[Federal Register Volume 72, Number 118 (Wednesday, June 20, 2007)]
[Rules and Regulations]
[Pages 33901-33907]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E7-11797]


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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[EPA-HQ-OPP-2006-0178; FRL-8132-9]


Lactofen; Pesticide Tolerance

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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SUMMARY: This regulation establishes a regional tolerance for residues 
of lactofen in or on vegetables, fruiting, group 08, and okra. 
Interregional Research Group Number 4 (IR-4)

[[Page 33902]]

requested this tolerance under the Federal Food, Drug, and Cosmetic Act 
(FFDCA).

DATES: This regulation is effective June 20, 2007. Objections and 
requests for hearings must be received on or before August 20, 2007, 
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-2006-0178. To access the 
electronic docket, go to http://www.regulations.gov, select ``Advanced 
Search,'' then ``Docket Search.'' Insert the docket ID number where 
indicated and select the ``Submit'' button. Follow the instructions on 
the regulations.gov web site to view the docket index or access 
available documents. All documents in the docket are listed in the 
docket index available in 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: Sidney Jackson, Registration Division 
(7505P), Office of Pesticide Programs, Environmental Protection Agency, 
1200 Pennsylvania Ave., NW., Washington, DC 20460-0001; telephone 
number: (703) 305-7610; 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 those 
engaged in the following activities:
     Crop production (NAICS code 111), e.g., agricultural 
workers; greenhouse, nursery, and floriculture workers; farmers.
     Animal production (NAICS code 112), e.g., cattle ranchers 
and farmers, dairy cattle farmers, livestock farmers.
     Food manufacturing (NAICS code 311), e.g., agricultural 
workers; farmers; greenhouse, nursery, and floriculture workers; 
ranchers; pesticide applicators.
     Pesticide manufacturing (NAICS code 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 to 
provide 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 EPA's tolerance regulations at 
40 CFR part 180 through the Government Printing Office's pilot e-CFR 
site at http://www.gpoaccess.gov/ecfr.

C. Can I File an Objection or Hearing Request?

    Under section 408(g) of the FFDCA, any person may file an objection 
to any aspect of this regulation and may also request a hearing on 
those objections. 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-2006-0178 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 as required by 40 CFR part 178 on or 
before August 20, 2007.
    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 this copy, identified by docket ID number 
EPA-HQ-OPP-2006-0178, 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'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. Petition for Tolerance

    In the Federal Register of April 12, 2006 (71 FR 18744) (FRL-7773-
3), EPA 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 
5E6930) by IR-4, 500 College Road East, Suite 201 W, Princeton, NJ 
08540. The petition requested that 40 CFR 180.432 be amended by 
establishing a tolerance for residues of the herbicide, lactofen, (1-
(carboethoxy) ethyl 5-2-chloro-4-(trifluoromethyl) phenoxy-2-
nitrobenzoate), in or on vegetable, fruiting, and okra at 0.01 parts 
per million (ppm). That notice referenced a summary of the petition 
prepared by Valent U.S.A. Corporation, the registrant, which is 
available to the public in the docket, http://www.regulations.gov. 
There were no comments received in response to the notice of filing.

III. Aggregate Risk Assessment and Determination of Safety

    Section 408(b)(2)(A)(i) of the 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 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

[[Page 33903]]

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. . . .'' These provisions were added to the 
FFDCA by the Food Quality Protection Act (FQPA) of 1996.
    Consistent with section 408(b)(2)(D) of the FFDCA, and the factors 
specified in section 408(b)(2)(D) of the 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 for the petitioned for 
tolerance for residues of lactofen in/on vegetables, fruiting, group 
08, at 0.02 ppm and okra at 0.02 ppm . 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 their 
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. Specific information on the studies received and the nature 
of the adverse effects caused by lactofen as well as the no-observed-
adverse-effect-level (NOAEL) and the lowest-observed-adverse-effect-
level (LOAEL) from the toxicity studies are discussed in support 
documents to this action under Docket ID number EPA-HQ-OPP-2006-0178.

B. Toxicological Endpoints

    For hazards that have a threshold below which there is no 
appreciable risk, the toxicological level of concern (LOC) is derived 
from the highest dose at which NOAEL in the toxicology study identified 
as appropriate for use in risk assessment. However, if a NOAEL cannot 
be determined, the LOAEL doseof concern are identified is sometimes 
used for risk assessment. Uncertainty/safety factors (UF) are used in 
conjunction with the LOC to take into account 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. Safety is assessed for acute and chronic risks by 
comparing aggregate exposure to the pesticide to the acute population 
adjusted dose (aPAD) and chronic population adjusted dose (cPAD). The 
aPAD and cPAD are calculated by dividing the LOC by all applicable 
uncertainty/safety factors. Short-term, intermediate-term, and long-
term risks are evaluated by comparing aggregate exposure to the LOC to 
ensure that the margin of exposure (MOE) called for by the product of 
all applicable uncertainty/safety factors is not exceeded.
    For non-threshold risks, the Agency assumes that any amount of 
exposure will lead to some degree of risk and estimates risk in terms 
of the probability of occurrence of additional adverse cases. 
Generally, cancer risks are considered non-threshold. For more 
information on the general principles EPA uses in risk characterization 
and a complete description of the risk assessment process, see http://www.epa.gov/fedrgstr/EPA-PEST/1997/November/Day-26/p30948.htm.
    A summary of the toxicological endpoints for lactofen used for 
human risk assessment can be found at www.regulations.gov in document 
``Lactofen: Human Health Risk Assessment for Proposed Uses of Fruiting 
Vegetables and Okra'' at page number 13 in docket ID number EPA-HQ-OPP-
2006-0178. To locate this information on the Regulation.gov website 
follow these steps:
     Select ``Advanced Search'', then ``Docket Search.''
     In the ``Docket ID number'' field type the docket number 
in the following format - ''OPP-year-docket number'' e.g., OPP-2005-
9999).
     Click the ``Submit'' button.
     Click on the docket to open.

C. Exposure Assessment

    1. Dietary exposure from food and feed uses. In evaluating dietary 
exposure to lactofen, EPA considered exposure under the petitioned-for 
tolerances as well as all existing lactofen tolerances in (40 CFR 180. 
432). Exposure assessment also considered exposures as a result of 
acifluorfen, an environmental degrade of lactofen.
    EPA assessed dietary exposures from lactofen 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.
    The Agency did not identify an endpoint for an acute dietary 
exposure assessment for the general population due to the lack of 
toxicological effects of concern attributable to a single exposure 
(dose) in studies available in the data base including oral 
developmental toxicity studies in rats and rabbits. An acute dietary 
exposure assessment was conducted for the population subgroup, female 
ages 13-49, only. In estimating acute dietary exposure, EPA used the 
Dietary Exposure Evaluation Model software with the Food Commodity 
Intake Database (DEEM-FCIDTM, Version 2.03), which 
incorporates consumption data from United States Department of 
Agriculture (USDA) Continuing Surveys of Food Intakes by Individuals 
(CSFII), 1994-1996 and 1998. As to residue levels in food, EPA assumed 
all foods for which there are proposed or existing tolerances were 
treated and contain tolerance-level residues.
    ii. Chronic exposure. In conducting the chronic dietary exposure 
assessment EPA used the DEEM/FCIDTM, Version 2.03, which 
incorporates food consumption data from USDA's 1994-1996 and 1998 
Nationwide Continuing Surveys of Food Intakes by Individuals (CSFII). 
The chronic dietary analysis assumed all crops for which there are 
proposed or existing tolerances were treated and contain tolerance-
level residues.
    iii. Cancer. Lactofen has been classified as ``not likely'' to be 
carcinogenic in humans because of available data on lactofen support 
activation of the peroxisome proliferator activated receptor alpha 
(PPAR[alpha]) as the mode of action which induced liver tumors in 
rodents. While the proposed mode of action for liver tumors in rodent 
is qualitatively possible in humans, it is quantitatively implausible 
and unlikely to take place in humans based on quantitative species 
toxicodynamic differences in PPAR[alpha] activation. The quantification 
of risk is not required.
    iv. Exposure assessment for acifluorfen. Lactofen degrades in the 
environment to acifluorfen. Sodium acifluorfen is a registered 
agricultural pesticide. Accordingly, an aggregate assessment for 
acifluorfen exposure resulting from both use of lactofen and sodium 
acifluorfen was also conducted. As to residue levels of acifluorfen in 
food from use of sodium acifluorfen, EPA assumed all foods for which 
there are tolerances were treated and contain tolerance level residues.
    2. Dietary exposure from drinking water. The Agency lacks 
sufficient

[[Page 33904]]

monitoring data to complete a comprehensive dietary exposure analysis 
and risk assessment for lactofen in drinking water. Because the Agency 
does not have comprehensive monitoring data, drinking water 
concentration estimates are made by reliance on simulation or modeling 
taking into account data on the environmental fate characteristics of 
lactofen. Further information regarding EPA drinking water models used 
in pesticide exposure assessment can be found at http://www.epa.gov/oppefed1/models/water/index.htm.
    The drinking water assessment of lactofen is complicated by the 
fact that lactofen has a major degradate in common with another 
registered herbicide, sodium acifluorfen. Lactofen and sodium 
acifluorfen also have common use sites. The Agency considered the 
contribution of acifluorfen as an environmental degradate of lactofen 
and from sodium acifluorfen in the aggregate assessment. The drinking 
water residues used in the dietary risk assessment were incorporated 
directly into this dietary exposure from drinking water assessment. 
Therefore, EPA estimated drinking water concentrations for both 
lactofen and acifluorfen from lactofen applications. Water residues 
were incorporated into DEEM-FCID as the food categories ``water, 
direct, all sources'' and ``water, indirect, all sources.''
    The Tier 2 surface water estimated drinking water concentrations 
(EDWCs) and estimated environmental concentrations (EECs) for lactofen 
and acifluorfen were generated with standard Florida pepper and Florida 
tomato cropping scenarios using EPA's pesticide root zone model (PRZM3) 
and EXAMS. PRZM simulates pesticide fate and transport as a result of 
leaching, direct spray drift, runoff and erosion from an agricultural 
field and EXAMS estimates environmental fate and transport of 
pesticides in surface water body for a 30-year period (1961-1990). The 
EDWCs and EECs assessment for surface water uses single or multiple 
sites which typically represent a high-end exposure scenario from 
pesticide use on a particular cropped or non-cropped site. Ground-water 
concentrations were estimated using the Tier 1 screening model 
screening concentration in ground water (SCI-GROW). The models and its 
description are available at EPA internet site: http://www.epa.gov/oppefed1/models/water/.
    Based on the PRZM3/EXAMS model, the EDWCs in surface water 
(lactofen and the acifluorfen derived from lactofen) for acute 
exposures are estimated to be 1.48 parts per billion (ppb) and 22.5 ppb 
for lactofen and acifluorfen, respectively, and for chronic exposures 
0.044 ppb and 3.9 ppb for lactofen and acifluorfen, respectively. By 
comparison, the EDWC for chronic exposure for acifluorfen derived from 
sodium acifluorfen use on soybeans is 3.3 ppb.
    For ground water, the SCI-GROW estimates of lactofen and 
acifluorfen EDWCs from application of lactofen for both acute and 
chronic exposures are 0.006 ppb lactofen and 2.0 ppb acifluorfen. By 
comparison, the SCI-GROW estimate of acifluofren EDWCs in ground water 
from applications of sodium acifluorfen is 3.67 ppb.
    Modeled estimates of drinking water concentrations were directly 
entered into the dietary exposure model. For the lactofen acute dietary 
risk assessment, the water concentration value of 1.48 ppb was used to 
assess the contribution to drinking water. For the lactofen chronic 
dietary risk assessment, the water concentration of value 0.044 ppb was 
used to assess the contribution to drinking water. For the acifluorfen 
acute dietary risk assessment, the water concentration value of 22.5 
ppb was used to assess the contribution to drinking water. For the 
acifluorfen chronic dietary risk assessment, the water concentration of 
value 3.9 ppb was used to assess the contribution to drinking water. 
Acifluorfen from lactofen and sodium acifluorfen were not combined 
because they are not expected to be used in the same area.
    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).
    There are no products containing lactofen as an active ingredient 
that are registered for use in a residential or other non-occupational 
setting. No residential exposure assessment is required.
    Residential exposures to the environmental degradate acifluorfen 
may occur as a result of the use of sodium acifluorfen, which has 
registered residential spot treatment uses. The only scenario for 
residential exposure is a short-term spot treatment. Due to the 
frequency, duration and location of residential spot treatment 
applications, the Agency considered exposure to adults applying sodium 
acifluorfen and does not anticipate post-application dermal exposures.
    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.''
    Lactofen is a member of the diphenyl ether chemical family. The 
common toxicity that these compounds share is induction of liver 
effects (liver hypertrophy, increase in liver weight, tumors). Members 
of this class have been shown to induce rodent liver effects /tumors 
through the activation of the PPAR[alpha]. It should be noted that 
liver hypertrophy and increases in liver weight are part of the range 
of morphological changes that result from chemically-mediated effects 
on the PPAR[alpha] receptor and hepatocarcinogenesis. Although 
PPAR[alpha] agonists can induce liver rodent tumors, the potential for 
PPAR[alpha] agonists to induce liver tumors in other species, including 
humans, appears to be unlikely. This is because evidence shows that 
these other species are quantitatively less sensitive to the effects of 
PPAR[alpha] agonism due to toxicodynamic differences between the human 
and rodent nuclear PPAR[alpha] receptor. Thus, while this mode of 
action for liver tumors in rodent is qualitatively possible in humans, 
it is quantitatively implausible and unlikely to take place in humans. 
Accordingly, although members of the diphenyl ether family as well as 
other classes of compounds may share a common hepatocarcinogenic mode 
of action, cumulative exposure to PPAR[alpha] agonists is unlikely to 
induce liver carcinogenesis in humans.
    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 the FFDCA provides that EPA shall 
apply an additional (10X) 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

[[Page 33905]]

different margin of safety will be safe for infants and children. This 
additional margin of safety is commonly referred to as the FQPA safety 
factor. 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 FQPA safety factor value based on the use of 
traditional uncertainty/safety factors and/or special FQPA safety 
factors, as appropriate.
    2. Prenatal and postnatal sensitivity. Although there is 
qualitative evidence of increased susceptibility in the prenatal 
developmental studies in rats and rabbits, the Agency did not identify 
any residual uncertainties after establishing toxicity endpoints and 
traditional uncertainty factors to be used in the risk assessment of 
lactofen. The degree of concern for prenatal and postnatal toxicity is 
low.
    3. Conclusion. Several factors weighed in favor of the conclusion 
that no additional safety factor is needed to protect the safety of 
infants and children.
     There are no outstanding data gaps for developmental 
toxicity or reproductive toxicity studies;
     There are no residual uncertainties regarding prenatal and 
postnatal toxicity; and
     There are no residual uncertainties regarding the exposure 
of infants and children to lactofen.
    Nonetheless, EPA determined that an additional safety factor was 
needed to address the lack of a NOAEL in the rabbit developmental 
study. Although sufficient reliable information has been submitted on 
developmental effects of lactofen in rabbits, no NOAEL was identified 
in one of the two rabbit developmental studies submitted. The endpoints 
of concern identified in available studies are: Decreased live young/
litter, increased embryonic death/litter, and increased incidence of 
post-implantation loss. These effects were noted at all dose levels (5, 
15, 50 mg/kg/day) thus a NOAEL was not established. Consequently, a 
LOAEL to NOAEL factor is appropriate and the risk assessment applies a 
3X uncertainty factor. A FQPA uncertainty factor of infants and 
children and will be used for the LOAEL to NOAEL extrapolation. The 3X 
factor is considered to be protective because the incidence of the 
effects at the lowest dose tested was only marginally higher than the 
historical controls.
    For sodium acifluorfen, the available toxicology database provides 
sufficient information for selecting various toxicity endpoints and 
doses for assessing the risks. The Agency evaluated the hazard and 
exposure data for sodium acifluorfen and recommended retaining the 
safety factor at 10X due to the data gap for the developmental 
neurotoxicity study in rats. In accordance with the current EPA policy, 
the 10x factor will be applied to all exposure durations.

E. Aggregate Risks and Determination of Safety

    Safety is assessed for acute and chronic risks by comparing 
aggregate exposure to the pesticide to the acute population adjusted 
dose (aPAD) and chronic population adjusted dose (cPAD). The aPAD and 
cPAD are calculated by dividing the LOC by all applicable uncertainty/
safety factors. For linear cancer risks, EPA calculates the probability 
of additional cancer cases given aggregate exposure. Short-term, 
intermediate-term, and long-term risks are evaluated by comparing 
aggregate exposure to the LOC to ensure that the margin of exposure 
(MOE) called for by the product of all applicable uncertainty/safety 
factors is not exceeded.
    1. Acute risk. Acute (1-day) exposures to lactofen may result from 
consuming treated food and drinking water. No endpoints were identified 
for the general population so the only assessment was conducted for 
females ages 13-49. The results of the acute aggregate assessment for 
lactofen for food and drinking water show that all exposures are below 
the level of concern, with the lactofen assessments at less than 1% of 
the aPAD.
    The acute aggregate assessment for acifluorfen includes food 
exposure from tolerance level residues (from sodium acifluorfen 
applications) and water exposures of acifluorfen as an environmental 
degradate of lactofen. No acute endpoints were identified for the 
general population so the only assessment was conducted for females 
ages 13-49. All exposures are below the level of concern, with the 
acifluorfen assessments at 6% of the aPAD.
    Both the lactofen and acifluorfen assessments are likely to be 
overestimates of risk because they assume all of the crops (for which 
there are registered uses) consumed in the U.S. are treated and bear 
tolerance-level residues.
    2. Chronic risk. Using the exposure assumptions described in this 
unit for chronic exposure, EPA has concluded that exposure to lactofen 
from food and water will utilize <1% of the cPAD for all the population 
subgroups. There are no residential uses for lactofen that result in 
chronic residential exposure to lactofen.
    The results of the long-term aggregate assessment for acifluorfen 
show that for food and drinking water, all exposures are below the 
level of concern. The most highly exposed subgroup in the acifluorfen 
assessment at 37% of the cPAD was infants, less than 1-year old.
    3. Short-term risk. Short-term aggregate exposure takes into 
account residential exposure plus chronic exposure to food and water 
(considered to be a background exposure level).
     Lactofen is not registered for use on any sites that would result 
in residential exposure. Therefore, the aggregate risk is the sum of 
the risk from food and water.
    An aggregate assessment was conducted for exposure to acifluorfen. 
Registered residential uses of sodium acifluorfen include spot 
treatments only. The short term endpoint selected applies to females 
ages 13-49, but is protective of all populations. The acifluorfen 
aggregate assessment for this exposure duration includes the average 
food exposure assuming tolerance level residues, average water exposure 
(acifluorfen as an environmental degradate of lactofen), and 
residential handler exposures. The MOE for the aggregate assessment is 
16,000, which exceeds the target MOE of 1,000. Therefore, the 
acifluorfen short term aggregate risks are not of concern.
    4. Intermediate-term risk. Intermediate-term aggregate exposure 
takes into account residential exposure plus chronic exposure to food 
and water (considered to be a background exposure level).
    An intermediate-term assessment is not required for lactofen as 
there are no residential uses of lactofen.
    Intermediate-term exposure is not expected for acifluorfen because 
residential uses of sodium acifluorfen are limited to spot treatments 
that do not include broadcast application to lawns.
    5. Aggregate cancer risk for U.S. population. For the reasons 
discussed in Unit III.C.1.iii. the chronic aggregate assessments are 
protective of the carcinogenic effects for both lactofen and 
acifluorfen.
    6. 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 or to infants and children from aggregate 
exposure to lactofen residues.

[[Page 33906]]

IV. Other Considerations

A. Analytical Enforcement Methodology

    Acceptable gas chromatography with electron capture detection (GC/
ECD) methods are available in the Pesticide Analytical Manual (PAM) 
Vol. II for the enforcement of tolerances of lactofen and metabolites 
in plant commodities. A modified version of Method B is listed in the 
EPA Index of Pesticide Analytical Methods under lactofen. Samples from 
the pepper and tomato field trials were analyzed using established GC/
ECD enforcement methods or modified versions of established enforcement 
methods. The validated limits of quantitation (LOQs) were 0.01 ppm for 
peppers and 0.02 ppm from all other trials. The methods are adequate 
for data collection based on acceptable method validation and 
concurrent recovery data.

B. International Residue Limits

    There are no established or proposed Codex, Canadian, or Mexican 
maximum residue limits (MRLs) for lactofen in any crops. Therefore, 
there are no international compatibility issues with respect to U.S. 
tolerances.

V. Conclusion

    Therefore, the regional tolerance is established for residues of 
[the herbicide lactofen, 1-(carboethoxy)ethyl 5-[2-chloro-4-
(trifluoromethyl)phenoxy]-2- nitrobenzoate, in or on the following raw 
agricultural commodities: Vegetables, fruiting, group 8 at 0.02 ppm, 
and okra at 0.02 ppm.

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, 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) 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 6, 
2000) do not apply to this rule. In addition, this 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).

VII. 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: June 7, 2007.
Lois Rossi,
Director, Registration Division, Office of Pesticide Programs.

0
Therefore, 40 CFR chapter I is amended as follows:

PART 180--[AMENDED]

0
1. The authority citation for part 180 continues to read as follows:

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

0
2. Section 180.432 is amended by adding text to paragraph (c) to read 
as follows:


Sec.  180.432  Lactofen; tolerances for residues.

* * * * *
    (c) Tolerances with regional registrations. Tolerances with 
regional registrations, as defined in 180.1(n) are established for 
residues of the herbicide, lactofen, 1-(carboethoxy)ethyl 5-[2-chloro-
4-(trifluoromethyl)phenoxy]-2- nitrobenzoate, in or on the following 
food commodities:

------------------------------------------------------------------------
                   Commodity                        Parts per million
------------------------------------------------------------------------
Okra...........................................                     0.02
------------------------------------------------------------------------
Vegetables, fruiting, group 08.................                     0.02
------------------------------------------------------------------------


[[Page 33907]]

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[FR Doc. E7-11797 Filed 6-19-07; 8:45 am]
BILLING CODE 6560-50-S