Diphenylamine; Proposed Pesticide Tolerance, 70703-70709 [E6-20648]

Download as PDF PWALKER on PRODPC60 with PROPOSALS Federal Register / Vol. 71, No. 234 / Wednesday, December 6, 2006 / Proposed Rules deliveries are only accepted during the Docket’s normal hours of operation, and special arrangements should be made for deliveries of boxed information. Instructions: Direct your comments to Docket ID No. EPA–R03–OAR–2006– 0933. EPA’s policy is that all comments received will be included in the public docket without change, and may be made available online at https:// www.regulations.gov, including any personal information provided, unless the comment includes information claimed to be Confidential Business Information (CBI) or other information whose disclosure is restricted by statute. Do not submit information that you consider to be CBI or otherwise protected through www.regulations.gov or e-mail. The www.regulations.gov Web site is an ‘‘anonymous access’’ system, which means EPA will not know your identity or contact information unless you provide it in the body of your comment. If you send an e-mail comment directly to EPA without going through www.regulations.gov, your e-mail address will be automatically captured and included as part of the comment that is placed in the public docket and made available on the Internet. If you submit an electronic comment, EPA recommends that you include your name and other contact information in the body of your comment and with any disk or CD–ROM you submit. If EPA cannot read your comment due to technical difficulties and cannot contact you for clarification, EPA may not be able to consider your comment. Electronic files should avoid the use of special characters, any form of encryption, and be free of any defects or viruses. Docket: All documents in the electronic docket are listed in the www.regulations.gov index. Although listed in the index, some information is not publicly available, i.e., CBI or other information whose disclosure is restricted by statute. Certain other material, such as copyrighted material, is not placed on the Internet and will be publicly available only in hard copy form. Publicly available docket materials are available either electronically in https:// www.regulations.gov or in hard copy during normal business hours at the Air Protection Division, U.S. Environmental Protection Agency, Region III, 1650 Arch Street, Philadelphia, Pennsylvania 19103. Copies of the State submittal are available at the Delaware Department of Natural Resources & Environmental Control, 89 Kings Highway, P.O. Box 1401, Dover, Delaware 19903. VerDate Aug<31>2005 16:05 Dec 05, 2006 Jkt 211001 FOR FURTHER INFORMATION CONTACT: Rosemarie Nino, (215) 814–3377, or by e-mail at nino.rose@epa.gov. SUPPLEMENTARY INFORMATION: For further information, please see the information provided in the direct final action, with the same title, that is located in the ‘‘Rules and Regulations’’ section of this Federal Register publication. This action approves an amendment to the Delaware Title V operating permit program to correct the definition of a ‘‘major source.’’ Dated: November 21, 2006. William T. Wisniewski, Acting Regional Administrator, Region III. [FR Doc. E6–20642 Filed 12–5–06; 8:45 am] BILLING CODE 6560–50–P ENVIRONMENTAL PROTECTION AGENCY 40 CFR Part 180 [EPA–HQ–OPP–2006–0731; FRL–8104–1] Diphenylamine; Proposed Pesticide Tolerance Environmental Protection Agency (EPA). ACTION: Proposed rule. AGENCY: SUMMARY: This document proposes to establish a tolerance for residues of diphenylamine in or on pear under the Federal Food, Drug, and Cosmetic Act (FFDCA), as amended by the Food Quality Protection Act of 1996 (FQPA). DATES: Comments must be received on or before February 5, 2007. ADDRESSES: Submit your comments, identified by docket identification (ID) number EPA–HQ–OPP–2006–0731, by one of the following methods: • Federal eRulemaking Portal: https:// www.regulations.gov. Follow the on-line instructions for submitting comments. • Mail: Office of Pesticide Programs (OPP) Regulatory Public Docket (7502P), Environmental Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460–0001. • Delivery: OPP Regulatory Public Docket (7502P), Environmental Protection Agency, Rm. S-4400, One Potomac Yard (South Building), 2777 S. Crystal Drive, Arlington, VA. Deliveries are only accepted during the Docket’s normal hours of operation (8:30 a.m. to 4 p.m., Monday through Friday, excluding legal holidays). Special arrangements should be made for deliveries of boxed information. The Docket telephone number is (703) 305– 5805. Instructions: Direct your comments to docket ID number EPA–HQ–OPP–2006– PO 00000 Frm 00021 Fmt 4702 Sfmt 4702 70703 0731. EPA’s policy is that all comments received will be included in the docket without change and may be made available on-line at https:// www.regulations.gov, including any personal information provided, unless the comment includes information claimed to be Confidential Business Information (CBI) or other information whose disclosure is restricted by statute. Do not submit information that you consider to be CBI or otherwise protected through regulations.gov or email. The Federal regulations.gov website is an ‘‘anonymous access’’ system, which means EPA will not know your identity or contact information unless you provide it in the body of your comment. If you send an e-mail comment directly to EPA without going through regulations.gov, your email address will be automatically captured and included as part of the comment that is placed in the docket and made available on the Internet. If you submit an electronic comment, EPA recommends that you include your name and other contact information in the body of your comment and with any disk or CD-ROM you submit. If EPA cannot read your comment due to technical difficulties and cannot contact you for clarification, EPA may not be able to consider your comment. Electronic files should avoid the use of special characters, any form of encryption, and be free of any defects or viruses. Docket: All documents in the docket are listed in the docket index. Although listed in the index, some information is not publicly available, e.g., CBI or other information whose disclosure is restricted by statute. Certain other material, such as copyrighted material, is not placed on the Internet and will be publicly available only in hard copy form. Publicly available docket materials are available either in the electronic docket at https:// www.regulations.gov, or, if only available in hard copy, at the OPP Regulatory Public Docket in Rm. S-4400, One Potomac Yard (South Building), 2777 S. Crystal Drive, Arlington, VA. The hours of operation of this Docket Facility are from 8:30 a.m. to 4 p.m., Monday through Friday, excluding legal holidays. The Docket telephone number is (703) 305–5805. FOR FURTHER INFORMATION CONTACT: Shaja R. Brothers, Registration Division (7505P), Office of Pesticide Programs, Environmental Protection Agency, 1200 Pennsylvania Ave, NW., Washington, DC 20460–0001; telephone number: (703) 308–3194; e-mail address: brothers.shaja@epa.gov. E:\FR\FM\06DEP1.SGM 06DEP1 70704 Federal Register / Vol. 71, No. 234 / Wednesday, December 6, 2006 / Proposed Rules SUPPLEMENTARY INFORMATION: I. General Information A. Does this Action Apply to Me? You may be potentially affected by this action if you are an agricultural producer, food manufacturer, or pesticide manufacturer. Potentially affected entities may include, but are not limited to: • Crop production (NAICS code 111). • Animal production (NAICS code 112). • Food manufacturing (NAICS code 311). • Pesticide manufacturing (NAICS code 32532). This listing is not intended to be exhaustive, but rather provides a guide for readers regarding entities likely to be affected by this action. Other types of entities not listed in this unit could also be affected. The North American Industrial Classification System (NAICS) codes have been provided to assist you and others in determining whether this action might apply to certain entities. To determine whether you or your business may be affected by this action, you should carefully examine the applicability provisions. If you have any questions regarding the applicability of this action to a particular entity, consult the person listed under FOR FURTHER INFORMATION CONTACT. PWALKER on PRODPC60 with PROPOSALS B. What Should I Consider as I Prepare My Comments for EPA? 1. Submitting CBI. Do not submit this information to EPA through www.regulations.gov or e-mail. Clearly mark the part or all of the information that you claim to be CBI. For CBI information in a disk or CD ROM that you mail to EPA, mark the outside of the disk or CD ROM as CBI and then identify electronically within the disk or CD ROM the specific information that is claimed as CBI. In addition to one complete version of the comment that includes information claimed as CBI, a copy of the comment that does not contain the information claimed as CBI must be submitted for inclusion in the public docket. Information so marked will not be disclosed except in accordance with procedures set forth in 40 CFR part 2. VerDate Aug<31>2005 16:05 Dec 05, 2006 Jkt 211001 2. Tips for preparing your comments. When submitting comments, remember to: i. Identify the document by docket ID number and other identifying information (subject heading, Federal Register date and page number). ii. Follow directions. The Agency may ask you to respond to specific questions or organize comments by referencing a Code of Federal Regulations (CFR) part or section number. iii. Explain why you agree or disagree; suggest alternatives and substitute language for your requested changes. iv. Describe any assumptions and provide any technical information and/ or data that you used. v. If you estimate potential costs or burdens, explain how you arrived at your estimate in sufficient detail to allow for it to be reproduced. vi. Provide specific examples to illustrate your concerns and suggest alternatives. vii. Explain your views as clearly as possible, avoiding the use of profanity or personal threats. viii. Make sure to submit your comments by the comment period deadline identified. II. Background and Statutory Findings EPA on its own initiative, under section 408(e) of the FFDCA, 21 U.S.C. 346a(e), is proposing to establish a tolerance for residues of the fungicide, diphenylamine in or on pear at 5.0 parts per million (ppm). The Interregional Research Project Number 4 (IR-4) submitted a petition (PP 0E6107) for this use. However, neither IR-4 nor Atomchem North American Incorporated, the registrant, submitted all required elements of a petition in support of establishing a tolerance. Because the petition was incomplete, EPA did not publish a Notice of Filing for the petition. 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) of the FFDCA defines ‘‘safe’’ to mean that ‘‘ there is a reasonable certainty that no harm will result from aggregate exposure to the pesticide chemical residue, including PO 00000 Frm 00022 Fmt 4702 Sfmt 4702 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) of the FFDCA requires EPA to give special consideration to exposure of infants and children to the pesticide chemical residue in establishing a tolerance and to ‘‘ensure that there is a reasonable certainty that no harm will result to infants and children from aggregate exposure to the pesticide chemical residue. . . .’’ EPA performs a number of analyses to determine the risks from aggregate exposure to pesticide residues. For further discussion of the regulatory requirements of section 408 of the FFDCA and a complete description of the risk assessment process, see https:// www.epa.gov/fedrgstr/EPA-PEST/1997/ November/Day-26/p30948.htm. III. Aggregate Risk Assessment and Determination of Safety Consistent with section 408(b)(2)(D) of the FFDCA, 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 and to make a determination on aggregate exposure, consistent with section 408(b)(2) of the FFDCA, for a tolerance for residues of diphenylamine on pear at 5.0 ppm. EPA’s assessment of exposures and risks associated with establishing the tolerance follows: A. Toxicological Profile EPA has evaluated the available toxicity data and considered its validity, completeness, and reliability as well as the relationship of the results of the studies to human risk. EPA has also considered available information concerning the variability of the sensitivities of major identifiable subgroups of consumers, including infants and children. The nature of the toxic effects caused by diphenylamine is discussed in Table 1 of this unit as well as the no-observed-adverse-effect-level (NOAEL) and the lowest-observedadverse-effect-level (LOAEL) from the toxicity studies reviewed. E:\FR\FM\06DEP1.SGM 06DEP1 Federal Register / Vol. 71, No. 234 / Wednesday, December 6, 2006 / Proposed Rules 70705 TABLE 1.—SUBCHRONIC, CHRONIC, AND OTHER TOXICITY Guideline No. Study Type Results 90–Day oral toxicity rodents NOAEL = 75 mg/kg/day LOAEL = 375 mg/kg/day based on decreased body weight and body weight gain, dark urine, increased absolute spleen and liver weights, congestion in spleen, kidney, and liver, discoloration and alterations in hematological and clinical chemistry parameters. 870.3100 90–Day oral toxicity rodents NOAEL = 2 mg/kg/day M/F LOAEL = 94/107 mg/kg/day based on liver/spleen alterations (extramedullary hematopoiesis in the liver, discoloration and hemosiderosis of the liver, congestion and extramedullary hematopoiesis in the spleen). 870.3150 90–Day oral toxicity nonrodents M/F NOAEL = 50 mg/kg/day LOAEL (mg/kg/day) not determined 870.3200 21/28–Day dermal toxicity NOAEL = 500 mg/kg/day LOAEL = 1,000 mg/kg/day based on effects in the stomach (dark foci-red foci in both sexes-6/10). Dermal: NOAEL = 1,000 mg/kg/day; LOAEL (mg/kg/day): Not determined. 870.3700 Prenatal developmental in rodents Maternal NOAEL = 50 mg/kg/day Maternal LOAEL = 100 mg/kg/daybased on decreased spleen weights and discoloration of the spleen Developmental NOAEL = 100 mg/kg/day Developmental LOAEL (mg/kg/day): Not determined 870.3700 Prenatal developmental in nonrodents Maternal NOAEL = 100 mg/kg/day Maternal LOAEL = 300 mg/kg/daybased on deceased body weight gains andfood consumption Developmental NOAEL = 300 mg/kg/day Developmental LOAEL (mg/kg/day): Not determined 870.3800 Reproduction and fertility effects Parental/Systemic NOAEL (mg/kg/day): Not determined. Parental/Systemic M/F LOAEL = 40/46 mg/kg/day based on gross pathological findings in the spleen and microscopic findings in the kidney, liver, and spleen. Reproductive M/F NOAEL = 115/131 mg/kg/day. Reproductive M/F LOAEL = 399/448 mg/kg/day based on decreased litter size in both generations. Offspring M/F NOAEL = 40/46 mg/kg/day. Offspring M/F LOAEL = 115/131 mg/kg/day based on decreased body weight of F2 pups in late lactation. 870.4100 Chronic toxicity dogs NOAEL = 10 mg/kg/day LOAEL = 50 mg/kg/day based on alterations in clinical chemistry parameters (increased BUN, cholesterol, total bilirubin) and increased absolute/relative kidney, liver and spleen weights. 870.4200 Carcinogenicity rats NOAEL (mg/kg/day): Not determined. M/F LOAEL = 73/91 mg/kg/day based on histopathological lesions in the spleen. No evidence of carcinogenicity. 870.4300 Carcinogenicity mice M/F NOAEL = 29/25 mg/kg/day. M/F LOAEL = 147/138 mg/kg/day based on reduced body weight and body weight gains, changes in hematological parameters, spleen and kidney lesions and increased clinical signs of toxicity. No evidence of carcinogenicity 870.5100 Gene mutation Negative 870.5300 Cytogenetics Weakly mutagenic in the presence of metabolic activation 870.5395 PWALKER on PRODPC60 with PROPOSALS 870.3100 Other effects Negative VerDate Aug<31>2005 16:05 Dec 05, 2006 Jkt 211001 PO 00000 Frm 00023 Fmt 4702 Sfmt 4702 E:\FR\FM\06DEP1.SGM 06DEP1 70706 Federal Register / Vol. 71, No. 234 / Wednesday, December 6, 2006 / Proposed Rules TABLE 1.—SUBCHRONIC, CHRONIC, AND OTHER TOXICITY—Continued Guideline No. 870.7485 Study Type Metabolism and pharmacokinetics B. Toxicological Endpoints The dose at which no adverse effects are observed (the NOAEL) from the toxicology study identified as appropriate for use in risk assessment is used to estimate the toxicological level of concern (LOC). However, the lowest dose at which adverse effects of concern are identified (the LOAEL) is sometimes used for risk assessment if no NOAEL was achieved in the toxicology study selected. An uncertainty factor (UF) is applied to reflect uncertainties inherent in the extrapolation from laboratory animal data to humans and in the variations in sensitivity among members of the human population as well as other unknowns. An UF of 100 is routinely used, 10X to account for interspecies differences and 10X for intra species differences. For dietary risk assessment (other than cancer) the Agency uses the UF to calculate an acute or chronic reference dose (acute RfD or chronic RfD) where Results Terminal distribution data showed no significant residual activity in tissues 168 hours post-dose for both the low and high oral dose groups: Urine was the major route for excretion. Recovery after 168 hours: Single/repeated low dose = urine 68-81% (both sexes) single high dose = 73-74% Male rats excreted a greater percentage of diphenylamine derived activity at the low dose, while female rats showed greater excretion in feces at this dose. At the high dose, the percentage eliminated in urine was equivalent in both males and females. Metabolites-urine: Dihydroxylated conjugates of diphenylamine, mono-hydroxylated sulfate conjugates of diphenylamine, monohydroxylated glucuronide conjugates of diphenylamine. Metabolites-feces: Parent chemical and 4-hydroxydiphenylamine, which comprised 0.5-3% administered dose in both sexes. the RfD is equal to the NOAEL divided by the appropriate UF (RfD = NOAEL/ UF). Where an additional safety factor is retained due to concerns unique to the FQPA, this additional factor is applied to the RfD by dividing the RfD by such additional factor. The acute or chronic Population Adjusted Dose (aPAD or cPAD) is a modification of the RfD to accommodate this type of FQPA Safety Factor (SF). For non-dietary risk assessments (other than cancer) the UF is used to determine the LOC. For example, when 100 is the appropriate UF (10X to account for interspecies differences and 10X for intraspecies differences) the LOC is 100. To estimate risk, a ratio of the NOAEL to exposures (margin of exposure (MOE) = NOAEL/exposure) is calculated and compared to the LOC. The linear default risk methodology (Q*) is the primary method currently used by the Agency to quantify carcinogenic risk. The Q* approach assumes that any amount of exposure will lead to some degree of cancer risk. A Q* is calculated and used to estimate risk which represents a probability of occurrence of additional cancer cases (e.g., risk is expressed as 1 x 106 or one in a million). Under certain specific circumstances, MOE calculations will be used for the carcinogenic risk assessment. In this non-linear approach, a ‘‘point of departure’’ is identified below which carcinogenic effects are not expected. The point of departure is typically a NOAEL based on an endpoint related to cancer effects though it may be a different value derived from the dose response curve. To estimate risk, a ratio of the point of departure to exposure (MOEcancer = point of departure/exposures) is calculated. A summary of the toxicological endpoints for diphenylamine used for human risk assessment is shown in Table 2 of this unit: TABLE 2.—SUMMARY OF TOXICOLOGICAL DOSE AND ENDPOINTS FOR DIPHENYLAMINE FOR USE IN HUMAN RISK ASSESSMENT Dose Used in Risk Assessment, UF Exposure Scenario FQPA SF* and Level of Concern for Risk Assessment Study and Toxicological Effects N/A N/A An acute reference dose for females aged 1350 has not been established. Developmental toxicity studies in rats and rabbits and a 2generation reproduction study in rats did not demonstrate evidence of toxicity attributable to a single dose. Acute Dietary (General population including infants and children) PWALKER on PRODPC60 with PROPOSALS Acute Dietary (Females 13-50 years of age) N/A N/A An endpoint attributable to a single dose was not identified from the available database. Chronic Dietary (All populations) NOAEL = 10 mg/kg/day UF = 100 Chronic RfD = 0.1 mg/kg/day FQPA SF = 1X cPAD = chronic RfD/FQPA SF = 0.1 mg/kg/day Chronic Toxicity - Dog LOAEL = 50 mg/kg/day based on alterations in clinical chemistry parameters (increased BUN, cholesterol, total bilirubin) and increased absolute/relative kidney, liver, and spleen weights. VerDate Aug<31>2005 16:05 Dec 05, 2006 Jkt 211001 PO 00000 Frm 00024 Fmt 4702 Sfmt 4702 E:\FR\FM\06DEP1.SGM 06DEP1 Federal Register / Vol. 71, No. 234 / Wednesday, December 6, 2006 / Proposed Rules 70707 TABLE 2.—SUMMARY OF TOXICOLOGICAL DOSE AND ENDPOINTS FOR DIPHENYLAMINE FOR USE IN HUMAN RISK ASSESSMENT—Continued Dose Used in Risk Assessment, UF Exposure Scenario FQPA SF* and Level of Concern for Risk Assessment Study and Toxicological Effects Short-Term Dermal (1 to 30 days) (Residential) Dermal (or oral) study NOAEL= 500 mg/kg/day LOC for MOE = 100 (Residential) 21–Day Dermal - Rabbit LOAEL = 1,000 mg/kg/day based on effects in the stomach (dark red foci in both sexes). Intermediate-Term Dermal (1 week to several months) (Residential) Dermal (or oral) study NOAEL = 500 mg/kg/day LOC for MOE = 100 (Residential) 21–Day Dermal- Rabbit LOAEL = 1,000 mg/kg/day based on effects in the stomach (dark red foci in both sexes). Short-Term Inhalation (1 to 30 days) (Residential) Inhalation (or oral) study NOAEL = 50 mg/kg/day (inhalation absorption rate = 100%) LOC for MOE = 100 (Residential) Developmental Toxicity - Rat LOAEL = 100 mg/kg/day based on increased spleen weights and discoloration of the spleen. Intermediate-Term Inhalation (1 week to several months) (Residential) Inhalation (or oral) study NOAEL = 50 mg/kg/day (inhalation absorption rate = 100%) LOC for MOE = 100 (Residential) Developmental Toxicity - Rat LOAEL = 100 mg/kg/day based on increased spleen weights and discoloration of the spleen. Cancer (oral, dermal, inhalation) N/A N/A Classification: This chemical is ‘‘not likely’’ to be a human carcinogen. PWALKER on PRODPC60 with PROPOSALS C. Exposure Assessment 1. Dietary exposure from food and feed uses. The residue of concern in plants and livestock for the tolerance enforcement and risk assessment is parent diphenylamine. Tolerances are established in 40 CFR 180.190(a) for diphenylamine residues in/on apple at 10 ppm and apple, wet pomace at 30 ppm. Diphenylamine (EC or SC/L) is applied to apples (pre- or post-harvest) as a spray, dip or drench application. Additionally, tolerances are established at 0.01 ppm in milk, meat, fat, and meat byproducts (except liver) of cattle, goat, horse, and sheep, and at 0.1 ppm in liver of these animals. Risk assessments were conducted by EPA to assess dietary exposures from diphenylamine in food as follows: i. Acute exposure. There were no toxic effects attributable to a single dose. An endpoint of concern was not identified to quantitate an acute-dietary risk to the U.S. general population or to the subpopulation females 13-50 years old. Therefore, an acute aggregate exposure assessment was not performed. ii. Chronic exposure.In conducting this chronic dietary risk assessment the Dietary Exposure Evaluation Model (DEEMTM) analysis evaluated the individual food consumption as reported by respondents in the USDA 1994–1996 and 1998 Nationwide Continuing Surveys of Food Intake by Individuals (CSFII) and accumulated exposure to the chemical for each commodity. The following assumptions were made for the chronic exposure VerDate Aug<31>2005 16:05 Dec 05, 2006 Jkt 211001 assessments: The chronic dietary exposure analysis was based on tolerance level residues, DEEM (Version 7.81) default processing factors, an empirical processing factor for apple juice, and 100% crop treated assumptions. iii. Cancer. Diphenylamine was classified as ‘‘not likely to be a human carcinogen;’’ therefore, a cancer dietary exposure analysis was not performed. 2. Dietary exposure from drinking water. Diphenylamine uses are postharvest; therefore, residues in drinking water are not relevant to this risk assessment. 3. Dietary exposure from non-dietary exposure. Diphenylamine is not registered for use on any sites that would result in residential exposure. Therefore a residential exposure risk assessment was not performed. 4. Cumulative effects from substances with a common mechanism of toxicity. Section 408(b)(2)(D)(v) of the FFDCA 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.’’ Unlike other pesticides for which EPA has followed a cumulative risk approach based on a common mechanism of toxicity, EPA has not made a common mechanism of toxicity finding as to diphenylamine and any other substances and diphenylamine does not appear to produce a toxic metabolite produced by other substances. For the PO 00000 Frm 00025 Fmt 4702 Sfmt 4702 purposes of this tolerance action, therefore, EPA has not assumed that diphenylamine has a common mechanism of toxicity with other substances. For information regarding EPA’s efforts to determine which chemicals have a common mechanism of toxicity and to evaluate the cumulative effects of such chemicals, see the policy statements released by EPA’s Office of Pesticide Programs concerning common mechanism determinations and procedures for cumulating effects from substances found to have a common mechanism on EPA’s website at https://www.epa.gov/ pesticides/cumulative/. D. Safety Factor for Infants and Children 1. In general. Section 408 of the FFDCA provides that EPA shall apply an additional tenfold margin of safety for infants and children in the case of threshold effects to account for prenatal and postnatal toxicity and the completeness of the data base on toxicity and exposure 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 MOE analysis or through using uncertainty (safety) factors in calculating a dose level that poses no appreciable risk to humans. 2. Prenatal and postnatal sensitivity. There is no indication of increased sensitivity of rats or rabbits to in utero and postnatal exposure to diphenylamine. In prenatal E:\FR\FM\06DEP1.SGM 06DEP1 70708 Federal Register / Vol. 71, No. 234 / Wednesday, December 6, 2006 / Proposed Rules PWALKER on PRODPC60 with PROPOSALS developmental toxicity studies in rats and rabbits, no evidence of developmental toxicity was observed. In a 2–generation reproduction study, offspring toxicity (decreased body weight) was seen only in the presence of maternal toxicity. 3. Conclusion. EPA recommended the FQPA safety factor be reduced to 1X for the following reasons: i. There is a complete toxicity data base for diphenylamine; ii. The toxicity database showed no increase in susceptibility in fetuses and pups with in utero and postnatal exposure, and iii. The dietary food exposure assessment is based on recommended tolerance-level residues (except those processed commodities for which processing factors were used) and assumes 100% crop treated for all commodities, which resulted in very high-end estimates of dietary exposure. E. Aggregate Risks and Determination of Safety 1. Acute risk. There were no toxic effects attributable to a single dose. An endpoint of concern was not identified to quantitate an acute-dietary risk to the U.S. general population or to the subpopulation females 13-50 years old. Therefore, diphenylamine is not expected to pose an acute risk. 2. Chronic risk. Using the exposure assumptions described in this unit for chronic exposure, EPA has concluded that exposure to diphenylamine from food will utilize 12% of the cPAD for the U.S. population, 69% of the cPAD for all infants <1 year old, and 90% of the cPAD for children 1-2 years old. There are no residential uses for diphenylamine that result in chronic residential exposure. In addition, there is no potential for chronic dietary exposure in drinking water as diphenylamine is applied only as a post-harvest use. Therefore, EPA does not expect the aggregate exposure to exceed 100% of the cPAD. 3. Short and intermediate-term risk. There are no residential uses for diphenylamine, and residues are not expected to occur in drinking water. Therefore, short and intermediate-term aggregate risk assessments were not performed. 4. Aggregate cancer risk for U.S. population. Diphenylamine is not likely to be carcinogenic to humans. Therefore, a cancer aggregate risk assessment was not performed. 5. Determination of safety. Based on these risk assessments, EPA concludes that there is a reasonable certainty that no harm will result to the general population, and to infants and children VerDate Aug<31>2005 16:05 Dec 05, 2006 Jkt 211001 from aggregate exposure to diphenylamine residues. IV. Other Considerations A. Analytical Enforcement Methodology An adequate gas chromatography/ mass-selective detector (GC/MSD) method is available for enforcing tolerances on apple commodities, and this method was used for data collection in the current post-harvest study. The method was adequately validated in conjunction with the sample analyses. A modification of this method was used in the pear analyses. Therefore, the Agency requires the registrant to submit an analytical reference standard of diphenylamine to the EPA National Pesticide Standards Repository. The method may be requested from: Chief, Analytical Chemistry Branch, Environmental Science Center, 701 Mapes Rd., Ft. Meade, MD 20755–5350; telephone number: (410) 305–2905; email address: residuemethods@epa.gov. B. International Residue Limits Codex MRLs have been established for the post harvest use of diphenylamine on pears. The MRL for pear is 5 ppm, and is the same as the recommended pear tolerance. V. Conclusion A tolerance is proposed for residues of diphenylamine in pear at 5.0 ppm. VI. Statutory and Executive Order Reviews This proposed rule establishes a tolerance under section 408(d) of the FFDCA in response to a petition submitted to the Agency. The Office of Management and Budget (OMB) has exempted these types of actions from review under Executive Order 12866, entitled Regulatory Planning and Review (58 FR 51735, October 4, 1993). Because this proposed rule has been exempted from review under Executive Order 12866 due to its lack of significance, this proposed rule is not subject to Executive Order 13211, Actions Concerning Regulations That Significantly Affect Energy Supply, Distribution, or Use (66 FR 28355, May 22, 2001). This proposed rule does not contain any information collections subject to OMB approval under the Paperwork Reduction Act (PRA), 44 U.S.C. 3501 et seq., or impose any enforceable duty or contain any unfunded mandate as described under Title II of the Unfunded Mandates Reform Act of 1995 (UMRA) (Public Law 104–4). Nor does it require any special considerations under Executive Order 12898, entitled Federal Actions to Address Environmental Justice in PO 00000 Frm 00026 Fmt 4702 Sfmt 4702 Minority Populations and Low-Income Populations (59 FR 7629, February 16, 1994); or OMB review or any Agency action under Executive Order 13045, entitled Protection of Children from Environmental Health Risks and Safety Risks (62 FR 19885, April 23, 1997). This action does not involve any technical standards that would require Agency consideration of voluntary consensus standards pursuant to section 12(d) of the National Technology Transfer and Advancement Act of 1995 (NTTAA), Public Law 104–113, section 12(d) (15 U.S.C. 272 note). Pursuant to the Regulatory Flexibility Act (RFA) (5 U.S.C. 601 et seq.), the Agency hereby certifies that this proposed action will not have significant negative economic impact on a substantial number of small entities. Establishment of a tolerance legalizes the presence of a pesticide residue in a food. In addition, the Agency has determined that this action will not have a substantial direct effect on States, on the relationship between the national government and the States, or on the distribution of power and responsibilities among the various levels of government, as specified in Executive Order 13132, entitled Federalism (64 FR 43255, August 10, 1999). Executive Order 13132 requires EPA to develop an accountable process to ensure ‘‘meaningful and timely input by State and local officials in the development of regulatory policies that have federalism implications.’’ ‘‘Policies that have federalism implications’’ is defined in the Executive order to include regulations that have ‘‘substantial direct effects on the States, on the relationship between the national government and the States, or on the distribution of power and responsibilities among the various levels of government.’’ This proposed rule directly regulates growers, food processors, food handlers and food retailers, not States. This action does not alter the relationships or distribution of power and responsibilities established by Congress in the preemption provisions of section 408(n)(4) of the FFDCA. For these same reasons, the Agency has determined that this proposed rule does not have any ‘‘tribal implications’’ as described in Executive Order 13175, entitled Consultation and Coordination with Indian Tribal Governments (65 FR 67249, November 6, 2000). Executive Order 3175, requires EPA to develop an accountable process to ensure ‘‘meaningful and timely input by tribal officials in the development of regulatory policies that have tribal implications.’’ ‘‘Policies that have tribal implications’’ is defined in the E:\FR\FM\06DEP1.SGM 06DEP1 Federal Register / Vol. 71, No. 234 / Wednesday, December 6, 2006 / Proposed Rules PWALKER on PRODPC60 with PROPOSALS Executive order to include regulations that have ‘‘substantial direct effects on one or more Indian tribes, on the relationship between the Federal Government and the Indian tribes, or on the distribution of power and responsibilities between the Federal Government and Indian tribes.’’ This proposed rule will not have substantial direct effects on tribal governments, on the relationship between the Federal Government and Indian tribes, or on the distribution of power and responsibilities between the Federal Government and Indian tribes, as specified in Executive Order 13175. Thus, Executive Order 13175 does not apply to this proposed rule. Proposed rule, extension of reply comment period. ACTION: SUMMARY: This document grants a motion requesting an extension of time to file reply comments on an intercarrier compensation reform plan, the ‘‘Missoula Plan.’’ The Order modifies the pleading cycle by extending the comment period in order to facilitate the development of a more substantive and complete record in this proceeding. DATES: Submit reply comments on or before January 11, 2007. ADDRESSES: You may submit comments, identified by CC Docket No. 01–92, by any of the following methods: • Federal eRulemaking Portal: https:// www.regulations.gov. Follow the List of Subjects in 40 CFR Part 180 instructions for submitting comments. Environmental protection, • Agency Web site: https:// Administrative practice and procedure, www.fcc.gov. Follow the instructions for Agricultural commodities, Pesticides submitting comments on the Electronic and pests, Reporting and recordkeeping Comment Filing System (ECFS) / https:// requirements. www.fcc.gov/cgb/ecfs/. • E-mail: To Dated: November 22, 2006. victoria.goldberg@fcc.gov. Include CC Donald R. Stubbs, Docket 01–92 in the subject line of the Acting Director, Registration Division, Office message. of Pesticide Programs. • Fax: To the attention of Victoria Therefore, it is proposed that 40 CFR Goldberg at 202–418–1567. Include CC chapter I be amended as follows: Docket 01–92 on the cover page. • Mail: Parties should send a copy of PART 180—AMENDED their filings to Victoria Goldberg, 1. The authority citation for part 180 Pricing Policy Division, Wireline continues to read as follows: Competition Bureau, Federal Communications Commission, Room 5– Authority: 21 U.S.C. 321(q), 346a and 371. A266, 445 12th Street, SW., 2. Section 180.190 is amended by Washington, DC 20554. alphabetically adding a commodity to • Hand Delivery / Courier: The the table in paragraph (a) to read as Commission’s contractor, Natek, Inc., follows: will receive hand-delivered or § 180.190 Diphenylamine; tolerances for messenger-delivered paper filings for residues. the Commission’s Secretary at 236 (a) * * * Massachusetts Avenue, NE., Suite 110, Washington, DC 20002. Parts per Commodity —The filing hours at this location are 8 million a.m. to 7 p.m. —All hand deliveries must be held * * * * * together with rubber bands or Pear (post harvest) ................... 5.0 * * * * * fasteners. —Any envelopes must be disposed of [FR Doc. E6–20648 Filed 12–5–06; 8:45 am] before entering the building. BILLING CODE 6560–50–S —Commercial overnight mail (other than U.S. Postal Service Express Mail and Priority Mail) must be sent to 9300 East Hampton Drive, Capitol FEDERAL COMMUNICATIONS Heights, MD 20743. COMMISSION People with Disabilities: To request materials in accessible formats for 47 CFR Chapter I people with disabilities (braille, large print, electronic files, audio format), [CC Docket No. 01–92; DA 06–2339] send an e-mail to fcc504@fcc.gov or call the Consumer & Governmental Affairs Developing a Unified Intercarrier Bureau at 202–418–0530 (voice), 202– Compensation Regime 418–0432 (tty). AGENCY: Federal Communications Instructions: All submissions received Commission. must include the agency name and VerDate Aug<31>2005 16:05 Dec 05, 2006 Jkt 211001 PO 00000 Frm 00027 Fmt 4702 Sfmt 4702 70709 docket number. All comments received will be posted without change to https:// www.fcc.gov/cgb/ecfs/, including any personal information provided. For detailed instructions on submitting comments and additional information on the rulemaking process, see the Public Notice requesting comment on the Missoula Plan. 71 FR 45510, Aug. 9, 2006. FOR FURTHER INFORMATION CONTACT: Jennifer McKee, Wireline Competition Bureau, Pricing Policy Division, (202) 418–1530, or Victoria Goldberg, Wireline Competition Bureau, Pricing Policy Division, (202) 418–7353. SUPPLEMENTARY INFORMATION: This is a summary of the Commission’s Order released November 20, 2006. The complete text of the Order is available for inspection and copying during business hours at the FCC Reference Information Center, Portals II, 445 12th St., SW., Room CY–A257, Washington, DC 20554. The complete text of this document also may be purchased from the Commission’s copy contractor, Best Copy and Printing, Inc., 445 12th Street, SW., Room, CY–B402, Washington, DC 20554. The complete text may also be downloaded at: https://www.fcc.gov. By the Order, the Wireline Competition Bureau (WCB) grants a motion requesting an extension of the date for filing reply comments on an intercarrier compensation plan called the ‘‘Missoula Plan.’’ The Missoula Plan was filed on July 24, 2006 by the National Association of Regulatory Utility Commissioners’ Task Force on Intercarrier Compensation. On July 25, 2006, the WCB released a Public Notice requesting that comments on the Missoula Plan be filed by September 25, 2006, and reply comments by November 9, 2006. 71 FR 45510, Aug. 9, 2006. On August 29, 2006, WCB released an order granting extensions of the comment and reply comment filing dates to October 25, 2006 and December 11, 2006. 71 FR 54008, Sep. 13, 2006. Over 110 parties filed initial comments on or before October 25, 2006. On November 17, 2006, the National Association of Regulatory Utility Commissioners filed a motion requesting an extension of the reply comment date to January 11, 2007. The WCB determined that providing additional time to file reply comments will facilitate the development of a more substantive and complete record in this proceeding. Although it is the policy of the Commission that extensions of time shall not be routinely granted, the WCB determined that given the number, length, and variety of initial comments, good cause exists to provide parties an extension of time, from December 11, E:\FR\FM\06DEP1.SGM 06DEP1

Agencies

ENVIRONMENTAL PROTECTION AGENCY

[Federal Register Volume 71, Number 234 (Wednesday, December 6, 2006)]
[Proposed Rules]
[Pages 70703-70709]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E6-20648]

-----------------------------------------------------------------------

ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[EPA-HQ-OPP-2006-0731; FRL-8104-1]

Diphenylamine; Proposed Pesticide Tolerance

AGENCY: Environmental Protection Agency (EPA).

ACTION: Proposed rule.

-----------------------------------------------------------------------

SUMMARY: This document proposes to establish a tolerance for residues
of diphenylamine in or on pear under the Federal Food, Drug, and
Cosmetic Act (FFDCA), as amended by the Food Quality Protection Act of
1996 (FQPA).

DATES: Comments must be received on or before February 5, 2007.

ADDRESSES: Submit your comments, identified by docket identification
(ID) number EPA-HQ-OPP-2006-0731, by one of the following methods:
Federal eRulemaking Portal: https://www.regulations.gov.
Follow the on-line instructions for submitting comments.
Mail: Office of Pesticide Programs (OPP) Regulatory Public
Docket (7502P), Environmental Protection Agency, 1200 Pennsylvania
Ave., NW., Washington, DC 20460-0001.
Delivery: OPP Regulatory Public Docket (7502P),
Environmental Protection Agency, Rm. S-4400, One Potomac Yard (South
Building), 2777 S. Crystal Drive, Arlington, VA. Deliveries are only
accepted during the Docket's normal hours of operation (8:30 a.m. to 4
p.m., Monday through Friday, excluding legal holidays). Special
arrangements should be made for deliveries of boxed information. The
Docket telephone number is (703) 305-5805.
Instructions: Direct your comments to docket ID number EPA-HQ-OPP-
2006-0731. EPA's policy is that all comments received will be included
in the docket without change and may be made available on-line at
https://www.regulations.gov, including any personal information
provided, unless the comment includes information claimed to be
Confidential Business Information (CBI) or other information whose
disclosure is restricted by statute. Do not submit information that you
consider to be CBI or otherwise protected through regulations.gov or e-
mail. The Federal regulations.gov website is an ``anonymous access''
system, which means EPA will not know your identity or contact
information unless you provide it in the body of your comment. If you
send an e-mail comment directly to EPA without going through
regulations.gov, your e-mail address will be automatically captured and
included as part of the comment that is placed in the docket and made
available on the Internet. If you submit an electronic comment, EPA
recommends that you include your name and other contact information in
the body of your comment and with any disk or CD-ROM you submit. If EPA
cannot read your comment due to technical difficulties and cannot
contact you for clarification, EPA may not be able to consider your
comment. Electronic files should avoid the use of special characters,
any form of encryption, and be free of any defects or viruses.
Docket: All documents in the docket are listed in the docket index.
Although listed in the index, some information is not publicly
available, e.g., CBI or other information whose disclosure is
restricted by statute. Certain other material, such as copyrighted
material, is not placed on the Internet and will be publicly available
only in hard copy form. Publicly available docket materials are
available either in the electronic docket at https://
www.regulations.gov, or, if only available in hard copy, at the OPP
Regulatory Public Docket in Rm. S-4400, One Potomac Yard (South
Building), 2777 S. Crystal Drive, Arlington, VA. The hours of operation
of this Docket Facility are from 8:30 a.m. to 4 p.m., Monday through
Friday, excluding legal holidays. The Docket telephone number is (703)
305-5805.

FOR FURTHER INFORMATION CONTACT: Shaja R. Brothers, Registration
Division (7505P), Office of Pesticide Programs, Environmental
Protection Agency, 1200 Pennsylvania Ave, NW., Washington, DC 20460-
0001; telephone number: (703) 308-3194; e-mail address:
brothers.shaja@epa.gov.

[[Page 70704]]

SUPPLEMENTARY INFORMATION:

I. General Information

A. Does this Action Apply to Me?

You may be potentially affected by this action if you are an
agricultural producer, food manufacturer, or pesticide manufacturer.
Potentially affected entities may include, but are not limited to:
Crop production (NAICS code 111).
Animal production (NAICS code 112).
Food manufacturing (NAICS code 311).
Pesticide manufacturing (NAICS code 32532).
This listing is not intended to be exhaustive, but rather provides
a guide for readers regarding entities likely to be affected by this
action. Other types of entities not listed in this unit could also be
affected. The North American Industrial Classification System (NAICS)
codes have been provided to assist you and others in determining
whether this action might apply to certain entities. To determine
whether you or your business may be affected by this action, you should
carefully examine the applicability provisions. If you have any
questions regarding the applicability of this action to a particular
entity, consult the person listed under FOR FURTHER INFORMATION
CONTACT.

B. What Should I Consider as I Prepare My Comments for EPA?

1. Submitting CBI. Do not submit this information to EPA through
www.regulations.gov or e-mail. Clearly mark the part or all of the
information that you claim to be CBI. For CBI information in a disk or
CD ROM that you mail to EPA, mark the outside of the disk or CD ROM as
CBI and then identify electronically within the disk or CD ROM the
specific information that is claimed as CBI. In addition to one
complete version of the comment that includes information claimed as
CBI, a copy of the comment that does not contain the information
claimed as CBI must be submitted for inclusion in the public docket.
Information so marked will not be disclosed except in accordance with
procedures set forth in 40 CFR part 2.
2. Tips for preparing your comments. When submitting comments,
remember to:
i. Identify the document by docket ID number and other identifying
information (subject heading, Federal Register date and page number).
ii. Follow directions. The Agency may ask you to respond to
specific questions or organize comments by referencing a Code of
Federal Regulations (CFR) part or section number.
iii. Explain why you agree or disagree; suggest alternatives and
substitute language for your requested changes.
iv. Describe any assumptions and provide any technical information
and/or data that you used.
v. If you estimate potential costs or burdens, explain how you
arrived at your estimate in sufficient detail to allow for it to be
reproduced.
vi. Provide specific examples to illustrate your concerns and
suggest alternatives.
vii. Explain your views as clearly as possible, avoiding the use of
profanity or personal threats.
viii. Make sure to submit your comments by the comment period
deadline identified.

II. Background and Statutory Findings

EPA on its own initiative, under section 408(e) of the FFDCA, 21
U.S.C. 346a(e), is proposing to establish a tolerance for residues of
the fungicide, diphenylamine in or on pear at 5.0 parts per million
(ppm). The Interregional Research Project Number 4 (IR-4) submitted a
petition (PP 0E6107) for this use. However, neither IR-4 nor Atomchem
North American Incorporated, the registrant, submitted all required
elements of a petition in support of establishing a tolerance. Because
the petition was incomplete, EPA did not publish a Notice of Filing for
the petition.
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) of the FFDCA 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) of the FFDCA requires EPA to give special
consideration to exposure of infants and children to the pesticide
chemical residue in establishing a tolerance and to ``ensure that there
is a reasonable certainty that no harm will result to infants and
children from aggregate exposure to the pesticide chemical residue. . .
.''
EPA performs a number of analyses to determine the risks from
aggregate exposure to pesticide residues. For further discussion of the
regulatory requirements of section 408 of the FFDCA and a complete
description of the risk assessment process, see https://www.epa.gov/
fedrgstr/EPA-PEST/1997/November/Day-26/p30948.htm.

III. Aggregate Risk Assessment and Determination of Safety

Consistent with section 408(b)(2)(D) of the FFDCA, 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 and to
make a determination on aggregate exposure, consistent with section
408(b)(2) of the FFDCA, for a tolerance for residues of diphenylamine
on pear at 5.0 ppm. EPA's assessment of exposures and risks associated
with establishing the tolerance follows:

A. Toxicological Profile

EPA has evaluated the available toxicity data and considered its
validity, completeness, and reliability as well as the relationship of
the results of the studies to human risk. EPA has also considered
available information concerning the variability of the sensitivities
of major identifiable subgroups of consumers, including infants and
children. The nature of the toxic effects caused by diphenylamine is
discussed in Table 1 of this unit as well as the no-observed-adverse-
effect-level (NOAEL) and the lowest-observed-adverse-effect-level
(LOAEL) from the toxicity studies reviewed.

[[Page 70705]]

Table 1.--Subchronic, Chronic, and Other Toxicity
----------------------------------------------------------------------------------------------------------------
Guideline No. Study Type Results
----------------------------------------------------------------------------------------------------------------
870.3100 90-Day oral toxicity NOAEL = 75 mg/kg/day
rodents LOAEL = 375 mg/kg/day based on decreased
body weight and body weight gain, dark
urine, increased absolute spleen and liver
weights, congestion in spleen, kidney, and
liver, discoloration and alterations in
hematological and clinical chemistry
parameters.
----------------------------------------------------------------------------------------------------------------
870.3100 90-Day oral toxicity NOAEL = 2 mg/kg/day
rodents M/F LOAEL = 94/107 mg/kg/day based on liver/
spleen alterations (extramedullary
hematopoiesis in the liver, discoloration
and hemosiderosis of the liver, congestion
and extramedullary hematopoiesis in the
spleen).
----------------------------------------------------------------------------------------------------------------
870.3150 90-Day oral toxicity non- M/F NOAEL = 50 mg/kg/day
rodents LOAEL (mg/kg/day) not determined
----------------------------------------------------------------------------------------------------------------
870.3200 21/28-Day dermal toxicity NOAEL = 500 mg/kg/day
LOAEL = 1,000 mg/kg/day based on effects in
the stomach (dark foci-red foci in both
sexes-6/10).
Dermal: NOAEL = 1,000 mg/kg/day;
LOAEL (mg/kg/day): Not determined.
----------------------------------------------------------------------------------------------------------------
870.3700 Prenatal developmental in Maternal NOAEL = 50 mg/kg/day
rodents Maternal LOAEL = 100 mg/kg/daybased on
decreased spleen weights and discoloration
of the spleen
Developmental NOAEL = 100 mg/kg/day
Developmental LOAEL (mg/kg/day): Not
determined
----------------------------------------------------------------------------------------------------------------
870.3700 Prenatal developmental in Maternal NOAEL = 100 mg/kg/day
nonrodents Maternal LOAEL = 300 mg/kg/daybased on
deceased body weight gains andfood
consumption
Developmental NOAEL = 300 mg/kg/day
Developmental LOAEL (mg/kg/day): Not
determined
----------------------------------------------------------------------------------------------------------------
870.3800 Reproduction and fertility Parental/Systemic NOAEL (mg/kg/day): Not
effects determined.
Parental/Systemic M/F LOAEL = 40/46 mg/kg/
day based on gross pathological findings
in the spleen and microscopic findings in
the kidney, liver, and spleen.
Reproductive M/F NOAEL = 115/131 mg/kg/day.
Reproductive M/F LOAEL = 399/448 mg/kg/day
based on decreased litter size in both
generations.
Offspring M/F NOAEL = 40/46 mg/kg/day.
Offspring M/F LOAEL = 115/131 mg/kg/day
based on decreased body weight of F2 pups
in late lactation.
----------------------------------------------------------------------------------------------------------------
870.4100 Chronic toxicity dogs NOAEL = 10 mg/kg/day
LOAEL = 50 mg/kg/day based on alterations
in clinical chemistry parameters
(increased BUN, cholesterol, total
bilirubin) and increased absolute/relative
kidney, liver and spleen weights.
----------------------------------------------------------------------------------------------------------------
870.4200 Carcinogenicity rats NOAEL (mg/kg/day): Not determined.
M/F LOAEL = 73/91 mg/kg/day based on
histopathological lesions in the spleen.
No evidence of carcinogenicity.
----------------------------------------------------------------------------------------------------------------
870.4300 Carcinogenicity mice M/F NOAEL = 29/25 mg/kg/day.
M/F LOAEL = 147/138 mg/kg/day based on
reduced body weight and body weight gains,
changes in hematological parameters,
spleen and kidney lesions and increased
clinical signs of toxicity. No evidence of
carcinogenicity
----------------------------------------------------------------------------------------------------------------
870.5100 Gene mutation Negative
----------------------------------------------------------------------------------------------------------------
870.5300 Cytogenetics Weakly mutagenic in the presence of
metabolic activation
----------------------------------------------------------------------------------------------------------------
870.5395 Other effects Negative
----------------------------------------------------------------------------------------------------------------

[[Page 70706]]

870.7485 Metabolism and Terminal distribution data showed no
pharmacokinetics significant residual activity in tissues
168 hours post-dose for both the low and
high oral dose groups: Urine was the major
route for excretion.
Recovery after 168 hours: Single/repeated
low dose = urine 68-81% (both sexes)
single high dose = 73-74%
Male rats excreted a greater percentage of
diphenylamine derived activity at the low
dose, while female rats showed greater
excretion in feces at this dose. At the
high dose, the percentage eliminated in
urine was equivalent in both males and
females.
Metabolites-urine: Dihydroxylated
conjugates of diphenylamine, mono-
hydroxylated sulfate conjugates of
diphenylamine, monohydroxylated
glucuronide conjugates of diphenylamine.
Metabolites-feces: Parent chemical and 4-
hydroxydiphenylamine, which comprised 0.5-
3% administered dose in both sexes.
----------------------------------------------------------------------------------------------------------------

B. Toxicological Endpoints

The dose at which no adverse effects are observed (the NOAEL) from
the toxicology study identified as appropriate for use in risk
assessment is used to estimate the toxicological level of concern
(LOC). However, the lowest dose at which adverse effects of concern are
identified (the LOAEL) is sometimes used for risk assessment if no
NOAEL was achieved in the toxicology study selected. An uncertainty
factor (UF) is applied to reflect uncertainties inherent in the
extrapolation from laboratory animal data to humans and in the
variations in sensitivity among members of the human population as well
as other unknowns. An UF of 100 is routinely used, 10X to account for
interspecies differences and 10X for intra species differences.
For dietary risk assessment (other than cancer) the Agency uses the
UF to calculate an acute or chronic reference dose (acute RfD or
chronic RfD) where the RfD is equal to the NOAEL divided by the
appropriate UF (RfD = NOAEL/UF). Where an additional safety factor is
retained due to concerns unique to the FQPA, this additional factor is
applied to the RfD by dividing the RfD by such additional factor. The
acute or chronic Population Adjusted Dose (aPAD or cPAD) is a
modification of the RfD to accommodate this type of FQPA Safety Factor
(SF).
For non-dietary risk assessments (other than cancer) the UF is used
to determine the LOC. For example, when 100 is the appropriate UF (10X
to account for interspecies differences and 10X for intraspecies
differences) the LOC is 100. To estimate risk, a ratio of the NOAEL to
exposures (margin of exposure (MOE) = NOAEL/exposure) is calculated and
compared to the LOC.
The linear default risk methodology (Q*) is the primary method
currently used by the Agency to quantify carcinogenic risk. The Q*
approach assumes that any amount of exposure will lead to some degree
of cancer risk. A Q* is calculated and used to estimate risk which
represents a probability of occurrence of additional cancer cases
(e.g., risk is expressed as 1 x 10\6\ or one in a million). Under
certain specific circumstances, MOE calculations will be used for the
carcinogenic risk assessment. In this non-linear approach, a ``point of
departure'' is identified below which carcinogenic effects are not
expected. The point of departure is typically a NOAEL based on an
endpoint related to cancer effects though it may be a different value
derived from the dose response curve. To estimate risk, a ratio of the
point of departure to exposure (MOEcancer = point of
departure/exposures) is calculated. A summary of the toxicological
endpoints for diphenylamine used for human risk assessment is shown in
Table 2 of this unit:

Table 2.--Summary of Toxicological Dose and Endpoints for Diphenylamine for Use in Human Risk Assessment
----------------------------------------------------------------------------------------------------------------
FQPA SF* and Level of
Exposure Scenario Dose Used in Risk Concern for Risk Study and Toxicological
Assessment, UF Assessment Effects
----------------------------------------------------------------------------------------------------------------
Acute Dietary (Females 13-50 years of N/A N/A An acute reference dose
age) for females aged 13-50
has not been
established.
Developmental toxicity
studies in rats and
rabbits and a 2-
generation
reproduction study in
rats did not
demonstrate evidence
of toxicity
attributable to a
single dose.
----------------------------------------------------------------------------------------------------------------
Acute Dietary (General population N/A N/A An endpoint
including infants and children) attributable to a
single dose was not
identified from the
available database.
----------------------------------------------------------------------------------------------------------------
Chronic Dietary (All populations) NOAEL = 10 mg/kg/day FQPA SF = 1X Chronic Toxicity - Dog
UF = 100 Chronic RfD = cPAD = chronic RfD/FQPA LOAEL = 50 mg/kg/day
0.1 mg/kg/day. SF = 0.1 mg/kg/day. based on alterations
in clinical chemistry
parameters (increased
BUN, cholesterol,
total bilirubin) and
increased absolute/
relative kidney,
liver, and spleen
weights.
----------------------------------------------------------------------------------------------------------------

[[Page 70707]]

Short-Term Dermal (1 to 30 days) Dermal (or oral) study LOC for MOE = 100 21-Day Dermal - Rabbit
(Residential)........................ NOAEL= 500 mg/kg/day... (Residential).......... LOAEL = 1,000 mg/kg/day
based on effects in
the stomach (dark red
foci in both sexes).
----------------------------------------------------------------------------------------------------------------
Intermediate-Term Dermal (1 week to Dermal (or oral) study LOC for MOE = 100 21-Day Dermal- Rabbit
several months) NOAEL = 500 mg/kg/day (Residential).......... LOAEL = 1,000 mg/kg/day
(Residential)........................ based on effects in
the stomach (dark red
foci in both sexes).
----------------------------------------------------------------------------------------------------------------
Short-Term Inhalation (1 to 30 days) Inhalation (or oral) LOC for MOE = 100 Developmental Toxicity
(Residential)........................ study (Residential).......... Rat
NOAEL = 50 mg/kg/day LOAEL = 100 mg/kg/day
(inhalation absorption based on increased
rate = 100%). spleen weights and
discoloration of the
spleen.
----------------------------------------------------------------------------------------------------------------
Intermediate-Term Inhalation (1 week Inhalation (or oral) LOC for MOE = 100 Developmental Toxicity
to several months) study (Residential).......... Rat
(Residential)........................ NOAEL = 50 mg/kg/day LOAEL = 100 mg/kg/day
(inhalation absorption based on increased
rate = 100%). spleen weights and
discoloration of the
spleen.
----------------------------------------------------------------------------------------------------------------
Cancer (oral, dermal, inhalation) N/A N/A Classification: This
chemical is ``not
likely'' to be a human
carcinogen.
----------------------------------------------------------------------------------------------------------------

C. Exposure Assessment

1. Dietary exposure from food and feed uses. The residue of concern
in plants and livestock for the tolerance enforcement and risk
assessment is parent diphenylamine. Tolerances are established in 40
CFR 180.190(a) for diphenylamine residues in/on apple at 10 ppm and
apple, wet pomace at 30 ppm. Diphenylamine (EC or SC/L) is applied to
apples (pre- or post-harvest) as a spray, dip or drench application.
Additionally, tolerances are established at 0.01 ppm in milk, meat,
fat, and meat byproducts (except liver) of cattle, goat, horse, and
sheep, and at 0.1 ppm in liver of these animals. Risk assessments were
conducted by EPA to assess dietary exposures from diphenylamine in food
as follows:
i. Acute exposure. There were no toxic effects attributable to a
single dose. An endpoint of concern was not identified to quantitate an
acute-dietary risk to the U.S. general population or to the
subpopulation females 13-50 years old. Therefore, an acute aggregate
exposure assessment was not performed.
ii. Chronic exposure.In conducting this chronic dietary risk
assessment the Dietary Exposure Evaluation Model (DEEM\TM\) analysis
evaluated the individual food consumption as reported by respondents in
the USDA 1994-1996 and 1998 Nationwide Continuing Surveys of Food
Intake by Individuals (CSFII) and accumulated exposure to the chemical
for each commodity. The following assumptions were made for the chronic
exposure assessments: The chronic dietary exposure analysis was based
on tolerance level residues, DEEM (Version 7.81) default processing
factors, an empirical processing factor for apple juice, and 100% crop
treated assumptions.
iii. Cancer. Diphenylamine was classified as ``not likely to be a
human carcinogen;'' therefore, a cancer dietary exposure analysis was
not performed.
2. Dietary exposure from drinking water. Diphenylamine uses are
post-harvest; therefore, residues in drinking water are not relevant to
this risk assessment.
3. Dietary exposure from non-dietary exposure. Diphenylamine is not
registered for use on any sites that would result in residential
exposure. Therefore a residential exposure risk assessment was not
performed.
4. Cumulative effects from substances with a common mechanism of
toxicity. Section 408(b)(2)(D)(v) of the FFDCA 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.''
Unlike other pesticides for which EPA has followed a cumulative
risk approach based on a common mechanism of toxicity, EPA has not made
a common mechanism of toxicity finding as to diphenylamine and any
other substances and diphenylamine does not appear to produce a toxic
metabolite produced by other substances. For the purposes of this
tolerance action, therefore, EPA has not assumed that diphenylamine has
a common mechanism of toxicity with other substances. For information
regarding EPA's efforts to determine which chemicals have a common
mechanism of toxicity and to evaluate the cumulative effects of such
chemicals, see the policy statements released by EPA's Office of
Pesticide Programs concerning common mechanism determinations and
procedures for cumulating effects from substances found to have a
common mechanism on EPA's website at https://www.epa.gov/pesticides/
cumulative/.

D. Safety Factor for Infants and Children

1. In general. Section 408 of the FFDCA provides that EPA shall
apply an additional tenfold margin of safety for infants and children
in the case of threshold effects to account for prenatal and postnatal
toxicity and the completeness of the data base on toxicity and exposure
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 MOE analysis or
through using uncertainty (safety) factors in calculating a dose level
that poses no appreciable risk to humans.
2. Prenatal and postnatal sensitivity. There is no indication of
increased sensitivity of rats or rabbits to in utero and postnatal
exposure to diphenylamine. In prenatal

[[Page 70708]]

developmental toxicity studies in rats and rabbits, no evidence of
developmental toxicity was observed. In a 2-generation reproduction
study, offspring toxicity (decreased body weight) was seen only in the
presence of maternal toxicity.
3. Conclusion. EPA recommended the FQPA safety factor be reduced to
1X for the following reasons:
i. There is a complete toxicity data base for diphenylamine;
ii. The toxicity database showed no increase in susceptibility in
fetuses and pups with in utero and postnatal exposure, and
iii. The dietary food exposure assessment is based on recommended
tolerance-level residues (except those processed commodities for which
processing factors were used) and assumes 100% crop treated for all
commodities, which resulted in very high-end estimates of dietary
exposure.

E. Aggregate Risks and Determination of Safety

1. Acute risk. There were no toxic effects attributable to a single
dose. An endpoint of concern was not identified to quantitate an acute-
dietary risk to the U.S. general population or to the subpopulation
females 13-50 years old. Therefore, diphenylamine is not expected to
pose an acute risk.
2. Chronic risk. Using the exposure assumptions described in this
unit for chronic exposure, EPA has concluded that exposure to
diphenylamine from food will utilize 12% of the cPAD for the U.S.
population, 69% of the cPAD for all infants <1 year old, and 90% of the
cPAD for children 1-2 years old. There are no residential uses for
diphenylamine that result in chronic residential exposure. In addition,
there is no potential for chronic dietary exposure in drinking water as
diphenylamine is applied only as a post-harvest use. Therefore, EPA
does not expect the aggregate exposure to exceed 100% of the cPAD.
3. Short and intermediate-term risk. There are no residential uses
for diphenylamine, and residues are not expected to occur in drinking
water. Therefore, short and intermediate-term aggregate risk
assessments were not performed.
4. Aggregate cancer risk for U.S. population. Diphenylamine is not
likely to be carcinogenic to humans. Therefore, a cancer aggregate risk
assessment was not performed.
5. Determination of safety. Based on these risk assessments, EPA
concludes that there is a reasonable certainty that no harm will result
to the general population, and to infants and children from aggregate
exposure to diphenylamine residues.

IV. Other Considerations

A. Analytical Enforcement Methodology

An adequate gas chromatography/mass-selective detector (GC/MSD)
method is available for enforcing tolerances on apple commodities, and
this method was used for data collection in the current post-harvest
study. The method was adequately validated in conjunction with the
sample analyses. A modification of this method was used in the pear
analyses. Therefore, the Agency requires the registrant to submit an
analytical reference standard of diphenylamine to the EPA National
Pesticide Standards Repository. The method may be requested from:
Chief, Analytical Chemistry Branch, Environmental Science Center, 701
Mapes Rd., Ft. Meade, MD 20755-5350; telephone number: (410) 305-2905;
e-mail address: residuemethods@epa.gov.

B. International Residue Limits

Codex MRLs have been established for the post harvest use of
diphenylamine on pears. The MRL for pear is 5 ppm, and is the same as
the recommended pear tolerance.

V. Conclusion

A tolerance is proposed for residues of diphenylamine in pear at
5.0 ppm.

VI. Statutory and Executive Order Reviews

This proposed rule establishes a tolerance under section 408(d) of
the FFDCA in response to a petition submitted to the Agency. The Office
of Management and Budget (OMB) has exempted these types of actions from
review under Executive Order 12866, entitled Regulatory Planning and
Review (58 FR 51735, October 4, 1993). Because this proposed rule has
been exempted from review under Executive Order 12866 due to its lack
of significance, this proposed rule is not subject to Executive Order
13211, Actions Concerning Regulations That Significantly Affect Energy
Supply, Distribution, or Use (66 FR 28355, May 22, 2001). This proposed
rule does not contain any information collections subject to OMB
approval under the Paperwork Reduction Act (PRA), 44 U.S.C. 3501 et
seq., or impose any enforceable duty or contain any unfunded mandate as
described under Title II of the Unfunded Mandates Reform Act of 1995
(UMRA) (Public Law 104-4). Nor does it require any special
considerations under Executive Order 12898, entitled Federal Actions to
Address Environmental Justice in Minority Populations and Low-Income
Populations (59 FR 7629, February 16, 1994); or OMB review or any
Agency action under Executive Order 13045, entitled Protection of
Children from Environmental Health Risks and Safety Risks (62 FR 19885,
April 23, 1997). This action does not involve any technical standards
that would require Agency consideration of voluntary consensus
standards pursuant to section 12(d) of the National Technology Transfer
and Advancement Act of 1995 (NTTAA), Public Law 104-113, section 12(d)
(15 U.S.C. 272 note). Pursuant to the Regulatory Flexibility Act (RFA)
(5 U.S.C. 601 et seq.), the Agency hereby certifies that this proposed
action will not have significant negative economic impact on a
substantial number of small entities. Establishment of a tolerance
legalizes the presence of a pesticide residue in a food. In addition,
the Agency has determined that this action will not have a substantial
direct effect on States, on the relationship between the national
government and the States, or on the distribution of power and
responsibilities among the various levels of government, as specified
in Executive Order 13132, entitled Federalism (64 FR 43255, August 10,
1999). Executive Order 13132 requires EPA to develop an accountable
process to ensure ``meaningful and timely input by State and local
officials in the development of regulatory policies that have
federalism implications.'' ``Policies that have federalism
implications'' is defined in the Executive order to include regulations
that have ``substantial direct effects on the States, on the
relationship between the national government and the States, or on the
distribution of power and responsibilities among the various levels of
government.'' This proposed rule directly regulates growers, food
processors, food handlers and food retailers, not States. This action
does not alter the relationships or distribution of power and
responsibilities established by Congress in the preemption provisions
of section 408(n)(4) of the FFDCA. For these same reasons, the Agency
has determined that this proposed rule does not have any ``tribal
implications'' as described in Executive Order 13175, entitled
Consultation and Coordination with Indian Tribal Governments (65 FR
67249, November 6, 2000). Executive Order 3175, requires EPA to develop
an accountable process to ensure ``meaningful and timely input by
tribal officials in the development of regulatory policies that have
tribal implications.'' ``Policies that have tribal implications'' is
defined in the

[[Page 70709]]

Executive order to include regulations that have ``substantial direct
effects on one or more Indian tribes, on the relationship between the
Federal Government and the Indian tribes, or on the distribution of
power and responsibilities between the Federal Government and Indian
tribes.'' This proposed rule will not have substantial direct effects
on tribal governments, on the relationship between the Federal
Government and Indian tribes, or on the distribution of power and
responsibilities between the Federal Government and Indian tribes, as
specified in Executive Order 13175. Thus, Executive Order 13175 does
not apply to this proposed rule.

List of Subjects in 40 CFR Part 180

Environmental protection, Administrative practice and procedure,
Agricultural commodities, Pesticides and pests, Reporting and
recordkeeping requirements.

Dated: November 22, 2006.
Donald R. Stubbs,
Acting Director, Registration Division, Office of Pesticide Programs.
Therefore, it is proposed that 40 CFR chapter I be amended as
follows:

PART 180--AMENDED

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

Authority: 21 U.S.C. 321(q), 346a and 371.
2. Section 180.190 is amended by alphabetically adding a commodity
to the table in paragraph (a) to read as follows:

Sec. 180.190 Diphenylamine; tolerances for residues.

(a) * * *

------------------------------------------------------------------------
Parts per
Commodity million
------------------------------------------------------------------------
* * * * *
Pear (post harvest)........................................ 5.0
* * * * *
------------------------------------------------------------------------

[FR Doc. E6-20648 Filed 12-5-06; 8:45 am]
BILLING CODE 6560-50-S

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