Document ID: EPA-HQ-OPP-2013-0003-0003
Agency: epa
Document Type: Rule
Title: Exemptions From the Requirement of a Tolerance: FD and C Green No. 3
Posted Date: 2013-11-08T05:00Z

[Federal Register Volume 78, Number 217 (Friday, November 8, 2013)]
[Rules and Regulations]
[Pages 67038-67042]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2013-26760]

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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[EPA-HQ-OPP-2013-0003; FRL-9402-7]

FD&C Green No. 3; 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 Green No. 3 (CAS Reg. No. 2353-45-
9) when used as an inert ingredient (dye) in antimicrobial 
formulations, for use on food contact surfaces in public eating places, 
dairy processing equipment, and food processing equipment and utensils. 
The firm Exponent, on behalf of Ecolab 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 FD&C Green No. 3. FD&C Green No. 3 is also known as 
Fast Green FCF.

DATES: This regulation is effective November 8, 2013. Objections and 
requests for hearings must be received on or before January 7, 2014, 
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-2013-0003, 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/.

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: 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).

[[Page 67039]]

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-2013-0003 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 
January 7, 2014. 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-2013-0003, 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.htm.

Additional instructions on commenting or visiting the docket, along 
with more information about dockets generally, is available at http://www.epa.gov/dockets gov/dockets.

II. Petition for Exemption

    In the Federal Register of February 15, 2013 (78 FR 11126) (FRL-
9378-4), EPA issued a document pursuant to FFDCA section 408, 21 U.S.C. 
346a, announcing the filing of a pesticide petition (PP IN-10527) by 
Exponent (1150 Connecticut Ave. NW., Suite 1100; Washington, DC 20036), 
on behalf of Ecolab, Inc., 370 N. Wabasha St., St. Paul, MN 55102. The 
petition requested that 40 CFR 180.940(a) be amended by establishing an 
exemption from the requirement of a tolerance for residues of FD&C 
Green No. 3 (CAS Reg. No. 2353-45-9) when used as an inert ingredient 
(dye) in antimicrobial formulations, for use on food contact surfaces 
in public eating places, dairy processing equipment, and food 
processing equipment and utensils. That document referenced a summary 
of the petition prepared by Exponent, on behalf of Ecolab, 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 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 Green No. 3 including 
exposure resulting from the exemption established by this action. EPA's 
assessment of exposures and risks associated with FD&C Green No. 3 
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 Green No. 3 as well as the no-
observed-adverse-effect-level (NOAEL) and the lowest-observed-adverse-
effect-

[[Page 67040]]

level (LOAEL) from the toxicity studies are discussed in this unit.
    FD&C Green No. 3 is not acutely toxic via the oral route in rats 
and dogs. In a long-term study in mice, there were no treatment-related 
effects on mortality. Histological examination of all animals did not 
reveal any treatment-related lesions. There was also no difference 
between control and treated animals in terms of the incidence of benign 
and malignant neoplasms. The NOAEL was 5% in the diet (equivalent of 
7,500 milligrams/kilogram bodyweight/day (mg/kg bw/day), the highest 
dose tested (HDT).
    Multiple long-term studies in mice, dogs and rats fed diets 
containing FD&C Green No. 3 were conducted. Microscopic examination 
revealed no treatment-related lesions attributable to feeding of the 
color in any of the studies. There were also no treatment-related 
effects on growth or mortality.
    A carcinogenicity study with an in utero phase was conducted with 
Charles-River albino rats. Rats were fed diets containing 0, 1.25, 2.5 
or 5.0% (equivalent to 0, 625, 1,250 and 2,500 mg/kg bw/day) FD&C No. 3 
for 2 months prior to mating and throughout gestation and lactation. 
The NOAEL for carcinogenicity was 5% in the diet (equivalent to 2,500 
mg/kg bw/day; the HDT). No reproductive toxicity was observed at doses 
up to 5% in the diet (equivalent to 2,500 mg/kg bw/day). The NOAEL for 
systemic toxicity in parental animals was 2.5% in the diet (equivalent 
to 1,250 mg/kg bw/day). The NOAEL is based on decreases in food 
consumption and increases in thyroid and kidney weights seen at the 
LOAEL of 5% in the diet. The NOAEL for offspring toxicity was 2.5% in 
the diet (equivalent to 1,250 mg/kg bw/day) based on decreases in pup 
body weight and pup mortality seen at the LOAEL of 5% in the diet 
(equivalent to 2,500 mg/kg bw/day), the HDT.
    A 3-generation reproduction study was completed on FD&C Green No. 3 
in Long-Evans rats at dose levels of 0, 10, 100, 300 or 1,000 mg/kg bw/
day. No treatment-related effects on food consumption, body weight, 
adult mortality, mating performance, pregnancy and fertility rates, 
gestation length, offspring survival, weights and sex, litter survival, 
resorption rates, or necropsy findings were observed in the study. 
There were also no macroscopic or microscopic tissue abnormalities 
attributable to treatment. The NOAEL was 1,000 mg/kg bw/day.
    FD&C Green No. 3 was determined to be non-mutagenic. The metabolism 
potential of FD&C Green No. 3 was tested in rats and dogs. Almost all 
of the color was excreted unchanged in the feces of the rats and no 
color was found in the urine. A smaller portion of the color, not 
exceeding 5% of the given dose, was found in the bile of the dogs.

B. Toxicological Points of Departure/Levels of Concern

    The available toxicity study indicates that FD&C Green No. 3 has a 
very low overall toxicity. The lowest NOAEL in the database is 1,000 
mg/kg bw/day. In the carcinogenicity study with an in utero phase, the 
effects on the pups (decreased body weights and pup mortality) and 
kidney and thyroid toxicity in adults were observed at 5% in diet 
(equivalent to 2,500 mg/kg/day). Since these effects were observed at 
2.5 times the limit dose of 1,000 mg/kg/day, there are low concerns for 
the hazard. Since no endpoint of concern was identified for the acute 
and chronic dietary exposure assessments and short- and intermediate-
term dermal and inhalation exposure assessments, a quantitative risk 
assessment for FD&C Green No. 3 is not necessary.

C. Exposure Assessment

    1. Dietary exposure from food and feed uses. In evaluating dietary 
exposure to FD&C Green No. 3, EPA considered exposure under the 
proposed exemption from the requirement of a tolerance. EPA assessed 
dietary exposures from FD&C Green No. 3 in food as follows: Dietary 
exposure to FD&C Green No. 3 can occur from eating food that has come 
in contact with surfaces treated with pesticide formulations containing 
this inert ingredient. Dietary exposure to FD&C Green No. 3 can also 
occur from eating foods which contain FD&C Green No. 3 as an 
ingredient. However, since an endpoint of concern for risk assessment 
was not identified, a quantitative dietary exposure assessment for FD&C 
Green No. 3 was not conducted.
    2. Dietary exposure from drinking water. Dietary exposure from 
drinking water to FD&C Green No. 3 can occur by drinking water that has 
been contaminated by contact with run-off from pesticide treated areas, 
such as countertops. Since an endpoint for risk assessment was not 
identified, a quantitative dietary exposure assessment from drinking 
water for FD&C Green No. 3 was not conducted.
    3. From non-dietary exposure. From non-dietary exposure. The term 
``residential exposure'' is used in this document to refer to non-
occupational, non-dietary exposure (e.g., for lawn and garden pest 
control, indoor pest control, termiticides, and flea and tick control 
on pets). The proposed use of FD&C Green No. 3 as a dye under 40 CFR 
180.940(a) is expected to result in residential exposure to this 
chemical.
    However, since there are no toxicological effects of concern 
identified in the available database, it is not necessary to conduct 
assessments of residential (non-occupational) exposures and risks. 
There are no dermal or inhalation toxicological endpoints of concern to 
the Agency; therefore, quantitative assessments have not been 
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.''
    EPA has not found FD&C Green No. 3 to share a common mechanism of 
toxicity with any other substances, and FD&C Green No. 3 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 Green No. 3 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:[sol][sol]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 Food Quality Protection Act 
(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.
    In the carcinogenicity study with an in utero phase, the effects on 
the pups (decreased body weights and pup mortality) and kidney and 
thyroid toxicity in adults were observed at 5% in diet (equivalent to 
2,500 mg/kg/day).

[[Page 67041]]

Since these effects were observed at 2.5 times the limit dose of 1,000 
mg/kg/day, there are low concerns for the hazard. Therefore, it is 
concluded that there is no evidence of qualitative or quantitative 
susceptibility of infants and children in the available database.
    The available toxicity studies suggest low toxicity of FD&C Green 
No. 3. The toxicity database for FD&C Green No. 3 contains an acute 
oral toxicity study and chronic toxicity studies, including 
carcinogenicity, and reproductive toxicity studies. No reproductive or 
developmental toxicity was observed in the 3-generation reproduction 
study at the limit dose. The database also contains mutagenicity 
studies, and metabolism data. There is no indication, based upon the 
available data, that FD&C Green No. 3 is a neurotoxic or immunotoxic 
chemical. Due to the lack of toxicity of FD&C Green No. 3, 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 Green 
No. 3, EPA has determined that there is a reasonable certainty that no 
harm to any population subgroup will result from aggregate exposure to 
FD&C Green No. 3 under reasonable foreseeable circumstances. Therefore, 
the establishment of an exemption from the requirement of a tolerance 
under 40 CFR 180.940(a) for residues of FD&C Green No. 3 when used as 
an inert ingredient (dye) in antimicrobial formulations, for use on 
food contact surfaces in public eating places, dairy processing 
equipment, and 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 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 (FAO/WHO) 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 Green No. 3.

VI. Conclusions

    Therefore, an exemption from the requirement of a tolerance is 
established under 40 CFR 180. 940(a) for FD&C Green No. 3 (CAS Reg. No. 
2353-45-9) when used as an inert ingredient (dye) in antimicrobial 
formulations, for use on food contact surfaces in public eating places, 
dairy processing equipment, and food processing equipment and utensils.

VII. Statutory and Executive Order Reviews

    This final rule establishes 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 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 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 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: October 30, 2013.
Lois Rossi,
Director, Registration Division, Office of Pesticide Programs.

    Therefore, 40 CFR chapter I is amended as follows:

[[Page 67042]]

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, in paragraph (a) alphabetically add the following 
inert ingredient 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
------------------------------------------------------------------------
 
                              * * * * * * *
FD&C Green No. 3..............  CAS Reg. No. 2353-45-  None.
                                 9.
 
                              * * * * * * *
------------------------------------------------------------------------

[FR Doc. 2013-26760 Filed 11-7-13; 8:45 am]
BILLING CODE 6560-50-P