[Federal Register Volume 69, Number 102 (Wednesday, May 26, 2004)]
[Rules and Regulations]
[Pages 29890-29894]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 04-11672]


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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[OPP-2004-0056; FRL-7357-6]


Ultramarine Blue; 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 ultramarine blue when used as an inert 
ingredient in pesticide products. Holliday Pigments Limited 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 ultramarine blue.

DATES: This regulation is effective May 26, 2004. Objections and 
requests for hearings must be received on or before July 26, 2004.

ADDRESSES: To submit a written objection or hearing request follow the 
detailed instructions as provided in Unit VIII. of the SUPPLEMENTARY 
INFORMATION. EPA has established a docket for this action under docket 
ID number OPP-2004-0056. All documents in the docket are listed in the 
EDOCKET index at http://www.epa.gov/edocket. Although listed in the 
index, some information is not publicly available, i.e., Confidential 
Business Information (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, 1921 Jefferson Davis Hwy., 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: James Parker, Registration Division 
(7505C), Office of Pesticide Programs, Environmental Protection Agency, 
1200 Pennsylvania Ave., NW., Washington, DC 20460-0001; telephone 
number: (703) 308-0371; e-mail address: [email protected].

SUPPLEMENTARY INFORMATION:

I. General Information

A. Does this Action Apply to Me?

    You may be potentially affected by this action if you are an 
agricultural producer, food manufacturer, or pesticide manufacturer. 
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 March 12, 2003 (68 FR 11843) (FRL-7295-
3), 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 (3E6549) by Holliday Pigments Limited, 
Morley Street, Hull, East Yorkshire, England, HU88DN. That notice 
included a summary of the petition prepared by the petitioner.
    The petition requested that 40 CFR part 180 be amended by 
establishing an exemption from the requirement of a tolerance for 
residues of ultramarine blue, which is also known as C.I. Pigment Blue 
29 (CAS Reg. No. 57455-37-5). There were no comments received in 
response to the notice of filing.

[[Page 29891]]

    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 ploymers 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 ultramarine blue are discussed in this unit. Ultramarines are 
inorganic pigments that are used as dyes. The color of ultramarine 
(blue, pink, green, red, or violet) is determined by the ratios of the 
materials used to manufacture the ultramarine pigment.
    Ultramarine blue is the manufactured or synthetic form of naturally 
occurring Lapis Lazuli. It was first manufactured in the early 1800s. 
The pigment is a complex sulfurized sodium aluminum silicate material 
having an approximate chemical formula of 
Na7Al6Si6O24S3. 
Ultramarine blue is obtained by calcining (thoroughly roasting or 
burning in the presence of oxygen) a mixture of kaolin, sulfur, sodium 
carbonate, and a source of carbon at temperatures above 700 [deg]C. The 
material obtained from this process is crushed, washed, purified, and 
ground.
    Ultramarine blue is known to form a rigid tetrahedra alumino-
silicate framework. Ultramarine blue is insoluble in water and organic 
solvents. Ultramarine blue is stable in alkali (pH 7 or greater) 
environments but decomposes and releases hydrogen sulfide in acidic 
environments. When used as a dye, it is non-migratory and bleed-
resistant, having excellent light fastness and heat stability.

A. Toxicology Studies

    The information available to the Agency consisted of detailed 
information concerning various pre-1981 studies conducted using 
ultramarine blue. The summaries provided sufficient detail for Agency 
evaluation. The available information consisted of the following:
     The acute oral lethal dose (LD)50 for 
ultramarine blue is equal to or greater than 10 grams/kilogram in both 
rats and mice.
     Ultramarine blue was found to be a non-sensitizer in 
guinea pigs and non-irritating in rabbits.
     In a short-term (15-day) study, mice were fed ultramarine 
blue at dose levels of 10,000 milligrams/kilogram/day (mg/kg/day) which 
resulted in no physiological changes or deaths.
     In a 90-day feeding study of rats and mice to ultramarine 
blue at levels up to 10,000 mg/kg/day, there were no adverse effects.
     In another 90-day feeding studying, rats were fed 100, 
1,000, 10,000, and 100,000 parts per million (ppm) (equivalent to 0.01, 
0.1, 1, or 10% of the diet) ultramarine blue, which showed inflammation 
of the GI (gastrointestinal) tract and the presence of siliceous stones 
in kidney and bladder at all dose levels were observed. Histologically, 
no pathological effects were observed in rats after ingestion of 100 or 
1,000 ppm ultramarine blue. At higher concentrations, 10,000 and 
100,000 ppm, there were increased excretion of silica and sodium, and 
pathological effects in the kidneys, stomach, intestine and bladder 
which could be associated with high and prolonged intake of siliceous 
earth.
     A developmental toxicity study showed no maternal deaths 
at any of the administered doses (0, 100, 1,000, 10,000, or 100,000 ppm 
which would be equivalent to 0, 0.01, 0.1, 1, or 10% of the diet). 
Histologically, no pathological effects were observed at 100 or 1,000 
ppm. At higher concentrations (10,000 and 100,000 ppm), there were 
pathological effects in the kidneys, stomach, intestine and bladder 
which could be associated with high and prolonged intake of siliceous 
earth. There was no significant difference in litter size, fetal 
weights, or resorptions between controls and dose level groups. No 
malformations were observed in controls or the highest dose group 
(100,000 ppm). At the 100, 1,000, and 10,000 ppm dose groups, 
malformations in the hind limbs were observed at a ratio of 2/177, 2/
146, and 1/159 fetuses, respectively. These malformations are not 
statistically significant. In both cases where 2 pups had 
malformations, they were from the same mother.
     Ultramarine blue was also shown to be non-mutagenic (via 
Ames assay) using two strains each of Salmonella typhimurium and 
Escherichia coli.
    Taken together, all of the studies indicate that ultramarine blue 
is of low or no toxicological concern. This is consistent with the fact 
that ultramarine blue is insoluble; therefore, it is likely that 
ultramarine blue would be poorly absorbed by any route. The only effect 
of concern occurred in those groups of animals that were fed a diet 
that contained 1% or 10% ultramarine blue. The effects that occurred 
are consistent with those of the body's being over-whelmed by being fed 
large amounts of a siliceous earth material, which describes 
ultramarine blue, a sulfurized sodium aluminum silicate.

B. FDA Evaluation

    Ultramarine blue is approved by the Food and Drug Administration as 
a color additive in cosmetics (21 CFR 73.2725), food contact materials 
(21 CFR 178.3297), and salts intended for animal feed (21 CFR 73.50) 
when used in

[[Page 29892]]

accordance with the following conditions.
    1. Cosmetics. Ultramarine pigments including ultramarine blue may 
be safely used for coloring externally applied cosmetics, including 
cosmetics intended for use in the area of the eye. These pigments are 
exempt from certification.
    2. Food contact materials. Ultramarine blue can be used as 
``colorants in the manufacture of articles or components of articles 
intended for use in producing, manufacturing, packing, processing, 
preparing, treating, packaging, transporting, or holding food.'' In 
this context ``colorant means a dye, pigment, or other substance that 
is used to impart color or to alter the color of a food-contact 
material, but that does not migrate to food in amounts that will 
contribute to that food any color apparent to the naked eye.''
    3. Animal feeds. Ultramarine blue can be used to color salt 
intended for ``animal feed subject to the restriction that the quantity 
of ultramarine blue does not exceed 0.5% by weight of the salt.'' 
Ultramarine blue is exempt from certification.

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).
    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.
    Ultramarine blue has been used world-wide for many years as a 
colorant. It is used to color food-contact plastics and rubber 
(packaging materials), toys, cosmetics including eye shadows and eye 
pencils, wallpaper, paints including children's fingerpaints, modeling 
clays, tile, cement, animal eartags, and salt intended for animal feed. 
Given its use as a colorant the amount of ultramarine blue that would 
be incorporated into any product is limited by the need for a certain 
shade or hue of blue.

A. Dietary Exposure

    1. Food. Due to the insolubility of ultramarine blue, it is not 
likely to be absorbed by any route. The available toxicity information 
indicates that ultramarine blue is of low or no toxicological concern.
    2. Drinking water exposure. Ultramarine blue is likely to absorb 
tightly to soil and not migrate to bodies of water. Due to the 
insolubility of ultramarine blue, it is highly unlikely that it would 
be found in drinking water.

B. Other Non-Occupational Exposure

    Ultramarine blue has many non-food uses including use in: Food-
contact plastics and rubber (packaging materials), toys, cosmetics 
including eye shadows and eye pencils, wallpaper, paints including 
children's fingerpaints, modeling clays, tile, cement, animal eartags, 
and salt intended for animal feed.

VI. Cumulative Effects

    Section 408 (b)(2)(D)(v) of FFDCA requires that, when considering 
whether to establish, modify, or revoke a tolerance or tolerance 
exemption, the Agency consider ``available information'' concerning the 
cumulative effects of a particular chemical's residues and ``other 
substances that have a common mechanism of toxicity.'' 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 as to ultramarine blue and any other substances and 
ultramarine blue does not appear to produce a toxic metabolite produced 
by other substances. For the purposes of this tolerance action, 
therefore, EPA has not assumed that ultramarine blue has 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. Additional 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 data base unless EPA concludes that a different 
margin of safety will be safe for infants and children. In a 
developmental toxicity study, female rats were fed ultramarine blue 
before and during pregnancy which resulted in no statistically 
significant malformations and no difference between fetuses in the 
control and highest dose group. Due to the lack of absorption by all 
routes of exposure and the expected low toxicity of ultramarine blue, 
EPA has not used a safety factor analysis to assess the risk. For the 
same reasons the additional tenfold safety factor is unnecessary.

VIII. Determination of Safety

    The available information indicates that ultramarine blue is 
insoluble in water and is not readily absorbed by any route of 
exposure. The only effects noted in any of the studies were effects 
consistent to those of other siliceous earth materials. The available 
toxicity information indicates that ultramarine blue is of low or no 
toxicological concern. Additionally, given its use as a colorant, the 
amount of ultramarine blue that would be incorporated into any 
pesticide product is limited by the need for a certain shade or hue of 
blue. Therefore, EPA concludes that use of ultramarine blue in 
pesticide products as a colorant is not likely to pose a dietary risk 
under reasonably foreseeable circumstances. There is a reasonable 
certainty of no harm to the general population, including infants and 
children, from aggregate exposure to residues of ultramarine blue.

IX. Other Considerations

A. 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.

B. Existing Exemptions

    There is an existing tolerance exemption in 40 CFR 180.930, 
formerly 180.1001(e), for ultramarine blue when used as a dye in animal 
ear tags.

[[Page 29893]]

C. International Tolerances

    The Agency is not aware of any country requiring a tolerance for 
ultramarine nor have any CODEX maximum residue levels been established 
for any food crops at this time.

D. List 4A (Minimal Risk) Classification

    The Agency established 40 CFR 180.950 (see the rationale in the 
proposed rule published January 15, 2002 (67 FR 1925) (FRL-6807-8)), to 
collect the tolerance exemptions for those substances classified as 
List 4A, i.e., minimal risk substances. As part of evaluating an inert 
ingredient and establishing the tolerance exemption, the Agency 
determines the chemical's list classification. Given the available 
information which indicates that ultramarine blue is insoluble in water 
and is not readily absorbed by any route of exposure, ultramarine blue 
(CAS Reg. No. 57455-37-5) is to be classified as a List 4A inert 
ingredient.

X. Conclusions

    Based on the information in this preamble, EPA concludes that there 
is a reasonable certainty of no harm from aggregate exposure to 
residues of ultramarine blue (CAS Reg. No. 57455-37-5). Accordingly, 
EPA finds that exempting ultramarine blue from the requirement of a 
tolerance will be safe.
    Since the tolerance exemption is established under 40 CFR 180.950, 
the existing tolerance exemption in 40 CFR 180.930 is a duplication, 
and will be removed.

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. EPA's 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 of 1996, EPA will continue to use those 
procedures, with appropriate adjustments, until the necessary 
modifications can be made. The new section 408(g) 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), as was provided in the old FFDCA sections 408 and 409. 
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 OPP-2004-0056 in the subject line on the 
first page of your submission. All requests must be in writing, and 
must be mailed or delivered to the Hearing Clerk on or before July 26, 
2004.
    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 issues(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 (1900C), 
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 Rm.104, Crystal Mall 2, 1921 
Jefferson Davis Hwy., Arlington, VA. 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 
(703) 603-0061.
    2. Tolerance fee payment. If you file an objection or request a 
hearing, you must also pay the fee prescribed by 40 CFR 180.33(i) or 
request a waiver of that fee pursuant to 40 CFR 180.33(m). You must 
mail the fee to: EPA Headquarters Accounting Operations Branch, Office 
of Pesticide Programs, P.O. Box 360277M, Pittsburgh, PA 15251. Please 
identify the fee submission by labeling it ``Tolerance Petition Fees.''
    EPA is authorized to waive any fee requirement ``when in the 
judgement of the Administrator such a waiver or refund is equitable and 
not contrary to the purpose of this subsection.'' For additional 
information regarding the waiver of these fees, you may contact James 
Tompkins by phone at (703) 305-5697, by e-mail at [email protected], 
or by mailing a request for information to Mr. Tompkins at Registration 
Division (7505C), Office of Pesticide Programs, Environmental 
Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460-
0001.
    If you would like to request a waiver of the tolerance objection 
fees, you must mail your request for such a waiver to: James Hollins, 
Information Resources and Services Division (7502C), Office of 
Pesticide Programs, Environmental Protection Agency, 1200 Pennsylvania 
Ave., NW., Washington, DC 20460-0001.
    3. Copies for the Docket. In addition to filing an objection or 
hearing request with the Hearing Clerk as described in Unit VIII.A., 
you should also send a copy of your request to the PIRIB for its 
inclusion in the official record that is described in Unit I.B.1. Mail 
your copies, identified by docket ID number OPP-2004-0056, 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. 
In person or by courier, bring a copy to the location of the PIRIB 
described in Unit I.B.1. You may also send an electronic copy of your 
request via e-mail to: [email protected]. 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 issues(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

[[Page 29894]]

requirement 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 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 FFDCA section 408(d), 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 FFDCA section 408(n)(4). 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.

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.

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. Section 180.950 is amended by adding alphabetically to the table in 
paragraph (e) the following insert ingredient to read as follows:


Sec.  180.950  Tolerance exemptions for minimal risk active and inert 
ingredient.

    (e) * * *

------------------------------------------------------------------------
                    Chemical Name                           CAS No.
------------------------------------------------------------------------
                                * * * * *
Ultramarine blue (C.I. Pigment Blue 29)..............         57455-37-5
                                * * * * *
------------------------------------------------------------------------

* * * * *


Sec.  180.930  [Amended]

0
3. Section 180.930 is amended by removing from the table the entry for 
ultramarine blue.

    Dated: May 14, 2004.
Betty Shackleford,
Acting Director, Registration Division, Office of Pesticide Programs.
[FR Doc. 04-11672 Filed 5-25-04; 8:45 am]
BILLING CODE 6560-50-S