Sustalife (Сусталифе) для суставов в Опочке

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sulfosate (touchdown) Pesticide Petition Filing 4/99

>From the Federal Register Online via GPO Access ----------------------------------------------------------------------- ENVIRONMENTAL PROTECTION AGENCY Notice of Filing of Pesticide Petitions AGENCY: Environmental Protection Agency (EPA).

ACTION: Notice. ----------------------------------------------------------------------- SUMMARY: This notice announces the initial filing of pesticide petitions proposing the establishment of regulations for residues of certain pesticide chemicals in or on various food commodities. DATES: Comments, identified by the docket control number PF-869, must be received on or before May 10, 1999. ADDRESSES: By mail submit written comments to: Public Information and Records Integrity Branch, Information Resources and Services Division (7502C), Office of Pesticides Programs, Environmental Protection Agency, 401 M St., SW., Washington, DC In person bring comments to: Rm.

119, CM #2, 1921 Jefferson Davis Highway, Arlington, VA. Comments and data may also be submitted electronically to: opp- docket@ Follow the instructions under ``SUPPLEMENTARY INFORMATION.'' No confidential business information should be submitted through e-mail. Information submitted as a comment concerning this document may be claimed confidential by marking any part or all of that information as ``Confidential Business Information'' (CBI). CBI should not be submitted through e-mail. Information marked as CBI will not be disclosed except in accordance with procedures set forth in 40 CFR part 2. A copy of the comment 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.

All written comments will be available for public inspection in Rm. 119 at the address given above, from 8:30 a.m. to 4 p.m., Monday through Friday, excluding legal holidays. FOR FURTHER INFORMATION CONTACT: The product manager listed in the table below: ------------------------------------------------------------------------ Office location/ Product Manager telephone number Address ------------------------------------------------------------------------ Sidney Jackson Rm. 272, CM #2, 703- 1921 Jefferson 305-7610, e- Davis Hwy, mail: @e Arlington, VA Lisa D. Jones Rm. 259, CM #2, 703- Do. 308-9424, e- mail: @epama # ------------------------------------------------------------------------ SUPPLEMENTARY INFORMATION: EPA has received pesticide petitions as follows proposing the establishment and/or amendment of regulations for residues of certain pesticide chemicals in or on various food commodities under section 408 of the Federal Food, Drug, and Comestic Act (FFDCA), 21 U.S.C.

346a. EPA has determined that these petitions contain data or information regarding the elements set forth in section 408(d)(2); however, EPA has not fully evaluated the sufficiency of the submitted data at this time or whether the data support granting of the petition. Additional data may be needed before EPA rules on the petition. The official record for this notice of filing, as well as the public version, has been established for this notice of filing under docket control number (including comments and data submitted electronically as described below). 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 official record is located at the address in ``ADDRESSES'' at the beginning of this document. Electronic comments can be sent directly to EPA at: opp-docket@ Electronic comments must be submitted as an ASCII file avoiding the use of special characters and any form of encryption. Comments and data will also be accepted on disks in Wordperfect 5.1 file format or ASCII file format. All comments and data in electronic form must be identified by the docket number (insert docket number) and appropriate petition number. Electronic comments on notice may be filed online at many Federal Depository Libraries.

List of Subjects Environmental protection, Agricultural commodities, Food additives, Feed additives, Pesticides and pests, Reporting and recordkeeping requirements. Dated: April 2, 1999.

onald R. Stubbs, Acting Director, Registration Division, Office of Pesticide Programs. Summaries of Petitions Petitioner summaries of the pesticide petitions are printed below as required by section 408(d)(3) of the FFDCA. The summaries of the petitions were prepared by the petitioners and represent the views of the petitioners. EPA is publishing the petition summaries verbatim without editing them in any way. The petition summary announces the availability of a description of the analytical methods ] available to EPA for the detection and measurement of the pesticide chemical residues or an explanation of why no such method is needed.

3. Zeneca Ag. Products PP 7F4854, 7F4876, and 7F4853 EPA has received pesticide petitions from Zeneca ts, 1800 Concord Pike, P. O. Box 15458, Wilmington, DE 19850-5458 proposing, pursuant to section 408(d) of the Federal Food, Drug, and Cosmetic Act (FFDCA), 21 U.S.C. 346a(d), to amend 40 CFR part 180 by establishing a tolerance for residues of sulfosate (the trimethylsulfonium salt of glyphosate, also known as glyphosate-trimesium in or on the raw agricultural commodity (RAC) the fruiting vegetables (except cucurbits) group at 0.05 ppm; the edible- podded legume vegetables subgroup at 0.5 ppm (of which no more than 0.3 ppm is trimethylsulfonium (TMS., the succulent shelled pea and bean subgroup at 0.2 ppm (of which no more than 0.1 ppm is TMS); the dried shelled pea and bean (except soybean) subgroup at 6 ppm (of which no more than 1.5 ppm is TMS); in cattle, goat, hog, sheep, and horse kidney at 3.5 ppm; in cattle, goat, hog, sheep, and horse meat by- products, except liver and kidney, at 2.5 ppm; and to increase the tolerance in cattle, goat, hog, sheep, and horse fat to 0.2 ppm; in cattle, goat, hog, sheep, and horse meat to 0.6 ppm; in cattle, goat, hog, sheep, and horse liver to 0.75 ppm; in milk to 1.1 ppm; in poultry liver to 0.1 ppm; in poultry meat by-products to 0.25 ppm; in or on soybean seed to 21 ppm (of which no more than 13 ppm is TMS); in soybean hulls to 45 ppm (of which no more than 25 ppm is TMS); and in aspirated grain fractions to 1,300 ppm (of which no more than 720 ppm is TMS) at parts per million (ppm).

EPA has determined that the petition contains data or information regarding the elements set forth in section 408(d)(2) of the FFDCA; however, EPA has not fully evaluated the sufficiency of the submitted data at this time or whether the data supports granting of the petition. Additional data may be needed before EPA rules on the petition. A. Residue Chemistry 1. Plant metabolism. The metabolism of sulfosate has been studied in corn, grapes, and soybeans. EPA has concluded that the nature of the residue is adequately understood and that the only residues of concern are the parent ionsN-(phosphonomethyl)-glycine anion (PMG) and trimethylsulfonium cation (TMS). 2. Analytical method. Gas chromatography/mass selective (GC/MS) detector methods have been developed for PMG analysis in crops, animal tissues, milk, and eggs.

Gas chromatography detection methods have been developed for TMS in crops, animal tissues, milk, and eggs. 3. Magnitude of residues--i. Magnitude of residues in crops-- Soybeans. Residue data are available for sulfosate in a total of 20 trials conducted in 3 different EPA regions and 15 different States representing 99% of the soybean production in the U.S. The proposed tolerance of 21 ppm (of which no more than 13 ppm is TMS) for soybean seed will accommodate any residue resulting from the proposed use pattern. Soybean seed for processing were obtained and samples were processed into hulls, meal, crude oil, refined oil, and soapstock.

Aspirated grain fractions were also collected. Analysis of the treated samples showed that residue of both TMS and PMG accumulated in hulls but did not accumulate in any other processed fractions. The proposed tolerance of 45 ppm (of which no more than 25 ppm is TMS) for soybean hulls and 1,300 ppm (of which no more than 720 ppm is TMS) for aspirated grain fractions will accommodate any residue resulting from the proposed use pattern. ii. Fruiting vegetables (except curcurbits) group.

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Residue data are available for sulfosate in a total of 12 trials in tomatoes conducted in 5 EPA regions and 5 different states; a total of 6 trials in bell peppers conducted in 5 EPA regions and 6 different States; and a total of 3 trials in chili peppers conducted in 3 EPA regions and 3 different States. The residue levels were below the limit of quantitation (LOQ) of 0.05 ppm in all samples. The proposed tolerance of 0.05 ppm will accommodate any residue resulting from the proposed use pattern. Tomato fruits for processing were obtained and samples were processed into puree and paste. After adjusting the results for the exaggerated rate, no concentration occurred in the puree and paste. No tolerances are required for puree and paste at the proposed use rates.

iii. Edible podded legume vegetables subgroup. Residue data are available for sulfosate in a total of 9 trials conducted in 5 different EPA regions and 8 different States representing 94% of the edible podded beans and peas in the U.S. The proposed tolerance of 0.5 ppm (of which no more than 0.3 ppm is TMS) for the Edible podded legume vegetables subgroup will accommodate any residue resulting from the proposed use pattern. iv. Succulent shelled pea and bean subgroup. Residue data are available for sulfosate in a total of 12 trials in 6 different EPA regions and 10 different States representing 97% of the green peas and lima beans in the United States.

The proposed tolerance of 0.2 ppm (of which no more than 0.1 ppm is TMS) for the Succulent shelled pea and bean subgroup will accommodate any residue resulting from the proposed use pattern. ] v. Dried shelled pea and bean (except soybean) subgroup. Residue data are available for sulfosate in a total of 14 trials conducted in 5 different EPA Regions and in 8 States representing 97% of dried pea and 96% of dried bean production in the United States. The proposed tolerance of 6 ppm (of which no more than 1.5 ppm is TMS) for the Dried shelled pea and bean (except soybean) subgroup will accommodate any residue resulting from the proposed use pattern.

vi. Magnitude of residue in animals--Ruminants. The maximum dietary burden in dairy cows results from a diet comprised of 20% aspirated grain fractions, 60% wheat forage, and 20% wheat hay for a total dietary burden of 409 ppm. The maximum dietary burden in beef cows results from a diet comprised of 20% aspirated grain fractions, 25% wheat forage, 25% wheat hay, 20% soybean hulls, and 10% soybean seed for a total dietary burden of 378 ppm. Comparison to a ruminant feeding study at a dosing level of 300 ppm indicates that the appropriate tolerance levels are 0.75 ppm in cattle, goat, hog, sheep, and horse liver; 3.5 ppm in cattle, goat, hog, sheep, and horse kidney; 2.5 ppm in cattle, goat, hog, sheep, and horse meat by-products, except kidney and liver; 0.6 ppm in cattle, goat, hog, sheep, and horse meat; 1.1 ppm in milk; and 0.2 ppm in cattle, goat, hog, sheep, and horse fat.

All of these tolerances exceed existing tolerances in 40 CFR vii. Poultry. The maximum dietary burden in poultry results from a diet comprised of 40% soybean meal, 20% soybean hulls, 20% soybean seed, and 20% wheat milled by-products for a total dietary burden of 24 ppm. Comparison to a poultry feeding study at a dosing level of 50 ppm indicates that the appropriate tolerance levels are below established tolerances for poultry meat, fat, and eggs. The appropriate tolerance for poultry liver is 0.1 ppm and for poultry meat by-products is 0.25 ppm.

B. Toxicological Profile 1. Acute toxicity. Several acute toxicology studies have been conducted placing technical grade sulfosate in Toxicity Category III and IV. 2. Genotoxicty. Mutagenicity data includes two Ames tests with Salmonella typhimurium; a sex linked recessive lethal test with Drosophila melanoga; a forward mutation (mouse lymphoma) test; an in vivo bone marrow cytogenetics test in rats; a micronucleus assay in mice; an in vitro chromosomal aberration test in Chinese hamster ovary cells (CHO) (no aberrations were observed either with or without S9 activation and there were no increases in sister chromatid exchanges); and a morphological transformation test in mice (all negative).

A chronic feeding/carcinogenicity study was conducted in male and female rats fed dose levels of 0, 100, 500 and 1,000 ppm (0, 4.2., 21.2 or 41.8 mg/kg/day in males and 0, 5.4, 27.0 or 55.7 mg/kg/day in females).

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No carcinogenic effects were observed under the conditions of the study. The systemic no-observable effect level (NOAEL) of 1,000 ppm ( mg/kg/day for males and females, respectively) was based on decreased body weight gains (considered secondary to reduced food consumption) and increased incidences of chronic laryngeal and nasopharyngeal inflammation (males). A chronic feeding/carcinogenicity study was conducted in male and female mice fed dosage levels of 0, 100, 1,000 and 8,000 ppm (0, 11.7, 118 or 991 mg/kg/day in males and 0, 16, 159 or 1,341 mg/kg/day in females). No carcinogenic effects were observed under the conditions of the study at dose levels up to and including the 8,000 ppm highest dose tested (HDT) which may have been excessive.

The systemic NOAEL was 1,000 ppm based on decreases in body weight and feed consumption (both sexes) and increased incidences of duodenal epithelial hyperplasia (females only). Sulfosate is classified as a Group E carcinogen based on no evidence of carcinogenicity in rat and mouse studies. 3.

Sustalife (Сусталифе) для суставов купить в Опочке

Reproductive and developmental toxicity. A developmental toxicity study in rats was conducted at doses of 0, 30, 100 and 333 mg/ kg/day. The maternal (systemic) NOAEL was 100 mg/kg/day, based on decreased body weight gain and food consumption, and clinical signs (salivation, chromorhinorrhea, and lethargy) seen at 333 mg/kg/day. The reproductive NOAEL was 100 mg/kg/day, based on decreased mean pup weight. The decreased pup weight is a direct result of the maternal toxicity. A developmental toxicity study was conducted in rabbits at doses of 0, 10, 40 and 100 mg/kg/day with developmental and maternal toxicity NOAELs of 40 mg/kg/day based on the following: (1) Maternal effects: 6 of 17 dams died (2 of the 4 non-gravid dams); 4 of 11 dams aborted; clinical signs - higher incidence and earlier onset of diarrhea, anorexia, decreased body weight gain and food consumption; and, (2) Fetal effects: decreased litter sizes due to increased post- implantation loss, seen at 100 mg/kg/day (HDT).

The fetal effects were clearly a result of significant maternal toxicity. A 2-generation reproduction study in rats fed dosage rates of 0, 150, 800 and 2,000 ppm (equivalent to calculated doses of 0, 7.5, 40, and 100 mg/kg/day for males and females, based on a conversion factor of 1 mg/kg-day = 20 ppm). The maternal (systemic) NOAEL was 150 ppm (7.5 mg/kg/day), based on decreases in body weight and body weight gains accompanied by decreased food consumption, and reduced absolute and sometimes relative organ (thymus, heart, kidney and liver) weights seen at 800 and 2,000 ppm (40 and 100 mg/kg/day). The reproductive NOAEL was 150 ppm (7.5 mg/ kg/day), based on decreased mean pup weights during lactation (after day 7) in the second litters at 800 ppm (40 mg/kg/day) and in all litters at 2,000 ppm (100 mg/kg/day), and decreased litter size in the F0a and F1b litters at 2,000 ppm (100 mg/kg/day).

The statistically significant decreases in pup weights at the 800 ppm level were borderline biologically significant because at no time were either the body weights or body weight gains less than 90% of the control values and because the effect was not apparent in all litters. Both the slight reductions in litter size at 2,000 ppm and the reductions in pup weights at 800 and 2,000 ppm appear to be secondary to the health of the dams. There was no evidence of altered intrauterine development, increased stillborns, or pup anomalies. The effects are a result of feed palatability leading to reduced food consumption and decreases in body weight gains in the dams. 4. Subchronic toxicity. Two sub-chronic 90-day feeding studies with dogs and a 1-year feeding study in dogs have been conducted.

In the 1- year study dogs were fed 0, 2, 10 or 50 mg/kg/day. The NOAEL was determined to be 10 mg/kg/day based on decreases in lactate dehydrogenase (LDH) at 50 mg/kg/day. In the first 90-day study, dogs were fed dosage levels of 0, 2, 10 and 50 mg/kg/day. The NOAEL in this study was 10 mg/kg/day based on transient salivation, and increased frequency and earlier onset of emesis in both sexes at 50 mg/kg/day. A second 90-day feeding study with dogs dosed at 0, 10, 25 and 50 mg/kg/ day was conducted to refine the threshold of effects. There was evidence of toxicity at the top dose of 50 mg/kg/day with a NOAEL of 25 mg/kg/day. Adverse effects from oral exposure to sulfosate occur at or above 50 mg/kg/day. These effects consist primarily of transient salivation, which is regarded as a pharmacological rather than toxicological effect, emesis and ] non-biologically significant hematological changes.

Exposures at or below 25 mg/kg/day have not resulted in significant biological adverse effects. In addition, a comparison of data from the 90-day and 1-year studies indicates that there is no evidence for increased toxicity with time. The overall NOAEL in the dog is 25 mg/kg/day. 5. Chronic toxicity.

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A chronic feeding/carcinogenicity study was conducted in male and female rats fed dose levels of 0, 100, 500 and 1,000 ppm (0, 4.2, 21.2 or 41.8 mg/kg/day in males and 0, 5.4, 27.0 or 55.7 mg/kg day in females). No carcinogenic effects were observed under the conditions of the study. The systemic NOAEL of 1,000 ppm ( mg/kg/day for males and females, respectively) was based on decreased body weight gains (considered secondary to reduced food consumption) and increased incidences of chronic laryngeal and nasopharyngeal inflammation (males).

A chronic feeding/carcinogenicity study was conducted in male and female mice fed dosage levels of 0, 100, 1,000 and 8,000 ppm (0, 11.7, 118 or 991 mg/kg/day in males and 0, 16, 159 or 1,341 mg/kg/day in females). No carcinogenic effects were observed under the conditions of the study at dose levels up to and including the 8,000 ppm HDT (highest dose may have been excessive). The systemic NOAEL was 1,000 ppm based on decreases in body weight and feed consumption (both sexes) and increased incidences of duodenal epithelial hyperplasia (females only).

Sulfosate is classified as a Group E carcinogen based on no evidence of carcinogenicity in rat and mouse studies. 6. Animal metabolism. The metabolism of sulfosate has been studied in animals. The residues of concern for sulfosate in meat, milk, and eggs are the parent ions PMG and TMS only. 7. Metabolite toxicology. There are no metabolites of toxicological concern. Only the parent ions, PMG and TMS are of toxicological concern. 8. Endocrine disruption. Current data suggest that sulfosate is not an endocrine disruptor. C. Aggregate Exposure 1. Dietary exposure.--i.

Food. For the purposes of assessing the potential dietary exposure, Zeneca has utilized the tolerance level for all existing and pending tolerances; and the proposed maximum permissible levels of 0.05 ppm for the fruiting vegetables (except cucurbits) group; 0.5 ppm for the edible-podded legume vegetables subgroup; 0.2 ppm for the succulent shelled pea and bean subgroup; 6 ppm for the dried shelled pea and bean (except soybean) subgroup; 3.5 ppm for cattle, goat, hog, sheep, and horse kidney; 2.5 ppm for cattle, goat, hog, sheep, and horse meat by-products, except liver and kidney; 0.6 ppm for cattle, goat, hog, sheep, and horse meat; 0.75 ppm for cattle, goat, hog, sheep, and horse liver; 1.1 ppm for milk; 0.1 ppm for poultry liver; 0.25 ppm for poultry meat by-products; 21 ppm for soybean seed; 45 ppm for soybean hulls; 1300 ppm for aspirated grain fractions; and 100% crop treated acreage for all commodities.

Assuming that 100% of foods, meat, eggs, and milk products will contain sulfosate residues and those residues will be at the level of the tolerance results in an overestimate of human exposure. This is a very conservative approach to exposure assessment. ii. Chronic exposure. For all existing tolerances and pending tolerances; and the proposed maximum permissible levels proposed in this notice of filing, the potential exposure for the U.S. population is 0.018 mg/kg bwt/day (7.4% of RfD). Potential exposure for children's population subgroups range from 0.015 mg/kg bwt/day (6.1% of RfD) for nursing infants (<1 year old) to 0.076 mg/kg bwt/day (30.5%) for non- nursing infants.

The chronic dietary risk due to food does not exceed the level of concern (100%) Acute exposure. The exposure to the most sensitive population subgroup, in this instance non-nursing infants, was 23.2% of the acute RfD. The acute dietary risk due to food does not exceed the level of concern (100%). iii. Drinking water. Results from computer modeling indicate that sulfosate in groundwater will not contribute significant residues in drinking water as a result of sulfosate use at the recommended maximum annual application rate (4.00 lbs. a.i. acre -1).

The computer model uses conservative numbers, therefore it is unlikely that groundwater concentrations would exceed the estimated concentration of parts per billion (ppb), and sulfosate should not pose a threat to ground water. The surface water estimates are based on an exposure modeling procedure called Generic Expected Environmental Concentration (GENEEC). The assumptions of 1 application of 4.00 lbs. a.i. acre -1 resulted in calculated estimated maximum concentrations of 64 ppb (acute, based on the highest 56-day value) and 43 ppb (chronic, average). GENEEC modeling procedures assumed that sulfosate was applied to a 10-hectare field that drained into a 1-hectare pond, 2-meters deep with no outlet.

As a conservative assumption, because sulfosate residues in ground water are expected to be insignificant compared to surface water, it has been assumed that 100% of drinking water consumed was derived from surface water in all drinking water exposure and risk calculations. To calculate the maximum acceptable acute and chronic exposures to sulfosate in drinking water, the dietary food exposure (acute or chronic) was subtracted from the appropriate (acute or chronic) RfD. Drinking water levels of concern (DWLOCs) were then calculated using the maximum acceptable acute or chronic exposure, default body weights (70 kg - adult, 10 kg - child), and drinking water consumption figures (2 liters - adult, 1 liter - child). The maximum concentration of sulfosate in surface water is 64 ppb.

The acute DWLOCs for sulfosate in surface water were all greater than 7,700 ppb. The estimated average concentration of sulfosate in surface water is 43 ppb which is much less than the calculated levels of concern (> 1,700 ppb) in drinking water as a contribution to chronic aggregate exposure. Therefore, for current and proposed uses of sulfosate, Zeneca concludes with reasonable certainty that residues of sulfosate in drinking water would not result in unacceptable levels of aggregate human health risk. 2.

Non-dietary exposure. Sulfosate is currently not registered for use on any residential non-food sites. Therefore, residential exposure to sulfosate residues will be through dietary exposure only. D. Cumulative Effects There is no information to indicate that toxic effects produced by sulfosate are cumulative with those of any other chemical compound. E. Safety Determination 1. U.S. population--i. Acute risk. Since there are no residential uses for sulfosate, the acute aggregate exposure only includes food and water. Using the conservative assumptions of 100% of all crops treated and assuming all residues are at the tolerance level for all established and proposed tolerances, the aggregate exposure to sulfosate will utilize 17.3% of the acute RfD for the U.S.

population. The estimated peak concentrations of sulfosate in surface and ground water are less than DWLOCs for sulfosate in drinking water as a contribution to acute aggregate exposure. Residues of sulfosate in drinking water do not contribute significantly to the aggregate acute human health risk considering the ] present uses and uses proposed in this action. ii. Chronic risk. Using the conservative exposure assumptions described above, the aggregate exposure to sulfosate from food will utilize 7.4% of the chronic RfD for the U.S. population. The estimated average concentrations of sulfosate in surface and ground water are less than DWLOCs for sulfosate in drinking water as a contribution to chronic aggregate exposure.

Residues of sulfosate in drinking water do not contribute significantly to the aggregate chronic human health risk considering the present uses and uses proposed in this action. 2. Infants and children. The database on sulfosate relative to pre- and post-natal toxicity is complete. Because the developmental and reproductive effects occurred in the presence of parental (systemic) toxicity, these data do not suggest an increased pre- or post-natal sensitivity of children and infants to sulfosate exposure. Therefore, Zeneca concludes, upon the basis of reliable data, that a 100-fold uncertainty factor is adequate to protect the safety of infants and children and an additional safety factor is unwarranted. i. Acute risk.

Using the conservative exposure assumptions described above, the aggregate exposure to sulfosate from food will utilize 23.2% of the acute RfD for the most highly exposed group, non- nursing infants. The estimated peak concentrations of sulfosate in surface and ground water are less than DWLOCs for sulfosate in drinking water as a contribution to acute aggregate exposure. Residues of sulfosate in drinking water do not contribute significantly to the aggregate acute human health risk considering the present uses and uses proposed in this action. ii. Chronic risk. Using the conservative exposure assumptions described above, we conclude that the percent of the RfD that will be utilized by aggregate exposure to residues of sulfosate is 30.5% for non-nursing infants, the most highly exposed group.

The estimated average concentrations of sulfosate in surface and ground water are less than DWLOCs for sulfosate in drinking water as a contribution to chronic aggregate exposure. Residues of sulfosate in drinking water do not contribute significantly to the aggregate chronic human health risk considering the present uses and uses proposed in this action. F. International Tolerances There are no Codex Maximum Residue Levels established for sulfosate. BILLING CODE 6560-50-F

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