[Federal Register Volume 74, Number 56 (Wednesday, March 25, 2009)]
[Rules and Regulations]
[Pages 12621-12625]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E9-6259]


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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[EPA-HQ-OPP-2008-0095; FRL-8404-7]


Tristyrylphenol Ethoxylates (CAS Reg. No. 70559-25-0) and (CAS 
Reg. No. 99734-09-5); 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 poly(oxy-1,2-ethanediyl), [alpha]-
[2,4,6-tris(1-phenylethyl)phenyl]-[omega]-hydroxy- (CAS Reg. No. 70559-
25-0) and poly(oxy-1,2-ethanediyl), [alpha]-[tris(1-
phenylethyl)phenyl]-[omega]-hydroxy-, (CAS Reg. No. 99734-09-5), herein 
referred to in this document as tristyrylphenol ethoxylates when used 
as inert ingredients in post-harvest applications to citrus crops, 
group 10, under 40 CFR 180.1288 at a maximum of 10.0% in pesticide 
formulations with azoxystrobin and fludioxonil. Syngenta Crop 
Protection, Inc. submitted a petition to EPA under the Federal Food, 
Drug, and Cosmetic Act (FFDCA), requesting an exemption from the 
requirement of a tolerance. This regulation eliminates the need to 
establish a maximum permissible level for residues of the 
tristyrylphenol ethoxylates.

DATES: This regulation is effective March 25, 2009. Objections and 
requests for hearings must be received on or before May 26, 2009, and 
must be filed in accordance with the instructions provided in 40 CFR 
part 178 (see also Unit I.C. of the SUPPLEMENTARY INFORMATION).

ADDRESSES: EPA has established a docket for this action under docket 
identification (ID) number EPA-HQ-OPP-2008-0095. All documents in the 
docket are listed in the docket index available at http://www.regulations.gov. Although listed in the index, some information is 
not publicly available, e.g., 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 in the electronic 
docket at http://www.regulations.gov, or, if only available in hard 
copy, at the OPP Regulatory Public Docket in Rm. S-4400, One Potomac 
Yard (South Bldg.), 2777 S. Crystal Dr., Arlington, VA. The Docket 
Facility is open from 8:30 a.m. to 4 p.m., Monday through Friday, 
excluding legal holidays. The Docket Facility telephone number is (703) 
305-5805.

FOR FURTHER INFORMATION CONTACT: Karen Samek, Registration Division 
(7505P), Office of Pesticide Programs, Environmental Protection Agency, 
1200 Pennsylvania Ave., NW., Washington, DC 20460-0001; telephone 
number: (703) 347-8825; 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?

    In addition to accessing electronically available documents at 
http://www.regulations.gov, you may access this Federal Register 
document electronically through the EPA Internet under the Federal 
Register listings at http://www.epa.gov/fedrgstr. You may also access a 
frequently updated electronic version of 40 CFR part 180 through the 
Government Printing Office's e-CFR cite at http://www.gpoaccess.gov/ecfr.

C. Can I File an Objection or Hearing Request?

    Under section 408(g) of FFDCA, 21 U.S.C. 346a, any person may file 
an objection to any aspect of this regulation and may also request a 
hearing on those objections. The EPA procedural regulations which 
govern the submission of objections and requests for hearings appear in 
40 CFR part 178. You must file your objection or request a hearing on 
this regulation in accordance with the instructions provided in 40 CFR 
part 178. To ensure proper receipt by EPA, you must identify docket ID 
number EPA-HQ-OPP-2008-0095 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 May 26, 2009.
    In addition to filing an objection or hearing request with the 
Hearing Clerk as described in 40 CFR part 178, please submit a copy of 
the filing that does not contain any CBI for inclusion in the public 
docket that is described in ADDRESSES. Information not marked 
confidential pursuant to 40 CFR part 2 may be disclosed publicly by EPA 
without prior notice. Submit your copies, identified by docket ID 
number EPA-HQ-OPP-2008-0095, by one of the following methods:
     Federal eRulemaking Portal: http://www.regulations.gov. 
Follow the on-line instructions for submitting comments.
     Mail: Office of Pesticide Programs (OPP) Regulatory Public 
Docket (7502P), Environmental Protection Agency, 1200 Pennsylvania 
Ave., NW., Washington, DC 20460-0001.
     Delivery: OPP Regulatory Public Docket (7502P), 
Environmental Protection Agency, Rm. S-4400, One Potomac Yard (South 
Bldg.), 2777 S. Crystal Dr., Arlington, VA. Deliveries are only 
accepted during the Docket Facility's normal hours of operation (8:30 
a.m. to 4 p.m., Monday through Friday, excluding legal holidays). 
Special arrangements should be made for deliveries of boxed 
information. The Docket Facility telephone number is (703) 305-5805.

II. Background and Statutory Findings

    In the Federal Register of March 12, 2008 (73 FR 13225) (FRL-8354-
6), EPA issued a notice pursuant to section 408 of FFDCA, 21 U.S.C. 
346a, as amended by FQPA (Public Law 104-170), announcing the filing of 
a pesticide petition (PP 7E7305) by Syngenta Crop Protection, Inc., 
P.O. Box 18300, Greensboro, NC 27409. The petition requested that 40 
CFR 180.910 be amended by establishing an exemption

[[Page 12622]]

from the requirement of a tolerance for residues of the tristyrylphenol 
ethoxylates when used as inert ingredients in post-harvest applications 
at a maximum of 10.0% in pesticide formulations. That notice included a 
summary of the petition prepared by the petitioner. This request is 
specific for the post-harvest uses of these tristyrylphenol ethoxylates 
and does not impact the existing pre-harvest tolerance exemptions under 
40 CFR 180.920 granted by the Agency for these tristyrylphenol 
ethoxylates with a limit of not more than 15% in pesticide 
formulations. There were no comments received in response to the notice 
of filing.
    Section 408(b)(2)(A)(i) of FFDCA allows EPA to establish an 
exemption from the requirement for a tolerance (the legal limit for a 
pesticide chemical residue in or on a food) only if EPA determines that 
the tolerance is ``safe.'' Section 408(b)(2)(A)(ii) of FFDCA defines 
``safe'' to mean that ``there is a reasonable certainty that no harm 
will result from aggregate exposure to the pesticide chemical residue, 
including all anticipated dietary exposures and all other exposures for 
which there is reliable information.'' This includes exposure through 
drinking water and in residential settings, but does not include 
occupational exposure. Section 408(b)(2)(C) of FFDCA requires EPA to 
give special consideration to exposure of infants and children to the 
pesticide chemical residue in establishing a tolerance and to ``ensure 
that there is a reasonable certainty that no harm will result to 
infants and children from aggregate exposure to the pesticide chemical 
residue. . . .''
    EPA 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 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 the 
tristyrylphenol ethoxylates are discussed in this unit.
     In 2006, EPA reassessed the inert ingredient tolerance exemptions 
under 40 CFR 180.920 for the tristyrylphenol ethoxylates when used as 
inert ingredients at not more than 15% in pesticide formulations 
applied to growing crops. This tolerance reassessment document can be 
found at http://www.epa.gov/opprd001/inerts/decisiondoc_a2k.html. As 
stated in that document, the tristyrylphenol ethoxylates have similar 
use patterns, restrictions/limitations, and potential exposures. A 
Structure Activity Relationship (SAR) assessment for the 
tristyrylphenol ethoxylates was performed by the Agency's Office of 
Pollution Prevention and Toxics (OPPT) Structure Activity Team (SAT). 
In the 2006 document, the SAT determined that the data presented on the 
analog compounds within the tristyrylphenol ethoxalates are adequate to 
characterize the expected toxicity of subject chemicals (CAS Reg. Nos. 
70559-25-0 and 99734-09-5) for the reasons set forth in Unit VII below. 
The available toxicity database for the tristyrylphenol ethoxylates 
consists of studies on some of the tristyrylphenol ethoxylate 
chemicals, such as CAS Reg. No. 90093-37-1 and 119432-41-6, and 
guideline studies on an analog chemical, CAS Reg. No. 105362-40-1. The 
studies on the tristyrylphenol ethoxylate chemicals and analog 
chemicals were considered appropriate to evaluate the toxicity of the 
tristyrylphenol ethoxylates because these chemicals share a common 
chemical structure and are members of the same chemical class. The 
tristyrylphenol ethoxylates and analog chemicals share a close 
structural similarity and same functional groups with the only 
difference being in the associated counterions. Therefore, the toxicity 
of these chemicals are expected to be similar.
     An acute toxicity battery conducted on the tristyrylphenol 
ethoxylates resulted in low acute oral toxicity, slight skin 
irritation, and slight eye irritation. In subchronic toxicity studies, 
the primary toxicity appears to be to the kidney and thyroid in rats 
and the liver in dogs. The kidney effects in rats appear to be the most 
sensitive endpoint. In this study, there were minimal effects observed 
at 100 milligrams/kilogram/day (mg/kg/day) but these effects were not 
considered adverse effects. Therefore, the no observed effect level 
(NOEL) for the study was 30 mg/kg/day and the no observed adverse 
effect level (NOAEL) was 100 mg/kg/day. No neurotoxicity studies are 
available; however, no signs of neurotoxicity were observed in any of 
the available studies.
     Based on the results of submitted mutagenicity studies, the 
tristyrylphenol ethoxylates are not likely to be mutagenic. There are 
no carcinogenicity studies available on the tristyrylphenol 
ethoxylates; however, the primary toxicity appears to be to the kidney 
and thyroid in rats and liver in dogs. The kidney effects in rats 
appear to be the most sensitive endpoint. The Agency has considerable 
knowledge of the intratubular mineralization toxic effect to the 
kidneys and has determined that by preventing the intratubular 
mineralization in the kidney, tumor formation is unlikely to occur. 
Since these kidney effects are the most sensitive endpoint, protective 
measures for kidney toxicity will be protective of any other long term 
effects. The thyroid toxicity in rats was observed at 1,500 mg/kg/day 
and the NOAEL was 500 mg/kg/day. The Agency has determined the mode of 
action of the compound causing thyroid toxicity and concluded that a 
dose preventing thyroid toxicity would be protective of both cancer and 
non cancer effects on the thyroid. In addition, the Agency also 
recognizes that the rats are more sensitive to thyroid effects than 
humans. The NOAEL used as the point of departure in calculating the 
chronic reference dose (cRfD) selected for this risk assessment is 
protective of any thyroid effects and is approximately 10 fold lower 
than the NOAEL established for the thyroid effects. There is not a 
concern for the liver toxicity seen in the dog study because the liver 
effects at dosages of 500 mg/kg/day were marginal and seen in only one 
dog out of six. The SAR models predicted low concern for the

[[Page 12623]]

carcinogenicity of the compounds. Considering the lack of mutagenicity, 
the lack of target organ toxicity in subchronic studies and known mode 
of action for the target organ toxicity seen, and the SAR prediction, 
the Agency concluded that carcinogenicity concerns are unlikely for the 
tristyrylphenol ethoxylates.
     The developmental toxicity study in which rats were administered 
CAS Reg. No. 119432-41-6, resulted in a NOAEL of 300 mg/kg/day for 
maternal toxicity (based on reduced body weights and increase in liver 
weights and loose feces seen at the lowest observed adverse effect 
level (LOAEL) of 1,000 mg/kg/day) and a NOAEL of 300 mg/kg/day for 
developmental toxicity based on increased skeletal variations 
(increased incidence of all unossified proximal phalanges of the hind 
limb seen at the LOAEL of 1,000 mg/kg/day).
    The cRfD of 0.5 mg/kg/day was established based on the 90-day 
subchronic toxicity study in dogs, with a NOAEL of 50 mg/kg/day and a 
safety factor of 100 (10x for interspecies and 10x for intraspecies 
variations). Since the Food Quality Protection Act (FQPA) safety factor 
is reduced from 10x to 1x, the chronic population adjusted dose (cPAD) 
is equal to the cRfD. In the dog study, the NOAEL of 50 mg/kg/day was 
based on equivocal liver toxicity seen at the LOAEL of 500 mg/kg/day. 
Therefore, in this dog study, the NOAEL would be between 50-500 mg/kg/
day. Since the NOAEL for the subchronic rat studies is 100 mg/kg/day 
based on kidney and thyroid toxicity, choosing the NOAEL of 50 mg/kg/
day would be protective of both the liver effects seen in the dog and 
the kidney and thyroid effects seen in the rat.

V. Aggregate Exposures

    In examining aggregate exposure, section 408 of 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.
     The primary route of exposure to these chemicals from their use as 
inert ingredients in pesticide products would most likely be through 
consumption of food to which pesticide products containing them have 
been applied, and possibly through drinking water (from runoff). Dermal 
and inhalation exposures are also possible from residential use of 
pesticide products containing these inert ingredients. However, the 
quantitative exposure assessment via inhalation and dermal routes of 
exposure was not performed because negligible inhalation and dermal 
absorption is expected based on the physicochemical properties of the 
compounds.
     There are no data available on tristyrylphenol ethoxylates 
residues in food or on non-occupational exposures to tristyrylphenol 
ethoxylates. In the absence of actual residue data for tristyrylphenol 
ethoxylates, the Agency performed a dietary (food and drinking water) 
exposure assessment for tristyrylphenol ethoxylates that included both 
the existing pre-harvest uses and the proposed post-harvest use on 
citrus crops in formulations of azoxystrobin and fludioxonil using 
worst-case assumptions as detailed below. The dietary exposure was 
calculated as a percentage of the cRfD. The chronic dietary estimate 
for the U.S. Population was 12.2% (non-nursing infants were the most 
highly exposed population with a chronic exposure estimate occupying 
35.6% of the cPAD). In addition, this exposure assessment assumed that:
     Tristyrylphenol ethoxylates would be used as an inert 
ingredient in all food use pesticide formulations applied to all crops.
      One hundred percent of all food crops would be treated 
with pesticides containing tristyrylphenol ethoxylates.
      Tristyrylphenol ethoxylates residues would be present in 
all crops at levels equal to or exceeding the highest established 
tolerance levels for any pesticide active ingredient for both the 
existing preharvest uses and the proposed postharvest use, and
     A conservative default value of 1,000 parts per billion 
(ppb) for the concentration of an inert ingredient in all sources of 
drinking water was used. This approach is highly conservative as it is 
extremely unlikely that tristyrylphenol ethoxylates would have such use 
as pesticide product inert ingredients and be present in food 
commodities and drinking water at such high levels. In addition, this 
highly conservative exposure assessment is protective of any possible 
non-occupational exposures to tristyrylphenol ethoxylates as it results 
in exposure estimates orders of magnitude greater than the high-end 
exposure estimates for residential uses of pesticides routinely used by 
the Office of Pesticide Programs.

VI. Cumulative Effects

    Section 408(b)(2)(D)(v) of FFDCA requires that, when considering 
whether to establish, modify, or revoke a tolerance, the Agency 
consider ``available information'' concerning the cumulative effects of 
a particular pesticide's residues and ``other substances that have a 
common mechanism of toxicity.'' Unlike other pesticide ingredients 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 tristyrylphenol ethoxylates and any other substances and 
tristyrylphenol ethoxylates do not appear to produce a toxic metabolite 
produced by other substances. For the purposes of this tolerance 
action, therefore, EPA has not assumed that tristyrylphenol ethoxylates 
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. Additional Safety Factor for the Protection of Infants and 
Children

     Section 408 of the FFDCA 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 on toxicity and exposure 
unless EPA determines that a different margin of safety will be safe 
for infants

[[Page 12624]]

and children. EPA concluded that the FQPA safety factor could be 
removed for tristyrylphenol ethoxylates for the following reasons:
     1. EPA has sufficient data to assess the toxicity of 
tristyrylphenol ethoxylates. The data presented in the assessment on 
the tristyrylphenol ethoxylates are adequate to characterize the 
expected behavior of the subject chemicals. There are no 
carcinogenicity studies available on the tristyrylphenol ethoxylates; 
however, the primary toxicity appears to be to the kidney and thyroid 
in rats and liver in dogs. The kidney effects in rats appear to be the 
most sensitive endpoint. The Agency has considerable knowledge of the 
intratubular mineralization toxic effect to the kidneys and has 
determined that by preventing the intratubular mineralization in the 
kidney, tumor formation is unlikely to occur. Since these kidney 
effects are the most sensitive endpoint, protective measures for kidney 
toxicity will be protective of any other long term effects. Further, 
EPA concluded that there is no need for the additional FQPA safety 
factor for use of subchronic toxicity for long term exposure 
assessment. The critical effect seen in the subchronic study 
(intratubular mineralization in the kidney) is believed to occur as a 
result of precipitation of a chemical based on its physicochemical 
properties. Precipitation of a chemical based on its physiochemical 
properties is a function primarily of dose level rather than duration 
of dosing. Thus, once the threshold for precipitation of the chemical 
is established (as it was in the subchronic dog study), this threshold 
level would be considered protective of any short or long term 
exposure. Therefore, the additional safety factor for the lack of long 
term studies is not warranted.
     2. EPA concluded that there is no evidence of increased 
susceptibility to infants and children. The developmental toxicity 
study in which rats were administered (CAS Reg. No. 119432-41-6) 
resulted in a NOAEL of 300 mg/kg/day for maternal toxicity (based on 
reduced body weights and increase in liver weights and loose feces seen 
at the LOAEL of 1,000 mg/kg/day) and a NOAEL of 300 mg/kg/day for 
developmental toxicity based on increased skeletal variations 
(increased incidence of all unossified proximal phalanges of the hind 
limb seen at the LOAEL of 1,000 mg/kg/day). Fetal effects were seen 
only at the limit dose and in the presence of maternal toxicity.
    3. No rabbit developmental study or reproductive toxicity studies 
are available for these chemicals, however, the developmental toxicity 
study in rats indicates no robust developmental toxicity at the limit 
dose and none of the reproductive parameters were affected in the rat 
developmental study at the limit dose of 1,000 mg/kg/day. This endpoint 
in the developmental study is considered conservative since the 
incidence of skeletal variations seen at 1,000 mg/kg/day was marginal.
     4. There is no indication in the database that the tristyrylphenol 
ethoxylates are neurotoxic chemicals and there is no evidence of 
increased susceptibility. Therefore, there is no need for a 
developmental neurotoxicity study.
     5. There are no residual uncertainties identified in the exposure 
databases. In the absence of actual exposure data on tristyrylphenol 
ethoxylates, a highly conservative dietary exposure assessment would 
not underestimate the risk to infants and children. Based on overall 
weight of evidence, the FQPA factor of 10X was reduced to 1X.

VIII. Determination of Safety for U.S. Population

    Residues of concern are not anticipated for dietary exposure (food 
and drinking water) or for residential exposure (inhalation and 
dermal). EPA determines whether pesticide chemical exposures are safe 
by comparing aggregate exposure estimates to the dose at which no 
adverse effects were seen in the most sensitive animal studies. In the 
case of tristyrylphenol ethoxylates, the estimated exposures are 
compared to a dose level equal to the chronic RfD of 0.5 mg/kg/day 
(based on the subchronic dog study). Utilizing a highly conservative 
aggregate exposure assessment, the resulting chronic exposure estimates 
do not exceed the Agency's level of concern (non-nursing infants were 
the most highly exposed population with the chronic exposure estimates 
occupying 35.6% of the cPAD). In addition, this highly conservative 
exposure assessment is protective of any possible non-occupational 
exposures to the tristyrylphenol ethoxylates as it results in exposure 
estimates orders of magnitude greater than the high-end exposure 
estimates for residential uses of pesticides routinely used by the 
Office of Pesticides Programs.
     Taking into consideration all available information on the 
tristyrylphenol ethoxylates, it has been determined that there is a 
reasonable certainty that no harm to any population subgroup, including 
infants and children, will result from aggregate exposure to these 
chemicals when used as inert ingredients in post-harvest applications 
to citrus crops, group 10, at a maximum of 10.0% in pesticide 
formulations with azoxystrobin and fludioxonil, when considering 
dietary exposure and all other non-occupational sources of pesticide 
exposure for which there is reliable information. Therefore, the 
exemption from the requirement of a tolerance for residues of poly(oxy-
1,2-ethanediyl), [alpha]-[2,4,6-tris(1-phenylethyl)phenyl]-[omega]-
hydroxy- (CAS Reg. No. 70559-25-0) and poly(oxy-1,2-ethanediyl), 
[alpha]-[tris(1-phenylethyl)phenyl]-[omega]-hydroxy-, (CAS Reg. No. 
99734-09-5), when used as inert ingredients in post-harvest 
applications to citrus crops, group 10, under 40 CFR 180.1288 at a 
maximum of 10.0% in pesticide formulations with azoxystrobin and 
fludioxonil can be considered safe under section 408 of the FFDCA.

IX. Other Considerations

A. 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.

B. Existing Exemptions

    The tristyrylphenol ethoxylates (CAS Reg. No. 70559-25-0 and CAS 
Reg. No. 99734-09-5) are exempted from the requirement of a tolerance 
under 40 CFR 180.920 when used as inert ingredients at not more than 
15% in pesticide formulations applied to growing crops only.

C. International Tolerances

     The Agency is not aware of any country requiring a tolerance for 
the tristyrylphenol ethoxylates nor have any CODEX Maximum Residue 
Levels (MRLs) been established for any food crops at this time.

X. Conclusions

    Accordingly, an exemption from the requirement for a tolerance is 
established for poly(oxy-1,2-ethanediyl), [alpha]-[2,4,6-tris(1-
phenylethyl)phenyl]-[omega]-hydroxy- (CAS Reg. No. 70559-25-0) and 
poly(oxy-1,2-ethanediyl), [alpha]-[tris(1-phenylethyl)phenyl]-[omega]-
hydroxy-, (CAS Reg. No. 99734-09-5), when used as inert ingredients in 
post-harvest applications to citrus crops, group 10, under 40 CFR 
180.1288 at a maximum of 10.0% in pesticide formulations with 
azoxystrobin and fludioxonil.

XI. Statutory and Executive Order Reviews

    This final rule establishes a tolerance under section 408(d) of 
FFDCA in response to a petition submitted to the

[[Page 12625]]

Agency. The Office of Management and Budget (OMB) has exempted these 
types of actions from review under Executive Order 12866, entitled 
Regulatory Planning and Review (58 FR 51735, October 4, 1993). Because 
this final rule has been exempted from review under Executive Order 
12866, this final rule is not subject to Executive Order 13211, 
entitled Actions Concerning Regulations That Significantly Affect 
Energy Supply, Distribution, or Use (66 FR 28355, May 22, 2001) or 
Executive Order 13045, entitled Protection of Children from 
Environmental Health Risks and Safety Risks (62 FR 19885, April 23, 
1997). This final rule does not contain any information collections 
subject to OMB approval under the Paperwork Reduction Act (PRA), 44 
U.S.C. 3501 et seq., nor does it require any special considerations 
under Executive Order 12898, entitled Federal Actions to Address 
Environmental Justice in Minority Populations and Low-Income 
Populations (59 FR 7629, February 16, 1994).
    Since tolerances and exemptions that are established on the basis 
of a petition under section 408(d) of FFDCA, such as the tolerance in 
this final rule, do not require the issuance of a proposed rule, the 
requirements of the Regulatory Flexibility Act (RFA) (5 U.S.C. 601 et 
seq.) do not apply.
    This final rule directly regulates growers, food processors, food 
handlers, and food retailers, not States or tribes, nor does this 
action alter the relationships or distribution of power and 
responsibilities established by Congress in the preemption provisions 
of section 408(n)(4) of FFDCA. As such, the Agency has determined that 
this action will not have a substantial direct effect on States or 
tribal governments, on the relationship between the national government 
and the States or tribal governments, or on the distribution of power 
and responsibilities among the various levels of government or between 
the Federal Government and Indian tribes. Thus, the Agency has 
determined that Executive Order 13132, entitled Federalism (64 FR 
43255, August 10, 1999) and Executive Order 13175, entitled 
Consultation and Coordination with Indian Tribal Governments (65 FR 
67249, November 9, 2000) do not apply to this final rule. In addition, 
this final rule does not impose any enforceable duty or contain any 
unfunded mandate as described under Title II of the Unfunded Mandates 
Reform Act of 1995 (UMRA) (Public Law 104-4).
    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).

XII. Congressional Review Act

    The Congressional Review Act, 5 U.S.C. 801 et seq., generally 
provides that before a rule may take effect, the agency promulgating 
the rule must submit a rule report 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 4, 2009.
Lois Rossi,
Director, Registration Division, Office of Pesticide Programs.

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Therefore, 40 CFR chapter I is amended as follows:

PART 180--[AMENDED]

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

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

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2. Section 180.1288 is added to read as follows:


Sec.  180.1288  Tristyrylphenol ethoxylates; exemption from the 
requirement of a tolerance.

    An exemption from the requirement of a tolerance is established for 
residues of poly(oxy-1,2-ethanediyl), [alpha]-[2,4,6-tris(1-
phenylethyl)phenyl]-[omega]-hydroxy-, (CAS Reg. No. 70559-25-0) and 
poly(oxy-1,2-ethanediyl), [alpha]-[tris(1-phenylethyl)phenyl]-[omega]-
hydroxy-, (CAS Reg. No. 99734-09-5) on citrus crops, group 10, when 
used as inert ingredients under the following conditions:
     (a) They are applied post-harvest;
    (b) They are used as inert ingredients in pesticide formulations 
with azoxystrobin and fludioxonil; and
    (c) They constitute no more than 10.0% of the formulated pesticide 
product.
[FR Doc. E9-6259 Filed 3-24-09; 8:45 am]
BILLING CODE 6560-50-S