Document ID: EPA-HQ-OPPT-2007-0670-0002
Agency: epa
Document Type: Supporting & Related Material
Title: 
Posted Date: 2007-12-21T05:00Z

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

The Paperwork Reduction Act

IDENTIFICATION OF THE INFORMATION COLLECTION

	1(a)	Title and Number of the Information Collection

		Title:	TSCA Section 8(a) Preliminary Assessment Information Rule
(PAIR)

EPA ICR No.:  0586.11	OMB Control No.:	2070-0054

	1(b)	Short Characterization

	On June 22, 1982, EPA promulgated the generic section 8(a) Preliminary
Assessment Information Rule (PAIR) (40 CFR Part 712, see Attachment C)
under the Toxic Substances Control Act (TSCA) (15 U.S.C. 2607, see
Attachment A).  EPA uses PAIR to collect information to identify, assess
and manage human health and environmental risks from chemical
substances, mixtures and categories.  PAIR requires chemical
manufacturers and importers to complete a standardized reporting form to
help evaluate the potential for adverse human health and environmental
effects caused by the manufacture or importation of identified chemical
substances, mixtures or categories.  Attachment B provides a specific
section-by-section listing of each of the requirements under Title 40 of
the Code of Federal Regulation related to this ICR.

	Chemicals identified by the existing chemical review program, any other
EPA office or federal agency, for which a justifiable information need
for production, use, or exposure-related data can be satisfied by the
use of the PAIR, is a proper subject for a chemical-specific TSCA
section 8(a) PAIR rulemaking.  Many of the chemical substances, mixtures
and categories listed in 40 CFR Part 712 have been recommended by the
Interagency Testing Committee (ITC) to EPA for test rule consideration. 
In most instances, such as in a preliminary risk determination, or in
reaching a decision whether testing of a chemical is necessary to
satisfy an identified data need, the information that EPA receives from
a PAIR report is sufficient to satisfy its information needs.

	This information collection activity also covers certain specific
chemical testing and reporting requirements under Subpart B of 40 CFR
part 766 (see Attachment E) that are very similar to the PAIR
requirements.  The Agency rarely receives submissions of the information
required by 40 CFR 766.  EPA received no more than 5 submissions over
the course of the last OMB approval for this particular aspect of the
information collection.  However, collection of this information is
covered under the PAIR ICR because the requirements are similar and
because the Paperwork Reduction Act requires that recordkeeping and
reporting activities contained in any regulation be approved by OMB even
if they involve less than 10 respondents or would otherwise not require
approval (see 5 CFR 1320.3(c)(4)(i)).

	The dibenzo-para-dioxin/dibenzofuran regulations at part 766 require
that any person who manufactures, imports, or processes a chemical
substance listed at 766.25 tests that chemical substance and submit
appropriate information to EPA according to the schedules described in
at 766.35.  These chemical substances are subject to testing immediately
upon manufacture, import or processing.  Persons who manufacture or
import a chemical substance listed under 766.25 must report results,
using the Dioxin/Furan Report form (EPA Form 7710-51, see Attachment F)
of all existing test data that show that chemical substance has been
tested for the presence of halogenated dibenzodioxins/halogenated
dibenzofurans (HDDs/HDFs), as defined in the regulation, no later than
90 days after the person first manufactures or imports the chemical
substance.  Additionally, any manufacturer or importer of a chemical
substance listed in 766.25 in possession of unpublished health and
safety studies on HDDs/HDFs is required to submit copies of such studies
to EPA, in accordance with various provisions of 40 CFR 716, no later
than 90 days after the person first manufactures or imports the chemical
substance.

2.	NEED FOR AND USE OF THE COLLECTION

	2(a)	Need/Authority for the Collection

	Under TSCA, which covers the production, distribution, and disposal of
commercial and industrial chemicals in the United States, EPA’s Office
of Pollution Prevention and Toxics (OPPT) is charged with the
responsibility for assuring that chemicals made available for sale and
use in the United States do not pose any unreasonable adverse risks to
human health or to the environment.  To carry out this mandate, EPA has
broad authority to issue regulations designed to gather health/safety
and exposure information on, require testing of, and control exposure to
chemical substances and mixtures.  Drugs, cosmetics, foods, food
additives, pesticides, and nuclear materials are exempt from TSCA and
are subject to control under other U.S. Government statutes (e.g.,
foods, food additives, drugs and cosmetics are under the purview of the
Federal Food, Drug, and Cosmetic Act (FFDCA)).

	TSCA section 8(a) gives EPA the authority to promulgate rules under
which manufacturers (which by statute includes importers) and processors
of chemical substances must maintain records and/or report such data as
EPA may reasonably require to carry out the TSCA mandates.  Examples of
information that can be required to be reported under TSCA Section 8(a)
include: 

- chemical or mixture identity;

- categories of use;

- quantity manufactured or processed;

- by-product description;

- health and environmental effects information;

- number of individuals exposed; and

- method(s) of disposal.

	Section 8(a) regulations can be tailored to meet unique information
needs (e.g., via chemical-specific rules, which are covered under EPA
ICR #1198.06; OMB Control #2070-0067) or information can be obtained via
the use of “model” or standardized reporting rules.  One example of
a model TSCA Section 8(a) reporting rule is the “Preliminary
Assessment Information Rule” (or PAIR).  Under PAIR, producers and
importers of a listed chemical are required to report the following
site-specific information on a two page form (described in more detail
in Chapter 4 of this ICR):

	- Quantity of chemical produced and/or imported;

	- Amount of chemical lost to the environment during production or
importation;

	- Quantity of enclosed, controlled and open releases of the chemical;
and

	- Per release, the number of workers exposed and the number of hours
exposed.

	Exemptions for such reporting are as follows:

	- Production or importation for the sole purpose of research and
development 

	(R&D);

- Production or importation of less than 500 kilograms during the
reporting period at single plant site;

- Companies whose total annual sales from all sites owned by the
domestic or foreign parent company are below $30 million for the
reporting period and who produced or imported less than 45,400 kilograms
of the chemical; and

- Production or importation of the listed chemical solely as an
impurity, a non-isolated intermediate, and under certain circumstances
as a by-product.

	This ICR addresses the information collection activities associated
with PAIR, which is promulgated at 40 CFR 712, which establishes
procedures for chemical manufacturers and processors to report
production, use, and exposure-related information on listed chemical
substances.  Subpart A establishes requirements that apply to all
reporting under PAIR, and Subpart B covers manufacturers’ and
processors’ reporting.  Processors are not required to report PAIR
information under this ICR.

	In addition, as described in the previous section, this ICR addresses
information collection activities associated with the reporting and
recordkeeping requirements contained in 40 CFR 766.

	2(b)	Use/Users of the Data

	EPA uses PAIR data to (1) monitor domestic manufacture and/or
importation of chemical substances, mixtures and categories, (2)
identify possible routes of human or environmental exposure, (3) support
regulations designed to prevent possible adverse health effects and (4)
support EPA programs.  The information provided by PAIR is needed to
complete assessments of chemicals of interest and to assist in the
development of regulations to control hazardous chemicals.

	All EPA program offices are potential users of the PAIR.  The
information helps EPA evaluate the potential for adverse human health or
environmental effects caused by the manufacture and importation of the
identified chemical substance, mixture or category.  If EPA does not
monitor these parameters, adverse human health or environmental effects
may occur without EPA’s knowledge.  Without this information, EPA
would not be able to evaluate the need for additional testing or further
regulatory action.

	Other federal agencies, which require data on the human health and
environmental effects of a chemical, use PAIR information.  States also
have access to public portions of PAIR information.  Public interest
groups use information reported under the public portions of PAIR.

3.	NON-DUPLICATION, CONSULTATION AND OTHER COLLECTION 

	CRITERIA

	3(a)	Non-Duplication

	PAIR reporting data assist EPA in identifying, evaluating and managing
the human health and environmental effects of chemical substances,
mixtures and categories.  EPA has developed procedures that must be met
to ensure that the chemicals added to the rule and the information
requested on these chemicals does not duplicate other activities or
impose a burden on industry that outweighs the need for the data.  These
procedures are for rule promulgation and implementation:

	(1)	A continuing evaluation of the information collection and
management activities;

	(2)	The management of the collected information;

	(3)	A chemical nomination, screening and selection process; and

	(4)	Technical assistance for persons subject to the rule.

	It is unlikely that the information to be reported is duplicative
because (1) EPA estimates that each rule will generate only a few
reports, (2) the information required by the PAIR is unique to the
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	 The Chemical Screening Branch’s Existing Chemical Assessment
Tracking System (CECATS), a database containing information on TSCA
section 8(e) and For Your Information (FYI) submissions and Chemical
Hazard Information Profiles (CHIPs);

	The Toxic Substances Control Act Test Submissions (TSCATS) database,
an on-line index to the compiled, unpublished health and safety studies
submitted to EPA;

	The Registry of Toxic Effects of Chemical Substances (RTECS), a file
containing chemical toxicity data;

	LEXIS/NEXUS, a data network with a wide range of fields including
information published in the Code of Federal Regulations (CFR) and
BNA’s Environmental Reporter and Chemical Regulation Reporter;

	The Toxicology Data Network (TOXNET), run by the National Library of
Medicine; and 

	The Toxic Substances Control Act section 8(b) inventory data (CICIS)
and inventory update data (CUS).

	Similar searches are conducted for each list of chemical substances,
mixtures or categories added to the PAIR.

	Some chemicals in PAIR are referred to EPA by other federal agencies. 
These agencies conduct searches of their own databases for existing
chemical information before they refer any chemical to EPA.  Referrals
are made to EPA only after a decision has been made that an agency’s
existing chemical information is inadequate to meet its needs.

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

	Prior to submission to OMB, this ICR will be made available to the
public for comment through a Federal Register notice.  The public will
have 60 days to provide comments.  Any comments received will be given
consideration when completing the supporting statement that is submitted
to OMB.

	3(c)	Consultations

	On numerous occasions, EPA has published in the Federal Register
notices requesting comments on the reporting requirements of TSCA
section 8(a) PAIR rules.  Industry and environmental groups generally
respond to these requests for comment.

	The American Chemistry Council (ACC), formerly the Chemical
Manufacturers Association (CMA), has responded to several Federal
Register notices.  The ACC is a nonprofit trade association whose
members account for more than 90 percent of the total U.S. production
capacity for basic industrial chemicals.  The ACC encourages EPA to use
PAIR and has not strongly objected to any of the information
requirements contained in PAIR.

	The Natural Resources Defense Council (NRDC) has also responded to
Federal Register notices.  NRDC is a national nonprofit environmental
organization dedicated to the protection of human health and the
environment.  NRDC generally urges EPA to adopt a more detailed set of
information requirements.

	Also, EPA routinely consults with other federal agencies (e.g., OSHA,
CPSC, DOT).  These consultations include exchanging information on
existing chemicals, and referrals of chemicals to EPA by other federal
agencies for information collection when the other agency’s own
authority or information collection requirements have not met their
information needs.

	In addition to the public notice and comment period required by the OMB
regulations that implement the Paperwork Reduction Act (see Section 3(b)
of this Supporting Statement), the OMB regulations, 5 CFR 1320.8(d)(1),
also require agencies to consult with potential ICR respondents and data
users about specific aspects of an ICR before the agency submits the ICR
to OMB for review and approval.  In accordance with this regulation and
based on OPPTS Regulatory Coordination Staff guidance, EPA will solicit
comments from potential ICR respondents and data users with respect to
the renewal of this ICR.

	3(d)	Effects of Less Frequent Collection

	Under PAIR, persons are required to report only once for a chemical
listed in the PAIR.  However, if information received from the initial
report indicates human health and environmental risks, then the Agency
may require that additional information be submitted at some future date
to monitor any changes pertaining to that chemical.  As such, the
reporting frequency for PAIR cannot be reduced without effectively
suspending the information collection requirement.

	3(e)	General Guidelines

	This collection does not exceed any of the Paperwork Reduction Act
guidelines at 5 CFR 1320.6.  Note that when this information collection
was last approved by OMB in October 2001, OMB established the following
terms of clearance:

“The Agency shall ensure that the approximate annual burden estimates
for each PAIR rule are provided in the preamble to each rule.  Upon
renewal of this ICR, the Agency shall provide a list of the chemicals
covered by the final PAIR rules issued by EPA over the next three
years.”

	As requested, in the preamble to each PAIR rule issued during the last
ICR approval period, EPA has provided an annual burden estimate for the
rules.  The list of chemicals in those final PAIR rules, along with the
burden estimate provided for those rules, is found under Attachment H to
this supporting statement.

	

	3(f)	Confidentiality

	Submitters may designate information reported under PAIR and Subpart B
of 40 CFR 766 as confidential business information (CBI).  EPA has
implemented procedures to protect any confidential, trade secret or
proprietary information from disclosure.  These procedures comply with
EPA’s confidentiality regulations at 40 CFR Part 2, Subpart B, and
TSCA Section 10.

	3(g)	Sensitive Questions

	This information collection does not include questions of a sensitive
nature.

4.	THE RESPONDENTS AND THE INFORMATION COLLECTED

	4(a)	Respondent NAICS Codes

	PAIR’s respondents are manufacturers and importers of chemical
substances, mixtures or categories.  Respondents affected by this
collection are included primarily in the following NAICS codes:

	3251	Basic Chemical Manufacturing

	3252	Resin, Synthetic Rubber, and Artificial Synthetic Fibers and
Filaments Manufacturing

	3255	Paint, Coating, and Adhesive Manufacturing

	3253	Pesticide, Fertilizer, and Other Agricultural Chemical
Manufacturing

	3259	Other Chemical Product and Preparation Manufacturing 

	32411	Petroleum Refineries 

	4(b)	Information Requested

i.  Data Items

	PAIR requires manufacturers or importers of the listed chemical
substances, mixtures or categories to report to EPA information such as
the substances’ chemical identification, quantity produced or
imported, chemical processes, employee exposure, environmental releases,
uses and products.  Respondents are only required to report information
that is known or reasonably ascertainable by them.  As described in the
previous section, extensive files searches are not required.  The PAIR
reporting requirements are included in the PAIR form and instructions
(EPA Form 7710-35).

ii.  Respondent Activities

	A representative respondent would engage in the following activities:

		Conduct an initial review of the rule to determine if their company
must 

		report;

		Familiarize themselves with the PAIR reporting form;

		Complete the PAIR reporting form;

		Provide trade name notification;

		Indicate CBI status if so desired; and

		Keep a copy for recordkeeping requirements.

	The PAIR generally requires one-time reporting and establishes the
reporting period for the listed chemical substances, mixtures or
categories.  Typically, the reporting period is 30 days from the
effective date of the PAIR rule.  Effective dates of PAIR rules are
typically 30 days after publication of the rule in the Federal Register.
 In other words, the reporting period is typically 60 days from the
publication of a final PAIR rule in the Federal Register.  Therefore, a
reporting schedule is not required.

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

	5(a)	Agency Activities

	The activities routinely conducted by EPA related to the rule
development, processing, analysis and storage of the information
collected under a PAIR rule are as follows:

	Chemical nomination, review and selection;

		Rule development;

		Evaluation of the rule (including impact assessments);

		Industry/public assistance;

		Compliance monitoring; and

		Processing of data received for listed chemicals (includes receipt,
dissemination, evaluation, etc.).

	5(b)	Collection Methodology and Management

	The PAIR requires respondents to submit TSCA section 8(a) notices to
the Information Management Division, Office of Pollution Prevention and
Toxics (OPPT), using EPA Form 7710-35.  Information collected under PAIR
is logged in and assigned a document control number (DCN), distributed
to appropriate EPA personnel for further processing, review, analysis,
etc.  The information is maintained by EPA’s Information Management
Division.

	5(c)	Small Entity Flexibility

	In accordance with TSCA section 8(a)(1)(B), PAIR contains a small
business exemption.  A manufacturer or importer is considered a small
business if (1) the firm’s total annual sales when combined with those
of its parent company (if any) are less than $30 million for the
reporting period and (2) its total production and/or importation of the
chemical substances, mixture or category, for the reporting period, does
not exceed 100,000 pounds (45,000 kilograms) at an individual site owned
and controlled by the firm.

	The small manufacturer/importer exemptions apply to PAIR, regardless of
which office or agency nominates a chemical.  In some instances, the EPA
Administrator can remove these exemptions on a chemical-specific basis,
provided notice and comment rulemaking is utilized.  EPA expects that
those offices that have a critical need for reporting from small
businesses usually exempt from PAIR reporting will use other mechanisms
to gather the data.  EPA does not expect to issue a PAIR rule during the
next 3 years that would impact such small businesses.

	5(d)	Collection Schedule

	Information collection under PAIR occurs after publication of a Federal
Register notice establishing the reporting period for the listed
chemical substances, mixtures or categories.  Respondents are asked to
respond once, within 30 days of the effective date of the final PAIR
rule (which is usually 30 days after publication of the rule in the
Federal Register).  The Agency has no plans to publish the data
collected by PAIR, although non-CBI information may be made available to
the public upon request.

	ESTIMATING THE BURDEN AND COST OF THE COLLECTION

	6(a)	Estimating Respondent Burden

	This section presents the Agency’s estimates of the burden associated
with the reporting and recordkeeping requirements under the TSCA section
8(a) PAIR.  The total annual industry burden for both reporting and
recordkeeping is estimated to be 1,568 hours.  These estimates are based
on the level of PAIR reporting activity expected during the ICR period
of FY 2009 through 2011.  In conducting any study that will be submitted
to EPA under TSCA, the respondent must comply with the Good Laboratory
Practice Standards (GLPS) at 40 CFR part 792 (see Attachment G).  Since
the GLPS represent basic standard practices used by laboratories, any
burden and costs related to the GLPS are fully captured in the cost and
burden estimates provided below.

	The PAIR report is submitted on EPA Form 7710-35, which is two pages
long (see Attachment D).  The first page asks the respondent to provide
basic identifying information, such as the identity of the chemical (CAS
number), the physical location of the plant and mailing address of the
responding entity.  The second page requires the respondent to provide
general information on the quantities of the chemical used and number of
workers exposed and some additional information on the categories of
products (e.g., industrial and consumer) associated with manufacture or
processing of the reported substance.

	Much of the information requested under this ICR is routinely collected
by manufacturers and processors for the maintenance and upkeep of health
and safety information but has not previously been made available to the
Agency.  This information should be readily available to the firm as it
is generated and maintained as part of their normal business practices. 
In fact, the regulations specifically state that the respondent is not
required to conduct an exhaustive search of their files (see 40 CFR
712.7).  The EPA has reviewed the average per-report burden estimate in
light of the Agency’s experience and feedback received from actual
submitters.  Our average estimate of 28.9 hours per response is
consistent with that information.

	The methodology used to develop these cost estimates follows principles
that have been used in previous ICRs.  The methodology and calculations
used in this analysis assume the employee responsible for filling out
the form has a reasonable level of familiarity with the company and
knowledge of the operation at the site.  The analysis deals with the
marginal costs of complying with this specific request and not the total
costs to the company of initial employee training and costs associated
with collecting and storing records or of file maintenance that enable a
company to comply with a range of other Federal and state environmental,
health and safety regulations or accounting requirements that rely on
this type of information.  The 8(a) PAIR requests are issued
infrequently and it is our experience, based on conversations with
respondents, that this duty is similar to other duties they perform
which require familiarity with EPA, state and other Federal agency
requests for chemical information and does not involve additional
familiarization or training to comply with information requested under
this ICR.  

	The Agency is not asserting an exact measurement of the burden and
costs that all potential respondents will incur while complying with
this information collection activity.  The Agency’s burden and cost
estimates are based on averages.  Some respondents may indeed require
more time to respond the information collection than the Agency’s
estimated average of 28.94 hours per report; however, the Agency
believes some respondents will be able to complete their response
activities in less time.  The Agency also intends to continue to provide
rule-specific estimates of burden and costs, presenting them in the
preamble to the PAIR rule.  Should the Agency determine in that context
that this average estimate is insufficient, it will adjust the ICR
accordingly.  Upon renewal, EPA will reassess its burden estimate based
on the next three-year approval period and make adjustments as
appropriate

	Based on information provided by EPA’s Information Management
Division (IMD), an average of 26.00 sites submitted a total of 54.20
reports per year (an average of 2.08 reports per site per year) during
the period of FY 2003 through FY 2007.  In general, the analysis uses
data and methodological assumptions from previous economic analyses of
the individual PAIR rules and other government data sources.  This
analysis also assumes that future annual reporting levels will be
similar to the annual reporting levels of the FY 2003 through FY 2007
period. This reporting level is substantially higher than had been
projected in earlier ICR-supporting analyses (somewhat less than triple
the estimate in the most recent previous ICR renewal analysis). The rate
at which new PAIR rule chemicals are added is sporadic and not entirely
predictable, but this higher level of projected reporting is consistent
with the Agency’s recent experience.  A detailed description of the
methodology used to derive the estimates follows.

Number of Sites and Reports per Site

	The burden hour estimates in this analysis are based on an estimate of
the level of PAIR reporting activity during the next three-year ICR
approval period (FY 2009 to FY 2011).  This, in turn, is related to the
number of PAIR chemical reports and reporting sites.  This report
utilizes data from the fiscal years 2003 to 2007 and annualizes the
number of sites reporting and the number of reports submitted to develop
estimates of future burden.  During the 2003 to 2007 period, an annual
average of 26.00 sites (respondents) submitted 54.20 reports (forms),
for an average of 2.08 reports per respondent.  Some PAIR reports
submitted during a given fiscal year may have resulted from chemicals
added to the PAIR during the previous year.

	Chemicals are added to the PAIR (via Federal Register (FR) notices)
based on Interagency Testing Committee reports as published in the FR.
The number of chemicals added to the PAIR recently is not used in
estimating burden but are provided as background (Source: US EPA, CCD,
Greg Schweer, (8(a) chemicals)).

Number of chemicals added to PAIR in recent fiscal years: 2003 – 47;
2004 – none; 2005 – 23; 2006 – 208; 2007 – none.

Sites Reporting and PAIR Reports Submitted

FY 2003 through 2007

Fiscal Year	Sites Reporting	Reports Submitted

2003	20	39

2004	6	7

2005	24	53

2006	3	3

2007	77	169

Totals	130	271

5-year average	26.00	54.20

Ratio Forms/Sites	2.08

Ratio Sites/Form	0.48

Unit Burden Estimates

	To estimate the burden and costs to industry respondents, several
reporting activities (or burden factors) are analyzed.  These burden
items include: form familiarization; reporting; trade name notification;
CBI substantiation; recordkeeping; and, report submission.  Each of
these activities requires the skills of various labor categories.  The
section below details each separate activity and presents the estimated
labor hours required by each task, by labor category (secretarial,
technical and managerial).

	1.  Form Familiarization

	In the 1981 PAIR economic analysis it was estimated that form
familiarization would require 3 hours of effort from managerial
personnel and 4 hours from technical personnel for a total of 7 hours
per site.  The estimate includes efforts for rule familiarization and to
determine if reporting is required.  To calculate the burden on a per
report basis, the above estimate was multiplied by 0.48, the expected
average number of sites per report (i.e., 26.00 sites / 54.20 reports). 
This results in a per report burden of 3.36 hours.

Per-Report Burden Hours for Form Familiarization

Activity	Secretarial	Technical	Managerial	Total

Form Familiarization	0.00	1.92	1.44	3.36

	2. Report Preparation

	The 1981 PAIR economic analysis estimated that direct reporting
activities would require a total of 16 hours of effort per report.  This
consists of the burden related to the completion of the PAIR form.  As
indicated previously, the respondents are not expected to conduct an
exhaustive search of their files.  Respondents are only required to
report what is known or reasonably ascertainable to them (see 40 CFR
712.7).  The relative distribution of reporting burden between
managerial, technical and secretarial personnel used in the 1992 PAIR
ICR update has been retained and is reflected below.

Per-Report Burden Hours for Report Preparation

Activity	Secretarial	Technical	Managerial	Total

Reporting	1.25	9.25	5.50	16.00

	Given that each site produces an average of 2.08 reports, the per-site
burden for report preparation is 2.08 x 16 hours, or 33.28 hours.

	3.  Trade Name Notification

	Some companies may report their customers’ uses as unknown for more
than twenty percent of their volume.  These companies must list under
Item 10 of the PAIR reporting form the market (trade) name(s) under
which they distribute the chemical.  This reporting is referred to as
trade name notification.

	All commercial manufacturing, importing and processing sites that
distribute any of the chemicals subjected to a PAIR reporting rule under
a trade name must take steps to ensure that information about the
downstream processors is submitted to EPA.  Firms may chose among
several options to meet trade name notification requirements, including:

1) Submit trade name data to EPA for listing in the Federal Register;

2) Notify all customers of the need to report; or 

3) Complete the reporting requirements for each customer.

	This ICR assumes that companies will adopt the least-costly reporting
alternative of providing a trade name list to EPA for inclusion in the
Federal Register.  However, trade name notification is not relevant if
processor reporting is not required.  Furthermore, this ICR also assumes
that all manufacturers and importers will incur trade name notification
costs, but does not address processors due to the lack of data on
processor reporting.  In the 1994 EPA PAIR ICR, the unit burden of trade
name notification was given as 3.2 hours (i.e., 2.2 hours managerial and
1.0 hours secretarial).  This unit burden assumption was retained for
this analysis.

Per-Report Burden Hours for Trade Name Notification

Activity	Secretarial	Technical	Managerial	Total

Trade Name Notification	1.00	0.00	2.20	3.20

	Given that each site produces an average of 2.08 reports, the trade
name notification per-site burden for trade name notification is 2.08 x
3.2 hours, or 6.66 hours.

	4.  CBI Substantiation

	A company may make claims of confidentiality for any data element
contained in its submission.  For each CBI (confidential business
information) claim, generic information must be supplied for a non-CBI
copy of the submission (i.e., a sanitized version must also be
submitted).  It is assumed that most of the time required for CBI
substantiation involves managerial staff discussion of whether or not to
make a CBI claim.  Furthermore, it is assumed that all firms will review
their submissions for CBI content.  As used in the previous PAIR ICR,
the 1986 alternative CAIR CBI substantiation burden estimates have been
used in this analysis with substantial downward adjustments to account
for the less rigorous substantiation requirements in PAIR reporting
rules.  CBI claims for a PAIR report can be made by simply checking the
appropriate boxes on the PAIR reporting form.  It is assumed that most
of the time required for PAIR CBI substantiation involves staff
discussion of whether or not to make a CBI claim.  As a result, burden
estimates used in CAIR has been reduced by one-half in both labor
categories to 0.5 hours of secretarial time and 4 hours of managerial
time per report.

Per-Substantiation Burden for CBI Substantiation

Activity	Secretarial	Technical	Managerial	Total

Trade Name Notification	0.50	0.00	4.00	4.50

	Based on an analysis of CBI claims for reporting to the TSCA Inventory
(discussed in the 1986 CAIR economic analysis), only 75 percent of
reports are expected to make CBI claims.  The burden distributed across
all reports is 4.5 hours x 0.75, or 3.38 hours.  Multiplying the
adjusted report burden and cost by 2.08, in turn, provides the per site
burden for CBI substantiations of 7.02 hours.

	5.  Recordkeeping

	Pursuant to TSCA Section 8(a), the manufacturer/importer or processors
of the chemical substances identified under PAIR must also maintain
records of the information submitted to EPA.  In addition, since
manufacturer/importer or processors that submit data to EPA must comply
with the GLPS in 40 CFR 792, this ICR also generally covers the burden
associated with maintaining records as required under the GLPS.  These
records are used for compliance monitoring and enforcement purposes.

	As in the previous ICR, EPA estimates that the recordkeeping burden
associated with this ICR involves about an hour of time for both the
secretarial and the technical labor category.  This burden estimate
represents the time necessary for the individuals to identify the
information, determine the appropriate location for the record to be
kept, and placing the record in such a location.  The per-report
recordkeeping burden is therefore estimated to be 2 hours.

Per-Report Burden Estimates for Recordkeeping

Activity	Secretarial	Technical	Managerial	Total

Trade Name Notification	1.00	1.00	0.00	2.00

	The per-site burden for recordkeeping is 2.08 reports x 2.0 hours, or
4.16 hours.

	6.  Report Submission

	Report submission consists of three elements: preparation and review of
a transmittal letter to accompany the submission of a report,
photocopying the report and mailing costs.

	As with the previous ICR, EPA estimates that the per report submission
will require 0.5 hours of secretarial time and 0.5 hours of managerial
time for a total of one hour.  The secretarial burden includes the time
required to type the transmittal letter, to photocopy the report, and
the steps necessary to mail the report package to EPA after management
review and approval.  The managerial time assumes an involvement in the
preparation of the transmittal letter and review of the report package
before it is submitted to EPA.

Per Report Burden Estimates for Report Submission

Activity	Secretarial	Technical	Managerial	Total

Trade Name Notification	0.50	0.00	0.50	1.00

	Given that each site produces an average of 2.08 reports, the per site
burden for report submission is 2.08 x 1 hour, or 2.08 hours.

	Total Industry Burden Estimates

	The following table presents the compilation of the annual burden hour
estimates for respondents.

Estimated Annual Burden Hours

(assuming 54.2 reports and 26 reporting sites per year)

Burden Item	Hours per Report	Hours per Site	Total Annual Hours

Form familiarization	3.36	7.00	182.11

Reporting	16.00	33.28	867.20

Trade name notification	3.20	6.66	173.44

CBI substantiation	3.38	7.02	182.93

Recordkeeping	2.00	4.16	108.40

Report submission	1.00	2.08	54.20

Totals	28.94	60.20	1,568.28

Note – calculated totals may not agree to reported accuracy due to
suppressed digits and/or rounding

	In summary, an average of 26.00 respondents would be required to spend
an estimated total of 1,568.28 hours each year to respond to PAIR rules
during the period of FY 2005 through FY 2008, requiring an average of
60.20 hours per respondent.

6(b)	Estimating Respondent Costs

	This section presents estimates of the cost expected to be incurred as
a result of reporting under the TSCA section 8(a) PAIR.  The total
annual industry cost for both reporting and recordkeeping is estimated
to be $89,593.  This estimate is based on the cost of the burden
estimate provided in section 6(a) above, and includes other costs
associated with this ICR.

	Labor costs in this report have been updated using the most recently
available, revised wage rates and information on benefits costs.  These
wage rates are taken from the Bureau of Labor Statistics (BLS) Employer
Costs for Employee Compensation Supplemental Tables, December 2006
(released on March 29, 2007), with the information extracted from Table
2, Private industry workers in manufacturing industries, by occupational
group. This table is available on-line at   SEQ CHAPTER \h \r 1     
HYPERLINK "http://www.bls.gov/ncs/ect/sp/ecsuptc.pdf" 
http://www.bls.gov/ncs/ect/sp/ecsuptc.pdf   in PDF format, or at   SEQ
CHAPTER \h \r 1   HYPERLINK "http://www.bls.gov/ncs/ect/sp/ecsuptc.txt" 
http://www.bls.gov/ncs/ect/sp/ecsuptc.txt  as text. The clerical wages
are taken from the BLS data for “office and administrative support.”
The technical wages are taken from the BLS data for “professional and
related.” The managerial wages are taken from the BLS data for
“management, business and financial.” Labor wage rates and hourly
benefit costs taken from those sources have been used to calculate the
labor cost to respondents, as shown below. The hourly overhead is
calculated as 17 percent of the base wage. This approach is used for
consistency with Office of Pollution Prevention and Toxics economics
practices, and is based on the analysis in Wage Rates for Economic
Analyses of the Toxics Release Inventory Program, Cody Rice, U.S. EPA,
Office of Pollution Prevention and Toxics, Economic and Policy Analysis
Branch, June 10, 2002. This approach, which is now standard practice in
this office, produces wage and cost estimates that are somewhat lower
than the data and methods used in the most recent previous 8(a) PAIR ICR
renewal analysis. 

Hourly Labor Costs

	Clerical	Technical	Managerial

Hourly wage rate	$16.07	$32.38	$39.77

Benefit costs	$8.20	$16.77	$18.83

Overhead 	$2.73	$5.50	$6.76

Total hourly cost	$27.00	$54.65	$65.36

	These labor costs are multiplied by the estimated burden hours per
activity and added to any non-labor costs to develop total unit costs
per report.  It is estimated that recordkeeping and report submission
tasks will require expenditures other than labor.  Recordkeeping is
estimated to require an additional $31.63 per report for miscellaneous
filing materials while report submission is estimated to require an
additional $19.04 per report for photocopying and mailing expenses. 
Total non-burden costs per report are estimated to be $50.67.  With an
annual estimate of 54.20 reports expected, the total non-burden cost for
this ICR is $2,746 (rounded to the nearest whole dollar).  These
non-burden hour costs are identified separately on the OMB Form 83-I
pursuant to OMB guidance, but are included in the total costs here. 
Finally, unit costs per report are multiplied by the number of reports
per site per year to arrive at unit costs per site (respondent costs).

	1.  Form Familiarization

	The per report cost of form familiarization is:

	Managerial labor: 1.44 hours@ $65.36/hour = $94.12

	Technical labor: 1.92 hours @ $54.65/hour = $104.93

	Cost per report = $199.05

	The per site cost of form familiarization is:

	Cost per report of $199.05 x 2.08 reports per site = $414.02

	2.  Report Preparation

	The per report cost for report preparation is:

	Managerial labor: 5.5 hours @ $65.36/hour = $359.48

	Technical labor: 9.25 hours @ $54.65/hour = $505.51

	Secretarial labor: 1.25 hours @ $27.00/hour = $33.75

	Cost per report = $898.74

	The per site cost of report preparation is:

	Cost per report of $898.74 x 2.08 reports per site = $1,869.38

	3.  Trade Name Notification

	The per report cost for trade name notification is:

	Managerial labor: 2.20 hours @ $65.36/hr = $143.79

	Secretarial labor: 1 hour @ $27.00/hr = $ 27.00

	Cost per report: $170.79 

	The per site cost of trade name notification is:

	Cost per report of $170.79 x 2.08 reports per site = $355.24

	4.  CBI Substantiation

	The per report cost for CBI substantiation is:

	Managerial labor: 4.0 hours @ $65.36/hour = $261.44

	Secretarial labor: 0.5 hours @ $27.00/hour = $13.50

	Cost per report = $274.94 

	Adjusted cost per report = $206.21

	(adjustment for 75 percent of reports claiming CBI)

	The per site cost of CBI substantiation is:

	Cost per report of $206.21 x 2.08 reports per site = $428.91

	5.  Recordkeeping

	The per report cost for recordkeeping is:

	Technical labor: 1.0 hours @ $54.65/hour = $54.65

	Secretarial labor: 1.0 hours @ $27.00/hour = $27.00

	Filing materials = $31.63

	Cost per report = $113.33

	The per site cost of recordkeeping is:

	Cost per report of $113.33 x 2.08 reports per site = $235.73 

	6.  Report Submission

	The per report cost of report submission:

	Managerial labor: 0.5 hours @ $65.36/hour = $32.68

	Secretarial labor: 0.5 hours@ $27.00/hour = $13.50

	Photocopying and mailing = $19.04

	Cost per report = $65.22

	The per site cost of report submission is:

	Cost per report of $65.22 x 2.08 reports per site = $133.49

The unit cost per report and unit cost per site, including a breakdown
of costs by labor category, are summarized in the following table:

 



Reporting Costs by Labor Category and Reporting Activity

in dollars of cost per report

	Secretarial	Technical	Managerial	Other direct cost	Total cost 

per report

Form Familiarization

$104.93	$94.12

$199.05

Reporting	$33.75	$505.51	$359.48

$898.74

Trade Name Notification	$27.00

$143.79

$170.79

CBI Substantiation	$10.13

$196.08

$206.21

Recordkeeping	$27.00	$54.65

$31.63	$113.28

Report Submission	$13.50

$32.68	$19.04	65.22

Per Report Total	$111.38	$665.09	$826.15	$50.67	$1,653.29

Note: Annual Average Reporting Cost per Respondent = $1653 * 2.08 =
$3,438  

	The average respondent is assumed to spend $1,653 per report, or $3,438
in total per respondent per year. As noted earlier, the Agency is
estimating an average of 26 reporting sites and 54.2 reports per year. 
Over all sites, responding to PAIR rules is estimated to cost industry a
total of $89,593 per year during the period of FY 2009 through FY 2011.

6(c)	Estimating Agency Burden and Cost

	The estimated annual cost of the PAIR to the Federal government is
calculated on an annual basis.  The FY 2007 cost to EPA of a full-time
equivalent employee (FTE), Grade 12, Step 1 in the Baltimore-Washington
pay area is $66,767 (U.S. Office of Personnel Management Internet site
at http://www.opm.gov).  One FTE is equivalent to 2,080 hours per year. 
The fully loaded FTE cost is $106,827. The annual costs per FTE are
derived by multiplying the annual pay rate by 1.6 (the benefits
multiplication factor). The multiplication factor used is recommended in
EPA’s Office of Policy, Planning, and Evaluation’s Instructions for
Preparing Information Collection Requests (ICRs), (June 1, 1992). 

	Data processing costs have been updated from 1996 to current dollars
using the GDP implicit price deflator from the Bureau of Economic
Analysis (BEA).  The BEA GDP price index series with a base of 2000 =
100 has the 1006 index at 93.859 and the 2006 index at 116.568, so the
adjustment factor from 1996 to 2006 is 1.242 (116.568/93.859 = 1.242).
Data processing costs for the 1996 PAIR ICR update were estimated to be
approximately $199.56 per report.  Adjusting this number to 2003 with
the GDP implicit price deflator yields an adjusted data processing cost
of $247.84 per report (i.e., $199.56 x 1.242 = $247.84).  Thus, the
total annual data processing cost is $12,442 ($247.84 per report x 50.20
annual reports).

	This analysis assumes that an annual average of 54.20 reports will be
submitted over the three year period of FY 2009 through 2011.  Personnel
burden and costs associated with industry/public assistance and data
processing activities have been adjusted based on that estimate.  From
the 1989 PAIR ICR update it has been derived that industry/public
assistance required approximately 1.5 hours per report. For 54.2
reports, that works out to 81 hours or about 0.04 FTEs. Similarly, the
1989 PAIR ICR update estimated that about 3.75 hours of data
processing/system support personnel time would be required per report.
For 54.2 reports, that works out to 203 hours or 0.10 FTEs. 

	The table presented below summarizes the government’s activities in
developing and administrating the PAIR.  The required FTEs per activity
are retained from the 1996 PAIR ICR update and from the previous 8(a)
PAIR ICR renewal analyses, for all activities except for the
recalculation of the two categories of burden discussed in the previous
paragraph.  

GOVERNMENT BURDEN SUMMARY

Activity	Annual Burden

Chemical nomination, review and selection	0.25 FTE

Rule development	0.90 FTE

Evaluation of rule	0.05 FTE

Industry/public assistance	0.04 FTE

Compliance monitoring	0.10 FTE

Data Processing and system support personnel	0.10 FTE

Total FTEs	1.44 FTE

	It is estimated that the annual cost to the Federal Government will be
$12,442 in data processing costs plus 1.44 FTEs.  At an estimated loaded
annual salary of $106,827 per FTE, the total of 1.44 FTEs will cost EPA
$153,831 in fully loaded labor cost (salaries, benefits, and overhead).
This brings the total costs to the Federal government to $166,273
annually (i.e., $12,442 + $153,831).

	Below is a summary of the costs to the federal government for this
information collection.

Government Estimated Annual Burden and Cost Summary

Total FTEs	1.44

Loaded Cost per FTE	$106,827

Government Labor Cost	$153,831

Government Data Processing Cost	$12,442

Total Annual Government Cost	$166,273

6(c)	Bottom Line Burden Hours and Costs: Master Tables

	Respondent Burden and Costs

	Total respondent annual burden hours = 1,568 hours

	Total respondent annual costs = $89,593

	Agency Burden and Costs

	Agency burden hours: 1.44 FTEs = 2,995 hours

	Agency annual costs = $166,273

6(d)	Reason for Change in Burden

	This request reflects an increase in the estimated annual burden of 988
hours (from 580 hours to 1,568 hours) from that currently in the OMB
inventory.  This increase is attributable to an increase in the assumed
number of PAIR reports filed annually, from an average of 19.67 per year
to 54.2 per year.  The more recent average is based on the past five
fiscal years (2003-2007) of PAIR reporting data.  The annual average
number of respondents (reporting sites) is 26.0, and has increased from
the previous estimated average of 11.0.

6(e)	Burden Statement

	The annual public burden for this collection of information, which is
approved under OMB Control No. 2070-0054, is estimated to average 28.9
hours per response.  According to the Paperwork Reduction Act,
“burden” means the total time, effort, or financial resources
expended by persons to generate, maintain, retain, or disclose or
provide information to or for a Federal agency.  For this collection it
includes the time needed to review instructions; develop, acquire,
install, and utilize technology and systems for the purposes of
collecting, validating, and verifying information, processing and
maintaining information, and disclosing and providing information;
adjust the existing ways to comply with any previously applicable
instructions and requirements; train personnel to be able to respond to
a collection of information; search data sources; complete and review
the collection of information; and transmit or otherwise disclose the
information.  An agency may not conduct or sponsor, and a person is not
required to respond to, a collection of information unless it displays a
currently valid OMB control number.  The OMB control number for this
information collection appears above.  The OMB control numbers for
EPA’s regulations in title 40 of the CFR, after appearing in the
Federal Register, are listed in 40 CFR part 9 and included on the
related collection instrument or form, if applicable.

	To comment on the Agency’s need for this information, the accuracy of
the provided burden estimates, and any suggested methods for minimizing
respondent burden, including the use of automated collection techniques,
EPA has established a public docket for this ICR under Docket ID No.
EPA-HQ-OPPT-2007-0670.  The docket is available for public viewing at
the Pollution Prevention and Toxics Docket in the EPA Docket Center
(EPA/DC).  The EPA/DC Public Reading Room is located in the EPA West
Building, Room 3334, 1301 Constitution Ave., NW., Washington, DC.  The
EPA/DC Public Reading Room is open from 8:30 a.m. to 4:30 p.m., Monday
through Friday, excluding legal holidays.  The telephone number for the
EPA/DC Public Reading Room is (202) 566-1744, and the telephone number
for the Pollution Prevention and Toxics Docket is (202) 566-0280.  An
electronic version of the public docket is available through the Federal
Docket Management System (FDMS) at www.regulations.gov.  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-2007-0670 and OMB control number
2070-0054 in any correspondence.

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㄀$摧֣VጀID 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-2007-0670 and OMB control number 2070-0054 in any
correspondence.

	 Economic Impact and Small Business Definition Analysis for the Final
TSCA Section 8(a) Preliminary Assessment Information Rule, Final Report,
prepared for the EPA by ICF, Inc., Washington, D.C., 1981.

	 40 CFR 712.28 (July 1, 1993).

	 Burden Hour and Cost Estimates for PAIR Section 8(a) Reporting (1994
Update), internal U.S. EPA memorandum from Carol Rawie, Economics,
Exposure, and Technology Division to Karen Boswell, Chemical Testing and
Information Branch, May 16, 1994.

	 The alternative Comprehensive Assessment Information Rule (CAIR)
estimate was developed to account for CAIR-listed chemicals for which
respondents were required to answer only a limited number of questions. 
A discussion of the alternative CAIR burden and cost estimates is found
in Section 6.6 (pp.  67-69) of the Estimated Cost of the Final
Comprehensive Assessment Information Rule, Final Report, U.S.
EPA/OPPT/EETD, June 1, 1986 (prepared for EPA by Kearney/Centaur).

	  The figures for filing materials (item 5, $31.63) and photocopying
and mailing ($19.04) were obtained by inflating the estimates from the
previous ICR ($28.29 and $17.03, respectively), using the consumer Price
Index for urban areas (2003 annual = 184.0; 2007 first half = 205.7).

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