[Federal Register Volume 86, Number 16 (Wednesday, January 27, 2021)]
[Rules and Regulations]
[Pages 7239-7240]
[FR Doc No: 2020-28710]

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DEPARTMENT OF HOMELAND SECURITY

Coast Guard

33 CFR Part 117

[Docket No. USCG-2018-0968]
RIN 1625-AA09

Drawbridge Operation Regulations; Old Fort Bayou, MS

AGENCY: Coast Guard, DHS.

ACTION: Final rule.

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SUMMARY: The Coast Guard is changing the operating schedule that
governs the State Road 609 highway bascule bridge across the Old Fort
Bayou mile 1.6, Ocean Springs, Harrison County, Mississippi. This
change was requested to address increased vehicular congestion, and
allows Mississippi Department of Transportation to operate the bridge
to meet vessel and traffic needs.

DATES: This rule is effective February 26, 2021.

ADDRESSES: To view documents mentioned in this preamble as being
available in the docket, go to https://www.regulations.gov. Type USCG-
2018-0968 in the ``SEARCH'' box and click ``SEARCH.'' Click on Open
Docket Folder on the line associated with this rule.

FOR FURTHER INFORMATION CONTACT: If you have questions on this rule,
call or email Mr. Doug Blakemore, Eighth Coast Guard District Bridge
Administrator; telephone<PHONE_NUMBER>, email
<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

I. Table of Abbreviations

CFR Code of Federal Regulations
DHS Department of Homeland Security
E.O. Executive Order
FR Federal Register
MDOT Mississippi Department of Transportation
OMB Office of Management and Budget
Pub. L. Public Law
NPRM Notice of proposed rulemaking
Sec.  Section
SR State Road
U.S.C. United States Code

II. Background, Purpose and Legal Basis

    On July 20, 2020 the Coast Guard published a notice of proposed
rulemaking entitled Drawbridge Operation Regulations; Old Fort Bayou,
MS in the Federal Register (85 FR 43773), to seek public comments on
whether the Coast Guard should consider modifying the current operating
schedule to the Old Fort Bayou drawbridge. We received 0 comments.

III. Discussion of Proposed Rule

    The Coast Guard is issuing this rule under authority 33 U.S.C. 499.
    The Mississippi Department of Transportation (MDOT) requested to
change the operating requirements for the SR 609 drawbridge across Old
Fort Bayou, mile 1.6, Ocean Springs, Harrison County, Mississippi. This
bridge currently operates according to the schedule found in 33 CFR
part 117. MDOT requested to close the bridge to vessels during peak
vehicle traffic periods, from 6:30 a.m. to 8:00 a.m. and from 4 p.m. to
6 p.m. Monday through Friday, except federal holidays and to require a
12 hour notification to open the bridge during periods of very little
vessel traffic activity on Thanksgiving Day, Christmas Day and New
Year's Day.
    This waterway is used by small tows and barges, commercial
fisherman and recreational vessels. Closing the bridge to vessel
traffic in the morning and evening commuting hours reduces vehicle
queues and does not create vessel queues. The reduction in vehicle
queues enhances safety by preventing vehicles from backing up on U.S.
90 highway. This bridge opens infrequently to vessels on Thanksgiving
Day, Christmas Day and New Year's Day, therefore requiring a 12 hour
notification provides vessels with a reasonable ability to use Old Fort
Bayou.
    Additionally the bridge is required to open for emergencies
according to 33 CFR 117.31.

IV. Discussion of Comments, Changes and the Final Rule

    There were no comments on this rule change. The Coast Guard
provided a comment period of 60 days. Based on the vessel data and
bridge openings this rule provides vessels with a reasonable ability to
use the waterway. We identified no impacts on marine navigation with
this proposed rule.

V. Regulatory Analyses

    The Coast Guard developed this proposed rule after considering
numerous statutes and Executive orders related to rulemaking. Below we
summarize our analyses based on these statutes and Executive orders and
we discuss First Amendment rights of protestors.

A. Regulatory Planning and Review

    Executive Orders 12866 and 13563 direct agencies to assess the
costs and benefits of available regulatory alternatives and, if
regulation is necessary, to select regulatory approaches that maximize
net benefits. Executive Order 13771 directs agencies to control
regulatory costs through a budgeting process. This NPRM has not been
designated a ``significant regulatory action,'' under Executive Order
12866. Accordingly, the NPRM has not been reviewed by the Office of
Management and Budget (OMB) and pursuant to OMB guidance it is exempt
from the requirements of Executive Order 13771. This regulatory action
determination is based on the ability that vessels can still open the
draw and transit given advance notice. Those

vessels with a vertical clearance requirement of less than 26 feet
above mean high water may transit the bridge at any time. Additionally
according to 33 CFR 117.31(b) the drawtender shall take all reasonable
measures to have the draw opened, regardless of the operating schedule
of the draw, for passage of certain vessels during emergency
situations. We believe this proposed change to the drawbridge operation
regulations at 33 CFR 117.675(a) will meet the reasonable needs of
navigation.

B. Impact on Small Entities

    The Regulatory Flexibility Act of 1980, 5 U.S.C. 601-612, as
amended, requires Federal agencies to consider the potential impact of
regulations on small entities during rulemaking. The term ``small
entities'' comprises small businesses, not-for-profit organizations
that are independently owned and operated and are not dominant in their
fields, and governmental jurisdictions with populations of less than
50,000. The Coast Guard certifies under 5 U.S.C. 605(b) that this
proposed rule would not have a significant economic impact on a
substantial number of small entities.
    The bridge provides a 26 foot vertical clearance at mean high water
that should accommodate most present vessel traffic and the bridge will
continue to open on signal during most daylight hours for any vessel
during the above federal holidays provided at least 12 hour notice is
given. While some owners or operators of vessels intending to transit
the bridge may be small entities, for the reasons stated in section
IV.A above, this proposed rule would not have a significant economic
impact on any vessel owner or operator.
    Under section 213(a) of the Small Business Regulatory Enforcement
Fairness Act of 1996 (Pub. L. 104-121), we want to assist small
entities in understanding this proposed rule. If the proposed rule
would affect your small business, organization, or governmental
jurisdiction and you have questions concerning its provisions or
options for compliance, please contact the person listed in the FOR
FURTHER INFORMATION CONTACT section. The Coast Guard will not retaliate
against small entities that question or complain about this proposed
rule or any policy or action of the Coast Guard.

C. Collection of Information

    This proposed rule would call for no new collection of information
under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3520).

D. Federalism and Indian Tribal Government

    A rule has implications for federalism under Executive Order 13132,
Federalism, if it has a substantial direct effect 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. We have analyzed this proposed rule under that Order and
have determined that it is consistent with the fundamental federalism
principles and preemption requirements described in Executive Order
13132.
    Also, this proposed rule does not have tribal implications under
Executive Order 13175, Consultation and Coordination with Indian Tribal
Governments, because it would not have a substantial direct effect on
one or more Indian tribes, on the relationship between the Federal
Government and Indian tribes, or on the distribution of power and
responsibilities between the Federal Government and Indian tribes. If
you believe this proposed rule has implications for federalism or
Indian tribes, please contact the person listed in the FOR FURTHER
INFORMATION CONTACT section above.

E. Unfunded Mandates Reform Act

    The Unfunded Mandates Reform Act of 1995 (2 U.S.C. 1531-1538)
requires Federal agencies to assess the effects of their discretionary
regulatory actions. In particular, the Act addresses actions that may
result in the expenditure by a State, local, or tribal government, in
the aggregate, or by the private sector of $100,000,000 (adjusted for
inflation) or more in any one year. Though this proposed rule will not
result in such expenditure, we do discuss the effects of this proposed
rule elsewhere in this preamble.

F. Environment

    We have analyzed this rule under Department of Homeland Security
Management Directive 023-01 and U.S. Coast Guard Environmental Planning
Policy COMDTINST 5090.1 (series) which guide the Coast Guard in
complying with the National Environmental Policy Act of 1969 (NEPA) (42
U.S.C. 4321-4370f). We have made a preliminary determination that this
action is one of a category of actions that do not individually or
cumulatively have a significant effect on the human environment. This
proposed rule promulgates the operating regulations or procedures for
drawbridges. Normally this action is categorically excluded from
further review, under paragraph L49, of Chapter 3, Table 3-1 of the
U.S. Coast Guard Environmental Planning Implementation Procedures.
    Neither a Record of Environmental Consideration nor a Memorandum
for the Record are required for this rule.

G. Protest Activities

    The Coast Guard respects the First Amendment rights of protesters.
Protesters are asked to contact the person listed in the FOR FURTHER
INFORMATION CONTACT section to coordinate protest activities so that
your message can be received without jeopardizing the safety or
security of people, places or vessels.

List of Subjects in 33 CFR Part 117

    Bridges.

    For the reasons discussed in the preamble, the Coast Guard amends
33 CFR part 117 as follows:

PART 117--DRAWBRIDGE OPERATION REGULATIONS

0
1. The authority citation for part 117 continues to read as follows:

    Authority: 33 U.S.C. 499; 33 CFR 1.05-1; Department of Homeland
Security Delegation No. 0170.1.

0
2. Revise Sec.  117.681 to read as follows:

Sec.  117.681  Old Fort Bayou.

    The draw of the bridge, mile 1.6 at Ocean Springs, shall open on
signal; except that, from 9 p.m. to 5 a.m., the draw shall open on
signal if at least eight hour notice is given; on Thanksgiving Day,
Christmas Day and New Year's Day the draw shall open on signal if at
least 12 hour notice is given; and the draw need not open to vessels
from 6:30 a.m. to 8 a.m. and from 4 p.m. to 6 p.m. Monday through
Friday, except federal holidays. The draw shall open anytime at the
direction of the District Commander.

    Dated: December 16, 2020.
John P. Nadeau,
Rear Admiral, U.S. Coast Guard, Commander, Eighth Coast Guard District.
[FR Doc. 2020-28710 Filed 1-26-21; 8:45 am]
BILLING CODE 9110-04-P


However, if the covered establishment makes a nutrient content claim or
health claim, the establishment is required to provide nutrition
information on the nutrient that is the subject of the claim in
accordance with Sec.  101.10. For standard menu items that contain
insignificant amounts of six or more of the required nutrients, the
declaration of nutrition information required by paragraph
(b)(2)(ii)(A) of this section may be presented in a simplified format.
    (1) An insignificant amount is defined as that amount that allows a
declaration of zero in nutrition labeling, except that for total
carbohydrates, dietary fiber, and protein, it must be an amount that
allows a declaration of ``less than one gram.''
    (2) The simplified format must include information, in a column,
list, or table, on the following nutrients:
    (i) Total calories, total fat, total carbohydrates, protein, and
sodium; and
    (ii) Calories from fat, and any other nutrients identified in
paragraph (b)(2)(ii)(A) of this section that are present in more than
insignificant amounts.
    (3) If the simplified format is used, the statement ``Not a
significant source of ___--'' (with the blank filled in with the names
of the nutrients required to be declared in the written nutrient
information and calories from fat that are present in insignificant
amounts) must be included at the bottom of the list of nutrients.
    (C) For variable menu items, the nutrition information listed in
paragraph (b)(2)(ii)(A) of this section must be declared as follows for
each size offered for sale:
    (1) The nutrition information required in paragraph (b)(2)(ii)(A)
of this section

must be declared for the basic preparation of the item and, separately,
for each topping, flavor, or variable component.
    (2) Additional format requirements for toppings if the amount of
the topping included on the basic preparation of the menu item
decreases based on the total number of toppings ordered for the menu
item (such as is sometimes the case with pizza toppings). The nutrients
for such topping must be declared as single values representing the
nutrients for each topping when added to a one-topping menu item,
specifying that the nutrient declaration is for the topping when added
to a one-topping menu item.
    (3) If the calories and other nutrients are the same for different
flavors, varieties, and variable components of the combination meal,
each variety, flavor, and variable component of the combination meal is
not required to be listed separately. All items that have the same
nutrient values could be listed together with the nutrient values
listed only once.
    (D) The written nutrition information required in paragraph
(b)(2)(ii)(A) of this section may be provided on a counter card, sign,
poster, handout, booklet, loose leaf binder, or electronic device such
as a computer, or in a menu, or in any other form that similarly
permits the written declaration of the required nutrient content
information for all standard menu items. If the written nutrition
information is not in a form that can be given to the customer upon
request, it must be readily available in a manner and location on the
premises that allows the customer/consumer to review the written
nutrition information upon request.
    (iii) The following must be provided for a standard menu item that
is self-service or on display.
    (A) Calories per displayed food item (e.g., a bagel, a slice of
pizza, or a muffin), or if the food is not offered for sale in a
discrete unit, calories per serving (e.g., scoop, cup), and the serving
or discrete unit used to determine the calorie content (e.g., ``per
scoop'' or ``per muffin'') on either: A sign adjacent to and clearly
associated with the corresponding food; (e.g., ``150 calories per
scoop''); a sign attached to a sneeze guard with the calorie
declaration and the serving or unit used to determine the calorie
content above each specific food so that the consumer can clearly
associate the calorie declaration with the food, except that if it is
not clear to which food the calorie declaration and serving or unit
refers, then the sign must also include the name of the food, e.g.,
``Broccoli and cheese casserole--200 calories per scoop''; or a single
sign or placard listing the calorie declaration for several food items
along with the names of the food items, so long as the sign or placard
is located where a consumer can view the name, calorie declaration, and
serving or unit of a particular item while selecting that item.
    (1) For purposes of paragraph (b)(2)(iii)(A) of this section, ``per
displayed food item'' means per each discrete unit offered for sale,
for example, a bagel, a slice of pizza, or a muffin.
    (2) For purposes of paragraph (b)(2)(iii)(A) of this section, ``per
serving'' means, for each food:
    (i) Per serving instrument used to dispense the food offered for
sale, provided that the serving instrument dispenses a uniform amount
of the food (e.g., a scoop or ladle);
    (ii) If a serving instrument that dispenses a uniform amount of
food is not used to dispense the food, per each common household
measure (e.g., cup or tablespoon) offered for sale or per unit of
weight offered for sale, e.g., per quarter pound or per 4 ounces; or
    (iii) Per total number of fluid ounces in the cup in which a self-
service beverage is served and, if applicable, the description of the
cup size (e.g., ``140 calories per 12 fluid ounces (small)'').
    (3) The calories must be declared in the following manner:
    (i) To the nearest 5-calorie increment up to and including 50
calories and to the nearest 10-calorie increment above 50 calories
except that amounts less than 5 calories may be expressed as zero.
    (ii) If the calorie declaration is provided on a sign with the
food's name, price, or both, the calorie declaration, accompanied by
the term ``Calories'' or ``Cal'' and the amount of the serving or
displayed food item on which the calories declaration is based must be
in a type size no smaller than the type size of the name or price of
the menu item whichever is smaller, in the same color, or a color that
is at least as conspicuous as that used for that name or price, using
the same contrasting background or a background at least as contrasting
as that used for that name or price. If the calorie declaration is
provided on a sign that does not include the food's name, price, or
both, the calorie declaration, accompanied by the term ``Calories'' or
``Cal'' and the amount of the serving or displayed food item on which
the calorie declaration is based must be clear and conspicuous.
    (iii) For self-service beverages, calorie declarations must be
accompanied by the term ``fluid ounces'' and, if applicable, the
description of the cup size (e.g., ``small,'' ``medium'').
    (B) For food that is self-service or on display and is identified
by an individual sign adjacent to the food itself where such sign meets
the definition of a menu or menu board under paragraph (a) of this
section, the statement required by paragraph (b)(2)(i)(B) of this
section and the statement required by paragraph (b)(2)(i)(C) of this
section. These two statements may appear on the sign adjacent to the
food itself; on a separate, larger sign, in close proximity to the food
that can be easily read as the consumer is making order selections; or
on a large menu board that can be easily read as the consumer is
viewing the food.
    (C) The nutrition information in written form required by paragraph
(b)(2)(ii) of this section, except for packaged food insofar as it
bears nutrition labeling information required by and in accordance with
paragraph (b)(2)(ii) of this section and the packaged food, including
its label, can be examined by a consumer before purchasing the food.
    (c) Determination of nutrient content. (1) A covered establishment
must have a reasonable basis for its nutrient declarations. Nutrient
values may be determined by using nutrient databases (with or without
computer software programs), cookbooks, laboratory analyses, or other
reasonable means, including the use of Nutrition Facts on labels on
packaged foods that comply with the nutrition labeling requirements of
section 403(q)(1) of the Federal Food, Drug, and Cosmetic Act and Sec.
101.9, FDA nutrient values for raw fruits and vegetables in Appendix C
of this part, or FDA nutrient values for cooked fish in Appendix D of
this part.
    (2) Nutrient declarations for standard menu items must be accurate
and consistent with the specific basis used to determine nutrient
values. A covered establishment must take reasonable steps to ensure
that the method of preparation (e.g., types and amounts of ingredients,
cooking temperatures) and amount of a standard menu item offered for
sale adhere to the factors on which its nutrient values were
determined.
    (3) A covered establishment must provide to FDA, within a
reasonable period of time upon request, information substantiating
nutrient values including the method and data used to derive these
nutrient values. This information must include the following:
    (i) For nutrient databases:
    (A) The name and version (including the date of the version) of the
database,

and, as applicable, the name of the applicable software company and any
Web site address for the database. The name and version of a database
would include the name and version of the computer software, if
applicable;
    (B) The recipe or formula used as a basis for the nutrient
declarations;
    (C)(1) Information on:
    (i) The amount of each nutrient that the specified amount of each
ingredient identified in the recipe contributes to the menu item; and
    (ii) How the database was used including calculations or operations
(e.g., worksheets or computer printouts) to determine the nutrient
values for the standard menu items;
    (2) If the information in paragraph (c)(3)(i)(C)(1) of this section
is not available, certification attesting that the database will
provide accurate results when used appropriately and that the database
was used in accordance with its instructions;
    (D) A detailed listing (e.g., printout) of the nutrient values
determined for each standard menu item.
    (E) Any other information pertinent to the final nutrient values of
the standard menu item (e.g., information about what might cause slight
variations in the nutrient profile such as moisture variations);
    (F) A statement signed and dated by a responsible individual,
employed at the covered establishment or its corporate headquarters or
parent entity, who can certify that the information contained in the
nutrient analysis is complete and accurate; and
    (G) A statement signed and dated by a responsible individual
employed at the covered establishment certifying that the covered
establishment has taken reasonable steps to ensure that the method of
preparation (e.g., types and amounts of ingredients in the recipe,
cooking temperatures) and amount of a standard menu item offered for
sale adhere to the factors on which its nutrient values were
determined.
    (ii) For published cookbooks that contain nutritional information
for recipes in the cookbook:
    (A) The name, author, and publisher of the cookbook used;
    (B) If available, information provided by the cookbook or from the
author or publisher about how the nutrition information for the recipes
was obtained;
    (C) A copy of the recipe used to prepare the standard menu item and
a copy of the nutrition information for that standard menu item as
provided by the cookbook; and
    (D) A statement signed and dated by a responsible individual
employed at the covered establishment certifying that that the covered
establishment has taken reasonable steps to ensure that the method of
preparation (e.g., types and amounts of ingredients in the recipe,
cooking temperatures) and amount of a standard menu item offered for
sale adhere to the factors on which its nutrient values were
determined. (Recipes may be divided as necessary to accommodate
differences in the portion size derived from the recipe and that are
served as the standard menu item but no changes may be made to the
proportion of ingredients used.)
    (iii) For laboratory analyses:
    (A) A copy of the recipe for the standard menu item used for the
nutrient analysis;
    (B) The name and address of the laboratory performing the analysis;
    (C) Copies of analytical worksheets, including the analytical
method, used to determine and verify nutrition information;
    (D) A statement signed and dated by a responsible individual,
employed at the covered establishment or its corporate headquarters or
parent entity, who can certify that the information contained in the
nutrient analysis is complete and accurate; and
    (E) A statement signed and dated by a responsible individual
employed at the covered establishment certifying that the covered
establishment has taken reasonable steps to ensure that the method of
preparation (e.g., types and amounts of ingredients in the recipe,
cooking temperatures) and amount of a standard menu item offered for
sale adhere to the factors on which its nutrient values were
determined.
    (iv) For nutrition information provided by other reasonable means:
    (A) A detailed description of the means used to determine the
nutrition information;
    (B) A recipe or formula used as a basis for the nutrient
determination;
    (C) Any data derived in determining the nutrient values for the
standard menu item, e.g., nutrition information about the ingredients
used with the source of the nutrient information;
    (D) A statement signed and dated by a responsible individual,
employed at the covered establishment or its corporate headquarters or
parent entity, who can certify that the information contained in the
nutrient analysis is complete and accurate; and
    (E) A statement signed and dated by a responsible individual
employed at the covered establishment certifying that the covered
establishment has taken reasonable steps to ensure that the method of
preparation (e.g., types and amounts of ingredients in the recipe,
cooking temperatures) and amount of a standard menu item offered for
sale adhere to the factors on which its nutrient values were
determined.
    (d) Voluntary registration to be subject to the menu labeling
requirements--(1) Applicability. A restaurant or similar retail food
establishment that is not part of a chain with 20 or more locations
doing business under the same name and offering for sale substantially
the same menu items may voluntarily register to be subject to the
requirements established in this section. Restaurants and similar
retail food establishments that voluntarily register will no longer be
subject to non-identical State or local nutrition labeling
requirements.
    (2) Who may register? The authorized official of a restaurant or
similar retail food establishment as defined in paragraph (a) of this
section, which is not otherwise subject to paragraph (b) of this
section, may register with FDA.
    (3) What information is required? Authorized officials for
restaurants and similar retail food establishments must provide FDA
with the following information on Form FDA 3757:
    (i) The contact information (including name, address, phone number,
and email address) for the authorized official;
    (ii) The contact information (including name, address, phone
number, and email address) of each restaurant or similar retail food
establishment being registered, as well as the name and contact
information for an official onsite, such as the owner or manager, for
each specific restaurant or similar retail food establishment;
    (iii) All trade names the restaurant or similar retail food
establishment uses;
    (iv) Preferred mailing address (if different from location address
for each establishment) for purposes of receiving correspondence; and
    (v) Certification that the information submitted is true and
accurate, that the person submitting it is authorized to do so, and
that each registered restaurant or similar retail food establishment
will be subject to the requirements of section 403(q)(5)(H) of the
Federal Food, Drug, and Cosmetic Act and this section.
    (4) How to register. Authorized officials of restaurants and
similar retail food establishments who elect to be subject to
requirements in section 403(q)(5)(H) of the Federal Food, Drug, and
Cosmetic Act can register by visiting http://www.fda.gov/food/ingredientspackaginglabeling/labelingnutrition/ucm217762.htm. FDA has
created a form (Form 3757) that contains fields requesting the
information in paragraph (d)(3) of this section and made the form
available at

this Web site. Registrants must use this form to ensure that complete
information is submitted.
    (i) Information should be submitted by email by typing complete
information into the form (PDF), saving it on the registrant's
computer, and sending it by email to<EMAIL_ADDRESS>    (ii) If email is not available, the registrant can either fill in
the form (PDF) and print it out (or print out the blank PDF and fill in
the information by hand or typewriter), and either fax the completed
form to<PHONE_NUMBER> or mail it to FDA, CFSAN Menu and Vending Machine
Registration, White Oak Building 22, Rm. 0209, 10903 New Hampshire
Ave., Silver Spring, MD 20993.
    (5) When to renew the registration. To keep the establishment's
registration active, the authorized official of the restaurant or
similar retail food establishment must register every other year within
60 days prior to the expiration of the establishment's current
registration with FDA. Registration will automatically expire if not
renewed.
    (e) Signatures. Signatures obtained under paragraph (d) of this
section that meet the definition of electronic signatures in Sec.
11.3(b)(7) of this chapter are exempt from the requirements of part 11
of this chapter.
    (f) Misbranding. A standard menu item offered for sale in a covered
establishment shall be deemed misbranded under sections 201(n), 403(a),
403(f) and/or 403(q) of the Federal Food, Drug, and Cosmetic Act if its
label or labeling is not in conformity with paragraph (b) or (c) of
this section.

    Dated: November 19, 2014.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2014-27833 Filed 11-25-14; 8:45 am]
BILLING CODE 4164-01-P


[Federal Register Volume 88, Number 60 (Wednesday, March 29, 2023)]
[Rules and Regulations]
[Pages 18428-18431]
[FR Doc No: 2023-06457]

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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[EPA-HQ-OPP-2021-0744; FRL-10769-01-OCSPP]

Fludioxonil; Pesticide Tolerances

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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SUMMARY: This regulation modifies existing tolerances for residues of
fludioxonil in or on mango and papaya. Syngenta Crop Protection, LLC
requested these tolerances under the Federal Food, Drug, and Cosmetic
Act (FFDCA).

DATES: This regulation is effective March 29, 2023. Objections and
requests for hearings must be received on or before May 30, 2023, and
must be filed in accordance with the instructions provided in 40 CFR
part 178 (see also Unit I.C. of the SUPPLEMENTARY INFORMATION).

ADDRESSES: The docket for this action, identified by docket
identification (ID) number EPA-HQ-OPP-2021-0744, is available at
https://www.regulations.gov or at the Office of Pesticide Programs
Regulatory Public Docket (OPP Docket) in the Environmental Protection
Agency Docket Center (EPA/DC), West William Jefferson Clinton Bldg.,
Rm. 3334, 1301 Constitution Ave. NW, Washington, DC 20460-0001. The
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 Public
Reading Room and the OPP Docket is<PHONE_NUMBER>. Please review the
visitor instructions and additional information about the docket
available at https://www.epa.gov/dockets.

FOR FURTHER INFORMATION CONTACT: Daniel Rosenblatt, Registration
Division (7505T), Office of Pesticide Programs, Environmental
Protection Agency, 1200 Pennsylvania Ave. NW, Washington, DC 20460-
0001; main telephone number:<PHONE_NUMBER>; email address:
[email protected].

SUPPLEMENTARY INFORMATION:

I. General Information

A. Does this action apply to me?

    You may be potentially affected by this action if you are an
agricultural producer, food manufacturer, or pesticide manufacturer.
The following list of North American Industrial Classification System
(NAICS) codes is not intended to be exhaustive, but rather provides a
guide to help readers determine whether this document applies to them.
Potentially affected entities may include:
     Crop production (NAICS code 111).
     Animal production (NAICS code 112).
     Food manufacturing (NAICS code 311).
     Pesticide manufacturing (NAICS code 32532).

B. How can I get electronic access to other related information?

    You may access a frequently updated electronic version of EPA's
tolerance regulations at 40 CFR part 180 through the Government
Publishing Office's e-CFR site at https://www.ecfr.gov/current/title-40/chapter-I/subchapter-E/part-180?toc=1.

C. How can I file an objection or hearing request?

    Under FFDCA section 408(g), 21 U.S.C. 346a(g), any person may file
an objection to any aspect of this regulation and may also request a
hearing on those objections. You must file your objection or request a
hearing on this regulation in accordance with the instructions provided
in 40 CFR part 178. To ensure proper receipt by EPA, you must identify
docket ID number EPA-HQ-OPP-2021-0744 in the subject line on the first
page of your submission. All objections and requests for a hearing must
be in writing, and must be received by the Hearing Clerk on or before
May 30, 2023. Addresses for mail and hand delivery of objections and
hearing requests are provided in 40 CFR 178.25(b).
    In addition to filing an objection or hearing request with the
Hearing Clerk as described in 40 CFR part 178, please submit a copy of
the filing (excluding any Confidential Business Information (CBI)) for
inclusion in the public docket. Information not marked confidential
pursuant to 40 CFR part 2 may be disclosed publicly by EPA without
prior notice. Submit the non-CBI copy of your objection or hearing
request, identified by docket ID number EPA-HQ-OPP-2021-0744, by one of
the following methods:
     Federal eRulemaking Portal: https://www.regulations.gov.
Follow the online instructions for submitting comments. Do not submit
electronically any information you consider to be CBI or other
information whose disclosure is restricted by statute.
     Mail: OPP Docket, Environmental Protection Agency Docket
Center (EPA/DC), (28221T), 1200 Pennsylvania Ave. NW, Washington, DC
20460-0001.
     Hand Delivery: To make special arrangements for hand
delivery or delivery of boxed information, please follow the
instructions at https://www.epa.gov/dockets.
    Additional instructions on commenting or visiting the docket, along
with more information about dockets generally, is available at https://www.epa.gov/dockets.

II. Summary of Petitioned-For Tolerance

    In the Federal Register of October 24, 2022 (87 FR 64196) (FRL-
9410-06-OCSPP), EPA issued a document pursuant to FFDCA section
408(d)(3), 21 U.S.C. 346a(d)(3), announcing the filing of a pesticide
petition (PP 1E8947) by Syngenta Crop Protection, LLC, 410

Swing Road, Greensboro, NC 27409. The petition requested that 40 CFR
180.516 be amended by establishing import tolerances for residues of
the fungicide fludioxonil, [4-(2,2-difluoro-1,3-benzodioxol-4-yl)-1H-
pyrrole-3-carbonitrile], in or on mango at 15 parts per million (ppm)
and papaya at 8 ppm. That document referenced a summary of the petition
prepared by Syngenta Crop Protection, LLC, the registrant, which is
available in the docket, https://www.regulations.gov. There were no
comments received in response to the notice of filing.
    Based upon review of the data supporting the petition and in
accordance with its authority under FFDCA section 408(d)(4)(A)(i), EPA
is modifying the existing tolerances for residues of fludioxonil in or
on mango and papaya at different levels than requested. The reasons for
these changes are explained in Unit IV.C.

III. Aggregate Risk Assessment and Determination of Safety

    Section 408(b)(2)(A)(i) of FFDCA allows EPA to establish a
tolerance (the legal limit for a pesticide chemical residue in or on a
food) only if EPA determines that the tolerance is ``safe.'' Section
408(b)(2)(A)(ii) of FFDCA defines ``safe'' to mean that ``there is a
reasonable certainty that no harm will result from aggregate exposure
to the pesticide chemical residue, including all anticipated dietary
exposures and all other exposures for which there is reliable
information.'' This includes exposure through drinking water and in
residential settings, but does not include occupational exposure.
Section 408(b)(2)(C) of FFDCA requires EPA to give special
consideration to exposure of infants and children to the pesticide
chemical residue in establishing a tolerance and to ``ensure that there
is a reasonable certainty that no harm will result to infants and
children from aggregate exposure to the pesticide chemical residue. . .
.''
    Consistent with FFDCA section 408(b)(2)(D), and the factors
specified therein, EPA has reviewed the available scientific data and
other relevant information in support of this action. EPA has
sufficient data to assess the hazards of and to make a determination on
aggregate exposure for fludioxonil, including exposure resulting from
the tolerances modified by this action. EPA's assessment of exposures
and risks associated with fludioxonil follows.
    In an effort to streamline its publications in the Federal
Register, EPA is not reprinting sections of the rule that repeat what
has been previously published in tolerance rulemakings for the same
pesticide chemical. Where scientific information concerning a
particular chemical remains unchanged, the content of those sections
would not vary between tolerance rulemakings, and EPA considers
referral back to those sections as sufficient to provide an explanation
of the information EPA considered in making its safety determination
for the new rulemaking.
    EPA has previously published a number of tolerance rulemakings for
fludioxonil in which EPA concluded, based on the available information,
that there is a reasonable certainty that no harm would result from
aggregate exposure to fludioxonil and established tolerances for
residues of that chemical. EPA is incorporating previously published
sections from those rulemakings as described further in this rule, as
they remain unchanged.

A. Toxicological Profile

    EPA has evaluated the available toxicity data and considered its
validity, completeness, and reliability as well as the relationship of
the results of the studies to human risk. EPA has also considered
available information concerning the variability of the sensitivities
of major identifiable subgroups of consumers, including infants and
children.
    Specific information on the studies received and the nature of the
adverse effects caused by fludioxonil as well as the no-observed-
adverse-effect-level (NOAEL) and the lowest-observed-adverse-effect-
level (LOAEL) from the toxicity studies are discussed in Unit III.A. of
the final rule published in the Federal Register of November 6, 2018
(83 FR 55491) (FRL-9982-75).

B. Toxicological Points of Departure/Levels of Concern

    A summary of the toxicological endpoints for fludioxonil used for
human health risk assessment is discussed in Unit III.B. of the final
rule published in the Federal Register of August 14, 2015 (80 FR 48743)
(FRL-9931-06).

C. Exposure Assessment

    Much of the exposure assessment remains the same although updates
have occurred to accommodate exposures from the petitioned-for
tolerances. These updates are discussed in this section; for a
description of the rest of the EPA approach to and assumptions for the
exposure assessment, please reference Unit III.C. of the November 6,
2018, rulemaking.
    1. Dietary exposure from food and feed uses. EPA's dietary exposure
assessments have been updated to include the additional exposure from
the petitioned-for tolerances for residues of fludioxonil on mango and
papaya. An acute dietary risk assessment was not performed since no
endpoint attributable to a single exposure (dose) was identified from
the available oral toxicity database. The chronic assessment is based
on tolerance-level residues and assumes 100 percent crop treated (PCT);
the chronic assessment is unrefined. The assessment was conducted using
the Dietary Exposure Evaluation Model software with the Food Commodity
Intake Database (DEEM-FCID), Version 4.02, which incorporates 2005-2010
food consumption information from the United States Department of
Agriculture's (USDA's) National Health and Nutrition Examination
Survey, What We Eat in America, (NHANES/WWEIA). A cancer dietary
exposure and risk assessment was not conducted for fludioxonil as it is
a Group D chemical--not classifiable as to human carcinogenicity.
    2. Dietary exposure from drinking water. The proposed post-harvest
application uses on imported fruit do not result in an increase in the
estimated residue levels in drinking water, so the estimated drinking
water concentrations used in the November 6, 2018, final rule are the
same as those used in this assessment.
    3. From non-dietary exposure. The term ``residential exposure'' is
used in this document to refer to non-occupational, non-dietary
exposure (e.g., for lawn and garden pest control, indoor pest control,
termiticides, and flea and tick control on pets). The assessment used
the same assumptions as the November 6, 2018. The residential exposures
used in the aggregate assessment are inhalation exposures from handlers
applying paints with airless sprayers for adults and incidental oral
exposures (hand-to-mouth) from post-application exposure to outdoor
treated turf for children 1 to <2 years old.
    4. Cumulative effects from substances with a common mechanism of
toxicity. Section 408(b)(2)(D)(v) of FFDCA requires that, when
considering whether to establish, modify, leave in effect, or revoke a
tolerance, the Agency consider ``available information'' concerning the
cumulative effects of a particular pesticide's residues and ``other
substances that have a common mechanism of toxicity.''
    Unlike other pesticides for which EPA has followed a cumulative
risk approach based on a common mechanism of toxicity, EPA has not made
a common

mechanism of toxicity finding as to fludioxonil and any other
substances, and fludioxonil does not appear to produce a toxic
metabolite produced by other substances. For the purposes of this
tolerance action, therefore, EPA has not assumed that fludioxonil has a
common mechanism of toxicity with other substances.

D. Safety Factor for Infants and Children

    EPA continues to conclude that there are reliable data to support
the reduction of the Food Quality Protection Act (FQPA) safety factor.
See Unit III.D. of the November 6, 2018, rulemaking for a discussion of
the Agency's rationale for that determination.

E. Aggregate Risks and Determination of Safety

    EPA determines whether acute and chronic dietary pesticide
exposures are safe by comparing aggregate exposure estimates to the
acute population adjusted dose (aPAD) and chronic population adjusted
dose (cPAD). For linear cancer risks, EPA calculates the lifetime
probability of acquiring cancer given the estimated aggregate exposure.
Short-, intermediate-, and chronic-term risks are evaluated by
comparing the estimated aggregate food, water, and residential exposure
to the appropriate points of departure (PODs) to ensure that an
adequate margin of exposure (MOE) exists.
    An acute dietary exposure assessment was not performed as there
were no indication of an adverse effects attributable to a single dose.
Fludioxonil is not expected to pose an acute risk. Chronic dietary
risks are below the Agency's level of concern of 100% of the cPAD; they
are 14% of the cPAD for the general population and 49% of the cPAD for
children 1-2 years old, the population subgroup receiving the highest
exposure.
    EPA has concluded the combined short-term food, water, and
residential exposures result in aggregate MOEs of 1200 for adults and
290 for children 1-2 years old. Because EPA's level of concern for
fludioxonil is an MOE of 100 or below, short-term aggregate risks are
not of concern. Intermediate- and long-term aggregate risk assessments
were not performed because there are no registered or proposed uses of
fludioxonil that result in intermediate- or long-term residential
exposures. Fludioxonil is not classifiable as to human carcinogenicity;
therefore, EPA does not expect exposures to pose an aggregate cancer
risk.
    Therefore, based on the risk assessments and information described
above, EPA concludes that there is a reasonable certainty that no harm
will result to the general population, or to infants and children, from
aggregate exposure to fludioxonil residues. More detailed information
on this action can be found in the document titled ``Fludioxonil. Human
Health Risk Assessment for the Proposed Tolerances without a U.S.
Registration for Residues of Fludioxonil in/on Mango and Papaya.'' in
docket ID number EPA-HQ-OPP-2021-0744.

IV. Other Considerations

A. Analytical Enforcement Methodology

    For a discussion of the available analytical enforcement method,
see Unit IV.A. of the November 6, 2018, rulemaking.

B. International Residue Limits

    In making its tolerance decisions, EPA seeks to harmonize U.S.
tolerances with international standards whenever possible, consistent
with U.S. food safety standards and agricultural practices. EPA
considers the international maximum residue limits (MRLs) established
by the Codex Alimentarius Commission (Codex), as required by FFDCA
section 408(b)(4).
    There is no Codex MRL for fludioxonil in or on papaya. Canada has
established an MRL for fludioxonil in or on papaya at 5 ppm, which is
the same as the U.S. tolerance as modified by this action. Codex and
Canada have established MRLs for fludioxonil in or on mango at 2 ppm.
These MRLs are different than the U.S. tolerance as modified by this
action, which is 8 ppm for fludioxonil residues in or on mango. EPA is
not harmonizing the U.S. tolerance with the Codex and Canadian MRLs
because the proposed post-harvest application use on fruit imported
into the United States results in residues greater than 2 ppm. The
increased tolerance of 8 ppm is needed to cover residues resulting from
post-harvest application to imported fruit and would not affect trade
channels with Canada or the European Union.

C. Revisions to Petitioned-For Tolerances

    The registrant petitioned for import tolerances of 15 ppm for mango
and 8 ppm for papaya. However, EPA has previously established
tolerances for residues of fludioxonil in or on mango and papaya, both
at 5.0 ppm, at 40 CFR 180.516. In this action, EPA is modifying these
established tolerances by increasing the tolerance for mango to 8 ppm
and revising the tolerance for papaya to 5 ppm based on the submitted
field trial data, Organization for Economic Co-operation and
Development (OECD) tolerance calculation procedures, and rounding
rules. These tolerances are inclusive of imported commodities as well
as domestically produced.

V. Conclusion

    Therefore, tolerances are modified for residues of fludioxonil, [4-
(2,2-difluoro-1,3-benzodioxol-4-yl)-1H-pyrrole-3-carbonitrile], in or
on mango at 8 ppm and papaya at 5 ppm.

VI. Statutory and Executive Order Reviews

    This action modified tolerances under FFDCA section 408(d) in
response to a petition submitted to the Agency. The Office of
Management and Budget (OMB) has exempted these types of actions from
review under Executive Order 12866, entitled ``Regulatory Planning and
Review'' (58 FR 51735, October 4, 1993). Because this action has been
exempted from review under Executive Order 12866, this action is not
subject to Executive Order 13211, entitled ``Actions Concerning
Regulations That Significantly Affect Energy Supply, Distribution, or
Use'' (66 FR 28355, May 22, 2001) or Executive Order 13045, entitled
``Protection of Children from Environmental Health Risks and Safety
Risks'' (62 FR 19885, April 23, 1997). This action does not contain any
information collections subject to OMB approval under the Paperwork
Reduction Act (PRA) (44 U.S.C. 3501 et seq.), nor does it require any
special considerations under Executive Order 12898, entitled ``Federal
Actions to Address Environmental Justice in Minority Populations and
Low-Income Populations'' (59 FR 7629, February 16, 1994).
    Since tolerances and exemptions that are established on the basis
of a petition under FFDCA section 408(d), such as the tolerance in this
final rule, do not require the issuance of a proposed rule, the
requirements of the Regulatory Flexibility Act (RFA) (5 U.S.C. 601 et
seq.), do not apply.
    This action directly regulates growers, food processors, food
handlers, and food retailers, not States or tribes, nor does this
action alter the relationships or distribution of power and
responsibilities established by Congress in the preemption provisions
of FFDCA section 408(n)(4). As such, the Agency has determined that
this action will not have a substantial direct effect on States or
tribal governments, on the relationship between the national government
and the States or tribal

governments, or on the distribution of power and responsibilities among
the various levels of government or between the Federal Government and
Indian tribes. Thus, the Agency has determined that Executive Order
13132, entitled ``Federalism'' (64 FR 43255, August 10, 1999) and
Executive Order 13175, entitled ``Consultation and Coordination with
Indian Tribal Governments'' (65 FR 67249, November 9, 2000) do not
apply to this action. In addition, this action does not impose any
enforceable duty or contain any unfunded mandate as described under
Title II of the Unfunded Mandates Reform Act (UMRA) (2 U.S.C. 1501 et
seq.).
    This action does not involve any technical standards that would
require Agency consideration of voluntary consensus standards pursuant
to section 12(d) of the National Technology Transfer and Advancement
Act (NTTAA) (15 U.S.C. 272 note).

VII. Congressional Review Act (CRA)

    Pursuant to the CRA (5 U.S.C. 801 et seq.), EPA will submit a
report containing this rule and other required information to the U.S.
Senate, the U.S. House of Representatives, and the Comptroller General
of the United States prior to publication of the rule in the Federal
Register. This action is not a ``major rule'' as defined by 5 U.S.C.
804(2).

List of Subjects in 40 CFR Part 180

    Environmental protection, Administrative practice and procedure,
Agricultural commodities, Pesticides and pests, Reporting and
recordkeeping requirements.

    Dated: March 16, 2023.
Daniel Rosenblatt,
Acting Director, Registration Division, Office of Pesticide Programs.

    Therefore, for the reasons stated in the preamble, EPA is amending
40 CFR chapter 1 as follows:

PART 180--TOLERANCES AND EXEMPTIONS FOR PESTICIDE CHEMICAL RESIDUES
IN FOOD

0
1. The authority citation for part 180 continues to read as follows:

    Authority: 21 U.S.C. 321(q), 346a and 371.

0
2. In Sec.  180.516, revise the commodities ``mango'' and ``papaya'' in
the table in paragraph (a)(1) to read as follows:

Sec.  180.516  Fludioxonil; tolerances for residues.

* * * * *

                       Table 1 to Paragraph (a)(1)
------------------------------------------------------------------------
                                                               Parts per
                          Commodity                             million
------------------------------------------------------------------------

                                * * * * *
Mango.......................................................           8

                                * * * * *
Papaya......................................................           5

                                * * * * *
------------------------------------------------------------------------

* * * * *
[FR Doc. 2023-06457 Filed 3-28-23; 8:45 am]
BILLING CODE 6560-50-P