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EPA ID: [EPA-HQ-OPP-2007-0178; FRL-8353-2]
SUBJECT CATEGORY: Prothioconazole; Pesticide Tolerance
DOCUMENT SUMMARY: This regulation establishes a tolerance for combined residues of prothioconzole and prothioconazoledesthio, calculated as parent, in or on soybean, forage; soybean, seed; soybean, hay; and sugar beet, roots. Bayer CropScience requested this tolerance under the Federal Food, Drug, and Cosmetic Act (FFDCA), as amended by the Food Quality Protection Act of 1996 (FQPA).
SUMMARY: Prothioconazole,
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 those engaged in the following activities:
This listing is not intended to be exhaustive, but rather to provide 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. If you have any questions regarding the applicability of this action to a particular entity, consult the person listed under FOR FURTHER INFORMATION CONTACT.
In addition to accessing an electronic copy of this Federal Register document through the electronic docket at http:// www.regulations.gov, you may access this Federal Register document electronically through the EPA Internet under the ``Federal Register'' listings at http://www.epa.gov/fedrgstr. You may also access a frequently updated electronic version of EPA's tolerance regulations at 40 CFR part 180 through the Government Printing Office's pilot eCFR site at http://www.gpoaccess.gov/ecfr. C. Can I File an Objection or Hearing Request?
Under section 408(g) of FFDCA, any person may file an objection to any aspect of this regulation and may also request a hearing on those objections. You must file your objection or request a hearing on this regulation in accordance with the instructions provided in 40 CFR part 178. To ensure proper receipt by EPA, you must identify docket ID number EPAHQOPP20070178 in the subject line on the first page of your submission. All requests must be in writing, and must be mailed or delivered to the Hearing Clerk as required by 40 CFR part 178 on or before May 19, 2008.
In addition to filing an objection or hearing request with the
Hearing Clerk as described in 40 CFR part 178, please submit a copy of
the filing that does not contain any CBI for inclusion in the public
docket that is described in ADDRESSES. Information not marked
confidential pursuant to 40 CFR part 2 may be disclosed publicly by EPA
without prior notice. Submit this copy, identified by docket ID number EPAHQOPP20070178, by one of the following methods:
In the Federal Register of June 27, 2007 (72 FR 35237) (FRL8133
4), and in the Federal Register of July 12, 2006 (71 FR 39313) (FRL
80749), EPA issued notices pursuant to section 408(d)(3) of FFDCA, 21
U.S.C. 346a(d)(3), announcing the filing of pesticide petitions (6F7134
and 6F7073, respectively) by Bayer CropScience, P.O. Box 12014, 2 T.W.
Alexander Dr., Research Triangle. These petitions requested that 40 CFR
180.626 be amended by establishing a tolerance for combined residues of the fungicide prothioconazole, 2[2(1chlorocyclopropyl)3(2
chlorophenyl)2hydroxypropyl]1,2dihydro3H1,2,4triazole3thione,
and prothioconazoledesthio, in or onsoybean, forage at 5 parts per
million (ppm); soybean, seed at 0.15 ppm; soybean, hay at 22 ppm; and
sugar beet, roots at 0.25 ppm and sugar beet, tops at 9 ppm. Those
notices referenced a summary of the petition prepared by Bayer
CropScience, the registrant, which is available to the public in the
docket, http://www.regulations.gov. There were no comments received in response to the notice of filings.
Section 408(b)(2)(A)(i) of 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 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 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....'' These provisions were added to FFDCA by the Food Quality Protection Act (FQPA) of 1996.
Consistent with FFDCA section 408(b)(2)(D), and the factors
specified in FFDCA 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
[[Page 14716]]
and to make a determination on aggregate exposure for the petitioned
for tolerance for combined residues of prothioconazole, and
prothioconazoledesthio, calculated as parent, in or on soybean, forage
at 4.5 ppm; soybean, seed at 0.15 ppm; soybean, hay at 17 ppm; sugar
beet, roots at 0.25 ppm. Sugar beet, tops do not need a tolerance
because they are not a human food commodity. 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.
Prothioconazole has low acute toxicity by oral, dermal, and inhalation routes. It is not a dermal sensitizer, or a skin or eye irritant. Prothioconazoledesthio also has low acute toxicity by oral, dermal, and inhalation routes. It is not a dermal sensitizer, or a skin irritant, but it is a slight eye irritant. Subchronic studies show that the target organs at the LOAEL include the liver, kidney, urinary bladder, thyroid and blood. Significant clinical chemistry findings were also made. NOAEL/LOAEL values across the family of chemicals (i.e., prothioconazole, and prothioconazoledesthio and prothioconazole sulfonic acid potassium salt metabolites) in the toxicity database indicate that prothioconazoledesthio is a most toxic chemical. In addition to the target organs and effects observed in the subchronic studies (i.e., liver, kidney, urinary bladder, thyroid, hematology and clinical chemistry), chronic toxicity at the LOAEL also included body weight and food consumption changes, and toxicity to the lymphatic and GI systems. The relative potency of prothioconazoledesthio was greater than prothioconazole.
Studies in the rat and mouse, using both prothioconazole and prothioconazoledesthio, showed no evidence of carcinogenicity. The data show that dosing was adequate, except in the rat cancer study using prothioconazole, where the dosing was considered too high.
The data indicate that prothioconazole and the three metabolites
evaluated (i.e., prothioconazoledesthio, prothioconazole sulfonic acid
potassium salt, and prothioconazoledeschloro) variously produce pre
natal developmental effects at levels equal to or below maternally
toxic levels. Prothioconazoledesthio is the most toxic orally and
dermally, with LOAELs significantly below that of the other chemicals.
The rabbit is the more sensitive species. Lastly, prothioconazole
desthio is a developmental neurotoxicant, producing changes in brain
morphometrics and increases in the occurrence of peripheral nerve
lesions in the neonate. A NOAEL was not determined, since these
observations were looked for only at the high dose level. Reproduction studies in the rat, conducted using prothioconazole and
prothioconazoledesthio, suggested that these chemicals may not be
primary reproductive toxicants. Reproductive and offspring toxicities
were observed only in the presence of parental toxicity. Indeed, the
parental LOAELs are lower. The data show that prothioconazoledesthio
is more toxic by an order of magnitude. The nature of parental toxicity
is similar to what was observed in the subchronic studies, such as body
weight and food consumption changes, liver effects, etc. Reproductive
effects included decreases in reproductive indices such as those that
indicate pup survival and growth. Offspring toxicity was manifested by
decreased pup weights and malformations such as cleft palate.
Specific information on the studies received and the nature of the adverse effects caused by prothioconazole as well as the noobserved adverseeffectlevel (NOAEL) and the lowestobservedadverseeffect level (LOAEL) from the toxicity studies can be found at http:// www.regulations.gov. The referenced document is available in the docket established by this action, which is described under ADDRESSES, and is identified as ``Prothioconazole: Human Health Risk Assessment for Proposed Uses on Soybeans and Sugarbeets'' in that docket.
For hazards that have a threshold below which there is no appreciable risk, the toxicological level of concern (LOC) is derived from the highest dose at which no adverse effects are observed (the NOAEL) in the toxicology study identified as appropriate for use in risk assessment. However, if a NOAEL cannot be determined, the lowest dose at which adverse effects of concern are identified (the LOAEL) is sometimes used for risk assessment. Uncertainty/safety factors (UFs) are used in conjunction with the LOC to take into account 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. Safety is assessed for acute and chronic risks by comparing aggregate exposure to the pesticide to the acute population adjusted dose (aPAD) and chronic population adjusted dose (cPAD). The aPAD and cPAD are calculated by dividing the LOC by all applicable UFs. Short, intermediate, and longterm risks are evaluated by comparing aggregate exposure to the LOC to ensure that the margin of exposure (MOE) called for by the product of all applicable UFs is not exceeded.
For nonthreshold risks, the Agency assumes that any amount of exposure will lead to some degree of risk and estimates risk in terms of the probability of occurrence of additional adverse cases. Generally, cancer risks are considered nonthreshold. For more information on the general principles EPA uses in risk characterization and a complete description of the risk assessment process, see http:// www.epa.gov/oppfead1/trac/science;http://www.epa.gov/pesticides/ factsheets/riskassess.htm; and http://www.epa.gov/pesticides/trac/ science/aggregate.pdf.
A summary of the toxicological endpoints for prothioconazole used for human risk assessment can be found at http://www.regulations.gov in the document ``Prothioconazole: Human Health Risk Assessment for Proposed Uses on Soybeans and Sugarbeets'' at page 24 in docket ID number EPAHQOPP20070178.
1. Dietary exposure from food and feed uses. In evaluating dietary exposure to prothioconazole, EPA considered exposure under the petitionedfor tolerances as well as all existing prothioconazole tolerances in 40 CFR 180.626. EPA assessed dietary exposures from prothioconazole residues in food as follows:
i. Acute exposure. Quantitative acute dietary exposure and risk assessments are performed for a fooduse pesticide, if a toxicological study has indicated the possibility of an effect of concern occurring as a result of a 1day or single exposure.
In estimating acute dietary exposure, EPA used food consumption
information from the U.S. Department of Agriculture (USDA) 19941996
and 1998 Nationwide Continuing Surveys of Food Intake by Individuals (CSFII). As to residue levels in food, EPA relied
[[Page 14717]]
upon average residues and 100% percent crop treated (PCT) information.
ii. Chronic exposure. In conducting the chronic dietary exposure assessment EPA used the food consumption data from the USDA [19941996, and 1998] CSFII. As to residue levels in food, EPA relied upon anticipated residues, and 100% percent crop treated (PCT) information for all commodities.
iii. Cancer. The available toxicology studies in the mouse and rat showed no increase in tumor incidence, and therefore the Agency has concluded that neither prothioconazole, nor its metabolites are carcinogenic. Thus classified, by the Agency, as ``Not Likely to be Carcinogenic to Humans'' according to the 2005 Cancer Guidelines. Consequently, a quantitative dietary cancer assessment was not performed.
iv. Anticipated residue information. Section 408(b)(2)(E) of FFDCA authorizes EPA to use available data and information on the anticipated residue levels of pesticide residues in food and the actual levels of pesticide residues that have been measured in food. If EPA relies on such information, EPA must pursuant to FFDCA section 408(f)(1) 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. For the present action, EPA will issue such data callins as are required by FFDCA section 408(b)(2)(E) and authorized under FFDCA section 408(f)(1). Data will be required to be submitted no later than 5 years from the date of issuance of this tolerance.
2. Dietary exposure from drinking water. The Agency lacks sufficient monitoring data to complete a comprehensive dietary exposure analysis and risk assessment for prothioconazole in drinking water. Because the Agency does not have comprehensive monitoring data, drinking water concentration estimates are made by reliance on simulation or modeling taking into account data on the environmental fate characteristics of prothioconazole. Further information regarding EPA drinking water models used in pesticide exposure assessment can be found at http://www.epa.gov/oppefed1/models/water/index.htm.
Based on the Pesticide Root Zone Model/Exposure Analysis Modeling System (PRZM/EXAMS) and Screening Concentration in Ground Water (SCI GROW) models, the estimated drinking water concentrations (EDWCs) of prothioconazole for acute exposures are estimated to be 29 parts per billion (ppb) for surface water and 0.67 ppb for ground water. The EDWCs for chronic exposures are estimated to be 13 ppb for surface water and 0.67 ppb for ground water.
Modeled estimates of drinking water concentrations were directly entered into the dietary exposure model. For acute dietary risk assessment, the water concentration value of 29 ppb was used to assess the contribution from drinking water. For chronic dietary risk assessment, the water concentration of value 13 ppb was used to assess the contribution from drinking water. EPA used the EDWCs from surface water only in assessing the risk from prothioconazole because the EDWCs from groundwater are minimal in comparison to surface water.
3. From nondietary exposure. The term ``residential exposure'' is used in this document to refer to nonoccupational, nondietary exposure (e.g., for lawn and garden pest control, indoor pest control, termiticides, and flea and tick control on pets).
Prothioconazole is not registered for use on any sites that would result in residential exposure.
4. Cumulative effects from substances with a common mechanism of toxicity. Section 408(b)(2)(D)(v) of 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.''
Prothioconazole is a member of the triazolecontaining class of pesticides. Although conazoles act similarly in plants (fungi) by inhibiting ergosterol biosynthesis, there is not necessarily a relationship between their pesticidal activity and their mechanism of toxicity in mammals. Structural similarities do not constitute a common mechanism of toxicity. Evidence is needed to establish that the chemicals operate by the same, or essentially the same, sequence of major biochemical events (EPA, 2002). In conazoles, however, a variable pattern of toxicological responses is found. Some are hepatotoxic and hepatocarcinogenic in mice. Some induce thyroid tumors in rats. Some induce developmental, reproductive, and neurological effects in rodents. Furthermore, the conazoles produce a diverse range of biochemical events including altered cholesterol levels, stress responses, and altered DNA methylation. It is not clearly understood whether these biochemical events are directly connected to their toxicological outcomes. Thus, there is currently no evidence to indicate that conazoles share common mechanisms of toxicity and EPA is not following a cumulative risk approach based on a common mechanism of toxicity for the conazoles. For information regarding EPA's procedures for cumulating effects from substances found to have a common mechanism of toxicity, see EPA's website at http://www.epa.gov/pesticides/ cumulative.
Prothioconazole is a triazolederived pesticide. This class of compounds can form the common metabolite, 1,2,4triazole and two triazole conjugates (triazolylalanine and triazolylacetic acid). To support existing tolerances and to establish new tolerances for triazolederivative pesticides, including prothioconazole, U.S. EPA conducted a human health risk assessment for exposure to 1,2,4 triazole, triazolylalanine, and triazolylacetic acid resulting from the use of all current and pending uses of any triazolederived fungicide. The risk assessment is a highly conservative, screeninglevel evaluation in terms of hazards associated with common metabolites (e.g., use of a maximum combination of uncertainty factors) and potential dietary and nondietary exposures (i.e., high end estimates of both dietary and nondietary exposures). In addition, the Agency retained the additional 10X FQPA safety factor for the protection of infants and children. The assessment includes evaluations of risks for various subgroups, including those comprised of infants and children. The Agency's complete risk assessment is found in the propiconazole reregistration docket at http://www.regulations.gov, Docket Identification (ID) Number EPAHQOPP20050497.
1. In general. Section 408 of FFDCA provides that EPA shall apply an additional (``10X'') 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 database on toxicity and exposure unless EPA determines, based on reliable data, that a different margin of safety will be safe for infants and children. This additional margin of safety is commonly referred to as the FQPA safety factor. In applying this provision, EPA either retains the default value of 10X when reliable data do not support the choice of a different factor, or, if reliable data are available, EPA uses a different additional FQPA safety factor value based on the use of traditional UFs and/or special FQPA safety factors, as appropriate. [[Page 14718]]
2. Prenatal and postnatal sensitivity. Available evidence from rat developmental toxicity studies with prothioconazole (oral) and its desthio (oral and dermal) and sulfonic acid K salt (oral) metabolites, rabbit developmental with desthio metabolite (oral), and rat developmental neurotoxicity with desthio metabolite (oral), as well as a multigeneration reproduction study with the desthio metabolite, indicates that there is concern for prenatal toxicity. Effects include skeletal structural abnormalities, such as cleft palate, deviated snout, malocclusion, and extra ribs; developmental delays; other effects include changes in brain morphometry, peripheral nerve lesions, and death.
Available data also show that the skeletal effects such as extra ribs are not completely reversible after birth in the rat, but persist as development continues. Data from the developmental neurotoxicity study also show that brain morphometry is abnormal postnatally, and there is an increased incidence of lesions of the peripheral nerves postnatally.
3. Conclusion. The toxicity database for prothioconazole (and its metabolites) is adequate for endpoint selection for exposure risk assessment scenarios and for FQPA evaluation, with the exception of the lack of data on brain morphometry at the lower and mid doses from the developmental neurotoxicity study. Data on brain morphometry at these doses have now been submitted and is currently in review.
Effects are seen in the 2generation reproduction studies in rats; developmental studies in rats and rabbits; and a developmental neurotoxicity study in rats which suggest that pups are more susceptible: Pup effects were seen at levels below the LOAELs for maternal toxicity and, in general, were of comparable or greater severity compared to the effects observed in adults. Additionally, there is uncertainty concerning the LOAEL/NOAEL for developmental effects seen in the developmental neurotoxicity study in rats (abnormal brain morphometry at high dose) due to a lack of information on brain morphometry at lower doses. Given that both quantitative and qualitative sensitivity was observed in pups in several studies and in more than one species and in at least one of these studies there is uncertainty concerning identification of the LOAEL/NOAEL for developmental effects, the additional 10X factor for the protection of infants and children is being retained.
Safety is assessed for acute and chronic risks by comparing aggregate exposure to the pesticide to the aPAD and cPAD. The aPAD and cPAD are calculated by dividing the LOC by all applicable UFs. For linear cancer risks, EPA calculates the probability of additional cancer cases given aggregate exposure. Short, intermediate, and long term risks are evaluated by comparing aggregate exposure to the LOC to ensure that the MOE called for by the product of all applicable UFs is not exceeded.
1. Acute risk. Using the exposure assumptions discussed in this unit for acute exposure, the acute dietary exposure from food and water to prothioconazole will occupy 76% of the aPAD for the population group (females 13 years and older).
2. Chronic risk. Using the exposure assumptions described in this unit for chronic exposure, EPA has concluded that exposure to prothioconazole from food and water will utilize 94% of the cPAD for the population group (infants less than 1 year old). There are no residential uses for prothioconazole that result in chronic residential exposure to prothioconazole.
3. Shortterm risk. Shortterm aggregate exposure takes into account residential exposure plus chronic exposure to food and water (considered to be a background exposure level).
Prothioconazole is not registered for use on any sites that would result in residential exposure. Therefore, the aggregate risk is the sum of the risk from food and water, which do not exceed the Agency's level of concern.
4. Intermediateterm risk. Intermediateterm aggregate exposure takes into account residential exposure plus chronic exposure to food and water (considered to be a background exposure level).
Prothioconazole is not registered for use on any sites that would result in residential exposure. Therefore, the aggregate risk is the sum of the risk from food and water, which do not exceed the Agency's level of concern.
5. Aggregate cancer risk for U.S. population. The available studies in the mouse and rat show no increase in tumor incidence, therefore the Agency has concluded that neither prothioconazole nor its metabolites are carcinogenic, and are classified ``Not likely to be Carcinogenic to Humans'' according to the 2005 Cancer Guidelines. Therefore, prothioconazole is not expected to pose a cancer risk.
6. 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, or to infants and children from aggregate exposure to prothioconazole residues.
IV. Other Considerations
Adequate enforcement methodology are available to enforce the
tolerance expression, consisting of liquid chromatography/tandem mass
spectrometry (LC/MS/MS) for both plant and livestock commodities, using
tandem mass spectrometry electrospray ionization in both the positive
and negative modes. Both methods (LC/MS/MS Method RPA JA/03/01 for
plants and LC/MS/MS Method Bayer Report No. 200537 for animals) have
successfully passed tolerance method validation at ACB/BEAD. The method
may be requested from: Chief, Analytical Chemistry Branch,
Environmental Science Center, 701 Mapes Rd., Ft. Meade, MD 207555350; telephone number: (410) 3052905; email address:
residuemethods@epa.gov. B. International Residue Limits
There are no maximum residue limits (MRLs) (tolerances) established for prothioconazole in Codex or in Mexico.
Therefore, tolerances are established for combined residues of prothioconazole, 2[2(1chlorocyclopropyl)3(2chlorophenyl)2
hydroxypropyl]1,2dihydro3H1,2,4triazole3thione, and
prothioconazoledesthio, [alpha](1chlorocyclopropyl)[alpha][(2
chlorophenyl)methyl]1H1,2,4triazole1ethanol, calculated as parent,
in or on the following commodities: soybean, forage at 4.5 ppm;
soybean, seed at 0.15 ppm; soybean, hay at 17 ppm; sugar beet, roots at
0.25 ppm. A tolerance is not needed for sugar beet tops because it is not a human food commodity.
This final rule establishes a tolerance under section 408(d) of
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 rule has been
exempted from review under Executive Order 12866, this 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) or Executive Order 13045,
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entitled Protection of Children from Environmental Health Risks and
Safety Risks (62 FR 19885, April 23, 1997). 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., nor does it
require any special considerations under Executive Order 12898,
entitled Federal Actions to Address Environmental Justice in Minority
Populations and LowIncome Populations (59 FR 7629, February 16, 1994).
Since tolerances and exemptions that are established on the basis of a petition under section 408(d) of FFDCA, 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.
This final rule directly regulates growers, food processors, food handlers, and food retailers, not States or tribes, nor does this action alter the relationships or distribution of power and responsibilities established by Congress in the preemption provisions of section 408(n)(4) of FFDCA. As such, the Agency has determined that this action will not have a substantial direct effect on States or tribal governments, on the relationship between the national government and the States or tribal governments, or on the distribution of power and responsibilities among the various levels of government or between the Federal Government and Indian tribes. Thus, the Agency has determined that Executive Order 13132, entitled Federalism (64 FR 43255, August 10, 1999) and Executive Order 13175, entitled Consultation and Coordination with Indian Tribal Governments (65 FR 67249, November 6, 2000) do not apply to this rule. In addition, This rule does not 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 1044).
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 104113, section 12(d) (15 U.S.C. 272 note).
The Congressional Review Act, 5 U.S.C. 801 et seq., generally provides that before a rule may take effect, the agency promulgating the rule must submit a rule report to each House of the Congress and to 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 this final rule in the Federal Register. This final rule is not a ``major rule'' as defined by 5 U.S.C. 804(2).
Environmental protection, Administrative practice and procedure,
Agricultural commodities, Pesticides and pests, Reporting and recordkeeping requirements.
Dated: March 10, 2008.
Lois Rossi,
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), 346a and 371.
2. Section 180.626 is amended by adding alphabetically entries to the table in paragraph (a)(1) to read as follows:
Sec. 180.626 Prothioconazole; tolerances for residues.
(a) * * *
(1) * * *
Parts per
Commodity million * * * * *
Beet, sugar, roots...................................... 0.25 * * * * *
Soybean, forage......................................... 4.5
Soybean, hay............................................ 17
Soybean, seed........................................... 0.15 * * * * *
* * * * *
[FR Doc. E85290 Filed 31808; 8:45 am]
BILLING CODE 656050S
FOR FURTHER INFORMATION CONTACT Bryant Crowe, Registration Division (7505P), Office of Pesticide Programs, Environmental Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 204600001; telephone number: (703) 3050025; email address: crowe.bryant@epa.gov.
14 CFR Part 39 40 CFR Part 52 14 CFR Part 71 33 CFR Part 165 50 CFR Part 679 26 CFR Part 1 40 CFR Part 180 47 CFR Part 73 50 CFR Part 17 33 CFR Part 117 44 CFR Part 67 50 CFR Part 648 14 CFR Part 97 33 CFR Part 100 40 CFR Part 63 50 CFR Part 622 26 CFR Part 301 39 CFR Part 111 40 CFR Part 300 50 CFR Part 660 44 CFR Part 65 40 CFR Parts 52 and 81 40 CFR Part 271 47 CFR Part 64 50 CFR Part 665 47 CFR Part 76 50 CFR Part 229 14 CFR Part 23 14 CFR Part 25 21 CFR Part 522