83 FR 46405 - Pepino Mosaic Virus, Strain CH2, Isolate 1906; Exemption From the Requirement of a Tolerance
ENVIRONMENTAL PROTECTION AGENCY Federal Register Volume 83, Issue 178 (September 13, 2018)
Federal Register Volume 83, Issue 178 (September 13, 2018)
| Page Range | 46405-46407 | |
| FR Document | 2018-19959 |
[Federal Register Volume 83, Number 178 (Thursday, September 13, 2018)] [Rules and Regulations] [Pages 46405-46407] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2018-19959] ----------------------------------------------------------------------- ENVIRONMENTAL PROTECTION AGENCY 40 CFR Part 180 [EPA-HQ-OPP-2017-0525; FRL-9983-31] Pepino Mosaic Virus, Strain CH2, Isolate 1906; 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 [[Page 46406]] tolerance for residues of Pepino mosaic virus, strain CH2, isolate 1906 in or on tomato when this pesticide chemical is used in accordance with label directions and good agricultural practices. Interregional Research Project Number 4 submitted a petition to EPA under the Federal Food, Drug, and Cosmetic Act (FFDCA), requesting an exemption from a requirement of a tolerance. This regulation eliminates the need to establish a maximum permissible level for residues of Pepino mosaic virus, strain CH2, isolate 1906 in or on tomato under FFDCA. DATES: This regulation is effective September 13, 2018. Objections and requests for hearings must be received on or before November 13, 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-2017-0525, 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 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-2017-0525 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 November 13, 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-2017-0525, 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 December 15, 2017 (82 FR 59604) (FRL- 9970-50), EPA issued a document pursuant to FFDCA section 408(d)(3), 21 U.S.C. 346a(d)(3), announcing the filing of a pesticide tolerance petition (PP 7E8567) by Interregional Research Project Number 4 (IR-4), Rutgers, The State University of New Jersey, 500 College Road East, Suite 201 W, Princeton, NJ 08540. The petition requested that 40 CFR part 180 be amended by establishing an exemption from the requirement of a tolerance for residues of the microbial pesticide Pepino mosaic virus, strain CH2, isolate 1906 in or on tomato. That document referenced a summary of the petition prepared by the petitioner IR-4 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. 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 [[Page 46407]] other substances that have a common mechanism of toxicity.'' EPA evaluated the available toxicological and exposure data on Pepino mosaic virus, strain CH2, isolate 1906 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 Pepino mosaic virus, strain CH2, isolate 1906'' (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 in regard to humans Pepino mosaic virus, strain CH2, isolate 1906 is not likely to be toxic or pathogenic, is not infective, and is not able to replicate in human cells. Furthermore, humans, including infants and children, continuously consume plant viruses, including Pepino mosaic virus, strain CH2, isolate 1906, due to the ubiquitous nature of these viruses in plants and fruits, and no cases have been documented of any plant virus causing toxicity or diseases in humans or animals. Although there may be some exposure to residues of Pepino mosaic virus, strain CH2, isolate 1906 that are used on tomato in accordance with label directions and good agricultural practices, such exposure is unlikely to cause any 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 Pepino mosaic virus, strain CH2, isolate 1906. 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 Pepino mosaic virus, strain CH2, isolate 1906. Therefore, an exemption from the requirement of a tolerance is established for residues of Pepino mosaic virus, strain CH2, isolate 1906 in or on tomato when this pesticide chemical is 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 Three 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. 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 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: September 6, 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. 180.1361 to subpart D to read as follows: Sec. 180.1361 Pepino mosaic virus, strain CH2, isolate 1906; exemption from the requirement of a tolerance. Residues of Pepino mosaic virus, strain CH2, isolate 1906 are exempt from the requirement of a tolerance in or on tomato when this pesticide chemical is used in accordance with label directions and good agricultural practices. [FR Doc. 2018-19959 Filed 9-12-18; 8:45 am] BILLING CODE 6560-50-P
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necessary as part of the qualitative Executive Order 12866, this action is Transfer and Advancement Act (15
assessment conducted for bacteriophage not subject to Executive Order 13211, U.S.C. 272 note).
active against Xanthomonas citri subsp. entitled ‘‘Actions Concerning
V. Congressional Review Act
citri. Regulations That Significantly Affect
Based upon its evaluation, EPA Energy Supply, Distribution, or Use’’ (66 Pursuant to the Congressional Review
concludes that there is a reasonable FR 28355, May 22, 2001), or Executive Act (5 U.S.C. 801 et seq.), EPA will
certainty that no harm will result to the Order 13045, entitled ‘‘Protection of submit a report containing this rule and
U.S. population, including infants and Children from Environmental Health other required information to the U.S.
children, from aggregate exposure to Risks and Safety Risks’’ (62 FR 19885, Senate, the U.S. House of
residues of bacteriophage active against April 23, 1997), nor is it considered a Representatives, and the Comptroller
Xanthomonas citri subsp. citri. regulatory action under Executive Order General of the United States prior to
Therefore, an exemption from the 13771, entitled ‘‘Reducing Regulations publication of the rule in the Federal
requirement of a tolerance is established and Controlling Regulatory Costs’’ (82 Register. This action is not a ‘‘major
for residues of lytic bacteriophage active FR 9339, February 3, 2017). This action rule’’ as defined by 5 U.S.C. 804(2).
against Xanthomonas citri subsp. citri does not contain any information
that are produced in Xanthomonas citri List of Subjects in 40 CFR Part 180
collections subject to OMB approval
subsp. citri in or on food commodities under the Paperwork Reduction Act, 44 Environmental protection,
included in the fruit, citrus groups 10 U.S.C. 3501 et seq., nor does it require Administrative practice and procedure,
and 10–10, when used in accordance any special considerations under Agricultural commodities, Pesticides
with label directions and good Executive Order 12898, entitled and pests, Reporting and recordkeeping
agricultural practices. ‘‘Federal Actions to Address requirements.
B. Analytical Enforcement Methodology Environmental Justice in Minority Dated: September 4, 2018.
Populations and Low-Income Richard P. Keigwin, Jr.,
An analytical method is not required Populations’’ (59 FR 7629, February 16,
because EPA is establishing an Director, Office of Pesticide Programs.
1994).
exemption from the requirement of a Therefore, 40 CFR chapter I is
Since tolerances and exemptions that
tolerance without any numerical amended as follows:
are established on the basis of a petition
limitation.
under FFDCA section 408(d), such as PART 180—[AMENDED]
C. Differences Between Petition and the tolerance exemption in this action,
Tolerance Exemption Rule do not require the issuance of a ■ 1. The authority citation for part 180
In its petition, the petitioner proposed rule, the requirements of the continues to read as follows:
requested generally that EPA issue an Regulatory Flexibility Act (5 U.S.C. 601
Authority: 21 U.S.C. 321(q), 346a and 371.
exemption from the requirement of a et seq.) do not apply.
This action directly regulates growers, ■ 2. Add § 180.1360 to subpart D to read
tolerance for residues of bacteriophage as follows:
active against Xanthomonas citri subsp. food processors, food handlers, and food
citri in or on citrus fruit, including retailers, not States or tribes. As a result, § 180.1360 Bacteriophage active against
orange, grapefruit, pummelo, mandarin, this action does not alter the Xanthomonas citri subsp. citri; exemption
lemon, lime, tangerine, tangelo, and relationships or distribution of power from the requirement of a tolerance.
kumquat. The petitioner’s supporting and responsibilities established by An exemption from the requirement
materials indicated that the actual Congress in the preemption provisions of a tolerance is established for residues
pesticide that would be used would be of FFDCA section 408(n)(4). As such, of lytic bacteriophage active against
safe because the bacteriophage was lytic EPA has determined that this action will Xanthomonas citri subsp. citri that are
and were produced in Xanthomonas not have a substantial direct effect on produced in Xanthomonas citri subsp.
citri subsp. citri. EPA believes that only States or tribal governments, on the citri in or on food commodities included
bacteriophage that have these same relationship between the national in the fruit, citrus groups 10 and 10–10,
characteristics as the organism tested government and the States or tribal when used in accordance with label
would be safe and should be exempt governments, or on the distribution of directions and good agricultural
from the requirement of a tolerance. power and responsibilities among the practices.
Therefore, EPA is issuing a tolerance various levels of government or between
[FR Doc. 2018–19958 Filed 9–12–18; 8:45 am]
exemption that differs slightly from the the Federal Government and Indian
BILLING CODE 6560–50–P
petition by limiting the exemption to tribes. Thus, EPA has determined that
residues of the bacteriophage that Executive Order 13132, entitled
possess the same characteristics as the ‘‘Federalism’’ (64 FR 43255, August 10, ENVIRONMENTAL PROTECTION
bacteriophage that were tested to 1999), and Executive Order 13175, AGENCY
support this exemption. entitled ‘‘Consultation and Coordination
with Indian Tribal Governments’’ (65 FR 40 CFR Part 180
IV. Statutory and Executive Order 67249, November 9, 2000), do not apply
Reviews to this action. In addition, this action [EPA–HQ–OPP–2017–0525; FRL–9983–31]
This action establishes a tolerance does not impose any enforceable duty or
Pepino Mosaic Virus, Strain CH2,
exemption under FFDCA section 408(d) contain any unfunded mandate as
Isolate 1906; Exemption From the
in response to a petition submitted to described under Title II of the Unfunded
Requirement of a Tolerance
EPA. The Office of Management and Mandates Reform Act (2 U.S.C. 1501 et
daltland on DSKBBV9HB2PROD with RULES
Budget (OMB) has exempted these types seq.). AGENCY: Environmental Protection
of actions from review under Executive This action does not involve any Agency (EPA).
Order 12866, entitled ‘‘Regulatory technical standards that would require ACTION: Final rule.
Planning and Review’’ (58 FR 51735, EPA’s consideration of voluntary
October 4, 1993). Because this action consensus standards pursuant to section SUMMARY: This regulation establishes an
has been exempted from review under 12(d) of the National Technology exemption from the requirement of a
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![46406 Federal Register / Vol. 83, No. 178 / Thursday, September 13, 2018 / Rules and Regulations
tolerance for residues of Pepino mosaic • Crop production (NAICS code 111). or visiting the docket, along with more
virus, strain CH2, isolate 1906 in or on • Animal production (NAICS code information about dockets generally, is
tomato when this pesticide chemical is 112). available at http://www.epa.gov/
used in accordance with label directions • Food manufacturing (NAICS code dockets.
and good agricultural practices. 311).
• Pesticide manufacturing (NAICS II. Background
Interregional Research Project Number 4
submitted a petition to EPA under the code 32532). In the Federal Register of December
Federal Food, Drug, and Cosmetic Act B. How can I get electronic access to 15, 2017 (82 FR 59604) (FRL–9970–50),
(FFDCA), requesting an exemption from other related information? EPA issued a document pursuant to
a requirement of a tolerance. This FFDCA section 408(d)(3), 21 U.S.C.
regulation eliminates the need to You may access a frequently updated 346a(d)(3), announcing the filing of a
establish a maximum permissible level electronic version of 40 CFR part 180 pesticide tolerance petition (PP 7E8567)
for residues of Pepino mosaic virus, through the Government Printing by Interregional Research Project
strain CH2, isolate 1906 in or on tomato Office’s e-CFR site at http://www.ecfr. Number 4 (IR–4), Rutgers, The State
under FFDCA. gov/cgi-bin/text-idx?&c=ecfr&tpl=/ University of New Jersey, 500 College
ecfrbrowse/Title40/40tab_02.tpl. Road East, Suite 201 W, Princeton, NJ
DATES: This regulation is effective
September 13, 2018. Objections and C. How can I file an objection or hearing 08540. The petition requested that 40
requests for hearings must be received request? CFR part 180 be amended by
on or before November 13, 2018, and establishing an exemption from the
Under FFDCA section 408(g), 21 requirement of a tolerance for residues
must be filed in accordance with the U.S.C. 346a(g), any person may file an
instructions provided in 40 CFR part of the microbial pesticide Pepino
objection to any aspect of this regulation mosaic virus, strain CH2, isolate 1906 in
178 (see also Unit I.C. of the and may also request a hearing on those
SUPPLEMENTARY INFORMATION). or on tomato. That document referenced
objections. You must file your objection a summary of the petition prepared by
ADDRESSES: The docket for this action, or request a hearing on this regulation the petitioner IR–4 and available in the
identified by docket identification (ID) in accordance with the instructions docket via http://www.regulations.gov.
number EPA–HQ–OPP–2017–0525, is provided in 40 CFR part 178. To ensure Comments were received on the notice
available at http://www.regulations.gov proper receipt by EPA, you must of filing. EPA’s response to these
or at the Office of Pesticide Programs identify docket ID number EPA–HQ– comments is discussed in Unit III.C.
Regulatory Public Docket (OPP Docket) OPP–2017–0525 in the subject line on
in the Environmental Protection Agency the first page of your submission. All III. Final Rule
Docket Center (EPA/DC), West William objections and requests for a hearing A. EPA’s Safety Determination
Jefferson Clinton Bldg., Rm. 3334, 1301 must be in writing, and must be
Constitution Ave. NW, Washington, DC received by the Hearing Clerk on or Section 408(c)(2)(A)(i) of FFDCA
20460–0001. The Public Reading Room before November 13, 2018. Addresses allows EPA to establish an exemption
is open from 8:30 a.m. to 4:30 p.m., for mail and hand delivery of objections from the requirement of a tolerance (the
Monday through Friday, excluding legal and hearing requests are provided in 40 legal limit for a pesticide chemical
holidays. The telephone number for the CFR 178.25(b). residue in or on a food) only if EPA
Public Reading Room is (202) 566–1744, In addition to filing an objection or determines that the exemption is ‘‘safe.’’
and the telephone number for the OPP hearing request with the Hearing Clerk Section 408(c)(2)(A)(ii) of FFDCA
Docket is (703) 305–5805. Please review as described in 40 CFR part 178, please defines ‘‘safe’’ to mean that ‘‘there is a
the visitor instructions and additional submit a copy of the filing (excluding reasonable certainty that no harm will
information about the docket available any Confidential Business Information result from aggregate exposure to the
at http://www.epa.gov/dockets. (CBI)) for inclusion in the public docket. pesticide chemical residue, including
FOR FURTHER INFORMATION CONTACT: Information not marked confidential all anticipated dietary exposures and all
Robert McNally, Biopesticides and pursuant to 40 CFR part 2 may be other exposures for which there is
Pollution Prevention Division (7511P), disclosed publicly by EPA without prior reliable information.’’ This includes
Office of Pesticide Programs, notice. Submit the non-CBI copy of your exposure through drinking water and in
Environmental Protection Agency, 1200 objection or hearing request, identified residential settings but does not include
Pennsylvania Ave. NW, Washington, DC by docket ID number EPA–HQ–OPP– occupational exposure. Pursuant to
20460–0001; main telephone number: 2017–0525, by one of the following FFDCA section 408(c)(2)(B), in
(703) 305–7090; email address: methods: establishing or maintaining in effect an
BPPDFRNotices@epa.gov. • Federal eRulemaking Portal: http:// exemption from the requirement of a
www.regulations.gov. Follow the online tolerance, EPA must take into account
SUPPLEMENTARY INFORMATION:
instructions for submitting comments. the factors set forth in FFDCA section
I. General Information Do not submit electronically any 408(b)(2)(C), which require EPA to give
information you consider to be CBI or special consideration to exposure of
A. Does this action apply to me? infants and children to the pesticide
other information whose disclosure is
You may be potentially affected by restricted by statute. chemical residue in establishing a
this action if you are an agricultural • Mail: OPP Docket, Environmental tolerance or tolerance exemption and to
producer, food manufacturer, or Protection Agency Docket Center (EPA/ ‘‘ensure that there is a reasonable
pesticide manufacturer. The following DC), (28221T), 1200 Pennsylvania Ave. certainty that no harm will result to
list of North American Industrial infants and children from aggregate
daltland on DSKBBV9HB2PROD with RULES
NW, Washington, DC 20460–0001.
Classification System (NAICS) codes is • Hand Delivery: To make special exposure to the pesticide chemical
not intended to be exhaustive, but rather arrangements for hand delivery or residue. . . .’’ Additionally, FFDCA
provides a guide to help readers delivery of boxed information, please section 408(b)(2)(D) requires that EPA
determine whether this document follow the instructions at http:// consider ‘‘available information
applies to them. Potentially affected www.epa.gov/dockets/contacts.html. concerning the cumulative effects of [a
entities may include: Additional instructions on commenting particular pesticide’s] . . . residues and
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![Federal Register / Vol. 83, No. 178 / Thursday, September 13, 2018 / Rules and Regulations 46407
other substances that have a common C. Response to Comments the Federal Government and Indian
mechanism of toxicity.’’ Three comments were received in tribes. Thus, EPA has determined that
EPA evaluated the available Executive Order 13132, entitled
response to the notice of filing. EPA
toxicological and exposure data on ‘‘Federalism’’ (64 FR 43255, August 10,
reviewed the comments and determined
Pepino mosaic virus, strain CH2, isolate 1999), and Executive Order 13175,
that they are irrelevant to the tolerance
1906 and considered their validity, entitled ‘‘Consultation and Coordination
exemption in this action.
completeness, and reliability, as well as with Indian Tribal Governments’’ (65 FR
the relationship of this information to IV. Statutory and Executive Order 67249, November 9, 2000), do not apply
human risk. A full explanation of the Reviews to this action. In addition, this action
data upon which EPA relied and its risk This action establishes a tolerance does not impose any enforceable duty or
assessment based on those data can be exemption under FFDCA section 408(d) contain any unfunded mandate as
found within the document entitled in response to a petition submitted to described under Title II of the Unfunded
‘‘Federal Food, Drug, and Cosmetic Act EPA. The Office of Management and Mandates Reform Act (2 U.S.C. 1501 et
(FFDCA) Safety Determination for Budget (OMB) has exempted these types seq.).
Pepino mosaic virus, strain CH2, isolate of actions from review under Executive This action does not involve any
1906’’ (Safety Determination). This technical standards that would require
Order 12866, entitled ‘‘Regulatory
document, as well as other relevant EPA’s consideration of voluntary
Planning and Review’’ (58 FR 51735,
information, is available in the docket consensus standards pursuant to section
October 4, 1993). Because this action
for this action as described under 12(d) of the National Technology
has been exempted from review under
ADDRESSES.
Executive Order 12866, this action is Transfer and Advancement Act (15
The available data demonstrated that
not subject to Executive Order 13211, U.S.C. 272 note).
in regard to humans Pepino mosaic
virus, strain CH2, isolate 1906 is not entitled ‘‘Actions Concerning
V. Congressional Review Act
likely to be toxic or pathogenic, is not Regulations That Significantly Affect
infective, and is not able to replicate in Energy Supply, Distribution, or Use’’ (66 Pursuant to the Congressional Review
human cells. Furthermore, humans, FR 28355, May 22, 2001), or Executive Act (5 U.S.C. 801 et seq.), EPA will
including infants and children, Order 13045, entitled ‘‘Protection of submit a report containing this rule and
continuously consume plant viruses, Children from Environmental Health other required information to the U.S.
including Pepino mosaic virus, strain Risks and Safety Risks’’ (62 FR 19885, Senate, the U.S. House of
CH2, isolate 1906, due to the ubiquitous April 23, 1997) nor is it considered a Representatives, and the Comptroller
nature of these viruses in plants and regulatory action under Executive Order General of the United States prior to
fruits, and no cases have been 13771, entitled ‘‘Reducing Regulations publication of the rule in the Federal
documented of any plant virus causing and Controlling Regulatory Costs’’ (82 Register. This action is not a ‘‘major
toxicity or diseases in humans or FR 9339, February 3, 2017). This action rule’’ as defined by 5 U.S.C. 804(2).
animals. Although there may be some does not contain any information
collections subject to OMB approval List of Subjects in 40 CFR Part 180
exposure to residues of Pepino mosaic
virus, strain CH2, isolate 1906 that are under the Paperwork Reduction Act (44 Environmental protection,
used on tomato in accordance with label U.S.C. 3501 et seq.) nor does it require Administrative practice and procedure,
directions and good agricultural any special considerations under Agricultural commodities, Pesticides
practices, such exposure is unlikely to Executive Order 12898, entitled and pests, Reporting and recordkeeping
cause any adverse effects. EPA also ‘‘Federal Actions to Address requirements.
determined in the Safety Determination Environmental Justice in Minority
Dated: September 6, 2018.
that retention of the Food Quality Populations and Low-Income
Richard P. Keigwin, Jr.,
Protection Act (FQPA) safety factor was Populations’’ (59 FR 7629, February 16,
1994). Director, Office of Pesticide Programs.
not necessary as part of the qualitative
assessment conducted for Pepino Since tolerances and exemptions that Therefore, 40 CFR chapter I is
mosaic virus, strain CH2, isolate 1906. are established on the basis of a petition amended as follows:
Based upon its evaluation in the under FFDCA section 408(d), such as
Safety Determination, EPA concludes the tolerance exemption in this action, PART 180—[AMENDED]
that there is a reasonable certainty that do not require the issuance of a
no harm will result to the U.S. proposed rule, the requirements of the ■ 1. The authority citation for part 180
population, including infants and Regulatory Flexibility Act (5 U.S.C. 601 continues to read as follows:
children, from aggregate exposure to et seq.) do not apply. Authority: 21 U.S.C. 321(q), 346a and 371.
residues of Pepino mosaic virus, strain This action directly regulates growers,
CH2, isolate 1906. Therefore, an food processors, food handlers, and food ■ 2. Add § 180.1361 to subpart D to read
exemption from the requirement of a retailers, not States or tribes. As a result, as follows:
tolerance is established for residues of this action does not alter the
§ 180.1361 Pepino mosaic virus, strain
Pepino mosaic virus, strain CH2, isolate relationships or distribution of power CH2, isolate 1906; exemption from the
1906 in or on tomato when this and responsibilities established by requirement of a tolerance.
pesticide chemical is used in Congress in the preemption provisions
of FFDCA section 408(n)(4). As such, Residues of Pepino mosaic virus,
accordance with label directions and
EPA has determined that this action will strain CH2, isolate 1906 are exempt
good agricultural practices.
not have a substantial direct effect on from the requirement of a tolerance in
daltland on DSKBBV9HB2PROD with RULES
B. Analytical Enforcement Methodology States or tribal governments, on the or on tomato when this pesticide
An analytical method is not required relationship between the national chemical is used in accordance with
because EPA is establishing an government and the States or tribal label directions and good agricultural
exemption from the requirement of a governments, or on the distribution of practices.
tolerance without any numerical power and responsibilities among the [FR Doc. 2018–19959 Filed 9–12–18; 8:45 am]
limitation. various levels of government or between BILLING CODE 6560–50–P
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Document Created: 2018-09-13 01:01:34
Document Modified: 2018-09-13 01:01:34
| Category | Regulatory Information | |
| Collection | Federal Register | |
| sudoc Class | AE 2.7: GS 4.107: AE 2.106: | |
| Publisher | Office of the Federal Register, National Archives and Records Administration | |
| Section | Rules and Regulations | |
| Action | Final rule. | |
| Dates | This regulation is effective September 13, 2018. Objections and requests for hearings must be received on or before November 13, 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). | |
| Contact | Robert McNally, Biopesticides and Pollution Prevention Division (7511P), Office of Pesticide Programs, Environmental Protection Agency, 1200 Pennsylvania Ave. NW, Washington, | |
| FR Citation | 83 FR 46405 | |
| CFR Associated | Environmental Protection; Administrative Practice and Procedure; Agricultural Commodities; Pesticides and Pests and Reporting and Recordkeeping Requirements |
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