Newest News from the Office of Pest Management Policy: June 19, 2003

Highlights

• Crop Profiles
• Pest Management Strategic Plans (PMS Plans)
• Chemical News
• Other Activities

Newly posted at www.ipmcenters.org
Kansas— apple
Arkansas — strawberry
Arkansas — blueberry
Arkansas — peach
Arkansas — grape
Arkansas — blackberry
Kentucky — soybean (update)
Texas — spinach (update)
Texas — cabbage
Texas — carrot
Texas — peach
Texas — sweet potato
Texas — honey bee
Vermont — alfalfa
Virginia — watermelon
Virginia — potato
Washington — sweet cherry

Newly posted at www.ipmcenters.org
Midwest - mint
Tennessee — cucurbits
Southeast — sweet potato (update)
Northwest — mint

Upcoming PMS meetings:
Apple — Mid-Atlantic (June 24)
Wine grapes — IA, IL, IN, AR, MN, MO, OH (July 15-16)
Wheat — ND, MN, NE, SD (September 11-12)
Mushrooms — Pennsylvania, Maryland, Delaware (mid-September)

(SMART meetings are pre-risk assessment meetings with EPA, Registrants and OPMP. The registrants present use and usage information, summarize or comment on any outstanding studies they may be submitting to EPA, and occasionally discuss their plans for maintaining or voluntarily canceling current uses. It is a meeting for the registrants to present information to EPA before the risk assessment really gets started.)

Carbaryl (this information is changing rapidly so things may not be as they seem).
Bayer is preparing a brief summary of the 5/21 negotiation meeting outcome to share with OPMP. OPMP had a conference call with the EPA team and here are the remaining issues:

Remaining Issues:
I. Dietary:
HED is correcting the water "error". Both citrus (FL) and apples are over the risk cup. The application rate, or number of applications, or the interval between applications needs to be reduced for both crops. OPMP is checking with growers.
a) Apples - label rate is 3 lb ai/A, and up to 5 times a year.
b) Citrus (oranges): The max label rate in FL = 7.5 LB AI/A. The water numbers are unacceptable even if EPA were to accept Bayer's proposal to reduce app rate to 3 LB AI/A 30 days before harvest.
EPA tells us that the acute dietary concerns will be mitigated if strawberries are dropped. Currently, the aPAD = 94%. If strawberry use is excluded, aPAD=71%. This may allow for citrus and apples to keep the higher rates/number of applications. CA growers are not using carbaryl- because the PHI was increased (by Bayer) from 3 to 7 days- growers would like to reduce this PHI- they need the product. CA Strawberry Commission is checking with IR4 re: necessary residue trails.

II. Residential:
Bayer will market granular in ready-to-use formulations only.

III. Unrealistic REIs:

1. Apple REI for thinning is 8 days (3 lbs AI), whereas the REI for harvest is 12 hrs. Bayer wants EPA to wait until the results from an AZM exposure study are available. EPA is not sure if this is acceptable
2. The REI for sweet corn and grapes are unacceptably high (even with ARTF data). The REI for grapes is 14 days (girdling and cane turning). If the REI is set based on hand harvest it will be 10 days. For sweet corn: REI is 30 days (hand detasseling, harvest)- this is a 'benefits case'- if the benefits are not high- a "lost use".

IV. Pasture PHI:
Currently at 14 days- EPA wants to reduce it to 0 day- to avoid unacceptable residues in meat/milk from cattle wandering into treated areas. Both the users and Bayer want to keep the 14 day PHI. (Dhol Herzi, 202-720-2664)

Chloroneb (Terraneb) - The SMART meeting for this chemical is not expected until the Fall of 2003. Chloroneb is registered by Kincaid Enterprises as a seed treatment fungicide on beans, cotton, soybeans, and sugar beets, and as a turfgrass fungicide. (Kent Smith, 202-720-3186)

Dacthal (DCPA)
EPA has now decided that the original risk assessment is seriously flawed because the registrant is dropping all turf uses and cotton use is essentially zero. The risk assessment was based on turf and cotton. Now they are looking at maybe doing another one on cole crops. This will no doubt delay any action on DCPA for a while. (Harold Coble, 919-690-8597)

DCNA (dicloran or Botran) - The SMART meeting for this chemical is not expected until the summer of 2003. DCNA (registered by Gowan) is a foliar fungicide for use on apricots, beans, celery, cherries, cucumbers, endive, fennel, garlic, grapes, lettuce, nectarines, onions, peaches, plums, potatoes, prunes, rhubarb, shallots, sweet potatoes, tomatoes, and certain forest and ornamental uses.

DDVP
OPMP heard that the AMVAC meeting with Jim Jones and company went much better than expected. Jim seemed to be amenable to looking at, at least a subset of their human data in the interim while the court case is being decided. Status quo will reign until there is a court decision. (Ted Rogers, 202-720-3846)

Diuron
OPMP received a response from Griffin on Diuron use in citrus. Dick Collier called and said that the use of Diuron at the 9.6 LB AI/a rate was limited to 5% or less of the citrus acreage in the Flatwoods region of Florida. They still want to retain that use. OPMP will contact EPA next week to see if they really want to pursue PDP data for citrus. (Harold Coble, 919-690-8597)

Malathion
EPA says the malathion RED schedule has been pushed back until January '04 at the earliest due to ongoing toxicological deliberations. (Teung Chin, 301-734-8943)

Methyl Bromide
Round two of the Critical Use Exemption process is occurring around the US this week. Part of the discussion will be about allocation issues. More in the next issue of the Newest News. (Burleson Smith; Al Jennings, 202-720-5375; Dhol Herzi, 202-720-2664)

Napthaleneacetic Acid (NAA)
An NAA application pre-harvest in Bartlett and Bosc pears is a little known practice outside the pear and the regulatory community. However, it is absolutely necessary to facilitate the harvesting of the full crop.  Approximately a week before harvest, pears tend to form an abscission layer of cells between the stem and tree limb which literally pushes (detach) the pear off the tree. An application of NAA prevents this layer of cells from forming. In the 1940’s, before NAA was registered and commercially available for pears, "old-timers" used an ounce or two of the weed killer 2-4-D per acre. This got the job done. You had to be really careful because too much would trigger ethylene production and prematurely ripen the fruit (turn it to mush would be a better description). Also, University of California Extension folks determined if too much NAA was applied in one application (50 grams/acre or more), there was a negative effect on the number of fruit buds formed for the following year. Thus, the label recommendation today is 25 grams per acre. Not more than 2 applications 5-7 days before harvest.

Another concern is that this growth regulator is not a big selling item for the registrant(s). Thus, should EPA require expensive new studies, the registrant(s) may just drop the label. It’s registered on apples, pears and olives. It’s a thinning agent on olives at 150 grams/acre.

From Bob McClain, California Pear Advisory Board, (916) 441-0432, www.calpear.com

Additional comments received on NAA
NAA is widely used by olive growers in California to thin fruit. I do not have the actual usage figures available to me, but many growers spray-thin if necessary.
I understand that NAA is on the list for review by EPA in the not too distant future. I wanted to make sure that OPMP is aware that the olive industry uses NAA in years when the fruit set is large. Please keep the olive industry informed of any issues regarding the use of this product.
From Jan Nelson, Manager, California Olive Committee, 559/456-9096

Oryzalin (Surflan)
A revised closure memo has been sent by EPA. OPMP has read it over and it looks OK. Apparently there are no real issues — at least the registrants seem satisfied. Looks like all the uses were kept. (Harold Coble, 919-690-8597)

PH3
OPMP heard from the Degesch folks this week and EPA has accepted the language that they (the registrants) proffered in the last exchange of drafts. So we should see a new label requirement soon and have new labels in the field on new products by next spring (approximate). (Ted Rogers, 202-720-3846)

Spinosad
Registration for use on stored grain has been pushed forward to 2005. This will cause difficulties with getting this use through the CODEX MRL process. The CRM for Reldan is going to rattle some chains in RD, she sounded like she had been given the authority to fix this. (Ted Rogers, 202-720-3846)

Thidiazuron (TDZ)
OPMP attended a SMART meeting on this chemical on Thursday, June 12. TDZ is the shorthand most cotton people use to refer to thidiazuron. TDZ is the active ingredient in Dropp 50 WP and Dropp SC cotton defoliant. Bayer Crop Science is the main registrant. MicroFlo and Crompton will also be selling material produced in China in 2003. Griffin sells a formulation called FreeFall supplied by Bayer. TDZ is also a component of Ginstar defoliant, which contains Diuron as well. Approximately 40% of US cotton acreage is treated annually with some form of TDZ. Dropp is the favored formulation in the humid areas of the Southeast, while Ginstar is favored in the west. Average use rate for TDZ is a little less than 0.06 LB AI/A, and total use is around 300,000 lbs per year. The major advantages from using TDZ include excellent defoliation at very low use rates and good control of cotton regrowth. TDZ is the only defoliant to provide control of regrowth. (Harold Coble, 919-690-8597)

Thiram
Matt Brooks of Ag Chem Consulting called OPMP on 5/23/03; he represents the registrant, UCB. He said EPA was planning to publish the risk assessments and that nothing had changed. EPA felt there was no reason to consult further with the registrant or USDA because there was no change in their position. Bob McNally from EPA has indicated that they will share a copy of the risk assessments with us and the registrant before publication. We should receive them in late June. (Kent Smith, 202-720-3186)

Human Data

6/4 BNA article on Fed court human testing decision.
Wednesday, June 4, 2003 Page A-1
ISSN 1521-9402
News
Pesticides
Federal Court Vacates Agency Policy;
Human Testing to Be Accepted Case-by-Case

A federal court June 3 reinstated a case-by-case approach for the Environmental Protection Agency to follow in evaluating third-party human studies of chemicals, pending further rulemaking at the agency (CropLife America v. EPA, D.C. Cir., No. 02-1057, 6/3/03).

The decision vacates the agency's policy stated in a December 2001 press release that said the agency would not rely on third-party human tests for regulatory decisions until the conclusion of a review by the National Academy of Sciences later this year.

"Because the new rule effects a dramatic change in the agency's established regulatory regime, EPA was required to follow notice and comment procedures under 21 U.S.C. Section 346a(e)(1)C) and (e)(2)," the court said.

The overturned agency directive had banned consideration of "third-party" human studies in evaluating the safety of pesticides, the U.S. Court of Appeals for the District of Columbia Circuit said June 3.

CropLife America challenged the directive March 17, arguing it was a binding regulation issued without notice of rulemaking and public comment (52 DEN A-1, 03/18/03 ).

The court agreed, reinstating EPA's earlier practice of considering the tests on a case-by-case basis in light of statutory requirements, the Common Rule, and ethical standards.

EPA had relied on the third-party human tests of pesticides for decades, the court said, until 1998. In 1998, environmental groups complained about the practice.

Press Release Was Binding, Court Says
In its briefs filed with the court, EPA had argued that the press release directive issued in December 2001 was not a binding regulation that could be reviewed by the court.

However, the court ruled the directive established a substantive rule that stated third-party human studies were immaterial in EPA regulatory decision-making under the Federal Food, Drug and Cosmetic Act and the Federal Insecticide, Fungicide, and Rodenticide Act.

"The disputed directive concretely injures petitioners, because it unambiguously precludes the agency's consideration of all third-party human studies, i.e., studies that petitioners previously have been permitted to use to verify the safety of their products," the court said.

The agency is already in the early stages of a rulemaking on human testing.

On May 7, EPA issued an advance notice of proposed rulemaking seeking comment on standards that could be applied to third-party human studies, particularly those conducted by pesticide manufacturers (87 DEN A-3, 5/6/03 ). Rule-makings at the agency can take years to complete, however, so the case-by-case approach is likely to remain in place for now. Comments on the notice are due Aug. 5.

A report from a NAS panel on its recommendations on the ethics of human testing is due out around the beginning of August.

NRDC Evaluates Options
An attorney for the Natural Resources Defense Council June 3 told BNA the group is evaluating its options on how to proceed with the case.

It is possible NRDC or EPA could file a petition for reconsideration, Aaron Colangelo said. NRDC had intervened in the litigation.

According to Colangelo, NRDC is disappointed in the court ruling against EPA on procedural grounds.

However, he said the decision also has confirmed EPA's ability to reject human studies that do not meet strict regulations and the highest ethical standards.

Following these standards, all the industry tests conducted so far would be rejected, he added.

In a statement, the group said the holding means that if EPA wants to refuse data from pesticide industry human experimentation, then it has to propose a formal rule.

NRDC Senior Attorney Erik Olson said June 3 the group is wary that the Bush administration might try to use the court decision as an excuse to accept industry's human tests, with EPA Administrator Christine Todd Whitman leaving the agency.

CropLife America Anticipates Use of Data
CropLife America said it was pleased the court had vacated EPA's moratorium on using human clinical data in pesticide risk assessment.

"We are pleased that the court recognized that EPA's moratorium constituted a binding regulation issued without notice and the opportunity to comment," CropLife America President Jay J. Vroom said.

"Not only was this a violation of the Federal Food, Drug, and Cosmetic Act, it also contradicted FFDCA's clear requirement that EPA consider all relevant reliable data in making pesticide decisions."

Vroom said CropLife America looks forward to working with EPA to utilize "these important test data in the regulation of the industry products."

The human clinical trials with pesticides are done to help refine parameters and limits of risk and to increase the confidence in risk assessment so risks are not under- or overestimated, Vroom said.

"The net benefit to society is that safe use of pesticides can be more closely aligned with efficacy using the least amount of product to accomplish the necessary crop protection and pest control," Vroom said.

The American Chemistry Council, which had intervened in the litigation, also was pleased with the decision, ACC counsel Jamie Conrad told BNA.

While the court had focused on pesticides in its decision, the holding strikes down the press release and eliminates the agency's moratorium on human testing of any chemical, Conrad said.
By Karen L. Werner

IR-4
EPA's Registration Division accepted this month amended labeling for propylene oxide to allow use to protect stored in-shell nuts and cocoa beans. This use was an IR-4 objective and it was accepted as a methyl bromide alternative post harvest use. The registrant is ABERCO, Inc., Seabrook, MD and a contact is Mr. Morris Warren (301)459-7090.

EPA Pesticide Program Update
s If you do not already receive this newsletter you can subscribe to it for free. The Web address is: http://www.epa.gov/oppfead1/cb/csbpage/form/form.html.

The following were recent announcements in the newsletter:

• Notice of Filing a Pesticide Petition to Establish a Tolerance for Cyprodinil in or on Food
• Registration Applications for Fluoxastrobin and Ipconazole
• Reopening of Comment Period for the Availability of the Preliminary Comparative Ecological Assessment for 12 Rodenticides
• Notice of Filing a Pesticide Petition to Establish a Tolerance for Fluoxastrobin in or on Food
• Receipt of Amendment/Extension Application for Experimental Use Permit for Bacillus thuringiensis Cry3Bb1 protein
• Emergency Exemption Process for Revisions Pilot and Request for Comment
• Time-Limited Pesticide Tolerance for Indoxacarb
• Pesticide Tolerances for Pyriproxyfen
• Notice of Filing a Pesticide Petition to Establish a Tolerance for Fluroxypyr in or on Sweet Corn
• Notice of Filing a Pesticide Petition to Establish a Tolerance for Forchlorfenuron in or on Grapes and Kiwifruit
• FY 2002 Annual Report Now Available
• An EPA First: Agency Approves Biological Pesticides for Use in Emergency Exemptions

Soybean Rust
On 6/6/03 the draft Section 18 soybean application was submitted to EPA for preliminary review. OPMP will arrange a call with EPA to discuss the draft in two weeks or so. All received efficacy information and accompanying contact information from the registrants has now been posted on the USDA Regional Pest Management Centers national website. http://www.ipmcenters.org Go to "News" then "Soybean Rust." Growers, CSREES, EPA and registrants have been informed.

The Section 18 draft application for minor legumes is still under preparation. Three chemicals have been identified. APHIS is holding weekly conference calls with ARS, grower reps, and others. Their Center for Plant Health Science and Technology (CPHST) is considering the air monitoring for spores at South American ports and at US ports. The main APHIS focus is to ensure that worrisome ships would not leave South American ports. APHIS is organizing an SBR conference, possibly in Illinois in October to discuss ongoing projects (not research) and communication efforts. Research projects will be adequately addressed during the APS meetings in August. (Teung Chin, 301-734-8943; Kent Smith, 202-720-3186)

More on Soybean Rust
With the help of the Economic Research Service of USDA, an economic analysis of soybean rust has been attached to the Section 18 draft. Also, ERS plans to conduct a more complete analysis that fulfills the needs of USDA in terms of international trade implications, USDA research, economic impact of all segments of the economy.

This past winter ARS in South America and Africa undertook two comparative efficacy trials. Due to unusually dry weather at the test sites, useful results are not expected from those experiments. CSREES plans to fund a trial in Asia (Thailand or Taiwan) as soon as possible to fill this data gap. (Kent Smith, 202-720-3186)

Ag Handler Exposure Task Force
OPMP was involved in a joint regulatory review of 11 worker exposure studies for possible inclusion in the new AHETF database. Four studies were rejected. Seven will go onto secondary review. OPMP looked into how many DFR studies are needed for ornamentals with a registrant for a single chemical. Four have been required. Contacted land-grants and APHIS Plant Protection & Quarantine to solicit usage of AZM on ornamentals for Bayer to justify Ohio as the single site for an AZM/ornamental study. The major ornamental use is a quarantine use against the black vine weevil. (Teung Chin, 301-734-8943)

Outdoor Residential Exposure Task Force (ORETF)
OPMP participated in the Joint Regulatory Review Committee meeting in Crystal City.

ORTEF and EPA are exploring the possibility of new algorithm for calculating exposure estimates. (Teung Chin, 301-734-8943)

Ag Re-Entry Task Force
OPMP participated in the Joint Regulatory Committee Meeting in Crystal City. EPA is expected to announce their next steps on using ARTF Transfer Coefficients soon. ARTF is still awaiting the provision of EPA reviews on ARTF data submitted in 2001. (Teung Chin, 301-734-8943)