[Federal Register Volume 87, Number 92 (Thursday, May 12, 2022)]
[Rules and Regulations]
[Pages 29050-29053]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2022-10162]


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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[EPA-HQ-OPP-2021-0632; FRL-9800-01-OCSPP]


Complex Polymeric Polyhydroxy Acid (CPPA); Exemption From the 
Requirement of a Tolerance

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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SUMMARY: This regulation amends an exemption from the requirement of a 
tolerance for residues of complex polymeric polyhydroxy acid (CPPA) by 
establishing use in or on all food commodities when used, in accordance 
with label directions and good agricultural practices. This regulation 
eliminates the need to establish a maximum permissible level for 
residues of CPPA.

DATES: This regulation is effective May 12, 2022. Objections and 
requests for hearings must be received on or before July 11, 2022 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-2021-0632, is available at 
https://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 and OPP Docket is (202) 566-1744. Due to the public health 
concerns related to COVID-19, the EPA Docket Center (EPA/DC) and 
Reading Room is open to visitors by appointment only. For the latest 
status information on EPA/DC services and 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: 
[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 Office of the Federal Register's e-CFR site at 
https://www.ecfr.gov/current/title-40.

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-2021-0632 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 
July 11, 2022. 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-2021-0632, by one of 
the following methods:
     Federal eRulemaking Portal: https://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 https://www.epa.gov/dockets/contacts.html.
    Additional instructions on commenting or visiting the docket, along 
with more information about dockets generally, is available at https://www.epa.gov/dockets.

II. Background and Statutory Findings

    In the Federal Register of November 23, 2021 (86 FR 66512) (FRL-
8792-05-OCSPP), EPA issued a document pursuant to FFDCA section 
408(d)(3), 21 U.S.C. 346a(d)(3), announcing the filing of two pesticide 
tolerance petitions (PP 1F8918 and 1F8928) by FBSciences, Inc., 153 N. 
Main St. Ste 100, Collierville, TN 38017. The petitions requested that 
the existing exemption from the requirement of a tolerance at 40 CFR 
180.1321 for residues of complex polymeric polyhydroxy acids (CPPA) be 
amended by adding uses as a fungicide and insecticide in accordance 
with label directions and good agricultural practices. Those documents 
referenced summaries of the petitions prepared by the petitioner, 
FBSciences, Inc, which are available in the docket, https://www.regulations.gov. There were no comments received in response to the 
notice of filing.

III. Aggregate Risk Assessment and Determination of Safety

    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

[[Page 29051]]

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 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 the Agency 
consider ``available information concerning the cumulative effects of a 
particular pesticide's residues'' and ``other substances that have a 
common mechanism of toxicity.''
    EPA establishes exemptions from the requirement of a tolerance only 
in those cases where it can be clearly demonstrated that the risks from 
aggregate exposure to pesticide chemical residues under reasonably 
foreseeable circumstances will pose no harm to human health. If EPA is 
able to determine that a tolerance is not necessary to ensure that 
there is a reasonable certainty that no harm will result from aggregate 
exposure to the pesticide chemical residue, an exemption from the 
requirement of a tolerance may be established.
    Consistent with FFDCA section 408(c)(2)(A), and the factors 
specified in FFDCA section 408(c)(2)(B), EPA has reviewed the available 
scientific data and other relevant information in support of this 
action. EPA has sufficient data to assess the hazards of and to make a 
determination on aggregate exposure for CPPA including exposure 
resulting from the exemption established by this action. EPA's 
assessment of exposures and risks associated with CPPA follows.

A. Toxicological Profile

    Complex Polymeric Polyhydroxy Acids (CPPA) is derived from 
naturally occurring organic matter (NOM) in soils and ground and 
surface waters. NOM is ubiquitous in soil and water. It is formed as a 
result of the decomposition of plants, animal, and microbial materials 
in soil and water, and is comprised of a variety of humic substances 
such as tannins, humic acids and fulvic acids. CPPA contains a complex 
mixture of these naturally occurring organic substances.
    EPA has previously assessed CPPA toxicity and concluded that, with 
regard to the overall toxicological profile, CPPA is of minimal 
toxicity. Specifically, based on acute studies, CPPA is of low acute 
oral toxicity, acute inhalation toxicity and acute dermal and is non-
irritating to the skin and eye. The chemical is not a skin sensitizer. 
All human health toxicity subchronic data requirements were satisfied 
by a combination of guideline studies and studies obtained from the 
open scientific literature for (90-day oral, developmental toxicity, 
reproductive toxicity and mutagenicity data). (See ``Biopesticides 
Registration Action Document, Complex Polymeric Polyhydroxy Acids 
(CPPA),'' which can be found on https://regulations.gov in Docket 
Number EPA-HQ-OPP-2009-0917; the document identification number is EPA-
HQ-OPP-2009-0917-0011.)
    There were no adverse subchronic effects for any route of exposure. 
The active ingredient was determined to be non-mutagenic, and no 
adverse effects were identified relative to either developmental 
toxicity or reproductive toxicity. Moreover, there are no known effects 
on endocrine systems via oral, dermal, or inhalation exposure. Based on 
this toxicological profile, EPA did not identify any toxicological 
endpoints of concern for CPPA.

B. Toxicological Points of Departure/Levels of Concern

    No toxicological endpoint of concern has been identified for CPPA.

C. Exposure Assessment

    1. Dietary exposure from food, feed uses, and drinking water. As 
part of its previous qualitative risk assessment for CPPA, the Agency 
considered the potential for dietary (food and drinking water) exposure 
to residues of this substance. CPPA is derived from naturally occurring 
organic matter (NOM) in soils and ground and surface waters, which is 
already present as an undesirable component of drinking water due to 
organoleptic effects. No significant exposure via drinking water or 
food beyond what is already present is expected when CPPA is used 
according to the product label directions. The active ingredient has a 
half-life of 25.7 days in the environment, is applied at extremely low 
application rates and is not directly applied to water; therefore, 
residues of CPPA are unlikely to accumulate in drinking water or exceed 
the levels at which NOM is already present. In the unlikely event that 
exposure to the active ingredient via drinking water does occur, the 
health risk(s) would be expected to be minimal based on the lack of 
acute oral toxicity (and overall lack of toxicity for all routes of 
exposure) of CPPA and the fact that CPPA (humic acids, fulvic acids and 
tannins) are substances that are ubiquitous in soil and water.
    2. From non-occupational exposure. Based on the Agency's current 
practices, a quantitative post-application inhalation exposure and risk 
assessment has not been performed for CPPA. Currently, there are no 
proposed residential uses for this active ingredient. However, even if 
non-occupational (residential) exposures were to occur, CPPA is 
presumed to have negligible risk in these scenarios due to low acute 
inhalation toxicity (Toxicity Category IV)) and minimal irritation to 
the eye or skin (Toxicity Category IV). Additionally, no adverse 
effects have been identified in repeat-dose toxicology studies.
    3. Cumulative effects from substances with a common mechanism of 
toxicity. Section 408(b)(2)(D)(v) of FFDCA requires that, when 
considering whether to establish, modify, or revoke a tolerance, the 
Agency consider ``available information'' concerning the cumulative 
effects of a particular pesticide's residues and ``other substances 
that have a common mechanism of toxicity.'' EPA has not found that CPPA 
shares a common mechanism of toxicity with any other substances, and 
they do not appear to produce a toxic metabolite produced by other 
substances. For the purposes of this tolerance action, therefore, EPA 
has assumed CPPA does not have a common mechanism of toxicity with 
other substances. For information regarding EPA's efforts to determine 
which chemicals have a common mechanism of toxicity and to evaluate the 
cumulative effects of such chemicals, see EPA's website at https://www.epa.gov/pesticides/cumulative.

D. Safety Factor for Infants and Children

    FFDCA Section 408(b)(2)(C) provides that EPA shall retain 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

[[Page 29052]]

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. An FQPA safety factor is not 
required at this time for CPPA because EPA has conducted a qualitative 
dietary assessment based on low toxicity and anticipated negligible 
exposure to the active ingredient.

E. Aggregate Risk

    Based on the available data and information, EPA has previously 
concluded that a qualitative aggregate risk assessment is appropriate 
to support the pesticidal uses (plant growth regulator and nematicide) 
of CPPA, and that risks of concern are not anticipated from aggregate 
exposure to the substance. This conclusion is based on the low toxicity 
of the active ingredient and expected degradation of CPPA in the 
environment. For the new uses (as an insecticide and fungicide), EPA 
similarly concludes that the use of CPPA will be safe, i.e., that there 
is a reasonable certainty that no harm will result from aggregate 
exposures to CPPA. In fact, EPA concludes that how CPPA is used as a 
pesticide (i.e., plant growth regulator, fungicide, etc.) is immaterial 
and that any use as a pesticide will be safe due to the lack of 
toxicity of CPPA. This lack of toxicity negates the need to compare 
exposure across use patterns and, therefore, supports all pesticidal 
uses of CPPA.
    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 ``Revised Science Review in Support of Adding a New Use as a 
Fungicide and Insecticide for the End-Use Product (EP) FBS Defense 500 
with 0.9% Complex Polymeric Polyhydroxy Acid (CPPA) as its Active 
Ingredient'' available in the docket for this action as described under 
ADDRESSES.

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

    Based on the Agency's assessment, EPA concludes that there is 
reasonable certainty that no harm will result to the U.S. population, 
including infants and children, from aggregate exposure to residues of 
CPPA.

V. Other Considerations

A. Analytical Enforcement Methodology

    An analytical method is not required for enforcement purposes since 
the Agency is establishing an exemption from the requirement of a 
tolerance without any numerical limitation.

B. Revisions to Petitioned-For Tolerances

    The petitioner requested that the exemption for CPPA be amended by 
adding the additional use patterns for CPPA of ``insecticide'' and 
``fungicide'', so that the exemption would apply to residues resulting 
from those additional uses. EPA has considered the available toxicity 
data and environmental fate information and concludes that the use 
restriction is unnecessary. Due to the lack of toxicity for this 
pesticide, EPA concludes that exposures will be safe regardless of the 
pesticidal use pattern and is modifying the regulatory text to reflect 
any pesticidal use, including, but not limited to, plant growth 
regulatory, nematocide, fungicide, and insecticide.

VI. Conclusions

    Therefore, EPA is amending the currently established exemption for 
residues of complex polymeric polyhydroxy acids (CPPA) when used on all 
food commodities in accordance with label directions and good 
agricultural practices.

VII. Statutory and Executive Order Reviews

    This action amends an exemption from the requirement of a tolerance 
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). 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 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).

VIII. 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: May 3, 2022.
Charles Smith,
Director, Biopesticides and Pollution Prevention Division, Office of 
Pesticide Programs.

    Therefore, for the reasons stated in the preamble, EPA is amending 
40 CFR chapter I as follows:

[[Page 29053]]

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 (CPPA); exemption 
from the requirement of a tolerance.

    An exemption from the requirement of a tolerance is established for 
residues of the pesticide complex polymeric polyhydroxy acids (CPPA) in 
or on all food commodities, when used in accordance with label 
directions and good agricultural practices.

[FR Doc. 2022-10162 Filed 5-11-22; 8:45 am]
BILLING CODE 6560-50-P


