[Federal Register Volume 82, Number 194 (Tuesday, October 10, 2017)]
[Rules and Regulations]
[Pages 46926-46929]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2017-21787]


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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[EPA-HQ-OPP-2017-0012; FRL-9965-58]


Tall Oil Fatty Acids; Exemption From the Requirement of a 
Tolerance

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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SUMMARY: This regulation establishes exemptions from the requirement of 
a tolerance for residues of tall oil fatty acids (CAS Reg. No. 61790-
12-3) when used as inert ingredients (solvent/carrier) in the following 
circumstances: In pesticide formulations applied to growing crops and 
raw agricultural commodities after harvest; in pesticides applied in/on 
animals, and in antimicrobial formulations for food contact surfaces. 
Spring Trading Company on behalf of Ingevity Corporation submitted a 
petition to EPA under the Federal Food, Drug, and Cosmetic Act (FFDCA), 
requesting establishment of these exemptions from the requirement of a 
tolerance. This regulation eliminates the need to establish maximum 
permissible levels for residues of tall oil fatty acids that are 
consistent with the conditions of these exemptions.

DATES: This regulation is effective October 10, 2017. Objections and 
requests for hearings must be received on or before December 11, 2017, 
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-2017-0012, 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: Michael L. Goodis, Registration 
Division (7505P), 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: [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).

[[Page 46927]]

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, 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-2017-0012 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 
December 11, 2017. 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-2017-0012, 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. Petition for Exemption

    In the Federal Register of April 10, 2017 (82 FR 17175) (FRL-9959-
61), EPA issued a document pursuant to FFDCA section 408, 21 U.S.C. 
346a, announcing the filing of pesticide petition (IN-11002) by Spring 
Trading Company (203 Dogwood Trail, Magnolia, TX 77354) on behalf of 
Ingevity Corporation (5255 Virginia Avenue, North Charleston, SC 
29406). This petition requested that 40 CFR 180.910, 40 CFR 180.930, 
and 40 CFR 180.940(a) be amended by establishing exemptions from the 
requirement of a tolerance for residues of tall oil fatty acids (CAS 
Reg. No. 61790-12-3) when used as an inert ingredient (solvent/carrier) 
in pesticide formulations applied to growing crops and to raw 
agricultural commodities after harvest, in pesticides applied in/on 
animals, or in antimicrobial formulations for food contact surfaces. 
That document referenced the summary of the petition prepared by Spring 
Trading Company on behalf of Ingevity Corporation, the petitioner, 
which are available in the docket, http://www.regulations.gov. There 
were no comments received in response to 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(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. 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 
is able to 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 tall oil fatty acids including 
exposure resulting from the exemption established by this action. EPA's 
assessment of exposures and risks associated with tall oil fatty acids 
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

[[Page 46928]]

by tall oil fatty acids 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.
    The acute oral toxicity is low in rats for tall oil fatty acids; 
the lethal dose (LD50) is >10,000 milligrams/kilogram (mg/
kg). Tall oil fatty acids are not a dermal sensitizer in the guinea pig 
maximization test. Acute dermal toxicity (study available with oleic 
acid) was not observed in guinea pigs. Skin and eye irritation and 
inhalation studies are not available.
    Tall oil fatty acids do not exhibit toxicity when administered via 
the diet to rats at 2,500 mg/kg/day for 90 days.
    A two-generation reproduction toxicity study in rats was available 
for tall oil fatty acids. Fetal susceptibility was not observed. 
Neither maternal nor developmental adverse effects were observed 
following oral administration of tall oil fatty acids at doses as high 
as 5,000 mg/kg/day.
    Carcinogenicity studies with tall oil fatty acids are not 
available; however, there is no toxicological endpoint of concern up to 
5,000 mg/kg/day nor is there a potential for mutagenicity. Therefore, 
tall oil fatty acids are not expected to be carcinogenic.
    Mutagenicity studies, the Ames test and mammalian gene mutations, 
are negative for tall fatty acids. Therefore, tall oil fatty acids are 
not mutagenic.
    Neurotoxicity and immunotoxicity studies are not available for 
review; however, evidence of neurotoxicity and immunotoxicity is not 
observed in the submitted studies.

B. Toxicological Points of Departure/Levels of Concern

    The available toxicity studies indicate that tall oil fatty acids 
have a very low overall toxicity. The NOAELs in a 90-day oral and a 
reproduction toxicity studies were =5,000 mg/kg/day; well 
above the limit dose of 1,000 mg/kg/day. Since no signs of toxicity 
were observed, even at doses above the limit dose, an endpoint of 
concern for risk assessment purposes was not identified. Therefore, a 
qualitative risk assessment was conducted for acute and chronic dietary 
exposures and short and intermediate dermal and inhalation exposures.

C. Exposure Assessment

    1. Dietary exposure from food and feed uses. In evaluating dietary 
exposure to tall oil fatty acids, EPA considered exposure under the 
proposed exemption from the requirement of a tolerance. EPA 
qualitatively assessed dietary exposures from tall oil fatty acids in 
food as follows:
    Dietary exposure (food and drinking water) to tall oil fatty acids 
can occur following ingestion of foods with residues from treated 
crops, animals or food contact surfaces. Use on food crops may result 
in residues in drinking water.
    2. 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).
    Tall oil fatty acids 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 tall oil fatty acids was not conducted.
    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.''
    Based on the available data, tall oil fatty acids do not have a 
toxic mechanism; therefore, section 408(b)(2)(D)(v) does not apply.

D. Safety Factor for Infants and Children

    1. In general. Section 408(b)(2)(C) of FFDCA 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.
    As part of its qualitative assessment, the Agency did 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 tall oil fatty acids, 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

    Because no toxicological endpoints of concern were identified, EPA 
concludes that aggregate exposure to residues of tall oil fatty acids 
will not pose a risk to the U.S. population, including infants and 
children, and that there is a reasonable certainty that no harm will 
result to the general population, or to infants and children from 
aggregate exposure to tall oil fatty acids residues.

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.

VI. Conclusions

    Therefore, exemptions from the requirement of a tolerance are 
established under for residues of tall oil fatty acids (CAS Reg. No. 
61790-12-3) when used as an inert ingredient (solvent/carrier) in 
pesticide formulations as follows: For application to growing crops and 
raw agricultural commodities after harvest under 40 CFR 180.910; for 
application to animals under 40 CFR 180.930; and for use in 
antimicrobial pesticide formulations applied to for food contact 
surfaces in public eating places, dairy-processing equipment, and food-
processing equipment and utensils under 40 CFR 180.940(a).

VII. Statutory and Executive Order Reviews

    This action establishes exemptions 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

[[Page 46929]]

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 exemptions 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: September 5, 2017.
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 to the 
table 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
------------------------------------------------------------------------
 
                                * * * * *
Tall oil fatty acids (CAS Reg. No.  .......  Solvent/carrier.
 61790-12-3).
 
                                * * * * *
------------------------------------------------------------------------


0
3. In Sec.  180.930, add alphabetically the inert ingredient to the 
table to read as follows:


Sec.  180.930  Inert ingredients applied to animals; exemptions from 
the requirement of a tolerance.

* * * * *

------------------------------------------------------------------------
         Inert ingredients           Limits              Uses
------------------------------------------------------------------------
 
                                * * * * *
Tall oil fatty acids (CAS Reg. No.  .......  Solvent/carrier.
 61790-12-3).
 
                                * * * * *
------------------------------------------------------------------------


0
4. In Sec.  180.940(a), add alphabetically the inert ingredient to the 
table to read as follows:


Sec.  180.940(a)  Tolerance exemptions for active and inert ingredients 
for use in antimicrobial formulations (Food contact surface sanitizing 
solutions).

* * * * *
    (a) * * *

------------------------------------------------------------------------
         Inert ingredients           Limits              Uses
------------------------------------------------------------------------
 
                                * * * * *
Tall oil fatty acid (CAS Reg. No.   .......  Solvent/carrier.
 61790-12-3).
 
                                * * * * *
------------------------------------------------------------------------

* * * * *
[FR Doc. 2017-21787 Filed 10-6-17; 8:45 am]
 BILLING CODE 6560-50-P