[Federal Register Volume 82, Number 229 (Thursday, November 30, 2017)]
[Rules and Regulations]
[Pages 56735-56739]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2017-25832]
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ENVIRONMENTAL PROTECTION AGENCY
40 CFR Part 180
[EPA-HQ-OPP-2016-0600; FRL-9968-95]
Boscalid; Pesticide Tolerance
AGENCY: Environmental Protection Agency (EPA).
ACTION: Final rule.
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SUMMARY: This regulation establishes a tolerance for residues of
boscalid in or on vegetable, legume, edible-podded subgroup 6A. BASF
Corporation requested these tolerances under the Federal Food, Drug,
and Cosmetic Act (FFDCA).
DATES: This regulation is effective November 30, 2017. Objections and
requests for hearings must be received on or before January 29, 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-2016-0600, 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: Michael L. 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
[[Page 56736]]
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 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, 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-2016-0600 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
January 29, 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-2016-0600, 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. Summary of Petitioned-For Tolerance
In the Federal Register of July 26, 2017 (82 FR 34664) (FRL-9963-
50), EPA issued a document pursuant to FFDCA section 408(d)(3), 21
U.S.C. 346a(d)(3), announcing the filing of a pesticide petition (PP
6E8503) by BASF Corporation, 26 Davis Drive, P.O. Box 13528, Research
Triangle Park, NC 27709. The petition requested that 40 CFR 180.589 be
amended by increasing the existing tolerance for residues of the
fungicide boscalid, 3-pyridinecarboxamide,2-chloro-N-(4'-chloro[1,1'-
biphenyl]-2-yl), in or on vegetable, legume, edible podded subgroup 6A
at from 1.6 parts per million (ppm) to 5.0 ppm. This document
referenced a summary of the petition prepared by BASF Corporation, the
registrant, which is available in the docket, http://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 boscalid including exposure
resulting from the tolerances established by this action. EPA's
assessment of exposures and risks associated with boscalid follows.
A. Toxicological Profile and Points of Departure
In the Federal Register of March 18, 2015 (80 FR 14009) (FRL-9921-
01), EPA published a final rule concerning tolerances for residues of
boscalid. The preamble to that rule contains a summary of the
toxicological profile and endpoints for assessing risk that EPA is
incorporating by reference here, as those elements have not changed.
B. Exposure Assessment
The petitioned-for tolerance increase is intended to facilitate
imports of commodities in subgroup 6A, rather than accommodate residues
resulting from changes in domestic uses; therefore, the only potential
impact on the Agency's previous exposure assessment is through
consumption of imported food containing boscalid residues. To assess
the new dietary exposure levels, EPA considered exposure under the
petitioned-for tolerances as well as all existing boscalid tolerances
in 40 CFR 180.589. EPA assessed dietary exposures from boscalid in food
as follows:
Acute exposure. Quantitative acute dietary exposure and risk
assessments are performed for a food-use pesticide, if a toxicological
study has indicated the possibility of an effect of concern occurring
as a result of a 1-day or single exposure. No such effects were
identified in the toxicological studies for boscalid; therefore, a
quantitative acute dietary exposure assessment is unnecessary.
Chronic exposure. In conducting the chronic dietary exposure
assessment EPA used food consumption information from the 2003-2008
food consumption data from the U.S. Department of Agriculture's
(USDA's) National Health and Nutrition Examination Survey, What We Eat
in America, (NHANES/WWEIA). As to residue levels in food, EPA assumed
tolerance-level residues and used some percent crop treated (PCT)
information as described below.
Cancer. As discussed in Unit III.A. of the March 18, 2015 Federal
Register, EPA has concluded that the chronic endpoint will be
protective of potential cancer effects. EPA's estimate of chronic
exposure as described above is relied upon to evaluate whether any
exposure could exceed the chronic population
[[Page 56737]]
adjusted doses (cPAD) and thus pose a cancer risk.
Anticipated residue and percent crop treated (PCT) information.
Section 408(b)(2)(F) of FFDCA states that the Agency may use data on
the actual percent of food treated for assessing chronic dietary risk
only if:
Condition a: The data used are reliable and provide a
valid basis to show what percentage of the food derived from such crop
is likely to contain the pesticide residue.
Condition b: The exposure estimate does not underestimate
exposure for any significant subpopulation group.
Condition c: Data are available on pesticide use and food
consumption in a particular area, the exposure estimate does not
understate exposure for the population in such area.
In addition, the Agency must provide for periodic evaluation of any
estimates used. To provide for the periodic evaluation of the estimate
of PCT as required by FFDCA section 408(b)(2)(F), EPA may require
registrants to submit data on PCT.
The Agency used the following chronic PCT for existing uses:
Almonds 45%; apples 15%; apricots 30%; green beans 5%; blueberries
35%; broccoli 2.5%; brussels sprouts 2.5%; cabbage 5%; caneberries 45%;
cantaloupes 5%; carrots 20%; cauliflower 2.5%; celery 10%; cherries
50%; chicory 5%; cucumbers 5%; dry beans/dry peas 5%; garlic 5%; grapes
30%; hazelnuts 5%; lemons 2.5%; lettuce 30%; nectarines 15%; onions
25%; oranges 1%; peaches 25%; peanuts 1%; pears 20%; green peas 1%;
peppers 2.5%; pistachios 30%; plums/prunes 5%; potatoes 25%; pumpkins
10%; squash 5%; strawberries 60%; sweet corn 1%; tomatoes 2.5%; walnuts
5%; and watermelons 25%.
In most cases, EPA uses available data from the United States
Department of Agriculture/National Agricultural Statistics Service
(USDA/NASS), proprietary market surveys, and the National Pesticide Use
Database for the chemical/crop combination for the most recent six
years. EPA uses an average PCT for chronic dietary risk analysis and a
maximum PCT for acute dietary risk analysis. The average PCT figure for
each existing use is derived by combining available public and private
market survey data for that use, averaging across all observations, and
rounding to the nearest 5%, except for those situations in which the
average PCT is less than 2.5%. The maximum PCT figure is the highest
observed maximum value reported within the most recent 6 years of
available public and private market survey data for the existing use
and rounded up to the nearest multiple of 5%, except for situations in
which the maximum PCT is less than 2.5%. In cases where the estimated
value is less than 2.5% but greater than 1%, the average and maximum
PCT used are 2.5%. If the estimated value is less than 1%, 1% is used
as the average PCT and 2.5% is used as the maximum PCT.
The Agency believes that the three conditions discussed above have
been met. With respect to Condition a, PCT estimates are derived from
Federal and private market survey data, which are reliable and have a
valid basis. The Agency is reasonably certain that the percentage of
the food treated is not likely to be an underestimation. As to
Conditions b and c, regional consumption information and consumption
information for significant subpopulations is taken into account
through EPA's computer-based model for evaluating the exposure of
significant subpopulations including several regional groups. Use of
this consumption information in EPA's risk assessment process ensures
that EPA's exposure estimate does not understate exposure for any
significant subpopulation group and allows the Agency to be reasonably
certain that no regional population is exposed to residue levels higher
than those estimated by the Agency. Other than the data available
through national food consumption surveys, EPA does not have available
reliable information on the regional consumption of food to which may
be applied in a particular area.
Because this tolerance increase does not impact drinking water or
residential exposures, the drinking water and non-dietary exposure
discussions from the March 18, 2015 Federal Register continue to be
valid. Those assumptions were used to assess aggregate exposure for
this tolerance action, and EPA incorporates them here by reference.
Moreover, the current action does not impact the Agency's previous
conclusions on cumulative effects; therefore, EPA incorporates the
cumulative effects section from the March 18, 2015 Federal Register as
well.
C. Safety Factor for Infants and Children
1. In general. Section 408(b)(2)(C) of FFDCA 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 (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.
2. Conclusion. The finding for the FQPA SF in the March 18, 2015
rule remains valid for this action. Therefore, for the reasons stated
in the March 18, 2015 Federal Register, EPA has determined that
reliable data show the safety of infants and children would be
adequately protected if the FQPA SF were reduced to 1X for all
scenarios, except residential handler inhalation exposure.
D. Aggregate Risks and Determination of Safety
EPA determines whether acute and chronic dietary pesticide
exposures are safe by comparing aggregate exposure estimates to the
acute PAD (aPAD) and chronic PAD (cPAD). For linear cancer risks, EPA
calculates the lifetime probability of acquiring cancer given the
estimated aggregate exposure. Short-, intermediate-, and chronic-term
risks are evaluated by comparing the estimated aggregate food, water,
and residential exposure to the appropriate PODs to ensure that an
adequate MOE exists.
1. Acute risk. An acute aggregate risk assessment takes into
account acute exposure estimates from dietary consumption of food and
drinking water. No adverse effect resulting from a single oral exposure
was identified and no acute dietary endpoint was selected. Therefore,
boscalid is not expected to pose an acute risk.
2. Chronic risk. Using the exposure assumptions described in this
unit for chronic exposure, EPA has concluded that chronic exposure to
boscalid from food and water will utilize 12% of the cPAD for the
general U.S. population and 27% of the cPAD for all infants (less than
1 year old), the population group receiving the greatest exposure.
Based on the explanation in Unit III.C.3., regarding residential use
patterns, chronic residential exposure to residues of boscalid is not
expected.
3. Short-term and intermediate-term risk. Short-term aggregate
exposure takes into account short-term residential exposure plus
chronic exposure to food and water (considered to be a background
exposure level).
Boscalid is currently registered for uses that could result in
short-term residential exposure, which the Agency
[[Page 56738]]
previously assessed and discussed in the March 18, 2015 Federal
Register. The preamble to the March 18, 2015 rule concluded that there
were no short-term risks of concern. Because the chronic dietary
exposure has only increased potential chronic risk 1% of the cPAD to
27% of the cPAD, which is still well below EPA's level of concern for
chronic risk, and there is no change to the domestic use pattern to
impact the non-occupational exposure, EPA concludes that the increase
in dietary exposure will not meaningfully impact the aggregate risk and
the short-term risk will continue to be below the Agency's levels of
concern.
4. Intermediate-term risk. Intermediate-term aggregate exposure
takes into account intermediate-term residential exposure plus chronic
exposure to food and water (considered to be a background exposure
level).
An intermediate-term adverse effect was identified; however,
boscalid is not registered for any use patterns that would result in
intermediate-term residential exposure. Intermediate-term risk is
assessed based on intermediate-term residential exposure plus chronic
dietary exposure. Because there is no intermediate-term residential
exposure and chronic dietary exposure has already been assessed under
the appropriately protective cPAD (which is at least as protective as
the POD used to assess intermediate-term risk), no further assessment
of intermediate-term risk is necessary, and EPA relies on the chronic
dietary risk assessment for evaluating intermediate-term risk for
boscalid.
5. Aggregate cancer risk for U.S. population. As discussed in Unit
III.A. of the March 18, 2015 Federal Register, EPA has concluded that
the cPAD is protective of possible cancer effects. Given the results of
the chronic risk assessment, cancer risk resulting from exposure to
boscalid is not of concern.
6. Determination of safety. Based on these risk assessments, EPA
concludes that there is a reasonable certainty that no harm will result
to the general population or to infants and children from aggregate
exposure to boscalid residues.
IV. Other Considerations
A. Analytical Enforcement Methodology
An adequate gas chromatography/mass spectrometric detection (GC/MS)
method (Method D0008) using selected ion monitoring (SIM) of major ions
is available for enforcing boscalid tolerances in plant commodities,
and an adequate GC/electron capture detection method (ECD) (Method DFG
S19) is available for enforcing the tolerances in livestock
commodities. The validated limit of quantitation (LOQ) for boscalid
residues in most plant matrices is 0.05 ppm. These methods have been
found adequate by the Analytical Chemistry Branch (ACB) of BEAD.
Residues of boscalid and its metabolite M510F01 were not adequately
recovered using the multiresidue methods.
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 established MRLs for boscalid in or on vegetable,
legume, edible-podded subgroup 6A at 3.0 ppm. These MRLs are different
than the tolerances established for boscalid in the United States. The
registrant has petitioned the EPA to increase the existing tolerance
level for edible-podded legume vegetable subgroup 6A from 1.6 ppm to
5.0 ppm in order to harmonize with MRL established by the European
Union of 5.0 ppm. This is not anticipated to cause a trade irritant
since the CODEX MRL will be lower than the U.S. tolerance, and CODEX
countries will still be able to export to the U.S. For these reasons,
EPA has determined it is appropriate to amend the tolerance for
residues of boscalid on edible podded legume vegetable subgroup 6A as
petitioned from 1.6 ppm to 5.0 ppm.
V. Conclusion
Therefore, a tolerance is established for residues of boscalid,
boscalid, 3-pyridinecarboxamide,2-chloro-N-(4'-chloro[1,1'-biphenyl]-2-
yl), in or on vegetable, legume, edible podded subgroup 6A at 5.0 ppm.
VI. Statutory and Executive Order Reviews
This action amends a tolerance 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), Executive Order 13045, entitled
``Protection of Children from Environmental Health Risks and Safety
Risks'' (62 FR 19885, April 23, 1997), or 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 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,
[[Page 56739]]
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: October 5, 2017.
Daniel Kenny,
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. 180.589, revise the entry for ``Vegetable, legume, edible
podded subgroup 6A'' in the table in paragraph (a)(1) to read as
follows:
Sec. 180.589 Boscalid; tolerances for residues.
(a) * * *
(1) * * *
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Parts per
Commodity million
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* * * * *
Vegetable, legume, edible podded subgroup 6A................ 5.0
* * * * *
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* * * * *
[FR Doc. 2017-25832 Filed 11-29-17; 8:45 am]
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