Calcium Salts of Phosphorous Acid; Exemption From the Requirement of a Tolerance, 3603-3605 [2018-01494]
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Federal Register / Vol. 83, No. 18 / Friday, January 26, 2018 / Rules and Regulations
‘‘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 174
Environmental protection,
Administrative practice and procedure,
Agricultural commodities, Pesticides
and pests, Reporting and recordkeeping
requirements.
Dated: December 28, 2017.
Hayley Hughes,
Director, Office of Pesticide Programs.
Therefore, 40 CFR chapter I is
amended as follows:
PART 174—[AMENDED]
1. The authority citation for part 174
continues to read as follows:
■
Authority: 7 U.S.C. 136–136y; 21 U.S.C.
321(q), 346a and 371.
2. Add § 174.539 to subpart W to read
as follows:
■
daltland on DSKBBV9HB2PROD with RULES
§ 174.539 Cry51Aa2.834_16 protein;
exemption from the requirement of a
tolerance.
Residues of the Cry51Aa2.834_16
protein, which is a modified protein
derived from the Cry51Aa2 protein of
Bacillus thuringiensis, in or on cotton
are exempt from the requirement of a
tolerance, when the Cry51Aa2.834_16
protein is used as a plant-incorporated
protectant.
[FR Doc. 2018–01519 Filed 1–25–18; 8:45 am]
17:29 Jan 25, 2018
40 CFR Part 180
[EPA–HQ–OPP–2016–0578; FRL–9970–96]
Calcium Salts of Phosphorous Acid;
Exemption From the Requirement of a
Tolerance
Environmental Protection
Agency (EPA).
AGENCY:
ACTION:
Final rule.
This regulation establishes an
exemption from the requirement of a
tolerance for the calcium salts of
phosphorous acid. Verdesian Life
Sciences, LLC., submitted a petition to
EPA under the Federal Food, Drug, and
Cosmetic Act (FFDCA). This regulation
eliminates the need to establish a
maximum permissible level for residues
of calcium salts of phosphorous acid
under FFDCA when used in accordance
with the terms of the exemption.
SUMMARY:
This regulation is effective
January 26, 2018. Objections and
requests for hearings must be received
on or before March 27, 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).
DATES:
The docket for this action,
identified by docket identification (ID)
number EPA–HQ–OPP–2016–0578, 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 is (202) 566–1744,
and the telephone number for the OPP
Docket is (703) 305–5805. Please review
the visitor instructions and additional
information about the docket available
at https://www.epa.gov/dockets.
ADDRESSES:
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:
(703) 305–7090; email address:
BPPDFRNotices@epa.gov.
SUPPLEMENTARY INFORMATION:
BILLING CODE 6560–50–P
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ENVIRONMENTAL PROTECTION
AGENCY
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3603
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 https://
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–2016–0578 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 March 27, 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–
2016–0578, by one of the following
methods:
• Federal eRulemaking Portal: https://
www.regulations.gov. Follow the online
E:\FR\FM\26JAR1.SGM
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3604
Federal Register / Vol. 83, No. 18 / Friday, January 26, 2018 / Rules and Regulations
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/contacts.html.
Additional instructions on commenting
or visiting the docket, along with more
information about dockets generally, is
available at https://www.epa.gov/
dockets.
II. Background
In the Federal Register of December
20, 2016 (81 FR 92758) (FRL–9956–04),
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 6F8481)
by Verdesian Life Sciences, LLC., 1001
Winstead Dr., Suite 480, Cary, NC
27513. The petition requested that 40
CFR 180.1210 be amended to include
residues of the systemic fungicide/
systemic acquired resistance (SAR)
inducer calcium salts of phosphorous
acid in or on all food commodities when
used as an agricultural fungicide and in
or on potatoes when applied as a postharvest treatment at 35,600 ppm or less
phosphorous acid. That document
referenced a summary of the petition
prepared by the petitioner Verdesian
Life Sciences, LLC, which is available in
the docket via https://
www.regulations.gov. There were no
comments received in response to the
notice of filing.
The exemption being established in
this action varies slightly from what the
petitioner requested, for the reasons
described in Unit III.C. below.
III. Final Rule
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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
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17:29 Jan 25, 2018
Jkt 244001
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 calcium salts of
phosphorous acid and considered their
validity, completeness, and reliability,
as well as the relationship of this
information to human risk.
Because of the structural and
functional similarity of calcium salts of
phosphorous acid with potassium salts
of phosphorous acid, Fosetyl-Al, and
phosphonic acid, EPA was able to rely
on toxicity data for those compounds to
assess the toxicity potential of calcium
salts of phosphorous acid. The resulting
assessment indicates that calcium salts
of phosphorous acid would not be
considered acutely toxic nor present
other concerns for subchronic or
chronic toxicity, developmental
toxicity, or mutagenicity. As such the
Agency has not identified any endpoints
of concern for calcium salts and has
conducted a qualitative assessment of
exposure. The Agency has determined
that there is a potential for dietary
exposure to residues of calcium salts of
phosphorous acid in or on food from
use as a pesticidal substance; exposures
PO 00000
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Sfmt 4700
in drinking water are not expected due
to the dissolution of calcium salts of
phosphorous acid in water, and nonoccupational exposures are not expected
since calcium salts of phosphorous acid
are not intended for residential use. A
full explanation of the data upon which
EPA relied and its risk assessment based
on those data can be found within the
November 8, 2017, document entitled
‘‘Federal Food, Drug, and Cosmetic Act
(FFDCA) Considerations for Calcium
Salts of Phosphorous Acid.’’ This
document, as well as other relevant
information, is available in the docket
for this action as described under
ADDRESSES.
Based upon its evaluation, EPA
concludes that calcium salts of
phosphorous acid are not toxic.
Although there may be some exposure
to residues in or on food when calcium
salts of phosphorous acid are used as an
agricultural fungicide or a systemic
acquired resistance inducer, there is a
lack of concern due to the lack of
potential for adverse effects. EPA also
determined that retention of the Food
Quality Protection Act (FQPA) safety
factor was not necessary due to the lack
of threshold effects.
Therefore, 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 calcium salts of
phosphorous acid. Therefore, EPA is
establishing an exemption from the
requirement of a tolerance for residues
of calcium salts of phosphorous acid.
B. Analytical Enforcement Methodology
An analytical method is not required
for enforcement purposes due to the
lack of concern about safety for calcium
salts of phosphorous acid at any
exposure level.
C. Revisions to Petitioned-for Tolerances
EPA is establishing an exemption that
varies slightly from what the petitioner
requested. Because the petitioner
requested the systemic acquired
resistance inducer use specifically for
calcium salts, which has not been
assessed for the other salts of
phosphorous acid, EPA is promulgating
this exemption as a separate paragraph
in the section for exemptions for
residues of phosphorous acid and its
salts. Moreover, the Agency is not
including any specific reference for the
post-harvest use on potatoes as
requested for two reasons. First, unless
otherwise specified, tolerances cover
both pre-harvest and post-harvest
applications. Second, because the
original numerical limitation is written
in terms of an amount of phosphorous
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Federal Register / Vol. 83, No. 18 / Friday, January 26, 2018 / Rules and Regulations
daltland on DSKBBV9HB2PROD with RULES
acid that may be used, this limitation
has no effect for an exemption based
only on the related calcium salts of
phosphorous acid, which have been
considered as a distinct fungicide,
although it is related to all the other
salts of phosphorous acid. In any case,
residues of calcium salts of
phosphorous acid are considered to be
covered for all post-harvest uses without
numerical limitation, including those on
potatoes.
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
(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
VerDate Sep<11>2014
17:29 Jan 25, 2018
Jkt 244001
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: January 5, 2018.
Richard P. Keigwin, Jr.,
Director, Office of Pesticide Programs.
Therefore, 40 CFR chapter I is
amended as follows:
PART 180—[AMENDED]
1. The authority citation for part 180
continues to read as follows:
■
Authority: 21 U.S.C. 321(q), 346a and 371.
2. Revise § 180.1210 to read as
follows:
■
§ 180.1210 Phosphorous acid; exemption
from the requirement of a tolerance.
(a) An exemption from the
requirement of a tolerance is established
for residues of phosphorous acid and its
ammonium, sodium and potassium salts
in or on all food commodities when
used as an agricultural fungicide and in
or on potatoes when applied as a post-
PO 00000
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Fmt 4700
Sfmt 4700
3605
harvest treatment at 35,600 ppm or less
phosphorous acid.
(b) An exemption from the
requirement of a tolerance is established
for residues of calcium salts of
phosphorous acid, including its
metabolites and degradates, in or on all
food commodities when used as a
fungicide or as a systemic acquired
resistance (SAR) inducer.
[FR Doc. 2018–01494 Filed 1–25–18; 8:45 am]
BILLING CODE 6560–50–P
ENVIRONMENTAL PROTECTION
AGENCY
40 CFR Part 180
[EPA–HQ–OPP–2016–0333; FRL–9970–88]
Chlorfenapyr; Pesticide Tolerances
Environmental Protection
Agency (EPA).
ACTION: Final rule.
AGENCY:
This regulation establishes
tolerances for residues of chlorfenapyr,
4-bromo-2-(4-chlorophenyl)-1(ethoxymethyl)-5-(trifluromethyl)-1Hpyrrole-3-carbonitrile, in or on tea,
dried. BASF Corporation requested
these tolerances under the Federal Food,
Drug, and Cosmetic Act (FFDCA).
DATES: This regulation is effective
January 26, 2018. Objections and
requests for hearings must be received
on or before March 27, 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–2016–0333, 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 is (202) 566–1744,
and the telephone number for the OPP
Docket is (703) 305–5805. Please review
the visitor instructions and additional
information about the docket available
at https://www.epa.gov/dockets.
FOR FURTHER INFORMATION CONTACT:
Michael L. Goodis, P.E., Director,
Registration Division (750P), Office of
Pesticide Programs, Environmental
Protection Agency, 1200 Pennsylvania
Ave. NW, Washington, DC 20460–0001;
SUMMARY:
E:\FR\FM\26JAR1.SGM
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Agencies
[Federal Register Volume 83, Number 18 (Friday, January 26, 2018)]
[Rules and Regulations]
[Pages 3603-3605]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2018-01494]
-----------------------------------------------------------------------
ENVIRONMENTAL PROTECTION AGENCY
40 CFR Part 180
[EPA-HQ-OPP-2016-0578; FRL-9970-96]
Calcium Salts of Phosphorous Acid; Exemption From the Requirement
of a Tolerance
AGENCY: Environmental Protection Agency (EPA).
ACTION: Final rule.
-----------------------------------------------------------------------
SUMMARY: This regulation establishes an exemption from the requirement
of a tolerance for the calcium salts of phosphorous acid. Verdesian
Life Sciences, LLC., submitted a petition to EPA under the Federal
Food, Drug, and Cosmetic Act (FFDCA). This regulation eliminates the
need to establish a maximum permissible level for residues of calcium
salts of phosphorous acid under FFDCA when used in accordance with the
terms of the exemption.
DATES: This regulation is effective January 26, 2018. Objections and
requests for hearings must be received on or before March 27, 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-2016-0578, 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 is (202) 566-1744, and the telephone number for the OPP
Docket is (703) 305-5805. Please review the visitor instructions and
additional information about the docket available at https://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: (703) 305-7090; 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 https://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-2016-0578 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
March 27, 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-2016-0578, by one of
the following methods:
Federal eRulemaking Portal: https://www.regulations.gov.
Follow the online
[[Page 3604]]
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/contacts.html. Additional
instructions on commenting or visiting the docket, along with more
information about dockets generally, is available at https://www.epa.gov/dockets.
II. Background
In the Federal Register of December 20, 2016 (81 FR 92758) (FRL-
9956-04), 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 6F8481) by Verdesian Life Sciences, LLC., 1001 Winstead
Dr., Suite 480, Cary, NC 27513. The petition requested that 40 CFR
180.1210 be amended to include residues of the systemic fungicide/
systemic acquired resistance (SAR) inducer calcium salts of phosphorous
acid in or on all food commodities when used as an agricultural
fungicide and in or on potatoes when applied as a post-harvest
treatment at 35,600 ppm or less phosphorous acid. That document
referenced a summary of the petition prepared by the petitioner
Verdesian Life Sciences, LLC, which is available in the docket via
https://www.regulations.gov. There were no comments received in response
to the notice of filing.
The exemption being established in this action varies slightly from
what the petitioner requested, for the reasons described in Unit III.C.
below.
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 calcium
salts of phosphorous acid and considered their validity, completeness,
and reliability, as well as the relationship of this information to
human risk.
Because of the structural and functional similarity of calcium
salts of phosphorous acid with potassium salts of phosphorous acid,
Fosetyl-Al, and phosphonic acid, EPA was able to rely on toxicity data
for those compounds to assess the toxicity potential of calcium salts
of phosphorous acid. The resulting assessment indicates that calcium
salts of phosphorous acid would not be considered acutely toxic nor
present other concerns for subchronic or chronic toxicity,
developmental toxicity, or mutagenicity. As such the Agency has not
identified any endpoints of concern for calcium salts and has conducted
a qualitative assessment of exposure. The Agency has determined that
there is a potential for dietary exposure to residues of calcium salts
of phosphorous acid in or on food from use as a pesticidal substance;
exposures in drinking water are not expected due to the dissolution of
calcium salts of phosphorous acid in water, and non-occupational
exposures are not expected since calcium salts of phosphorous acid are
not intended for residential use. A full explanation of the data upon
which EPA relied and its risk assessment based on those data can be
found within the November 8, 2017, document entitled ``Federal Food,
Drug, and Cosmetic Act (FFDCA) Considerations for Calcium Salts of
Phosphorous Acid.'' This document, as well as other relevant
information, is available in the docket for this action as described
under ADDRESSES.
Based upon its evaluation, EPA concludes that calcium salts of
phosphorous acid are not toxic. Although there may be some exposure to
residues in or on food when calcium salts of phosphorous acid are used
as an agricultural fungicide or a systemic acquired resistance inducer,
there is a lack of concern due to the lack of potential for adverse
effects. EPA also determined that retention of the Food Quality
Protection Act (FQPA) safety factor was not necessary due to the lack
of threshold effects.
Therefore, 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 calcium salts of
phosphorous acid. Therefore, EPA is establishing an exemption from the
requirement of a tolerance for residues of calcium salts of phosphorous
acid.
B. Analytical Enforcement Methodology
An analytical method is not required for enforcement purposes due
to the lack of concern about safety for calcium salts of phosphorous
acid at any exposure level.
C. Revisions to Petitioned-for Tolerances
EPA is establishing an exemption that varies slightly from what the
petitioner requested. Because the petitioner requested the systemic
acquired resistance inducer use specifically for calcium salts, which
has not been assessed for the other salts of phosphorous acid, EPA is
promulgating this exemption as a separate paragraph in the section for
exemptions for residues of phosphorous acid and its salts. Moreover,
the Agency is not including any specific reference for the post-harvest
use on potatoes as requested for two reasons. First, unless otherwise
specified, tolerances cover both pre-harvest and post-harvest
applications. Second, because the original numerical limitation is
written in terms of an amount of phosphorous
[[Page 3605]]
acid that may be used, this limitation has no effect for an exemption
based only on the related calcium salts of phosphorous acid, which have
been considered as a distinct fungicide, although it is related to all
the other salts of phosphorous acid. In any case, residues of calcium
salts of phosphorous acid are considered to be covered for all post-
harvest uses without numerical limitation, including those on potatoes.
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 (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: January 5, 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. Revise Sec. 180.1210 to read as follows:
Sec. 180.1210 Phosphorous acid; exemption from the requirement of a
tolerance.
(a) An exemption from the requirement of a tolerance is established
for residues of phosphorous acid and its ammonium, sodium and potassium
salts in or on all food commodities when used as an agricultural
fungicide and in or on potatoes when applied as a post-harvest
treatment at 35,600 ppm or less phosphorous acid.
(b) An exemption from the requirement of a tolerance is established
for residues of calcium salts of phosphorous acid, including its
metabolites and degradates, in or on all food commodities when used as
a fungicide or as a systemic acquired resistance (SAR) inducer.
[FR Doc. 2018-01494 Filed 1-25-18; 8:45 am]
BILLING CODE 6560-50-P