Document ID: EPA-HQ-OPP-2005-0486-0001
Agency: epa
Document Type: Rule
Title: FD&C Blue No. 1 PEG Derivatives; Exemptions from the Requirement of a Tolerance
Posted Date: 2006-04-12T14:02:50Z

[Federal Register: April 12, 2006 (Volume 71, Number 70)]
[Rules and Regulations]               
[Page 18635-18642]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr12ap06-10]                         

-----------------------------------------------------------------------

ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[EPA-HQ-OPP-2005-0486; FRL-7765-1]

 
FD&C Blue No. 1 PEG Derivatives; Exemptions from the Requirement 
of a Tolerance

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

-----------------------------------------------------------------------

[[Page 18636]]

SUMMARY: This regulation establishes two exemptions from the 
requirement of a tolerance for residues of FD&C Blue No. 1 Polyethylene 
Glycol (PEG) Derivative and FD&C Blue No. 1, Methyl-PEG Derivative when 
used as inert ingredients (dye or coloring agent) in a seed-treatment 
pesticide product. Milliken submitted a petition to EPA under the 
Federal Food, Drug, and Cosmetic Act (FFDCA), as amended by the Food 
Quality Protection Act of 1996 (FQPA), requesting 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, 
PEG Derivative and FD&C Blue No. 1, Methyl-PEG Derivative.

DATES: This regulation is effective April 12, 2006. Objections and 
requests for hearings must be received on or before June 12, 2006.

ADDRESSES: To submit a written objection or hearing request follow the 
detailed instructions as provided in Unit XI. of the SUPPLEMENTARY 
INFORMATION. EPA has established a docket for this action under docket 
identification (ID) number EPA-HQ-OPP-2005-0486. All documents in the 
docket are listed on the http://www.regulations.gov website. EDOCKET, EPA's 

electronic public docket and comment system was replaced on November 
25, 2005, by an enhanced federal-wide electronic docket management and 
comment system located at http://www.regulations.gov/. Follow the on-

line instructions. Although listed in the index, some information is 
not publicly available, i.e., CBI or other information whose disclosure 
is restricted by statute. Certain other material, such as copyrighted 
material, is not placed on the Internet and will be publicly available 
only in hard copy form. Publicly available docket materials are 
available either electronically in EDOCKET or in hard copy at the 
Public Information and Records Integrity Branch (PIRIB), Rm. 119, 
Crystal Mall 2, 1801 S. Bell St., Arlington, VA. This docket 
facility is open from 8:30 a.m. to 4 p.m., Monday through Friday, 
excluding legal holidays. The docket telephone number is (703) 305-
5805.

FOR FURTHER INFORMATION CONTACT: Kathryn Boyle, Registration Division 
(7505C), Office of Pesticide Programs, Environmental Protection Agency, 
1200 Pennsylvania Ave., NW., Washington, DC 20460-0001; telephone 
number: (703) 305-6304; e-mail address: boyle.kathryn@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. 
Potentially affected entities may include, but are not limited to:
     Crop production (NAICS code 111).
     Animal production (NAICS code 112).
     Food manufacturing (NAICS code 311).
     Pesticide manufacturing (NAICS code 32532).
    This listing is not intended to be exhaustive, but rather provides 
a guide for readers regarding entities likely to be affected by this 
action. Other types of entities not listed in this unit could also be 
affected. The North American Industrial Classification System (NAICS) 
codes have been provided to assist you and others in determining 
whether this action might apply to certain entities. If you have any 
questions regarding the applicability of this action to a particular 
entity, consult the person listed under FOR FURTHER INFORMATION 
CONTACT.

B. How Can I Access Electronic Copies of this Document and Other 
Related Information?

    In addition to using EDOCKET (http://www.epa.gov/edocket/), you may 

access this Federal Register document electronically through the EPA 
Internet under the ``Federal Register'' listings at http://www.epa.gov/fedrgstr/.
 A frequently updated electronic version of 40 CFR part 180 

is available at E-CFR Beta Site Two at http://www.gpoaccess.gov/ecfr/.

II. Background and Statutory Findings

    In the Federal Register of August 29, 1997 (62 FR 45804) (FRL-5738-
2), EPA issued a notice pursuant to section 408 of the FFDCA, 21 U.S.C. 
346a, as amended by the FQPA (Public Law 104-170), announcing the 
filing of a pesticide petition (PP 5E4597) by Milliken and Company, Box 
1927, Spartanburg, SC 29304-1927. That notice included a summary of the 
petition prepared by the petitioner.
    The petition requested that 40 CFR 180.1001(c) now redesignated as 
40 CFR 180.910 be amended by establishing exemptions from the 
requirement of a tolerance for residues of three PEG-modified dyes to 
impart color to pesticidally-treated seeds. The two dyes subject to 
this final rule are poly(ethylene glycol) modified FD&C Blue No. 1 and 
methyl-poly(ethylene glycol) modified FD&C Blue No. 1. The third dye 
has been withdrawn by the petitioner. In the Federal Register of 
October 8, 1997 (62 FR 52563) (FRL-5746-7), EPA issued a notice of 
correction to specify that the concentration of the dyes in a 
formulated pesticide product would not ``exceed 1 to 5% of the final 
formulation.''
    Methyl-polyethylene glycol modified FD&C Blue No. 1 is also known 
as FD&C Blue No. 1 methyl-PEG derivative or poly(oxy-1,2-ethanediyl), 
[alpha], [alpha]', [alpha]'', [alpha]'''-[[2-
sulfophenyl)methyliumylidene]bis[(3-methyl-4,1-phenylene)nitrolodi-2, 
1-ethanediyl]]tetrakis[.omega.-hydroxy-, chloride, monosodium salt. 
(CAS Reg. No. 9079-34-9).
    Polyethylene glycol modified FD&C Blue No. 1 is also known as FD&C 
Blue No. 1 PEG derivative or poly(oxy-1,2-ethanediyl), [alpha], 
[alpha]', [alpha]'', [alpha]'''-[[2-
sulfophenyl)methyliumylidene]bis[(4,1-phenylene)nitrolodi-2, 1-
ethanediyl]]tetrakis[.omega.-hydroxy-, chloride, monosodium salt. (CAS 
Reg. No. 9079-33-8).
    There were no comments received in response to the notice of filing 
or the notice of correction.
    Most pesticide products that are applied to field crops do not 
contain a dye or coloring agent. Dyes or colorants that are 
incorporated into pesticide products used on field crops are often used 
as alerting agents. For example, a dormancy breaker pesticide product 
may be colored so that the applicator can see which branches have been 
sprayed and which have not. Another use of dyes in a pesticide product 
is to color pesticidally-treated seeds. Under 40 CFR 153.155 seed-
treatment pesticide products must contain a dye ``to impart an 
unnatural color to the seed'' so that the treated seed is not confused 
with food or feed stocks. The use pattern requested by the petitioner 
is very limited, that of seed-treatment and at a concentration in the 
pesticide product that is not to exceed 5%. The Agency has determined 
to establish this tolerance exemption in 40 CFR 180.920 (pre-harvest 
uses only), as this is a more appropriate placement for a chemical that 
is only to be used as a seed-treatment.
    Both of the FD&C Blue No. 1 derivatives are manufactured via the 
attachment of varying lengths of polyethylene glycol side-chains to 
FD&C Blue No. 1. This process results in a polymeric-type of matrix.
    For use in pesticide products, the Agency has determined that the 
molecular weight of these PEG derivatives of FD&C Blue No. 1 must be 
greater than 1,000 amu. It is possible for

[[Page 18637]]

a polyethylene glycol chain to act as a surfactant, but only if the 
chain is shortened. If the PEG side chains that are attached to the 
FD&C Blue No. 1 are too short, then there is the possibility that these 
dyes could begin to act as a surfactant. The Agency has considered the 
use of these chemicals only as dyes or coloring agents, and does not 
intend for their use as surfactants. The Agency believes that the 
molecular weight limitation of greater than 1,000 amu will assure that 
the side-chains are of adequate length.
    Section 408(b)(2)(A)(i) of the 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 the 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 the 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 performs a number of analyses to determine the risks from 
aggregate exposure to pesticide residues. First, EPA determines the 
toxicity of pesticides. Second, EPA examines exposure to the pesticide 
through food, drinking water, and through other exposures that occur as 
a result of pesticide use in residential settings.

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. Toxicological Profile

    Consistent with section 408(b)(2)(D) of the FFDCA, EPA has reviewed 
the available scientific data and other relevant information in support 
of this action and considered its validity, completeness and 
reliability and the relationship of this information 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. The nature of the toxic effects caused 
by FD&C Blue No. 1 PEG derivative and FD&C Blue No. 1 methyl-PEG 
derivative are discussed in this unit.
    The two chemicals considered today in this final rule are derived 
from FD&C Blue No. 1 via the attachment of side-chains which are 
composed of multiple (repeating) units of ethylene glycol. For this 
action FD&C Blue No. 1 is used as surrogate data for these PEG 
derivative chemicals. Both of the derivatives of FD&C Blue No. 1 are 
considered to be no more toxic and as explained below are likely to be 
even less toxic than that of FD&C Blue No. 1, per se.

A. Toxicity of FD&C Blue No. 1

    FD&C Blue No. 1 (CAS Reg. No. 3844-45-9) is also known as CI Acid 
Blue 9, disodium salt; CI No. 42090; and Brillant Blue FCF. FD&C Blue 
No. 1 has been extensively studied over a number of years in different 
toxicity studies using different routes of exposure. A search of the 
open literature was conducted for EPA by the Department of Energy's 
Oakridge National Laboratory (ORNL). ORNL prepared summaries of that 
information which served as the basis for the Agency's December 2005 
assessment of FD&C Blue No. 1 for the purpose of tolerance 
reassessment.
    The petitioner for this action submitted to the Agency two FDA 
memos dated January 12, 1968 and May 10, 1982 which contain the results 
of FDA's review and analysis of the data which were used to support the 
1982 Acceptable Daily Intake (ADI). Comparison of these memos to the 
information from the open literature indicate that the database used by 
EPA for the purposes of tolerance reassessment and the database used by 
FDA are much the same.
    Table 1 summarizes various oral toxicity studies reviewed and 
evaluated by the Food and Drug Administration (FDA), BIBRA, and the 
World Health Organization, as well as summaries taken from open 
literature. The two FDA memos, FDA's final rule on FD&C Blue No. 1 
published in the Federal Register of September 28, 1982 (47 FR 42563), 
and EPA's Tolerance Reassessment Document are all placed in the docket 
for this action. (see http://www.regulations.gov).

               Table 1.--FD&C Blue No. 1 Toxicity Studies
------------------------------------------------------------------------
               Study Type                             Results
------------------------------------------------------------------------
2-year (oral) rat                         Test animals received 0.0,
                                           0.5, 1.0, 2.0, or 5.0% of
                                           FD&C Blue No. 1 in the diet.
                                          The 5% FD&C Blue No. 1 was a
                                           ``no effect level'' Note that
                                           5% (50,000 ppm) in the diet
                                           is approximately equivalent
                                           to 2.5 g/kg/day.
                                          This study served as the basis
                                           for the WHO ADI.
------------------------------------------------------------------------
75-week (oral) rat                        Test animals received 0.0,
                                           0.03, 0.3, or 3.0% of
                                           Brillant Blue FCF in the
                                           diet.
                                          The color had no adverse
                                           effect on food consumption,
                                           food efficiency, and growth
------------------------------------------------------------------------
1-year (oral) dog                         FD&C Blue was fed in the diet
                                           at levels of 0, 1, or 2%.
                                          The 2% FD&C Blue No. 1 was a
                                           ``no effect'' level. Note
                                           that 2% (20,000 ppm) in the
                                           diet, is approximately
                                           equivalent to 500 mg/kg/day.
------------------------------------------------------------------------

[[Page 18638]]

Metabolism (oral) rat                     Adult rats were given 200 mg/
                                           kg FD&C Blue No. 1. Urine and
                                           feces were collected for 36
                                           hours.
                                          ``The color was almost
                                           completely excreted unchanged
                                           in the feces, an average of
                                           96 +/-2.16% having been
                                           recovered. None of the color
                                           was found in the urine.''
------------------------------------------------------------------------
3-generation reproductive (oral) rat      No adverse effects observed
                                           with dietary doses of up to
                                           about 1 g/kg/day
------------------------------------------------------------------------
Developmental (stomach tube) rat          Pregnant rats were given 0.2,
                                           0.6, or 2 g/kg/day on
                                           gestation days 6 to 15.
                                          No convincing signs of
                                           maternal or fetal toxicity
------------------------------------------------------------------------
2-year chronic (within-utero phase)       Test animals received 0, 0.1,
 (oral) rat                                1.0, or 2.0% Brillant Blue
                                           FCF in the diet.
                                          There were no significant
                                           differences in reproduction/
                                           fertility data between
                                           control and treated animals
                                          A no-effect level of 2% (1,200
                                           mg/kg/day) was determined.
                                          FDA determined that FD&C Blue
                                           No. 1 is not carcinogenic in
                                           the rat after lifetime
                                           dietary exposures of 2.0%.
                                          This study served as the basis
                                           for the FDA ADI
------------------------------------------------------------------------
2-year (oral) mouse                       Test animals received 0, 0.5,
                                           1.5, or 5.0% Brilliant Blue
                                           FCF in the diet.
                                          There were no statistically
                                           significant effects observed
                                           in any of the parameters
                                           examined. The no-effect level
                                           is 5.0% (7,354 mg/kg/day
                                           (male) and 8,966 mg/kg/day
                                           (female).
                                          FDA determined that FD&C Blue
                                           No. 1 is not carcinogenic in
                                           the mouse after lifetime
                                           dietary exposures of 5.0%.
------------------------------------------------------------------------

B. Toxicity of the PEG Derivatives of FD&C Blue No. 1

    The petitioner also submitted several toxicity studies conducted 
using the PEG FD&C Blue No. 1 Derivatives as the test substance. The 
results of these studies are in Table 2:

        Table 2.--FD&C Blue No. 1 PEG-Derivative Toxicity Studies
------------------------------------------------------------------------

------------------------------------------------------------------------
Acute Oral Toxicity in the Rat            The estimated acute oral LD50
                                           for FD&C Blue No. 1 methyl-
                                           PEG Derivative is greater
                                           than 5,000 mg/kg.
------------------------------------------------------------------------
Dermal Irritation in the Rabbit           No erythema, edema, or other
                                           dermal effects were noted at
                                           any of the test sites during
                                           the study.
------------------------------------------------------------------------
Mutagenicity--in Vitro Transformation of  The FD&C Blue No. 1 PEG
 Balb/3T3 Cells Assay                      Derivative ``did not induce
                                           the appearance of a
                                           significant number of
                                           transformed foci over the
                                           concentration range of 7.2 to
                                           5.38 [mu]L/mL. This
                                           concentration range
                                           corresponded to approximately
                                           85% to near 10% survival in
                                           the preliminary cytotoxicity
                                           test.''
------------------------------------------------------------------------
Mutagenicity--Mouse Lymphoma Forward      The FD&C Blue No. 1 PEG
 Mutation Assay                            Derivative ``did not induce
                                           significant increases in the
                                           mutant frequency at the TK
                                           locus in L5178Y mouse
                                           lymphoma cells. The test
                                           material was assayed up to 10
                                           [mu]L/mL without inducing
                                           significant increases in the
                                           background.''
------------------------------------------------------------------------
Mutagenicity - Salmonella/Mammalian-      Under the conditions of this
 Microsome Reverse Mutation Assay (Ames    study, FD&C Blue No. 1 methyl-
 Test)                                     PEG derivative, ``did not
                                           cause a positive increase in
                                           the number of histidine
                                           revertants per plate of any
                                           of the tester strains either
                                           in the presence or absence
                                           of'' S9 activation.
------------------------------------------------------------------------

C. Toxicity of Polyethylene Glycol (PEG) Side Chains

    As previously discussed, the side-chains of the PEG derivatives of 
FD&C Blue No. 1 are composed of multiple (repeating) units of ethylene 
glycol. A group of ethylene glycol chemicals represented by the generic 
structure, HO(CH2CH2O)nH where n = 1-5 has been reviewed and evaluated 
by the Organization for Economic Cooperation and Development (OECD). 
The agreed upon conclusions and recommendations of OECD's Screening 
Information Dataset Initial Assessment Profile (SIAP) are available via 
the internet (see http://cs3-hq.oecd.org/scripts/hpv/Home.asp using 

ethylene glycols as the search term). The SIAP contains summarized 
results of OECD's review of various toxicity studies performed using 
ethylene glycol or a chain of ethylene glycol varying from 2 to 5 
units. According to the SIAP, ``[a]vailable data and modeling confirm 
that as the molecular weight increases, the potential for systemic, 
reproductive, and developmental toxicity decreases''. Thus, 
pentaethylene glycol (5 units) would be the least toxic of all the 
ethylene glycol chemicals evaluated by OECD in this group of chemicals. 
It is of importance to note that the SIAP also indicated that larger ( 
n= 6-8) ethylene glycol chemicals were deliberately excluded from this 
category of

[[Page 18639]]

chemicals, because at . ``n=6-8, absorption from ingestion decreases.'' 
Thus, the larger the ethylene glycol chain, the less the toxicity. The 
Agency believes that the molecular weight limitation of greater than 
1,000 amu will assure that the side-chains are of adequate length.

D. Conclusions

    In its Tolerance Reassessment Document, EPA discusses the low 
toxicity of FD&C Blue No1. This finding was based on the toxicity 
profile which indicated that via the oral route of exposure that FD&C 
Blue No. 1 demonstrated no adverse effects in developmental, 
reproductive, or chronic/carcinogenicity studies. The available 
information also indicates that FD&C Blue No. 1 is not metabolized in 
the mammalian body and that almost 100% of the ingested chemical is 
excreted within 36 hours. The molecular weight of FD&C Blue No. 1 is 
almost 800 amu. Generally, larger molecules are less well absorbed. 
Since both of these derivatives of FD&C Blue No. 1 are, in fact, larger 
than FD&C Blue No. 1, with molecular weights greater than 1,000 amu, 
and displaying characteristics of a polymeric/matrix nature, it is 
likely that the derivatives are even less well-absorbed. Therefore, 
based on their relationship to FD&C Blue No. 1, these PEG derivatives 
are likely to be even less toxic.
    The Agency also notes that these derivatives of FD&C Blue No. 1 
contain PEG or methyl-PEG side chains. The Agency has no definitive 
information on the role of these side-chains in the metabolism of the 
two chemicals considered today. However, the available information in 
the SIAP suggests that the PEG side-chains are not readily metabolized.
    Given the data in Table 2, FD&C Blue No. 1, PEG derivative and FD&C 
Blue No. 1, methyl-PEG derivative are of low oral and dermal acute 
toxicity. These two chemicals are not mutagenic. Given the available 
toxicity information on FD&C Blue No. 1 and on chains of polyethylene 
glycol, the Agency believes that FD&C Blue No. 1, PEG derivative and 
FD&C Blue No. 1, methyl-PEG derivative of molecular weight greater than 
1,000 amu are not well-absorbed in the mammalian body and therefore are 
not likely to be carcinogenic, or to cause adverse developmental or 
reproductive effects.

V. Aggregate Exposures

    In examining aggregate exposure, section 408 of the FFDCA directs 
EPA to consider available information concerning exposures from the 
pesticide residue in food and all other non-occupational exposures, 
including drinking water from ground water or surface water and 
exposure through pesticide use in gardens, lawns, or buildings 
(residential and other indoor uses).

A. Dietary Exposure

    1. Food. As part of its review and analysis of FD&C Blue No. 1, FDA 
not only evaluated various toxicity studies (Table 1), but also 
estimated ADIs. In 1968, the ADI was estimated as 300 mg/person/day or 
5 mg/kg/day. In 1982, as a result of its review of additional toxicity 
studies, the ADI was re-estimated as 717.6 mg/day or 12 mg/kg/day.
    There is the potential for exposures through food and drinking 
water resulting from the use of FD&C Blue No. 1 PEG derivative and FD&C 
Blue No. 1 methyl-PEG derivative in a pesticide product. Given the 
Agency's experience with its generic inert ingredient modeling, as 
evidenced by the discussion in the FD&C Blue No. 1 Tolerance 
Reassessment Document, and in light of the low percents in the 
formulation for dyes that are used in pesticide products, the Agency 
believes that potential dietary exposures through food would be much 
less than FDA's ADI for FD&C Blue No. 1.
    2. Drinking water exposure.Since the PEG-derivatives of FD&C Blue 
No. 1 are only to be used in seed treatment products, exposures will 
occur via applications to ground (both surface and subsurface) and 
subsequent leaching from the seed into the surrounding soil. Transport 
to ground water via leaching and to surface water via the dissolved and 
sorbed phase will then occur. The extent to which the substance is 
available for leaching and runoff will be controlled by the rate of 
leaching from the seed. It is important to note that the formulation of 
dyes, such as FD&C Blue No. 1 into a polyethylene glycol matrix is to 
minimize ``bleeding'' of the dye into the surrounding area.
    The environmental fate of FD&C Blue No. 1 PEG derivative and FD&C 
Blue No. 1 methyl-PEG derivative is highly uncertain because of the 
polymeric type of matrix, and the varying lengths of the chains of 
polyethylene glycol incorporated into the matrix. No physical-chemical 
properties and no environmental transformation and/or occurrence data 
were located in the readily available open literature. Therefore, the 
Agency's assessment is based on projected physical/chemical properties, 
and two modified Zahn-Wellens Ready Biodegradability tests supplied by 
the petitioner. The results of these two studies indicate that these 
derivatives of FD&C Blue No. 1 are not expected to rapidly biodegrade 
in the environment; the studies indicated very little degradation, 
approximately 20 percent over a 42 day test period. Degradation reached 
a plateau at about day 28 of the study. Therefore, primary degradation 
is likely to occur on the order of months and ultimate degradation 
(mineralization) on the order of many months. Both of these PEG 
derivatives of FD&C Blue No. 1 are classified as not readily 
biodegradable.
    Because of the difficulties in ascertaining a representative 
molecular structure, the estimated fate and potential exposures are 
deemed uncertain; however, the Agency has used a bounding approach that 
should not under-estimate the potential exposures to the two PEG 
derivatives of FD&C Blue No. 1. The PEG derivatives of FD&C Blue No. 1 
are likely to be dispersible in water, nonvolatile, and not very 
mobile. Leaching to ground water is not expected to be appreciable. The 
Agency believes that the likelihood of these two chemicals reaching 
surface water is limited, and the likelihood of reaching ground water 
and bioaccumulating in the environment is even more limited.

B. Other Non-Occupational Exposure

    As part of its evaluation, FDA also estimated a maximum 
(conservative) daily intake of 35.4 mg/person/day (or 0.59 mg/kg/day) 
for exposure via food, dietary supplements, drugs, and cosmetics for 
FD&C Blue No. 1.
    The available information indicates that neither of these PEG 
derivatives of FD&C Blue No. 1 are as widely used in consumer products 
as FD&C Blue No. 1. Therefore, the exposures that could occur from the 
use of these PEG derivatives in either residential pesticidal or 
consumer non-pesticidal products is expected to be much less than that 
estimated for FD&C Blue No. 1.

VI. Cumulative Effects

    Unlike other pesticides for which EPA has followed a cumulative 
risk approach based on a common mechanism of toxicity, EPA has not made 
a common mechanism of toxicity finding for FD&C Blue No. 1, PEG 
derivative and FD&C Blue No. 1, methyl-PEG derivative. These chemicals 
are structurally-related to FD&C Blue No. 1, which is considered over-
all to be a chemical of lower toxicity. EPA has assessed exposure and 
risk to FD&C Blue No. 1 generally. These chemicals do not appear to 
produce any toxic metabolite produced by other substances. For the

[[Page 18640]]

purposes of this tolerance action, therefore, EPA has not assumed that 
FD&C Blue No. 1, FD&C Blue No. 1, PEG derivative and FD&C Blue No. 1, 
methyl-PEG derivative 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 the policy statements 
released by EPA's Office of Pesticide Programs concerning common 
mechanism determinations and procedures for cumulating effects from 
substances found to have a common mechanism on EPA's website at http://www.epa.gov/pesticides/cumulative/
.

VII. Safety Factor for Infants and Children

    FFDCA section 408 provides that EPA shall apply an additional 
tenfold 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 unless EPA concluded that a different 
margin of safety will be safe for infants and children.
    Using the available data on FD&C Blue No. 1, PEG derivative and 
FD&C Blue No. 1, methyl-PEG derivative and the surrogate data on FD&C 
Blue No. 1, these chemicals over-all present as chemicals of lower 
toxicity. In a FD&C Blue No. 1 reproductive toxicity study reviewed and 
evaluated by FDA, there were no ``significant differences in 
reproduction/fertility data between control and treated animals.'' The 
exposure pattern considered in this final rule is that of seed-
treatment only and at a low percent in the formulation. Due to the 
expected low oral toxicity, and considering the low potential for 
exposure, a safety factor analysis has not been used to assess the risk 
of FD&C Blue No. 1, PEG derivative and FD&C Blue No. 1, methyl-PEG 
derivative. For the same reasons, the additional tenfold safety factor 
for the protection of infants and children is unnecessary.

VIII. Determination of Safety for U.S. Population, and Infants and 
Children

    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.
    Based on the available toxicity data, EPA believes that FD&C Blue 
No. 1, PEG derivative and FD&C Blue No. 1, methyl-PEG derivative are 
chemicals of lower oral toxicity, and that exposure to residues from 
these pesticide chemicals under reasonably forseeable circumstances 
will pose no appreciable risk to human health. Therefore, EPA concludes 
that there is a reasonable certainty of no harm from aggregate exposure 
to residues of FD&C Blue No. 1, PEG derivative (CAS Reg. No. 9079-33-8) 
and FD&C Blue No. 1, methyl-PEG derivative (CAS Reg. No. 9079-34-9). 
EPA finds that establishing exemptions from the requirement of a 
tolerance for FD&C Blue No. 1, PEG derivative (CAS Reg. No. 9079-33-8) 
and FD&C Blue No. 1, methyl-PEG derivative (CAS Reg. No. 9079-34-9) 
will be safe for the general population including infants and children.

IX. Other Considerations

A. Endocrine Disruptors

    FQPA requires EPA to develop a screening program to determine 
whether certain substances, including all pesticide chemicals (both 
inert and active ingredients), ``may have an effect in humans that is 
similar to an effect produced by a naturally occurring estrogen, or 
such other endocrine effect * * * '' EPA has been working with 
interested stakeholders to develop a screening and testing program as 
well as a priority setting scheme. As the Agency proceeds with 
implementation of this program, further testing of products containing 
FD&C Blue No. 1, PEG derivative (CAS Reg. No. 9079-33-8) and FD&C Blue 
No. 1, methyl-PEG derivative (CAS Reg. No. 9079-34-9) for endocrine 
effects may be required.

B. Analytical Method(s)

    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.

C. Existing Exemptions

    There are no existing tolerances or tolerance exemptions for FD&C 
Blue No. 1, PEG derivative (CAS Reg. No. 9079-33-8) and FD&C Blue No. 
1, methyl-PEG derivative (CAS Reg. No. 9079-34-9)

D. International Tolerances

    The Agency is not aware of any country requiring a tolerance for 
FD&C Blue No. 1, PEG derivative (CAS Reg. No. 9079-33-8) and FD&C Blue 
No. 1, methyl-PEG derivative (CAS Reg. No. 9079-34-9) nor have any 
CODEX Maximum Residue Levels (MRLs) been established for any food crops 
at this time.

X. Conclusions

    Accordingly, two exemptions from the requirement for a tolerance 
are established for FD&C Blue No. 1, polyethylene glycol derivative 
(CAS Reg. No. 9079-33-8) and FD&C Blue No. 1, methyl-polyethylene 
glycol derivative (CAS Reg. No. 9079-34-9). These exemptions are 
limited to seed treatment only, the concentration is not to exceed 5% 
of the formulated pesticide product, and number average molecular 
weight must be greater than 1,000 amu.

XI. Objections and Hearing Requests

    Under section 408(g) of the FFDCA, as amended by the FQPA, any 
person may file an objection to any aspect of this regulation and may 
also request a hearing on those objections. The EPA procedural 
regulations which govern the submission of objections and requests for 
hearings appear in 40 CFR part 178. Although the procedures in those 
regulations require some modification to reflect the amendments made to 
the FFDCA by the FQPA, EPA will continue to use those procedures, with 
appropriate adjustments, until the necessary modifications can be made. 
The new section 408(g) of the FFDCA provides essentially the same 
process for persons to ``object'' to a regulation for an exemption from 
the requirement of a tolerance issued by EPA under new section 408(d) 
of the FFDCA, as was provided in the old FFDCA sections 408 and 409 of 
the FFDCA. However, the period for filing objections is now 60 days, 
rather than 30 days.

A. What Do I Need to Do to File an Objection or Request a Hearing?

    You must file your objection or request a hearing on this 
regulation in accordance with the instructions provided in this unit 
and in 40 CFR part 178. To ensure proper receipt by EPA, you must 
identify docket ID number EPA-HQ-OPP-2005-0486 in the subject line on 
the first page of your submission. All requests must be in writing, and 
must be mailed or

[[Page 18641]]

delivered to the Hearing Clerk on or before June 12, 2006.
    1. Filing the request. Your objection must specify the specific 
provisions in the regulation that you object to, and the grounds for 
the objections (40 CFR 178.25). If a hearing is requested, the 
objections must include a statement of the factual issue(s) on which a 
hearing is requested, the requestor's contentions on such issues, and a 
summary of any evidence relied upon by the objector (40 CFR 178.27). 
Information submitted in connection with an objection or hearing 
request may be claimed confidential by marking any part or all of that 
information as CBI. Information so marked will not be disclosed except 
in accordance with procedures set forth in 40 CFR part 2. A copy of the 
information that does not contain CBI must be submitted for inclusion 
in the public record. Information not marked confidential may be 
disclosed publicly by EPA without prior notice.
    Mail your written request to: Office of the Hearing Clerk (1900L), 
Environmental Protection Agency, 1200 Pennsylvania Ave., NW., 
Washington, DC 20460-0001. You may also deliver your request to the 
Office of the Hearing Clerk in Suite 350, 1099 14th St., NW., 
Washington, DC 20005. The Office of the Hearing Clerk is open from 8 
a.m. to 4 p.m., Monday through Friday, excluding legal holidays. The 
telephone number for the Office of the Hearing Clerk is (202) 564-6255.
    2. Copies for the Docket. In addition to filing an objection or 
hearing request with the Hearing Clerk as described in Unit XI.A., you 
should also send a copy of your request to the PIRIB for its inclusion 
in the official record that is described in ADDRESSES. Mail your 
copies, identified by docket ID number EPA-HQ-OPP-2005-0486, to: Public 
Information and Records Integrity Branch, Information Resources and 
Services Division (7502C), Office of Pesticide Programs, Environmental 
Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460-
0001. In person or by courier, bring a copy to the location of the 
PIRIB described in ADDRESSES. Please use an ASCII file format and avoid 
the use of special characters and any form of encryption. Copies of 
electronic objections and hearing requests will also be accepted on 
disks in WordPerfect 6.1/8.0 or ASCII file format. Do not include any 
CBI in your electronic copy. You may also submit an electronic copy of 
your request at many Federal Depository Libraries.

B. When Will the Agency Grant a Request for a Hearing?

    A request for a hearing will be granted if the Administrator 
determines that the material submitted shows the following: There is a 
genuine and substantial issue of fact; there is a reasonable 
possibility that available evidence identified by the requestor would, 
if established resolve one or more of such issues in favor of the 
requestor, taking into account uncontested claims or facts to the 
contrary; and resolution of the factual issue(s) in the manner sought 
by the requestor would be adequate to justify the action requested (40 
CFR 178.32).

XII. Statutory and Executive Order Reviews

    This final rule establishes an exemption from the tolerance 
requirement under section 408(d) of the FFDCA 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 rule has been exempted from review under Executive 
Order 12866 due to its lack of significance, this rule is not subject 
to Executive Order 13211, Actions Concerning Regulations That 
Significantly Affect Energy Supply, Distribution, or Use (66 FR 28355, 
May 22, 2001). 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., or impose any enforceable duty or 
contain any unfunded mandate as described under Title II of the 
Unfunded Mandates Reform Act of 1995 (UMRA) (Public Law 104-4). 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); 
or OMB review or any Agency action under Executive Order 13045, 
entitled Protection of Children from Environmental Health Risks and 
Safety Risks (62 FR 19885, April 23, 1997). 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), 
Public Law 104-113, section 12(d) (15 U.S.C. 272 note). Since 
tolerances and exemptions that are established on the basis of a 
petition under section 408(d) of the FFDCA, such as the exemption in 
this final rule, do not require the issuance of a proposed rule, the 
requirements of the Regulatory Flexibility Act (RFA) (5 U.S.C. 601 et 
seq.) do not apply. In addition, the Agency has determined that this 
action will not have a substantial direct effect on States, on the 
relationship between the national government and the States, or on the 
distribution of power and responsibilities among the various levels of 
government, as specified in Executive Order 13132, entitled 
Federalism(64 FR 43255, August 10, 1999). Executive Order 13132 
requires EPA to develop an accountable process to ensure ``meaningful 
and timely input by State and local officials in the development of 
regulatory policies that have federalism implications.'' ``Policies 
that have federalism implications'' is defined in the Executive order 
to include regulations that have ``substantial direct effects on the 
States, on the relationship between the national government and the 
States, or on the distribution of power and responsibilities among the 
various levels of government.'' This final rule directly regulates 
growers, food processors, food handlers and food retailers, not States. 
This action does not alter the relationships or distribution of power 
and responsibilities established by Congress in the preemption 
provisions of section 408(n)(4) of the FFDCA. For these same reasons, 
the Agency has determined that this rule does not have any ``tribal 
implications'' as described in Executive Order 13175, entitled 
Consultation and Coordination with Indian Tribal Governments (65 FR 
67249, November 6, 2000). Executive Order 13175, requires EPA to 
develop an accountable process to ensure ``meaningful and timely input 
by tribal officials in the development of regulatory policies that have 
tribal implications.'' ``Policies that have tribal implications'' is 
defined in the Executive order to include regulations that have 
``substantial direct effects on one or more Indian tribes, on the 
relationship between the Federal Government and the Indian tribes, or 
on the distribution of power and responsibilities between the Federal 
Government and Indian tribes.'' This rule will not have substantial 
direct effects on tribal governments, on the relationship between the 
Federal Government and Indian tribes, or on the distribution of power 
and responsibilities between the Federal Government and Indian tribes, 
as specified in Executive Order 13175. Thus, Executive Order 13175 does 
not apply to this rule.

[[Page 18642]]

XIII. Congressional Review Act

    The Congressional Review Act, 5 U.S.C. 801 et seq., as added by the 
Small Business Regulatory Enforcement Fairness Act of 1996, generally 
provides that before a rule may take effect, the agency promulgating 
the rule must submit a rule report, which includes a copy of the rule, 
to each House of the Congress and to the Comptroller General of the 
United States. 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 this final rule in the Federal Register. This final 
rule 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: March 27, 2006.
Lois Rossi,
Director, Registration Division, Office of Pesticide Programs.

0
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, the table is amended by adding alphabetically the 
following inert ingredients to read as follows:

Sec.  180.920  Exemptions from the requirement of a tolerance.

* * * * *

------------------------------------------------------------------------
        Inert ingredients               Limits               Uses
------------------------------------------------------------------------
                              * * * * * * *
FD&C Blue No. 1, methyl-          For seed treatment  Dye, coloring
 polyethylene glycol derivative    use only; Number    agent
 (CAS Reg. No. 9079-34-9).         average molecular
                                   weight (in amu)
                                   is greater than
                                   1,000; Not to
                                   exceed 5% of the
                                   formulated
                                   pesticide
                                   product.
FD&C Blue No. 1, polyethylene     For seed treatment  Dye, coloring
 glycol derivative (CAS Reg. No.   use only; Number    agent
 9079-33-8).                       average molecular
                                   weight (in amu)
                                   is greater than
                                   1,000; Not to
                                   exceed 5% of the
                                   formulated
                                   pesticide
                                   product.
                              * * * * * * *
------------------------------------------------------------------------

[FR Doc. 06-3307 Filed 4-11-06; 8:45 am]

BILLING CODE 6560-50-S