Document ID: EPA-HQ-OPPT-2008-0221-0002
Agency: epa
Document Type: Supporting & Related Material
Title: 
Posted Date: 2008-06-18T04:00Z

SEQ CHAPTER \h \r 1 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

	  SEQ CHAPTER \h \r 1 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,   SEQ CHAPTER \h \r 1 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.

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

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:     HYPERLINK
"http://www.epa.gov/opptintr/chemtest/index.htm" 
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 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 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

	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 Employees	Average Number of Employees
per Firm

13,521	871,709	64

Estimate of the Number of Allegations of Significant Adverse Health
Reactions

	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 of Employees	Average Annual # of Allegations per Firm
Total Allegations

Employee	Public	Total

	13,521	64	0.32	0.11	0.43	5,841

	Estimate of the Number of Reports

	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) and these
two notices covered two chemicals and two chemical categories.  A total
of 31 reports have been received under TSCA section 8(c), .  This
represents an average of only about 1.3 reports per year since the rule
was promulgated in 1983.

	Estimated Wage Rates

	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, administrative, and managerial 	Management,
business, and financial

Professional/Technical	Professional specialty and technical	Professional
and related

Clerical	Administrative support, including clerical 	Office and
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.  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.  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

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

Labor Category

	Data Sources

	Wages and Fringe / Hour(1)	Overhead as % of Wage(2)

	Fringe + Overhead Factor

	Loaded Wage Rate

Date

	Wages 

	Fringe Benefits 

	Technical	BLS Employer Costs for Employee Compensation. All workers in
manufacturing; Professional and related.	Sept.

2007	$33.25	$16.54	17%	$22.19	$55.44

Managerial 	BLS Employer Costs for Employee Compensation.  All workers
in manufacturing; Management, business, and financial.	Sept.

2007	$41.40	$19.74	17%	$26.78	$68.18

Clerical	BLS Employer Costs for Employee Compensation. All workers in
manufacturing; Office and administrative support.	Sept.

2007	$16.40	$8.28	17%	$11.07	$27.47

(1) Wages and fringe benefits are from BLS website   HYPERLINK
"http://www.bls.gov/ncs/ect/sp/ecsuptc4.pdf_" 
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 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 notice (see Table 4).

	The unit cost for Federal Register notice review is $17.05.

Table 4.  Unit Respondent Burden and Cost Estimates

Activity

	Clerical

Hours	Technical

Hours	Manager Hours	Total

Hours	Total Cost

Recordkeeping, per allegation	0.50	0.00	3.50	4.00	$252.37

Reporting, per report	1.00	2.00	5.00	8.00	$479.25

Federal Register Notice review, per Notice	0.00	0.00	0.25	0.25	$17.05

Total unit burden per respondent	1.50	2.00	8.75	12.25	$748.67

	Total Industry Burden and Cost

	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 Firms	Total Allegations	Hours per Allegation	Total Burden
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 Firms	Allegations per Firm	Cost per Allegation	Total Cost

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 Reports	Hours per Report	Total  Burden Hours

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 Reports	Cost per Report	Total Cost

1.3	$479.25	$623.02

	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.  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 Firms	Notices per Year	Hours per Notice	Total Hours

13,521	0.08	0.25	270

The total cost to industry of reviewing the Federal Register 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 notice review cost is $18,389, which includes
managerial labor.



Table 11.  Total Annual Burden to Industry

Collection Activity	Hours

per Respondent	Respondents 

per Year	Hours per Year

Recordkeeping	  4.00	5,814 (1)	23,256

Reporting	  8.00	1.3	      10

Notice Review	  0.25	1,082(2)	    270

Total Annual Burden  Hours	12.25

23,536

(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 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 Register Review	     $18,389	     270

Total	$1,486,311	23,536

	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 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 notice review cost per firm	    $1.36(3)

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 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 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 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 Hours	Annual Cost

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

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 data entry	$53.66 (2)	1.1	$59

Totals

931 	$  =SUM(ABOVE) \# "0.00"  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 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.

	  SEQ CHAPTER \h \r 1 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     HYPERLINK "http://www.regulations.gov"  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 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.

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.

 U.S.EPA. [Untitled Computer Printout], IMD; June 3, 1992.

 Sherlock, Scott, Information Management Division.  Phone conversation
with Wendy Hoffman based upon “TSCA Reports to Congress for EPA Fiscal
Years 1992-93;” August 1994.

 BLS 2007.  Employer Costs for Employee Compensation Supplementary
Tables, September 2007.  Supplementary Table 2.    HYPERLINK
"http://www.bls.gov/ncs/ect/sp/ecsuptc4.pdf_" 
http://www.bls.gov/ncs/ect/sp/ecsuptc4.pdf .

  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.

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