[Federal Register Volume 78, Number 187 (Thursday, September 26, 2013)]
[Rules and Regulations]
[Pages 59265-59269]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2013-23391]


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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[EPA-HQ-OPP-2012-0945; FRL-9400-6]


FD&C Yellow No. 5; 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 FD&C Yellow No. 5 (CAS Reg. No. 1934-21-
0) when used as an inert ingredient (dye) in antimicrobial pesticide 
formulations applied to food-contact surfaces in public eating places, 
dairy-processing equipment, and food-processing equipment and utensils. 
Exponent, Inc. on behalf of Ecolab, Inc., submitted a petition to EPA 
under the Federal Food, Drug, and Cosmetic Act (FFDCA), requesting 
establishment of an exemption from the requirement of a tolerance. 
These regulations eliminate the need to establish a maximum permissible 
level for residues of FD&C Yellow No. 5.

DATES: This regulation is effective September 26, 2013. Objections and 
requests for hearings must be received on or before November 25, 2013, 
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)

[[Page 59266]]

number EPA-HQ-OPP-2012-0945, 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), 
EPA West 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: Lois Rossi, Registration Division 
(7505P), Office of Pesticide Programs, Environmental Protection Agency, 
1200 Pennsylvania Ave. NW., Washington, DC 20460-0001; 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. To access the OCSPP test guidelines referenced in this document 
electronically, please go to http://www.epa.gov/ocspp and select ``Test 
Methods and Guidelines.''

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-2012-0945 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 
November 25, 2013. 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-2012-0945, 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 January 16, 2013 (78 FR 3377) (FRL-9375-
4), EPA issued a document pursuant to FFDCA section 408, 21 U.S.C. 
346a, announcing the filing of a pesticide petition (PP IN-10528) by 
Exponent, Inc. on behalf of Ecolab, Inc., 370 N. Wabasha Street, St. 
Paul, MN 55102. The petition requested an exemption from the 
requirement of a tolerance be established for residues of FD&C Yellow 
No. 5 (CAS Reg. No. 1934-21-0) when used as an inert ingredient under 
40 CFR 180.940(a) for use in antimicrobial pesticide formulations 
applied to food-contact surfaces in public eating places, dairy-
processing equipment, and food-processing equipment and utensils at an 
end-use concentration not to exceed 1,000 parts per million (ppm). That 
document referenced a summary of the petition submitted by Ecolab, 
Inc., the petitioner, which is 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(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

[[Page 59267]]

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 FD&C Yellow No. 5 including 
exposure resulting from the exemption established by this action. EPA's 
assessment of exposures and risks associated with FD&C Yellow No. 5 
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 FD&C Yellow No. 5 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.
    FD&C Yellow No. 5 is a FDA permanently listed color additive used 
in food, drugs and cosmetics, including drugs and cosmetics for the eye 
area. FDA's color additive evaluation included the consideration of an 
extensive set of toxicological data on FD&C Yellow No. 5. FDA concluded 
that this colorant was safe and established a maximum acceptable daily 
intake for FD&C Yellow No. 5. Similarly, the Joint Expert Committee on 
Food Additives of the Food and Agriculture Organization/World Health 
Organization (JECFA) as well as the European Union Scientific Committee 
for Food (SCF) has evaluated FD&C Yellow No. 5 for the purpose of 
establishing estimates of acceptable daily intake (ADI) as a food 
additive. In 2004, EPA conducted a tolerance reassessment of the 
tolerance exemptions for FD&C Yellow No. 5 (also referred to as 
tartrazine) under 40 CFR 180.910, 180.930, 180.940(b), and 180.940(c) 
which included a summary of the FDA and JECFA evaluations of FD&C 
Yellow No. 5.
    The FDA and JECFA evaluations of FD&C Yellow No. 5 included reviews 
of an extensive set of toxicological data including genotoxicity, 
chronic toxicity/carcinogenicity and reproductive and developmental 
toxicity. Both evaluations concluded that the available data 
demonstrated that no adverse effects were seen in studies at limit dose 
levels. The FDA evaluation resulted in the establishment of an ADI of 
5.0 milligrams/kilogram/day (mg/kg/day) based on a chronic oral 
toxicity study in dogs in which the no-observed adverse effect level 
(NOAEL) was 500 mg/kg/day (highest dose tested) with a safety factor of 
100. The JECFA and SCF evaluations of FD&C Yellow No. 5 established 
ADIs of 7.5 mg/kg/day based upon a chronic dietary toxicity study in 
rats in which the no-observed adverse effect level (NOAEL) was 750 mg/
kg/day (highest dose tested) with a safety factor of 100. More 
recently, the European Food Safety Authority has reevaluated FD&C 
Yellow No. 5 and concluded that the present database does not give 
reason to revise the ADI of 7.5 mg/kg bw/day.
    As a result of these extensive evaluations of FD&C Yellow No. 5, in 
which either no adverse effects were noted, or the effects of single or 
repeated dosing were observed only at levels beyond the respective 
limit doses, EPA has utilized a qualitative approach to assessing human 
health risks from exposure to FD&C Yellow No. 5. No hazard endpoint of 
concern was identified for the acute and chronic dietary assessment 
(food and drinking water), or for the short-, intermediate-, and long-
term residential assessments (via all exposure routes), therefore, 
acute and chronic dietary and short-, intermediate-, and long-term 
residential exposure assessments were not performed.

B. Toxicological Points of Departure/Levels of Concern

    There were no adverse effects in repeat dose toxicity, 
reproductive, and developmental studies with FD&C Yellow No. 5 at or 
above limit dose levels to either parental animals or their offspring. 
Based on the available mutagenicity studies, EPA concluded that FD&C 
Yellow No. 5 is not likely to be genotoxic. There was no evidence of 
carcinogenicity in rats and mice up to the limit dose at 24 and 18 
months, respectively. Thus, due to its low potential hazard and lack of 
hazard endpoint, the Agency has determined that a quantitative risk 
assessment using safety factors applied to a point of departure 
protective of an identified hazard endpoint is not appropriate for FD&C 
Yellow No. 5.

C. Exposure Assessment

    1. Dietary exposure from food and feed uses. In evaluating dietary 
exposure to FD&C Yellow No. 5, EPA considered exposure under the 
proposed exemptions from the requirement of a tolerance. Dietary 
exposure to FD&C Yellow No. 5 can occur when eating food treated with 
pesticide formulation containing this inert ingredient. In addition, 
dietary exposure to FD&C Yellow No. 5 could occur via residues from 
treated food contact surfaces; and from food that contains FD&C Yellow 
No. 5, as a color additive. Since an endpoint for risk assessment was 
not identified, a quantitative dietary exposure assessment for FD&C 
Yellow No. 5 was not conducted.
    2. Dietary exposure from drinking water. Dietary exposure from 
drinking water to FD&C Yellow No. 5 can occur by drinking water that 
has been contaminated by run-off from a pesticide treated area and from 
antimicrobial formulations used in food-contact surface sanitizing 
solutions. Since an endpoint for risk assessment was not identified, a 
quantitative dietary exposure assessment from drinking water for FD&C 
Yellow No. 5 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).
    Residential (oral, dermal and inhalation) exposure to FD&C Yellow 
No. 5 from its use as an inert ingredient in food-contact surface 
sanitizing solutions for public eating places, dairy-processing 
equipment, food-processing equipment and utensils is possible. 
Residential exposure to, FD&C Yellow No. 5 as a result of its use as a 
color additive in foods, drugs and cosmetics is also possible. Since an 
endpoint for risk assessment was not identified, a quantitative 
residential exposure assessment for FD&C Yellow No. 5 was not 
conducted.

[[Page 59268]]

    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 FD&C Yellow No. 5 to share a common mechanism of 
toxicity with any other substances, and FD&C Yellow No. 5 does not 
appear to produce a toxic metabolite produced by other substances. For 
the purposes of this tolerance action, therefore, EPA has assumed that 
FD&C Yellow No. 5 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

    The toxicity database for FD&C Yellow No. 5 contains several acute, 
subchronic, long-term, developmental, reproductive and carcinogenic 
studies, as well as mutagenicity studies. No adverse effects were 
identified in those studies. There were no clinical signs of 
neurotoxicity or systemic toxicity observed with FD&C Yellow No. 5 in 
the available database up to the limit dose. No developmental or 
reproductive effects were seen in the available developmental and 
reproductive toxicity studies at doses of FD&C Yellow No. 5 up to the 
limit dose, 1,064 mg/kg/day. Thus, there is no residual uncertainty 
regarding prenatal and/or postnatal toxicity of FD&C Yellow No. 5. Due 
to the lack of toxicity of FD&C Yellow No. 5, the Agency determined 
that a quantitative risk assessment using safety factors was not 
necessary for assessing risk. For the same reason, 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 FD&C Yellow 
No. 5, EPA has determined that there is a reasonable certainty that no 
harm to any population subgroup, including infants and children, will 
result from aggregate exposure to FD&C Yellow No. 5 under reasonable 
foreseeable circumstances. Therefore, the establishment of exemptions 
from tolerance under 180.940(a) for residues of FD&C Yellow No. 5 when 
used as an inert ingredient in food-contact surface sanitizing 
solutions for public eating places, dairy-processing equipment, food-
processing equipment and utensils, 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 exemptions 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 FD&C Yellow No. 5.

VI. Conclusions

    Therefore, exemptions from the requirement of a tolerance are 
established for residues of FD&C Yellow No. 5 (CAS Reg. No. 1934-21-0) 
under 180.940(a) when used as an inert ingredient (dye) in food-contact 
surface sanitizing solutions for public eating places, dairy-processing 
equipment, food-processing equipment and utensils.

VII. Statutory and Executive Order Reviews

    This final rule 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 final rule has been exempted from review 
under Executive Order 12866, this final rule 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 final rule 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 final rule 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 final rule. In addition, 
this final rule does not impose any enforceable duty or contain any 
unfunded mandate as described under Title II of the Unfunded Mandates 
Reform Act of 1995 (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 of 1995 (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

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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 17, 2013.
Lois Rossi,
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.  180.940, alphabetically add the following inert ingredient 
to the table in paragraph (a) 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) * * *

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                   Pesticide chemical                        CAS Reg. No.                   Limits
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                                                  * * * * * * *
FD&C Yellow No. 5.......................................          1934-21-0  When ready for use, the end-use
                                                                              concentration is not to exceed
                                                                              1000 ppm.
 
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[FR Doc. 2013-23391 Filed 9-25-13; 8:45 am]
BILLING CODE 6560-50-P