[Federal Register Volume 69, Number 188 (Wednesday, September 29, 2004)]
[Rules and Regulations]
[Pages 58066-58071]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 04-21587]


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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[OPP-2004-0300; FRL-7677-6]


Citrate Esters; Exemption from the Requirement of a Tolerance

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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SUMMARY: This regulation establishes exemptions from the requirement of 
a tolerance for residues of acetyl tributyl citrate (ATBC) also known 
as citric acid, 2-(acetyloxy)-, tributyl ester (CAS Reg. No. 77-90-7) 
and triethyl citrate (TEC) also known as citric acid, triethyl ester 
(CAS Reg. No. 77-93-0) when used as inert ingredients in pesticide 
products. Morflex 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 the exemptions from the 
requirement of a tolerance. This regulation eliminates the need to 
establish a maximum permissible level for residues of ATBC or TEC.

DATES: This regulation is effective September 29, 2004. Objections and 
requests for hearings must be received on or before November 29, 2004.

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 OPP-2004-0300. 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., 
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

[[Page 58067]]

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: [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 Get Electronic Documents and Other Related Information?

    In addition to using EDOCKET at (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 January 5, 2001 (66 FR 1129) (FRL-6761-
4), 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 pesticide petitions (PP (8E4966 and 8E4967) by Morflex Inc., 
2110 High Point Road, Greensboro, NC 27403. That notice included a 
summary of the petition prepared by the petitioner.
    The petition requested that 40 CFR 180.1001 (c), and (e) be amended 
by establishing an exemption from the requirement of a tolerance for 
residues of acetyl tributyl citrate (ATBC) also known as citric acid, 
2-(acetyloxy)-, tributyl ester (CAS Reg. No. 77-90-7) and triethyl 
citrate (TEC) also known as citric acid, triethyl ester (CAS Reg. No. 
77-93-0). There were no comments received in response to the notice of 
filing.
    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 ATBC also known as citric acid, 2-(acetyloxy)-, tributyl ester (CAS 
Reg. No. 77-90-7) and TEC also known as citric acid, triethyl ester 
(CAS Reg. No. 77-93-0) are discussed in this unit. Both chemicals are 
derivatives of citric acid. ATBC is prepared by esterification of butyl 
alcohol with citric acid, followed by acetylation. TEC is prepared by 
esterification of ethyl alcohol with citric acid.
    The Agency evaluated the toxicity data base submitted by the 
petitioner, Morflex which included a 2-generation reproductive study, 
and several articles from open literature. Other reliable sources of 
information used by the Agency in performing this assessment are 
information from the internet on (1) World Health Organization (WHO) 
evaluations, (2) British Industrial Biological Research Association 
(BIBRA) abstracts, and (3) the Opinion of the European Commission, 
Health and Consumer Protection Directorate-General (CSTEE), and (4) 
structure-activity-relationship (SAR) assessments performed on 
surrogate chemicals as prepared by the Agency's Office of Pollution 
Prevention and Toxics. The toxicological databases for these chemicals 
are a mixture of guideline studies performed in the last 15 years and 
older studies from the 1970s and 1950s. These older studies are more 
difficult to evaluate given the different standards of reporting that 
existed some years ago.
    Both ATBC and TEC have low acute oral toxicity (Toxicity Category 
IV). Ocular irritation is moderate. Both are Toxicity Category IV for 
dermal irritation. Neither are human sensitizers. Both chemicals have 
been reviewed by other entities. None of these organizations indicated 
any specific concerns for ATBC or TEC. Based on the submitted studies, 
neither ATBC or TEC is mutagenic.

[[Page 58068]]

    In a rat metabolism study, ATBC was readily absorbed and rapidly 
excreted in urine and feces within 48 hours. The following metabolites 
were detected in the urine: Acetyl citrate, monobutyl citrate, acetyl 
monobutyl citrate, dibutyl citrate, and acetyl dibutyl citrate. ATBC 
was hydrolyzed in both human and rat liver homogenates resulting in n-
butanol and tributyl citrate (TBC). However, in human serum the half-
life was 7 hours versus 30 minutes in the rat. These in vivo and in 
vitro studies indicate that ATBC is hydrolysed.
    No metabolism studies were reviewed for TEC. However, it is 
expected that all citrate esters would undergo hydrolysis to citric 
acid and the corresponding alcohol. For TEC, this would be ethanol. The 
human body is able to effectively metabolize both ethanol and citric 
acid. Thus, the human body has known pathways to metabolize TEC 
hydrolysis metabolites.
    The ATBC 2-generation reproductive toxicity study was recently re-
evaluated by the Agency. No adverse reproductive performance was 
observed at any dose. The reproductive toxicity no observed adverse 
level (NOAEL) was 1,000 milligrams/kilograms/day (mg/kg/day), the 
highest dose tested. A lowest observed adverse level (LOAEL) was not 
observed. The parental no observed level (NOEL) and the offspring NOEL 
is 1,000 mg/kg/day. The parental lowest observed level (LOEL) and the 
offspring LOEL was not observed.
    The available information consists of the FDA-affirmed GRAS status 
of TEC (21 CFR 184.1911), ATBC's approval as a synthetic flavoring 
substance under 21 CFR 172.515, the approval of both ATBC and TEC under 
21 CFR 181.27 as prior sanctioned plasticizers, the abstracts of the 
BIBRA toxicity profiles, several evaluations by the World Health 
Organization, the SAR assessments of the structurally-related 
chemicals, the CSTEE Opinion, and the toxicity studies submitted by the 
petitioner. Taken together the weight of evidence of the available 
information indicate chemicals of lower toxicity.
    Greater detail on the Agency's review and evaluation of the 
submitted studies and articles from open literature are in the ATBC and 
TEC Science Assessment in EDOCKET at (http://www.epa.gov/edocket/) (See 
OPP-2004-0300).

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.
    Various publicly-available screening-level models were used to 
estimate some of the existing levels of exposure that could occur in 
and around the home. To assure protectiveness, these models create 
estimates that are deliberately intended to over-estimate exposure. All 
modeling (with the exception of the CSTEE plastic toy scenario) was 
performed by EPA. The highest potential exposure level was 0.422 mg/kg/
day for children (1-2 years old) for dietary exposure through 
consumption of food (as a result of application of a pesticide product 
containing either ATBC or TEC to crops). All of the screening-level 
exposures are much less than any of the NOAELs/NOELs from the repeated 
dose oral toxicity studies. Greater detail on the Agency's exposure 
assessment are in the ATBC and TEC Science Assessment in EDOCKET at 
(http://www.epa.gov/edocket/) (See OPP-2004-0300).

VI. Cumulative Effects

    Section 408(b)(2)(D)(v) of the 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.''
    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 acetyl tributyl citrate, 
triethyl citrate or any citrate esters. These esters do not appear to 
produce a toxic metabolite produced by other substances. These are 
lower toxicity chemicals; therefore, the resultant risks separately 
and/or combined should also be low. For the purposes of this action, 
therefore, EPA has not assumed that acetyl tributyl citrate or triethyl 
citrate 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. Children's Safety Factor

    The toxicity database for ATBC includes a rat oral reproductive 
toxicity study in which NOELs of 1,000 mg/kg/day were identified. There 
are also the SARs on structurally-related citrate esters which did not 
indicate any concerns for developmental or reproductive toxicity.
    ATBC, given the additional acetylation step, is the more complex, 
larger molecule. The acetylation step also increases the number of 
possible metabolites as evidenced by the results of the ATBC rat 
metabolism study. ATBC data can be used as surrogate data for TEC. TEC 
cannot be used as surrogate data for ATBC. ATBC is the more toxic of 
the two chemicals and has the larger available data base.
    There is sufficient information for the Agency to judge the 
potential for developmental and reproductive effects of ATBC and TEC. 
No additional data are needed to assess the toxicity of ATBC and TEC. 
There is no reason to expect that the reasonably, foreseeable uses of 
ATBC and TEC will constitute any significant hazard. 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 for U.S. Population, Infants and Children

    The Agency believes that ATBC and TEC are of low toxicity. Of 
highest consideration in this judgement is the body's ability to 
effectively metabolize both ATBC and TEC to citric acid and the 
corresponding alcohols. The metabolism studies provided by the 
petitioner were helpful in reaching this determination. Both of these 
chemicals

[[Page 58069]]

are well-studied. FDA, WHO, and CSTEE have all conducted assessments on 
the uses of these chemicals. No toxicological concerns were specified 
in any of the reviews and evaluations.
    The Agency has used various screening-level models to estimate some 
of the existing levels of exposure to ATBC and TEC. To assure 
protectiveness, these estimates are deliberately intended to over-
estimate exposure. Given the consistent pattern of NOAELs/NOELs of 
1,000 mg/kg/day, an understanding of the metabolism of ATBC and TEC, 
and a significant gap between very over-estimated exposure numbers and 
the NOAELs/NOELs, there is no need to pursue further numerical 
refinements to the estimated exposures.
    EPA concludes that there is a reasonable certainty of no harm from 
aggregate exposure to residues of citric acid, 2-(acetyloxy)-, tributyl 
ester (CAS Reg. No. 77-90-7) and citric acid, triethyl ester (CAS Reg. 
No. 77-93-0). Accordingly, EPA finds that exempting citric acid, 2-
(acetyloxy)-, tributyl ester (CAS Reg. No. 77-90-7) and citric acid, 
triethyl ester (CAS Reg. No. 77-93-0) will be safe.

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 ATBC and TEC for 
endocrine effects may be required.

B. Analytical Method

    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 is an existing tolerance exemption for acetyl tributyl 
citrate (CAS Reg. No. 77-90-7) in 40 CFR 180.930 when used as a 
component of plastic animal tags.

D. International Tolerances

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

E. 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 the body's ability to effectively 
metabolize both ATBC and TEC to citric acid and the corresponding 
alcohols and the consistent pattern of NOAELs/NOELs of 1,000 mg/kg/day, 
citric acid, 2-(acetyloxy)-, tributyl ester (CAS Reg. No. 77-90-7) and 
citric acid, triethyl ester (CAS Reg. No. 77-93-0) are to be classified 
as List 4A inert ingredients.

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 acetyl tributyl citrate (ATBC) also known as citric acid, 
2-(acetyloxy)-, tributyl ester (CAS Reg. No. 77-90-7) and triethyl 
citrate (TEC) also known as citric acid, triethyl ester (CAS Reg. No. 
77-93-0) Accordingly, EPA finds that exempting citric acid, 2-
(acetyloxy)-, tributyl ester (CAS Reg. No. 77-90-7) and citric acid, 
triethyl ester (CAS Reg. No. 77-93-0) from the requirement of a 
tolerance will be safe.
    Therefore, the exemptions from the requirement of a tolerance for 
citric acid, 2-(acetyloxy)-, tributyl ester (CAS Reg. No. 77-90-7) and 
citric acid, triethyl ester (CAS Reg. No. 77-93-0) are established in 
40 CFR 180.950. Since the tolerance exemptions are established under 40 
CFR 180.950, the existing tolerance exemption for acetyl tributyl 
citrate (CAS Reg. No. 77-90-7) 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. 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 OPP-2004-0300 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 November 
29, 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 (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 14\th\ 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

[[Page 58070]]

copies, identified by docket ID number OPP-2004-0300, 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. 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 two exemptions 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.

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: September 14, 2004.
Lois Rossi,
Director, Registration Division, Office of Pesticide Programs.

    Therefore, 40 CFR chapter I is amended as follows:

PART 180--[AMENDED]

    1. The authority citation for part 180 continues to read as 
follows:

    Authority: 21 U.S.C. 321(q), 346a and 371.


    2. In Sec.  180.930, the table is amended by removing the entry for 
``acetyl tributyl citrate'' (CAS Reg. No. 77-90-7).

    3. In Sec.  180.950, the table in paragraph (e) is amended by 
adding alphabetically

[[Page 58071]]

the following inert ingredients to read as follows


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

* * * * *
    (e) * * *

------------------------------------------------------------------------
                    Chemical Name                           CAS No.
------------------------------------------------------------------------
                                * * * * *
Citric acid, 2-(acetyloxy)-, tributyl ester..........            77-90-7
                                * * * * *
Citric acid, triethyl ester..........................            77-93-0
                                * * * * *
------------------------------------------------------------------------


[FR Doc. 04-21587 Filed 9-28-04; 8:45 am]
BILLING CODE 6560-50-S