[Federal Register Volume 84, Number 78 (Tuesday, April 23, 2019)]
[Rules and Regulations]
[Pages 16789-16791]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2019-08111]


-----------------------------------------------------------------------

ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[EPA-HQ-OPP-2017-0593; FRL-9991-86]


Bacteriophage Active Against Xylella fastidiosa; Exemption From 
the Requirement of a Tolerance

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

-----------------------------------------------------------------------

SUMMARY: This regulation establishes an exemption from the requirement 
of a tolerance for residues of lytic bacteriophage active against 
Xylella fastidiosa in or on all food commodities when the bacteriophage 
are sequenced and have sequences free of toxins and lysogenic genes and 
are used in accordance with label directions and good agricultural 
practices. Otsuka Pharmaceutical Co., Ltd. (c/o Technology Sciences 
Group Inc.) submitted a petition to EPA under the Federal Food, Drug, 
and Cosmetic Act (FFDCA), requesting an exemption from the requirement 
of a tolerance. This regulation eliminates the need to establish a 
maximum permissible level for residues of bacteriophage active against 
Xylella fastidiosa in or on all food commodities under FFDCA.

DATES: This regulation is effective April 23, 2019. Objections and 
requests for hearings must be received on or before June 24, 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 docket for this action, identified by docket 
identification (ID) number EPA-HQ-OPP-2017-0593, is available at http://www.regulations.gov or at the Office of Pesticide Programs Regulatory 
Public Docket (OPP Docket) in the Environmental Protection Agency 
Docket Center (EPA/DC), West William Jefferson Clinton Bldg., Rm. 3334, 
1301 Constitution Ave. NW, Washington, DC 20460-0001. The Public 
Reading Room is open from 8:30 a.m. to 4:30 p.m., Monday through 
Friday, excluding legal holidays. The telephone number for the Public 
Reading Room is (202) 566-1744, and the telephone number for the OPP 
Docket is (703) 305-5805. Please review the visitor instructions and 
additional information about the docket available at http://www.epa.gov/dockets.

FOR FURTHER INFORMATION CONTACT: Robert McNally, 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 Publishing 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-2017-0593 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 
June 24, 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 number EPA-HQ-OPP-2017-0593, 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

[[Page 16790]]

available at http://www.epa.gov/dockets.

II. Background

    In the Federal Register of March 6, 2018 (83 FR 9471) (FRL-9973-
27), EPA issued a document pursuant to FFDCA section 408(d)(3), 21 
U.S.C. 346a(d)(3), announcing the filing of a pesticide tolerance 
petition (PP 7F8562) by Otsuka Pharmaceutical Co., Ltd. (Otsuka), 2-9 
Kanda-Tsukasamachi, Chiyoda-ku, Tokyo, 101-8535, Japan (c/o Technology 
Sciences Group Inc., 712 Fifth St., Suite A, Davis, CA 95616). The 
petition requested that 40 CFR part 180 be amended by establishing an 
exemption from the requirement of a tolerance for residues of the 
bactericide bacteriophages active against Xylella fastidiosa in or on 
all food commodities. That document referenced a summary of the 
petition prepared by the petitioner Otsuka (c/o Technology Sciences 
Group Inc.) and available in the docket via http://www.regulations.gov. 
Comments were received on the notice of filing. EPA's response to these 
comments is discussed in Unit III.C.
    Based upon review of data and other information supporting the 
petition, EPA is granting a tolerance exemption that differs slightly 
from what the petition requested. The reason for this difference is 
explained in Unit III.D.

III. Final Rule

A. EPA's Safety Determination

    Section 408(c)(2)(A)(i) of FFDCA allows EPA to establish an 
exemption from the requirement of a tolerance (the legal limit for a 
pesticide chemical residue in or on a food) only if EPA determines that 
the exemption is ``safe.'' Section 408(c)(2)(A)(ii) of FFDCA defines 
``safe'' to mean that ``there is a reasonable certainty that no harm 
will result from aggregate exposure to the pesticide chemical residue, 
including all anticipated dietary exposures and all other exposures for 
which there is reliable information.'' This includes exposure through 
drinking water and in residential settings but does not include 
occupational exposure. Pursuant to FFDCA section 408(c)(2)(B), in 
establishing or maintaining in effect an exemption from the requirement 
of a tolerance, EPA must take into account the factors set forth in 
FFDCA section 408(b)(2)(C), which require EPA to give special 
consideration to exposure of infants and children to the pesticide 
chemical residue in establishing a tolerance or tolerance exemption and 
to ``ensure that there is a reasonable certainty that no harm will 
result to infants and children from aggregate exposure to the pesticide 
chemical residue. . . .'' Additionally, FFDCA section 408(b)(2)(D) 
requires that EPA consider ``available information concerning the 
cumulative effects of [a particular pesticide's] . . . residues and 
other substances that have a common mechanism of toxicity.''
    EPA evaluated the available toxicity and exposure data on 
bacteriophage active against Xylella fastidiosa and considered their 
validity, completeness, and reliability, as well as the relationship of 
this information to human risk. A full explanation of the data upon 
which EPA relied and its risk assessment based on those data can be 
found within the document entitled ``Federal Food, Drug, and Cosmetic 
Act (FFDCA) Safety Determination for Bacteriophage Active Against 
Xylella fastidiosa'' (Safety Determination). 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, with regard to humans, 
bacteriophage active against Xylella fastidiosa are not anticipated to 
be toxic, pathogenic, or infective via any route of exposure. 
Furthermore, humans, including infants and children, have been exposed 
to bacteriophage through food and water, where they are commonly found, 
with no known adverse effects. Although there may be some exposure to 
residues when bacteriophage active against Xylella fastidiosa is used 
on food commodities in accordance with label directions and good 
agricultural practices (only grape for now), there is a lack of concern 
due to the lack of potential for adverse effects. EPA also determined 
in the Safety Determination that retention of the Food Quality 
Protection Act (FQPA) safety factor was not necessary as part of the 
qualitative assessment conducted for bacteriophage active against 
Xylella fastidiosa.
    Based upon its evaluation in the Safety Determination, 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 bacteriophage active against Xylella 
fastidiosa. Therefore, an exemption from the requirement of a tolerance 
is established for residues of lytic bacteriophage active against 
Xylella fastidiosa in or on all food commodities when the bacteriophage 
are sequenced and have sequences free of toxins and lysogenic genes and 
are used in accordance with label directions and good agricultural 
practices.

B. Analytical Enforcement Methodology

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

C. Response to Comments

    Nine comments were received in response to the notice of filing. 
EPA reviewed the comments and determined that they are irrelevant to 
the tolerance exemption in this action.

D. Differences Between Petition and Tolerance Exemption Rule

    In its petition, the petitioner requested generally that EPA issue 
an exemption from the requirement of a tolerance for residues of 
bacteriophage active against Xylella fastidiosa in or on all food 
commodities. The petitioner's supporting materials indicated that the 
actual pesticide that would be used would be safe because the 
bacteriophage were lytic and were sequenced and have sequences free of 
toxins and lysogenic genes. EPA believes that only bacteriophage that 
have these same characteristics as the organism tested would be safe 
and should be exempt from the requirement of a tolerance. Therefore, 
EPA is issuing a tolerance exemption that differs slightly from the 
petition by limiting the exemption to residues of the bacteriophage 
that possess the same characteristics as the bacteriophage that were 
tested to support this exemption.

IV. Statutory and Executive Order Reviews

    This action establishes a tolerance exemption under FFDCA section 
408(d) in response to a petition submitted to EPA. The Office of 
Management and Budget (OMB) has exempted these types of actions from 
review under Executive Order 12866, entitled ``Regulatory Planning and 
Review'' (58 FR 51735, October 4, 1993). Because this action has been 
exempted from review under Executive Order 12866, this action is not 
subject to Executive Order 13211, entitled ``Actions Concerning 
Regulations That Significantly Affect Energy Supply, Distribution, or 
Use'' (66 FR 28355, May 22, 2001), or Executive Order 13045, entitled 
``Protection of Children from Environmental Health Risks and Safety 
Risks'' (62 FR 19885, April 23, 1997), 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, 44

[[Page 16791]]

U.S.C. 3501 et seq., nor does it require any special considerations 
under Executive Order 12898, entitled ``Federal Actions to Address 
Environmental Justice in Minority Populations and Low-Income 
Populations'' (59 FR 7629, February 16, 1994).
    Since tolerances and exemptions that are established on the basis 
of a petition under FFDCA section 408(d), such as the tolerance 
exemption in this action, do not require the issuance of a proposed 
rule, the requirements of the Regulatory Flexibility Act (5 U.S.C. 601 
et seq.) do not apply.
    This action directly regulates growers, food processors, food 
handlers, and food retailers, not States or tribes. As a result, this 
action does not alter the relationships or distribution of power and 
responsibilities established by Congress in the preemption provisions 
of FFDCA section 408(n)(4). As such, EPA has determined that this 
action will not have a substantial direct effect on States or tribal 
governments, on the relationship between the national government and 
the States or tribal governments, or on the distribution of power and 
responsibilities among the various levels of government or between the 
Federal Government and Indian tribes. Thus, EPA has determined that 
Executive Order 13132, entitled ``Federalism'' (64 FR 43255, August 10, 
1999), and Executive Order 13175, entitled ``Consultation and 
Coordination with Indian Tribal Governments'' (65 FR 67249, November 9, 
2000), do not apply to this action. In addition, this action does not 
impose any enforceable duty or contain any unfunded mandate as 
described under Title II of the Unfunded Mandates Reform Act (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 (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: April 12, 2019.
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.  180.1365 to subpart D to read as follows:


Sec.  180.1365  Bacteriophage active against Xylella fastidiosa; 
exemption from the requirement of a tolerance.

    An exemption from the requirement of a tolerance is established for 
residues of lytic bacteriophage active against Xylella fastidiosa in or 
on all food commodities when the bacteriophage are sequenced and have 
sequences free of toxins and lysogenic genes and are used in accordance 
with label directions and good agricultural practices.

[FR Doc. 2019-08111 Filed 4-22-19; 8:45 am]
BILLING CODE 6560-50-P