[Federal Register Volume 78, Number 218 (Tuesday, November 12, 2013)]
[Notices]
[Pages 67421-67424]
[FR Doc No: 2013-26933]

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SECURITIES AND EXCHANGE COMMISSION

[Release No. 34-70805; File No. SR-BOX-2013-51]

Self-Regulatory Organizations; BOX Options Exchange LLC; Notice
of Filing and Immediate Effectiveness of a Proposed Rule Change to
Amend the Fee Schedule on BOX

November 5, 2013.
    Pursuant to Section 19(b)(1) under the Securities Exchange Act of
1934 (the ``Act'')\1\ and Rule 19b-4 thereunder,\2\ notice is hereby
given that on October 31, 2013, BOX Options Exchange LLC (the
``Exchange'') filed with the Securities and Exchange Commission (the
``Commission'') the proposed rule change as described in Items I, II,
and III below, which Items have been prepared by the Exchange. The
Exchange filed the proposed rule change pursuant to Section
19(b)(3)(A)(ii) of the

Act,\3\ and Rule 19b-4(f)(2) thereunder,\4\ which renders the proposal
effective upon filing with the Commission. The Commission is publishing
this notice to solicit comments on the proposed rule change from
interested persons.
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    \1\ 15 U.S.C. 78s(b)(1).
    \2\ 17 CFR 240.19b-4.
    \3\ 15 U.S.C. 78s(b)(3)(A)(ii).
    \4\ 17 CFR 240.19b-4(f)(2).
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I. Self-Regulatory Organization's Statement of the Terms of Substance
of the Proposed Rule Change

    The Exchange is filing with the Securities and Exchange Commission
(``Commission'') a proposed rule change to amend the Fee Schedule for
trading on the BOX Market LLC (``BOX'') options facility. While changes
to the fee schedule pursuant to this proposal will be effective upon
filing, the changes will become operative on November 1, 2013. The text
of the proposed rule change is available from the principal office of
the Exchange, at the Commission's Public Reference Room and also on the
Exchange's Internet Web site at http://boxexchange.com.

II. Self-Regulatory Organization's Statement of the Purpose of, and
Statutory Basis for, the Proposed Rule Change

    In its filing with the Commission, the Exchange included statements
concerning the purpose of and basis for the proposed rule change and
discussed any comments it received on the proposed rule change. The
text of these statements may be examined at the places specified in
Item IV below. The Exchange has prepared summaries, set forth in
Sections A, B, and C below, of the most significant aspects of such
statements.

A. Self-Regulatory Organization's Statement of the Purpose of, and
Statutory Basis for, Proposed Rule Change

1. Purpose
    The Exchange proposes to amend the Fee Schedule for trading on BOX.
In particular, the Exchange proposes to amend certain Exchange Fees for
Professionals and Broker Dealers and adjust the Tiered Auction
Transaction Fees for Initiating Participants based upon monthly average
daily volume (ADV) as set forth in Section I of the Fee Schedule.
Additionally, the Exchange proposes to increase the existing liquidity
fees and credits for certain PIP Transactions within Section II of the
Fee Schedule.
    In Section I., Exchange Fees, the Exchange proposes to increase
Auction Transaction \5\ fees for Professional Customers and Broker
Dealers to $0.37 from $0.35. For Non-Auction Transactions, the Exchange
proposes to increase Professional Customer and Broker Dealer fees to
$0.42 from $0.40. The Exchange notes that the proposed fees for
Professionals are within the range of fees presently assessed in the
industry.\6\
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    \5\ Auction Transactions are those transactions executed through
the Price Improvement Period (``PIP''), Solicitation, and
Facilitation auction mechanisms.
    \6\ For example, on the NASDAQ Options Market (``NOM''), in non-
Penny Pilot securities both Professional Customers and Broker
Dealers are charged $0.45 per contract for adding liquidity and
$0.89 for removing liquidity. In Penny Pilot securities,
Professional Customers are credited $0.25 to $0.48 (depending on
ADV) for adding liquidity and charged $0.48 for removing liquidity;
while Broker Dealers are credited $0.10 for adding liquidity and
charged $0.48 for removing liquidity. See the NOM Fee Schedule,
available at: http://www.nasdaqtrader.com/Micro.aspx?id=OptionsPricing
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    In Section I.A., Auction Transaction Tiered Fee Schedule for
Initiating Participant based upon Monthly Average Daily Volume
(``ADV'') in Auction Transactions, the Exchange proposes to remove the
top two volume tiers and lower the per contract fees within each of the
remaining tiers. The Exchange currently gives volume incentives for
auction transactions to Initiating Participants that, on a daily basis,
trade an average daily volume, as calculated at the end of the month,
of more than 5,000 contracts on BOX. The new per contract fee for
Initiating Participants in Auction Transactions set forth in Section
I.A. of the BOX Fee Schedule will be as follows:

------------------------------------------------------------------------
                                                       Per contract fee
    Initiating participant monthly ADV in auction        (all account
                    transactions                            types)
------------------------------------------------------------------------
>=50,001............................................               $0.03
20,001 to 50,000 contracts..........................                0.12
10,001 to 20,000 contracts..........................                0.20
5,001 to 10,000 contracts...........................                0.25
1 to 5,000 contracts................................                0.30
------------------------------------------------------------------------

    In Section II., Liquidity Fees and Credits, the Exchange proposes
to increase the fees and credits for PIP Transactions in classes with a
minimum price variation of $0.01 (i.e., Penny Pilot classes where the
trade price is less than $3.00 and all series in QQQ, SPY, and IWM).
Currently transactions in the BOX PIP are either assessed a fee for
adding liquidity or provided a credit for removing liquidity regardless
of account type.\7\ PIP Orders (i.e., the agency orders opposite the
Primary Improvement Order \8\) receive the ``removal'' credit and
Improvement Orders \9\ are charged the ``add'' fee. For orders that
remove liquidity from the BOX Book, the Exchange proposes to raise the
Penny Pilot class per contract credit to $0.35 from $0.30. Accordingly,
for orders that add liquidity to the BOX Book, the Exchange also
proposes to raise the Penny Pilot class per contract fee to $0.35 from
$0.30
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    \7\ See Section II of the BOX Fee Schedule.
    \8\ A Primary Improvement Order is the matching contra order
submitted to the PIP on the opposite side of an agency order.
    \9\ An Improvement Order is a response to a PIP auction.
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2. Statutory Basis
    The Exchange believes that the proposal is consistent with the
requirements of Section 6(b) of the Act, in general, and Section
6(b)(4) and 6(b)(5) of the Act,\10\ in particular, in that it provides
for the equitable allocation of reasonable dues, fees, and other
charges among BOX Participants and other persons using its facilities
and does not unfairly discriminate between customers, issuers, brokers
or dealers.
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    \10\ 15 U.S.C. 78f(b)(4) and (5).
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Exchange Fees

    The Exchange believes that raising the per executed contract fee
for Professionals and Broker-Dealers in both Auction Transactions and
non-Auction Transactions is reasonable, equitable and not unfairly
discriminatory. BOX simply aims to recover costs incurred by assessing
Professionals and Broker-Dealers a market competitive fee. Further, the
proposed fees charged to Professionals and Broker-Dealers have been
designed to be comparable to the fees that such accounts would be
charged at competing venues. Finally, the Exchange believes that
charging Professionals and Broker-Dealers the same fee for all
transactions is not unfairly discriminatory as the fees will apply to
all Professionals and Broker-Dealers equally. Professionals and Broker-
Dealers remain free to change the manner in which they access BOX.
    The Exchange believes it is equitable and not unfairly
discriminatory that Public Customers be charged lower fees in both
Auction Transactions and non-Auction Transactions than Professionals
and Broker-Dealers. The securities markets generally, and BOX in
particular, have historically aimed to improve markets for investors
and develop various features within the market structure for customer
benefit. The Exchange also believes it is equitable and not unfairly
discriminatory for BOX Market Makers

to be charged lower Exchange fees than those charged to Professional
Customers and Broker Dealers. Market Makers have obligations that other
Participants do not. In particular, they must maintain active two-sided
markets in the classes in which they are appointed, and must meet
certain minimum quoting requirements.
    Secondly, the Exchange believes its proposed amendments to the
tiered fee structure for Initiating Participants in Auction
Transactions are reasonable, equitable and not unfairly discriminatory.
The reduced fees related to trading activity in BOX Auction
Transactions are available to all BOX Options Participants that
initiate Auction Transactions, and they may choose whether or not to
trade on BOX to take advantage of the discounted fees for doing so. The
Exchange also believes that amending the volume discounts to Options
Participants initiating Auction Transactions is reasonable as
Participants will benefit from the opportunity to aggregate their
trading in the BOX Auction mechanisms to more easily attain a
discounted fee tier.
    The Exchange believes it is appropriate to provide an incentive to
BOX Participants to submit their customer orders to BOX, particularly
into the PIP for potential price improvement. Such a discount will
limit the exposure Initiating Participants have to Section II fees,
where they are charged a fee for adding liquidity should their
principal order execute against the customer order in any BOX Auction
Transaction. The Exchange believes that lowering the fees in this
tiered fee structure will attract more order flow to BOX, providing
greater potential liquidity within the overall BOX market and its
auction mechanisms, to the benefit of all BOX market participants.

Liquidity Fees and Credits

    The Exchange believes that it is equitable and not unfairly
discriminatory to increase the fees and credits for PIP Transactions in
classes with a minimum price variation of $0.01 (i.e., Penny Pilot
classes where the trade price is less than $3.00 and all series in QQQ,
SPY, and IWM). Such fees and credits apply uniformly to all categories
of Participants, across all account types.
    The Exchange believes it is reasonable to raise the liquidity fees
and credits for PIP transactions in these classes. The Exchange notes
that the proposed fees and credits for transactions on BOX offset one
another in any particular transaction. The result is that BOX will
collect a fee from Participants that add liquidity on BOX and credit
another Participant an equal amount for removing liquidity. Stated
otherwise, the collection of these liquidity fees will not directly
result in revenue to BOX, but will simply allow BOX to provide the
credit incentive to Participants to attract order flow. The Exchange
believes it is appropriate to provide incentives to market participants
to use PIP, because doing so may result in potential benefit to
customers through price improvement, and to all market participants
from greater liquidity on BOX.
    As stated above, BOX operates within a highly competitive market in
which market participants can readily direct order flow to any of the
other competing venues if they deem fees at a particular venue to be
excessive. The Exchange believes that these higher PIP transaction fees
and credits are fair and reasonable and must be competitive with fees
and credits in place on other exchanges.

B. Self-Regulatory Organization's Statement on Burden on Competition

    The Exchange does not believe that the proposed rule change will
impose any burden on competition not necessary or appropriate in
furtherance of the purposes of the Act. The Exchange believes the
proposed fee changes are reasonably designed to enhance competition in
BOX transactions, particularly auction transactions.
    The proposed rule change raises the fees charged to Broker Dealers
and Professional Customers in both Auction and non-Auction
transactions, which the Exchange believes does not impose a burden on
competition because all transactions for these Participants are
affected to the same extent. Further, the Exchange fees for Broker
Dealers and Professional Customer will continue to be identical.
    The proposed rule change also modifies the tiered fees charged to
Initiating Participants based on their monthly ADV in Auction
Transactions, and raises the liquidity fees and credits for certain PIP
transactions. BOX notes that its market model and fees are generally
intended to benefit retail customers by providing incentives for
Participants to submit their customer order flow to BOX, and to the PIP
in particular. The Exchange does not believe that the proposed
liquidity fees and credits burden competition by creating such a
disparity between the fees an Initiating Participant pays and the fees
a competitive responder pays that would result in certain participants
being unable to compete with initiators. In fact, the Exchange believes
that these changes will not impair these Participants from adding
liquidity and competing in Auction Transactions and will help promote
competition by providing incentives for market participants to submit
customer order flow to BOX and thus, create a greater opportunity for
retail customers to receive additional price improvement.

C. Self-Regulatory Organization's Statement on Comments on the Proposed
Rule Change Received From Members, Participants or Others

    No written comments were either solicited or received.

III. Date of Effectiveness of the Proposed Rule Change and Timing for
Commission Action

    The foregoing rule change has become effective pursuant to Section
19(b)(3)(A)(ii) of the Exchange Act \11\ and Rule 19b-4(f)(2)
thereunder,\12\ because it establishes or changes a due, or fee.
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    \11\ 15 U.S.C. 78s(b)(3)(A)(ii).
    \12\ 17 CFR 240.19b-4(f)(2).
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    At any time within 60 days of the filing of the proposed rule
change, the Commission summarily may temporarily suspend the rule
change if it appears to the Commission that the action is necessary or
appropriate in the public interest, for the protection of investors, or
would otherwise further the purposes of the Act. If the Commission
takes such action, the Commission shall institute proceedings to
determine whether the proposed rule should be approved or disapproved.

IV. Solicitation of Comments

    Interested persons are invited to submit written data, views and
arguments concerning the foregoing, including whether the proposed rule
change is consistent with the Act. Comments may be submitted by any of
the following methods:

Electronic Comments

     Use the Commission's Internet comment form (http://www.sec.gov/rules/sro.shtml ); or
     Send an email to<EMAIL_ADDRESS>Please include
File Number SR-BOX-2013-51 on the subject line.

Paper Comments

     Send paper comments in triplicate to Elizabeth M. Murphy,
Secretary, Securities and Exchange Commission, 100 F Street NE.,
Washington, DC 20549-1090.
All submissions should refer to File Number SR-BOX-2013-51. This file
number should be included on the

subject line if email is used. To help the Commission process and
review your comments more efficiently, please use only one method. The
Commission will post all comments on the Commission's Internet Web site
(http://www.sec.gov/rules/sro.shtml). Copies of the submission, all
subsequent amendments, all written statements with respect to the
proposed rule change that are filed with the Commission, and all
written communications relating to the proposed rule change between the
Commission and any person, other than those that may be withheld from
the public in accordance with the provisions of 5 U.S.C. 552, will be
available for Web site viewing and printing in the Commission's Public
Reference Room, 100 F Street NE., Washington, DC 20549, on official
business days between the hours of 10:00 a.m. and 3:00 p.m. Copies of
such filing also will be available for inspection and copying at the
principal office of the Exchange. All comments received will be posted
without change; the Commission does not edit personal identifying
information from submissions. You should submit only information that
you wish to make available publicly. All submissions should refer to
File Number SR-BOX-2013-51 and should be submitted on or before
December 3, 2013.

    For the Commission, by the Division of Trading and Markets,
pursuant to delegated authority.\13\
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    \13\ 17 CFR 200.30-3(a)(12).
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Kevin M. O'Neill,
Deputy Secretary.
[FR Doc. 2013-26933 Filed 11-8-13; 8:45 am]
BILLING CODE 8011-01-P


Statement Supporting the Renewal of the Information Collection Request

for the Community Right-to-Know Reporting Requirements of the

Emergency Planning and Community Right-to-Know Act

1.	IDENTIFICATION OF THE INFORMATION COLLECTION

1(a)	Title of the Information Collection Request

Community Right-to-Know Reporting Requirements under sections 311 and
312 of the Emergency Planning and Community Right-to-Know Act
(EPCRA)(Renewal) – EPA No. 1352.12.

1(b)	Short Characterization

This information collection request (ICR) was previously approved as OMB
No. 2050-0072 through July 31, 2011, for, 3,792,432 hours. The owner or
operator of any facility that is required to prepare or have available a
Material Safety Data Sheet (MSDS) for a hazardous chemical under the
Occupational Safety and Health Act of 1970 must submit an MSDS to the
state emergency response commission (SERC), the local emergency planning
committee (LEPC), and the local fire department for each hazardous
chemical stored on-site in a quantity greater than the reporting
threshold.  Alternatively, a list of subject chemicals, grouped by
hazard type, may be submitted.  The reporting threshold is 10,000 pounds
unless the chemical is specifically listed as an extremely hazardous
substance (EHS) under EPCRA section 302, in which case the reporting
threshold becomes 500 pounds or the threshold planning quantity (TPQ),
whichever is less.  The reporting threshold for gasoline (all grades
combined) is 75,000 gallons and for diesel fuel (all grades combined) is
100,000 gallons, when stored entirely underground at retail gas stations
that are in compliance with UST regulations.  Section 311 of EPCRA
allows the public the same access to MSDSs that facilities provide to
their employees.

The submittal of a list of chemicals or MSDSs was a one-time
requirement, to be completed by October 17, 1987.  However, facilities
must submit updates to the list or MSDSs, within three months, when a
hazardous chemical comes on-site above the reporting threshold.  If
significant new information arises concerning a previously submitted
MSDS, a facility must submit a revised MSDS.  Additionally, if the SERC
or LEPC receives a request, the facility must provide an MSDS, even if
the hazardous chemical is stored below the reporting threshold.

Section 312 of EPCRA requires owners and operators of facilities subject
to section 311 to annually report the inventories of those chemicals
reported under section 311.  The Environmental Protection Agency (EPA)
is required to publish two emergency and hazardous chemical inventory
forms, known as “Tier I” and “Tier II,” for use by these
facilities.  The Tier I form provides the minimum amount of information
necessary to comply with the section.  Any facility that is required to
submit an MSDS or list of chemicals under section 311 must submit a Tier
I form annually on March 1, incorporating the chemicals reported under
section 311.  Tier I form is submitted to the SERC, LEPC, and local fire
department.  The Tier II form, which provides chemical-specific
information, should be submitted upon request by the SERC or LEPC.

States were always given the flexibility to implement the EPCRA program
as appropriate for their State to meet the goals of EPCRA, which is to
prepare for and respond to releases of EHSs and to provide the public
with information on potential chemical risks in their communities.  This
flexibility includes adding more chemicals, setting lower reporting
thresholds and creating a reporting form or format that includes more
information than is required by the federal reporting requirements.
Many States have more stringent requirements, such as additional
chemicals and lower reporting thresholds.  Some States developed their
own inventory reporting form, including electronic reporting format and
certification.  Other States use the federal inventory reporting form or
the federal electronic reporting format, Tier2 Submit.

EPCRA authorized EPA to publish regulations and the forms for hazardous
chemical reporting.  On October 15, 1987, EPA published the final rule
and the emergency and hazardous chemical inventory reporting forms (Tier
I and Tier II).   The regulations and forms were revised in July 26,
1990.

EPA published a proposed rule on June 8, 1998 to streamline the
reporting requirements for hazardous chemical reporting and provided
draft guidance on various reporting options that states may implement
under EPCRA section 312.  Parts of the 1998 proposed rule were finalized
in stages, February 11, 1999 and November 3, 2008.  EPA finalized the
guidance on reporting options for States and locals on July 13, 2010.
Other issues that were proposed in 1998 will be finalized in the near
future.

EPA estimates that 390,000 manufacturing and non-manufacturing
facilities are currently subject to reporting and recordkeeping
requirements under EPCRA sections 311 and 312.  The total annual burden
to all facilities is estimated to be 3,772,292 hours at a cost of
$236,884,010.  There are estimated to be 3,552 SERCs and LEPCs.  The
total annual burden associated with state and local activities is
estimated to be 136,840 hours at a cost of $4,300,484.

2.	NEED FOR AND USE OF THE COLLECTION

2(a)	Need/Authority for the Collection

The authority for these requirements is EPCRA sections 311 and 312 (42
U.S.C. §11011 and §11012).

Section 311 requires the owner or operator of any facility that is
required to prepare or have available an MSDS for a hazardous chemical
under OSHA regulations to submit an MSDS for each such chemical, or a
list of chemicals, to the SERC, LEPC, and local fire department.  This
submittal allows local emergency planners/responders and the community
to have the same information regarding the hazards of a chemical at the
facility.

Section 312 requires the same owners or operators of facilities to
annually report the inventories of the chemicals reported under section
311.  Section 312(g) requires EPA to publish emergency and hazardous
chemical inventory forms for use by facilities subject to this section.
In final rules published in the Federal Register on October 15, 1987,
and July 26, 1990, EPA published the two “formats” required under
EPCRA, “Tier I” and “Tier II.”  Tier I is the minimum amount of
information necessary to comply with the section.  Using Tier I,
facilities aggregate reportable chemicals by hazard type and provide the
quantities and locations of the chemicals.  The Tier II Form is
chemical-specific information and only needs to be submitted (in lieu of
the Tier I Form) if specifically requested by the SERC or LEPC.

Currently some states require facilities to submit the federal Tier II
inventory form.  Other states developed their own reporting form or
format.  None of the states accept Tier I inventory form.

2(b)	Practical Utility/Users of the Data

The reports required under sections 311 and 312 are submitted to the
state and local officials which will be then accessible to the public.
The public will have knowledge of the hazards in their community.  State
and local officials also use the information submitted to them for
developing or modifying emergency response plans for their community.

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

3(a)	Non-Duplication

Many states have laws that require information similar to that called
for by sections 311 and 312 of EPCRA.  EPA allows the state program to
suffice for reporting provided that the minimum reporting requirements
are met.  The burden estimate in this ICR also includes burden imposed
on facilities that comply with State requirements.

3(b)	Public Notice

In compliance with the Paperwork Reduction Act (44 U.S.C. 3501 et seq.),
the Agency has notified the public through the Federal Register notice
on the renewal of this ICR on February 14, 2011 (76 FR 8363).  EPA
received one comment from an environmental consultant.  The commenter
stated that facilities should notify the state and local officials if
there are no more hazardous chemicals present on the site or if
ownership changes occur at facilities.

The Tier I and the Tier II inventory forms contain a check box to
indicate if the information reported is same as the previous year.  The
Agency has guidance in a Question and Answer format on the website at
HYPERLINK "http://www.epa.gov/emergenies"  www.epa.gov/emergenies  under
the policy and guidance page that facilities should notify the state and
local officials if there is a change in ownership.  For facilities that
are covered by the emergency planning notification under EPCRA section
302 have to notify the SERC and LEPC within 30 days if any changes occur
the facility relevant to emergency planning (40 CFR 355.20(c)).  Some
states may have more stringent requirement for facilities to notify
state and local agencies if any changes occur.

3(c)	Effects of Less Frequent Collection

The reporting deadlines for sections 311 and 312 are set by statute.
EPA has no authority to allow less frequent collection.

3(d)	General Guidelines

The collection activities specified in this renewal ICR adhere to the
guidelines specified by OMB.

3(e)	Confidentiality

The respondent may claim specific chemical identities as trade secret in
reports submitted under Section 312 and in the list of chemicals and
material safety data sheets submitted under Section 311.  Such
information must be submitted to EPA according to EPCRA sections 322 and
323 (40 CFR Part 350).

All trade secrecy claims submitted to EPA under EPCRA are handled and
stored according to procedures set out in the Manual for Physical
Handling, Security, and Protection of Files containing Trade Secret
Claims Submitted under Sections 303, 311 and 312 of the Emergency
Planning and Community Right-to-Know Act (EPCRA), March 2010.  These
procedures were developed for EPCRA trade secrecy claims with the
knowledge that these documents are sensitive.  Handling and review of
documents containing EPCRA trade secret information is permitted only by
persons who have obtained formal clearance to access the information
based on a work-related need to engage in these activities.  When not
being processed or reviewed by authorized individuals, the claim
submissions containing trade secret information are stored in restricted
access areas.  To ensure that appropriate handling procedures are
activated and the confidentiality of EPCRA trade secret submissions is
maintained, the Agency attaches a cover sheet to the top of each trade
secret document and otherwise marks the document to clearly identify the
document as “confidential”.

3(f)	Sensitive Questions

The information gathering activities under this renewal ICR do not
involve any sensitive questions.

4.	THE RESPONDENTS AND THE INFORMATION REQUESTED

4(a)	Respondents

Sections 311 and 312 are applicable to all facilities that are required
to prepare or have available an MSDS for a hazardous chemical as
required under OSHA and its implementing regulations.

Section 1910.1200 of the OSHA regulations provides exemptions from the
definition of hazardous chemical.

In addition, Section 311(e) of EPCRA excludes the following substances:

•	Any food, food additive, color additive, drug, or cosmetic regulated
by the Food and Drug Administration;

•	Any substance present as a solid in any manufactured item to the
extent exposure to the substance does not occur under normal conditions
of use;

•	Any substance to the extent it is used for personal, family, or
household purposes, or is present in the same form and concentration as
a product packaged for distribution and use by the general public;

•	Any substance to the extent it is used in a research laboratory,
hospital, or other medical facility under the direct supervision of a
technically qualified individual; and

•	Any substance to the extent it is used in routine agricultural
operations or is a fertilizer held for sale by a retailer to the
ultimate customer.

Also, reporting thresholds have been established under sections 311 and
312 (codified in 40 CFR part 370).  A facility must report those
hazardous chemicals that are present at the facility at any time at or
above the following levels:

•	For hazardous chemicals other than EHSs, the reporting threshold is
10,000 pounds.

•	For EHSs, 500 pounds or the threshold planning quantity (TPQ),
whichever is less.

For gasoline, 75,000 gallons (all grades combined) and 100,000 gallons
for diesel fuel (all grades combined), when stored entirely underground
at retail gas stations that are in compliance with UST regulations.

4(b)	Information Requested

4(b)(i)	Data Items

Facilities having chemicals subject to section 311 are required to
submit MSDSs for these chemicals.  These MSDSs are the same as those
required under OSHA regulations.  A facility can also fulfill its
section 311 reporting obligation by submitting a list of chemicals that
are subject to the requirements, grouped by the following hazard types:
fire, sudden release of pressure, reactivity, immediate health hazard,
and acute health hazard.

On or before March 1 of each year, facilities having chemicals that need
reporting must submit a Tier I Form.  However, the statute requires that
the Tier II Form must be submitted upon request by the SERC, LEPC or the
fire department with jurisdiction over the facility.  Currently all
states require facilities to submit federal Tier II inventory form or
the state developed inventory reporting form.

 The Tier I Form includes the following information as required by the
statute:

An estimate in ranges of the maximum amount of hazardous chemicals in
each hazardous category present at the facility at any time during the
previous year;

An estimate in ranges of the average daily amount of hazardous chemicals
on-site in each hazard category present at the facility during the
preceding calendar year; and

The general location of hazardous chemicals in each category.

EPA has added the following information on the Tier I form in the final
rule published on October 15, 1987 (52 FR 38344) and July 26, 1990 (55
FR 30632).

NAICS code and Dun and Bradstreet number of the facility

Emergency contact (added to give SERCs, LEPCs, and local fire
departments a contact at the facility who could clarify information at
any time, particularly in the event of an emergency); and

Number of days on-site (added to produce a more accurate estimate of the
average daily amount, particularly for those chemicals that are on-site
for only a short period of time each year).

The Tier II Form includes the following information as required by
statute:

The chemical name or the common name of the chemical as provided on the
material safety data sheet;

An estimate (in ranges) of the maximum amount of the hazardous chemical
present at the facility at any time during the preceding calendar year;

•	An estimate (in ranges) of the average daily amount of hazardous
chemical present at the facility during the preceding calendar year;

•	A brief description of the manner of storage of the hazardous
chemical; and

•	The location of the hazardous chemical within the facility.

The following data elements were added to the Tier II form in the final
rules published on October 15, 1987 and July 26, 1990.

•	CAS number to identify more accurately each chemical that is
reported;

•	The physical state to help identify the type of hazard a chemical
represents in an emergency;

•	The physical and health hazards associated with the chemical;

•	Primary NAICS code and Dun and Bradstreet number of the facility

•	Two emergency contacts (added to give SERCs, LEPCs, and local fire
departments a contact at the facility who could clarify information at
any time, particularly in the event of an emergency); and

•	Number of days on-site (added to produce a more accurate estimate of
the average daily amount, particularly for those chemicals that are
on-site for only a short period of time each year).

	4(b)(ii)	Respondent Activities

To determine if it is subject to section 311, a facility must look at
inventory records for all of its chemicals that are required to have
MSDSs.  The facility would also have to review the EHS list to determine
if any of its chemicals are subject to a lower reporting threshold.

If the facility determines that it has chemicals that must be reported,
it must determine the address of the SERC, LEPC, and local fire
department.  Copies of the MSDSs for these chemicals may be submitted,
or if preferred, the facility may provide a list of the subject
chemicals grouped by hazard type.  To use the list option, the facility
would have to read the MSDS to determine into which of the five hazard
types the chemical falls and to identify it on the list.

The same chemicals that a facility would need to report under section
311 would need to be reported under section 312.  To complete the Tier
II form, the facility would need to monitor its inventory records for
the chemical (to determine the inventory information), add the
quantities together for chemicals having the same hazards, and determine
the correct code for the total quantity.

A site map may be easier to show locations of hazardous chemicals, or
the facility may choose to provide the general location.

As mentioned in the previous section of this document, all states now
require facilities to submit the federal Tier II inventory form or the
state developed inventory reporting format, including electronic
submission.

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

5(a)	Agency Activities

No information provided under sections 311 and 312 is sent to EPA.  All
of the information is collected and kept at the state and local
agencies.

EPA developed an electronic reporting software, Tier2 Submit, for
facilities to submit their hazardous chemical inventory form.  Some
states use Tier2 Submit and some states have created software using
their own resources and require facilities to submit electronically.
Eight to ten states request EPA to add state specific fields to the
Tier2 Submit.

5(b)	Collection Methodology and Management

EPA does not receive the data; therefore, EPA does not have any special
data collection methodology and management.  .

5(c)	Small Entity Flexibility

The burden hours for small businesses are considered to be smaller than
those for large facilities because of the reduced number of chemicals
present at smaller facilities.

5(d)	Collection Schedule

The frequency of collection for these sections of EPCRA is required by
statute.  The submittal of a list of chemicals or MSDSs under Section
311 is a one-time requirement, unless significant new information arises
concerning a previously submitted MSDS, in which case, a facility should
submit a revised MSDS.  Facilities must submit updates to the list or
MSDSs, within three months, when a new hazardous chemical comes on-site
above the reporting threshold.   The facilities subject to Section 312
is required to submit either Tier II (or state equivalent) on March 1
annually.

6.	ESTIMATING THE BURDEN AND COST OF THE COLLECTION

6(a)	Estimating Respondent Burden

EPA estimated the respondent burden hours and costs associated with all
recordkeeping and reporting requirements of EPCRA sections 311 and 312.
EPA estimates that there are 390,000 facilities that may be subject to
the requirements covered by this ICR.  EPA estimates that out of 390,000
facilities, there are 120,000 manufacturers and 270,000
non-manufacturers.  There is an increase of 40,000 facilities from the
previous ICR based on the number of facilities Tier II data contained on
the E-Plan database.  As of November 2010, E-Plan contains Tier II data
from 36 states.  EPA used this data to estimate the total number of
respondents.  (Note:  E-Plan is a database system developed for first
responders and other emergency preparedness personnel with on-site
hazardous chemical information around the U.S.  Some states require
facilities to submit their hazardous chemical inventory information via
E-Plan).

	According to the Census data in 2006 and 2008, there is a decline in
the number of manufacturing facilities.  However, EPA estimates that
during the period covered by this ICR, there will be a slight increase
in the number of manufacturers and non-manufacturers.  As in the
previous ICR, EPA estimates for the three years covered by this ICR,
there will be 420 (140 annually) new facilities covered by the
requirements under sections 311 and 312.

The initial reporting burdens such as reading and understanding
regulations and section 311 submission(s) for currently covered
facilities under EPCRA sections 311 and 312 are assumed to have occurred
and are not included in this ICR.  This ICR accounts for reporting
updates under section 311, annual reporting and recordkeeping activities
under section 312 that apply to all currently regulated facilities, as
well as all initial reporting burdens for new facilities that are
expected to become subject to the reporting requirements over the
three-year ICR-approval period.  The estimated burden to complete each
reporting and recordkeeping activity is outlined below.

There are estimated to be 3,500 LEPCs and 52 SERCs.  These numbers are
assumed to remain the same during the period covered by this ICR.

The unit burden estimates associated with this collection for facilities
is in Exhibit 1.  For State and local agencies the unit burden estimate
is in Exhibit 1.

Read and Understand Regulations

EPA estimates that 140 newly regulated facilities will need to read and
understand the regulations (40 CFR Part 370).  SERCs and LEPCs are
assumed to have already completed the rule familiarization activities.
EPA assumes that it takes an average of 11.0 hours per facility to read
and understand regulations in 40 CFR Part 370.

Section 311:  MSDS Reporting for Facilities (40 CFR 370.21)

EPA estimates that 140 newly regulated facilities will need to determine
which chemicals exceed the threshold limits.  Of this universe, EPA
estimates that 30 percent (42 facilities) will submit MSDSs to LEPCs,
SERCs, and local fire departments.  Alternatively, facilities may submit
a list of hazardous chemicals grouped by hazard category or a list of
the chemical or common names of each hazardous chemical in lieu of
submitting an MSDS.  Based on these options, 70 percent (98 facilities)
are expected to submit such lists.

Of those facilities submitting lists in lieu of MSDSs, all facilities
(91 facilities) are expected to elect the option of submitting a list of
hazardous chemicals grouped by hazard category.  Facilities may comply
with this option by simply copying their Tier II form.

In addition, EPA estimates that 19,500 facilities (five percent of the
390,000 facilities reporting under section 312) will need to submit a
revised MSDS(s) and the same number of facilities (19,500 facilities)
will need to submit a new MSDS(s) in accordance with 40 CFR 370.21(c)(1)
and (2).  This activity represents the incremental burden for a facility
that has acquired a new chemical or has otherwise changed its inventory.
 Because little information is required from facilities after the
initial submittal, EPA also estimates that only one percent of the total
universe (3,900 facilities) may be specifically requested to submit an
MSDS in accordance with 40 CFR 370.21(d).  Unit burden for each activity
under section 311 is in Exhibit 1.

Section 312:  Inventory Reporting for Facilities (40 CFR 370.25)

The inventory reporting burden applies to new and currently covered
facilities.  Although EPA published two inventory forms, Tier I and Tier
II, all the States accepts only Tier II or form developed by States.
Approximately 43 states accept inventory forms electronically, either
Tier2 Submit or the state developed electronic reporting format.  EPA is
not aware of any States that will accept Tier I form.  Therefore, EPA
did not account any burden for complying with Tier I form.  Tier II form
or State developed forms are useful for developing emergency response
plans since these forms contain detailed information than Tier I.

For this ICR, EPA assumes small facilities are those less than 100
employees, medium facilities are those that have up to 500 employees,
and large facilities are those greater than 500 employees.  These
assumptions are used for both manufacturers and non-manufacturers.  The
majority of facilities in the non-manufacturing sector store few
chemicals in amounts that exceed reporting thresholds in relation to the
number stored at manufacturing facilities.  The corresponding burden
estimates for completing Tier II inventory forms are lower for
non-manufacturing facilities.  Small manufacturers and non-manufacturers
are assumed to take 1 to 8 hours annually to gather information and
submit their inventory form.  For this ICR, EPA applied the average of 6
hours for small manufacturers and 4 hours for small non-manufacturers.
Facilities that EPA has contacted in prior years have informed us that
when the regulations were promulgated in 1987, gathering information and
completing the form took longer time.  It is now easier since the
information is usually same as previous year and also majority of
facilities submit their inventory electronically.  Medium size
facilities are estimated to take 8 to 80 hours annually.  These
facilities are assumed to have up to 15 chemicals that may exceed
reporting thresholds.  For this ICR, EPA applied 80 hours for medium
manufacturers.  Large manufacturers that EPA contacted previously have
informed us that it takes 8 hours to 120 hours to gather information and
complete the form.  These facilities may have up to 25 chemicals that
may exceed reporting thresholds.  For these facilities, EPA applied 120
hours for large manufacturers.  EPA also contacted one small and one
large non-manufacturer in prior years.  They have informed the Agency
that it takes 6 hours for small manufacturer and 40 hours for large
non-manufacturer to complete and submit the form under section 312.  EPA
then used the average, 23 hours to apply for medium size
non-manufacturers.  Although EPA believes that most of the facilities
burden may have reduced since most states require electronic reporting,
EPA is using the same estimates from the previous ICRs.

Most of the States require facilities to submit using electronic
reporting method that State created or the Tier2 Submit.  Therefore, the
burden incurred on these facilities is lower than those submitting in
paper form.  EPA believes that those facilities submitting
electronically will have the Tier II or the State form stored which can
be revised easily.  Most of the information may be the same as previous
year.  Although the burden incurred may be lower for those submitting
electronically, EPA applied the same unit burden for both electronic
submitters and paper submitters.

Information Requests for SERCs and LEPCs (40 CFR 370.30)

Information request burdens in 40 CFR 370.61 are incurred by LEPCs and
SERCs.  These agencies are required to provide public access to the
MSDSs and Tier I/II forms submitted by facilities.  EPA estimates that
the LEPCs or SERCs will be requested to provide MSDSs to the public for
one percent of the total universe of facilities reporting Tier I or Tier
II inventories annually (3,900 facilities).  SERCs and LEPCs are also
estimated to provide Tier II information on one percent of the same
universe of facilities (3,900 facilities) as a result of requests from
the public for such information.

Data Management for SERCs and LEPCs

SERCs and LEPCs receive annual inventory forms from facilities, which
they must make available to the public on request.  The level of effort
needed to manage these forms varies depending on both the number of
forms received and the ways the LEPC or SERC uses the data.  Smaller
LEPCs receive few forms each year; LEPCs in industrialized areas or that
cover several counties and SERCs may receive a large number of forms.
The degree to which the information is used depends on whether the LEPC
or SERC has the resources to actively handle the data.  Based on earlier
discussions with LEPCs, EPA determined that small LEPCs spend on average
five hours a year handling the forms; large LEPCs may spend as much as
three months processing the forms.  SERCs supported by fees are also
likely to spend considerable time on the data.  As in the previous ICR,
EPA developed a weighted average of 32.5 hours a year, based on the
assumption that 120 LEPCs and 27 SERCs would devote considerable effort
organizing and checking the data.  In addition, a limited number of
SERCs and LEPCs have developed databases and input the 312 data into
their CAMEO software systems.  Based on discussions with LEPCs that have
databases, EPA estimates that this effort would require two months or
320 hours.  The number of SERCs and LEPCs with databases is estimated to
be 45, a third of the SERCs and large LEPCs.  About 43 states have the
capability to accept inventory forms electronically.

6(b)	Estimating Respondent Costs

The annual costs to respondents were estimated by multiplying the
respondent burden estimates for each labor category by the corresponding
labor rate for that category.  The unit costs for each respondent or
activity are then multiplied by the number of respondents or activities
performed on an annual basis to yield a total cost for each information
collection activity in Section 6(d).  These costs are shown in Exhibit
1.

EPA estimates an hourly respondent labor cost for manufacturing facility
respondents of $58.18 for managerial staff, $58.18 for technical staff
and $27.87 for clerical staff including wages and benefits. Hourly
respondent labor costs for non-manufacturing facility respondents are
estimated at $48.36 for managerial staff, $48.36 for technical staff and
$21.35 for clerical staff including wages and benefits.  (Source:
Bureau of Labor and Statistics December 2010)

EPA estimates an hourly respondent labor cost (including overhead) for
LEPCs and SERCs of $48.93 for managerial staff, $48.09 for technical
staff and $28.05 for clerical staff.  (Source:  Bureau of Labor and
Statistics December 2010)

Capital and O&M Costs

Approximately 40 states require facilities to submit their inventory
reports electronically.  Therefore, EPA estimates that only the
remaining states would be storing these reports in file cabinets.
However, EPA assumes that some LEPs and fire departments do not have the
capability to store these reports electronically, so these agencies
would need to purchase file cabinets.  Capital costs include the cost of
space required to store information in filing cabinets. Given that the
standard-size, five-drawer, lateral file cabinet is expected to hold
approximately 36,000 pages of material, EPA estimates that the LEPCs and
fire departments would need to purchase approximately 100 file cabinets
within the time period of this ICR.  (EPA assumed that MSDSs are four
pages and inventory forms one page and that the SERC and LEPC or fire
department (but not both) would maintain the records.)  Facilities are
assumed to need only 10 file cabinets to maintain copies of their annual
inventory reports; the cost for storing MSDSs for facilities is covered
by the OSHA’s hazard communication standard (29 CFR 1910.1200).  Using
an estimated cost of $600 per filing cabinet, the cost of purchasing the
100 filing cabinets is estimated to be $60,000.  Annualizing the costs
over 15 years, a single file cabinet has annual cost of $40.

	State and local governments are assumed to incur capital costs in the
form of filing cabinets for the storing new and revised MSDSs, lists of
hazardous chemicals, and the annual inventory reports.  State and local
governments are expected to incur postage costs to provide MSDSs upon
written request and to provide Tier II information upon written request.
 In addition, facilities were assumed to incur postage costs for mailing
new and revised MSDSs, lists of hazardous chemicals, and the annual
inventory reports.  Postage is estimated to cost $5 per certified
package.

	Although some facilities covered by these regulations are now
submitting 312 reports electronically, EPA kept the estimates derived in
the previous ICR for capital and O&M costs for SERCs, LEPCs and
facilities.

Estimating Agency Burden and Cost

EPA estimates no annual Agency burden associated with this ICR.  Only
state and local government entities will incur burden and cost to manage
information submitted by facilities.

EPA update the electronic reporting software, Tier2 Submit annually and
accommodate state requests by including state required fields.

6(d)	Estimating Total Annual Respondent Burden

Exhibit 4 presents the respondent burden for each information collection
activity and for the sum of all information collection activities
performed by each respondent type.  Exhibit 2 and 3 present the hour and
cost burden for SERCs and LEPCs for implementing the program.  Exhibit 5
and 6 show the capital and O&M costs to facilities over the three-year
information collection period.  The total average annual respondent
burden for facilities is 3,772,292 hours, for a total annualized cost of
$236,884,010.  The total average annual respondent burden for state and
local governments for the three-year period is 136,840 hours, for a
total annualized cost of $4,300,484.  These burden estimates are
summarized in Exhibits 5 and 6.

6(e)	Bottom Line Burden Hours and Cost

The total burden to facility respondents over three years is
11,316,876hours at a cost of $710,652,030.  The total burden to LEPC and
SERC respondents over three years is 410,520 hours at a cost of
$12,901,453.  Exhibits 5 and 6 present a summary of the bottom line
burden and cost estimates for section 311 and 312 reporting for
facilities and state and local governments, respectively.

6(f)	Reasons for Change in Burden

The estimated average annual burden for facilities for reporting and
recordkeeping activities under EPCRA sections 311 and 312 is 3,772,292
hours per year.  There is an increase of 116,700 hours from the previous
ICR for the facilities.  There is an increase in the number of
respondents from the data extrapolated from the number of facilities
Tier II data on the E-Plan.

6(g)	Burden Statement

The average burden for MSDS reporting (basic and additional reporting)
is estimated at 6.75 hours for new facilities.  Additional reporting,
which is to submit revised and new MSDSs for currently covered and new
facilities is 2 hours.  The average burden for new and currently covered
facilities to submit MSDS upon request is 1 hour.  The average burden to
comply with Tier II inventory reporting for small, medium and large
manufacturers is 8, 80 and 120 hours, respectively.  The average burden
to comply with Tier II inventory reporting for small, medium and large
non-manufacturers is 6, 20, and 40 hours, respectively.  There are no
recordkeeping requirements for facilities under EPCRA sections 311 and
312 although it is assumed that they will maintain a copy of annual
reports to use for future filings.  The recordkeeping for MSDSs is
mandated under OSHA rules.

The average burden for state and local governments to respond to
requests for MSDSs or Tier II information under 40 CFR 370.30 is
estimated to be one hour per request. The average burden for managing
and maintaining the reports and MSDS files is estimated to be 32.50
hours.  The average burden for maintaining and updating a 312 database
is estimated to be 320 hours.

	Burden means the total time, effort, or financial resources expended by
persons to generate, maintain, retain, or disclose or provide
information to or for a Federal agency.  This includes the time needed
to review instructions; develop, acquire, install, and utilize
technology and systems for the purposes of collecting, validating, and
verifying information, processing and maintaining information, and
disclosing and providing information; adjust the existing ways to comply
with any previously applicable instructions and requirements; train
personnel to be able to respond to a collection of information; search
data sources; complete and review the collection of information; and
transmit or otherwise disclose the information.  An agency may not
conduct or sponsor, and a person is not required to respond to, a
collection of information unless it displays a currently valid OMB
control number.  The OMB control numbers for EPA's regulations are
listed in 40 CFR part 9 and 48 CFR chapter 15.

	To comment on the Agency’s need for this information, the accuracy of
the provided burden estimates, and any suggested methods for minimizing
respondent burden, including the use of automated collection techniques,
EPA has established a public docket for this ICR under Docket ID number
EPA-HQ-SFUND-2004-0006, which is available for online viewing at
www.regulations.gov, or in person viewing at the Superfund Docket in the
EPA Docket Center (EPA/DC),  EPA West, Room 3334, 1301 Constitution
Ave., NW, Washington, DC.  The EPA Docket Center Public Reading Room is
open from 8:30 a.m. to 4:30 p.m., Monday through Friday, excluding legal
holidays.  The telephone number for the Reading Room is<PHONE_NUMBER>,
and the telephone number for the Superfund Docket is<PHONE_NUMBER>.  An
electronic version of the public docket is available
www.regulations.gov.  This site can be used 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.  When in the system, select “search,” then key in
the Docket ID number identified above.  Also, you can send comments to
the Office of Information and Regulatory Affairs, Office of Management
and Budget, 725 17th Street, NW, Washington, DC 20503, Attention: Desk
Officer for EPA.  Please include the EPA Docket ID Number
EPA-HQ-SFUND-2004-0006 and OMB Control Number 2050-0072 in any
correspondence.

Exhibit 1

Section 311 and 312 Reporting and Recordkeeping Requirements

Estimated Unit Burden and Cost

Facilities

Information Collection Activity	Annual Unit Hours  	Total Hours 	Annual
Unit Cost

	Legal	Management	Technical	Clerical

RULE FAMILIARIZATION

  Read and understand regulations 	1.00	2.50	7.5	0.00	11.00	$681.80

MSDS REPORTING

Basic Reporting

Determine which chemicals meet/exceed the thresholds (new facilities)
0.00	1.00	3.00	0.00	4.00	$232.72

Submit MSDSs to SERC, LEPC, and fire department (new facilities)	0.00
0.25	1.00	0.50	1.75	$86.65

Alternative Reporting

Submit list of hazardous chemicals grouped by hazard category (new
facilities) 	0.00	0.00	1.00	0.25	1.25	$65.15

Submit revised MSDSs (new and currently covered facilities)	0.00	0.25
0.50	0.25	1.00	$50.59

Submit new MSDSs (new and currently covered facilities)	0.00	0.25	0.50
0.25	1.00	$50.59

Additional Reporting

Submit MSDS upon request (new and currently covered facilities)	0.00
0.25	0.50	0.25	1.00	$50.59

INVENTORY REPORTING

Basic Reporting

Develop and submit Tier II (new and currently covered facilities

Manufacturers

Small 	1.00	1.00	6.00	0.00	8.00	$507.26

Medium	2.00	4.00	74.00	0.00	80.00	$4,738.04

Large	4.00	8.00	108.00	0.00	120.00	$7,148.88

Non-manufacturers

Small	1.00	1.00	4.00	0.00	6.00	$390.90

Medium	2.00	2.00	16.00	0.00	20.00	$1,247.24

Large	4.00	4.00	32.00	0.00	40.00	$2,669.02

Exhibit 2

Sections 311 and 312 Reporting and Recordkeeping Requirements

Estimated Unit Burden and Cost

State and Local Governments

	Annual Unit Hours 	Total Hours	Annual Unit Cost

	Legal	Management	Technical	Clerical

INFORMATION REQUESTS

File and maintain annual inventory forms and data	0.00	0.00	5.0	27.5
32.50	$1,011.82

Input data and maintain database of 312 data	0.00	0.00	40.0	280.00
320.00	$9,777.60

Provide MSDSs upon written request	0.00	0.00	0.50	0.50	1.00	$38.06

Provide Tier II information upon written request	0.00	0.00	0.50	0.50
1.00	$38.06

Exhibit 3

Sections 311 and 312 Reporting and Recordkeeping Requirements

Estimated Annual Burden

State and Local Governments

	Number of Respondents	Annual Hours Burden	Total Hours

Burden	Annual Cost

Legal	Management	Technical 	Clerical

INFORMATION REQUESTS

	File and maintain annual inventory forms and data	3,552	0.00	0.00
17,760	97,680	115,440	$3,594,002.40

Input data and maintain database of 312 data	45	0.00	0.00	1,800	12,600
14,400	$439,992.00

Provide MSDS on written request	3,500	0.00	0.00	1,750	1,750	3,500
$133,245.00

Provide Tier II information upon written request	3,500	0.00	0.00	1,750
1,750	3,500	$133,245.00

Total

136,840	$4,300,484.40

Exhibit 4

Section 311 and 312 Reporting and Recordkeeping Requirements

Estimated Annual Burden and Cost

Facilities

	Number of Respondents	Legal	Management	Technical	Clerical	Total Hours
Burden	Annual Cost

RULE FAMILIARIZATION

	  Read and understand regulations 	140	140	325	975	0.00	1,440
$89,634.00

	MSDS REPORTING

	Basic Reporting

	Determine which chemicals meet/exceed the thresholds (new facilities)
140	0.00	140	390	0.00	530	$30,835.40

Submit MSDSs to SERC, LEPC, and fire department (new facilities)	39	0.00
9.75	39	19.50	68.25	$3,379.74

Alternative Reporting

	Submit list of hazardous chemicals grouped by hazard category (new
facilities) 	91	0.00	0.00	91.00	22.75	113.75	$5,928.42

Submit revised MSDSs (new and currently covered facilities)	19,500	0.00
4,875	9,750	4,875	19,500	$986,748.75

Submit new MSDSs (new and currently covered facilities)	19,500	0.00
4,875	9,750	4,875	19,500	$986,748.75

Additional Reporting

	Submit MSDS upon request (new and currently covered facilities)	3,900
0.00	975	1,950	975	3,900	$197,349.75

Subtotal

40,652	$2,300,624.81

INVENTORY REPORTING

	Basic Reporting

	Develop and submit Tier II (new and currently covered facilities

	Manufacturers

	Small 	107,400	107,400	107,400	644,400	0.00	859,200	$54,479,724

Medium	9,000	18,000	36,000	666,000	0.00	720,000	$42,642,360

Large	3,600	14,400	28,800	388,800	0.00	432,000	$25,735,968

Non-manufacturers

	Small	265,140	265,140	265,140	1,060,560	0.00	1,590,840	$103,643,230

Medium	3,240	6,480	6,480	51,840	0.00	64,800	$4,041,057

Large	1,620	6,480	6,480	51,840	0.00	64,800	$4,041,057

Subtotal

3,731,640	$ 234,583,386

Total (Facilities)

3,772,292	$ 236,884,010

Exhibit 5

Summary of Total Burden and Cost Estimates

Facilities

	Total Hours

Burden (Hours)	Total Cost

Labor	Capital	O&M

	Annual	3,772,292	$236,884,010	$900	$6,330,300

	Three-Year	11,316,876	$710,652,030	$2,700	$18,990,900

Exhibit 6

Summary of Total Burden and Cost Estimates

 SERCs and LEPCs

	Total Hours

Burden

(Hours)	Total Cost

Labor	Capital	O&M

	Annual	136,840	$4,300,484	$2,700	$56,000

	Three-Year	410,520	$12,901,453	$8,100	$168,000

Page   PAGE  1  of   NUMPAGES   17


[Federal Register: April 12, 2010 (Volume 75, Number 69)]
[Notices]
[Page 18523]
[DOCID:fr12ap10-87]

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DEPARTMENT OF HOMELAND SECURITY

Federal Emergency Management Agency

[Internal Agency Docket No. FEMA-1886-DR; Docket ID FEMA-2010-0002]

South Dakota; Amendment No. 1 to Notice of a Major Disaster
Declaration

AGENCY: Federal Emergency Management Agency, DHS.

ACTION: Notice.

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

SUMMARY: This notice amends the notice of a major disaster declaration
for the State of South Dakota (FEMA-1886-DR), dated March 9, 2010, and
related determinations.

DATES: Effective Date: April 6, 2010.

FOR FURTHER INFORMATION CONTACT: Peggy Miller, Recovery Directorate,
Federal Emergency Management Agency, 500 C Street, SW., Washington, DC
20472,<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION: The notice of a major disaster declaration
for the State of South Dakota is hereby amended to include the
following area among those areas determined to have been adversely
affected by the event declared a major disaster by the President in his
declaration of March 9, 2010.

    Brule County for Public Assistance.

The following Catalog of Federal Domestic Assistance Numbers (CFDA)
are to be used for reporting and drawing funds: 97.030, Community
Disaster Loans; 97.031, Cora Brown Fund; 97.032, Crisis Counseling;
97.033, Disaster Legal Services; 97.034, Disaster Unemployment
Assistance (DUA); 97.046, Fire Management Assistance Grant; 97.048,
Disaster Housing Assistance to Individuals and Households In
Presidentially Declared Disaster Areas; 97.049, Presidentially
Declared Disaster Assistance--Disaster Housing Operations for
Individuals and Households; 97.050 Presidentially Declared Disaster
Assistance to Individuals and Households--Other Needs; 97.036,
Disaster Grants--Public Assistance (Presidentially Declared
Disasters); 97.039, Hazard Mitigation Grant.

W. Craig Fugate,
Administrator, Federal Emergency Management Agency.
[FR Doc. 2010-8266 Filed 4-9-10; 8:45 am]
BILLING CODE 9111-23-P


[Federal Register Volume 76, Number 103 (Friday, May 27, 2011)]
[Rules and Regulations]
[Page 30821]
[FR Doc No: 2011-13109]

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

DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

14 CFR Part 71

[Docket No. FAA-2011-0123; Airspace Docket No. 11-AGL-2]

Amendment of Class E Airspace; Duluth, MN

AGENCY: Federal Aviation Administration (FAA), DOT.

ACTION: Final rule.

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

SUMMARY: This action amends Class E airspace for Duluth, MN, to
accommodate new Area Navigation (RNAV) Standard Instrument Approach
Procedures at Duluth International Airport. The FAA is taking this
action to enhance the safety and management of Instrument Flight Rule
(IFR) operations at the airport.

DATES: Effective date: 0901 UTC, August 25, 2011. The Director of the
Federal Register approves this incorporation by reference action under
1 CFR part 51, subject to the annual revision of FAA Order 7400.9 and
publication of conforming amendments.

FOR FURTHER INFORMATION CONTACT: Scott Enander, Central Service Center,
Operations Support Group, Federal Aviation Administration, Southwest
Region, 2601 Meacham Blvd., Fort Worth, TX 76137; telephone (817) 321-
7716.

SUPPLEMENTARY INFORMATION:

History

    On March 23, 2011, the FAA published in the Federal Register a
notice of proposed rulemaking to amend Class E airspace for Duluth, MN,
creating additional controlled airspace at Duluth International Airport
(76 FR 16348) Docket No. FAA-2011-0123. Interested parties were invited
to participate in this rulemaking effort by submitting written comments
on the proposal to the FAA. No comments were received. Class E airspace
designations are published in paragraph 6005 of FAA Order 7400.9U dated
August 18, 2010, and effective September 15, 2010, which is
incorporated by reference in 14 CFR 71.1. The Class E airspace
designations listed in this document will be published subsequently in
the Order.

The Rule

    This action amends Title 14 Code of Federal Regulations (14 CFR)
Part 71 by amending Class E airspace, as an extension to a Class D or
Class E surface area; and Class E airspace extending upward from 700
feet above the surface, for new standard instrument approach procedures
at Duluth International Airport, Duluth, MN. This action is necessary
for the safety and management of IFR operations at the airport.
Geographic coordinates will also be updated to coincide with the FAA's
aeronautical database.
    The FAA has determined that this regulation only involves an
established body of technical regulations for which frequent and
routine amendments are necessary to keep them operationally current.
Therefore, this regulation: (1) Is not a ``significant regulatory
action'' under Executive Order 12866; (2) is not a ``significant rule''
under DOT Regulatory Policies and Procedures (44 FR 11034; February 26,
1979); and (3) does not warrant preparation of a regulatory evaluation
as the anticipated impact is so minimal. Since this is a routine matter
that will only affect air traffic procedures and air navigation, it is
certified that this rule, when promulgated, will not have a significant
economic impact on a substantial number of small entities under the
criteria of the Regulatory Flexibility Act.
    The FAA's authority to issue rules regarding aviation safety is
found in Title 49 of the U.S. Code. Subtitle 1, section 106, describes
the authority of the FAA Administrator. Subtitle VII, Aviation
Programs, describes in more detail the scope of the agency's authority.
This rulemaking is promulgated under the authority described in
subtitle VII, part A, subpart I, section 40103. Under that section, the
FAA is charged with prescribing regulations to assign the use of
airspace necessary to ensure the safety of aircraft and the efficient
use of airspace. This regulation is within the scope of that authority
as it amends controlled airspace for Duluth International Airport,
Duluth, MN.

List of Subjects in 14 CFR Part 71

    Airspace, Incorporation by reference, Navigation (air).

Adoption of the Amendment

    In consideration of the foregoing, the Federal Aviation
Administration amends 14 CFR part 71 as follows:

PART 71--DESIGNATION OF CLASS A, B, C, D, AND E AIRSPACE AREAS; AIR
TRAFFIC SERVICE ROUTES; AND REPORTING POINTS

0
1. The authority citation for 14 CFR Part 71 continues to read as
follows:

    Authority:  49 U.S.C. 106(g), 40103, 40113, 40120; E. O. 10854,
24 FR 9565, 3 CFR, 1959-1963 Comp., p. 389.

Sec.  71.1  [Amended]

0
2. The incorporation by reference in 14 CFR 71.1 of the Federal
Aviation Administration Order 7400.9U, Airspace Designations and
Reporting Points, dated August 18, 2010, and effective September 15,
2010, is amended as follows:

Paragraph 6004 Class E airspace areas designated as an extension to
a Class D or Class E surface area.

* * * * *

AGL MN E4 Duluth, MN [Amended]

Duluth International Airport, MN
    (Lat. 46[deg]50'32'' N., long. 92[deg]11'37'' W.)
Duluth VORTAC
    (Lat. 46[deg]48'08'' N., long. 92[deg]12'10'' W.)

    That airspace extending upward from the surface within 3.4 miles
each side of the Duluth VORTAC 193[deg] radial extending from the
4.9-mile radius of Duluth International Airport to 14.2 miles south
of the VORTAC, and within 3.6 miles each side of the 267[deg]
bearing from Duluth International Airport extending from the 4.9-
mile radius of the airport to 9.7 miles west of the airport.

Paragraph 6005 Class E Airspace areas extending upward from 700
feet or more above the surface of the earth.

* * * * *

AGL MN E5 Duluth, MN [Amended]

Duluth International Airport, MN
    (Lat. 46[deg]50'32'' N., long. 92[deg]11'37'' W.)

    That airspace extending upward from the 700 feet above the
surface within a 7.1-mile radius of Duluth International Airport,
and within 4.4 miles each side of the 267[deg] bearing from the
airport extending from the 7.1-mile radius to 7.7 miles west of the
airport.

    Issued in Fort Worth, Texas, on May 17, 2011.
Walter L. Tweedy,
Acting Manager, Operations Support Group, ATO Central Service Center.
[FR Doc. 2011-13109 Filed 5-26-11; 8:45 am]
BILLING CODE 4910-13-P


[Federal Register Volume 84, Number 119 (Thursday, June 20, 2019)]
[Rules and Regulations]
[Pages 28726-28728]
[FR Doc No: 2019-12983]

=======================================================================
-----------------------------------------------------------------------

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 101

[Docket No. FDA-2018-D-0075]

The Declaration of Added Sugars on Honey, Maple Syrup, Other
Single-Ingredient Sugars and Syrups, and Certain Cranberry Products;
Guidance for Industry; Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notification of availability.

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

SUMMARY: The Food and Drug Administration (FDA or we) is announcing the
availability of a final guidance for industry entitled ``The
Declaration of Added Sugars on Honey, Maple Syrup, Other Single-
Ingredient Sugars and Syrups, and Certain Cranberry Products.'' This
guidance provides clarification on the labeling requirements for
single-ingredient packages and/or containers of pure honey, pure maple
syrup, and other pure sugars and syrups, which are not required to bear
the words ``Includes Xg Added Sugars,'' but must still include the
percent Daily Value for added sugars on their labels. This guidance is
also intended to advise food manufacturers of our intent to exercise
enforcement discretion related to the use of a ``[dagger]'' symbol
immediately following the percent Daily Value for added sugars on
single-ingredient packages and/or containers of pure honey, pure maple
syrup, and other pure sugars and syrups; the ``[dagger]'' symbol would
lead the consumer to a statement that is truthful and not misleading in
a footnote at the bottom of the Nutrition Facts label. The guidance
also advises food manufacturers of our intent to exercise enforcement
discretion with respect to the use of a ``[dagger]'' symbol immediately
after the added sugars percent Daily Value information that leads the
consumer to a statement that is truthful and not misleading outside of
the Nutrition Facts label on certain dried cranberry and cranberry
beverage products that are made up of cranberry juice sweetened with
added sugars and that contain total sugars at levels no greater than
comparable products with endogenous (inherent) sugars, but no added
sugars. Further, this guidance advises of our intent to exercise
enforcement discretion regarding compliance with Nutrition Facts label
final rule and Serving Size final rule requirements until July 1, 2021,
for the single-ingredient sugars and syrups as well as the cranberry
products discussed in the guidance document.

DATES: The announcement of the guidance is published in the Federal
Register on June 20, 2019.

ADDRESSES: You may submit either electronic or written comments on FDA
guidances at any time as follows:

Electronic Submissions

    Submit electronic comments in the following way:
     Federal eRulemaking Portal: https://www.regulations.gov.
Follow the instructions for submitting comments. Comments submitted
electronically, including attachments, to https://www.regulations.gov
will be posted to the docket unchanged. Because your comment will be
made public, you are solely responsible for ensuring that your comment
does not include any confidential information that you or a third party
may not wish to be posted, such as medical information, your or anyone
else's Social Security number, or confidential business information,
such as a manufacturing process. Please note that if you include your
name, contact information, or other information that identifies you in
the body of your comments, that information will be posted on https://www.regulations.gov.
     If you want to submit a comment with confidential
information that you do not wish to be made available to the public,
submit the comment as a written/paper submission and in the manner
detailed (see ``Written/Paper Submissions'' and ``Instructions'').

Written/Paper Submissions

    Submit written/paper submissions as follows:
     Mail/Hand delivery/Courier (for written/paper
submissions): Dockets Management Staff (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
     For written/paper comments submitted to the Dockets
Management Staff, FDA will post your comment, as well as any
attachments, except for information submitted, marked and identified,
as confidential, if submitted as detailed in ``Instructions.''

    Instructions: All submissions received must include the Docket No.
FDA-2018-D-0075 for ``The Declaration of Added Sugars on Honey, Maple
Syrup, Other Single-Ingredient Sugars and Syrups, and Certain Cranberry
Products: Guidance for Industry.'' Received comments will be placed in
the docket and, except for those submitted as ``Confidential
Submissions,'' publicly viewable at https://www.regulations.gov or at
the Dockets Management Staff between 9 a.m. and 4 p.m., Monday through
Friday.
     Confidential Submissions--To submit a comment with
confidential information that you do not wish to be made publicly
available, submit your comments only as a written/paper submission. You
should submit two copies total. One copy will include the information
you claim to be confidential with a heading or cover note that states
``THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.'' We will review
this copy, including the claimed confidential information, in our
consideration of comments. The second copy, which will have the claimed
confidential information redacted/blacked out, will be available for
public viewing and posted on https://www.regulations.gov. Submit both
copies to the Dockets Management Staff. If you do not wish your name
and contact information to be made publicly available, you can provide
this information on the cover sheet and not in the body of your
comments and you must identify this information as ``confidential.''
Any information marked as ``confidential'' will not be disclosed except
in accordance with 21 CFR 10.20 and other applicable disclosure law.
For more information about FDA's posting of comments to public dockets,
see 80 FR 56469, September 18, 2015, or access the information at:
https://www.gpo.gov/fdsys/pkg/FR-2015-09-18/pdf/2015-23389.pdf.
    Docket: For access to the docket to read background documents or
the electronic and written/paper comments received, go to https://www.regulations.gov and insert the docket number, found in brackets in
the heading of this document, into the ``Search'' box and follow the
prompts and/or go to the Dockets Management Staff, 5630 Fishers Lane,
Rm. 1061, Rockville, MD 20852.
    You may submit comments on any guidance at any time (see 21 CFR
10.115(g)(5)).
    Submit written requests for single copies of the guidance to the
Office of Nutrition and Food Labeling, Nutrition Programs Staff, Center
for Food Safety and Applied Nutrition, Food and Drug Administration,
5001 Campus Dr., College Park, MD 20740. Send two self-addressed
adhesive labels to assist that office in processing your request. See
the SUPPLEMENTARY INFORMATION section for electronic access to the
guidance.

FOR FURTHER INFORMATION CONTACT: Blakeley Fitzpatrick, Center for Food
Safety and Applied Nutrition, Office of Nutrition and Food Labeling,
5001 Campus Dr., College Park, MD 20740,<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

I. Background

    We are announcing the availability of a guidance for industry
entitled ``The Declaration of Added Sugars on Honey, Maple Syrup, Other
Single-Ingredient Sugars and Syrups, and Certain Cranberry Products.''
We are issuing this guidance consistent with our good guidance
practices regulation (21 CFR 10.115). The guidance represents the
current thinking of FDA on this topic. It does not establish any rights
for any person and is not binding on FDA or the public. You can use an
alternative approach if it satisfies the requirements of the applicable
statutes and regulations. This guidance is not subject to Executive
Order 12866.
    This guidance provides clarification on the labeling requirements
for single-ingredient packages and/or containers of pure honey, pure
maple syrup, and other pure sugars and syrups, which are not required
to bear the words ``Includes Xg Added Sugars'' but must still include
the percent Daily Value for added sugars on their labels. This guidance
is also intended to advise food manufacturers of our intent to exercise
enforcement discretion related to use of a ``[dagger]'' symbol on
single-ingredient packages and/or containers of pure honey, pure maple
syrup, and other pure sugars and syrups immediately following the
percent Daily Value for the contribution of added sugars to the diet
obtained from these products. This would lead the consumer to a
statement that is truthful and not misleading in a footnote at the
bottom of the Nutrition Facts label. We also intend to exercise our
enforcement discretion with respect to the use of a ``[dagger]'' symbol
immediately after the added sugars percent Daily Value information that
would lead the consumer to a statement outside of the Nutrition Facts
label on certain dried cranberry and cranberry beverage products that
are made up of cranberry juice sweetened with added sugars and that
contain total sugars at levels no greater than comparable products with
endogenous (inherent) sugars, but no added sugars.
    In the Federal Register of May 27, 2016, FDA issued a final rule
entitled ``Food Labeling: Revision of the Nutrition and Supplement
Facts Labels'' (81 FR 33742; the ``Nutrition Facts label final rule'').
The Nutrition Facts label final rule amended the regulations for the
nutrition labeling of conventional foods and dietary supplements to
provide updated nutrition information and to improve how the nutrition
information is presented to consumers. The Nutrition Facts label final
rule also revised the Nutrition Facts label to replace ``sugars'' with
``total sugars'' and to include the declaration of added sugars. The
Nutrition Facts label final rule defines ``added sugars,'' in part, to
include sugars that are either added during the processing of foods or
are packaged as such. The definition includes free sugars (free mono-
and disaccharides), sugars from syrups and honey, and sugars from
concentrated fruit or vegetable juices that are in excess of what would
be expected from the same volume of 100 percent fruit or vegetable
juice of the same type. The Nutrition Facts label final rule requires
added sugars to be declared on the food label by stating ``Includes Xg
Added Sugars'' indented directly below ``Total Sugars,'' where X
represents the amount, in grams, of added sugars (see 21 CFR
101.9(c)(6)(ii)).
    On December 20, 2018, the President signed into law the Agriculture
Improvement Act of 2018 (Pub. L. 115-334) (``the Farm Bill''). Section
12516 of the Farm Bill states that the food labeling requirements under
section 403(q) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C.
343(q)) shall not require that the Nutrition Facts label of any single-
ingredient sugar, honey, agave, or syrup, including maple syrup, that
is packaged and offered for sale as a single-ingredient food bear the
declaration ``Includes Xg Added Sugars.'' Therefore, single-ingredient
sugars, honey, agave, and syrups, including maple syrup, do not need to
have the statement ``Includes Xg Added Sugars'' on their label. At the
same time, the Farm Bill did not change the requirement under the final
rule to include the percent Daily Value for the contribution of added
sugars to the diet obtained from these products.
    In the Federal Register of March 2, 2018 (83 FR 8953), we made
available a draft guidance for industry entitled ``The Declaration of
Added Sugars on Honey, Maple Syrup, and Certain Cranberry Products''
(hereafter referred to as ``the draft guidance'') and gave interested
parties an opportunity to submit comments by May 1, 2018. In response
to requests for more time to

comment on the draft guidance, we issued a notice in the Federal
Register of April 25, 2018 (83 FR 17961) extending the comment period
to June 15, 2018. We received over 3,600 comments to the draft guidance
from industry, consumer advocacy groups, trade associations, members of
Congress, State governments, and private citizens.
    After consideration of the comments to the draft guidance, as well
as Public Law 115-334, we have made changes in the final guidance to
clarify the requirements for the labeling of added sugars on packages
and/or containers of single ingredient honey, maple syrup, and other
single ingredient sugars and syrups. The final guidance clarifies that
the line representing added sugars on the Nutrition Facts label, as
well as the percent Daily Value on that line, are retained for single-
ingredient sugars and syrup, however these products do not need to have
the statement ``Includes Xg Added sugars'' on that line. The final
guidance also explains our intent to exercise enforcement discretion
for all single ingredient sugars and syrups with respect to the
inclusion of a ``[dagger]'' symbol after the percent Daily Value, which
leads the reader to a truthful and not misleading statement within a
footnote at the bottom of the Nutrition Facts label that includes a
description of the gram amount of sugar added to the diet by one
serving of the product and its contribution to the percent Daily Value
for added sugars in the diet.
    We are finalizing the guidance without any changes with respect to
our intent to exercise enforcement discretion for the use of a
``[dagger]'' symbol that would direct consumers to truthful and not
misleading statements on the package outside the Nutrition Facts label
on certain cranberry products sweetened with added sugars that provide
an amount of total sugars in a serving that does not exceed the level
of total sugars in a serving of a comparable product with no added
sugars.
    At this time, we are not aware of products, other than the
cranberry products discussed in the guidance document, for which the
addition of sugars is intended to increase palatability, and for which
the amount of total sugars per serving is at a level that does not
exceed the amount of total sugars in a comparable product with no added
sugars. Therefore, at this time we do not intend to exercise
enforcement discretion with respect to the use of the ``[dagger]'' that
would direct consumers to truthful and not misleading statements on the
package outside the Nutrition Facts label on products, including dairy
products and whole grain products, other than the cranberry products
discussed in the guidance document. We specifically note that we do not
intend to exercise enforcement discretion with respect to beverages
made from a[ccedil]a[iacute] berries because it appears that
a[ccedil]a[iacute] berry beverages are made, at least in part, from
a[ccedil]a[iacute] berries combined with water. Therefore, we do not
consider a[ccedil]a[iacute] berry beverages to be a comparable product
to other naturally sweet juices. Furthermore, we do not have sufficient
evidence to show that sugars are added to a[ccedil]a[iacute] berries to
increase palatability like the naturally tart fruit described in the
2015-2020 Dietary Guidelines for Americans (available at https://www.dietaryguidelines.gov/current-dietary-guidelines). We note that we
would consider whether the same type of enforcement discretion
discussed with respect to certain cranberry products might be warranted
for other products for which the addition of sugars is intended to
increase palatability, such as naturally tart fruits, and for which the
amount of total sugars per serving is at a level that does not exceed
the amount of total sugars in a comparable product with no added
sugars.
    Further, the final guidance announces our intent to exercise
enforcement discretion, until July 1, 2021, regarding the compliance
with the Nutritional Facts Label final rule and Serving Size final rule
(81 FR 33742 and 81 FR 34000 (May 27, 2016)) requirements for single-
ingredient packages and/or containers of pure honey, pure maple syrup,
and other pure sugars and syrups, as well as certain dried cranberry
and cranberry beverage products. We recognize the importance of giving
manufacturers of such products additional time to make appropriate
label changes consistent with the Farm Bill and this final guidance.
With respect to our enforcement discretion policy pertaining to
compliance with updated Nutrition Facts label and serving size
requirements, this part of the guidance is being implemented without
prior public comment because we have determined that prior public
participation is not feasible or appropriate (21 CFR 10.115(g)(2)).

II. Paperwork Reduction Act of 1995

    This guidance refers to previously approved collections of
information found in FDA regulations. These collections of information
are subject to review by the Office of Management and Budget (OMB)
under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3521). The
collections of information in 21 CFR part 101 have been approved under
OMB control number 0910-0813.

III. Electronic Access

    Persons with access to the internet may obtain the guidance at
either 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 guidance.

    Dated: June 14, 2019.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2019-12983 Filed 6-18-19; 11:15 am]
BILLING CODE 4164-01-P