83 FR 64027 - [EPA-HQ-OPP-2017-0288 and EPA-HQ-OPP-2017-0283; FRL-9986-73] HEAD6-Benzyladenine; Pesticide Tolerances

ENVIRONMENTAL PROTECTION AGENCY

Federal Register Volume 83, Issue 239 (December 13, 2018)

This regulation establishes tolerances for residues of 6- benzyladenine in or on avocados, peppers, tomatoes, cucumbers, melons, and squash. Interregional Research Project Number 4 and Valent BioSciences LLC have requested these tolerances under the Federal Food, Drug, and Cosmetic Act (FFDCA).

[Federal Register Volume 83, Number 239 (Thursday, December 13, 2018)]
[Rules and Regulations]
[Pages 64027-64030]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2018-27047]


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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180


[EPA-HQ-OPP-2017-0288 and EPA-HQ-OPP-2017-0283; FRL-9986-73]

6-Benzyladenine; Pesticide Tolerances

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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SUMMARY: This regulation establishes tolerances for residues of 6-
benzyladenine in or on avocados, peppers, tomatoes, cucumbers, melons, 
and squash. Interregional Research Project Number 4 and Valent 
BioSciences LLC have requested these tolerances under the Federal Food, 
Drug, and Cosmetic Act (FFDCA).

DATES: This regulation is effective December 13, 2018. Objections and 
requests for hearings must be received on or before February 11, 2019, 
and must be filed in accordance with the instructions provided in 40 
CFR part 178 (see also Unit I.C. of the SUPPLEMENTARY INFORMATION).

ADDRESSES: The dockets for this action, identified by docket 
identification (ID)

[[Page 64028]]

numbers EPA-HQ-OPP-2017-0288 and EPA-HQ-OPP-2017-0283, are 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, 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: 
[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 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-2017-0288 and EPA-HQ-OPP-2017-0283 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 February 11, 2019. Addresses for mail and 
hand delivery of objections and hearing requests are provided in 40 CFR 
178.25(b).
    In addition to filing an objection or hearing request with the 
Hearing Clerk as described in 40 CFR part 178, please submit a copy of 
the filing (excluding any Confidential Business Information (CBI)) for 
inclusion in the public docket. Information not marked confidential 
pursuant to 40 CFR part 2 may be disclosed publicly by EPA without 
prior notice. Submit the non-CBI copy of your objection or hearing 
request, identified by docket ID numbers EPA-HQ-OPP-2017-0288 and EPA-
HQ-OPP-2017-0283, 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

    In the Federal Register of September 15, 2017 (82 FR 43352) (FRL-
9965-43), EPA issued a document pursuant to FFDCA section 408(d)(3), 21 
U.S.C. 346a(d)(3), announcing the filing of two pesticide petitions: PP 
6E8526 by Interregional Research Project Number 4 (IR-4), Rutgers, 
State University of New Jersey, 681 U.S. Highway No. 1, S. North New 
Brunswick, NJ 08902; and PP 7F8548 by Valent BioSciences LLC (Valent), 
870 Technology Way, Libertyville, IL 60048. Petition 6E8526 requested 
that 40 CFR part 180 be amended by establishing a tolerance for 
residues of the plant growth regulator 6-benzyladenine, in or on 
avocados at 0.05 parts per million (ppm). Petition 7F8548 requested 
amendment of the current exemption from the requirement of tolerance 
for residues of 6-benzyladenine, 40 CFR 180.1150, to add fruiting 
vegetables (tomatoes and peppers) and cucurbit vegetables (cucumbers, 
melons, and squash). That document referenced summaries of the 
petitions prepared by Valent, the registrant, which are available in 
the respective dockets via, www.regulations.gov. Comments were received 
on the notice of filing, and the Agency's response can be found in Unit 
III.D.
    Based upon review of the data supporting each petition, EPA is 
establishing tolerance levels for 6-benzyladenine on avocados, 
tomatoes, peppers, cucumbers, melons and squash in one final rule. The 
reasons for these changes are explained in Part III.E. of this 
document.

III. Final Rule

A. EPA's Safety Determination

    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. 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 evaluated the available toxicological and exposure data on 6-
benzyladenine and considered their validity, completeness, and 
reliability, as well as the relationship of this information to human 
risk. A summary of the data upon which EPA relied and its risk 
assessment based on those data can be found within the document

[[Page 64029]]

entitled ``Federal Food, Drug, and Cosmetic Act (FFDCA) Safety 
Assessment for Tolerances for Residues of 6-benzyladenine.'' This 
document, as well as other relevant information, is available in the 
docket for this action as described under ADDRESSES.
    The available data demonstrated that the predominant adverse effect 
from exposure to 6-benzyladenine was a significant reduction in body 
weight, including an increased susceptibility of body weight effects in 
fetuses and offspring. Despite these effects, EPA determined that 
reliable data show the safety of infants and children would be 
adequately protected if the Food Quality Protection Act (FQPA) safety 
factor was reduced to 1X. EPA conducted a quantitative aggregate risk 
assessment, taking into account chronic exposures to residues of 6-
benzyladenine in food and drinking water (no residential exposures are 
anticipated) and concluded that risks do not exceed EPA's level of 
concern.
    Based upon its evaluation, 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 6-
benzyladenine. Therefore, tolerances are established for residues of 6-
benzyladenine, in or on tomato, pepper, cucumber, melon, and squash at 
0.01 ppm and in or on avocado at 0.02 ppm.

B. Analytical Enforcement Methodology

    Adequate enforcement methodologies to quantitatively determine 6-
benzyladenine residues by liquid chromatography/mass spectrometer/mass 
spectrometer (LC/MS/MS) (Meth-209, Determination of 6-Benzyladenine (6-
BA) in Selected Fruiting Vegetable and Cucurbit Vegetable Raw 
Agricultural and Processed Commodities and Meth-210, Determination of 
6-Benzyladenine (6-BA) in Selected Oily Crop Raw Agricultural 
Commodities) are available to enforce the tolerance expression. The 
methods 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].

C. International Residue Limits

    In making its tolerance decisions, EPA seeks to harmonize U.S. 
tolerances with international standards whenever possible, consistent 
with U.S. food safety standards and agricultural practices. EPA 
considers the international maximum residue limits (MRLs) established 
by the Codex Alimentarius Commission (Codex), as required by FFDCA 
section 408(b)(4). The Codex Alimentarius is a joint United Nations 
Food and Agriculture Organization/World Health Organization food 
standards program, and it is recognized as an international food safety 
standards-setting organization in trade agreements to which the United 
States is a party. EPA may establish a tolerance that is different from 
a Codex MRL; however, FFDCA section 408(b)(4) requires that EPA explain 
the reasons for departing from the Codex level. The Codex has not 
established an MRL for 6-benzyladenine; however, Canada and the 
European Union (EU) have set default MRLs at 0.1 ppm (Canada) and 0.01 
ppm (EU), respectively.

D. Response to Comments

    One comment was received in response to each of the petitions. Each 
comment generally opposed pesticide residues on food; only one 
mentioned 6-benzyladenine by name. Neither comment was accompanied by 
any substantiation or data supporting a conclusion that the tolerances 
being established in this action do not meet the FFDCA safety standard. 
Although EPA recognizes that some individuals would oppose any use of 
pesticides on food, section 408 of the FFDCA authorizes EPA to set 
tolerances for residues of pesticide chemicals in or on food when it 
determines that the tolerance meets the safety standard imposed by that 
statute. EPA has made that determination for the 6-benzyladenine 
tolerances established by this final rule.

E. Revisions to Petitioned-For Tolerance and Tolerance Exemption

    The applicant requested a tolerance for residues of 6-benzyladenine 
on avocado at 0.05 ppm. Based on available residue data and using the 
Organisation for Economic Co-operation and Development (OECD) 
calculator, EPA has determined that a tolerance for residues of 6-
benzyladenine on avocado at 0.02 ppm is appropriate. In addition, the 
applicant requested to amend the current exemption, 40 CFR 180.1150, 
for residues of 6-benzyladenine by adding fruiting vegetables (tomatoes 
and peppers) and cucurbit vegetables (cucumbers, melons, and squash) at 
20 parts per million (ppm) at a maximum of five applications (total 
18.8 grams of active ingredient per acre per season) with a seven-day 
interval between applications. Due to the toxicological profile of the 
chemical and the measurable residues, EPA has concluded that a 
tolerance is the appropriate regulatory mechanism for covering residues 
of 6-benzyladenine under the FFDCA. Based on the available residue data 
and using the OECD calculator, EPA has determined that tolerances for 
residues of 6-benzyladenine on tomato, pepper, cucumber, melon, and 
squash at 0.01 ppm are appropriate.

IV. Statutory and Executive Order Reviews

    This action establishes tolerances 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) 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 tolerance 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

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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).

V. 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: November 28, 2018.
Richard P. Keigwin, Jr.,
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.  180.703 to subpart C to read as follows:


Sec.  180.703   6-benzyladenine; tolerances for residues.

    (a) General. Tolerances are established for residues of the plant 
growth regulator, 6-benzyladenine in or on the commodities listed in 
the table below. Compliance with the tolerance levels specified in this 
paragraph is to be determined by measuring only 6-benzyladenine in or 
on the commodity.

------------------------------------------------------------------------
                                                               Parts per
                          Commodity                             million
------------------------------------------------------------------------
Avocado.....................................................        0.02
Cucumber....................................................        0.01
Melon.......................................................        0.01
Pepper......................................................        0.01
Squash......................................................        0.01
Tomato......................................................        0.01
------------------------------------------------------------------------

    (b) Section 18 emergency exemptions. [Reserved]
    (c) Tolerances with regional registrations. [Reserved]
    (d) Indirect or inadvertent residues. [Reserved]

[FR Doc. 2018-27047 Filed 12-12-18; 8:45 am]
 BILLING CODE 6560-50-P