[Federal Register Volume 85, Number 74 (Thursday, April 16, 2020)]
[Notices]
[Pages 21247-21249]
[FR Doc No: 2020-08009]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2011-N-0424]

Agency Information Collection Activities; Proposed Collection;
Comment Request; Temporary Marketing Permit Applications

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 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 reporting requirements contained in
existing FDA regulations governing temporary marketing permit
applications.

DATES: Submit either electronic or written comments on the collection
of information by June 15, 2020.

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 June 15, 2020. The https://www.regulations.gov electronic filing system will accept comments until
11:59 p.m. Eastern Time at the end of June 15, 2020. 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-2011-N-0424 for ``Agency Information Collection Activities;
Proposed Collection; Comment Request; Temporary Marketing Permit
Applications.'' 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.govinfo.gov/content/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: Domini Bean, Office of Operations,
Food and Drug Administration, Three White Flint North, 10A-12M, 11601
Landsdown St., North Bethesda, MD 20852,<PHONE_NUMBER>,
<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION: Under the PRA (44 U.S.C. 3501-3521), Federal
Agencies must obtain approval from the Office of Management and Budget
(OMB) for each collection of information they conduct or sponsor.
``Collection of information'' is defined in 44 U.S.C. 3502(3) and 5 CFR
1320.3(c) and includes Agency requests or requirements that members of
the public submit reports, keep records, or provide information to a
third party. Section 3506(c)(2)(A) of the PRA (44 U.S.C. 3506(c)(2)(A))
requires Federal Agencies to provide a 60-day notice in the Federal
Register concerning each proposed collection of information, 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.

Temporary Marketing Permit Applications--21 CFR 130.17(c) and (i)

OMB Control Number 0910-0133--Extension

    Section 401 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C.
341) (FD&C Act) directs FDA to issue regulations establishing
definitions and standards of identity for food. Under section 403(g) of
the FD&C Act (21 U.S.C. 343(g)), a food that is subject to a definition
and standard of identity prescribed by regulation is misbranded if it
does not conform to such definition and standard of identity. Section
130.17 (21 CFR 130.17) provides for the issuance by FDA of temporary
marketing permits that enable the food industry to test consumer
acceptance and measure the technological and commercial feasibility in
interstate commerce of experimental packs of food that deviate from
applicable definitions and standards of identity. Section 130.17(c)
enables the Agency to monitor the manufacture, labeling, and
distribution of experimental packs of food that deviate from applicable
definitions and standards of identity. The information so obtained can
be used in support of a petition to establish or amend the applicable
definition or standard of identity to provide for the variations.
Section 130.17(i) specifies the information that a firm must submit to
FDA to obtain an extension of a temporary marketing permit.
    Description of Respondents: Respondents to this collection of
information include private sector businesses including institutional
and/or industrial customers and food industry members such as
manufacturers, packers, or distributors desiring to apply for a
temporary marketing permit or permit extension.
    We estimate the burden of this collection of information as
follows:

                                 Table 1--Estimated Annual Reporting Burden \1\
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                                                     Number of                    Average burden
    21 CFR section; activity         Number of     responses per   Total annual    per response     Total hours
                                    respondents     respondent       responses      (in hours)
----------------------------------------------------------------------------------------------------------------
130.17(c); Request for temporary              13               2              26              25             650
 marketing permit...............
130.17(i); Request to extend                   1               2               2               2               4
 marketing permit...............
                                 -------------------------------------------------------------------------------
    Total.......................  ..............  ..............  ..............  ..............             654
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\1\ There are no capital costs or operating and maintenance costs associated with this collection of
  information.

    Based on a review of the information collection since our last
request for OMB approval, we have made no adjustments to our burden
estimate.

    Dated: April 3, 2020.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2020-08009 Filed 4-15-20; 8:45 am]
 BILLING CODE 4164-01-P


[Federal Register Volume 77, Number 135 (Friday, July 13, 2012)]
[Rules and Regulations]
[Pages 41271-41273]
[FR Doc No: 2012-17085]

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DEPARTMENT OF HOMELAND SECURITY

Coast Guard

33 CFR Part 165

[Docket Number USCG-2012-0538]
RIN 1625-AA00

Safety Zone; Newburgh to Beacon Swim, Newburgh, Hudson River, NY

AGENCY: Coast Guard, DHS.

ACTION: Temporary final rule.

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SUMMARY: The Coast Guard is establishing a temporary safety zone on the
navigable waters of the Hudson River, NY in the vicinity of Newburgh,
NY for the annual Newburgh Beacon Swim event. This temporary safety
zone is necessary to protect swimmers, spectators and vessels from the
hazards associated with swimmers competing in a swim across the Hudson
River. Persons and vessels are prohibited from entering into,
transiting through, or anchoring within the safety zone unless
authorized by the Captain of the Port (COTP) New York or the designated
representative.

DATES: This rule is effective from 9:30 a.m. until 11:30 a.m. on July
21, 2012.

ADDRESSES: Documents mentioned in this preamble are part of docket
[USCG-2012-0538]. To view documents mentioned in this preamble as being
available in the docket, go to http://www.regulations.gov, type the
docket number in the ``SEARCH'' box and click ``SEARCH.'' Click on Open
Docket Folder on the line associated with this rulemaking. You may also
visit the Docket Management Facility in Room W12-140 on the ground
floor of the Department of Transportation West Building, 1200 New
Jersey Avenue SE., Washington, DC 20590, between 9 a.m. and 5 p.m.,
Monday through Friday, except Federal holidays.

FOR FURTHER INFORMATION CONTACT: If you have questions on this rule,
call or email Ensign Kimberly Farnsworth, Coast Guard; Telephone (718)
354-4163, email<EMAIL_ADDRESS>If you have questions
on viewing or submitting material to the docket, call Renee V. Wright,
Program Manager, Docket Operations, telephone<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

Table of Acronyms

DHS Department of Homeland Security
FR Federal Register
CFR Code of Federal Regulations
NPRM Notice of Proposed Rulemaking
COTP Captain of the Port

A. Regulatory History and Information

    The Newburgh Beacon Swim is an annual recurring event that has a
permanent safety zone found at 33 CFR 165.160. The effective date for
the permanent safety zone is the last weekend in July with a rain date
as the first weekend in August each year.
    The Coast Guard is issuing this final rule without prior notice and
opportunity to comment pursuant to authority under section 4(a) of the
Administrative Procedure Act (APA) (5 U.S.C. 553(b)). This provision
authorizes an agency to issue a rule without prior notice and
opportunity to comment when the agency for good cause finds that those
procedures are ``impracticable, unnecessary, or contrary to the public
interest.'' Under 5 U.S.C. 553(b)(B), the Coast Guard finds that good
cause exists for not publishing a notice of proposed rulemaking (NPRM)
with respect to this rule because delaying this event would be contrary
to the public interest.
    The Newburgh Beacon Swim event will occur this year on July 21,
2012. On May 24, 2012, the sponsor of the event advised the Coast Guard
that due to optimal tide, current, and weather conditions needed to
promote the safety of the swim participants, they were changing the
date of the event from the last weekend in July (with a rain date as
the first weekend in August) to July 21, 2012, thereby rendering the
permanent safety zone set forth in 33 CFR 165.160 inapplicable for this
year's event.
    Any delay in the effective date of this rule would be contrary to
the public interest because immediate action is needed to provide for
the safety of life on the navigable waters from the hazards of swimming
in the Hudson River, particularly in the vicinity of the shipping
channel. The safety zone is necessary to provide for the safety of
event participants, spectator crafts, and other vessels operating near
the event area. For the safety concerns noted, it is in the public
interest to have this

regulation in effect during this event. In addition, any change to the
date of the event could potentially cause economic hardship on the
marine event sponsor and negatively impact other activities being held
in conjunction with these events (e.g., the ``Hudson River Day
Celebration'') by potentially causing numerous event participant
cancellations.
    Under 5 U.S.C. 553(d)(3), the Coast Guard finds for the reasons
stated above that good cause exists for making this rule effective less
than 30 days after publication in the Federal Register.

B. Basis and Purpose

    The legal basis for this rule is 33 U.S.C. 1231; 46 U.S.C Chapter
701, 3306, 3703; 50 U.S.C. 191, 195; 33 CFR 1.05-1, 6.04-1, 6.04-6,
160.5; Public Law 107-295, 116 Stat. 2064; Department of Homeland
Security Delegation No. 0170.1.
    The Coast Guard received an application to hold the annual Newburgh
Beacon Swim on the waters of the Hudson River in the vicinity of
Newburgh, NY. With this application, the event sponsor requested that
the event be permitted to take place on Saturday, July 21, 2012 rather
than the usual last weekend in July. The deviation from the permanent
regulation was requested to avoid unsafe tide and current conditions
expected to occur during the last weekend in July and to have the event
in conjunction with the ``Hudson River Day Celebration.''

C. Discussion of the Final Rule

    The Coast Guard is establishing a temporary safety zone on the
waters of the Hudson River in the vicinity of Newburgh, NY for the
annual Newburgh Beacon Swim event. This temporary rule will restrict
vessels from a portion of the Hudson River during the swim event on
Saturday, July 21, 2012.

D. Regulatory Analyses

    We developed this rule after considering numerous statutes and
executive orders related to rulemaking. Below we summarize our analyses
based on 13 of these statutes or executive orders.

1. Regulatory Planning and Review

    This rule is not a significant regulatory action under section 3(f)
of Executive Order 12866, Regulatory Planning and Review, as
supplemented by Executive Order 13563, Improving Regulation and
Regulatory Review, and does not require an assessment of potential
costs and benefits under section 6(a)(3) of Executive Order 12866 or
under section 1 of Executive Order 13563. The Office of Management and
Budget has not reviewed it under those Orders.
    We expect the economic impact of this rule to be very minimal.
Although this regulation may have some impact on the public, the
potential impact will be minimized for the following reasons. Vessels
will only be restricted from the safety zone for a short duration of
time. Before activating the zone, we will notify mariners by
appropriate means including but not limited to Local Notice to Mariners
and Broadcast Notice to Mariners. Additionally, the Coast Guard
promulgated a permanent safety zone found in 33 CFR Part 165 for the
event area in the past and no adverse comments or notice of any
negative impact caused by the safety zone were received.

2. Impact on Small Entities

    The Regulatory Flexibility Act of 1980 (RFA), 5 U.S.C. 601-612, as
amended, requires federal agencies to consider the potential impact of
regulations on small entities during rulemaking. The Coast Guard
certifies under 5 U.S.C. 605(b) that this rule will not have a
significant economic impact on a substantial number of small entities.
    (1) This rule would affect the following entities, some of which
might be small entities: The owners or operators of vessels intending
to transit or anchor in a portion of the Hudson River during the
effective period.
    (2) This safety zone will not have a significant economic impact on
a substantial number of small entities for the following reasons. This
safety zone will be enforced for only 2 hours. Vessel traffic can pass
safely through the safety zone with permission from the COTP or a
designated representative. Before activating the zone, we will notify
mariners by appropriate means including but not limited to Local Notice
to Mariners and Broadcast Notice to Mariners.

3. Assistance for Small Entities

    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 rule. If the 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,
above.
    Small businesses may send comments on the actions of Federal
employees who enforce, or otherwise determine compliance with, Federal
regulations to the Small Business and Agriculture Regulatory
Enforcement Ombudsman and the Regional Small Business Regulatory
Fairness Boards. The Ombudsman evaluates these actions annually and
rates each agency's responsiveness to small business. If you wish to
comment on actions by employees of the Coast Guard, call 1-888-REG-FAIR
(1-888-734-3247). The Coast Guard will not retaliate against small
entities that question or complain about this rule or any policy or
action of the Coast Guard.

4. Collection of Information

    This rule will not call for a new collection of information under
the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3520).

5. Federalism

    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 rule under that Order and determined
that this rule does not have implications for federalism.

6. 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.

7. 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 rule will not result in
such an expenditure, we do discuss the effects of this rule elsewhere
in this preamble.

8. Taking of Private Property

    This rule will not cause a taking of private property or otherwise
have taking implications under Executive Order 12630, Governmental
Actions and Interference with Constitutionally Protected Property
Rights.

9. Civil Justice Reform

    This rule meets applicable standards in sections 3(a) and 3(b)(2)
of Executive Order 12988, Civil Justice Reform, to minimize litigation,
eliminate ambiguity, and reduce burden.

10. Protection of Children

    We have analyzed this rule under Executive Order 13045, Protection
of Children from Environmental Health Risks and Safety Risks. This rule
is not an economically significant rule and does not create an
environmental risk to health or risk to safety that may
disproportionately affect children.

11. Indian Tribal Governments

    This rule does not have tribal implications under Executive Order
13175, Consultation and Coordination with Indian Tribal Governments,
because it does 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.

12. Energy Effects

    This action is not a ``significant energy action'' under Executive
Order 13211, Actions Concerning Regulations That Significantly Affect
Energy Supply, Distribution, or Use.

13. Technical Standards

    This rule does not use technical standards. Therefore, we did not
consider the use of voluntary consensus standards.

14. Environment

    We have analyzed this rule under Department of Homeland Security
Management Directive 023-01 and Commandant Instruction M16475.lD, which
guide the Coast Guard in complying with the National Environmental
Policy Act of 1969 (NEPA) (42 U.S.C. 4321-4370f), and have determined
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 rule involves the establishment of a temporary safety
zone. This rule is categorically excluded from further review under
paragraph 34(g) of Figure 2-1 of the Commandant Instruction. An
environmental analysis checklist supporting this determination and a
Categorical Exclusion Determination are available in the docket where
indicated under ADDRESSES. We seek any comments or information that may
lead to the discovery of a significant environmental impact from this
rule.

List of Subjects in 33 CFR Part 165

    Marine safety, Navigation (water), Reporting and recordkeeping
requirements, waterways.

    For the reasons discussed in the preamble, the Coast Guard amends
33 CFR part 165 as follows:

PART 165--REGULATED NAVIGATION AREAS AND LIMITED ACCESS AREA

0
1. The authority citation for part 165 continues to read as follows:

    Authority:  33 U.S.C. 1231; 46 U.S.C. Chapter 701, 3306, 3703;
50 U.S.C. 191, 195; 33 CFR 1.05-1, 6.04-1, 6.04-6, 160.5; Public Law
107-295, 116 Stat. 2064; Department of Homeland Security Delegation
No. 0170.1.

0
2. Add Sec.  165.T01-0538 to read as follows:

Sec.  165.T01-0538  Safety Zone; Newburgh Beacon Swim, Newburgh, Hudson
River, NY.

    (a) Regulated Area. The following area is a regulated area: All
navigable waters of the Hudson River, NY in the vicinity of Newburgh,
NY bound by the following points: 41[deg]30'33.67'' N 073[deg]0'20.09''
W; thence to 41[deg]30'29.17'' N 073[deg]59'06.89'' W; thence to
41[deg]30'11.53'' N 073[deg]59'14.83'' W; thence to 41[deg]30'15.15'' N
073[deg]0'17.80'' W; thence north along the shoreline to the point of
the beginning. This area is approximately 1500 yards south of the
Newburgh-Beacon Bridges.
    (b) Effective Date. This rule is effective from 9:30 a.m. until
11:30 a.m. on July 21, 2012.
    (c) Definitions. The following definitions apply to this section:
    (1) Designated Representative. A ``designated representative'' is
any Coast Guard commissioned, warrant or petty officer of the U.S.
Coast Guard who has been designated by the Captain of the Port Sector
New York (COTP), to act on his or her behalf. The designated
representative may be on an official patrol vessel or may be on shore
and will communicate with vessels via VHF-FM radio or loudhailer. In
addition, members of the Coast Guard Auxiliary may be present to inform
vessel operators of this regulation.
    (2) Official Patrol Vessels. Official patrol vessels may consist of
any Coast Guard, Coast Guard Auxiliary, state, or local law enforcement
vessels assigned or approved by the COTP.
    (3) Spectators. All persons and vessels not registered with the
event sponsor as participants or official patrol vessels.
    (d) Regulations.
    (1) The general regulations contained in 33 CFR 165.23, as well as
the following regulations, apply.
    (2) No vessels, except for event coordinators and support vessels,
will be allowed to transit the safety zone without the permission of
the COTP. Vessels not associated with the event that are permitted to
enter the regulated areas shall maintain a separation of at least 100
yards from the participants.
    (3) All persons and vessels shall comply with the instructions of
the COTP or the designated representative. Upon being hailed by a U.S.
Coast Guard vessel by siren, radio, flashing light, or other means, the
operator of a vessel shall proceed as directed. Failure to comply with
a lawful direction may result in expulsion from the regulated area,
citation for failure to comply, or both.
    (4) Vessel operators desiring to enter or operate within the
regulated area shall contact the COTP or the designated representative
via VHF channel 16 or<PHONE_NUMBER> (Sector New York command center) to
obtain permission to do so.
    (5) Spectators or other vessels shall not anchor, block, loiter, or
impede the transit of event participants or official patrol vessels in
the regulated areas during the effective dates and times, unless
authorized by COTP or the designated representative.
    (6) The COTP or the designated representative may delay or
terminate any marine event in this subpart at any time it is deemed
necessary to ensure the safety of life or property.

    Dated: June 27, 2012.
G.A. Loebl,
Captain, U.S. Coast Guard, Captain of the Port New York.
[FR Doc. 2012-17085 Filed 7-12-12; 8:45 am]
BILLING CODE 9110-04-P


[Federal Register Volume 83, Number 154 (Thursday, August 9, 2018)]
[Rules and Regulations]
[Pages 39373-39375]
[FR Doc No: 2018-17081]

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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[EPA-HQ-OPP-2017-0315; FRL-9980-51]

Cerevisane (Cell Walls of Saccharomyces cerevisiae Strain
LAS117); 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 cerevisane (cell walls of Saccharomyces cerevisiae
strain LAS117) in or on all food commodities when used in accordance
with label directions and good agricultural practices. Lesaffre Yeast
Corporation 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 cerevisane (cell walls of
Saccharomyces cerevisiae strain LAS117) under FFDCA.

DATES: This regulation is effective August 9, 2018. Objections and
requests for hearings must be received on or before October 9, 2018,
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-2017-0315, 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 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 40 CFR
part 180 through the Government Printing 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-2017-0315 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
October 9, 2018. 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-2017-0315, 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 March 6, 2018 (83 FR 9471) (FRL-9973-
27), EPA issued a document pursuant to FFDCA section 408(d)(3), 21
U.S.C. 346a(d)(3), announcing the filing of a pesticide tolerance
petition (PP 6F8535) by Technology Sciences Group Inc., 712 Fifth
Street, Suite A, Davis, CA 95616 (on behalf of Lesaffre Yeast
Corporation, 7475 W Main St., Milwaukee, WI 53214). The petition
requested that 40 CFR 180 be amended by establishing an exemption from
the requirement of a tolerance for residues of the systemic resistance
inducer (SRI) cerevisane (cell walls of Saccharomyces cerevisiae strain
LAS117) in or on all food commodities. That document referenced a
summary of the petition prepared by the petitioner, Technology Sciences
Group Inc., (on behalf of Lesaffre Yeast Corporation), which is
available in the docket via http://www.regulations.gov. There were no
relevant comments received in response to the notice of filing.

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 for 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.'' FFDCA section 408(b)(2)(C) provides that EPA shall apply an
additional tenfold (10X) margin of safety for infants and children in
the case of threshold effects to account for prenatal and postnatal
toxicity and the completeness of the database on toxicity and exposure
unless EPA determines based on reliable data that a different margin of
safety will be safe for infants and children. This additional margin of
safety is commonly referred to as the FQPA Safety Factor (SF). In
applying this provision, EPA either retains the default value of 10X,
or uses a different additional safety factor when reliable data
available to EPA support the choice of a different factor.
    EPA evaluated the available toxicity and exposure data on
cerevisane (cell walls of Saccharomyces cerevisiae strain LAS117) and
considered their validity, completeness, and reliability, as well as
the relationship of this information to human risk. EPA also considered
available information concerning the variability of the sensitivities
of major identifiable subgroups of consumers, including infants and
children.
    Cerevisane is a whole cell wall extract of Saccharomyces cerevisiae
strain LAS117. Saccharomyces cerevisiae is a common source of yeast,
commonly used in the manufacturing of beers, wines, and liquor intended
for human consumption because of its ability to ferment sugars into
ethanol.
    Cerevisane is a systemic resistance inducer (SRI) that aids in the
up-regulation of plant defense genes resulting in physiological
changes, including the reinforcement of plant cell walls and the
production of antimicrobial compounds, e.g., hydrogen peroxide (an
oxidant active against a wide variety of microorganisms) and
phytoalexins (which inhibit mycelium growth and the fruitification of
susceptible fungal pathogens), that impart resistance against fungal
diseases.
    Based on the data submitted in support of this petition and the
Agency's assessment of that data, EPA concludes that there is a
reasonable certainty that no harm will result to the U.S. population,
including infants and children from aggregate exposures to a cerevisane
(cells walls of Saccharomyces cerevisiae strain LAS117). This
conclusion is based on the lack of toxicity associated with this
pesticide chemical residue; the available toxicology data indicate that
the active ingredient is of low toxicity and is not a developmental
toxicant or a mutagen; therefore, no toxicological endpoints were
identified. Accordingly, given the lack of threshold effects, the FQPA
Safety Factor need not be retained. The Agency has conducted a
qualitative assessment of exposure and determined that dietary and
drinking water exposure from the pesticide use is expected to be
negligible since significant residues are not expected due to low
application rates and rapid degradation rates following application.
Non-occupational exposures are not expected since cerevisane (cells
walls of Saccharomyces cerevisiae strain LAS117) is not intended for
residential use. Given the lack of toxicity, this minimal exposure
aggregated with the background levels already present in commonly
consumed foods that contain baker's yeast, or beer, wine, and liquor do
not pose a risk of concern. A full explanation of the data upon which
EPA relied, its risk assessment, and other supporting documents is
available in the docket for this action as described under ADDRESSES.
    Based on its safety determination, EPA is establishing an exemption
from the requirement of a tolerance for residues of cerevisane (cell
walls of Saccharomyces cerevisiae strain LAS117) in or on all food
commodities when used in accordance with label directions and good
agricultural practices.

B. Analytical Enforcement Methodology

    An analytical method is not required for enforcement purposes due
to the lack of concern about safety for cerevisane (cell walls of
Saccharomyces cerevisiae strain LAS117) at any exposure level.

IV. Statutory and Executive Order Reviews

    This action establishes an exemption from the requirement of a
tolerance 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 (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
exemption in this action, 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. 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 (UMRA) (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 (NTTAA) (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: July 31, 2018.
Richard P. Keigwin, Jr.,
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.  180.1357 to subpart D to read as follows:

Sec.  180.1357  Cerevisane (cell walls of Saccharomyces cerevisiae
strain LAS117); exemption from the requirement of a tolerance.

    Residues of the biochemical pesticide cerevisane (cell walls of
Saccharomyces cerevisiae strain LAS117) 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. 2018-17081 Filed 8-8-18; 8:45 am]
 BILLING CODE 6560-50-P


Call from Ram Singh, Amity International

 1/18/06

Ram Singh called to ask about the status of nPB.  I explained that we
have a large amount of new information since our previous proposal
(e.g., Ichihara 2004 studies on workers) and a proposal for a new end
use, coatings.  Based on our current discussions with legal counsel, we
expect to provide this information to the public and take public
comment, probably through a notice of proposed rulemaking.

Ram Singh asked about whether nPB would be acceptable.  I said that this
might vary by the end use, and that adhesive use is of particular
concern.  Mr. Singh inquired about solvent cleaning.  I said that the
information we had seen showed that the vast majority of worker exposure
measurements were able to meet even the ACGIH TLV, making it extremely
likely that we would allow nPB for that sector.  Ram Singh mentioned
that when Amity receives workplace exposure data, no measurements have
been above 5 ppm.

Mr. Singh asked about the status of NTP testing and EPA’s docket.  I
sent him an email with web links to both.