65 FR 26 pgs. 6208-6211 - Formetanate Hydrochloride; Receipt of Requests to Voluntarily Delete Uses, Request for Cancellation, and Advance Notification of Tolerance Revocation
Type: NOTICEVolume: 65Number: 26Pages: 6208 - 6211
Docket number: [OPP-64046; FRL-6489-6]
FR document: [FR Doc. 00-2828 Filed 2-7-00; 8:45 am]
Agency: Environmental Protection Agency
Official PDF Version: PDF Version
ENVIRONMENTAL PROTECTION AGENCY
[OPP-64046; FRL-6489-6]
Formetanate Hydrochloride; Receipt of Requests to Voluntarily Delete Uses, Request for Cancellation, and Advance Notification of Tolerance Revocation
AGENCY:
Environmental Protection Agency (EPA).
ACTION:
Notice.
SUMMARY:
AgrEvo USA Company, the company that holds the pesticideregistration of pesticide products containing formetanate hydrochloride (m-[[(dimethylamino)methylene]amino]phenyl methylcarbamate hydrochloride) has asked EPA toamend its registration to delete use on plums, prunes, and greenhouse grown ornamental plants,and cancel six pesticide products registered for greenhouse grown ornamental plants undersection 24(c) of the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA). In accordancewith section 6(f)(1) of FIFRA, as amended, EPA is issuing a notice of receipt of this request bythe registrant. The request to delete the aforementioned uses from the registration, and voluntarycancellation of 24(c) registrations for greenhouse grown ornamental plants are the result of anagreement between EPA and the registrant regarding the registration of pesticide productscontaining formetanate hydrochloride. Given the potential dietary risks from formetanatehydrochloride use on registered food crops, the registrant requested, among other things, thatuses that appear to be of little benefit (i.e., plums and prunes) be deleted from pesticide productlabels. In addition, due to potential worker exposure risks from formetanate hydrochloridepesticide product use on greenhouse grown ornamental plants, the registrant requested that thisuse also be terminated and registrations for this use under section 24(c) of FIFRA be canceled.Following publication of this Notice and completion of a 30-day public comment period, EPAintends to grant the requested amendments to delete uses and voluntary registration cancellations.
DATES:
Comments on the requested amendments to delete uses andvoluntary registration cancellations must be submitted to the address provided below by March 9, 2000.
FOR FURTHER INFORMATION CONTACT:
By mail: Michael Goodis, SpecialReview and Reregistration Division (7508C), Office of Pesticide Programs, EnvironmentalProtection Agency, 1200 Pennsylvania Avenue, NW, Washington, DC 20460; telephone (703)308-8157; e-mail address: goodis.michael@epa.gov.
SUPPLEMENTARY INFORMATION:
I. General Information
A. Does this Action Apply to Me?
This action is directed to the public in general. You may potentially be affected by thisaction if you manufacture, sell, distribute, or use pesticide products containing the active ingredient formetanate hydrochloride. Formetanate hydrochloride, trade name is Carzol® SP, isan insecticide/miticide of the carbamate class, and is presently registered in the United States andis used on citrus, stone and pome fruits, alfalfa (grown for seed), and greenhouse grownornamental plants. AgrEvo USA Company is the sole technical manufacturer of formetanatehydrochloride.
Although this action may be of particular interest to persons who produce or usepesticides, the Agency has not attempted to describe all the specific entities that may be affectedby this action. If you have any questions regarding the information in this notice, consult theperson listed under "FOR FURTHER INFORMATION CONTACT."
B. How Can I Get Additional Information, Including Copies of this Document and OtherRelated Documents?
Electronically. You may obtain electronic copies of this document,and certain other related documents that might be available electronically, from the EPA InternetHome Page at http://www.epa.gov/. To access this document, on the Home Page select "Lawsand Regulations" and then look up the entry for this document under the " FederalRegister -Environmental Documents." You can also go directly to the FederalRegister listings at http://www.epa.gov/fedrgstr/.
In Person. The Agency has established an official record for this action under docketcontrol number OPP-64046. The official record consists of thedocuments specifically referenced in this action, any public comments received during anapplicable comment period, and other information related to this action, including anyinformation claimed as confidential business information (CBI). This official record includes thedocuments that are physically located in the docket, as well as the documents that are referencedin those documents. The public version of the official record does not include any informationclaimed as CBI. The public version of the official record, which includes printed, paper versionsof any electronic comments submitted during an applicable comment period, is available forinspection in the Public Information and Records Integrity Branch (PIRIB), Rm. 119, Crystal Mall #2, 1921 Jefferson Davis Hwys, Arlington, VA, from 8:30 a.m. to 4 p.m., Mondaythrough Friday, excluding legal holidays. The PIRIB telephone number is (703) 305-5805.
C. How and to Whom Do I Submit Comments?
You may submit comments through the mail, in person, or electronically. To ensureproper receipt by EPA, it is imperative that you identify docket control number OPP-64046 in the subject line on the first page of your response.
By mail. Submit your comments to: Public Information and Records Integrity Branch(PIRIB), Information Resources and Services Division (7502C), Office of Pesticide Programs(OPP), Environmental Protection Agency, 1200 Pennsylvania Avenue, NW, Washington, DC20460.
In person or by courier. Deliver your comments to: Public Information and RecordsIntegrity Branch (PIRIB), Information Resources and Services Division (7502C), Office ofPesticide Programs (OPP), Environmental Protection Agency, Rm. 119, Crystal Mall #2, 1921Jefferson Davis Hwys, Arlington, VA. The PIRIB is open from 8 a.m. to 4 p.m., Mondaythrough Friday, excluding legal holidays. The PIRIB telephone number is (703) 305-5805.
Electronically. You may submit your comments electronically by E-mail to:"opp-docket@epa.gov," or you can submit a computer disk as described above. Do not submitany information electronically that you consider to be CBI. Avoid the use of special charactersand any form of encryption. Electronic submissions will be accepted in Wordperfect 6.1/8.0 orASCII file format. All comments in electronic form must be identified by the docket controlnumber OPP-64046. Electronic comments may also be filed online at manyFederal Depository Libraries.
D. How Should I Handle CBI That I Want to Submit to the Agency?
Do not submit any information electronically that you consider to be CBI. You mayclaim information that you submit to EPA in response to this document as CBI by marking anypart or all of that information as CBI. Information so marked will not be disclosed except inaccordance with procedures set forth in 40 CFR part 2. In addition to one complete version ofthe comment that includes any information claimed as CBI, a copy of the comment that does notcontain the information claimed as CBI must be submitted for inclusion in the public version ofthe official record. Information not marked confidential will be included in the public version ofthe official record without prior notice. If you have any questions about CBI or the proceduresfor claiming CBI, please consult the person identified in the "FOR FURTHER INFORMATIONCONTACT."
E. What Should I Consider as I Prepare My Comments for EPA?
You may find the following suggestions helpful for preparing your comments:
• Explain your views/interests as clearly as possible.
• Describe any assumptions that you used.
• Provide copies of any technical information and/or data you used that support your views.
• Make sure to submit your comments by the deadline in this notice.
• To ensure proper receipt by EPA, be sure to identify the docket control number assignedto this action in the subject line on the first page of your response. You may also providethe name, date, and Federal Register citation.
II. What Action is the Agency Taking?
This notice announces the Agency's receipt of a request from the registrant to amend theirpesticide products registered under section 3 of FIFRA. In a memorandum of agreement("Agreement") effective October 14, 1999, EPA and the registrant of products containingformetanate hydrochloride agreed to several voluntary measures to reduce dietary, agriculturalworker, and ecosystem risks associated with formetanate hydrochloride exposure. EPA initiatedthe negotiations with registrants after formetanate hydrochloride, as currently registered, wasfound to pose an unacceptable dietary risk, especially to children ages 1 to 6 years old, risksof concern to agricultural workers, and unacceptable risks to birds, terrestrial mammals, andaquatic invertebrates. As part of the Agreement, the registrant agreed, among other things, toreduce application rates on all food crops, reduce the number of applications, and to take anumber of steps to reduce worker exposure. The registrant also agreed to terminate formetanatehydrochloride product use on plums and prunes, which appear to benefit little from use of theproduct, and greenhouse grown ornamentals, to address worker risk concerns. In return, EPAagreed at this time not to initiate any cancellation or suspension proceedings under section 6(b)or 6(c) of FIFRA to achieve the risk reduction measures set forth in the Agreement.
In order to terminate formetanate hydrochloride use on plums, prunes, and greenhousegrown ornamentals, the registrant has submitted a request to amend their registration of pesticideproducts containing formetanate hydrochloride pursuant to section 6(f)(1)(A) of FIFRA. Theseregistrations are listed in the following Table 1:
| Registration No. | Product |
|---|---|
| 45639-82 | Formetanate HydrochlorideTechnical |
| 45639-163 | Carzol® SP |
This notice also announces receipt by the Agency of an application from the registrant tocancel six pesticide products registered under section 24(c) of FIFRA. These registrations arelisted in alphabetic order of the registration number in Table 2 below.
| Registration No. | Product |
|---|---|
| IN-97000400 | Carzol® SP |
| NC-97000200 | Carzol® SP |
| OH-97000800 | Carzol® SP |
| SC-97000700 | Carzol® SP |
| TX-98000800 | Carzol® SP |
| UT-92000100 | Carzol® SP |
The following Table 3 includes the name and address of record forthe registrant of the products listed in Tables 1 and 2:
| EPA Company No. | Company name and address |
|---|---|
| 45639 | AgrEvo USA Company,Little Falls Centre One,2711 Centerville Road,Wilmington, DE 19808 |
III. What is the Agency's Authority for Taking this Action?
Under section 6(f)(1)(A) of FIFRA, registrants may request, at any time, that theirpesticide registrations be canceled or amended to terminate one or more pesticide uses. Section6(f)(1)(B) of FIFRA further provides that, before acting on the request, EPA must publisha notice of receipt of any such request in the Federal Register .
Section 6(f)(1)(B) of FIFRA requires that EPA provide a 30-day period in which thepublic may comment before the Agency may act on the request to cancel registrations or deletepesticide uses. In the case of minor agricultural uses, section 6(f)(1)(C) of FIFRA requires thatEPA provide a 180-day comment period under certain circumstances.
For this action, the registrant of formetanate hydrochloride has requested that EPA waiveany public comment period provided in 6(f) of FIFRA. In light of this request, EPA is grantingthe request to waive the 180-day comment period, but is providing a 30-day public commentperiod before taking action on the requested voluntary cancellations and amendments to deleteuses.
IV. Procedures for Withdrawal of Request
Registrants who choose to withdraw a request for cancellation must submit such withdrawal in writing to the person listed under "FOR FURTHER INFORMATION CONTACT," postmarked before March 9, 2000. This written withdrawal of the request for cancellation willapply only to the applicable FIFRA section 6(f)(1) request listed in this notice. If the product(s)have been subject to a previous cancellation action, the effective date of cancellation and allother provisions of any earlier cancellation action are controlling. The withdrawal request mustalso include a commitment to pay any reregistration fees due, and to fulfill any applicableunsatisfied data requirements.
V. Provisions for Disposition of Existing Stocks
The registrant has requested amendment of the formetanate hydrochloride registrationsidentified in Table 1 and voluntary cancellation of the formetanate hydrochloride registrationsidentified in Table 2. Pursuant to section 6(f) of FIFRA, EPA intends to grant the requests forvoluntary amendment and cancellation. For purposes of the cancellation order that the Agencyintends to issue at the close of the comment period for this announcement, the term "existingstocks" will be defined, pursuant to EPA's existing stocks policy as prescribed in the FederalRegister of June 26, 1991, (56 FR 29362) (FRL-3846-4), as those stocks of a registered pesticideproduct which are currently in the United States and which have been packaged, labeled, andreleased for shipment prior to the effective date of the amendment or cancellation.
As part of the October 14, 1999, Agreement negotiated with the registrant, allformetanate hydrochloride products sold or distributed, including existing stocks, (except for thepurpose of relabeling according to the Agreement) by the registrant after December 1, 1999, shallbear labeling approved by EPA pursuant to the Agreement. Moreover, sale and distribution bypersons other than the registrant of products, including existing stocks, not bearing labelingapproved by EPA pursuant to the Agreement (except for the purpose of relabeling according tothe Agreement), shall be prohibited after June 1, 2000.
VI. Notification of Intent to Revoke Tolerances
This document also serves as an advance notification that the Agency intends to proposeto revoke the tolerances found in: 40 CFR 180.276 for residues of formetanate hydrochloridein or on plums (fresh prunes) and dried prunes. This action reflects the October 14, 1999,Agreement, in which the registrant agreed to delete the use of formetanate hydrochlorideproducts on plums and prunes. In accordance with the October 14, 1999, Agreement, the Agencyintends to revoke these tolerances to help reduce acute dietary risks that currently exceed themargins of safety deemed acceptable by the Agency. The Agency intends that the tolerancerevocations become effective June 1, 2000.
VII. Import Tolerance Guidance
The Agency is willing to consider requests to modify or maintain a tolerance followingthe cancellation of the accompanying registration. Such request should be sent to the personidentified in the "FOR FURTHER INFORMATION CONTACT" section. If EPA receives arequest to modify or maintain a tolerance in response to this Notice, the Agency will issue aNotice under section 408(f) of FFDCA informing the public of the data required to support thetolerance and stating the time period for submitting the required data. Regardless of whether atolerance applies solely to domestic food uses or solely to imported foods, the same technicalchemistry and toxicology data are required to support tolerances under FFDCA section 408. Forpesticide chemicals used in or on food, EPA requires residue chemistry data that arerepresentative of growing conditions in exporting countries in the same manner that the EPArequires representative residue chemistry data from different U.S. regions to support domesticuse of the pesticide and the tolerance. Persons supporting the maintenance or modification oftolerances to cover residues in or on imported food have the burden of demonstrating therelevance of any existing domestic data to foreign growing conditions.
If EPA does not receive any indication of a need to retain a tolerance for imported foodsfollowing the cancellation of the registered food use, the Agency will publish in the FederalRegister a notice proposing to revoke the tolerance. That notice will again give interested partiesthe opportunity to come forward to support the maintenance of the tolerance.
List of Subjects
Environmental protection, Pesticides and pests, Product registrations.
Dated: February 1, 2000.
Lois A. Rossi,
Director, Special Review and Reregistration Division, Office of Pesticide Programs.
[FR Doc. 00-2828 Filed 2-7-00; 8:45 am]
BILLING CODE 6560-50-F