[Federal Register Volume 83, Number 37 (Friday, February 23, 2018)]
[Rules and Regulations]
[Pages 8003-8006]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2018-03759]



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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[EPA-HQ-OPP-2017-0179; FRL-9974-14]


Distillates (Petroleum), Solvent-Dewaxed Heavy Paraffinic; 
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 distillates (petroleum), solvent-dewaxed 
heavy paraffinic (CAS Reg. No. 64742-65-0) when used as an inert 
ingredient (carrier) in pesticide products applied to growing crops and 
raw agricultural commodities after harvest and to animals. SciReg., 
Inc., on behalf of HollyFrontier Refining & Marketing LLC, 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 distillates (petroleum), solvent-
dewaxed heavy paraffinic when used in accordance with the terms of 
those exemptions.

DATES: This regulation is effective February 23, 2018. Objections and 
requests for hearings must be received on or before April 24, 2018, 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-2017-0179, 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), Office of Pesticide Programs, Environmental 
Protection Agency, 1200 Pennsylvania Ave. NW, Washington, DC 20460-
0001; main telephone number: (703) 305-7090; email address: 
[email protected].

SUPPLEMENTARY INFORMATION:

I. General Information

A. Does this action apply to me?

    You may be potentially affected by this action if you are an 
agricultural producer, food manufacturer, or pesticide manufacturer. 
The following list of North American Industrial Classification System 
(NAICS) codes is not intended to be exhaustive, but rather provides a 
guide to help readers determine whether this document applies to them. 
Potentially affected entities may include:
     Crop production (NAICS code 111).
     Animal production (NAICS code 112).
     Food manufacturing (NAICS code 311).
     Pesticide manufacturing (NAICS code 32532).

B. How can I get electronic access to other related information?

    You may access a frequently updated electronic version of 40 CFR 
part 180 through the 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-2017-0179 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 24, 2018. 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-2017-0179, 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 September 15, 2017 (82 FR 43352) (FRL-
9965-43), EPA issued a document pursuant to FFDCA section 408, 21 
U.S.C. 346a, announcing the filing of a pesticide petition (IN-11015) 
by SciReg., Inc. (12733 Director's Loop, Woodbridge, VA 22192) on 
behalf of HollyFrontier Refining & Marketing LLC (401 Plymouth Road, 
Suite 350, Plymouth Meeting, PA 19462). The petition requested that 40 
CFR 180.910 and 40 CFR 180.930 be amended by establishing exemptions 
from the requirement of a tolerance for residues of distillates 
(petroleum), solvent-dewaxed heavy paraffinic (CAS Reg. No. 64742-65-0) 
when used as an inert ingredient (carrier) in pesticide formulations 
applied to growing crops and to raw agricultural commodities after 
harvest and in pesticides applied to animals. That document referenced 
a summary of the petition prepared by SciReg., Inc. on behalf of 
HollyFrontier Refining & Marketing LLC, 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 this comment is 
discussed in Unit V.B.

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

[[Page 8004]]

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)(B) requires EPA to take into 
account the considerations set forth in subparagraphs (C) and (D) of 
subsection (b)(2) when making this exemption 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 distillates (petroleum), 
solvent-dewaxed heavy paraffinic including exposure resulting from the 
exemption established by this action. EPA's assessment of exposures and 
risks associated with distillates (petroleum), solvent-dewaxed heavy 
paraffinic 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 distillates (petroleum), solvent-
dewaxed heavy paraffinic 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.
    Petroleum materials are defined by how they are processed, physical 
properties and product use specifications. Distillates (petroleum), 
solvent-dewaxed heavy paraffinic are characterized as highly and 
severely refined distillate base oils. Petroleum materials processed in 
this manner behave similarly. Therefore, toxicity data on highly and 
severely refined distillate base oils are used as read across data to 
characterize the toxicity of similarly processed petroleum materials. 
Since limited toxicity data exist on distillates (petroleum), solvent-
dewaxed heavy paraffinic, toxicity data on other highly and severely 
refined distillate base oils are used to characterize toxicity due to 
distillates (petroleum), solvent-dewaxed heavy paraffinic.
    The acute oral toxicity is low in rats for distillates (petroleum), 
solvent-dewaxed heavy paraffinic; the lethal dose, LD50 is 
>15,000 milligrams/kilogram (mg/kg). Distillates (petroleum), solvent-
dewaxed heavy paraffinic has low acute dermal toxicity; the 
LD50 is >5,000 mg/kg in rabbits. In rats, acute inhalation 
toxicity is also low, the LD50 is >4.0 milligrams/liter (mg/
L). It is not a dermal sensitizer in the guinea pig. Skin and eye 
irritation studies are not available.
    Oral repeated dose studies are not available on distillates 
(petroleum), solvent-dewaxed heavy paraffinic; however, studies are 
available on a similarly processed petroleum material (C10-
C13 dearomatized solvent). Following 90 days of exposure via 
gavage to C10-C13 dearomatized solvent, the bench 
mark dose lower confidence limit (BMDL) was established at 1,857 mg/kg/
day based on increased serum alanine aminotransferase (ALT) levels in 
rats.
    No systemic toxicity is observed up to 2,000 mg/kg/day following 28 
days or 13 weeks of dermal exposure to distillates (petroleum), 
solvent-dewaxed heavy paraffinic in rabbits and rats. No systemic 
toxicity is observed in a 90-day or 13-week dermal toxicity studies in 
male rats at 1,000 mg/kg/day and 2,000 mg/kg/day of distillates 
(petroleum), solvent-dewaxed heavy paraffinic, respectively. In an OECD 
guideline developmental toxicity study via dermal exposure, no systemic 
or dermal toxicity is observed at 2,000 mg/kg/day.
    Following inhalation exposure, multiple lung effects are observed 
at 0.52 g/m\3\ (0.52 mg/L). However, the lung effects were not due to 
chemical toxicity but rather the irritating nature of distillates 
(petroleum), solvent-dewaxed heavy paraffinic.
    No maternal, offspring or reproduction toxicity is observed up to 
1,150 mg/kg/day in a 2-generation reproduction toxicity study in rats 
on a similarly processed petroleum, distillates (petroleum), 
hydrotreated heavy paraffinic.
    Although no carcinogenicity studies with distillates (petroleum), 
solvent-dewaxed heavy paraffinic are available, none of the available 
data concerning highly and severely refined distillate base oils 
indicate any toxicological endpoint of concern up to 1,000 mg/kg/day. 
Additionally, a Derek Nexus structural alert analysis was conducted 
with distillates (petroleum), solvent-dewaxed heavy paraffinic and 
indicated no structural alerts for carcinogenicity or mutagenicity. 
Therefore, distillates (petroleum), solvent-dewaxed heavy paraffinic is 
not expected to be carcinogenic.
    Evidence of neurotoxicity and immunotoxicity is not observed in the 
submitted studies. Therefore, distillates (petroleum), solvent-dewaxed 
heavy paraffinic is not expected to be neurotoxic or immunotoxic.

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    Metabolism studies show that mineral oils and aliphatic petroleum 
hydrocarbons are poorly absorbed across the gastrointestinal tract 
lining and rapidly eliminated unchanged in the feces. Also, dermal 
absorption and inhalation absorption is very poor.

B. Toxicological Points of Departure/Levels of Concern

    The available toxicity studies support a conclusion that 
distillates (petroleum), solvent-dewaxed heavy paraffinic have very low 
overall toxicity. The NOAELs in a 90-day oral and reproduction toxicity 
studies on similarly processed petroleum distillates were >1,000 mg/kg/
day; the limit dose. Effects observed in inhalation studies are due to 
irritating effects rather than systemic toxicity. Since toxicity was 
only observed 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 distillates (petroleum), solvent-dewaxed heavy paraffinic, 
EPA considered exposure under the proposed exemption from the 
requirement of a tolerance. EPA assessed dietary exposures from 
distillates (petroleum), solvent-dewaxed heavy paraffinic in food as 
follows:
    Dietary exposure (food and drinking water) to distillates 
(petroleum), solvent-dewaxed heavy paraffinic may occur following 
ingestion of foods with residues from treated crops or animals. 
However, a quantitative dietary exposure assessment was not conducted 
since a toxicological endpoint for risk assessment 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).
    Distillates (petroleum), solvent-dewaxed heavy paraffinic 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 distillates (petroleum), solvent-
dewaxed heavy paraffinic 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.''
    Based on the available data, distillates (petroleum), solvent-
dewaxed heavy paraffinic does 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.
    Based on the lack of threshold effects, EPA has not identified any 
toxicological endpoints of concern and is conducting a qualitative 
assessment of distillates (petroleum), solvent-dewaxed heavy 
paraffinic. 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 distillates 
(petroleum), solvent-dewaxed heavy paraffinic, 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 distillates 
(petroleum), solvent-dewaxed heavy paraffinic 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 
distillates (petroleum), solvent-dewaxed heavy paraffinic 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.

B. Response to Comments

    One comment was received urging the Agency not to allow residues of 
pesticides in or on food. Although the Agency recognizes that some 
individuals believe that no residue of pesticides should be allowed in 
or on food, the existing legal framework provided by section 408 of the 
Federal Food, Drug and Cosmetic Act (FFDCA) authorizes the 
establishment of pesticide tolerances or exemptions where the Agency 
determines that tolerance or exemption meets the safety standard 
imposed by the statute. EPA has sufficient data to support a safety 
determination for the exemption from the requirement of a tolerance for 
distillates (petroleum), solvent-dewaxed heavy paraffinic. The 
commenter provided no additional information supporting a determination 
that the exemption is not safe.

VI. Conclusions

    Therefore, exemptions from the requirement of a tolerance are 
established for residues of distillates (petroleum), solvent-dewaxed 
heavy paraffinic (CAS Reg. No. 64742-65-0) when used as an inert 
ingredient (carrier) in pesticide formulations applied to growing crops 
and raw agricultural commodities after harvest under 40 CFR 180.910 and 
when applied to animals under 40 CFR 180.930.

VII. Statutory and Executive Order Reviews

    This action establishes tolerance exemptions 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

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22, 2001); Executive Order 13045, entitled ``Protection of Children 
from Environmental Health Risks and Safety Risks'' (62 FR 19885, April 
23, 1997); or 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 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: February 12, 2018.
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
------------------------------------------------------------------------
 
                              * * * * * * *
Distillates (petroleum), solvent-        .........  Carrier.
 dewaxed heavy paraffinic (CAS Reg. No.
 64742-65-0).
 
                              * * * * * * *
------------------------------------------------------------------------


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
------------------------------------------------------------------------
 
                              * * * * * * *
Distillates (petroleum), solvent-        .........  Carrier.
 dewaxed heavy paraffinic (CAS Reg. No.
 64742-65-0).
 
                              * * * * * * *
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[FR Doc. 2018-03759 Filed 2-22-18; 8:45 am]
 BILLING CODE 6560-50-P