[Federal Register Volume 85, Number 118 (Thursday, June 18, 2020)]
[Rules and Regulations]
[Pages 36752-36755]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2020-12375]


-----------------------------------------------------------------------

ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[EPA-HQ-OPP-2018-0152; FRL-10007-74]


Fulvic 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 residues of fulvic acid when used as an inert 
ingredient (carrier) in pesticide formulations applied to growing crops 
and to raw agricultural commodities after harvest. Nutri Ag Inc. 
submitted a petition to EPA under the Federal Food, Drug, and Cosmetic 
Act (FFDCA), requesting establishment of an exemption from the 
requirement of a tolerance. This regulation eliminates the need to 
establish a maximum permissible level for residues of fulvic acid when 
used in accordance with the terms of the exemption.

DATES: This regulation is effective June 18, 2020. Objections and 
requests for hearings must be received on or before August 17, 2020, 
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-2018-0152, is available at http://www.regulations.gov or by one of the follow 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 Confidential Business 
Information (CBI) or other information whose disclosure is restricted 
by statute.
     Mail: Document Control Office (7505PM), Office of 
Pesticide Programs (OPP), Environmental Protection Agency, 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.

FOR FURTHER INFORMATION CONTACT: Michael Goodis, Registration Division 
(7505P), Office of Pesticide Programs, Environmental Protection Agency, 
1200 Pennsylvania Ave. NW, Washington, DC 20460-0001; main telephone 
number: (703) 305-7090; email address: RDFRNotices@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, 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-2018-0152 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 
August 17, 2020. 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-2018-0152, 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.

[[Page 36753]]

II. Petition for Exemption

    In the Federal Register of May 18, 2018 (83 FR 23247) (FRL-9976-
87), EPA issued a document pursuant to FFDCA section 408, 21 U.S.C. 
346a, announcing the filing of a pesticide petition (PP IN-11102) by 
Nutri Ag Inc., 4740 N. Interstate 35 E, Waxahachie, TX 75165. The 
petition requested that 40 CFR 180.910 be amended by establishing an 
exemption from the requirement of a tolerance for residues of fulvic 
acid (CAS Reg. No. 479-66-3) when used as an inert ingredient (carrier) 
in pesticide formulations applied to growing crops and to raw 
agricultural commodities after harvest. That document referenced a 
summary of the petition prepared by OMC AG CONSULTING, INC., the 
petitioner, which is available in the docket, http://www.regulations.gov. No relevant comments were received on the notice 
of filing.

III. Inert Ingredient Definition

    Inert ingredients are all ingredients that are not active 
ingredients as defined in 40 CFR 153.125 and include, but are not 
limited to, the following types of ingredients (except when they have a 
pesticidal efficacy of their own): Solvents such as alcohols and 
hydrocarbons; surfactants such as polyoxyethylene polymers and fatty 
acids; carriers such as clay and diatomaceous earth; thickeners such as 
carrageenan and modified cellulose; wetting, spreading, and dispersing 
agents; propellants in aerosol dispensers; microencapsulating agents; 
and emulsifiers. The term ``inert'' is not intended to imply 
nontoxicity; the ingredient may or may not be chemically active. 
Generally, EPA has exempted inert ingredients from the requirement of a 
tolerance based on the low toxicity of the individual inert 
ingredients.

IV. 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 tolerance is ``safe.'' Section 408(b)(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. Section 408(b)(2)(C) of FFDCA requires 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. . . .''
    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 appreciable risks to human 
health. In order to determine the risks from aggregate exposure to 
pesticide inert ingredients, the Agency considers the toxicity of the 
inert in conjunction with possible exposure to residues of the inert 
ingredient through food, drinking water, and through other exposures 
that occur as a result of pesticide use in residential settings. If EPA 
can determine that a finite tolerance is not necessary to ensure that 
there is a reasonable certainty that no harm will result from aggregate 
exposure to the inert ingredient, 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 fulvic acid including exposure 
resulting from the exemption established by this action. EPA's 
assessment of exposures and risks associated with fulvic acid follows.

A. Toxicological Profile

    EPA has evaluated the available toxicity data and considered their 
validity, completeness, and reliability as well as the relationship of 
the results of the studies to human risk. EPA has also considered 
available information concerning the variability of the sensitivities 
of major identifiable subgroups of consumers, including infants and 
children. Specific information on the studies received and the nature 
of the adverse effects caused by fulvic acid as well as the no-
observed-adverse-effect-level (NOAEL) and the lowest-observed-adverse-
effect-level (LOAEL) from the toxicity studies are discussed in this 
unit.
    Fulvic acid is a humic substance; other humic substances include 
humic acid and humin. Humic substances are present wherever organic 
matter is being decomposed and can be defined as ``. . . a general 
category of naturally occurring, biogenic, heterogeneous organic 
substances that can generally be characterized as being yellow to black 
in color and of high molecular weight''. Humic acids are found in 
soils, waters, sewage, compost heaps, marine and lake sediments, peat 
bogs, carbonaceous shales, lignites, and brown coals. Due to their 
properties, humic substances play a major role in soil fertilization. 
Many products of different origins (peat, compost, leonardite) are 
commonly used in agriculture to develop organic fertilization methods. 
For several years, various products containing humic acids have been 
commercialized for use on grass, horticultural plants or crop 
production.
    In acute studies, exposure to fulvic acid resulted in no observable 
or minimal toxicity. The acute oral LD50 in rats is >5,000 
mg/kg. Minimal eye irritation was observed with New Zealand Albino 
rabbits. Minimal dermal irritation was observed in an acute dermal 
study with New Zealand Albino rabbits. No indications of sensitization 
have been observed in hypersensitivity studies. A 7-day dermal study 
was conducted with female mice in which no adverse effects were noted. 
A 6-month oral toxicity study with female rats fed by gavage a dose of 
100 mg/kg/day suggested that the product was nontoxic with regards to 
liver and kidney function in rats. No other adverse effects were 
observed at the study's conclusion.
    In a developmental toxicity study with rats, no adverse effects 
were noted.
    Mutagenic activity was determined by the Ames test procedures using 
Salmonella typhimurium TA100 and TA98. Humic acid, which is the 
precursor to fulvic acids and used as a surrogate, was not found to be 
mutagenic, nor did it decrease spontaneous mutations.

B. Toxicological Points of Departure/Levels of Concern

    Based on available information on the fulvic acid and similar 
compounds such as humic acid and humin, no toxicological endpoint of 
concern was identified, and a quantitative risk assessment is not 
required for these compounds.

C. Exposure Assessment

    1. Dietary exposure from food and feed uses. In evaluating dietary 
exposure to fulvic acid, EPA considered exposure under the proposed 
exemption from the requirement of a tolerance.

[[Page 36754]]

EPA assessed dietary exposures from fulvic acid in food as follows:
    Dietary exposure (food and drinking water) to fulvic acid may occur 
following ingestion of foods with residues from treated crops. However, 
a quantitative dietary exposure assessment was not conducted since a 
toxicological endpoint for risk assessment purposes was not identified.
    2. Dietary exposure from drinking water. Since a hazard endpoint of 
concern was not identified for the acute and chronic dietary 
assessment, a quantitative dietary exposure risk assessment for 
drinking water was not conducted, although exposures may be expected 
from use on food crops.
    3. From non-dietary exposure. The term ``residential exposure'' is 
used in this document to refer to non-occupational, non-dietary 
exposure (e.g., textiles (clothing and diapers), carpets, swimming 
pools, and hard surface disinfection on walls, floors, tables).
    Fulvic acid may be used in pesticide products and non-pesticide 
products that may be used in and around the home. Based on the 
discussion above, a quantitative residential exposure assessment for 
fulvic acid was not conducted.
    4. 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 fulvic 
acid to share a common mechanism of toxicity with any other substances, 
and fulvic acid does not appear to produce a toxic metabolite produced 
by other substances. For the purposes of this tolerance action, 
therefore, EPA has assumed that fulvic acid 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 http://www.epa.gov/pesticides/cumulative.

D. Safety Factor for Infants and Children

    Based on the lack of threshold effects, EPA has not identified any 
toxicological endpoints of concern and is conducting a qualitative 
assessment of fulvic acid. That qualitative assessment does not use 
safety factors for assessing risk, and no additional safety factor is 
needed for assessing risk to infants and children. Based on an 
assessment of fulvic acid, EPA has concluded that there are no 
toxicological endpoints of concern for the U.S. population, including 
infants and children.

E. Aggregate Risks and Determination of Safety

    Taking into consideration all available information on fulvic acid, 
EPA has determined that there is a reasonable certainty that no harm to 
any population subgroup will result from aggregate exposure to fulvic 
acid under reasonably foreseeable circumstances. Although there may be 
exposure to residues of fulvic acid from use of this pesticide (as well 
as other non-occupational exposures), the lack of toxicity supports a 
finding of no harm. Therefore, the establishment of an exemption from 
tolerance under 40 CFR 180.910 for residues of fulvic acid when used as 
an inert ingredient in pesticide formulations applied to growing crops 
and to raw agricultural commodities after harvest, is safe under FFDCA 
section 408.

V. 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.

VI. Conclusions

    Therefore, an exemption from the requirement of a tolerance is 
established under 40 CFR 180.910 for fulvic acid (CAS Reg. No. 479-66-
3) when used as an inert ingredient (carrier) in pesticide formulations 
applied to growing crops and to raw agricultural commodities after 
harvest.

VII. Statutory and Executive Order Reviews

    This action establishes 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), 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 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.

[[Page 36755]]

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 15, 2020.
Michael Goodis,
Director, Registration Division, 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. In Sec.  180.910, add alphabetically the inert ingredient ``Fulvic 
acid (CAS Reg. No. 479-66-3)'' to table 1 to read as follows:


Sec.  180.910  Inert ingredients used pre- and post-harvest; exemptions 
from the requirement of a tolerance.

* * * * *

------------------------------------------------------------------------
           Inert ingredients                 Limits            Uses
------------------------------------------------------------------------
                                * * * * *
Fulvic acid (CAS Reg. No. 479-66-3)...  ...............                Carrier
                                * * * * *
------------------------------------------------------------------------

[FR Doc. 2020-12375 Filed 6-17-20; 8:45 am]
BILLING CODE 6560-50-P


