83 FR 3603 - Calcium Salts of Phosphorous Acid; Exemption From the Requirement of a Tolerance
ENVIRONMENTAL PROTECTION AGENCY Federal Register Volume 83, Issue 18 (January 26, 2018)
Federal Register Volume 83, Issue 18 (January 26, 2018)
| Page Range | 3603-3605 | |
| FR Document | 2018-01494 |
[Federal Register Volume 83, Number 18 (Friday, January 26, 2018)] [Rules and Regulations] [Pages 3603-3605] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2018-01494] ----------------------------------------------------------------------- ENVIRONMENTAL PROTECTION AGENCY 40 CFR Part 180 [EPA-HQ-OPP-2016-0578; FRL-9970-96] Calcium Salts of Phosphorous Acid; 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 the calcium salts of phosphorous acid. Verdesian Life Sciences, LLC., submitted a petition to EPA under the Federal Food, Drug, and Cosmetic Act (FFDCA). This regulation eliminates the need to establish a maximum permissible level for residues of calcium salts of phosphorous acid under FFDCA when used in accordance with the terms of the exemption. DATES: This regulation is effective January 26, 2018. Objections and requests for hearings must be received on or before March 27, 2018, and must be filed in accordance with the instructions provided in 40 CFR part 178 (see also Unit I.C. of the SUPPLEMENTARY INFORMATION). ADDRESSES: The docket for this action, identified by docket identification (ID) number EPA-HQ-OPP-2016-0578, 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-2016-0578 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 March 27, 2018. Addresses for mail and hand delivery of objections and hearing requests are provided in 40 CFR 178.25(b). In addition to filing an objection or hearing request with the Hearing Clerk as described in 40 CFR part 178, please submit a copy of the filing (excluding any Confidential Business Information (CBI)) for inclusion in the public docket. Information not marked confidential pursuant to 40 CFR part 2 may be disclosed publicly by EPA without prior notice. Submit the non-CBI copy of your objection or hearing request, identified by docket ID number EPA-HQ-OPP-2016-0578, by one of the following methods: Federal eRulemaking Portal: http://www.regulations.gov. Follow the online [[Page 3604]] 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 20, 2016 (81 FR 92758) (FRL- 9956-04), 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 6F8481) by Verdesian Life Sciences, LLC., 1001 Winstead Dr., Suite 480, Cary, NC 27513. The petition requested that 40 CFR 180.1210 be amended to include residues of the systemic fungicide/ systemic acquired resistance (SAR) inducer calcium salts of phosphorous acid in or on all food commodities when used as an agricultural fungicide and in or on potatoes when applied as a post-harvest treatment at 35,600 ppm or less phosphorous acid. That document referenced a summary of the petition prepared by the petitioner Verdesian Life Sciences, LLC, which is available in the docket via http://www.regulations.gov. There were no comments received in response to the notice of filing. The exemption being established in this action varies slightly from what the petitioner requested, for the reasons described in Unit III.C. below. 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 for 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.'' FFDCA section 408(b)(2)(C) provides that EPA shall apply an additional tenfold (10X) margin of safety for infants and children in the case of threshold effects to account for prenatal and postnatal toxicity and the completeness of the database on toxicity and exposure unless EPA determines based on reliable data that a different margin of safety will be safe for infants and children. This additional margin of safety is commonly referred to as the FQPA Safety Factor (SF). In applying this provision, EPA either retains the default value of 10X, or uses a different additional safety factor when reliable data available to EPA support the choice of a different factor. EPA evaluated the available toxicity and exposure data on calcium salts of phosphorous acid and considered their validity, completeness, and reliability, as well as the relationship of this information to human risk. Because of the structural and functional similarity of calcium salts of phosphorous acid with potassium salts of phosphorous acid, Fosetyl-Al, and phosphonic acid, EPA was able to rely on toxicity data for those compounds to assess the toxicity potential of calcium salts of phosphorous acid. The resulting assessment indicates that calcium salts of phosphorous acid would not be considered acutely toxic nor present other concerns for subchronic or chronic toxicity, developmental toxicity, or mutagenicity. As such the Agency has not identified any endpoints of concern for calcium salts and has conducted a qualitative assessment of exposure. The Agency has determined that there is a potential for dietary exposure to residues of calcium salts of phosphorous acid in or on food from use as a pesticidal substance; exposures in drinking water are not expected due to the dissolution of calcium salts of phosphorous acid in water, and non-occupational exposures are not expected since calcium salts of phosphorous acid are not intended for residential use. A full explanation of the data upon which EPA relied and its risk assessment based on those data can be found within the November 8, 2017, document entitled ``Federal Food, Drug, and Cosmetic Act (FFDCA) Considerations for Calcium Salts of Phosphorous Acid.'' This document, as well as other relevant information, is available in the docket for this action as described under ADDRESSES. Based upon its evaluation, EPA concludes that calcium salts of phosphorous acid are not toxic. Although there may be some exposure to residues in or on food when calcium salts of phosphorous acid are used as an agricultural fungicide or a systemic acquired resistance inducer, there is a lack of concern due to the lack of potential for adverse effects. EPA also determined that retention of the Food Quality Protection Act (FQPA) safety factor was not necessary due to the lack of threshold effects. Therefore, 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 calcium salts of phosphorous acid. Therefore, EPA is establishing an exemption from the requirement of a tolerance for residues of calcium salts of phosphorous acid. B. Analytical Enforcement Methodology An analytical method is not required for enforcement purposes due to the lack of concern about safety for calcium salts of phosphorous acid at any exposure level. C. Revisions to Petitioned-for Tolerances EPA is establishing an exemption that varies slightly from what the petitioner requested. Because the petitioner requested the systemic acquired resistance inducer use specifically for calcium salts, which has not been assessed for the other salts of phosphorous acid, EPA is promulgating this exemption as a separate paragraph in the section for exemptions for residues of phosphorous acid and its salts. Moreover, the Agency is not including any specific reference for the post-harvest use on potatoes as requested for two reasons. First, unless otherwise specified, tolerances cover both pre-harvest and post-harvest applications. Second, because the original numerical limitation is written in terms of an amount of phosphorous [[Page 3605]] acid that may be used, this limitation has no effect for an exemption based only on the related calcium salts of phosphorous acid, which have been considered as a distinct fungicide, although it is related to all the other salts of phosphorous acid. In any case, residues of calcium salts of phosphorous acid are considered to be covered for all post- harvest uses without numerical limitation, including those on potatoes. 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 (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 exemption 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 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: January 5, 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. Revise Sec. 180.1210 to read as follows: Sec. 180.1210 Phosphorous acid; exemption from the requirement of a tolerance. (a) An exemption from the requirement of a tolerance is established for residues of phosphorous acid and its ammonium, sodium and potassium salts in or on all food commodities when used as an agricultural fungicide and in or on potatoes when applied as a post-harvest treatment at 35,600 ppm or less phosphorous acid. (b) An exemption from the requirement of a tolerance is established for residues of calcium salts of phosphorous acid, including its metabolites and degradates, in or on all food commodities when used as a fungicide or as a systemic acquired resistance (SAR) inducer. [FR Doc. 2018-01494 Filed 1-25-18; 8:45 am] BILLING CODE 6560-50-P
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‘‘Federalism’’ (64 FR 43255, August 10, ENVIRONMENTAL PROTECTION I. General Information
1999), and Executive Order 13175, AGENCY A. Does this action apply to me?
entitled ‘‘Consultation and Coordination
with Indian Tribal Governments’’ (65 FR 40 CFR Part 180 You may be potentially affected by
67249, November 9, 2000), do not apply this action if you are an agricultural
to this action. In addition, this action [EPA–HQ–OPP–2016–0578; FRL–9970–96] producer, food manufacturer, or
does not impose any enforceable duty or pesticide manufacturer. The following
contain any unfunded mandate as Calcium Salts of Phosphorous Acid; list of North American Industrial
described under Title II of the Unfunded Exemption From the Requirement of a Classification System (NAICS) codes is
Mandates Reform Act (UMRA) (2 U.S.C. Tolerance not intended to be exhaustive, but rather
1501 et seq.). provides a guide to help readers
AGENCY: Environmental Protection determine whether this document
This action does not involve any
Agency (EPA). applies to them. Potentially affected
technical standards that would require
entities may include:
EPA’s consideration of voluntary ACTION: Final rule. • Crop production (NAICS code 111).
consensus standards pursuant to section • Animal production (NAICS code
12(d) of the National Technology SUMMARY: This regulation establishes an 112).
Transfer and Advancement Act exemption from the requirement of a • Food manufacturing (NAICS code
(NTTAA) (15 U.S.C. 272 note). tolerance for the calcium salts of 311).
V. Congressional Review Act phosphorous acid. Verdesian Life • Pesticide manufacturing (NAICS
Sciences, LLC., submitted a petition to code 32532).
Pursuant to the Congressional Review EPA under the Federal Food, Drug, and B. How can I get electronic access to
Act (5 U.S.C. 801 et seq.), EPA will Cosmetic Act (FFDCA). This regulation other related information?
submit a report containing this rule and eliminates the need to establish a
other required information to the U.S. maximum permissible level for residues You may access a frequently updated
Senate, the U.S. House of of calcium salts of phosphorous acid electronic version of 40 CFR part 180
Representatives, and the Comptroller under FFDCA when used in accordance through the Government Printing
General of the United States prior to with the terms of the exemption. Office’s e-CFR site at http://
publication of the rule in the Federal www.ecfr.gov/cgi-bin/text-idx?&c=
Register. This action is not a ‘‘major DATES: This regulation is effective ecfr&tpl=/ecfrbrowse/Title40/40tab_
rule’’ as defined by 5 U.S.C. 804(2). January 26, 2018. Objections and 02.tpl.
requests for hearings must be received
List of Subjects in 40 CFR Part 174 on or before March 27, 2018, and must C. How can I file an objection or hearing
be filed in accordance with the request?
Environmental protection,
instructions provided in 40 CFR part Under FFDCA section 408(g), 21
Administrative practice and procedure,
178 (see also Unit I.C. of the U.S.C. 346a(g), any person may file an
Agricultural commodities, Pesticides
SUPPLEMENTARY INFORMATION). objection to any aspect of this regulation
and pests, Reporting and recordkeeping
and may also request a hearing on those
requirements. ADDRESSES: The docket for this action, objections. You must file your objection
Dated: December 28, 2017. identified by docket identification (ID) or request a hearing on this regulation
Hayley Hughes, number EPA–HQ–OPP–2016–0578, is in accordance with the instructions
Director, Office of Pesticide Programs.
available at http://www.regulations.gov provided in 40 CFR part 178. To ensure
or at the Office of Pesticide Programs proper receipt by EPA, you must
Therefore, 40 CFR chapter I is Regulatory Public Docket (OPP Docket) identify docket ID number EPA–HQ–
amended as follows: in the Environmental Protection Agency OPP–2016–0578 in the subject line on
Docket Center (EPA/DC), West William the first page of your submission. All
PART 174—[AMENDED] Jefferson Clinton Bldg., Rm. 3334, 1301 objections and requests for a hearing
Constitution Ave. NW, Washington, DC must be in writing, and must be
■ 1. The authority citation for part 174 20460–0001. The Public Reading Room received by the Hearing Clerk on or
continues to read as follows: is open from 8:30 a.m. to 4:30 p.m., before March 27, 2018. Addresses for
Authority: 7 U.S.C. 136–136y; 21 U.S.C. Monday through Friday, excluding legal mail and hand delivery of objections
321(q), 346a and 371. holidays. The telephone number for the and hearing requests are provided in 40
Public Reading Room is (202) 566–1744, CFR 178.25(b).
■ 2. Add § 174.539 to subpart W to read and the telephone number for the OPP In addition to filing an objection or
as follows: Docket is (703) 305–5805. Please review hearing request with the Hearing Clerk
the visitor instructions and additional as described in 40 CFR part 178, please
§ 174.539 Cry51Aa2.834_16 protein;
exemption from the requirement of a information about the docket available submit a copy of the filing (excluding
tolerance. at http://www.epa.gov/dockets. any Confidential Business Information
FOR FURTHER INFORMATION CONTACT:
(CBI)) for inclusion in the public docket.
Residues of the Cry51Aa2.834_16 Information not marked confidential
protein, which is a modified protein Robert McNally, Biopesticides and
Pollution Prevention Division (7511P), pursuant to 40 CFR part 2 may be
derived from the Cry51Aa2 protein of disclosed publicly by EPA without prior
Bacillus thuringiensis, in or on cotton Office of Pesticide Programs,
daltland on DSKBBV9HB2PROD with RULES
Environmental Protection Agency, 1200 notice. Submit the non-CBI copy of your
are exempt from the requirement of a objection or hearing request, identified
tolerance, when the Cry51Aa2.834_16 Pennsylvania Ave. NW, Washington, DC
20460–0001; main telephone number: by docket ID number EPA–HQ–OPP–
protein is used as a plant-incorporated 2016–0578, by one of the following
protectant. (703) 305–7090; email address:
BPPDFRNotices@epa.gov. methods:
[FR Doc. 2018–01519 Filed 1–25–18; 8:45 am] • Federal eRulemaking Portal: http://
BILLING CODE 6560–50–P SUPPLEMENTARY INFORMATION: www.regulations.gov. Follow the online
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![3604 Federal Register / Vol. 83, No. 18 / Friday, January 26, 2018 / Rules and Regulations
instructions for submitting comments. residential settings but does not include in drinking water are not expected due
Do not submit electronically any occupational exposure. Pursuant to to the dissolution of calcium salts of
information you consider to be CBI or FFDCA section 408(c)(2)(B), in phosphorous acid in water, and non-
other information whose disclosure is establishing or maintaining in effect an occupational exposures are not expected
restricted by statute. exemption from the requirement of a since calcium salts of phosphorous acid
• Mail: OPP Docket, Environmental tolerance, EPA must take into account are not intended for residential use. A
Protection Agency Docket Center (EPA/ the factors set forth in FFDCA section full explanation of the data upon which
DC), (28221T), 1200 Pennsylvania Ave. 408(b)(2)(C), which require EPA to give EPA relied and its risk assessment based
NW, Washington, DC 20460–0001. special consideration to exposure of on those data can be found within the
• Hand Delivery: To make special infants and children to the pesticide November 8, 2017, document entitled
arrangements for hand delivery or chemical residue in establishing a ‘‘Federal Food, Drug, and Cosmetic Act
delivery of boxed information, please tolerance or tolerance exemption and to (FFDCA) Considerations for Calcium
follow the instructions at http:// ‘‘ensure that there is a reasonable Salts of Phosphorous Acid.’’ This
www.epa.gov/dockets/contacts.html. certainty that no harm will result to document, as well as other relevant
Additional instructions on commenting infants and children from aggregate information, is available in the docket
or visiting the docket, along with more exposure to the pesticide chemical for this action as described under
information about dockets generally, is residue . . . .’’ Additionally, FFDCA ADDRESSES.
available at http://www.epa.gov/ section 408(b)(2)(D) requires that EPA Based upon its evaluation, EPA
dockets. consider ‘‘available information concludes that calcium salts of
concerning the cumulative effects of [a phosphorous acid are not toxic.
II. Background particular pesticide’s] . . . residues and Although there may be some exposure
In the Federal Register of December other substances that have a common to residues in or on food when calcium
20, 2016 (81 FR 92758) (FRL–9956–04), mechanism of toxicity.’’ FFDCA section salts of phosphorous acid are used as an
EPA issued a document pursuant to 408(b)(2)(C) provides that EPA shall agricultural fungicide or a systemic
FFDCA section 408(d)(3), 21 U.S.C. apply an additional tenfold (10X) acquired resistance inducer, there is a
346a(d)(3), announcing the filing of a margin of safety for infants and children lack of concern due to the lack of
pesticide tolerance petition (PP 6F8481) in the case of threshold effects to potential for adverse effects. EPA also
by Verdesian Life Sciences, LLC., 1001 account for prenatal and postnatal determined that retention of the Food
Winstead Dr., Suite 480, Cary, NC toxicity and the completeness of the Quality Protection Act (FQPA) safety
27513. The petition requested that 40 database on toxicity and exposure factor was not necessary due to the lack
CFR 180.1210 be amended to include unless EPA determines based on reliable of threshold effects.
residues of the systemic fungicide/ data that a different margin of safety Therefore, EPA concludes that there is
systemic acquired resistance (SAR) will be safe for infants and children. a reasonable certainty that no harm will
inducer calcium salts of phosphorous This additional margin of safety is result to the U.S. population, including
acid in or on all food commodities when commonly referred to as the FQPA infants and children, from aggregate
used as an agricultural fungicide and in Safety Factor (SF). In applying this exposure to residues of calcium salts of
or on potatoes when applied as a post- provision, EPA either retains the default phosphorous acid. Therefore, EPA is
harvest treatment at 35,600 ppm or less value of 10X, or uses a different establishing an exemption from the
phosphorous acid. That document additional safety factor when reliable requirement of a tolerance for residues
referenced a summary of the petition data available to EPA support the choice of calcium salts of phosphorous acid.
prepared by the petitioner Verdesian of a different factor.
EPA evaluated the available toxicity B. Analytical Enforcement Methodology
Life Sciences, LLC, which is available in
the docket via http:// and exposure data on calcium salts of An analytical method is not required
www.regulations.gov. There were no phosphorous acid and considered their for enforcement purposes due to the
comments received in response to the validity, completeness, and reliability, lack of concern about safety for calcium
notice of filing. as well as the relationship of this salts of phosphorous acid at any
The exemption being established in information to human risk. exposure level.
this action varies slightly from what the Because of the structural and
C. Revisions to Petitioned-for Tolerances
petitioner requested, for the reasons functional similarity of calcium salts of
phosphorous acid with potassium salts EPA is establishing an exemption that
described in Unit III.C. below. varies slightly from what the petitioner
of phosphorous acid, Fosetyl-Al, and
III. Final Rule phosphonic acid, EPA was able to rely requested. Because the petitioner
on toxicity data for those compounds to requested the systemic acquired
A. EPA’s Safety Determination resistance inducer use specifically for
assess the toxicity potential of calcium
Section 408(c)(2)(A)(i) of FFDCA salts of phosphorous acid. The resulting calcium salts, which has not been
allows EPA to establish an exemption assessment indicates that calcium salts assessed for the other salts of
from the requirement for a tolerance (the of phosphorous acid would not be phosphorous acid, EPA is promulgating
legal limit for a pesticide chemical considered acutely toxic nor present this exemption as a separate paragraph
residue in or on a food) only if EPA other concerns for subchronic or in the section for exemptions for
determines that the exemption is ‘‘safe.’’ chronic toxicity, developmental residues of phosphorous acid and its
Section 408(c)(2)(A)(ii) of FFDCA toxicity, or mutagenicity. As such the salts. Moreover, the Agency is not
defines ‘‘safe’’ to mean that ‘‘there is a Agency has not identified any endpoints including any specific reference for the
reasonable certainty that no harm will post-harvest use on potatoes as
daltland on DSKBBV9HB2PROD with RULES
of concern for calcium salts and has
result from aggregate exposure to the conducted a qualitative assessment of requested for two reasons. First, unless
pesticide chemical residue, including exposure. The Agency has determined otherwise specified, tolerances cover
all anticipated dietary exposures and all that there is a potential for dietary both pre-harvest and post-harvest
other exposures for which there is exposure to residues of calcium salts of applications. Second, because the
reliable information.’’ This includes phosphorous acid in or on food from original numerical limitation is written
exposure through drinking water and in use as a pesticidal substance; exposures in terms of an amount of phosphorous
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acid that may be used, this limitation relationship between the national harvest treatment at 35,600 ppm or less
has no effect for an exemption based government and the States or tribal phosphorous acid.
only on the related calcium salts of governments, or on the distribution of (b) An exemption from the
phosphorous acid, which have been power and responsibilities among the requirement of a tolerance is established
considered as a distinct fungicide, various levels of government or between for residues of calcium salts of
although it is related to all the other the Federal Government and Indian phosphorous acid, including its
salts of phosphorous acid. In any case, tribes. Thus, EPA has determined that metabolites and degradates, in or on all
residues of calcium salts of Executive Order 13132, entitled food commodities when used as a
phosphorous acid are considered to be ‘‘Federalism’’ (64 FR 43255, August 10, fungicide or as a systemic acquired
covered for all post-harvest uses without 1999), and Executive Order 13175, resistance (SAR) inducer.
numerical limitation, including those on entitled ‘‘Consultation and Coordination [FR Doc. 2018–01494 Filed 1–25–18; 8:45 am]
potatoes. with Indian Tribal Governments’’ (65 FR BILLING CODE 6560–50–P
IV. Statutory and Executive Order 67249, November 9, 2000), do not apply
Reviews to this action. In addition, this action
does not impose any enforceable duty or ENVIRONMENTAL PROTECTION
This action establishes a tolerance contain any unfunded mandate as AGENCY
exemption under FFDCA section 408(d) described under Title II of the Unfunded
in response to a petition submitted to Mandates Reform Act (UMRA) (2 U.S.C. 40 CFR Part 180
EPA. The Office of Management and 1501 et seq.).
Budget (OMB) has exempted these types [EPA–HQ–OPP–2016–0333; FRL–9970–88]
This action does not involve any
of actions from review under Executive technical standards that would require Chlorfenapyr; Pesticide Tolerances
Order 12866, entitled ‘‘Regulatory EPA’s consideration of voluntary
Planning and Review’’ (58 FR 51735, consensus standards pursuant to section AGENCY: Environmental Protection
October 4, 1993). Because this action 12(d) of the National Technology Agency (EPA).
has been exempted from review under Transfer and Advancement Act ACTION: Final rule.
Executive Order 12866, this action is (NTTAA) (15 U.S.C. 272 note).
not subject to Executive Order 13211, SUMMARY: This regulation establishes
entitled ‘‘Actions Concerning V. Congressional Review Act tolerances for residues of chlorfenapyr,
Regulations That Significantly Affect Pursuant to the Congressional Review 4-bromo-2-(4-chlorophenyl)-1-
Energy Supply, Distribution, or Use’’ (66 Act (5 U.S.C. 801 et seq.), EPA will (ethoxymethyl)-5-(trifluromethyl)-1H-
FR 28355, May 22, 2001) or Executive submit a report containing this rule and pyrrole-3-carbonitrile, in or on tea,
Order 13045, entitled ‘‘Protection of other required information to the U.S. dried. BASF Corporation requested
Children from Environmental Health Senate, the U.S. House of these tolerances under the Federal Food,
Risks and Safety Risks’’ (62 FR 19885, Representatives, and the Comptroller Drug, and Cosmetic Act (FFDCA).
April 23, 1997); nor is it considered a General of the United States prior to DATES: This regulation is effective
regulatory action under Executive Order publication of the rule in the Federal January 26, 2018. Objections and
13771, entitled ‘‘Reducing Regulations Register. This action is not a ‘‘major requests for hearings must be received
and Controlling Regulatory Costs’’ (82 rule’’ as defined by 5 U.S.C. 804(2). on or before March 27, 2018, and must
FR 9339, February 3, 2017). This action be filed in accordance with the
does not contain any information List of Subjects in 40 CFR Part 180
instructions provided in 40 CFR part
collections subject to OMB approval Environmental protection, 178 (see also Unit I.C. of the
under the Paperwork Reduction Act Administrative practice and procedure, SUPPLEMENTARY INFORMATION).
(PRA), 44 U.S.C. 3501 et seq., nor does Agricultural commodities, Pesticides ADDRESSES: The docket for this action,
it require any special considerations and pests, Reporting and recordkeeping
under Executive Order 12898, entitled identified by docket identification (ID)
requirements. number EPA–HQ–OPP–2016–0333, is
‘‘Federal Actions to Address
Dated: January 5, 2018. available at http://www.regulations.gov
Environmental Justice in Minority
Populations and Low-Income Richard P. Keigwin, Jr., or at the Office of Pesticide Programs
Populations’’ (59 FR 7629, February 16, Director, Office of Pesticide Programs. Regulatory Public Docket (OPP Docket)
1994). Therefore, 40 CFR chapter I is in the Environmental Protection Agency
Since tolerances and exemptions that amended as follows: Docket Center (EPA/DC), West William
are established on the basis of a petition Jefferson Clinton Bldg., Rm. 3334, 1301
under FFDCA section 408(d), such as PART 180—[AMENDED] Constitution Ave. NW, Washington, DC
the tolerance exemption in this action, 20460–0001. The Public Reading Room
do not require the issuance of a ■ 1. The authority citation for part 180 is open from 8:30 a.m. to 4:30 p.m.,
proposed rule, the requirements of the continues to read as follows: Monday through Friday, excluding legal
Regulatory Flexibility Act (RFA) (5 Authority: 21 U.S.C. 321(q), 346a and 371. holidays. The telephone number for the
U.S.C. 601 et seq.) do not apply. Public Reading Room is (202) 566–1744,
■ 2. Revise § 180.1210 to read as and the telephone number for the OPP
This action directly regulates growers, follows:
food processors, food handlers, and food Docket is (703) 305–5805. Please review
retailers, not States or tribes. As a result, § 180.1210 Phosphorous acid; exemption the visitor instructions and additional
this action does not alter the from the requirement of a tolerance. information about the docket available
relationships or distribution of power (a) An exemption from the at http://www.epa.gov/dockets.
daltland on DSKBBV9HB2PROD with RULES
and responsibilities established by requirement of a tolerance is established FOR FURTHER INFORMATION CONTACT:
Congress in the preemption provisions for residues of phosphorous acid and its Michael L. Goodis, P.E., Director,
of FFDCA section 408(n)(4). As such, ammonium, sodium and potassium salts Registration Division (750P), Office of
EPA has determined that this action will in or on all food commodities when Pesticide Programs, Environmental
not have a substantial direct effect on used as an agricultural fungicide and in Protection Agency, 1200 Pennsylvania
States or tribal governments, on the or on potatoes when applied as a post- Ave. NW, Washington, DC 20460–0001;
VerDate Sep<11>2014 17:29 Jan 25, 2018 Jkt 244001 PO 00000 Frm 00043 Fmt 4700 Sfmt 4700 E:\FR\FM\26JAR1.SGM 26JAR1](https://thefederalregister.org/doc/83_FR_3621/page/3.svg)
Document Created: 2018-10-26 10:05:43
Document Modified: 2018-10-26 10:05:43
| 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 January 26, 2018. Objections and requests for hearings must be received on or before March 27, 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 3603 | |
| CFR Associated | Environmental Protection; Administrative Practice and Procedure; Agricultural Commodities; Pesticides and Pests and Reporting and Recordkeeping Requirements |
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