
[Federal Register: February 27, 2008 (Volume 73, Number 39)]
[Rules and Regulations]               
[Page 10390-10396]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr27fe08-6]                         

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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[EPA-HQ-OPP-2006-0857; FRL-8350-3]

 
Cyfluthrin; Pesticide Tolerance

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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SUMMARY: This regulation establishes tolerances for residues of 
cyfluthrin in or on grass, forage, fodder and hay group 17, forage at 
12 ppm; grass, forage, fodder and hay, group 17, hay at 50 ppm; beet, 
sugar, roots at 0.10 ppm; and beet, sugar, dried pulp at 1.0 ppm. 
Interregional Research Project Number 4 (IR-4), and Bayer CropScience 
requested these tolerances under the Federal Food, Drug, and Cosmetic 
Act (FFDCA).

DATES: This regulation is effective February 27, 2008. Objections and 
requests for hearings must be received on or before April 28, 2008, 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-2006-0857. 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 website 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: Shaja R. Brothers, Registration 
Division (7505P), Office of Pesticide Programs, Environmental 
Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460-
0001; telephone number: (703) 308-3194; e-mail address: 
brothers.shaja@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 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

[[Page 10391]]

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 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-2006-0857 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 April 28, 2008.
    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-2006-0857, 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 Registers of October 27, 2006 (71 FR 63011) (FRL-
8100-2), and May 9, 2007 (72 FR 26372) (FRL-8121-5) EPA issued notices 
pursuant to section 408(d)(3) of FFDCA, 21 U.S.C. 346a(d)(3), 
announcing the filing of pesticide petitions (PP) 6E7058 by IR-4, 500 
College Road East, Suite 201 W, Princeton, NJ, 08540; and (PP) 6F7160 
by Bayer CropScience, 2.T.W. Alexander Drive, PO Box 12014, Research 
Triangle Park, NC 27709. The petitions requested that 40 CFR 180.436 be 
amended by establishing tolerances for residues of the insecticide 
cyfluthrin, cyano(4-fluoro-3-phenoxyphenyl)methyl 3-(2,2-
dichloroethenyl)-2,2-dimethylcyclopropanecarboxylate, in or on grass, 
forage at 15 parts per million (ppm) (PP 6E7058); grass, hay at 40 ppm 
(PP 6E7058); beet, sugar, roots at 0.09 ppm (PP 6F7160); and beet, 
sugar, dried pulp at 11 ppm (PP 6F7160). The notices referenced a 
summary of the petition prepared by Bayer CropScience, the registrant, 
which is available to the public in the docket, http://
www.regulations.gov. Comments were received from a private citizen on 
the notices of filing concerning the tolerances for grass, forage; 
grass, hay; beet, sugar, roots; and beet, sugar, dried pulp. EPA's 
response to these comments is discussed in Unit IV.C.
    Based upon review of the data supporting the petition, EPA has 
revised the commodity and/or tolerance expressions for the proposed 
petitions. The reason for these changes is explained in Unit IV.C.

III. Aggregate Risk Assessment and Determination of Safety

    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....'' These provisions were added to FFDCA by the Food Quality 
Protection Act (FQPA) of 1996.
    Consistent with FFDCA section 408(b)(2)(D), and the factors 
specified in FFDCA section 408(b)(2)(D), 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 cyfluthrin on grass, forage, fodder and hay, group 17, 
forage at 12 ppm; grass, forage, fodder and hay, group 17, hay at 50 
ppm; beet, sugar, roots at 0.10 ppm; and beet, sugar, dried pulp at 1.0 
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 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.
    Toxicologically, the primary target for cyfluthrin/beta-cyfluthrin 
is the neuromuscular system; other non-specific effects include 
decreased body weight gain, and decreased food consumption. The 
observed neuromuscular effects (tremors, gait abnormities, abnormal 
postural reactions, splaying of limbs and decreases in activity) 
occurred mainly in oral studies in the dog and the rat. In general, the 
toxicity data base does not indicate that any major differences in 
toxicity exist between beta-cyfluthrin and cyfluthrin via the oral 
route. Data from the inhalation toxicity study showed evidence of 
clinical signs as well as hypothermia and decreased body weight gains. 
In a postnatal inhalation study in mice, there were clinical signs of 
neurotoxicity in the pups as well as increased spontaneous motor 
activity and paresthesia (tingling, burning or prickling - also seen in 
oral studies).
    In oral developmental studies no increased susceptibility was 
observed in the rat or rabbit; however, increased susceptibility was 
observed in inhalation developmental studies. Increased susceptibility 
was also seen in oral reproduction studies and in a

[[Page 10392]]

developmental neurotoxicity study on beta-cyfluthrin. The data also 
demonstrate increased susceptibility of rats and mice to cyfluthrin 
postnatally.
    The database does not indicate that either cyfluthrin or beta-
cyfluthrin induces any endocrine disruption; and, there is no concern 
of mutagenicity. EPA has classified cyfluthrin/beta-cyfluthrin as ``not 
likely to be carcinogenic to humans.''
    Specific information on the studies received and the nature of the 
adverse effects caused by cyfluthrin as well as the no-observed-
adverse-effect-level (NOAEL) and the lowest-observed-adverse-effect-
level (LOAEL) from the toxicity studies can be found in the Cyfluthrin: 
Human Health Risk Assessment for New Uses on Grasses, Alfalfa, and 
Sugar Beet Seed and Revised Tolerances on Cereal Grain Commodities on 
pages 54-64 at www.regulations.gov. The referenced document is 
available in docket EPA-HQ-OPP-2006-0857.

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 no adverse effects are observed (the 
NOAEL) in the toxicology study identified as appropriate for use in 
risk assessment. However, if a NOAEL cannot be determined, the lowest 
dose at which adverse effects of concern are identified (the LOAEL) is 
sometimes used for risk assessment. Uncertainty/safety factors (UFs) 
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 UFs. Short-, intermediate-, 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 
UFs 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 cyfluthrin used for 
human risk assessmentcan be found at http://www.regulations.gov in the 
Cyfluthrin: Human Health Risk Assessment for New Uses of Grasses, 
Alfalfa, and Sugar Beet Seed and Revised Tolerances on Cereal Grain 
Commodities on pages 23 and 24 for docket ID number EPA-HQ-OPP-2006-
0857.

C. Exposure Assessment

    1. Dietary exposure from food and feed uses. In evaluating dietary 
exposure to cyfluthrin, EPA considered exposure under the petitioned-
for tolerances as well as all existing cyfluthrin tolerances in (40 CFR 
180.436). EPA assessed dietary exposures from cyfluthrin 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. In estimating acute dietary 
exposure, EPA used food consumption information from the U.S. 
Department of Agriculture (USDA) 1994-1996 and 1998 Nationwide 
Continuing Surveys of Food Intakes by Individuals (CSFII). As to 
residue levels in food, EPA's analysis was based on tolerance level 
residues, crop field trial data, Pesticide Data Program (PDP) 
monitoring data, percent crop treated, anticipated residues in animal 
commodities, and processing factors.
    ii. Chronic exposure. In conducting the chronic dietary exposure 
assessment, EPA used the food consumption data from the USDA 1994-1996, 
and 1998 CSFII. As to residue levels in food, EPA's analysis was based 
on tolerance level residues, crop field trial data, PDP monitoring 
data, average percent crop treated, anticipated residues in animal 
commodities, and processing factors.
    iii. Cancer. A cancer dietary exposure analysis was not performed 
because EPA has classified cyfluthrin as being ``not likely to cause 
cancer in humans.''
    iv. Anticipated residue and percent crop treated (PCT) information. 
Section 408(b)(2)(E) of FFDCA authorizes EPA to use available data and 
information on the anticipated residue levels of pesticide residues in 
food and the actual levels of pesticide residues that have been 
measured in food. If EPA relies on such information, EPA must pursuant 
to FFDCA section 408(f)(1) require that data be provided 5 years after 
the tolerance is established, modified, or left in effect, 
demonstrating that the levels in food are not above the levels 
anticipated. For the present action, EPA will issue such data call-ins 
as are required by FFDCA section 408(b)(2)(E) and authorized under 
FFDCA section 408(f)(1). Data will be required to be submitted no later 
than 5 years from the date of issuance of this tolerance.
    Section 408(b)(2)(F) of FFDCA states that the Agency may use data 
on the actual percent of food treated for assessing chronic dietary 
risk only if:
    a. The data used are reliable and provide a valid basis to show 
what percentage of the food derived from such crop is likely to contain 
such pesticide residue.
    b. The exposure estimate does not underestimate exposure for any 
significant subpopulation group.
    c. Data are available on pesticide use and food consumption in a 
particular area, the exposure estimate does not understate exposure for 
the population in such area. In addition, the Agency must provide for 
periodic evaluation of any estimates used. To provide for the periodic 
evaluation of the estimate of PCT as required by FFDCA section 
408(b)(2)(F), EPA may require registrants to submit data on PCT.
    The Agency used PCT information for chronic dietary exposures as 
follows:
    Almond 1%; cabbage 5%; cantaloupe 1%; field corn 5%; cotton 10%; 
cucumber 1%; pecan 1%; pepper 10%; potato 25%; pumpkin 1%; sorghum 1%; 
soybean 1%; squash 5%; sugarcane 1%; sunflower 1%; and watermelon 2.5%.
    EPA uses an average PCT for the acute and chronic dietary risk 
analysis. The average PCT figure for each existing use is derived by 
combining available federal, state, and private market survey data for 
that use, averaging by year, averaging across all years, and rounding 
up to the nearest multiple of 5% except for those situations in which 
the average PCT is less than one. In those cases <1% is used as the 
average and <2.5% is used as the maximum. EPA uses a maximum PCT for 
acute dietary risk analysis. The maximum PCT figure is the single 
maximum value reported overall from available Federal, State, and 
private market survey data on the existing use, across all years, and 
rounded up to the nearest multiple of 5%. In most cases, EPA uses 
available data from United States Department of Agriculture/National 
Agricultural Statistics Service (USDA/NASS), Proprietary Market 
Surveys, and the National Center for Food and Agriculture Policy 
(NCFAP) for the most recent 6 years.

[[Page 10393]]

    The Agency used projected PCT information for chronic dietary 
exposures as follows:
    Apple 69%; collard 22%; grape 15%; kale 13%; mustard greens 7%; 
grass <1 %; peach 43%; pear 62%; plum 37%; spinach 39%; turnip 14%, and 
wheat 2%.
    EPA estimates an upper bound of projected percent crop treated 
(PPCT) for a new pesticide use by assuming that the percent crop 
treated (PCT) during the pesticide's initial 5 years of use on a 
specific crop will not exceed the average PCT of the dominant pesticide 
(i.e., the one with the greatest PCT) on that crop over the three most 
recent surveys. EPA calls this the market leader PPCT estimate. The 
average market leader PCTs may be based on one or two survey years if 
three are not available. Also, with limited availability of data, the 
average market leader PCTs may be based on a cross-section of state 
PCTs. Comparisons are only made initially among pesticides of the same 
pesticide type (e.g., leading insecticides on the crop compared with 
the new insecticide), or, for more refined estimates, comparisons may 
be made among pesticides in a subcategory of the same pesticide type 
(e.g., leading pyrethroid insecticides compared with the new pyrethroid 
insecticide). The PCTs included in the average may be each for the same 
pesticide or for different pesticides since the same or different 
pesticides may dominate each year selected. Typically, EPA uses U.S. 
Department of Agriculture/National Agricultural Statistics Service 
(USDA/NASS) as the source for raw PCT data because it is publicly 
available. When a specific crop is not surveyed by USDA/NASS, EPA uses 
other sources including proprietary data and calculates the estimated 
PCT.
    An estimated PPCT, based on the average PCT of the market leaders, 
is appropriate for use in chronic dietary risk assessment. This method 
of estimating PPCT for a new use of a registered pesticide or a new 
pesticide produces high-end estimate that is unlikely, in most cases, 
to be exceeded during the initial 5 years of actual use. Predominant 
factors that bear on whether the PPCT could be exceeded may include 
PCTs of similar chemistries, pests controlled by alternatives, pest 
prevalence in the market and other factors. All relevant information 
currently available for predominant factors has been considered for the 
use of cyfluthrin on apples, cabbage, cauliflower, collards, grapes, 
kale, mustard greens, pasture/rangeland, peaches, pears, peas, plums, 
spinach, turnip greens, and wheat. It is unlikely that actual PCTs for 
cyfluthrin will exceed the corresponding estimated PPCTs during the 
next 5 years because cyfluthrin shares many pest control attributes and 
constraints with other members of the pyrethroid class and will likely 
replace or be used in a similar manner to currently registered 
pyrethroids.
    The Agency believes that the three conditions listed above have 
been met. With respect to Condition a, PCT estimates are derived from 
Federal and private market survey data, which are reliable and have a 
valid basis. The Agency is reasonably certain that the percentage of 
the food treated is not likely to be an underestimation. As to 
Conditions b and c, regional consumption information and consumption 
information for significant subpopulations is taken into account 
through EPA's computer-based model for evaluating the exposure of 
significant subpopulations including several regional groups. Use of 
this consumption information in EPA's risk assessment process ensures 
that EPA's exposure estimate does not understate exposure for any 
significant subpopulation group and allows the Agency to be reasonably 
certain that no regional population is exposed to residue levels higher 
than those estimated by the Agency. Other than the data available 
through national food consumption surveys, EPA does not have available 
information on the regional consumption of food to which cyfluthrin may 
be applied in a particular area.
    2. Dietary exposure from drinking water. The Agency lacks 
sufficient monitoring data to complete a comprehensive dietary exposure 
analysis and risk assessment for cyfluthrin 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 
cyfluthrin. 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.
    Based on survey of all the currently registered and proposed uses 
of cyfluthrin, it was determined that cyfluthrin use on alfalfa and 
cotton would lead to the highest surface water and ground water 
estimated groundwater concentrations (EDWCs), respectively. Based on 
the First Index Reservoir Screening Tool (FIRST), and Screening 
Concentration in Ground Water (SCI-GROW) models, the estimated 
environmental concentrations (EECs) of cyfluthrin are estimated to be 
3.677 parts per billion (ppb) and 0.155 ppb for acute and chronic 
exposure in surface water respectively. The EEC for chronic groundwater 
exposure is 0.457 ppb.
    Modeled estimates of drinking water concentrations were directly 
entered into the dietary exposure model. For acute dietary risk 
assessment, the water concentration value of 3.677 ppb was used to 
access the contribution of residues in drinking water to dietary risk. 
For chronic dietary risk assessment, the water concentration of value 
0.457 ppb was used to access the contribution to drinking water.
    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).
    Cyfluthrin products are registered for use at residential sites 
including indoor (total release fogger, and crack and crevice spray), 
and outdoor uses (spray fogger, and lawn applications). Residential 
exposure for adults was assessed via the inhalation and dermal routes, 
while exposure for infants and children was assessed via inhalation, 
dermal, and oral (hand-to-mouth) routes. Exposure for outdoor handlers 
was assessed via the Inhalation and dermal routes. Residential 
applicator for indoor total release fogger was not assessed 
quantitatively, because indoor inhalation exposure to a homeowner would 
likely be less than inhalation exposure to homeowner that would result 
from outdoor lawn treatments.
    Residential MOEs were assessed for indoor and outdoor uses for 
application and post-application exposures. This is considered a 
conservative assessment assuming the lawn and carpet uses happen on the 
same day.
    4. Cumulative effects from substances with a common mechanism of 
toxicity. Cyfluthrin and beta-cyfluthrin are members of the pyrethroid 
class of pesticides. Although all pyrethroids alter nerve function by 
modifying the normal biochemistry and physiology of nerve membrane 
sodium channels, EPA is not currently following a cumulative risk 
approach based on a common mechanism of toxicity for the pyrethroids. 
Although all pyrethroids interact with sodium channels, there are 
multiple types of sodium channels and it is currently unknown whether 
the pyrethroids have similar effects on all channels. The Agency does 
not have a clear understanding of effects on key downstream neuronal 
function e.g.,

[[Page 10394]]

nerve excitability, nor does the Agency understand how these key events 
interact to produce their compound specific patterns of neurotoxicity. 
There is ongoing research by EPA's Office of Research and Development 
and pyrethroid registrants to evaluate the differential biochemical and 
physiological actions of pyrethroids in mammals. When the results of 
the research become available, the Agency will consider the findings 
and make a determination of common mechanism as a basis for assessing 
cumulative risk. Information regarding EPA's procedures for cumulating 
effects from substances found to have a common mechanism can be found 
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 (``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 database on toxicity and exposure 
unless EPA determines based on reliable data that a 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 UFs and/or special 
FQPA safety factors, as appropriate.
    2. Prenatal and postnatal sensitivity. There was no evidence of 
increased susceptibility of rats or rabbits in utero exposure in 
developmental oral studies; however, there was some indication of 
increased susceptibility in developmental inhalation studies. A clear 
NOAEL was established for the fetal effects in every case. No residual 
uncertainties were identified.
    The data also showed increased susceptibility of rats and mice from 
postnatal exposure to cyfluthrin. A clear NOAEL was established for the 
offspring effects in every case. No residual uncertainties were 
identified.
    3. Conclusion. EPA has determined that reliable data show that it 
would be safe for infants and children to reduce the FQPA safety factor 
to 1X. That decision is based on the following findings:
    i. The toxicology databases for cyfluthrin and beta-cyfluthrin 
together are considered complete and adequate for selecting toxicity 
endpoints for risk assessment. The toxicity profiles of both cyfluthrin 
and beta-cyfluthrin can be characterized for all effects, including 
potential developmental, reproductive and neurotoxic effects. Exposure 
data are complete or are estimated based on data that reasonably 
accounts for potential exposures.
    ii. There is no evidence of increased susceptibility of rats or 
rabbits to in utero exposure in developmental oral studies, and the 
degree of concern for the effects observed in the inhalation 
developmental studies is considered low since a clear NOAEL was 
established for the fetal effects in every case.
    iii. The NOAEL used for short-term inhalation exposure scenarios is 
protective of the effects seen in the developmental studies via the 
inhalation route.
    iv. The degree of concern for the effects observed in the 
reproductive studies was considered low since a clear NOAEL was 
established for the offspring effects in every case.
    v. The NOAEL used to establish the cPAD for all populations is 
protective of the effects seen in the young in the reproduction 
studies.
    vi. A beta-cyfluthrin developmental neurotoxicity study has been 
submitted for review and indicated both the LOAEL and NOAEL from this 
study are higher than the LOAEL and NOAEL chosen for risk assessment 
purposes.
    vii. There are no residual uncertainties identified in the exposure 
databases. Although the acute and chronic food exposure assessments are 
refined, EPA believes that the assessments are based on reliable data 
and will not underestimate exposure/risk. The drinking water estimates 
were derived from conservative screening models. The residential 
exposure assessment utilizes reasonable high-end variables set out in 
EPA's Occupational/Residential Exposure SOPs (Standard Operating 
Procedures). The aggregate assessment is based upon reasonable worst-
case residential assumptions, and is also not likely to underestimate 
exposure/risk to any subpopulation, including those comprised of 
infants and children.

E. Aggregate Risks and Determination of Safety

    Safety is assessed for acute and chronic risks by comparing 
aggregate exposure to the pesticide to the aPAD and cPAD. The aPAD and 
cPAD are calculated by dividing the LOC by all applicable UFs. For 
linear cancer risks, EPA calculates the probability of additional 
cancer cases given aggregate exposure. Short-, intermediate-, and long-
term risks are evaluated by comparing aggregate exposure to the LOC to 
ensure that the MOE called for by the product of all applicable UFs is 
not exceeded.
    1. Acute risk. Using the exposure assumptions discussed in this 
unit for acute exposure, the acute dietary exposure from food and water 
to cyfluthrin will occupy 53% of the aPAD for the population group 
children 1 to 2 years old receiving the greatest exposure. Therefore, 
EPA does not expect the aggregate exposure to exceed 100% of the aPAD.
    2. Chronic risk. Using the exposure assumptions described in this 
unit for chronic exposure, EPA has concluded that exposure to 
cyfluthrin from food and water will utilize 17% of the cPAD for the 
population group children 1 to 2 years old receiving the greatest 
exposure. Based on the use pattern, chronic residential exposure to 
residues of cyfluthrin is not expected. Therefore, EPA does not expect 
the aggregate exposure to exceed 100% of the cPAD.
    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). Cyfluthrin is currently 
registered for use(s) that could result in short-term residential 
exposure and the Agency has determined that it is appropriate to 
aggregate chronic food and water and short-term exposures for 
cyfluthrin.
    Using the exposure assumptions described in this unit for short-
term exposures, EPA has concluded that food, water, and residential 
exposures aggregated result in aggregate MOEs of 320 for children 1 to 
2 years old; 400 for infants < 1 year old; and 420 for the U.S. 
population. These aggregate MOEs do not exceed the Agency's level of 
concern for aggregate exposure to food, water and residential uses. 
Therefore, EPA does not expect short-term aggregate exposures to exceed 
the Agency's level 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).
    Cyfluthrin is currently registered for use(s) that could result in 
intermediate-term residential exposure and the Agency has determined 
that it is appropriate to aggregate chronic food and water and 
intermediate-term exposures for cyfluthrin. Using the exposure 
assumptions described in this unit for intermediate-term exposures, EPA 
has concluded that food, water, and residential exposures aggregated

[[Page 10395]]

result in aggregate MOEs of 220 for the U.S. population; 240 for 
infants < 1 year old; and 230 for children 1 to 2 years old. These 
aggregate MOEs do not exceed the Agency's level of concern for 
aggregate exposure to food, water and residential uses. Therefore, EPA 
does not expect intermediate-term aggregate exposures to exceed the 
Agency's level of concern.
    5. Aggregate cancer risk for U.S. population. EPA has classified 
cyfluthrin as ``not likely to be carcinogenic to humans'' and concludes 
that it poses no greater than a negligible cancer risk to humans.
    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 cyfluthrin residues.

IV. Other Considerations

A. Analytical Enforcement Methodology

    Adequate enforcement methodology (gas chromatography (GC)/electron-
capture detection (ECD)) is available to enforce the tolerance 
expression. The method may be requested from: Chief, Analytical 
Chemistry Branch, Environmental Science Center, 701 Mapes Rd., Ft. 
Meade, MD 20755-5350; telephone number: (410) 305-2905; e-mail address: 
residuemethods@epa.gov.

B. International Residue Limits

    With regard to international MRLs for cyfluthrin, harmonization of 
the proposed tolerances is not an issue for grass forage, grass hay, 
sugar beet roots, and sugar beet dried pulp, as there are no 
established or proposed Canadian, Mexican or Codex MRLs for cyfluthrin 
residues on grass or sugar beet commodities.

C. Explanation of Tolerance Revisions

    1. Grasses. The available field trial data support the use of up to 
four broadcast foliar applications of cyfluthrin (EC) to grasses grown 
throughout the United States at a maximum single application rate of 
0.044 lb active ingredient/Acre (ai/A), with a minimum RTI of 5 days, 
for a maximum of 0.178 lb ai/A/season. The data also support a 0-day 
preharvest interval for cutting of both forage and hay. The available 
data support tolerances of 50 ppm on grass hay and 12 ppm on grass 
forage.
    2. Sugar beets. The available field trial data are adequate. The 
number and geographic distribution of the field trials are adequate, 
and the appropriate samples were collected at normal crop maturity. The 
samples were analyzed using an adequate analytical method and the 
sample storage intervals are supported by the available storage 
stability data. The available data support the use of cyfluthrin 
(suspoemulsion) as a seed treatment for sugar beets at a rate of 0.035 
lb ai/100,000 seeds. The residue data on roots support a tolerance of 
0.10 ppm. For both roots and tops, most of the field trial values were 
below the LOQ. As a result, EPA's statistical tolerance generator was 
not used to determine tolerances.

D. Response to Comments

    Comments were received from a private citizen who opposed the 
authorization to sell any pesticide that leaves a residue on food. The 
Agency has received this same comment from this commenter on numerous 
previous occasions and rejects it for the reasons previously stated in 
the Federal Register of January 7, 2005 (70 FR 1349).

V. Conclusion

    Therefore, the tolerances are established for residues of 
cyfluthrin, cyano(4-fluoro-3-phenoxyphenyl)methyl 3-(2,2-
dichloroethenyl)-2,2-dimethylcyclopropanecarboxylate, in or on grass, 
forage, fodder and hay, group 17, forage at 12 ppm; grass, forage, 
fodder and hay, group 17, hay at 50 ppm; beet, sugar, roots at 0.10 
ppm; and beet, sugar, dried pulp at 1.0 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).

[[Page 10396]]

List of Subjects in 40 CFR Part 180

    Environmental protection, Administrative practice and procedure, 
Agricultural commodities, Pesticides and pests, Reporting and 
recordkeeping requirements.


    Dated: February 14, 2008.
Donald R. Stubbs,
Acting 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 180.436 is amended by adding alphabetically commodities to 
the table in paragraph (a)(1), and by removing and reserving paragraph 
(c) to read as follows:


Sec.  180.436  Cyfluthrin: tolerances for residues.

    (a) * * *

------------------------------------------------------------------------
                                                              Parts per
                         Commodity                             million
------------------------------------------------------------------------
                                * * * * *
Beet, sugar, roots.........................................         0.10
Beet, sugar, dried pulp....................................          1.0
                                * * * * *
Grass, forage, fodder and hay, group 17, forage............           12
Grass, forage, fodder and hay, group 17, hay...............           50
                                * * * * *
------------------------------------------------------------------------

* * * * *
    (c) Tolerances with regional registrations. [Reserved]
* * * * *

[FR Doc. E8-3393 Filed 2-26-08; 8:45 am]

BILLING CODE 6560-50-S
