Document ID: EPA-HQ-OPPT-2008-0868-0002
Agency: epa
Document Type: Supporting & Related Material
Title: 
Posted Date: 2008-12-24T05:00Z

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:	Health and Safety Data Reporting, Submission of Lists and Copies
of Health

		and Safety Studies

		EPA ICR No.:   0575.12	OMB Control No.:   2070-0004

	1(b)	Short Characterization

	On September 2, 1982, EPA promulgated the final Toxic Substances
Control Act (TSCA) section 8(d) Health and Safety Data Reporting Rule. 
The Model Rule was revised by amendments on September 15, 1986 (51 FR
32720) and April 1, 1998 (63 FR 15965). The Model Rule describes the
requirements and procedures for submitting lists and copies of
unpublished health and safety studies under section 8(d) of TSCA (40 CFR
716).  It requires manufacturers and (if specified) processors to submit
lists and copies of health and safety studies relating to the health
and/or environmental effects of the chemical substances and mixtures
listed in the TSCA section 8(d) rule.  The listed chemical substances
and mixtures include chemicals recommended for testing under section 4
by the Interagency Testing Committee (ITC) and other chemical substances
that EPA (particularly the Office of Pollution Prevention and Toxics
(OPPT)), or other federal agencies, wish to assess for health or
environmental effects.  EPA amends the TSCA section 8(d) rule
periodically to add chemical substances and mixtures.

	To comply with the reporting requirements of the rule, the respondents
(manufacturers and processors) must search their files to identify any
health and safety studies in their possession, copy and process the
relevant studies, make lists of studies that are currently in progress,
and review the studies for confidential business information.

	All studies submitted to EPA will be verified and the contents of the
submissions recorded and inspected for the inclusion of confidential
business information.  Photocopies of the documents will then be
prepared and distributed, 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.

	EPA will use the studies to support its investigation of the risks
posed by listed chemicals and, in particular, to support its decisions
on whether to require industry to test chemicals under section 4 of
TSCA.

2	NEED FOR AND USE OF THE COLLECTION

	2(a)	Need/Authority for the Collection

	TSCA section 8(d), 15 U.S.C. 2607(d), requires EPA to promulgate rules
requiring persons who manufacture, process or distribute, or propose to
manufacture, process or distribute chemical substances and mixtures, to
submit to EPA lists and copies of health and safety studies in their
possession.  OPPT reviews these studies to determine the kinds of
testing needed to fill the information gaps in known effects of the
listed chemicals, to make decisions during the risk assessment process,
and for considering control actions.  Other federal agencies use the
studies when they are assessing a listed chemical substance for health
or environmental effects.

	2(b)	Use/Users of the Data

	Studies submitted pursuant to TSCA section 8(d) rules will be evaluated
in conjunction with other available data.  EPA and other federal
agencies will use the data to construct a complete picture of the known
effects of the chemical substance.  From this picture, OPPT will be able
to determine what kinds of testing, if any, are needed.  The TSCA
section 8(d) studies will ensure that OPPT bases its testing decisions
on the most complete information available and does not require testing
that may have already been done.

	In addition, EPA will require that copies of health and safety studies
be submitted on other chemicals that are under investigation either in
the early stages of risk assessment or when action to control exposure
is being considered by EPA or another federal agency.  These chemicals
may be ones for which persons have submitted substantial risk
notification under TSCA section 8(e), or other chemicals for which data
are needed to support a control measure under sections 5 and 6 of TSCA
or under other EPA-administered statutes.  If this information
collection did not exist, EPA would not be able to obtain the necessary
information for evaluating the need for testing under section 4 of TSCA
or controlling chemical substances under TSCA sections 5 and 6.

	 In the past, the studies submitted have also been utilized by the
following offices: the Office of Air and Radiation (OAR) for developing
Tier II analyses; the Office of Research and Development (ORD) for
developing extended risk assessments; the Consumer Product Safety
Commission (CPSC) for assessing the hazards of known consumer exposure;
the American Council for Government Industrial Hygienists (ACGIH), and
the National Institute for Occupational Safety and Health (NIOSH) for
developing recommended occupational exposure levels.

3	NON-DUPLICATION, CONSULTATIONS AND OTHER COLLECTION CRITERIA

	3(a)	Non-Duplication

	In drafting a TSCA section 8(d) rule, EPA considers all available
information, i.e., published and unpublished literature, databases, and
all data available from EPA programs and offices and other federal
entities.  If existing data are sufficient for assessment or control
purposes, EPA will not require TSCA section 8(d) reporting.  However, if
that information is not sufficient, or is obtained in a way that makes
EPA doubt its validity, then the Agency must require the submission of
non-published health and safety studies.

	The health and safety studies to be submitted under the TSCA section
8(d) rule are not available from any other source.  The TSCA section
8(d) rule requires the listing and submission of studies that are
conducted in-house by industry or by industry contractors and not
published in the scientific literature.  Under the revisions to the
Model Rule promulgated in September 1986, respondents do not have to
list or submit any studies that have been published in the scientific
literature, or submitted previously to OPPT on a non-confidential basis.
 Studies that have previously been submitted on a non-confidential basis
to other EPA offices or programs need only be listed.

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

	Existing Chemical Assessment Division (ECAD) staff met on several
occasions during 1988 and 1989 with interested industry members to
discuss aspects of reporting, monitoring and  modeling health and safety
studies under the TSCA section 8(d) model rule.  The result of these
meetings was two interpretative guidance question-and-answer documents
that clarify the modeling and monitoring studies that are and are not
subject to reporting at 40 CFR Part 716.

	In September 1996, EPA held a public meeting and solicited comments
from industry to discuss a variety of revisions to TSCA section 8(d). 
This meeting focused on reducing the burden associated with the
reporting regulations under TSCA section 8(d) while still providing EPA
and other federal agencies with the data necessary for risk
characterization.  These revisions were implemented in a Direct Final
Rule entitled “Revisions to Reporting Regulations under TSCA Section
8(d).” (63 FR 15765, April 1, 1998).  These revisions became effective
June 30, 1998.

	Additionally,   SEQ CHAPTER \h \r 1 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

	In most instances, respondents will be required to make only initial
submissions under the TSCA section 8(d) rule.  However, after the
initial submission of lists and studies, respondents are required to
notify EPA when certain health and safety studies are initiated by
submitting a list of newly initiated studies.  Because the reporting
frequency for the TSCA section 8(d) rule is generally once, the
reporting frequency cannot be reduced without suspending the information
requirement.  If this were to happen, EPA would not be able to obtain
the necessary information for evaluating the need for testing under
section 4 of TSCA or controlling chemical substances under sections 5
and 6 of TSCA.

	3(e)	General Guidelines

	This information collection activity is necessary to implement the
statutory requirements of section 8(d) of TSCA and is consistent with
the requirements of the PRA, OMB implementing regulations (5 CFR
1320.6), and OMB Guidance.

	3(f)	Confidentiality

	Under the TSCA section 8(d) rule, a person submitting a health and
safety study may claim certain parts of the study confidential.  EPA has
implemented procedures to protect confidential, trade secret and
proprietary information from disclosure.  These procedures comply with
EPA’s confidentiality regulation, 40 CFR Part 2, Subpart B.

	3(g)	Sensitive Questions

	This section is not applicable.  The information requested is not
sensitive in nature.		

			

4	THE INFORMATION COLLECTED - AGENCY ACTIVITIES, COLLECTION METHODOLOGY,
AND INFORMATION
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	Review and select chemicals;

	Develop and issue an amendment to the TSCA section 8(d) rule to add
the substances or mixtures;

	Answer respondents’ questions;

	Process and analyze rule submissions, including requests for
confidentiality; and

	Maintain and distribute the data. 

	4(b)	Collection Methodology and Management

	EPA’s current collection methodology and information management
system is based on the current requirements (40 CFR 716.30 and 716.35)
for the submission of hard copies. EPA is continuing to explore
alternative reporting procedures involving electronic submission. 

	To aid persons subject to this information collection, OPPT has set up
a TSCA Hotline that provides information regarding TSCA section 8(d)
reporting as well as other regulatory information. When Hotline staff
are unable to answer questions regarding TSCA section 8(d), the
questions are referred to OPPT staff for appropriate resolution.

	All Non-Confidential Business Information submitted under TSCA section
8(d) is placed in the OPPT public docket, indexed and available for
public inspection.  A vast majority of TSCA section 8(d) submissions to
date are reflected in the TSCA Test Submissions (TSCATS) database, a
publicly available and searchable database.

	4(c)	Small Entity Flexibility

	The TSCA section 8(d) rule applies to all manufacturers and processors
of chemicals and others in possession of studies, regardless of size. 
However, EPA does not anticipate that many small businesses possess
health and safety studies because they are unlikely to have the
financial resources to perform the studies on chemicals subject to the
rule.  Therefore, the burden on such companies should be minimal.

	4(d)	Collection Schedule

	The collection scheduled under this ICR is chemical-specific in nature
and occurs once in an established time frame between 60 days and 2
years.  Reporting of information is only required when the subject
matter information (i.e., the lists of studies and final study reports)
is available.  Availability of study reports on the list may occur after
the established reporting period for the list, and must still be
submitted when they become available.  In any case, submission of the
list or any study report for a listed study occurs once for each
chemical covered by a TSCA section 8(d) rule. Studies previously
submitted to OPPT are exempt. 

	Amendments adding substances are made to the Health and Safety Data
Reporting Rule subsequent to the ITC’s semiannual addition of
substances and categories of substances to the TSCA section 4(e)
Priority List.  Other substances are added when there is a demonstrated
need for the information.

5	THE RESPONDENTS AND THE INFORMATION REQUESTED

	5(a)	Respondents/NAICS Codes

	Respondents affected by this collection activity are identified mainly
by North American Industry Classification System (NAICS) codes 325
(chemical manufacturing and allied products) and 32411 (petroleum
refiners).

	5(b)	Information Requested

	(i)	Data Items

	Persons who manufacture (including import) chemical substances and
mixtures, or propose to do so, and processors of such substances and
mixtures (if specifically identified in a particular rule) must submit
copies of the unpublished health and safety studies in their possession
for the listed substances or mixtures.  They must also submit lists of
reportable studies that they initiate or, about which they know,  for
each of the listed substances or listed mixtures.

	All submitted studies must be accompanied by a cover letter that
contains the following data (40 CFR 716.30):

	•	Name,

	•	job title,

	•	address, and

	•	telephone numbers of the submitting official.

	•	Name and address of the manufacturing or processing establishment
on whose

		behalf the submission was made

	•	Identify any impurity or additive known to have been present in the
substance or 

		listed mixtures as studied, unless so noted in the study.

	•	Identify that the study is being submitted under Part 716.

	Respondents may voluntarily choose to develop and submit robust
summaries of the full toxicological study reports in conjunction with
the submitted full study reports.  The robust summaries should contain
technical information to adequately describe the study and results, and
should be written such that the information provided is sufficient to
allow a technically qualified person to evaluate study results without
needing to review an entire study report.  Typically, a robust summary
would include a description of the test substance, methods, results,
conclusions, data quality description, and references associated with
the full study.

	List of studies shall include (40 CFR 716.35): (1) ongoing health and
safety studies conducted by or initiated by them; (2) studies they know
about but do not have copies of; and, (3) studies that have been sent to
another federal agency with no claims of confidentiality.

For ongoing health and safety studies conducted by or initiated for the
respondent, the list should include the following data:

	•	Beginning date of the study

	•	Purpose of the study

	•	Types of data to be collected

	•	Anticipated date of completion

	•	Name and address of the laboratory conducting the study

For studies known to the respondent but for which they do not possess
copies, the list should include the following data:

	•	Name and address of a person known to them that possess a copy of
the study.

	

For studies previously sent to a federal agency with no claims of
confidentiality, the list should include the following data:

	•	Title of the study

	•	Name and address of the person to whom the study was sent

	•	Month and year in which the study was submitted

	(ii)	Respondent Activities

A representative respondent would engage in the following activities in
order to produce the lists of studies and required data listed in
section 5(b)(i) of this supporting statement:

	Conduct an initial review of the rule to determine if its company
must report;

	Conduct a corporate review to identify which company sites must be
searched to locate the appropriate health and safety studies;

	Search its files at each site to locate the studies;

	Compile and transcribe a list of studies being submitted, studies in
progress, and studies known to exist but not known to be in the
respondent’s possession;

	Photocopy the studies;

	Review the studies and title lists for possible confidential
business information;

	After initial study submissions, notify EPA when other studies are
initiated; and

Submit studies completed after the initial reporting period.

6	ESTIMATING THE COST AND BURDEN OF THE COLLECTION

	The methodology used in estimating the burden and costs to industry
resulting from the addition of chemicals to the TSCA section 8(d) rule
over the next three years is derived from the previous information
collection request (ICR), revised to reflect recent experience with the
program.  EPA has added chemicals to the TSCA section 8(d) list on an
episodic basis.  As shown in Table 1, chemicals were added to the list
three times since 1996.  Most recently, EPA added 208 High Production
Volume (HPV) chemicals to the list in 2006. 

Table 1.  Number of Chemicals Added to TSCA Section 8(d) Reporting List

Year	Number of Chemicals 

1996	47

1997	0

1998	0

1999	0

2000	0

2001	0

2002	0

2003	0

2004	15

2005	0

2006	208

2007	0

2008	0

Average	20.8

	The estimates in this ICR renewal are based primarily on the reporting
for the 208 chemicals added to the TSCA section 8(d) list in 2006. 
Chemicals with high production volumes tend to have more unpublished
health and safety data than other chemicals that may be considered for
inclusion on the TSCA section 8(d) list.  As shown in Table 2, the
average number of studies submitted per company was nearly twice as high
for the HPV chemicals in the 2006 rule compared to the chemicals in the
2004 rule.  If the chemicals that are added to the TSCA section 8(d)
list over the next three years are more like the 2004 list than the 2006
list, basing predictions on the 2006 results may overestimate the cost
and burden of future reporting. 

Table 2.  Reporting Statistics for Recent TSCA Section 8(d) Rules

	2004 rule	2006 rule

Number of chemicals added to 8(d) list	15	208

Number of chemicals for which 8(d) reports were submitted	3	54

Number of companies submitting 8(d) reports	3	59

Total number of 8(d) studies submitted	14	527

Average number of studies submitted per company	5	9

Average page length of studies submitted	67	20

Median page length of studies submitted	20	14

	6(a)	Estimating Respondent Burden

	Firms will undertake the following actions in response to a TSCA
section 8(d) listing:

		Determine whether the firm may be required to report.  If
so, review the rule in 

more detail;

		Conduct a corporate review to identify which firm sites
must be searched to locate 

		the appropriate health and safety studies;

		Search the files at appropriate sites to locate relevant
studies;

		Compile and transcribe lists of studies being submitted,
ongoing studies, newly 

initiated studies, studies known to exist but not known to be in the
respondent’s possession, and studies previously submitted to other
Federal agencies without confidentiality claims;

		Photocopy the studies being submitted;

		Voluntarily prepare robust summaries of the studies; 

		Review the responses for possible confidential business
information; and

		Submit studies completed after the reporting period.

The unit burden associated with each of these tasks is discussed in more
detail below and summarized in Table 3.

Step 1.  Review the Rule.  Firms in the relevant industries that may
have unpublished health and safety studies will have to determine
whether they manufacture a listed chemical and thus may be required to
report.  If so, they will have to review the rule in detail to
understand its requirements, such as the types of health and safety
studies EPA is asking for, the grade or purity of the test material, and
the time frame of the reporting period.  

	Unless EPA specifies otherwise, the coverage of 8(d) rules is limited
to chemical manufacturers and petroleum refineries.  Most firms in these
industries will not manufacture a listed chemical, and many will spend a
de minimis amount of time making that determination.  Those firms that
manufacture a listed chemical must review the rule to understand its
specific requirements.  This is estimated to take an average of two
hours of managerial time for each firm manufacturing a listed chemical.

Step 2.  Corporate Review for Site Identification.  Firms that
manufacture a listed chemical will need to conduct a corporate review to
identify which of the firm’s sites must be searched for appropriate
health and safety studies.  This corporate review is estimated to
require an average of three managerial hours per firm.

Step 3.  Site File Search.  Firms that manufacture a listed chemical
must search the files at appropriate sites to look for studies that are
responsive to the TSCA section 8(d) rule.  It is estimated that the
search will take an average of three hours of technical time per site. 
Based on reporting under EPA’s TSCA Inventory Update Rule (IUR),
manufacturers of the 208 chemicals added to the section 8(d) list in
2006 had an average of 1.5 sites per firm manufacturing a listed
chemical.  Assuming that this is representative of the chemicals that
will be added to the TSCA section 8(d) list under this ICR yields an
average burden of 4.5 technical hours per firm for site file searching
(3 hours per site * 1.5 sites per firm).  

Step 4.  Study Title Lists.  Respondents are required to submit lists
containing the titles of any studies being submitted, titles of studies
that are initiated or ongoing during the reporting period but that have
not been completed yet, titles of any unpublished studies that the
respondent knows to exist but does not have in its possession, and
titles of studies previously submitted to other Federal agencies without
confidentiality claims.  Because the major burden of compiling this list
was incurred during the file search, the only significant remaining
burden is the clerical time involved in transcribing the lists.  The
transcription is estimated to require an average of one hour of time per
firm.  

Step 5.  Photocopying Studies.  As shown in Table 2, companies reporting
under the 2006 TSCA section 8(d) rule submitted an average of 9 studies
with an average page length of 20 pages, for an average of 180 pages per
company.  Copying the studies to be submitted is estimated to require an
average of 1 hour of clerical time per firm. 

Step 6.  Robust Summaries.    Respondents may choose to develop and
submit robust summaries of the full toxicological study reports.  The
robust summaries should contain technical information to adequately
describe the study and results, and should be written such that the
information provided is sufficient to allow a technically qualified
person to evaluate study results without needing to review an entire
study report.  Typically, a robust summary would include a description
of the test substance, methods, results, conclusions, data quality
description, and references associated with the full study.  It is
estimated that 8 to 16 hours of technical time are needed to develop and
QA/QC a robust summary, depending on the type of study conducted.  This
analysis assumes an average of 12 hours of technical time to prepare a
robust summary.  Because submission of robust summaries is voluntary,
EPA does not expect that many companies will undertake this activity. 
EPA estimates that 10% of studies may include a robust summary.  As
shown in Table 2, companies reporting under the 2006 TSCA section 8(d)
rule submitted an average of 9 studies.  Assuming that future reporting
is similar to the 2006 experience, the estimated average burden per firm
for robust summaries is 11 hours of technical time (0.1 summaries/study
* 9 studies/firm * 12 hours/summary).

Step 7.  Review Responses for Confidential Business Information.  Firms
will need to review responses for possible confidential business
information (CBI) and delete any material that is considered by the firm
to be CBI from one copy of the study.  (Another copy must be submitted
without deletions.)  As shown in Table 2, companies reporting under the
2006 TSCA section 8(d) rule submitted an average of 9 studies with an
average page length of 20 pages.  CBI review is estimated to take an
average of one hour of managerial time for each study.  Assuming that
future reporting is similar to the 2006 experience, this results in an
estimate that CBI review will require an average of 9 hours of
managerial time per firm.

Step 8.  Post-Reporting Period Submission of Ongoing or Newly Initiated
Studies.  Firms that have an ongoing or newly initiated study during the
reporting period are required to provide EPA with a copy of the study
once it is completed.  Photocopying is estimated to require an average
of 0.1 hours per firm of clerical labor and CBI review will require an
average of one hour of managerial time.

Table 3.  Unit Burden for TSCA Section 8(d) Reporting

Collection Activity	Average Burden per Firm

1. Review of Rule	2 hours managerial

2. Site Identification	3 hours managerial

3. Site File Search	  4.5 hours technical

4. Study Title Lists	1 hour clerical

5. Photocopy Studies	1 hour clerical

6. Robust Summaries	11 hours technical

7. CBI Review	9 hours managerial

8. Post-Reporting Period Submission	1 hour managerial

0.1 hours clerical

Note: Not all respondents perform all activities.

	These unit burden estimates are average values.  As with any average,
some firms will be above the average and others will be below it.  Large
multi-divisional, multi-departmental firms may require more than the
average time to comply.  However, there are smaller firms that are less
complicated, and these firms may have a simpler process that requires
less time than the average.

6(b)	Estimating Respondent Costs

Unit labor costs are calculated by adding fringe benefits and overhead
to the wage or salary to derive a fully loaded labor cost.  Costs are
calculated for managerial, professional/ technical, and clerical
workers.  Wages and fringe benefits for managerial, professional/
technical, and clerical labor are taken from the Bureau of Labor
Statistics (BLS) Employer Costs for Employee Compensation (ECEC)
manufacturing industry data for December 2007.

	The cost of fringe benefits such as paid leave and insurance are taken
from the same ECEC series for each labor category.  Fringe benefits as a
percent of wages are calculated separately for each labor category.  For
example, the average hourly wage rate for professional/technical labor
was $33.14 and the average fringe benefit was $16.65.  Fringe benefits
as a percent of wages were $16.65/$33.14, or approximately 50 percent.

Table 4.  Derivation of Loaded Wage Rates

Labor Category	Data Sources

 	Wage	Fringe Benefit	Fringes as % wage	Over-head % wage	Fringe 
overhead factor	Loaded Wages

(a)	(b)	(c) =(b)/(a)	(d)	(e)=(c)(d)1	(f)=(a) x (e)

Managerial	BLS ECEC, Private Manufacturing industries, “Mgt, Business,
and Financial”1	$41.93 	$20.15 	48%	17%	1.65	$69.21

Professional/

Technical	BLS ECEC, Private Manufacturing industries, “Professional
and related“1	$33.14 	$16.65 	50%	17%	1.67	$55.42

Clerical	BLS ECEC, Private Manufacturing industries, “Office and
Administrative Support” 1	$16.47 	$8.32 	51%	17%	1.68	$27.59

Notes:

1 Employer Costs for Employee Compensation Supplementary Tables:
December 2007, US Bureau of Labor Statistics, March 12, 2008 at 
http://www.bls.gov/ncs/ect/sp/ecsuptc5.pdf 

Fully loaded costs for managerial and clerical labor are calculated in a
similar manner.  As shown in Table 4, the estimated fully loaded wage
rates are $69.21 per hour for managerial staff, $55.42 per hour for
technical staff, and $27.59 per hour for clerical staff. 

	Table 5 calculates the average unit costs for respondents by combining
the unit burden estimates from Table 3 with the loaded wage rates from
Table 4.

Table 5.  Respondent Unit Costs

Collection Activity	Average Burden Hours per Firm	Managerial

$69.21/hr	Technical

$55.42/hr	Clerical

$27.59/hr	Total

1. Review of Rule	2 hours managerial	$138.42

	$138.42

2. Site Identification	3 hours managerial	$207.63

	$207.63

3. Site File Search	4.5 hours technical

$249.39

$249.39

4. Study Title Lists	1 hour clerical

	$27.59	$27.59

5. Photocopy Studies	1 hour clerical

	$27.59	$27.59

6. Robust Summaries 	11 hours technical

$609.62

$609.62

7. CBI Review	9 hours managerial	$622.89

	$622.89

8. Post-Reporting Period 

Submission 	1 hour managerial

0.1 hours clerical	$69.21

$2.76	$71.97

Note: Not all respondents perform all activities.

	A typical firm submitting a response will engage in review of the rule,
site identification, site file search, preparing study title lists,
photocopying studies, and CBI review, but not submitting a robust
summary or a post-reporting period submission.  Assuming that 20
chemicals per year are added to the TSCA section 8(d) list and that
reporting is similar to the 2006 experience, the annual cost for a
typical firm is estimated to be $1,274.

6(c)	Estimating the Respondent Universe and Total Burden and Costs

	The number of chemicals added to the section 8(d) list has varied
significantly from year to year and has been zero in many years.  EPA
has added a total of 270 chemicals to the list since 1996 (47 in 1996,
15 in 2004, and 208 in 2006), which is an average of approximately 20
chemicals per year.  This ICR assumes that an average of 20 chemicals
per year will be added to the section 8(d) list from 2009 to 2011, for a
total of 60 chemicals over the three year ICR period.  

	The number of responses over the next three years is projected based on
the 8(d) reports submitted in response to the 2006 rule.  According to
TSCA IUR data, 344 firms reported manufacturing (including importing)
one or more of the chemicals listed on the 2006 TSCA section 8(d) rule,
an average of 1.7 manufacturers per chemical (344 firms / 208
chemicals).  There were 59 firms, or 17% of the number of manufacturers,
that submitted studies in response to the TSCA section 8(d) rule (59
respondents / 344 manufacturers).  The 59 firms submitted a total of 527
studies, an average of approximately 9 studies per reporting firm.

	Applying the average of 1.7 manufacturers per chemical to the average
of 20 chemicals per year that are assumed to be added to the section
8(d) list over the next three years results in an estimate that there
will be 34 manufacturers per year with chemicals added to the section
8(d) list during the time frame covered by this ICR.  

	Assuming that reporting over the next three years is similar to the
2006 experience then 17 percent of the manufacturers of listed
chemicals, or 6 firms (0.17 * 34 manufacturers), will submit reports
each year.  The 6 firms are estimated to submit a total of 54 studies
annually (6 firms* 9 studies per firm).  One of these respondents (5% of
6 firms) is also assumed to submit a second response (for a newly
initiated or ongoing study) after the reporting period ends. 

	The number of firms estimated to engage in the various activities is
described below.

Step 1.  Review the Rule.  Unless EPA specifies otherwise, the coverage
of section 8(d) rules is limited to chemical manufacturers and petroleum
refiners.  Most firms in these industries do not manufacture a listed
chemical, and many will spend a de minimis amount of time determining
that.  There will be a smaller group of firms that manufacture a listed
chemical and will need to spend time reviewing the rule to understand
its specific requirements such as the type(s) of health and safety data
needed, the chemical grade or purity of the test material, and the time
frame of the reporting period (typically 60 days but it can be up to two
years).

	The group of firms that must review the specific requirements of the
rule is approximated as the number of firms that manufacture (including
import) a listed chemical.  If 20 chemicals are added to the TSCA
section 8(d) list, EPA estimates that 34 manufacturers will need to
perform such a review. 

Step 2.  Corporate Review for Site Identification.  If 20 chemicals are
added to the TSCA section 8(d) list, EPA estimates that 34 manufacturers
will conduct an additional review to determine which corporate sites
must be searched to locate any appropriate health and safety studies.  

Step 3.  Site File Search.  Firms that manufacture a listed chemical
must search the files at appropriate sites to look for studies that are
responsive the TSCA section 8(d) rule.  If 20 chemicals are added to the
TSCA section 8(d) list, EPA estimates that 34 manufacturers will need to
search their files for the appropriate studies.  

Steps 4, 5, and 7.  If 20 chemicals are added to the TSCA section 8(d)
list, EPA estimates that 6 firms will prepare a study title listing,
photocopy studies, and review studies for confidential business
information.

Step 6.  Robust Summaries.  Submitting a robust summary is a voluntary
activity.  If 20 chemicals are added to the TSCA section 8(d) list, EPA
assumes that the 6 firms will provide robust summaries for an average of
10% of the total number of studies that are submitted.

Step 8.  Post-Reporting Period Submission of Ongoing or Newly Initiated
Studies.  EPA assumes that 5% of respondents will submit a study after
the end of the reporting period because the study was ongoing or newly
initiated during the reporting period.  With 6 respondents per year,
this is equivalent to one firm per year submitting a post-reporting
period study.

	The number of firms or studies described above is combined with the
estimated average unit burden hours and cost from Tables 3 and 5 to
estimate the total burden hours and cost per year based on three types
of response activities:  searching files, submitting studies during the
reporting period, and submitting studies after the reporting period. 
The results are shown in Table 6. 

Table 6.  Annual Respondent Cost and Burden Hour Estimates

Type of Response	Activities	Burden per Response	Cost per Response	Number
of Responses	Total Burden

Hours	Total Cost

Search files

Subtotal	1. Review of Rule

2. Site Identification

3. Site File Search	  2 hours  

+3 hours  

+4.5 hours 

9.5 hours	  $138.42 

+$207.63 

+$249.39

$595	34*	323	

$20,230

Submit studies during the reporting period

Subtotal	4. Study Title Lists

5. Photocopy Studies

6. Robust Summaries 

7. CBI Review 	1 hour 

+ 1 hour  

+ 11 hours 

+ 9 hours 

22 hours	$27.59 

+ $27.59 

+ $609.62 

+ $622.89

$1,288	6  	132	$7,728

Submit studies after the reporting period	8. Post-Reporting Period
Submission 	1. 1 hours 	$72	1 	1.1	$72

Total	456.1	$28,030

* “Number of responses” for searching files is presented only to
compute total burden.  Some firms that search their files do not have
any studies that must be reported under the TSCA section 8(d) rule.

	6(d)	Bottom Line Burden Hours and Cost Tables

	As shown in Table 7, if EPA adds 20 chemicals per year to the TSCA
section 8(d) list during the time period covered by this ICR, there will
be an estimated total of 456.1 burden hours per year at a cost of
$28,030 per year.  There are an estimated 34 respondents that search
their files, at an average burden of 9.5 hours each; 6 responses during
the reporting period (from 6 respondents submitting one response each)
at an average burden of 22 hours per response; and one response (from a
single respondent) with a post-reporting period submission at an average
burden of 1.1 hours.

Table 7.  Bottom Line Burden Hours and Cost Tables

Type of Response	Burden per Response	Cost per Response	Number of
Responses	Total Burden	Total Cost

Search files	9.5 hours	$595	34*	323	$20,230

Submit studies during the reporting period	22 hours	$1,288	6  	132
$7,728

Submit studies after the reporting period	1.1 hours 	$72	1 	1.1	$72

Total	456.1	$28,030

* “Number of responses” for searching files is presented only to
compute total burden.  Some firms that search their files do not have
any studies that must be reported under the TSCA section 8(d) rule. 

	As noted earlier, basing the future burden estimates on the reporting
from the 2006 rule may overestimate reporting burden and cost if number
and characteristics of the chemicals that are added to the TSCA section
8(d) list during the next three years are not like the 208 HPV chemicals
that were added in 2006.  For purposes of comparison, EPA added 15
chemicals to the TSCA section 8(d) list in 2004 (only slightly less than
the 20 chemicals predicted to be added per year for the next three
years).  But as shown in Table 1, the 2004 rule generated only 3
responses representing 14 studies, compared to the 7 responses (6 during
the reporting period and one after the reporting period) representing 55
studies.  

6(e)	Estimating Agency Cost 

	The activities routinely conducted by EPA related to processing and
storage of the information collected under this rule include the
following:

	Answer respondents’ questions;

	Process and analyze rule submissions, including requests for
confidentiality; and,

	Maintain and distribute the data.

	The activities associated with Agency responses to TSCA section 8(d)
listings are assumed to be accomplished by a GS 13, Step 5 federal
employee.  The 2007 hourly wage rate for this level of employee in the
Washington, D.C. locality is $43.12 per hour.  Adding 60% for benefits
and overhead yields a loaded annual wage rate of $69 per hour.

	The estimated annual cost to the Federal government for TSCA section
8(d) data collection is summarized in Table 8.



Table 8.  Agency Annual Cost Estimates

Collection Activity	FTEs 	Hours 

(at $69/hour)	Annual Cost

Data processing and system support	0.025	50	$3,450

Storage and distribution	0.01	20	$1,380

GRAND TOTALS

	0.035

	70	$4,830

	6(f)	Reasons For Changes in Burden			

	Since the last clearance, estimated reporting burden has decreased from
1,278 hours to 456.1 hours, a reduction of 821.9 hours.  This change is
due to the episodic nature of rulemakings to add chemicals to the TSCA
section 8(d) list.  EPA has added chemicals to the TSCA section 8(d)
list only three of the last 13 years, adding an average of 20 chemicals
per year over that time period.  The ICR for the 2006 to 2008 time
period assumed that an average of 100 chemicals per year would be added
to the TSCA section 8(d) list (or 300 chemicals over the three year ICR
period), because EPA was planning on adding 243 HPV chemicals to the
TSCA section 8(d) list.  This was an unusually large number of chemicals
to be added to the TSCA section 8(d) list.  Because EPA does not
anticipate adding such a large number of chemicals during this three
year ICR period, the burden estimated for this ICR has decreased.  It is
now more consistent with the number of chemicals that EPA added to the
TSCA section 8(d) list during the 2003 to 2005 ICR period.

 

	6(g)	Burden Statement

	The annual public burden for this collection of information, which is
approved under OMB Control No. 2070-0004, is estimated to range between
1.1 and 22 hours per response, depending upon the nature of each
respondent’s reporting responsibility.  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.  In addition, the OMB control
numbers for EPA’s regulation in Title 40 of the CFR, after initial
display in the final rule, are listed in 40 CFR part 9.

	The Agency has established a public docket for this ICR under Docket ID
No. EPA-HQ-OPPT-2008-0868, which is available for online viewing at
www.regulations.gov, or in person viewing at the EPA Docket Center
(EPA/DC), EPA West, Room 3334, 1301 Constitution Ave., NW., Washington,
DC.  The EPA Docket Center Public Reading Room is open from 8:30 a.m. to
4:30 p.m., Monday through Friday, excluding legal holidays.  The
telephone number for the Reading Room is (202) 566-1744, and the
telephone number for the Pollution Prevention and Toxics Docket is (202)
566-0280.  You may submit comments regarding the Agency's need for this
information, the accuracy of the provided burden estimates and any
suggested methods for minimizing respondent burden, including the use of
automated collection techniques.

	

	Submit your comments, referencing Docket ID No. EPA-HQ-OPPT-2008-0868
and OMB Control No. 2070-0004, to EPA online using www.regulations.gov
(our preferred method), or by mail to: Document Control Office (DCO),
Office of Pollution Prevention and Toxics (OPPT), Environmental
Protection Agency, Mail Code: 7407T, 1200 Pennsylvania Ave., NW, 
Washington, D.C. 20460.

Attachment List

					

All of the attachments listed below can be found in the docket for this
ICR (unless otherwise noted); accessible electronically through  
HYPERLINK "http://www.regulations.gov"  www.regulations.gov . On the
main page, select Advanced Search from the menu bar at the top and
select Docket Search. Enter the Docket ID Number, EPA-HQ-OPPT-2008-0868
in the Docket ID field. Click on the Submit button. From the results
page, you will be able to link to the docket view or directly open
select documents found in the docket.

Attachment 1 - Toxic Substances Control Act Section 8(d), 15 U.S.C.
2607(d)

Attachment 2 - Health and Safety Data Reporting, 40 CFR 716



  SEQ CHAPTER \h \r 1 ATTACHMENT 1

Toxic Substances Control Act Section 8(d)

15 U.S.C. 2607(d)

  SEQ CHAPTER \h \r 1 U.S. Code

Sec. 2607. Reporting and retention of information

 * * *

(d) Health and safety studies

    The Administrator shall promulgate rules under which the
Administrator shall require any person who manufactures, processes, or
distributes in commerce or who proposes to manufacture, process, or
distribute in commerce any chemical substance or mixture (or with
respect to paragraph (2), any person who has possession of a study) to
submit to the Administrator--

(1) lists of health and safety studies (A) conducted or initiated by or
for such person with respect to such substance or mixture at any time,
(B) known to such person, or (C) reasonably ascertainable by such
person, except that the Administrator may exclude certain types or
categories of studies from the requirements of this subsection if the
Administrator finds that submission of lists of such studies are
unnecessary to carry out the purposes of this chapter; and

(2) copies of any study contained on a list submitted pursuant to
paragraph (1) or otherwise known by such person.



  SEQ CHAPTER \h \r 1 ATTACHMENT 2

Health and Safety Data Reporting

40 CFR 716

TITLE 40--PROTECTION OF ENVIRONMENT

CHAPTER I--ENVIRONMENTAL PROTECTION AGENCY (CONTINUED)

PART 716 - HEALTH AND SAFETY DATA REPORTING

Sec. 716.1  Scope and compliance.

(a) This subpart sets forth requirements for the submission of lists and
copies of health and safety studies on chemical substances and mixtures
selected for priority consideration for testing rules under section 4(a)
of the Toxic Substances Control Act (TSCA) and on other chemical
substances and mixtures for which EPA requires health and safety
information in fulfilling the purposes of TSCA. 

(b) Section 15(3) of TSCA makes it unlawful for any person to fail or
refuse to submit information required under this subpart. Section 16
provides that a violation of section 15 renders a person liable to the
United States for a civil penalty and possible criminal prosecution.
Under section 17, the district courts of the United States have
jurisdiction to restrain any violation of section 15.

Sec. 716.3  Definitions. 

The definitions in section 3 of TSCA apply to this subpart. In addition,
the following definitions are provided for the purposes of this subpart:

Byproduct means a chemical substance produced without a separate
commercial intent during the

manufacture, processing, use, or disposal of another chemical
substance(s) or mixture(s).

Co-product means a chemical substance produced for a commercial purpose
during the manufacture, processing, use, or disposal of another chemical
substance(s) or mixture(s).

Copy of study means the written presentation of the purpose and
methodology of a study and its results.

EPA means the United States Environmental Protection Agency.

Health and safety study or study means any study of any effect of a
chemical substance or mixture on health or the environment or on both,
including underlying data and epidemiological studies, studies of
occupational exposure to a chemical substance or mixture, toxicological,
clinical, and ecological or other studies of a chemical substance or
mixture, and any test performed under TSCA.

(1) It is intended that the term health and safety study be interpreted
broadly. Not only is information which arises as a result of a formal,
disciplined study included, but other information relating to the
effects of a chemical substance or mixture on health or the environment
is also included. Any data that bear on the effects of a chemical
substance on health or the environment would be included. Chemical
identity is part of, or underlying data to, a health and safety study.

(2) Examples are:

(i) Long- and short-term tests of mutagenicity, carcinogenicity, or
teratogenicity; data on behavioral disorders; dermatoxicity;
pharmacological effects; mammalian absorption, distribution, metabolism,
and excretion; cumulative, additive, and synergistic effects; and acute,
subchronic, and chronic effects.

(ii) Tests for ecological or other environmental effects on
invertebrates, fish, or other animals, and plants, including: Acute
toxicity tests, chronic toxicity tests, critical life-stage tests,
behavioral tests, algal growth tests, seed germination tests, plant
growth or damage tests, microbial function tests, bioconcentration or
bioaccumulation tests, and model ecosystem (microcosm) studies.

(iii) Assessments of human and environmental exposure, including
workplace exposure, and impacts of a particular chemical substance or
mixture on the environment, including surveys, tests, and studies of:
Biological, photochemical, and chemical degradation; structure/activity
relationships; air, water, and soil transport; biomagnification and
bioconcentration; and chemical and physical properties, e.g., boiling
point, vapor pressure, evaporation rates from soil and water,
octanol/water partition coefficient, and water solubility.

(iv) Monitoring data, when they have been aggregated and analyzed to
measure the exposure of humans or the environment to a chemical
substance or mixture.

Import means to import for commercial purposes.

Import for commercial purposes means to import with the purpose of
obtaining an immediate or eventual commercial advantage for the
importer, and includes the importation of any amount of a chemical
substance or mixture. If a chemical substance or mixture containing
impurities is imported for commercial purposes, then those impurities
are also imported for commercial purposes.

Importer means any person who imports a chemical substance, including a
chemical substance as a part of a mixture or article, into the customs
territory of the United States and includes the person primarily liable
for the payment of any duties on the merchandise or an authorized agent
acting on his behalf (as defined in 19 CFR 1.11). Importer also
includes, as appropriate:

(1) The consignee.

(2) The importer of record.

(3) The actual owner, if an actual owner's declaration and superseding
bond has been filed in accordance with 19 CFR 141.20.

(4) The transferee, if the right to draw merchandise in a bonded
warehouse has been transferred in accordance with subpart C of 19 CFR
part 144. For the purpose of this definition, the customs territory of
the United States consists of the 50 States, Puerto Rico, and the
District of Columbia.

Impurity means a chemical substance which is unintentionally present
with another chemical substance.

Listed mixture means any mixture listed in Sec. 716.120.

Manufacture means to manufacture for commercial purposes.

Manufacture for commercial purposes means: (1) To produce, 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 commercial distribution, 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 byproducts and
impurities. 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.

Manufacturer means a person who produces or manufactures a chemical
substance. A person who extracts a component chemical substance from a
previously existing chemical substance or a complex combination of
substances is a manufacturer of that component chemical substance.

Person includes any individual, firm, company, corporation,
joint-venture, partnership, sole proprietorship, association, or any
other business entity, any State or political subdivision thereof, any
municipality, any interstate body, and any department, agency, or
instrumentality of the Federal government.

Process means to process for commercial purposes.

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.

Propose to manufacture, import, or process means that a person has made
a management decision to commit financial resources toward the
manufacture, importation, or processing of a substance or mixture.

Substance means chemical substance as defined at section 3(2)(A) of
TSCA, 15 U.S.C. 2602(2)(A).

TSCA means the Toxic Substances Control Act (15 U.S.C. 2601 et seq.).

Sec. 716.5   Persons who must report.

(a) Except as provided in paragraphs (b) and (c) of this section, only
those persons described in this section are required to report under
this part. Persons who must report include manufacturers (including
importers) who fall within the North American Industry Classification
System (NAICS) (in effect as of January 1, 1997) Subsector 325 (chemical
manufacturing and allied products) or Industry Group 32411 (petroleum
refineries), who:

(1) In the 10 years preceding the effective date on which a substance or
mixture is added to Sec.716.120, either had proposed to manufacture
(including import), or had manufactured (including imported) the listed
substance or listed mixture (including as a known byproduct), are
required to report during the reporting period specified in Sec.716.65.

(2) As of the effective date on which a substance or mixture is added to
Sec. 716.120, and who propose to manufacture (including import), or who
are manufacturing (including importing) the listed substance or listed
mixture (including as a known byproduct), are required to report during
the reporting period specified in Sec.716.65.

(3) After the effective date on which a substance or mixture is added to
Sec. 716.120, and who propose to manufacture (including import) the
listed substance or listed mixture (including as a known byproduct), are
required to report during the reporting period specified in Sec. 716.65.

(b) A rule promulgated under the authority of 15 U.S.C. 2607(d) may
require that any person who does not fall within NAICS (in effect as of
January 1, 1997) Subsector 325 or Industry Group 32411, and who had
proposed to manufacture (including import) or process, had manufactured
(including imported) or processed, proposes to manufacture (including
import) or process, or is manufacturing (including importing) or
processing a substance or mixture listed in Sec. 716.120 must report
under this part.

(c) Processors and persons who propose to process a substance or mixture
otherwise subject to the reporting requirements imposed by this part are
not subject to this part unless EPA specifically states otherwise in a
particular notice or rule promulgated under the authority of 15 U.S.C.
2607(d).

[63 FR 15773, Apr. 1, 1998]

Sec. 716.10  Studies to be reported.

(a) In general, health and safety studies, as defined in Sec. 716.3, on
any substance or listed mixture listed in Sec. 716.120, that are
unpublished are reportable, i.e., must be submitted or listed. However,
this requirement has limitations according to the nature of the material
studied, so that:

(1) All studies of substances and listed mixtures are reportable.
However, in the case of physical and chemical properties, only those
studies listed in Sec. 716.50 must be submitted.

(2) Studies of mixtures known to contain substances or listed mixtures
listed in Sec. 716.120 are reportable except for studies of physical and
chemical properties and the studies exempted at Sec. 716.20(a)(6) (i)
through (vi).

(3) Studies of substances or listed mixtures that a person who is
reporting has manufactured, imported, or processed or proposed to
manufacture, import, or process only as impurities are not generally
reportable under Sec. 716.20(a)(9).

(4) Underlying data, such as medical or health records, individual
files, lab notebooks, and daily monitoring records supporting studies do
not have to be submitted initially. EPA may request underlying data
later under Sec. 716.40.

(b) [Reserved]

Sec. 716.20  Studies not subject to the reporting requirements.

(a) Excluding paragraph (a)(3) of this section, the following types of
studies are exempt from the copy and list submission requirements of
Sections 716.30 and 716.35.

(1) Studies which have been published in the scientific literature.

(2) Studies previously submitted to the EPA Office of Pollution
Prevention and Toxics. These studies are limited to section 8(e)
submissions, studies submitted during section 4 proceedings, studies
submitted with premanufacture notices or significant new use notices,
and studies submitted "for your information" (FYI submissions) in
support of EPA's TSCA Existing Chemicals Program. Studies which have
been initiated pursuant to a TSCA section 4(a) test rule, for which the
person has submitted a letter of intent to conduct testing in accordance
with the provisions of Sec. 790.25 of part 790 of this chapter, are
exempt from the list submission requirements of Sec. 716.35.

(3) Except for those studies described in paragraph (a)(2) of this
section, studies previously submitted to any Federal agency with no
claims of confidentiality are exempt only from the copy submission
requirements of Sec. 716.30, and must be listed in accordance with the
provisions of Sec. 716.35.

(4) Studies conducted or initiated by or for another person who is
subject to, and who will report the studies under Sections 716.30 and
716.35.

(5) Studies of chemical substances which are not on the TSCA Chemical
Substances Inventory. This exemption applies only to those substances
within categories listed under Sec. 716.120(c).

(6) The following types of studies when the subject of the study is a
mixture known to contain a substance or listed mixture listed under Sec.
716.120.

(i) Acute oral toxicity studies.

(ii) Acute dermal toxicity studies.

(iii) Acute inhalation toxicity studies.

(iv) Primary eye irritation studies.

(v) Primary dermal irritation studies.

(vi) Dermal sensitization studies.

(vii) Physical and chemical properties. If the substance or listed
mixture is an impurity, no reporting is required (see paragraph (a)(9)
of this section).

(7) Analyzed aggregations of monitoring data based on monitoring data
acquired more than 5 years preceding the date the substance or listed
mixture was added to the list under Sec. 716.120.

(8) Analyzed aggregations of monitoring data on mixtures known to
contain one or more substances or listed mixtures listed in Sec.
716.120, when the monitoring data are not analyzed to determine the
exposure or concentration levels of the substances or listed mixture
listed under Sec. 716.120.

(9) Studies on a substance or listed mixture listed under Sec. 716.120
that the person who is reporting has manufactured, imported, or
processed or proposed to manufacture, import, or process only as an
impurity. When reporting of such studies is to be required, that
reporting will be separately proposed in the Federal Register.

(10) Studies of chemical substances or listed mixtures previously
submitted by trade associations in accordance with the provisions of
Sec. 716.30.

(b) The following types of studies on substances or listed mixtures
listed under Sec. 716.120 are exempt from the copy and list submission
requirements of Sections 716.30 and 716.35.

(1) For the listed ureaformaldehyde resins (CAS Nos. 9011-05-6 and
68611-64-3), studies on agronomic plant growth or damage which
demonstrate only that the resins stimulate plant growth or cause plant
damage when applied as a fertilizer.

(2) For the specified chemicals in Sec. 716.120(d) under the category
"Siloxanes," acute oral, dermal, and inhalation toxicity studies and
primary eye and dermal irritation studies.

(3) For the listed chemicals under Sec. 716.120(d) in the category "OSHA
Chemicals in Need of Dermal Absorption Testing," studies on ecological
effects.

(4) For the chemicals listed at Sec. 716.120 with a special exemption
referencing this paragraph, studies on mixtures containing the listed
substance at levels below 1 percent of the mixture, except when a
purpose of the study includes the investigation of the effects of the
listed substance at levels below 1 percent.

(5) Rulemaking proceedings that add substances and mixtures to Sec.
716.120 will specify the types of health and/or environmental effects
studies that must be reported and will specify the chemical grade/purity
requirements that must be met or exceeded in individual studies.
Chemical grade/purity requirements will be specified on a per chemical
basis or for a category of chemicals for which reporting is required.

[51 FR 32726, Sept. 15, 1986, as amended at 58 FR 47649, Sept. 10, 1993;
58 FR 68315, Dec. 27, 1993; 60 FR 34884, July 5, 1995; 63 FR 15773, Apr.
1, 1998]

Sec. 716.25   Adequate file search.

The scope of a person's responsibility to search records is limited to
records in the location(s) where the required information is typically
kept, and to records kept by the person or the person's individual
employee(s) who is/are responsible for keeping such records or advising
the person on the health and environmental effects of chemicals. Persons
are not required to search for reportable information dated before
January 1, 1977, to comply with this subpart unless specifically
required to do so in a rule.

[63 FR 15773, Apr. 1, 1998]

Sec. 716.30  Submission of copies of studies.

(a)(1) Except as provided in Sections 716.5, 716.20, and 716.50, persons
must send to EPA copies of any health and safety studies in their
possession for the substances or mixtures listed in Sec. 716.120.
Persons are responsible for submitting copies on only the substances or
listed mixtures which they: Have manufactured, imported, or processed or
proposed to manufacture, import, or process (including as known
byproducts) within the 10 years preceding the effective date for
reporting on the substances or listed mixtures; manufacture, import, or
process on the effective date for reporting on the substances or listed
mixtures; and propose to manufacture, import, or process following the
effective date for reporting on the substances or listed mixtures.
Persons who list studies as ongoing or initiated under Sec. 716.35(a)
(1) and (2) must submit them when they are completed.

(2) [Reserved]

(b) Submissions under paragraph (a) of this section must be identified
either on the face of the study or otherwise by the applicable chemical
name and CAS number (if any) listed in Sec. 716.120(a) (1) and (2), and
must be accompanied by a cover letter containing the name, job title,
address and telephone number of the submitting official, and the name
and address of the manufacturing or processing establishment on whose
behalf the submission is made. In the cover letter, submitters must
identify any impurity or additive known to have been present in the
substance or listed mixtures as studied unless its presence is
specifically noted in the study itself. The cover letter accompanying a
study submitted by a trade association must also state that the
submission is to satisfy reporting requirements under this part.

(c) Copies of health and safety studies and the accompanying cover
letters must be submitted, preferably by certified mail, to the Document
Control Office (7407), Office of Pollution Prevention and Toxics, U.S.
Environmental Protection Agency, Room G-099, 1200 Pennsylvania Ave.,
NW., Washington, DC 20460, ATTN: 8(d) Health and Safety Reporting Rule
(Notification/Reporting).

[51 FR 32726, Sept. 15, 1986, as amended at 52 FR 20084, May 29, 1987;
52 FR 44828, Nov. 20, 1987; 53 FR 12523, Apr. 15, 1988; 60 FR 34463,
July 3, 1995; 63 FR 15773, Apr. 1, 1998]

Sec. 716.35  Submission of lists of studies.

(a) Except as provided in Sections 716.5, 716.20, and 716.50, persons
subject to this rule must send lists of studies to EPA for each of the
listed substances or listed mixtures (including as a known byproduct) in
Sec. 716.120 which they are manufacturing, importing, or processing, or
which they propose to manufacture (including import) or process.

(1) Ongoing studies. As of the date a person becomes subject to this
part, a list of ongoing health and safety studies being conducted by or
initiated for them, noting for each entry: The beginning date of the
study, the purpose of the study, the types of data to be collected, the
anticipated date of completion, and the name and address of the
laboratory conducting the study.

(2) Initiated studies. After the date a person becomes subject to this
part, a list of studies initiated by or for them, noting for each entry:
The beginning date of the study, the purpose of the study, the types of
data to be collected, the anticipated date of completion, and the name
and address of the laboratory conducting the study.

(3) Studies which are known but without possession of copies. As of the
date a person becomes subject to this part, a list of unpublished health
and safety studies known to them of which they do not have copies. The
name and address of any person known to them to possess a copy of the
unpublished study must accompany each entry on the list. For purposes of
this section only, an unpublished study will be considered to be "known
to" a person, if the study can be discovered by a file search in
accordance with Sec. 716.25.

(4) Studies previously sent to Federal agencies without confidentiality
claims. A list of unpublished studies which have been sent to a Federal
Agency with no claims of confidentiality. The submission must for each
study: Identify the study by title, state the name and address to whom
the study was sent, and the month and year in which the study was
submitted. Any study identified will be treated as if it were submitted
under section 8(d) and will be available for public disclosure under
section 14(b) of TSCA. Persons subject to this requirement may submit
either a list of unpublished health and safety studies previously
submitted to any Federal agency without claims of confidentiality in
accordance with Sec. 716.35(a)(4), or copies of each such study in
accordance with Sec. 716.30.

(b) Submission under paragraph (a) of this section must be identified
either on the face of the study or otherwise by the applicable chemical
name and CAS number (if any) listed in Sec. 716.120(a) (1) and (2), and
must be accompanied by a cover letter containing the name, job title,
address and telephone numbers of the submitting official, and the name
and address of the manufacturing or processing establishment on whose
behalf the submission is made.

(c) Lists of health and safety studies should be submitted, preferably
by certified mail, to the Document Control Office (7407), Office of
Pollution Prevention and Toxics, U.S. Environmental Protection Agency,
Room G-099, 1200 Pennsylvania Ave., NW., Washington, DC 20460, ATTN:
8(d) Health and Safety Reporting Rule (Notification Reporting).

[51 FR 32726, Sept. 15, 1986, as amended at 52 FR 20084, May 29, 1987;
52 FR 44828, Nov. 20, 1987; 53 FR 12523, Apr. 15, 1988; 53 FR 46746,
Nov. 18, 1988; 60 FR 34463, July 3, 1995; 63 FR 15774, Apr. 1, 1998]

Sec. 716.40  EPA requests for submission of further information.

EPA may, by letter, request a person to submit or make available for
review the following information after the initial reporting under
Sections 716.30 and 716.35. If the requested submissions are not made,
EPA may subpoena them under section 11 of TSCA, 15 U.S.C. 2610.

(a) Submission of underlying data of the kind described in Sec.
716.10(a)(4) by persons who submit copies of studies under Sec. 716.30
or list studies under Sec. 716.35(a)(1) or Sec. 716.35(a)(2).

(b) Submission of preliminary reports of ongoing studies by persons who
list the studies under

Sec. 716.35(a)(1) or Sec. 716.35(a)(2).

(c) Submission of copies of studies by persons listed under Sec.
716.35(a)(3) as possessing them.

Sec. 716.45  How to report on substances and mixtures.

Section 716.120 lists substances and mixtures, in order by Chemical
Abstract Service Registry Number and by alphabetical order. Studies of
listed substances and listed mixtures shall be reported as follows:

(a) When a substance is individually listed under Sec. 716.120(a),
studies of the substance and studies of mixtures known to contain the
substance must be reported as studies of that substance.

(b) When two or more substances are listed as a mixture under Sec.
716.120(b), studies of the listed mixture and studies of any mixture
known to contain the listed mixture must be reported as studies of the
listed mixture.

(c) Studies of the following preparations of a substance must be
reported as studies of the substance itself, not as studies of mixtures
known to contain the substance.

(1) The substance in aqueous solution.

(2) The substance containing a small amount of an additive, such as a
stabilizer, emulsifier, or other chemical added for purposes of
maintaining the integrity or physical form of the substance.

(3) The substance of the grade/purity specified in each rule promulgated
under 15 U.S.C. 2607(d).

[51 FR 32726, Sept. 15, 1986, as amended at 63 FR 15774, Apr. 1, 1998]

Sec. 716.50  Reporting physical and chemical properties.

Studies of physical and chemical properties must be reported under this
subpart if performed for the purpose of determining the environmental or
biological fate of a substance, and only if they investigated one or
more of the following properties:

(a) Water solubility.

(b) Adsorption/desorption on particulate surfaces, e.g., soil.

(c) Vapor pressure.

(d) Octanol/water partition coefficient.

(e) Density/relative density (specific gravity).

(f) Particle size distribution for insoluble solids.

(g) Dissociation constant.

(h) Degradation by photochemical mechanisms -- aquatic and atmospheric.

(i) Degradation by chemical mechanisms -- hydrolytic, reductive, and
oxidative.

(j) Degradation by biological mechanisms -- aerobic and anaerobic.

Sec. 716.55  Confidentiality claims.

(a)(1) Section 14(b) of TSCA provides that EPA may not withhold from
disclosure, on the grounds that they are confidential business
information, health and safety studies of any substance or mixture that
has been offered for commercial distribution (including for test
marketing purposes and for use in research and development), any
substance or mixture for which testing is required under TSCA section 4,
or any substance for which notice is required under TSCA section 5,
except to the extent that disclosure of data from such studies would
reveal --

(i) Processes used in the manufacturing, importing, or processing of the
substance or mixture, or

(ii) The portion of a mixture comprised by any of the substances in the
mixture.

(2) Any respondent who wishes to assert a claim that part of a study
should be withheld from disclosure because disclosure would reveal a
confidential process or quantitative mixture composition should briefly
state the basis of the claim, e.g., by saying "reveals confidential
mixture proportion data," and clearly identify the material subject to
the claim.

(3) Any respondent may assert a confidentiality claim for company name
or address, financial statistics, and product codes used by a company.
This information will not be subject to the disclosure requirements of
section 14(b) of TSCA.

(4) Information other than company name or address, financial
statistics, and product codes used by a company, which is contained in a
study, the disclosure of which would clearly be an unwarranted invasion
of personal privacy (such as individual medical records), will be
considered confidential by EPA as provided in Title 5, United States
Code, section 552(b)(6).

(b) To assert a claim of confidentiality for data contained in a
submitted document, the respondent must submit two copies of the
document:

(1) One copy must be complete. In that copy, the respondent must
indicate what data, if any, are claimed as confidential by bracketing or
underlining the specific information. Each page containing data claimed
as confidential must also contain a brief statement for the basis of the
claim as well as a label such as "confidential," "proprietary," or
"trade secret."

(2) The second copy must be complete, except that all information
claimed as confidential in the first copy must be deleted. The second
copy will be immediately subject to public disclosure.

(3) 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 his or her receipt of this 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.

(c) If no claim of confidentiality 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.

Sec. 716.60  Reporting schedule.

(a) General requirements. Except as provided in Sec. 716.5 and
paragraphs (b) and (c) of this section, submissions under Sections
716.30 and 716.35 must be postmarked on or before 60 days after the
effective date of the listing of a substance or mixture in Sec. 716.120
or within 60 days of proposing to manufacture (including import) or
process a listed substance or listed mixture (including as a known
byproduct) if first done after the effective date of the substance or
mixture being listed in Sec. 716.120.

(b)(1) Submission of lists of initiated studies. Persons subject to the
listing requirements of Sec. 716.35(a)(2) must inform EPA of the
initiated study within 30 days of its initiation.

(2) Submission of copies of completed studies. Persons must submit
copies of studies listed as ongoing or initiated under Sec. 716.35(a)
(1) and (2) within 30 days of completing the study.

(c) Requests for extensions of time. Respondents who cannot meet a
deadline under this section may apply for a reasonable extension of
time. Requests for extensions must be in writing and addressed to the
Director, Office of Pollution Prevention and Toxics (7401), U.S.
Environmental Protection Agency, Room E-539, 1200 Pennsylvania Ave.,
NW., Washington, DC 20460, ATTN: Section 8(d) extension. Extension
requests must be postmarked on or before 40 days after the effective
date of the listing of a substance or mixture in Sec. 716.120. The
Director of EPA's Office of Pollution Prevention and Toxics will grant
or deny extension requests.

[51 FR 32726, Sept. 15, 1986, as amended at 60 FR 34464, July 3, 1995;
63 FR 15774, Apr. 1, 1998]

Sec. 716.65   Reporting period.

Unless otherwise required in a rule promulgated under 15 U.S.C. 2607(d)
relating to a listed chemical substance or listed mixture [hereinafter
"rule"], the reporting period for a listed chemical substance or listed
mixture will terminate 60 days after the effective date on which the
listed chemical substance or listed mixture is added to 40 CFR 716.120.
EPA may require reporting for a listed chemical substance or listed
mixture beyond the 60 day period in a rule promulgated under 15 U.S.C.
2607(d), however EPA will not extend any reporting period later than 2
years after the effective date on which a listed chemical substance or
listed mixture is added to 40 CFR 716.120. After the applicable
reporting period terminates, any person subject to the rule under 40 CFR
716.5 (a)(2) or (a)(3) and who has submitted to EPA lists of ongoing or
initiated studies under 40 CFR 716.35 (a)(1) or (a)(2) must submit a
copy of any such study within 30 days after its completion, regardless
of the study's completion date.

[63 FR 15774, Apr. 1, 1998]

Sec. 716.105  Additions of substances and mixtures to which this subpart
applies.

The requirements of this subpart will be extended periodically to cover
additional substances and mixtures. Two procedures will be used to add
substances and mixtures.

(a) Except as provided in paragraph (b) of this section, substances and
mixtures will be added to Sec. 716.120 after publication in the Federal
Register of a notice of proposed amendment to this subpart. There will
be at least a 30-day public comment period on the notice. After
consideration of the comments, EPA will amend Sec. 716.120 by final rule
to add the substances and listed mixtures.

(b) Except as provided in paragraph (c) of this section, chemical
substances, mixtures, and categories of chemical substances that have
been added to the TSCA section 4(e) Priority List by the Interagency
Testing Committee, established under section 4 of TSCA, will be added to
Sec. 716.120 but only to the extent that the total number of designated
and recommended substances, mixtures and categories of chemical
substances has not exceeded 50 in any 1 year. The addition of such
chemical substances, mixtures, and categories of chemical substances to
Sec. 716.120 will be effective 30 days after publication of a notice to
that effect in the Federal Register.

(c) Prior to the effective date of an amendment under paragraph (b) of
this section, the Assistant Administrator for Prevention, Pesticides and
Toxic Substances may for good cause withdraw a chemical substance,
mixture, or category of chemical substances from Sec. 716.120. Any
information submitted showing why a chemical substance, mixture, or
category of chemical substances should be withdrawn from the amendment
must be received by EPA within 14 days after the date of publication of
the notice under paragraph (b) of this section. If a chemical substance,
mixture, or category of chemical substances is withdrawn, a Federal
Register notice announcing this decision will be published no later than
the effective date of the amendment under paragraph (b) of this section.
Persons who wish to submit information that shows why a chemical should
be withdrawn must address their comments, in writing to the Document
Control Office (7407), Office of Pollution Prevention and Toxics, U.S.
Environmental Protection Agency, Room G-099, 1200 Pennsylvania Ave.,
NW., Washington, DC 20460, ATTN: 8(d) Auto-ITC.

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摧曲[ᰀ[51 FR 32726, Sept. 15, 1986, as amended at 60 FR 34464, July
3, 1995]

       EPA issued a TSCA section 8(d) rule (71 FR 47130) on August 16,
2006 for 243 HPV chemicals that were not sponsored in the voluntary
portion of the HPV Challenge Program.  EPA later withdrew 33 of these
chemicals in a final rule issued on September 29, 2006 (71 FR 57439). 
In a subsequent direct final rule issued on April 30, 2007, EPA removed
two additional chemicals (72 FR 21119), resulting in a total of 208
chemicals subject to Section 8(d) reporting.

 According to 40 CFR '716.5, persons are required to report under a TSCA
section 8(d) rule if, during the 10 years preceding the effective date
of the rule, they manufactured (including imported) or planned to
manufacture (including import) a listed chemical.  To represent the 10
year period prior to the 2006 TSCA section 8(d) rule, this analysis used
TSCA IUR data from the 1998, 2002, and 2006 reporting cycles.  The IUR
data used for this analysis was not limited to reporting from chemical
manufacturers and petroleum refiners.

  A response can include more than one study.  Based on the 2006
experience (when there were an average of 9 studies submitted per
company), EPA estimates that the 6 respondents will submit a total of 55
studies, 54 during the reporting period and one after the reporting
period.  Alternatively, EPA could have estimated the number of studies
based on the average number of studies per chemical added to the TSCA
section 8(d) list.  In 2006, 208 chemicals were added to the TSCA
section 8(d) list and 527 studies were submitted, an average of
approximately 2.5 studies per chemical.  Using this basis would yield an
estimate that adding 20 chemicals to the TSCA section 8(d) list will
result in 51 studies being submitted, 50 during the reporting period and
one after the reporting period. 

 The EPA wage rate is calculated based on the GS-13 Step 5 wage rate for
calendar 2007, from the Office of Personnel Management salary and wage
tables for Washington-Baltimore-Northern Virginia at
http://www.opm.gov/oca/07tables/html/dcb_h.asp. The 60%
fringes-and-overhead rate is from ICR Handbook: EPA’s Guide to Writing
Information Collection Requests Under the Paperwork Reduction Act of
1995.  (EPA Office of Environmental Information, 2005).

  PAGE  17