[Federal Register Volume 73, Number 64 (Wednesday, April 2, 2008)]
[Rules and Regulations]
[Pages 17918-17924]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E8-6668]


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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[EPA-HQ-OPP-2007-0338; FRL-8356-7]


Flonicamid; Pesticide Tolerance

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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SUMMARY: This regulation establishes tolerances for combined residues 
of flonicamid and its metabolites TFNA, TFNA-AM, and TFNG in or on 
Brassica, leafy greens, subgroup 5B; hop, dried cones; okra; radish, 
tops; turnip, greens; vegetable, root, except sugar beet, subgroup 1B; 
and vegetable, tuberous and corm, subgroup 1C. It also increases 
established tolerances for combined residues of flonicamid and its 
metabolites TFNA and TFNA-AM in or on cattle, fat; cattle, meat; egg; 
goat, fat; goat, meat; horse, fat; horse, meat; milk; poultry, fat; 
poultry, meat; poultry, meat byproducts; sheep, fat; and sheep, meat. 
Interregional Research Project Number 4 (IR-4) requested these 
tolerances under the Federal Food, Drug, and Cosmetic Act (FFDCA). This 
regulation also removes existing tolerances for flonicamid and its 
metabolites on mustard greens and potatoes which are superseded by the 
new tolerances on ``Brassica, leafy greens, subgroup 5B'' and 
``vegetable, tuberous and corm, subgroup 1C,'' respectively.

DATES: This regulation is effective April 2, 2008. Objections and 
requests for hearings must be received on or before June 2, 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-2007-0338. To access the 
electronic docket, go to http://www.regulations.gov, select ``Advanced 
Search,'' then ``Docket Search.'' Insert

[[Page 17919]]

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: Susan Stanton, Registration Division 
(7505P), Office of Pesticide Programs, Environmental Protection Agency, 
1200 Pennsylvania Ave., NW., Washington, DC 20460-0001; telephone 
number: (703) 305-5218; 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 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-2007-0338 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 June 2, 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-2007-0338, 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 June 27, 2007 (72 FR 35237) (FRL-8133-
4), 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 
6E7081) by Interregional Research Project Number 4 (IR-4), 500 College 
Road East, Suite 201 W, Princeton, NJ 08540-6635. The petition 
requested that 40 CFR 180.613 be amended by establishing tolerances for 
combined residues of the insecticide flonicamid, [N-(cyanomethyl)-4-
(trifluoromethyl)-3-pyridinecarboxamide] and its metabolites TFNA [4-
trifluoromethylnicotinic acid], TFNA-AM [4-trifluoromethylnicotinamide] 
TFNG [N-(4-trifluoromethylnicotinoyl)glycine], in or on vegetables, 
root, except sugar beet, subgroup 1B at 0.45 parts per million (ppm); 
radish, tops at 16 ppm; vegetables, tuberous and corm, subgroup 1C at 
0.2 ppm; Brassica, leafy greens, subgroup 5B at 16 ppm; turnip, greens 
at 16 ppm; hop, dried cone at 7.0 ppm; and okra at 0.4 ppm. That notice 
referenced a summary of the petition prepared by ISK Biosciences 
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.
    Based upon review of the data supporting the petition, EPA has 
determined that the proposed tolerance on ``vegetables, root, except 
sugar beet, subgroup 1B'' should be increased to 0.60 ppm and that 
existing tolerances for several livestock commodities should be 
increased. The reasons for these changes are 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

[[Page 17920]]

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 combined residues of flonicamid and its metabolites TFNA, TFNA-AM, 
and TFNG on Brassica, leafy greens, subgroup 5B at 16 parts per million 
(ppm); hop, dried cones at 7.0 ppm; okra at 0.40 ppm; radish, tops at 
16 ppm; turnip, greens at 16 ppm; vegetable, root, except sugar beet, 
subgroup 1B at 0.60 ppm; and vegetable, tuberous and corm, subgroup 1C 
at 0.20 ppm; and for combined residues of flonicamid and its 
metabolites TFNA and TFNA-AM in or on cattle, fat at 0.03 ppm; cattle, 
meat at 0.08 ppm; egg at 0.04 ppm; goat, fat at 0.03 ppm; goat, meat at 
0.08 ppm; horse, fat at 0.03 ppm; horse, meat at 0.08 ppm; milk at 0.03 
ppm; poultry, fat at 0.03 ppm; poultry, meat at 0.03 ppm; poultry, meat 
byproducts at 0.03 ppm; sheep, fat at 0.03 ppm; and sheep, meat at 0.08 
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.
    Flonicamid has low acute toxicity via the oral, dermal, and 
inhalation routes of exposure. Its metabolites TFNA, TFNA-AM, and TFNG 
also demonstrated low toxicity in acute oral toxicity studies. 
Flonicamid is non-irritating to the eye and skin and is not a dermal 
sensitizer. In the 28-day dermal study no dermal or systemic toxicity 
was seen at the limit dose for flonicamid technical.
    The oral studies in rats and dogs indicate the kidney and liver are 
the target organs for flonicamid toxicity. Kidney weight increases, 
kidney hyaline deposition and liver centrilobular hypertrophy effects 
were seen in the rat 28-day oral range-finding study, 90-day oral 
study, developmental toxicity study, and reproduction study. These 
effects were not observed in the rabbit developmental study. The 90-day 
dog study showed kidney tubular vacuolation, as well as increased 
adrenal weights, increased reticulocytes and decreased thymus weights. 
Increased reticulocyte was noted in both the subchronic and chronic dog 
studies.
    There is no evidence that flonicamid results in increased 
susceptibility (qualitative or quantitative) in in utero rats or 
rabbits in the prenatal developmental studies or in young rats in the 
2-generation reproduction study. Developmental effects (increased 
incidence of cervical rib) were observed only in the rat at high doses, 
and the developmental and reproductive effects (decreased uterus 
weights and delayed sexual maturation) that were seen in these studies 
occurred only at doses that were also maternally toxic. Further, 
although neurotoxic signs (decreased motor activity, tremors, impaired 
respiration, and impaired gait) were noted in the acute and subchronic 
neurotoxicity studies, they occurred only at high doses and were not 
seen in other flonicamid toxicity studies.
    Mutagenicity studies were negative for the parent chemical, 
flonicamid, and its metabolites TFNA, TFNA-AM, TFNG, TFNG-AM, and TFNA-
OH. Flonicamid was carcinogenic in CD-1 mice, based on increased 
incidences of lung tumors associated with Clara cell activation; the 
effects, however, were associated with species and strain sensitivity 
and thus not deemed highly relevant to human cancer risk. Nasal cavity 
tumors in male Wistar rats were linked to incisor inflammation; data 
were not sufficient to make a similar determination in female rats. 
Based on these findings and analysis of the cancer and mutagenicity 
studies, EPA classified flonicamid as having suggestive evidence of 
carcinogenicity but concluded that the carcinogenic potential of 
flonicamid is very low and has determined that quantification of human 
cancer risk is not appropriate.
    Specific information on the studies received and the nature of the 
adverse effects caused by flonicamid 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 at http://www.regulations.gov in the document Flonicamid: Human Health Risk 
Assessment for Proposed Uses on Root Vegetables (Except Sugar beet; 
Subgroup 1B), Tuberous and Corm Vegetables (Subgroup 1C), Leafy 
Brassica Green Vegetables (Subgroup 5B), Turnip Greens, Hops, and Okra. 
The referenced document is available in the docket established by this 
action, which is described under ADDRESSES, and is identified as docket 
ID number EPA-HQ-OPP-2007-0338-0003 in that docket.

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/pesticides/factsheets/riskassess.htm.
    A summary of the toxicological endpoints for flonicamid used for

[[Page 17921]]

human risk assessment can be found at http://www.regulations.gov in the 
document Flonicamid: Human Health Risk Assessment for Proposed Uses on 
Root Vegetables (Except Sugar beet; Subgroup 1B), Tuberous and Corm 
Vegetables (Subgroup 1C), Leafy Brassica Green Vegetables (Subgroup 
5B), Turnip Greens, Hops, and Okra at pages 22-23. The referenced 
document is available in the docket established by this action, which 
is described under ADDRESSES, and is identified as docket ID number 
EPA-HQ-OPP-2007-0338-0003 in that docket.

C. Exposure Assessment

    1. Dietary exposure from food and feed uses. In evaluating dietary 
exposure to flonicamid, EPA considered exposure under the petitioned-
for tolerances as well as all existing flonicamid tolerances in 40 CFR 
180.613. EPA assessed dietary exposures from flonicamid 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. No such effects were 
identified in the toxicological studies for flonicamid; therefore, a 
quantitative acute dietary exposure assessment is unnecessary.
    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 assumed all foods for 
which there are tolerances were treated and contain tolerance-level 
residues. EPA did not rely on any anticipated residues or percent crop 
treated (PCT) estimates in the chronic dietary exposure assessment.
    iii. Cancer. As noted in Unit III.A., EPA has concluded that 
flonicamid has low carcinogenic potential and that, accordingly, 
quantitative assessment of cancer risk is not appropriate. Therefore, a 
cancer exposure assessment was not conducted.
    2. Dietary exposure from drinking water. The Agency lacks 
sufficient monitoring data to complete a comprehensive dietary exposure 
analysis and risk assessment for flonicamid 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 
flonicamid. 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 residues of concern in drinking water include flonicamid and 
its degradates TFNA, TFNG-AM, TFNG, TFNA-OH, and TFNA-AM. Based on the 
Pesticide Root Zone Model /Exposure Analysis Modeling System (PRZM/
EXAMS) and Screening Concentration in Ground Water (SCI-GROW) models, 
the estimated environmental concentrations (EECs) of flonicamid and its 
degradates for acute exposures are estimated to be 9.8 parts per 
billion (ppb) for surface water and 0.00132 ppb for ground water. The 
EECs for chronic exposures are estimated to be 1.5 ppb for surface 
water and 0.00132 ppb for ground water.
    Modeled estimates of drinking water concentrations were directly 
entered into the dietary exposure model. As explained in Unit 
III.C.1.i., an acute dietary risk assessment was not conducted for 
flonicamid. For chronic dietary risk assessment, the water 
concentration value of 1.5 ppb was used to assess 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).
    Flonicamid is currently registered for use on landscape 
ornamentals, which could include landscape ornamentals in residential 
areas. Since applications to landscape ornamentals are limited to 
professional pest control operators, residential handler exposures are 
not expected and were not assessed. There may be potential for post-
application dermal exposure of adults or children entering areas 
previously treated with flonicamid; however, since a dermal endpoint of 
concern was not identified in the toxicity studies for flonicamid, a 
dermal assessment is unnecessary and was not conducted. Post-
application inhalation exposures are expected to be negligible.
    4. Cumulative effects from substances with a common mechanism of 
toxicity. Section 408(b)(2)(D)(v) of FFDCA requires that, when 
considering whether to establish, modify, or revoke a tolerance, the 
Agency consider ``available information'' concerning the cumulative 
effects of a particular pesticide's residues and ``other substances 
that have a common mechanism of toxicity.''
    Unlike other 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 flonicamid and any other 
substances and flonicamid 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 flonicamid 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 
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 (10X) 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. The pre- and postnatal 
toxicity database for flonicamid includes prenatal developmental 
toxicity studies in rats and rabbits and a 2-generation reproduction 
toxicity study in rats. There is no evidence that flonicamid results in 
increased susceptibility (qualitative or quantitative) in in utero rats 
or rabbits in the prenatal developmental studies or in young rats in 
the 2-generation reproduction study. Developmental effects (increased 
incidence of cervical rib) were observed only in the rat at high doses, 
and the developmental and reproductive effects (decreased uterus 
weights and delayed sexual maturation) seen in these studies occurred 
only in the presence of maternal effects (including increased liver 
weights, liver and kidney pathological changes, increased relative 
kidney weight and increased blood serum LH levels in F1 females).
    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

[[Page 17922]]

decision is based on the following findings:
    i. The toxicity database for flonicamid is complete.
    ii. Neurotoxic signs were seen in the acute and subchronic 
neurotoxicity studies, but only at the high doses and in the presence 
of other effects indicating general overt toxicity (mortality in the 
acute neurotoxicity study and decreases in body weight and body weight 
gain, along with reduced food consumption in the subchronic 
neurotoxicity study). Neurotoxic signs were not observed in other 
studies, and systemic toxicity was observed at considerably lower doses 
than those that produced neurotoxic effects in the acute and subchronic 
neurotoxicity studies. Further, there were no signs of neurotoxicity 
and no indications of increased susceptibility of in utero rats or 
rabbits or offspring in the developmental and reproduction studies for 
flonicamid. Based on these considerations, EPA has determined that 
there is no need for a developmental neurotoxicity study or additional 
UFs to account for neurotoxicity.
    iii. There is no evidence that flonicamid results in increased 
susceptibility in in utero rats or rabbits in the prenatal 
developmental studies or in young rats in the 2-generation reproduction 
study.
    iv. There are no residual uncertainties identified in the exposure 
databases. The dietary food exposure assessments were performed based 
on 100% crop treated and tolerance-level residues. Conservative ground 
and surface water modeling estimates were used. There may be potential 
for residential dermal exposure of children entering areas previously 
treated with flonicamid; however, since a dermal endpoint of concern 
was not identified in the toxicity studies for flonicamid, such 
exposures are not expected to pose a health risk to children. These 
assessments will not underestimate the exposure and risks posed by 
flonicamid.

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. None of the toxicology studies available for 
flonicamid has indicated the possibility of an effect of concern 
occurring as a result of a 1-day or single exposure; therefore, 
flonicamid is not expected to pose an acute risk.
    2. Chronic risk. Using the exposure assumptions described in this 
unit for chronic exposure, EPA has concluded that exposure to 
flonicamid from food and water will utilize 23 % of the cPAD for 
children 1 to 2 years old, the population group with the greatest 
estimated exposure. Based on the use pattern, chronic residential 
exposure to residues of flonicamid is not expected.
    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). Although short-term, 
post-application dermal exposures could occur from residential use of 
flonicamid on landscape ornamentals, no toxicological effects from 
dermal exposure have been identified for flonicamid. Therefore, the 
aggregate risk is the sum of the risk from food and water.
    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). Flonicamid is 
not registered for use on any sites that would result in intermediate-
term residential exposure. Therefore, the aggregate risk is the sum of 
the risk from food and water, which do not exceed the Agency's level of 
concern.
    5. Aggregate cancer risk for U.S. population. As discussed in Unit 
III.A., EPA regards the carcinogenic potential of flonicamid as very 
low 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 flonicamid residues.

IV. Other Considerations

A. Analytical Enforcement Methodology

    Adequate enforcement methods (FMC No. P-3561M, a Liquid 
Chromatography/Mass Spectrometry/Mass Spectrometry (LC/MS/MS) method 
and FMC No. P-3822, a modification of FMC No. P-3561M) are available to 
enforce the tolerances for flonicamid and its metabolites, TFNA, TFNA-
AG, and TFNG in plants. For enforcement of tolerances for livestock 
commodities, three methods are available: LC/MS/MS method (RCC No. 
844743) for residues in eggs and livestock tissues; LC/MS method (RCC 
No. 842993) for residues in milk; and LC/MS/MS method (FMC P3580) which 
includes an acid hydrolysis step for residues in cattle muscle, kidney, 
and liver. The methods 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: 
[email protected].

B. International Residue Limits

    There are currently no established Codex, Canadian, or Mexican 
maximum residue levels (MRLs) for flonicamid.

C. Changes to Proposed Tolerances

    Based upon review of the data supporting the petition, EPA 
determined that the proposed tolerance on ``vegetables, root, except 
sugar beet, subgroup 1B'' should be increased from 0.45 ppm to 0.60 
ppm. EPA revised the tolerance level based on analysis of the residue 
field trial data using the Agency's Tolerance Spreadsheet in accordance 
with the Agency's Guidance for Setting Pesticide Tolerances Based on 
Field Trial Data Standard Operating Procedure (SOP). EPA also 
determined that existing tolerances for residues of flonicamid, TFNA 
and TFNA-AM in or on cattle, fat; cattle, meat; egg; goat, fat; goat, 
meat; horse, fat; horse, meat; milk; poultry, fat; poultry, meat; 
poultry, meat byproducts; sheep, fat; and sheep, meat should be 
increased to the following levels: cattle, fat at 0.03 ppm; cattle, 
meat at 0.08 ppm; egg at 0.04 ppm; goat, fat at 0.03 ppm; goat, meat at 
0.08 ppm; horse, fat at 0.03 ppm; horse, meat at 0.08 ppm; milk at 0.03 
ppm; poultry, fat at 0.03 ppm; poultry, meat at 0.03 ppm; poultry, meat 
byproducts at 0.03 ppm; sheep, fat at 0.03 ppm; and sheep, meat at 0.08 
ppm. EPA revised these levels based on recalculated livestock dietary 
burdens for poultry and ruminants, taking into account potential 
flonicamid residues under the proposed tolerances.

V. Conclusion

    Therefore, tolerances are established for combined residues of 
flonicamid, [N-(cyanomethyl)-4-(trifluoromethyl)-3-pyridinecarboxamide] 
and its metabolites TFNA [4-trifluoromethylnicotinic acid], TFNA-AM [4-
trifluoromethylnicotinamide] TFNG [N-(4-
trifluoromethylnicotinoyl)glycine], in or on Brassica, leafy greens, 
subgroup 5B at 16 ppm; hop, dried cones at 7.0 ppm; okra at 0.40 ppm; 
radish, tops at 16

[[Page 17923]]

ppm; turnip, greens at 16 ppm; vegetable, root, except sugar beet, 
subgroup 1B at 0.60 ppm; and vegetable, tuberous and corm, subgroup 1C 
at 0.20 ppm. Revised tolerances are established for combined residues 
of flonicamid its metabolites TFNA and TFNA-AM in or on cattle, fat at 
0.03 ppm; cattle, meat at 0.08 ppm; egg at 0.04 ppm; goat, fat at 0.03 
ppm; goat, meat at 0.08 ppm; horse, fat at 0.03 ppm; horse, meat at 
0.08 ppm; milk at 0.03 ppm; poultry, fat at 0.03 ppm; poultry, meat at 
0.03 ppm; poultry, meat byproducts at 0.03 ppm; sheep, fat at 0.03 ppm; 
and sheep, meat at 0.08 ppm.
    Tolerances currently exist for combined residues of flonicamid and 
its metabolites TFNA, TFNA-AM, and TFNG in or on mustard greens at 11 
ppm and potato at 0.20 ppm. These tolerances are no longer needed, 
since residues on these commodities will be covered by the new 
tolerances being established on ``Brassica, leafy greens, subgroup 5B'' 
at 16 ppm and ``vegetable, tuberous and corm, subgroup 1C'' at 0.20 
ppm. Therefore, EPA is revoking these existing, redundant tolerances.

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 final rule has been 
exempted from review under Executive Order 12866, this final 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 final rule. In addition, 
this final rule does not impose any enforceable duty or contain any 
unfunded mandate as described under Title II of the Unfunded Mandates 
Reform Act of 1995 (UMRA) (Public Law 104-4).
    This action does not involve any technical standards that would 
require Agency consideration of voluntary consensus standards pursuant 
to section 12(d) of the National Technology Transfer and Advancement 
Act of 1995 (NTTAA), Public Law 104-113, section 12(d) (15 U.S.C. 272 
note).

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 rule in the Federal 
Register. This rule is not a ``major rule'' as defined by 5 U.S.C. 
804(2).

List of Subjects in 40 CFR Part 180

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


    Dated: March 21, 2008.
Lois Rossi,
Director, Registration Division, Office of Pesticide Programs.

0
Therefore, 40 CFR part 180 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 180.613 is amended as follows:
0
a. By removing the commodities ``Mustard greens'' and ``Potato'' from 
the table in paragraph (a)(1).
0
b. By alphabetically adding commodities to the table in paragraph 
(a)(1).
0
c. By revising the table in paragraph (a)(2).


Sec.  180.613  Flonicamid; tolerances for residues.

    (a) General. (1) * * *

------------------------------------------------------------------------
                                                              Parts per
                         Commodity                             million
------------------------------------------------------------------------
                                * * * * *
Brassica, leafy greens, subgroup 5B........................           16
                                * * * * *
Hop, dried cones...........................................          7.0
Okra.......................................................         0.40
                                * * * * *
Radish, tops...............................................           16
                                * * * * *
Turnip, greens.............................................           16
                                * * * * *
Vegetable, root, except sugar beet, subgroup 1B............         0.60
Vegetable, tuberous and corm, subgroup 1C..................         0.20
------------------------------------------------------------------------

    (2) * * *

------------------------------------------------------------------------
                                                              Parts per
                         Commodity                             million
------------------------------------------------------------------------
Cattle, fat................................................         0.03
Cattle, meat...............................................         0.08
Cattle, meat byproducts....................................         0.08
Egg........................................................         0.04
Goat, fat..................................................         0.03
Goat, meat.................................................         0.08
Goat, meat byproducts......................................         0.08
Horse, fat.................................................         0.03
Horse, meat................................................         0.08
Horse, meat byproducts.....................................         0.08
Milk.......................................................         0.03
Poultry, fat...............................................         0.03
Poultry, meat..............................................         0.03
Poultry, meat byproducts...................................         0.03
Sheep, fat.................................................         0.03
Sheep, meat................................................         0.08
Sheep, meat byproducts.....................................         0.08
------------------------------------------------------------------------


[[Page 17924]]

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[FR Doc. E8-6668 Filed 4-1-08; 8:45 am]
BILLING CODE 6560-50-S