Source: https://www.federalregister.gov/articles/2012/01/27/2012-1815/cyazofamid-pesticide-tolerances-for-emergency-exemptions
Timestamp: 2015-08-31 15:23:52
Document Index: 217762764

Matched Legal Cases: ['art 178', 'art 178', 'art 180', 'art 178', 'art 178', 'art 2', '§ 180']

Federal Register | Cyazofamid; Pesticide Tolerances for Emergency Exemptions
Cyazofamid; Pesticide Tolerances for Emergency Exemptions
Dates: This regulation is effective January 27, 2012. Objections and requests for hearings must be received on or before March 27, 2012, and must be filed in accordance with the instructions provided in 40 CFR part 178 (see also Unit I.C. of the SUPPLEMENTARY INFORMATION).
77 FR 4248
-4252 (5 pages)
EPA-HQ-OPP-2011-0697
FRL-9332-5
Document Number: 2012-1815
Shorter URL: https://federalregister.gov/a/2012-1815 Related Topics
This regulation establishes time-limited tolerances for residues of cyazofamid in or on basil, fresh and dried. This action is in response to EPA's granting of an emergency exemption under section 18 of the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) authorizing use of the pesticide on basil. This regulation establishes a maximum permissible level for residues of cyazofamid in or on these commodities. The time-limited tolerances expire on December 31, 2014.
III. Emergency Exemption for Cyazofamid on Basil and FFDCA Tolerances
This regulation is effective January 27, 2012. Objections and requests for hearings must be received on or before March 27, 2012, and must be filed in accordance with the instructions provided in 40 CFR part 178 (see also Unit I.C. of the SUPPLEMENTARY INFORMATION).
EPA has established a docket for this action under docket identification (ID) number EPA-HQ-OPP-2011-0697. All documents in the docket are listed in the docket index available in http://www.regulations.gov. Although listed in the index, some information is not publicly available, e.g., Confidential Business Information (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 in the electronic docket at http://www.regulations.gov, or, if only available in hard copy, at the OPP Regulatory Public Docket in Rm. S-4400, One Potomac Yard (South Bldg.), 2777 S. Crystal Dr., Arlington, VA. The Docket Facility is open from 8:30 a.m. to 4 p.m., Monday through Friday, excluding legal holidays. The Docket Facility telephone number is (703) 305-5805.
Princess Campbell, Registration Division (7505P), Office of Pesticide Programs, Environmental Protection Agency, 1200 Pennsylvania Ave. NW., Washington, DC 20460-0001; telephone number: (703) 308-8033; email address: campbell.princess@epa.gov.
You may access a frequently updated electronic version of 40 CFR part 180 through the Government Printing Office's e-CFR site at http://ecfr.gpoaccess.gov/cgi/t/text/text-idx?&amp;c=ecfr&amp;tpl=/ecfrbrowse/Title40/40tab_02.tpl. http://ecfr.gpoaccess.gov/cgi/t/text/text-idx?&amp;c=ecfr&amp;tpl=/ecfrbrowse/Title40/40tab_02.tpl. To access the harmonized test guidelines referenced in this document electronically, please go to http://www.epa.gov/ocspp and select “Test Methods and Guidelines.”
Under section 408(g) of the Federal Food, Drug, and Cosmetic Act (FFDCA), 21 U.S.C. 346a, 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 EPA-HQ-OPP-2011-0697 in the subject line on the first page of your submission. All objections and requests for a hearing must be in writing, and must be received by the Hearing Clerk on or before March 27, 2012. Addresses for mail and hand delivery of objections and hearing requests are provided in 40 CFR 178.25(b).
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. Information not marked confidential pursuant to 40 CFR part 2 may be disclosed publicly by EPA without prior notice. Submit a copy of your non-CBI objection or hearing request, identified by docket ID number EPA-HQ-OPP-2011-0697, by one of the following methods:
Delivery: OPP Regulatory Public Docket (7502P), Environmental Protection Agency, Rm. S-4400, One Potomac Yard (South Bldg.), 2777 S. Crystal Dr. Arlington, VA. Deliveries are only accepted during the Docket Facility'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 Facility telephone number is (703) 305-5805.
EPA, on its own initiative, in accordance with sections 408(e) and 408(l)(6) of the Federal Food, Drug, and Cosmetic Act (FFDCA), 21 U.S.C. 346a(e) and 346a(1)(6), is establishing time-limited tolerances for combined residues of the fungicide cyazofamid, in or on fresh basil at 12 parts per million (ppm), and on dried basil at 144 ppm. These time-limited tolerances expire on December 31, 2014. Section 408(l)(6) of FFDCA requires EPA to establish a time-limited tolerance or exemption from the requirement for a tolerance for pesticide chemical residues in food that will result from the use of a pesticide under an emergency exemption granted by EPA under section 18 of FIFRA. Such tolerances can be established without providing notice or period for public comment. EPA does not intend for its actions on FIFRA section 18 related time-limited tolerances to set binding precedents for the application of section 408 of FFDCA and the safety standard to other tolerances and exemptions. Section 408(e) of FFDCA allows EPA to establish a tolerance or an exemption from the requirement of a tolerance on its own initiative, i.e., without having received any petition from an outside party.
III. Emergency Exemption for Cyazofamid on Basil and FFDCA Tolerances Back to Top
The Illinois Department of Agriculture (IDA) submitted a Section 18 Specific Exemption request (10IL02). After having reviewed the submission, EPA determined that an emergency condition exists for this State, and that the criteria for approval of an emergency exemption were met. EPA has authorized a specific exemption under FIFRA section 18 for the use of cyazofamid on basil for control of downy mildew (Peronospora balbahrii) in Illinois. This new food use for cyazofamid triggered the requirement for the establishment of tolerances under FFDCA.
As part of its evaluation of the emergency exemption application, EPA assessed the potential risks presented by residues of cyazofamid in or on basil. In doing so, EPA considered the safety standard in section 408(b)(2) of FFDCA, and EPA decided that the necessary tolerance under section 408(l)(6) of FFDCA would be consistent with the safety standard and with FIFRA section 18. Consistent with the need to move quickly on the emergency exemption in order to address an urgent non-routine situation and to ensure that the resulting food is safe and lawful, EPA is issuing this tolerance without notice and opportunity for public comment as provided in section 408(l)(6) of FFDCA. Although these time-limited tolerances expire on December 31, 2014, under section 408(l)(5) of FFDCA, residues of the pesticide not in excess of the amounts specified in the tolerance remaining in or on basil after that date will not be unlawful, provided the pesticide was applied in a manner that was lawful under FIFRA, and the residues do not exceed a level that was authorized by these time-limited tolerances at the time of that application. EPA will take action to revoke these time-limited tolerances earlier if any experience with, scientific data on, or other relevant information on this pesticide indicate that the residues are not safe.
Because these time-limited tolerances are being approved under emergency conditions, EPA has not made any decisions about whether cyazofamid meets FIFRA's registration requirements for use on basil or whether permanent tolerances for this use would be appropriate. Under these circumstances, EPA does not believe that this time-limited tolerance decision serves as a basis for registration of cyazofamid by a State for special local needs under FIFRA section 24(c). Nor does this tolerance by itself serve as the authority for persons in any State other than Illinois to use this pesticide on the applicable crops under FIFRA section 18 absent the issuance of an emergency exemption applicable within that State. For additional information regarding the emergency exemption for cyazofamid, contact the Agency's Registration Division at the address provided under FOR FURTHER INFORMATION CONTACT.
Consistent with 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 and to make a determination on aggregate exposure expected as a result of this emergency exemption request and the time-limited tolerances for combined residues of cyazofamid on fresh basil at 12 ppm, and on dried basil at 144 ppm. EPA's assessment of exposures and risks associated with establishing time-limited tolerances follows.
A summary of the toxicological endpoints for cyazofamid used for human risk assessment is discussed in Unit III. B. of the final rule published in the Federal Register of July 14, 2010 (75 FR 40745) (FRL-8833-1).
1. Dietary exposure from food and feed uses. In evaluating dietary exposure to cyazofamid, EPA considered exposure under the time- limited tolerances established by this action as well as all existing cyazofamid tolerances in 40 CFR 180.601. EPA assessed dietary exposures from cyazofamid in food as follows:
i. Acute exposure. No acute toxicity endpoint was identified for cyazofamid for the general population including infants and children, because no acute effects were observed which could be attributed to a single-dose exposure. Nevertheless, EPA estimated acute exposure for the subpopulation, females 13-49 years, based on the developmental toxicity risk. In estimating acute dietary exposure, EPA used food consumption information from the United States Department of Agriculture (USDA) 1994-1996 and 1998 Nationwide Continuing Surveys of Food Intake by Individuals (CSFII). Tolerance level residues and 100 percent crop treated (PCT) assumptions were used. Anticipated residues and PCT information were not used.
ii. Chronic exposure. In conducting the chronic dietary exposure assessment EPA used the food consumption data from the USDA 1994-1996 and 1998 CSFII. Tolerance level residues and 100 PCT assumptions were used. Anticipated residues and PCT information were not used.
iii. Cancer. Based on the data summarized in Unit III.A., July 14, 2010, and at http://www.regulation.gov in document “Cyazofamid. Human Health Risk Assessment for Proposed Section 18 Use on Basil, item 4.4 Dietary Exposure and Risk,” p.14, EPA has concluded that cyazofamid does not pose a cancer risk to humans. Cyazofamid has been classified as “not likely to be carcinogenic in humans,” based on the absence of significant tumor increases in two rodent carcinogenic studies. Therefore, a dietary exposure assessment for the purpose of assessing cancer risk is unnecessary.
2. Dietary exposure from drinking water. The Agency used screening level water exposure models in the dietary exposure analysis and risk assessment for cyazofamid in drinking water. These simulation models take into account data on the physical, chemical, and fate/transport characteristics of cyazofamid. 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), the estimated drinking water concentrations (EDWCs) of cyazofamid for acute exposures are estimated to be 136 parts per billion (ppb) for surface water and 2.18 ppb for ground water. For chronic exposures for non-cancer assessments EDWCs are estimated to be 133 ppb for surface water and 2.18 ppb for ground water.
3. Sources of non-dietary exposure. The term “residential exposure” is used in this document to refer to non-occupational, non-dietary exposure (e.g., for lawn and garden pest control, indoor pest control, termiticides, and flea and tick control on pets).
Cyazofamid is currently registered for the following uses that could result in residential exposures: Commercially-treated residential turf and ornamentals. EPA assessed residential exposure using the following assumptions: Non-occupational handler exposures are not expected; however, post-application exposure is possible for children and adults. Non-occupational/residential MOEs were estimated for “Day 0” exposure. The post-application children's aggregate MOE (including incidental oral exposures) is 1,600. The Agency is concerned when MOEs are <100. All MOEs, including the children's aggregate, are >100, and therefore not a risk concern.
EPA has not found cyazofamid to share a common mechanism of toxicity with any other substances, and cyazofamid does not appear to produce a toxic metabolite produced by other substances. For the purposes of this tolerance action, therefore, EPA has assumed that cyazofamid does not have 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 EPA's Web site at http://www.epa.gov/pesticides/cumulative.
2. Prenatal and postnatal sensitivity. The prenatal and postnatal toxicology database for cyazofamid includes rat and rabbit developmental toxicity studies and a 2-generation reproduction toxicity study in rats. There was some evidence of increased susceptibility following in utero exposure to rats in the prenatal developmental toxicity study; the increased incidence of bent ribs in the high dose fetuses was considered adverse and was used for setting the developmental NOAEL/LOAEL.
i. The toxicity database for cyazofamid is sufficient to characterize the hazard, to conduct FQPA assessment, and to select toxicity endpoints for risk assessment. Under current data requirement guidelines, functional immunotoxicity data (OPPTS 780.7800) is a data gap. However, the cyazofamid toxicology database does not show any evidence of biologically relevant effects on the immune system that relate to this chemical. The Agency does not believe that conducting a functional immunotoxicity study will result in a lower NOAEL than the regulatory dose for this risk assessment, and an additional uncertainty factor (UF) for the data gap is unnecessary.
ii. There is no indication that cyazofamid is a neurotoxic chemical and there is no need for a developmental neurotoxicity study or additional UFs to account for neurotoxicity for this time-limited tolerance.
iii. There was some evidence of increased susceptibility following in utero exposure to rats in the prenatal developmental toxicity study. As described earlier, the increased incidence of bent ribs in the high dose fetuses was considered adverse and was used for setting the developmental NOAEL/LOAEL. EPA considers this approach conservative and highly protective because bent ribs are a reversible developmental anomaly rather than a malformation.
iv. There are no residual uncertainties identified in the exposure databases. The dietary food exposure assessments were performed based on 100 PCT and tolerance-level residues. EPA made conservative (protective) assumptions in the ground and surface water modeling used to assess exposure to cyazofamid in drinking water. EPA used similarly conservative assumptions to assess post-application exposure of children as well as incidental oral exposure of toddlers. These assessments will not underestimate the exposure and risks posed by cyazofamid.
EPA determines whether acute and chronic dietary pesticide exposures are safe by comparing aggregate exposure estimates to the acute PAD (aPAD) and chronic PAD (cPAD). For cancer risks, EPA calculates the lifetime probability of acquiring cancer given the estimated aggregate exposure. Short-, intermediate-, and chronic-term risks are evaluated by comparing the estimated aggregate food, water, and residential exposure to the appropriate PODs to ensure that an adequate MOE exists.
1. Acute risk. Using the exposure assumptions discussed in this unit for acute exposure, the acute dietary exposure from food and water to cyazofamid will occupy 1.2% of the aPAD for females 13-49 years, the only subpopulation assessed. For the population of concern, the acute dietary (food and drinking water) risk assessment represents acute aggregate risk.
2. Chronic risk. Using the exposure assumptions described in this unit for chronic exposure, EPA has concluded that chronic exposure to cyazofamid from food and water will utilize <1% of the cPAD for children 1-2 years old, the population group receiving the greatest exposure. Based on the explanation in Unit III.C.3. regarding residential use patterns, chronic residential exposure to residues of cyazofamid is not expected.
3. Short-term and intermediate term risk. Short-term and intermediate-term risks have been assessed together because both scenarios have the same endpoints and PODs. Short-intermediate term aggregate exposure takes into account short-intermediate term residential exposure plus chronic exposure to food and drinking water (considered to be a background exposure level). Cyazofamid is currently registered for uses that could result in short-term and/or intermediate term residential exposure, and the Agency has determined that it is appropriate to aggregate chronic exposure through food and water with short-intermediate term residential exposures to cyazofamid.
Using the exposure assumptions described in this unit for short-intermediate term exposures, EPA has concluded the combined short-intermediate term food, water, and residential exposures result in aggregate MOEs of >100 for all scenarios. Because EPA's level of concern for cyazofamid is a MOE of 100 or below, these MOEs are not of concern.
4. Aggregate cancer risk for U.S. population. Based on the lack of evidence of carcinogenicity in two adequate rodent (both the rat and the mouse) carcinogenicity studies, cyazofamid is not expected to pose a cancer risk to humans.
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, or to infants and children, from aggregate exposure to cyazofamid residues.
Adequate enforcement methodologies are available to enforce the tolerance expression. Cyazofamid its and metabolite CCIM are completely recovered (>80% recovery) using FDA's Multiresidue Protocol D (without cleanup). In addition, an acceptable high performance liquid chromatography/ultraviolet/detector (HPLC/UV) method (“Independent Laboratory Validation of the Residue Method for IKF-916 and CCIM in Tomatoes”, Document Number 013033-0, Pyxant Labs Inc., with slight modification) is available for use as a single analyte confirmatory method.
The Codex has not established a MRL for cyazofamid on basil.
Therefore, time-limited tolerances are established for residues of cyazofamid, 4-chloro-2-cyano-N,N-dimethyl-5-(4-methylphenyl)-1 H-imidazole-1-sulfonamide,and its metabolites and degradates in or on basil, fresh, at 12 ppm, and basil, dried, at 144 ppm. These tolerances expire on December 31, 2014.
This final rule establishes time-limited tolerances under sections 408(e) and 408(l)(6) of FFDCA. The Office of Management and Budget (OMB) has exempted these types of actions from review under Executive Order 12866, entitled Regulatory Planning and Review (58 FR 51735, October 4, 1993). Because this final rule has been exempted from review under Executive Order 12866, this final rule is not subject to Executive Order 13211, entitled Actions Concerning Regulations That Significantly Affect Energy Supply, Distribution, or Use (66 FR 28355, May 22, 2001) or Executive Order 13045, 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 Low-Income Populations (59 FR 7629, February 16, 1994).
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.
2.Section 180.601 is amended by revising paragraph (b) to read as follows: § 180.601 Cyazofamid; tolerances for residues.
(b) Section 18 emergency exemptions. Time-limited tolerances are established for residues of the fungicide cyazofamid, including its metabolites and degradates, in or on the commodities in the following table. Compliance with the tolerance levels specified in the following table is to be determined by measuring only the sum of cyazofamid, 4-chloro-2-cyano-N,N-dimethyl-5-(4-methylphenyl)-1H-imidazole-1-sulfonamide and its metabolite CCIM, 4-chloro-5-(4-methylphenyl)-1H-imidazole-2-carbonitrile, calculated as the stoichiometric equivalent of cyazofamid, resulting from use of the pesticide under FIFRA section 18 emergency exemptions. The tolerances expire and are revoked on the date specified in the table.
Expiration/revocation
[FR Doc. 2012-1815 Filed 1-26-12; 8:45 am]