83 FR 19968 - Duddingtonia flagrans strain IAH 1297; Exemption from the Requirement of a Tolerance

ENVIRONMENTAL PROTECTION AGENCY

Federal Register Volume 83, Issue 88 (May 7, 2018)

Page Range		19968-19972
FR Document		2018-09647

This regulation establishes an exemption from the requirement of a tolerance for residues of Duddingtonia flagrans strain IAH 1297 in or on all food commodities when used in accordance with label directions and good agricultural practices. International Animal Health Products Pty. Ltd. submitted a petition to EPA under the Federal Food, Drug, and Cosmetic Act (FFDCA), requesting an exemption from the requirement of a tolerance. This regulation eliminates the need to establish a maximum permissible level for residues of Duddingtonia flagrans strain IAH 1297 under FFDCA.

Federal Register, Volume 83 Issue 88 (Monday, May 7, 2018)

[Federal Register Volume 83, Number 88 (Monday, May 7, 2018)]
[Rules and Regulations]
[Pages 19968-19972]
From the Federal Register Online [www.thefederalregister.org]
[FR Doc No: 2018-09647]

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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[EPA-HQ-OPP-2017-0294; FRL-9977-31]

Duddingtonia flagrans strain IAH 1297; Exemption from the
Requirement of a Tolerance

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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SUMMARY: This regulation establishes an exemption from the requirement
of a tolerance for residues of Duddingtonia flagrans strain IAH 1297 in
or on all food commodities when used in accordance with label
directions and good agricultural practices. International Animal Health
Products Pty. Ltd. submitted a petition to EPA under the Federal Food,
Drug, and Cosmetic Act (FFDCA), requesting an exemption from the
requirement of a tolerance. This regulation eliminates the need to
establish a maximum permissible level for residues of Duddingtonia
flagrans strain IAH 1297 under FFDCA.

DATES: This regulation is effective May 7, 2018. Objections and
requests for hearings must be received on or before July 6, 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-2017-0294, 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 (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 http://www.epa.gov/dockets.

FOR FURTHER INFORMATION CONTACT: Robert McNally, Director,
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:

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-2017-0294 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 6, 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-2017-0294, 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 and Statutory Findings

In the Federal Register of October 23, 2017 (82 FR 49022) (FRL-
9967-37), 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 6F8531) by International Animal Health Products Pty. Ltd.,
18 Healey Circuit, Huntingwood, New South Wales 2148, Australia (in
care of SciReg. Inc., 12733 Director's Loop, Woodbridge, VA 22192). The
petition requested that 40 CFR part 180 be amended by establishing an
exemption from the requirement of a tolerance for residues of
Duddingtonia flagrans strain IAH 1297 in or on all raw and processed
agricultural commodities. That document referenced a summary of the
petition prepared by the petitioner International Animal Health
Products Pty. Ltd., which is available in the docket via http://www.regulations.gov.

[[Page 19969]]

There were no comments received in response to the notice of filing.
EPA changed the commodity to be reflected in the tolerance
expression from ``in or on all raw and processed agricultural
commodities'' to ``in or on all food commodities.'' The reason for this
change is explained in Unit VII.B.
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.''
EPA performs a number of analyses to determine the risks from
aggregate exposure to pesticide residues. First, for microbial
pesticides, EPA determines the pathogenicity and toxicity of the
pesticide. Second, EPA examines exposure to the pesticide through food,
drinking water, and other exposures that occur as a result of pesticide
use in residential settings, as well as other non-occupational exposure
to the substance.

III. Toxicological Profile

Consistent with FFDCA section 408(b)(2)(D), EPA reviewed the
available scientific data and other relevant information on
Duddingtonia flagrans strain IAH 1297 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.

A. Overview of Duddingtonia flagrans Strain IAH 1297 (Refs. 1 and 2)

Duddingtonia flagrans is a fungus commonly found worldwide in
soils, various plant materials, and animal feces that, in the presence
of nematodes, forms looped adhesive network traps in animal feces in
pasture when the diet of grazing animals is supplemented with the
fungus' chlamydospores or the chlamydospores are acquired naturally
from soil or plant material while the animals graze. Duddingtonia
flagrans strain IAH 1297 chlamydospores can survive passage through the
rumen and gastrointestinal tract after ingestion by grazing animals and
then germinate on pasture (i.e., the chlamydospores do not germinate in
animals and cannot grow at normal body temperature or under anaerobic
conditions). Nematode eggs excreted by pastured or wild animals hatch
in the presence of Duddingtonia flagrans strain IAH 1297. Thereafter,
Duddingtonia flagrans strain IAH 1297 passively traps nematodes,
penetrates the nematode cuticle and kills them within 4-8 hours,
occupies the nematode body with hyphae within 20-36 hours, and consumes
nematodes within 48 hours, thus breaking the infection excretion and
reinfection cycle of nematodes. Duddingtonia flagrans strain IAH 1297's
use as a feed-through nematicide comes as growing anthelmintic
(antiparasitic drug) resistance and general lack of new drug options to
treat affected animals is becoming a concern.

B. Microbial Pesticide Toxicology Data Requirements

All applicable mammalian toxicology data requirements supporting
the request for an exemption from the requirement of a tolerance for
residues of Duddingtonia flagrans strain IAH 1297 in or on all food
commodities have been fulfilled with data submitted by the petitioner
or data waiver requests that have been granted by EPA. The toxicity
tests (acute oral and dermal) and the primary dermal irritation test
that address potential routes of exposure to the active ingredient are
all classified in Toxicity Category IV (see section II of Ref. 3) and
reveal no toxicity or irritation attributed to Duddingtonia flagrans
strain IAH 1297. Moreover, during typical toxicity/pathogenicity
testing done with microbial pesticides, Duddingtonia flagrans strain
IAH 1297 showed no toxicity, pathogenicity, or infectivity via the
pulmonary route of exposure. The conclusions and classifications from
all toxicological information associated with the active ingredient and
submitted by the petitioner are briefly described below.
1. Acute oral toxicity--rat (Harmonized Guideline 870.1100; Master
Record Identification Number (MRID) No. 503887-01). An acceptable acute
oral toxicity study demonstrated that Duddingtonia flagrans strain IAH
1297 is not toxic to female rats when dosed via the oral route at 5,000
milligrams per kilogram (mg/kg) of bodyweight. The oral median lethal
dose (LD50), which is a statistically derived single dose
that can be expected to cause death in 50% of test animals, was greater
than 5,000 mg/kg of bodyweight for female rats (Toxicity Category IV).
(Refs. 1 and 2).
2. Acute oral toxicity/pathogenicity (Harmonized Guideline
885.3050; MRID Nos. 501117-14 and 501117-27). An acceptable scientific
rationale was submitted by the petitioner; therefore, EPA waived acute
oral toxicity/pathogenicity testing for Duddingtonia flagrans strain
IAH 1297. An acute oral toxicity study conducted on female rats (MRID
No. 503887-01) demonstrated that Duddingtonia flagrans strain IAH 1297
was not toxic (LD50 greater than 5,000 mg/kg; Toxicity
Category IV). Further, field studies were conducted on animal groups in
Australia under direction of veterinarians. A 56-day study using young
cattle demonstrated that a test substance containing Duddingtonia
flagrans strain IAH 1297 had no discernible health effects when given
with feed at 125 grams per 100 kilograms of bodyweight per day
(representing 10X the label use rate). A 42-day study using Merino ewes
had no findings attributable to treatment with a test substance
containing Duddingtonia flagrans strain IAH 1297, and both groups had
statistically similar weight gains throughout at 1 kilogram per group
per day (representing 5X the label use rate). A 56-day study using
horses demonstrated that a test substance containing Duddingtonia
flagrans strain IAH 1297 had no discernible health effects when given
with feed at 1 gram per kilogram bodyweight per day (representing 10X
the label use rate). No signs of any infection were observed during
these lengthy studies. EPA believes these data, when taken together,
indicate that this fungus would not be toxic, infective, and/or
pathogenic through the oral route of exposure and that further testing
is not necessary. (Refs. 1 and 2).
3. Acute pulmonary toxicity/pathogenicity--rat (Harmonized
Guideline 885.3150; MRID Nos. 501117-

[[Page 19970]]

15, 501117-16, 505317-00, and 505318-00). An acceptable acute pulmonary
toxicity/pathogenicity study performed with Duddingtonia flagrans
strain IAH 1297 did not induce signs of toxicity, infectivity, or
pathogenicity when administered to rats as a single, intratracheal dose
of 5.8 x 10\4\ spores per animal. Additionally, clearance was
established by day 42 of the test. (Refs. 1, 2, and 4).
4. Acute injection toxicity/pathogenicity (Harmonized Guideline
885.3200; MRID No. 501117-17). An acceptable scientific rationale was
submitted by the petitioner; therefore, EPA waived acute injection
toxicity/pathogenicity testing for Duddingtonia flagrans strain IAH
1297. Intratracheal pulmonary administration of the highest possible
dose of Duddingtonia flagrans strain IAH 1297 did not show any sign of
infection or pathogenicity (MRID No. 501117-16). Lengthy oral dosing of
cattle, sheep, and horses demonstrated no effects at doses of 5-10X the
label use rates (MRID No. 501117-27), and an oral dose of 5,000 mg/kg
of bodyweight to female rats also demonstrated no effects (MRID No.
503887-01). Further, injection is expected to result in minimal
breakdown of spores, and the relatively large size of the spores makes
injection testing impractical. The lack of growth when Duddingtonia
flagrans strain IAH 1297 was tested at 37[deg]C (oral dosing) also
allays the need to test infectivity and pathogenicity by the injection
route. Duddingtonia flagrans strain IAH 1297 has not shown any ability
to germinate or grow when mammals were exposed by various other routes,
and injection of these large spores is not expected to result in
infection even if possible to perform the test. Thus, EPA believes
these data and information, when taken together, indicate that this
fungus would not be toxic, infective, and/or pathogenic through the
injection route of exposure and that further testing is not necessary.
(Refs. 1 and 2).
5. Acute dermal toxicity--rat (Harmonized Guideline 870.1200; MRID
No. 501113-05). An acceptable acute dermal toxicity study conducted
using a test substance containing Duddingtonia flagrans strain IAH 1297
demonstrated that the fungus was not toxic to rats when dosed at 5,000
mg/kg of bodyweight for 24 hours to a body surface area of
approximately 10 percent. Following exposure, animals were observed for
14 days. All animals survived, gained weight, appeared active and
healthy, and had no signs of dermal irritation throughout the study. No
observable abnormalities were found in any animal at necropsy. The
dermal LD50 for male and female rats combined was greater
than 5,000 mg/kg of bodyweight (Toxicity Category IV). (Refs. 1 and 2).
6. Primary dermal irritation--rabbit (Harmonized Guideline
870.2500; MRID No. 501113-07). An acceptable primary dermal irritation
study conducted using a test substance containing Duddingtonia flagrans
strain IAH 1297 demonstrated that the fungus was non-irritating to the
skin of rabbits. No dermal erythema, edema, or irritation was noted on
any animal during the study. The primary irritation index was 0.0, and
all animals gained weight normally during the study (Toxicity Category
IV). (Refs. 1 and 2).

IV. Aggregate Exposure

In examining aggregate exposure, FFDCA section 408 directs EPA to
consider available information concerning exposures from the pesticide
residue in food and all other non-occupational exposures, including
drinking water from ground water or surface water and exposure through
pesticide use in gardens, lawns, or buildings (residential and other
indoor uses).

A. Dietary Exposure (Refs. 1 and 2)

1. Food exposure. The proposed use of Duddingtonia flagrans strain
IAH 1297 is as a feed-through product for grazing animals such as
sheep, goats, cattle, horses, deer, alpacas and zoo animals. As
Duddingtonia flagrans is naturally present in soils and commonly found
in various plant materials, it is likely that grazing animals have
natural background exposure to the fungus. No adverse effects have been
reported as a result of these types of exposures. Studies performed
with Duddingtonia flagrans strain IAH 1297 have not shown that this
strain has the ability to germinate or grow when mammals are exposed by
various routes, including the oral route. Further, no foodborne disease
outbreaks or cases of mammalian toxin production from Duddingtonia
flagrans have been reported. As a result, dietary exposure to
Duddingtonia flagrans strain IAH 1297 through agricultural commodities
is not anticipated from use of the pesticide products as the spores
and/or components of the spores are unlikely to remain in the treated
animals. Should Duddingtonia flagrans strain IAH 1297 be present in
food, however, supporting toxicological data and information indicate
that no toxicity, pathogenicity, or infectivity is likely to occur with
this type of exposure resulting from the use of this microbial
pesticide when applied in accordance with label directions and good
agricultural practices.
2. Drinking water exposure. Since Duddingtonia flagrans is
naturally present in the environment and Duddingtonia flagrans strain
IAH 1297 will be present in the feces of treated animals, exposure to
surface and possibly groundwater can be expected. Water treatment
processes should remove any Duddingtonia flagrans or Duddingtonia
flagrans strain IAH 1297 present in these water sources, and no adverse
effects have been reported from exposure to Duddingtonia flagrans
through drinking water. As a result, dietary exposure to Duddingtonia
flagrans strain IAH 1297 through drinking water is not anticipated from
use of the pesticide products as the spores and/or components of the
spores are unlikely to survive the water treatment process. Should
Duddingtonia flagrans strain IAH 1297 be present in water, however,
supporting toxicological data and information indicate that no
toxicity, pathogenicity, or infectivity is likely to occur with this
type of exposure resulting from the use of this microbial pesticide
when applied in accordance with label directions and good agricultural
practices.

B. Other Non-Occupational Exposure

The pesticide products containing Duddingtonia flagrans strain IAH
1297 are proposed for agricultural use sites and zoos. As a result,
residential exposures resulting from use of these products are not
anticipated. Nevertheless, Duddingtonia flagrans strain IAH 1297 was
not toxic or irritating by dermal exposure and was not toxic,
infective, or pathogenic by pulmonary exposure. Further, the products
are mixed into feed ingredients at 2-34.6% so it is not in pure form,
and the spore size is at the upper end of the respirable range so human
exposures to Duddingtonia flagrans strain IAH 1297 by inhalation from
contact with animal feed supplements is unlikely.

V. Cumulative Effects From Substances With a Common Mechanism of
Toxicity

Section 408(b)(2)(D)(v) of FFDCA requires that, when considering
whether to establish, modify, or revoke a tolerance, EPA consider
``available information concerning the cumulative effects of [a
particular pesticide's] . . . residues and other substances that have a
common mechanism of toxicity.''
Duddingtonia flagrans strain IAH 1297 is not toxic and does not
have a common mechanism of toxicity with other substances.
Consequently, FFDCA section 408(b)(2)(D)(v) does not apply.

[[Page 19971]]

VI. Determination of Safety for U.S. Population, Infants and Children

A. U.S. Population

For all of the reasons discussed previously, EPA concludes that
there is reasonable certainty that no harm will result to the U.S.
population, including infants and children, from aggregate exposure to
residues of Duddingtonia flagrans strain IAH 1297. This includes all
anticipated dietary exposures and all other exposures for which there
is reliable information.

B. Infants and Children

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 Food Quality Protection Act
Safety Factor. 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. As discussed above, EPA has concluded that Duddingtonia
flagrans strain IAH 1297 is not toxic, pathogenic, or infective to
mammals, including infants and children. Because there are no threshold
levels of concern to infants, children, and adults when Duddingtonia
flagrans strain IAH 1297 is used in accordance with label directions
and good agricultural practices, EPA concludes that no additional
margin of safety is necessary to protect infants and children.

VII. Other Considerations

A. Analytical Enforcement Methodology

An analytical method is not required for enforcement purposes
because EPA is establishing an exemption from the requirement of a
tolerance without any numerical limitation.

B. Revisions to Requested Tolerance Exemption

One modification has been made to the requested tolerance
exemption. EPA is changing ``in or on all raw and processed
agricultural commodities'' to ``in or on all food commodities'' to
align with the terminology the Agency currently uses when establishing
tolerance exemptions for residues of other like active ingredients.

VIII. Conclusions

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 Duddingtonia flagrans strain IAH
1297. Therefore, an exemption from the requirement of a tolerance is
established for residues of Duddingtonia flagrans strain IAH 1297 in or
on all food commodities when used in accordance with label directions
and good agricultural practices.

IX. References

1. U.S. EPA. 2017. Duddingtonia flagrans strain IAH 1297. Memorandum
from J.V. Gagliardi, Ph.D. through M.J. Perry to M. Glikes, dated
October 17, 2017 (available as a ``Supporting Document'' within
Docket ID Number EPA-HQ-OPP-2017-0296 at http://www.regulations.gov).
2. U.S. EPA. 2018. Duddingtonia flagrans strain IAH-1297 (PC Code
033000)--Human Health Risk Assessment Summary. Memorandum from M.
Perry through J. Kough, Ph.D. to C. Kendrick, dated March 26, 2018
(available as a ``Supporting Document'' within Docket ID Number EPA-
HQ-OPP-2017-0296 at http://www.regulations.gov).
3. U.S. EPA. 2014. Chapter 7 of the Label Review Manual
(Precautionary Statements) (Revised July 2014). Available from
https://www.epa.gov/sites/production/files/2015-03/documents/chap-07-jul-2014.pdf.
4. U.S. EPA. 2018. Duddingtonia flagrans strain IAH-1297. Memorandum
from J.V. Gagliardi, Ph.D. through J.L. Kough, Ph.D. to C. Kendrick,
dated March 27, 2018 (available as a ``Supporting Document'' within
Docket ID Number EPA-HQ-OPP-2017-0296 at http://www.regulations.gov).

X. 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). 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).

XI. 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,

[[Page 19972]]

Agricultural commodities, Pesticides and pests, Reporting and
recordkeeping requirements.

Dated: April 26, 2018.
Wynne Miller,
Acting 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. 180.1355 to subpart D to read as follows:

Sec. 180.1355 Duddingtonia flagrans strain IAH 1297; exemption from
the requirement of a tolerance.

An exemption from the requirement of a tolerance is established for
residues of Duddingtonia flagrans strain IAH 1297 in or on all food
commodities when used in accordance with label directions and good
agricultural practices.

[FR Doc. 2018-09647 Filed 5-4-18; 8:45 am]
BILLING CODE 6560-50-P

19968 Federal Register / Vol. 83, No. 88 / Monday, May 7, 2018 / Rules and Regulations

fendering systems, support columns, in the Environmental Protection Agency OPP–2017–0294 in the subject line on
spans or any other portion of the bridge, Docket Center (EPA/DC), West William the first page of your submission. All
is strictly prohibited. Report any contact Jefferson Clinton Bldg., Rm. 3334, 1301 objections and requests for a hearing
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immediately to VTS Port Arthur on 20460–0001. The Public Reading Room received by the Hearing Clerk on or
channels 65A, 13 or 16 VHF–FM or by is open from 8:30 a.m. to 4:30 p.m., before July 6, 2018. Addresses for mail
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through VTS Advisories, Broadcast Docket is (703) 305–5805. Please review hearing request with the Hearing Clerk
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Dated: May 1, 2018. Robert McNally, Director, Biopesticides Information not marked confidential
and Pollution Prevention Division pursuant to 40 CFR part 2 may be
Jacqueline Twomey,
(7511P), Office of Pesticide Programs, disclosed publicly by EPA without prior
Captain, U.S. Coast Guard, Captain of the
Environmental Protection Agency, 1200 notice. Submit the non-CBI copy of your
Port Marine Safety Unit Port Arthur.
Pennsylvania Ave. NW, Washington, DC objection or hearing request, identified
[FR Doc. 2018–09667 Filed 5–4–18; 8:45 am]
20460–0001; main telephone number: by docket ID number EPA–HQ–OPP–
BILLING CODE 9110–04–P 2017–0294, by one of the following
(703) 305–7090; email address:
BPPDFRNotices@epa.gov. methods:
• Federal eRulemaking Portal: http://
ENVIRONMENTAL PROTECTION SUPPLEMENTARY INFORMATION: www.regulations.gov. Follow the online
AGENCY I. General Information instructions for submitting comments.
Do not submit electronically any
40 CFR Part 180 A. Does this action apply to me? information you consider to be CBI or
[EPA–HQ–OPP–2017–0294; FRL–9977–31] You may be potentially affected by other information whose disclosure is
this action if you are an agricultural restricted by statute.
Duddingtonia flagrans strain IAH 1297; producer, food manufacturer, or • Mail: OPP Docket, Environmental
Exemption from the Requirement of a pesticide manufacturer. The following Protection Agency Docket Center (EPA/
Tolerance list of North American Industrial DC), (28221T), 1200 Pennsylvania Ave.
Classification System (NAICS) codes is NW, Washington, DC 20460–0001.
AGENCY: Environmental Protection • Hand Delivery: To make special
Agency (EPA). not intended to be exhaustive, but rather
provides a guide to help readers arrangements for hand delivery or
ACTION: Final rule. delivery of boxed information, please
determine whether this document
SUMMARY: This regulation establishes an applies to them. Potentially affected follow the instructions at http://
exemption from the requirement of a entities may include: www.epa.gov/dockets/contacts.html.
tolerance for residues of Duddingtonia • Crop production (NAICS code 111). Additional instructions on commenting
flagrans strain IAH 1297 in or on all • Animal production (NAICS code or visiting the docket, along with more
food commodities when used in 112). information about dockets generally, is
accordance with label directions and • Food manufacturing (NAICS code available at http://www.epa.gov/
good agricultural practices. 311). dockets.
International Animal Health Products • Pesticide manufacturing (NAICS II. Background and Statutory Findings
Pty. Ltd. submitted a petition to EPA code 32532).
In the Federal Register of October 23,
under the Federal Food, Drug, and B. How can I get electronic access to 2017 (82 FR 49022) (FRL–9967–37),
Cosmetic Act (FFDCA), requesting an other related information? EPA issued a document pursuant to
exemption from the requirement of a FFDCA section 408(d)(3), 21 U.S.C.
tolerance. This regulation eliminates the You may access a frequently updated
electronic version of 40 CFR part 180 346a(d)(3), announcing the filing of a
need to establish a maximum pesticide tolerance petition (PP 6F8531)
permissible level for residues of through the Government Printing
Office’s e-CFR site at http:// by International Animal Health
Duddingtonia flagrans strain IAH 1297 Products Pty. Ltd., 18 Healey Circuit,
under FFDCA. www.ecfr.gov/cgi-bin/text-
idx?&c=ecfr&tpl=/ecfrbrowse/Title40/ Huntingwood, New South Wales 2148,
DATES: This regulation is effective May Australia (in care of SciReg. Inc., 12733
40tab_02.tpl.
7, 2018. Objections and requests for Director’s Loop, Woodbridge, VA
hearings must be received on or before C. How can I file an objection or hearing 22192). The petition requested that 40
July 6, 2018, and must be filed in request? CFR part 180 be amended by
accordance with the instructions Under FFDCA section 408(g), 21 establishing an exemption from the
provided in 40 CFR part 178 (see also U.S.C. 346a(g), any person may file an requirement of a tolerance for residues
Unit I.C. of the SUPPLEMENTARY objection to any aspect of this regulation of Duddingtonia flagrans strain IAH
INFORMATION). and may also request a hearing on those 1297 in or on all raw and processed
daltland on DSKBBV9HB2PROD with RULES

ADDRESSES: The docket for this action, objections. You must file your objection agricultural commodities. That
identified by docket identification (ID) or request a hearing on this regulation document referenced a summary of the
number EPA–HQ–OPP–2017–0294, is in accordance with the instructions petition prepared by the petitioner
available at http://www.regulations.gov provided in 40 CFR part 178. To ensure International Animal Health Products
or at the Office of Pesticide Programs proper receipt by EPA, you must Pty. Ltd., which is available in the
Regulatory Public Docket (OPP Docket) identify docket ID number EPA–HQ– docket via http://www.regulations.gov.

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Federal Register / Vol. 83, No. 88 / Monday, May 7, 2018 / Rules and Regulations 19971

VI. Determination of Safety for U.S. VIII. Conclusions U.S.C. 3501 et seq., nor does it require
Population, Infants and Children EPA concludes that there is a any special considerations under
reasonable certainty that no harm will Executive Order 12898, entitled
A. U.S. Population
result to the U.S. population, including ‘‘Federal Actions to Address
For all of the reasons discussed infants and children, from aggregate Environmental Justice in Minority
previously, EPA concludes that there is exposure to residues of Duddingtonia Populations and Low-Income
reasonable certainty that no harm will flagrans strain IAH 1297. Therefore, an Populations’’ (59 FR 7629, February 16,
result to the U.S. population, including exemption from the requirement of a 1994).
infants and children, from aggregate Since tolerances and exemptions that
tolerance is established for residues of
exposure to residues of Duddingtonia are established on the basis of a petition
Duddingtonia flagrans strain IAH 1297
flagrans strain IAH 1297. This includes under FFDCA section 408(d), such as
in or on all food commodities when
all anticipated dietary exposures and all the tolerance exemption in this action,
used in accordance with label directions
other exposures for which there is do not require the issuance of a
and good agricultural practices.
reliable information. proposed rule, the requirements of the
IX. References Regulatory Flexibility Act (RFA) (5
B. Infants and Children U.S.C. 601 et seq.) do not apply.
1. U.S. EPA. 2017. Duddingtonia flagrans
This action directly regulates growers,
FFDCA section 408(b)(2)(C) provides strain IAH 1297. Memorandum from J.V.
Gagliardi, Ph.D. through M.J. Perry to M. food processors, food handlers, and food
that EPA shall apply an additional retailers, not States or tribes. As a result,
Glikes, dated October 17, 2017 (available
tenfold (10X) margin of safety for infants this action does not alter the
as a ‘‘Supporting Document’’ within
and children in the case of threshold Docket ID Number EPA–HQ–OPP–2017– relationships or distribution of power
effects to account for prenatal and 0296 at http://www.regulations.gov). and responsibilities established by
postnatal toxicity and the completeness 2. U.S. EPA. 2018. Duddingtonia flagrans Congress in the preemption provisions
of the database on toxicity and strain IAH–1297 (PC Code 033000)— of FFDCA section 408(n)(4). As such,
exposure, unless EPA determines based Human Health Risk Assessment EPA has determined that this action will
on reliable data that a different margin Summary. Memorandum from M. Perry
not have a substantial direct effect on
of safety will be safe for infants and through J. Kough, Ph.D. to C. Kendrick,
dated March 26, 2018 (available as a States or tribal governments, on the
children. This additional margin of relationship between the national
‘‘Supporting Document’’ within Docket
safety is commonly referred to as the government and the States or tribal
ID Number EPA–HQ–OPP–2017–0296 at
Food Quality Protection Act Safety http://www.regulations.gov). governments, or on the distribution of
Factor. In applying this provision, EPA 3. U.S. EPA. 2014. Chapter 7 of the Label power and responsibilities among the
either retains the default value of 10X or Review Manual (Precautionary various levels of government or between
uses a different additional safety factor Statements) (Revised July 2014). the Federal Government and Indian
when reliable data available to EPA Available from https://www.epa.gov/ tribes. Thus, EPA has determined that
support the choice of a different factor. sites/production/files/2015-03/
Executive Order 13132, entitled
As discussed above, EPA has concluded documents/chap-07-jul-2014.pdf.
4. U.S. EPA. 2018. Duddingtonia flagrans ‘‘Federalism’’ (64 FR 43255, August 10,
that Duddingtonia flagrans strain IAH 1999), and Executive Order 13175,
strain IAH–1297. Memorandum from J.V.
1297 is not toxic, pathogenic, or entitled ‘‘Consultation and Coordination
Gagliardi, Ph.D. through J.L. Kough,
infective to mammals, including infants Ph.D. to C. Kendrick, dated March 27, with Indian Tribal Governments’’ (65 FR
and children. Because there are no 2018 (available as a ‘‘Supporting 67249, November 9, 2000), do not apply
threshold levels of concern to infants, Document’’ within Docket ID Number to this action. In addition, this action
children, and adults when EPA–HQ–OPP–2017–0296 at http:// does not impose any enforceable duty or
Duddingtonia flagrans strain IAH 1297 www.regulations.gov). contain any unfunded mandate as
is used in accordance with label described under Title II of the Unfunded
X. Statutory and Executive Order
directions and good agricultural Mandates Reform Act (UMRA) (2 U.S.C.
Reviews
practices, EPA concludes that no 1501 et seq.).
additional margin of safety is necessary This action establishes a tolerance This action does not involve any
to protect infants and children. exemption under FFDCA section 408(d) technical standards that would require
in response to a petition submitted to EPA’s consideration of voluntary
VII. Other Considerations EPA. The Office of Management and consensus standards pursuant to section
A. Analytical Enforcement Methodology Budget (OMB) has exempted these types 12(d) of the National Technology
of actions from review under Executive Transfer and Advancement Act
An analytical method is not required Order 12866, entitled ‘‘Regulatory
for enforcement purposes because EPA (NTTAA) (15 U.S.C. 272 note).
Planning and Review’’ (58 FR 51735,
is establishing an exemption from the October 4, 1993). Because this action XI. Congressional Review Act
requirement of a tolerance without any has been exempted from review under Pursuant to the Congressional Review
numerical limitation. Executive Order 12866, this action is Act (5 U.S.C. 801 et seq.), EPA will
B. Revisions to Requested Tolerance not subject to Executive Order 13211, submit a report containing this rule and
Exemption entitled ‘‘Actions Concerning other required information to the U.S.
Regulations That Significantly Affect Senate, the U.S. House of
One modification has been made to Energy Supply, Distribution, or Use’’ (66 Representatives, and the Comptroller
the requested tolerance exemption. EPA FR 28355, May 22, 2001), or Executive General of the United States prior to
is changing ‘‘in or on all raw and Order 13045, entitled ‘‘Protection of
daltland on DSKBBV9HB2PROD with RULES

publication of the rule in the Federal
processed agricultural commodities’’ to Children from Environmental Health Register. This action is not a ‘‘major
‘‘in or on all food commodities’’ to align Risks and Safety Risks’’ (62 FR 19885, rule’’ as defined by 5 U.S.C. 804(2).
with the terminology the Agency April 23, 1997). This action does not
currently uses when establishing contain any information collections List of Subjects in 40 CFR Part 180
tolerance exemptions for residues of subject to OMB approval under the Environmental protection,
other like active ingredients. Paperwork Reduction Act (PRA), 44 Administrative practice and procedure,

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19972 Federal Register / Vol. 83, No. 88 / Monday, May 7, 2018 / Rules and Regulations

Agricultural commodities, Pesticides provided in 40 CFR part 178 (see also objection to any aspect of this regulation
and pests, Reporting and recordkeeping Unit I.C. of the SUPPLEMENTARY and may also request a hearing on those
requirements. INFORMATION). objections. You must file your objection
Dated: April 26, 2018. ADDRESSES: The docket for this action, or request a hearing on this regulation
Wynne Miller, identified by docket identification (ID) in accordance with the instructions
number EPA–HQ–OPP–2017–0249, is provided in 40 CFR part 178. To ensure
Acting Director, Office of Pesticide Programs.
available at http://www.regulations.gov proper receipt by EPA, you must
Therefore, 40 CFR chapter I is identify docket ID number EPA–HQ–
amended as follows: or at the Office of Pesticide Programs
Regulatory Public Docket (OPP Docket) OPP–2017–0249 in the subject line on
in the Environmental Protection Agency the first page of your submission. All
PART 180—[AMENDED]
Docket Center (EPA/DC), West William objections and requests for a hearing
■ 1. The authority citation for part 180 Jefferson Clinton Bldg., Rm. 3334, 1301 must be in writing, and must be
continues to read as follows: Constitution Ave. NW, Washington, DC received by the Hearing Clerk on or
before July 6, 2018. Addresses for mail
Authority: 21 U.S.C. 321(q), 346a and 371. 20460–0001. The Public Reading Room
and hand delivery of objections and
■ 2. Add § 180.1355 to subpart D to read is open from 8:30 a.m. to 4:30 p.m.,
hearing requests are provided in 40 CFR
as follows: Monday through Friday, excluding legal
178.25(b).
holidays. The telephone number for the In addition to filing an objection or
§ 180.1355 Duddingtonia flagrans strain Public Reading Room is (202) 566–1744, hearing request with the Hearing Clerk
IAH 1297; exemption from the requirement and the telephone number for the OPP
of a tolerance. as described in 40 CFR part 178, please
Docket is (703) 305–5805. Please review submit a copy of the filing (excluding
An exemption from the requirement the visitor instructions and additional any Confidential Business Information
of a tolerance is established for residues information about the docket available (CBI)) for inclusion in the public docket.
of Duddingtonia flagrans strain IAH at http://www.epa.gov/dockets. Information not marked confidential
1297 in or on all food commodities FOR FURTHER INFORMATION CONTACT: pursuant to 40 CFR part 2 may be
when used in accordance with label Michael Goodis, Registration Division disclosed publicly by EPA without prior
directions and good agricultural (7505P), Office of Pesticide Programs, notice. Submit the non-CBI copy of your
practices. Environmental Protection Agency, 1200 objection or hearing request, identified
[FR Doc. 2018–09647 Filed 5–4–18; 8:45 am] Pennsylvania Ave. NW, Washington, DC by docket ID number EPA–HQ–OPP–
BILLING CODE 6560–50–P 20460–0001; main telephone number: 2017–0249, by one of the following
(703) 305–7090; email address: methods:
RDFRNotices@epa.gov. • Federal eRulemaking Portal: http://
ENVIRONMENTAL PROTECTION SUPPLEMENTARY INFORMATION: www.regulations.gov. Follow the online
AGENCY instructions for submitting comments.
I. General Information
Do not submit electronically any
40 CFR Part 180 A. Does this action apply to me? information you consider to be CBI or
[EPA–HQ–OPP–2017–0249; FRL–9976–60] You may be potentially affected by other information whose disclosure is
this action if you are an agricultural restricted by statute.
Konjac Glucomannan; Exemption producer, food manufacturer, or • Mail: OPP Docket, Environmental
From the Requirement of a Tolerance pesticide manufacturer. The following Protection Agency Docket Center (EPA/
list of North American Industrial DC), (28221T), 1200 Pennsylvania Ave.
AGENCY: Environmental Protection NW, Washington, DC 20460–0001.
Agency (EPA). Classification System (NAICS) codes is
• Hand Delivery: To make special
ACTION: Final rule.
not intended to be exhaustive, but rather
arrangements for hand delivery or
provides a guide to help readers
delivery of boxed information, please
SUMMARY: This regulation establishes an determine whether this document
follow the instructions at http://
exemption from the requirement of a applies to them. Potentially affected
www.epa.gov/dockets/contacts.html.
tolerance for residues of konjac entities may include:
• Crop production (NAICS code 111). Additional instructions on commenting
glucomannan (CAS Reg. No. 37220–17– or visiting the docket, along with more
0) when used as an inert ingredient on • Animal production (NAICS code
112). information about dockets generally, is
growing crops only at a concentration available at http://www.epa.gov/
not to exceed 1% by weight in a • Food manufacturing (NAICS code
311). dockets.
pesticide formulation. Technology
Services Group, on behalf of, Attune • Pesticide manufacturing (NAICS II. Petition for Exemption
Agriculture, LLC, submitted a petition code 32532).
In the Federal Register of September
to EPA under the Federal Food, Drug, B. How can I get electronic access to 15, 2017 (82 FR 43352) (FRL–9965–43),
and Cosmetic Act (FFDCA), requesting other related information? EPA issued a document pursuant to
establishment of an exemption from the You may access a frequently updated FFDCA section 408, 21 U.S.C. 346a,
requirement of a tolerance. This electronic version of 40 CFR part 180 announcing the filing of a pesticide
regulation eliminates the need to through the Government Printing petition (PP IN–11048) by Technology
establish a maximum permissible level Office’s e-CFR site at http:// Services Group, on behalf of, Attune
for residues of konjac glucomannan www.ecfr.gov/cgi-bin/text- Agriculture, LLC, 10552 Philadelphia
resulting from use in accordance with Road, White Marsh, MD 21162. The
daltland on DSKBBV9HB2PROD with RULES

idx?&c=ecfr&tpl=/ecfrbrowse/Title40/
the terms of this exemption. 40tab_02.tpl. petition requested that 40 CFR 180.920
DATES: This regulation is effective May be amended by establishing an
7, 2018. Objections and requests for C. How can I file an objection or hearing exemption from the requirement of a
hearings must be received on or before request? tolerance for residues of konjac
July 6, 2018, and must be filed in Under FFDCA section 408(g), 21 glucomannan (also referred to as konjac
accordance with the instructions U.S.C. 346a, any person may file an mannan) (CAS Reg. No. 37220–17–0)

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Document Created: 2018-05-05 02:48:39
Document Modified: 2018-05-05 02:48:39

Category		Regulatory Information
Collection		Federal Register
sudoc Class		AE 2.7: GS 4.107: AE 2.106:
Publisher		Office of the Federal Register, National Archives and Records Administration
Section		Rules and Regulations
Action		Final rule.
Dates		This regulation is effective May 7, 2018. Objections and requests for hearings must be received on or before July 6, 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).
Contact		Robert McNally, Director, 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-
FR Citation		83 FR 19968
CFR Associated		Environmental Protection; Administrative Practice and Procedure; Agricultural Commodities; Pesticides and Pests and Reporting and Recordkeeping Requirements