[Federal Register Volume 78, Number 221 (Friday, November 15, 2013)]
[Rules and Regulations]
[Pages 68713-68714]
[FR Doc No: 2013-27381]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 73

[Docket No. FDA-2011-C-0878]

Listing of Color Additives Exempt From Certification; Spirulina
Extract; Confirmation of Effective Date

AGENCY: Food and Drug Administration, HHS.

ACTION: Final rule; confirmation of effective date.

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SUMMARY: The Food and Drug Administration (FDA or we) is confirming the
effective date of September 13, 2013, for the final rule that appeared
in the Federal Register of August 13, 2013. The final rule amended the
color additive regulations to provide for the safe use of spirulina
extract made from the dried biomass of the cyanobacteria Arthrospira
platensis (A. platensis), as a color additive in candy and chewing gum.

DATES: The effective date for the final rule published August 13, 2013
(78 FR 49117), is confirmed as September 13, 2013.

FOR FURTHER INFORMATION CONTACT: Felicia M. Ellison, Center for Food
Safety and Applied Nutrition (HFS-265), Food and Drug Administration,
5100 Paint Branch Pkwy., College Park, MD 20740-3835,<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION: In the Federal Register of August 13, 2013
(78 FR 49117), we amended the color additive regulations to add Sec.
73.530 Spirulina extract (21 CFR 73.530) to provide for the safe use of
spirulina extract made from the dried biomass of the cyanobacteria A.
platensis, as a color additive in candy and chewing gum.
    We gave interested persons until September 12, 2013, to file
objections or

requests for a hearing. We received no objections or requests for a
hearing on the final rule. Therefore, we find that the effective date
of the final rule that published in the Federal Register of August 13,
2013, should be confirmed.

List of Subjects in 21 CFR Part 73

    Color additives, Cosmetics, Drugs, Medical devices.

    Therefore, under the Federal Food, Drug, and Cosmetic Act (21
U.S.C. 321, 341, 342, 343, 348, 351, 352, 355, 361, 362, 371, 379 e)
and under authority delegated to the Commissioner of Food and Drugs,
and redelegated to the Director, Office of Food Additive Safety, we are
giving notice that no objections or requests for a hearing were filed
in response to the August 13, 2013, final rule. Accordingly, the
amendments issued thereby became effective September 13, 2013.

    Dated: November 8, 2013.
Susan M. Bernard,
Director, Office of Regulations, Policy and Social Sciences, Center for
Food Safety and Applied Nutrition.
[FR Doc. 2013-27381 Filed 11-14-13; 8:45 am]
BILLING CODE 4160-01-P


[Federal Register Volume 81, Number 168 (Tuesday, August 30, 2016)]
[Notices]
[Pages 59636-59638]
[FR Doc No: 2016-20779]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2013-N-1427]

Agency Information Collection Activities; Proposed Collection;
Comment Request; Hazard Analysis and Critical Control Point Procedures
for the Safe and Sanitary Processing and Importing of Juice

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA or we) is announcing an
opportunity for public comment on the proposed collection of certain
information by the Agency. Under the Paperwork Reduction Act of 1995
(the PRA), Federal Agencies are required to publish notice in the
Federal Register concerning each proposed collection of information,
including each proposed extension 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 information collection
provisions of our regulations mandating the application of hazard
analysis and critical control point (HACCP) principles to the
processing of fruit and vegetable juices.

DATES: Submit either electronic or written comments on the collection
of information by October 31, 2016.

ADDRESSES: You may submit comments as follows:

Electronic Submissions

    Submit electronic comments in the following way:
     Federal eRulemaking Portal: http://www.regulations.gov.
Follow the instructions for submitting comments. Comments submitted
electronically, including attachments, to http://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 http://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): Division of Dockets Management (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
     For written/paper comments submitted to the Division of
Dockets Management, 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-2013-N-1427 for ``Agency Information Collection Activities;
Proposed Collection; Comment Request; Hazard Analysis and Critical
Control Point Procedures for the Safe and Sanitary Processing and
Importing of Juice.'' Received comments will be placed in the docket
and, except for those submitted as ``Confidential Submissions,''
publicly viewable at http://www.regulations.gov or at the Division of
Dockets Management 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 http://www.regulations.gov.
Submit both copies to the Division of Dockets Management. 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: http://www.fda.gov/regulatoryinformation/dockets/default.htm.
    Docket: For access to the docket to read background documents or
the electronic and written/paper comments received, go to http://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 Division of Dockets Management, 5630 Fishers
Lane, Rm. 1061, Rockville, MD 20852.

FOR FURTHER INFORMATION CONTACT: FDA PRA Staff, Office of Operations,
Food and Drug Administration, Three White Flint North, 10A63, 11601
Landsdown St., North Bethesda, MD 20852<EMAIL_ADDRESS>
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 extension
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.

Hazard Analysis and Critical Control Point (HACCP) Procedures for the
Safe and Sanitary Processing and Importing of Juice--21 CFR Part 120
OMB Control Number 0910-0466--Extension

    FDA's regulations in part 120 (21 CFR part 120) mandate the
application of HACCP procedures to the processing of fruit and
vegetable juices. HACCP is a preventative system of hazard control
designed to help ensure the safety of foods. The regulations were
issued under FDA's statutory authority to regulate food safety under
section 402(a)(4) of the Federal Food, Drug, and Cosmetic Act (the FD&C
Act) (21 U.S.C. 342(a)(4)). Under section 402(a)(4) of the FD&C Act, a
food is adulterated if it is prepared, packed, or held under insanitary
conditions whereby it may have been contaminated with filth or rendered
injurious to health. The Agency also has authority under section 361 of
the Public Health Service Act (42 U.S.C. 264) to issue and enforce
regulations to prevent the introduction, transmission, or spread of
communicable diseases from one State, territory, or possession to
another, or from outside the United States into this country. Under
section 701(a) of the FD&C Act (21 U.S.C. 371(a)), FDA is authorized to
issue regulations for the efficient enforcement of that act.
    Under HACCP, processors of fruit and vegetable juices establish and
follow a preplanned sequence of operations and observations (the HACCP
plan) designed to avoid or eliminate one or more specific food hazards,
and thereby ensure that their products are safe, wholesome, and not
adulterated; in compliance with section 402 of the FD&C Act.
Information development and recordkeeping are essential parts of any
HACCP system. The information collection requirements are narrowly
tailored to focus on the development of appropriate controls and
document those aspects of processing that are critical to food safety.
    FDA estimates the burden of this collection of information as
follows:

                               Table 1--Estimated Annual Recordkeeping Burden \1\
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                                                      Number of       Total
          21 CFR Section              Number of      records per      annual    Average  burden per  Total hours
                                    recordkeepers   recordkeeper     records        recordkeeping
----------------------------------------------------------------------------------------------------------------
120.6(c) and 120.12(a)(1) and               1,875             365      684,375  0.1 (6 minutes)....       68,438
 (b)--Require written monitoring
 and correction records for
 Sanitation Standard Operating
 Procedures.
120.7, 120.10(a), and                       2,300             1.1        2,530  20.................       50,600
 120.12(a)(2), (b) and (c)--
 Require written hazard analysis
 of food hazards.
120.8(a) and 20.12(a)(3), (b),              1,560             1.1        1,716  60.................      102,960
 and (c)--Require written HACCP
 plan.
120.8(b)(7) and 120.12(a)(4)(i)             1,450          14,600   21,170,000  0.01 (1 minute)....      211,700
 and (b)--Require a recordkeeping
 system that documents monitoring
 of the critical control points
 and other measurements as
 prescribed in the HACCP plan.
120.10(c) and 120.12(a)(4)(ii)              1,840              12       22,080  0.1 (6 minutes)....        2,208
 and (b)--Require that all
 corrective actions taken in
 response to a deviation from a
 critical limit be documented.
120.11(a)(1)(iv) and (a)(2) and             1,840              52       95,680  0.1 (6 minutes)....        9,568
 120.12 (a)(5) and (b)--Require
 records showing verification
 activities associated with the
 HACCP system.
120.11(b) and 120.12(a)(5) and              1,840               1        1,840  4..................        7,360
 (b)--Require records showing
 validation activities associated
 with the HACCP system.
120.11(c) and 120.12(a)(5) and              1,840               1        1,840  4..................        7,360
 (b)--Require documentation of
 revalidation of the hazard
 analysis upon any changes that
 might affect the original hazard
 analysis (applies when a firm
 does not have a HACCP plan
 because the original hazard
 analysis did not reveal hazards
 likely to occur).
120.14(a)(2), (c), and (d) and                308               1          308  4..................        1,232
 120.12(b)--Require that juice
 importers have written
 procedures to ensure that the
 juice is processed in accordance
 with our regulations in part 120.
                                  ------------------------------------------------------------------------------
    Total........................  ..............  ..............  ...........  ...................      461,426
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\1\ There are no capital costs or operating and maintenance costs associated with this collection of
  information.

    Table 1 provides our estimate of the total annual recordkeeping
burden of our regulations in part 120. We base our estimate of the
average burden per recordkeeping on our experience with the application
of HACCP principles in food processing. We base our estimate of the
number of recordkeepers on our estimate of the total number of juice
manufacturing plants affected by the regulations (plants identified in
our official establishment inventory plus very small apple juice and
very small orange juice manufacturers). These estimates assume that
every processor will prepare sanitary standard operating procedures and
an HACCP plan and maintain the associated monitoring records, and that
every importer will require product safety specifications. In fact,
there are likely to be some small number of juice processors that,
based upon their hazard analysis, determine that they are not required
to have an HACCP plan under these regulations.

    Dated: August 25, 2016.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2016-20779 Filed 8-29-16; 8:45 am]
 BILLING CODE 4164-01-P


[Federal Register Volume 77, Number 94 (Tuesday, May 15, 2012)]
[Notices]
[Page 28653]
[FR Doc No: 2012-11733]

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SECURITIES AND EXCHANGE COMMISSION

[Release No. 34-66954; File No. SR-MSRB-2012-04]

Self-Regulatory Organizations; Municipal Securities Rulemaking
Board; Notice of a Designation of a Longer Period for Commission Action
on Proposed Rule Change Relating to Proposed Rule G-43, on Broker's
Brokers; Proposed Amendments to Rule G-8, on Books and Records, Rule G-
9, on Record Retention, and Rule G-18, on Execution of Transactions;
and a Proposed Interpretive Notice on the Duties of Dealers That Use
the Services of Broker's Brokers

May 9, 2012
    On March 5, 2012, the Municipal Securities Rulemaking Board
(``MSRB'') filed with the Securities and Exchange Commission
(``Commission''), pursuant to Section 19(b)(1) of the Securities
Exchange Act of 1934 (``Act'') \1\ and Rule 19b-4 thereunder,\2\ a
proposed rule change consisting of proposed MSRB Rule G-43, on broker's
brokers; amendments to MSRB Rule G-8, on books and records; amendments
to MSRB Rule G-9, on record retention; amendments to MSRB Rule G-18, on
execution of transactions; and a proposed interpretive notice on duties
of dealers that use the services of broker's brokers. The proposed rule
change was published for comment in the Federal Register on March 26,
2012.\3\ The Commission received five comment letters regarding the
proposal.\4\ On May 3, 2012, the MSRB submitted a response to the
comment letters \5\ and filed Amendment No. 1 to the proposed rule
change.
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    \1\ 15 U.S.C. 78s(b)(1).
    \2\ 17 CFR 240.19b-4.
    \3\ See Securities Exchange Act Release No. 66625 (March 20,
2012), 77 FR 17548.
    \4\ See Letters to Elizabeth M. Murphy, Secretary, Commission,
from John Webber, Chief Compliance Officer, Advisors Asset
Management, Inc., dated April 16, 2012; Michael Nicholas, Chief
Executive Officer, Bond Dealers of America, dated April 16, 2012;
Thomas S. Vales, Chief Executive Officer, TMC Bonds, LLC, received
April 16, 2012; Mark J. Epstein, President & Chief Executive
Officer, Hartfield, Titus & Donnelly, dated April 18, 2012; and
Paige W. Pierce, President & Chief Executive Officer, RW Smith &
Associates, Inc., received April 19, 2012. The comment letters
received by the Commission are available at http://www.sec.gov/comments/sr-msrb-2012-04/msrb201204.shtml.
    \5\ See Letter to Elizabeth M. Murphy, Secretary, Commission,
from Margaret C. Henry, General Counsel, Market Regulation, MSRB,
dated May 3, 2012.
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    Section 19(b)(2) of the Act \6\ provides that within 45 days of the
publication of notice of the filing of a proposed rule change, or
within such longer period up to 90 days as the Commission may designate
if it finds such longer period to be appropriate and publishes its
reasons for so finding or as to which the self-regulatory organization
consents, the Commission shall either approve the proposed rule change,
disapprove the proposed rule change, or institute proceedings to
determine whether the proposed rule change should be disapproved. The
45th day from the publication of notice of filing of this proposed rule
change is May 10, 2012. The Commission is extending the 45-day time
period.
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    \6\ 15 U.S.C. 78s(b)(2).
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    The Commission finds that it is appropriate to designate a longer
period within which to take action on this proposed rule change. In
particular, an extension of time will ensure the Commission has
sufficient time to consider and take action on the MSRB's proposal in
light of, among other things, the comment letters received on the
proposal, and the MSRB's response to those comment letters.
    Accordingly, the Commission, pursuant to Section 19(b)(2) of the
Act,\7\ designates June 22, 2012 as the date by which the Commission
should either approve or disapprove or institute proceedings to
determine whether to disapprove this proposed rule change.
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    \7\ 15 U.S.C. 78s(b)(2).
    \8\ 17 CFR 200.30-3(a)(31).

    For the Commission, by the Division of Trading and Markets,
pursuant to delegated authority.\8\
Kevin M. O'Neill,
Deputy Secretary.
[FR Doc. 2012-11733 Filed 5-14-12; 8:45 am]
BILLING CODE 8011-01-P


[Federal Register Volume 85, Number 46 (Monday, March 9, 2020)]
[Rules and Regulations]
[Pages 13546-13548]
[FR Doc No: 2020-04525]

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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[EPA-HQ-OPP-2018-0571; FRL-10003-94]

Chrysodeixis includens; Nucleopolyhedrovirus Isolate #460;
Exemption From the Requirement of a Tolerance

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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SUMMARY: This regulation establishes an exemption from the requirement
of a tolerance for residues of Chrysodeixis includens
nucleopolyhedrovirus isolate #460 in or on all food commodities when
used in accordance with label directions and good agricultural
practices. AgBiTech Pty Ltd. submitted a petition to EPA under the
Federal Food, Drug, and Cosmetic Act (FFDCA), requesting an exemption
from the requirement of a tolerance. This regulation eliminates the
need to establish a maximum permissible level for residues of
Chrysodeixis includens nucleopolyhedrovirus isolate #460 in or on all
food commodities under FFDCA.

DATES: This regulation is effective March 9, 2020. Objections and
requests for hearings must be received on or before May 8, 2020 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-2018-0571, is available at http://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 is<PHONE_NUMBER>, and the telephone number for the OPP
Docket is<PHONE_NUMBER>. Please review the visitor instructions and
additional information about the docket available at http://www.epa.gov/dockets.

FOR FURTHER INFORMATION CONTACT: Robert McNally, Biopesticides and
Pollution Prevention Division (7511P), Office of Pesticide Programs,
Environmental Protection Agency, 1200 Pennsylvania Ave. NW, Washington,
DC 20460-0001; main telephone number:<PHONE_NUMBER>; email address:
<EMAIL_ADDRESS>
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 40 CFR
part 180 through the Government Publishing Office's e-CFR site at
http://www.ecfr.gov/cgi-bin/text-idx?&c=ecfr&tpl=/ecfrbrowse/Title40/40tab_02.tpl.

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-2018-0571 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 8, 2020. 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-2018-0571, by one of
the following methods:
     Federal eRulemaking Portal: http://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 http://www.epa.gov/dockets/contacts.html.
    Additional instructions on commenting or visiting the docket, along
with more information about dockets generally, is available at http://www.epa.gov/dockets.

II. Background

    In the Federal Register of December 21, 2018 (83 FR 65660) (FRL-
9985-67), EPA issued a notice pursuant to FFDCA section 408(d)(3), 21
U.S.C. 346a(d)(3), announcing the filing of a pesticide tolerance
exemption petition (PP 7F8641) by AgBiTech Pty Ltd., 8 Rocla Ct.,
Glenvale, Queensland 4350, Australia (c/o MacIntosh & Associates,

Inc., 1203 Hartford Ave., St. Paul, MN 55116-1622). The petition
requested that 40 CFR part 180 be amended by establishing an exemption
from the requirement of a tolerance for residues of the insecticide
Chrysodeixis includens nucleopolyhedrovirus isolate #460 in or on all
agricultural commodities. That notice referenced a summary of the
petition prepared by the petitioner AgBiTech Pty Ltd. and available in
the docket via http://www.regulations.gov. One comment was received on
the notice of filing. EPA's response to this comment is discussed in
Unit III.C.

III. Final Rule

A. EPA's Safety Determination

    Section 408(c)(2)(A)(i) of FFDCA allows EPA to establish an
exemption from the requirement of a tolerance (the legal limit for a
pesticide chemical residue in or on a food) only if EPA determines that
the exemption is ``safe.'' Section 408(c)(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. Pursuant to FFDCA section 408(c)(2)(B), in
establishing or maintaining in effect an exemption from the requirement
of a tolerance, EPA must take into account the factors set forth in
FFDCA section 408(b)(2)(C), which require EPA to give special
consideration to exposure of infants and children to the pesticide
chemical residue in establishing a tolerance or tolerance exemption 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. . . .'' Additionally, FFDCA section 408(b)(2)(D)
requires that EPA consider ``available information concerning the
cumulative effects of [a particular pesticide's] . . . residues and
other substances that have a common mechanism of toxicity.''
    EPA evaluated the available toxicological and exposure data on
Chrysodeixis includens nucleopolyhedrovirus isolate #460 and considered
their validity, completeness, and reliability, as well as the
relationship of this information to human risk. A summary of the data
upon which EPA relied and its risk assessment based on those data can
be found within the document entitled ``Federal Food, Drug, and
Cosmetic Act (FFDCA) Safety Determination for Chrysodeixis includens
Nucleopolyhedrovirus isolate #460'' (``Safety Determination
Document''). This document, as well as other relevant information, is
available in the docket for this action as described under ADDRESSES.
    The available data demonstrated that, with regard to humans,
Chrysodeixis includens nucleopolyhedrovirus isolate #460 is not toxic,
pathogenic, or infective via any reasonably foreseeable route of
exposure and when used in accordance with label directions and good
agricultural practices. Baculoviruses, such as Chrysodeixis includens
nucleopolyhedrovirus isolate #460, are ubiquitous in the environment
and have been extensively studied with no adverse effects in mammals
observed or known. Although there may be dietary and non-occupational
exposure to residues when Chrysodeixis includens nucleopolyhedrovirus
isolate #460 is used on food commodities, there is not a concern due to
the lack of potential for adverse effects when used in accordance with
label directions and good agricultural practices. EPA also determined
that retention of the Food Quality Protection Act safety factor was not
necessary as part of the qualitative assessment conducted for
Chrysodeixis includens nucleopolyhedrovirus isolate #460.
    Based upon its evaluation in the Safety Determination Document, EPA
concludes that there is a reasonable certainty that no harm will result
to the U.S. population, including infants and children, from aggregate
exposure to residues of Chrysodeixis includens nucleopolyhedrovirus
isolate #460 when used in accordance with label directions and good
agricultural practices. Therefore, an exemption from the requirement of
a tolerance is established for residues of Chrysodeixis includens
nucleopolyhedrovirus isolate #460 in or on all food commodities when
used in accordance with label directions and good agricultural
practices.

B. Analytical Enforcement Methodology

    An analytical method for enforcement purposes is not required
because EPA has determined that reasonably foreseeable exposure to
residues of Chrysodeixis includens nucleopolyhedrovirus isolate #460
from use of the pesticide will be safe, due to lack of toxicity,
pathogenicity, and infectivity. Under those circumstances, it is
unnecessary to have an analytical method to monitor for residues.

C. Response to Comments

    EPA received one comment on the notice of filing expressing concern
about the petitioner's belief that an analytical method is not needed.
The FFDCA allows EPA to establish a tolerance exemption without an
analytical method if it determines that there is no need for such a
method and states its reasons for such determination. 21 U.S.C.
346a(c)(3)(B). As indicated in Unit III.B., EPA has determined that
such a method is not needed and explained its reasons for that
determination.

IV. Statutory and Executive Order Reviews

    This action establishes a tolerance exemption under FFDCA section
408(d) in response to a petition submitted to EPA. 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), nor is it considered a
regulatory action under Executive Order 13771, entitled ``Reducing
Regulations and Controlling Regulatory Costs'' (82 FR 9339, February 3,
2017). This action does not contain any information collections subject
to OMB approval under the Paperwork Reduction Act, 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
exemption in this action, do not require the issuance of a proposed
rule, the requirements of the Regulatory Flexibility Act (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. As a result, this
action does not alter the relationships or distribution of power and
responsibilities established by Congress in the preemption provisions

of FFDCA section 408(n)(4). As such, EPA 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, EPA 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 (2 U.S.C.
1501 et seq.).
    This action does not involve any technical standards that would
require EPA's consideration of voluntary consensus standards pursuant
to section 12(d) of the National Technology Transfer and Advancement
Act (15 U.S.C. 272 note).

V. Congressional Review Act

    Pursuant to the Congressional Review Act (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: February 13, 2020.
Richard Keigwin,
Director, Office of Pesticide Programs.

    Therefore, 40 CFR chapter I is amended as follows:

PART 180--[AMENDED]

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. Add Sec.  180.1373 to subpart D to read as follows:

Sec.  180.1373  Chrysodeixis includens nucleopolyhedrovirus isolate
#460; exemption from the requirement of a tolerance.

    Residues of Chrysodeixis includens nucleopolyhedrovirus isolate
#460 are exempt from the requirement of a tolerance in or on all food
commodities, when used in accordance with label directions and good
agricultural practices.

[FR Doc. 2020-04525 Filed 3-6-20; 8:45 am]
BILLING CODE 6560-50-P