[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

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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,

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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) * * *

------------------------------------------------------------------------
                                                               Parts per
                          Commodity                             million
------------------------------------------------------------------------
 
                                * * * * *
Vegetable, legume, edible podded subgroup 6A................         5.0
 
                                * * * * *
------------------------------------------------------------------------

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[FR Doc. 2017-25832 Filed 11-29-17; 8:45 am]
BILLING CODE 6560-50-P