Page 1 of 9 UNITED STATES ENVIRONMENTAL PROTECTION AGENCY WASHINGTON, D. C. 20460 OFFICE OF PREVENTION, PESTICIDES AND TOXIC SUBSTANCES April 4, 2006 MEMORANDUM DATE: 4/ 04/ 2006 SUBJECT: 2( Thiocyanomethylthio) benzothiazole Dietary Assessment for the Reregistration Eligibility Document REVIEWER: Robert Quick, Chemist Risk Assessment & Science Support Branch Antimicrobials Division ( 7510C)

THROUGH: Norm Cook, Chief Risk Assessment & Science Support Branch Antimicrobials Division ( 7510C)

TO: Kathryn Avivah Jakob, Chemical Review Manager Regulatory Management Branch Antimicrobials Division ( 7510C)

PC CODES: 035603 DP BARCODES: D322616 Page 2 of 9 I. Introduction 2( Thiocyanomethylthio) benzothiazole ( TCMTB) Dietary Exposure The Antimicrobials Division has assessed the potential antimicrobial dietary exposure to the active ingredient 2( Thiocyanomethylthio) benzothiazole ( TCMTB). The dietary exposure use for this chemical results from a pulp and paper use.

The paper uses for TCMTB include uses as a slimicide, a wood chip use, a bacteriostatic paper use, a paper adhesive preservative use and an agricultural mulch paper use. The registrant stated at the SMART meeting that he plans to cancel the wood chip use, bacteriostatic paper use and the agricultural mulch paper use. There is a use for wood treatment but the registrant states that the use is not intended for fruit and vegetable packing crates.

There is a Food & Drug Administration ( FDA) regulation for the use of TCMTB as a slimicide ( 21 CFR 176.300).

21 CFR 176.170 relates to " Components of paper and paperboard in contact with aqueous and fatty foods". The 21 CFR 176.170 ( a)( 4) states, " Substances that by regulation in Parts 170 through 189 of this chapter may be safely used without extractives limitations as components of the uncoated or coated surfaces of paper or paperboard in contact with aqueous or fatty food, subject to the provisions of such regulation". Our AD interpretation of this paragraph ( personal communication between Mr. Dennis Edwards, RMB I Branch Chief and Robert Quick, RASSB) is that this paragraph would also permit TCMTB to be used as a paper coating that is permitted to contact aqueous or fatty food.

2( Thiocyanomethylthio) benzothiazole ( TCMTB) can be used to preserve paper coating formulations. Several labels bear paper coating uses but the use rate for application to the coating is unclear. Example: EPA Reg.# 1448 37. The label states: " Rate of application will vary per coating rate." The registrant must clarify the labeling to show the label rates( ranges) for the paper coating uses.

The registrant has been requested by the CRM, Kathryn Avivah Jakob, to clarify the use pattern for coatings. In the registrant's latest e mail response dated 12/ 14/ 2005, the registrant states, " It might be more efficient to put limitations in the label use directions in which text is added stating in effect of ` Not for use in coatings intended for food contact'. Will this suffice?" AD does not consider label restrictions such as, " Not for food contact use", to be practical. AD would consider a label restriction( s) for paper that defines the type of paper that is to be treated; e. g., use sites such as wallboard paper, insulation backing, newsprint, photographic paper, drawing paper, etc. for label restrictions that preclude food contact as practical. These types of paper are not likely to be used for food contact. Page 3 of 9 The registrant could also revise the slimicide use on the labels in the same manner that AD has suggested above for the paper coating use; i. e. define the type of paper that is to be treated. This would help preclude food contact with TCMTB treated paper.

There are agricultural food uses for TCMTB which are for seed treatment uses to a variety of crops. These agricultural food uses will be reviewed by the Health Effects Division.

The chemical, 2 mercaptobenzothiazole, is the main mammalian metabolite of TCMTB ( Timothy McMahon memo dated 12/ 22/ 2005). This chemical and its sodium and potassium salts are also permitted for use as slimicides by the Food & Drug Administration in pulp and papermaking ( 21 CFR 176.300). Residues of this chemical may also be present as a result of this use of TCMTB in papermaking. See Other Issues below.

II. Dietary Exposure for TCMTB Slimicide Use As regulated under 21CFR 176.300, TCMTB can be used for controlling bacteria, fungi and yeasts which cause deterioration of paper and paperboard products. Dietary exposure to TCMTB as a slimicide in these paper mill systems were estimated using the following assumptions:

  The slimicide is added to the pulp slurry at a maximum application rate of 2.0 lbs of slimicide per ton of dry fiber produced, which is equivalent to 1.2 lbs of TCMTB per 2000 lbs of paper ( EPA Reg. No. 1448 37 is 60.0% ai). Since there is no control over how the paper will be used in commerce, AD assumes that all paper can contact food and have therefore assessed the dietary exposure using maximum application rate which comes from the non food use. Since paper pulp is diluted with water to form the paper slurry, the application rate must be adjusted to account for only the pulp/ paper present in the slurry. Prior to entering the paper machine, the paper slurry consists of less than 1% paper pulp. Therefore, the adjusted application rate was 6.0 ppm ( or µ g ai/ g pulp).   Prior to entering the driers, the slurry consists of 33% pulp and 67% water. The application rate was further adjusted to account for the amount of pulp present in the finished paper.   The finished paper ( after paper making) contains 92% pulp and 8% water.   The standard basis weight of paper is 50 mg/ in2.   The amount of food contacting the paper packaging is 10 g of food/ in2 of paper.   The consumption factor ( percentage of food packaging that contacts food) is 10%.   There is 100% migration of TCMTB from the treated paper into food.   Adult food consumption is 3 kg/ day; child food consumption is 1.5 kg/ day.   Adult body weight is 70 kg for a male; 60 kg for a female and 15 kg for a child. Page 4 of 9 Calculations:

Determination of the application rate in terms of ai and finished paper is:

Application rate on label: 1.2 lbs ai/ 2000 lbs of finished paper Pulp slurry ( e. g., water/ paper pulp mixture) is 1% pulp therefore, 2000 lbs paper/ 0.01 = 200,000 lbs of slurry 1.2 lbs ai/ 200,000 lbs of slurry = 6.0 ppm of ai in the slurry Conc. of ai in the pulp prior to entering the driers is: Adjusted application rate x water/ pulp ratio ( 6.0 µ g ai/ g slurry water) x ( 67 g water/ 33 g pulp) = 12.2 µ g ai/ g pulp Conc. of ai in the finished paper is: Adjusted application rate x percentage of pulp in finished paper: ( 12.2 µ g ai/ g pulp) x ( 0.92 g pulp / g finished paper) = 11.2 µ g ai/ g paper Determination of dietary concentration: App rate x Basis paperweight x Surface area contacting food x Consumption factor x % migration ( 11.2 µ g ai/ g paper) ( 0.05 g paper/ in2 paper) ( in2 paper/ 10 g food) ( 0.1) ( 100%) = 0.0056 µ g ai/ g food or 5.6 ppb Determination of the Estimated Daily Intake ( EDI): Dietary conc. x Daily food consumption Adult: ( 0.0056 µ g ai/ g food) ( 3000 g food / day) = 16.8 µ g ai/ person/ day Child: ( 0.0056 µ g ai/ g food) ( 1500 g food / day) = 8.4 µ g ai/ person/ day Determination of the Daily Dietary Dose: EDI / Body Weight Adult: ( 16.8 µ g ai / day) ( mg/ 1000 µ g) / ( 70 kg) = 0.00024 mg ai/ kg bw/ day Adult: ( 16.8 µ g ai / day) ( mg/ 1000 µ g) / ( 60 kg) = 0.00028 mg ai/ kg bw/ day Child: ( 8.4 µ g ai/ day) ( mg/ 1000 µ g) / ( 15 kg) = 0.00056 mg ai/ kg bw/ day Paper Coating Preservative Use The label use appears to permit the use of coated paper for both dry and wet food.

2( Thiocyanomethylthio) benzothiazole ( TCMTB) can be used to preserve paper coating formulations. Several labels bear paper coating uses but the use rate for application to the coating is unclear. Example: EPA Reg.# 1448 37. The label states: " Rate of application will vary per coating rate." The registrant must clarify the labeling to show the label rates( ranges) for the paper coating uses.

In the case of EPA Reg. # 1448 81, label directions state: " To inhibit the growth of bacteria and fungi in paper making additives ( including alum solutions, animal glue Page 5 of 9 solutions, pigment slurries, coating formulations, and starch slurries and solutions) Busan 1009 is added to these materials in concentrations of 50 400 ppm ( weight/ weight)". The calculations for TCMTB residues in the paper coating and in food are:

Dietary exposures to TCMTB from this formulation were estimated using the following assumptions:

  The preservative is added to paper coating formulations at a maximum application rate of 400 ppm, which is equivalent to 40 ppm on an ai basis ( EPA Reg. No. 1448 81 contains 10.0% ai).

  The paper coating is approximately 10%, by weight, of paper.

  The standard basis weight of paper is 50 mg/ in2.

  The amount of food contacting the paper packaging is 10 g of food/ in2 of paper.

  The consumption factor ( CF) ( percentage of daily diet expected to contact paper coatings) is 20%.

  There is 100% migration of TCMTB from the treated paper into food.

  Adult food consumption is 3 kg/ day; child food consumption is 1.5 kg/ day.

  Adult body weight is 70 kg for a male and 60 kg for a female; child body weight is 15 kg.

In the case of EPA Reg.# 1448 81, the calculations for TCMTB residues in the paper coating and in food are:

Calculations:

Determination of dietary concentration: App rate x % of paper that is coating x Basis paperweight x Surface area contacting food x Consumption factor x % migration ( 40 µ g ai/ g coating) ( 0.10 g coating/ g paper) ( 0.05 g paper/ in2 paper) ( in2 paper/ 10 g food) ( 0.2) = 0.004 µ g ai/ g food or 4.0 ppb Determination of the Estimated Daily Intake ( EDI): Dietary conc. x Daily food consumption Adult: ( 0.004 µ g ai/ g food) ( 3000 g food / day) = 12.0 µ g ai/ person/ day Child: ( 0.004 µ g ai/ g food) ( 1500 g food / day) = 6.0 µ g ai/ person/ day Determination of the Daily Dietary Dose: Page 6 of 9 EDI / Body Weight Adult: ( 12.0 µ g ai / day) ( mg/ 1000 µ g) / ( 70 kg) = 0.00017 mg ai/ kg ( 0.17ppb) bw/ day Adult: ( 12.0 µ g ai / day) ( mg/ 1000 µ g) / ( 60 kg) = 0.0002 mg ai/ kg ( 0.2 ppb) bw/ day Child: ( 6.0 µ g ai/ day) ( mg/ 1000 µ g) / ( 15 kg) = 0.0004 mg ai/ kg ( 0.4 ppb) bw/ day Paper Adhesive Preservative Use Several labels claim that TCMTB can be used to preserve paper adhesive formulations. However, it does not appear that this use has been cleared by the US FDA under 21 CFR175.105. Although the adhesive use has not been officially cleared by US FDA, it was included in this assessment in order to determine the total dietary exposure from all paper uses. Dietary exposures to TCMTB from this type of use were estimated using the following assumptions:

  Based on FDA's guidance document, it was assumed that a chemical used as " an adhesive or adhesive component in accordance with the limitations of 21CFR175.105, migration levels for the substance generally will be assumed to be no greater that 50 ppb. Applying a CF ( consumption factor) of 0.14 for adhesives gives a dietary concentration of 7 ppb" ( US FDA, 2002). Note: CF is the percentage of daily diet expected to contact paper adhesives.   Adult food consumption is 3 kg/ day; child food consumption is 1.5 kg/ day. Adult body weight is 70 kg for a male, 60 kg for a female and for a child 15 kg.

Calculations:

Determination of the Estimated Daily Intake ( EDI): Dietary conc. x Daily food consumption Adult: ( 0.007 µ g ai/ g food) ( 3000 g food / day) = 21.0 µ g ai/ person/ day Child: ( 0.007 µ g ai/ g food) ( 1500 g food / day) = 10.5 µ g ai/ person/ day Determination of the Daily Dietary Dose: EDI / Body Weight Adult: ( 21.0 µ g ai / day) ( mg/ 1000 µ g) / ( 70 kg) = 0.00030 mg ai/ kg bw/ day Adult: ( 21.0 µ g ai / day) ( mg/ 1000 µ g) / ( 60 kg) = 0.00035 mg ai/ kg bw/ day Child: ( 10.5 µ g ai/ day) ( mg/ 1000 µ g) / ( 15 kg) = 0.0007 mg ai/ kg bw/ day Page 7 of 9 TABLE 1 Cumulative Estimated Dietary Intake of TCMTB Use Dietary Conc. ( ppb) Estimated Daily Intake ( µ g/ person/ day) Daily Dietary Dose ( mg/ kg bw/ day) Pulp/ Paper Slimicide 5.6 16.8 ( adult M) 16.8 ( adult F) 8.4( child) 0.00024( adult) 0.00028 ( adult) 0.00056 ( child) Paper Coating Preservative 4 12 ( adult M) 12 ( adult F) 6 ( child) 0.00017 ( adult) 0.0002 ( adult) 0.0004 ( child) Paper Adhesive Preservative 7 21 ( adult M) 21 ( adult F) 10.5 ( child) 0.00030 ( adult) 0.00035 ( adult) 0.0007 ( child) Cumulative 16.6 49.8 ( adult) 24.9 ( child) 0.00071( adult M) 0.00083 ( adult F) 0.0017 ( child)

Utilizing the acute RfD or aPAD of 0.25 mg/ kg day taken from the Timothy McMahon memo dated 12/ 22/ 2005, the dietary risks were estimated and summarized in Table 2.

Utilizing the chronic RfD or cPAD of 0.013 mg/ kg day taken from the Timothy McMahon memo, the dietary risks were estimated and summarized in Table 2. Page 8 of 9 TABLE 2 Dietary Risks of TCMTB USE Daily Dietary Dose ( mg/ kg bw/ day) % aPAD % cPAD Pulp/ Paper Slimicide 0.00024 ( adult M) 0.00028 ( adult F) 0.00056 ( child) 0.096 ( adult M) 0.11 ( adult F) 0.22 ( child) 1.8 ( adult M) 2.2 ( adult F) 4.3 ( child) Paper Coating Preservative 0.00017 ( adult M) 0.0002 ( adult F) 0.0004 ( child) 0.07 ( adult M) 0.08 ( adult F) 0.16 ( child) 1.31 ( adult M) 1.54 ( adult F) 3.08 ( child) Paper Adhesive Preservative 0.00030 ( adult M) 0.00035 ( adult F) 0.0007 ( child) 0.12 ( adult M) 0.14 ( adult F) 0.28 ( child) 2.3 ( adult M) 2.7 ( adult F) 5.38 ( child) Cumulative 0.00071 ( adult M) 0.00083 ( adult F) 0.0017 ( child) 0.29 ( adult M) 0.33 ( adult F) 0.66 ( child) 5.41 ( adult M) 6.44 ( adult F) 12.8 ( child)

Other Issues 1. The chemical, 2 mercaptobenzothiazole, is the main mammalian metabolite of TCMTB ( Timothy McMahon memo dated 12/ 22/ 2005). This chemical and its sodium and potassium salts are also permitted for use as slimicides by the Food & Drug Administration in pulp and papermaking ( 21 CFR 176.300). Residues of this chemical may also be present as a result of this use of TCMTB in papermaking.

The registrant must address the question of whether the use of TCMTB in pulp and papermaking will result in residues of 2 mercaptobenzothiazole in paper produced using TCMTB and provide information on the level of 2 mercaptobenzothiazole that will occur in paper.

The EPA OPPIN reference does not show any active registrations for 2 mercaptobenzothiazole.

2. The registrant must clarify the labeling to show the label rates ( ranges) for the paper coating uses.

3. In the registrant's latest e mail response dated 12/ 14/ 2005, the registrant states, " It might be more efficient to put limitations in the label use directions in which text is added Page 9 of 9 stating in effect of ` Not for use in coatings intended for food contact'. Will this suffice?" AD does not consider label restrictions such as, " Not for food contact use", to be practical. AD would consider a label restriction( s) for paper that defines the type of paper that is to be treated; e. g., use sites such as wallboard paper, insulation backing, newsprint, photographic paper, drawing paper, etc. for label restrictions that preclude food contact as practical. These types of paper are not likely to be used for food contact.

The registrant could also revise the slimicide use on the labels in the same manner that AD has suggested above for the paper coating use; i. e. define the type of paper that is to be treated. This would help preclude food contact with TCMTB treated paper.


[Federal Register Volume 83, Number 26 (Wednesday, February 7, 2018)]
[Notices]
[Pages 5441-5445]
[FR Doc No: 2018-02413]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2018-N-0270]

Agency Information Collection Activities; Proposed Collection;
Comment Request; Survey on the Occurrence of Foodborne Illness Risk
Factors in Selected Institutional Foodservice and Retail Food Stores
Facility Types

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA or Agency) is announcing
an opportunity for public comment on the proposed collection of certain
information by the Agency. Under the Paperwork Reduction Act of 1995
(PRA), Federal Agencies are required to publish notice in the Federal
Register concerning each proposed collection of information, including
each proposed reinstatement of an existing collection of information,
and to allow 60 days for public comment in response to the notice. This
notice solicits comments on the ``Survey on the Occurrence of Foodborne
Illness Risk Factors in Selected Institutional Foodservice and Retail
Food Stores Facility Types.''

DATES: Submit either electronic or written comments on the collection
of information by April 9, 2018.

ADDRESSES: You may submit comments as follows. Please note that late,
untimely filed comments will not be considered. Electronic comments
must be submitted on or before April 9, 2018. The https://www.regulations.gov electronic filing system will accept comments until
midnight Eastern Time at the end of April 9, 2018. Comments received by
mail/hand delivery/courier (for written/paper submissions) will be
considered timely if they are postmarked or the delivery service
acceptance receipt is on or before that date.

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-N-0270 for ``Survey on the Occurrence of Foodborne Illness
Risk Factors in Selected Institutional Foodservice and Retail Food
Stores Facility Types.'' Received comments, those filed in a timely
manner (see ADDRESSES), 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.'' The Agency will
review this copy, including the claimed confidential information, in
its 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.

FOR FURTHER INFORMATION CONTACT: Ila S. Mizrachi, Office of Operations,
Food and Drug Administration, Three White Flint North, 10A-12M, 11601
Landsdown St., North Bethesda, MD 20852,<PHONE_NUMBER>,
[email protected].

SUPPLEMENTARY INFORMATION: Under the PRA (44 U.S.C. 3501-3520), 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, including
each proposed reinstatement of an existing 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.

Survey on the Occurrence of Foodborne Illness Risk Factors in Selected
Institutional Foodservice and Retail Food Stores Facility Types

OMB Control Number 0910-0799--Reinstatement

I. Background
    From 1998 to 2008, FDA's National Retail Food Team conducted a
study to measure trends in the occurrence of foodborne illness risk
factors, preparation practices, and employee behaviors most commonly
reported to the Centers for Disease Control and Prevention as
contributing factors to foodborne illness outbreaks at the retail
level. Specifically, data was collected by FDA specialists in retail
and foodservice establishments at 5-year intervals (1998, 2003, and
2008) to observe and document trends in the occurrence of the following
foodborne illness risk factors:
     Food from Unsafe Sources,
     Poor Personal Hygiene,
     Inadequate Cooking,
     Improper Holding/Time and Temperature, and
     Contaminated Equipment/Cross-Contamination.
    FDA developed reports summarizing the findings for each of the
three data collection periods (1998, 2003, and 2008) (Refs. 1 to 3).
Data from all three data collection periods were analyzed to detect
trends in improvement or regression over time and to determine whether
progress had been made toward the goal of reducing the occurrence of
foodborne illness risk factors in selected retail and foodservice
facility types (Ref. 4).
    Using this 10-year survey as a foundation, in 2013-2014, FDA
initiated a new study in full service and fast food restaurants. This
study will span 10 years with additional data collections planned for
2017-2018 and 2021-2022.
    FDA recently completed the baseline data collection in select
health care, school, and retail food store facility types in 2015-2016.
This proposed study will also span 10 years with additional data
collections planned for 2019-2020 (the subject of this information
collection request reinstatement) and 2023-2024 (which

will be posted in the Federal Register at the next renewal).

    Table 1--Description of the Facility Types Included in the Survey
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        Facility type                         Description
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Health Care Facilities.......  Hospitals and long-term care facilities
                                foodservice operations that prepare
                                meals for highly susceptible populations
                                as defined as follows:
                                Hospitals--A foodservice
                                operation that provides for the
                                nutritional needs of inpatients by
                                preparing meals and transporting them to
                                the patient's room and/or serving meals
                                in a cafeteria setting (meals in the
                                cafeteria may also be served to hospital
                                staff and visitors).
                                Long-term care facilities--A
                                foodservice operation that prepares
                                meals for the residents in a group care
                                living setting such as nursing homes and
                                assisted living facilities.
                               Note: For the purposes of this study,
                                health care facilities that do not
                                prepare or serve food to a highly
                                susceptible population, such as mental
                                health care facilities, are not included
                                in this facility type category.
Schools (K-12)...............  Foodservice operations that have the
                                primary function of preparing and
                                serving meals for students in one or
                                more grade levels from kindergarten
                                through grade 12. A school foodservice
                                may be part of a public or private
                                institution.
Retail Food Stores...........  Supermarkets and grocery stores that have
                                a deli department/operation as described
                                as follows:
                                Deli department/operation--Areas
                                in a retail food store where foods, such
                                as luncheon meats and cheeses, are
                                sliced for the customers and where
                                sandwiches and salads are prepared
                                onsite or received from a commissary in
                                bulk containers, portioned, and
                                displayed. Parts of deli operations may
                                include:
                                Salad bars, pizza stations, and
                                other food bars managed by the deli
                                department manager.
                                Areas where other foods are
                                cooked or prepared and offered for sale
                                as ready-to-eat and are managed by the
                                deli department manager.
                               Data will also be collected in the
                                following areas of a supermarket or
                                grocery store, if present:
                                Seafood department/operation--
                                Areas in a retail food store where
                                seafood is cut, prepared, stored, or
                                displayed for sale to the consumer. In
                                retail food stores where the seafood
                                department is combined with another
                                department (e.g. meat), the data
                                collector will only assess the
                                procedures and practices associated with
                                the processing of seafood.
                                Produce department/operation--
                                Areas in a retail food store where
                                produce is cut, prepared, stored, or
                                displayed for sale to the consumer. A
                                produce operation may include salad bars
                                or juice stations that are managed by
                                the produce manager.
------------------------------------------------------------------------

    The purpose of the study is to:
     Assist FDA with developing retail food safety initiatives
and policies focused on the control of foodborne illness risk factors;
     Identify retail food safety work plan priorities and
allocate resources to enhance retail food safety nationwide;
     Track changes in the occurrence of foodborne illness risk
factors in retail and foodservice establishments over time; and
     Inform recommendations to the retail and foodservice
industry and State, local, tribal, and territorial regulatory
professionals on reducing the occurrence of foodborne illness risk
factors.
    The statutory basis for FDA conducting this study is derived from
the Public Health Service Act (PHS Act) (42 U.S.C. 243, section
311(a)). Responsibility for carrying out the provisions of the PHS Act
relative to food protection was transferred to the Commissioner of Food
and Drugs in 1968 (21 CFR 5.10(a)(2) and (4)). Additionally, the
Federal Food, Drug, and Cosmetic Act (21 U.S.C. 301 et seq.) and the
Economy Act (31 U.S.C. 1535) require FDA to provide assistance to other
Federal, State, and local government bodies.
    The objectives of the study are to:
     Identify the least and most often occurring foodborne
illness risk factors and food safety behaviors/practices in health
care, school, restaurant, and retail food store facility types during
each data collection period;
     Track improvement and/or regression trends in the
occurrence of foodborne illness risk factors during the 10-year study
period;
     Examine potential correlations between operational
characteristics of food establishments and the control of foodborne
illness risk factors;
     Examine potential correlations between elements within
regulatory retail food protection programs and the control of foodborne
illness risk factors; and
     Determine the extent to which food safety management
systems and the presence of a certified food protection manager impact
the occurrence of foodborne illness risk factors.
    The methodology to be used for this information collection is
described as follows. To obtain a sufficient number of observations to
conduct statistically significant analysis, FDA will conduct
approximately 400 data collections in each facility type. This sample
size has been calculated to provide for sufficient observations to be
95 percent confident that the compliance percentage is within 5 percent
of the true compliance percentage.
    A geographical information system database containing a listing of
businesses throughout the United States provides the establishment
inventory for the data collections. FDA samples establishments from the
inventory based on the descriptions in table 1. FDA does not intend to
sample operations that handle only prepackaged food items or conduct
low-risk food preparation activities. The ``FDA Food Code'' contains a
grouping of establishments by risk, based on the type of food
preparation that is normally conducted within the operation (Ref. 5).
The intent is to sample establishments that fall under risk categories
2 through 4.
    FDA has approximately 25 Regional Retail Food Specialists
(Specialists) who serve as the data collectors for the 10-year study.
The Specialists are geographically dispersed throughout the United
States and possess technical expertise in retail food safety and a
solid understanding of the operations within each of the facility types
to be surveyed. The Specialists are also standardized by FDA's Center
for Food Safety and Applied Nutrition personnel in the application and
interpretation of the FDA Food Code (Ref. 5).
    Sampling zones have been established that are equal to the 150-mile
radius

around a Specialist's home location. The sample is selected randomly
from among all eligible establishments located within these sampling
zones. The Specialists are generally located in major metropolitan
areas (i.e., population centers) across the contiguous United States.
Population centers usually contain a large concentration of the
establishments FDA intends to sample. Sampling from the 150-mile radius
sampling zones around the Specialists' home locations provides three
advantages to the study:
    1. It provides a cross-section of urban and rural areas from which
to sample the eligible establishments.
    2. It represents a mix of small, medium, and large regulatory
entities having jurisdiction over the eligible establishments.
    3. It reduces overnight travel and therefore reduces travel costs
incurred by the Agency to collect data.
    The sample for each data collection period is evenly distributed
among Specialists. Given that participation in the study by industry is
voluntary and the status of any given randomly selected establishment
is subject to change, substitute establishments have been selected for
each Specialist for cases where the institutional foodservice, school,
or retail food store facility is misclassified, closed, or otherwise
unavailable, unable, or unwilling to participate.
    Prior to conducting the data collection, Specialists contact the
State or local jurisdiction that has regulatory responsibility for
conducting retail food inspections for the selected establishment. The
Specialist verifies with the jurisdiction that the facility has been
properly classified for the purposes of the study and is still in
operation. The Specialist ascertains whether the selected facility is
under legal notice from the State or local regulatory authority. If the
selected facility is under legal notice, the Specialist will not
conduct a data collection, and a substitute establishment will be used.
An invitation is extended to the State or local regulatory authority to
accompany the Specialist on the data collection visit.
    A standard form is used by the Specialists during each data
collection. The form is divided into three sections: Section 1--
``Establishment Information''; Section 2--``Regulatory Authority
Information''; and Section 3--``Foodborne Illness Risk Factor and Food
Safety Management System Assessment''. The information in Section 1--
``Establishment Information'' of the form is obtained during an
interview with the establishment owner or person in charge by the
Specialist and includes a standard set of questions.
    The information in Section 2--``Regulatory Authority Information''
is obtained during an interview with the program director of the State
or local jurisdiction that has regulatory responsibility for conducting
inspections for the selected establishment. Section 3 includes three
parts: Part A for tabulating the Specialists' observations of the food
employees' behaviors and practices in limiting contamination,
proliferation, and survival of food safety hazards; Part B for
assessing the food safety management system being implemented by the
facility; and Part C for assessing the frequency and extent of food
employee hand washing. The information in Part A is collected from the
Specialists' direct observations of food employee behaviors and
practices. Infrequent, nonstandard questions may be asked by the
Specialists if clarification is needed on the food safety procedure or
practice being observed. The information in Part B is collected by
making direct observations and asking follow up questions of facility
management to obtain information on the extent to which the food
establishment has developed and implemented food safety management
systems. The information in Part C is collected by making direct
observations of food employee hand washing. No questions are asked in
the completion of Section 3, Part C of the form.
    FDA collects the following information associated with the
establishment's identity: Establishment name, street address, city,
state, ZIP code, county, industry segment, and facility type. The
establishment identifying information is collected to ensure the data
collections are not duplicative. Other information related to the
nature of the operation, such as seating capacity and number of
employees per shift, is also collected. Data will be consolidated and
reported in a manner that does not reveal the identity of any
establishment included in the study.
    FDA has collaborated with the Food Protection and Defense Institute
to develop a web-based platform in FoodSHIELD to collect, store, and
analyze data for the Retail Risk Factor Study. This platform is
accessible to State, local, territorial, and tribal regulatory
jurisdictions to collect data relevant to their own risk factor
studies. For the 2015-2016 data collection, FDA piloted the use of
hand-held technology for capturing the data onsite during the data
collection visits. The tablets that were made available for the data
collections were part of a broader Agency initiative focused on
internal uses of hand-held technology. The tablets provided for the
data collection presented several technical and logistical challenges
and increased the time burden associated with the data collection as
compared to the manual entry of data collections. FDA continues to
assess the feasibility for fully incorporating use of hand-held
technology in subsequent data collections during the 10-year study
period.
    When a data collector is assigned a specific establishment, he or
she conducts the data collection and enters the information into the
web-based data platform. The interface will support the manual entering
of data, as well as the ability to directly enter information in the
database via a web browser.
    The burden for the 2019-2020 data collection is as follows. For
each data collection, the respondents will include: (1) The person in
charge of the selected facility (whether it be a health care facility,
school, or supermarket/grocery store) and (2) the program director (or
designated individual) of the respective regulatory authority. To
provide the sufficient number of observations needed to conduct a
statistically significant analysis of the data, FDA has determined that
400 data collections will be required in each of the three facility
types. Therefore, the total number of responses will be 2,400 (400 data
collections x 3 facility types x 2 respondents per data collection).
    The burden associated with the completion of Sections 1 and 3 of
the form is specific to the persons in charge of the selected
facilities. It includes the time it will take the person in charge to
accompany the data collector during the site visit and answer the data
collector's questions. The burden related to the completion of Section
2 of the form is specific to the program directors (or designated
individuals) of the respective regulatory authorities. It includes the
time it will take to answer the data collectors' questions and is the
same regardless of the facility type.
    To calculate the estimate of the hours per response, FDA uses the
average data collection duration for similar facility types during the
FDA's 2008 Risk Factor Study (Ref. 3) plus an additional 30 minutes
(0.5 hours) for the information related to Section 3, Part B of the
form. FDA estimates that it will take the persons in charge of health
care facility types, schools, and retail food stores 150 minutes (2.5
hours), 120 minutes (2 hours), and 180 minutes (3 hours), respectively,
to accompany the data

collectors while they complete Sections 1 and 3 of the form. FDA
estimates that it will take the program director (or designated
individual) of the respective regulatory authority 30 minutes (0.5
hours) to answer the questions related to Section 2 of the form. This
burden estimate is unchanged from the last data collection. Hence, the
total burden estimate for a data collection in health care facility
types is 180 minutes (150 + 30) (3 hours), in schools is 150 minutes
(120 + 30) (2.5 hours), and retail food stores is 210 minutes (180 +
30) (3.5 hours).
    Based on the number of entry refusals from the 2015-2016 baseline
data collection, we estimate a refusal rate of 2 percent for the data
collections within health care, school, and retail food store facility
types. The estimate of the time per non-respondent is 5 minutes (0.08
hours) for the person in charge to listen to the purpose of the visit
and provide a verbal refusal of entry.
    FDA estimates the burden of this collection of information as
follows:

                                                      Table 2--Estimated Annual Reporting Burden 1
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                   Number of                              Number of
                                      Number of    responses      Total      Number of    responses      Total         Average  burden per       Total
              Activity               respondents      per         annual        non-       per non-   annual non-           response             hours
                                                   respondent   responses   respondents   respondent   responses
--------------------------------------------------------------------------------------------------------------------------------------------------------
2019-2020 Data Collection (Health            400            1          400  ...........  ...........  ...........  2.5.......................      1,000
 Care Facilities)--Completion of
 Sections 1 and 3.
2019-2020 Data Collection                    400            1          400  ...........  ...........  ...........  2.........................        800
 (Schools)--Completion of Sections
 1 and 3.
2019-2020 Data Collection (Retail            400            1          400  ...........  ...........  ...........  3.........................      1,200
 Food Stores)--Completion of
 Sections 1 and 3.
2019-2020 Data Collection-                 1,200            1        1,200  ...........  ...........  ...........  .5 (30 minutes)...........        600
 Completion of Section 2--All
 Facility Types.
2019-2020 Data Collection-Entry      ...........  ...........  ...........           24            1           24  .08 (5 minutes)...........       1.92
 Refusals--All Facility Types.
                                    --------------------------------------------------------------------------------------------------------------------
    Total..........................  ...........  ...........  ...........  ...........  ...........  ...........  ..........................   3,601.92
--------------------------------------------------------------------------------------------------------------------------------------------------------
1 There are no capital costs or operating and maintenance costs associated with this collection of information.

    The burden for this information collection has not changed since
the last OMB approval.
II. References
    The following references are on display in the Dockets Management
Staff (see ADDRESSES) and are available for viewing by interested
persons between 9 a.m. and 4 p.m., Monday through Friday; they are also
available electronically at https://www.regulations.gov. FDA has
verified the website addresses, as of the date this document publishes
in the Federal Register, but websites are subject to change over time.

1. ``Report of the FDA Retail Food Program Database of Foodborne
Illness Risk Factors'' (2000). Available at: https://wayback.archive-it.org/7993/20170406023019/https://www.fda.gov/downloads/Food/GuidanceRegulation/UCM123546.pdf.
2. ``FDA Report on the Occurrence of Foodborne Illness Risk Factors
in Selected Institutional Foodservice, Restaurant, and Retail Food
Store Facility Types'' (2004). Available at: https://wayback.archive-it.org/7993/20170406023011/https://www.fda.gov/downloads/Food/GuidanceRegulation/RetailFoodProtection/FoodborneIllnessRiskFactorReduction/UCM423850.pdf.
3. ``FDA Report on the Occurrence of Foodborne Illness Risk Factors
in Selected Institutional Foodservice, Restaurant, and Retail Food
Store Facility Types'' (2009). Available at: https://wayback.archive-it.org/7993/20170406023004/https://www.fda.gov/Food/GuidanceRegulation/RetailFoodProtection/FoodborneIllnessRiskFactorReduction/ucm224321.htm.
4. FDA National Retail Food Team. ``FDA Trend Analysis Report on the
Occurrence of Foodborne Illness Risk Factors in Selected
Institutional Foodservice, Restaurant, and Retail Food Store
Facility Types (1998-2008).'' Available at: https://wayback.archive-it.org/7993/20170406022950/https://www.fda.gov/Food/GuidanceRegulation/RetailFoodProtection/FoodborneIllnessRiskFactorReduction/ucm223293.htm.
5. ``FDA Food Code.'' Available at: https://www.fda.gov/Food/GuidanceRegulation/RetailFoodProtection/FoodCode/default.htm.

    Dated: January 31, 2018.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2018-02413 Filed 2-6-18; 8:45 am]
BILLING CODE 4164-01-P


[Federal Register Volume 87, Number 119 (Wednesday, June 22, 2022)]
[Rules and Regulations]
[Pages 37235-37237]
[FR Doc No: 2022-13292]

=======================================================================
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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 52

[EPA-R04-OAR-2022-0506; FRL-9895-01-R4]

Finding of Failure To Submit a Clean Air Act Section 110 State
Implementation Plan for Interstate Transport for the 2015 Ozone
National Ambient Air Quality Standards (NAAQS)

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final action.

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SUMMARY: The Environmental Protection Agency (EPA) is taking final
action, finding that the State of Alabama failed to submit a complete
infrastructure State Implementation Plan (SIP) revision to satisfy
certain interstate transport requirements of the Clean Air Act (CAA or
Act) with respect to the 2015 8-hour ozone national ambient air quality
standards (NAAQS). Specifically, these requirements pertain to
prohibiting significant contribution to nonattainment, or interference
with maintenance, of the 2015 8-hour ozone NAAQS in other states. This
finding of failure to submit a complete revision establishes a 2-year
deadline for EPA to promulgate a Federal Implementation Plan (FIP) to
address these interstate transport requirements for Alabama unless,
prior to EPA promulgating a FIP, Alabama submits, and EPA approves, a
SIP that meets these requirements.

DATES: Effective date of this action is July 22, 2022.

ADDRESSES: EPA has established a docket for this action under Docket
Identification No. EPA-R04-OAR-2022-0506. All documents in the docket
are listed on the www.regulations.gov website. Although listed in the
index, some information may not be publicly available, i.e.,
Confidential Business Information or other information whose disclosure
is restricted by statute. Certain other material, such as copyrighted
material, is not placed on the internet and will be publicly available
only in hard copy form. Publicly available docket materials can either
be retrieved electronically via www.regulations.gov or in hard copy at
the Air Regulatory Management Section, Air Planning and Implementation
Branch, Air and Radiation Division, U.S. Environmental Protection
Agency, Region 4, 61 Forsyth Street SW, Atlanta, Georgia 30303-8960.
EPA requests that if at all possible, you contact the person listed in
the FOR FURTHER INFORMATION CONTACT section to schedule your
inspection. The Regional Office's official hours of business are Monday
through Friday 8:30 a.m. to 4:30 p.m., excluding Federal holidays.

FOR FURTHER INFORMATION CONTACT: Evan Adams of the Air Regulatory
Management Section, Air Planning and Implementation Branch, Air and
Radiation Division, U.S. Environmental Protection Agency, Region 4, 61
Forsyth Street SW, Atlanta, Georgia 30303-8960. Mr. Adams can be
reached by telephone at<PHONE_NUMBER>, or via electronic mail at
[email protected].

SUPPLEMENTARY INFORMATION:

I. Notice and Comment Under the Administrative Procedure Act (APA)

    Section 553 of the APA, 5 U.S.C. 553(b)(3)(B), provides that, when
an agency for good cause finds that notice and public procedure are
impracticable, unnecessary, or contrary to the public interest, the
agency may issue a rule without providing notice and an opportunity for
public comment. EPA has determined that there is good cause for making
this final agency action without prior proposal and opportunity for
comment because no significant EPA judgment is involved in making a
finding of failure to submit SIPs, or elements of SIPs, required by the
CAA, where states have made no submissions or incomplete submissions,
to meet the requirement. Specifically, and as discussed further in the
preamble, Alabama has withdrawn a prior submission and has not made a
complete submission under CAA section 110(a)(2)(D)(i)(I) for the 2015
ozone NAAQS. Thus, notice and public procedure are unnecessary. EPA
finds that this constitutes good cause under 5 U.S.C. 553(b)(3)(B).

II. Background and Overview

A. Interstate Transport SIPs

    CAA section 110(a) imposes an obligation upon states to submit SIP
revisions that provide for the implementation, maintenance, and
enforcement of a new or revised NAAQS within 3 years following the
promulgation of that NAAQS. CAA section 110(a)(2) lists specific
requirements that states must meet in these SIP submissions, as
applicable. EPA refers to this type of SIP as an

``infrastructure'' SIP because it ensures that states can implement,
maintain, and enforce the new or revised air standards. Within these
requirements, CAA section 110(a)(2)(D)(i) contains requirements to
address interstate transport of NAAQS pollutants. A SIP for this sub-
section is referred to as an ``interstate transport SIP.'' In turn, CAA
section 110(a)(2)(D)(i)(I) requires that such a plan contain adequate
provisions to prohibit emissions from the state that will contribute
significantly to nonattainment of the NAAQS in any other state (``prong
1'') or interfere with maintenance of the NAAQS in any other state
(``prong 2''). Interstate transport prongs 1 and 2, also called
collectively the ``good neighbor'' provision, are the requirements
relevant to this action.
    Pursuant to CAA section 110(k)(1)(B), EPA must determine within 60
days of receipt, but no later than 6 months after the date by which a
state is required to submit a SIP revision, whether a state has made a
submission that meets the minimum completeness criteria established
pursuant to CAA section 110(k)(1)(A). These criteria are set forth at
40 CFR part 51, appendix V. EPA refers to the determination that a
state has not submitted a SIP submission that meets the minimum
completeness criteria as a ``finding of failure to submit.'' If EPA
finds a state has failed to submit a SIP revision to meet its statutory
obligation to address CAA section 110(a)(2)(D)(i)(I), then pursuant to
CAA section 110(c)(1), EPA has not only the authority, but the
obligation, to promulgate a FIP within 2 years to address the CAA
requirement. This finding, therefore, starts a 2-year ``clock'' for
promulgation by EPA of a FIP, in accordance with CAA section 110(c)(1),
unless prior to such promulgation the state submits, and EPA approves,
a revision from the state to meet the requirements of CAA section
110(a)(2)(D)(i)(I). Even where EPA has promulgated a FIP, EPA will
withdraw that FIP if a state submits, and EPA approves, a SIP
satisfying the relevant requirements. EPA notes that this action does
not start a mandatory sanctions clock pursuant to CAA section 179
because this finding of failure to submit does not pertain to a part D
plan for nonattainment areas, required under CAA section 110(a)(2)(I),
or a SIP call pursuant to CAA section 110(k)(5).

B. Background on 2015 Ozone NAAQS, Alabama SIP Revisions, and
Incompleteness Determination

    On October 1, 2015, EPA promulgated a new 8-hour primary and
secondary ozone NAAQS of 70 parts per billion (ppb), which is met when
the 3-year average of the annual fourth highest daily maximum 8-hour
concentration does not exceed 70 ppb.\1\ Pursuant to the 3-year period
provided in CAA section 110(a)(1), infrastructure SIP revisions
addressing the revised standard were due on October 1, 2018.\2\
---------------------------------------------------------------------------

    \1\ See Final Rule, National Ambient Air Quality Standards for
Ozone, 80 FR 65292 (October 26, 2015).
    \2\ EPA previously made findings of failure to submit with
respect to interstate transport obligations for the 2015 8-hour
ozone NAAQS for a number of other states. See 84 FR 66612 (December
5, 2019). As discussed further in this notice, at the time EPA made
those findings, Alabama had provided a complete submission, which it
has subsequently withdrawn.
---------------------------------------------------------------------------

    On August 20, 2018, Alabama submitted a SIP revision to address the
interstate transport requirements for the 2015 8-hour ozone NAAQS. On
February 22, 2022, EPA proposed to disapprove Alabama's August 20,
2018, SIP revision because the Agency preliminarily determined, based
on updated EPA modeling, that Alabama's SIP revision did not meet CAA
requirements to contain the necessary provisions to eliminate emissions
that will contribute significantly to nonattainment or interfere with
maintenance of the 2015 8-hour ozone NAAQS in any other state.\3\ See
87 FR 9545.
---------------------------------------------------------------------------

    \3\ Previously, EPA proposed approval of Alabama's August 20,
2018, interstate transport SIP submission for the 2015 8-hour ozone
NAAQS based on modeling released in 2018. See 84 FR 71854 (December
30, 2019). However, based on new modeling released in 2020, it
became evident that Alabama was projected to be linked above 1
percent of the 2015 8-hour ozone NAAQS to downwind nonattainment and
maintenance receptors (see 87 FR 9553 n.40). As a result, EPA
deferred acting on Alabama's SIP submission when it published a
supplemental proposal in 2021 to approve four other southeastern
states' good neighbor SIP submissions using the updated modeling.
See 86 FR 37942, 37943 (July 19, 2021). Additional modeling
confirmed the results of the 2020 modeling. In its February 22,
2022, notice, EPA announced that the Agency was withdrawing its 2019
proposed approval and was proposing disapproval of that submission
instead. See 87 FR 9545 (February 22, 2022).
---------------------------------------------------------------------------

    On April 21, 2022, Alabama withdrew its August 20, 2018, SIP
revision.\4\ Additionally, on that same day, Alabama provided EPA a new
SIP revision to address the CAA interstate transport requirements for
the 2015 8-hour ozone NAAQS.
---------------------------------------------------------------------------

    \4\ See the docket for this rulemaking for a copy of Alabama's
April 21, 2022, withdrawal letter.
---------------------------------------------------------------------------

    According to the CAA, a SIP revision may be considered ``complete''
by either of two methods: (1) EPA may make a determination that a SIP
is complete under the ``completeness criteria'' set out at 40 CFR part
51, appendix V, see CAA section 110(k)(1); or (2) a SIP may be deemed
complete by operation of law if EPA has failed to make a completeness
determination within 6 months after receipt of the State's SIP
submission, see CAA section 110(k)(1)(B).
    EPA evaluated the SIP revision that Alabama sent on April 21, 2022,
for completeness pursuant to the criteria in 40 CFR part 51, appendix
V, and concluded it is an incomplete SIP submission. On June 15, 2022,
EPA sent a letter to Alabama explaining the Agency's incompleteness
determination. This letter is included in the docket for this
action.\5\
---------------------------------------------------------------------------

    \5\ While this letter is included in the docket for this action,
and explains the deficiencies in the April 21, 2022, document, EPA
is not reopening its determination of incompleteness in this action.
---------------------------------------------------------------------------

    Where EPA determines that a SIP revision does not meet the Appendix
V completeness criteria, the state shall be treated as not having made
the submission. See CAA section 110(k)(1)(C). Accordingly, EPA is
finding that Alabama has failed to submit a complete SIP revision
addressing the requirements of CAA section 110(a)(2)(D)(i)(I) for the
2015 8-hour ozone NAAQS. Notwithstanding this finding, and the
associated obligation of EPA to promulgate a FIP for Alabama within two
years of this finding, EPA intends to continue to work with Alabama in
order to provide assistance as necessary to help the State develop an
approvable SIP revision.\6\
---------------------------------------------------------------------------

    \6\ EPA notes that there is no mechanism for the State to
rescind the prior withdrawal of its August 20, 2018, submission.
See, e.g., 80 FR 39961, 39964-65 (July 13, 2015); see also Letter,
from Beverly H. Banister, USEPA Region 4, to Sheila Holman, NCDENR,
``Response to North Carolina's June 26, 2015 Letter Seeking to
Rescind the September 3, 2014 Withdrawal of the 2008 Ozone
Infrastructure State Implementation Plan Certification Regarding
Interstate Transport'' (June 30, 2015) (EPA-HQ-OAR-2012-0943-0062)
(finding rescission of SIP withdrawal to constitute an incomplete
SIP revision and ``inappropriate'' where the withdrawal was relied
upon by plaintiffs and EPA in resolving deadline-suit litigation).
---------------------------------------------------------------------------

III. Finding of Failure To Submit for Failing To Make an Interstate
Transport SIP Submission for the 2015 Ozone NAAQS

    As explained in Section II of this preamble, EPA finds the Alabama
has not submitted a complete interstate transport SIP revision to meet
the requirements of CAA section 110(a)(2)(D)(i)(I) for the 2015 8-hour
ozone NAAQS.

IV. Environmental Justice Considerations

    This notice makes a procedural finding that Alabama has failed to
submit a SIP revision to address CAA section 110(a)(2)(D)(i)(I) for the
2015 ozone NAAQS. EPA did not conduct an

environmental analysis for this action because it would not directly
affect the air emissions of particular sources. Because this action
will not directly affect the air emissions of particular sources, it
does not affect the level of protection provided to human health or the
environment. Therefore, this action will not have potential
disproportionately high and adverse human health or environmental
effects on minority, low-income or indigenous populations.

V. Statutory and Executive Order Reviews

A. Executive Orders 12866: Regulatory Planning and Executive Order
13563: Improving Regulation and Regulatory Review

    This action is not a significant regulatory action and was,
therefore, not submitted to the Office of Management and Budget (OMB)
for review.

B. Paperwork Reduction Act

    This action does not impose an information collection burden under
the provisions of the Paperwork Reduction Act. This final action does
not establish any new information collection requirement apart from
what is already required by law. This finding relates to the
requirement in the CAA for states to submit SIPs under section
110(a)(2)(D)(i)(I) of the CAA for the 2015 ozone NAAQS.

C. Regulatory Flexibility Act (RFA)

    This action is not subject to the RFA. The RFA applies only to
rules subject to notice and comment rulemaking requirements under the
Administrative Procedure Act (APA), 5 U.S.C. 553 or any other statute.
This action is not subject to notice and comment requirements because
the agency has invoked the APA ``good cause'' exemption under 5 U.S.C.
553(b).

D. Unfunded Mandates Reform Act of 1995 (UMRA)

    This action does not contain any unfunded mandate as described in
UMRA 2 U.S.C. 1531-1538 and does not significantly or uniquely affect
small governments. The action imposes no enforceable duty on any state,
local or tribal governments or the private sector.

E. Executive Order 13132: Federalism

    This action does not have federalism implications. It will not have
substantial direct effects on the states, on the relationship between
the national government and the states, or on the distribution of power
and responsibilities among the various levels of government.

F. Executive Order 13175: Consultation and Coordination With Indian
Tribal Governments

    This action does not have tribal implications as specified in
Executive Order 13175. This action finds that Alabama has failed to
complete the requirement in the CAA to submit a SIP under section
110(a)(2)(D)(i)(I) of the CAA for the 2015 ozone NAAQS. No tribe is
subject to the requirement to submit a transport SIP under section
110(a)(2)(D)(i)(I) of the CAA for the 2015 ozone NAAQS. In addition,
the SIP is not approved to apply on any Indian reservation land or in
any other area where EPA or an Indian tribe has demonstrated that a
tribe has jurisdiction. Thus, Executive Order 13175 does not apply to
this action.

G. Executive Order 13045: Protection of Children From Environmental
Health and Safety Risks

    EPA interprets Executive Order 13045 as applying only to those
regulatory actions that concern health or safety risks that EPA has
reason to believe may disproportionately affect children, per the
definition of ``covered regulatory action'' in section 2-202 of the
Executive Order. This action is not subject to Executive Order 13045
because it is a finding that Alabama has failed to submit a complete
SIP that satisfies interstate transport requirements under section
110(a)(2)(D)(i)(I) of the CAA for the 2015 ozone NAAQS and does not
directly or disproportionately affect children.

H. Executive Order 13211: Actions That Significantly Affect Energy
Supply, Distribution or Use

    This action is not subject to Executive Order 13211, because it is
not a significant regulatory action under Executive Order 12866.

I. National Technology Transfer and Advancement Act

    This rulemaking does not involve technical standards.

J. Executive Order 12898: Federal Actions To Address Environmental
Justice in Minority Populations and Low-Income Populations

    EPA believes the human health or environmental risk addressed by
this action will not have potential disproportionately high and adverse
human health or environmental effects on minority, low-income, or
indigenous populations. In finding that Alabama has failed to submit a
complete SIP that satisfies the interstate transport requirements under
section 110(a)(2)(D)(i)(I) of the CAA for the 2015 ozone NAAQS, this
action does not adversely affect the level of protection provided to
human health or the environment.

K. Congressional Review Act (CRA)

    This action is subject to the CRA, and EPA will submit a rule
report to each House of the Congress and to the Comptroller General of
the United States. This action is not a ``major rule'' as defined by 5
U.S.C. 804(2).

L. Judicial Review

    Under section 307(b)(1) of the CAA, petitions for judicial review
of this action must be filed in the United States Court of Appeals for
the appropriate circuit by August 22, 2022. Filing a petition for
reconsideration by the Administrator of this final rule does not affect
the finality of this rule for the purposes of judicial review nor does
it extend the time within which a petition for judicial review may be
filed, and shall not postpone the effectiveness of such rule or action.
This action may not be challenged later in proceedings to enforce its
requirements (see CAA section 307(b)(2)).

List of Subjects in 40 CFR Part 52

    Environmental protection, Air pollution control, Incorporation by
reference, Intergovernmental relations, Ozone, Reporting and
recordkeeping requirements.

    Dated: June 15, 2022.
Daniel Blackman,
Regional Administrator, Region 4.
[FR Doc. 2022-13292 Filed 6-21-22; 8:45 am]
BILLING CODE 6560-50-P


[Federal Register Volume 76, Number 240 (Wednesday, December 14, 2011)]
[Notices]
[Pages 77863-77865]
[FR Doc No: 2011-32000]

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SECURITIES AND EXCHANGE COMMISSION

[Release No. 34-65915; File No. SR-NASDAQ-2011-166]

Self-Regulatory Organizations; The NASDAQ Stock Market LLC;
Notice of Filing and Immediate Effectiveness of Proposed Rule Change To
Amend Rule 4613(a)(2)(D) To Clarify That the Designated Percentage for
Rights and Warrants Is Thirty Percent

 December 8, 2011.
    Pursuant to Section 19(b)(1) of the Securities Exchange Act of 1934
(``Act''),\1\ and Rule 19b-4 thereunder,\2\ notice is hereby given that
on November 29, 2011, The NASDAQ Stock Market LLC (``NASDAQ''), filed
with the Securities and Exchange Commission (``Commission'') the
proposed rule change as described in Items I and II below, which Items
have been prepared by NASDAQ. The Commission is publishing this notice
to solicit comments on the proposed rule change from interested
persons.
---------------------------------------------------------------------------

    \1\ 15 U.S.C. 78s(b)(1).
    \2\ 17 CFR 240.19b-4.
---------------------------------------------------------------------------

I. Self-Regulatory Organization's Statement of the Terms of Substance
of the Proposed Rule Change

    NASDAQ proposes to amend Rule 4613(a)(2)(D) to clarify that the
Designated Percentage for rights and warrants, which are no longer
subject to Rule 4120(a)(11), is 30 percent.

    The text of the proposed rule change is below. Proposed new
language is italicized.

4613. Market Maker Obligations

    A member registered as a Market Maker shall engage in a course
of dealings for its own account to assist in the maintenance,
insofar as reasonably practicable, of fair and orderly markets in
accordance with this Rule.
    (a) Quotation Requirements and Obligations
    (1) No change.
    (2) Pricing Obligations. For NMS stocks (as defined in Rule 600
under Regulation NMS) a Market Maker shall adhere to the pricing
obligations established by this Rule during Regular Trading Hours;
provided, however, that such pricing obligations (i) shall not
commence during any trading day until after the first regular way
transaction on the primary listing market in the security, as
reported by the responsible single plan processor, and (ii) shall be
suspended during a trading halt, suspension, or pause, and shall not
re-commence until after the first regular way transaction on the
primary listing market in the security following such halt,
suspension, or pause, as reported by the responsible single plan
processor.
    (A)-(C) No change.
    (D) For purposes of this Rule, the ``Designated Percentage''
shall be 8% for securities subject to Rule 4120(a)(11)(A), 28% for
securities subject to Rule 4120(a)(11)(B), and 30% for securities
subject to Rule 4120(a)(11)(C), except that between 9:30 a.m. and
9:45 a.m. and between 3:35 p.m. and the close of trading, when Rule
4120(a)(11) is not in effect, the Designated Percentage shall be 20%
for securities subject to Rule 4120(a)(11)(A), 28% for securities
subject to Rule 4120(a)(11)(B), and 30% for securities subject to
Rule 4120(a)(11)(C).
     The Designated Percentage for rights and warrants shall be 30%.
    (E)-(K) No change.
    (b)-(e) No change.
* * * * *

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

    In its filing with the Commission, NASDAQ 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. NASDAQ 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 the
Statutory Basis for, the Proposed Rule Change

1. Purpose
    NASDAQ proposes to amend Rule 4613(a)(2)(D) to clarify that the
Designated Percentage for rights and warrants, which are not subject to
Rule 4120(a)(11), is 30 percent.
    On June 23, 2011, the Commission approved a proposed rule change of
NASDAQ, together with the analogous rule changes of other equity
exchanges and FINRA to amend their respective rules, to expand Rule
4120(a)(11) to include all remaining NMS stocks, which included rights
and warrants.\3\ In expanding the coverage of Rule 4120(a)(11), NASDAQ
also amended Rule 4613(a)(2)(D) to state specific Designated
Percentages for the securities covered under new Rules 4120(a)(11)(A)-
(C). Prior to the expansion, all NMS stocks not covered by Rule
4120(a)(11), including rights and warrants, had a Designated Percentage
of 30 percent. Given that rights and warrants are once again excluded
from the Rule 4120(a)(11) trading pause,\4\ NASDAQ is making a
clarifying change to Rule 4613(a)(2)(D) to state that rights and
warrants shall have a Designated Percentage of 30 percent.
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    \3\ See Securities Exchange Act Release No. 64735 (June 23,
2011), 76 FR 38243 (June 29, 2011) (SR-NASDAQ-2011-067, et al.).
    \4\ See Securities Exchange Act Release No. 65814 (November 23,
2011) (SR-NASDAQ-2011-154).
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2. Statutory Basis
    The proposed rule change is consistent with Section 6(b) of the
Act,\5\ in general, and furthers the objectives of Section 6(b)(5),\6\
in particular, in that it is designed to prevent fraudulent and
manipulative acts and practices, to promote just and equitable
principles of trade, to foster cooperation and coordination with
persons engaged in facilitating transactions in securities, and to
remove impediments to and perfect the mechanism of a free and open
market and a national market system. The proposed rule change also is
designed to support the principles of Section 11A(a)(1) \7\ of the Act
in that it seeks to ensure fair competition among brokers and dealers
and among exchange markets. NASDAQ believes that the proposed rule
meets these requirements because it makes a clarifying change to a rule
that is currently silent on how it is applied to certain securities.
NASDAQ is applying the same Designated Percentage to rights and
warrants, which are no longer covered by the trading pause under Rule
4120(a)(11), as it had prior to recent changes to the rule.
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    \5\ 15 U.S.C. 78f(b).
    \6\ 15 U.S.C. 78f(b)(5).
    \7\ 15 U.S.C. 78k-1(a)(1).
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B. Self-Regulatory Organization's Statement on Burden on Competition

    NASDAQ does not believe that the proposed rule change will result
in any burden on competition that is not necessary or appropriate in
furtherance of the purposes of the Act, as amended.

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

    Written comments were neither solicited nor received.

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

    The Exchange has filed the proposed rule change pursuant to Section
19(b)(3)(A)(iii) of the Act \8\ and Rule 19b-4(f)(6) thereunder.\9\
Because the proposed rule change does not: (i) Significantly affect the
protection of investors or the public interest; (ii) impose any
significant burden on competition; and (iii) become operative prior to
30 days from the date on which it was filed, or such shorter time as
the Commission may designate, if consistent with the protection of
investors and the public interest, the proposed rule change has become
effective pursuant to Section 19(b)(3)(A) of the Act \10\ and Rule 19b-
4(f)(6)(iii) thereunder.\11\
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    \8\ 15 U.S.C. 78s(b)(3)(A)(iii).
    \9\ 17 CFR 240.19b-4(f)(6).
    \10\ 15 U.S.C. 78s(b)(3)(A).
    \11\ 17 CFR 240.19b-4(f)(6). In addition, Rule 19b-4(f)(6)(iii)
requires the Exchange to give the Commission written notice of the
Exchange's intent to file the proposed rule change along with a
brief description and text of the proposed rule change, at least
five business days prior to the date of filing of the proposed rule
change, or such shorter time as designated by the Commission. The
Exchange has satisfied this requirement.
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    A proposed rule change filed under Rule 19b-4(f)(6) \12\ normally
does not become operative for 30 days after the date of filing.
However, pursuant to Rule 19b-4(f)(6)(iii) \13\ the Commission may
designate a shorter time if such action is consistent with the
protection of investors and the public interest. The Exchange has asked
the Commission to waive the 30-day operative delay so that the proposal
may become operative immediately upon filing.
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    \12\ 17 CFR 240.19b-4(f)(6).
    \13\ 17 CFR 240.19b-4(f)(6)(iii).

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    The Commission believes that waiving the 30-day operative delay is
consistent with the protection of investors and the public interest.
Specifying 30% as the Designated Percentage for rights and warrants in
Rule 4613(a)(2)(D) would restore the Market Maker quoting obligations
that existed prior to the recent inclusion and subsequent exclusion of
rights and warrants from the single-stock circuit breaker pilot
program. Allowing the change to be operative upon filing should
minimize investor confusion on how Rule 4613(a)(2)(D) will operate for
rights and warrants in light of the recent exclusion of rights and
warrants from Rule 4120(a)(11). For this reason, the Commission
designates the proposed rule change as operative upon filing with the
Commission.\14\
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    \14\ For purposes only of waiving the 30-day operative delay,
the Commission has also considered the proposed rule's impact on
efficiency, competition, and capital formation. See 15 U.S.C.
78c(f).
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    At any time within 60 days of the filing of the proposed rule
change, the Commission summarily may temporarily suspend such rule
change if it appears to the Commission that such action is necessary or
appropriate in the public interest, for the protection of investors, or
otherwise in furtherance of the purposes of the Act.

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 No. SR-NASDAQ-2011-166 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 No. SR-NASDAQ-2011-166. 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
a.m. and 3 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 No. SR-NASDAQ-2011-166 and should be
submitted on or before January 4, 2012.

    For the Commission, by the Division of Trading and Markets,
pursuant to delegated authority.\15\
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    \15\ 17 CFR 200.30-3(a)(12).
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Kevin M. O'Neill,
Deputy Secretary.
[FR Doc. 2011-32000 Filed 12-13-11; 8:45 am]
BILLING CODE 8011-01-P