Document ID: EPA-HQ-OPP-2006-0582-0001
Agency: epa
Document Type: Rule
Title: Isophorone; Exemption from the Requirement of a Tolerance
Posted Date: 2006-08-09T14:30:17Z

[Federal Register: August 9, 2006 (Volume 71, Number 153)]
[Rules and Regulations]               
[Page 45403-45408]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr09au06-18]                         

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

ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[EPA-HQ-OPP-2006-0582; FRL-8082-1]

 
Isophorone; Exemption from the Requirement of a Tolerance

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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

SUMMARY: This regulation amends existing exemption from the requirement 
of a tolerance for residues of isophorone (CAS Reg. No. 78-59-1) to 
limit the use to beets, ginseng, rice, spinach, sugar beets, and Swiss 
chard. The Isophorone Task Group (ITG) requested this revised exemption 
from the requirement of a tolerance under the Federal Food, Drug, and 
Cosmetic Act (FFDCA), as amended by the Food Quality Protection Act 
(FQPA) of 1996. This regulatory action contributes toward the Agency's 
tolerance reassessment requirements under FFDCA section 408(q), as 
amended by the FQPA of 1996. By law, EPA is required by August 2006 to 
reassess the tolerances that were in existence on August 2, 1996. The 
regulatory action in this document pertains to the revision of one 
existing tolerance exemption which is counted as a tolerance 
reassessment toward the August 2006 review deadline.

DATES: This regulation is effective August 9, 2006. Objections and 
requests for hearings must be received on or before October 10, 2006, 
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-2006-0582. All documents in the 
docket are listed in the index for the docket. 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 Building), 2777 S. Crystal Drive, 
Arlington, VA. The 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: Kerry Leifer, Registration Division 
(7505P), Office of Pesticide Programs, Environmental Protection Agency, 
1200 Pennsylvania Ave., NW., Washington, DC 20460-0001; telephone 
number: (703) 308-8811; e;mail address: leifer.kerry@epa.gov.

SUPPLEMENTARY INFORMATION:

I. General Information

A. Does this Action Apply to Me?

    You may be potentially affected by this action if you are an 
agricultural producer, food manufacturer, or pesticide manufacturer. 
Potentially affected entities may include, but are not limited to:
     Crop production (NAICS 111), e.g., agricultural workers; 
greenhouse, nursery, and floriculture workers; farmers.
     Animal production (NAICS 112), e.g., cattle ranchers and 
farmers, dairy cattle farmers, livestock farmers.
     Food manufacturing (NAICS 311), e.g., agricultural 
workers; farmers; greenhouse, nursery, and floriculture workers; 
ranchers; pesticide applicators.
     Pesticide manufacturing (NAICS 32532), e.g., agricultural 
workers; commercial applicators; farmers; greenhouse, nursery, and 
floriculture workers; residential users.
    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 an electronic copy of this Federal 
Register document through the electronic docket 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 pilot e-CFR site at http://www.gpoaccess.gov/ecfr.
 To access the OPPTS Harmonized Guidelines 

referenced in this document, go directly to the guidelines at http://www.epa.gpo/opptsfrs/home/guidelin.htm

C. Can I File an Objection or Hearing Request?

    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. 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-2006-0582 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 October 10, 2006.
    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-2006-0582, 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 
Building), 2777 S. Crystal Drive, Arlington, VA. Deliveries are only 
accepted during the Docket'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 telephone number is (703) 305-5805.

II. Background and Statutory Findings

    In the Federal Register of April 27, 2005 (70 FR 7951) (FRL-7710-
1), EPA

[[Page 45404]]

issued a notice pursuant to section 408(d)(3) of FFDCA, 21 U.S.C. 
346a(d)(3), announcing the filing of a pesticide petition (PP 4E6894) 
The Isophorone Task Group (ITG) of the Ketones Panel of the American 
Chemistry Council, 1300 Wilson Blvd., Arlington, VA 22209. The petition 
requested that 40 CFR 180.920 be amended by limiting the existing 
exemption from the requirement for isophorone (CAS Reg. No. 78-59-1) to 
rice, spinach, and sugar beets. That notice included a summary of the 
pesticide petition prepared by ITG, the petitioner. Comments were 
received on the notice of filing. EPA's response to these comments is 
discussed in Unit IV.
    Section 408(b)(2)(A)(i) of FFDCA allows EPA to establish 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. For further discussion of the 
regulatory requirements of section 408 of the FFDCA and a complete 
description of the risk assessment process, see http://www.epa.gov/fedrgstr/EPA-PEST/1997/November/Day-26/p30948.htm
.

III. Aggregate Risk Assessment and Determination of Safety

    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. EPA has sufficient data to assess the hazards of and to 
make a determination on aggregate exposure, consistent with section 
408(b)(2) of FFDCA, for an exemption from the requirement of a 
tolerance for residues of isophorone in or on beets, ginseng, rice, 
spinach, sugar beets, and Swiss chard. EPA's assessment of exposures 
and risks associated with establishing the tolerance follows.

A. Toxicological Profile

    EPA has evaluated the available toxicity data and considered its 
validity, completeness, and reliability as well as the relationship of 
the results of the studies to human risk. EPA has also considered 
available information concerning the variability of the sensitivities 
of major identifiable subgroups of consumers, including infants and 
children. The nature of the toxic effects caused by isophorone are 
discussed in the following Table 1 as well as the no-observed-adverse-
effect-level (NOAEL) and the lowest-observed-adverse-effect-level 
(LOAEL) from the reviewed toxicity studies.

            Table 1.--Subchronic, Chronic, and Other Toxicity
------------------------------------------------------------------------
          Guideline No.               Study Type            Results
------------------------------------------------------------------------
870.3100                          90-Day oral         NOAEL = 233.8/
                                   toxicity rodents    >311.8 milligram/
                                   (rats)              kilogram/day (mg/
                                                       kg/day) male/
                                                       female.
------------------------------------------------------------------------
                                                      LOAEL = 102.5 (M)/
                                                       not established
                                                       (F) mg/kg/day
                                                       based on M
                                                       decrease in body
                                                       weight
------------------------------------------------------------------------
870.3150                          90-Day oral         NOAEL = 150 mg/kg/
                                   toxicity study in   day higest dose
                                   nonrodents (dogs)   tested (HDT)
                                                      LOAEL = cannot be
                                                       established
------------------------------------------------------------------------
870.3700                          Prenatal            Maternal NOAEL =
                                   developmental       50 ppm
                                   (inhalation) in    LOAEL = 115 ppm
                                   rodents (mice)      based on
                                                       decreased
                                                       gestation day 18
                                                       body weight,
                                                       corrected for
                                                       uterine weight
                                                      Developmental
                                                       NOAEL = >115 ppm
                                                      Developmental
                                                       LOAEL = cannot be
                                                       established
------------------------------------------------------------------------
870.3700                          Prenatal            Maternal NOAEL =
                                   developmental       25 ppm
                                   (inhalation) in    LOAEL = 50 ppm
                                   rodents (rats)      based on
                                                       increased
                                                       incidence of
                                                       clinical signs
                                                       (alopecia, ano-
                                                       genital and
                                                       cervical
                                                       staining)
                                                      Developmental
                                                       NOAEL = 115 ppm
                                                       HDT
                                                      Developmental
                                                       LOAEL = cannot be
                                                       established
------------------------------------------------------------------------
870.4200                          Carcinogenicity     NOAEL = 250/500 mg/
                                   (rats)              kg/day (M/F)
                                                      LOAEL = 500 (M)/
                                                       not established
                                                       (F) based on M =
                                                       increased
                                                       incidence of
                                                       preputial gland
                                                       carcinoma
------------------------------------------------------------------------
870.4200                          Carcinogenicity     NOAEL = 500 mg/kg/
                                   (mice)              day HDT
                                                      LOAEL = cannot be
                                                       established
------------------------------------------------------------------------

[[Page 45405]]

    Isophorone was evaluated as part of the International Programme on 
Chemical Safety (ICPS). The IPCS is a joint venture of the United 
Nations Environment Programme, the International Labour Organisation, 
and the World Health Organization. The main objective of the IPCS is to 
carry out and disseminate evaluations of the effects of chemicals on 
human health and the quality of the environment.
    The ICPS Environmental Health Criteria monograph for isophorone 
critically evaluated the available toxicity data on isophorone, which 
included a consideration of the studies summarized in Table 1 as well 
as other available toxicity data on isophorone. As part of the human 
health risk assessment of isophorone, the ICPS monograph states that 
``limited studies in rats and mice indicate that isophorone does not 
affect fertility nor does it cause developmental toxicity in 
experimental animals.'' Additionally in summarizing the results of 
genotoxicity testing, the ICPS further concluded that ``the weight of 
evidence of all mutagenicity data supports the contention that 
isophorone is not a potent DNA-reactive compound.''

B. Toxicological Endpoints

    For hazards that have a threshold below which there is no 
appreciable risk, the NOAEL from the toxicology study identified as 
appropriate for use in risk assessment is used to estimate the 
toxicological level of concern (LOC). However, the LOAEL are identified 
is sometimes used for risk assessment if no NOAEL was achieved in the 
toxicology study selected. An uncertainty factor (UF) is applied to 
reflect uncertainties inherent in the extrapolation from laboratory 
animal data to humans and in the variations in sensitivity among 
members of the human population as well as other unknowns.
    The linear default risk methodology (Q*) is the primary method 
currently used by the Agency to quantify non-threshold hazards such as 
cancer. The Q* approach assumes that any amount of exposure will lead 
to some degree of cancer risk, estimates risk in terms of the 
probability of occurrence of additional cancer cases.
    A summary of the toxicological endpoints for isophorone used for 
human risk assessment is shown in the following Table 2:

      Table 2.--Summary of Toxicological Dose and Endpoints for isophorone for Use in Human Risk Assessment
----------------------------------------------------------------------------------------------------------------
                                          Dose Used in Risk
                                             Assessment,          Special FQPA SF and
          Exposure/Scenario                Interspecies and       Level of Concern for   Study and Toxicological
                                         Intraspecies and any       Risk Assessment              Effects
                                            Traditional UF
----------------------------------------------------------------------------------------------------------------
Chronic dietary (all populations)....  NOAEL = 150 mg/kg/day
                                       UF = 1.000.............
                                       Chronic RfD = 0.2 mg/kg/
                                        day.
Special FQPA SF = 1..................  90-Day oral dog
cPAD = chronic RfD...................   toxicity study. No
Special FQPA SF = 0.2 mg/kg/day......   toxicity was seen at
                                        the HDT
----------------------------------------------------------------------------------------------------------------
Cancer (oral, dermal, inhalation)....  NOAEL = 250 mg/kg/day    NA                       Increased incidence of
                                                                                          preputial gland
                                                                                          carcinomas in male
                                                                                          rats Toxicology and
                                                                                          Carcinogenesis Study
                                                                                          of Isophorone in F344/
                                                                                          N Rats
----------------------------------------------------------------------------------------------------------------
                                        Classification: Under the 1986 cancer classification scheme, isophorone
                                        was classified as Group C- Possible Human Carcinogen, with a linear low-
                                         dose extrapolation approach and a 3/4s interspecies scaling factor for
                                        human risk. The upper bound estimate of unit risk, Q1* is 6.08 x 10-4 in
                                                                    human equivalents
----------------------------------------------------------------------------------------------------------------

C. Exposure Assessment

    1. Dietary exposure from food and feed uses. An exemption from the 
requirement of a tolerances has been established (40 CFR 180.40 CFR 
site) for the residues of isophorone, in or on beet, ginseng, rice, 
spinach, sugar beet and Swiss chard commodities. Risk assessments were 
conducted by EPA to assess dietary exposures from isophorone in food as 
follows:
    i. Acute exposure. Quantitative acute dietary exposure and risk 
assessments are performed for a food-use pesticide, if a toxicological 
study has indicated the possibility of an effect of concern occurring 
as a result of a 1-day or single exposure.
    Option 1. No such effects were identified in the toxicological 
studies for isophorone; therefore, a quantitative acute dietary 
exposure assessment is unnecessary.
    ii. Chronic exposure.--Option 2. In conducting the chronic dietary 
exposure assessment EPA used the Dietary Exposure Evaluation Model 
software with the Food Commodity Intake Database (DEEM-
FCIDTM), which incorporates food consumption data as 
reported by respondents in the United States Department of Agriculture 
(USDA) 1994-1996 and 1998 Nationwide Continuing Surveys of Food Intake 
by Individuals (CSFII), and accumulated exposure to the chemical for 
each commodity. The following assumptions were made for the chronic 
exposure assessments: The assessment was based on a screening level 
dietary assessment that assumed residues of isophorone in beet, 
ginseng, rice, spinach, sugar beet and Swiss chard commodities 
corresponding to the highest established active ingredient tolerance 
level residues for those commodities and 100% crop treated. The highest 
established tolerance level active ingredient residue level is chosen 
as ``worst-case'' chronic exposure scenario as it would be highly 
unlikely that residues of isophorone in the above-listed crops would be 
at such levels.
    iii. Cancer. The assessment assumed residues of isophorone in beet, 
ginseng, rice, spinach, sugar beet and Swiss chard commodities 
corresponding to the highest established active ingredient tolerance 
level residues for those commodities and 100% crop treated. The highest 
established tolerance level active ingredient residue level is chosen 
as ``worst-case'' cancer exposure scenario as it would be highly 
unlikely that residues of isophorone in the above-listed crops would be 
at such levels.
    2. Dietary exposure from drinking water. Monitoring exposure data 
are utilized to complete a dietary exposure

[[Page 45406]]

analysis and risk assessment for isophorone in drinking water. The 
estimated drinking water concentration (EDWC) of isophorone of 10 
[mu]g/L utilized for the purposes of this tolerance action is a value 
equivalent to the highest measured concentration of isophorone in 
drinking water sources in monitoring studies used by EPA to establish 
ambient water quality criteria for isophorone. (EPA 440/5-80-056; NTIS 
PB81-11767).
    3. From non-dietary exposure. The term ``residential exposure'' is 
used in this document to refer to non-occupational, non-dietary 
exposure (e.g., for lawn and garden pest control, indoor pest control, 
termiticides, and flea and tick control on pets).
    Since the use of isophorone is limited to pesticide productswhich 
are not registered for use on any sites that would result in 
residential exposure, no residential exposures are expected and a 
residential exposure assessment has not been conducted
    4. Cumulative effects from substances with a common mechanism of 
toxicity. 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 isophorone and any other 
substances and isophorone 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 isophorone 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.

D. Safety Factor for Infants and Children

    1. In general. Section 408 of 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 data base on toxicity and exposure 
unless EPA determines based on reliable data that a different margin of 
safety will be safe for infants and children. Margins of safety are 
incorporated into EPA risk assessments either directly through use of a 
MOE analysis or through using uncertainty (safety) factors in 
calculating a dose level that poses no appreciable risk to humans. In 
applying this provision, EPA either retains the default value of 10X 
when reliable data do not support the choice of a different factor, or, 
if reliable data are available, EPA uses a different additional safety 
factor value based on the use of traditional uncertainty factors and/or 
special FQPA safety factors, as appropriate.
    2. Prenatal and postnatal sensitivity. There was no evidence of 
increased prenatal or postnatal susceptibility of isophorone following 
in utero exposure to rats and mice.
    3. Conclusion. There is an adequate toxicity database for the 
selection of doses and endpoints for use in risk assessment for 
isophorone. Exposure data are complete or are estimated based on data 
that reasonably account for potential exposures. The use of the IRIS 
chronic reference dose (cRfD) utilizes an additional 10X UF beyond the 
traditional UFs for intraspecies variability and interspecies 
extrapolation of 100X . This is protective of any potential concerns 
for increased susceptibility of infants and children to isophorone. The 
additional 10X uncertainty factor incorporated into the IRIS RfD is 
based on the use of a subchronic toxicity study, which, given the lack 
of increased pre-natal and postnatal susceptibility of isophorone, 
would address any potential concerns for increased susceptibility of 
infants and children to isophorone, therefore the FQPA factor is 
removed.

E. Aggregate Risks and Determination of Safety

    1. Acute risk. As there were no toxic effects attributable to a 
single dose, an endpoint of concern was not identified to quantitate 
acute dietary risk to the general population or to the subpopulation 
females 13-50 years old. No acute risk is expected from exposure to 
isophorone
    2. Chronic risk. The chronic dietary exposure analysis is based on 
a screening level dietary assessment that assumed residues of 
isophorone in beets, ginseng, rice, spinach, sugar beet and Swiss chard 
commodities corresponding to the highest established active ingredient 
tolerance level residues for those commodities and 100% crop treated 
Even with these highly conservative assumptions, the risk estimates are 
well below the Agency's level of concern. Using the exposure 
assumptions described in this unit for chronic exposure, EPA has 
concluded that exposure to isophorone from food and drinking water will 
utilize 1.8% of the chronic population adjusted dose (cPAD) for the 
U.S. population, and 4.4% of the cPAD for non-nursing infants, the most 
highly exposed population subgroup. Based on the use pattern, chronic 
residential exposure to residues of isophorone is not expected. 
Drinking water was incorporated directly into the dietary assessment 
using the concentration for drinking water given in unit III.C.2.
    3. Aggregate cancer risk for U.S. population. A non-threshold 
(Q1*) approach is used to estimate estimate cancer risk. The 
upper bound estimate of lifetime cancer risk for the U.S population is 
2.14 x 10-6. This value is derived by multiplying the upper 
bound estimate of unit risk, 6.08 x 10-4 by the chronic 
dietary exposure (food + drinking water) for the U.S. general 
population (0.003520 mg/kg/day). Drinking water was incorporated 
directly into the dietary assessment using the concentration for 
drinking water given in unit III.C.2. Since this upper bound estimate 
of cancer risk is based on a very conservative exposure estimate, and 
is within the range of one in one million cancer risk that is typically 
considered to not be a concern. EPA therefore concludes that isophorone 
is not expected to pose a carcinogenic risk to humans. If applicable, 
insert text. There is no boilerplate for this section.
    4. Determination of safety. Based on these risk assessments, EPA 
concludes that there is a reasonable certainty that no harm will result 
to the general population, and to infants and children from aggregate 
exposure to isophorone residues.

IV. Other Considerations

A. Analytical Enforcement Methodology

    An analytical method is not required for enforcement purposes since 
the Agency is establishing an exemption from the requirement of a 
tolerance without any numerical limitation.

B. International Residue Limits

    There are currently no Codex Maximum Residue Limits for isophorone

[[Page 45407]]

C. Response to Comments

    Ten comments were received regarding petition PP 4E6894. One 
comment, from B. Sachau, regarded general opposition to Agency approval 
of tolerances and exemptions other than zero, and general opposition to 
any residue left on a treated crop. The Agency finds that this comment 
contained no scientific data or evidence to rebut the Agency's 
conclusion that there is a reasonable certainty that no harm will 
result from aggregate exposure to isophorone including all anticipated 
dietary exposures and other exposures for which there is reliable 
information. This comment, as well as prior similar comments from B. 
Sachau have been responded to by the Agency on several occasions. For 
example, (October 29, 2004, 69 FR 63083), (January 7, 2005, 70 FR 
1349), and (June 30, 2005, 70 FR 37683. The other nine comments 
regarded the use of isophorone in desmedipham and phenmedipham 
formulations for use on beets, Swiss chard and ginseng. These uses are 
either part of existing section 24(c) registrations or section 18 
emergency exemptions, with each of the commentors requesting that these 
commodities be included in the reassessment of the isophorone tolerance 
exemption. The Agency agrees that these commodities should be included 
in the tolerance exemption expression for isophorone and has included 
these commodities in the aggregrate risk assessment and safety 
determination provided in Unit III.

V. Conclusion

    Therefore, an exemption from the requirement of a tolerance is 
established for residues of the inert ingredient isophorone, in or on 
beets, ginseng, rice, spinach, sugar beets, and Swiss chard.

VI. 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 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 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 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 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.

VII. 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: July 28, 2006.
Lois Rossi,
Director, 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.

[[Page 45408]]

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2. Section 180.920 is amended in the table by removing the entry 
Isophorone.
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Section 180.1270 is added to subpart D to read as follows:

Sec.  180.1270  Isophorone; exemption from the requirement of a 
tolerance.

    Isophorone (CAS Reg. No. 78-59-1) is exempt from the requirement of 
a tolerance when used as an inert ingredient in pesticide formulations 
applied to beets, ginseng, rice, spinach, sugar beets, and Swiss chard.

[FR Doc. E6-12547 Filed 8-8-06; 8:45 am]

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