd |     |      | age^( | Fact | Rat |
|      |                    | Fr |     |      | 2)^** | or** | e** |
|      |                    | in |     |      |       |      |     |
|      |                    | ge |     |      |       |      |     |
|      |                    | /  |     |      |       |      |     |
|      |                    | H  |     |      |       |      |     |
|      |                    | ou |     |      |       |      |     |
|      |                    | r^ |     |      |       |      |     |
|      |                    | (1 |     |      |       |      |     |
|      |                    | )^ |     |      |       |      |     |
|      |                    | ** |     |      |       |      |     |
+------+--------------------+----+-----+------+-------+------+-----+
|      |                    | ** | **W | **Fr |       |      |     |
|      |                    | Da | age | inge |       |      |     |
|      |                    | te | s** | Be   |       |      |     |
|      |                    | ** |     | nefi |       |      |     |
|      |                    |    |     | ts** |       |      |     |
+------+--------------------+----+-----+------+-------+------+-----+
| T    | *BLS Employer      | S  | \   | \$1  | 17%   | \$2  | \   |
| echn | Costs for Employee | ep | $33 | 6.54 |       | 2.19 | $55 |
| ical | Compensation*. All | t. | .25 |      |       |      | .44 |
|      | workers in         |    |     |      |       |      |     |
|      | manufacturing;     | 20 |     |      |       |      |     |
|      | Professional and   | 07 |     |      |       |      |     |
|      | related.           |    |     |      |       |      |     |
+------+--------------------+----+-----+------+-------+------+-----+
| Ma   | *BLS Employer      | S  | \   | \$1  | 17%   | \$2  | \   |
| nage | Costs for Employee | ep | $41 | 9.74 |       | 6.78 | $68 |
| rial | Compensation*. All | t. | .40 |      |       |      | .18 |
|      | workers in         |    |     |      |       |      |     |
|      | manufacturing;     | 20 |     |      |       |      |     |
|      | Management,        | 07 |     |      |       |      |     |
|      | business, and      |    |     |      |       |      |     |
|      | financial.         |    |     |      |       |      |     |
+------+--------------------+----+-----+------+-------+------+-----+
| Cler | *BLS Employer      | S  | \   | \$   | 17%   | \$1  | \   |
| ical | Costs for Employee | ep | $16 | 8.28 |       | 1.07 | $27 |
|      | Compensation*. All | t. | .40 |      |       |      | .47 |
|      | workers in         |    |     |      |       |      |     |
|      | manufacturing;     | 20 |     |      |       |      |     |
|      | Office and         | 07 |     |      |       |      |     |
|      | administrative     |    |     |      |       |      |     |
|      | support.           |    |     |      |       |      |     |
+------+--------------------+----+-----+------+-------+------+-----+

^(1)^ Wages and fringe benefits are from BLS website
[[http://www.bls.gov/ncs/ect/sp/ecsuptc4.pdf]{.underline}](http://www.bls.gov/ncs/ect/sp/ecsuptc4.pdf_).

^(2)^ An overhead rate of 17 percent applied to wages is used for
consistency with EPAB economic analyses for two major rulemakings: "Wage
Rates for Economic Analyses of the Toxics Release Inventory Program,"
June 10, 2002, and the "Revised Economic Analysis for the Amended
Inventory Update Rule: Final Report;" August 2002.

Note: Calculations are based on unrounded values, so the total may not
equal the product of the rounded factors.

*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.^9^ 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 will require 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 \$252.37.

*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]{.underline} notice or letter from EPA to determine
whether the company manufactures (including imports) or processes
substances subject to the reporting requirement.

Technical personnel would then spend an estimated two hours conducting a
search of the company's TSCA section 8(c) files for any relevant
allegation records. Once the file search is complete, EPA estimates that
a managerial employee would spend two hours preparing a transmittal
letter and other explanatory material to accompany the allegation
records. An upper-level management official would spend an additional
two hours reviewing these materials. One hour of clerical labor would be
required to prepare and mail the response. A total of eight hours is
expended per report (five managerial hours, two technical hours and one
clerical hour).

The unit cost for reporting, per report, is \$467.25

*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]{.underline} notice (see Table 4).

The unit cost for [Federal Register]{.underline} notice review is
\$17.05.

**Table 4. Unit Respondent Burden and Cost Estimates**

+----------------------+--------+--------+--------+--------+--------+
| **Activity**         | **Cler | *      | **M    | **T    | *      |
|                      | ical** | *Techn | anager | otal** | *Total |
|                      |        | ical** | H      |        | Cost** |
|                      | **H    |        | ours** | **H    |        |
|                      | ours** | **H    |        | ours** |        |
|                      |        | ours** |        |        |        |
+----------------------+--------+--------+--------+--------+--------+
| Recordkeeping, per   | 0.50   | 0.00   | 3.50   | 4.00   | \$     |
| allegation           |        |        |        |        | 252.37 |
+----------------------+--------+--------+--------+--------+--------+
| Reporting, per       | 1.00   | 2.00   | 5.00   | 8.00   | \$     |
| report               |        |        |        |        | 479.25 |
+----------------------+--------+--------+--------+--------+--------+
| [Federal             | 0.00   | 0.00   | 0.25   | 0.25   | \      |
| R                    |        |        |        |        | $17.05 |
| egister]{.underline} |        |        |        |        |        |
| Notice review, per   |        |        |        |        |        |
| Notice               |        |        |        |        |        |
+----------------------+--------+--------+--------+--------+--------+
| **Total unit burden  | **     | **     | **     | **1    | **\$74 |
| per respondent**     | 1.50** | 2.00** | 8.75** | 2.25** | 8.67** |
+----------------------+--------+--------+--------+--------+--------+

[Total Industry Burden and Cost]{.underline}

*i Total Recordkeeping Burden and Cost*

The unit burden for recordkeeping is multiplied by the total number of
allegations. Total annual recordkeeping burden is 23,256 hours (5,814
allegations x 4 hours per allegation).

**Table 5. Total Industry Recordkeeping Burden**

  ------------------ ----------------- ---------------- -----------------
  **Number of        **Total           **Hours per      **Total Burden
  Firms**            Allegations**     Allegation**     Hours**

  13,521             5,814             4                23,256
  ------------------ ----------------- ---------------- -----------------

The unit cost for recordkeeping 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 \$1,467,299, which
includes managerial and clerical labor.

**Table 6. Total Industry Recordkeeping Costs**

  ---------------- -------------------- ----------------- ----------------
  **Number of      **Allegations per    **Cost per        **Total Cost**
  Firms**          Firm**               Allegation**      

  13,521           0.43                 \$252.37          \$1,467,299
  ---------------- -------------------- ----------------- ----------------

*ii. Total Reporting Burden and Cost*

EPA assumes that 1.3 TSCA section 8(c) reports will be required
annually, based on the 31 reports received in the 24--year history of
the rule (31÷24 = 1.3). Total reporting burden hour is 1.3 reports x 8
hours per report (from Unit Reporting Burden and Costs), or 10 hours.

**Table 7. Total Industry Reporting Burden**

  ----------------------- ----------------------- -----------------------
  **Annual Number of      **Hours per Report**    **Total Burden Hours**
  Reports**                                       

  1.3                     8                       10
  ----------------------- ----------------------- -----------------------

The cost of submitting these reports is determined by multiplying the
annual number of reports by the unit reporting cost, which includes
managerial, technical and clerical labor. The total cost is \$623.02.

**Table 8. Total Industry Reporting Cost**

  ----------------------- ----------------------- -----------------------
  **Annual Number of      **Cost per Report**     **Total Cost**
  Reports**                                       

  1.3                     \$479.25                \$623.02
  ----------------------- ----------------------- -----------------------

*iii. Total [Federal Register]{.underline} Notice Review Burden and
Cost*

Historically, the Agency has published an average of only 0.08 notices
each year since 1983. Using that figure, each firm would require only
slightly more than one minute, or 0.02 hour of managerial labor per year
for notice review in the current ICR period. The total industry burden
is 270 hours.

**Table 9. Federal Register Notice Review Burden**

  ----------------- ----------------- ----------------- -----------------
  **Number of       **Notices per     **Hours per       **Total Hours**
  Firms**           Year**            Notice**          

  13,521            0.08              0.25              270
  ----------------- ----------------- ----------------- -----------------

The total cost to industry of reviewing the [Federal
Register]{.underline} notices is estimated below.

**Table 10. Federal Register Notice Review Cost**

  ----------------------- ----------------------- -----------------------
  **Number of Firms**     **Cost per Firm**       **Total Cost**

  13,521                  \$1.36                  \$18,389
  ----------------------- ----------------------- -----------------------

Total [Federal Register]{.underline} notice review cost is \$18,389,
which includes managerial labor.

**Table 11. Total Annual Burden to Industry**

+-----------------+-----------------+-----------------+----------------+
| **Collection    | **Hours**       | **Respondents** | **Hours per    |
| Activity**      |                 |                 | Year**         |
|                 | **per           | **per Year**    |                |
|                 | Respondent**    |                 |                |
+-----------------+-----------------+-----------------+----------------+
| Recordkeeping   | 4.00            | 5,814 ^(1)^     | 23,256         |
+-----------------+-----------------+-----------------+----------------+
| Reporting       | 8.00            | 1.3             | 10             |
+-----------------+-----------------+-----------------+----------------+
| Notice Review   | 0.25            | 1,082^(2)^      | 270            |
+-----------------+-----------------+-----------------+----------------+
| **Total Annual  | **12.25**       |                 | **23,536**     |
| Burden Hours**  |                 |                 |                |
+-----------------+-----------------+-----------------+----------------+

^(1)^ Calculated as 13,521 firms subject to recordkeeping x 0.43 average
number of allegations per firm each year is 5,814.

^(2)^ Historically, EPA has issued an average of only 0.08 notices per
year. Therefore, on an average annual basis, 1,082 of the estimated
total of 13,512 firms subject to TSCA section 8(c) would conduct notice
reviews.

*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]{.underline} notice
review). These costs, shown in the table below, would be incurred in
each of the three years covered by this ICR.

**Table 12. Total Industry Costs and Burdens**

  ----------------------- ----------------------- -----------------------
  **Collection Activity** **Total Annual Cost**   **Total Annual Burden
                                                  Hours**

  Recordkeeping           \$1,467,299             23,258

  Reporting               \$623                   10

  [Federal                \$18,389                270
  Register]{.underline}                           
  Review                                          

  **Total**               **\$1,486,311**         **23,536**
  ----------------------- ----------------------- -----------------------

[Regulatory Flexibility Analysis]{.underline}

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 13. Average Total Costs per Firm**

  ----------------------------------- -----------------------------------
  **Type of Cost**                    **Cost**

  Average recordkeeping cost          \$108.52^(1)^

  Reporting cost per firm             \$0.05^(2)^

  [Federal Register]{.underline}      \$1.36^(3)^
  notice review cost per firm         

  **Average total cost per firm**     **\$109.93**
  ----------------------------------- -----------------------------------

^(1)^ Calculated as the average cost per allegation times the average
number of allegations per year (\$252.37 x 0.43 = \$108.52). Smaller
firms with fewer employees can expect fewer allegations, and thus lower
costs.

^(2)^ Calculated as the total industry reporting costs divided by the
total number of firms (\$623.02÷13,521 = \$0.05).

^(3)^ Calculated as the total industry review costs divided by the total
number of firms (\$18,389÷13,521 = \$1.36).

The average annual recordkeeping, reporting, and review costs to an
average firm are \$109.93. 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 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 \$54,872. This figure was
calculated from cost estimates provided in the 1986 and 1989 ICRs. These
costs were adjusted based on wages and salaries in 2007 GS-schedule.

Annual costs to EPA associated with the recordkeeping portion of the
rule include general administration of the rule, education and outreach
activities, and compliance monitoring. Costs associated with reporting
involve preparation of reporting notices, [Federal Register]{.underline}
printing costs, document control, and document review. Annual costs to
EPA were derived based on an analysis of the cost of performing these
various activities. The various elements involved in calculating EPA
costs are described in more detail below.

-   Each year, general administration of the rule involves approximately
    one-tenth of a staff specialist's time plus approximately one weeks
    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, therefore,
    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]{.underline} notices, or the insertion of boilerplate
    segments in other rule preambles.

-   Time will be required to process submissions based upon such
    reporting requirements and to review them for confidentiality
    considerations.

-   The [Federal Register]{.underline} 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).

    **Table 14. Annual Burden and Cost to the Federal Government**

  ------------------------------ ----------------- ------------- ------------
  **Activity**                   **Hourly Wage**   **Burden      **Annual
                                                   Hours**       Cost**

  Administrative maintenance     \$63.82/88.71\$   288           \$20,372
                                 ^(1)^                           

  Education/Outreach             \$53.66 ^(2)^     240           \$12,878

  Compliance monitoring          \$53.66 ^(2)^     400           \$21,464

  Develop reporting notices      \$53.66 ^(2)^     1.1           \$59

  Document control functions     \$53.66 ^(2)^     0.75          \$40

  Notice review, referral and    \$53.66 ^(2)^     1.1           \$59
  data entry                                                     

  **Totals**                                       931           \$54,872
  ------------------------------ ----------------- ------------- ------------

\(1\) This activity is estimated to require 208 hours at the GS-13 level
and 80 hours at the GS-15 level. The 2007 base wage for a GS-13, Step 1
is \$82,961, plus 60 percent overhead and benefits of \$49,777, for a
total of \$132,738. Dividing this by the 2,080 hours in a work year
yields an hourly wage rate of \$63.82. The base wage for a GS-15, Step 1
is \$115,317, plus overhead and benefits of \$69,190, for a total of
\$184,507. Dividing this by the 2,080 hours in a work year yields an
hourly wage rate of \$88.71.

\(2\) The estimated total cost to the EPA of a full time employee (FTE)
at a GS 12, Step 1 level for 2007 is \$111,662. This includes a base
wage of \$69,764, and 60 percent for overhead and benefits, or \$41,858.
Dividing this by the 2,080 hours in a work year yields an hourly wage
rate of \$53.66.

**6(e) Reasons for Change in Burden**

The total estimated respondent burden has decreased by 1,012 hours (from
24,548 hours to 23,536 hours) compared to the ICR most recently approved
by OMB. This decrease is an adjustment and reflects a reduced estimated
burden for respondents based on several factors.

-   The number of firms in the affected NAICS codes rose very slightly
    since the last ICR (13,445 to 13,521), but the total number of
    employees fell by four percent (909,562 to 871,709). Because the
    allegation rate is based on the number of employees, the decrease in
    the number of employees resulted in a decrease in total allegations
    (6,050 to 5,814), and thus a reduction in burden.

-   The burden associated with reviewing [Federal Register]{.underline}
    notices has also seen a small reduction. Based on EPA's history of
    issuing notices over the life of the rule, and because no new
    notices were published during the previous three-year ICR period,
    the average annual number of notices the Agency is expected to issue
    in the current ICR renewal period fell from an estimated 0.1 in the
    most recent ICR, to 0.08 notices per year estimated in this renewal.

-   An additional small reduction is attributable to reduced industry
    reporting requirements, which have fallen from an estimated 1.5
    reports per year (31 reports total ÷21 years of the rule), to 1.3
    reports per year, over the 24 years of the rule (31 reports ÷ 24
    years). None of the unit burden estimates have been changed since
    the previous ICR renewal, nor do these changes reflect any actual
    changes in the collection activity.

    **6(f) Burden Statement**

    The total annual public burden for this collection of information is
    estimated to be about 23,536 hours, 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. According to
    the Paperwork Reduction Act, "burden" means the total time, effort,
    or financial resources expended by persons to generate, maintain,
    retain, or disclose or provide information to or for a Federal
    agency. For this collection it includes the time needed to review
    instructions; develop, acquire, install, and utilize technology and
    systems for the purposes of collecting, validating, and verifying
    information, processing and maintaining information, and disclosing
    and providing information; adjust the existing ways to comply with
    any previously applicable instructions and requirements; train
    personnel to be able to respond to a collection of information;
    search data sources; complete and review the collection of
    information; and transmit or otherwise disclose the information. An
    agency may not conduct or sponsor, and a person is not required to
    respond to, a collection of information unless it displays a
    currently valid OMB control number. The OMB control number for this
    information collection appears above. The OMB control numbers for
    EPA's regulations in title 40 of the CFR, after appearing in the
    Federal Register, are listed in 40 CFR part 9 and included on the
    related collection instrument or form, if applicable.

    To comment on the Agency's need for this information, the accuracy
    of the provided burden estimates, and any suggested methods for
    minimizing respondent burden, including the use of automated
    collection techniques, EPA has established a public docket for this
    ICR under Docket ID No. EPA-HQ-OPPT-2008-0221. The docket is
    available for public viewing at the Pollution Prevention and Toxics
    Docket in the EPA Docket Center (EPA/DC). The EPA/DC Public Reading
    Room is located in the EPA West Building, Room 3334, 1301
    Constitution Ave., NW., Washington, DC. The EPA/DC 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 EPA/DC Public
    Reading Room is (202) 566-1744, and the telephone number for the
    Pollution Prevention and Toxics Docket is (202) 566-0280. An
    electronic version of the public docket is available through the
    Federal Docket Management System (FDMS) at
    [[www.regulations.gov]{.underline}](http://www.regulations.gov/).
    Use FDMS to submit or view public comments, access the index listing
    of the contents of the public docket, and to access those documents
    in the public docket that are available electronically. Once in the
    system, select "search," then key in the docket ID number identified
    above. Also, you can send comments to the Office of Information and
    Regulatory Affairs, Office of Management and Budget, 725 17th
    Street, NW, Washington, DC 20503, Attention: Desk Office for EPA.
    Please include the EPA Docket ID No. EPA-HQ-OPPT-2008-0221 and OMB
    control number 2070-0017 in any correspondence.

    **ATTACHMENTS TO THE SUPPORTING STATEMENT**

    **Attachment 1** **15 USC 2607(c)** - *TSCA section 8(c)* - This
    attachment is available as part of the electronic copy of the ICR's
    Supporting Statement.

    **Attachment 2** **40 CFR 717** -- *Records and Reports of
    Allegations that Chemical Substances Cause Significant Adverse
    Reactions to Health or the Environment* -- This attachment is
    available as part of the electronic copy of the ICR's Supporting
    Statement.

    **ATTACHMENT 1**

    **Toxic Substances Control Act**

    **Section 8(c)**

    **15 USC 2607(c)**

    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.

    **ATTACHMENT 2**

    **Records and Reports of Allegations that Chemical Substances Cause
    Significant Adverse Reactions to Health or the Environment**

    **40 CFR 717**

    Code of Federal Regulations

    Revised as of July 1, 2000

    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

    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-of-way 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 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 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 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.

    \(b\) 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.

    \[48 FR 38187, Aug. 22, 1983, as amended at 49 FR 23183, June 5,
    1984; 58 FR 34204, June 23, 1993\]

    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.

[^1]: ^1^ ^1^ U.S. EPA. "Comparison of Data Sources for Characterizing
    Manufacturers and Processors," Draft Report, Prepared by Centaur
    Associates, Inc. under EPA contract No. 68-02-3980, Washington, DC;
    November 6, 1986.

[^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]: BLS 2007. Employer Costs for Employee Compensation Supplementary
    Tables, September 2007. Supplementary Table 2.
    [[http://www.bls.gov/ncs/ect/sp/ecsuptc4.pdf]{.underline}](http://www.bls.gov/ncs/ect/sp/ecsuptc4.pdf_).

[^6]: ^?^ 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.

    ^9^ U.S.EPA. "Economic Analysis of TSCA Section 8(c) Significant
    Adverse Reaction Recordkeeping Rule, OTS/ETD/RIB." January 1983.