An Agreement Between EPA and Pesticide Manufacturers to Mitigate the Risks of Chlorpyrifos

Elaine Bueschen

The author is an attorney in the Pesticides and Toxics Substances Law Office of the U.S. Environmental Protection Agency's (EPA's) Office of General Counsel. The views expressed in this Dialogue are those of the author and do not necessarily represent the official position of EPA. The author wishes to thank her colleagues at EPA who reviewed and provided advice on the content of this Dialogue.

[31 ELR 10452]

Introduction

On June 7, 2000, the U.S. Environmental Protection Agency (EPA) reached an agreement¹ with the basic manufacturers of chlorpyrifos to reduce potential risks from exposure to residues from pesticide products containing chlorpyrifos. More commonly known by the trade names Dursban and Lorsban, chlorpyrifos is the most commonly used pesticide in and around homes in the United States. Prior to this agreement, chlorpyrifos was the active ingredient in more than 800 chlorpyrifos pesticide products registered by EPA for a variety of uses,² including termite control, home lawn and garden use, pet collars, mosquito and fire ant control, indoor crack and crevice treatment, and as an insecticide on more than 40 agricultural crops.³ In June 2000, EPA estimated that 21 to 24 million pounds of chlorpyrifos are applied on average per year, with one-half of this amount applied in nonagricultural settings such as in and around homes, schools, office buildings, and parks.⁴

Prior to negotiating the Memorandum of Agreement Between EPA and Signatory Registrants Regarding the Registration of Pesticide Products Containing Chlorpyrifos (Chlorpyrifos Agreement or Agreement), EPA reviewed several hundred studies, conducted several assessments of the potential risks posed by chlorpyrifos, and determined that many registered uses of chlorpyrifos potentially pose unacceptable levels of risk, especially to children.⁵ The Agreement uses a phaseout approach that ceases production of the riskiest uses first. Ultimately, it will eliminate the following uses of chlorpyrifos: all termite control uses; all residential uses (except for ant and roach baits in child-resistant packaging and certain public health uses); all indoor nonresidential uses (except use on ship holds, industrial plants, manufacturing plants, food processing plants, and containerized baits in child-resistant packaging); all outdoor nonresidential uses (except use on golf courses, road medians, industrial plant sites, nonstructural wood treatments, and fire ant mound drenches and mosquito control for public health purposes); and use on tomatoes and post-bloom apple trees.⁶ This Dialogue begins with a brief overview of the statutory and regulatory setting that provided the foundation for the Agreement. It then goes on to discuss the negotiations leading up to the Agreement, the Chlorpyrifos Agreement itself, and the resulting aftermath.

Statutory Background

The actions leading up to the Chlorpyrifos Agreement were initiated as a result of the Food Quality Protection Act (FQPA).⁷ Passed unanimously by Congress in 1996, the FQPA amended the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA)⁸ and the Federal Food, Drug, and Cosmetic Act (FFDCA).⁹ As amended, FFDCA § 408 requires EPA to reassess pesticide residue tolerances, which are the maximum pesticide residue limits established for pesticide residues on food, to determine if they meet a new more stringent safety standard.¹⁰ Under the new safety standard, there must be "a reasonable certainty that no harm will result from aggregate exposure to the pesticide chemical residue, including all other exposures for which there is reliable information."¹¹ In examining aggregate exposure, EPA must assess risks from multiple sources and routes of exposure for a single chemical, including exposure from food and drinking water, as well as residential exposures that occur from the use of a pesticide in and around homes and other nonoccupational exposures.¹² In addition, as amended, FFDCA § 408 requires EPA to consider cumulative effects of pesticides with a common mechanism of toxicity.¹³ In considering cumulative exposure, the Agency must assess risks from multiple sources and routes of exposure for multiple chemicals.¹⁴

[31 ELR 10453]

FQPA amendments to FFDCA § 408 also require EPA to give special consideration to the safety of infants and children.¹⁵ Infants and children may be more susceptible to the risks from pesticide residues because their bodies are still developing, they eat and drink more than adults in relation to their body weight, and they may increase their exposure to pesticides by playing on floors or lawns and placing their hands in their mouths.¹⁶ Therefore, the FFDCA mandates that "an additional tenfold margin of safety for the pesticide chemical residue and other sources of exposure shall be applied for infants and children," unless EPA determines that a lower margin of safety will be safe for infants and children.¹⁷ This margin of safety is commonly referred to as the FQPA safety factor, e.g., 10X safety factor.

Regulatory Background

Chlorpyrifos was first registered as a pesticide by Dow Chemical Company in 1965.¹⁸ It is part of an older, riskier group of pesticides called organophosphates, which exhibit a common mechanism of toxicity.¹⁹ Chlorpyrifos and other organophosphates "affect[] the nervous system by reversibly inhibiting the activity of cholinesterase, an enzyme necessary for proper functioning of the nervous system."²⁰ Cholinesterase inhibition "allows nerve impulses to remain active longer than they should, resulting in overstimulation of the nervous system."²¹ Consequently, exposure to chlorpyrifos and other organophosphates can cause acute and chronic effects in humans.²² Low to moderate exposures may cause headaches, dizziness, nausea, confusion, muscle twitching, loss of coordination, vomiting, and diarrhea.²³ At high exposures, chlorpyrifos and other organophosphates can result in respiratory paralysis and death.²⁴

Organophosphates are one of the first groups of pesticides to be reassessed by EPA under the FQPA.²⁵ In reassessing chlorpyrifos, EPA completed the most extensive scientific risk assessment of a pesticide ever conducted by the Agency. In October 1999, EPA released its preliminary risk assessment on chlorpyrifos for public comment.²⁶ The Agency received over 4,000 comments from registrants, growers, retailers, pesticide applicators, environmental groups, and government officials.²⁷ Applying an FQPA safety factor of 3X,²⁸ the preliminary risk assessment indicated that acute and chronic dietary risks were below the Agency's level of concern,²⁹ but that residential and occupational risks exceeded the Agency's level of concern.³⁰

When revising its risk assessment, EPA decided to retain the 10X FQPA safety factor for the protection of infants and children.³¹ This decision was based on new data showing increased sensitivity and susceptibility at low doses to neonates as compared to adult rats.³² Consequently, the revised risk assessment indicated that acute dietary risk from food exceeded the Agency's level of concern and that residential risks were an even greater concern.³³ Both the acute dietary and residential uses of concern posed the greatest risk to children.³⁴ The Agency determined that fresh tomatoes, apples, and grapes were the major contributors to the acute dietary risk.³⁵ The residential risks of concern resulted from a variety of uses including post-construction termite control, broadcast lawn treatments, indoor crack and crevice applications, and use in pet collars to name a few.³⁶ Because the FQPA safetyfactor does not apply to worker risks, the increase from 3X to 10X did not affect the Agency's assessment of occupational risks.

After revising its risk assessment for chlorpyrifos and finding that several uses of chlorpyrifos exceeded EPA's levels of concern, EPA was faced with the task of managing the potential risks from exposure to chlorpyrifos. Under FIFRA, the Agency is authorized to issue a notice of intent to cancel a pesticide if a pesticide, "when used in accordance with widespread and commonly recognized practice, generally causes unreasonable adverse effects on the environment."³⁷ Utilizing this authority, attorneys in the Pesticides and Toxics Substances Law Office of EPA's Office of General Counsel began to draft a notice of intent to cancel chlorpyrifos uses that potentially posed "unreasonable adverse effects on the environment."³⁸ In addition, in hopes of reaching an agreement with registrants of pesticide products [31 ELR 10454] containing chlorpyrifos to ban these uses, EPA officials and representatives from Dow AgroSciences LLC (Dow), the registrant that had generated and submitted to the Agency most of the chlorpyrifos-related data and studies, began discussing how to mitigate the potential risks posed by chlorpyrifos.

After several weeks of ongoing discussions, Dow presented EPA with a proposal that the Agency believed would mitigate the major risks of concern. After determining that Dow's proposal represented a suitable starting point for negotiations, EPA contacted the other basic manufacturers of chlorpyrifos to try to reach an agreement to mitigate the risks associated with chlorpyrifos.

Negotiations

The negotiations between EPA and all of the basic manufacturers of chlorpyrifos began on May 31, 2000, and culminated with a signed agreement on June 7, 2000. From the outset of the negotiations, the Agency established June 8, 2000, the date scheduled for the technical briefing on chlorpyrifos,³⁹ as the deadline for reaching an agreement with the registrants. At technical briefings, EPA presents the findings of its revised risk assessments to the public. However, because the Agency's revised risk assessment for chlorpyrifos indicated that estimated acute dietary, residential, and occupational risks exceeded EPA's level of concern, the Agency planned to announce on the day of the technical briefing for chlorpyrifos how it intended to address these risks—whether through an agreement reached with the registrants or by announcing that a notice of intent to cancel was being sent to the U.S. Department of Agriculture and the Scientific Advisory Panel in accordance with FIFRA §§ 6(b)(2) and 25(d)(1).

At the request of the registrants, EPA agreed to temporarily set aside the detailed draft memorandum of agreement it had prepared and to start negotiations with a two-page document outlining the substantive terms of the draft agreement. This two-page document quickly became referred to as the "agreement in principle." The second and third days of the negotiations were spent discussing and revising the agreement in principle. By day four, EPA attorneys incorporated the negotiated agreement in principle into a draft memorandum of agreement, and the remaining days were spent negotiating the specific language and procedural provisions of the Agreement. On June 6, 2000, EPA revised the draft agreement for the last time and sent an electronic copy of the final Agreement to the technical registrants. EPA instructed the registrants who wished to sign the Agreement to obtain the necessary signatures and return the signature page to the Agency the following day. Pursuant to the take-effect clause of the Agreement, which requires all of the registrants of technical manufacturing-use chlorpyrifos products and EPA to sign the Chlorpyrifos Agreement in order for it to take effect,⁴⁰ the Agreement became effective on June 7, 2000.

On June 8, 2000, at the press briefing announcing the Agreement, EPA Administrator Carol M. Browner, proclaimed: "This action is good news for the protection of our country's public health. It is good news for the environment. And it is particularly good news for children, who are among the most vulnerable to the risks posed by pesticides."⁴¹ For the most part, the Agreement was applauded by environmental and health advocates for stopping the production of chlorpyrifos products that pose potential heath risks. However, it was criticized by some for not requiring pesticide registrants to immediately pull the cancelled products from store shelves.⁴²

The Agreement

The Chlorpyrifos Agreement will effectively ban all agricultural use on tomatoes and the post-bloom use on apple trees and virtually all nonagricultural uses of chlorpyrifos in both residential and nonresidential areas that pose potential health risks, especially to children.⁴³ To eliminate these uses, the Agreement provides for a three-part process. First, to eliminate these uses from the products that are directly subject to the Agreement—that is, all of the signatories' pesticide products containing chlorpyrifos—the signatories agreed to request registration cancellations and registration amendments to delete these uses and amend product labeling accordingly.⁴⁴ Second, to eliminate these uses from products that are not directly subject to the Agreement, the signatories agreed to modify product labeling such that the use deletions set forth in the Agreement will "trickle down" from the signatories' products to products that are not subject to the Agreement but are manufactured from the signatories' products.⁴⁵ Finally, to make the use deletions enforceable, the Agreement sets forth existing stocks provisions for any cancellation order that the Agency issues in response [31 ELR 10455] to requests for registration cancellations and amendments to delete uses.⁴⁶

Products Subject to the Agreement

There are two basic categories of pesticide products: end-use products (EPs) and manufacturing-use products (MPs). EPA regulations define an EP as:

a pesticide product whose labeling (1) Includes directions for use of the product (as distributed or sold, or after combination by the user with other substances) for controlling pests or defoliating, desiccating or regulating growth of plants, and (2) Does not state that the product may be used to manufacture or formulate other pesticide products.⁴⁷

Thus, EPs are the pesticide products used by homeowners, farmers, pest control applicators, etc., for the uses prescribed on the labeling of the product. MPs, as the name implies, are used by companies to manufacture other pesticide products—either other MPs or EPs. EPA regulations define an MP as "any pesticide product other than an end use product. A product may consist of the technical grade of active ingredient only, or may contain inert ingredients, such as stabilizers or solvents."⁴⁸ Ultimately, all of the registrants holding MP registrations for the technical grade of the active ingredient chlorpyrifos, i.e., the companies that manufacture the nearly pure form of the ingredient for sale to all the other MP and EP registrants, and their affiliated companies signed the Chlorpyrifos Agreement.⁴⁹ Thus, all of the chlorpyrifos products registered by the signatories, i.e., all of the technical MPs plus any other MPs and EPs for which they hold registrations, are subject to the Agreement.⁵⁰

When negotiating past agreements to mitigate the risks of a pesticide, EPA has typically sought the signature of all the registrants of the pesticide at issue.⁵¹ However, given the large number of chlorpyrifos registrants⁵² and the short amount of time in which the Agency hoped to negotiate an agreement,⁵³ reaching an agreement with all of the chlorpyrifos registrants was not feasible. Instead, EPA sought to reach an agreement with the companies that hold the registrations for the technical grade (nearly pure form) MPs and their affiliated companies. This meant, however, that the hundreds of chlorpyrifos products registered by other companies would not be subject to the Agreement. Therefore, the Agreement was crafted so that the use deletions set forth in the Agreement would "trickle down" from the signatories' products via certain label modifications to the hundreds of other products containing chlorpyrifos that are not directly subject to the Agreement.

Use Deletions

To eliminate a use (also referred to as a site of application) of a pesticide product, it is necessary to delete the use not only from the product labeling being marketed but also from the "approved label" on file with EPA. This can be accomplished through use deletion or cancellation of the entire product. The Agreement provides for a twofold process to eliminate the aforementioned uses of chlorpyrifos. First, in order to remove uses from product labeling, the signatories agreed to submit applications for replacement registrations for their MPs and applications for either replacement or amended registrations for their EPs pursuant to FIFRA § 3(c)(7)(A)⁵⁴ along with five copies of draft labeling that is consistent with the terms of the Agreement.⁵⁵ EPA committed to review these applications and draft labeling on an expedited schedule and to approve those that comply with the terms of the Agreement.⁵⁶ Second, to eliminate uses from product registrations, the signatories agreed to submit, pursuant to FIFRA § 6(f), a request for cancellation of any product for which an application for replacement registration is submitted or a request for use deletion for any product for which an application for amended registration is submitted.⁵⁷

Specifically, the signatories agreed to the following use deletions: all termite control uses (these will be phased out); all residential uses (except for ant and roach baits in child-resistant packaging 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 nonresidential uses (except ship holds, industrial plants, manufacturing plants, food processing plants, and containerized baits in child-resistant packaging); all outdoor nonresidential sites (except golf courses, road medians, industrial plant sites, nonstructural 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.

Label Modifications

Label modifications are the principle means by which the use deletions set forth in the Agreement will trickle down [31 ELR 10456] from the signatories' MPs to products that are not directly subject to the Agreement but are manufactured from the signatories' MPs. Therefore, a brief background on labeling is in order. As defined by FIFRA, the term "label" means "the written, printed, or graphic matter on, or attached to, the pesticide or device or any of its containers or wrappers."⁵⁸ In general, all pesticide labels must be approved by EPA.⁵⁹ Further, each label must include a "Directions for Use" section that identifies the sites, e.g., the crops, animals, areas, or objects to be treated, in which the product may be lawfully applied.⁶⁰ If a use or site of application is not identified in the "Directions for Use" section of the label, the product may not be used for that particular purpose. Moreover, all pesticide labels must clearly state in the "Directions for Use" section of the label: "It is a violation of Federal law to use this product in a manner inconsistent with its labeling."⁶¹

To comply with the terms of the Agreement, the signatories must revise their MP labels to include several specific statements in the "Directions for Use" section of these labels.⁶² These label statements restrict the conditions in which the product may be used to formulate other products—first other MPs that are not subject to the Agreement and then EPs. For instance, MP labels revised to comply with the Agreement must include the following statement in the "Directions for Use" section of the label: "After October 1, 2000, any manufacturing-use product formulated from this product must bear EPA-approved labeling that is consistent with the terms of the June 7, 2000, memorandum of agreement between EPA and registrants of pesticide products containing chlorpyrifos."⁶³ This label statement effectively required nonsignatory registrants to revise their MP labeling to comply with the Agreement by October 1, 2000, in order to avoid any delays in production. In addition, all MP labels revised to comply with the Agreement must state in the "Directions for Use" section that the product may not be used to formulate EPs labeled for termite control, nonagricultural uses (other than termite control), or agricultural uses, unless the EP labeling meets certain specified conditions⁶⁴ with respect to these uses.⁶⁵ Thus, the label modifications will enable the substantive provisions of the Agreement—that is, the use eliminations—to "trickle down" from the signatories MPs to other MPs and EPs that are formulated from these products.

Conditions for Termite Control Use

The Agreement phases out all termiticide uses of chlorpyrifos, eliminating the riskiest uses first.⁶⁶ MP labels revised to comply with the Agreement must state that the product may not be used after December 1, 2000, to formulate an EP labeled for termite control, unless it bears EPA-approved labeling that (1) does not include directions for use for full barrier (whole house) post-construction applications, (2) states that the product may only be used for spot and local treatment of termites until December 31, 2002, and (3) has a maximum chlorpyrifos end-use dilution of 0.5% active ingredient.⁶⁷ Revised MP labeling must also state that the product may not be used after December 31, 2004, to formulate any product labeled for termite control, unless, prior to that date, EPA has made a written determination that preconstruction termite control use may continue.⁶⁸

Conditions for Nonagricultural Uses (Other Than Termite Control)

In addition to termite control uses, the Agreement effectively bans all other nonagricultural uses of chlorpyrifos that could result in exposure to children.⁶⁹ Specifically, the Agreement addresses four other types of nonagricultural uses: indoor residential, outdoor residential, indoor nonresidential, and outdoor nonresidential. MP labels revised to comply with the Agreement must state that after December 1, 2000, the product may not be used to formulate EPs labeled for any indoor residential use,⁷⁰ other than containerized ant or roach baits in child-resistant packaging.⁷¹ Consequently, to ensure continued production of EPs after December 1, 2000, crack and crevice treatments and all other indoor residential uses had to be removed from EP product labeling to ensure continued production of EPs after December 1, 2000. Revised MP labels must also state that after December 1, 2000, the product may not be used to formulate EPs labeled for any residential outdoor use, except for fire ant mounds drenches and mosquito control applied by licensed applicators for public health purposes only.⁷² Thus, all homeowner uses (except for baits in child-resistant packaging) must be removed from new EP labeling by December 1, 2000. In addition, revised MP labeling must state that the product may not be used after December 1, 2000, to formulate any product bearing instructions for any indoor nonresidential use other than one or more of the following: warehouses, ship holds, railroad boxcars, industrial plants, manufacturing plants, food processing plants, or containerized baits in child-resistant packaging.⁷³ Finally, revised MP labeling must also state that the product may not be used after December 1, 2000, to formulate any EP labeled for any outdoor nonresidential use other than one or more of the following: (1) golf courses, road medians, and industrial plant sites provided maximum label application rate is no greater than one pound of active ingredient per acre; (2) mosquito control for public health purposes; (3) fire ant mounds for public health purposes; and (4) certain $=P9991*10457nonstructural wood uses (limited to fence posts, utility poles, railroad ties, landscape timbers, logs, pallets, wooden containers, poles, posts, and processed wood products).⁷⁴ Although applications of chlorpyrifos products to golf courses may result in exposure to children, with a maximum application rate of no greater than one pound of active ingredient per acre, the Agency's revised risk assessment indicates that golf course exposure does not exceed its levels of concern for children and others.⁷⁵

Conditions for Agricultural Use

With respect to agricultural uses, the Agreement eliminates the use of chlorpyrifos pesticide products on tomatoes and post-bloom use on apple trees.⁷⁶ Revised MPs labeled for formulation into EPs labeled for agricultural uses may not bear use directions permitting formulation into products registered for tomatoes.⁷⁷ In addition, MP labels revised to comply with the Agreement must state that the product may not be used to formulate any EP bearing directions for use on apples unless the EP labeling prohibits post-bloom application to apples.⁷⁸ Agricultural use of chlorpyrifos products will be further restricted because the Agency has announced its intention to lower the tolerances for fresh grapes and apples and to revoke the tolerance for fresh tomatoes.⁷⁹

General Condition for All Use

Finally, to ensure that all homeowner uses of chlorpyrifos products are eliminated, the Agreement provides that after December 1, 2000, all new chlorpyrifos EPs (except for roach and ant baits in child-resistant packaging) must be classified as a restricted-use product or packaged in large commercial-size containers, depending on the formulation type.⁸⁰ If the product is an emulsifiable concentrate, it must be classified as restricted use. But if the product is some other formulation type, e.g., granular or microencapsulated, the registrant may choose whether to classify the product as restricted or to package it in large commercial-size containers.

Existing Stocks Provisions

The Agreement also set forth existing stocks provisions to be included in any cancellation order that EPA issues in response to the signatories' FIFRA § 6(f) requests for registration cancellations and use deletions.⁸¹ For the purposes of the Agreement, the Agency defined "existing stocks"⁸² 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] action."⁸³ Existing stocks provisions address "whether, and under what conditions, the Agency will permit the continued sale, distribution, and use of existing stocks of pesticide products whose registrations under FIFRA are amended, canceled, or suspended."⁸⁴ After the effective date of the cancellation order, any distribution, sale, or use of existing stocks that is not in accordance with the order will be a violation of FIFRA § 12(a)(2)(K)⁸⁵ and 12(a)(1)(A).⁸⁶ Thus, existing stocks provisions are the means by which the Agency will enforce the substantive provisions of the Agreement.

MPs

The agreed upon existing stocks provisions provided that all distribution or sale of existing stocks of MPs will be unlawful 30 days after the Agency issues the cancellation order.⁸⁷ After October 1, 2000, existing stocks of MPs may not be used to formulate other MPs bearing labeling that is inconsistent with the terms of the Agreement.⁸⁸ In addition, existing stocks of MPs may not be used to formulate EPs bearing instructions for use on tomatoes or post-bloom apple trees upon issuance of the cancellation order.⁸⁹ The use of existing stocks of MPs to formulate EPs bearing instructions for any of the other uses eliminated by the Agreement (except for preconstruction termite control use) will be unlawful after December 1, 2000.⁹⁰ Finally, the use of existing stocks of MPs for formulation into EPs bearing instructions for preconstruction termite control use will be unlawful after December 31, 2004, unless, prior to that date, EPA has issued a written determination that such use may continue consistent with the requirements of FIFRA.⁹¹ In short, production of chlorpyrifos products for all of the uses eliminated by the Agreement (except for spot and local termite treatment and preconstruction termite control) should have ceased by the end of 2000.

EPs

With two exceptions, the agreed upon existing stocks provisions provide that all distribution and sale by registrants of existing stocks of EPs (that do not meet any of the conditions described above) will be unlawful after February 1, 2001, and distribution and sale by retailers will be unlawful after December 31, 2001.⁹² The first exception is that the distribution, sale, or use of existing stocks of EPs that bear instructions for use on tomatoes or post-bloom apple trees will not be lawful after December 31, 2000.⁹³ The second [31 ELR 10458] exception is that the distribution, sale, or use of existing stocks for EPs bearing instructions for preconstruction termite control use will be unlawful 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.⁹⁴ In short, retail sale of existing stocks of EPs (except those labeled solely for preconstruction termite control) will cease by the end of 2001.

Aftermath

Negotiating the Chlorpyrifos Agreement was a significant step toward mitigating the risks associated with chlorpyrifos. Still, even after the Agreement took effect, much work remained to be done to ensure that chlorpyrifos meets the new safety standard established by the FQPA. First, EPA was faced with implementing the Agreement. Implementation involves interpreting the provisions of the Agreement and quickly reviewing hundreds of replacement and amendment applications for registration and approving those that comply with the Agreement.⁹⁵ Implementation also involves publishing a notice in the Federal Register announcing the receipt of the registrants' requests for registration cancellations and amendments to terminate uses of chlorpyrifos and providing the public with 30 days to comment on the notice.⁹⁶ Second, EPA must enforce the terms of the Agreement and the resulting use eliminations. To do this, EPA's Office of Pesticide Programs issued a cancellation order with the agreed upon existing stocks provisions.⁹⁷ Furthermore, EPA's Office of Enforcement and Compliance developed a FIFRA compliance/enforcement strategy to address how states should monitor compliance with the Agreement and the cancellation order through inspections.

In addition to implementing the terms of the Agreement, EPA has taken other steps to ensure that the Agreement has the intended results. Shortly after the Agreement took effect, the Agency contacted all of the nonsignatory registrants of MPs containing chlorpyrifos. EPA explained that as a result of the Agreement, no technical MP containing chlorpyrifos may be used to formulate an MP after October 1, 2000, unless the MP bears EPA-approved labeling consistent with the terms of the Agreement. Therefore, EPA asked all of the nonsignatory registrants to sign ancillary agreements, which provide that the MP registrant and the Agency will comply with all of the applicable terms in the Chlorpyrifos Agreement and in the manner set forth in the Agreement. The ancillary agreements ensure EPA that these registrants will revise their MP labels in accordance with the Agreement and provide registrants with a guarantee that can avoid any delays in production. All of the nonsignatory registrants of MPs containing chlorpyrifos agreed to sign an ancillary agreement with the Agency.

Furthermore, the Agency sent a letter to all of the companies that hold registrations for EPs containing the active ingredient chlorpyrifos.⁹⁸ The letter briefly summarizes the provisions of the Agreement and explains that, as a result of the Agreement, no MP containing chlorpyrifos may be used to formulate an EP after December 1, 2000, unless the EP bears EPA-approved labeling consistent with the terms of the Agreement. It also provides guidance on the actions that these companies should take to ensure continued production of EPs after December 1, 2000.

Finally, as required by the FQPA, the Agency must complete a cumulative assessment of the risk from food, water, residential, and other nonoccupational exposure to all pesticides and other substances that share a common mechanism of toxicity.⁹⁹ The Agency must consider cumulative exposure and risks because:

A person exposed to a pesticide at [a] level that is considered safe may in fact experience harm if that person is also exposed to other substances that cause a common toxic effect by a mechanism common with that of the subject pesticide, even if the individual exposure levels to the other substances are also considered safe.¹⁰⁰

The Agency has determined that the organophosphates share a common mechanism of toxicity—cholinesterase inhibition.¹⁰¹ Although chlorpyrifos is an organophosphate, the Agency's revised risk assessment for chlorpyrifos only looks at the risks from chlorpyrifos exposure alone; it does not assess the cumulative risks of organophosphates.¹⁰² The Agency is currently developing a methodology for conducting a cumulative risk assessment of pesticides that exhibit a common mechanism of toxicity.¹⁰³ Once this methodology is finalized and a cumulative risk assessment of the organophosphates has been completed, it is highly likely further risk reduction measures will be necessary for chlorpyrifos and other organophosphates.

1. Memorandum of Agreement Between EPA and Signatory Registrants Regarding the Registration of Pesticide Products Containing Chlorpyrifos, June 7, 2000 (on file with author) [hereinafter Chlorpyrifos Agreement].

2. Id.

3. OFFICE OF PESTICIDE PROGRAMS, U.S. EPA, OVERVIEW OF CHLORPYRIFOS REVISED RISK ASSESSMENT 1-2 (2000).

4. OFFICE OF PESTICIDE PROGRAMS, U.S. EPA, HUMAN HEALTH RISK ASSESSMENT CHLORPYRIFOS 27 (2000) [hereinafter REVISED RISK ASSESSMENT].

5. See, e.g., id. at 5, 9-10, 30-95.

6. See generally Chlorpyrifos Agreement, supra note 1.

7. Pub. L. No. 104-170, 110 Stat. 1489 (1996).

8. 7 U.S.C. §§ 136-136y, ELR STAT. FIFRA §§ 2-34.

9. 21 U.S.C. §§ 301-394.

10. Id. § 346a(q).

11. Id. § 346a(b)(2)(A)(ii).

12. See generally OFFICE OF PESTICIDE PROGRAMS, U.S. EPA, GUIDANCE FOR PERFORMING AGGREGATE EXPOSURE AND RISK ASSESSMENT (1999), available at http://www.epa.gov/pesticides/trac/science/ (last visited Feb. 27, 2001).

13. See 21 U.S.C. § 346a(b)(2)(D)(v).

14. See generally OFFICE OF PESTICIDE PROGRAMS, U.S. EPA, GUIDANCE FOR IDENTIFYING PESTICIDE CHEMICALS AND OTHER SUBSTANCES THAT HAVE A COMMON MECHANISM OF TOXICITY (1999), available at http://www.epa.gov/pesticides/trac/science/ (last visited Feb. 27, 2001).

15. 21 U.S.C. §§ 346a(b)(2)(C).

16. OFFICE OF PESTICIDE PROGRAMS, U.S. EPA, Pesticides and Food: What Your Family Needs to Know, at http://www.epa.gov/pesticides/food/ (last modified Oct. 20, 1999).

17. 21 U.S.C. § 346a(b)(2)(C).

18. OFFICE OF PESTICIDE PROGRAMS, U.S. EPA, SPECIAL REVIEW AND REREGISTRATION, CHLORPYRIFOS TECHNICAL BRIEFING 4 (2000) [hereinafter CHLORPYRIFOS TECHNICAL BRIEFING].

19. See REVISED RISK ASSESSMENT, supra note 4, at 115.

20. Id. at 2.

21. OFFICE OF PESTICIDE PROGRAMS, U.S. EPA, ORGANOPHOSPHATE (OP) PESTICIDE REVIEW PROCESS, at http://www.epa.gov/pesticides/op/process.htm (last modified Nov. 23, 1999) [hereinafter OP REVIEW PROCESS].

22. REVISED RISK ASSESSMENT, supra note 4, at 95-98.

23. Id.

24. Id.

25. FFDCA § 408(q) provides that EPA "shall give priority to the review of the tolerances or exemptions that appear to pose the greatest risk to public health." 21 U.S.C. § 346a(q)(2).

26. OFFICE OF PESTICIDE PROGRAMS, U.S. EPA, CHLORPYRIFOS PRELIMINARY RISK ASSESSMENT (1999).

27. See CHLORPYRIFOS TECHNICAL BRIEFING, supra note 18.

28. See supra notes 15-17 and accompanying text.

29. OFFICE OF PESTICIDE PROGRAMS, U.S. EPA, OVERVIEW OF CHLORPYRIFOS PRELIMINARY RISK ASSESSMENT 4-8 (1999).

30. Id. at 10-20.

31. REVISED RISK ASSESSMENT, supra note 4, at 3-4.

32. See Memorandum from Brenda Tarplee, Executive Secretary, FQPA Safety Factor Committee, U.S. EPA, Office of Pesticide Programs, Health Effects Division, to Deborah Smegal, Risk Assessor, Health Effects Division, U.S. EPA, Office of Pesticide Programs, on Chlorpyrifos—Reevaluation Report of the FQPA Safety Factor (Apr. 4, 2000).

33. REVISED RISK ASSESSMENT, supra note 4, at 4, 34 (acute dietary risk); id. at 10, 69 (residential risk).

34. Id. at 34.

35. Id.

36. Id. at 69.

37. 7 U.S.C. § 136d(b), ELR STAT. FIFRA § 6(b).

38. FIFRA § 2(bb) defines "unreasonable adverse effects on the environment" as:

(1) any unreasonable risk to man or the environment, taking into account the economic, social, and environmental costs and benefits of the use of any pesticide, or (2) a human dietary risk from residues that result from a use of a pesticide in or on any food inconsistent with the standard under section [408 of the FFDCA].

Id. § 136(2)(bb), ELR STAT. FIFRA § 2(bb).

39. There is a six-phase pilot process for reviewing organophosphates that was designed to ensure transparency and public participation. In phase 1 (30 days), there is a registrant "error only" review of the Agency's risk assessment. In phase 2 (up to 30 days), EPA considers the registrants comments. During phase 3 (60 days), the Agency invites the public to comment on its preliminary risk assessment. During phase 4 (90 days), EPA revises its risk assessments. EPA explains its revised risk assessments at a public technical briefing. In phase 5 (60 days). EPA solicits risk management ideas. And finally, in phase 6 (up to 60 days), EPA develops final risk management strategies. Thus, the technical briefing kicks off phase 5 of the pilot review process. See OP REVIEW PROCESS, supra note 21.

40. See Chlorpyrifos Agreement, supra note 1, at 19-20.

41. Carol M. Browner, Administrator, U.S. EPA, Dursban Announcement, Remarks Prepared for Delivery June 8, 2000, Washington, D.C., at http://www.epa.gov/epahome/speeches_0608.htm.

42. Shortly after the Agreement was announced, some public interest groups urged large retail chains, such as Home Depot and Wal-Mart, to voluntarily remove pesticide products containing chlorpyrifos from their shelves as soon as possible. Subsequently, Wal-Mart announced that it would stop selling chlorpyrifos products by October 31, 2000, and Home Depot decided to hang signs in its stores identifying alternatives to chlorpyrifos pesticide products. See Andrew C. Revkin, EPA, Citing Risks to Children, Signs Accord to Limit Insecticide, N.Y. TIMES, June 9, 2000, at A1, A20; Statement by Todd Hetttenbach, EWG Pesticide Analyst, EWG Says EPA Right to Ban Home, Lawn Uses of Dangerous Pesticides, June 7, 2000, at http://www.ewg.org/pressreleases/epadursban.html.

43. In a separate action to further reduce potential food risks from chlorpyrifos that is not part of the Agreement, the Agency proposed to reduce the chlorpyrifos tolerance (maximum chlorpyrifos residue limit) for fresh apples and grapes, and to revoke the tolerance for chlorpyrifos residues in or on fresh tomatoes. The Agency intends to reduce the tolerance for grapes to a level that will allow for dormant applications, which is the only domestic use allowed, but not foliar applications that are typically used abroad. See U.S. EPA. Chlorpyrifos; Receipt of Requests for Amendments, Cancellations, and Notification of Tolerance Revocation and Modifications, 65 Fed. Reg. 56886 (Sept. 20, 2000) [hereinafter Cancellation Notice].

44. Chlorpyrifos Agreement, supra note 1, at 1-5.

45. Id. at 10-14.

46. Id. at 5-10.

47. 40 C.F.R. § 158.153(b).

48. Id. § 158.153(h).

49. The registrants that signed the Agreement include: Cheminova A/S; Cheminova Inc.; Dow AgroSciences LLC; Gharda USA, Inc.; Luxembourg Industries (Pamol) Ltd.; Makhteshim-Agan of North America, Inc.; Makhteshim Chemical Works, Ltd.; and Platte Chemical Co.

50. See Chlorpyrifos Agreement, supra note 1, at app. A, app. B.

51. For example, two agreements negotiated and signed on August 2, 1999—the memorandum of agreement between EPA and registrants of pesticide products containing azinphos methyl, and the memorandum of agreement between EPA and registrants of pesticide products containing methyl parathion—were signed by virtually all of the registrants holding registrations for pesticide products containing azinphos methyl and methyl parathion. In the case of azinphos methyl, there were 6 registrants, and in the case of methyl parathion, there were 12 registrants.

52. According to the Registration Division in EPA's Office of Pesticide Programs, there are more than 100 companies holding registrations for more than 800 pesticide products containing chlorpyrifos.

53. The Agency hoped to reach an agreement with registrants to mitigate the risks associated with chlorpyrifos before the technical briefing for chlorpyrifos, which was scheduled just eight days away from the time that EPA initiated negotiations with the basic manufacturers of chlorpyrifos See supra note 39 and accompanying text.

54. 7 U.S.C. § 136a(c)(7)(A), ELR STAT. FIFRA § 3(c)(7)(A). See Chlorpyrifos Agreement, supra note 1, at 1-2.

55. See 40 C.F.R. § 152.50(e); Chlorpyrifos Agreement, supra note 1, at app. C.

56. Chlorpyrifos Agreement, supra note 1, at 4-5.

57. FIFRA § 6(f)(1)(A) provides that "[a] registrant may, at any time, request that a pesticide registration of the registrant be canceled or amended to terminate one or more pesticide uses." 7 U.S.C. § 136d(f)(1)(A), ELR STAT. FIFRA § 6(f)(1)(A). See Chlorpyrifos Agreement, supra note 1, at 2-4.

58. 7 U.S.C. § 136(p)(1), ELR STAT. FIFRA § 2(p)(1).

59. See 40 C.F.R. § 156.10(a)(6).

60. See id. § 156.10(i)(2)(iii).

61. Id. § 156.10(i)(2)(ii). See also 7 U.S.C. § 136j(a)(2)(G), ELR STAT. FIFRA § 12(a)(2)(G).

62. Chlorpyrifos Agreement, supra note 1, at 10-12.

63. Id. at 10.

64. See infra notes 65-79 and accompanying text.

65. Chlorpyrifos Agreement, supra note 1, at 10-12.

66. Id. at 10-11.

67. Id. at 11.

68. Id.

69. Id. at 11-13.

70. The term "residential use" means:

use of a pesticide directly: (1) On humans or pets, (2) In, on, or around any structure, vehicle, article, surface, or area associated with the household, including but not limited to areas such as non-agricultural outbuildings, non-commercial greenhouses, pleasure boats and recreational vehicles, or (3) In any preschool or day care facility.

40 C.F.R. § 152.3(u).

71. Chlorpyrifos Agreement, supra note 1, at 12.

72. Id.

73. Id.

74. Id. at 12-13.

75. REVISED RISK ASSESSMENT, supra note 4, at 69. Golf course exposure following treatment at the maximum rate of four pounds of active ingredient per acre, however, did exceed the Agency's level of concern. Id.

76. Chlorpyrifos Agreement, supra note 1, at 13-14.

77. Id. at 13.

78. Id.

79. See supra note 43.

80. Chlorpyrifos Agreement, supra note 1, at 11, 12, 14.

81. Id. at 5-10. The cancellation order was published on December 6, 2000. U.S. EPA, Chlorpyrifos; Cancellation Order, 65 Fed. Reg. 76233 (Dec. 6, 2000) [hereinafter Cancellation Order].

82. Chlorpyrifos Agreement, supra note 1, at 5-6 (defining "existing stocks" as that term is defined in U.S. EPA, Existing Stocks. Statement of Policy, 56 Fed. Reg. 29362 (June 26, 1991)).

83. 56 Fed. Reg. at 29362.

84. Id.

85. 7 U.S.C. § 136j(a)(2)(K), ELR STAT. FIFRA § 12(a)(2)(K).

86. Id. § 136j(a)(1)(A), ELR STAT. FIFRA § 12(a)(1)(A).

87. Chlorpyrifos Agreement, supra note 1, at 6.

88. Id. at 6-7.

89. Id. at 6.

90. Id. at 7-8.

91. Id. at 8.

92. Id. at 9-10.

93. Id. at 9.

94. Id. at 10.

95. Id. at 4-5; Cancellation Notice, supra note 43, at 56886.

96. See Chlorpyrifos Agreement, supra note 1, at 5; 7 U.S.C. § 136d(f)(2), ELR STAT. FIFRA § 6(f)(2).

97. See Chlorpyrifos Agreement, supra note 1, at 5-10; Cancellation Order, supra note 81, at 76233.

98. Guidance from Lois A. Rossi, Director, Special Review and Registration Division, and James J. Jones, Director, Registration Division, Office of Pesticide Programs, U.S. EPA, to Formulators of End-Use Products Containing Chlorpyrifos (July 28, 2000).

99. FFDCA § 408(b)(2)(D), 21 U.S.C. § 346a(b)(2)(D). The Agency describes cumulative risk assessment as "the process of combining exposure (the amount of a pesticide to which an individual is exposed) and hazard (the health effects a pesticide could cause) from all substances that share a common mechanism of toxicity." OFFICE OF PREVENTION, PESTICIDES, AND TOXIC SUBSTANCES, U.S. EPA, QUESTIONS & ANSWERS: PROPOSED GUIDANCE ON CUMULATIVE RISK ASSESSMENT OF PESTICIDE CHEMICALS THAT HAVE A COMMON MECHANISM OF TOXICITY 1 (2000).

100. REVISED RISK ASSESSMENT, supra note 4, at 115.

101. Id.

102. Id. at 116.

103. See OFFICE OF PESTICIDE PROGRAMS, U.S. EPA, PROPOSED GUIDANCE ON CUMULATIVE RISK ASSESSMENT FOR PESTICIDE CHEMICALS THAT HAVE A COMMON MECHANISM OF TOXICITY (2000), available at http://www.epa.gov/pesticides/trac/science/ (last visited Feb. 27, 2001).