[Federal Register Volume 83, Number 18 (Friday, January 26, 2018)]
[Rules and Regulations]
[Pages 3603-3605]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2018-01494]


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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.

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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: 
BPPDFRNotices@epa.gov.

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]

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1. The authority citation for part 180 continues to read as follows:

    Authority: 21 U.S.C. 321(q), 346a and 371.


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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