FD&C Green No. 3; Exemption From the Requirement of a Tolerance
Federal Register, Volume 78 Issue 217 (Friday, November 8, 2013)
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
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:
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General Information
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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).
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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.
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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.
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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.
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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.
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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.
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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-
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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.
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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.
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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:solsolwww.epa.gov/pesticides/cumulative.
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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).
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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.
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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.
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Other Considerations
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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.
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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.
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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.
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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).
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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:
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PART 180--AMENDED
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1. The authority citation for part 180 continues to read as follows:
Authority: 21 U.S.C. 321(q), 346a and 371.
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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).
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(a) * * *
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Pesticide chemical CAS Reg. No. Limits
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FD&C Green No. 3.............. CAS Reg. No. 2353-45- None.
9.
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FR Doc. 2013-26760 Filed 11-7-13; 8:45 am
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