MEMORANDUM							April 5, 2007

Subject: 		Dietary Risk Assessment for Triclosan for the RED Process

From:			A. Najm Shamim, PhD., Chemist

			Regulatory Management Branch II

			Antimicrobials division (7510P)

To:	Tim McMahon, PhD., Senior Toxicologist

Antimicrobials Division (7510P)

Thru:	Diane Isbell, Triclosan CRM / Team Leader

	Regulatory Management Branch II

	Antimicrobials Division (7510P)

			And

	Mark Hartman, Chief

	Regulatory Management Branch II

	Antimicrobials Division (7510P)

DP Barcode:

EXECUTIVE SUMMARY

As pursuant to the Agency policy AD has carried out the dietary risk assessment form the AD use patterns which present the indirect food contact scenarios. AD has conducted the risk assessment of those use patterns which triggered the possibility of indirect food migration from paper/pulp use ,  ice-making equipmentd, adhesives cutting boards, and counter tops uses as well use in conveyer belts. All  % aPADs and  % cPADs  for adults and children for Triclosan uses fall well below Agency’s level of  concern.

DIETARY RISK ASSESSMENT FROM INDIRECT FOOD USES OF TRICLOSAN

Background:

AD’s label search has shown that Triclosan is used in may scenarios which trigger risk assessment for the  indirect food contact purposes. The following table lists the use patterns, and application rates of  Triclosan.

					Table I

Product Name/EPA Reg#	Use Scenario	Application Rates

DPN-10/Sanitized Brand T96-2/ 3090-165	Paper	10% Formulation; no other information is provided

Ultra Fresh NM/10466-27	Adhesives	3% Formulation; no other information is provided

Ultra Fresh FT-7/10466-42	Emulsions/adhesives	1.5%

Microban  Additive B 	Counter tops, cutting boards, conveyer belts, ice-making equipments, paper/paperboard	0.1%  to 1.0% of the 99% TGAI

Igraguard B1000/70474-5	Conveyer Belt, cutting board	Conveyer belt: 2% Formulations

Cutting Boards: 1% formulations

	RESIDUE CHEMISTRY

	All uses of Triclosan are nonagricultural, and no residue chemistry data based on Agency’s Residue Chemistry Guidelines (OPPTS GLN 860.xxx) were submitted nor the Agency asked for it.  Therefore, The Agency has used available methods to estimate Triclosan residues on food due to migration of this chemical, when this chemical comes in to contact with food-contact paper. In this regard Food and Drug Administration has developed guidelines to estimate residues in food due to migration into food.

Antimicrobials Division in the recent REDs has included the scenarios like: paper/pulp, paperboard, adhesives, counter tops, cutting boards, conveyer belts, and ice-making equipments as a source of indirect food contacts surfaces and a cause of migration of pesticides into foods.  For all  senarios AD has heavily used FDA methodology for calculating the estimated daily intakes (EDI),  and daily dietary doses (DDD). In turn, we calculate the % a-and cPADs for the US populations to determine if there any exceedences. For conveyer belt scenario, we have adapted the FDA methodology to calculate the EDI, DDDs to estimate the %  a-and cPADs

Detailed Discussion:

1) 	Paper and Paperboard Use:

	FDA1,2, Method makes a number of assumptions for calculating migration of active (in this case Triclosan) from food contact surfaces (paper): 1. Food contact surface (paper) can be a one time use/day or a repeat use material; 2. Consumption factor (CF) or fraction of daily food which comes in to contact with the packaging surface (paper). CF represents the actual weight of food that comes into contact with the paper to the weight of all food packaged with paper; 3. The CF varies from one type of packaging (type of paper) to the other (type of paper). FDA methodology of migration of active assumes a 100% migration to the food commodities(This represents a worst case scenario).

Note:	No information is provided  for application rate on paper use of Triclosan as a fungicide; but the percent of the active (Triclosan) in the formulation  10%. In the absence of actual data, we will use the highest application rate which is 10% of formulations. It is therefore assumed that  the  amount (lb) of Triclosan in the formulation is: 10 lbs x 10% = 1 lbs active per 1000 lbs paper For 2000 lbs of the product, the amount of the active = 2 lbs. For our calculations  we assume  2000 lbs paper ~ 1 ton paper.

2 lb active /2000 lb of finished paper = 908 ppm active  mg/kg of  finished paper

 But the paper slurry is 1% ; 908 mg x 01 = 9.08  active mg/kg of finished paper = ~ 10 ppm of active in the paper slurry= Application Rate

Application  rate x % water / % pulp = 10 ppm  = 5µg/g pulp slurry x 0.67g water/0.33.g pulp = 20 µ g of active/g pulp.

Consumption Factor (CF) = 0.10

	Likely amount of Triclosan  migrating into food:

20 µg of Triclosan ⁄ mass of pulp x 0.92 g pulp∕ g of paper x 0.05 g ∕ in2 x 1 in2 ∕ 10 g food = 0.092µ g of Triclosan ∕ g food

Since the Consumption factor for paper, based on FDA’s methodology is 0.10

The  actual amount of Triclosan in daily diet will be:

0.092µg of Triclosan g food x 0.10 = 0.0092 µg ∕ g food

Estimated Daily Intake (EDI) of Triclosan for an adult:

0.0092µg of Triclosan∕ g food x 3000 g food =27.6µg of Triclosan/person/day

Estimated Daily Intake (EDI) of Triclosan for a child:

0.0092µg of Triclosan ∕ g food x 1500 g food = 13.8 µg of Triclosan/person/ day

 (A Memo by Tim McMahon  to Jess Rowland, Executive Secretary for Agency’s HIARC Committee, 1998)  indicated that AD scientists determined both the Acute dietary and chronic dietary end points and based on the selection, the aRfD  (aPAD)and cRfD (aPAD)  have the same value i.e.,:  0.30 mg/kg/day

In Table  II estimations are given for % aPAD and % cPAD.

				Table II

		Dietary Exposure of Triclosan from Paper/Pulp/ Paperboard

Dietary Conc. of  Triclosan	Estimated Daily Intake (EDI)	Daily Dietary Dose (DDD): mg/kg/day	% aPAD

(aPAD = 0.30 mg/kg/day)	% cPAD (cPAD = 0.30 mg/kg/day)

20.0 µ g	Adult: 27.6 µg

	Adult: 27.6 µg/70 kg/day = 0.00039 mg/kg/day

	Adult: 0.00039 mg/kg/day ∕ 0.30 mg/kg/day x 100

= 0.13%	Adult: 0.00039 mg/kg/day/0.30 mg/kg/day x 100 = 0.13%

	Child: 13.8  µg 	Child: 13.8µg/ 15 kg/day = 0.00092 mg/kg/day	Child: 0.00092 mg/kg/day ∕ 0.37 mg/kg/day = 0.30% 	Child: 0.00092 mg/kg/day / 0.037 mg/kg/day = 0.30%

The calculations of % aPAD and cPAD  show that there are no acute  and chronic dietary concerns from the migration of Triclosan from paper to food.

Adhesive Use of Triclosan

As a matter of policy, AD has assessed adhesive use as an indirect food use.  Since it is likely that adhesives may end up in the food packaging materials, and this may result in the migration of the pesticide into the food indirectly.  For the indirect food dietary assessment, AD has adopted Food & Drug Administration (FDA) methodology.  For adhesive use, FDA has provided guidance for dietary estimation that a maximum of 7 ppb of a pesticide is likely to migrate from the food packaging materials into the food. The quantity of 7 ppb can be used to calculate the Estimated Daily Intake (EDI), Daily Dietary Dose (DDD), and using the acute and dietary end points from toxicity data, one calculates the overall risks to general and subgroups of populations ( % aPAD, and % cPAD).

For the present case: FDA’s assumptions are: 1) Maximum migration of  Triclosan  into food from adhesive use = 7 ppb = 7µg/g; 2) Maximum adult food intake = 3000 g; 3) Maximum food intake for a child = 1500 g.

In general, % PAD =  DDD/% a PAD or % cPAD.

Table III gives estimates of % cPAD for adhesive use of Triclosan

Table III

			Dietary Exposure of Triclosan from Adhesive Use

Use	Dietary Conc. (ppb)	Estimated Daily Intake (EDI) µg/p/day	Daily Dietary Dose (DDD) mg/kg/day

	% aPAD

(aPAD= 0.30 mg/kg/d)	% cPAD

( cPAD = 0.30 mg/kg/d)

Adhesive	7	Adult: 7µg/g x 3000g = 21 µg/p/day

Child: 7 µg/g x 1500 g = 10.5 µg/p/day	Adult: 21 µg/70 kg/day = 0.0003 mg/kg/day

Child: 10.5 µg/15kg/day = 0.0007 mg/kg/day	Adult: 0.0003/0.30 x 100) = 0.10%

Child: 0.0007/0.30 x100 = 0.23%	Adult:  0.0003 mg/kg/day ∕ 0.3 mg/kg/day x100 = 0.10%

Child: 0.0007 mg/kg/day ∕ 0.30 mg/kg/day x 100  = 0.23 %

These calculations assume that the adhesive use is 100% of the chemical produced, which is not a likely scenario. The actual  % cPAD is going to be much lower than the estimated one The Agency has no chronic dietary concerns from the use of Triclosan in adhesives.

Ice-making Equipment

AD makes the following assumptions to calculate the exposure of Tricolsan use  from ice-making equipments:

Use of Ice/water/day = 50%  ice/water mixture

Male adult uses 2000L/day and child uses 1000L/day of ice-water mixture

Table IV summarizes the daily dietary dose and % aPAD and % cPAD for ice-making equipment:

				Table IV

	Exposure from Triclosan Use  from Ice-Making Equipment

Daily Dietary Dose (DDD) mg/kg/day1	% aPAD ( aPAD = 0.30 mg/kg/day)	% cPAD (cPAD = 0.30 mg/kg/day)

Male Adult: 1.13 x10-8  mg/kg/day

Child: 2.65 x 10-8  mg/kg/day	Male Adult: 1.13 x10-8  mg/kg/day/ 0.30 mg/kg/day = 3.76 x 10-8  x 100 = 3.76 x 10-6  %

Child: 2.65 x 10-8  mg/kg/day /0.30 mg/kg/day = 8.83 x 10-8  x 100 =  8.83  x 10-6  %	Male Adult: 1.13 x10-8  mg/kg/day/ 0.30 mg/kg/day = 3.76 x 10-8  x 100 = 3.76 x 10-6  %

Child: 2.65 x 10-8  mg/kg/day /0.30 mg/kg/day = 8.83 x 10-8  x 100 =  8.83  x 10-6  %

	Note: 1) Calculations reported by Bob Quick in  a  Memo by Bob Quick to Bob Brennis, 1998.

4) 	Counter Tops and Cutting Boards:

Table V lists the input parameters and explanations for EDI, DDD, % aPAD and % cPAD for Triclosan use on counter tops, and cutting board.

					Table V

Parameter	Comment	Value/Units

AR	Application Rate, usually highest application rate is used	ppm or  µg

RS	Residual solution	1 mg/cm2 , adapted from FDA methodology

SA	Treated surface area which comes into contact with food	Cm2 ; assumed to be 2000 cm2 for counter tops and cutting boards

F	% fraction of the active	No units; normally Agency has sued 10%.

BW	Body Weight	Adult: 70 kg; child: 15 kg

EDI	Estimated Daily Intake	= AR * RS * SA * F

DDD	Daily Dietary Dose	= EDI/BW

aPAD	Acute dietary end points	For Triclosan: 0.30 mg/kg/day

cPAD	Chronic Dietary end point	For Triclosan: 0.30 mg/kg/day

% aPAD	Ratio of DDD and aPAD	% population affected (acute)

% cPAD	Ratio of DDD and cPAD	% population affected

Table VI provides the summary of calculations and results for EDI, DDD, % aPAD, and % cPAD; based on: a) maximum application rate = 1%; aPAD = 0.30 mg/kg/day and cPAD = 0.30 mg/kg/day; fraction % = 10%; and maximum  surface area food is exposed to the pesticide = 2000 cm2

					Table VI

Parameter	Calculations/Results

EDI	AR * RS* SA * F; =  10,000 µg/1000 mg (ppm) * 1 mg/cm2 * 10/100 * 2000 cm2 = 2000 µg

DDD	Adult: EDI/70 kg/day = 2000µg/70 = 28.6 µg/kg/day; Child: EDI/15 kg/day = 2000µg/15 kg/day = 133. 3 µg/kg/day

% aPAD	DDD/ aPAD x 100 ; Adult: 0.0286 mg/kg/day/ 0.30 mg/kg/day = 9.53%

Child: 0.1333 mg/kg/day/ 0.3 mg/kg/day x 100 = 44.3%

% cPAD	 Adult = 9.53%; Child = 44.3%

All results  are below level of concern. These results are very conservative and the likelihood of exposure from counter tops and cutting board use on a regular basis of 7/24/year is minimum.  In addition use of surface area of 2000 cm2  of 7/24/year is also not likely. The Agency believes the actual exposure form counter tops and cutting boards will be much lower than the results shown here

Conveyer Belt Use.

Triclosan is used as a material preservative in a number of  commodities made up of synthetic fibers  as thin films like polyesters, latex, polypropylene, polyethylene etc.

Conveyer belts are generally made from polyethylene materials and Triclosan is used as a material preservative.  In food establishments, grocery stores, food storage establishments, conveyer belts are used to move foods along. There is a likelihood that some of the Triclosan migrates form the belts to the food which is being moved on the belt. FDA has established some in put parameters for such a scenario.  In addition, AD industry provded us with a few parameters which are used as a common industry practice. Although  label Triclosan (EPA REG#: 70404-5) has provided the maximum rate of application of 2% formulation, it is not clear how this is spread out on the conveyer belt and in this regard Agency has made its own assumptions.

Table VII lists the FDA and industry parameters, and Agency’s assumptions for calculating the EDIs for Triclosan when it is migrated into food through indirect contact with the conveyer belt surfaces.

					Table VII

In Put Parameters /Assumptions	Explanations/ Units

Average length of  conveyer belt 13 meters	Industry practice

Average Width of conveyer belt: 1 m	Industry practice

Surface area of  conveyer belt (A)	13 m x m = 13 m2 = 20386 in2

Volume/surface ratio for food simulating liquid= 6.7 mL/in2 (B)	FDA assumption

Amount of food placed on 1150 in2 = 8 x 103 kg   or 8 x 106 g/1150 in2   (C)	FDA assumption

Polyethylene used to make conveyer belt	EPA assumption

Maximum migration of Triclosan into food simulating liquid (50% ethanol/water) = 0.9 ppm (D)	FDA assumption

Rate of Application on the conveyer belt = 2% solution (E)	Industry data

2% solution = 2g/100 g ; 20 g/kg solution spread over/meter of conveyer belt  (F)	EPA assumption

Use of conveyer belt /year (G)	260 days/Industry practice

Time period of maximum migration (H)	First  5 days: industry data

Amount of food which passes through the conveyer belt: A * C

X = A * C = 20386 in2  * 8 x 106 = 1.42 x 108  g

Maximum Migration of Triclosan from the conveyer belt: B * D = Y

Y =  0.90ppm = 900 ng/ml x 6.7 ml/ in2 = 6.03 µg/in2

Total migration of Triclosan into all food: A * Y /X = Z

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 = 0.000866 mg/day = Estimated daily intake (EDI)

Table VIII summarized the DDD,  % aPAD and % cPAD

				TableVIII

Parameter	Calculations/Results

DDD	Adult: 0.000866 mg/70kg/day = 0.0000123 mg/kg/day

Child: 0.000866 mg/15kg/day = 0.000057 mg/kg/day

% aPAD and % cPAD	Adult: 0.0000123 mg/kg/day/0.30 mg/kg/day x 100 = 0.041%

Child:  0.000057 mg/kg/day / 0.30 mg/kg/day x 100 = 0.019%

Conclusions:

	None of the indirect food contact scenarios appear to exceed  Agency’s level of concern.

				BIBLIOGRAPHY

FDA, 2003, A Guidance For Industry: Preparations of food Contact Notifications and Food Additive Petitions for Food Contact Substances, Chemistry Recommendations. Final Guidance, April 2003.   HYPERLINK "http://www.cfsan.fda.gov"  http://www.cfsan.fda.gov

FDA, 2003.  Sanitizing  Solutions: Chemistry Guidance for Food Additive Petitions, January 2003.   HYPERLINK "Http://www.cfsan.fda.gov"  Http://www.cfsan.fda.gov

An AD Memo by Tim McMahon  to Jess Rowland, Executive Secretary for Agency’s HIARC Committee, 1998)

4.	Calculations reported by Bob Quick in  an AD   Memo by Bob Quick to Bob Brennis, 1998.


[Federal Register Volume 82, Number 75 (Thursday, April 20, 2017)]
[Notices]
[Pages 18684-18686]
[FR Doc No: 2017-08008]

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

DEPARTMENT OF TRANSPORTATION

National Highway Traffic Safety Administration

[Docket No. NHTSA-2017-0010; Notice 1]

Sumitomo Rubber USA, LLC, Receipt of Petition for Decision of
Inconsequential Noncompliance

AGENCY: National Highway Traffic Safety Administration (NHTSA),
Department of Transportation (DOT).

ACTION: Receipt of petition.

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

SUMMARY: Sumitomo Rubber USA, LLC (SRUSA), has determined that certain
Sumitomo Kelly brand commercial truck tires do not fully comply with
Federal Motor Vehicle Safety Standard (FMVSS) No. 119, New Pneumatic
Tires for Motor Vehicles with a GVWR of more than 4,536 kilograms
(10,000

pounds) and Motorcycles. SRUSA filed a noncompliance report dated
January 3, 2017. SRUSA also petitioned NHTSA on January 31, 2017, for a
decision that the subject noncompliance is inconsequential as it
relates to motor vehicle safety.

DATES: The closing date for comments on the petition is May 22, 2017.

ADDRESSES: Interested persons are invited to submit written data,
views, and arguments on this petition. Comments must refer to the
docket and notice number cited in the title of this notice and
submitted by any of the following methods:
     Mail: Send comments by mail addressed to U.S. Department
of Transportation, Docket Operations, M-30, West Building Ground Floor,
Room W12-140, 1200 New Jersey Avenue SE., Washington, DC 20590.
     Hand Delivery: Deliver comments by hand to U.S. Department
of Transportation, Docket Operations, M-30, West Building Ground Floor,
Room W12-140, 1200 New Jersey Avenue SE., Washington, DC 20590. The
Docket Section is open on weekdays from 10 a.m. to 5 p.m. except
Federal Holidays.
     Electronically: Submit comments electronically by logging
onto the Federal Docket Management System (FDMS) Web site at https://www.regulations.gov/. Follow the online instructions for submitting
comments.
     Comments may also be faxed to<PHONE_NUMBER>.
    Comments must be written in the English language, and be no greater
than 15 pages in length, although there is no limit to the length of
necessary attachments to the comments. If comments are submitted in
hard copy form, please ensure that two copies are provided. If you wish
to receive confirmation that comments you have submitted by mail were
received, please enclose a stamped, self-addressed postcard with the
comments. Note that all comments received will be posted without change
to https://www.regulations.gov, including any personal information
provided.
    All comments and supporting materials received before the close of
business on the closing date indicated above will be filed in the
docket and will be considered. All comments and supporting materials
received after the closing date will also be filed and will be
considered to the fullest extent possible.
    When the petition is granted or denied, notice of the decision will
also be published in the Federal Register pursuant to the authority
indicated at the end of this notice.
    All comments, background documentation, and supporting materials
submitted to the docket may be viewed by anyone at the address and
times given above. The documents may also be viewed on the Internet at
https://www.regulations.gov by following the online instructions for
accessing the dockets. The docket ID number for this petition is shown
in the heading of this notice.
    DOT's complete Privacy Act Statement is available for review in a
Federal Register notice published on April 11, 2000, (65 FR 19477-78).

SUPPLEMENTARY INFORMATION:
    I. Overview: Sumitomo Rubber USA, LLC (SRUSA), has determined that
certain Sumitomo Kelly brand commercial truck tires do not fully comply
with S6.5 of Federal Motor Vehicle Safety Standard (FMVSS) No. 101, New
Pneumatic Tires for Motor Vehicles with a GVWR of more than 4,536
kilograms (10,000 pounds) and Motorcycles. SRUSA filed a noncompliance
report dated January 3, 2017, and amended on January 25, 2017, pursuant
to 49 CFR part 573, Defect and Noncompliance Responsibility and
Reports. SRUSA also petitioned NHTSA on January 31, 2017, pursuant to
49 U.S.C. 30118(d) and 30120(h) and 49 CFR part 556, for an exemption
from the notification and remedy requirements of 49 U.S.C. Chapter 301
on the basis that this noncompliance is inconsequential as it relates
to motor vehicle safety.
    This notice of receipt of SRUSA's petition is published under 49
U.S.C. 30118 and 30120 and does not represent any agency decision or
other exercise of judgment concerning the merits of the petition.
    II. Tires Involved: Affected are approximately 138 Sumitomo Kelly
KDA size 11R22.5 commercial truck tires manufactured between December
4, 2016, and December 17, 2016.
    III. Noncompliance: SRUSA explains that the noncompliance is that
the required markings on the sidewall of the subject tires were
inadvertently omitted and therefore do not comply with paragraph S6.5
of FMVSS No. 119.
    IV. Rule Text: Paragraph S6.5 of FMVSS No. 119 states in pertinent
part:

    S6.5 Tire markings. Except as specified in this paragraph, each
tire shall be marked on each sidewall with the information specified
in paragraphs (a) through (j) of this section. The markings shall be
placed between the maximum section width (exclusive of sidewall
decorations or curb ribs) and the bead on at least one sidewall,
unless the maximum section width of the tire is located in an area
which is not more than one-fourth of the distance from the bead to
the shoulder of the tire . . .

    V. Summary of SRUSA's Petition: SRUSA described the subject
noncompliance and stated its belief that the noncompliance is
inconsequential as it relates to motor vehicle safety.
    In support of its petition, SRUSA submitted the following
reasoning:
    SRUSA submits that the condition described above is inconsequential
as it relates to motor vehicle safety. The tires were manufactured as
designed and meet or exceed all performance requirements of applicable
Federal motor vehicle safety standards. All of the subject tires are
marked with the correct information; however, the information appears
only on one sidewall. Therefore, the noncompliant condition does not
affect motor vehicle safety because the required information is still
visible and available to the consumer on one sidewall of the tire.
Additionally, SRUSA is not aware of any customer complaints related to
this condition. The affected tire mold was immediately corrected and no
additional tires were or will be manufactured with this noncompliance.
    NHTSA previously granted petitions for similar noncompliance
conditions related to tire information on tires because of surveys that
show most consumers do not base tire purchases on tire information
found on the tire sidewall.
    Moreover, the absence of the markings on one sidewall has no impact
on the operational performance of the tires at issue or on the safety
of the vehicles on which these tires may be mounted.
    SRUSA concluded by expressing the belief that the subject
noncompliance is inconsequential as it relates to motor vehicle safety,
and that its petition to be exempted from providing notification of the
noncompliance, as required by 49 U.S.C. 30118, and a remedy for the
noncompliance, as required by 49 U.S.C. 30120, should be granted.
    In a supplemental email dated February 24, 2017, SRUSA stated that
the subject tires are not Asymmetric tires and is not labeled as
``OUTERSIDE'' or ``OUTER.'' SRUSA also stated that there is no specific
outboard or inner sidewall, thus, the tires may be mounted either way.
    To view SRUSA's petition, analyses, and any supplemental
documentation in its entirety you can visit https://www.regulations.gov
by following the online instructions for accessing the dockets and by
using the docket ID number for this petition show in the heading of
this notice.
    NHTSA notes that the statutory provisions (49 U.S.C. 30118(d) and
30120(h)) that permit manufacturers to file petitions for a
determination of

inconsequentiality allow NHTSA to exempt manufacturers only from the
duties found in sections 30118 and 30120, respectively, to notify
owners, purchasers, and dealers of a defect or noncompliance and to
remedy the defect or noncompliance. Therefore, any decision on this
petition only applies to the subject tires that SRUSA no longer
controlled at the time it determined that the noncompliance existed.
However, any decision on this petition does not relieve equipment
distributors and dealers of the prohibitions on the sale, offer for
sale, or introduction or delivery for introduction into interstate
commerce of the noncompliant tires under their control after SRUSA
notified them that the subject noncompliance existed.

    Authority:  (49 U.S.C. 30118, 30120: Delegations of authority at
49 CFR 1.95 and 501.8)

Jeffrey M. Giuseppe,
Director, Office of Vehicle Safety Compliance.
[FR Doc. 2017-08008 Filed 4-19-17; 8:45 am]
 BILLING CODE 4910-59-P


[Federal Register Volume 83, Number 182 (Wednesday, September 19, 2018)]
[Notices]
[Pages 47395-47396]
[FR Doc No: 2018-20293]

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DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

Agency Information Collection Activities: Requests for Comments;
Clearance of Renewed Approval of Information Collection: Fractional
Aircraft Ownership Programs

AGENCY: Federal Aviation Administration (FAA), DOT.

ACTION: Notice and request for comments.

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SUMMARY: In accordance with the Paperwork Reduction Act of 1995, FAA
invites public comments about our intention to request the Office of
Management and Budget (OMB) approval for to renew an information
collection. The Federal Register Notice with a 60-day comment period
soliciting comments on the following collection of information was
published on July 23, 2018. Each fractional ownership program manager
and each fractional

owner must comply with regulations. Information is used to determine if
these entities are operating in accordance with the minimum safety
standards of these regulations. The FAA will use the information it
reviews and collects to evaluate the effectiveness of the program and
make improvements as needed, and ensure compliance and adherence to
regulations.

DATES: Written comments should be submitted by October 19, 2018.

ADDRESSES: Interested persons are invited to submit written comments on
the proposed information collection to the Office of Information and
Regulatory Affairs, Office of Management and Budget. Comments should be
addressed to the attention of the Desk Officer, Department of
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the Office of Information and Regulatory Affairs, Office of Management
and Budget, Docket Library, Room 10102, 725 17th Street NW, Washington,
DC 20503.

PUBLIC COMMENTS INVITED: You are asked to comment on any aspect of this
information collection, including (a) Whether the proposed collection
of information is necessary for FAA's performance; (b) the accuracy of
the estimated burden; (c) ways for FAA to enhance the quality, utility
and clarity of the information collection; and (d) ways that the burden
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information. The agency will summarize and/or include your comments in
the request for OMB's clearance of this information collection.

FOR FURTHER INFORMATION CONTACT: Barbara Hall at<PHONE_NUMBER>, or by
email at: [email protected].

SUPPLEMENTARY INFORMATION:
    OMB Control Number: 2120-0684.
    Title: Fractional Aircraft Ownership Programs.
    Form Numbers: There are no FAA forms associated with this
collection.
    Type of Review: This is a renewal of an existing information
collection.
    Background: The Federal Register Notice with a 60-day comment
period soliciting comments on the following collection of information
was published on July 23, 2018 (83 FR 34910). Fractional Ownership is a
program that offers increased flexibility in aircraft ownership. Owners
purchase shares of an aircraft and agree to share their aircraft with
others having an ownership share in that same aircraft. Owners agree to
put their aircraft into a ``pool'' of other shared aircraft and to
lease their aircraft to another owner in that pool. Each fractional
ownership program manager and each fractional owner must comply with
the requirements of 14 CFR part 91, subpart K. Information is used to
determine if these entities are operating in accordance with the
minimum safety standards of these regulations. The FAA will use the
information it reviews and collects to evaluate the effectiveness of
the program and make improvements as needed, and ensure compliance and
adherence to regulations.
    Respondents: 8 fractional aircraft program managers/operators.
    Frequency: Information is collected on occasion.
    Estimated Average Burden per Response: 1 hour, 20 minutes.
    Estimated Total Annual Burden: 13,736 hours, or 1,717 hours per
respondent.

    Issued in Washington, DC, on September 8, 2018.
Barbara Hall,
FAA Information Collection Clearance Officer, IT Enterprises Business
Services Division, ASP-110.
[FR Doc. 2018-20293 Filed 9-18-18; 8:45 am]
 BILLING CODE 4910-13-P


SF 83 SUPPORTING STATEMENT ENVIRONMENTAL PROTECTION AGENCY NSPS Subpart Db, Standards of Performance for Industrial Commercial Institutional Steam Generating Units 1. Identification of the Information Collection 1( a) Title of the Information Collection NSPS Subpart Db, Standards of Performance for Industrial Commercial Institutional Steam Generating Units 1( b) Short Characterization/ Abstract The New Source Performance Standards ( NSPS), for the regulations published at 40 CFR Part 60, Subpart Db for the pollutant sulfur dioxide ( SO 2 ) were proposed on June 19, 1986 and promulgated on December 16, 1987. These regulations apply to the following facilities in 40 CFR Part 60, Subpart Db: those which are industrial commercial institutional steam generating units ( boilers) that commenced construction, modification, or reconstruction after June 19, 1984, and that have a heat input capacity from fuels combusted in the unit of greater than 29 MW ( 100 million Btu/ hour). This information is being collected to assure compliance with 40 CFR Part 60, Subpart Db.

In general, all NSPS standards require initial notifications, performance tests, and periodic reports. Owners or operators are also required to maintain records of the occurrence and duration of any startup, shutdown, or malfunction in the operation of an affected facility, or any period during which the monitoring system is inoperative. These notifications, reports, and records are essential in determining compliance, and are required of all sources subject to NSPS.

Any owner or operator subject to the provisions of this part shall maintain a file of these measurements, and retain the file for at least two years following the date of such measurements, maintenance reports, and records. All reports are sent to the delegated State or local authority. In the event that there is no such delegated authority, the reports are sent directly to the United States Environmental Protection Agency ( EPA) Regional Office.

Size of the Regulated Community In a study from 1979, EPA modeled the total capacity of U. S. industrial/ commercial boilers for 1980, 1985 and 2000, for boilers with capacities greater than 29 MW ( 100 million BTU/ hour) (" Population and Characteristics of Industrial/ Commercial Boilers in the U. S. from 1979"; EPA No. PB80  150881). 2 This model shows an increase of 4,139 new industrial/ commercial boilers between 1985 and 2000 with capacities greater than 29 MW ( 100 million BTU/ hour), and these would be subject to NSPS Db. Therefore, according to this model there should be approximately 4,139 steam generating units ( or boilers) currently subject to NSPS Subpart Db. Assuming one boiler per facility, the number of facilities subject to NSPS Subpart Db would be 4,139.

However, during the NOx NSPS revision, information on industrial boilers subject to NSPS Db was obtained from three sources: a best available technology/ lowest achievable emission rate database search; copies of permits obtained from EPA Regional offices; and telephone contacts with EPA Regions, State agencies, and boiler vendors. Based on the information obtained, as of 1995 only 45 NSPS Db boilers were identified. Since NSPS Db was in affect for ten years in 1995, 45 boilers is probably a low number and model projects indicate that it may be far from the true regulated universe for 1995. The 4,139 boilers projected for 2000 is based on energy consumption and it is probably too high. The previous ICR estimated 957 facilities subject to NSPS Db.

During the NOx NSPS revision mentioned above an analysis was conducted to determine the projected growth of new industrial boilers over the period between 1996 to 2000. This analysis showed that the growth rate would be 76 new industrial boilers per year. Therefore, using the estimate from the previous ICR of 957 and assuming a growth rate of 76 new industrial boilers per year over the three year period since the last ICR. The 76 new boilers per year would sum to 228 new industrial boilers. Assuming one boiler per facility this would come out to 228 new NSPS Db facilities added to the estimated number from the last ICR submittal ( 957) for a total of 1,185 NSPS Db facilities estimated for this ICR.

Growth Rate for the Next Three Years In the Industrial Boiler MACT rulemaking a projection of new industrial, commercial, and institutional boilers was performed for economic analysis in October 2002. This analysis showed that 134 industrial, commercial, and institutional boilers would become subject to NSPS Subpart Db over the next three years ( or 45 per year). This is the most recent growth projection for these facilities.

Therefore, this ICR is estimating that approximately 1,185 sources are currently subject to the regulation, and it is estimated that an additional 45 sources per year will become subject to the regulation in the next three years.

2. Need for and Use of the Collection 2( a) Need/ Authority for the Collection 3 The EPA is charged under Section 111 of the Clean Air Act ( CAA), as amended, to establish standards of performance for new stationary sources that reflect:

. . . application of the best technological system of continuous emissions reduction which ( taking into consideration the cost of achieving such emissions reduction, or any non air quality health and environmental impact and energy requirements) the Administrator determines has been adequately demonstrated. Section 111( a)( l)

The Agency refers to this charge as selecting the best demonstrated technology ( BDT). Section 111 also requires that the Administrator review and, if appropriate, revise such standards every four years.

In addition, Section 114( a) states that the Administrator may require any owner or operator subject to any requirement of this Act to:

( A) Establish and maintain such records; ( B) make such reports; ( C) install, use, and maintain such monitoring equipment, and use such audit procedures, or methods; ( D) sample such emissions ( in accordance with such procedures or methods, at such locations, at such intervals, during such periods, and in such manner as the Administrator shall prescribe); ( E) keep records on control equipment parameters, production variables or other indirect data when direct monitoring of emissions is impractical; ( F) submit compliance certifications in accordance with Section 114( a)( 3); and ( G) provide such other information as the Administrator may reasonably require.

In the Administrator's judgment, SO 2 , PM, and NO x emissions from Industrial Commercial Institutional Steam Generating units cause or contribute to air pollution that may reasonably be anticipated to endanger public health or welfare. Therefore, the NSPS were promulgated for this source category at 40 CFR Part 60, Subpart Db.

2( b) Practical Utility/ Users of the Data The control of emissions of SO 2 PM, and NO x from Industrial Commercial Institutional Steam Generating units requires not only the installation of properly designed equipment, but also the operation and maintenance of that equipment. Emissions of SO 2 , PM, and NO x from Industrial Commercial Institutional Steam Generating units are the result of operation of the 4 affected facilities. The subject standards are achieved by the capture and/ or reduction of SO 2 , PM, and NO x emissions using control technologies such as sorbent injection technologies and wet and dry scrubbers for SO 2 ; cyclones, electrostatic precipitators, and fabric filters for PM; and low NOx burners and selective catalytic or noncatalytic reduction technologies for NOx. The notifications required in the applicable regulations are used to inform the Agency or delegated authority when a source becomes subject to the requirements of the regulations. The reviewing authority may then inspect the source to check if the pollution control devices are properly installed and operated and the regulations are being met. Performance test reports are needed as these are the Agency's record of a source's initial capability to comply with the emission standards, and serve as a record of the operating conditions under which compliance was achieved. The semiannual reports are used for problem identification, as a check on source operation and maintenance, and for compliance determinations. The information generated by the monitoring, recordkeeping and reporting requirements described in this ICR is used by the Agency to ensure that facilities affected by the NSPS continue to operate the control equipment and achieve compliance with the regulation. Adequate monitoring, recordkeeping, and reporting are necessary to ensure compliance with the applicable regulations, as required by the Clean Air Act. The information collected from recordkeeping and reporting requirements is also used for targeting inspections, and is of sufficient quality to be used as evidence in court.

3. Nonduplication, Consultations, and Other Collection Criteria The requested recordkeeping and reporting are required under 40 CFR Part 60, Subpart Db.

3( a) Nonduplication If the subject standards have not been delegated, the information is sent directly to the appropriate EPA Regional Office. Otherwise, the information is sent directly to the delegated State or local agency. If a State or local agency has adopted their own similar standards to implement the Federal standards, a copy of the report submitted to the State or local agency can be sent to the Administrator in lieu of the report required by the Federal standards. Therefore, no duplication exists.

3( b) Public Notice Required Prior to ICR Submission to OMB An announcement of a public comment period for the renewal of this ICR was published in the Federal Register on June 20, 2002. No comments were received on the burden published in the Federal Register.

3( c) Consultations 5 To determine the size of the regulated community and the rate of industry growth, the EPA Office of Air Quality Planning and Standards, and the Department of Energy's Energy Information Agency were consulted.

3( d) Effects of Less Frequent Collection Less frequent information collection would decrease the margin of assurance that facilities are continuing to meet the standards. Requirements for information gathering and recordkeeping are useful techniques to ensure that good operation and maintenance practices are applied and emission limitations are met. If the information required by these standards was collected less frequently, the likelihood of detecting poor operation and maintenance of control equipment and noncompliance would decrease.

3( e) General Guidelines None of these reporting or recordkeeping requirements violate any of the regulations established by OMB at 5 CFR 1320.5.

3( f) Confidentiality The required information has been determined not to be confidential. However, any information submitted to the Agency for which a claim of confidentiality is made will be safeguarded according to the Agency policies set forth in Title 40, Chapter 1, Part 2, Subpart B  Confidentiality of Business Information ( see 40 CFR 2; 41 FR 36902, September 1, 1976; amended by 43 FR 40000, September 8, 1978; 43 FR 42251, September 20, 1978; 44 FR 17674, March 23, 1979).

3( g) Sensitive Questions None of the reporting or recordkeeping requirements contain sensitive questions.

4. The Respondents and the Information Requested 4( a) Respondents/ SIC Codes Characterization and Classification of Boilers and Boiler Related Industries 6 Industrial commercial institutional boilers ( also know as steam generating units) are classified by type, fuel, and method of construction. The three main types are cast iron, fire tube and water tube. These three categories of boilers are designed and manufactured to meet specific applications and site requirements. Unit size, design pressure and temperature all depend on boiler application. Each boiler type may burn coal , oil or natural gas, and are increasingly being designed to burn more than one fuel type.

All boilers subject to NSPS Subpart Db are water tubed boilers. Water tubed boilers are used in a variety of applications ranging from supplying large amounts of process steam to providing space heat for industrial facilities or commercial buildings. Water tubed boilers range from a low of 2.9 mega watts ( MW) to greater than 200 MW. Water tubed boilers are available over a larger size range than the other types. Water tubed boilers are fueled by coal, 25%; oil, 32%, and natural gas, 43%. Process steam accounts for the largest use of fuel to fire boilers, using about one third of all industrial fuel.

The following industries use water tubed boilers with capacities greater than 29 MW ( 100 mmBtu/ hr). In EPA's studies energy usage was used to estimate the potential for industry boiler usage. The chemical and paper industries use the most energy accounting for about a third of all U. S. industrial fuel usage. Most of the remainder of industrial fuel is used by petroleum refineries, steel and aluminum manufacturers and food processing industries. Other industries using smaller, but significant amounts of fuel are the textiles, lumber, and rubber manufacturers, and metal fabrication and transportation industries. The other two industries that would be expected to have boilers large enough to be subject to NSPS Subpart Db are Office and Shopping Center heating and, Boiler Rentals.

The respondents to the recordkeeping and reporting requirements are facilities subject to NSPS Subpart Db that commenced construction, modification, or reconstruction after June 19, 1984, and that have a heat input capacity from fuels combusted in the steam generating unit of greater than 29 MW ( 100 mmBtu/ hr).

Regulation SIC Codes NAICS Codes 40 CFR Part 60, Subpart Db 1531 23332 2033 311421 Major Group 22 Major Group 313 Major Group 24 Major Group 321 2611 322110 7 Major Group 28 Major Group 325 2911 324110 Major Group 30 Major Group 326 Major Group 33 Major Group 331 Major Group 34 Major Group 332 Major Group 37 Major Group 336 7299 81299 4( b) Information Requested ( i) Data Items All data in this ICR that is recorded and/ or reported is required by 40 CFR Part 60, Subpart Db.

A source must make the following reports:

Reports for 40 CFR Part 60, Subpart Db Construction/ reconstruction 60.7( a)( 1)

Actual startup 60.7( a)( 3), 60.49b( a)

Initial performance test results 60.8 ( a), 60.49b( b)

Initial performance test 60.8( d)

Demonstration of continuous monitoring system 60.7( a)( 5)

Physical or operational change 60.7( a)( 4)

Operating conditions for compliance with NOx standard 60.49b( c)

Monitoring results 60.49b( i)( n), ( q)( t) 8 Reports for 40 CFR Part 60, Subpart Db Excess emissions ( semiannual) 60.7( c), 60.49b( h), 60.49b( w)

Quarterly reporting for Cytec Industries Fortier Plant's C. AOG incinerator, Westwego, LA 60.49b( s)

Quarterly reporting for Rohm and Haas Kentucky Incorporated's Boiler No. 100, Louisville, KY 60.49b( t)

Quarterly reporting ( electronic) 60.49b( v)

A source must maintain the following records:

Recordkeeping for 40 CFR Part 60, Subpart Db Startups, shutdowns, malfunctions, periods where the continuous monitoring system is inoperative. 60.7( b)

Fuel Monitoring 60.49b( d), 60.49b( r)

Nitrogen content of residual oil combusted 60.49b( e)

Opacity 60.49b( f)

Nitrogen oxide emission rates 60.49b( g), ( p)

Records are required to be retained at the facility for two years. 60.7( f), 60.49b( o)

( ii) Respondent Activities Respondent Activities Read instructions.

Install, calibrate, maintain, and operate Continuous Monitoring System ( CMS) for opacity, or for pressure drop and liquid supply pressure for wet scrubber.

Perform initial performance test, reference method tests ( method 19 ( SO2); method 5 & 17 ( PM); method 17 ( opacity); method 7 ( NOx), and repeat performance tests if necessary. 9 Respondent Activities Write the notifications and reports listed above.

Enter information required to be recorded above.

Submit the required reports developing, acquiring, installing, and utilizing technology and systems for the purpose of collecting, validating, and verifying information.

Develop, acquire, install, and utilize technology and systems for the purpose of processing and maintaining information.

Develop, acquire, install, and utilize technology and systems for the purpose of 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.

Transmit, or otherwise disclose the information.

5. The Information Collected: Agency Activities, Collection Methodology, and Information Management 5( a) Agency Activities EPA conducts the following activities in connection with the acquisition, analysis, storage, and distribution of the required information.

Agency Activities Observe initial performance tests and repeat performance tests if necessary.

Review notifications and reports, including performance test reports, and excess emissions reports, required to be submitted by industry.

Audit facility records.

Input, analyze, and maintain data in the AIRS ( Aerometric Information Retrieval System) Facility Subsystem ( AFS) database.

5( b) Collection Methodology and Management 10 Following notification of startup, the reviewing authority might inspect the source to determine whether the pollution control devices are properly installed and operated. Performance test reports are used by the Agency to discern a source's initial capability to comply with the emission standard. Data and records maintained by the respondents are tabulated and published for use in compliance and enforcement programs. The semiannual reports are used for problem identification, as a check on source operation and maintenance, and for compliance determinations.

Information contained in the reports is entered into AFS which is operated and maintained by EPA's Office of Air Quality Planning and Standards. AFS is EPA's database for the collection, maintenance, and retrieval of compliance and annual emission inventory data for over 100,000 industrial and government owned facilities. EPA uses AFS for tracking air pollution compliance and enforcement by local and State regulatory agencies, EPA Regional Offices and EPA Headquarters. EPA and its delegated authorities can edit, store, retrieve, and analyze the data. The records required by this regulation must be retained by the owner or operator for two years.

5( c) Small Entity Flexibility There are no small businesses affected by this regulation.

5( d) Collection Schedule The specific frequency for each information collection activity within this request is shown in Table 2: Average Annual EPA Resource Requirement for Fossil Fuel Fired Steam Generating Units/ NSPS Subpart Db..

6. Estimating the Burden and Cost of the Collection Table 1 documents the computation of individual burdens for the recordkeeping and reporting requirements applicable to the industry for the Subpart included in this ICR. The individual burdens are expressed under standardized headings believed to be consistent with the concept of burden under the Paperwork Reduction Act. Where appropriate, specific tasks and major assumptions have been identified. Responses to this information collection are mandatory.

The 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.

6( a) Estimating Respondent Burden The average annual burden to industry over the next three years from these recordkeeping and reporting requirements is estimated to be 591,389 person hours (" Total annual person hours" 11 from Table 1). These hours are based on Agency studies and background documents from the development of the regulation, Agency knowledge and experience with the NSPS program, the previously approved ICR, and any comments received.

6( b) Estimating Respondent Costs ( i) Estimating Labor Costs This ICR uses a Technical Labor Rate of $ 57.12 per hour. This rate is from the United States Department of Labor, Bureau of Labor Statistics, March 2001, " Table 10. Private industry, by occupational and industry group." The rates are from column 1, " Total compensation." The wage rate of $ 27.20 has been increased by 110% to account for the benefit packages available to those employed by private industry for a labor rate of $ 57.12 per hour.

( ii) Estimating Capital/ Startup and Operation and Maintenance Costs The type of industry costs associated with the information collection activity in the regulations are for labor and continuous emission monitoring ( CEM). The capital/ startup costs are one time costs when a facility becomes subject to the regulation. The annual operation and maintenance costs are the ongoing costs to maintain the monitor and other costs such as photocopying and postage.

( iii) Capital/ Startup vs. Operation and Maintenance ( O& M) Costs Capital/ Startup vs. Operation and Maintenance ( O& M) Costs ( A)

Continuous Monitoring Device ( B)

Startup Cost ($) for One Affected Facility ( C)

Number of New Affected Facilities to Startup ( D)

Total Startup ( B X C) ( E)

Annual O& M Costs ($) for One Affected Facility ( F)

Number of Affected Facilities with O& M ( G)

Total O& M ( E X F)

SO2, PM, and NOx $ 200,000 45 $ 9,000,000 $ 15,000 1,185 $ 17,775,000 The total capital/ startup costs for this ICR are $ 9,000,000. This is the total of column D in the above table. These costs are shown in block 14( a), Total annualized capital/ startup costs, on the OMB 83 I form. It should be noted that the numbers in block 14 of the OMB 83 I form are rounded to show the cost in thousands of dollars. 12 The total operation and maintenance ( O& M) costs for this ICR are $ 17,775,000 . This is the total of column G. These costs are shown in block 14( b), Total annual costs ( O& M), on the OMB 83 I form.

The total respondent non labor costs in block 14 have been calculated as the addition of the capital/ startup costs, and the annual operation and maintenance costs. The average annual cost for capital/ startup and operation and maintenance costs to industry over the next three years of the ICR is estimated to be $ 26,775,000. This cost is shown on the OMB 83 I form in block 14 ( c), Total annualized cost requested. The numbers in block 14 of the OMB 83 I form are rounded to show the cost in thousands of dollars.

6( c) Estimating Agency Burden and Cost The only costs to the Agency are those costs associated with analysis of the reported information. Publication and distribution of the information are part of the AFS program. Examination of records to be maintained by the respondents will occur as part of the periodic inspection of sources, which is part of EPA's overall compliance and enforcement program.

The average annual Agency cost during the three years of the ICR is estimated to be $ 22,361,749 [ see Table 2 in Section 6( e)]. This cost is based on the average hourly labor rate at a GS 12, Step 1, times a 1.6 benefits multiplication factor to account for government overhead expenses for a total of $ 38.30 ($ 23.94 x 1.6). These rates are from the Office of Personnel Management ( OPM) " 2002 General Schedule" which excludes locality rates of pay. Details upon which this estimate is based appear in Table 2 Annual EPA Resource Requirement for Industrial Commercial Institutional Steam Generating Units/ NSPS Subpart Db, below.

6( d) Estimating the Respondent Universe and Total Burden and Costs Approximately 1,185 sources are currently subject to the regulation, and it is estimated that an additional 45 sources per year will become subject to the regulation in the next three years.

Respondent Universe and Number of Responses Per Year Regulation Citation ( A)

Average Number of New Respondents per Year ( B)

Number of Reports for New Sources ( C)

Number of Existing Respondents ( D)

Number of Reports for Existing Sources ( E)

Number of Respondents that keep records but do not submit reports ( F)

Total Annual Responses = ( AxB)+( CxD)+ E 40 CFR 60.49b ( w) 36 2 948 2 0 1,968 13 Respondent Universe and Number of Responses Per Year 40 CFR 60.49b ( v) 9 4 237 4 0 984 Total 45 1,185 2,952 The number of total respondents is 1,230. This number is the sum of column A and column C of the Respondent Universe and Number of Responses Per Year table. This represents the number of existing sources plus the number of new sources averaged over the three year period ( i. e., the number of new respondents over the three year period divided by three years). It is shown in block 13 ( a), Number of respondents, on the OMB 83 I form.

The number of Total Annual Responses is 2,952. This is the number in column F of the Respondent Universe and Number of Responses Per Year table. It is shown in block 13 ( b), Total annual responses, on the OMB 83 I form.

The total annual labor costs are $ 32,609,435. This number is not shown on the OMB 83 I form. Details upon which this estimate is based appear in Table 1: Annual Respondent Burden and Cost  NSPS Subpart Db, Standards of Performance for Industrial Commercial Institutional Steam Generating Units.

The total annual capital and O& M costs to the regulated entity are $ 26,775,000. This number is shown on the OMB 83 I form in block 14 ( c), Total annualized cost requested. These costs are detailed in section 6( b)( iii), Capital/ Startup vs. Operating and Maintenance ( O& M) Costs.

6( e) Bottom Line Burden Hours Burden Hours And Cost Tables The bottom line burden hours and cost tables for both the Agency and the respondents are attached below. The annual public reporting and recordkeeping burden for this collection of information is estimated to average 200 hours per response.

6( f) Reasons for Change in Burden The increase in burden from the most recently approved ICR is due to an increase in the size of the regulated universe.

6( g) Burden Statement The annual public reporting and recordkeeping burden for this collection of information is estimated to average 200 hours per response. Burden means the total time, effort, or financial 14 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.

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 Number OECA 2002 0017, which is available for public viewing at the Enforcement and Compliance Docket and Information Center in the EPA Docket Center ( EPA/ DC), EPA West, Room B102, 1301 Constitution Ave., N. W., Washington, D. C. The EPA Docket Center Public Reading Room is open from 8: 30 a. m. to 4: 30 p. m., Monday through Friday, excluding legal holidays. The telephone number for the Reading Room is ( 202) 566 1744, and the telephone number for the Enforcement and Compliance Docket and Information Center is ( 202) 566 1514. 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, N. W., Washington, D. C. 20503, Attention: Desk Office for EPA. Please include the EPA Docket ID Number OECA 2002 0017 and OMB Control Number 2060 0072 in any correspondence.

Part B of the Supporting Statement This part is not applicable because no statistical methods were used in collecting this information. 15 TABLE 1. ANNUAL BURDEN OF RECORDKEEPING AND REPORTING REQUIREMENTS AS A RESULT OF THE STANDARDS FOR INDUSTRIAL COMMERCIAL INSTITUTIONAL STEAM GENERATING UNITS/ NSPS SUBPART DB.

A B C D E F Reporting and recordkeeping requirements Person hours per occurrence Annual occurrences per respondent Annual person hours per respondent ( A x B) Total number of respondents Total annual person hours ( C x D) Total annual cost ( E x $ 57.12)

1. Applicants N/ A 2. Survey and Studies N/ A 3. Reporting Requirements ( b)

A. Read Instructions ( c) 1 1 1 45 45 $ 2,570 B. Required Activities Initial Performance Test:

PM ( c) 330 1 330 19 6,270 $ 358,142 24 hour test for Gas Units ( c) 250 1 250 25 6,250 $ 357,000 Repeat of Performance Test:

PM ( c, d) 330 1 330 9 2,970 $ 169,646 24 hour tests for Gas Units ( c, d) 250 1 250 5 1,250 $ 71,400 Report of Initial Performance Test:

( c) 16 SO2 16 1 16 13 208 $ 11,881 A B C D E F Reporting and recordkeeping requirements Person hours per occurrence Annual occurrences per respondent Annual person hours per respondent ( A x B) Total number of respondents Total annual person hours ( C x D) Total annual cost ( E x $ 57.12)

PM 16 1 16 19 304 $ 17,364 NOx 16 1 16 45 720 $ 41,126 Notification of CEMS Demonstration ( c) SO2 2 1 2 13 26 $ 1,485 PM 2 1 2 19 38 $ 2,171 NOx 2 1 2 45 90 $ 5,141 Demonstration of CEMS ( c)

SO2 150 1 150 13 1,950 $ 111,384 PM 100 1 100 19 1,900 $ 108,528 NOx 350 1 350 45 15,750 $ 899,640 Repeat Demonstration of CEMS ( c, d)

SO2 150 1 150 3 450 $ 25,704 17 PM 100 1 100 4 400 $ 22,848 NOx 350 1 350 9 3,150 $ 179,928 A B C D E F Reporting and recordkeeping requirements Person hours per occurrence Annual occurrences per respondent Annual person hours per respondent ( A x B) Total number of respondents Total annual person hours ( C x D) Total annual cost ( E x $ 57.12)

Report of CEMS Demonstration ( c) See 3B Reports for SO2 ( h)

Quarterly( j) 16 4 64 130 8,320 $ 475,238 Semiannual 16 2 32 520 16,640 $ 950,477 Reports for PM ( h, i)

Quarterly:( j)

Excess 16 4 64 25 1,600 $ 91,392 No Excess 8 4 32 102 3,264 $ 186,440 Semiannual:

Excess 16 2 32 127 4,064 $ 232,136 No Excess 8 2 16 368 5,888 $ 336,323 Reports for NOx 18 Quarterly:( j)

CEMS Compliance 16 4 64 135 832 $ 47,524 A B C D E F Reporting and recordkeeping requirements Person hours per occurrence Annual occurrences per respondent Annual person hours per respondent ( A x B) Total number of respondents Total annual person hours ( C x D) Total annual cost ( E x $ 57.12)

Excess 16 4 64 27 1,728 $ 98,703 No Excess 8 4 32 108 3,456 $ 197,407 Semiannual:

CEMS Compliance 16 2 32 541 17,312 $ 988,861 Excess 16 2 32 108 3,456 $ 197,407 No Excess 8 2 16 433 6,928 $ 395,589 Appendix F Report ( h)

Quarterly:( j)

SO2 11 4 44 102 4,488 $ 256,265 NOx 11 4 44 135 5,940 $ 339,293 Semiannual:

SO2 11 2 22 406 8,932 $ 510,196 19 NOx 11 2 22 541 11,902 $ 679,842 Annual Compliance Tests for NOx ( h) 250 1 250 239 59,750 $ 3,412,920 A B C D E F Reporting and recordkeeping requirements Person hours per occurrence Annual occurrences per respondent Annual person hours per respondent ( A x B) Total number of respondents Total annual person hours ( C x D) Total annual cost ( E x $ 57.12)

Appendix F Annual Accuracy Test:

( e, h)

SO2 36 1 36 676 24,336 $ 1,390,072 NOx 36 1 36 508 18,288 $ 1,044,611 Appendix F Audits ( e, f, h)

Quarterly SO2  In Situ 125 4 500 34 17,000 $ 850,000 SO2  Extractive 36 4 144 101 14,544 $ 727,200 Semiannual SO2  In Situ 125 2 250 135 33,750 $ 1,687,500 SO2  Extractive 36 2 72 406 29,234 $ 1,461,700 Quarterly 20 NOx  In Situ 125 4 500 25 12,500 $ 625,000 NOx  Extractive 36 4 144 74 10,656 $ 532,800 Semiannual A B C D E F Reporting and recordkeeping requirements Person hours per occurrence Annual occurrences per respondent Annual person hours per respondent ( A x B) Total number of respondents Total annual person hours ( C x D) Total annual cost ( E x $ 57.12)

NOx  In Situ 125 2 250 99 24,750 $ 1,237,500 NOx  Extractive 36 2 72 295 21,240 $ 1,062,000 C. Create Information ( c) Included in 3B D. Gather Existing Information Included in 3B E. Write Report Notify of Construction/ Reconstruction ( c) 2 1 2 45 90 $ 5,141 Notify of Anticipated Startup ( c) 2 1 2 45 90 $ 5,141 Notify of Actual Startup ( c) 2 1 2 45 90 $ 5,141 Monitoring Plan ( c) 4 1 4 22 88 $ 5,027 21 Notification of Initial Performance Test ( c)

SO2 2 1 2 13 26 $ 1,485 PM 2 1 2 19 38 $ 2,171 NOx 2 1 2 45 90 $ 5,141 A B C D E F Reporting and recordkeeping requirements Person hours per occurrence Annual occurrences per respondent Annual person hours per respondent ( A x B) Total number of respondents Total annual person hours ( C x D) Total annual cost ( E x $ 57.12)

4. RECORDKEEPING REQUIREMENTS ( g)

Read Instructions See 3A Plan Activities N/ A Implement Activites N/ A Develop Record System N/ A Time to Enter Information Records of Startup, Shutdown,

Malfunction 1.5 52 78 1,143 89,154 $ 5,092,476 Records of All Measurements 1.5 52 78 1,143 89,154 $ 5,092,476 22 TOTAL ANNUAL BURDEN 591,389 $ 32,609,435 Footnotes:

a) Assume an hourly wage of $ 57.12. This amount was multiplied by the hours per year in column E.

b) EPA estimates that there will be 25 new gas fired steam generating units per year ( which require NOx controls), 13 new coal fired generating units per year ( which require SO2, NOx, and PM controls), and 6 new biomass/ wood ( which require NOx and PM controls).

c) One time only costs associated with the anticipated 45 new sources per year over the next three years.

d) Assume 20 percent of initial performance tests and CEMS demonstrations are repeated due to failures.

e) Appendix F costs are based on contractor costs of $ 50.00 per hour.

f) Assume that 25 percent of units have in situ CEMS and 75% have extractive CEMS.

g) Respondents per year amounts ( column D) in the RECORDKEEPING REQUIREMENTS section are based on the average number of plants in existence over the next three years.

h) The number of controls for SO2, PM and NOx for existing sources is based on the number of existing sources from the last ICR and the ratios established by computer modeling in the first ICR issued after Subpart Db was revised. The average number of new sources for each control ( X* 3/ 2) for SO2, Pm and NOx have been added to the number of existing sources to obtain the figures for " Total number of respondents."

i) Assume the 20 percent of units are found to be in excess of emission standard, 80 percent are found to be in no excess.

j) Assume that 20 percent of respondents will choose to report quarterly. 23 TABLE 2. ANNUAL EPA RESOURCE REQUIREMENT FOR INDUSTRIAL COMMERCIAL INSTITUTIONAL STEAM GENERATING UNITS/ NSPS SUBPART Db. ( A) ( B) ( C) ( D) ( E) ( F)

Activity EPA hours per occurrence Occurrencs per plant per year EPA hours per plant per year ( A x B) Plants per year EPA hours per year ( C x D) Total annual cost ( E x $ 38.30)

Initial Performance Tests For New Plants ( d) 240 1 240 45 10,800 $ 413,640 Observe Retesting ( e) 240 1 240 9 2,160 $ 82,728 Report Review For Construction,

Anticipated Startup, Actual Startup ( f) 116 1 116 45 5,220 $ 199,926 Review Notification of Initial Test:

SO2 ( g) 70 1 70 13 910 $ 34,853 PM ( g) 72 1 72 19 1,368 $ 52,394 NOx ( g) 104 1 104 45 4,680 $ 179,244 Review Initial Test Results:

SO2 ( g) 280 1 280 13 3,640 $ 139,412 PM ( g) 288 1 288 19 5,472 $ 209,578 NOx ( g) 416 1 416 45 18,720 $ 716,976 24 Review Notification of CMS Demonstration: ( A) ( B) ( C) ( D) ( E) ( F)

Activity EPA hours per occurrence Occurrencs per plant per year EPA hours per plant per year ( A x B) Plants per year EPA hours per year ( C x D) Total annual cost ( E x $ 38.30)

SO2 ( g) 56 1 56 13 728 $ 27,882 PM ( g) 82 1 82 19 1,558 $ 59,671 NOx ( g) 42 1 42 45 1,890 $ 72,387 Review CMS Performance Demonstration:

SO2 ( g) 448 1 448 13 5,824 $ 223,059 PM ( g) 656 1 656 19 12,464 $ 477,371 NOx ( g) 336 1 336 45 15,120 $ 579,096 Review Monitoring Plan 108 1 108 373 40,280 $ 1,542,712 Review NOx Compliance Reports ( i) Quarterly 42 4 168 89 14,952 $ 572,662 Semiannual 42 2 84 355 29,820 $ 1,142,106 25 Review SO2 Compliance Reports ( i) Quarterly 70 4 280 130 36,400 $ 1,394,120 ( A) ( B) ( C) ( D) ( E) ( F)

Activity EPA hours per occurrence Occurrencs per plant per year EPA hours per plant per year ( A x B) Plants per year EPA hours per year ( C x D) Total annual cost ( E x $ 38.30)

Semiannual 70 2 140 520 Review Excess Emissions Reports:

SO2: ( i) Quarterly 130 4 520 159 82,680 $ 3,166,644 Semiannual 130 2 260 637 165,620 $ 6,343,246 NOx: ( i) Quarterly 92 4 368 89 32,752 $ 1,254,402 Semiannual 92 2 184 355 65,320 $ 2,501,756 Review Appendix F QA Data Assessment Reports:

SO2 ( i) 42 1 42 524 22,008 $ 842,906 NOx ( i) 56 1 56 444 24,864 $ 952,291 26 SUBTOTAL 605,250 $ 23,181,062 Travel Expenses ( c) $ 7,125 TOTAL ANNUAL COST $ 23,188,187 Footnotes:

a) A x B = C b) C x D = E c) Burden cost is calculated at a rate of $ 38.30 ($ 23.94 x 1.6 to account for government benefits and overhead expenses).

d) All new plants subject to the standard must conduct initial performance tests as required by Sections 60.42b, 60.43b, 60.44b.

e) Assume 20% of initial performance tests must be repeated due to failure.

f) All new plants subject to the standard must provide reports of these events as required by Section 60.7.

g) EPA estimates that there will be 25 new gas fired steam generating units per year ( which require NOx controls), 13 new coal fired generating units per year ( which require SO2, NOx, and PM controls), and 6 new biomass/ wood ( which require NOx and PM controls).

h) Owners of plants rated at 250 MMBTU/ hr and utilizing an annual capacity factor who seek to predict and monitor NOx emission rates submit this plan. It is estimated that 84% of NOx producing facilities meet this criteria ( 84% of the 444 sources with NOx controls over the next three years).

I) Semiannual reports are required of most facilities subject to the regulation. Assume approximately 20% of plants report electronically. The number of plants per year in these catagories were established during promulgation of the regulation and adjusted accordingly for this update.

j) Travel expenses ( 1 person x 15/ plants/ yr x 3 days/ plant x $ 75 per diem) + ($ 250 round trip/ plant x 15 plants/ yr)