Glufosinate Ammonium; Pesticide Tolerances, 21706-21708 [2019-10054]
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21706
Federal Register / Vol. 84, No. 94 / Wednesday, May 15, 2019 / Rules and Regulations
(b) Effective period. This section is
effective without actual notice from 8:45
a.m. until 11:59 p.m. on May 14, 2019.
For the purposes of enforcement, actual
notice will be used from May 9, 2019
until 11:59 a.m. on May 14, 2019.
(c) Period of enforcement. This
section will be enforced from the time
LNGC MARVEL FALCON moors and
while the vessel is transiting outbound
through the La Quinta Channel and
Corpus Christi Ship Channel from May
9, 2019 through May 14, 2019.
(d) Regulations. (1) The general
regulations in § 165.33 apply. Entry into
these zones is prohibited unless
authorized by the Captain of the Port
Sector Corpus Christi (COTP) or a
designated representative. A designated
representative is a commissioned,
warrant, or petty officer of the U.S.
Coast Guard assigned to units under the
operational control of USCG Sector
Corpus Christi.
(2) Persons or vessels desiring to enter
or pass through the zones must request
permission from the COTP or a
designated representative on VHF–FM
channel 16 or by telephone at 361–939–
0450.
(3) If permission is granted, all
persons and vessels shall comply with
the instructions of the COTP or
designated representative.
(e) Information broadcasts. The COTP
or a designated representative will
inform the public through Broadcast
Notices to Mariners (BNMs) of the
enforcement times and date for these
security zones.
Dated: May 6, 2019.
E.J. Gaynor,
Captain, U.S. Coast Guard, Captain of the
Port Sector Corpus Christi.
[FR Doc. 2019–10090 Filed 5–14–19; 8:45 am]
BILLING CODE 9110–04–P
ENVIRONMENTAL PROTECTION
AGENCY
40 CFR Part 180
[EPA–HQ–OPP–2018–0207; FRL–9991–49]
Glufosinate Ammonium; Pesticide
Tolerances
Environmental Protection
Agency (EPA).
ACTION: Final rule.
AGENCY:
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The docket for this action,
identified by docket identification (ID)
number EPA–HQ–OPP–2018–0207, 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 Goodis, Registration Division
(7505P), Office of Pesticide Programs,
Environmental Protection Agency, 1200
Pennsylvania Ave. NW, Washington, DC
20460–0001; main telephone number:
(703) 305–7090; email address:
RDFRNotices@epa.gov.
SUPPLEMENTARY INFORMATION:
ADDRESSES:
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?
This regulation amends
tolerances for residues of glufosinate
ammonium in or on Olive; Fruit, Stone
(crop group 12–12); Nuts, Tree (crop
group 14–12) and Soybean Hulls.
DATES: This regulation is effective May
15, 2019. Objections and requests for
SUMMARY:
hearings must be received on or before
July 15, 2019, and must be filed in
accordance with the instructions
provided in 40 CFR part 178 (see also
Unit I.C. of the SUPPLEMENTARY
INFORMATION).
You may access a frequently updated
electronic version of EPA’s tolerance
regulations at 40 CFR part 180 through
the Government Printing Office’s e-CFR
site at https://www.ecfr.gov/cgi-bin/textidx?&c=ecfr&tpl=/ecfrbrowse/Title40/
40tab_02.tpl.
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Fmt 4700
Sfmt 4700
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–2018–0207 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 July
15, 2019. 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–
2018–0207, by one of the following
methods:
• Federal eRulemaking Portal: https://
www.regulations.gov. Follow the online
instructions for submitting comments.
Do not submit electronically any
information you consider to be CBI or
other information whose disclosure is
restricted by statute.
• Mail: OPP Docket, Environmental
Protection Agency Docket Center (EPA/
DC), (28221T), 1200 Pennsylvania Ave.
NW, Washington, DC 20460–0001.
• Hand Delivery: To make special
arrangements for hand delivery or
delivery of boxed information, please
follow the instructions at https://
www.epa.gov/dockets/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. Summary of Petitioned-For
Tolerance
In the Federal Register of August 14,
2018 (83 FR 40272) (FRL–9981–10),
EPA issued a notice pursuant to FFDCA
section 408(d)(3), 21 U.S.C. 346a(d)(3),
announcing the filing of a pesticide
petition (PP#8F8668) by Bayer
CropScience, 2 T.W. Alexander Drive,
P.O. Box 12014, RTP, NCP 27709. The
petition requested that 40 CFR 180.473
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Federal Register / Vol. 84, No. 94 / Wednesday, May 15, 2019 / Rules and Regulations
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be amended by establishing tolerances
for residues of the herbicide glufosinate
ammonium, butanoic acid, 2-amino-4(hydroxymethylphosphinyl)
monoammonium salt, and its
metabolites, 2-(acetylamino)-4(hydroxymethyl phosphinyl) butanoic
acid, and 3-(hydroxymethylphosphinyl)
propanoic acid, expressed as 2-amino-4(hydroxymethylphosphinyl) butanoic
acid equivalents, in or on olive at 0.50
parts per million (ppm); fruit, stone
(crop group 12–12) at 0.30 ppm; nut,
tree (crop group 14–12) at 0.50 ppm,
and soybean hulls at 10 ppm. That
document referenced a summary of the
petition prepared by Bayer CropScience,
the registrant, which is available in the
docket, https://www.regulations.gov.
There were no comments received in
response to the notice of filing.
III. Aggregate Risk Assessment and
Determination of Safety
Section 408(b)(2)(A)(i) of FFDCA
allows EPA to establish a tolerance (the
legal limit for a pesticide chemical
residue in or on a food) only if EPA
determines that the tolerance is ‘‘safe.’’
Section 408(b)(2)(A)(ii) of FFDCA
defines ‘‘safe’’ to mean that ‘‘there is a
reasonable certainty that no harm will
result from aggregate exposure to the
pesticide chemical residue, including
all anticipated dietary exposures and all
other exposures for which there is
reliable information.’’ This includes
exposure through drinking water and in
residential settings but does not include
occupational exposure. Section
408(b)(2)(C) of FFDCA requires EPA to
give special consideration to exposure
of infants and children to the pesticide
chemical residue in establishing a
tolerance and to ‘‘ensure that there is a
reasonable certainty that no harm will
result to infants and children from
aggregate exposure to the pesticide
chemical residue. . . .’’
Consistent with FFDCA section
408(b)(2)(D), and the factors specified in
FFDCA section 408(b)(2)(D), EPA has
reviewed the available scientific data
and other relevant information in
support of this action. EPA has
sufficient data to assess the hazards of
and to make a determination on
aggregate exposure for glufosinate
ammonium including exposure
resulting from the tolerances established
by this action. EPA’s assessment of
exposures and risks associated with
glufosinate ammonium follows.
In the Federal Register of September
26, 2012 (77 FR 59106) (FRL–9363–6),
EPA established tolerances for residues
of glufosinate ammonium in or on corn,
sweet, forage; corn, sweet, kernel plus
cob with husks removed; corn, sweet,
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stover; fruit, citrus (crop group 10–10);
olive; fruit, pome (crop group 11–10);
and fruit, stone (crop group 12–12). EPA
concluded a risk assessment in 2013 for
the registration review of glufosinate
and in 2017 for an increase in use rates
in/on canola, corn (field and sweet), and
soybean and to incorporate 6(a)(2) data
on pistachio. The 2018 risk assessment
for an increase in tolerances for olive;
fruit, stone (group 12–12); nut, tree
(group 14–12); and soybean, hulls
concluded that the 2012, 2013, and 2017
risk assessments support the tolerance
increases. The tolerance increases do
not increase the dietary or aggregate risk
estimates. A detailed discussion of the
aggregate risk assessments and
determination of safety for the tolerance
increases can be found at https://
www.regulations.gov in documents
titled ‘‘Glufosinate Ammonium.
Abbreviated Risk Assessment for
Increase in Tolerances for Olive, Stone
Fruit (Group 12–12), Tree Nuts (Group
14–12), and Soybean Hull.’’,
‘‘Glufosinate ammonium. Human Health
Risk Assessment for the Label
Amendment Increasing the Use Rate in/
on Canola, Com (Field and sweet), and
Soybean; and to Incorporate 6(a)(2) Data
on Pistachio.’’, ‘‘Glufosinate
Ammonium. Human Health Risk
Assessment for Registration Review.’’,
and ‘‘Glufosinate Ammonium. Updated
Human Health Risk Assessment for the
Proposed New Use of Glufosinate
Ammonium in/on Citrus Fruit (Crop
Group 10), Pome Fruit (Crop Group 11),
Stone Fruit (Crop Group 12), Olives and
Sweet Corn’’ in docket ID number EPA–
HQ–OPP–2018–0207.
EPA concludes that there is
reasonable certainty that no harm will
result to the general population or to
infants and children from aggregate
exposure to glufosinate ammonium
residues.
IV. Other Considerations
A. Analytical Enforcement Methodology
An adequate enforcement
methodology (high performance liquid
chromatography-electrospray
ionization/tandem mass spectrometry
(LC/MS/MS)) is available to enforce the
tolerance expression. The method may
be requested from: Chief, Analytical
Chemistry Branch, Environmental
Science Center, 701 Mapes Rd., Ft.
Meade, MD 20755–5350; telephone
number: (410) 305–2905; email address:
residuemethods@epa.gov.
B. International Residue Limits
In making its tolerance decisions, EPA
seeks to harmonize U.S. tolerances with
international standards whenever
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possible, consistent with U.S. food
safety standards and agricultural
practices. EPA considers the
international maximum residue limits
(MRLs) established by the Codex
Alimentarius Commission (Codex), as
required by FFDCA section 408(b)(4).
The Codex Alimentarius is a joint
United Nations Food and Agriculture
Organization/World Health
Organization food standards program,
and it is recognized as an international
food safety standards-setting
organization in trade agreements to
which the United States is a party. EPA
may establish a tolerance that is
different from a Codex MRL; however,
FFDCA section 408(b)(4) requires that
EPA explain the reasons for departing
from the Codex level.
The Codex has not established a MRL
for glufosinate ammonium in or on olive
or soybean hulls. Codex has set a MRL
for stone fruit at 0.15 ppm, and a MRL
for tree nuts at 0.1 ppm. EPA cannot
harmonize recommended U.S. tolerance
values with the Codex MRLs for stone
fruit or tree nuts because the lower
MRLs could be exceeded with the uses
petitioned-for in this action.
V. Conclusion
Therefore, tolerances are established
for residues of glufosinate ammonium,
butanoic acid, 2-amino-4(hydroxymethylphosphinyl)
monoammonium salt, and its
metabolites, 2-(acetylamino)-4(hydroxymethyl phosphinyl) butanoic
acid, and 3-(hydroxymethylphosphinyl)
propanoic acid, expressed as 2-amino-4(hydroxymethylphosphinyl) butanoic
acid equivalents, in or on olive at 0.50
ppm; fruit, stone (crop group 12–12) at
0.30 ppm; nut, trees (crop group 14–12)
at 0.50 ppm; and soybean, hulls at 10
ppm.
VI. Statutory and Executive Order
Reviews
This action establishes tolerances
under FFDCA section 408(d) in
response to a petition submitted to the
Agency. The Office of Management and
Budget (OMB) has exempted these types
of actions from review under Executive
Order 12866, entitled ‘‘Regulatory
Planning and Review’’ (58 FR 51735,
October 4, 1993). Because this action
has been exempted from review under
Executive Order 12866, this action is
not subject to Executive Order 13211,
entitled ‘‘Actions Concerning
Regulations That Significantly Affect
Energy Supply, Distribution, or Use’’ (66
FR 28355, May 22, 2001) or Executive
Order 13045, entitled ‘‘Protection of
Children from Environmental Health
Risks and Safety Risks’’ (62 FR 19885,
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April 23, 1997). This action does not
contain any information collections
subject to OMB approval under the
Paperwork Reduction Act (PRA) (44
U.S.C. 3501 et seq.), nor does it require
any special considerations under
Executive Order 12898, entitled
‘‘Federal Actions to Address
Environmental Justice in Minority
Populations and Low-Income
Populations’’ (59 FR 7629, February 16,
1994).
Since tolerances and exemptions that
are established on the basis of a petition
under FFDCA section 408(d), such as
the tolerance in this final rule, do not
require the issuance of a proposed rule,
the requirements of the Regulatory
Flexibility Act (RFA) (5 U.S.C. 601 et
seq.), do not apply.
This action directly regulates growers,
food processors, food handlers, and food
retailers, not States or tribes, nor does
this action alter the relationships or
distribution of power and
responsibilities established by Congress
in the preemption provisions of FFDCA
section 408(n)(4). As such, the Agency
has determined that this action will not
have a substantial direct effect on States
or tribal governments, on the
relationship between the national
government and the States or tribal
governments, or on the distribution of
power and responsibilities among the
various levels of government or between
the Federal Government and Indian
tribes. Thus, the Agency has determined
that Executive Order 13132, entitled
‘‘Federalism’’ (64 FR 43255, August 10,
1999) and Executive Order 13175,
entitled ‘‘Consultation and Coordination
with Indian Tribal Governments’’ (65 FR
67249, November 9, 2000) do not apply
to this action. In addition, this action
does not impose any enforceable duty or
contain any unfunded mandate as
described under Title II of the Unfunded
Mandates Reform Act (UMRA) (2 U.S.C.
1501 et seq.).
This action does not involve any
technical standards that would require
Agency consideration of voluntary
consensus standards pursuant to section
12(d) of the National Technology
Transfer and Advancement Act
(NTTAA) (15 U.S.C. 272 note).
VII. Congressional Review Act
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).
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List of Subjects in 40 CFR Part 180
Environmental protection,
Administrative practice and procedure,
Agricultural commodities, Pesticides
and pests, Reporting and recordkeeping
requirements.
hazardous substances, pollutants or
contaminants throughout the United
States. The National Priorities List
(‘‘NPL’’) constitutes this list. The NPL is
intended primarily to guide the
Environmental Protection Agency (‘‘the
EPA’’ or ‘‘the agency’’) in determining
Dated: April 3, 2019.
which sites warrant further
Donna Davis,
investigation. These further
Acting Director, Registration Division, Office
investigations will allow the EPA to
of Pesticide Programs.
assess the nature and extent of public
health and environmental risks
Therefore, 40 CFR chapter I is
associated with the site and to
amended as follows:
determine what CERCLA-financed
PART 180—[AMENDED]
remedial action(s), if any, may be
appropriate. This rule adds seven sites
■ 1. The authority citation for part 180
to the General Superfund section of the
continues to read as follows:
NPL and changes the name of an NPL
Authority: 21 U.S.C. 321(q), 346a and 371.
site.
DATES: The document is effective on
■ 2. In § 180.473, revise the entries
June 14, 2019.
‘‘Fruit, stone, group 12–12’’; ‘‘Nut, tree,
ADDRESSES: Contact information for the
group 14–12’’; ‘‘Olive’’; and ‘‘Soybean,
EPA Headquarters:
hulls’’ in the table in paragraph (a) to
• Docket Coordinator, Headquarters;
read as follows:
U.S. Environmental Protection Agency;
§ 180.473 Glufosinate ammonium;
CERCLA Docket Office; 1301
tolerances for residues.
Constitution Avenue NW; William
(a) * * *
Jefferson Clinton Building West, Room
3334, Washington, DC 20004, 202/566–
Parts per
0276.
Commodity
million
The contact information for the
regional dockets is as follows:
• Holly Inglis, Region 1 (CT, ME, MA,
*
*
*
*
*
Fruit, stone, group 12–12 ...........
0.30 NH, RI, VT), U.S. EPA, Superfund
Records and Information Center, 5 Post
*
*
*
*
*
Office Square, Suite 100, Boston, MA
Nut, tree, group 14–12 ...............
0.50 02109–3912; 617/918–1413.
Olive ............................................
0.50
• Ildefonso Acosta, Region 2 (NJ, NY,
PR, VI), U.S. EPA, 290 Broadway, New
*
*
*
*
*
York, NY 10007–1866; 212/637–4344.
Soybean, hulls ............................
10
• Lorie Baker (ASRC), Region 3 (DE,
DC, MD, PA, VA, WV), U.S. EPA,
*
*
*
*
*
Library, 1650 Arch Street, Mailcode
[FR Doc. 2019–10054 Filed 5–14–19; 8:45 am]
3HS12, Philadelphia, PA 19103; 215/
BILLING CODE 6560–50–P
814–3355.
• Cathy Amoroso, Region 4 (AL, FL,
GA, KY, MS, NC, SC, TN), U.S. EPA, 61
ENVIRONMENTAL PROTECTION
Forsyth Street SW, Mailcode 9T25,
AGENCY
Atlanta, GA 30303; 404/562–8637.
• Todd Quesada, Region 5 (IL, IN, MI,
40 CFR Part 300
MN, OH, WI), U.S. EPA Superfund
[EPA–HQ–SFUND–1989–0007, EPA–HQ–
Division Librarian/SFD Records
OLEM–2018–0253, 0580, 0581, 0582, 0583,
Manager SRC–7J, Metcalfe Federal
0585, and 0586; FRL–9993–49–OLEM]
Building, 77 West Jackson Boulevard,
Chicago, IL 60604; 312/886–4465.
National Priorities List
• Brenda Cook, Region 6 (AR, LA,
AGENCY: Environmental Protection
NM, OK, TX), U.S. EPA, 1445 Ross
Agency (EPA).
Avenue, Suite 1200, Mailcode 6SFTS,
Dallas, TX 75202–2733; 214/665–7436.
ACTION: Final rule.
• Kumud Pyakuryal, Region 7 (IA,
SUMMARY: The Comprehensive
KS, MO, NE), U.S. EPA, 11201 Renner
Environmental Response,
Blvd., Mailcode SUPRSTAR, Lenexa, KS
Compensation, and Liability Act of 1980 66219; 913/551–7956.
(‘‘CERCLA’’ or ‘‘the Act’’), as amended,
• Victor Ketellapper, Region 8 (CO,
requires that the National Oil and
MT, ND, SD, UT, WY), U.S. EPA, 1595
Hazardous Substances Pollution
Wynkoop Street, Mailcode 8EPR–B,
Contingency Plan (‘‘NCP’’) include a list Denver, CO 80202–1129; 303/312–6578.
of national priorities among the known
• Sharon Bowen, Region 9 (AZ, CA,
releases or threatened releases of
HI, NV, AS, GU, MP), U.S. EPA, 75
PO 00000
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Agencies
[Federal Register Volume 84, Number 94 (Wednesday, May 15, 2019)]
[Rules and Regulations]
[Pages 21706-21708]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2019-10054]
=======================================================================
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ENVIRONMENTAL PROTECTION AGENCY
40 CFR Part 180
[EPA-HQ-OPP-2018-0207; FRL-9991-49]
Glufosinate Ammonium; Pesticide Tolerances
AGENCY: Environmental Protection Agency (EPA).
ACTION: Final rule.
-----------------------------------------------------------------------
SUMMARY: This regulation amends tolerances for residues of glufosinate
ammonium in or on Olive; Fruit, Stone (crop group 12-12); Nuts, Tree
(crop group 14-12) and Soybean Hulls.
DATES: This regulation is effective May 15, 2019. Objections and
requests for hearings must be received on or before July 15, 2019, 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-2018-0207, 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 Goodis, Registration Division
(7505P), 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 EPA's
tolerance regulations at 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-2018-0207 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
July 15, 2019. 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-2018-0207, by one of
the following methods:
Federal eRulemaking Portal: https://www.regulations.gov.
Follow the online instructions for submitting comments. Do not submit
electronically any information you consider to be CBI or other
information whose disclosure is restricted by statute.
Mail: OPP Docket, Environmental Protection Agency Docket
Center (EPA/DC), (28221T), 1200 Pennsylvania Ave. NW, Washington, DC
20460-0001.
Hand Delivery: To make special arrangements for hand
delivery or delivery of boxed information, please follow the
instructions at https://www.epa.gov/dockets/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. Summary of Petitioned-For Tolerance
In the Federal Register of August 14, 2018 (83 FR 40272) (FRL-9981-
10), EPA issued a notice pursuant to FFDCA section 408(d)(3), 21 U.S.C.
346a(d)(3), announcing the filing of a pesticide petition (PP#8F8668)
by Bayer CropScience, 2 T.W. Alexander Drive, P.O. Box 12014, RTP, NCP
27709. The petition requested that 40 CFR 180.473
[[Page 21707]]
be amended by establishing tolerances for residues of the herbicide
glufosinate ammonium, butanoic acid, 2-amino-4-
(hydroxymethylphosphinyl) monoammonium salt, and its metabolites, 2-
(acetylamino)-4-(hydroxymethyl phosphinyl) butanoic acid, and 3-
(hydroxymethylphosphinyl) propanoic acid, expressed as 2-amino-4-
(hydroxymethylphosphinyl) butanoic acid equivalents, in or on olive at
0.50 parts per million (ppm); fruit, stone (crop group 12-12) at 0.30
ppm; nut, tree (crop group 14-12) at 0.50 ppm, and soybean hulls at 10
ppm. That document referenced a summary of the petition prepared by
Bayer CropScience, the registrant, which is available in the docket,
https://www.regulations.gov. There were no comments received in response
to the notice of filing.
III. Aggregate Risk Assessment and Determination of Safety
Section 408(b)(2)(A)(i) of FFDCA allows EPA to establish a
tolerance (the legal limit for a pesticide chemical residue in or on a
food) only if EPA determines that the tolerance is ``safe.'' Section
408(b)(2)(A)(ii) of FFDCA defines ``safe'' to mean that ``there is a
reasonable certainty that no harm will result from aggregate exposure
to the pesticide chemical residue, including all anticipated dietary
exposures and all other exposures for which there is reliable
information.'' This includes exposure through drinking water and in
residential settings but does not include occupational exposure.
Section 408(b)(2)(C) of FFDCA requires EPA to give special
consideration to exposure of infants and children to the pesticide
chemical residue in establishing a tolerance and to ``ensure that there
is a reasonable certainty that no harm will result to infants and
children from aggregate exposure to the pesticide chemical residue. . .
.''
Consistent with FFDCA section 408(b)(2)(D), and the factors
specified in FFDCA section 408(b)(2)(D), EPA has reviewed the available
scientific data and other relevant information in support of this
action. EPA has sufficient data to assess the hazards of and to make a
determination on aggregate exposure for glufosinate ammonium including
exposure resulting from the tolerances established by this action.
EPA's assessment of exposures and risks associated with glufosinate
ammonium follows.
In the Federal Register of September 26, 2012 (77 FR 59106) (FRL-
9363-6), EPA established tolerances for residues of glufosinate
ammonium in or on corn, sweet, forage; corn, sweet, kernel plus cob
with husks removed; corn, sweet, stover; fruit, citrus (crop group 10-
10); olive; fruit, pome (crop group 11-10); and fruit, stone (crop
group 12-12). EPA concluded a risk assessment in 2013 for the
registration review of glufosinate and in 2017 for an increase in use
rates in/on canola, corn (field and sweet), and soybean and to
incorporate 6(a)(2) data on pistachio. The 2018 risk assessment for an
increase in tolerances for olive; fruit, stone (group 12-12); nut, tree
(group 14-12); and soybean, hulls concluded that the 2012, 2013, and
2017 risk assessments support the tolerance increases. The tolerance
increases do not increase the dietary or aggregate risk estimates. A
detailed discussion of the aggregate risk assessments and determination
of safety for the tolerance increases can be found at https://www.regulations.gov in documents titled ``Glufosinate Ammonium.
Abbreviated Risk Assessment for Increase in Tolerances for Olive, Stone
Fruit (Group 12-12), Tree Nuts (Group 14-12), and Soybean Hull.'',
``Glufosinate ammonium. Human Health Risk Assessment for the Label
Amendment Increasing the Use Rate in/on Canola, Com (Field and sweet),
and Soybean; and to Incorporate 6(a)(2) Data on Pistachio.'',
``Glufosinate Ammonium. Human Health Risk Assessment for Registration
Review.'', and ``Glufosinate Ammonium. Updated Human Health Risk
Assessment for the Proposed New Use of Glufosinate Ammonium in/on
Citrus Fruit (Crop Group 10), Pome Fruit (Crop Group 11), Stone Fruit
(Crop Group 12), Olives and Sweet Corn'' in docket ID number EPA-HQ-
OPP-2018-0207.
EPA concludes that there is reasonable certainty that no harm will
result to the general population or to infants and children from
aggregate exposure to glufosinate ammonium residues.
IV. Other Considerations
A. Analytical Enforcement Methodology
An adequate enforcement methodology (high performance liquid
chromatography-electrospray ionization/tandem mass spectrometry (LC/MS/
MS)) is available to enforce the tolerance expression. The method may
be requested from: Chief, Analytical Chemistry Branch, Environmental
Science Center, 701 Mapes Rd., Ft. Meade, MD 20755-5350; telephone
number: (410) 305-2905; email address: [email protected].
B. International Residue Limits
In making its tolerance decisions, EPA seeks to harmonize U.S.
tolerances with international standards whenever possible, consistent
with U.S. food safety standards and agricultural practices. EPA
considers the international maximum residue limits (MRLs) established
by the Codex Alimentarius Commission (Codex), as required by FFDCA
section 408(b)(4). The Codex Alimentarius is a joint United Nations
Food and Agriculture Organization/World Health Organization food
standards program, and it is recognized as an international food safety
standards-setting organization in trade agreements to which the United
States is a party. EPA may establish a tolerance that is different from
a Codex MRL; however, FFDCA section 408(b)(4) requires that EPA explain
the reasons for departing from the Codex level.
The Codex has not established a MRL for glufosinate ammonium in or
on olive or soybean hulls. Codex has set a MRL for stone fruit at 0.15
ppm, and a MRL for tree nuts at 0.1 ppm. EPA cannot harmonize
recommended U.S. tolerance values with the Codex MRLs for stone fruit
or tree nuts because the lower MRLs could be exceeded with the uses
petitioned-for in this action.
V. Conclusion
Therefore, tolerances are established for residues of glufosinate
ammonium, butanoic acid, 2-amino-4-(hydroxymethylphosphinyl)
monoammonium salt, and its metabolites, 2-(acetylamino)-4-
(hydroxymethyl phosphinyl) butanoic acid, and 3-
(hydroxymethylphosphinyl) propanoic acid, expressed as 2-amino-4-
(hydroxymethylphosphinyl) butanoic acid equivalents, in or on olive at
0.50 ppm; fruit, stone (crop group 12-12) at 0.30 ppm; nut, trees (crop
group 14-12) at 0.50 ppm; and soybean, hulls at 10 ppm.
VI. Statutory and Executive Order Reviews
This action establishes tolerances under FFDCA section 408(d) in
response to a petition submitted to the Agency. The Office of
Management and Budget (OMB) has exempted these types of actions from
review under Executive Order 12866, entitled ``Regulatory Planning and
Review'' (58 FR 51735, October 4, 1993). Because this action has been
exempted from review under Executive Order 12866, this action is not
subject to Executive Order 13211, entitled ``Actions Concerning
Regulations That Significantly Affect Energy Supply, Distribution, or
Use'' (66 FR 28355, May 22, 2001) or Executive Order 13045, entitled
``Protection of Children from Environmental Health Risks and Safety
Risks'' (62 FR 19885,
[[Page 21708]]
April 23, 1997). This action does not contain any information
collections subject to OMB approval under the Paperwork Reduction Act
(PRA) (44 U.S.C. 3501 et seq.), nor does it require any special
considerations under Executive Order 12898, entitled ``Federal Actions
to Address Environmental Justice in Minority Populations and Low-Income
Populations'' (59 FR 7629, February 16, 1994).
Since tolerances and exemptions that are established on the basis
of a petition under FFDCA section 408(d), such as the tolerance in this
final rule, do not require the issuance of a proposed rule, the
requirements of the Regulatory Flexibility Act (RFA) (5 U.S.C. 601 et
seq.), do not apply.
This action directly regulates growers, food processors, food
handlers, and food retailers, not States or tribes, nor does this
action alter the relationships or distribution of power and
responsibilities established by Congress in the preemption provisions
of FFDCA section 408(n)(4). As such, the Agency has determined that
this action will not have a substantial direct effect on States or
tribal governments, on the relationship between the national government
and the States or tribal governments, or on the distribution of power
and responsibilities among the various levels of government or between
the Federal Government and Indian tribes. Thus, the Agency has
determined that Executive Order 13132, entitled ``Federalism'' (64 FR
43255, August 10, 1999) and Executive Order 13175, entitled
``Consultation and Coordination with Indian Tribal Governments'' (65 FR
67249, November 9, 2000) do not apply to this action. In addition, this
action does not impose any enforceable duty or contain any unfunded
mandate as described under Title II of the Unfunded Mandates Reform Act
(UMRA) (2 U.S.C. 1501 et seq.).
This action does not involve any technical standards that would
require Agency consideration of voluntary consensus standards pursuant
to section 12(d) of the National Technology Transfer and Advancement
Act (NTTAA) (15 U.S.C. 272 note).
VII. Congressional Review Act
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: April 3, 2019.
Donna Davis,
Acting Director, Registration Division, 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. In Sec. 180.473, revise the entries ``Fruit, stone, group 12-12'';
``Nut, tree, group 14-12''; ``Olive''; and ``Soybean, hulls'' in the
table in paragraph (a) to read as follows:
Sec. 180.473 Glufosinate ammonium; tolerances for residues.
(a) * * *
------------------------------------------------------------------------
Parts per
Commodity million
------------------------------------------------------------------------
* * * * *
Fruit, stone, group 12-12................................... 0.30
* * * * *
Nut, tree, group 14-12...................................... 0.50
Olive....................................................... 0.50
* * * * *
Soybean, hulls.............................................. 10
------------------------------------------------------------------------
* * * * *
[FR Doc. 2019-10054 Filed 5-14-19; 8:45 am]
BILLING CODE 6560-50-P