Document ID: EPA-HQ-OPP-2020-0146-0004
Agency: epa
Document Type: Rule
Title: Amendment to the Exemption From the Requirement of a Tolerance: Complex Polymeric Polyhydroxy Acids
Posted Date: 2021-02-19T05:00Z

[Federal Register Volume 86, Number 32 (Friday, February 19, 2021)]
[Rules and Regulations]
[Pages 10178-10180]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2021-03362]

[[Page 10178]]

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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[EPA-HQ-OPP-2020-0146; FRL-10018-54]

Complex Polymeric Polyhydroxy Acids (CPPA); Amendment to the 
Exemption From the Requirement of a Tolerance

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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SUMMARY: This regulation amends the existing tolerance exemption for 
residues of Complex Polymeric Polyhydroxy Acids (CPPA) in or on all 
food commodities as a plant growth regulator to add use as a nematicide 
in pesticide formulations. FBSciences, Inc. submitted a petition to EPA 
under the Federal Food, Drug, and Cosmetic Act (FFDCA) requesting this 
amendment. This regulation adds use as a nematicide to the existing 
tolerance exemption of CPPA under FFDCA.

DATES: This regulation is effective February 19, 2021. Objections and 
requests for hearings must be received on or before April 20, 2021, 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-2020-0146, 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.
    Due to the public health concerns related to COVID-19, the EPA 
Docket Center (EPA/DC) and Reading Room is closed to visitors with 
limited exceptions. The staff continues to provide remote customer 
service via email, phone, and webform. For the latest status 
information on EPA/DC services and docket access, visit https://www.epa.gov/dockets.

FOR FURTHER INFORMATION CONTACT: Charles Smith, 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 Publishing Office's e-CFR site at 
http://www.ecfr.gov/cgi-bin/text-idx?&c=ecfr&tpl=/ecfrbrowse/Title40/40tab_02.tpl.

C. How can I file an objection or hearing request?

    Under FFDCA section 408(g), 21 U.S.C. 346a(g), any person may file 
an objection to any aspect of this regulation and may also request a 
hearing on those objections. You must file your objection or request a 
hearing on this regulation in accordance with the instructions provided 
in 40 CFR part 178. To ensure proper receipt by EPA, you must identify 
docket ID number EPA-HQ-OPP-2020-0146 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 
April 20, 2021. 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-2020-0146, 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 May 05, 2020 (85 FR 26684) (FRL-10008-
46), 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 0F8822) by FBSciences, Inc., 153 N. Main Street, Ste. 100, 
Collierville, TN 38017-2691. The petition requested that 40 CFR 
180.1321 be amended by the addition of use as a nematicide to the 
already established exemption from the requirement of a tolerance for 
residues of Complex Polymeric Polyhydroxy Acids (CPPA). That document 
referenced a summary of the petition prepared by the petitioner 
FBSciences, Inc., which is available in the docket for this action at 
http://www.regulations.gov. Although comments were received on the 
notice of filing, none were relevant to this tolerance rulemaking.
    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 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 
making a determination to establish or maintain in effect an exemption 
from the

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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 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 the Agency 
consider ``available information concerning the cumulative effects of 
such residues and other substances that have a common mechanism of 
toxicity. . . .''
    EPA performs a number of analyses to determine the risks from 
aggregate exposure to pesticide residues. First, EPA determines the 
toxicity of pesticides. Second, EPA examines exposure to the pesticide 
through food, drinking water, and through other exposures that occur as 
a result of pesticide use in residential settings.

II. Toxicological Profile

    Consistent with FFDCA section 408(b)(2)(D), EPA has reviewed the 
available scientific data and other relevant information in support of 
this action and considered its risk. EPA has also considered available 
information concerning the variability of the sensitivities of major 
identifiable subgroups of consumers, including infants and children.

A. Overview of Complex Polymeric Polyhydroxy Acids

    Complex Polymeric Polyhydroxy Acids (CPPA) is a complex mixture of 
naturally occurring organic substances found in dead plant materials. 
The components of CPPA are widespread in nature, being found in soils 
and fresh and saltwater environments as a result of decaying plant 
materials and are used to condition agricultural soils. Its major 
components are humic acid, fulvic acid, and tannins, and their relative 
concentrations in soil and water systems are influenced by 
environmental conditions, such as climate, soil types, vegetation, and 
hydrology. CPPA is made by concentrating the organic substances from 
water leached through forest soil using a proprietary manufacturing 
process.

B. Biochemical Pesticide Toxicology Data Requirements

    All applicable mammalian toxicology data requirements supporting 
the existing tolerance exemption for residues of CPPA in or on all food 
commodities as a plant growth regulator have been fulfilled. The 
mammalian toxicology data requirements supporting the addition of 
nematicide use to the existing tolerance exemption have also been 
fulfilled as EPA has relied upon the same mammalian toxicology data 
that supported the existing tolerance exemption for CPPA. No acute, 
subchronic, or chronic toxicity endpoints were identified in guideline 
studies or in data obtained from open technical literature. Moreover, 
CPPA is not a mutagen, and is not a developmental toxicant. There are 
no known effects on endocrine systems via oral, dermal, or inhalation 
exposure. A more in-depth synopsis of the data upon which EPA relied 
and its human health risk assessment based on that data can be found in 
the document ``Biopesticides Registration Action Document, Complex 
Polymeric Polyhydroxy Acids (CPPA),'' which is available in Docket 
Number EPA-HQ-OPP-2009-0917-0011, as well as the docket for this 
action, via www.regulations.gov as described under ADDRESSES.

IV. Aggregate Exposures

    In examining aggregate exposure, FFDCA section 408 directs EPA to 
consider available information concerning exposures from the pesticide 
residue in food and all other non-occupational exposures, including 
drinking water from ground water or surface water and exposure through 
pesticide use in gardens, lawns, or buildings (residential and other 
indoor uses).

A. Dietary Exposure

    The proposed use pattern may result in dietary exposure with 
possible residues in or on agricultural commodities. No significant 
exposure via drinking water is expected beyond what is already present, 
when CPPA is used according to the product label directions, because 
the active ingredient biodegrades rapidly (half-life = 25.7 days) in 
the environment, is applied at low application rates, and is not 
directly applied to water. Should exposure occur, however, minimal to 
no risk is expected for the general population, including infants and 
children, due to low toxicity of CPPA and its components as 
demonstrated in the data submitted and evaluated by the Agency. In 
addition, the lack of reported incidents in spite of the exposure from 
use in commercial agriculture for years to condition soils and its 
abundance in nature support a conclusion that minimal to no risk is 
expected.

B. Other Non-Occupational Exposure

    Non-occupational exposure is not expected because CPPA will be 
applied as a plant growth regulator and nematicide for agricultural 
purposes only and there are no residential uses.

V. Cumulative Effects From Substances With a Common Mechanism of 
Toxicity

    Section 408(b)(2)(D)(v) of FFDCA requires that, in establishing a 
tolerance or tolerance exemption for a pesticide chemical residue, the 
Agency consider ``available information concerning the cumulative 
effects of such residues and other substances that have a common 
mechanism of toxicity. . . .'' EPA has determined CPPA to have a non-
toxic mode of action; therefore, 408(b)(2)(D)(v) does not apply.

VI. Determination of Safety for U.S. Population, Infants and Children

    FFDCA section 408(b)(2)(C) provides that, in establishing a 
tolerance or tolerance exemption for a pesticide chemical residue, EPA 
shall assess the available information about consumption patterns among 
infants and children, special susceptibility of infants and children to 
pesticide chemical residues, and the cumulative effects on infants and 
children of the residues and other substances with a common mechanism 
of toxicity. In addition, 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 that a different margin of safety 
will be safe for infants and children. This additional margin of safety 
is commonly referred to as the Food Quality Protection Act Safety 
Factor. In applying this provision, EPA either retains the default 
value of 10X, or uses a different additional safety factor when 
reliable data are available to support the choice of a different safety 
factor. As part of its qualitative assessment, EPA evaluated the 
available toxicity and exposure data on CPPA and considered its 
validity, completeness, and reliability, as well as the relationship of 
this information to human risk. EPA considers the toxicity database to 
be complete and has identified no residual uncertainty with regard to 
prenatal and postnatal toxicity or exposure. No hazard was identified 
based on the available studies. Based upon its evaluation, EPA 
concludes that there are no threshold effects of concern to infants, 
children, or adults when CPPA

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is applied as a plant growth regulator or nematicide and used in 
accordance with label directions and good agricultural practices. As a 
result, EPA concludes that no additional margin of exposure (safety) is 
necessary.

VII. Other Considerations

A. Analytical Enforcement Methodology

    An analytical method is not required for Complex Polymeric 
Polyhydroxy Acids (CPPA) because EPA is amending an exemption from the 
requirement of a tolerance without any numerical limitation.

B. International Residue Limits

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

VIII. Conclusion

    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 CPPA. Therefore, EPA is 
establishing an exemption from the requirement of a tolerance for 
residues of CPPA in or on all food commodities when applied as a 
nematicide and used in accordance with good agricultural practices.

IX. Statutory and Executive Order Reviews

    This action establishes a tolerance exemption under FFDCA section 
408(d) in response to a petition submitted to the Agency. 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 final rule, 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, nor does this 
action alter the relationships or distribution of power and 
responsibilities established by Congress in the preemption provisions 
of FFDCA section 408(n)(4). As such, the Agency 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, the Agency 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 Agency 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).

X. 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: February 16, 2021.
Charles Smith,
Acting Director, Biopesticides and Pollution Prevention Division, 
Office of Pesticide Programs.

    Therefore, 40 CFR chapter I is amended as follows:

PART 180--TOLERANCES AND EXEMPTIONS FOR PESTICIDE CHEMICAL RESIDUES 
IN FOOD

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.  180.1321 to read as follows:

Sec.  180.1321  Complex Polymeric Polyhydroxy Acids; exemption from the 
requirement of a tolerance.

    (a) An exemption from the requirement of a tolerance is established 
for the residues of complex polymeric polyhydroxy acids in or on all 
food commodities when applied as a plant growth regulator and used in 
accordance with good agricultural practices.
    (b) An exemption from the requirement of a tolerance is established 
for the residues of complex polymeric polyhydroxy acids in or on all 
food commodities when applied as a nematicide and used in accordance 
with good agricultural practices.

[FR Doc. 2021-03362 Filed 2-18-21; 8:45 am]
BILLING CODE 6560-50-P