Daily Rules, Proposed Rules, and Notices of the Federal Government
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 111)
• Animal production (NAICS 112)
• Food manufacturing (NAICS 311)
• Pesticide manufacturing (NAICS 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. If you have any questions regarding the applicability of this action to a particular entity, consult the person listed under
An electronic version of the public docket is available through EPA's electronic public docket and comment system, EPA dockets. You may use EPA Dockets at
Certain types of information will not be placed in EPA dockets. Information claimed as CBI and other information whose disclosure is restricted by statute, which is not included in the official public docket, will not be available for public viewing in EPA's electronic public docket. EPA's policy is that copyrighted material will not be placed in EPA's electronic public docket but will be available only in printed paper form in the official public docket. To the extent feasible, publicly available docket materials will be made available in EPA's electronic public docket. When a document is selected from the index list in EPA dockets, the system will identify whether the document is available for viewing in EPA's electronic public docket. Although, not all docket materials may be available electronically, you may still access any of the publicly available docket materials through the docket facility identified in Unit I.B. EPA intends to work towards providing electronic access to all of the publicly available docket materials through EPA's electronic public docket.
For public commenters, it is important to note that EPA's policy is that public comments, whether submitted electronically or on paper, will be made available for public viewing in EPA's electronic public docket as EPA receives them and without change, unless the comment contains copyrighted material, CBI, or other information whose disclosure is restricted by statute. When EPA identifies a comment containing copyrighted material, EPA will provide a reference to that material in the version of the comment that is placed in EPA's electronic public docket. The entire printed comment, including the copyrighted material, will be available in the public docket.
Public comments submitted on computer disks that are mailed or delivered to the docket will be transferred to EPA's electronic public docket. Public comments that are mailed or delivered to the docket will be scanned and placed in EPA's electronic public docket. Where practical, physical objects will be photographed, and the photograph will be placed in EPA's electronic public docket along with a brief description written by the docket staff.
You may submit comments electronically, by mail, or through hand delivery/courier. To ensure proper receipt by EPA, identify the appropriate docket ID number in the subject line on the first page of your comment. Please ensure that your comments are submitted within the specified comment
Do not submit information that you consider to be CBI electronically through EPA's electronic public docket or by e-mail. You may claim information that you submit to EPA as CBI by marking any part or all of that information as CBI (if you submit CBI on disk or CD ROM, 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 CBI). Information so marked will not be disclosed except in accordance with procedures set forth in 40 CFR part 2.
In addition to one complete version of the comment that includes any 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 and EPA's electronic public docket. If you submit the copy that does not contain CBI on disk or CD ROM, mark the outside of the disk or CD ROM clearly that it does not contain CBI. Information not marked as CBI will be included in the public docket and EPA's electronic public docket without prior notice. If you have any questions about CBI or the procedures for claiming CBI, please consult the person listed under
You may find the following suggestions helpful for preparing your comments:
1. Explain your views as clearly as possible.
2. Describe any assumptions that you used.
3. Provide copies of any technical information and/or data you used that support your views.
4. If you estimate potential burden or costs, explain how you arrived at the estimate that you provide.
5. Provide specific examples to illustrate your concerns.
6. Make sure to submit your comments by the deadline in this notice.
7. To ensure proper receipt by EPA, be sure to identify the docket ID number assigned to this action in the subject line on the first page of your response. You may also provide the name, date, and
EPA has received a pesticide petition as follows proposing the establishment and/or amendment of regulations for residues of a certain pesticide chemical in or on various food commodities under section 408 of the Federal Food, Drug, and Cosmetic Act (FFDCA), 21 U.S.C. 346a. EPA has determined that this petition contains data or information regarding the elements set forth in FFDCA section 408(d)(2); however, EPA has not fully evaluated the sufficiency of the submitted data at this time or whether the data support granting of the petition. Additional data may be needed before EPA rules on the petition.
Environmental protection, Agricultural commodities, Feed additives, Food additives, Pesticides and pests, Reporting and recordkeeping requirements.
The petitioner's summary of the pesticide petition is printed below as required by FFDCA section 408(d)(3). The summary of the petition was prepared by the petitioner and represents the view of the petitioner. The petition summary announces the availability of a description of the analytical methods available to EPA for the detection and measurement of the pesticide chemical residues or an explanation of why no such method is needed.
EPA has received a pesticide petition [1F6305] from ISK Biosciences Corporation, 7470 Auburn Road, Suite A, Concord OH 44077, proposing, pursuant to section 408(d) of the Federal Food, Drug, and Cosmetic Act (FFDCA), 21 U.S.C. 346a(d), to amend 40 CFR part 180 by establishing a tolerance for residues of the fungicide cyazofamid, 4-chloro-2-cyano-N, N-dimethyl-5-(4-methylphenyl)-1H-imidazole-1-sulfonamide (CA), in or on the raw agricultural commodity (RAC) potatoes at 0.01 parts per million (ppm) and cucurbits at 0.1 ppm and the fungicide cyazofamid and the metabolite CCIM, 4-chloro-5-(4-methylphenyl)-1H-imidazole-2-carbonitrile (CA) in or on the RAC tomatoes at 0.2 ppm and wine grapes at 1.0 ppm. EPA has determined that the petition contains data or information regarding the elements set forth in section 408(d)(2) of the FFDCA; however, EPA has not fully evaluated the sufficiency of the submitted data at this time or whether the data support granting of the petition. Additional data may be needed before EPA rules on the petition.
Data from 18 field trials in potatoes conducted in 1999-2000 showed that no residues of cyazofamid or CCIM were observed in any of the RAC commodity at any location (7-day PHI). There were up to 10 applications of 0.071 lb. of active ingredient per acre (0.70 lb a.i./acre total) of the Cyazofamid 400SC formulation at 7-day intervals. The PHI for most trials was 7-days; however, residue dissipation studies with PHIs of 0-, 1-, 3- and 7-days were run at 2 locations. Maximum residues of 0.01 ppm of cyazofamid were seen at 0- and 1-day PHIs at one location and no residues were found at the other location. The results of a processing study in which the final application was at a 3X application rate showed that for samples taken with a 3-day PHI no detectable residues of cyazofamid or CCIM were found in potato flakes, chips or wet peels. Therefore, no concentration of residues occurred during processing.
For tomatoes, residues of cyazofamid were determined in the treated samples from 35 RAC trials (0- and 7-day PHI) conducted from 1999-2001. The mean per site residues ranged from non-detected (
The results of a tomato processing study in which the final application was at a 3X application rate showed that for samples taken with a 3-day PHI, cyazofamid was
Data from 15 field trials in grapes conducted from 1999-2001 in the United States, Argentina, Mexico and Europe showed that mean cyazofamid residues ranged from
Grapes from six of the sites were processed into must and wine. Most samples had cyazofamid residues ranging from 0.01 to 0.09 ppm. The CCIM residues in must ranged from
Even using all of the worst case exposure scenarios listed above, the Tier 1 chronic dietary exposure estimates resulted in an estimated exposure for the U.S. population of 0.000594 mg/kg bwt/day. This exposure corresponds to 0.3% of the RfD of 0.17 mg/kg bwt/day. The highest exposure estimate was calculated for the children 1-6 years population subgroup. This exposure was determined to be 0.000939 mg/kg bwt/day (0.6% of the RfD).
The Tier 1 acute assessment for the U.S. population resulted in a margin of exposure (MOE) of 35,789 at the 95
Cyazofamid is a cyanoimidazole fungicide. Since there are no other members of this class of fungicides, it is considered unlikely that cyazofamid would have a common mechanism of toxicity with any other pesticide in use at this time.
Using only pesticide handlers exposure data base (PHED) data levels A and B (those with a high level of confidence), MOE for occupational exposure is 5,195 for mixer/loaders, and 5,884 for aerial applicators. Based on the completeness and reliability of the toxicity data and the conservative exposure assessments, there is a reasonable certainty that no harm will result from the aggregate exposure of residues of cyazofamid including all anticipated dietary exposure and all other non-occupational exposures.
There are no residential uses of cyazofamid. Based on the completeness and reliability of the toxicity data, the lack of toxicological endpoints of special concern, the lack of any indication of greater sensitivity of children, and the conservative exposure assessment; there is a reasonable certainty that no harm will result to infants and children from the aggregate exposure to residues of cyazofamid from all anticipated sources of dietary and non-occupational exposure. Accordingly, there is no need to apply an additional safety factor for infants and children.
There are presently no Codex maximum residue limits established for residues of cyazofamid on any crop.