[Federal Register Volume 85, Number 157 (Thursday, August 13, 2020)]
[Rules and Regulations]
[Pages 49261-49264]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2020-16457]


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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[EPA-HQ-OPP-2019-0249; FRL-10011-78]


Novaluron; Pesticide Tolerances

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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SUMMARY: This regulation establishes and modifies tolerances for 
residues of novaluron in or on multiple commodities which are 
identified and discussed later in this document. Interregional Research 
Project Number 4 (IR-4) requested these tolerances and modifications 
under the Federal Food, Drug, and Cosmetic Act (FFDCA).

DATES: This regulation is effective August 13, 2020. Objections and 
requests for hearings must be received on or before October 13, 2020 
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-2019-0249, 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 note that due to the public health emergency, the EPA Docket 
Center (EPA/DC) and Reading Room was closed to public visitors on March 
31, 2020. Our EPA/DC staff will continue to provide customer service 
via email, phone, and webform. For further information on EPA/DC 
services, docket contact information and the current status of the EPA/
DC and Reading Room, please visit https://www.epa.gov/dockets.

FOR FURTHER INFORMATION CONTACT: Michael Goodis, Registration Division 
(7505P), Office of Pesticide Programs, Environmental Protection Agency, 
1200 Pennsylvania Ave. NW, Washington, DC 20460-0001; main telephone 
number: (703) 305-7090; email address: [email protected].

SUPPLEMENTARY INFORMATION: 

I. General Information

A. Does this action apply to me?

    You may be potentially affected by this action if you are an 
agricultural producer, food manufacturer, or pesticide manufacturer. 
The following list of North American Industrial Classification System 
(NAICS) codes is not intended to be exhaustive, but rather provides a 
guide to help readers determine whether this document applies to them. 
Potentially affected entities may include:
     Crop production (NAICS code 111).
     Animal production (NAICS code 112).
     Food manufacturing (NAICS code 311).
     Pesticide manufacturing (NAICS code 32532).

B. How can I get electronic access to other related information?

    You may access a frequently updated electronic version of EPA's 
tolerance regulations at 40 CFR part 180 through the Government 
Printing Office's e-CFR site at 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-2019-0249 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 
October 13, 2020. 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-2019-0249, 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 August 30, 2019 (84 FR 45702) (FRL-9998-
15), 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 
9E8746) by IR-4, IR-4 Project Headquarters, Rutgers, The State 
University of New Jersey, 500 College Road East, Suite 201 W, 
Princeton, NJ 08540. The petition requested to amend 40 CFR 180.598 by 
establishing tolerances for residues of the insecticide novaluron, 
including its metabolites and degradates, in or on the following 
commodities: Brassica, leafy greens, subgroup 4-16B at 25 parts per 
million (ppm); cottonseed subgroup 20C at 0.6 ppm; kohlrabi at 0.7 ppm; 
sunflower subgroup 20B at 0.07 ppm; tropical and subtropical, small 
fruit, inedible peel, subgroup 24A at 9 ppm;

[[Page 49262]]

and vegetable, brassica, head and stem, group 5-16 at 0.7 ppm; and by 
modifying the existing tolerance on vegetable, fruiting, group 8-10 
from 1.0 ppm to 1.5 ppm due to the proposed use on greenhouse grown 
peppers. The document also requested to remove the established 
tolerances in or on the following commodities: Brassica, head and stem, 
subgroup 5A at 0.50 ppm; brassica, leafy greens, subgroup 5B at 25 ppm; 
cotton, undelinted seed at 0.60 ppm; and turnip, greens at 25 ppm 
because these commodities would be covered by the new tolerances 
established for the crop group expansions and conversions above.
    That document referenced a summary of the petition prepared by 
Makhteshim (d/b/a ADAMA), the registrant, which is available in the 
docket, http://www.regulations.gov. A comment was received in response 
to the notice of filing. EPA's response to this comment is discussed in 
Unit IV.C.
    Based upon review of the data supporting the petition, EPA is 
establishing and modifying tolerances that vary from what was 
requested. The reason for these changes is explained in Unit IV.D.

III. Aggregate Risk Assessment and Determination of Safety

    Section 408(b)(2)(A)(i) of the 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 the 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 the 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 therein, 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 novaluron, including exposure resulting from the 
tolerances established or modified by this action. EPA's assessment of 
exposures and risks associated with novaluron follows.
    On July 22, 2015, EPA published in the Federal Register a final 
rule establishing tolerances for residues of novaluron in or on 
multiple agricultural commodities based on the Agency's conclusion that 
aggregate exposure to novaluron is safe for the general population, 
including infants and children. See 80 FR 43329 (FRL-9929-57). EPA is 
incorporating the following portions of that document by reference 
here, as they have not changed in the Agency's current assessment of 
exposures and risks associated with novaluron: The toxicological 
profile and points of departure, certain assumptions for exposure 
assessment, cumulative effects from substances with a common mechanism 
of toxicity, and the Agency's determination regarding the children's 
safety factor.
    EPA's dietary exposure assessments have been updated to include the 
additional exposure from the new uses of novaluron on the tropical and 
subtropical, small fruit, inedible peel, subgroup 24A, the sunflower 
subgroup 20B, and greenhouse-grown peppers; the crop group expansion 
for the cottonseed subgroup 20C; and the crop group conversions for 
Brassica, leafy greens, subgroup 4-16B, the vegetable, Brassica, head 
and stem, group 5-16, and kohlrabi. An acute dietary exposure 
assessment was not performed as there are no appropriate toxicological 
effects attributable to a single exposure (dose). A partially refined 
chronic dietary (food and drinking water) exposure and risk assessment 
was conducted that incorporated tolerance-level residues for the 
proposed new uses, crop group expansions, and crop group conversions. 
The chronic analysis also incorporated average percent crop treated 
(PCT) data for several registered commodities. For the remaining 
commodities, 100 PCT was assumed. Anticipated residues for meat, milk, 
hog, and poultry commodities were incorporated as well. A cancer 
dietary assessment was not conducted because novaluron is classified as 
``not likely to be carcinogenic to humans.'' In addition, the chronic 
dietary exposure and risk assessment incorporated the highest total 
estimated drinking water concentration of 8.4 parts per billion into 
this dietary assessment. EPA's aggregate exposure assessment 
incorporated this additional assumed dietary exposure in food and 
drinking water and residential exposure for existing uses; the 
residential exposure assessment has not changed since the 2015 final 
rule because no new residential uses are being added by this action.
    Chronic dietary risks are below the Agency's level of concern of 
100% of the chronic population adjusted dose (cPAD); they are estimated 
to be 50% of the cPAD for children 1 to 2 years old, the population 
subgroup with the highest exposure estimate. Short- and intermediate-
term aggregate (dietary and residential) margins of exposure (MOEs) are 
3,400 for adults and 420 for children 1-2 years old, which are not of 
concern because they are greater than EPA's levels of concern (MOEs 
less than or equal to 100). There are no anticipated long-term 
exposures because the pet spot-on use of novaluron was voluntarily 
cancelled in 2017, so the long-term aggregate assessment is equivalent 
to the chronic dietary.
    Therefore, based on the risk assessments and information described 
above, EPA concludes there is a reasonable certainty that no harm will 
result to the general population, or to infants and children, from 
aggregate exposure to novaluron residues. Further information about 
EPA's risk assessment and determination of safety supporting the 
tolerances established and modified in this regulation can be found at 
http://www.regulations.gov in the document titled, ``Novaluron. Human 
Health Risk Assessment for Proposed New Uses on Tropical and 
Subtropical, Small Fruit, Inedible Peel, Subgroup 24A; Sunflower 
Subgroup 20B; and Greenhouse-Grown Peppers; and Crop Group Expansion 
for Cottonseed Subgroup 20C, and Crop Group Conversions for Brassica, 
Leafy Greens, Subgroup 4-16B, Vegetable, Brassica, Head and Stem, Group 
5-16, and Kohlrabi'' dated June 30, 2020 in docket ID number EPA-HQ-
OPP-2019-0249.

IV. Other Considerations

A. Analytical Enforcement Methodology

    Adequate enforcement methodology (gas chromatography/electron-
capture detection (GC/ECD) and high-performance liquid chromatography/
ultraviolet (HPLC/UV)) is available to enforce the tolerance 
expression.
    The method may be requested from: Chief, Analytical Chemistry 
Branch, Environmental Science Center, 701 Mapes Rd., Ft. Meade, MD 
20755-5350; telephone number: (410) 305-2905; email address: 
[email protected].

B. International Residue Limits

    In making its tolerance decisions, EPA seeks to harmonize U.S. 
tolerances with international standards whenever possible, consistent 
with U.S. food

[[Page 49263]]

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 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.
    Codex MRLs are established for residues of novaluron in mustard 
greens (part of the Brassica, leafy greens, subgroup 4-16B), the group 
of Brassica vegetables (which includes the commodities in the 
vegetable, Brassica, head and stem, group 5-16 and kohlrabi), and 
cotton seed (part of the cottonseed subgroup 20C) at the same levels as 
the U.S. tolerances and are thus harmonized. There are no Codex MRLs 
for any of the commodities in the tropical and subtropical, small 
fruit, inedible peel, subgroup 24A or sunflower subgroup 20B and 
therefore harmonization is not an issue. There are Canadian MRLs at 1 
ppm and Codex MRLs at 0.7 ppm for pepper, bell; pepper, non-bell; and 
tomato, which are the representative commodities in the vegetable, 
fruiting, group 8-10. Based on the data submitted with this petition, 
EPA is revising the existing tolerance in/on the vegetable, fruiting, 
group 8-10 to be 2 ppm. Harmonization with the Canada or Codex MRLs is 
not possible because lowering the tolerance could cause U.S. growers to 
have violative residues despite using the pesticide according to the 
label.

C. Response to Comments

    One comment was received in response to the notice of filing that 
stated in part that ``increasing the tolerance so that more pesticide 
junk can be on brassica and turnips--that is a very bad idea.''
    Although the Agency recognizes that some individuals believe that 
pesticides should be banned on agricultural crops, the existing legal 
framework provided by section 408 of the FFDCA authorizes EPA to 
establish tolerances when it determines that the tolerance is safe. 
Upon consideration of the validity, completeness, and reliability of 
the available data as well as other factors the FFDCA requires EPA to 
consider, EPA has determined that the novaluron residue tolerances 
established and modified by this action are safe. The commenter has 
provided no information supporting a contrary conclusion.

D. Revisions to Petitioned-For Tolerances

    The Agency is modifying the tolerance for vegetable, fruiting, 
group 8-10 to 2 ppm, rather than 1.5 ppm as proposed by the petitioner. 
The petitioner did not use the Organization for Economic Cooperation 
and Development (OECD) tolerance calculator and instead estimated the 
proposed tolerance level. To be conservative, EPA utilized all of the 
submitted field trial data for greenhouse pepper (which is a 
representative commodity in the vegetable, fruiting, group 8-10) at the 
pre-harvest interval (PHI) which gave the highest residue levels, 
because data showed that residues increased with increasing PHI. These 
values were input into the OECD calculator.
    Also, although the petitioner proposed a 0.6 ppm tolerance for the 
cottonseed subgroup 20C, the Agency is establishing the tolerance at 
0.5 ppm for harmonization with Codex. While the OECD calculator 
determined a rounded tolerance of 0.6 ppm based on previously submitted 
cotton field trial data, EPA concludes that a 0.5 ppm tolerance is 
appropriate because it is based on the following conservative 
tolerance-setting assumptions: Cottonseed is a blended commodity 
(therefore, residues are likely to be lower), and field trials are 
based on maximum application rates (which provides a ``worst-case'' 
residue level). Furthermore, the OECD calculator provided an unrounded 
maximum residue limit (MRL) of 0.52 ppm, which is close to 0.5 ppm.

V. Conclusion

    Therefore, tolerances are established for residues of novaluron in 
or on Brassica, leafy greens, subgroup 4-16B at 25 ppm; cottonseed 
subgroup 20C at 0.5 ppm; kohlrabi at 0.7 ppm; sunflower subgroup 20B at 
0.07 ppm; tropical and subtropical, small fruit, inedible peel, 
subgroup 24A at 9 ppm; and vegetable, Brassica, head and stem, Group 5-
16 at 0.7 ppm. Furthermore, the existing tolerance for vegetable, 
fruiting, group 8-10 is modified from 1.0 ppm to 2 ppm. Lastly, the 
following tolerances are removed as unnecessary due to the 
establishment of the above tolerances: Brassica, head and stem, 
subgroup 5A; Brassica, leafy greens, subgroup 5B; cotton, undelinted 
seed; and turnip greens.

VI. Statutory and Executive Order Reviews

    This action establishes and modifies tolerances under FFDCA section 
408(d) in response to a petition submitted to the Agency. The Office of 
Management and Budget (OMB) has exempted these types of actions from 
review under Executive Order 12866, entitled ``Regulatory Planning and 
Review'' (58 FR 51735, October 4, 1993). Because this action has been 
exempted from review under Executive Order 12866, this action is not 
subject to Executive Order 13211, entitled ``Actions Concerning 
Regulations That Significantly Affect Energy Supply, Distribution, or 
Use'' (66 FR 28355, May 22, 2001) or Executive Order 13045, entitled 
``Protection of Children from Environmental Health Risks and Safety 
Risks'' (62 FR 19885, April 23, 1997), nor is it considered a 
regulatory action under Executive Order 13771, entitled ``Reducing 
Regulations and Controlling Regulatory Costs'' (82 FR 9339, February 3, 
2017). This action does not contain any information collections subject 
to OMB approval under the Paperwork Reduction Act (PRA) (44 U.S.C. 3501 
et seq.), nor does it require any special considerations under 
Executive Order 12898, entitled ``Federal Actions to Address 
Environmental Justice in Minority Populations and Low-Income 
Populations'' (59 FR 7629, February 16, 1994).
    Since tolerances and exemptions that are established on the basis 
of a petition under FFDCA section 408(d), such as the tolerances and 
modifications in this final rule, do not require the issuance of a 
proposed rule, the requirements of the Regulatory Flexibility Act (RFA) 
(5 U.S.C. 601 et seq.), do not apply.
    This action directly regulates growers, food processors, food 
handlers, and food retailers, not States or tribes, nor does this 
action alter the relationships or distribution of power and 
responsibilities established by Congress in the preemption provisions 
of FFDCA section 408(n)(4). As such, the Agency has determined that 
this action will not have a substantial direct effect on States or 
tribal governments, on the relationship between the national government 
and the States or tribal governments, or on the distribution of power 
and responsibilities among the various levels of government or between 
the Federal Government and Indian tribes. Thus, the Agency has 
determined that Executive Order 13132, entitled ``Federalism'' (64 FR 
43255, August 10, 1999) and Executive Order 13175, entitled 
``Consultation and Coordination with Indian Tribal Governments'' (65 FR

[[Page 49264]]

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: July 16, 2020.
Michael Goodis,
Director, Registration Division, Office of Pesticide Programs.
    Therefore, for the reasons states in the preamble, the EPA amend 40 
CFR chapter I as follows:

PART 180--TOLERANCES AND EXEMPTIONS FOR PESTICIDE CHEMICAL RESIDUES 
IN FOOD

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.  180.598, amend the table in paragraph (a) by:
0
a. Removing the entry for ``Brassica, head and stem, subgroup 5A'';
0
b. Adding in alphabetical order an entry for ``Brassica, leafy greens, 
subgroup 4-16B'';
0
c. Removing the entries for ``Brassica, leafy greens, subgroup 5B'' and 
``Cotton, undelinted seed'';
0
d. Adding in alphabetical order entries for ``Cottonseed subgroup 
20C,'' ``Kohlrabi,'' ``Sunflower subgroup 20B,'' ``Tropical and 
subtropical, small fruit, inedible peel, subgroup 24A'';
0
e. Removing the entry for ``Turnip greens'';
0
f. Adding in alphabetical order an entry for ``Vegetable, Brassica, 
head and stem, Group 5-16''; and
0
g. Revising the entry for ``Vegetable, fruiting, group 8-10''.
    The additions and revision read as follows:


Sec.  180.598  Novaluron; tolerances for residues.

    (a) * * *

------------------------------------------------------------------------
                                                             Parts per
                        Commodity                             million
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                              * * * * * * *
Brassica, leafy greens, subgroup 4-16B..................              25
 
                              * * * * * * *
Cottonseed subgroup 20C.................................             0.5
 
                              * * * * * * *
Kohlrabi................................................             0.7
 
                              * * * * * * *
Sunflower subgroup 20B..................................            0.07
 
                              * * * * * * *
Tropical and subtropical, small fruit, inedible peel,                  9
 subgroup 24A...........................................
Vegetable, Brassica, head and stem, Group 5-16..........             0.7
 
                              * * * * * * *
Vegetable, fruiting, group 8-10.........................               2
 
                              * * * * * * *
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[FR Doc. 2020-16457 Filed 8-12-20; 8:45 am]
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