Memo

To:	Docket EPA-HQ-OAR-2009-0472

From:	Michael Olechiw, U.S. EPA-OTAQ-ASD

Date:	25 March 2010

Re:	“Binning” of FEV Costs to GDI, Turbo-charging, and Engine
Downsizing

1.0	Introduction

*** This document is meant to be referenced in conjunction with a
spreadsheet by the same name.***

As a general matter, the best way to derive technology cost estimates is
to conduct real-world tear down studies.  These studies break down each
technology into its respective components, evaluate the costs of each
component, and build up the costs of the entire technology based on the
contribution of each component.  As such, tear down studies require a
significant amount of time and are very costly.  EPA has been conducting
tear down studies to assess the costs of vehicle technologies under a
contract with FEV.  The values presented in this memo are direct
manufacturing costs developed by FEV for the EPA through the case
studies noted below.  These costs could be termed “intermediate
values” in that they are used to develop overall costs for conditions
where tear downs were not performed.  While the costs presented here
were used to develop those presented in the final rule, they are not the
final rule costs.  For the final rule costs, refer to Chapter 3 of the
joint Technical Support Document (TSD).

To date, the following three engine technologies have been evaluated:

1.	Stoichiometric gasoline direct injection (SGDI) and turbo charging
with engine downsizing for a 	large Dual Overhead Cam DOHC 4 cylinder
engine to a small DOHC 4 cylinder engine.

2.	SGDI and turbo charging with engine downsizing for a Single Overhead
Cam (SOHC) 3 	valve/cylinder V8 engine to a DOHC V6 engine.

3.	SGDI and turbo charging with engine downsizing for a DOHC V6 engine
to a DOHC 4 cylinder 	engine.

Using the costing methodology described in report (EPA-F-09-020) , FEV
has developed costs for each of the above technologies.  These studies
consist of complete system tear-downs to evaluate technologies down to
the nuts and bolts to arrive at very detailed estimates of the
associated manufacturing costs.  In addition to the above case studies,
FEV and EPA extrapolated the engine downsizing costs for the following
scenarios that were outside of the noted study cases.

A.	Downsizing a SOHC 2 valve/cylinder V8 engine to a DOHC V6.

B.	Downsizing a DOHC V8 to a DOHC V6.

C.	Downsizing a SOHC V6 engine to a DOHC 4 cylinder engine.

D.	Downsizing a DOHC 4 cylinder engine to a DOHC 3 cylinder engine

E.	V8 SGDI incremental to V6 SGDI

This memo to the docket describes how the costs developed by FEV were
parsed or “binned” into the individual technologies; GDI,
turbo-charging, and downsizing and then extrapolated to determine the
costs associated with the 5 conditions identified above.

2.0	Cost calculation summary

The FEV tear-down studies developed an incremental cost associated with
each one of their case studies for each of the major subsystems.  The
case studies are numbers 1, 2, and 3 identified above, and the
subsystems considered were:

a.	Crank Drives

b.	Counter balance systems

c.	Cylinder block

d.	Cylinder heads

e.	Valvetrain subsystem

f.	Timing drive system

g.	Accessory drive subsystem

h.	Intake subsystem

i.	Fuel subsystem

j.	Exhaust subsystem

k.	Lubrication subsystem

l.	Cooling subsystem

m.	Induction air charging subsystem

n.	Exhaust gas re-circulation subsystem

o.	Breather subsystem

p.	Electrical subsystem

q.	Accessories subsystem (Starter, Generators, Power Steering, etc.)

These subsystem costs were then assigned to the three major technologies
under consideration: SGDI, Turbo Charging, and Engine Downsizing.  In
some cases a portion of the overall cost result was distributed over
several technologies (i.e. Cylinder head costs were distributed between
GDI and downsizing).  The sum of the costs associated with these three
major technologies adds up to the results of the FEV tear-down studies.

2.1 	Universally applied cost results

NHTSA and EPA agreed that some of the results from the FEV studies would
be considered universal.  In other words, the cost of turbo charging an
I4 engine, as determined from the FEV study of downsizing a 2.4L MPFI
engine to a 1.6L Turbo charged engine, would be applied to all I4
engines that were turbocharged.  The following results from the cost
assignment were universally applied:

1.	Stoichiometric gasoline direct injection (SGDI) and turbo charging
with engine downsizing for a large Dual Overhead Cam DOHC 4 cylinder
engine to a small DOHC 4 cylinder engine.

Turbo charging an I4 Engine

Conversion of an I4 MPFI to I4 SGDI

2.	SGDI and turbo charging with engine downsizing for a Single Overhead
Cam (SOHC) 3 valve/cylinder V8 engine to a DOHC V6 engine.

Turbo charging a V6 Engine

Converting a V6 MPFI to V6 SGDI

3.	V8 SGDI

2.2	Scaled costs

With each one of the case study costs broken into its constituent
technology, and each technology broken into the subsystems above, FEV,
EPA, and NHTSA could then consider how each subsystem would scale from a
set of technologies that were part of an actual tear-down, to
technologies that were not part of an actual tear down.  For example,
given the cost results for a 3V SOHC V8 to V6 DOHC tear-down, we could
estimate the incremental cost to create a DOHC V8 from a SOHC V8.  Prior
to describing the details of how this was done for each subsystem and
each engine it is important to note that FEV and the agencies did not
consider Overhead Valve (OHV) configurations, as there were no OHV case
studies.  The actual tear-downs conducted simply were not considered by
the agencies to be relevant for scaling to OHV configurations.
Secondly, note that the costs were scaled as closely as possible to a
similar technology and case study.  For example, the creation of an I3
downsizing cost was estimated from the I4 engine downsize to a smaller
I4 rather than the V8 to V6 case.  Under some conditions the scaling was
informed across tear down analyses, this was required to determine the
most accurate estimate possible.

Table 1 summarizes the results of binning the costs:

Engine	Incremental to	FEV Results	SGDI	Turbo- Charging	Downsizing

3.5L V6 DOHC Turbo SGDI	5.4L V8 MPFI 3-valve SOHC	$846	$321	$681	($155)

I4 DOHC	3.0L V6 MPFI V6 DOHC	$69	$213	$404	($547)

1.6L I4 DOHC Turbo SGDI	2.4L I4 MPFI DOHC	$532	$213	$404	($85)

Table   SEQ Table \* ARABIC  1 :  Summary of binning analysis from FEV
results

Table 2 below shows the final results for non-tear down conditions.
Recognize that the SGDI and Turbo-charging costs are carried down from
the actual FEV results above.

Engine	Incremental to	FEV Results	SGDI	Turbo- Charging	Downsizing

V6 DOHC	V8 SOHC (2-valve)	n/a	$321	$681	($83)

V6 DOHC	V8 DOHC	n/a	$321	$681	($274)

I4 DOHC	V6 SOHC	n/a	$213	$404	($382)

I3 DOHC	I4 DOHC	n/a	$213	$404	($193)

V8 2V SOHC	V8 3V SOHC	n/a	n/a	n/a	($72)

V8 DOHC	V8 3V SOHC	n/a	n/a	n/a	$119

V8 SGDI	V8 MPFI	n/a	$386	n/a	n/a

Table   SEQ Table \* ARABIC  2 :  Calculated FEV results for non-tear
down conditions.

Because the costs were calculated in increments, Table 3 shows the steps
taken to arrive at extrapolated costs.

Change	Step #1	Step #2	Final result

V8 SOHC 2-valve to V6 DOHC	Downsizing a V8 SOHC 3-valve to V6 DOHC is a
$155 cost savings	V8 SOHC 2-valve is $72 less costly than a 3-valve
configuration	($155) – ($72) = ($83)

V8 DOHC to V6 DOHC	A V8 DOHC is $119 more costly than the 3-valve
configuration	V6 DOHC is $155 less costly than a V8 SOHC 3-valve
configuration	($119) – $155 = ($274)

V6 SOHC to I4 DOHC	V6 DOHC is $165 more costly than a V6 SOHC	V6 DOHC is
$547 more costly than an I4 DOHC	($547) – ($165) = ($382)

Table   SEQ Table \* ARABIC  3 :  Cost calculations from tear-downs to
FRM results

3.0	Cost calculation details

Note:  The reader should be able to follow the logical progression of
these descriptions by referencing the related spreadsheet

3.1	I3 DOHC downsized from an I4 DOHC =  ($193)

Downsizing an I4 DOHC to an I3 DOHC engine is relevant to small and
compact cars.  The cost estimates associated with this change are fairly
straightforward.  Most of the scaling is simply a ratio of the number of
cylinders.

3.1.1		Crank drive

The crank shaft was scaled by the number of cylinders and the cost of
one piston, and one connecting rod as determined from the 2.0L study,
were subtracted.  The one wrist pin cost of $1.14 was missed.

3.1.2		Counter balance systems

No changes due to downsizing.

3.1.3		Cylinder block

The cylinder block cost was scaled down 25% due to the reduced number of
cylinders from the 2.0L study.

3.1.4		Cylinder heads

The cylinder head cost was scaled down 25% due to the reduced number of
cylinders from the 2.0L study.

3.1.5		Valvetrain subsystem

The valvetrain system cost was scaled down 25% due to the reduced number
of cylinders from the 2.0L study.

3.1.6		Timing drive system

No changes due to downsizing.

3.1.7		Accessory drive subsystem

No changes due to downsizing.

3.1.8		Intake subsystem

No changes due to downsizing.

3.1.9		Fuel subsystem

System cost reduced by one fuel injector.  Fuel rail scaled down by 25%
due to the reduced number of cylinders.

3.1.10	Exhaust subsystem

Exhaust manifold cost reduced by 25%.  Remainder of the exhaust was
determined to remain the same under the premise of constant power and
flow.

3.1.11	Lubrication subsystem

Oil pan scaled down by 25% due to the reduced number of cylinders.

3.1.12	Cooling subsystem

No changes due to downsizing.

3.1.13	Induction air charging subsystem

No changes due to downsizing.

3.1.14	Exhaust gas re-circulation subsystem

No changes due to downsizing.

3.1.15	Breather subsystem

No changes due to downsizing.

3.1.16	Electrical subsystem

The cost was reduced by one less spark plug, one less coil-on-plug, and
the associated wiring.

3.1.17	Accessories subsystem (Starter, Generators, Power Steering, etc.)

No changes due to downsizing.

3.2	I4 DOHC to an I4 SOHC = ($80)

The calculation for changing to a I4 DOHC valvetrain configuration from
a I4 SOHC configuration is required for 2 reasons.  The first is to
account for the cost in the baseline fleet, and the second is that the
mechanical change improves pumping losses.

3.2.1	Crank drive

No changes due to downsizing.

3.2.2		Counter balance systems

No changes due to downsizing.

3.2.3		Cylinder block

No changes due to downsizing.

3.2.4		Cylinder heads

The cylinder head costs were calculated  by taking the 2.0L I4 Turbo GDI
head machining costs minus the machining costs for Turbo GDI features
(based on 3.5L V6 Turbo/GDI to 3.0L V6 naturally aspirated MPFI) x 65%
(estimate of machining associated with valvetrain) x 50%  (reduction in
valvetrain).  All the costs were from FEV cost analyses.

3.2.5		Valvetrain subsystem

Costs for the intake camshaft, the exhaust cam phaser, and cam phaser
solenoid were taken directly from the 2.0L I4 study.  In addition there
was a $7.38 credit for a reduction in valvetrain components, replacement
of direct acting mechanical buckets (DAMB) valvetrain components with
roller finger followers (RFF) valvetrain and an OEM engine labor
assembly difference for RFF versus DAMB.

3.2.6		Timing drive system

No changes due to downsizing.

3.2.7		Accessory drive subsystem

No changes due to downsizing.

3.2.8		Intake subsystem

No changes due to downsizing.

3.2.9		Fuel subsystem

No changes due to downsizing.

3.2.10	Exhaust subsystem

No changes due to downsizing.

3.2.12	Lubrication subsystem

No changes due to downsizing.

3.2.12	Cooling subsystem

No changes due to downsizing.

3.2.13	Induction air charging subsystem

No changes due to downsizing.

3.2.14	Exhaust gas re-circulation subsystem

No changes due to downsizing.

3.2.15	Breather subsystem

No changes due to downsizing.

3.2.16	Electrical subsystem

A penalty for the cam sensor wiring, ~$1.00,  should have been
calculated but was missed.

3.2.17	Accessories subsystem (Starter, Generators, Power Steering, etc.)

No changes due to downsizing.

3.3	V6 DOHC to a V6 SOHC = ($165)

The calculation for changing to a V6 DOHC valvetrain configuration from
a V6 SOHC configuration is required for 2 reasons.  The first is to
account for the cost in the baseline fleet, and the second is that the
mechanical change improves pumping losses.

3.3.1		Crank drive

No changes due to downsizing.

3.3.2		Counter balance systems

No changes due to downsizing.

3.3.3		Cylinder block

No changes due to downsizing.

3.3.4		Cylinder heads

The cylinder head costs were calculated by taking the machining cost for
3.0L V6 head, equal to $50.60, then taking 65% of  that to estimate the
machining cost for valvetrain.  Finally a 50% reduction in cost was
applied based on the reduced valve count. This value was multiplied by 2
to account for 2 heads.

3.3.5		Valvetrain subsystem

Costs for the intake camshaft, exhaust cam shaft, the intake cam phaser,
and exhaust cam phaser, and cam phaser solenoids were taken directly
from the 3.0L V6 analysis.  In addition there was a $7.54 credit for a
reduction in valvetrain components, replacement of DAMB valvetrain
components with RFF valvetrain,  the OEM engine labor assembly
difference for RFF versus DAMB.  Component costs were taken from 3.0L V6
base cost analysis.

3.3.6		Timing drive system

Timing Drive subsystem cost for DOHC 3.0L V6 ($70.71) has been reduced
by approximately 25% for SOHC.

3.3.7		Accessory drive subsystem

No changes due to downsizing.

3.3.8		Intake subsystem

No changes due to downsizing.

3.3.9		Fuel subsystem

No changes due to downsizing.

3.3.10	Exhaust subsystem

No changes due to downsizing.

3.3.12	Lubrication subsystem

No changes due to downsizing.

3.3.12	Cooling subsystem

No changes due to downsizing.

3.3.13	Induction air charging subsystem

No changes due to downsizing.

3.3.14	Exhaust gas re-circulation subsystem

No changes due to downsizing.

3.3.15	Breather subsystem

No changes due to downsizing.

3.3.16	Electrical subsystem

No changes due to downsizing.

3.3.17	Accessories subsystem (Starter, Generators, Power Steering, etc.)

No changes due to downsizing.

3.4	V8 SOHC 3-valve to a V8 SOHC 2-valve = ($72)

While the change from a V8 SOHC 2-valve configuration to a V8 SOHC
3-valve configuration is not something that would be anticipated by the
GHG rule, this cost was an important stepping stone to calculate the
cost of a V8 2-valve configuration to a V8 DOHC.

3.4.1		Crank drive

No changes due to downsizing.

3.4.2		Counter balance systems

No changes due to downsizing.

3.4.3		Cylinder block

No changes due to downsizing.

3.4.4		Cylinder heads

The cylinder head costs were calculated by first estimating the
machining cost for 5.4L V8 SOHC to be equal to $53.80.  We then
estimated that 50% of that value could be attributed to machining
valvetrain specific items.  A on third reduction of machining of
valvetrain for 2 valves versus 3 valves was then applied.

3.4.5		Valvetrain subsystem

The valvetrain system costs were calculated by reducing the 5.4L V8
3-valve valvetrain component costs by one third.

3.4.6		Timing drive system

Timing Drive subsystem cost for DOHC 3.0L V6 ($70.71) has been reduced
by approximately 25% for SOHC.

3.4.7		Accessory drive subsystem

No changes due to downsizing.

3.4.8		Intake subsystem

No changes due to downsizing.

3.4.9		Fuel subsystem

No changes due to downsizing.

3.4.10	Exhaust subsystem

No changes due to downsizing.

3.4.12	Lubrication subsystem

No changes due to downsizing.

3.4.12	Cooling subsystem

No changes due to downsizing.

3.4.13	Induction air charging subsystem

No changes due to downsizing.

3.4.14	Exhaust gas re-circulation subsystem

No changes due to downsizing.

3.4.15	Breather subsystem

No changes due to downsizing.

3.4.16	Electrical subsystem

No changes due to downsizing.

3.4.17	Accessories subsystem (Starter, Generators, Power Steering, etc.)

No changes due to downsizing.

3.5	V8 DOHC from a V8 SOHC 3-valve = $119

Once again, this change from a V8 SOHC 3-valve to a V8 DOHC accounts for
initial changes in the baseline fleet.

3.5.1		Crank drive

No changes due to downsizing.

3.5.2		Counter balance systems

No changes due to downsizing.

3.5.3		Cylinder block

No changes due to downsizing.

3.5.4		Cylinder heads

The cylinder head costs were calculated by taking the 3.0L V6 cylinder
head costs and scaling it upward by 4/3 (cylinder ratio), multiplying
the result by 2 for two heads, and subtracting that value from the 5.4L
V8 3-valve head costs.  ($324.54)

3.5.5		Valvetrain subsystem

The valvetrain system costs were calculated by taking the engine
assembly cost of ($61.32) and scaling up by valve count (32/24) to
calculate the incremental cost.

3.5.6		Timing drive system

The timing drive system cost was calculated by increasing the timing
drive subsystem roll-up for the 5.4L V8 ($61.50) by 25%, the increase in
the number of valves.

3.5.7		Accessory drive subsystem

No changes due to downsizing.

3.5.8		Intake subsystem

No changes due to downsizing.

3.5.9		Fuel subsystem

No changes due to downsizing.

3.5.10	Exhaust subsystem

No changes due to downsizing.

3.5.12	Lubrication subsystem

No changes due to downsizing.

3.5.12	Cooling subsystem

No changes due to downsizing.

3.5.13	Induction air charging subsystem

No changes due to downsizing.

3.5.14	Exhaust gas re-circulation subsystem

No changes due to downsizing.

3.5.15	Breather subsystem

No changes due to downsizing.

3.5.16	Electrical subsystem

No changes due to downsizing.

3.5.17	Accessories subsystem (Starter, Generators, Power Steering, etc.)

No changes due to downsizing.

3.6	V8 GDI incremental to a V6 = $65

This cost calculation provides the basis for all V8 GDI calculations.
It is an incremental cost to the V6 condition studied by FEV.

3.6.1		Crank drive

The incremental cost to the V6 crank drive system consisted of 2 piston
upgrades at a cost of $2 per piston.

3.6.2		Counter balance systems

No changes due to GDI.

3.6.3		Cylinder block

The incremental cost to the V6 cylinder block is the addition of 2
piston squirters at a cost of $2.09 per squirter.

3.6.4		Cylinder heads

The cylinder head costs were calculated by scaling the cylinder head
incremental costs for a 3.5L V6 Turbo GDI by the cylinder count and
adding the engine upgrades also scaled from the 3.5L by cylinder count.

3.6.5		Valvetrain subsystem

The valvetrain system costs were calculated by adding the extra cost to
upgrade the intake and exhaust valves for two additional cylinder banks.

3.6.6		Timing drive system

The timing drive system cost was calculated by increasing the timing
drive subsystem roll-up for the 5.4L V8 ($61.50) by 25%, the increase in
the number of valves.

3.6.7		Accessory drive subsystem

No changes due to GDI.

3.6.8		Intake subsystem

No changes due to GDI.

3.6.9		Fuel subsystem

The fuel subsystem costs were calculated by scaling the 3.5L V6 GDI fuel
substem costs of $142.00 by 25%.

3.6.10	Exhaust subsystem

No changes due to downsizing.

3.6.12	Lubrication subsystem

No changes due to downsizing.

3.6.12	Cooling subsystem

No changes due to downsizing.

3.6.13	Induction air charging subsystem

No changes due to downsizing.

3.6.14	Exhaust gas re-circulation subsystem

No changes due to downsizing.

3.6.15	Breather subsystem

No changes due to downsizing.

3.6.16	Electrical subsystem

Two additional spark plugs required, two additional coil on plugs (COP),
and PCM upgrades to support GDI.

3.6.17	Accessories subsystem (Starter, Generators, Power Steering, etc.)

No changes due to downsizing.

3.0 	Contact Information

Questions regarding this analysis and results may be directed to:

Michael Olechiw

EPA – OAR – OTAQ – ASD

2000 Traverwood Drive

Ann Arbor, MI 48165

(734)-214-4297

<EMAIL_ADDRESS>
 U.S. Environmental Protection Agency, “Light-Duty Technology Cost
Analysis,” EPA-F-09-020, Contract No. EP-C-07-069, Work Assignment
2-3, December 25, 2009.  (Docket #:   EPA-HQ-OAR-2009-0472-11551)

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FOR FURTHER INFORMATION CONTACT:
    With regard to the guidance documents: Carol D'Lima, Office of
Nutrition and Food Labeling (HFS-800), Center for Food Safety and
Applied Nutrition, Food and Drug Administration, 5001 Campus Dr.,
College Park, MD 20740,<PHONE_NUMBER>; or Denise See, Office of
Regulations and Policy (HFS-024), Center for Food Safety and Applied
Nutrition, Food and Drug Administration, 5001 Campus Dr., College Park,
MD 20740,<PHONE_NUMBER>.
    With regard to the proposed collection of information: Domini Bean,
Office of Operations, Food and Drug Administration, Three White Flint
North, 10A-12M, 11601 Landsdown St., North Bethesda, MD 20852, 301-796-
5733, [email protected].

SUPPLEMENTARY INFORMATION:

I. Background

    FALCPA (Pub. L. 108-282) was enacted in August 2004 and, in part,
amended the Federal Food, Drug, and Cosmetic Act (the FD&C Act) by
defining the term ``major food allergen'' and requiring that the
presence of any major food allergen be declared on the labels of FDA-
regulated foods. FALCPA defined a major food allergen as milk, egg,
fish (e.g., bass, flounder, or cod), crustacean shellfish (e.g., crab,
lobster,

or shrimp), tree nuts (e.g., almonds, pecans, or walnuts), wheat,
peanuts, and soybeans and as a food ingredient that contains protein
derived from these foods (section 201(qq) (21 U.S.C. 321(qq)) of the
FD&C Act). In addition, the FASTER Act (Pub. L. 117-11) was enacted in
April 2021 and, in part, amended the definition of major food allergen
in the FD&C Act to include sesame, effective January 1, 2023.
Exceptions to the definition include highly refined oil derived from a
major food allergen and any ingredient derived from the highly refined
oil. FALCPA also amended the FD&C Act to include provisions to request
an exemption from the food allergen labeling requirements through a
petition process when a food ingredient is demonstrated to not cause an
allergic response that poses a risk to human health or through a
notification process when processing of a food ingredient results in
the removal of the allergenic protein (section 403(w)(6) and (7) of the
FD&C Act (21 U.S.C. 343(w)(6) and (7))).
    Since the passage of FALCPA, FDA has received numerous questions
about food allergen labeling requirements. To explain FALCPA's
requirements as well as FDA's current thinking on issues relating to
the regulation of food allergens, on October 5, 2005, FDA issued the
first edition of a guidance entitled ``Guidance for Industry: Questions
and Answers Regarding Food Allergens, including the Food Allergen
Labeling and Consumer Protection Act of 2004.'' We subsequently updated
the guidance in December 2005 (Edition 2), April 2006 (Edition 3), and
October 2006 (Edition 4).
    FDA is issuing a draft guidance for industry entitled ``Questions
and Answers Regarding Food Allergens, Including the Food Allergen
Labeling Requirements of the Federal Food, Drug, and Cosmetic Act
(Edition 5).'' The draft guidance is a revision of Edition 4 originally
entitled ``Questions and Answers Regarding Food Allergens, Including
the Food Allergen Labeling and Consumer Protection Act of 2004'' that
contains revised and new questions and answers relating to food
allergens, including questions and answers about FALCPA and the FASTER
Act. Editorial changes, such as renumbering and organizational changes
have also been made in this revision.
    FDA is also issuing a final guidance, ``Questions and Answers
Regarding Food Allergens, Including the Food Allergen Labeling
Requirements of the Federal Food, Drug, and Cosmetic Act (Edition 5),''
that contains the questions and answers from Edition 4 that remain
unchanged, with the exception of editorial changes such as renumbering
and organizational changes, and are therefore being reissued as final
guidance. FDA is issuing the draft guidance document to receive
comments on the new or revised questions and answers, and, as
appropriate, will move the questions and answers to the final guidance
document, after reviewing comments and incorporating any changes to the
questions and answers, when appropriate. Note that some questions and
answers that were in Edition 4 of the final guidance have been
withdrawn and moved to the draft guidance document if FDA determined
that the question and answer should be revised in some respect and
reissued in draft for comment. For ease of reference, a question
retains the same number when it moves from the draft guidance to the
final guidance and we use the term ``RESERVED'' after some question
numbers, where appropriate, to facilitate this process.
    We are issuing these guidance documents consistent with our good
guidance practices regulation (21 CFR 10.115). The guidance documents
do not establish any rights for any person and are not binding on FDA
or the public. You can use an alternate approach if it satisfies the
requirements of the applicable statutes and regulations.
    The draft guidance (``Questions and Answers Regarding Food
Allergens, Including the Food Allergen Labeling Requirements of the
Federal Food, Drug, and Cosmetic Act (Edition 5)'' responds to new
questions about food allergen labeling requirements, including, but not
limited to, the labeling of sesame, milk, eggs, incidental additives,
highly refined oils, dietary supplement products, and certain specific
packing and labeling situations (e.g., individual units within a
multiunit package). For example, we have included draft questions and
answers regarding our historical interpretation of the terms ``milk''
and ``eggs;'' for purposes of the definition of a ``major food
allergen'' under section 201(qq) of the FD&C Act and complying with the
food allergen labeling requirements of the FD&C Act. FDA has
historically interpreted ``milk'' as milk from the domesticated cow and
``eggs'' as eggs from the domesticated chicken.
    Since 2005, when we first issued the guidance document, there have
been changes in our laws as well as in the overall food marketplace.
For example, in 2011, the FDA Food Safety Modernization Act (FSMA)
added new allergen control provisions for major food allergens. We are
also aware that, while the market in the United States for milk and
eggs from species other than domesticated cows and chickens remains
limited, it has increased in recent years. Given that, we are
considering whether we should modify our historical interpretations of
``milk'' and ``eggs'' for purposes of the definition of ``major food
allergen'' under 201(qq) of the FD&C Act and complying with the food
allergen labeling requirements of the FD&C Act as set forth in the
guidance document.
    For example, for ``milk,'' we note that our regulation, at 21 CFR
131.110, defines ``milk'' as the lacteal secretion, practically free
from colostrum, obtained by the complete milking of one or more healthy
cows, and our historical interpretation of ``milk'' in the context of a
major food allergen under the FD&C Act has been consistent with this
definition. However, we are aware that foods from ruminant species such
as goat's milk, sheep's milk and buffalo's milk are sold or used in
human food, and that allergic reactions associated with consumption of
milk from other ruminants have been reported in some individuals. While
consumption of such foods in the United States is limited, in light of
the risk of allergic reactions associated with consumption of milk from
other ruminants, we invite comment on whether we should revise our
interpretation of ``milk'' for this guidance, what a revised
interpretation should be, and the potential implications or impact of a
revised interpretation.
    Similarly, some FDA documents interpret ``eggs'' as coming solely
from chickens, and our historical interpretation in the context of a
major food allergen under the FD&C Act has been to consider eggs as
coming from chickens. However, we are aware that eggs from various bird
species (such as turkey, duck, goose, and guinea) can be purchased and
are used as human food. In addition, we are aware that allergic
reactions associated with eggs from birds other than chickens have been
reported in some individuals. Thus, we invite comment on whether we
should revise our interpretation of ``eggs'' for this guidance, what a
revised interpretation should be, and the potential implications or
impact of a revised interpretation.
    We also have revised several questions and answers to update and
clarify information presented in previous editions, including, among
other things, questions related to the labeling of tree nuts, fish, and
crustacean shellfish. We also invite comments on these draft questions
and answers.

II. Paperwork Reduction Act of 1995

    Under the Paperwork Reduction Act of 1995 (PRA) (44 U.S.C. 3501-
3521), Federal Agencies must obtain approval from the Office of
Management and Budget (OMB) for each collection of information they
conduct or sponsor. ``Collection of information'' is defined in 44
U.S.C. 3502(3) and 5 CFR 1320.3(c) and includes Agency requests or
requirements that members of the public submit reports, keep records,
or provide information to a third party. Section 3506(c)(2)(A) of the
PRA (44 U.S.C. 3506(c)(2)(A)) requires Federal Agencies to provide a
60-day notice in the Federal Register concerning each proposed
collection of information before submitting the collection to OMB for
approval. To comply with this requirement, FDA is publishing notice of
the proposed collection of information set forth in this document.
    With respect to the following collection of information, FDA
invites comments on these topics: (1) whether the proposed collection
of information is necessary for the proper performance of FDA's
functions, including whether the information will have practical
utility; (2) the accuracy of FDA's estimate of the burden of the
proposed collection of information, including the validity of the
methodology and assumptions used; (3) ways to enhance the quality,
utility, and clarity of the information to be collected; and (4) ways
to minimize the burden of the collection of information on respondents,
including through the use of automated collection techniques, when
appropriate, and other forms of information technology.

Questions and Answers Regarding Food Allergens, Including the Food
Allergen Labeling Requirements of the Federal Food, Drug, and Cosmetic
Act (Edition 5): Guidance for Industry

OMB Control Number 0910-0792--Revision

    The draft guidance, when finalized, will explain FDA's current
thinking on the labeling requirements in FALCPA and the FASTER Act. The
draft guidance will assist food manufacturers to comply with new
requirements under the FASTER Act for treating sesame as a major
allergen and declaring sesame on the label of food products, effective
January 1, 2023.
    Description of respondents: The respondents to this collection of
information are manufacturers and packers of packaged foods sold in the
United States.
    We estimate the burden of this collection of information as
follows:

                                               Table 1--Estimated Annual Third-Party Disclosure Burden \1\
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                           Number of
              FD&C act section; activity                  Number of     disclosures per    Total annual   Average burden    Total hours    Total capital
                                                         respondents       respondent       disclosures   per disclosure                       costs
--------------------------------------------------------------------------------------------------------------------------------------------------------
403(w)(1) (FALCPA); Review labels to comply with               77,500                  1          77,500               1          77,500               0
 sesame labeling requirements pursuant to the FASTER
 Act.................................................
403(w)(1) (FALCPA); Redesign labels to comply with                775                  1             775              16          12,400      $1,414,375
 sesame labeling requirements pursuant to the FASTER
 Act.................................................
                                                      --------------------------------------------------------------------------------------------------
    Total............................................  ..............  .................  ..............  ..............          89,900       1,414,375
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\ There are no operating and maintenance costs associated with this collection of information.

    We base these estimates from our experience with our food allergen
labeling program and our labeling cost model. We estimate that there
are approximately 775,000 Universal Product Codes (UPCs) of FDA-
regulated foods. Using FDA's labeling cost model, we estimate the entry
rate of new UPCs to be approximately 8 percent per year. Based on the
approximate entry rate of new UPCs, we estimate the rate of new or
reformulated UPCs to be approximately 10 percent per year, or 77,500
products (775,000 x 10 percent). Thus, we estimate that 77,500 new or
reformulated products are sold annually in the United States. Assuming
an association of one respondent to each of the 77,500 new or
reformulated products, we estimate that 77,500 respondents will each
review the label of one of the 77,500 new or reformulated products, as
reported in table 1, row 1. We have no data on how many label reviews
would identify the need to redesign the label. Therefore, we further
estimate, for the purposes of this analysis, that 1 percent of the
reviewed labels of new or reformulated products, or 775 labels (77,500
x 1 percent) would need to be redesigned to comply with the labeling
requirements of the FASTER Act. Assuming an association of one
respondent to each of the 775 labels, we estimate that 775 respondents
will each redesign one label. Using our labeling cost model, we
estimate that it will take an average of 16 hours to complete the
administration and internal design work for the redesign of a label to
comply with the labeling requirements of the FASTER Act. Consequently,
the burden of redesigning the 775 labels of new or reformulated
products is 12,400 hours, as reported in table 1, row 2. Thus, the
total third-party disclosure burden would be 89,900 hours.

                                 Table 2--Estimated Annual Reporting Burden \1\
----------------------------------------------------------------------------------------------------------------
                                                     Number of                        Average
   FD&C act section; activity        Number of     responses per   Total annual     burden per      Total hours
                                    respondents     respondent       responses       response
----------------------------------------------------------------------------------------------------------------
403(w)(6) (FALCPA); petition for               1               1               1             100             100
 exemption for sesame...........
403(w)(7) (FALCPA); notification               1               1               1              68              68
 for sesame.....................
                                 -------------------------------------------------------------------------------
    Total.......................  ..............  ..............  ..............  ..............             168
----------------------------------------------------------------------------------------------------------------
\1\ There are no operating and maintenance costs associated with this collection of information.

    Based on the number of petitions and notifications under FALCPA
received in recent years, we estimate that we will receive one
additional petition and one additional notification annually for
sesame, over the next 3 years. We base

our estimate of the average burdens per response reported in table 2 on
our experience with the existing FALCPA petition process. We estimate
that a petition would take, on average, 100 hours to develop and
submit.
    The burden of a notification involves collecting documentation that
a food ingredient does not pose an allergen risk. Either we can make a
determination that the ingredient does not cause an allergic response
that poses a risk to human health under a premarket approval or
notification program under section 409 of the FD&C Act (21 U.S.C. 348),
or the respondent would submit scientific evidence demonstrating that
the ingredient when manufactured as described does not contain
allergenic protein. Based on the existing FALCPA notification process,
we estimate that the average time to prepare and submit a notification
for sesame is approximately 68 hours. Thus, the total annual reporting
burden would be 168 hours over the next 3 years.

III. Electronic Access

    Persons with access to the internet may obtain the guidance
documents at https://www.fda.gov/regulatory-information/search-fda-guidance-documents, https://www.fda.gov/FoodGuidances, or https://www.regulations.gov. Use the FDA website listed in the previous
sentence to find the most current version of the guidances.

    Dated: November 23, 2022.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2022-26110 Filed 11-29-22; 8:45 am]
BILLING CODE 4164-01-P


[Federal Register Volume 78, Number 135 (Monday, July 15, 2013)]
[Notices]
[Pages 42102-42103]
[FR Doc No: 2013-16801]

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

DEPARTMENT OF HOMELAND SECURITY

Coast Guard

[Docket No. USCG-2013-0521]

Termination of Radiotelephone Medium Frequency 2182 kHz
Watchkeeping, 2187.5 kHz Digital Selective Calling Channel Guard, and
2670 kHz Broadcasts

ACTION: Notice.

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

SUMMARY: The United States Coast Guard is announcing that it will no
longer maintain a watch on 2182 kHz, will no longer guard the Digital
Selective Calling (DSC) channel 2187.5 kHz, and will no longer transmit
Marine Information Broadcasts on 2670 kHz. The minimal use of these
channels by mariners for distress and safety coupled with antenna site
deterioration, costly upkeep, and extensive maintenance required to
support the medium frequency (MF) system have led to a Coast Guard
decision to terminate the MF services and direct the public mariner to
use more modern safety and distress services which can be more reliably
received by the Coast Guard.

DATES: The termination announced in this notice is effective on August
1, 2013.

FOR FURTHER INFORMATION CONTACT: For questions on this Notice, contact
Larry S. Solomon, Spectrum Management and Telecommunications Policy
Counsel (Commandant CG-652) telephone:<PHONE_NUMBER>; email:
<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION: The frequency 2182 kHz (which is in the
frequency band generally referred to as medium frequency (MF)), was
designated more than 65 years ago at the International
Telecommunications Union Radio Conference (Atlantic City, 1947) as an
international radiotelephone distress frequency. Shore stations that
operated in this MF band, and ships subject to the International
Convention for the Safety of Life at Sea Ch. IV, Reg. 5 (SOLAS) were
required to maintain a watch on this frequency.
    Beginning in 1987, the International Telecommunications Union Radio
Regulations and SOLAS were amended to incorporate this MF
radiotelephone watchkeeping requirement within the Global Maritime
Distress and Safety System (GMDSS), an internationally agreed-upon set
of satellite and terrestrial communications systems used to increase
safety and facilitate the location and rescue of distressed ships,
boats and aircraft. Under GMDSS, ship and shore exclusive watchkeeping
on MF 2182 kHz was no longer a requirement, but instead became only one
of several frequencies available for distress communications.
    No domestic regulations exist requiring the Coast Guard to provide
MF distress safety watchkeeping services, although Federal
Communications Commission regulations in 47 CFR Part 80 mandate certain
carriage requirements in order to communicate in an emergency. SOLAS
requires the Coast Guard to provide, as it deems practical and
necessary, appropriate shore-based facilities for GMDSS services
including those in the 1.6-4 MHz range (SOLAS). The Coast Guard, in
cooperation with other agencies and organizations, provides each of the
other five services listed in SOLAS regulations, including satellite
communications, support for 406 MHz satellite emergency position-
indicating radio beacons (EPIRBs), VHF communications through Rescue
21, high frequency radiocommunications, and NAVTEX \1\ broadcasts of
maritime safety information.
---------------------------------------------------------------------------

    \1\ NAVTEX is a broadcast warning system that delivers
navigational warnings, meteorological warnings and forecasts, and
other marine safety information.
---------------------------------------------------------------------------

    While many countries terminated 2182 kHz watchkeeping from shore
when GMDSS was implemented in 1999, the Coast Guard continued its watch
on this frequency to support smaller vessels not subject to SOLAS that
operate between approximately 20 and 100 miles from shore. Advancements
in satellite, digital, very high frequency (VHF), and high frequency
(HF) radio communication equipment, including satellite service
provider competition, have improved service and reduced costs of this
equipment causing MF radiotelephone to become obsolete.
    In addition, a detailed review of several Coast Guard MF sites
revealed significant antenna ground deterioration and infrastructure
support degradation, leaving the Coast Guard at risk for not being able
to receive or respond to maritime distress calls on 2182 kHz or 2187.5
kHz, and not being able to transmit effectively on 2670 kHz. Early last
year, as a result of physical site surveys, the Coast Guard confirmed
the

significant site deterioration and, therefore, the unreliability of
receiving MF distress transmissions at many locations. The Coast Guard
provided notifications of the situation to mariners using Local Notice
to Mariners and radio broadcasts. The Coast Guard did not receive any
adverse reaction to those notifications.
    The site deterioration, costly upkeep, and extensive maintenance
required to support this legacy MF system, as well as the relatively
minimal use by mariners, has led the Coast Guard to decide to
discontinue support of the MF system. The Coast Guard will discontinue
all watchkeeping and transmissions on MF channels, namely the 2182 kHz
voice channel, the 2187.5 kHz Digital Selective Calling (DSC) channel
and Marine Information Broadcasts (MIBs) on 2670 kHz.
    Mariners have several increasingly low cost and commonly available
alternatives to using MF distress and non-distress channels. Instead of
relying on 2182 kHz voice and 2187.5 kHz DSC, mariners can tune their
existing HF radios to other GMDSS radiotelephone distress voice
frequencies the Coast Guard monitors (i.e., 4125, 6215, 8291, or 12290
kHz voice), use satellite-based communication for EPIRB and voice
communications, or use HF radios equipped with DSC. The information in
the 2670 kHz broadcasts (weather forecasts and warnings, Notice to
Mariners, and urgent marine information broadcasts) will continue to be
available from other broadcast sources (e.g., SafetyNet \2\, NAVTEX,
VHF) and online. The Coast Guard urges mariners to use these other
alternatives to the MF channels for distress calls, DSC calls, and
information broadcasts.
---------------------------------------------------------------------------

    \2\ SafetyNET is a satellite-based broadcast warning system that
delivers high seas navigational warnings, meteorological warnings
and forecasts, ice reports, and other marine safety information.
---------------------------------------------------------------------------

    Mariners should not need to purchase any new equipment to make this
change from 2182 kHz to other GMDSS distress frequencies. Most
radiocommunications equipment carried by vessels is able to operate in
the 2-27.5 MHz range in addition to the VHF radiotelephone also carried
by ships. While some older radios may not tune to other frequencies,
these radios are no longer sold, parts are not available for repairing
them and they are not typically found on vessels. Therefore, the
overwhelming majority of vessels simply need to tune their radios from
2182 kHz to another GMDSS distress frequency (such as 4125, 6215, 8291,
or 12290 kHz). Because VHF frequencies may not be reliable more than 20
nautical miles from shore, any vessel that operates more than 20
nautical miles from the coast should carry radiocommunications
equipment capable of tuning to distress frequencies other than VHF to
ensure the vessel is able to make a distress call when needed.
    All vessel owners and operators are strongly advised to check their
communication equipment regularly to ensure it is properly installed,
operating and tuned to the most reliable distress channels. For more
information visit the Coast Guard's Navigation Center Web site at
www.navcen.uscg.gov.

Authority

    This notice is issued under authority of 14 U.S.C. 93(a)(16) and 5
U.S.C. 552(a).

    Dated: July 9, 2013.
Alfredo Mistichelli,
U.S. Coast Guard, Acting Chief, Office of Information Assurance and
Spectrum Policy, Commandant (CG-65).
[FR Doc. 2013-16801 Filed 7-12-13; 8:45 am]
BILLING CODE 9110-04-P


To: Bill Neuffer/RTP/USEPA/US@EPA From: Larry Fitzwater<EMAIL_ADDRESS>Date: 01/16/2012 04:52PM Cc: "Gershman, Lorraine"<EMAIL_ADDRESS>Subject: RE: Nitric Acid 30-Day Rolling Average Data for NSPS Background (See attached file: West hourly data with 30 day rolling 2011 FINAL BP (2).xlsx)

Bill Forgot to attach the West unit data to my earlier email.  Here it is.

Larry