FEDERAL REGISTER
Open comment period on US EPA proposals
for fluorine and organofluorine pesticides

 
 

The Federal Register (FR) is the official daily publication for Rules, Proposed Rules, and Notices of
U.S. Federal agencies and organizations, as well as Executive Orders and other Presidential Documents.

The US Environmental Protection Agency (EPA) publishes pesticide proposals and Final Rules in the FR
and for each they solict public comment. Details for submitting comments are given in each FR notice and
email submissions are accepted.

See FAN's index on

CLOSED Comment Periods: January 2005 to present

CLOSED Comment Periods: August 2001 - December 2004

See FAN's Table on US EPA's Pesticide Tolerance Fees

Pesticide

Docket ID Number

Date Published

Comments due by

Applicant

Proposal

-click on for more about this pesticide - - click on to read Federal Register Notice

Flumioxazin

EPA-HQ-OPP-2007-0871

and

EPA-HQ-OPP-2006-0781

September 28, 2007

October 29, 2007

Valent U.S.A. Corporation. Proposed pesticide tolerance.

Pesticide Petition (PP 7F7243) to establish a tolerance for residues of the herbicide flumioxazin in or on the food commodities
-- corn, field grain at 0.02 ppm
-- corn, field forage at 0.02 ppm
-- corn, field stover at 0.02 ppm

Pesticide Petition (6F7092) proposes to establish a tolerance for residues of the herbicide in or on the food commodities
-- alfalfa, forage at 1.0 ppm and
-- alfalfa, hay at 2.0 ppm.

See Adverse Effects:

Anemia
Blood
Body Weight Decrease
Bone
Brain
Cholesterol
Cytotoxic (results equivocal)
Endocrine: Adrenal
Endocrine: Testicular
Endocrine: Thymus
Endocrine: Thyroid
Heart
Kidney
Liver
Lymph Node
Teratogen

Fomesafen

EPA-HQ-OPP-2007-0097

September 12, 2007

November 13, 2007

Tolerance Actions. FINAL RULE. EPA is inceasing the following tolerances for fomesafen from 0.025 to 0.05 ppm in order to harmonize with the Canadian MRLs in support of North American Free Trade Agreement (NAFTA) (see June 2007 proposal):

Bean, dry - 0.05 ppm
Bean, snap, succulent - 0.05 ppm

See Adverse Effects:
Blood
Body Weight Decrease
Bone
Cancer: Possible Human Carcinogen - LIVER
Liver
Stomach
Phototoxic Pesticide.
Potential ground water contaminant

Oxyfluofen

EPA-HQ-OPP-2007-0036

September 19, 2007

November 19, 2007

Tolerance Actions. FINAL RULE. EPA is modifying certain tolerances for the herbicide oxyfluorfen and is establishing new tolerances. See all tolerances.

New tolerances are:
-- Corn, pop, grain - 0.05 ppm
-- Peppermint, tops - 0.05 ppm
-- Spearmint, tops - 0.05 ppm

New Emergency Exemptions are:
Grass, forage - 0.05 ppm
Grass, hay - 0.05 ppm
Grass, seed screenings - 0.05 ppm

Revised tolerances are:
Hog, fat - from 0.05 to 0.01 ppm
Hog, meat byproducts - from 0.05 to 0.01 ppm
Hog, meat - from 0.05 to 0.01 ppm
Horse, fat - from 0.05 to 0.01 ppm
Horse, meat byproducts - from 0.05 to 0.01 ppm
Horse, meat - from 0.05 to 0.01 ppm
Milk - from 0.05 to 0.01 ppm
Poultry, fat - from 0.05 to 0.2 ppm
Poultry, meat byproducts - from 0.05 to 0.01 ppm
Poultry, meat - from 0.05 to 0.01 ppm
Sheep, fat - from 0.05 to 0.01 ppm
Sheep, meat byproducts - from 0.05 to 0.01 ppm
Sheep, meat - from 0.05 to 0.01 ppm

EPA is revising the commodity terminology in 40 CFR 180.381(a) from cocoa bean, dried bean to cacao bean, dried bean..

See Adverse Effects:
Anemia
Blood
Body Weight Decrease
Bone
Brain
Cancer: Possible Human Carcinogen - LIVER
Endocrine: Adrenal
Endocrine: Pituitary
Endocrine: Thymus
Endocrine: Thyroid
Kidney
Liver

Spleen
Contamination Incidents
Environmental

Trifloxystrobin

EPA-HQ-OPP-2007-0539

September 19, 2007

November 19, 2007

Bayer CropScience. Pesticide tolerance. FINAL RULE. This regulation establishes a tolerance for combined residues of Trifloxystrobin and the acid metabolite CGA-321113, at higher levels than requested by Bayer, in or on

-- Grass, forage at 12 ppm (Bayer requested 10.0 ppm)
-- Grass, hay at 17 ppm (Bayer requested 14.0 ppm)

April 11, 2007: Human Health Risk Assessment for Section 3 Registration for the Proposed Uses on Grasses Grown for Seed.

Based upon review of the data supporting the petition, EPA has modified the tolerances proposed for grass, forage and grass, hay. The appropriate tolerances for grass forage and hay were calculated to be 12 and 17 ppm, respectively. Although residue data were also provided for grass straw and seed screenings, tolerances are not required on these commodities as the Agency no longer considers them to be significant livestock feedstuffs. The recommended tolerance levels for grass forage and hay were determined considering recent Agency Guidance (Guidance for Setting Pesticide Tolerances Based on Field Trial Data).

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 toxicity database for Trifloxystrobin is complete except for an acute neurotoxicity study which is classified as unacceptable. The toxicity database contains developmental toxicity studies in two species (rats and rabbits) and a 2-generation reproduction study in rats which are adequate to assess pre and/or post natal susceptibility to infants and children. Although the available, submitted acute neurotoxicity study was found to be unacceptable, based on a weight-of- the evidence review of the available data, the lack of this study does not impact the Agency's ability to make an FQPA safety factor decision. Given that there was no evidence of neurotoxicity in this study at the Limit Dose nor in the other subchronic and chronic studies in the database there is not an uncertainty concerning neurotoxic effects and EPA has reliable data to show that removal of the FQPA safety factor is safe for children. Additionally, these data demonstrate that a developmental neurotoxicity study is not required for this pesticide.

Fludioxonil

EPA-HQ-OPP-2007-0940

October 24 , 2007

November 23, 2007

IR-4. Petition for New Tolerances. Pesticide Petition: PP 7E7234. Proposal for tolerances in or on food commodities

-- tomato - 0.4 ppm
-- tomatillo- 0.4 ppm
-- tomato, paste - 1.0 ppm
-- avocado - 0.45 ppm
-- black sapote - 0.45 ppm
-- canistel - 0.45 ppm
-- mamey sapote - 0.45 ppm
-- mango - 0.45 ppm
-- papaya - 0.45 ppm
-- sapodilla - 0.45 ppm
-- star apple - 0.45 ppm
-- herb, subgroup 19A, fresh - 13 ppm (currently 10 ppm)
-- herb, subgroup 19A, dried - 55 ppm (currently 65 ppm)
-- leaves of root and tuber vegetables - 40 ppm
-- •• root vegetables, except sugar beet subgroup - 0.5 ppm
-- lemon - 0.25 ppm
-- lime - 0.25 ppm
-- cucurbits - 0.6 ppm
-- ••• tuberous and corm vegetables, except potato subgroup - 4.0 ppm

Subgroup 19a includes 42 commodities: angelica • balm • basil • borage • burnet • camomile • catnip • chervil dried • chive • chive, chinese • clary • coriander, leaf • costmary • culantro leaf • culantro leaf • culantro leaf • curry • dillweed • dillweed herbs, dried • herbs, fresh • horehound • hyssop • lavender • lemongrass • lovage leaf • marigold • marjoram • nasturtium • parsley dried • pennyroyal • rosemary • rue • sage • savory, summer • savory, winter • sweet bay • tansy • tarragon • thyme • wintergreen • woodruff • wormwood
•• This subgroup (1B) includes 19 commodities: beet, garden • burdock, edible • carrot • carrot culls • celeriac • chervil, turnip rooted • chicory root • ginseng • horseradish • parsley, turnip rooted • parsnip • radish • radish, oriental • rutabaga • salsify • salsify, black • salsify, spanish • skirret • turnip
••• This subgroup (1D) includes 16 commodities: arracacha • arrowroot • artichoke, chinese • artichoke, jerusalem • canna, edible • cassava • chayote root • chufa • dasheen • ginger • leren • sweet potato • tanier • turmeric • yam bean • yam, true

SEE Adverse Effects:
Body Weight Decrease
Cancer: "currently unclassifiable" - statistically significant trend for malignant LYMPHOMAS in female mice; statistically significant increases in LIVER tumors in female rats
Cholesterol
Endocrine: Ovary, Thymus
Genotoxic
Kidney
Liver
Spleen
Environmental

Fludioxonil

EPA-HQ-OPP-2007-0940

October 24 , 2007

November 23, 2007

IR-4. Amendment to Existing Tolerances. Pesticide Petition: PP 7E7234. Upon approval of request of new tolerances (see above), this proposal requests an amendment of tolerances in 40 CFR 180.516 by removing the established tolerances for residues of the fungicide fludioxonil in or on the food commodities

-- herb, subgroup 19A, fresh at 10 ppm
-- herb, subgroup 19A, dried at 65 ppm
-- carrot at 0.75 ppm
-- turnip, greens at 10 ppm

Florasulam

EPA-HQ-OPP-2006-0993

September 28, 2007

November 27, 2007

Dow AgroSciences. Pesticide Tolerance. FINAL RULE. FIRST-TIME APPROVAL FOR THE USE OF FLORASULAM IN THE US. Florasulam is a selective triazolopyrimidine sulfonanilide post-emergent herbicide, approved for use in or on the following food commodities.:

at 0.01 ppm: Barley, grain; Oat, grain; Rye, grain; Wheat, grain
at 0.05 ppm: Barley, hay; Barley, straw ; Oat, forage ; Oat, hay ; Oat, straw ; Rye, forage ; Rye, straw; Wheat, forage; Wheat, hay; Wheat, straw

The mode of action for florasulam is through inhibition of the plant enzyme acetolactate synthase (ALS). The inhibition of ALS results in retardation of plant growth processes leading to death of the plant. Florasulam was first registered in Israel in 1998.

Florasulam: Human Health Risk Assessment for Proposed Use on Cereal Grains. May 31, 2007.

-- Developmental Toxicity Studies. In the rat developmental toxicity study, at 750 mg/kg/day, body weights were decreased by 4-6 during GD 6-19, resulting in a 16% decrease in body weight gains during treatment (GD 6-16); food consumption was also decreased (not statistically analyzed) by 6-13% during the treatment period. Additionally at this dose, absolute and relative (to body weight) kidney weights were increased (p<=0.05) by 8 and 12%, respectively. At ≥250 mg/kg/day, slight decreases (3-4%) were observed in fetal body weight, accompanied by delayed ossification (not significant) of the skull, ribs, and sternebrae at 750mg/kg/day. However, both findings were within the historical control range.

ENDPOINTS OF CONCERN in EPA's human health risk assessment:
• Acute dietary (Females 13-49 years of age): No appropriate endpoint identified.
• Acute dietary( General population including infants and children): No appropriate endpoint identified.
• Chronic dietary (All populations): Chronic toxicity - dogs. LOAEL = 50 mg/kg/day, based on decreased body weights (17%), decreased body weight gains (68%), and food consumption in the females; adverse liver alterations; slight vacuolation of the zona reticularis and zona fasciculate in the adrenal gland (fatty change) in both sexes.
• Short-term dermal (1 to 30 days) (Residential): No appropriate endpoint identified.
• Inhalation Short-term (1-30 days): 90-day oral toxicity - dogs. LOAEL = 50 mg/kg/day based on increased incidence/severity of hepatic vacuolation in both sexes.

In aquatic systems, florasulam degrades with half-lives of 3-18 days in aerobic systems and half- lives of 2-13 days in anaerobic systems. In aerobic aquatic systems, florasulam is biotransformed to 5-OH-XDE-570, which is then further biotransformed to DFP-ASTCA and STCA (tentative identification). However, 5-OH-XDE-570 degrades much more slowly than the parent, degrading with a half-life of 169 days in one aerobic system and remaining stable in another aerobic system. In anaerobic aquatic systems, 5-OH-XDE-570 is stable. Thus, 5-OH-XDE-570 is expected to be persistent in both aerobic and anaerobic aquatic systems... both florasulam and 5-OH-XDE-570 are very mobile in soil and, thus, have the potential to leach - the potential to leach will be greater when there is excessive rainfall or irrigation. (Page 24 of the Human Health Risk Assessment)

Tembotrione

EPA-HQ-OPP-2006-0072

September 28, 2007

November 27, 2007

Bayer CropScience. Pesticide tolerance. FINAL RULE.FIRST-TIME APPROVAL FOR THE USE OF FLORASULAM IN THE US. This regulation establishes tolerances for combined residues of tembotrione and its metabolite (M5); 2-[2-chloro-4-(methylsulfonyl)-3-[(2,2,2- trifluoroethoxy)methyl]benzoyl]-4,6-dihydroxy-1,3-cyclohexanedione in or on

Corn, sweet: forage and stover
Corn, field: forage, grain, stover
Corn, pop: grain and stover
Corn, sweet, kernel plus cob with husks removed
Cattle, Goat, Horse, Poultry, Sheep: liver
Cattle, Goat, Horse, Sheep: meat byproducts, except liver

See details of adverse effects noted in Health Risk Assessment:
Blood
Body Weight Decrease
Bone
Brain
Carcinogenicity: EYE
Cholesterol
Endocrine: Ovary
Endocrine: Pancreas
Endocrine: Pituitary
Endocrine: Suspected Disruptor
Endocrine: Testes
Endocrine: Thyroid
Eye
Gallbladder
Kidney
Liver
Sciatic nerve

Sodium fluoride

EPA-HQ-OPP-2007-0833

October 10, 2007

December 10, 2007

Sodium Fluoride Risk Assessment; Notice of Availability and Risk Reduction Options. This notice announces the availability of EPA's risk assessment, and related documents for the pesticide Sodium Fluoride and opens a public comment period on these documents. Comments on the following documents are due by December 10.

Sodium Fluoride Preliminary Risk Assessment for the Reregistration Eligibility Decision (RED) Document . Sept. 30, 2007 (87 pages)
Revised Occupational and Residential Exposure Chapter for the Sodium Fluoride Reregistration Eligibility Decision (RED). Oct. 1, 2007 (12 pages)
Environmental Fate Science Chapter for the Sodium Fluoride Reregistration Eligibility Decision (RED) Document. Sept. 25, 2007 (8 pages)
Sodium Fluoride Toxicology Chapter for Issuance of the Reregistration Eligibility Decision (RED) Document. Sept. 30, 2007 (78 pages)
Product Chemistry Science Chapter For: Sodium Fluoride Reregistration Eligibility Decision (RED). Sept. 25, 2007 (2 pages)
Revised Ecological Hazard and Environmental Risk Assessment Science Chapter for the Sodium Fluoride Reregistration Eligibility Decision (RED). Sept. 25, 2007 (13 pages)
Sodium Fluoride – Incident Report Summary. Aug. 3, 2007 (11 pages)

Bifenthrin

EPA-HQ-OPP-2007-0471

October 24, 2007

December 24, 2007

IR-4. Pesticide tolerance. FINAL RULE. Commodities approved for residues in and or on:
Beet, garden, roots and tops; Grain, aspirated fractions; Groundcherry; Mayhaw; Peanut; Pepino; Pistachio; Radish, tops; Soybean, hulls; Soybean, refined oil; Soybean, seed;
Vegetable, root, subgroup 1B except sugar beet and garden beet. This subgroup includes 19 commodities: beet, garden • burdock, edible • carrot • carrot culls • celeriac • chervil, turnip rooted • chicory root • ginseng • horseradish • parsley, turnip rooted • parsnip • radish • radish, oriental • rutabaga • salsify • salsify, black • salsify, spanish • skirret • turnip

From July 25, 2007, Health Risk Assessment;
• Page 3. NEUROTOXIC: Bifenthrin is a neurotoxic insecticide acting through direct contact and ingestion, having a slight repellent effect. The primary biological effects of bifenthrin and other pyrethroids on insects and vertebrates are inhibition of the voltage-gated Ca 2+ channels coupled with a stimulatory effect on the voltage-gated Na+ channels. All pyrethroids act as axonic poisons, affecting both the peripheral and central nervous systems, and share similar modes of action. Pyrethroids, including bifenthrin, stimulate repetitive action in the nervous system by binding to voltage-gated sodium channels, prolonging the sodium ion permeability during the excitatory phase of the action potential. This action leads to spontaneous depolarizations, augmented neurotransmitter secretion rate and neuromuscular block, which ultimately results in paralysis of the insect.

• Page 4. NEUROTOXIC: Bifenthrin produces characteristic pyrethroid neurotoxicity. Findings consisted of tremors, abnormal posture, splayed hindlimbs, staggered gait, altered activity, altered landing foot-splay, twitching, uncoordinated movement/ataxia, and convulsions.

• Pages 13-14. CANCER: EPA's Carcinogenicity Peer Review Committee CPRC (1992) has characterized bifenthrin as Category C (possible human carcinogen) and recommended that for the purpose of risk characterization, the RfD approach should be used for quantification of human cancer risk. This decision was based in part on the statistically significant increased trend for hemangiopericytomas in the urinary bladders’ of Swiss Webster mice. The incidence of these lesions was double at the highest dose tested (HDT; 600 ppm) as compared to controls. The male mice also had significant dose-related trends with respect to hepatocellular carcinomas and combined hepatocellular adenomas and carcinomas, and increased incidences of bronchioalveolar adenomas and adenocarcinomas of the lung in females at 50, 200 and 600 ppm (but not 500 ppm) relative to their controls.

• Page 24. BRAIN, OVARY, ADRENAL, HEART: In a 2-generation study (MRID 00157225), liquified bifenthrin (88.35% ai) mixed with acetone was administered in the diet to TAC(SD)fBR rats (25/sex/dose) at dose levels of 0, 30, 60, or 100 ppm as FMC 54800 technical (approximately equivalent to 0, 1.5, 3.0 and 5.0 mg/kg/day)... In the high-dose P generation females, there was a statistically significant increase in absolute and relative brain weights... In the 100 ppm group F1b female progeny, absolute adrenal and heart weights were statistically elevated compared to control values. Significantly elevated absolute ovary and ovary/brain weights were also observed in these animals.

See Adverse Effects:
Ataxia
Bladder
Body Weight Decrease
Cancer: Possible Human Carcinogen URINARY BLADDER, LIVER, LUNG
Endocrine: Ovary/Estrus
Endocrine: Suspected Disruptor
Endocrine: Thyroid
Liver
Lung
Tremors/Convulsions
Environmental

Fluazinam

EPA-HQ-OPP-2007-0234

October 24, 2007

December 24, 2007

IR-4 and ISK Biosciences. Pesticide tolerance. FINAL RULE for PP 6E7137. Two of four documents in the docket:

Fluazinam: Human Health Risk Assessment for Proposed Use on Edible-Podded beams. Shelled and Succulent and Dried Beans, Bassica Lafy Vegetables, Bushberriews, and Gingseng. August 22,2007. EPA Office of Pesticides. Docket No. EPA-HQ-OPP-2007-0234-0004.

Fluazinam Acute and Chronic Aggregate Dietary (Food and Drinking Water) Exposure and Risk Assessments for the Secion 3 Registration Action on Gingseng, Brassica Vegetables, Legume Vegetables, and Bushberries. August 1, 2007. US EPA Office of Pesticides. Docket No. EPA-HQ-OPP-2007-0234-0005.

SEE Adverse Effects:
Body Weight Decrease
Bone (including Cleft Palate)
Brain
Cancer- Suggestive evidence: THYROID, LIVER
Cholesterol
Dermal
Endocrine: Pancreas, Testicular, Thymus, Thyroid, Uterus
Eye
Liver
Lung
Spinal Cord
Stomach
Environmental

Commodity

Tolerance
PPM:


FINAL RULE

Tolerance
PPM:

PETITIONED

Aronia berry
7.0
4.5
Buffalo currant
7.0
4.5

Bushberry subgroup 13B. This subgroup includes 5 commodities: blueberry • currant • elderberry • gooseberry • huckleberry

7.0
4.5
Chilean guava
7.0
4.5
European barberry
7.0
4.5
Ginseng
4.5
3.0
Highbush cranberry
7.0
4.5
Honeysuckle, edible
7.0
4.5
Jostaberry
7.0
4.5
Juneberry
7.0
4.5
Lingonberry
7.0
4.5
Native currant
7.0
4.5
Pea and bean, dried shelled, except soybean, subgroup 6C, except pea. This subgroup includes 27 commodities. bean, adzuki • bean, broad dry • bean, dry • bean, kidney • bean, lablab • bean, lima dry • bean, moth • bean, mung • bean, navy • bean, pink • bean, pinto • bean, rice • bean, tepary • bean, urd • catjang • chickpea • cowpea • guar • lentil • lupin, grain • lupin, sweet • pea, blackeyed • pea, crowder • pea, field • pea, field seed • pea, pigeon • pea, southern
0.02
0.01

Pea and bean, succulent shelled, subgroup 6B, except pea. This subgroup includes 10 commodities: bean, broad succulent • bean, lima succulent • cowpea • cowpea seed • pea, blackeyed • pea, english • pea, garden • pea, green • pea, pigeon • pea, southern

0.04
0.02
Salal
7.0
4.5
Sea buckthorn
7.0
4.5
Turnip, greens
0.01
0.02
Vegetable, Brassica leafy, group 5. This group includes 16 commodities. broccoli • broccoli raab • broccoli, chinese • brussels sprouts • cabbage • cabbage, chinese, bok choy • cabbage, chinese, mustard • cabbage, chinese, napa • cauliflower • collards • kale • kohlrabi • mustard greens • mustard spinach • rape greens • vegetable, brassica, leafy, group
0.01
0.02

Vegetable, legume, edible-podded, subgroup 6A, except pea. This subgroup includes14 commodities. bean, moth • bean, runner • bean, snap • bean, wax • bean, yardlong • jackbean • longbean, chinese • pea, dwarf • pea, edible podded • pea, pigeon • pea, snow • pea, sugar snap • soybean immature seed • swordbean

0.10
0.15

 

 

 

 
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