Rule2022-10162
Complex Polymeric Polyhydroxy Acid (CPPA); Exemption From the Requirement of a Tolerance
Primary source
Metadata and text below are from the Federal Register, a public-domain U.S. government work. Always verify the official published version before relying on it for any legal matter.
Published
May 12, 2022
Effective
May 12, 2022
Issuing agencies
Environmental Protection Agency
Abstract
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.
Full Text
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<title>Federal Register, Volume 87 Issue 92 (Thursday, May 12, 2022)</title>
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[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 [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[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
<a href="https://www.regulations.gov">https://www.regulations.gov</a> 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 <a href="https://www.epa.gov/dockets">https://www.epa.gov/dockets</a>.
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:
<a href="/cdn-cgi/l/email-protection#612331312527332f0e1508020412210411004f060e17"><span class="__cf_email__" data-cfemail="256775756163776b4a514c464056654055440b424a53">[email protected]</span></a>.
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:
<bullet> Crop production (NAICS code 111).
<bullet> Animal production (NAICS code 112).
<bullet> Food manufacturing (NAICS code 311).
<bullet> 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
<a href="https://www.ecfr.gov/current/title-40">https://www.ecfr.gov/current/title-40</a>.
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:
<bullet> Federal eRulemaking Portal: <a href="https://www.regulations.gov">https://www.regulations.gov</a>.
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.
<bullet> Mail: OPP Docket, Environmental Protection Agency Docket
Center (EPA/DC), (28221T), 1200 Pennsylvania Ave. NW, Washington, DC
20460-0001.
<bullet> Hand Delivery: To make special arrangements for hand
delivery or delivery of boxed information, please follow the
instructions at <a href="https://www.epa.gov/dockets/contacts.html">https://www.epa.gov/dockets/contacts.html</a>.
Additional instructions on commenting or visiting the docket, along
with more information about dockets generally, is available at <a href="https://www.epa.gov/dockets">https://www.epa.gov/dockets</a>.
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, <a href="https://www.regulations.gov">https://www.regulations.gov</a>. 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 <a href="https://regulations.gov">https://regulations.gov</a> 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 <a href="https://www.epa.gov/pesticides/cumulative">https://www.epa.gov/pesticides/cumulative</a>.
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
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