FD&C Blue No. 1; Exemption From the Requirement of a Tolerance, 58886-58890 [2013-23371]

Agencies

• ENVIRONMENTAL PROTECTION AGENCY

[Federal Register Volume 78, Number 186 (Wednesday, September 25, 2013)]
[Rules and Regulations]
[Pages 58886-58890]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2013-23371]


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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[EPA-HQ-OPP-2012-0568; FRL-9396-1]


FD&C Blue No. 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 FD&C Blue No. 1 (CAS Reg. No. 3844-45-9) 
when used as an inert ingredient (dye) in pesticides formulation 
applied to growing crops (seed treatment). Exponent on behalf of 
Sensient Colors, LLC submitted a petition to EPA under the Federal 
Food, Drug, and Cosmetic Act (FFDCA), requesting establishment of an 
exemption from the requirement of a tolerance. This regulation 
eliminates the need to establish a maximum permissible level for 
residues of FD&C Blue No. 1.

DATES: This regulation is effective September 25, 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) number EPA-HQ-OPP-2012-0568, is available at https://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 https://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: 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).

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 https://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-2012-0568 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-2012-0568, by one of 
the following methods:
     Federal eRulemaking Portal: https://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.

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     Hand Delivery: To make special arrangements for hand 
delivery or delivery of boxed information, please follow the 
instructions at https://www.epa.gov/dockets/contacts.html.
    Additional instructions on commenting or visiting the docket, along 
with more information about dockets generally, is available at https://www.epa.gov/dockets.

II. Petition for Exemption

    In the Federal Register of August 22, 2012 (77 FR 50661) (FRL-9358-
9), EPA issued a document pursuant to FFDCA section 408, 21 U.S.C. 
346a, announcing the filing of a pesticide petition (PP 2E8004) by 
Exponent (1150 Connecticut Ave. NW., Suite 1100, Washington, DC 20036) 
on behalf of Sensient Colors, LLC (2515 N. Jefferson Ave., St. Louis, 
MO 63106). The petition requested that 40 CFR 180.920 be amended by 
establishing an exemption from the requirement of a tolerance for 
residues of FD&C Blue No. 1 (CAS Reg. No. 3844-45-9) when used as an 
inert ingredient (dye) in pesticide formulations applied to growing 
crops (seed treatment). That document referenced a summary of the 
petition prepared by Exponent on behalf of Sensient Colors, LLC, the 
petitioner, which is available in the docket, https://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 Blue No. 1 including 
exposure resulting from the exemption established by this action. EPA's 
assessment of exposures and risks associated with FD&C Blue No. 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 FD&C Blue No. 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 chemical is also referred to as Brilliant Blue FCF in this 
document, as this name is synonymous with FD&C Blue No. 1.
    FD&C Blue No. 1 is not acutely toxic via the oral route in rats and 
via subcutaneous injection in mice. Long-term studies of the effects of 
the color administered in the diet to dogs, rats and mice did not 
indicate any significant toxic effects. In a chronic dog study, 
treatment at doses up to 200 milligrams/kilogram bodyweight/day (mg/kg 
bw/day) for a time period of 1 year did not show any treatment related 
signs of toxicity or histological abnormalities. In a 2-year study, 
rats fed a diet containing up to 2,000 mg/kg bw/day Brilliant Blue FCF 
showed no evidence of treatment related effects. In a second long term 
study in rats, Brilliant Blue FCF was fed as part of the diet for 75 
weeks. No treatment related effects were found at 1,500 mg/kg bw/day, 
the highest dose tested.
    Lifetime exposure of mice to Brilliant Blue FCF as part of the diet 
did not result in consistent biologically significant, compound related 
adverse effects on behavior, morbidity, mortality, hematology, general 
physical observations or tumor incidence. The NOAEL for this study was 
determined to be 7,354 mg/kg bw/day for male and 8,966 mg/kg bw/day for 
female, the highest doses tested.
    Rats were treated with Brilliant Blue FCF in a chronic toxicity 
study coupled with a reproductive study. The NOAEL was 1,072 mg/kg bw/
day for male rats and 631 mg/kg bw/day for females, based on a 15% 
decrease in terminal mean body weight and decreased survival in high 
dose females. In the reproductive portion of the study, there were no 
compound related effects on fertility, gestation, parturition, 
lactation, pup survival through weaning, or on number of live and 
stillborn pups. The NOAEL was 1,073 mg/kg bw/day male rats and 1,318 
mg/kg bw/day for females.
    Brilliant Blue FCF was fed to three successive generations of male 
and female rats at dose levels up to 1,000 mg/kg bw/day. There were no 
treatment related effects on adult mortality, mating, pregnancy and 
fertility rates, lengths of gestation period, offspring survival or 
sex, litter survival or

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necropsy findings. The NOAEL for this study was 1,000 mg/kg bw/day, the 
highest dose tested. Two additional reproductive studies in rats and 
rabbits did not result fetal toxicity or anomalies at doses up to 2,000 
mg/kg bw/day and 200 mg/kg bw day, respectively.
    Based on the results of the available genotoxicity studies, it was 
concluded that Brilliant Blue FCF is not of concern with respect to 
genotoxicity. A developmental neurotoxicity study also indicates that 
there were no toxicological effects of concern. Immunotoxicity studies 
were not available for review. However, signs of immunotoxicity were 
not observed in any of the available studies conducted at doses above 
the limit dose of 1,000 mg/kg/day. The metabolism of Brilliant Blue FCF 
was determined in multiple studies. In three studies with rats that 
were given Brilliant Blue FCF either via gavage or in the diet, the 
major route of excretion was through the feces with total recoveries at 
a minimum of 92% indicating very limited absorption via oral route of 
exposure. The lack of gastrointestinal absorption and metabolism was 
confirmed by studies in guinea pigs and mice.

B. Toxicological Points of Departure/Levels of Concern

    The available toxicity studies indicate that FD&C Blue No. 1 has a 
very low overall toxicity. A NOAEL of 1,072 mg/kg bw/day for male rats 
and 631 mg/kg bw/day for females can be derived from a chronic toxicity 
study coupled with a reproductive study based on a 15% decrease in 
terminal mean body weight and decreased survival in high dose females. 
However, these results were not reproducible in several other chronic 
longer duration studies at higher doses. Several long-term studies 
indicate a higher NOAEL above the limit dose. Therefore, EPA concludes 
that the existing database does not show a toxic endpoint of concern 
for acute, chronic, and short- and intermediate-term risks, and, 
accordingly, a quantitative risk assessment for FD&C Blue No. 1 is not 
necessary.

C. Exposure Assessment

    1. Dietary exposure from food and feed uses. In evaluating dietary 
exposure to FD&C Blue No. 1, EPA considered exposure under the proposed 
exemption from the requirement of a tolerance. EPA assessed dietary 
exposures from FD&C Blue No. 1 in food as follows: Dietary exposure to 
FD&C Blue No. 1 can occur from eating food treated with pesticide 
formulations containing this inert ingredient. Dietary exposure can 
also occur from eating foods which contain FD&C Blue No. 1 as an 
ingredient. It is widely used as an ingredient in food products such as 
ice cream, bottled food coloring, icings, ice pops, dairy products, 
sweets and drinks. However, since an endpoint of concern for risk 
assessment was not identified, a quantitative dietary exposure 
assessment for FD&C Blue No. 1 was not conducted.
    2. Dietary exposure from drinking water. Dietary exposure from 
drinking water to FD&C Blue No. 1 can occur by drinking water that has 
been contaminated by run-off from a pesticide treated area. Since an 
endpoint for risk assessment was not identified, a quantitative dietary 
exposure assessment from drinking water for FD&C Blue No. 1 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., lawn and garden pest control, indoor pest control, 
termiticides, and flea and tick control on pets). The proposed use of 
FD&C Blue No. 1 as a seed treatment/dye under 40 CFR 180.920 is not 
expected to result in residential exposure to this chemical. 
Residential exposure is possible based on other currently approved 
inert uses of this chemical. However, since there are no toxicological 
effects of concern identified, 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 Blue No. 1 to share a common mechanism of 
toxicity with any other substances, and FD&C Blue No. 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 FD&C 
Blue No. 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 https://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.
    The available toxicity studies suggest low toxicity of FD&C Blue 
No. 1. The toxicity database for FD&C Blue No. 1 contains an acute oral 
toxicity study, sub-chronic and chronic toxicity studies, including 
carcinogenicity, reproductive and developmental toxicity studies. No 
reproductive or developmental toxicity was observed in the modified 
reproduction study, 3-generation reproduction study and developmental 
toxicity studies in rats and rabbits. The database also contains 
mutagenicity studies, neurotoxicity data and metabolism data. There is 
no indication, based upon the available data, that FD&C Blue No. 1 is a 
neurotoxic or immunotoxic chemical or results in increased qualitative 
or quantitative susceptibility in infants or children. Based on this 
information, there is no concern, at this time, for increased 
sensitivity to infants and children to this chemical when used as inert 
ingredient in pesticides formulations. Due to the lack of toxicity of 
FD&C No. 1, EPA did not use safety factors in qualitatively assessing 
its risk, and, 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 Blue 
No. 1, EPA has determined that there is a reasonable certainty that no 
harm will result to the general population, or to infants and children, 
from aggregate exposure to FD&C Blue No. 1 residues under reasonably 
foreseeable circumstances. Therefore, the establishment of an exemption 
from tolerance under 40 CFR 180.920 for residues of FD&C Blue No. 1 
when used

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as an inert ingredient (dye) in pesticide formulations applied to 
growing crops (seed treatment) 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 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 Blue No. 1.

VI. Conclusions

    Therefore, an exemption from the requirement of a tolerance is 
established under 40 CFR 180.920 for FD&C Blue No. 1 (CAS Reg. No. 
3844-45-9) when used as an inert ingredient (dye) in pesticide 
formulations applied to growing crops (seed treatment).

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: 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.  180.920, alphabetically add the following inert ingredient 
to the table, after the entry for Europic chloride and before the entry 
for FD&C Blue No. 1, methyl-polyethylene glycol derivative (CAS Reg. 
No. 9079-34-9), to read as follows:


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

* * * * *

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           Inert ingredients                       Limits                                Uses
----------------------------------------------------------------------------------------------------------------
 
                                                  * * * * * * *
FD&C Blue No. 1 (CAS Reg. No. 3844-45-   For seed treatment use      Dye, coloring agent
 9).                                      only.
 
                                                  * * * * * * *
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[FR Doc. 2013-23371 Filed 9-24-13; 8:45 am]
BILLING CODE 6560-50-P