Pesticide tolerance. FINAL RULE. EPA, on its own initiative, establishes a time-limited tolerance for diflubenzuron and its metabolites p-chlorophenylurea and p- chloroaniline in or on lemon at 0.8 ppm. This action is in response to EPA's granting of an emergency exemption under section 18 of the Federal Insecticide, Fungicide, and Rodenticide Act authorizing use of the pesticide on lemon. This regulation establishes a maximum permissible level for combined residues of diflubenzuron and its metabolites p-chlorophenylurea and p-chloroaniline, in this food commodity expressed in terms of the combined residues of diflubenzuron and its metabolites CPU and PCA. The tolerance expires and is revoked on December 31, 2010.

Document available with this final rule: Diflubenzuron. Human Health Risk Assessment for the Proposed Establishment of an Emergency Exemption Tolerance for Use in/on Lemons. April 16, 2007. Docket ID: EPA-HQ-OPP-2007-0446-0002. Excerpt:

(page 6): In subchronic and chronic feeding studies, the primary endpoint of concern, produced most likely by PCA, was methemoglobinemia and/or sulfhemoglobinemia. These effects were evident in both sexes of mice, rats, and dogs and were produced by more than one route of administration in rats [i.e., oral, dermal and inhalation]. The general consequence of methemoglobinemia and/or sulfhemoglobinemia is the impairment of the oxygen transportation capacity of the blood, which is generally known to be caused by aromatic amines in both humans and animals.

Cancer. The Agency has classified diflubenzuron as ``Group E,'' evidence of non-carcinogenicity for humans, based on lack of evidence of carcinogenicity in rats and mice. There are also two metabolites of diflubenzuron; PCA and CPU. PCA tested positive for splenic tumors in male rats and hepatocellular adenomas/carcinomas in male mice in a National Toxicology Program (NTP) study. Therefore, EPA classified PCA as a ``Group B2'' probable human carcinogen. The Agency determined for those commodities that contained PCA and CPU, the Q1* of PCA should be used to calculate the cancer risk from the sum of these two metabolites.
Based on the submitted metabolism studies, there are two possible sources for dietary exposure to PCA and CPU: Residues in mushrooms and residues in milk and liver. Because human exposure to PCA and CPU will not be affected by the proposed new uses, and EPA has previously concluded that exposure to these compounds is safe, therefore, the cancer dietary risk from PCA and CPU will not be addressed in this document. For a detailed discussion on the exposure and risks to PCA and CPU, please refer to the September, 2002 Federal Register document titled Diflubenzuron; Pesticide Tolerances (September 19, 2002, FR 67 59006).

IR-4. Pesticide tolerance. Final Rule.
Tolerances are established for combined residues of diflubenzuron, (N-[[(4-chlorophenyl)amino]carbonyl]-2,6-
difluorobenzamide and its metabolites 4-chlorophenylurea and 4-chloroaniline in or on the raw agricultural commodities

Barley, grain at 0.06 ppm
Barley, hay at 3.0 ppm
Barley, straw at 1.8 ppm

Brassica, leafy greens, subgroup 5B at 9.0 ppm

This subgroup includes 10 commodities: broccoli • broccoli, cavalo • broccoli, chinese • brussels sprout • cabbage • cabbage, chinese mustard • cabbage, chinese napa • cauliflower • cavalo broccolo • kohlrabi

Grain, aspirated fractions at 11 ppm
Oat, forage at 7.0 ppm
Oat, grain at 0.06 ppm
Oat, hay at 6.0 ppm
Oat, straw at 3.5 ppm
Peanut at 0.10 ppm
Peanut, hay at 55 ppm
Peanut, refined oil at 0.20 ppm
Pummelo at 0.50 ppm
Turnip greens at 9.0 ppm
Wheat, forage at 7.0 ppm
Wheat, grain at 0.06 ppm
Wheat, hay at 6.0 ppm
Wheat, straw at 3.5 ppm

Request for Public Comment on Proposed Stipulated Injunction Involving 66 Pesticides and the California Red-legged Frog.
Center for Biological Diversity
vs
EPA

IR-4. Pesticide petitions: 5E6965, 5E6966, and 5E6967.
Diflubenzuron and metabolites convertible to p-chloroaniline.

PP 5E6965 proposes to establish tolerances for
-- barley, grain; oat, grain; and wheat, grain at 0.06 ppm
-- barley, forage; oat, forage; and wheat, forage at 5.0 ppm
-- barley, hay; oat, hay; and wheat, hay at 2.0 ppm
-- barley, straw; oat, straw; and wheat, straw at 2.0 ppm
-- barley, aspirated barley fractions at 3.0 ppm
-- oat, aspirated oat fractions at 3.0 ppm
-- wheat, aspirated wheat fractions at 3.0 ppm
-- pummelo at 0.5 ppm.

PP 5E6966 proposes to establish tolerances for
-- brassica, leafy greens subgroup 5B; turnip at 8.0 ppm

This subgroup includes 8 commodities.
broccoli raab • cabbage, chinese bok choy • collards • kale • mizuna • mustard greens • mustard spinach • rape greens

-- eggplant at 1.0 ppm
-- okra at 1.0 ppm.

PP 5E6967 proposes to establish a tolerance for
-- peanut at 0.2 ppm.

Extension of Tolerances for Emergency Exemptions. FINAL RULE.

EPA has authorized under FIFRA section 18 the use of diflubenzuron on wheat and barley for control of grasshoppers in Montana, Washington, and Idaho. This regulation extends time-limited tolerances for combined residues of the insecticide diflubenzuron and its metabolites 4-chlorophenlyurea and 4-chloroaniline (CPU) and (PCA) in or on wheat and barley grain at 0.05 ppm, wheat and barley straw at 0.50 ppm, wheat and barley hay at 1.0 ppm, wheat milled byproducts at 0.10 ppm, and aspirated grain fractions at 30 ppm for an additional 3-year period. These tolerances will expire and are revoked on December 31, 2008. Time-limited tolerances were originally published in the Federal Register of August 27, 2003.

Pesticide Emergency Exemptions:

• Montana. EPA authorized the use of diflubenzuron on barley and wheat to control grasshoppers; June 22, 2005 to July 15, 2005. Contact: (Libby Pemberton).
• Nevada. EPA authorized the use of diflubenzuron on alfalfa to control Mormon cricket and grasshopper; June 3, 2005 to October 31, 2005. Contact: (Libby Pemberton).
• Utah. Specific: EPA authorized the use of diflubenzuron on alfalfa to control Mormon cricket and grasshopper; June 8, 2005 to October 31, 2005. Contact: (Libby Pemberton).
• Wyoming. Specific: EPA authorized the use of diflubenzuron on alfalfa to control Mormon cricket and grasshoppers; June 23, 2005 to October 31, 2005. Contact: (Libby Pemberton).

Cancellation of Pesticides for Non-payment of Year 2005 Registration Maintenance Fees.

Seven Pesticide Emergency Exemptions.
• Idaho
--- Crisis: On May 3, 2004, for the use of diflubenzuron on alfalfa to control Mormon cricket and grasshoppers. This program is expected to end on October 31, 2004. Contact: (Libby Pemberton)
--- On June 8, 2004, for the use of diflubenzuron on barley and wheat to control Mormon cricket and grasshoppers. This program ended on July 14, 2004. Contact: (Libby Pemberton)
• Montana
--- Crisis: On May 20, 2004, for the use of diflubenzuron on alfalfa to control grasshoppers. This program is expected to end on September 30, 2004. Contact: (Libby Pemberton)
--- EPA authorized the use of diflubenzuron on wheat and barley to control grasshoppers and Morom crickets; April 16, 2004 to July 15, 2004. Contact: (Barbara Madden)
• Nevada - Specific: EPA authorized the use of diflubenzuron on alfalfa to control grasshoppers and Mormon crickets; April 16, 2004 to October 31, 2004. Contact: (Barbara Madden)
• North Dakota - EPA authorized the use of diflubenzuron on wheat and barley to control various grasshopper species; June 30, 2004 to July 15, 2004. Contact: (Libby Pemberton)
• Washington - Crisis: On June 3, 2004, for the use of diflubenzuron on barley and wheat to control Mormon cricket and grasshoppers. This program ended on July 14, 2004. Contact: (Libby Pemberton)

Pesticide Emergency Exemptions.
Utah - EPA authorized the use of diflubenzuron on alfalfa hay to control
grasshoppers and Mormon crickets; May 1, 2004 to October 31, 2004.

Availability of Court Orders in Washington Toxics Coalition v. EPA Litigation. The Order (with some exceptions) enjoins, vacates and sets aside EPA's authorization of certain pesticides' uses within 20 yards for ground applications and 100 yards for aerial applications, adjacent to salmon supporting waters in California, Oregon and Washington, effectively establishing buffer zones around those waters. This order applies to 38 pesticides, including the fluoridated
Diflubenzuron, Oxyfluorfen, Trifluralin.
The Court's January 22 Order, which carries an effective date of February 5, 2004, and other related materials, including the Court's previous Orders, are available at:
January 22, 2004
August 8, 2003
July 16, 2003
July 2, 2002

Pesticide Tolerances for Emergency Exemptions. The requesting States (Idaho, Montana, and Washington) are experiencing severe outbreaks of grasshoppers in their wheat and barley fields this year. In most areas, densities of grasshoppers have reached 40 or more per square yard, and without the use of diflubenzuron, the Applicants estimate that yield could drop by 50%, resulting in severe crop devastation and significant economic impact to wheat and barley producers in these States.
-- Refer also to the September 19, 2002 Federal Register [see below] document for a detailed discussion of the aggregate risk assessments and determination of safety. EPA relies in part upon that risk assessment and the findings made in that Federal Register document in support of this action.
-- EPA has received objections to a separate tolerance-setting involving the use of diflubenzuron on pears. These objections were filed by the Natural Resources Defense Council (NRDC) and raised several issues regarding aggregate exposure estimates and the additional safety factor for the protection of infants and children. Although that proceeding remains ongoing, EPA has considered whether it is appropriate to establish the emergency exemption tolerances for diflubenzuron on wheat and barley commodities while the objections are still pending... First, the objections proceeding is unlikely to conclude prior to when action is necessary on this petition. [NRDC's objections raise complex legal, scientific, policy, and factual matters and EPA initiated a 60 day public comment period on them in the Federal Register on June 19, 2002 (67 FR 41628) (FRL-7167-7). Moreover, NRDC itself submitted further information to the Agency in June 2003, and the Agency is in the process of evaluating that information as well. Second, the nature of the current actions are extremely time-sensitive as they address emergency situations. Third, the issues raised by NRDC are not new matters but questions that already have been the subject of considerable evaluation by EPA and comment by stakeholders. Accordingly, EPA is proceeding with establishing these tolerances for diflubenzuron.
-- Conditions One application per growing season may be made of the pesticide, diflubenzuron, to wheat and barley, at a rate of 2.0 fl. oz. product (0.44 fl. oz. of active ingredient) per acre. Applications may be made by ground or aerial equipment. A preharvest interval of 45 days must be observed, and all label directions on the federally registered label, as well as the section 18 use directions must be followed.

EPA approved the use of Diflubenzuron for 2 Emergency Exemptions.

-- Utah: Crisis: On May 14, 2002, for the use of diflubenzuron on alfalfa to control grasshoppers and crickets. This program ended on October 31, 2002.
-- Utah: Specific: EPA authorized the use of diflubenzuron on alfalfa to control grasshoppers and crickets; September 13, 2002 to October 31, 2002.

Pesticide Tolerances for Emergency Exemption. Final Rule. For residue tolerances in or on alfalfa, forage and alfalfa, hay at 6.0 ppm. These tolerances will expire and are revoked on June 30, 2004.
-- The Applicant (Utah Department of Agriculture and Food) states that diflubenzuron is the only pesticide that has been proven effective for full-season control of grasshopper and cricket outbreaks. Diflubenzuron has a longer period of residual activity than the registered alternatives... The Applicant asserts that the registered alternative have very short residual activity and/or are prohibitively expensive for use in this situation. Significant economic losses were expected to occur this year for alfalfa producers, without the use of diflubenzuron to control these pests.
-- No alfalfa residue data were submitted for this request... Since alfalfa is not consumed by humans, any exposure to residues of diflubenzuron from this emergency exemption use will result from the consumption of meat or milk. The use of diflubenzuron in alfalfa is not expected to result in exceedances of the tolerances that already exist for meat and milk. Therefore, establishing the alfalfa tolerances will not increase the most recent estimated aggregate risks resulting from the use of diflubenzuron, as discussed in the Federal Register for February 15, 2002 - EPA relies upon that risk assessment and the findings made in the Federal Register document in support of this action.
-- Although diflubenzuron itself is not classified as a carcinogen, two of its metabolites, PCA (p- chloroaniline) and CPU (p-chlorophenylurea) are probable human carcinogens and have been assigned Q1*s. Since these degradates are found in mushrooms, milk, and liver, as a result of diflubenzuron use, EPA has concluded that the residues of concern are diflubenzuron and its metabolites PCA and CPU.
-- Recently, EPA has received objections to a tolerance it established for diflubenzuron on a different food commodity. The objections were filed by the Natural Resources Defense Council and raised several issues regarding aggregate exposure estimates and the additional safety factor for the protection of infants and children. Although these objections concern separate rulemaking proceedings under the FFDCA, EPA has considered whether it is appropriate to establish the emergency exemption tolerances for diflubenzuron while the objections are still pending... EPA is proceeding with establishing these tolerances for diflubenzuron.

IR-4 and Uniroyal. Pesticide Tolerances. FINAL RULE for residues of the insecticide diflubenzuron (N-[[4-chlorophenyl)amino]-carbonyl]-2,6- difluorobenzamide) and its metabolites, 4-chlorophenylurea (CPU) and 4- chloroaniline (PCA) on

-- 90-Day oral toxicity rodents: NOAEL < 8 mg/kg/day; LOAEL = 8 mg/kg/day based on increased methemoglobinemia, and signs of hemolytic anemia, erythrocyte destruction in the spleen and liver and regeneration of erythrocytes in the bone marrow.
-- 90-Day oral toxicity in nonrodents: NOAEL = 2 mg/kg/day nonrodents LOAEL = 6.24 mg/kg/day based on methemoglobinemia.
--21/28-Day dermal toxicity NOAEL = 500 mg/kg/day LOAEL = 1,000 mg/kg/day based on methemoglobinemia (limit dose).
-- Reproduction and fertility effects: Parental/Systemic NOAEL < 36 mg/kg/day (LDT) LOAEL = 36 mg/kg/day based on dose-related decreased hematocrit, hemoglobin concentration, red blood cell count and an increase in percent methemoglobin, changes in cell morphology and brown pigment in Kupffer cells.
-- Chronic toxicity dogs NOAEL = 2 mg/kg/day LOAEL = 10 mg/kg/day based on methemoglobinemia and sulfhemoglobinemia.
-- Carcinogenicity rats NOAEL was not established LOAEL = 7.8 mg/kg/day based on histological evidence of erythrocyte destruction and compensatory regeneration. No evidence of carcinogenicity.
-- EPA does not have available information on the regional consumption of food to which diflubenzuron may be applied in a particular area.
-- EPA determined that the 10X safety factor to protect infants and children (as required by FQPA) should be removed.
-- Conditions Environmental fate. Edge of field monitoring study for peppers.

Objections submitted by the Natural Resource Defense Council (N÷RDC) to five final pesticide tolerances. One was for Diflubenzuron which was published in the FR on February 15, 2002. NRDC stated:
-- EPA failed to include an additional 10X safety factor for infants and children as required by the FQPA. Under the FQPA's precautionary approach to protecting children, EPA must maintain an additional 10-fold margin of safety in its risk assessments for individual pesticides to ``take into account potential pre-natal and post-natal developmental toxicity and completeness of the data with respect to exposure and toxicity to infants and children.'' 21 U.S.C. 346a(b)(2)(C). EPA can use a different margin of safety ``only if, on the basis of reliable data, such margin will be safe for infants and children.'' Id. Yet there are significant toxicity and exposure data gaps for each of these new tolerances established by EPA...
-- EPA lacks reliable data to overturn the presumption of a 10X FQPA safety factor for any of the five pesticides addressed in these objections. Where there are no data or where there are gaps in data--either for particular toxic effects, for specific patterns of food consumption, or for particular routes of exposure--there cannot be the ``reliable data'' required by the FQPA to remove 10X.
-- Data gaps include missing residue chemistry and toxicology data for two diflubenzuron metabolites, deemed necessary by EPA to justify an unconditional registration.
-- In addition to the above data gaps, for all five pesticides EPA has failed to collect pesticide-specific data on water-based exposure, rendering it impossible to find that ``reliable data'' exist to reduce the tenfold safety factor.
-- EPA cites no provision of the statute or any other authority to support its repeated incantation that aggregate exposure does not include occupational exposure... The statute's provision stating that EPA ``shall consider, among other relevant factors... available information concerning the aggregate exposure from other non-occupational sources'' does not justify ignoring farmworkers' exposure in setting tolerances... Clearly farmworkers are a high risk population deserving of careful consideration and protection 12-23. EPA's failure to consider worker risks in establishing these tolerances violates the FQPA's mandate that aggregate exposure assessments include allexposures for which there is reliable information.
-- none of the regulations establishing tolerances for these five pesticides consider exposure through air drift, migration of contaminated soil, or residential take-home exposures.
-- For all five pesticides, EPA incorrectly concluded that the new tolerances would not result in any increased residential exposure because the tolerances themselves were not for residential uses... This ignores reliable data concerning take-home exposure resulting from agricultural uses 9, 24. NRDC's 1998 report, Trouble on the Farm, documents the scientific evidence supporting the potential for take-home exposures from pesticides, even when not registered for residential use. See NRDC, Trouble on the Farm: Growing up with Pesticides in Agricultural Communities, 1998. As many as a dozen different pesticide residues have been found in household dust in some homes, including agricultural insecticides and herbicides not registered for use in the home.
-- Diflubenzuron is registered for use on outdoor residential and recreational areas. 67 FR 7089 (Feb.15, 2002). But EPA wrongly chose not to evaluate exposure through these uses because diflubenzuron ``is only applied to the tree canopy.'' Id. The above deficiencies reveal that EPA improperly underestimated aggregate exposure to these pesticides and their residues that may occur from dietary, residential, and all other known or plausible exposure routes. The assumptions and missing data in EPA's analysis of aggregate exposure for these five pesticides systematically serve to underestimate exposure and therefore underestimate risk, contrary to the requirements of the FQPA.
-- To assess chronic dietary exposure, EPA relied on estimates of ``anticipated residues'' for diflubenzuron. In doing so, EPA failed to account for the dietary exposure of a significant number of consumers who purchase produce at farmers markets, farm stands, and ``U-Pick'' farming operations. Over 1.9 million people buy vegetables and fruits from nearly 13,000 farmers, at more than 2,000 community-based farmers markets and farm stands in the United States. See National Association of Farmers' Market Nutrition Programs (http://www.nafmnp.org/)... These consumers include pregnant women, infants, and children, and must be protected. By ignoring this significant community of consumers, EPA vastly underestimates dietary exposure and cannot ensure that exposure to residues of diflubenzuron at the tolerance level will be safe. Reliance on 21 U.S.C. 346a(b)(2)(E) to factor in anticipated residues of diflubenzuron does not justify ignoring the known dietary exposure of potentially millions of consumers to residues of these pesticides at the tolerance level. EPA must ensure that the legal level of pesticide chemical residue--the established tolerance levels--are themselves safe.

IR-4 and UNIROYAL - Pesticide tolerance in or on Pear at 0.50 ppm. - FINAL RULE. EPA classifies Diflubenzuron as a``Group B2'' probably human carcinogen -tested positive for splenic tumors in male rats and heptocellular adenomas/carcinomas in male mice in a National Toxicology Program (NTP) study. There are several data gaps for assessing diflubenzuron's adverse impact on human health:

1. "EPA does not have, at this time, available data to determine whether diflubenzuron 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, diflubenzuron does not appear to produce a toxic metabolite produced by other substances."

2. EPA is not requiring a developmental neurotoxicity study.

3. "An acute risk assessment was not performed because an acute dietary endpoint was not identified and therefore, diflubenzuron is not expected to pose an acute risk."

4. Cancer aggregate risk assessments were not performed.

5. Short-term and intermediate-term risk assessments were not performed since an acute dietary endpoint was not identified and there are no registered or proposed non-food uses resulting in significant residential exposure.

• IR-4 and UNIROYAL - Three Pesticide Petitions (PP):
• PP 0E6167 proposes the establishment of a tolerance for pear at 0.5 ppm.
• PP 1E6347 proposes the establishment of a tolerance for the grass, forage, fodder, and hay group at 6.0 ppm.
• PP 1F6235 proposes the establishment of tolerances for stonefruit (except cherries) at 0.05 ppm, tree nuts and pistachios at 0.05 ppm, almond hulls at 5.0 ppm, peppers at 1.0 ppm, and meat-by- products at 0.15 ppm.
• Comments, identified by docket control number PF-1060, must be received on or before January 14, 2002

• Public Report on Minor Use Pesticides; Notice of Availability.
• "Minor uses of pesticides are those for which the total U.S.acreage for a particular crop is less than 300,000 acres or those for which the use does not provide sufficient economic incentive to support its registration." - see Report cited in the Federal Register which includes the following fluorinated pesticides:
• Bifenthrin Insecticide (Trade names Capture,Brigade,Talstar,Biflex)
• Diflubenzuron Insect Growth Regulator Insecticide (Trade name Dimilin)
• Fludioxonil Fungicide (Trade names Maxim,Medallion)

UNIROYAL -Request to Voluntarily Cancel pesticide registration for Dimilin 21.

UNIROYAL - Request to Voluntarily Cancel Dimilin W-25.

UNIROYAL - Pesticide Tolerances for residues of the insecticide and its metabolites in or on rice grain at 0.02 ppm and rice straw at 0.8 ppm. - FINAL RULE.

UNIROYAL - Temporary Pesticide Tolerance for residues in or on rice grain at 0.01 ppm. - FINAL RULE.

UNIROYAL - Petition for Pesticide Tolerance for residues in or on rice at 0.02 ppm and rice straw at 0.8 ppm.

UNIROYAL - Petition to Voluntarily Cancel the product Dimilin - 2F.

IR-4* - Petition for Pesticide Tolerance for residues in or on artichokes at 6 ppm. - FINAL RULE.

IR-4* - Petition for Proposed Pesticide Tolerance for residues in or on the raw agricultural commodity artichokes at 6.0 ppm.

SOLVAY DUPHAR - Petition; Pesticide Tolerances for residues in or on the raw agricultural commodities orange, grapefruit, and tangerine at 0.05 ppm. - FINAL RULE. Thompson-Hayward Chemical Co. requested this regulation to establish maximum permissible levels, published in the Federal Register of June 22, 1981 (46 FR 32313). They assigned all data rights and obligations connected to diflubenzuron to Duphar B. V. of Amsterdam, Holland. Since then, Duphar B.V. has merged with Solvay and is now known as Solvay Duphar.

Federal Register 47:32535-32536 - TOLERANCES AND EXEMPTIONS FROM TOLERANCES FOR PESTICIDE CHEMICALS IN OR ON RAW AGRICULTURAL COMMODITIES: DIFLUBENZURON