Cyfluthrin: [cyano[4-fluoro-3-phenoxyphenyl]-methyl-3-[2,2- dichloroethenyl]-2,2-dimethyl-cyclopropanecarboxylate]; Pesticide Tolerance

In the Federal Register of July 5, 1995 (60 FR 34874) (FRL-4963-2), EPA issued a time-limited tolerance for cyfluthrin use in or on corn (field, pop, and sweet) in combination with another insecticide, the organophosphate tebupirimifos (originally known as phostebupirim) (O-[2-(1-dimethylethyl)-5-pyrimidinyl]O-ethyl- O-ethyl-O-(1-methylethyl)phosphorothioate) with an expiration date of 5 July 1999. These time-limited tolerances were established due to a lack of mammalian neurotoxicity data and the need for confirmatory soil metabolism and product chemistry data for tebupirimiphos. Bayer Corporation requested the Agency to remove the time limitations for cyfluthrin on corn in a notice of filing published in the Federal Register of September 25, 1997 (62 FR 50337) (FRL-5748-2), and in a March 8, 1999 letter based on the fact that the time limitation was due to data deficiencies for tebupirimifos and not for cyfluthrin. Since (1) cyfluthrin is registered for use on corn; (2) the data base is complete for tolerance assessment purposes and ; (3) these tolerances were considered by EPA for risk assessment purposes, EPA has no objection to the removal of the time-limitations and the establishment of permanent tolerances for the residues of cyfluthrin on corn. In the Federal Register of August 14, 1998 (63 FR 43705) (FRL-6019-8), EPA issued a notice pursuant to section 408 of the Federal Food, Drug, and Cosmetic Act (FFDCA), 21 U.S.C. 346a as amended by the Food Quality Protection Act of 1996 (FQPA) (Public Law 104-170) announcing the filing of a pesticide petition (PP) 4F4330 for tolerance by Bayer Corporation, 8400 Hawthorn Road, Kansas City, MO 64120. This notice included a summary of the petition prepared by Bayer Corporation, the registrant. The petition requested that 40 CFR 180.436 be amended by establishing a tolerance for residues of the insecticide cyfluthrin: [cyano[4-fluoro-3-phenoxyphenyl]-methyl-3-[2,2-dichloroethenyl]-2,2- dimethyl-cyclopropanecarboxylate], in or on potatoes at 0.01 ppm. Cyfluthrin controls cabbage looper, potato leafhopper, Colorado potato beetle, European corn borer, flea beetles, potato tuberworm, potato psyllid, tarnished plant bug and aphids on potatoes. There were no comments received in response to the Notices of Filing.

I. Background and Statutory Findings

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) 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) requires EPA to give special consideration to exposure of infants and children to the pesticide chemical residue in establishing a tolerance and to ``ensure that there is a reasonable certainty that no harm will result to infants and children from aggregate exposure to the pesticide chemical residue....'' EPA performs a number of analyses to determine the risks from aggregate exposure to pesticide residues. For further discussion of the regulatory requirements of section 408 and a complete description of the risk assessment process, see the final rule on Bifenthrin Pesticide Tolerances (62 FR 62961, November 26, 1997) (FRL-5754-7).

II. Aggregate Risk Assessment and Determination of Safety

Consistent with 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 cyfluthrin: [cyano[4-fluoro-3-phenoxyphenyl]-methyl-3-[2,2- dichloroethenyl]-2,2-dimethyl-cyclopropanecarboxylate] and to make a determination on aggregate exposure, consistent with section 408(b)(2), for a tolerance for residues of cyfluthrin on potatoes at 0.01 ppm and removal of time limitations for tolerances for residues of cyfluthrin on corn (field, pop, and sweet). EPA's assessment of the dietary exposures and risks associated with establishing the tolerance follows.

A. Toxicological Profile

EPA has evaluated the available toxicity data and considered its validity, completeness, and reliability as well as the relationship of the results of the studies to human risk. EPA has also considered available information concerning the variability of the sensitivities of major identifiable subgroups of consumers, including infants and children. The nature of the toxic effects caused by cyfluthrin are discussed in this unit. 1. Acute toxicity. The required toxicity battery studies for acute oral (LD50 16.2 miligrams/kilograms (mg/kg)), dermal (LD50 >5,000 mg/kg), inhalation (LC50 0.468 mg/liter (L)), primary eye irritation (category III), primary dermal irritation (category IV), and dermal sensitization have been conducted and were found adequate. Cyfluthrin is not a dermal sensitizer. 2. Mutagenicity. There are seven acceptable studies upon which the Agency based its evaluation: three reverse mutation assays (Salmonella typhimurium, E. coli and Saccharomyces cerevisiae); one reverse mutation, mitotic recombination and conversion assay in Saccharomyces cerevisiae); one Chinese Hampster Ovary/ Hypoxanthine guanine phophoribosyl transferase (CHO/HGPRT) assay; one sister chromatid exchange assay in CHO cells; and one Unscheduled DNA synthesis (UDS) assay in primary rat hepatocytes. All these studies were negative. There is no mutagenicity concern. 3. Reproductive and developmental toxicity -- i. Oral developmental study in rats. Cyfluthrin was administered via gavage to pregnant female rats during

days 6-15 of gestation at dose levels of 0, 1, 3, or 10 mg/kg/day. A maternal Lowest Observable Adverse Effect Level (LOAEL) was not observed (i.e., the maternal No Observable Adverse Effect Level (NOAEL) is 10 mg/kg/day). A developmental LOAEL was not observed. The developmental NOAEL is 10mg/kg/day. This developmental study in rats was classified core guideline. ii. Oral developmental study in rabbits. Cyfluthrin was administered via gavage to pregnant female rabbits during days 6-18 of gestation at dose levels of 0, 20, 60, or 180 mg/kg/day. The maternal LOAEL is 60 mg/kg/day based on decreased body weight gain and food consumption during the dosing period. The maternal NOAEL is 20 mg/kg/ day. The developmental LOAEL is 60 mg/kg/day based on increased numbers of resorptions and percent incidence of postimplantation loss. The developmental NOAEL is 20 mg/kg/day. This study was classified core guideline. iii. Rat developmental studies via inhalation. In the first study, pregnant female rats at day 0 gestation were exposed head-only to cyfluthrin concentrations of 0, 1.1, 4.7 or 23.7mg/m3/day (milligrams per cubic meter per day) for 6 hours/day on gestation days 6-15. In the second study, the dams were exposed to analytical concentrations of 0, 0.09, 0.25, 0.59 or 4.2 mg/m3 of the test material. The dams were sacrificed on day 20 and their pups removed by caesarian section. The maternal NOAEL was 1.1 mg/ m3 and the maternal LOAEL was 4.7 mg/m3 (reduced motility, dyspnea, piloerection, ungroomed coats and eye irritation). The developmental NOAEL was 0.59 mg/m3 and the developmental LOAEL was 1.1 mg/m3 based on increases in the incidence of runts and skeletal anomalies in the sternum (1.1 mg/m3 and above); and increases in post-implantation losses and decreases in pup weights (4.7 mg/m3 and above) and increased incidences of late embryonic deaths, in skeletal anomalies in the extremities, pelvis and skull and microphthalmia (23.7mg/m3). The study was graded core minimum. In a third study, a developmental toxicity study via inhalation, cyfluthrin was administered to female rats at 0.46, 2.55, 11.9 or 12.8 mg/m3 exposure levels for gestational days 6-15 in a nose only inhalation chamber. The rats were exposed to the test material 6 hr/day, 7 days/week. The maternal NOAEL/LOAEL were 3 based on decreased body weight gain and reduced relative food efficiency. The developmental NOAEL/LOAEL were 0.46/2.55 mg/ m3 based on reduced fetal and placental weight, reduced ossification in the phalanx, metacarpals and vertebrae. This study was classified as core guideline. iv. 3-Generation reproduction study. Cyfluthrin was administered in the diet to male and female rats dose levels of 0, 50, 150, or 450 ppm (actual animal intake; 0, 2.5, 7.5, or 22.5 mg/kg/day). The LOAEL for parental toxicity was 450 ppm (22.5 mg/kg/day) based on decreased body weight gains. The NOAEL for parental toxicity is 150 ppm (7.5 mg/kg/ day). The LOAEL for reproductive toxicity was 150 ppm (7.5 mg/kg/day) based on decreased viability and lactational indices and decreased pup body weight gains. The reproductive NOAEL was 50 ppm (2.5 mg/kg/day). The multigeneration reproductive study in the rat was classified core minimum. 4. Subchronic toxicity -- i. 28-Day oral toxicity study in rats. Cyfluthrin was administered to SPF-Wistar rats via gavage at 0, 5, 20, or 80 (40) mg/kg/day. The high dose was 80 mg/kg/day during the first and third weeks and 40 mg/kg/day during the second and fourth weeks. The LOAEL was 80 (40) mg/kg/day in both sexes based on clinical signs of nerve toxicity, decreases in body weight gain, and changes in liver and adrenal weights. The NOAEL was 20 mg/kg/day. This study was classified as core minimum. ii. 28-Day oral toxicity study in rats. Rats were dosed with cyfluthrin in the diet at 0, 100, 300, or 1,000 ppm (equivalent to 0, 5, 15, or 50 mg/kg/day). The LOAEL was 15 mg/kg/day in both sexes based on decreased blood glucose. The NOAEL was 5 mg/kg/day. This study was classified core supplementary. iii. 3-Month feeding study in rats. SPF Wistar rats were dosed with cyfluthrin in the diet at 0, 30, 100, or 300 ppm (equivalent to 0, 1.5, 5, or 15 mg/kg/day) for 3 months. No treatment related effects were observed at any of the levels tested, thus the NOAEL for this 3-month rat feeding study was 15 mg/kg/day for both sexes. This study was classified core minimum. iv. 6-Month dog feeding study. Cyfluthrin was administered in the diet to dogs at 0, 65, 200 or 600 ppm (equivalent to 0, 1.62, 5 or 15 mg/kg/day) for 26 weeks. The LOAEL for this study was 15 mg/kg/day for both sexes, based on neurological effects (hindlimb abnormalities) and gastrointestinal disturbances. The NOAEL was 5 mg/kg/day for males and females. The study was classified as core minimum. v. 21-Day dermal study in rats. In a 21-day repeated dose dermal toxicity study, male and female rats were treated with cyfluthrin by dermal occlusion at target doses of 0, 100, 340, or 1,000 mg/kg/day for 6 hours/day (average actual dose levels were 0, 113, 376, or 1,077 mg/ kg/day). No mortality was observed, and there were no treatment-related effects on body weight, ophthalmology, organ weights, clinical biochemistry, or hematology. The LOAEL for dermal effects was 376 mg/ kg/day for male and female Sprague-Dawley rats based on gross and histological skin lesions. The NOAEL for dermal effects for technical Baythroid was 113 mg/kg/day. The LOAEL for systemic effects was 1,077 mg/kg/day based on decreased food consumption, red nasal discharge and urine staining. The NOAEL for systemic effects was 376 mg/kg/day. This study was classified as acceptable. vi. 3-Week inhalation toxicity studies in rats --a. Wistar rats were dynamically exposed by nose-only inhalation to cyfluthrin at concentrations of 0, 2.3, 11.5, or 69.6 mg/kg/day for 6 hours/day, 5 consecutive days/week for 3 weeks (total of 15 exposures). The LOAEL was 2.3 mg/m3, based on the treatment-related effects on body weight and temperature observed during the 3-week exposure period. A NOAEL was not established; therefore this study was repeated using lower doses. b. Wistar rats were dynamically exposed by nose-only inhalation to cyfluthrin at concentrations of 0, 0.4, 1.4, or 10.5 mg/m3 for 6 hours/day, 5 consecutive days/week for 3 weeks (total of 15 exposures). The LOAEL was 10.5 mg/m3, based on the treatment-related behavioral effects as well as effects on body and organ (spleen) weights. The NOAEL is 1.4 mg/m3. These studies were classified as core minimum. vii. 4-Week inhalation toxicity study in rats. Rats were dynamically exposed by inhalation (nose only) to cyfluthrin at concentrations of 0, 0.44, 6.04, or 46.6 mg/m3 for 6 hours/ day, 5 consecutive days/week for 4 weeks (20 exposures). The LOAEL is 6.04 mg/m3 based on the decrease in body and thymus weights, hypothermia, reduction in leukocytes counts (females), and low serum protein. The NOAEL is 0.44 mg/m3. This subacute inhalation toxicity study in rats was classified as supplementary. viii. 13-Week inhalation toxicity study in rats. Rats were dynamically exposed by head-only inhalation to cyfluthrin at concentrations of 0, 0.09, 0.71, or 4.51 mg/m3 for 6 hours/ day, 5 consecutive days/week for 13 weeks. All animals survived the 13- week study, and no treatment-related changes were observed in organ weight, gross pathology and histopathology. The LOAEL was 0.71 mg/ m3, based on the

treatment-related behavioral effects in females as well as the increased urinary protein in males. The NOAEL was 0.09 mg/ m3. This study was classified as core minimum. 5. Chronic toxicity -- i. 1-Year dog study. Cyfluthrin was fed to beagle dogs at 0, 40, 160, or 640 ppm (equivalent to 0, 1, 4, or 16 mg/ kg/day) for 52 weeks. The NOAEL was 4 mg/kg bw/day. The LOAEL was 16 mg/kg bw/day for both sexes, based on slight ataxia in two dogs on single occasions, decreased body weight in males, and on observations of increased vomiting and diarrhea at the high dose. The NOAEL is 4 mg/ kg bw/day. This study was classified as core minimum. ii. Chronic/carcinogenicity-rat. Cyfluthrin was administered for 24 months in the diet to rats at dose levels of 0, 50, 150, or 450 ppm (equivalent to 2.02, 6.19, or 19.20 mg/kg bw/day in males and 2.71, 8.15, or 25.47 mg/kg/day in females based on food consumption and body weights). The chronic LOAEL was 150 ppm (equivalent to 6.19 mg/kg/day in males and 8.15 mg/kg/day in females) based on decreased body weights in the high-dose animals and the mid-dose males. The chronic NOAEL was 50 ppm (equivalent to 2.02 mg/kg/day in males and 2.71 mg/kg/day in females). Under the conditions of this study, there was no evidence of carcinogenic potential. The study was classified core minimum for both chronic toxicity and oncogenicity. iii. Chronic/carcinogenicity- mouse. In a chronic/carcinogenicity study, cyfluthrin was administered in the diet for 23 months to mice at dose levels of 0, 50, 200, or 800 ppm (equivalent to 11.6, 45.8, or 194.5 mg/kg/day in males and 15.3, 63.0, or 259.9 in females based on food consumption and body weights). There were no treatment related changes noted in the clinical observation, food consumption, hematology, gross observation, organ weight, and microscopic data. The chronic LOAEL is 50 ppm (equivalent to 11.6 mg/kg/day in males and 15.3 mg/kg/day in females) based on increased alkaline phosphatase activity in the dosed males. A chronic NOAEL was not established in male and female mice. Under the conditions of this study, there was no evidence of carcinogenic potential. This study was classified core minimum for carcinogenicity and supplementary for chronic toxicity. 6. Animal metabolism. Metabolism studies in rats showed that cyfluthrin is rapidly absorbed and excreted, mostly as conjugated metabolites in the urine, within 48 hours. An enterohepatic circulation was observed. 7. Neurotoxicity. Other studies evaluated included a subacute oral neurotoxicity study in rats (LOAEL of 50 mg/kg/day; no NOAEL observed); a second subacute oral neurotoxicity study (NOAEL of 40 mg/kg/day); a subchronic neurotoxicity study in rats (NOAEL g/L for acute surface water and 0.044 g/L for chronic surface water. The primary use of these models is to provide a screen for sorting out pesticides for which EPA has a high degree of confidence tht the true levels of the pesticide in drinking water will be less that the human health drinking water levels of concern (DWLOCs). A DWLOC is a theoretical upper limit of a pesticide's concentration in drinking water in light of total aggregate exposure to that pesticide in food and through residential uses. A DWLOC will vary depending on the toxic endpoint, consumption and body weight. Different populations will have different DWLOCs. EPA uses DWLOCs internally in the risk assessment process as a surrogate measure of potential exposure associated with pesticide exposure through drinking water. In the absence of monitoring data for pesticides, the DWLOC is used as a point of comparison against conservative model estimates of potential pesticide concentration in water. DWLOC values are not regulatory standards for drinking water. For this acute risk assessment, the estimated maximum concentration for cyfluthrin in surface and ground waters (which is 0.236 g/ L) is used for comparison to the back-calculated human health drinking water levels of concern (DWLOCs) for the acute endpoint. These DWLOCs for various population categories are summarized in Table 3.

Table 3. Drinking Water Levels of Comparison for Acute Exposure to Cyfluthrin\1\ -------------------------------------------------------------------------------------------------------------------------------------------------------- Food Exposure (mg/kg/ Max. Water Exposure3 DWLOC 4,5,6 (g/L) DWEC,7 (g/L) -------------------------------------------------------------------------------------------------------------------------------------------------------- U.S. Population (48 Contiguous 0.07.................. 0.0045................ 0.066................ 2300................. 0.24 States) Male. U.S. Population (48 Contiguous 0.07.................. 0.0045................ 0.066................ 2000................. 0.24 states) Females. Non-Nursing Infants (g/L) = Max. water exposure (mg/kg/day) x body wt (kg) [(10-3 mg/g) x water consumed daily (L/day)]. \5\ HED Default body weights are: General U.S. Population, 70 kg; Males (13+ years old), 70 kg; Females (13+ years old), 60 kg; Other Adult Populations, 70 kg; and, All Infants/Children, 10 kg. \6\ HED Default daily drinking rates are 2 L/day for adults and 1 L/day for children. \7\ DWEC: Drinking Water Estimate Concentration. (Acute value).

For purposes of chronic risk assessment, the estimated maximum concentration for cyfluthrin in surface and ground waters (which is 0.04 g/L) should be used for comparison to the back-calculated human health DWLOCs for the chronic (non-cancer) endpoint. These DWLOCs for various population categories are summarized in Table 4.

Table 4. Drinking Water Levels of Comparison for Chronic Exposure to Cyfluthrin\1\ -------------------------------------------------------------------------------------------------------------------------------------------------------- Max. Water DWLOC Population Category\2\ cPAD (mg/kg/day) Food Exposure (mg/ Exposure\3\ (mg/ \4\,\5\,\6\(g/ DWEC,\7\(g/ kg/day) kg/day) L) L) -------------------------------------------------------------------------------------------------------------------------------------------------------- U.S. Population (48 Contiguous States) Male..... 0.008 0.000067 0.0079 270 0.044 U.S. Population (48 Contiguous States) Female... 0.008 0.000067 0.0079 240 0.044 Non-Nursing infants g/L) = Max. water exposure (mg/kg/day) x body wt (kg) [(10-3 mg/g) x water consumed daily (L/day)]. \5\ HED Default body weights are: General U.S. Population, 70 kg; Males (13+ years old), 70 kg; Females (13+ years old), 60 kg; Other Adult Populations, 70 kg; and, All Infants/Children, 10 kg. \6\ HED Default daily drinking rates are 2 L/day for adults and 1 L/day for children. \7\DWEC: Drinking Water Estimate Concentration. (Acute value).

As indicated in the Tables above, the estimated maximum concentration of cyfluthrin in surface and ground water are less than the DWLOCs as a contribution to acute and chronic exposure. The estimated concentrations of cyfluthrin in surface and ground water are conservative estimates. Therefore the Agency concludes with reasonable certainty that residues of cyfluthrin in food and drinking water will not result in an unacceptable estimate of acute or chronic human health risk. 3. From non-dietary exposure. Cyfluthrin is currently registered for use on the following residential non-food sites: outdoor lawn/ gardens, inside households, carpets and as a termiticide. Exposure to cyfluthrin may occur as a result of inhalation or contact from indoor and outdoor uses. Thus these uses constitute a short- and intermediate- term exposure scenario. A worst case scenario which aggregates all the above exposure routes was conducted for risk assessment purposes. 4. Cumulative exposure to substances with common mechanism of toxicity. Section 408(b)(2)(D)(v) 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.'' Cyfluthrin is a member of the Synthetic Pyrethroids. Other members of this class include bifenthrin, cypermethrin, lambda-cyhalothrin, zeta-cypermethrin, deltamethrin, esfenvalerate, permethrin, fenpropathrin, tefluthrin and tralomethrin. Four members of this class produce a common metabolite known as DCVA. These pyrethroids are cyfluthrin, cypermethrin, z- cypermethrin and permethrin. Although the residues of DCVA can be estimated, no toxicology data on the compound per se are available to directly conduct a hazard evaluation and therby establish an appropriate endpoint for use in a joint risk assessment. To date, for the purpose of assessing the risk of the parent compound the toxicity of DCVA has been assumed to be equivalent to the parent compound. However, due to the different toxicological profiles of cyfluthrin, cypermethrin, z-cypermethrin, and permethrin, EPA does not believe that it would be appropriate to cumulate DCVA for these pesticides, or DCVA residues from one of these pesticides with the parent of another of these pesticides, in conducting the risk assessment for these pesticides. EPA does not have, at this time, available data to determine whether cyfluthrin has a common mechanism of toxicity with other substances or how to include this pesticide in a cumulative risk assessment. Unlike other pesticides for which EPA has followed a cumulative risk approach based on a common mechanism of toxicity, cyfluthrin 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 cyfluthrin has a common mechanism of toxicity with other substances. For information regarding EPA's efforts to determine which chemicals have a common mechanism of toxicity and to evaluate the cumulative effects of such chemicals, see the final rule for Bifenthrin Pesticide Tolerances (62 FR 62961, November 26, 1997).

D. Aggregate Risks and Determination of Safety for U.S. Population

1. Acute risk. Using a Monte Carlo analysis, it is estimated the acute exposure to cyfluthrin from food for the population subgroup (U.S. Population- all season) will utilize 6.4% of the aPAD, and for the most highly exposed population subgroup that includes children (Non-Nursing infants, -8 torr). The Agency concludes that there is a reasonable certainty that no harm will result to adults, infants and children from chronic aggregate exposure to cyfluthrin residues. 3. Short- and intermediate-term risk. The short- and intermediate- term aggregate risks are estimated by combining exposure from food (chronic), water and residential uses. Since residue values in water from monitoring data were not available, the DWLOCs have to be back calculated for the short- and intermediate-term aggregate risk assessments. For cyfluthrin, the registered residential use sites include outdoor lawn/gardens, inside households and termiticide. These uses constitute a short, and intermediate term exposure scenario. Endpoints have been selected for short- and intermediate-term dermal and inhalation exposures. For adults, the routes of exposure from these registered residential uses include dermal and inhalation, and for infants and children, the routes of exposure include dermal, inhalation, and oral (nondietary). According to Agency aggregate risk assessment guidelines, exposures with toxicological endpoints selected from different studies with different toxicological effects should not be aggregated. Since the toxicological effects through the inhalation exposure route is different from those toxicological effects through the dermal, chronic food, and oral non-dietary routes, short- and intermediate-term aggregate risk assessment should only include dermal, chronic food and water, and oral non-dietary exposure routes. However, a worst case scenario which aggregated all exposure routes (includes inhalation, dermal, chronic food and water, and oral non-dietary) has previously been calculated (see the Final Rule on Cyfluthrin Residue Tolerances (62 FR 62961), November 26, 1997 (FRL-5755-2), and the Margin of Exposure (MOE) is above 2,000 for all population subgroups. The current action does not change this previous assessment. EPA generally has no concern for MOEs greater than 300. 4. Aggregate cancer risk for U.S. population. The Agency has concluded that there is no evidence of carcinogenicity in studies of either the rat or mouse. Therefore a carcinogenicity risk assessment is not required. 5. Determination of safety. Based on the above risk assessments, EPA concludes that there is a reasonable certainty that no harm will result from aggregate exposure to cyfluthrin residues.

E. Aggregate Risks and Determination of Safety for Infants and Children

1. Safety factor for infants and children--i. In general. In assessing the potential for additional sensitivity of infants and children to residues of cyfluthrin, EPA considered data from developmental toxicity studies in the rat and rabbit and a 2-generation reproduction study in the rat. The developmental toxicity studies are designed to evaluate adverse effects on the developing organism resulting from maternal pesticide exposure gestation. Reproduction studies provide information relating to effects from exposure to the pesticide on the reproductive capability of mating animals and data on systemic toxicity. FFDCA section 408 provides that EPA shall apply an additional tenfold margin of safety for infants and children in the case of threshold effects to account for pre-and postnatal toxicity and the completeness of the database unless EPA determines that a different margin of safety will be safe for infants and children. Margins of safety are incorporated into EPA risk assessments either directly through use of a margin of exposure (MOE) analysis or through using uncertainty (safety) factors in calculating a dose level that poses no appreciable risk to humans. EPA believes that reliable data support using the standard uncertainty factor (usually 100 for combined inter- and intra-species variability) and not the additional tenfold MOE/ uncertainty factor when EPA has a complete data base under existing guidelines and when the severity of the effect in infants or children or the potency or unusual toxic properties of a compound do not raise concerns regarding the adequacy of the standard MOE/safety factor. The Agency has determined that an additional UF is needed for risk assessments for cyfluthrin. This is due to evidence of increased sensitivity of pups in the 3-generation reproduction study. It was observed that there were decreased pup weight gains at a dose in which there were no effects in the parents. The additional UF is determined to be 3x due to the lack of severity of effects (reduced body weight gain in pups) and the availability of acceptable reproduction (rat) and developmental (rats and rabbits) toxicity studies. ii. Conclusion. There is a complete toxicity database for cyfluthrin and exposure data is complete or is estimated based on data that reasonably accounts for potential exposures. Taking into account the completeness of the data base, EPA concludes the use of the additional safety factor would be safe for infants and children. 2. Acute risk. For nonnursing infants >1 year old, the aggregate acute exposure is 0.0068 mg/kg bw/day and a MOE 2000. For cyfluthrin, EPA has no concern for MOEs over 300. 3. Chronic risk. Using the exposure assumptions described in this unit, EPA has concluded that aggregate exposure to cyfluthrin from food will utilize 9.7% of the aPAD for the most highly exposed population subgroup (non-nursing infants less than 1-year). It is determined that an acceptable chronic dietary exposure (food plus water) of 100% or less of the cPAD is neede to protect the safety of all populations subgroups. The Agency generally has no concern for exposures below 100% of the cPAD because the cPAD represents the level at or below which daily aggregate dietary exposure over a lifetime will not pose appreciable risks to human health. 4. Short or intermediate term risk. For children and non-nursing infants tompkins.jim@epa.gov. Requests for waiver of tolerance objection fees should be sent to James Hollins, Information Resources and Services Division (7502C), Office of Pesticide Programs, Environmental Protection Agency, 401 M St., SW., Washington, DC 20460. If a hearing is requested, the objections must include a statement of the factual issues on which a hearing is requested, the requestor's contentions on such issues, and a summary of any evidence relied upon by the requestor (40 CFR 178.27). A request for a hearing will be granted if the Administrator determines that the material submitted shows the following: There is genuine and substantial issue of fact; there is a reasonable possibility that available evidence identified by the requestor would, if established, resolve one or more of such issues in favor of the requestor, taking into account uncontested claims or facts to the contrary; and resolution of the factual issues in the manner sought by the requestor would be adequate to justify the action requested (40 CFR 178.32). Information submitted in connection with an objection or hearing request may be claimed confidential by marking any part or all of that information as CBI. Information so marked will not be disclosed except in accordance with procedures set forth in 40 CFR part 2. A copy of the information that does not contain CBI must be submitted for inclusion in the public record. Information not marked confidential may be disclosed publicly by EPA without prior notice.

VI. Public Record and Electronic Submissions

EPA has established a record for this regulation under docket control number [OPP-300887] (including any comments and data submitted electronically). A public version of this record, including printed, paper versions of electronic comments, which does not include any information claimed as CBI, is available for inspection from 8:30 a.m. to 4 p.m., Monday through Friday, excluding legal holidays. The public record is located in Rm. 119 of the Public Information and Records Integrity Branch, Information Resources and Services Division (7502C), Office of Pesticide Programs, Environmental Protection Agency, CM #2, 1921 Jefferson Davis Hwy., Arlington, VA. Objections and hearing requests may be sent by e-mail directly to EPA at:

opp-docket@epa.gov

E-mailed objections and hearing requests must be submitted as an ASCII file avoiding the use of special characters and any form of encryption. The official record for this regulation, as well as the public version, as described in this unit will be kept in paper form. Accordingly, EPA will transfer any copies of objections and hearing requests received electronically into printed, paper form as they are received and will place the paper copies in the official record which will also include all comments submitted directly in writing. The official record is the paper record maintained at the Virginia address in ``ADDRESSES'' at the beginning of this document.

VII. Regulatory Assessment Requirements

A. Certain Acts and Executive Orders

This final rule establishes a tolerance under section 408(d) of the 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). This final rule does not contain any information collections subject to OMB approval under the Paperwork Reduction Act (PRA), 44 U.S.C. 3501 et seq., or impose any enforceable duty or contain any unfunded mandate as described under Title II of the Unfunded Mandates Reform Act of 1995 (UMRA) (Public Law 104-4). Nor does it require any special considerations as required by Executive Order 12898, entitled Federal Actions to Address Environmental Justice in Minority Populations and

Low-Income Populations (59 FR 7629, February 16, 1994), or require OMB review in accordance with Executive Order 13045, entitled Protection of Children from Environmental Health Risks and Safety Risks (62 FR 19885, April 23, 1997). In addition, since tolerances and exemptions that are established on the basis of a petition under FFDCA section 408(d), 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. Nevertheless, the Agency previously assessed whether establishing tolerances, exemptions from tolerances, raising tolerance levels or expanding exemptions might adversely impact small entities and concluded, as a generic matter, that there is no adverse economic impact. The factual basis for the Agency's generic certification for tolerance actions published on May 4, 1981 (46 FR 24950), and was provided to the Chief Counsel for Advocacy of the Small Business Administration.

B. Executive Order 12875

Under Executive Order 12875, entitled Enhancing the Intergovernmental Partnership (58 FR 58093, October 28, 1993), EPA may not issue a regulation that is not required by statute and that creates a mandate upon a State, local or tribal government, unless the Federal government provides the funds necessary to pay the direct compliance costs incurred by those governments. If the mandate is unfunded, EPA must provide to OMB a description of the extent of EPA's prior consultation with representatives of affected State, local, and tribal governments, the nature of their concerns, copies of any written communications from the governments, and a statement supporting the need to issue the regulation. In addition, Executive Order 12875 requires EPA to develop an effective process permitting elected officials and other representatives of State, local, and tribal governments ``to provide meaningful and timely input in the development of regulatory proposals containing significant unfunded mandates.'' Today's rule does not create an unfunded Federal mandate on State, local, or tribal governments. The rule does not impose any enforceable duties on these entities. Accordingly, the requirements of section 1(a) of Executive Order 12875 do not apply to this rule.

C. Executive Order 13084

Under Executive Order 13084, entitled Consultation and Coordination with Indian Tribal Governments (63 FR 27655, May 19, 1998), EPA may not issue a regulation that is not required by statute, that significantly or uniquely affects the communities of Indian tribal governments, and that imposes substantial direct compliance costs on those communities, unless the Federal government provides the funds necessary to pay the direct compliance costs incurred by the tribal governments. If the mandate is unfunded, EPA must provide OMB, in a separately identified section of the preamble to the rule, a description of the extent of EPA's prior consultation with representatives of affected tribal governments, a summary of the nature of their concerns, and a statement supporting the need to issue the regulation. In addition, Executive Order 13084 requires EPA to develop an effective process permitting elected officials and other representatives of Indian tribal governments ``to provide meaningful and timely input in the development of regulatory policies on matters that significantly or uniquely affect their communities.'' Today's rule does not significantly or uniquely affect the communities of Indian tribal governments. This action does not involve or impose any requirements that affect Indian tribes. Accordingly, the requirements of section 3(b) of Executive Order 13084 do not apply to this rule.

VIII. Submission to Congress and the Comptroller General

The Congressional Review Act, 5 U.S.C. 801 et seq., as added by the Small Business Regulatory Enforcement Fairness Act of 1996, generally provides that before a rule may take effect, the Agency promulgating the rule must submit a rule report, which includes a copy of the rule, to each House of the Congress and 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 the 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: June 24, 1999.

James Jones,

Director, Registration Division, Office of Pesticide Programs. Therefore, 40 CFR chapter I is amended as follows:

PART 180--[AMENDED]

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

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

2. Section 180.436, is amended to read as follows: i. By alphabetically adding ``Potatoes'' to the table under paragraph (a)(1). ii. By transferring the entries in the table in paragraph (a)(2) to the table in paragraph (a)(1) and removing the expiration dates; and removing the remainder of paragraph (a)(2). iii. By redesignating paragraphs (a)(3) and (a)(4) as paragraphs (a)(2) and (a)(3). The additions and amendments to Sec. 180.436 read as follows:

180.436 Cyfluthrin; tolerances for residues

(a)(1) * * *

------------------------------------------------------------------------ Commodity Parts per million ------------------------------------------------------------------------ * * * * * Corn, forage and fodder field and pop..... 0.01 Corn, grain, field and pop................ 0.01 Corn, sweet, (K+CWHR)..................... 0.05 Corn, sweet, fodder....................... 15.00 Corn, sweet, forage....................... 30.00 * * * * * Potatoes.................................. 0.01 * * * * * ------------------------------------------------------------------------

* * * * *

[FR Doc. 99-16637 Filed 6-29-99; 8:45 am] BILLING CODE 6560-50-F