  SEQ CHAPTER \h \r 1 Supporting Statement for a Request for OMB Review
under

the Paperwork Reduction Act

  SEQ CHAPTER \h \r 1 1.  IDENTIFICATION OF THE INFORMATION COLLECTION

	l(a)	Title of the Information Collection

	TITLE:	Chemical-Specific Rules, Toxic Substances Control Act Section
8(a)

	EPA ICR No.:	1198.08	OMB Control No:	2070-0067

	1(b)	Short Characterization

	This information collection request requires OMB’s approval for the
continued collection of chemical-specific information under section 8(a)
of the Toxic Substance Control Act (TSCA,  15 U.S.C. 2607); see
Attachment 1.  TSCA section 8(a) authorizes the Administrator of the EPA
to promulgate rules that require persons who manufacture, import or
process chemical substances and mixtures, or who propose to manufacture,
import, or process chemical substances and mixtures, to maintain such
records and submit such reports to EPA as may be reasonably required. 
Information that may be collected under TSCA section 8(a) includes, but
is not limited to, chemical names, categories of use, production volume,
byproducts of chemical production, existing data on deaths and
environmental effects, exposure data, and disposal information.  These
data are collected by the Office of Pollution Prevention and Toxics
(OPPT) and may be used by other EPA offices and/or Federal agencies to
ensure knowledge of specific practices that may affect human health and
the environment.

	There may be circumstances when EPA may require different information
than is readily available or information that is different from that
available through existing regulatory information collection tools, like
the TSCA section 8(a) Preliminary Assessment Information Rule (PAIR)
which is discussed in another ICR under a different OMB control number. 
EPA promulgated PAIR on June 22, 1982 (see 40 CFR Part 712).  Whenever a
substance is added to the PAIR, manufacturers and importers of the
substance are required to complete a PAIR report form.  The PAIR report
requests a very limited amount of information on listed chemicals
regarding activities occurring over a specific time period.

	Any chemical covered by TSCA for which OPPT, other EPA Offices or
another Federal agency has a reasonable need for information, and which
cannot be satisfied via readily available sources or by use of PAIR, is
a proper potential subject for a chemical-specific TSCA section 8(a)
rulemaking.  For instance EPA may wish to ask detailed questions in
regard to how industry oversees the use and production of a chemical. 
These specific monitoring capabilities could allow EPA to react to
change in market conditions that may warrant a change in EPA’s
regulatory strategy.  Therefore, EPA could promulgate a TSCA section
8(a) rule to gather this information by requesting that current or
potential manufacturers, importers or processors of the substance
provide chemical-specific information.

	EPA’s OPPT, other EPA Offices and/or other Federal agencies will
generally be the primary groups for which information will be collected.
 However, to the extent that reported information is not considered to
be confidential business information (CBI), environmental groups,
environmental justice advocates, state and local government entities and
other members of the public will have access to this information for
their own use.

	Rather than requiring respondents to submit information on reporting
forms such as those used for PAIR, EPA has in the past allowed
individual firms to choose the reporting means and format that is best
suited to their recordkeeping resources.  EPA believes that for TSCA
section 8(a) chemical-specific rules, this allowance keeps reporting
costs low.

	Total annual cost of a rule varies depending upon the number of
chemicals per rule and the number of respondents per chemical.  Based on
the recent past usage of chemical-specific TSCA section 8(a) rules and
expected future usage, EPA assumes  that it will promulgate one TSCA
section 8(a) chemical-specific rule with four respondents (notices) per
year  for the three-year duration of the ICR (see Section 6(b), below). 
The maximum total annual number of burden hours for respondents range
from 134 hours to 594 hours per TSCA section 8(a) chemical-specific
rule.  The maximum cost associated with the promulgation of a TSCA
section 8(a) chemical-specific rule is $6,868 to $30,504.  However, the
cost per respondent varies with the type of chemical-specific
information requested, and subsequently, the tasks required to comply
with a TSCA section 8(a) chemical-specific rule. Because all respondents
may not have to provide information on all data items listed (see
Sections 3 and 6(b), below), the ranges presented above are maximums. 
Assuming that all respondents do not have to complete all tasks
identified to comply with a TSCA section 8(a) chemical-specific rule,
total annual reporting costs to all respondents range from $3,375 to
$14,080 per rule.

2.  NEED FOR AND USE OF THE COLLECTION

	2(a)	Need/Authority for the Collection

	Generally, EPA may need chemical-specific information under TSCA
section 8(a) to evaluate the potential for adverse human health and
environmental effects caused by the manufacture, importation,
processing, use or disposal of identified chemical substances and
mixtures.  Additionally, EPA may use TSCA section 8(a) information to
assess the need or set priorities for testing and/or further regulatory
action.

	The information required in TSCA section 8(a) chemical-specific rules
can be custom-tailored to aid in achieving EPA’s goals of protecting
human health and the environment.  Information collected may vary
depending on the substance, its current and potential uses and EPA’s
concerns about potential human or environmental risks caused by
exposures to the substance.  Promulgated TSCA section 8(a) rules may
require persons manufacturing, importing or processing the chemical
substance to report to EPA on specific information such as: a
chemical’s composition, byproducts, quantity produced, employee
exposure and environmental release.  Persons have in the past also been
required to notify EPA of a management decision to initiate the
manufacturing, importing, or processing of a chemical substance or
mixture.

	The legal authority for this information collection is TSCA section
8(a), U.S.C. 2607(a).  TSCA section 8(a) chemical-specific rules have
been codified at 40 CFR 704, subpart B; see Attachment 2.

	2(b)	Use/Users of the Data

	EPA will use the information obtained through the TSCA section 8(a)
reporting rules to satisfy specifically identified data needs.  The
information collected will be relevant to risk identification, all
stages of risk assessment, and/or control action functions.  Receipt of
TSCA section 8(a) information may also give the Agency an opportunity to
work with the respondent, if necessary, to minimize exposure risks
associated with specific uses.  Generally, a specific information
collection request would be made by the Chemical Control Division,
Chemical Management Division, or the Chemical Screening and Risk
Assessment Division in OPPT.  However, other regulatory agencies and
departments, such as Occupational Safety and Health Administration
(OSHA), the Food and Drug Administration (FDA), and other members of the
Interagency Testing Committee (ITC) may also present a need for and
subsequently use TSCA section 8(a) data to, for example, assess worker
or consumer exposures.

	An example of a use of a TSCA section 8(a) chemical-specific rule that
was key in affecting a benefit to human health was 1,1-aminoundecanoic
acid (1,1-AA).  From submitted TSCA section 8(e) “substantial risk”
reports, EPA discovered that 1,1-AA is a carcinogen in one sex of one
rodent species (male rat), and that exposure is limited to workers
producing the nylon in which the chemical is an ingredient.  The
manufacturer was contacted to obtain exposure data for this chemical. 
From this contact EPA learned: (1) 1,1-AA was imported and converted
into nylon by one company and there was no domestic manufacture; (2)
1,1-AA was handled and transferred in a closed system and all 1,1-AA was
converted during the reaction to produce nylon.  Consequently, because
of limited exposure potential, 1,1-AA was dropped from further review. 
However, concern would arise if 1,1-AA were to be manufactured
domestically because of the greater likelihood for worker exposure.  To
alert EPA to domestic manufacture, on May 28, 1987, OPPT promulgated a
TSCA section 8(a)/5 (SNUR) rule for 1,1-AA (52 FR 19860) .  Users of
TSCA section 8(a) chemical-specific data rarely make a judgment based
solely on the content of the TSCA section 8(a) information received but
rather use the TSCA section 8(a) chemical-specific information as part
of the larger risk management strategy.  1,1-AA TSCA section 8(a)
information would be instrumental in affecting a benefit to human health
if a company were to begin to manufacture the substance.

3.  NON-DUPLICATION, CONSULTATION, AND OTHER COLLECTION CRITERIA

	3(a)	Non-Duplication

	Section 8(a)(2) of TSCA states, “To the extent feasible, the
Administrator shall not require any reporting which is unnecessary or
duplicative.”  The reporting requirements of TSCA section 8(a) rules
only require information that EPA believes will assist in a reasoned
evaluation of the human health and environmental effects of chemical
substances and mixtures.  This information is unlikely to be duplicative
since, (1) EPA estimates that each rule will generate only a few
notices, (2) the information required by the TSCA section 8(a) rule is
unique to the manufacturer, importer or processor (e.g., the proposed
date of production or importation, the amount produced or imported, the
chemical composition, and uses of the chemical substance or mixture),
and (3) EPA thoroughly checks other public and unpublished sources to
see if the required data may already be available.  Finally, once EPA
became aware of a source of substantially similar information, for
example via comments on a proposed rule, EPA would not continue with the
information collection.

	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

	EPA has not published a proposed or final TSCA section 8(a)
chemical-specific information gathering rule for more than fifteen years
and, therefore, has received no comments since that time.  EPA has
received comments on the use of TSCA section 8(a) reporting rules
through published Federal Register notices.  Various organizations
responded to EPA’s request for comments during the 1985 to 1988 ICR
period.  For example, the Agency originally proposed a SNUR for
4,4,1-methylenebis (2-chloroaniline) (MBOCA) but public comments
received in July and August of 1986 on the  proposed SNUR suggested that
a TSCA section 8(a) rule would be more appropriate.  This suggestion was
followed, reducing the burden on the public since the TSCA section 8(a)
rule exempted small manufacturers, whereas the proposed SNUR would not
have had this exemption.

	Also, after receiving public comment on the proposed SNUR/8(a) rule for
1,1- aminoundecanoic acid (July 22, 1986), the proposed definition of
the term “enclosed process” was modified to account for possible
releases through emergency pressure relief, thus expanding the number of
processes that would be considered “enclosed” and lessening
compliance costs.

	The Natural Resources Defense Council (NRDC) has also responded to
several TSCA section 8(a) chemical-specific rules.  The NRDC is a
national nonprofit environmental organization dedicated to the
protection of human health and the environment.  The NRDC generally
urges EPA to adopt a more extensive, detailed set of information
requirements.

EPA will pursue additional consultations with interested parties during
the development of the renewal of this collection.

	3(d)	Effects of Less Frequent Collection

	Generally companies are required to report only once under a TSCA
section 8(a) reporting rule.  EPA may consider requiring reporting on an
annual, semiannual, monthly or other basis if the Administrator deems
this necessary to protect human health and the environment.  EPA tailors
each rule to meet chemical-specific data requirements, thus reducing the
potential for too frequent data collections.

	3(e)	General Guidelines

	This information collection activity is necessary to implement the
statutory requirements of section 8(a) of TSCA and is consistent with
the requirements of 5 CFR 1320.6.

	3(f)	Confidentiality

	Submitters may designate information as confidential, trade secret or
proprietary.  EPA has implemented procedures to protect any
confidential, trade secret or 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.  TSCA section 8(a) reporting rules do
not include any questions of a sensitive nature.

4.  THE RESPONDENTS AND THE INFORMATION REQUESTED

	4(a)   Respondents/North American Industrial Classification System
(NAICS) Codes

	Respondents affected by this collection activity primarily include
those businesses that fall under NAICS codes 325, Chemical Manufacturers
and Processors, and 324110, Petroleum Refineries.

	4(b)	Information Requested

		4(b)(i)	 Data Items

	Section 8(a) of TSCA specifically lists a wide range of data items that
may be required by EPA, including information on use, production volume,
exposure, and health and safety.  Data items requested of manufacturers,
importers, or processors of certain chemicals vary with each collection
request, but will not repeat information previously requested in the
PAIR or other information gathering tools.  Some data items requested
under TSCA section 8(a) chemical-specific rules in the past include:
notification and description of changes in the end use of identified
substances and mixtures, information on planned manufacturing and
on-site processing, and notification of changes to the method of
manufacturing the substance (see 40 CFR subpart B).

	An example of a past TSCA section 8(a) chemical-specific rule is one
issued on 4,4,1-methylenebis (2-chloroaniline) (MBOCA).  It required
persons who propose to manufacture MBOCA to notify EPA of that intent
and to submit information on their planned manufacturing and on-site
processing activities.  The rule also required persons who are
manufacturing MBOCA to notify the Agency if they propose to alter their
manner or method of manufacturing the substance.

		4(b)(ii)  Respondent Activities

	Activities a respondent may be required to perform as a result of TSCA
section 8(a) chemical-specific rule are as follows:

9 to 29.5 Hours of Managerial Labor

- Identify listed chemicals;

- Assign principal technical contact person;

- Identify by-product;

- Review marketing data;

- Research the date of the initiation of manufacture or importation of
the chemical;

- Research occupational exposure, environmental release, health and
environmental data, disposal methods; and

- Process, compile, and review information for accuracy, substantiate a
claim of confidential business information.

17.5 to 98 Hours of Technical Labor

- Identify chemical and trade name and chemical composition;

- Identify by-product;

- Describe use of chemical;

- Report quantity manufactured or imported;

- Research workplace exposures, environmental releases, health and
environmental data, and disposal methods; and

- Provide occupational description.

7 to 21 Hours of Clerical Labor

- Format research on occupational exposures, environmental releases,
health and environmental data;

- Format attachments; and

- Prepare notice.

Recordkeeping Estimate

	TSCA section 8(a) chemical-specific rules may contain recordkeeping
requirements.  The recordkeeping estimate is rough, but it is reasonably
related to the maximum reporting burden.  EPA estimates that
recordkeeping will account for approximately five percent of the
reporting burden, or a maximum of 12 hours (see Table 2.)

5.	THE INFORMATION COLLECTED -- AGENCY ACTIVITIES, COLLECTION
METHODOLOGY AND INFORMATION MANAGEMENT

	5(a)	Agency Activities Inventory

	For any TSCA section 8(a) chemical-specific rule the Agency would have
to perform a number of tasks.  They are:

	Industry/Public Assistance (answering questions regarding rule)

	Data Processing and System Support Personnel

	Storage and Distribution

	Compliance Monitoring

	5(b)	Collection Methodology and Management

	An improved information technology to minimize burden of a TSCA section
8(a) chemical-specific rule has not been found.  EPA has not been able
to identify a more efficient, less expensive, or more flexible means of
obtaining the required data than the one currently being used.  To the
extent data are not CBI, all information collected is made available to
the public through the public docket office.  At the present time, EPA
is not requiring firms to submit this information on one standard
reporting form.  Reporting facilities will be able to choose the format
that best suits their reporting resources.  TSCA section 8(a)
chemical-specific rules typically require one-time reporting.  As future
data needs arise, EPA will consider the use of electronic or other types
of reporting methods.  EPA believes the flexibility already allowed in
the reporting structure significantly eases burden.

	5(c)	Small Entity Flexibility

	Section 8(a) of TSCA generally exempts small manufacturers and
processors.  However, under TSCA section 8(a)(3), EPA may require small
manufacturers and processors to report or keep records if the substance
or mixture is subject to a rule proposed or promulgated under TSCA
sections 4, 5(b)(4), or 6 or with respect to which relief has been
granted pursuant to a civil action brought under sections 5 or 7 of
TSCA.  All respondents to TSCA section 8(a) chemical-specific rules,
including small businesses, are granted flexibility in their reporting
methods.

	5(d)	Collection Schedule

	TSCA section 8(a) chemical-specific rules are generally one-time
collections of specific information, usually regarding one chemical
substance.  Proposed TSCA section 8(a) chemical-specific rules request
comments.  The comments are then addressed and incorporated as
appropriate in the final rule, which specifies the reporting deadline. 
Generally, EPA requires that information be reported no sooner than 30
days after the effective date of a final rule.

6.  ESTIMATING THE BURDEN AND COST OF THE COLLECTION

	6(a)	Estimating Respondent Burden

	Wage rates including fringe benefits and overhead for three broad
categories of labor (managerial, technical, and clerical) were used in
this analysis.  The labor categories and methods for estimating loaded
wage rates were developed during previous studies.  The basis for
estimating wage rates for these purposes is the Bureau of Labor
Statistics (BLS) Employer Costs for Employee Compensation: Private
Manufacturing Industry by Occupation, December 2005. The data series
used for this and other analyses is no longer published directly by the
BLS, but the BLS continues to make this data available to EPA. Based on
the BLS data, the average hourly wage rates (as of December 2005) are
$38.22for managerial personnel, $31.02 for technical personnel and
$15.73 for clerical personnel.

	The benefits and overhead loading factors are calculated from the BLS
data on the cost of benefits, with 17 percent of the average wage added
for overhead. The overhead factor of 17 percent is based on information
provided by the chemical industry and chemical industry trade
associations. The loaded hourly wage rates are $63.61 for managerial
personnel, $53.02 for technical personnel and $26.37 for clerical
personnel, as shown in Table 1.

TABLE 1: LOADED HOURLY WAGE RATES BY LABOR CATEGORY

Labor Category	December 2005 

Average Wages	December 2005

Benefits and Overhead

Loading Factor	December 2005

Loaded 

Hourly Rate

Managerial	$38.22	1.66	$63.61

Technical	$31.02	1.71	$53.02

Clerical	$15.73	1.68	$26.37

Sources:	Unpublished Employer Costs for Employee Compensation: Private
Manufacturing Industry by Occupation, December 2005. Data received by
Carol Rawie, US EPA, from Raphael Branch, US Bureau of Labor Statistics,
May 10, 2006. 

	This ICR maintains the assumption of the previous ICR that an average
of four notices per year are submitted in response to one section 8(a)
chemical-specific rule per year. Current labor rates and burden hours
used to calculate cost to respondents are listed below.

     Labor Category	Burden Hours	Hourly Rate

     Managerial	  9 to 29.5	$ 63.61

     Technical	17.5 to 98	$ 53.02

     Clerical	  7 to 21	$ 26.37

	6(b)	Estimating Respondent Costs

	

	The following are the tasks that managers, technical, and clerical
personnel are expected to perform in preparing a notice.  However, as
discussed at the end of this section and presented in Table 1, not all
respondents are likely to be required to perform all tasks under each
labor category.  Therefore, the ranges of labor hours presented below
for each labor category (e.g., 9 to 29.5 hours for managers) are the
maximums and are based on the assumption that all tasks are performed
for each notice.

Managerial Labor

1.  Manufacturer identifies listed chemicals;

2.  Assign principal technical contact person;

3.  Identify by-product;

4.  Review marketing data;

5.  Research the date of the initiation of manufacture or importation of
the chemical;

6.  Research occupational exposure, environmental release, health and
environmental data, disposal methods;

7.  Process, compile, and review information for accuracy, substantiate
a claim of

	     confidential business information.

	In performing these tasks, managerial labor hours have been estimated
to range from 9.5 to 29.5 hours per TSCA section 8(a) chemical-specific
rule.  At $63.61 per hour for management labor times the range of hours
predicted, [$63.61 x (9.5 to 29.5)], the range of cost for management
work is $604 to $1,876 per notice resulting from a TSCA section 8(a)
chemical-specific rule.  With an average of four notices per year for
the three-year ICR period, the range of  costs per year for managerial
labor is [4 x ($604 to $1,876)] = $2,416 to $7,504.

Technical Labor

1.  Identify chemical and trade name and chemical composition;

2.  Identify by-product;

3.  Describe use of chemical;

4.  Report quantity manufactured or imported;

5.  Research occupational exposures, environmental releases, health and
environmental data, and disposal methods; 

	6.  Provide occupational description.

	In performing these tasks, technical labor hours have been estimated to
range from 17.5 to 98 hours per notice resulting from a TSCA section
8(a) chemical-specific rule.  At $53.02 per hour for technical labor,
times the range of hours predicted, ($53.02 x [17.5 to 98]), a range of
cost for technical work is estimated to be $928 to $5,196 per notice
resulting from a TSCA section 8(a) chemical-specific rule.  With four
notices per year for a three-year period, the range of annual costs for
technical labor is [4 x ($928 to $5,196)] = $3,712 to $20,784.

Clerical Labor 

1.  Format research on occupational exposure, environmental releases,
health and

	     environmental data;

2.  Format attachments;

3.  Prepare Notice.

	In performing these tasks, clerical labor has been estimated to range
from 7 to 21 hours per notice resulting from a TSCA section 8(a)
chemical-specific rule.  At $26.37 per hour for clerical labor, times
the range of hours predicted, ($26.37 x [7 to 21]), the range of cost
for clerical work is estimated to be $185 to $554 per notice resulting
from a TSCA section 8(a) chemical-specific rule.  With four notices per
TSCA section 8(a) chemical-specific rule, the range of costs per year
for clerical labor is [4 x ($185 to $554)] = $740 to $2,216.

	The cost to a respondent for filing a TSCA section 8(a) notice depends
upon the various tasks performed.  These tasks could include gathering
the required data, preparing and submitting the TSCA section 8(a)
notice, and possibly keeping records.  Based on promulgated TSCA section
8(a) rules, EPA estimates that each respondent will submit one notice
per TSCA section 8(a) chemical-specific rule.  EPA anticipates issuing
one TSCA section 8(a) rule per year and expects to receive an average of
four notices per year.

	The cost to a respondent for submitting a TSCA section 8(a) notice is a
function of the number of hours and the hourly labor costs for the
individuals developing and preparing the notice.  The annual estimated
range of cost to the respondent is $1,717 ($604 +  $928 + $185) to
$7,626 ($1,876 + $5,196 + $554) per notice, and $6,868 to $30,504 per
TSCA section 8(a) chemical-specific rule (above estimates multiplied by
four, the number of notices expected per rule.) However, as mentioned
above, these figures are likely to overstate the true cost because not
all respondents may be required to supply information regarding each
activity. Thus, the average actual cost to the respondent will be lower
than the $1,717 to $7,626 per notice estimate calculated above. The
estimated frequency of each activity, along with total respondent cost
and burden calculations, is presented in Table 1.  The total cost to all
respondents of reporting under a TSCA section 8(a) chemical-specific
rule is estimated to range from $3,375 to $14,080 per year.  On a per
respondent basis, the annual cost is estimated to range from $894 to
$3,520 per notice, based on four notices per year.

Table 2.  Total Annual Respondent Burden and Costs Associated with
Preparing and Filing a TSCA Section 8(a) Notice

Activity	Managerial Hours $92.33/hr	Technical Hours $68.35/hr	Clerical
Hours $27.24/hr	Notices per Year	Annual Burden Hours	Annual Costs

Manufacturer ID

and Principal Technical Contact	1 - 4

	  4	 4 - 16	$254-

$1,018

Chemical and

Trade Name

1 - 4

  3	3 - 12	$159-

$636

Chemical

Composition

0.5 - 2

  4	2 - 8	$106-

$424

Byproduct ID	1	1 - 4

  2	4 - 10	$233-

$551

Use Description

1 - 4

  4	4 - 16	$212-

$848

Quantity Manufactured

or Imported

1 - 4

  4	4 - 16	$212-

$848

Marketing Data	1 - 2

	  2	2 - 4	$127-

$254

Date of Initiation

of  Manufacture or Importation	0.5

	  4	2	$127

Occupational Exposure	1 - 4	2 - 16	1 - 3	  2	8 - 46	$392-

$2,364

Environmental Release	1 - 4	1 - 8	1 - 3	  2	6 - 30	$286-

$1,515

Occupational Description

1 - 10

  1	1 - 10	$53-

$530

Health and Envi-ronmental Data	2 - 8	8 - 40	1-3	  1	11 - 51	$578-

$2,709

Disposal Methods	1 - 2	1 - 6

  1	2 - 8	$117-

$445

Attachments

	2 - 6	  1	2 - 6	$53-

$158

Preparation of

Notice

	1 - 3	  4	4 - 12	$105-

$316

Managerial/Legal Review of Submission	1 - 4

	  4	4 - 16	$254-

$1,018

Recordkeeping

	1 - 3	  4	4 - 12	$105-

$316

TOTAL	9.5 - 29.5	17.5 - 98	7 - 21

67 - 275	$3,375 -

$14,080

	6(c)	Estimating Agency Burden and Cost

	The Agency has developed the following burden hour estimates for
activities related to promulgating a section 8(a) Chemical Specific
rule.

	Activity							Burden

		o  Industry/Public Assistance	(answering		0.1  FTE

	     	    questions regarding the rule)

		o  Data processing and systems support personnel	0.2  FTE

		o  Storage and Distribution				0.1  FTE

		o Compliance monitoring				0.1  FTE

	Total FTEs							0.5  FTE

	The Office of Pollution Prevention and Toxics bases its burden hour and
labor cost estimates on prior experience in gathering and processing
information associated with other information collections.  Because
Agency activities involve a team approach, the Agency has used a
composite burden hour estimate containing workers at various GS levels
and calculated hourly costs based upon the wage rate for a GS-12 Step 1.
 The year 2006 annual salary for a GS-12 Step 1 in the Washington DC
locality area is $65,048.  The cost for 0.5 FTE is $32,524. 
Incorporation of an overhead and benefits factor of .6 yields a fully
loaded cost of $52,038 to the Agency for promulgating and supporting a
TSCA section 8(a) chemical-specific rule. The full-time work year is
considered to be 2,080 so that there are 1,040 burden hours associated
with 0.5 FTE.

					

	6(d)	Bottom Line Burden Hours and Costs

	The following table displays the annual burden and costs borne by
respondents and EPA associated with preparing, filing and reviewing a
notice resulting from a TSCA section 8(a) chemical-specific rule.

Table 3.  Annual Burden and Cost of a TSCA Section 8(a)
Chemical-Specific Rule

	Annual Burden Hours	Annual Costs

Industry	67 to 275 	$3,375 to $14,080

Agency	1,040	 $52,038



	6(e)	Reasons for Change in Burden

	

	The current request for renewal estimates a total annual burden to
respondents of 275 hours, which is unchanged from the previous ICR
renewal.

 

	EPA anticipates issuing one TSCA section 8(a) chemical-specific rule
per year with an average of four respondents submitting notices per
rule.  EPA may promulgate more than one TSCA section 8(a)
chemical-specific rule per year over the next three years.  If EPA does
this, the Agency will submit a technical amendment to OMB to reflect the
change in estimated burden to the regulated industry and the government.

	(6)(f)	Burden Statement

	The public burden for this collection of information is estimated to
average 68.8 hours per response (one-quarter of maximum annual burden of
275 hours for four notices).  Of the 68.8 hours, 65.8 hours are
associated with reporting tasks such as reviewing instructions,
gathering the data needed, and completing and reviewing the collection
of information.  The remaining three hours are associated with
recordkeeping.  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.  This includes the
time needed to review instructions; develop, acquire, install, and
utilize technology and systems for the purposes of collecting,
validating, and verifying 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;
and transmit or otherwise disclose the information.  An Agency may not
conduct or sponsor such a request and a person or facility is not
required to respond to a collection of information unless it displays a
currently valid OMB control number.  The OMB control numbers for EPA’s
regulations are listed in 40 CFR Part 9 and 48 CFR Part 15.

	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-2006-0852.  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-2006-

0852 and OMB control number 2070-0067 in any correspondence.

					

						

  SEQ CHAPTER \h \r 1 

ATTACHMENT 1

Toxic Substances Control Act Section 8(a)

15 U.S.C. 2607

Sec. 2607. Reporting and retention of information 

(a) Reports 

(1) The Administrator shall promulgate rules under which - 

(A) each person (other than a small manufacturer or processor) who
manufactures or processes or proposes to manufacture or process a
chemical substance (other than chemical substance described in
subparagraph (B)(ii)) shall maintain such records, and shall submit to
the Administrator such reports, as the Administrator may reasonably
require, and 

(B) each person (other than a small manufacturer or processor) who
manufactures or processes or proposes to manufacture or process - 

			(i) a mixture, or 

(ii) a chemical substance in small quantities (as defined by the
Administrator by rule) solely for purposes of scientific experimentation
or analysis or chemical research on, or analysis of, such substance or
another                    substance, including any such research or
analysis for the                    development of a product, shall
maintain records and submit to the Administrator reports but only to the
extent the Administrator determines the  maintenance of records or
submission of reports, or both, is necessary for the effective
enforcement of this chapter. The Administrator may not require in a rule
promulgated under this paragraph the maintenance of records or the
submission of reports with respect to changes in the proportions of the
components of a mixture unless the Administrator finds that the
maintenance of such records or the submission of such reports, or both,
is necessary for the  effective enforcement of this chapter. For
purposes of the compilation of the list of chemical substances required
under subsection (b) of this section, the Administrator shall promulgate
rules pursuant to this subsection not later than 180 days after January
1, 1977. 

(2) The Administrator may require under paragraph (1) maintenance of
records and reporting with respect to the following insofar as known to
the person making the report or insofar as reasonably ascertainable:

(A) The common or trade name, the chemical identity, and the molecular
structure of each chemical substance or mixture for which such a report
is required.

(B) The categories or proposed categories of use of each such substance
or mixture. 

(C) The total amount of each such substance and mixture manufactured or
processed, reasonable estimates of the total amount to be manufactured
or processed, the amount manufactured or processed for each of its
categories of use, and reasonable estimates of the amount to be
manufactured or processed for each of its categories of use or proposed
categories of use.

(D) A description of the byproducts resulting from the manufacture,
processing, use, or disposal of each such substance or mixture.

(E) All existing data concerning the environmental and health effects of
such substance or mixture. 

(F) The number of individuals exposed, and reasonable estimates of the
number who will be exposed, to such substance or mixture in their places
of employment and the duration of such exposure. 

(G) In the initial report under paragraph (1) on such substance or
mixture, the manner or method of its disposal, and in any subsequent
report on such substance or mixture, any change in such manner or
method. To the extent feasible, the Administrator shall not require
under paragraph (1), any reporting which is unnecessary or duplicative. 

	(3)

		(A)

(i) The Administrator may by rule require a small manufacturer or
processor of a chemical substance to submit to the Administrator such
information respecting the chemical substance as the Administrator may
require for publication of the first list of chemical substances
required by subsection (b) of this section.

(ii) The Administrator may by rule require a small manufacturer or
processor of a chemical substance or mixture -

(I) subject to a rule proposed or promulgated under section 2603,
2604(b)(4), or 2605 of this title, or an order in effect under section
2604(e) of this title, or

(II) with respect to which relief has been granted pursuant to a civil
action brought under section 2604 or 2606 of this title, to maintain
such records on such substance or mixture, and to submit to the
Administrator such reports on such substance or mixture, as the
Administrator may reasonably require. A rule under this clause requiring
reporting may require reporting with respect to the matters referred to
in paragraph (2).

(B) The Administrator, after consultation with the Administrator of the
Small Business Administration, shall by rule prescribe standards for
determining the manufacturers and processors which qualify as small
manufacturers and processors for purposes of this paragraph and
paragraph (1). 



ATTACHMENT 2

40 CFR 704

General Reporting and Recordkeeping Provisions

for Section 8(a) Information-Gathering Rules

PART 704--REPORTING AND RECORDKEEPING REQUIREMENTS--Table of Contents

 

Subpart A--General Reporting and Recordkeeping Provisions for Section
8(a) Information-Gathering Rules

Sec. 704.1  Scope.

(a) This part specifies reporting and recordkeeping procedures under
section 8(a) of the Toxic Substances Control Act (TSCA) for
manufacturers, importers, and processors of chemical substances and
mixtures (hereafter collectively referred to as substances) that are
identified in subpart B of this part. The reporting and recordkeeping
provisions in subpart A of this part apply throughout this part unless
revised in any other subpart.

(b) Subpart B of this part sets out chemical-specific reporting and
recordkeeping requirements under section 8(a) of TSCA.

[53 FR 51715, Dec. 22, 1988, as amended at 60 FR 31920, June 19, 1995]

Sec. 704.3  Definitions.

All definitions as set forth in section 3 of TSCA apply in this part. In
addition, the following definitions are provided for the purposes of
this part.

Annual means the corporate fiscal year.

Article means a manufactured item (1) which is formed to a specific
shape or design during manufacture, (2) which has end use function(s)
dependent in whole or in part upon its shape or design during end use,
and (3) which has either no change of chemical composition during its
end use or only those changes of composition which have no commercial
purpose separate from that of the article, and that result from a
chemical reaction that occurs upon end use of other chemical substances,
mixtures, or articles; except that fluids and particles are not
considered articles regardless of shape or design.

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).

CAS Number means Chemical Abstracts Service Registry Number.

Coproduct means a chemical substance produced for a commercial purpose
during the manufacture, processing, use, or disposal of another chemical
substance or mixture.

Customer means any person to whom a manufacturer, importer, or processor
directly distributes any quantity of a chemical substance, mixture,
mixture containing the substance or mixture, or article containing the
substance or mixture, whether or not a sale is involved.

Domestic means within the geographical boundaries of the 50 United
States, including the District of Columbia, the Commonwealth of Puerto
Rico, the Virgin Islands, Guam, American Samoa, the Northern Mariana
Islands, and any other territory or possession of the United States.

Enclosed process means a manufacturing or processing operation that is
designed and operated so that there is no intentional release into the
environment of any substance present in the operation. An operation with
fugitive, inadvertent, or emergency pressure relief releases remains an
enclosed process so long as measures are taken to prevent worker
exposure to and environmental contamination from the releases.

EPA means the United States Environmental Protection Agency.

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
also are imported for commercial purposes.

Import in bulk form means to import a chemical substance (other than as
part of a mixture or article) in any quantity, in cans, bottles, drums,
barrels, packages, tanks, bags, or other containers, if the chemical
substance is intended to be removed from the container and the substance
has an end use or commercial purpose separate from the container.

Importer means 

(1) any person who imports any chemical substance or any chemical
substance as part of a mixture or article into the customs territory of
the United States, and includes:

(i) The person primarily liable for the payment of any duties on the
merchandise, or

(ii) An authorized agent acting on his behalf (as defined in 19 CFR
1.11).

(2) Importer also includes, as appropriate:

(i) The consignee.

(ii) The importer of record.

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

(iv) 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.

(3) For the purposes 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.

Intermediate means any chemical substance that is consumed, in whole or
in part, in chemical reactions used for the intentional manufacture of
other chemical substances or mixtures, or that is intentionally present
for the purpose of altering the rates of such chemical reactions.

Known to or reasonably ascertainable by means all information in a
person's possession or control, plus all information that a reasonable
person similarly situated might be expected to possess, control, or
know.

Manufacture means to manufacture for commercial purposes.

Manufacture for commercial purposes means: 

(1) 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 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 both byproducts that
are separated from that other substance 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.

Manufacturer means a person who imports, 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.

Non-isolated intermediate means any intermediate that is not
intentionally removed from the equipment in which it is manufactured,
including the reaction vessel in which it is manufactured, equipment
which is ancillary to the reaction vessel, and any equipment through
which the substance passes during a continuous flow process, but not
including tanks or other vessels in which the substance is stored after
its manufacture. Mechanical or gravity transfer through a closed system
is not considered to be intentional removal, but storage or transfer to
shipping containers ``isolates'' the substance by removing it from
process equipment in which it is manufactured.

Own or control means ownership of 50 percent or more of a company's
voting stock or other equity rights, or the power to control the
management and policies of that company. A company may own or control
one or more sites. A company may be owned or controlled by a foreign or
domestic parent company.

Parent company is a company that owns or controls another company.

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.

Possession or control means in the possession or control of any person,
or of any subsidiary, partnership in which the person is a general
partner, parent company, or any company or partnership which the parent
company owns or controls, if the subsidiary, parent company, or other
company or partnership is associated with the person in the research,
development, test marketing, or commercial marketing of the substance in
question. Information is in the possession or control of a person if it
is:

(1) In the person's own files including files maintained by employees of
the person in the course of their employment.

(2) In commercially available data bases to which the person has
purchased access.

(3) Maintained in the files in the course of employment by other agents
of the person who are associated with research, development, test
marketing, or commercial marketing of the chemical substance in
question.

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 in this definition. If a chemical
substance or mixture containing impurities is processed for commercial
purposes, then the impurities also are processed for commercial
purposes.

Processor means any person who processes a chemical substance or
mixture.

Production volume means the quantity of a substance which is produced by
a manufacturer, as measured in kilograms or pounds.

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

Site means a contiguous property unit. Property divided only by a public
right-of-way shall be considered one site. There may be more than one
plant on a single site. The site for a person who imports a substance is
the site of the operating unit within the person's organization which is
directly responsible for importing the substance and which controls the
import transaction and may in some cases be the organization's
headquarters office in the United States.

Small manufacturer or importer means a manufacturer or importer that
meets either of the following standards:

(1) First standard. A manufacturer or importer of a substance is small
if its total annual sales, when combined with those of its parent
company (if any), are less than $40 million. However, if the annual
production or importation volume of a particular substance at any
individual site owned or controlled by the manufacturer or importer is
greater than 45,400 kilograms (100,000 pounds), the manufacturer or
importer shall not qualify as small for purposes of reporting on the
production or importation of that substance at that site, unless the
manufacturer or importer qualifies as small under standard (2) of this
definition.

(2) Second standard. A manufacturer or importer of a substance is small
if its total annual sales, when combined with those of its parent
company (if any), are less than $4 million, regardless of the quantity
of substances produced or imported by that manufacturer or importer.

(3) Inflation index. EPA shall make use of the Producer Price Index for
Chemicals and Allied Products, as compiled by the U.S. Bureau of Labor
Statistics, for purposes of determining the need to adjust the total
annual sales values and for determining new sales values when
adjustments are made. EPA may adjust the total annual sales values
whenever the Agency deems it necessary to do so, provided that the
Producer Price Index for Chemicals and Allied Products has changed more
than 20 percent since either the most recent previous change in sales
values or the date of promulgation of this rule, whichever is later. EPA
shall provide Federal Register notification when changing the total
annual sales values.

Small quantities solely for research and development (or “small
quantities solely for purposes of scientific experimentation or analysis
or chemical research on, or analysis of, such substance or another
substance, including such research or analysis for the development of a
product”) means quantities of a chemical substance manufactured,
imported, or processed or proposed to be manufactured, imported, or
processed solely for research and development that are not greater than
reasonably necessary for such purposes.

Substance means either a chemical substance or mixture unless otherwise
indicated.

Test marketing means the distribution in commerce of no more than a
predetermined amount of a chemical substance, mixture, article
containing that chemical substance or mixture, or a mixture containing
that substance, by a manufacturer or processor, to no more than a
defined number of potential customers to explore market capability in a
competitive situation during a predetermined testing period prior to the
broader distribution of that chemical substance, mixture, or article in
commerce.

Total annual sales means the total annual revenue (in dollars) generated
by the sale of all products of a company. Total annual sales must
include the total annual sales revenue of all sites owned or controlled
by that company and the total annual sales revenue of that company's
subsidiaries and foreign or domestic parent company, if any.

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

[53 FR 51715, Dec. 22, 1988]

Sec. 704.5  Exemptions.

A person who is subject to reporting requirements for a substance
identified in this part is exempt from those requirements to the extent
that the person and that person's use of the substance is described in
this section. This section is superseded by any TSCA section 8(a) rule
that adds to, removes, or revises the exemptions described in this
section.

(a) Articles. A person who imports, processes, or proposes to import or
process a substance identified in this part solely as part of an article
is exempt from the reporting requirements of this part with regard to
that substance.

(b) Byproducts. A person who manufactures, imports, or proposes to
manufacture or import a substance identified in this part solely as a
byproduct is exempt from the reporting requirements of this part.

(c) Impurities. A person who manufactures, imports, processes, or
proposes to manufacture, import, or process a substance identified in
this part solely as an impurity is exempt from the reporting
requirements of this part.

(d) Non-isolated intermediate. A person who manufactures or proposes to
manufacture a substance identified in this part solely as a non-isolated
intermediate is exempt from the reporting requirements of this part.

(e) Research and development. A person who manufactures, imports,
processes, or proposes to manufacture, import, or process a substance
identified in this part only in small quantities solely for research and
development is exempt from the reporting requirements of this part.

(f) Small manufacturers and importers. Small manufacturers and importers
are exempt from the reporting requirements of this part.

[53 FR 51717, Dec. 22, 1988]

Sec. 704.7  Confidential business information claims.

(a) Any person submitting a notice under this rule may assert a business
confidentiality claim covering all or any part of the notice. Any
information covered by a claim will be disclosed by EPA only to the
extent and by means of the procedures set forth in part 2 of this title.

(b) If no claim accompanies the notice at the time it is submitted to
EPA, the notice will be placed in an open file available to the public
without further notice to the respondent.

(c) To assert a claim of confidentiality for data contained in a notice,
the respondent must submit two copies of the notice.

(1) One copy of the notice must be complete. In that copy the respondent
must indicate what data, if any, are claimed as confidential by marking
the specific information on each page with a label such as
``confidential'', ``proprietary'', or ``trade secret''.

(2) If some data in the notice are claimed as confidential, the
respondent must submit a second copy. The second copy must be complete
except that all information claimed as confidential in the first copy
must be deleted.

(3) The first copy of the notice 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 of the notice 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 has 15 days
from the date of receipt of notification to submit the required second
copy. Failure to submit the second copy will cause EPA to place the
first copy in the public file.

(d) In submitting a claim of confidentiality, a person attests to the
truth of the following four statements concerning all information which
is claimed confidential:

(1) My company has taken measures to protect the confidentiality of the
information, and it intends to continue to take such measures.

(2) The information is not, and has not been, reasonably obtainable
without our consent by other persons (other than government bodies) by
use of legitimate means (other than discovery based on a showing of
special need in a judicial or quasi-judicial proceeding).

(3) The information is not publicly available elsewhere.

(4) Disclosure of the information would cause substantial harm to our
competitive position.

[48 FR 23420, May 25, 1983, as amended at 53 FR 51717, Dec. 22, 1988]

Sec. 704.9  Where to send reports.

Reports must be submitted 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, ATT: 8(a) Reporting.

[60 FR 34463, July 3, 1995]

Sec. 704.11  Recordkeeping.

Each person who is subject to the reporting requirements of this part
must retain the following records for 3 years following the creation or
compilation of the record.

(a) A copy of each report submitted by the person in response to the
requirements of this part.

(b) Materials and documentation sufficient to verify or reconstruct the
values submitted in the report.

(c) A copy of each notice sent by the person, return receipt requested,
to that person's customers for the purpose of notifying their customers
of the customer's reporting obligations under this part.

(d) All return receipts signed by the person's customers who received
the notice described in paragraph (c) of this section.

[53 FR 51717, Dec. 22, 1988, as amended at 58 FR 34204, June 23, 1993]

Sec. 704.13  Compliance and enforcement.

Violators of the requirements of this part may be subject to civil
administrative penalties up to $25,000 per day of violation or criminal
prosecution, as provided in sections 15 and 16 of TSCA. In addition,
under section 17, EPA may seek judicial relief to compel submission of
required information.

[53 FR 51717, Dec. 22, 1989]

Subpart B--Chemical-Specific Reporting and Recordkeeping Rules

Sec. 704.25  11-Aminoundecanoic acid.

(a) Definitions.

(1) 11-AA means the chemical substance 11-aminoundecanoic acid, CAS
Number 2432-99-7.

(2) Enclosed process means a process that is designed and operated so
that there is no intentional release of any substance present in the
process. A process with fugitive, inadvertent, or emergency pressure
relief releases remains an enclosed process so long as measures are
taken to prevent worker exposure to an environmental contamination from
the releases.

(3) Internal subunit means a subunit that is covalently linked to at
least two other subunits. Internal subunits of polymer molecules are
chemically derived from monomer molecules that have formed covalent
links between two or more other molecules.

(4) Monomer means a chemical substance that has the capacity to form
links between two or more other molecules.

(5) Polymer means a chemical substance that consists of at least a
simple weight majority of polymer molecules but consists of less than a
simple weight majority of molecules with the same molecular weight.
Collectively, such polymer molecules must be distributed over a range of
molecular weights wherein differences in molecular weight are primarily
attributable to differences in the number of internal subunits.

(6) Polymer molecule means a molecule which includes at least four
covalently linked subunits, at least two of which are internal subunits.

(7) Small processor means a processor that meets either the standard in
paragraph (a)(7)(i) of this section or the standard in paragraph
(a)(7)(ii) of this section.

(i) First standard. A processor of a chemical substance is small if its
total annual sales, when combined with those of its parent company, if
any, are less than $40 million. However, if the annual processing volume
of a particular chemical substance at any individual site owned or
controlled by the processor is greater than 45,400 kilograms (100,000
pounds), the processor shall not qualify as small for purposes of
reporting on the processing of that chemical substance at that site,
unless the processor qualifies as small under paragraph (a)(7)(ii) of
this section.

(ii) Second standard. A processor of a chemical substance is small if
its total annual sales, when combined with those of its parent company
(if any), are less than $4 million, regardless of the quantity of the
particular chemical substance processed by that company.

(iii) Inflation index. EPA will use the Inflation Index described in the
definition of small manufacturer set forth in Sec. 704.3, for purposes
of adjusting the total annual sales values of this small processor
definition. EPA will provide notice in the Federal Register when
changing the total annual sales values of this definition.

(8) Subunit means an atom or group of associated atoms chemically
derived from corresponding reactants.

(b) Persons who must report. Except as provided in paragraph (c) of this
section, the following persons are subject to this section:     

(1) Persons who manufacture or propose to manufacture 11-AA:

(i) For use as an intermediate in the manufacture of polymers in an
enclosed process when it is expected that the 11-AA will be fully
polymerized during the manufacturing process, or

(ii) For use as a component in photoprocessing solutions.

(2) Persons who import or propose to import 11-AA:

(i) For use as an intermediate in the manufacture of polymers in an
enclosed process when it is expected that the 11-AA will be fully
polymerized during the manufacturing process, or

(ii) For use as a component in photoprocessing solutions.

(3) Persons who process or propose to process 11-AA:

(i) For use as an intermediate in the manufacture of polymers in an
enclosed process when it is expected that the 11-AA will be fully
polymerized during the manufacturing process, or

(ii) For use as a component in photoprocessing solutions.

(c) Persons not subject to this section. The following persons are not
subject to this section:

(1) Small manufacturers (includes importers) as described in Sec. 704.3.

(2) Small processors.

(3) Persons described in Sec. 704.5.

(4) Persons who, at any time during the 3-year period ending July 22,
1986, manufactured, imported, or processed 11-AA:

(i) For use as an intermediate in the manufacture of polymers in an
enclosed process when it is expected that the 11-AA will be fully
polymerized during the manufacturing process, or

(ii) For use as a component in photoprocessing solutions.

(d) What information to report. Persons identified in paragraph (b) of
this section must submit a Premanufacture Notice Form (EPA Form
7710-25).

(e) When to report. 

(1) Persons who intend to manufacture, import, or process 11-AA for use
as an intermediate in the manufacture of polymers in an enclosed process
when it is expected that the 11-AA will be fully polymerized during the
manufacturing process or for use as a component in photoprocessing
solutions must notify EPA within 30 days after making a firm management
decision to commit financial resources for the manufacturing, importing,
or processing of 11-AA.

(2) Persons who initiated manufacturing, importing, or processing of
11-AA for use as an intermediate in the manufacture of polymers in an
enclosed process when it is expected that the 11-AA will be fully
polymerized during the manufacturing process, or for use as a component
in photoprocessing solutions during the time period between July 22,
1986 and July 13, 1987 must notify EPA by August 10, 1987.

(f) Recordkeeping. Persons subject to the reporting requirements of this
section must retain documentation of information contained in their
reports for a period of 5 years from the date of submission of the
report.

(g) Where to send reports. Reports must be submitted 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, ATT: 11-AA Notification.

[52 FR 19864, May 28, 1987, as amended at 60 FR 16308, Mar. 29, 1995; 60
FR 34463, July 3, 1995]

Sec. 704.33  P-tert-butylbenzoic acid (P-TBBA), p-tert-butyltoluene
(P-TBT) and p-tert-butylbenzaldehyde (P-TBB).

(a) Definitions. 

(1) P-TBBA means the substance p-tert-butylbenzoic acid, also identified
as 4-(1,1-dimethylethyl)benzoic acid, CAS No. 98-73-7.

(2) P-TBT means the substance p-tert-butyltoluene, also identified as
1-(1,1-dimethylethyl)-4-methylbenzene, CAS No. 98-51-1.

(3) P-TBB means the substance p-tert-butylbenzaldehyde, also identified
as 4-(1,1-dimethylethyl)benzaldehyde, CAS No. 939-97-9.

(4) Small processor means a processor that meets either the standard in
paragraph (a)(4)(i) of this section or the standard in paragraph
(a)(4)(ii) of this section.

(i) First standard. A processor of a chemical substance is small if its
total annual sales, when combined with those of its parent company, if
any, are less than $40 million. However, if the annual processing volume
of a particular chemical substance at any individual site owned or
controlled by the processor is greater than 45,400 kilograms (100,000
pounds), the processor shall not qualify as small for purposes of
reporting on the processing of that chemical substance at that site,
unless the processor qualifies as small under paragraph (a)(1)(ii) of
this section.

(ii) Second standard. A processor of a chemical substance is small if
its total annual sales, when combined with those of its parent company
(if any), are less than $4 million, regardless of the quantity of the
particular chemical substance processed by that company.

(iii) Inflation index. EPA shall use the Inflation Index described in
the definition of small manufacturer that is set forth in Sec. 704.3,
for purposes of adjusting the total annual sales values of this small
processor definition. EPA shall provide Federal Register notification
when changing the total annual sales values of this definition.

(b) Persons who must report. Except as provided in paragraph (c) of this
section, the following persons are subject to the reporting requirements
of this rule; a person may become subject to this rule more than once,
for more than one substance or under more than one of the criteria
listed in this paragraph (b).

(1) Persons who manufactured, imported, or processed P-TBBA, P-TBT,
and/or P-TBB for commercial purposes during the person's latest complete
corporate fiscal year prior to June 25, 1986. For purposes of this
provision, processors of P-TBBA, P-TBT, and/or P-TBB shall include only
those persons who processed the substances other than as non-isolated
intermediates.

(2) Persons who commence manufacture or importation of P-TBBA, P-TBT,
and/or P-TBB for commercial purposes after June 25, 1986. This provision
is applicable to persons who cease manufacture or importation of P-TBBA,
P-TBT, and/or P-TBB after June 25, 1986 and then subsequently resume
manufacture or importation of the substance(s).

(3) Persons who process P-TBBA, P-TBT, and/or P-TBB for commercial
purposes in any way other than as a non-isolated intermediate after June
25, 1986.

(c) Persons not subject to this rule. In addition to the persons
described in Sec. 704.5, small processors, as defined in paragraph
(a)(4) of this section, are not subject to this rule.

(d) Information to report. Persons subject to this rule as described in
paragraph (b) of this section shall report information to EPA as
specified in this paragraph (d). Respondents to this rule shall report
all information that is known to or reasonably ascertainable by the
person reporting. For purposes of importer reporting under this
paragraph, a site is the operating unit within the person's organization
which is directly responsible for importing the substance and which
controls the import transaction. The import site may in some cases be
the organization's headquarters office in the United States.

(1) All manufacturers, importers, and processors specified in paragraph
(b) of this section shall report their name and headquarters address.

(2) All manufacturers, importers, and processors specified in paragraph
(b) of this section shall report the name, address, and office telephone
number (including area code) of their principal technical contact.

(3) All manufacturers, importers, and processors specified in paragraph
(b) of this section shall report the name and address of each site where
P-TBBA, P-TBT, and/or P-TBB is manufactured, imported, or processed.

(4) All manufacturers, importers, and processors specified in paragraph
(b)(1) of this section only shall report the information described in
this paragraph (d)(4). Respondents to this paragraph (d)(4) shall report
separately for each substance that they manufacture, import, or process,
and for each site at which they do so. However, if the information to be
reported in response to this paragraph (d)(4) is the same for different
sites, the respondent need not report separately for each site but need
only notify EPA that the information is the same for each site. The
information to be reported under this paragraph (d)(4) shall cover the
respondent's latest complete corporate fiscal year prior to June 25,
1986. Respondents to this paragraph (d)(4) shall report the following
information:

(i) The total quantity (by weight) of P-TBBA, P-TBT, or P-TBB
manufactured, imported, or processed for commercial purposes per site.

(ii) A narrative description of the manufacturing, importing, or
processing operation(s) involving P-TBBA, P-TBT, or P-TBB at each site.

(iii) A narrative description of worker activities involving P-TBBA,
P-TBT, or P-TBB at each site, including the number of workers
potentially exposed to each substance and, if applicable, the number of
workers potentially exposed to more than one substance.

(iv) The potential routes of worker exposure to P-TBBA, P-TBT, or P-TBB
at each site (e.g., inhalation, ingestion, dermal absorption).

(v) Available monitoring data from employee breathing zones with
potential exposure to P-TBBA, P-TBT, or P-TBB at each site, including a
description of the method of monitoring, the number of samples taken,
and the potential number of workers similarly exposed for each worker
job category. Respondents to this paragraph (d)(4)(v) shall submit data
showing a range of 8-hour time weighted averages (TWAs), provided that
the data are available in that form. Respondents also shall submit a
calculated geometric mean of these data, with an explanation of the
method by which the mean was derived. However, if the monitoring data
are not available in the form of 8-hour TWAs, respondents shall submit
raw sample data results and the duration time of sampling for each job
category.

(vi) A narrative description of any personal protective equipment and/or
engineering controls used to prevent exposure to P-TBBA, P-TBT, or P-TBB
at each site.

(vii) A listing of the estimated quantities of P-TBBA, P-TBT, or P-TBB
released directly into air, water, or land from each site.

(viii) A narrative description of the times during the manufacturing,
importing, or processing operations involving P-TBBA, P-TBT, or P-TBB
when environmental release occurs at each site.

(ix) A narrative description of any engineering controls used to prevent
environmental release of P-TBBA, P-TBT, or P-TBB at each site.

(x) A narrative description of all known end uses of any P-TBBA, P-TBT,
or P-TBB that is manufactured, imported, or processed by the respondent.
The narrative need not include customer identity.

(xi) A narrative description of the methods used at each site for
disposing of wastes generated during the manufacture, importation, or
processing of P-TBBA, P-TBT, or P-TBB, including the quantity and
content of such wastes (per site), the method of disposal, and an
identification of the disposal site(s).

(5) All manufacturers, importers, and processors specified in paragraph
(b) of this section shall report the information described in this
paragraph (d)(5). Respondents to this paragraph (d)(5) shall report
separately for each substance that they intend to manufacture, import,
or process during the first 2 years following the date on which they
become subject to this rule. The data reported under this paragraph
(d)(5) shall cover that 2-year period. Respondents to this paragraph
(d)(5) shall report separately for each site at which they intend to
manufacture, import, or process each substance. Respondents need not
comply with this paragraph (d)(5) if the information to be reported is
identical to that reported by the respondent under paragraph (d)(4) of
this section, provided that the respondent makes note of that fact to
EPA. Respondents to this paragraph (d)(5) shall report the following
information:

(i) An estimate of the total quantity (by weight) of P-TBBA, P-TBT, or
P-TBB that the respondent intends to manufacture, import, or process for
commercial purposes per site during each of the first 2 years following
the date on which the respondent becomes subject to this rule.

(ii) A narrative description of the intended manufacturing, importing,
or processing activities involving P-TBBA, P-TBT, or P-TBB at each site
during the first 2 years following the date on which the respondent
becomes subject to this rule. The description shall include a summary of
the intended manufacturing, importing, or processing operation(s); a
summary of intended worker activities involving the substances,
including an estimate of the number of persons anticipated to be exposed
annually to P-TBBA, P-TBT, or P-TBB (per site) during the 2-year period,
the anticipated routes of worker exposure to the substances (e.g.,
inhalation, ingestion, dermal absorption); and a summary of any personal
protective equipment and/or engineering controls that the respondent
intends to use to prevent exposure to the substances.

(iii) A narrative description of anticipated environmental releases of
P-TBBA, P-TBT, or P-TBB at each site from the manufacture, importation,
or processing of these substances during the first 2 years following the
date on which the respondent becomes subject to this rule. The narrative
shall include the anticipated quantities of each substance released
directly into air, water, or land, the anticipated routes of
environmental release, and any intended engineering controls to be used
to prevent environmental release of the substances.

(iv) A narrative description of all anticipated end uses or P-TBBA,
P-TBT, or P-TBB resulting from the respondent's manufacture,
importation, or processing of the substances during the first 2 years
following the date on which the respondent becomes subject to this rule.
The summary need not include customer identity.

(v) A narrative summary of the anticipated disposal of wastes generated
from the manufacture, importation, or processing of P-TBBA, P-TBT, or
P-TBB during the first 2 years following the date on which the
respondent becomes subject to this rule. The summary shall include the
anticipated quantity and content of such wastes (per site), the intended
method of disposal, and an identification of intended disposal site(s).

(e) When to report. Persons subject to this rule must submit the
requisite information to EPA within 60 days of becoming subject to the
rule under the standards set forth in paragraph (b) of this section.

(f) Certification. Persons subject to this rule must attach the
following statement to any information submitted to EPA in response to
this rule: ``I hereby certify that, to the best of my knowledge and 

belief, all of the attached information is complete and accurate.'' This
statement shall be signed and dated by the company's principal technical
contact.

(g) Recordkeeping. Persons subject to the reporting requirements of this
section must retain documentation of information contained in their
reports for a period of 5 years from the date of the submission of the
report.

[51 FR 17339, May 12, 1986; 51 FR 18323, May 19, 1986, as amended at 52
FR 20083, May 29, 1987; 58 FR 34204, June 23, 1993]

Sec. 704.43  Chlorinated naphthalenes.

(a) Definitions. 

	(1) Extent of chlorination means the percent by weight of chlorine.

	(2) Import means to import in bulk form or as part of a mixture.

(3) Isomeric ratio means the relative amounts of each isomeric
chlorinated naphthalene that composes the chemical substance; and for
each isomer the relative amounts of each chlorinated naphthalene
designated by the position of the chlorine atom(s) on the naphthalene.

(4) Polychlorinated biphenyl means any chemical substance that is
limited to the biphenyl molecule and that has been chlorinated to
varying degrees.

(5) Small manufacturer means a manufacturer (including importers) who
meets either paragraph (a)(5) (i) or (ii) of this section:

(i) A manufacturer of a chemical substance is small if its total annual
sales, when combined with those of its parent company (if any), are less
than $40 million. However, if the annual production volume of a
particular chemical substance at any individual site owned or controlled
by the manufacturer is greater than 45,400 kilograms (100,000 pounds),
the manufacturer shall not qualify as small for purposes of reporting on
the production of that chemical substance at that site, unless the
manufacturer qualifies as small under paragraph (a)(5)(ii) of this
section.

(ii) A manufacturer of a chemical substance is small if its total annual
sales, when combined with those of its parent company (if any), are less
than $4 million, regardless of the quantity of the particular chemical
substance produced by that manufacturer.

(iii) For imported mixtures containing a chemical substance identified
in paragraph (b) of this section, the 45,400 kilograms (100,000 pounds)
standard in paragraph (a)(5)(i) of this section applies only to the
amount of the chemical substance in a mixture and not the other
components of the mixture.

(6) Waste means any solid liquid, semisolid, or contained gaseous
material that results from the production of a chemical substance
identified in paragraph (b) of this section and which is to be disposed.

(b) Substances for which reports must be submitted.

------------------------------------------------------------------------

        CAS registry number                  Chemical substance

------------------------------------------------------------------------

   90-13-1..........................  Naphthalene, 1-chloro-

   91-58-7..........................  Naphthalene, 2-chloro-

 1321-64-8........................  Naphthalene, pentachloro-

 1321-65-9........................  Naphthalene, trichloro-

 1335-87-1........................  Naphthalene, hexachloro-

 1335-88-2........................  Naphthalene, tetrachloro-

 1825-30-5........................  Naphthalene, 1,5-dichloro-

 1825-31-6........................  Naphthalene, 1,4-dichloro-

 2050-69-3........................  Naphthalene, 1,2-dichloro-

 2050-72-8........................  Naphthalene, 1,6-dichloro-

 2050-73-9........................  Naphthalene, 1,7-dichloro-

 2050-74-0........................  Naphthalene, 1,8-dichloro-

 2050-75-1........................  Naphthalene, 2,3-dichloro-

 2065-70-5........................  Naphthalene, 2,6-dichloro-

 2198-75-6........................  Naphthalene, 1,3-dichloro-

 2198-77-8........................  Naphthalene, 2,7-dichloro-

 2234-13-1........................  Naphthalene, octachloro-

25586-43-0.......................  Naphthalene, chloro-

32241-08-0.......................  Naphthalene, heptachloro-

70776-03-3.......................  Naphthalene, chloro derivatives.

------------------------------------------------------------------------

(c) Persons who must report. 

(1) Persons who are manufacturing or importing a chemical substance
identified in paragraph (b) of this section on October 8, 1984.

(2) Persons who propose to import a chemical substance identified in
paragraph (b) of this section on or after October 8, 1984.

(3) Persons who manufacture a chemical substance identified in paragraph
(b) of this section after October 8, 1984.

(4) A person is required to report only once for each chemical substance
identified in paragraph (b) of this section.

(d) Persons exempt from reporting. 

	(1) Small manufacturers.

	(2) Persons described in Sec. 704.5.

(e) What information to report. Persons described in paragraph (c) of
this section must notify EPA of current or prospective manufacture or
import. The notice must include, to the extent that it is known to or
reasonably ascertainable by the person making the report, the following
information:

(1) Company name and address.

(2) Name, address, and telephone number of the principal technical
contact.

(3) For chemical substances proposed to be imported, the proposed date
of import.

(4) A description of the use(s) or intended use(s) for the chemical
substance.

(5) A description of the isomeric ratio and extent of chlorination of
the chemical substance and the impurity level of polychlorinated
biphenyls.

(6) The quantity (by weight) manufactured or imported within 12 months
prior to October 8, 1984, if any, and the estimated quantity (by weight)
to be manufactured or imported for the first 3 years following the date
of the report or the date of the intended start of import whichever
occurs later.

(7) The number of persons exposed to the chemical substance during
manufacture, import, processing, distribution in commerce, use, and
disposal.

(8) If a manufacturer's waste contains one or more of the chemical
substances identified in paragraph (b) of this section, the manufacturer
must:

(i) Provide the quantity (by weight) of the chemical substances
identified in paragraph (b) of this section present in the waste,

(ii) Identify the constituents of the waste and their concentrations,

(iii) State the rate of waste generation as a percentage of production
volume,

(iv) Describe where in the manufacturing process the waste is generated,
and

(v) Describe the method for disposal of the waste.

(f) When to report. 

(1) Persons who are manufacturing or importing a chemical substance
identified in paragraph (b) of this section on October 8, 1984 must
notify EPA by November 6, 1984.

(2) Persons who propose to import a chemical substance identified in
paragraph (b) of this section on or after October 8, 1984 must notify
EPA by November 6, 1984, or 15 days after making the management decision
described in Sec. 704.3, whichever is later in time.

(3) Persons who manufacture a chemical substance identified in paragraph
(b) of this section after October 8, 1984 must notify EPA within 30 days
after the initial date of manufacture.

[49 FR 33653, Aug. 24, 1984; 49 FR 45133, Nov. 15, 1984; 50 FR 1215,
Jan. 10, 1985; 51 FR 19839, June 3, 1986; 52 FR 20083, May 29, 1987.
Redesignated at 53 FR 51717, Dec. 22, 1988]

Sec. 704.45  Chlorinated terphenyl.

(a) Definitions. 

(1) Chlorinated terphenyl means a chemical substance, CAS No.
61788-33-6, comprised of chlorinated ortho-, meta-, and paraterphenyl.

(2) Extent of chlorination means the percent by weight of chlorine for
each isomer (ortho, meta, and para).

(3) Isomeric ratio means the ratios of ortho-, meta-, and
parachlorinated terphenyls.

(4) Polychlorinated biphenyl means any chemical substance that is
limited to the biphenyl molecule that has been chlorinated to varying
degrees.

(5) Small manufacturer means a manufacturer (importers are defined as
manufacturers under TSCA) who meets either of the following standards
under this rule:

(i) First standard. A manufacturer of an existing chemical substance is
small if its total annual sales, when combined with those of its parent
company (if any), are less than $40 million. However, if the annual
production volume of a particular chemical substance at any individual
site owned or controlled by the manufacturer is greater than 45,400
kilograms (100,000 pounds), the manufacturer shall not qualify as small
for purposes of reporting on the production of that chemical substance
at the site, unless the manufacturer qualified as small under paragraph
(a)(5)(ii) of this section.

(ii) Second standard. A manufacturer of an existing chemical substance
is small if its total annual sales, when combined with those of its
parent company (if any), are less than $4 million, regardless of the
quantity of chemicals produced by that manufacturer.

(b) Persons who must report. Except for small manufacturers and as
provided in Sec. 704.5, the following persons are subject to the rule:

(1) Persons who manufacture or propose to manufacture chlorinated
terphenyl.

(2) Persons who import (importers) or propose to import chlorinated
terphenyl as a chemical substance in bulk or as part of a mixture.

(c) What information to report. Persons subject to this rule as
described in paragraph (b) of this section must notify EPA of current or
proposed manufacture or import of chlorinated terphenyl. The notice must
include, to the extent that it is known to the person making the report
or is reasonably ascertainable, the following information:

(1) Company name and address.

(2) Name, address, and telephone number of principal technical contact.

(3) A description of the use(s) or intended use(s) for chlorinated
terphenyl.

(4) A description of the isomeric ratio and extent of chlorination of
the chlorinated terphenyl and the impurity level of polychlorinated
biphenyls.

(5) The quantity (by weight) manufactured or imported within 12 months
prior to the effective date of the rule, if any, and the estimated
quantity (by weight) to be manufactured or imported for the first three
years following the date of the report or the date of the intended start
of production, whichever occurs later.

(6) The proposed date for the initiation of manufacturing or importation
of chlorinated terphenyl, if appropriate.

(d) When to report. Persons who are manufacturing or importing
chlorinated terphenyl on the effective date of the rule must notify EPA
within 30 days of the effective date of the rule. Persons who propose to
manufacture or import chlorinated terphenyl must notify EPA within 15
days after making the management decision described in Sec. 704.3
``Proposed to manufacture or import''.

[49 FR 11184, Mar. 26, 1984, as amended at 49 FR 32068, Aug. 10, 1984;
50 FR 2048, Jan. 15, 1985; 52 FR 20083, May 29, 1987. Redesignated at 53
FR 51717, Dec. 22, 1988; 58 FR 34204, June 23, 1993]

Sec. 704.95  Phosphonic acid, [1,2-ethanediyl-bis[nitrilobis-
(methylene)]]tetrakis- (EDTMPA) and its salts.

(a) Substances for which reporting is required. The chemical substances
for which reporting is required under this section are:

------------------------------------------------------------------------

  CAS No.                           Chemical name

------------------------------------------------------------------------

1429-50-1.	Phosphonic acid, [1,2-ethanediyl-bis[nitrilobis(methylene)]]
tetrakis- (EDTMPA)

15142-96-8.	Phosphonic acid, [1,2-ethanediyl-bis[nitrilobis(methylene)]]
tetrakis-, hexasodium salt

34274-30-1.	Phosphonic acid, [1,2-ethanediyl-bis[nitrilobis(methylene)]]
tetrakis-, potassium salt

57011-27-5. 	Phosphonic acid,
[1,2-ethanediyl-bis[nitrilobis(methylene)]] tetrakis-, ammonium salt

67924-23-6.	Cobaltate (6-), [[[1,2-ethanediylbis
[nitrilobis(methylene)]] tetrakis-[phosphonato]] (8-)]-, pentapotassium
hydrogen, (OC-6-21)-

67969-67-9.	Cobaltate (6-), [[[1,2-ethanediylbis
[nitrilobis(methylene)]] tetrakis- [phosphonato]]
(8-)-N,N',O,O'',O'''',O'''''']-, pentasodium hydrogen, (OC-6-21)-

67989-89-3.	Cuprate (6-), [[[1,2-ethanediylbis [nitrilobis(methylene)]]
tetrakis- [phosphonato]] (8-)]-,pentapotassium hydrogen, (OC-6-21)-

68025-39-8.	Cobaltate (6-), [[[1,2-ethanediylbis
[nitrilobis(methylene)]] tetrakis- [phosphonato]]
(6-)-N,N',O,O'',O'''',O'''''']-, pentaammonium hydrogen, (OC-6-21)-

68188-96-5.	Phosphonic acid, [1,2-ethanediylbis [nitrilobis(methylene)]]
tetrakis-, tetrapotassium salt

68309-98-8.	Cadmate (6-), [[[1,2-ethanediylbis [nitrilobis(methylene)]]
tetrakis- [phosphonato]] (8-)]-, pentapotassium hydrogen, (OC-6-21)-

68901-17-7.	Phosphonic acid, [1,2-ethanediylbis [nitrilobis(methylene)]]
tetrakis-, octaammonium salt

68958-86-1.	Nickelate (6-), [[[1,2-ethanediylbis
[nitrilobis(methylene)]] tetrakis- [phosphonato]] (8-)]-,pentaammonium
hydrogen, (OC-6-21)-

68958-87-2.	Nickelate (6-), [[[1,2-ethanediylbis
[nitrilobis(methylene)]] tetrakis- [phosphonato]] (8-)]-,pentapotassium
hydrogen, (OC-6-21)-

68958-88-3.	Nickelate (6-), [[[1,2-ethanediylbis
[nitrilobis(methylene)]] tetrakis [phosphonato]] (8-)]-,
pentasodiumhydrogen, (OC-6-21)-

------------------------------------------------------------------------

(b) Persons who must report. Unless exempt as provided in Sec. 704.5,
reports must be submitted by:

(1) Persons who manufacture or import any of the substances identified
in paragraph (a) of this section.

(2) Persons who propose to manufacture or propose to import any of the
substances identified in paragraph (a) of this section. For the purposes
of importer reporting under this section, an import site is the
operating unit within the person's organization which is directly
responsible for importing the substance and which controls the import
transaction; the import site may in some cases be the organization's
headquarters office in the United States.

(c) What information to report. Persons identified in paragraph (b) of
this section must report to EPA, for each of the substances identified
in paragraph (a) of this section, the following information 

to the extent known to or reasonably ascertainable by them.

(1) Initial Report:

(i) Name and Chemical Abstracts Service Registry Number of the substance
for which the report is submitted.

(ii) Company name and headquarters address.

(iii) Name, address, and telephone number of the principal technical
contact.

(iv) The total quantity (by weight in pounds) of the substance
manufactured or imported for the person's most recently completed
corporate fiscal year.

(v) A description of the commercial uses of the substance during the
person's most recently completed corporate fiscal year, including the
production volume for each use.

(vi) The estimated quantity (by weight in pounds) of the substance
proposed to be manufactured or imported in the person's current
corporate fiscal year.

(vii) A description of the intended commercial uses of the substance
during the person's current corporate fiscal year, including the
estimated production volume for each use.

(2) Follow-up Report:

(i) Name and Chemical Abstracts Service Registry Number of the substance
for which the report is submitted.

(ii) Company name and headquarters address.

(iii) Name, address, and telephone number of the principal technical
contact.

(iv) The estimated quantity (by weight in pounds) of the substance
proposed to be manufactured or imported in the person's current
corporate fiscal year.

(v) A description of the intended commercial uses of the substance
during the person's current corporate fiscal year, including the
estimated production volume for each use.

(d) When to report. 

(1) Persons specified in paragraph (b)(1) of this section who are
manufacturing or importing the substance as of December 5, 1988 must
submit an initial report described in paragraph (c)(1) of this section
by January 3, 1989.

(2) Persons specified in paragraph (b)(2) of this section must submit an
initial report within 30 days after making the management decision
described in Sec. 704.3 or by January 3, 1989, whichever is later.

(3) Persons specified in paragraph (b) of this section, who submitted a
report described in paragraph (c)(1) of this section, must submit a
follow-up report described in paragraph (c)(2) of this section within 30
days of making the management decision, described at Sec. 704.3, to do
either of the following events:

(i) Manufacture or import the substance in a quantity 50 percent greater
than the quantity reported in the most recently submitted report.

(ii) Manufacture or import the substance for a use not reported for that
substance in any previous report.

(e) Certification. Persons subject to this section must attach the
following statement to any information submitted to EPA in response to
this section: ``I hereby certify that, to the best of my knowledge and
belief, all of the attached information is complete and accurate.'' This
statement must be signed and dated by the company's principal technical
contact.

(f) Recordkeeping. Persons subject to the reporting requirements of this
section must retain documentation of information contained in their
reports for a period of 5 years from the date of the submission of the
report.

[53 FR 41337, Oct. 21, 1988, as amended at 58 FR 34204, June 23, 1993]

Sec. 704.102  Hexachloronorbornadiene.

(a) Definitions. 

(1) Endrin means the pesticide 2,7:3,6-Dimethano-naphth[2,3-b] oxirene,
3,4,5,6,9,9- hexachloro-1a,2,2a,3,6,6a,7,7a-octahydro-, (1aalpha, 2beta,
2abeta, 3alpha, 6alpha, 6abeta, 7beta, 7aalpha)-, CAS Number 72-20-8.

(2) HEX-BCH means the chemical substance
1,2,3,4,7,7-hexachloronorbornadiene, CAS Number 3389-71-7.

(3) Isodrin means the pesticide 1,4:5,8-Dimethanonaphthalene,
1,2,3,4,10,10-hexacholoro-1,4,4a,5,8,8a-hexahydro-, (1alpha, 4alpha,
4abeta, 5beta, 8beta, 8abeta)-, CAS Number 465-73-6.

(4) Small business means any manufacturer, importer, or processor who
meets either paragraph (a)(4)(i) or (ii) of this section:

(i) A business is small if its total annual sales, when combined with
those of its parent (if any), are less than $40 million. However, if the
annual manufacture, importation, or processing volume of a particular
chemical substance at any individual site owned or controlled by the
business is greater than 45,400 kilograms (100,000 pounds), the business
shall not qualify as small for purposes of reporting on the manufacture,
importation, or processing of that chemical substance at that site,
unless the business qualifies as small under paragraph (a)(4)(ii) of
this section.

(ii) A business is small if its total annual sales, when combined with
those of its parent company (if any), are less than $4 million,
regardless of the quantity of the particular chemical substance
manufactured, imported, or processed by that business.

(iii) For imported and processed mixtures containing HEX-BCH, the 45,400
kilograms (100,000 pounds) standard in paragraph (a)(4)(i) of this
section applies only to the amount of HEX-BCH in a mixture and not the
other components of the mixture.

(5) 8-hour time weighted average means the cumulative exposure for an
8-hour work shift computed as follows:

C<INF>a</INF> T<INF>a</INF>+C<INF>b</INF> T<INF>b</INF>+ . . .
C<INF>n</INF> T<INF>n</INF>

E =        
------------------------------------------------------------------------
--------------------------------------------------------------

 8

Where:

E is the equivalent exposure for the working shift.

C<INF>i</INF> is the concentration (i.e., parts per million) during any
period of time (T<INF>i</INF>) where the concentration remains constant.

T<INF>i</INF> is the duration in hours of the exposure at the
concentration C<INF>i</INF>.

(6) Year means corporate fiscal year.

(b) Persons who must report. 

(1) Reports must be submitted by:

(i) Persons who are manufacturing, importing, or processing HEX-BCH for
use as an intermediate in the production or isodrin or endrin on or
after January 2, 1986; and

(ii) Persons who propose to manufacture, import, or process HEX-BCH for
use as an intermediate in the production of isodrin or endrin, on or
after January 2, 1986.

(2) Persons described in paragraph (b)(1) of this section who engage or
propose to engage in more than one activity (i.e., manufacture and
processing) must report the information required in paragraph (d)
separately for each activity.

(c) Persons exempt from reporting. 

(1) Small businesses.

(2) Persons described in Sec. 704.5(a) and (c).

(d) Information to report. 

(1) Initial reports must include, to the extent that it is known to or
reasonably ascertainable by the person reporting, the following
information:

(i) Company name and address.

(ii) Name, address, and telephone number of the principal contact.

(iii) Name and address of plant sites where HEX-BCH is or is proposed to
be manufactured, imported, or processed, noting for each plant site
which activity takes or would take place at each site.

(iv) If applicable, the intended date for initiating the manufacture,
import, or processing of HEX-BCH.

(v) If applicable, the actual quantity (by weight) of HEX-BCH
manufactured, imported, or processed during the most recently concluded
year.

(vi) The estimated quantity (by weight) of HEX-BCH to be manufactured,
imported, or processed each year during the first 3 years following the
date of the report or the date of the intended start of manufacture,
import, or processing, whichever occurs later.

(vii) For each year described in paragraphs (d)(1) (v) and (vi) of this
section: the number or expected number of employees exposed to HEX-BCH
during the manufacture, import, processing, distribution in commerce,
use, and disposal; the routes of exposure; and the 8-hour time weighted
average of exposure.

(viii) If employees are exposed or expected to be exposed to HEX-BCH,
state for each reported route of exposure, whether personal protective
equipment is used or expected to be used, and a description of the
personal protective equipment.

(ix) The actual or anticipated quantity, content, method of disposal,
and disposal site of any wastes generated or expected to be generated
during the manufacture, importation, or processing of HEX-BCH.

(2) Subsequent reports must provide, to the extent known to or
reasonably ascertainable by the person reporting, the information in
paragraph (d)(1) of this section and a statement explaining why the
subsequent report is required.

(e) When to report. 

(1) Persons who are manufacturing, importing, or processing HEX-BCH on
January 2, 1986, must submit an initial report to EPA by February 3,
1986.

(2) Persons who propose to manufacture, import, or process HEX-BCH on or
after January 2, 1986, must submit an initial report to EPA by February
3, 1986, or 30 days after making the management decision described in
Sec. 704.3 “Propose to manufacture, import, or process,” whichever
is later in time.

(3) Persons described in paragraph (b) of this section, who have
submitted a report described in paragraph (d) of this section, must
submit a subsequent report within 30 days of any of the following
events. Based on the most recently submitted report:

(i) The manufacture, importation, or processing of HEX-BCH begins at a
plant site different than that reported pursuant to paragraph
(d)(1)(iii) of this section.

(ii) The actual quantity (by weight) of HEX-BCH manufactured, imported,
or processed in a given year is greater than or equal to 200 percent of
the estimated value for that year reported pursuant to paragraph
(d)(1)(vi) of this section.

(iii) The total number of employees exposed to HEX-BCH is greater than
130 percent of the projected value reported pursuant to paragraph
(d)(1)(vii) of this section.

(iv) The route of exposures to HEX-BCH differs from that reported
pursuant to paragraph (d)(1)(vii) of this section.

(v) The actual 8-hour time weighted average exposure for any activity
exceeds the projection reported pursuant to paragraph (d)(1)(vii) of
this section by more than 100 percent.

(vi) The method of disposal or disposal site reported pursuant to
paragraph (d)(1)(ix) of this section has changed.

(vii) Three years have passed since the most recent submission of a
report and the person is still engaged in the manufacture, importation,
or processing of HEX-BCH.

(f) Certification of review. Each person who submits a report under this
section must for 3 years following the submission date of the most
recent submission, review their activities at the end of each year to
determine whether any reportable event specified in paragraph (e)(3) of
this section has occurred. If a review shows that none of these events
has occurred, the person is required to certify this fact in writing.

(g) Recordkeeping. Any person subject to the reporting requirements of
this section must:

(1) Retain documentation of information contained in their reports. This
documentation must be maintained for a period of 3 years from the date
of the submission of the report; and

(2) Retain the certification required by paragraph (f) of this section
for 3 years from the date of its creation.

[50 FR 47536, Nov. 19, 1985, as amended at 52 FR 20083, May 29, 1987.
Redesignated at 53 FR 51717, Dec. 22, 1988; 58 FR 34204, June 23, 1993]

Sec. 704.104  Hexafluoropropylene oxide.

(a) Definitions. 

(1) “HFPO” means the chemical substance hexafluoropropylene oxide,
CAS Number 428-59-1. [Listed in TSCA Inventory as oxirane,
trifluoro(trifluoromethyl)-]

(2) “Enclosed process” means a process that is designed and operated
so that there is no intentional release of any substance present in the
process. A process with fugitive, inadvertent, or emergency pressure
relief releases remains an enclosed process so long as measures are
taken to prevent worker exposure to and environmental contamination from
the releases.

(3) “Small processor” means a processor that meets either the
standard in paragraph (a)(3)(i) of this section or the standard in
paragraph (a)(3)(ii) of this section.

(i) First standard. A processor of a chemical substance is small if its
total annual sales, when combined with those of its parent company, if
any, are less than $40 million. However, if the annual processing volume
of a particular chemical substance at any individual site owned or
controlled by the processor is greater than 45,400 kilograms (100,000
pounds), the processor shall not qualify as small for purposes of
reporting on the processing of that chemical substance at that site,
unless the processor qualifies as small under paragraph (a)(3)(ii) of
this section.

(ii) Second standard. A processor of a chemical substance is small if
its total annual sales, when combined with those of its parent company
(if any), are less than $4 million, regardless of the quantity of the
particular chemical substance processed by that company.

(iii) Inflation index. EPA will use the Inflation Index described in the
definition of “small manufacturer” that is set forth in Sec. 704.3
for purposes of adjusting the total annual sales values of this small
processor definition. EPA will provide Federal Register notification
when changing the total annual sales values of this definition.

(b) Persons who must report. Except as provided in paragraph (c) of this
section, the following persons are subject to this section:

(1) Persons who manufacture or propose to manufacture HFPO for use as an
intermediate in the manufacture of fluorinated substances in an enclosed
process.

(2) Persons who import or propose to import HFPO for use as an
intermediate in the manufacture of fluorinated substances in an enclosed
process.

(3) Persons who process or propose to process HFPO as an intermediate in
the manufacture of fluorinated substances in an enclosed process.

(c) Persons not subject to this rule. The following persons are not
subject to this rule:

(1) Small processors.

(2) Persons described in Sec. 704.5 (a) through (d).

(3) Persons who have already submitted to EPA a completed copy of the
Preliminary Assessment Information Manufacturer's Report (EPA Form
7710-35, as described at Sec. 712.28 of this chapter) for HFPO are not
required to report under this section with respect to activities
previously reported on.

(d) What information to report. Persons identified in paragraph (b) of
this section must submit a Premanufacture Notice Form (EPA Form
7710-25).

(e) When to report. 

(1) Persons who are manufacturing, importing, or processing, or who
propose to manufacture, import, or process HFPO for use as an
intermediate in the manufacture of fluorinated substances in an enclosed
process as of December 10, 1987, must report by February 8, 1988.

(2) Persons who propose to manufacture, import, or process HFPO for use
as an intermediate in the manufacture of fluorinated substances in an
enclosed process after December 10, 1987, must report within 30 days
after making a firm management decision to commit financial resources
for the manufacturing, importing, or processing of HFPO.

(f) Recordkeeping. Persons subject to the reporting requirements of this
section must retain documentation of information contained in their
reports for a period of 5 years from the date of submission of the
reports.

(g) Where to send reports. Reports must be submitted 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: HFPO Reporting.

[52 FR 41299, Oct. 27, 1987, as amended at 58 FR 34204, June 23, 1993;
60 FR 16308, Mar. 29, 1995; 60 FR 31920, June 19, 1995; 60 FR 34463,
July 3, 1995]

Sec. 704.175  4,4'-methylenebis(2-chloroaniline) (MBOCA).

(a) Substance subject to reporting. The chemical substance
4,4'-methylenebis(2-chloroaniline) (CAS No. 101-14-4) is subject to
reporting under this section. The substance also is identified as 4,4'-

methylenebis(2-chlorobenzenamine) and MBOCA.

(b) Persons who must report. Except as provided in paragraph (c) of this
section, the following persons are subject to this rule.

(1) Persons who propose to manufacture MBOCA in the United States on or
after June 2, 1986.

(2) Persons who are manufacturing MBOCA in the United States as of June
2, 1986.

(3) Persons manufacturing MBOCA in the United States on or after June 2,
1986 who propose to change their manner or method of manufacturing the
substance from a manner or method of manufacturing that previously was
reported under this section.

(c) Persons not subject to this rule. The following persons are exempt
from the reporting requirements of this section:

(1) Persons who import MBOCA into the customs territory of the United
States and do not otherwise manufacture the substance in the United
States.

(2) Persons who complied with the requirements of this section prior to
June 2, 1986 and received written notification of compliance from EPA.

(d) What information to report. Persons who are subject to this rule as
described in paragraph (b) of this section must report information to
EPA by completing the following parts of the notice form contained in
appendix A to part 720 of this chapter: Parts I.A., I.B., I.C.1.,
I.C.3., and II.A.; also, part III as appropriate. Persons subject to the
requirements of this section also must submit a narrative description of
any processing and packaging of MBOCA that occurs at the manufacturing
plant site, including the number of workers potentially exposed to MBOCA
during on-site processing and packaging of MBOCA and a description of
any personal protective equipment and/or engineering controls that would
be used to prevent release of and exposure to MBOCA during on-site
processing and packaging. Persons subject to the requirements of this
section are not required to submit information on processing or use of
MBOCA away from the manufacturing plant site. Respondents to this rule
shall report all information that is known to or reasonably
ascertainable by the person reporting.

(e) When to report. 

(1) Persons specified in paragraph (b)(1) of this section must report by
July 2, 1986 or within 30 days after making a firm management decision
to commit financial resources for the manufacture of MBOCA, whichever is
later in time.

U

V

¦

§

옍

Æ

„@

^„@

this section must report within 30 days of making a firm management
decision to commit financial resources to change their manner or method
of manufacturing the substance from a manner or method of manufacturing
that previously was reported under this
sect潩⹮഍㕛‱剆ㄠ㈳㌲‬灁⹲ㄠⰸㄠ㠹ⰶ愠⁳浡湥敤
⁤瑡㔠′剆㈠〰㌸‬慍⁹㤲‬㤱㜸※㠵䘠⁒㐳〲ⰴ䨠湵
⁥㌲‬㤱㌹൝ऍउउउउउ̍഍ഄ̍഍ഄ഍഍

഍

഍഍഍

഍

഍഍഍഍഍഍

