Statement Supporting the Renewal of the

Information Collection Procedure for Title III

Trade Secrecy Regulations

1.	Identification of the Information Collection

1 (a)	Trade Secret Claims for Community Right-to-Know and

          		Emergency Planning (EPCRA Section 322) - EPA No. 1428.07

1 (b)  Short Characterization

This information collection request pertains to trade secrecy claims
submitted under section 322 of the Emergency Planning and Community
Right-to-Know Act of 1986 (EPCRA), also known as Title III of SARA, the
Superfund Amendments and Reauthorization Act.  Title III contains
provisions requiring facilities to report to State and local
authorities, and EPA, the presence, use and release of extremely
hazardous substances (described in sections 302 and 304) and hazardous
and toxic chemicals (described in sections 311, 312 and 313
respectively).  Section 322 of Title III allows a facility to withhold
the specific chemical identity from these Title III reports if the
facility asserts a claim of trade secrecy for that chemical identity.
The provision establishes the requirements and procedures that
facilities must follow to request trade secrecy treatment of chemical
identities, as well as the procedures for submitting public petitions to
the Agency for review of the “sufficiency” of trade secrecy claims.
EPA published the trade secrecy regulations on July 29, 1988 (58 FR
28772), codified in 40 CFR Part 350.

Trade secrecy protection is provided for specific chemical identities
contained in reports submitted under each of the following Title III
sections:

o	303 (d)(2)  Facility notification of changes that have or are about to
occur;

o	303 (d)(3)  Local Emergency Planning Committee (LEPC) requests for
facility information to develop or implement emergency plans;

o	311 Material Safety Data Sheets (MSDSs) submitted by facilities, or
lists of those                         	chemicals submitted in place of
the MSDSs;

o	312 Tier II emergency and hazardous chemical inventory forms; and,

o	313 Toxic chemical release inventory forms.

Section 322 requires that facilities requesting trade secrecy protection
submit to EPA, in conjunction with their Title III report, an
explanation showing that their claim for the chemical identity meets the
four statutory criteria of trade secrecy enumerated in subsection (b) of
that provision.

Facility owners and operators submit trade secrecy claims only to EPA.
Claims consist of either one or two versions of the Title III report
depending on the type of report, and two versions of an up-front
substantiation of the trade secrecy claim.  The substantiation is
designed to gather sufficient factual support to indicate whether the
claim will meet the four statutory criteria of trade secrecy.  It is an
EPA-developed form, and is discussed in detail in Part 3(b)(i) below.

Section 322(d) also provides for a public petition process to request
the disclosure of chemical identities claimed as trade secret.  The
final rule does not specify a petition format, but does require that a
petition contain certain elements set forth below in Part 3(b)(ii).

EPA is required by section 322(h) to identify the adverse health and
environmental effects associated with the section 313 toxic chemicals
claimed as trade secret and to include this information in the Toxic
Chemical Release Inventory database required by section 313(j).

This provision also instructs the governor or State Emergency Response
Commission to identify the adverse health effects of the chemicals
claimed as trade secret under sections 303, 311 and 312 and provide this
information to persons requesting the information.

Section 323 regulations contain provisions allowing health professionals
to gain access to trade secret chemical identities under three different
circumstances:

o	Non-emergency treatment and diagnosis.  The chemical identity of a
hazardous chemical, extremely hazardous substance or toxic chemical must
be given to a health professional if the information is needed in the
diagnosis or treatment of an exposed individual;

o	Medical emergencies.  Expedited access to the identity of chemicals to
which people have been exposed is provided for health professionals;
and,

o	Preventative measures.  Health professionals studying chemical
exposure and health effects for local governments are also given access
to chemical identities upon written request.

Two preconditions must be met in order for health professionals to gain
access to trade secret chemical identity in non-emergency and
preventative measure situations: they must submit a written statement of
need and a written confidentiality agreement to the facility owner or
operator prior to obtaining the information.  No such requirements exist
in the medical emergency situation, but the owner or operator disclosing
the information may require a written confidentiality agreement and
statement of need as soon as circumstances permit.

The Offices that will use trade secret information are the Office of
Emergency Management (OEM) in the Office of Solid Waste and Emergency
Response (OSWER) and the TRI Program Division in the Office of
Environmental Information (OEI).  Trade secrecy claims are stored in
areas designed to assure the confidentiality of the collected
information.

2.  Need/Authority for Collection; Use/Users of the Data

2 (a)  Need/Authority for Collection

The specific provision of Title III authorizing this collection is
section 322, Trade Secrets.  Congressional intent in writing trade
secrecy provisions under Title III was to balance industry's concern
with the protection of legitimate trade secrets, with communities’
right-to-know chemical identification information.  Congress established
procedures for companies to assert claims, for the public to obtain
review of their validity, and for an Agency claim review process which
eliminates legally invalid and frivolous claims.

Section 322(a)(1)(B) requires a facility that requests trade secrecy
protection for a Title III chemical to substitute a generic chemical
class or category name in the place on the Title III submittal where the
withheld specific chemical identity is normally reported.  A copy of
this Title III submittal, as well as the chemical identification
information that is withheld, are to be submitted separately to the EPA
pursuant to sections 322(a)(2)(A)(iii) and (a)(2)(B)(ii).

A facility is entitled to withhold chemical identification information
according to section 322(a)(2)(A)(i), only if that facility claims that
such information is a trade secret on the basis of the following four
factors which are enumerated in the provisions of section 322(b)(1)-(4):

o	The facility has not disclosed the chemical identity to any other
person, other than a member of a local emergency planning committee, an
officer or employee of the United States or a State or local government,
an employee of such person, or a person who is bound by a
confidentiality agreement, and the facility has taken reasonable
measures to protect the confidentiality of such information and will
continue to take such measures;

o	The information is not required to be disclosed or otherwise made
available to the public under any other Federal or State law;

o	Disclosure of the information is likely to cause substantial harm to
the competitive position of the facility; and,

o	The chemical identity is not readily discoverable through reverse
engineering.

A facility is required under section 322(a)(2)(A) to make its claim of
trade secrecy by submitting, in conjunction with its Title III report,
an explanation containing the reasons, including specific descriptions,
why the subject information satisfies the four statutory criteria.
Within 30 days after receipt of a public petition, EPA is required under
section 322(d) to review the information contained in a claimant’s
explanation to determine whether a claim is “sufficient.”  If the
Agency determines a claim is sufficient, section 322(d)(3)(A) provides
for the claimant's submission of supplemental information to establish
the veracity of the assertions contained in the substantiation.  If the
Agency determines that a claim is insufficient, or that the chemical
identity is not a trade secret, and further determines that the claim is
frivolous, section 325(d) requires that the Agency assess a civil or
administrative penalty for the claim.

Section 322(f) permits a facility to designate, apart from the specific
chemical identity, information which is contained in their claim
explanation to be entitled to protection under the Trade Secrets Act, 18
U.S.C., section 1905.  Except for information entitled to such
protection, the provision requires that the Agency make all claim
explanations publicly available.  Further, Title III section 324(a)
mandates that EPA, the States, and local authorities, make each hardcopy
Title III report publicly available during normal working hours at
locations designated by the above entities, as appropriate, in a manner
consistent with the provisions of section 322, (i.e., with the generic
chemical name substituted for the specific chemical identity where a
trade secrecy claim is made for the latter).

The regulations contained in 40 CFR Part 350 provides for the submission
of two versions of the report and the substantiation, enables EPA, State
Emergency Response Commissions (SERCs) and LEPCs to fulfill the
statutory mandate that public access be readily available to documents
containing only the generic chemical descriptions, and that the specific
chemical identity and other designated trade secret information be
accorded confidential treatment.

The regulations also provides for submission to EPA of a sanitized and
an unsanitized version of the substantiation form, a sanitized and where
indicated, an unsanitized version of the Title III report by a facility
requesting trade secrecy protection for a Title III reported chemical.
The sanitized and unsanitized versions of these documents are identical
in all respects except that the trade secret chemical identification
information reported in the unsanitized version is deleted from the
sanitized version and a generic class or category name is substituted in
its place.  Also, other information provided in the unsanitized
substantiation that is designated as a trade secret by a facility is
deleted from the sanitized substantiation.  Claimants submit only a
sanitized version of  section 303(d)(2) and (d)(3) reports, and section
311 MSDS’ to appropriate State and local authorities.

Answers to the substantiation questions described below provide the
“specific description” stipulated in section 322(a)(2)(ii) on why a
facility believes trade secrecy should apply.  Without this information,
the Agency would not be in a position to evaluate whether or not a claim
to withhold the chemical identity is sufficient, nor would it have the
time (statutorily set at 30 days) required to request and review the
data in response to a petition for identity disclosure.  Further, this
information is needed in order for the Agency to evaluate claims for
frivolousness and seek related penalties under section 325.  On a
broader scale, the information collection request is also necessary in
order for EPA to evaluate whether the claim is complete under sections
322(a)(1) and (a)(2).

The Agency developed a standardized claim substantiation form to help
it assess the sufficiency, validity and frivolousness of claims.  The
Agency anticipated that the form would reduce confusion about what
information is to be supplied to meet the four statutory criteria.  The
Agency also anticipated that the form would help submitters more easily
determine if they have a sufficient basis to make trade secrecy claims,
ensure that all submissions are evaluated on the basis of comparable
information, and “flag” the documents for procedural safeguards to
quickly identify, review and protect the confidentiality of the claim.

Based on reviews of the substantiations submitted in past reporting
years, EPA's experience has been that use of a standardized
substantiation form has: (1) enabled submitters to adequately understand
and develop information necessary to submit a sufficient claim; (2)
enabled EPA to ensure that all submissions are evaluated on the basis of
comparable information, and; (3) served as an efficient identifier of
the trade secret status of the document and associated report, and
hence, has ensured the use of appropriate Agency handling and routing
procedures protective of their confidentiality.

2 (b)  Use/Users of the Data

The trade secrecy claim information is used only by OSWER and OEI and is
needed by these Offices in order to: (1) perform the Agency’s review
of claims as required by section 322(d) to determine whether the claims
are sufficient to support a finding that the specific chemical identity
withheld is a trade secret; (2) ensure that claims for all withheld
chemical identities are complete in accordance with the requirements of
sections 322 (a)(1) and (a)(2), and; (3) evaluate claims for
frivolousness and the attendant assessment of penalties stipulated in
section 325 (d)(1).

3.	Respondents/SIC Codes; Information Requested

3 (a)  Respondents/SIC Codes

Sections 303, 311 and 312 claims are submitted by both the manufacturing
sector, (SIC codes 20-39) and the non-manufacturing sector.  No range of
SIC codes exists for the non-manufacturing sector.  Examples of this
sector include the construction industry and dry cleaners.  Examples of
the manufacturing sector include chemical manufacturers and paper
manufacturers.

Section 313 claims are submitted by covered sectors, which, as of
reporting year 2005, include: metal mining ((SIC code 10 (except 1011,
1081, and 1094)); coal mining ((SIC code 12 (except 1241));
manufacturers (SIC codes 20-39); electric utilities (SIC codes 4911
(limited to facilities that combust coal and/or oil for the purpose of
generating electricity for distribution in commerce), 4931 (limited to
facilities that combust coal and/or oil for the purpose of generating
electricity for distribution in commerce), and 4939 (limited to
facilities that combust coal and/or oil for the purpose of generating
electricity for distribution in commerce)); commercial hazardous waste
treatment (SIC code 4953 (limited to facilities regulated under the RCRA
Subtitle C, 42 U.S.C. section 6921 et seq.)); chemical and allied
products-wholesale (SIC code 5169); petroleum bulk terminals and plants
(also known as stations)-wholesale (SIC code 5171); and, solvent
recovery services (SIC code 7389 (limited to facilities primarily
engaged in solvents recovery services on a contract or fee basis)).  EPA
intends to require reporting on the same universe of SIC codes discussed
above using NAICS codes beginning with RY 2006 for which reports are due
July 1, 2007.  In addition, federal facilities were added to the
respondent community by Executive Order 12856, and were required to
report beginning calendar year 1994.

3 (b)  Information Requested

       (i)  Data Items for Trade Secrecy Claims

Based on the four substantiation requirements in section 322(b), the
Agency developed six core questions to comprise a standard
substantiation form.  (See Attachment 1)

Questions one and two refer directly to the first criterion of section
322(b).  The first question, on “specific measures” is the detail
required by the submitter to prove to the EPA reviewer that reasonable
safeguards have been taken to prevent unauthorized disclosure of the
specific chemical identity.  Answers to the second question will be used
by the Agency to evaluate the facility's claim that the specific
chemical identity has not been disclosed to anyone not bound by a
confidentiality agreement.

Question three corresponds to the statute’s second criterion that the
submitter show either that a State or Federal agency has not already
determined that the chemical identity is not a trade secret, or that no
existing State or Federal statutes prohibit claiming the chemical
identity as a trade secret.

Questions four and five require information about the facility’s known
connection with the use of the chemical, and estimates of competitive
harm that would result from disclosure.  Submitters must provide EPA
with a description of their unique use of the chemical (3.4i), known
linkages of the chemical to the facility in publications and patents
(3.4ii), an explanation of how competitors could deduce use from
disclosure of the chemical identity (3.4iii), and why knowledge of this
use would be valuable to competitors (3.4iv).  Specific indications of
the competitive harm resulting from disclosures must be provided in
question five.  These questions refer back to the third criterion of
section 322.

Question six enables EPA to identify the prevalence of the chemical in
the company’s products or releases, and the corresponding ability of
competitors to identify the chemical through reverse engineering.  This
issue is specifically addressed in the fourth criterion.

In addition, blocks on the first page of the form provide space for
accurate identification of the claimed trade secret chemical (CAS
number, chemical identity), a field for substitution of the generic
class or category, a check-off box to clearly identify the type of Title
III report for which the claim is being asserted, and the facility’s
Dun and Bradstreet number (for precise facility and record
identification).  Collecting this information generates no additional
burden because it is transferred directly from the reports required
under the various sections of Title III for which a claim is being made.

Finally, the submitter must sign a certification statement, found on the
last page of the form, that the information is true to the best
knowledge and belief of the submitter.

  (ii)  Data Items for Public Petition Process

No specific petition format is required.  However, the rule does require
that the following be included in a petition:

o	The name, address and telephone number of the petitioner;

o	The name and address of the company claiming the chemical identity as
trade secret;

o	A copy of the relevant sanitized Title III report (e.g., MSDS, Tier II
or toxic chemical release form); and,

o	A specific indication of the chemical identity that is being requested
for disclosure.

EPA requires a copy of the Title III report in order to prevent any
confusion about the particular disclosure in question.  By statute,
copies of facility filings are available at the offices of designated
State or local entities.  In writing the proposed and final regulations,
the Agency considered these elements to be the minimum needed to
successfully identify and begin the review of a trade secrecy claim.

4.	The Information Collected -- Agency Activities, Collection
Methodology, and Information Management

4 (a) Agency Activities

o	Process and store the data;

o	Review the claims for completeness, sufficiency, and frivolousness;

o	Respond to requests for confidential information from State governors,
and non-confidential information from the public;

o	Respond to petitions from the public for disclosure of chemical
identities claimed as trade secret; and,

o	Prepare adverse health and environmental effects data for relevant
chemical identities claimed as trade secret.

4 (b) Collection Methodology and Management

The collection of trade secrecy claims is accomplished by respondents
sending their claim submissions to EPA.  The sanitized or non-trade
secret versions of the Title III report and the substantiation are
stored so as to be easily accessible to the public.  Data reported on
the sanitized version of a  Title III, section 313 report are entered in
the Toxic Chemical Inventory database. The unsanitized versions of the
Title III report and the substantiation are handled, labeled and stored
in a manner protective of their confidentiality.

The unsanitized trade secret versions of these documents are reviewed to
determine the sufficiency, validity and frivolousness of the claims.
Both the sanitized and unsanitized documents are used to review the
generic chemical class or category name in light of the specific
chemical identity claimed as trade secret, to ensure the appropriateness
of the generic description.  For section 313 claims, both chemical
descriptions are reviewed and used to develop adverse health and
environmental effects data which are representative of the
characteristics of the specific chemical identity withheld, and
protective of the trade secret chemical identity.

While use of information technology is being encouraged in the
relatively uniform Title III reporting sections, the unique nature and
length of trade secrecy substantiation responses will not confer any
special advantage to their being reported on alternative media.
Standardized responses are not expected, or encouraged, to questions
about facility safeguards to protect confidentiality of a chemical; the
extent of disclosure to local, State and Federal government entities;
discussions of the use of the chemical and competitors’ ability to
discover it; and, statements on harm to competitive position.

The public petition process applies only to a chemical identity that a
facility claims as trade secret, and not to other information contained
in a substantiation which a facility has claimed as a trade secret.
After receiving a petition, EPA has 30 days to determine whether the
assertions on a facility’s substantiation form (if true) would form a
sufficient basis for a trade secrecy claim.  If the form meets the
criteria of sufficiency, EPA will notify the submitter that they have 30
days to submit supplemental material supporting the truth of the
assertions made in the substantiation.  If the claim does not meet the
criteria of sufficiency, EPA will notify the submitter that the claim
will be denied.  The facility may appeal to the Office of General
Counsel or submit a statement of good cause to amend the substantiation.
 EPA will then accept or reject the statement, allowing or disallowing
the submission of additional information.  Finally, based on all the
information a facility has submitted, EPA will determine whether the
claim warrants trade secrecy protection.

EPA-initiated reviews are conducted following the same steps involved
in the public petition process and may result in an Agency decision
regarding the sufficiency of the trade secrecy claims.  However,
EPA-initiated reviews may be less formal and culminate in the withdrawal
of a claim by a facility prior to the issuance of a formal Agency
decision on the merits of the claim.  The less formal reviews usually
involve claims which are determined incomplete upon EPA review or
complete claims which are thought by EPA to demonstrate obvious problems
or weaknesses.  In the circumstance of an incomplete package (no
substantiation form), the Agency issues an NDC (Notice of Data Change).
In those instances when a complete but deficient package is submitted,
the Agency issues a notice of insufficiency which is some times accepted
by the facility and on one occasion during the last ICR timeframe,
appealed to OGC.

4 (c) Small Entity Flexibility

The regulatory provisions of sections 311/312 and the statutory
provision of section 313 inherently minimize the burden for small
entities.  Sections 311/312 have reporting thresholds below which
facilities are not required to report.  Section 313 applies only to
facilities with 10 or more full-time employees.

The decision to submit a trade secrecy claim on a Title III report is
voluntary.  Facilities that submit trade secrecy claims are doing so
because they believe it is to their benefit.  In addition, the need to
claim trade secrecy protection for a chemical identity is just as
important to small companies as it is to large companies.  Therefore,
the need to supply information to support a submission, as well as to
review it, is dependent upon a firm’s demonstration that it can
adequately answer the four criteria found in the statute.  Any firm,
regardless of size, need only provide as much, or as little, detail as
it feels necessary to support its claim under the statute.

4 (d) Collection Schedule

Under section 322, a specific chemical identity claimed as a trade
secret is withheld from the face of Title III reports.  That provision
requires that claim explanations, and the information claimed as a trade
secret, be submitted concurrently with the submission of the Title III
reports.  Apart from the statutory mandate that requires the filing of a
claim each time the subject chemical is reported in a Title III
submission, an updated claim is necessary to establish the current
applicability of the four statutory criteria of trade secrecy.  Even the
slightest change in the circumstances which support the claim can be
pivotal to the sufficiency, validity, and frivolousness of the claim.
Even where previously created substantiations are relevant and
appropriate for use at a later time, EPA encourages submitters to
carefully review the substantiations.

In the case of sections 312 and 313, the reporting is annual and
facilities submit a current claim annually with those reports.  Under
section 311, a claim must be resubmitted to EPA if an MSDS or list is
updated.  Under sections 311 and 312, an initial MSDS or list must be
updated within three months after the facility owner or operator
discovers significant new information regarding an aspect of a hazardous
chemical.  Under section 303(d)(2) and (d)(3), a claim need not be
resubmitted to EPA after the initial communication to the relevant LEPC
unless further communication follows between the facility and LEPC which
discusses the specific chemical identity in question.

5.	Nonduplication, Consultations, and other Collection Criteria

5 (a) Nonduplication

The information that EPA requires from trade secrecy claim submitters is
not duplicated by any other Agency collection because the collection of
information is entirely Title III oriented.  In addition, unlike other
statutes permitting confidential business information claims, Title III:
(1) permits trade secrecy claims only for specific chemical
identification information; (2) permits claims for a chemical identity
only in very narrowly defined circumstances which are stipulated in the
statute; and, (3) requires an up-front substantiation of the
applicability of those narrowly defined circumstances by a claimant at
the time the report for a chemical claimed as trade secret is filed.

5 (b) Consultations

EPA contacted few facilities that submitted trade secrecy claims to
develop an average estimate on how much burden the trade secrecy
regulations impose on the facilities.  The following facilities were
contacted.

Susie Price 						Marco Salenda

Clairant LSM (America) Inc.  			Akzo Nobel Surface Chemistry LLC

Elgin,  SC 29045					McCook, IL 60525-1569

(803) 438-7747<PHONE_NUMBER>

Laura Davila						Bette Davis

Schlumberger Technology Corporation		Monsanto Company

Maurice, LA 70555					Muscatine, IA 52761

(281) 285-7058<PHONE_NUMBER>

Vern Winge						Tom Young

3M							A-Carb L.L.C.

Brownwood, TX 76801				Walton KY

(651) 737-4330<PHONE_NUMBER>

Greg Johnson						Brian Zoretich

American Acryl L.P.					Lubrizol Petroleum Chemicals

Pasadena, TX 					Painesville, OH

(281) 909-2618<PHONE_NUMBER>

5(c) Public Notice

In compliance with the Paperwork Reduction Act (44 U.S.C. 3501 et seq.),
the Agency notified the public through a Federal Register notice on the
resubmission of this ICR on April 26, 2006 (71 FR 24670).   EPA did not
receive any comments.

5(d) Effects of Less Frequent Collection

Although submitting answers to the questions on the trade secrecy
substantiation form is a necessary step towards ensuring eventual
protection of a chemical identity, the decision to seek that protection
is entirely voluntary.  The submission process involves one initial
collection of information for sufficiency, with the possibility of a
request for supplementary information [as provided in section 322
(d)(3)(A)] to establish veracity of the assertions stated in the
substantiation if EPA determines that a claim is initially sufficient
during a review initiated by public petition or the Agency.

5 (e) Confidentiality and Sensitive Questions

All trade secrecy claims submitted to EPA under Title III are handled
and stored according to procedures set out in the Manual for Physical
Handling, Security, and Protection of files containing Trade Secret
Claims submitted under Sections 303, 311, 312 and/or 313 of the
Emergency Planning and Community Right-to-Know Act (EPCRA).   These
procedures were developed expressly for Title III trade secrecy claims
with the knowledge that these documents are sensitive.  Handling and
review of documents containing Title III trade secret information is
permitted only by persons who have obtained formal clearance to access
the information based on a work-related need to engage in these
activities.  When not being processed or reviewed by authorized
individuals, the claim submissions containing trade secret information
are stored in restricted access areas.  To ensure that appropriate
handling procedures are activated and the confidentiality of Title III
trade secret submissions is maintained, the Agency attaches a cover
sheet to the top of each trade secret document and otherwise marks the
document to clearly identify the document as Title III confidential.

6.   Estimating the Burden and Cost of the Collection

6(a)  Estimated Number of Trade Secrecy Claims

Costs to the Government and to respondents are based on actual numbers
of trade secrecy claims received during reporting years (RYs) 2002
through 2004 and on estimates of future activity for the upcoming
three-year period.  The reporting year corresponds to the calendar year.
The deadline for submitting claims for a given reporting year falls in
the following calendar year.  For example, the deadline for submitting
claims under section 311/312 for RY 2005 is March 1, 2006 (the deadline
for submitting the hazardous chemical inventory reports under section
312), and the deadline for RY 2005 for section 313 claims is July 1,
2006 (the deadline for submitting Toxic Chemical Release Reporting
Form).  Any facilities that wish to file trade secrecy claims in these
reporting forms must submit the trade secrecy claim package with these
reports.

The cost and burden of processing the claims submitted for RY 2005 are
incurred in FY06.  There is a one-year lag between the reporting year
for submitting claims (e.g., RY05) and the fiscal year for processing
claims (e.g. FY06).  In this ICR all section 311/312 and 313 claims from
one reporting year will be treated as having been processed in the
following fiscal year.

Table 1 presents the actual number of submissions indicating trade
secret claims for all sections of Title III for FY03 to FY05
(corresponding to RY02 through RY04).  For the three-year period, the
total number of claims submitted under section 313 was 32 (24 of which
are comprised of the same 8 claims filed by 2 facilities(6 claims by one
facility and 2 claims by the other facility) for each of the three
years, RY 02 - RY 04).  In summary, there were 12 claims by 3 facilities
in RY 02, 10 claims by 4 facilities in RY 03, and 10 claims by 4
facilities in RY 04.  In previous ICRs, the number of claims submitted
under section 313 was reported to be much higher, because the number
included claims that were later withdrawn by submitters.  This year, all
claims fell under one of two categories.  They were either submitted
complete, with the necessary supporting documentation, or submitters had
mistakenly checked the trade secret claim box on Form R or Form A but
had no intention of actually submitting a claim.  EPA is not reporting
as actual trade secret claims cases where the box was checked purely in
error and no supporting documentation was submitted.  No burden was
incurred by the facility, and EPA corrected the error with a Notice of
Data Change (NDC).  The facility has an opportunity to refute the NDC,
but no facilities chose to do so. (Memorandum from Larry Reisman and
Josh Woodyard, OEI/EPA 02/23/06).

Table 2 shows the estimated numbers of trade secret claims under
sections 303, 311 and 312 expected to be filed by facilities in the new
ICR period of FY06 through FY08.  No claims are expected to be filed
under section 303.

Table 1

	Actual Number of Trade Secret Claims

FY 2003 - FY 2005

(RY 2002 - RY 2004)

________________________________________________________________________
_

SARA Section			FY03		FY04		FY05     	Total

________________________________________________________________________
_

303(d)2 and (d)(3)		  	0	       	0         		0        		0

311					12		65		32		109

312					347		539		398                	1284

313					12		10		10		32

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

Total					371		614		440		1425

Table 2

	Estimated Number of Trade Secret Claims

FY 2006 - FY 2008

(RY 2005 - RY 2007)

________________________________________________________________________
__

SARA Section			FY06		FY07		FY08     	Total

________________________________________________________________________
__

303(d)2 and (d)(3)		  	0	       	0         		0        		0

311					36		36		36		108

312					428		428		428		1,284

313					10		10		10		30

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

Total					474		474		474		1422

6(b)  Estimating Agency Burden and Cost

Costs to the Federal Government for processing trade secret claims, the
petition and review processes, and for providing adverse health effects
data, are presented in Table 3.  Each of the three cost areas is
discussed below.

(i)  Processing and Storage of Trade Secret Claims

EPA incurs expenses to process and store each trade secret claim
submission.  These activities include affixing document control number
labels and trade secret cover sheets, processing basic information about
the claims, checking for completeness, and storing the submissions.  EPA
must store all trade secret submissions and be prepared to respond to
public petitions for disclosure of the subject chemical identities.
Both fixed and variable costs are estimated.

Fixed costs are incurred for maintenance and operation of the existing
storage and filing system for section 313 claims.  Fixed costs for the
three-year period (FY03 through FY05) covered by the expiring ICR for
storage space were $2,552 (Memorandum from Larry Reisman and Josh
Woodyard, OEI/EPA, 02/23/06).  Fixed costs for 311/312 claims for the
three-year period (FY03 through FY05) covered by the expiring ICR were
$5,124.

Variable costs are estimated by program.  For sections 303 and 311/312
of EPCRA, costs supporting inventory of new claims; and storage,
retrieval, and checking of claims for completeness, are estimated to be
approximately $10,784.  Variable costs associated with processing
section 313 claims are estimated to be approximately $2000.

Based on these figures, costs for processing trade secret submissions
for OEI and OSWER are estimated to be $20,460 per year for FY06 through
FY08, or a total of $61,380 for the three-year period covered by this
ICR.

 (ii)  Petition/Claim Review

In addition to the costs associated with processing and storing trade
secret claim documents, the Federal government will also incur costs by
responding to petitions filed by the public requesting the Agency’s
review of specific claims, and as a result of EPA initiated review of
claims.

The process established for petitioning and reviewing trade secret
claims follows a standard series of steps.  The costs of this process,
however, are dependent on the merits of the claims and decisions that
facilities make to contest an EPA finding if a trade secret claim is
disallowed.  The costs are also dependent on the number of petitions
that the public files and the number and magnitude of EPA-initiated
reviews.

The actual number of petitions which has been filed over the history of
the program is two; the first petition during FY89 pertained to one
claim, and the second during FY90 pertained to 10 claims asserted by one
facility.  No new petitions have been received by the Agency during the
period of the expiring ICR.  In the absence of any new petition activity
in recent years, the Agency is continuing to use the assumption of one
petition per year (assuming each petition pertains to one claim) for
this ICR, as it has in the previous two ICRs.

 	The estimates for the costs of the petition process to the government
included in the initial ICR originated from the Regulatory Impact
Analysis (RIA), which developed three scenarios to identify the
potential steps and time involved for EPA, as well as petitioners and
facilities in claim reviews.  The scenarios ranged from a low level to a
high level, or complex review.  Based on State community right-to-know
programs, an estimate of the likelihood of occurrence for each petition
scenario was identified and a weighted average cost of petition review
was calculated.  The RIA assumed that no public petitions would result
in a petitioner, the EPA, or a facility taking legal action.  In the
event of a court challenge, the RIA recognized that the costs of the
process would likely be much higher than the estimated cost of the most
complicated review case.  However, the RIA did not consider the cost
associated with a court challenge because estimating legal costs is
difficult and there were no cases under existing programs on which to
base such an estimate.

These assumptions, in combination with the actual costs incurred to
review the 10 claims pertaining to the 1990 petition and the actual
costs incurred in connection with the internally-generated Agency review
of trade secret claims, were used to determine the estimated costs to
EPA shown in Table 3.  Burden and cost for low level and complex review
are estimated separately.

Low level review burden and cost were estimated based on an actual
public citizen petition received, pertaining to one claim asserted by
one facility.  The review involved approximately 30 hours of Agency time
primarily spent by professional staff at the GS-13, Step 5 level.  The
annual cost for 1 petition that the agency may receive during the period
coverd by this ICR is $1,716.  The Agency’s finding of insufficiency
was not challenged.

In the previous ICR, the Agency based its estimates of future burden
and costs for complex reviews on data pertaining to actual reviews
conducted under section 313, which were estimated to be five per year.
However, no high level, complex reviews were performed in the previous
three-year ICR period. This ICR is estimating that three high-level
Agency reviews,

or nine for the three-year period of FY06 through FY08, will take place
during the next three-year period.(Memorandum from Larry Reisman,
OEI/EPA, 2/23/06). The average burden per complex review is estimated at
37 hours, and the average cost per review is estimated to be $2,116 (all
labor at fully-loaded GS 13, Step 5, rate for 2005).  The annual burden
for three complex reviews is thus estimated to be 111 hours and the
total annual cost, $6,348.  For the three-year period, the total burden
is estimated to be 333 hours, and the cost, $19,044.  All
Agency-initiated reviews were carried out under section 313; the Agency
does not initiate reviews of claims made under sections 311 and 312

EPA recognizes that the estimated burden hours per review presented here
for complex reviews exceed those estimated for low level reviews by only
about 20 percent on average (30 hours versus 37 hours).  However, based
on review activities conducted for previous ICRs, this narrow range was
believed to provide the most reasonable estimate of anticipated resource
requirements over the three-year period.  Agency staff do not expect the
hourly burden estimates to change over the next three-year period .

Under section 322(g), EPA has the responsibility to provide trade secret
information to States that request such information.  One such request
was received, but the company withdrew its trade secret claim.
Therefore, this ICR does not estimate costs or burdens because no
additional requests are expected, and the Agency does not have adequate
experience on which to base an estimate.

(iii)  Provision of Adverse Health Effects Information

Table 3 also shows the estimated costs incurred to collect and
distribute health hazard data for EPCRA section 313 chemicals claimed as
trade secret.  Three profiles are expected to be prepared each year
during FY06 through FY08.  The burden estimate for FY06 through FY08
shown in the table is based on an annual projected burden of 11.2 hours
per profile, or 33.6 hours per year at the GS-13, Step 5 level
($57.20/hr, 2005).  The estimated burden per profile has not changed
from the previous ICR.  The total annual cost is estimated to be $1,922.
 For the three-year period, the total burden is estimated to be 100
hours, at a cost of $5,766.

Although the RIA identified three additional tasks included as part of
the provision of health effects data, no additional burden was estimated
to be associated with these tasks.  This is because these tasks
(sanitizing hazard profiles, provision of section 313 data to the public
upon request, and provision of section 313 data to states upon request)
are either not performed (e.g., no requests for trade secret data have
been received from the states) or are performed routinely as part of the
normal Toxic Release Inventory (TRI) data release.

The total burden to the Federal government for managing claims and
petitions submitted under sections 303, and 311/312 over the three-year
period covered by this ICR will be at a cost of $52,902.  For handling
section 313 claims and reviews, and providing adverse health effects
information, the Federal government cost for the three-year period is
estimated to be $38,466.    The grand total cost is $30,456 per year, or
$91,368 for the three-year period.

6(c) Estimating Respondent Burden and Costs

(i)	Forms Completion

One of the major cost components associated with trade secret claims is
the cost to facilities to prepare substantiations.  The time required to
complete this process for each chemical will vary with the complexity of
the situation, the number of chemicals that a facility seeks to claim as
trade secrets, and the amount of detail that a facility includes in each
answer.  The cost estimates presented in Table 4 are based on phone
conversations with trade secret submitters and on assumptions about the
time it takes to complete various activities, which are explained
briefly below.

Facilities will incur two types of costs in the handling and filing of
trade secret claims:  fixed costs (i.e., costs that do not vary with the
number of chemicals claimed trade secret) and variable costs, which are
incurred on a per claim basis.  In all cases, all facilities that file
trade secret claims will incur fixed costs; these costs will be incurred
only once, however, reflecting the fact that actions such as rule
familiarization, chemical selection, and preparation of facility
identification information will be undertaken only once.  This analysis
assumes that only facilities making first-time trade secret claims incur
fixed costs; although other facilities may spend time reading the rule
and deciding whether to make a claim, this analysis does not attribute
those costs to the regulation.

The number of first-time claims prepared annually was estimated based on
an assumption that approximately one-quarter of the claims received are
submitted by new facilities (first-time filers) or pertain to chemicals
for which an existing submitter is claiming a trade secret for the first
time.  (See Table 4, 1. Forms Completion - Facilities, Fixed Costs: 474
x .25 = 118.5   , rounded up to 119)  While the burden associated with
claims falling into the second category will not include rule
familiarization, it does include time spent by the submitter to
determine whether a trade secret claim is necessary (chemical
selection).  This effort is a major portion of overall fixed costs.  The
22 hours allocated to forms completion, fixed costs are broken down as
follows: 10.8 hours, management; 11 hours, technical; and .2 hours,
secretarial.

The second type of costs that facilities will incur are variable costs;
facilities will incur these costs for each chemical claimed as trade
secret.  These costs include preparing the trade secret substantiation,
sanitizing the report, and mailing the report to EPA.  Burden hours used
to calculate variable costs for all trade secret claims reflect the
effort required to prepare original substantiations for a given chemical
that does not have a previously submitted substantiation prepared, as
well as resubmittal of previously submitted claims.  Repeat submitters
incur somewhat lower per unit preparation cost than those incurred by
facilities filing first-time, or original claims for several reasons.

First, resubmitting facilities that assert a claim repeatedly for the
same chemical under the same Title III section 313, 311/312 or 303 can
use essentially the same substantiation form answers that were used in
the original substantiation claim.  Second, facilities save money by
filing essentially the same substantiation with reports submitted under
multiple Title III sections during the same reporting year.  Third,
facilities save by submitting essentially the same substantiation form
answers to support claims for multiple chemicals reported pursuant to
the same Title III section.  These cost savings occur when, for
instance, a facility makes claims for multiple chemicals which comprise
the same formulation or portions of a formulation.

For this ICR, the Agency contacted eight actual submitters of trade
secret claims under sections 311/312 and 313 to obtain burden estimates
for submitting claims. Submitters of new claims reported time
requirements of two to four hours, with an average of three hours.
Submitters of previously submitted claims, who submitted between one and
40 claims, reported times of one to three hours, with an average of two
hours total for all claims. Erring on the conservative side, this ICR
assumes that each facility spends the highest amount, four hours per
claim, for variable costs.  The hours are broken down as follows: .25
hour, management; 2 hours, technical; and 1.75 hours, secretarial.

 	The cost to respondents is estimated based on the time needed to
complete the tasks described above, and the hourly labor wage rates at
appropriate levels. Hourly wage rates, including fringe costs and
overhead, are $129.29 for management labor, $39.97 for technical labor,
and $23.38 for clerical labor1.

ii)	 Petition and Review

The petition and review process will also cause certain facilities and
public petitioners to incur costs when the Agency reviews the validity
of trade secrets claims.  Petitioner efforts involve preparing the
petition requesting that EPA review the trade secret claim.  The
requisite elements of a petition include the following:  the
petitioner’s name, address and telephone number; the name and address
of the company claiming trade secrecy; and a copy of the submission in
which the chemical identity is claimed as trade secret with a specific
indication as to which chemical identity the petitioner seeks to have
disclosed.  In the absence of any petitions during the past three-year
reporting period, this ICR is continuing to assume that one petition
will be submitted from the public each year, and will require 2.5 hours
to prepare, costed at the technical wage rate.

The Agency assumes that the two scenarios regarding complexity of
claims which were considered in estimating EPA costs (see Table 3) also
apply to costs to petitioners and facilities in the petition process and
to facilities in EPA-initiated reviews.  The previous ICR assigned no
facility burden in connection with Agency-initiated reviews of trade
secret claims.  As in the previous ICR, the Agency assumes that all
Agency-initiated reviews would involve facilities at an increased level
of effort, relative to a low level petition-initiated review.  The
additional effort was assumed proportional to the additional effort
required by EPA (20 percent above low level).  Table 4 incorporates the
burden required by these additional reviews in a weighted average cost
per review.   This weighted average cost was calculated based on the
estimate of 28 burden hours required for low level petition review used
in previous ICRs.  Thus, 28 hours was used as the burden estimate for
all low level reviews.  For Agency-initiated reviews, 33.6 hours (28 x
1.20) was used.  The Agency did not receive any petitions from the
public during the previous ICR period for sections 311/312.  The number
of one petition for section 313 is from the assumption of an average of
one petition (containing 1 claim) per year, and the projected number of
three Agency-initiated complex reviews is from Table 3.  Costs were
calculated using the technical hourly wage rate of $39.97 for the one
petition from the general public, and the managerial hourly wage rate of
$129.29 for the three complex petitions/reviews.

(iii) Third Party Notification

Also under the heading of variable costs is the burden and cost to
facilities responding to requests for information on the health effects
of trade secret chemicals in non-emergency and preventative measure
situations from health professionals and state governors or State
Emergency Response Commissions (SERCs).  The state government inquiries
can be made as the result of a public request for the information.
These costs and burdens were not required to be included in previous
ICRs.

Based on limited telephone inquiries made in 1996, in 1995 the estimated
number of information requests from state governors was one, and from
health professions, one (Memorandum from Lea Anne Gleason, OSWER/EPA,
10/30/96.)  Even though no activity was reported in the previous
three-year ICR period, this ICR is making the conservative assumption
that three inquiries will be made each year by three different state
governments and health professionals each, for a total of six inquiries
each year.  Facilities are therefore assumed to respond to six inquiries
each year, and the burden per inquiry is not expected to change from the
previous ICR.

The estimated burden for each organization is one hour (.5 hour
management, or GS-13, Step 5 equivalent for the State government, and .5
hour for secretarial, or GS-7, Step 5 for States).  For health
professionals, the estimated burden is one hour technical labor.  The
cost per inquiry is estimated to be $42 for state governments, $43 for
health professionals, and $38 for facilities.  The total burden for all
three types of organizations is estimated to be 12 hours per year, and
the cost, $546 per year.

(iv) Respondent Burden

Table 5 presents the corresponding burden hours  and costs for each
category of respondent discussed in the previous sections.

(v) Capital and O&M Costs

No capital and operation and maintenance costs are associated with any
requirements in this ICR.

(vi)  Explanation of Difference of Annual Reporting Burden

The previous ICR requested an average annual burden of 3,473 hours,
while this ICR requests 4,658 hours.  The average annual burden per
respondent has fallen very slightly from 9.8 hours to 9.7 hours, which
is most likely caused by rounding.  All changes in total burden hour
estimates are caused by changes in the volume of activity, and
consequently, respondents performing those activities, not by changes in
the underlying assumptions of how long it takes to perform an activity.
The total burden hours (annual) has increased from the previous ICR due
to number of trade secret claim submitters increased.

The estimated annual number of respondents making trade secrecy claims
under sections 303, 311/312, and 313 is 474 for the next three years.

6(d) Burden Statement

The annual public reporting and recordkeeping burden for this collection
of information is estimated to average 9.7 hours per claim.  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, 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 numbers for EPA's regulations are listed in 40 CFR part
9 and 48 CFR chapter 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.
SFUND-2006-0361, which is available for public viewing at the Superfund
Docket in the EPA Docket Center (EPA/DC), EPA West, Room B102, 1301
Constitution Ave., NW, Washington, DC. The EPA Docket Center Public
Reading Room  is open from 8:30 a.m. to 4:30 p.m., Monday through
Friday, excluding legal holidays.  The telephone number for the Reading
Room is<PHONE_NUMBER>, and the telephone number for the Docket is (202)
566-0276.  An electronic version of the public docket is available
through EPA Dockets (EDOCKET) at http://www.epa.gov/edocket.  Use
EDOCKET 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.  SFUND-2006-0361) and OMB control number 2050-0078
in any correspondence.

	Table 3

	Cost to Federal Government - Sections 322/323

Cost Type						  	FY06		     	FY07			FY08       	Total

________________________________________________________________________
_____________________________

1.	Processing and Storing Trade Secret Claims

Fixed Costs

Section 313:

Cost			     			$2,552            		$2,552	    		$2,552     	$7,656

	Sections 303,311/312

		Cost						$5,124			$5,124			$5,124		$15,372

Variable Costs

Sections 303, 311/312:

	Cost						$10,784		$10,784		$10,784	$32,352

Section 313:

	Cost						$2,000			$2,000			$2,000		$6,000

________________________________________________________________________
______________________________

Subtotals for Processing and Storing Trade Secret Claims

								$20,460		$20,460		$20,460	$61,380

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

Cost Type						  	FY06		     	FY07			FY08        	Total

________________________________________________________________________
______________________________

2.	Agency Review Process

A.	Low Level Review - Sections 311/312

(Assumes each petition pertains to one claim)

Number of Petitions		    		1			1	  	    	1	      	3

Hours per Petition		    		30		 	30	         		30

Cost per Petition				$1,726             	$1,726          		$1,726

Hours all Petitions	   			30	    	       	30             		30		90

Cost all Petitions    				$1,726             	$1,726          		$1,726
 	$5,178

B.	Complex Review - Section 313

Number of Reviews		    		3		 	  3	      	    	 3        		9

Hours per Review	         			37			  37	     	    	37		111

Cost per Review       				$2,116           	 	$2,116           		$2,116

Hours all Reviews				111			111			111		333

Cost all Reviews				$6,348			$6,348			$6,348		$19,044

Subtotals for Agency Review (low-level and complex)

Hours       					141		    	141	   	      	141	  	423

Cost      					$8,074       	  	$8,074          		$8,074   	$24,222

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

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

Cost Type						 	 FY03		     	FY04			FY05        	Total

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

3.	Provision of Adverse Health Effects Information -Section 313

Number of Profiles				3			   3			     3         	9

Hours per Profile		  		11.2			11.2			  11.2

Cost per Profile		  		$640			$640			  $640

Hours all Profiles				 33.6	 	 	  33.6		         	   33.6		100.8

Cost all Profiles				$1,922			$1,922			$1,922		$5,766

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

Federal Government Totals

A.	Sections 303, 311/312

Cost			     			$17,624            	$17,624          		$17,624   	$52,872

B.	Section 313

Cost				   		$14,744	          	$14,744		$14,744   	$44,232

Grand Totals

Cost						$32,368		$32,368		$32,368	$97,104

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

Note: Totals may not add up exactly due to rounding.

	Table 4

	Burden/Costs to Respondents by Activity- Sections 322/323

________________________________________________________________________
___________________________

Affected Entity				  FY06		 	FY07		 	FY08        		Total

________________________________________________________________________
___________________________

1.	Forms Completion - Facilities

Fixed Costs (rule familiarization, chemical selection etc.)

Number Affected			119			119		   	119			357

Hours per Facility			22			22		   	22

Cost per Facility	     		$1841	          		$1841   	    	$1841

Hours All		  		2,618	     		2,618			2,618	   		7,854

Cost All		  	   	$219,079		$219,079	  	$219,079 		$657,237

Variable Costs (preparing the forms)

Number Affected			474			474		  	474			1422

Hours per Facility			4		   	4		   	4

Cost per Facility	       		$153	 		$153  	     		$153

Hours All		  		1,896          		1,896          		1,896           		5,688

Cost All		  	   	$72,522		$72,522	  	$72,522		$217,566

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

Subtotals for Forms Completion - Facilities

Hours All		  		4,514			4,514			4,514			13,542

Cost All		  	   	$291,601		$291,601	  	$291,601		$874,803

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

_______________________________________________________________________
_______________________________

Affected Entity				  FY06		      	FY07		  	FY08      		Total

________________________________________________________________________
______________________________

2.	Petition Process

Petitioners (General Public)

Number of Petitions		         	1		       	1	  	   	1	      		3

Hours Per Petition	     	  	2.5		       	 2.5		   	2.5

Cost per Petition		  	$100               		$100
 	$100

Hours All	    			2.5	    	        	2.5              	   	 2.5			 7.5

Cost All	 	    	  	$100		    	$100   	 		$100	  		$300

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

Facilities

Number of Petitions/Reviews       	4		  	4	         	     	4	     		12

Weighted Avg. Hours Per Petition  	32.2			32.2		    	32.2

Cost per Petition			$4,240             	$4,240          	 	$4,240

Hours All	    			129			129   	      		129	   		387

Cost All	 	    	  	$16,960	  	$16,960	   	$16,960		$50,880

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

Subtotal Petition Process

Hours All               		 	131.5         		131.5         		131.5
    		394.5

Cost All 				$17,060	 	$17,060	   	$17,060    		$51,180

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

________________________________________________________________________
_____________________________

Affected Entity				  FY06		      		FY07		  	FY08     		Total

________________________________________________________________________
_____________________________

3.  Third Party Notification

State Gov’ts/SERCS

Number of Inquiries			   3			    	3			3			9

Hours per Inquiry			   1			   	 1			1

Cost per Inquiry			   $42			  	$42		   	$42

Health Professionals

Number of Inquiries			   3			    	3			3			9

Hours per Inquiry			   1			    	1			1

Cost per Inquiry			   $43			  	$43		   	$43

Facilities

Number of Inquiries			   6			   	6		    	6			18

Hours per Inquiry			   1			    	1			1

Cost per Inquiry			   $38			  	$38		   	$38

Subtotal Third Party Notification

Hours All				  12			   	12		    	12			36

Cost All				$546			 	$546		  	$546	 		$1,638

Total Respondent Burden

Hours All				 4,658				4,658 			4,658      		13,974

Cost All			   	$308,954           		$308,954	  	$308,954 		$926,862

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

Note: Totals may not add up exactly due to rounding.

Table 5

Summary of Burden & Cost to Respondents

Annual

	Hours	Costs

Facilities (forms, Petitions, response to third party notification)
4,649	$308,599

Public (petitions)	2.5	$100

State/Health Officials (third party notification)	6	$255

Total 	4,658	$308,954

     Government labor costs are calculated using the following fully
loaded wage rates for 2005: GS-12, Step 5, $48.09/hr; GS-13, Step 5,
$57.20, GS-14, Step 5, $67.58/hr; GS-15 Step 5, $79.50/hr.

     1Bureau of Labor Statistics, Occupational Employment and Wages,
March 2005.

 PAGE  6

 PAGE  16

 PAGE  27


60233 Federal Register / Vol. 67, No. 186 / Wednesday, September 25, 2002 / Notices Under FIFRA, as amended in 1988, EPA is conducting an accelerated reregistration program to reevaluate existing pesticides to make sure they meet current scientific and regulatory standards. The data base to support the reregistration of diazinon is substantially complete. Taking into account both the risks and benefits of diazinon uses, the Agency has determined that with the adoption of all the mitigation measures recommended in the IRED, use of diazinon will not pose unreasonable adverse risks to people or the environment when used according to its currently approved labeling. Please note that this is only an interim decision. Upon the Agency's completion of its assessment of the cumulative risk posed by the organophosphates as a class, EPA will issue a final reregistration eligibility decision on pesticides containing diaizinon. All registrants of pesticide products containing diazinon will be sent the appropriate REDs, labeling requirements and product specific data requirements pending OMB approval of the diazinon Data Call In. The reregistration program is being conducted under Congressionally mandated time frames, and EPA recognizes both the need to make timely reregistration decisions and to involve the public. Therefore, EPA is issuing this IRED with a 60 day comment period. The comment period is intended to provide an opportunity for public input and a mechanism for initiating any necessary amendment to the IRED. EPA invites comment specifically on the use of the diazinon benefit assessments which can be found with the diazinon documents on the EPA's website at http:// www. epa. gov/ pesticides/ reregistration/ status. htm. All comments will be carefully considered by the Agency. If any comment significantly affects this IRED, EPA will amend the IRED by publishing the amendment in the Federal Register.

B. What is the Agency's Authority for Taking this Action?

The legal authority for this IRED falls under FIFRA, as amended in 1988 and 1996. Section 4( g)( 2)( A) of FIFRA directs that, after submission of all data concerning a pesticide active ingredient, `` the Administrator shall determine whether pesticides containing such active ingredient are eligible for reregistration, '' before calling in product specific data on individual end use products, and either reregistering products or taking `` other appropriate regulatory action. '' List of Subjects Environmental protection, Chemicals, Pesticides and pests.

Dated: September 13, 2002. Lois Ann Rossi, Director, Special Review and Reregistration Division, Office of Pesticide Programs.

[FR Doc. 02Ð 24231 Filed 9Ð 24Ð 02; 8: 45 am]

BILLING CODE 6560– 50– S ENVIRONMENTAL PROTECTION AGENCY [OPP– 2002– 0214; FRL– 7194– 1]

Notice of Filing a Pesticide Petition to Establish a Tolerance fora Certain Pesticide Chemical in or on Food AGENCY: Environmental Protection Agency (EPA).

ACTION: Notice.

SUMMARY: This notice announces the initial filing of a pesticide petition proposing the establishment of regulations for residues of a certain pesticide chemical in or on various food commodities.

DATES: Comments, identified by docket ID number OPPÐ 2002Ð 0214, must be received on or before October 25, 2002.

ADDRESSES: Comments may be submitted by mail, electronically, or in person. Please follow the detailed instructions for each method as provided in Unit I. C. of the SUPPLEMENTARY INFORMATION. To ensure proper receipt by EPA, it is imperative that you identify docket ID number OPPÐ 2002Ð 0214 in the subject line on the first page of your response.

FOR FURTHER INFORMATION CONTACT: By mail: Andrew Bryceland, Biochemical Pesticides Branch, Biopesticides and Pollution Prevention Division (7511C), Office of Pesticide Programs, Environmental Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460; telephone number: (703) 305Ð 6928; e mail address; bryceland. andrew@ epa. gov.

SUPPLEMENTARY INFORMATION:

I. General Information A. Does this Action Apply to Me?

You may be affected by this action if you are an agricultural producer, food manufacturer, or pesticide manufacturer. Potentially affected categories and entities may include, but are not limited to: Categories NAICS codes Examples of potentially affected entities Industry 111 Crop production 112 Animal production 311 Food manufacturing 32532 Pesticide manufacturing This listing is not intended to be exhaustive, but rather provides a guide for readers regarding entities likely to be affected by this action. Other types of entities not listed in the table could also be affected. The North American Industrial Classification System (NAICS) codes have been provided to assist you and others in determining whether or not this action might apply to certain entities. If you have questions regarding the applicability of this action to a particular entity, consult the person listed under FOR FURTHER INFORMATION CONTACT.

B. How Can I Get Additional Information, Including Copies of this Document and Other Related Documents? 1. Electronically. You may obtain electronic copies of this document, and certain other related documents that might be available electronically, from the EPA Internet Home Page at http:// www. epa. gov/. To access this document, on the Home Page select `` Laws and Regulations, '' `` Regulations and Proposed Rules, '' and then look up the entry for this document under the `` Federal RegisterÑ Environmental Documents. '' You can also go directly to the Federal Register listings at http:// www. epa. gov/ fedrgstr/. 2. In person. The Agency has established an official record for this action under docket ID number OPPÐ 2002Ð 0214. The official record consists of the documents specifically referenced in this action, any public comments received during an applicable comment period, and other information related to this action, including any information claimed as confidential business information (CBI). This official record includes the documents that are physically located in the docket, as well as the documents that are referenced in those documents. The public version of the official record does not include any information claimed as CBI. The public version of the official record, which includes printed, paper versions of any electronic comments submitted during an applicable comment period, is available for inspection in the Public Information and Records Integrity VerDate Sep< 04> 2002 16: 34 Sep 24, 2002 Jkt 197001 PO 00000 Frm 00026 Fmt 4703 Sfmt 4703 E:\ FR\ FM\ 25SEN1. SGM 25SEN1 60234 Federal Register / Vol. 67, No. 186 / Wednesday, September 25, 2002 / Notices Branch (PIRIB), Rm. 119, Crystal Mall #2, 1921 Jefferson Davis Highway, Arlington, VA, from 8: 30 a. m. to 4 p. m., Monday through Friday, excluding legal holidays. The PIRIB telephone number is (703) 305Ð 5805.

C. How and to Whom Do I Submit Comments? You may submit comments through the mail, in person, or electronically. To ensure proper receipt by EPA, it is imperative that you identify docket ID number OPPÐ 2002Ð 0214 in the subject line on the first page of your response. 1. By mail. Submit your comments to: Public Information and Records Integrity Branch (PIRIB), Information Resources and Services Division (7502C), Office of Pesticide Programs (OPP), Environmental Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460. 2. In person or by courier. Deliver your comments to: Public Information and Records Integrity Branch (PIRIB), Information Resources and Services Division (7502C), Office of Pesticide Programs (OPP), Environmental Protection Agency, Rm. 119, Crystal Mall #2, 1921 Jefferson Davis Highway, Arlington, VA. The PIRIB is open from 8: 30 a. m. to 4 p. m., Monday through Friday, excluding legal holidays. The PIRIB telephone number is (703) 305Ð 5805. 3. Electronically. You may submit your comments electronically by e mail to: opp docket@ epa. gov, or you can submit a computer disk as described above. Do not submit any information electronically that you consider to be CBI. Avoid the use of special characters and any form of encryption. Electronic submissions will be accepted in Wordperfect 6.1/ 8.0 or ASCII file format. All comments in electronic form must be identified by docket ID number OPPÐ 2002Ð 0214. Electronic comments may also be filed online at many Federal Depository Libraries.

D. How Should I Handle CBI That I Want to Submit to the Agency? Do not submit any information electronically that you consider to be CBI. You may claim information that you submit to EPA in response to this document as CBI by marking any part or all of that information as CBI. Information so marked will not be disclosed except in accordance with procedures set forth in 40 CFR part 2. In addition to one complete version of the comment that includes any information claimed as CBI, a copy of the comment that does not contain the information claimed as CBI must be submitted for inclusion in the public version of the official record. Information not marked confidential will be included in the public version of the official record without prior notice. If you have any questions about CBI or the procedures for claiming CBI, please consult the person identified under FOR FURTHER INFORMATION CONTACT.

E. What Should I Consider as I Prepare My Comments for EPA?

You may find the following suggestions helpful for preparing your comments: 1. Explain your views as clearly as possible. 2. Describe any assumptions that you used. 3. Provide copies of any technical information and/ or data you used that support your views. 4. If you estimate potential burden or costs, explain how you arrived at the estimate that you provide. 5. Provide specific examples to illustrate your concerns. 6. Make sure to submit your comments by the deadline in this notice. 7. To ensure proper receipt by EPA, be sure to identify the docket control number assigned to this action in the subject line on the first page of your response. You may also provide the name, date, and Federal Register citation.

II. What Action is the Agency Taking?

EPA has received a pesticide petition as follows proposing the establishment and/ or amendment of regulations for residues of a certain pesticide chemical in or on various food commodities under section 408 of the Federal Food, Drug, and Cosmetic Act (FFDCA), 21 U. S. C. 346a. EPA has determined that this petition contains data or information regarding the elements set forth in section 408( d)( 2); however, EPA has not fully evaluated the sufficiency of the submitted data at this time or whether the data support granting of the petition. Additional data may be needed before EPA rules on the petition.

List of Subjects Environmental protection, Agricultural commodities, Feed additives, Food additives, Pesticides and pests, Reporting and recordkeeping requirements. Dated: September 16, 2002. Janet L. Andersen, Director, Biopesticides and Pollution Prevention Division, Office of Pesticides Programs.

Summary of Petition The petitioner summary of the pesticide petition is printed below as required by section 408( d)( 3) of the FFDCA. The summary of the petition was prepared by Certis USA LLC and represents the view of Certis USA LLC. EPA is publishing the petition summary verbatim without editing it in any way. The petition summary announces the availability of a description of the analytical methods available to EPA for the detection and measurement of the pesticide chemical residues or an explanation of why no such method is needed.

Certis USA LLC PP 2F6477 EPA has received a pesticide petition [2F6477] from Certis USA LLC 9145 Guild Road, Suite 175, Columbia, MD 21046, proposing pursuant to section 408( d) of the Federal Food, Drug, and Cosmetic Act (FFDCA), 21 U. S. C. 346a( d), to amend 40 CFR part 180 to establish an exemption from the requirement of a tolerance for the biochemical pesticide ammonium bicarbonate. Pursuant to section 408( d)( 2)( A)( i) of the FFDCA, as amended, Certis USA LLC has submitted the following summary of information, data, and arguments in support of their pesticide petition. This summary was prepared by Certis USA LLC and EPA has not fully evaluated the merits of the pesticide petition. The summary may have been edited by EPA if the terminology used was unclear, the summary contained extraneous material, or the summary unintentionally made the reader conclude that the findings reflected EPA's position and not the position of the petitioner.

A. Product Name and Proposed Use Practices 1. The biochemical ammonium bicarbonate is proposed for use as an insect feeding attractant in the end use product olive fly attract and kill (A& K) target device; EPA registration pending. Ammonium bicarbonate acts as a feeding attractant to the olive fruit fly (Bactrocera oleae.) The end use product also contains the active ingredients lambda cyhalothrin insecticide and the pheromone 1,7 dioxaspiro( 5,5) undecane The proposed use of the product is in olive orchards to control the olive fruit fly. The active ingredient,

VerDate Sep< 04> 2002 16: 34 Sep 24, 2002 Jkt 197001 PO 00000 Frm 00027 Fmt 4703 Sfmt 4703 E:\ FR\ FM\ 25SEN1. SGM 25SEN1 60235 Federal Register / Vol. 67, No. 186 / Wednesday, September 25, 2002 / Notices ammonium bicarbonate, is listed by the U. S. Food and Drug Administration as a direct food additive under 21 CFR 73.85, 163.110, 163.111, 163.112 and is listed as generally recognized as safe (GRAS) under 21 CFR 184.1135. It is exempt from the requirement of a tolerance under 40 CFR 180.1001( c) when used as an inert ingredient in pesticide formulations applied to growing crops or to raw agricultural commodities after harvest. 2. The ammonium bicarbonate in the end use product, when exposed to air, decomposes and releases gaseous ammonia. Ammonia is a by product of protein decomposition and as such is recognized by the olive fruit fly as a potential food source. The ammonia released from the end use product attracts the insects to the device. Ammonia per se is exempt from the requirement of a tolerance under 40 CFR 180.1003 when used as a fungicide applied to grapefruit, lemons, oranges and corn grain.

B. Product Identity/ Chemistry 1. Identity of the pesticide and corresponding residues. Ammonium bicarbonate, CAS number 1066Ð 33Ð 7, is also known as ammonium hydrogen carbonate. It is a naturally occurring mineral. It is a white, crystalline powder soluble in water but non soluble in alcohol and acetone. It decomposes at 36 to 60 degrees centigrade to ammonia, carbon dioxide and water vapor. It has many applications including use in baking powders, fire extinguishing mixtures, agricultural fertilizers and is used as a surfactant, suspending agent and dispersing agent in pesticide formulations. 2. Magnitude of residue at the time of harvest and method used to determine the residue. The end use product contains 4 grams of ammonium bicarbonate bound in a polymer. The polymer is attached to a cellulose card material which is approximately 19 centimeters (cm) by 20 cm in size. The card is suspended from olive tree limbs at a rate of 42 cards per acre of olive orchard resulting in 168 grams (0.37 pounds) of ammonium bicarbonate per acre of orchard. Being contained in the polymer and attached to the cellulose card there is little opportunity for the ammonium bicarbonate to come in contact with either the fruit or the soil. Upon application the end use product will be constantly exposed to sunlight and elevated temperatures which will continually release very small amounts of gaseous ammonia. Ammonia is a naturally occurring compound which is a key intermediate in the nitrogen cycle. Under normal conditions, ammonia is essential for many biological processes. Ammonia may be released to the atmosphere by volatilization from numerous sources including: Decaying organic matter, animal livestock excreta, fertilization of soil, and burning of coal, wood, and other natural products. Because of its significance in natural cycles, ammonia is found at a local concentration in most environmental media. The half life of atmospheric ammonia is estimated to be only a few days. In olive orchards atmospheric concentrations of ammonia will be present from the decay of organic matter and from the application of fertilizer to soil as ammonia, ammonium compounds or ammonia precursors (such as urea). Because ammonia, as ammonium ion, is the nutrient of choice for many plants, uptake of soil ammonia by living plants is an important fate process. The rate of uptake by plants varies with the growing season. At normal environmental concentrations, ammonia does not have a very long soil half life. It is either rapidly taken up by plants, bioconverted by the microbial population, or volatilized to the atmosphere. Under the conditions of use proposed and given the natural background levels of ammonia in the atmosphere and in the soil, no residues of ammonia or of ammonium bicarbonate are expected to occur in olive fruit from the use of the olive fly attract and kill (A& K) target device. 3. Residues in olive fruit are not expected from the use of the olive fly attract and kill target device; therefore, an analytical method is not needed.

C. Mammalian Toxicological Profile Because toxicity studies in the scientific literature are limited for ammonium bicarbonate, data on the related ammonium salt, ammonium chloride, and on the carbonate salt, sodium bicarbonate, are discussed. The single dose LD50 of ammonium chloride in the mouse and the rat, administered orally, is reported in scientific literature as 1,300 milligrams/ kilogram (mg/ kg) and 1,650 mg/ kg, respectively. The single dose LD50 of sodium bicarbonate in the mouse and rat, administered orally, is reported in scientific literature as 5,650 mg/ kg and 3,400 mg/ kg, respectively. For ammonia, the acute inhalation LC50 in the rat exposed for a single period of 15 minutes, was reported in scientific literature as 17,401 parts per million (ppm). The acute inhalation LC50 in the mouse exposed for a single period of 30 minutes was reported as 21,430 ppm. D. Aggregate Exposure 1. Dietary exposureÑ i. Food. Ammonium bicarbonate as used in the olive fly attract and kill target device will not come into direct contact with olives. Therefore, no residues of this compound are expected to occur in olives. Ammonium bicarbonate is listed by the U. S. Food and Drug Administration as a direct food additive and is commonly used as a leavening agent in baked goods. There is some potential for the decomposition product ammonia gas to come into contact with growing olives. However, it is expected that levels of gaseous ammonia would be well below the normal background levels of atmospheric ammonia present in an area of crop production. ii. Drinking water. Given the mode of application whereby the ammonium bicarbonate is bound in a polymer matrix attached to a cellulose card which is suspended from olive tree branches, there is little likelihood that residues of ammonium bicarbonate would occur in drinking water from this use. 2. Non dietary exposure. When exposed to air, sun and elevated temperatures in an olive orchard, the ammonium bicarbonate will slowly decompose to ammonia, carbon dioxide, and water vapor. The total amount of ammonium bicarbonate applied per acre in the olive fly attract and kill target devices is 168 grams. Assuming the complete consumption of the ammonium bicarbonate during the growing season, the theoretical yield of ammonia would be equal to approximately 36.1 grams. Assuming that this amount of ammonia is distributed over an acre of olive orchard to a height of 15 feet at a single point in time, this is equal to a theoretical concentration of 3 parts per billion (ppb) of ammonia. But a more realistic scenario would take into account that the release of ammonia would occur over the 4Ð 5 month period after application in the orchard resulting in a daily concentration that is approximately one hundred times less, i. e. 0.025 ppb. This concentration of ammonia would be well below the worldwide atmospheric background concentration of ammonia that has been estimated in scientific literature at approximately 1Ð 3 ppb. Also by comparison, farmers can be exposed to ammonia when applying fertilizer. The ammonia concentration over a field during the application of gaseous anhydrous ammonia fertilizer was reported in scientific literature as high as 213 microgram/ cubic meter (ug/ m 3 )

VerDate Sep< 04> 2002 16: 34 Sep 24, 2002 Jkt 197001 PO 00000 Frm 00028 Fmt 4703 Sfmt 4703 E:\ FR\ FM\ 25SEN1. SGM 25SEN1 60236 Federal Register / Vol. 67, No. 186 / Wednesday, September 25, 2002 / Notices 300 ppb. This is ten thousand fold higher than the theoretical exposure from the olive fly attract and kill target device.

E. Cumulative Exposure Because of the method of application and the low use rates of ammonium bicarbonate, little to no exposure is expected. Since ammonium bicarbonate is approved as a direct food additive and is listed as `` Generally Recognized as Safe'' by the U. S. Food and Drug Administration, there is no concern regarding the potential for cumulative effects of ammonium bicarbonate from the proposed use with other substances due to a common mechanism of action.

F. Safety Determination 1. U. S. population. Evidence of ammonium bicarbonate's low toxicity is demonstrated in the data reported for the related salts, ammonium chloride and sodium bicarbonate. The U. S. Food and Drug Administration has placed the following limitations on the maximum allowable levels of ammonium bicarbonate in processed foods: up to 3.2% in baked goods, grain, snack foods and reconstituted vegetables. This is the equivalent of 32,000 ppm of ammonium bicarbonate concentration in these foods. Ammonium bicarbonate is exempt from the requirement of a tolerance under 40 CFR 180.1001( c) when it is used as a surfactant, suspending agent or dispensing agent in pesticide formulations applied to growing crops or to raw agricultural commodities after harvest. The amount of ammonium bicarbonate used in a pesticide formulation is not restricted by 40 CFR 180.1001( c). Therefore, any level of residue of ammonium bicarbonate in or on olives is currently acceptable when used for these purposes. Given the method of application of ammonium bicarbonate where it is bound in a polymer within a discrete target device it is extremely unlikely for this compound to come into contact with and result in residues in or on olive fruit. Thus, aggregate exposure to ammonium bicarbonate from use in the olive fly attract and kill target device and any risk to human health will be negligible. 2. Infants and children. Given the low toxicity of the related salts ammonium chloride and sodium bicarbonate and the allowable levels of ammonium bicarbonate in processed foods, there is a reasonable certainty of no harm to children and infants from the use of the olive fly attract and kill target device in olive orchards. G. Effects on the Immune and Endocrine Systems Certis USA has no information to suggest that ammonium bicarbonate will adversely affect the immune or endocrine systems.

H. Existing Tolerances Ammonium bicarbonate is exempt from the requirement of a tolerance under 40 CFR 180.1001( c) when used as an inert ingredient in pesticide formulations applied to growing crops or to raw agricultural commodities after harvest. Ammonia is exempt from the requirement of a tolerance under 40 CFR 180.1003 when used as a fungicide applied to grapefruit, lemons, oranges, and corn grain.

I. International Tolerances There is no Codex maximum residue level (MRL) for ammonium bicarbonate. Canada has established permitted residue levels of ammonium bicarbonate in cocoa products and in unstandardized food products. [FR Doc. 02Ð 24343 Filed 9Ð 24Ð 02; 8: 45 am]

BILLING CODE 6560– 50– S ENVIRONMENTAL PROTECTION AGENCY [FRL– 7382– 9]

Office of Environmental Information Contact Information Data Standard AGENCY: Environmental Protection Agency (EPA). ACTION: Notice of information availability and request for comments.

SUMMARY: Notice of availability is hereby given for a 45 day public comment period on the Contact Information Data Standard. The draft standard consists of a list of data elements, definitions for these elements, notes, and explanatory preamble language. Also included in the Docket are a set of Frequently Asked Questions Concerning the Contact Information Data Standard. The draft standard was developed by the partnership efforts of States, Tribes, and U. S. Environmental Protection Agency participating in the Environmental Data Standards Council (EDSC). The EDSC convened Action Teams consisting of representatives from EPA, and the States to develop the core set of data elements to facilitate the sharing of information regarding contact name, address, and communication information. The EPA and the EDSC invite comment on these standards from States, EPA, Tribes, database managers in the public and private sectors, and the general public with interest in development and use of data for which defines the who, where, and how in contacting a person or organization. DATES: Comments must be submitted on or before November 12, 2002. ADDRESSES: Comments may be submitted electronically, by mail, by facsimile, or through hand delivery/ courier. Follow the detailed instructions as provided in the SUPPLEMENTARY INFORMATION section. FOR FURTHER INFORMATION CONTACT: Linda Spencer, OEI/ OIC/ CSTD, U. S. Environmental Protection Agency, 1200 Pennsylvania Avenue (MC 2822T), Washington, DC 20460, Phone: 202 566 1651, Fax: 202 566 1624, e mail: spencer. linda@ epa. gov.

SUPPLEMENTARY INFORMATION:

I. General Information A. How Can I Get Copies of This Document and Other Related Information?

1. Docket EPA has established an official public docket for this action under Docket ID No. OEIÑ 2002Ð 0007. The official public docket consists of the documents specifically referenced in this action, any public comments received, and other information related to this action. Although a part of the official docket, the public docket does not include Confidential Business Information (CBI) or other information whose disclosure is restricted by statute. The official public docket is the collection of materials that is available for public viewing at the OEI Docket in the EPA Docket Center, (EPA/ DC) EPA West, Room B102, 1301 Constitution Ave., NW, Washington, DC. The EPA Docket Center Public Reading Room is open from 8: 30 a. m. to 4: 30 p. m., Monday through Friday, excluding legal holidays. The telephone number for the Reading Room is (202) 566Ð 1742, and the telephone number for the OEI Docket is (202) 566Ð 1752).

2. Electronic Access You may access this Federal Register document electronically through the EPA Internet under the `` Federal Register'' listings at http:// www. epa. gov/ fedrgstr/. An electronic version of the public docket is available through EPA's electronic public docket and comment system, EPA Dockets. You may use EPA Dockets at http:// www. epa. gov/ edocket/ to submit or view public comments, access the index listing of the contents of the official public docket, and to access those documents in the public docket that are available electronically. Once in the system, select `` search, ''

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