Chlorpyrifos; Receipt of Requests for Amendments, Cancellations, and Notification of Tolerance Revocation and Modifications

AGENCY:

Environmental Protection Agency (EPA).

ACTION:

Notice.

SUMMARY:

The companies that hold the pesticide registrations of manufacturing-use pesticide products containing chlorpyrifos [O,O-diethyl O-(3,5,6-trichloro-2-pyridinyl)phosphorothioate] have asked EPA to cancel their registrations for these products. In addition, these companies have asked EPA to cancel or amend their registrations for end-use products containing chlorpyrifos. Pursuant to section 6(f)(1) of the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA), EPA is announcing the Agency's receipt of these requests from the registrants. These requests for voluntary cancellation and amendment are the result of a memorandum of agreement signed by EPA and a number of registrants of products containing chlorpyrifos on June 7, 2000, and ancillary agreements signed by other registrants shortly thereafter. Given the potential risks, both dietary and non-dietary, that chlorpyrifos use poses, especially to children, EPA intends to grant the requested cancellations and amendments to delete uses. EPA also plans to issue a cancellation order for the deleted uses and the canceled registrations at the close of the comment period for this announcement. Upon the issuance of the cancellation order, any distribution, sale, or use of chlorpyrifos products will only be permitted if such distribution, sale, or use is consistent with the terms of that order. In addition, EPA is announcing its intention to revoke the tolerance for chlorpyrifos residues in or on tomatoes and to lower the tolerance for chlorpyrifos residues in or on apples and grapes.

DATES:

Comments on the requested amendments to delete uses and the requested registration cancellations must be submitted to the address provided below and identified by docket control number OPP-34203D. Comments must be received on or before October 20, 2000.

ADDRESSES:

Comments may be submitted by mail, electronically, or in person. Please follow the detailed instructions for each method as provided in Unit I. of the SUPPLEMENTARY INFORMATION. To ensure proper receipt by EPA, it is imperative that you identify docket control number OPP-34203D in the subject line on the first page of your response.

FOR FURTHER INFORMATION CONTACT:

Tom Myers, Special Review and Reregistration Division (7508C), Office of Pesticide Programs, Environmental Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460; telephone number: 703 308-8589; fax number: 703-308-8041; e-mail address: myers.tom@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 be potentially affected by this action if you manufacture, sell, distribute, or use chlorpyrifos products. The Congressional Review Act, 5 U.S.C. 801 et seq., as added by the Small Business Regulatory Enforcement Fairness Act of 1996, does not apply because this action is not a rule, for purposes of 5 U.S.C. 804(3). Since other entities may also be interested, the Agency has not attempted to describe all the specific entities that may be affected by this action. 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. How Can I Get Additional Information, Including Copies of this Document and Other Related Documents?

1. Electronically. You may obtain electronic copies of this document, and certain other related documents that might be available electronically, from the EPA Internet Home Page at http://www.epa.gov/. To access this document, on the Home Page select “Laws and Regulations,” “Regulations and Proposed Rules” and then look up the entry for this document under the “Federal Register—Environmental Documents.” You can also go directly to the Federal Register listings at http://www.epa.gov/fedrgstr/. To access information about the risk assessment for chlorpyrifos, go to the Home Page for the Office of Pesticide Programs or go directly to http://www.epa.gov/pesticides/op/chlorpyrifos.htm.

2. In person. The Agency has established an official record for this action under docket control number OPP-34203D. The official record consists of the documents specifically referenced in this action, any public comments received during an applicable comment period, and other information related to this action, including any information claimed as Confidential Business Information (CBI). This official record includes the documents that are physically located in the docket, as well as the documents that are referenced in those documents. The public version of the official record does not include any information claimed as CBI. The public version of the official record, which includes printed, paper versions of any electronic comments submitted during an applicable comment period, is available for inspection in the Public Information and Records Integrity Branch (PIRIB), Rm. 119, Crystal Mall #2, 1921 Jefferson Davis Hwy., Arlington, VA, from 8:30 a.m. to 4 p.m., Monday through 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 ensure proper receipt by EPA, it is imperative that you identify docket control number OPP-34203D in the subject line on the first page of your response.

1. 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 Ave., NW., Washington, DC 20460.

2. In person or by courier. Deliver your comments to: Public Information and Records Integrity Branch (PIRIB), Information Resources and Services Division (7502C), Office of Pesticide Programs (OPP), Environmental Protection Agency, Rm. 119, Crystal Mall #2, 1921 Jefferson Davis Hwy., Arlington, VA. The PIRIB is open from 8:30 a.m. to 4 p.m., Monday through Friday, excluding legal holidays. The PIRIB telephone number is (703) 305-5805.

3. 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 submit any information electronically that you consider to be CBI. Avoid the use of special characters and any form of encryption. Electronic submissions will be accepted in WordPerfect 6.1/8.0 or ASCII file format. All comments in electronic form must be identified by docket control number OPP-34203D. Electronic comments may also be filed online at many Federal 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 may claim information that you submit to EPA in response to this document as CBI by marking any part or all of that information as 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 version of the official record. Information not marked confidential will be included in the public version of the official record without prior notice. If you have any questions about CBI or the procedures for claiming CBI, please consult the person listed under FOR FURTHER INFORMATION CONTACT.

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

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. Offer alternative ways to improve the notice or collection activity.

7. Make sure to submit your comments by the deadline in this notice.

8. To ensure proper receipt by EPA, be sure to identify the docket control number assigned to this action in the subject line on the first page of your response. You may also provide the name, date, and Federal Register citation.

II. Receipt of Requests to Cancel and Amend Registrations to Delete Uses.

A. Background

In a memorandum of agreement (Agreement) effective June 7, 2000, EPA and a number of registrants of pesticide products containing chlorpyrifos agreed to several voluntary measures that will reduce the potential exposure to children associated with chlorpyrifos containing products. Shortly thereafter, EPA and several other pesticide registrants of manufacturing-use products containing chlorpyrifos signed ancillary agreements in which the parties agreed to comply with the terms of the June 7, 2000, agreement. EPA initiated the negotiations with registrants after finding chlorpyrifos, as currently registered, was an exposure risk especially to children. As part of the Agreement, the signatory registrants that hold the pesticide registrations of manufacturing-use pesticide products containing chlorpyrifos have asked EPA to cancel their registrations for these products. In addition, these companies have asked EPA to cancel or amend their registrations for end-use products containing chlorpyrifos. Pursuant to section 6(f)(1) of FIFRA, EPA is announcing the Agency's receipt of these requests from the registrants. With respect to the registration amendments, the companies have asked EPA to amend end-use product registrations to delete the following uses: all termite control uses (these will be phased out); all residential uses (except for ant and roach baits in child resistant packaging (CRP) and fire ant mound drenches for public health purposes by licensed applicators and mosquito control for public health purposes by public health agencies); all indoor non-residential uses (except ship holds, industrial plants, manufacturing plants, food processing plants, and containerized baits in CRP); all outdoor non-residential sites (except golf courses, road medians, industrial plant sites, non-structural wood treatments, and fire ant mound drenches for public health purposes by licensed applicators and mosquito control for public health purposes by public health agencies); and use on tomatoes and post-bloom apple trees. With respect to the registration cancellations, the companies have submitted replacement applications for registration with new labeling that would also eliminate all of these uses. In addition, the companies agreed to limit the maximum chlorpyrifos end-use dilution to 0.5% active ingredient (a.i.) for termiticide uses that will be phased out, limit the maximum label application rate for outdoor non-residential use on golf courses, road medians, and industrial plant sites to 1 lb/a.i. per acre, and either classify all new/amended chlorpyrifos products (except baits in CRP) as Restricted Use or package the products in large containers, depending on the formulation type, to ensure that remaining chlorpyrifos products are not available to homeowners. In return, EPA stated that with this Agreement, it had no current intention to initiate any cancellation or suspension proceedings under section 6(b) or 6(c) of FIFRA with respect to the issues addressed in the Agreement.

B. Requests for Voluntary Cancellation of Manufacturing-Use Products

Pursuant to the Agreement and FIFRA section 6(f)(1)(A), the registrants have submitted requests for voluntary cancellation of registrations for their manufacturing-use products. The registrations for which cancellations were requested are identified in the following Table 1:

Under section 6(f)(1)(A) of FIFRA, registrants may request, at any time, that EPA cancel any of their pesticide registrations. Section 6(f)(1)(B) of FIFRA requires that EPA provide a 30-day period in which the public may comment before the Agency may act on the request for voluntary cancellation. In addition, section 6(f)(1)(C) of FIFRA requires that EPA provide a 180-day comment period on a request for voluntary termination of any minor agricultural use before granting the request, unless (1) the registrants request a waiver of the comment period, or (2) the Administrator determines that continued use of the pesticide would pose an unreasonable adverse effect on the environment. The registrants have requested that EPA waive the 180-day comment period. In light of this request, EPA is granting the request to waive the 180-day comment period and is providing a 30-day public comment period before taking action on the requested cancellations. Given the potential risks, both dietary and non-dietary, that chlorpyrifos use poses, especially to children, EPA intends to grant the requested cancellations at the close of the comment period for this announcement.

C. Requests for Voluntary Cancellation of End-Use Products

In addition to requesting voluntary cancellation of manufacturing-use products, several registrants have submitted requests for voluntary cancellation of some of their registrations for end-use pesticide products containing chlorpyrifos. The end-use registrations for which cancellation was requested are identified in the following Table 2:

Under section 6(f)(1)(A) of FIFRA, registrants may request, at any time, that EPA cancel any of their pesticide registrations. The registrants have requested that EPA waive the 180-day public comment period under section 6(f)(1)(C)(ii) of FIFRA In light of this request, EPA is granting the request to waive the 180-day comment period and is providing a 30-day public comment period before taking action on the requested cancellations. Given the potential dietary and non-dietary risks that chlorpyrifos use poses, especially to children, EPA intends to grant the requested cancellations at the close of the comment period for this announcement.

1. Requests for voluntary amendments to delete uses from the registrations of end-use products. Pursuant to section 6(f)(1)(A) of FIFRA, the signatory registrants have also submitted requests to amend their other end-use registrations of pesticide products containing chlorpyrifos to delete the aforementioned uses from any product bearing such use. The registrations for which amendments to delete uses were requested are identified in the following Table 3:

Under section 6(f)(1)(A) of FIFRA, registrants may request, at any time, that their pesticide registrations be amended to delete one or more pesticide uses. The registrants have requested that EPA waive the 180-day comment period. In light of this request, EPA is granting the request to waive the 180-day comment period and is providing a 30-day public comment period before taking action on the requested amendments to delete uses. Given the potential dietary and non-dietary risks that chlorpyrifos use poses, especially to children, EPA intends to grant the requested amendments to delete uses at the close of the comment period for this announcement.

III. Proposed Existing Stocks Provisions

The registrants have requested voluntary cancellation of the chlorpyrifos registrations identified in Tables 1 and 2 and voluntary amendment to terminate certain uses of the chlorpyrifos registrations identified in Table 3. Pursuant to section 6(f) of FIFRA, EPA intends to grant the requests for voluntary cancellation and amendment. For purposes of the cancellation order that the Agency intends to issue at the close of the comment period for this announcement, the term “existing stocks ” will be defined, pursuant to EPA's existing stocks policy as published in the Federal Register of June 26, 1991, (56 FR 29362), as those stocks of a registered pesticide product which are currently in the United States and which have been packaged, labeled, and released for shipment prior to the effective date of the cancellation or amendment. Any distribution, sale, or use of existing stocks after the effective date of the cancellation order that the Agency intends to issue that is not consistent with the terms of that order will be considered a violation of section 12(a)(2)(K) and /or 12(a)(1)(A) of FIFRA.

A. Manufacturing-Use Products

1. Distribution or sale. The distribution or sale of existing stocks of any manufacturing-use product identified in Table 1 will not be lawful under FIFRA as of the 30th day following the issuance of the cancellation order canceling the registrations of the products identified in Table 1, except for the purposes of returns for relabeling consistent with the Agreement, shipping such stocks for export consistent with the requirements of section 17 of FIFRA, or for proper disposal.

2. Use for producing other manufacturing-use products. The use of existing stocks of any manufacturing-use product identified in Table 1 for formulation into any other manufacturing-use product will not be lawful under FIFRA as of the date of the cancellation order unless such product bears an EPA-approved label that is consistent with the provisions of the Agreement.

3. Use for producing end-use products— (i) Restricted use and package size limitations—(a) The use of existing stocks of any manufacturing-use product identified in Table 1 for formulation into any end-use product that is an emulsifiable concentrate (EC) will not be lawful under FIFRA as of December 1, 2000, unless the end-use product is labeled for restricted use.

(b) The use of existing stocks of any manufacturing-use product identified in Table 1 for formulation into any end-use product labeled for any agricultural use (other than cattle ear tags) and that is not an EC, will not be lawful under FIFRA as of December 1, 2000, unless the product is either labeled for restricted use or packaged in containers no smaller than 15 gallons of a liquid formulation, 50 pounds of a granular formulation, or 25 pounds of any other dry formulation;

(c) The use of existing stocks of any manufacturing-use product identified in Table 1 for formulation into any end-use product labeled solely for non-agricultural uses (other than containerized baits in Child Resistant Packaging (CRP)) and that is not an EC, will not be lawful under FIFRA as of December 1, 2000, unless the product is either labeled for restricted use or packaged in containers no smaller than 15 gallons of a liquid formulation or 25 pounds of a dry formulation.

(ii) Use in products labeled for use on tomatoes or use on apple trees post bloom. The use of existing stocks of any manufacturing-use product identified in Table 1 for formulation into end-use products bearing instructions for use on tomatoes or use on apple trees following bloom will not be lawful under FIFRA as of the date of issuance of the cancellation order canceling the manufacturing-use products listed in Table 1.

(iii) Use in products labeled for other end-uses. The use of existing stocks of any manufacturing-use product identified in Table 1 for formulation into any end-use product bearing instructions for any of the following uses will not be lawful under FIFRA after December 1, 2000:

(a) All termite control uses, unless the end-use product bears directions for use of a maximum 0.5% chlorpyrifos end-use dilution;

(b) Post-construction termite control, except for spot and local termite treatment, provided the label of the end-use product states that the product may not be used for spot and local treatment after December 31, 2002;

(c) Indoor residential, except for containerized baits in CRP;

(d) Indoor non-residential, except for containerized baits in CRP and products with formulations other than EC that bear labeling solely for one or more of the following uses: warehouses, ship holds, railroad boxcars, industrial plants, manufacturing plants, or food processing plants;

(e) Outdoor residential, except for products bearing labeling solely for one or more of the following public health uses: individual fire ant mound treatment by licensed applicators or mosquito control by public health agencies;

(f) Outdoor non-residential, except for products that bear labeling solely for one or more of the following uses: golf courses, road medians, and industrial plant sites, provided the maximum label application rate does not exceed 1lb./ai per acre; mosquito control for public health purposes by public health agencies; individual fire ant mound treatment for public health purposes by licensed applicators; and fence posts, utility poles, railroad ties, landscape timbers, logs, pallets, wooden containers, poles, posts and processed wood products;

(iv) Final use date for any manufacturing-use product labeled for termite control. The use of existing stocks of any manufacturing-use product identified in Table 1 for formulation into any end-use product labeled for termite control will not be lawful under FIFRA after December 31, 2004, except that EPA will permit the continued use for the manufacture of end-use products labeled solely for pre-construction termite control if EPA has issued a written determination that the pre-construction use may continue consistent with the requirements of FIFRA.

4. All other use. Any use of existing stocks of a canceled manufacturing-use product identified in Table 1 that is not otherwise limited or prohibited as set forth in Unit III.A.1.-3. of this document may continue until such stocks are exhausted provided such use is in accordance with the existing label of that product.

B. End-Use Products

1. Distribution, sale or use of products bearing instructions for use on tomatoes or apples trees post bloom. The distribution, sale or use of existing stocks by any person of any product listed in Table 2 or 3 that bears instructions for post-bloom application to apple trees or use on tomatoes will not be lawful under FIFRA after December 31, 2000. Any use of such product until that date must be in accordance with the existing labeling of that product.

2. Distribution or sale by registrants of products bearing other uses— (i) Restricted use and package size limitations— (a) The distribution or sale by registrants of existing stocks of any EC formulation product listed in Table 2 or 3 will not be lawful under FIFRA after February 1, 2001 unless the product is labeled as restricted use.

(b) The distribution or sale by registrants of existing stocks of any product listed in Table 2 or 3 labeled for any agricultural use and that is not an EC, will not be lawful under FIFRA after of February 1, 2001, unless the product is either labeled for restricted use or packaged in containers no smaller than 15 gallons of a liquid formulation, 50 pounds of a granular formulation, or 25 pounds of any other dry formulation;

(c)The distribution or sale by registrants of existing stocks of any product listed in Table 2 or 3 labeled solely for non-agricultural uses (other than containerized baits in CRP) and that is not an EC, will not be lawful under FIFRA after of February 1, 2001, unless the product is either labeled for restricted use or packaged in containers no smaller than 15 gallons of a liquid formulation or 25 pounds of a dry formulation.

(ii) Prohibited uses. The distribution or sale of existing stocks by registrants of any product identified in Table 2 or 3 that bears instructions for any of the following uses will not be lawful under FIFRA after February 1, 2001:

(a) Termite control, unless the product bears directions for use of a maximum 0.5% active ingredient chlorpyrifos end-use dilution;

(b) Post-construction termite control, except for spot and local termite treatment, provided the label of the product states that the product may not be used for spot and local treatment after December 31, 2002;

(c) Indoor residential except for containerized baits in CRP;

(d) Indoor non-residential except for containerized baits in CRP and products with formulations other than EC that bear labeling solely for one or more of the following uses: warehouses, ship holds, railroad boxcars, industrial plants, manufacturing plants, or food processing plants;

(e) Outdoor residential except for products bearing labeling solely for one or more of the following public health uses: individual fire ant mound treatment by licensed applicators or mosquito control by public health agencies;

(f) Outdoor non-residential except for products that bear labeling solely for one or more of the following uses: golf courses, road medians, and industrial plant sites, provided the maximum label application rate does not exceed 1lb./ai per acre; mosquito control for public health purposes by public health agencies; individual fire ant mound treatment for public health purposes by licensed applicators; and fence posts, utility poles, railroad ties, landscape timbers, logs, pallets, wooden containers, poles, posts and processed wood products.

3. Retail and other distribution or sale. The retail sale of existing stocks of products listed in Table 2 or 3 bearing instructions for the prohibited uses set forth in Unit III.B.2.(b)(i)-(vi) of this document will not be lawful under FIFRA after December 31, 2001. Except as provided in the previous sentence or in Units III.B.1. and III.B.4 of this document, EPA intends to permit distribution or sale of products identified in Table 2 or 3 by persons other than registrants until such stocks are exhausted.

4. Final distribution, sale and use date for preconstruction termite control. The distribution, sale or use of any product listed in Table 2 or 3 bearing instructions for pre-construction termiticide use will not be lawful under FIFRA after December 31, 2005, unless, prior to that date, EPA has issued a written determination that such use may continue consistent with the requirements of FIFRA.

5. Use of existing stocks. Except for products bearing those uses identified in Units III.B.1. and III.B.4. of this document, EPA intends to permit the use of existing stocks of products listed in Table 2 or 3 until such stocks are exhausted, provided such use is in accordance with the existing labeling of that product.

IV. Notification of Intent to Revoke Tolerances

This document also serves to give notice that the Agency intends to propose to revoke the tolerance found in 40 CFR 180.342 for residues of chlorpyrifos in or on tomatoes with a revocation date of June 30, 2001. Accordingly, the Agency will issue such a proposed rule to be published in the Federal Register. In the June 7, 2000, Agreement, the registrants agreed to cancel the use of chlorpyrifos products on tomatoes. The Agreement states that chlorpyrifos manufacturing-use products may not be reformulated for use on tomatoes, and that EPA intends to prohibit all distribution, sale, or use of any end-use product bearing instructions for post-bloom application to apple trees or use on tomatoes after December 31, 2000. In addition, this document serves to give notice that the Agency intends to propose to lower tolerances found in 40 CFR 180.342 for residues of chlorpyrifos in or on apples and grapes. The Agency will issue such a proposed rule to be published in the Federal Register.

V. Import Tolerance Guidance

The Agency recognizes that interested parties may want to retain a tolerance in the absence of a U.S. registration, to allow legal importation of food into the United States. To assure that all food marketed in the United States is safe, under the FFDCA, EPA may require the same technical chemistry and toxicology data for such import tolerances (tolerances without related U.S. registrations) as required to support U.S. food use registrations and any resulting tolerances. In addition, EPA may require residue chemistry data (crop field trials) that are representative of growing conditions in exporting countries in the same manner that the Agency requires representative residue chemistry data from different U.S. regions to support domestic use of the pesticides and the tolerance. Interested parties should contact the Agency for written guidance on adapting U.S. residue chemistry data requirements to non-U.S. growing conditions in order to support an import tolerance.

List of Subjects

• Environmental protection
• Memorandum of Agreement
• Pesticides and pests