Document ID: EPA-HQ-OPP-2018-0032-0004
Agency: epa
Document Type: Rule
Title: Tolerance Exemption: Waxes and Waxy Substances, Rice Bran, Oxidized
Posted Date: 2019-02-26T05:00Z

[Federal Register Volume 84, Number 38 (Tuesday, February 26, 2019)]
[Rules and Regulations]
[Pages 6081-6084]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2019-03295]

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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[EPA-HQ-OPP-2018-0032; FRL-9987-83]

Waxes and Waxy Substances, Rice Bran, Oxidized; Exemption From 
the Requirement of a Tolerance

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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SUMMARY: This regulation establishes an exemption from the requirement 
of a tolerance for residues of waxes and waxy substances, rice bran, 
oxidized when used as an inert ingredient in pesticide formulations 
applied to growing crops and raw agricultural commodities after 
harvest, on animals, and in antimicrobial formulations (food-contact 
surface sanitizing solutions). Spring Trading Company, on behalf of 
Clariant Corporation, 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 waxes and waxy substances, rice bran, oxidized in 
accordance with the terms of the exemptions.

DATES: This regulation is effective February 26, 2019. Objections and 
requests for hearings must be received on or before April 29, 2019, 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-2018-0032, 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 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 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-2018-0032 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 29, 2019. 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-2018-0032, 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 11, 2018 (83 FR 15528) (FRL-9975-
57), EPA issued a document pursuant to FFDCA section 408, 21 U.S.C. 
346a, announcing the filing of a pesticide petition (PP IN-11074) by 
Spring Trading Company, 203 Dogwood Trail, Magnolia, TX 77354, on 
behalf of Clariant Corporation. The petition requested that 40 CFR 
180.910, 180.930, and 180.940(a) be amended by establishing an 
exemption from the requirement of a tolerance for residues of waxes and 
waxy substances, rice bran, oxidized (CAS Reg. No. 1883583-80-9) 
(``rice bran wax oxidized''), when used as an inert ingredient as a 
flow aid, surface protection, film-forming, carrier, coating agent, and 
adjuvant in pesticide formulations applied on growing crops and raw 
agricultural commodities after harvest, to animals, and in 
antimicrobial formulations (food-contact surface sanitizing solutions). 
That document referenced a summary of the petition prepared by Spring 
Trading Company on behalf of Clariant Corporation, the petitioner, 
which is available in the docket, http://www.regulations.gov. One 
comment was received on the notice of filing. EPA's response to these 
comments is discussed in Unit V.C.

III. Inert Ingredient Definition

    Inert ingredients are all ingredients that are not active 
ingredients as defined

[[Page 6082]]

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(c)(2) requires EPA to take into 
account the factors specified in subparagraphs (b)(2)(C) and (D) in 
making this safety determination. 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 rice bran wax oxidized 
including exposure resulting from the exemption established by this 
action. EPA's assessment of exposures and risks associated with rice 
bran wax oxidized 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 rice bran wax oxidized, 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.
    Available studies on rice bran wax oxidized include an acute oral 
toxicity study, a dermal irritation study, an eye irritation study, a 
dermal sensitization study, and an Ames assay. No subchronic or chronic 
studies are available for rice bran wax oxidized. Because data on rice 
bran wax oxidized is limited, surrogate data on various other long 
chain fatty acids, long chain fatty alcohols, and long chain fatty 
esters were used to support the safety finding for rice bran wax 
oxidized as rice bran wax oxidized is a natural substance comprised 
predominantly of long chain fatty acids, long chain fatty alcohols, and 
long chain fatty esters. Submitted data consisted of numerous 
subchronic, chronic, and reproductive/developmental studies on 
substances including carnauba wax, rice bran wax, a mixture of beeswax 
long chain alcohols, a mixture of sugar cane wax fatty acids, 
docosanol, docosanoic acid, and policosanol.
    Rice ban wax oxidized was shown to have low acute oral toxicity. 
There were no acute dermal or inhalation studies submitted; however, 
dermal and eye irritation studies showed the rice bran wax oxidized was 
not an irritant. Rice bran wax oxidized was also not considered a skin 
sensitizer in related studies.
    No endpoint of concern was identified for any of the acute, 
subchronic, chronic, or reproductive/developmental studies conducted at 
any dose level including the limit dose of 1000 mg/kg/day. There was 
also no evidence of carcinogenicity in any of the studies including 
chronic studies and studies on mutagenicity and cytotoxicity. In 
addition, no neuropathological changes or effects were reported in any 
of the studies. There is also no indication in the database that rice 
bran wax oxidized will be immunotoxic.
    Furthermore, the potential for absorption of rice bran wax via the 
gastrointestinal (GI) tract is limited. The long-chain fatty acid 
esters present in plant-based waxes are generally thought to be poorly 
absorbed in the GI tract as uptake is thought to decrease as chain 
length and hydrophobicity increase. Rice bran wax is being used as a 
surrogate for rice bran wax oxidized based on its similar physical and 
chemical properties and expected potential for toxicity. Similar to 
rice bran wax, which is poorly absorbed, it is unlikely that rice bran 
wax oxidized would be systemically available for GI absorption, as both 
substance are comprised of very long carbon chain lengths which are not 
absorbed.

B. Toxicological Points of Departure/Levels of Concern

    Available toxicity studies on rice bran wax oxidized indicate that 
it has a very low acute, subchronic, and chronic toxicity. No adverse 
effects were seen in any of the studies presented at the limit dose of 
1000 mg/kg/day; therefore, no endpoint of concern has been identified 
for acute, subchronic, or chronic toxicity.

C. Exposure Assessment

    1. Dietary exposure from food and feed uses. In evaluating dietary 
exposure to rice bran wax oxidized, EPA considered exposure under the 
proposed exemption from the requirement of a tolerance and other 
natural sources of rice bran wax. EPA assessed dietary exposures from 
rice bran wax oxidized in food as follows:
    Dietary exposure to rice bran wax oxidized may occur from eating 
foods naturally containing rice bran wax

[[Page 6083]]

(which is metabolized by the body to rice bran wax oxidized) and foods 
treated with pesticide formulations containing rice bran wax oxidized 
as an inert ingredient. Because no toxicological endpoint of concern 
was identified for rice bran wax oxidized, a quantitative dietary 
exposure assessment for rice bran wax oxidized was not conducted.
    2. Dietary exposure from drinking water. Although drinking water 
exposures from use of pesticide formulations containing rice bran wax 
oxidized on food crops is possible, an endpoint of concern was not 
identified for the acute or chronic dietary assessment; therefore, a 
quantitative dietary exposure risk assessment for drinking water was 
not conducted.
    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). Rice 
bran wax oxidized may be used as inert ingredient in pesticide products 
that are registered for specific uses that may result in indoor or 
outdoor residential exposures. Since there are no toxicological effects 
of concern at the limit dose in available studies, a quantitative 
assessment of residential (non-occupational) exposures and risks is not 
necessary.
    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.''
    Rice bran wax oxidized does not have toxic mode of action and 
therefore, cumulative risk assessment is not necessary.

D. Safety Factor for Infants and Children

    Section 408(b)(2)(C) requires EPA to retain an additional tenfold 
margin of safety in the case of threshold effects 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. As 
noted in Unit IV.B., there is no indication of threshold effects being 
caused by rice bran wax oxidized at the limit dose. Therefore, due to 
the lack of any toxicological endpoints of concern at the limit dose, 
EPA is conducting a qualitative assessment of rice bran wax oxidized 
which does not use safety factors for assessing risk, and no additional 
safety factor is needed for assessing risk to infants and children.

E. Aggregate Risks and Determination of Safety

    Taking into consideration all available information on rice bran 
wax oxidized, EPA has determined that there is a reasonable certainty 
that no harm to any population subgroup will result from aggregate 
exposure to rice bran wax oxidized under reasonably foreseeable 
circumstances. Therefore, the establishment of exemptions from the 
requirement of a tolerance under 40 CFR 180.910, 180.930, and 
180.940(a) for residues of waxes and waxy substances, rice bran, 
oxidized when used as an inert ingredient in pesticide formulations 
applied pre- and post-harvest, on animals, and in antimicrobial 
formulations (food-contact surface sanitizing solutions), is safe under 
FFDCA section 408.

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. Response to Comments

    One comment was received in response to the Notice of Filing, 
generally stating that exposure to unnecessary pesticides needs to be 
decreased. The Agency recognizes that some individuals believe that 
pesticides should be limited or banned on agricultural crops. However, 
the existing legal framework provided by section 408 of the Federal 
Food, Drug and Cosmetic Act (FFDCA) states that tolerances may be set 
when persons seeking such tolerances or exemptions have demonstrated 
that the pesticide meets the safety standard imposed by that statute. 
This citizen's comment appears to be directed at the underlying statute 
and not EPA's implementation of it; the citizen has provided no 
information that would support a conclusion that these exemptions are 
not safe.

VI. Conclusions

    Therefore, exemptions from the requirement of a tolerance are 
established under 40 CFR 180.910, 180.930, and 180.940(a) for residues 
of waxes and waxy substances, rice bran, oxidized (CAS Reg. No. 
1883583-80-9) when used as an inert ingredient (flow aid, surface 
protectant, film-forming agent, carrier, coating agent, or adjuvant) in 
pesticide formulations applied to growing crops and raw agricultural 
commodities after harvest, to animals, and in antimicrobial 
formulations (food-contact surface sanitizing solutions).

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 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

[[Page 6084]]

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: December 21, 2018.
Donna Davis,
Acting 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 ``Waxes 
and waxy substances, rice bran, oxidized (CAS Reg. No. 1883583-80-9)'' 
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
------------------------------------------------------------------------
 
                              * * * * * * *
Waxes and waxy substances,    ....................  Flow aid, surface
 rice bran, oxidized (CAS                            protectant, film-
 Reg. No. 1883583-80-9).                             forming agent,
                                                     carrier, coating
                                                     agent, or adjuvant.
 
                              * * * * * * *
------------------------------------------------------------------------

0
3. In Sec.  180.930, add alphabetically the inert ingredient ``Waxes 
and waxy substances, rice bran, oxidized (CAS Reg. No. 1883583-80-9)'' 
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
------------------------------------------------------------------------
 
                              * * * * * * *
Waxes and waxy substances,    ....................  Flow aid, surface
 rice bran, oxidized (CAS                            protectant, film-
 Reg. No. 1883583-80-9).                             forming agent,
                                                     carrier, coating
                                                     agent, or adjuvant.
 
                              * * * * * * *
------------------------------------------------------------------------

0
4. In Sec.  180.940(a), add alphabetically the inert ingredient ``Waxes 
and waxy substances, rice bran, oxidized'' to the table to read as 
follows:

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

* * * * *
    (a) * * *

----------------------------------------------------------------------------------------------------------------
               Pesticide chemical                   CAS Reg. No.                       Limits
----------------------------------------------------------------------------------------------------------------
 
                                                  * * * * * * *
Waxes and waxy substances, rice bran, oxidized.       1883583-80-9  None.
 
                                                  * * * * * * *
----------------------------------------------------------------------------------------------------------------

* * * * *
[FR Doc. 2019-03295 Filed 2-25-19; 8:45 am]
 BILLING CODE 6560-50-P