Pesticides; tolerances in food, animal feeds, and raw agricultural commodities: Diuron,

[Federal Register: July 30, 1999 (Volume 64, Number 146)]

[Rules and Regulations]

[Page 41297-41305]

From the Federal Register Online via GPO Access [wais.access.gpo.gov]

[DOCID:fr30jy99-13]

ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[OPP-300881; FRL 6087-2]

RIN 2070-AB78

Diuron; Pesticide Tolerances for Emergency Exemptions

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

SUMMARY: This regulation establishes a time-limited tolerance for combined residues of diuron in or on catfish. 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 in catfish ponds. This regulation establishes a maximum permissible level for residues of diuron in this food commodity pursuant to section 408(l)(6) of the Federal Food, Drug, and Cosmetic Act, as amended by the Food Quality Protection Act of 1996. The tolerance will expire and is revoked on June 30, 2001.

DATES: This regulation is effective July 30, 1999. Objections and requests for hearings must be received by EPA on or before September 28, 1999.

ADDRESSES: Written objections and hearing requests, identified by the docket control number [OPP-300881], must be submitted to: Hearing Clerk (1900), Environmental Protection Agency, Rm. M3708, 401 M St., SW., Washington, DC 20460. Fees accompanying objections and hearing requests shall be labeled ``Tolerance Petition Fees'' and forwarded to: EPA Headquarters Accounting Operations Branch, OPP (Tolerance Fees), P.O. Box 360277M, Pittsburgh, PA 15251. A copy of any objections and hearing requests filedwith the Hearing Clerk identified by the docket control number, [OPP-300881], must also be submitted to: Public Information and Records Integrity Branch, Information Resources and Services Division (7502C), Office of Pesticide Programs, Environmental Protection Agency, 401 M St., SW., Washington, DC 20460. In person, bring a copy of objections and hearing requests to Rm. 119, Crystal Mall #2, 1921 Jefferson Davis Hwy., Arlington, VA.

A copy of objections and hearing requests filedwith the Hearing Clerk may also be submitted electronically by sending electronic mail (e-mail) to: opp-docket@epa.gov. Copies of electronic objections and hearing requests must be submitted as an ASCII file avoiding the use of special characters and any form of encryption. Copies of objections and hearing requests will also be accepted on disks in WordPerfect 5.1/6.1 or ASCII file format. All copies of electronic objections and hearing requests must be identified by the docket control number [OPP-300881]. No Confidential Business Information (CBI) should be submitted through e-mail. Copies of electronic objections and hearing requests on this rule may be filedonline at many Federal Depository Libraries.

FOR FURTHER INFORMATION CONTACT: By mail: David Deegan, Registration Division (7505C), Office of Pesticide Programs, Environmental Protection Agency, 401 M St., SW., Washington, DC 20460. Office location, telephone number, and e-mail address: Rm. 286, Crystal Mall #2, 1921 Jefferson Davis Hwy., Arlington, VA, 703-308-9358; e-mail: deegan.dave@epa.gov.

SUPPLEMENTARY INFORMATION: EPA, on its own initiative, pursuant to sections 408(l)(6) of the Federal Food, Drug, and Cosmetic Act (FFDCA), 21 U.S.C. 346a, is establishing a tolerance for combined residues of the herbicide diuron and its metabolites, convertible to 3,4- dichloroaniline in or on catfish at 2.0 parts per million (ppm). This tolerance will expire and is revoked on June 30, 2001. EPA will publish a document in the Federal Register to remove the revoked tolerance from the Code of Federal Regulations.

1. Background and Statutory Findings

   The Food Quality Protection Act of 1996 (FQPA)(Public Law 104-170) was signed into law August 3, 1996. FQPA amends both the Federal Food, Drug, and Cosmetic Act (FFDCA), 21 U.S.C. 301 et seq., and the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA), 7 U.S.C. 136 et seq. The FQPA amendments went into effect immediately. Among other things, FQPA amends FFDCA to bring all EPA pesticide tolerance-setting activities under a new section 408 with a new safety standard and new procedures. These activities are described in this preamble and discussed in greater detail in the final rule establishing the time- limited tolerance associated with the emergency exemption for use of propiconazole on sorghum (61 FR 58135, November 13, 1996) (FRL-5572-9).

   New 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. . . .''

   Section 18 of FIFRA authorizes EPA to exempt any Federal or State agency from any provision of FIFRA, if EPA determines that ``emergency conditions exist which require such exemption.'' This provision was not amended by FQPA. EPA has established regulations governing such emergency exemptions in 40 CFR part 166.

   Section 408(l)(6) of the FFDCA requires EPA to establish a time- limited tolerance or exemption from the requirement for a tolerance for pesticide chemical residues in food that will result from the use of a pesticide under an emergency exemption granted by EPA under section 18 of FIFRA. Such tolerances can be established without providing notice or period for public comment.

   [[Page 41298]]

   Because decisions on section 18-related tolerances must proceed before EPA reaches closure on several policy issues relating to interpretation and implementation of the FQPA, EPA does not intend for its actions on such tolerances to set binding precedents for the application of section 408 and the new safety standard to other tolerances and exemptions.

2. Emergency Exemption for Diuron on Catfish and FFDCA Tolerances

   EPA has authorized, under FIFRA section 18, the use of diuron in and on catfish ponds for control of algae in Mississippi, Louisiana, and Arkansas. After having reviewed the submissions, EPA concurs that emergency conditions exist in these States. The three applicants requested use of diuron in catfish ponds to control unwanted growth of blue-green algae. The rapid spread of the blue-green algae makes it a secondary food source--albeit undesirable--for the catfish. If algae is present in the ponds, the catfish consume large quantities of it, resulting in an undesirable flavor in the catfish fillet, when the fish are harvested and eaten. Fish with this off flavor are less marketable for producers.

   As part of its assessment of this emergency exemption, EPA assessed the potential risks presented by residues of diuron in or on catfish. In doing so, EPA considered the safety standard in FFDCA section 408(b)(2), and EPA decided that the necessary tolerance under FFDCA section 408(l)(6) would be consistent with the safety standard and with FIFRA section 18. Consistent with the need to move quickly on the emergency exemption in order to address an urgent non-routine situation and to ensure that the resulting food is safe and lawful, EPA is issuing this tolerance without notice and opportunity for public comment under section 408(e), as provided in section 408(l)(6). Although this tolerance will expire and is revoked on June 30, 2001, under FFDCA section 408(l)(5), residues of the pesticide not in excess of the amounts specified in the tolerance remaining in or on catfish after that date will not be unlawful, provided the pesticide is applied in a manner that was lawful under FIFRA, and the residues do not exceed a level that was authorized by this tolerance at the time of that application. EPA will take action to revoke this tolerance earlier if any experience with, scientific data on, or other relevant information on this pesticide indicate that the residues are not safe.

   Because this tolerance is being approved under emergency conditions, EPA has not made any decisions about whether diuron meets EPA's registration requirements for use on catfish or whether a permanent tolerance for this use would be appropriate. Under these circumstances, EPA does not believe that this tolerance serves as a basis for registration of diuron by a State for special local needs under FIFRA section 24(c). Nor does this tolerance serve as the basis for any State other than Mississippi, Louisiana, and Arkansas to use this pesticide on this crop under section 18 of FIFRA without following all provisions of EPA's regulations implementing section 18 as identified in 40 CFR part 166. For additional information regarding the emergency exemption for diuron, contact the Agency's Registration Division at the address provided under the ``ADDRESSES'' section.

3. Aggregate Risk Assessment and Determination of Safety

   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).

   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 diuron and to make a determination on aggregate exposure, consistent with section 408(b)(2), for a time-limited tolerance for combined residues of diuron on catfish at 2.0 ppm. EPA's assessment of the dietary exposures and risks associated with establishing the tolerance follows.

   1. 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 diuron are discussed in this unit.

   2. Toxicological Endpoint

      1. Acute toxicity. Acute reference dose (RfD) 0.16 milligram/ kilogram/day (mg/kg/day). For acute dietary risk assessment, EPA has identified the no observed adverse effect level (NOAEL) of 16.0 mg/kg/ day, based on decreased body weight (beginning at gestation day 9) and food consumption (during gestation days 6-10) at the lowest observed adverse effect level (LOAEL) of 80 mg/kg/day, from the developmental study in the rat. EPA's risk assessment has evaluated acute dietary risk to all population subgroups.

      2. Chronic toxicity. EPA has established the RfD for diuron at 0.003 mg/kg/day. This RfD is based on a 2-year chronic feeding/ oncogenicity study in the rat with a LOAEL of 1.02 mg/kg/day and an uncertainty factor (UF) of 300 (additional UF of 3 for the use of a LOAEL) based on decreased erythrocyte count in females, increased hemosiderin in the spleen, increased spleen weight, bone marrow activation, increased hematopoietic marrow, decreased fat marrow (% surface area of fat marrow in bone marrow) and thickened urinary bladder wall in males.

      3. Carcinogenicity. Diuron has been classified as a ``known/ likely'' human carcinogen by all routes, based on urinary bladder carcinomas in both sexes of the Wistar rat, kidney carcinomas in the male rat (a rare tumor), and mammary gland carcinomas in the female NMRI mouse. A Q‹INF›1‹/INF›*(mg/kg/day)‹SUP›-1‹/SUP› of 1.91 x 10‹SUP›-2‹/SUP› in human equivalents has been calculated based on the male rat urinary bladder carcinomas.

   3. Exposures and Risks

      1. From food and feed uses. Tolerances have been established (40 CFR 180.106) for the combined residues of diuron (3-(3,4- dichlorophenyl)-1,1-dimethylurea), in or on a variety of raw agricultural commodities at levels ranging from 0.1 ppm in nuts and peaches to 7 ppm in bermuda grass. The residues of concern for diuron in plant commodities are the parent compound and all metabolites convertible to 3,4-dichloroaniline (DCA). Although the Code of Federal Regulations (CFR) only mentions diuron in the tolerance expression, the analytical methods determine all metabolites convertible to 3,4- dichloroaniline. The parent compound usually comprises only a small portion of the total residue or of the DCA-containing residues. For both the acute and chronic dietary risk assessments it was assumed that total residues of the closely related herbicides, linuron and propanil will contribute to the toxicological effects of concern (with the acute dietary analysis, there were two exceptions: residues of linuron on potatoes and soybeans where metabolism studies were examined to determine which metabolites are common to those from diuron). It was

         [[Page 41299]]

         also assumed that the tolerances for linuron and propanil represent total residues convertible to 3,4-dichloroaniline, although petition files and residue data were not examined for linuron to confirm this. The propanil residue studies which were reviewed for chronic anticipated residues did involve determination of total base-released 3,4-dichloroaniline. Risk assessments were conducted by EPA to assess dietary exposures and risks from diuron as follows:

         i. Acute exposure and risk. Acute dietary risk assessments are performed for a food-use pesticide if a toxicological study has indicated the possibility of an effect of concern occurring as a result of a 1-day or single exposure. For this risk assessment of the section 18 requests to use diuron, EPA has identified an acute RfD of 0.16 mg/ kg/day. In conducting this acute dietary risk analysis, EPA used partially refined, i.e., percent crop treated data. In those cases where data indicated ‹1% crop treated, a value of 1% was used for the analysis. For those crops where information was not available to EPA, a default value of 100% crop treated was used for this risk assessment, EPA assumed that 100% of catfish would contain residues of diuron. At the time the anticipated residues (ARs) were developed for the acute dietary risk assessment, percent crop treated data were not available for linuron and propanil; therefore, it was assumed that 100% of the crop was treated for commodities having tolerances for those herbicides. The Novigen DEEM (Dietary Exposure Evaluation Model) system was used for the acute dietary exposure analysis, utilizing mixtures of tolerances/anticipated residues and percent crop treated data for diuron, linuron and propanil. With respect to fruit juices, the default concentration factors in the DEEM run were used except for grape juice and pineapple juice.

         The population subgroup with the highest acute dietary exposure (food only) is non-nursing infants. With a high-end anticipated residue contribution (ARC) exposure estimate of 0.03810 mg/kg/day, it was estimated that only 24% of the acute RfD population adjusted dose (PAD) would be utilized for this population subgroup. This acute dietary risk estimate (food only) should be viewed as a partially refined risk estimate (the diuron assessment was highly refined); further refinement using additional anticipated residue values and percent crop treated data for linuron and propanil in conjunction with another Monte Carlo analysis would result in a lower acute dietary exposure estimate. To arrive at this conclusion, EPA determined that for this tolerance action only, the FQPA Safety Factor be removed (1x) in assessing the risk posed by diuron (see aggregate risk section for infants and children). Therefore, the acute RfD is identical to the acute PAD.

         ii. Chronic exposure and risk. For this risk assessment, EPA has identified a chronic RfD of 0.003 mg/kg/day. For this risk assessment, EPA has utilized the Novigen DEEM system for the chronic dietary exposure analysis. In conducting the chronic dietary risk analysis, EPA used highly refined data. As stated previously, EPA included percent crop treated data for diuron (see acute risk section, above). Percent crop treated data for linuron uses were taken from the dietary risk evaluation system (DRES) run conducted in 1995 and propanil uses (1995- 98) were also utilized by EPA in this risk assessment. For those crops where EPA did not have information, a default value of 100% crop treated was used. Anticipated residues of diuron have been developed previously for numerous commodities. These anticipated residues were used with the following additions: 0.03 ppm for alfalfa sprouts (1% crop treated) and 0.92 ppm for fish-finfish/freshwater (76% crop treated). For the purposes of the present section 18 use, an updated analysis of linuron residues in food was not conducted; therefore, the most recent percent crop treated data for linuron (1995-97) was not used. Chronic exposures from linuron for various populations were taken from the DRES analysis conducted in 1995 in support of the increase in the asparagus tolerance. That analysis used anticipated residues (mean field trial values) and percent crop treated available at that time for numerous crops. For propanil, the chronic anticipated residues and percent crop treated have also been calculated by EPA. The chronic dietary risk analysis includes monitoring data for residues in drinking water. Therefore, in this document EPA summarizes risk of exposure for both food and water in the aggregate risk section.

         Section 408(b)(2)(E) authorizes EPA to use available data and information on the anticipated residue levels of pesticide residues in food and the actual levels of pesticide chemicals that have been measured in food. If EPA relies on such information, EPA must require that data be provided 5 years after the tolerance is established, modified, or left in effect, demonstrating that the levels in food are not above the levels anticipated. Following the initial data submission, EPA is authorized to require similar data on a time frame it deems appropriate. As required by section 408(b)(2)(E), EPA will issue a data call-in for information relating to anticipated residues to be submitted no later than 5 years from the date of issuance of this tolerance.

         Section 408(b)(2)(F) states that the Agency may use data on the actual percent of crop treated (PCT) for assessing chronic dietary risk only if the Agency can make the following findings: That the data used are reliable and provide a valid basis to show what percentage of the food derived from such crop is likely to contain such pesticide residue; that the exposure estimate does not underestimate exposure for any significant subpopulation group; and if data are available on pesticide use and food consumption in a particular area, the exposure estimate does not understate exposure for the population in such area. In addition, the Agency must provide for periodic evaluation of any estimates used. To provide for the periodic evaluation of the estimate of PCT as required by the section 408(b)(2)(F), EPA may require registrants to submit data on PCT.

         The Agency used PCT information as follows: As detailed above, in conducting both the acute and chronic dietary risk analyses, EPA used PCT data. In order to conduct such a refined analysis, EPA utilized the Novigen DEEM system for the dietary exposure analysis, with which EPA calculated mixtures of tolerances/ anticipated residues and percent crop treated data for diuron, linuron uses taken from the DRES run conducted in 1995, and propanil uses (1995-98). With respect to fruit juices, the default concentration factors in the DEEM run were used except for grape juice and pineapple juice. Processing studies indicated that residues did not concentrate in the latter two juices. In those cases where data indicated ‹1% crop treated, a value of 1% was used for the analysis. For those crops where information was not available to EPA, a default value of 100% crop treated was used. At the time the anticipated residues were developed for the acute dietary risk assessment, percent crop treated data were not available for linuron and propanil; therefore, it was assumed that 100% of the crop was treated for commodities having tolerances for those herbicides.

         Anticipated residues of diuron have been developed previously for numerous commodities. These anticipated residues were used with the following additions: 0.03 ppm for alfalfa sprouts (1% crop treated) and 0.92 ppm for fish-finfish/freshwater (76% crop

         [[Page 41300]]

         treated). For the purposes of the present action, an updated analysis of linuron residues in food was not conducted; therefore, the most recent percent crop treated data for linuron (1995-97) was not used. Chronic exposures from linuron for various populations were taken from EPA's Dietary Risk Evaluation System (DRES) analysis conducted in 1995 in support of the increase in the asparagus tolerance. That analysis used anticipated residues (mean field trial values) and percent crop treated available at that time for numerous crops. For propanil, the chronic anticipated residues and percent crop treated have also been calculated by EPA. The chronic dietary risk analysis includes monitoring data for residues in drinking water.

         The Agency believes that the three conditions, discussed in section 408(2)(F) in this unit concerning the Agency's responsibilities in assessing chronic dietary risk findings, have been met. The PCT estimates are derived from Federal and private market survey data, which are reliable and have a valid basis. Typically, a range of estimates are supplied and the upper end of this range is assumed for the exposure assessment. By using this upper end estimate of the PCT, the Agency is reasonably certain that the percentage of the food treated is not likely to be underestimated. The regional consumption information and consumption information for significant subpopulations is taken into account through EPA's computer-based model for evaluating the exposure of significant subpopulations including several regional groups. Use of this consumption information in EPA's risk assessment process ensures that EPA's exposure estimate does not understate exposure for any significant subpopulation group and allows the Agency to be reasonably certain that no regional population is exposed to residue levels higher than those estimated by the Agency. Other than the data available through national food consumption surveys, EPA does not have available information on the regional consumption of food to which diuron may be applied in a particular area.

      2. From drinking water. EPA conducted an analysis of the contribution of residues of diuron from drinking water based upon monitoring data for water with emphasis on the US Geological Survey (USGS) National Water Quality Assessment Program (NAWQA) surface water sampling in central California. The NAWQA program analyzed 3,417 samples of surface water for diuron throughout the United States. Approximately 13% of the samples (429) contained detectable diuron residues (only parent compound analyzed) ranging from 0.001 to 14 parts per billion (ppb). The average value for the detectable samples was 0.8 ppb. The 95th percentile value for the surface water samples was 0.2 ppb. For ground water there were 2,726 samples analyzed and about 2% (51) contained diuron residues with values ranging from 0.002 to 2 ppb.

         However, EPA's analysis has concluded that the above data may underestimate or under represent concentrations of diuron to be expected in surface water, due to low recovery rates and incomplete sampling in some areas. Furthermore, estimates for diuron degradates in drinking water could not be provided due to the small amount of data and the data not being representative of drinking water. In light of these factors, EPA has concluded that the highest value of 14 ppb of all surface water samples having detectable residues should be used for acute risk assessment and that the average value of 0.8 ppb of all the surface water samples having detectable residues should be used for chronic risk assessment. By using these upper end values of diuron parent in surface water as the estimates, at least some compensation can be made for the poor recoveries of the analytical method and the lack of sufficient data to predict levels of diuron degradates, many of which are likely to be formed by linuron and propanil as well. For the acute dietary aggregate risk analysis, 14 ppb was used as a value for comparison in calculating a drinking water level of comparison (DWLOC). When the acute DEEM run was conducted, it was determined at that point that the percentage of the acute RfD (PAD) taken up by residue exposure in food only was sufficiently low such that a DWLOC could be calculated in lieu of conducting a probabilistic analysis with inclusion of water. However, for the chronic dietary aggregate risk analysis, 0.8 ppb was incorporated into the DEEM assessment as a value taken from monitoring data.

         The above risk assessment is sufficient for the purposes of the related section 18 emergency exemption authorized by the Agency. However, EPA expects that for it to take action on a registration and establishment of a permanent tolerance for the catfish pond use, a more thorough analysis would be undertaken to determine which degradates of diuron, linuron and propanil would be included in drinking water residue estimates.

      3. From non-dietary exposure. Diuron is currently not registered for use on any residential sites.

      4. Cumulative exposure to substances with a common mechanism of toxicity. Diuron is a member of the phenylurea class of pesticides. Other members of this class include fluometuron, fenuron-TCA, linuron, siduron and tebuthiuron. 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.''

         The Agency believes that ``available information'' in this context might include not only toxicity, chemistry, and exposure data, but also scientific policies and methodologies for understanding common mechanisms of toxicity and conducting cumulative risk assessments. For most pesticides, although the Agency has some information in its files that may turn out to be helpful in eventually determining whether a pesticide shares a common mechanism of toxicity with any other substances, EPA does not at this time have the methodologies to resolve the complex scientific issues concerning common mechanism of toxicity in a meaningful way. EPA has begun a pilot process to study this issue further through the examination of particular classes of pesticides. The Agency hopes that the results of this pilot process will increase the Agency's scientific understanding of this question such that EPA will be able to develop and apply scientific principles for better determining which chemicals have a common mechanism of toxicity and evaluating the cumulative effects of such chemicals. The Agency anticipates, however, that even as its understanding of the science of common mechanisms increases, decisions on specific classes of chemicals will be heavily dependent on chemical-specific data, much of which may not be presently available.

         Although at present the Agency does not know how to apply the information in its files concerning common mechanism issues to most risk assessments, there are pesticides as to which the common mechanism issues can be resolved. These pesticides include those that are toxicologically dissimilar to existing chemical substances (in which case the Agency can conclude that it is unlikely that a pesticide shares a common mechanism of activity with other substances) and pesticides that produce a common toxic metabolite (in which case common mechanism of activity will be assumed).

         [[Page 41301]]

         Diuron shares a common metabolite with linuron and propanil. The non-cancer dietary risk assessments take this into consideration. For the purposes of this section 18, residues from linuron and propanil were not taken into consideration for the carcinogenicity risk assessment because the target organs (i.e., the tumors) for diuron versus linuron and propanil are of different origins and because metabolism and mechanistic data indicate that the mechanism of action for tumor induction are different for diuron when compared to linuron and propanil.

         The residues of concern for diuron are the parent compound and all metabolites convertible to 3,4-dichloroaniline (DCA). There are two closely related herbicides which are also metabolized to DCA and/or other residues convertible to DCA (linuron and propanil). Therefore, it was assumed that residues from the use of these two pesticides will contribute to the toxicological effects of concern for the dietary risk analyses (for further explantion, see exposure discussion in section III. C. below). The toxicological data bases for these two pesticides were examined to see if there are similar target organs. For the acute dietary risk analysis, the toxicological endpoint, decreased bodyweight and food consumption, is not specific enough for comparison. Nevertheless, it was still assumed that residues from all three herbicides will contribute to the same acute effects. For chronic exposure, these three pesticides share a similar toxicological endpoint: hematological effects, particularly methemoglobinemia. These effects were observed in chronic feeding studies, in either the rat, dog or mouse. The target organs for carcinogenicity may be similar for linuron and propanil, but not for diuron. Diuron induces urinary bladder carcinomas in rats (both sexes) and mammary gland carcinomas in female mice. In addition, an increase in the incidence of a rare kidney tumor was observed in male rats. Linuron induces testicular interstitial cell adenomas in rats and hepatocellular adenomas in mice. Available mechanistic and metabolism data indicate that linuron and diuron may be inducing tumors through different mechanisms of action. Propanil has not been reviewed by the Office of Pesticide Programs Cancer Assessment Review Committee (CARC). However, two new studies have been received which indicate that it may induce malignant lymphomas of the spleen in female mice, testicular interstitial cell tumors in male rats and hepatocellular adenomas in female rats, the latter at a dose level which probably exceeds the maximum tolerated dose. Therefore, since the target organs for tumor induction for diuron are different than those for linuron and propanil, and data are available which indicate that the mechanism of action may be different for diuron, for the purpose of this tolerance action, the estimated dietary carcinogenic risk will not include residues from linuron and propanil. However, for any future permanent tolerance requests, a detailed analysis of any potential contribution of residues from linuron and propanil to the dietary carcinogenic risk will be conducted, including examination of available toxicological and mechanistic data.

         EPA does not have, at this time, available data to determine whether diuron has a common mechanism of toxicity with any other substances or how to include this pesticide in a cumulative risk assessment. For the purposes of this tolerance action, therefore, EPA has not assumed that diuron has a common mechanism of toxicity with substances other than linuron and propanil. For more 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).

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

      1. Acute risk. The acute dietary risk analysis estimated that the acute dietary exposure (food only) for the U.S. Population will utilize 17% of the acute RfD, which, because there is no FQPA 10x Safety Factor added to this risk assessment, is identical to the acute population adjusted dose (PAD). All other adult population subgroups have acute risk estimates (food only) below that of the U.S. population. As stated previously, the acute dietary risk analysis used partially refined ARC exposure estimates and percent crop treated values. The analysis included total residues convertible to the diuron metabolite, DCA from food. Residue contributions from diuron, linuron and propanil uses were taken into account. For DCA-convertible residues from diuron, linuron and propanil, it was determined that an acute dietary exposure (food plus water) of 100% or less of the acute RfD (PAD) is acceptable to protect the safety of all population subgroups. The estimated exposures at the 99.9th percentile for all population subgroups utilize less than 100% of the acute RfD (PAD).

         Monitoring data were available for drinking water for the acute aggregate risk estimate. However, since the percentage of the acute RfD (PAD) taken up by exposure to DCA residues from food only was sufficiently low, it was decided that a DWLOC would be calculated. Therefore, for this tolerance, the estimated maximum concentration of 14 ppb from the monitoring data was used for comparison to the back calculated human health DWLOC for the acute endpoint. The DWLOCs for the specific population subgroups are calculated as follows:

         The maximum water exposure (acute) (mg/kg/day) = acute PAD - food exposure (mg/kg/day) from acute DEEM run.

         The DWLOC (‹greek-m›g/L) = max. water exposure (mg/kg/day) x body wt (kg) ‹divide› (10‹SUP›-3‹/SUP› mg/‹greek-m›g) x water consumption (L/day).

         EPA used the following default body weights in these calculations: General U.S. population, 70 kg; males (13+ years old), 70 kg; females (13+ years old), 60 kg; and other adult populations, 70 kg.

         EPA's default daily drinking rates are 2L/day for adults.

         The DWLOCs are between 4,300 and 5,000 ppb for acute dietary risk. Based on a comparison of the calculated DWLOCs and the estimated exposure to diuron in drinking water (14 ppb), EPA does not expect the aggregate exposure to exceed 100% of the Acute RfD for any of the U.S. population. The DWLOCs are at least 100 times higher than the maximum value observed in monitoring studies. Therefore, EPA concludes that there is a reasonable certainty that no harm will result to the U.S. population from acute aggregate exposure to diuron residues.

      2. Chronic risk. EPA determined that for this tolerance, the FQPA Safety Factor can be removed (1x) in assessing the risk posed by diuron. Therefore, because there is not a FQPA 10x Safety Factor added to this risk assessment, the chronic RfD is identical to the chronic PAD. EPA has calculated that chronic dietary exposure to diuron alone from food and water will utilize 4.7% of the chronic RfD (PAD) for the U.S. population. When residues from linuron and propanil are included, the dietary exposure to residues convertible to the metabolite (DCA) from food and water will utilize 12% of the chronic RfD (PAD) for the U.S. population and 15% of the chronic RfD (PAD) for the non-hispanic, non-white, non-black U.S. population.

         As stated previously, the chronic dietary risk analysis used highly refined

         [[Page 41302]]

         ARC exposure estimates and percent crop treated values. EPA generally has no concern for exposures below 100% of the chronic RfD (PAD) because the chronic RfD (PAD) represents the level at or below which daily aggregate dietary exposure over a lifetime will not pose appreciable risks to human health. There are no registered residential uses for diuron. Therefore, EPA concludes that there is a reasonable certainty that no harm to adults will result from chronic aggregate exposure to DCA-convertible residues from diuron, linuron and propanil.

      3. Short- and intermediate-term risk. Short- and intermediate-term aggregate exposure takes into account chronic dietary food and water (considered to be a background exposure level) plus non-dietary, non- occupational exposures. Since there are no registered uses of diuron that would result in such exposures, short- and intermediate-term aggregate risk estimates were not conducted.

      4. Aggregate cancer risk for U.S. population. The dietary cancer risk for the U.S. population is calculated by multiplying the Q‹INF›1‹/INF›* by the dietary exposure value. The Q‹INF›1‹/INF›*(mg/kg/ day)‹SUP›-1‹/SUP› for diuron is 1.91 x 10‹SUP›-2‹/SUP›. The dietary exposure value for registered food crops for the U.S. population is 0.000092 mg/kg/day. This highly refined value does not include either the drinking water exposure value or the catfish exposure that was included in the exposure values described above in the discussion on chronic aggregate risk. Multiplying the Q‹INF›1‹/INF›* by the dietary exposure value for the U.S. population, the cancer risk for the U.S. population is 1.76 x 10‹SUP›-6‹/SUP› for all registered foods. Adding in calculated risks from catfish and the average monitoring value of 0.8 ppb diuron parent in all drinking water, the total estimation of cancer risk for the U.S. population is 2.71 x 10‹SUP›-6‹/SUP›. This value does not include contributions from linuron and propanil metabolites because, as explained in the toxicological endpoints section, the tumor target organs are different for diuron when compared to linuron and propanil and because mechanistic and metabolism data indicate that diuron may be inducing tumors through a different mechanism of action. Metabolites in water are also not included; however, EFED's upper end value of diuron parent in surface water partially compensates for not including metabolites in water.

      5. Determination of safety. Based on these risk assessments, EPA concludes that there is a reasonable certainty that no harm will result from aggregate exposure to diuron residues.

   5. 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 diuron, 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 during 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 data base 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 MOE and 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.

         ii. Developmental toxicity studies--Rats. In the developmental study in rats, the maternal (systemic) NOAEL was 16 mg/kg/day, based on reduction in body weight and food consumption at the LOAEL of 80 mg/kg/ day. The developmental (fetal) NOAEL was 80 mg/kg/day, based on increases in delayed ossification of vertebrae and sternebrae as well as decreased fetal weights at the LOAEL of 400 mg/kg/day.

         Rabbits. In the developmental toxicity study in rabbits, the maternal (systemic) NOAEL was 10 mg/kg/day, based on decreased body weight and food comsumption at the LOAEL of 50 mg/kg/day. The developmental (pup) NOAEL was 50 mg/kg/day, the highest dose tested. There were no developmental effects.

         iii. Reproductive toxicity study--Rats. In the 2-generation reproductive toxicity study in rats, the parental (systemic) NOAEL was 16.9 (males) and 20.3 (females) mg/kg/day, based on decreased body weight, body weight gain and food consumption in both sexes at the LOAEL of 120 (males) and 144 (females) mg/kg/day. The developmental (pup) NOAEL was 20.3 mg/kg/day, based on decreased pup body weight during the lactation period for both sexes and generations at the LOAEL of 144 mg/kg/day. The reproductive NOAEL was 120 (males) and 144 (females) mg/kg/day, the highest dose tested. There were no reproductive effects.

         iv. Pre- and postnatal sensitivity. The toxicological data base for evaluating pre- and postnatal toxicity for diuron is complete with respect to current data requirements. Based on the developmental and reproductive toxicity studies discussed above for diuron, there does not appear to be an extra sensitivity for pre- or postnatal effects. EPA has concluded that the FQPA Safety Factor can be removed (1x) in assessing the risk posed by this chemical. The decision applies only to this tolerance action.

         v. Conclusion. There is a complete toxicity data base for diuron and exposure data are complete or are estimated based on data that reasonably accounts for potential exposures.

      2. Acute risk. The acute dietary risk analysis using partially refined data estimated that the acute dietary exposure (food only) for the population subgroup, non-nursing infants will utilize 24% of the acute RfD (PAD). All other infant and children population subgroups have acute risk estimates (food only) below that of non-nursing infants (see discussion on residue contributions in the Acute Aggregate Risk section for the U.S. population). For DCA-convertible residues from diuron, linuron and propanil, it was determined that an acute dietary exposure (food plus water) of 100% or less of the acute RfD (PAD) is acceptable to protect the safety of all infant and children population subgroups. The estimated exposures at the 99.9th percentile for all infant and children population subgroups utilize less than 100% of the Acute RfD, which, because there is no FQPA 10x Safety Factor, is identical to the acute PAD.

         As stated in the aggregate risk section for the U.S. population, for purposes of risk assessment, the estimated maximum concentration of 14 ppb from the monitoring data will be used for comparison to the back-calculated human health DWLOC for the acute endpoint. For the DWLOC calculations, the EPA default body weights are:

         [[Page 41303]]

         Females (13+ years old), 60 kg and all infants/children, 10 kg.

         EPA has used daily drinking rates of 2L/day for adults and 1L/day for children.

         The DWLOCs are between 1,200 and 4,300 ppb for acute dietary risk. Based on a comparison of the calculated DWLOCs and the estimated exposure to diuron in drinking water (14 ppb), EPA does not expect the aggregate exposure to exceed 100% of the Acute RfD for either infants or children. The DWLOCs are approximately 100 times higher than the maximum value observed in monitoring studies. Therefore, EPA concludes that there is a reasonable certainty that no harm will result to either infants or children from acute aggregate exposure to diuron residues.

      3. Chronic risk. Using the exposure assumptions described in this unit, EPA has concluded that aggregate exposure to diuron from food will utilize 28% of the chronic RfD for non-nursing infants, which is the highest exposed population subgroup. All other infant and children population subgroups have lower chronic dietary exposure. EPA generally has no concern for exposures below 100% of the chronic RfD (PAD) because the chronic RfD (PAD) represents the level at or below which daily aggregate dietary exposure over a lifetime will not pose appreciable risks to human health. There are no registered residential uses for diuron. EPA concludes that there is a reasonable certainty that no harm will result to infants and children from chronic aggregate exposure to DCA residues from diuron, linuron and propanil. Despite the potential for exposure to diuron in drinking water and from non- dietary, non-occupational exposure, EPA does not expect the aggregate exposure to exceed 100% of the RfD/PAD.

      4. Short- or intermediate-term risk. Short- and intermediate-term aggregate exposure takes into account chronic dietary food and water (considered to be a background exposure level) plus non-dietary, non- occupational exposures. Since there are no registered uses of diuron which would result in such exposures, short- and intermediate- term aggregate risk estimates were not conducted.

      5. Determination of safety. Based on these risk assessments, EPA concludes that there is a reasonable certainty that no harm will result to infants and children from aggregate exposure to diuron residues.

4. Other Considerations

   1. Metabolism in Plants and Animals

      The nature of the residue in plants is adequately understood. The parent compound usually comprises only a small portion of the total residue. Significant residues formed by demethylation include dichlorophenylmethylurea (DCPMU) and dichlorophenylurea (DCPU). Although tolerances in 40 CFR 180.106 are expressed simply as ``residues of the herbicide diuron,'' as part of the reregistration process EPA has noted that the residue to be regulated in plants is diuron and its related compounds convertible to 3,4-dichloroaniline as determined by the enforcement and data collection methods. The tolerance expression should be revised in this manner when reregistration eligibility decisions are made for diuron. For the purposes of the current action, the tolerance will be based on the combined residues of diuron and its metabolites convertible to 3,4- dichloroaniline.

      EPA addressed the residues of concern in livestock commodities. While DCPMU and DCPU are also formed in livestock, five hydroxylated metabolites are found that are not observed in plants. EPA concluded these residues are not of concern in livestock tissues and eggs as the DCA method determined 80% or more of the total radioactive residue in these commodities. In milk the DCA method recovered only 10% of the TRR and EPA concluded that while the remaining 90% of the residue need not be quantified using a different method, the diuron residues observed in milk (by conversion to DCA) in the feeding study will be multiplied by 10 for purposes of risk assessment. Although livestock are not directly involved in this tolerance action, a tolerance is being established for residues in catfish. For the purposes of this tolerance, the residue of concern in catfish will be considered the same as in plants and livestock tissues (i.e., diuron and it metabolites convertible to DCA).

   2. Analytical Enforcement Methodology

      Adequate enforcement methodology (example - gas chromotography) is available to enforce the tolerance expression. The method may be requested from: Calvin Furlow, PIRIB, IRSD (7502C), Office of Pesticide Programs, Environmental Protection Agency, 401 M St., SW., Washington, DC 20460. Office location and telephone number: Rm 101FF, Crystal Mall #2, 1921 Jefferson Davis Hwy., Arlington, VA, (703) 305-5229.

   3. Magnitude of Residues

      Residue data were provided for four different application schemes to catfish ponds. In all cases, the application rate or concentration (0.01 ppm) in the water was the same as that authorized in the section 18 exemptions. In three ponds, the treatments were made every 5 days (versus proposed 7-day interval) with the total number of applications being 7, 13 or 19 (for total treatment periods of 30, 60 or 90 days). The maximum DCA-containing residues in catfish fillets for the three treatment patterns were 0.90, 1.76 and 1.52 ppm, respectively. The values apparently reflect averages of triplicate analyses. The highest residue from an individual analysis is 1.88 ppm. The fourth pond (described as an efficacy study) more closely resembled the proposed emergency use in that the 0.01 ppm water treatments were made every 7 days, although more applications were made (17 over 112 days versus maximum of 9 requested in the section 18). Fillets were collected after the final treatment and found to contain 0.59-1.16 ppm total DCA- containing residues. Based on these data, EPA concludes that a 2.0 ppm time-limited tolerance should be established for residues of diuron and its metabolites convertible to 3,4-dichloroaniline in catfish fillets.

      There are no livestock feed items associated with the proposed use in catfish ponds. Therefore, tolerances are not required for residues of diuron and metabolites in meat, milk, poultry and eggs. Tolerances of 1 ppm are established for residues of diuron in the meat, fat and meat byproducts of cattle, goats, hogs, horses and sheep (40 CFR 180.106) in conjunction with registered uses of the herbicide.

   4. International Residue Limits

      There are no Codex, Canadian, or Mexican tolerances or maximum residue limits for diuron in catfish. Therefore, harmonization with international tolerances is not an issue for this tolerance.

   5. Rotational Crop Restrictions

      Since the requested use is for catfish ponds, which are essentially permanent structures, there are no rotational crops that would be planted in the treated areas. Thus, no plantback intervals need to be specified for rotational crops.

5. Conclusion

   Therefore, the tolerance is established for combined residues of diuron and its metabolites convertible to 3,4-dichloroaniline in catfish fillets at 2.0 ppm.

   [[Page 41304]]

6. Objections and Hearing Requests

   The new FFDCA section 408(g) provides essentially the same process for persons to ``object'' to a tolerance regulation as was provided in the old section 408 and in section 409. However, the period for filing objections is 60 days, rather than 30 days. EPA currently has procedural regulations which govern the submission of objections and hearing requests. These regulations will require some modification to reflect the new law. However, until those modifications can be made, EPA will continue to use those procedural regulations with appropriate adjustments to reflect the new law.

   Any person may, by September 28, 1999, file written objections to any aspect of this regulation and may also request a hearing on those objections. Objections and hearing requests must be filedwith the Hearing Clerk, at the address given under the ``ADDRESSES'' section (40 CFR 178.20). A copy of the objections and/or hearing requests filed with the Hearing Clerk should be submitted to the OPP docket for this rulemaking. The objections submitted must specify the provisions of the regulation deemed objectionable and the grounds for the objections (40 CFR 178.25). Each objection must be accompanied by the fee prescribed by 40 CFR 180.33(i). EPA is authorized to waive any fee requirement ``when in the judgement of the Administrator such a waiver or refund is equitable and not contrary to the purpose of this subsection.'' For additional information regarding tolerance objection fee waivers, contact James Tompkins, Registration Division (7505C), Office of Pesticide Programs, Environmental Protection Agency, 401 M St., SW., Washington, DC 20460. Office location, telephone number, and e-mail address: Rm. 239, Crystal Mall #2, 1921 Jefferson Davis Hwy., Arlington, VA, (703) 305-5697, 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.

7. Public Record and Electronic Submissions

   EPA has established a record for this regulation under docket control number [OPP-300881] (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 Room 119 of the Public Information and Records Integrity Branch, Information Resources and Services Division (7502C), Office of Pesticide Programs, Environmental Protection Agency, Crystal Mall #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.

8. Regulatory Assessment Requirements

   1. Certain Acts and Executive Orders

      This final rule establishes a tolerance under section 408 of the FFDCA. 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) (Pub. L. 104-4). Nor does it require 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 under FFDCA section 408(l)(6), 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.

   2. 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

      [[Page 41305]]

      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.

   3. 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.

9. 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: July 14, 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), 346(a) and 371.

   2. Section Sec. 180.106, is amended by adding new paragraph (b) to read as follows.

      Sec. 180.106 Diuron; tolerances for residues.

      * * * * *

      (b) Section 18 emergency exemptions. Time-limited tolerances are established for combined residues of the herbicide diuron and its metabolites convertible to 3,4-dichloroaniline in connection with use of the pesticide under section 18 emergency exemptions granted by EPA. These tolerances will expire and are revoked on the dates specified in the following table.

      Parts Expiration/ Commodity

      per Revocation million date

      Catfish fillets................................... 2.0 06/30/01

      * * * * *

      [FR Doc. 99-19591Filed7-29-99; 8:45 am]

      BILLING CODE 6560-50-F