[Federal Register Volume 79, Number 237 (Wednesday, December 10, 2014)]
[Rules and Regulations]
[Pages 73224-73227]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2014-28936]


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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[EPA-HQ-OPP-2014-0122; FRL-9919-40]


C.I. Pigment Yellow 1; 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 C.I. Pigment Yellow 1 (butanamide, 2- 
(4-methyl-2-nitrophenyl) azo -3-oxo-N-phenyl-) when used as an inert 
ingredient as a colorant in seed treatment formulations not to exceed 
10% weight(wt)/wt under 40 CFR 180.920. Exponent Inc. 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 C.I. Pigment Yellow 1.

DATES: This regulation is effective December 10, 2014. Objections and 
requests for hearings must be received on or before February 9, 2015, 
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-2014-0122, 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: Susan T. Lewis, 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-2014-0122 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 
February 9, 2015. 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-2014-0122, 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 October 24, 2014 (79 FR 63594) (FRL-
9916-03), EPA issued a document pursuant to FFDCA section 408, 21 
U.S.C. 346a, announcing the filing of a pesticide petition (PP IN-
10661) by Exponent, Inc. (1150 Connecticut Ave. NW., Suite 1100, 
Washington, DC 20036) on behalf of Clariant Corporation (4000 Monroe 
Road, Charlotte, NC 28205). The petition requested that 40 CFR 180.920 
be amended by establishing an exemption from the requirement of a 
tolerance for residues of C.I. Pigment Yellow 1 (butanamide, 2- (4-
methyl-2-nitrophenyl) azo -3-oxo-N-phenyl-) (CAS Reg. No. 2512-29-0) 
when used as an inert ingredient as a colorant in pesticide 
formulations applied as a seed treatment not to exceed 10% wt/wt. That 
document referenced a summary of the petition prepared by Exponent, 
Inc., the petitioner, which is available in the docket, http://www.regulations.gov. Comments were 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 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;

[[Page 73225]]

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 
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 C.I. Pigment Yellow 1 including 
exposure resulting from the exemption established by this action. EPA's 
assessment of exposures and risks associated with C.I. Pigment Yellow 1 
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 C.I. Pigment Yellow 1 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 lethal dose (LD)50 of C.I. Pigment Yellow 
1 in rat was greater than 10,000 milligram/kilogram (mg/kg). The acute 
dermal LD50 of C.I. Pigment Yellow 1 in rats was greater 
than 2,000 mg/kg. In a primary skin and eye irritation study in 
rabbits, C.I. Pigment Yellow 1 was not irritating to the skin or eyes 
of rabbits. C.I. Pigment Yellow 1 was not a sensitizer as determined by 
mouse Local Lymph Node Assay (LLNA)/Redfern Contract Consultants (LLNA/
RCC) cytotest cell assay.
    In a repeated dose toxicity study with a reproduction/developmental 
toxicity screening test, C.I. Pigment Yellow 1 was administered orally 
to groups of 11 male and female Wistar rats at dose levels of up to 
1,000 mg/kg/day. Parental systemic toxicity, functional observation 
battery (FOB) parameters, locomotor activity, reproductive function and 
performance, and offspring viability and growth were assessed in this 
study. Over the entire treatment period, weight gain was decreased by 
11% and 16% in mid- and high-dose group males, respectively, however, 
the absolute body weights were not affected. The parental systemic 
toxicity, reproductive toxicity and offspring toxicity NOAEL for C.I. 
Pigment Yellow 1 was 1,000 mg/kg/day (the limit dose).
    C.I. Pigment Yellow 1 was negative for mutagenicity in a reverse 
gene mutation assay and in an in vitro mammalian cell gene mutation 
assay using Chinese hamster cells.
    No studies investigating the carcinogenic potential of C.I. Pigment 
Yellow 1 are available. A Deductive Estimation of Risk from Existing 
Knowledge (DEREK) evaluation of the toxicity of C.I. Pigment Yellow 1 
indicated structural alerts based on the aromatic nitrogen structure 
and included plausible outcome for mutagenicity in vitro and plausible 
outcomes for carcinogenicity and hepatoxicity. However, based on the 
lack of target organ toxicity at the limit dose, lack of mutagenicity, 
limited solubility and limited bioavailability, C.I. Pigment Yellow 1 
is not expected to be carcinogenic.

B. Toxicological Points of Departure/Levels of Concern

    Once a pesticide's toxicological profile is determined, EPA 
identifies toxicological points of departure (POD) and levels of 
concern to use in evaluating the risk posed by human exposure to the 
pesticide. For hazards that have a threshold below which there is no 
appreciable risk, the toxicological POD is used as the basis for 
derivation of reference values for risk assessment. PODs are developed 
based on a careful analysis of the doses in each toxicological study to 
determine the dose at which the NOAEL and the LOAEL are identified. 
Uncertainty/safety factors are used in conjunction with the POD to 
calculate a safe exposure level--generally referred to as a population-
adjusted dose (PAD) or a reference dose (RfD)--and a safe margin of 
exposure (MOE). For non-threshold risks, the Agency assumes that any 
amount of exposure will lead to some degree of risk. Thus, the Agency 
estimates risk in terms of the probability of an occurrence of the 
adverse effect expected in a lifetime. For more information on the 
general principles EPA uses in risk characterization and a complete 
description of the risk assessment process, see http://www.epa.gov/pesticides/factsheets/riskassess.htm.
    The available data suggest low acute oral toxicity. There was no 
evidence systemic toxicity in the reproductive and developmental study 
at the limit dose. There were no effects on reproductive, developmental 
and offspring toxicity at the limit dose of 1,000 mg/kg/day. It was 
negative for mutagenicity in two in vitro assays. In addition, based on 
its limited water solubility of C.I. Pigment Yellow 1 is not expected 
significantly via oral and dermal routes. Based on above consideration, 
EPA concluded that it is not necessary to conduct quantitative dietary 
risk as well as risk from exposure via dermal and inhalation.

C. Exposure Assessment

    1. Dietary exposure from food and feed uses. In evaluating dietary

[[Page 73226]]

exposure to C.I. Pigment Yellow 1, EPA considered exposure under the 
proposed exemption from the requirement of a tolerance. EPA assessed 
dietary exposures from C.I. Pigment Yellow 1 in food as follows:
    Dietary exposure can occur from eating foods containing residues of 
C.I. Pigment Yellow 1. Because no hazard endpoint of concern was 
identified for the acute and chronic dietary assessment (food and 
drinking water), a quantitative dietary exposure risk assessment was 
not conducted.
    2. Dietary exposure from drinking water. C.I. Pigment Yellow 1 
residues may be found in drinking water. However, since an endpoint of 
concern was not identified for the dietary assessment (food and 
drinking water), a quantitative dietary exposure risk assessment 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). C.I. 
Pigment Yellow 1 is used as an inert ingredient in pesticide products 
that could result in short- and intermediate-term residential exposure. 
However, based on the lack of toxicity, a quantitative exposure 
assessment from residential exposures was not performed.
    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 C.I. Pigment Yellow 1 to share a common mechanism 
of toxicity with any other substances, and C.I. Pigment Yellow 1 does 
not appear to produce a toxic metabolite produced by other substances. 
For the purposes of this tolerance action, therefore, EPA has assumed 
that C.I. Pigment Yellow 1 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 Web site 
at http://www.epa.gov/pesticides/cumulative.

D. Safety Factor for Infants and Children

    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 an assessment of C.I. Pigment Yellow 1, EPA has concluded 
that there are no toxicological endpoints of concern for the U.S. 
population, including infants and children, and has conducted a 
qualitative assessment. 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.

E. Aggregate Risks and Determination of Safety

    EPA determines whether acute and chronic dietary pesticide 
exposures are safe by comparing aggregate exposure estimates to the 
acute PAD (aPAD) and chronic PAD (cPAD). For linear cancer risks, EPA 
calculates the lifetime probability of acquiring cancer given the 
estimated aggregate exposure. Short-, intermediate-, and chronic-term 
risks are evaluated by comparing the estimated aggregate food, water, 
and residential exposure to the appropriate PODs to ensure that an 
adequate MOE exists.
    Based on the lack of any endpoints of concern, EPA concludes that 
there is a reasonable certainty that no harm will result to the general 
population or to infants and children from aggregate exposure to C.I. 
Pigment Yellow 1 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. International Residue Limits

    In making its tolerance decisions, EPA seeks to harmonize U.S. 
tolerances with international standards whenever possible, consistent 
with U.S. food safety standards and agricultural practices. EPA 
considers the international maximum residue limits (MRLs) established 
by the Codex Alimentarius Commission (Codex), as required by FFDCA 
section 408(b)(4). The Codex Alimentarius is a joint United Nation Food 
and Agriculture Organization/World Health Organization food standards 
program, and it is recognized as an international food safety 
standards-setting organization in trade agreements to which the United 
States is a party. EPA may establish a tolerance that is different from 
a Codex MRL; however, FFDCA section 408(b)(4) requires that EPA explain 
the reasons for departing from the Codex level.
    The Codex has not established a MRL for C.I. Pigment Yellow 1.

C. Response to Comments

    One comment was received for a notice of filing from a private 
citizen who opposed the authorization to sell any pesticide that leaves 
a residue on food. The Agency understands the commenter's concerns and 
recognizes that some individuals believe that no residue of pesticides 
should be allowed. However, under the existing legal framework provided 
by section 408 of the Federal Food, Drug and Cosmetic Act (FFDCA), EPA 
is authorized to establish pesticide tolerances or exemptions where 
persons seeking such tolerances or exemptions have demonstrated that 
the pesticide meets the safety standard imposed by the statute.

VI. Conclusions

    Therefore, an exemption from the requirement of a tolerance is 
established under 40 CFR 180.920 for C.I. Pigment Yellow 1 (2512-29-0) 
when used as an inert ingredient colorant in seed treatment 
formulations not to exceed 10% wt/wt.

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

[[Page 73227]]

Energy Supply, Distribution, or Use'' (66 FR 28355, May 22, 2001) or 
Executive Order 13045, entitled ``Protection of Children from 
Environmental Health Risks and Safety Risks'' (62 FR 19885, April 23, 
1997). This action does not contain any information collections subject 
to OMB approval under the Paperwork Reduction Act (PRA) (44 U.S.C. 3501 
et seq.), nor does it require any special considerations under 
Executive Order 12898, entitled ``Federal Actions to Address 
Environmental Justice in Minority Populations and Low-Income 
Populations'' (59 FR 7629, February 16, 1994).
    Since tolerances and exemptions that are established on the basis 
of a petition under FFDCA section 408(d), such as the exemption 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: November 26, 2014.
Susan Lewis,
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.  180.920, add alphabetically the inert ingredient in the 
table to read as follows:


Sec.  180.920  Inert ingredients used pre-harvest; exemptions from the 
requirement of a tolerance.

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       Inert ingredients                Limits                Uses
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                              * * * * * * *
C.I. Pigment Yellow 1 (CAS      Not to exceed 10%       Colorant.
 Reg. No. 2512-29-0).            (weight/weight) in
                                 pesticide formulation.
 
                              * * * * * * *
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[FR Doc. 2014-28936 Filed 12-9-14; 8:45 am]
BILLING CODE 6560-50-P