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Chlorfenapyr. Remarks by Lynn Goldman on "The Impact of the 1996 Food Quality Protection Act on Louisiana Growers." January 23, 1998.

Note from FAN:
We've highlighted the fluorinated pesticides discussed in
Lynn Goldman's remarks presented below. They are:

Chlorphenapyr (variation of Chlorfenapyr) [Pirate]
Fipronil
Indoxacarb [Steward]
lambda cyhalothrin [Karate]
Bathroid is listed. Error? perhaps Cyfluthrn's Baythroid
Non-fluorinated pesticides highlighted in blue

The Impact of the 1996 Food Quality Protection Act
On Louisiana Growers

Remarks Prepared for Delivery by

Lynn R. Goldman, M.D.
Assistant Administrator

Office of Prevention, Pesticides and Toxic Substances
U.S. Environmental Protection Agency
401 M Street, S.W. (7101)
Louisiana Cotton Producers Association
Holiday Inn/Holidome, Monroe, Louisiana

January 23, 1998

Good afternoon. I would like to thank representatives from Senator Mary Landrieu's and Congressman John Cooksey's offices for your encouragement and Louisiana Cotton Producers Association President Donna Winters for your invitation to me to talk with you. Thanks also to Commissioner Odom and others with the Louisiana Agriculture Commission who have worked so hard to protect our food supply. We at EPA appreciate it. And it's a great pleasure to be here. Monroe has a rich history: Delta Airlines got started here as a crop duster and Joseph Biedenharn built the first Coke bottling plant right in this town.

This is an opportunity for us to come to a greater understanding of each of our roles in ensuring that American agricultural products are produced safely, abundantly, and profitably. All too often federal regulators and the industries they oversee pass each other without really understanding the other's job, but needing the other's support. Clearly, we in the public and private sectors can greatly improve our chances of survival in this complex world if we communicate effectively and candidly -- and that is what I would like to try to do today.

It has been 17 months since President Clinton signed the Food Quality Protection Act. This landmark law overhauling pesticide regulation reflects the Clinton Administration's commitment to the protection of children, to the expansion of consumers' right-to-know, and to a new type of public health protection based on encouraging innovations that prevent pollution and reduce risks. These are top priorities for EPA Administrator Carol Browner and they are the top priorities for my office.

The new food law has catapulted EPA's pesticide office and agribusiness into a new era, a new way of doing business. This offers us tremendous challenges as well as opportunities. Clearly, as growers in the Mid-South region of our country, you may be among those that feel the greatest impact of the law simply because you face some of the more severe insect and production problems in the United States. The law's more protective requirements will make your already tough job even tougher. Yet, I honestly don't know of any group whose past experiences and achievements make them better equipped to deal with change. For decades, cotton growers have aggressively pursued safer, innovative growing methods. You have worked shoulder to shoulder with the state, researchers, chemical companies and EPA through voluntary programs, such as Cotton Cares and Careful By Nature, to find safer, more efficient and more profitable growing methods. As a result, cotton growers have shown the way for many other crop producers. You have virtually pioneered integrated pest management. The plan developed by Louisiana in 1986 to tackle pesticide resistance has prolonged the life of almost all insecticides used for cotton insect control. At the same time, your resistance monitoring and scouting has decreased insecticide use by reducing the number of applications. Your recent experience working through resistance problems with Bt cotton has helped sustain that innovation. Cotton growers' intensive campaign to eradicate the boll weevil led to reduced insecticide use in eight states, and Louisiana's current effort on that front holds similar promise. EPA values its relationship with Louisiana growers. We have been supporters and collaborators in the past and hope to be in the future.

And now you face losing some of the conventional pesticides you currently use despite your hard work and past success in reducing risks by seeking safer alternatives. I can only imagine your frustration. Yet, it is clear that many current pesticide uses could be discontinued in the coming years, and therefore I urge you to respond now as you have in the past -- decisively and creatively. Collaborate with other growers, with researchers, with chemical manufacturers and with EPA to devise strategies that will give you the best pest management program possible in light of the upcoming changes. That is how you'll gain the greatest financial advantage.

I will try to shed as much light as I can on decisions that affect Louisiana's main crops -- cotton, rice and sugar cane. But first I would like to put those decisions in the context of the new law.

As you know, the food quality law requires EPA to look at risks very differently than we did before. We must now make a finding that each individual pesticide use poses a "reasonable certainty of no harm" to human health considering a host of new requirements. No single use of a pesticide can exceed the "reasonable certainty of no harm" standard, taking into account risks from all dietary exposures to that pesticide, including those from drinking water and any household and lawn use. We must also have reasonable certainty that every pesticide use poses no harm to human health after taking into account the risks it may pose cumulatively with other substances that share common mechanisms of toxicity, or, in other words, that act in a similar way in the body to cause an adverse effect. And on top of this we must add a 10-fold uncertainty factor to take into account developmental risks and incomplete data with respect to exposure and toxicity to infants and children. A different uncertainty factor may be used where reliable data indicate a lesser factor will be safe for infants and children. We must also consider in utero effects. Finally, EPA must make a positive finding that each tolerance will protect children.

In determining whether a pesticide meets the "reasonable certainty of no harm" standard, we prepare a risk assessment that takes total risks from the pesticide into account. We use the analogy of a risk cup. A full cup represents the total maximum toxicity level allowed per person for each pesticide. Each exposure fills the risk cup a bit more. As long as the cup is not full -- in other words, the combined exposures have not reached the maximum allowable toxicity level -- the agency can continue to register the pesticide for additional uses. Once the total risk exceeds the allowable level, we can register no more uses for that pesticide. Keep in mind that the degree of risk posed by a pesticide is determined not only by risks occurring where the pesticide was applied but from all risks encountered nationwide through foods, drinking water and any household or lawn use. So residues in groundwater across the country affect decisions on a pesticide's use in Louisiana.

And two other requirements have dramatically changed the timing and substance of our decisions. First, Congress has prohibited EPA from considering benefits in setting tolerances for any new pesticide; it only allows us to consider benefits in maintaining existing tolerances and then only in very limited circumstances. Congress also set a 10-year schedule for EPA to review about 10,000 existing tolerances for pesticide residues on food. Over the next two years, EPA will review the first third, or about 3,300 tolerances, that pose the greatest hazards. The first group of 228 pesticides includes the organophosphate, carbamate and organochlorine classes, as well as chemicals that may be human carcinogens. As you know, this first group includes some of the pesticides on which you have traditionally relied.

Most of these provisions became effective on August 3, 1996, the day the law was signed by President Clinton. Since then, EPA has been racing to implement a streamlined and more protective, but more far more scientifically complicated pesticide program. Our greatest challenge has been developing -- with the scientific community and our other stakeholders -- methods needed to implement the new requirements. For the past year, with guidance from our Scientific Advisory Panel, we have been learning how to devise new risk assessments. This independent scientific panel was established under the Federal Advisory Committees Act, and it reviews all of EPA's scientific work under the new food quality law.

In making risk-based decisions, here as elsewhere we are committed to the precautionary principle, which requires us to err on the side of safety. Some of the decisions are time-limited or conditional. Our goal is to be cautious but flexible.

Over the past year, many of our resources have been devoted to creating the foundations to carry out the new law. But, as our record shows, EPA also has been making regulatory decisions.

Under the new law, EPA has registered 28 new pesticides. Of those, 15 were biopesticides and four were reduced risk chemicals. We have received 422 requests for Section 18s, of which 384 were approved, including 121 crisis exemption requests. Fourteen were denied and another 29 requests were withdrawn by the states. Last year was our second best year for production of decisions by EPA's pesticide program. Why second best? Well, most of the numbers were down slightly from 1996 and our critics will tell you -- and I agree -- that new uses of already registered pesticides were way down. I believe, though, that we are "over the hump" for the transition in FQPA and that this next year we will show more productivity.

In 1997, EPA granted emergency exemptions to Louisiana to use chlorfenapyr, or Pirate, and also to use tebufenozide, or Confirm, a reduced risk insecticide, for control of the beet armyworm and resistant tobacco bud worm for cotton. As you know, we denied a request for an emergency exemption to use carbofuran on cotton against the cotton aphid due to an acute dietary risk. EPA also granted emergency exemptions for the application of lambda cyhalothrin, or Karate, and later granted Karate Section 3 registration for use on rice. We also granted a Section 18 emergency exemptions for azoxystrobin, or Quadris, a reduced risk fungicide, and maleic hydrazide for rice. And we granted Section 18s for Karate and Confirm for use on sugarcane.

As you know from our denial of Louisiana's request for a Sec.18 emergency exemption to use carbofuran on cotton and our recent decision not to extend tolerances for the herbicide bromoxynil on cotton, the new law's provisions are prompting decisions that we may not have made under the previous law. For bromoxynil, the problem was concerns about the developmental risks to infants and children. We also denied the renewal of a tolerance for residues of the fungicide iprodione on cotton seed because after adding the additional risk from drinking water, the cancer risk was too high.

Louisiana's Situation: Cotton

Obviously, you are interested in hearing about the availability of some key pesticides for cotton in the next growing year. First, an interesting fact. Your region uses the greatest amount of insecticides per acre compared to other cotton growing regions. Why? Not because you want to spend the money. As you and EPA recognizes, you do have serious pest problems in this area.

Organophosphate insecticides represent about 50 percent of your insecticide use on cotton. Unlike many cotton growing states that rely principally on carbofuran for aphid control, Louisiana growers rely most heavily on the organophosphates methyl and ethyl parathion. Last year they were applied to 35 percent of your treated acreage. Carbofuran, a carbamate pesticide, is also used by some of you and we are already receiving Section 18 requests from some states.

It is possible that many organophosphate uses will be curtailed or dropped under the new law. The International Life Sciences Institute, which prepared a case study for EPA on the organophosphates, has preliminarily concluded that they all share a common mechanism of toxicity and should be reviewed together. Many of the individual organophosphates have unacceptable risks in themselves; therefore doing a cumulative risk assessment on all 43 may result in them all having unacceptable risks.

The agency is trying to develop an approach to regulating them that poses the least economic disruption while also meeting the law's tight tolerance reassessment deadline.

Clearly, the approach will have to meet the law's requirements. You, other agribusiness groups, environmental groups, minor crop producers, and others must be involved in formulating such a plan. Ideally we would like to put in place a strategy to reduce dietary risks, leave growers with adequate insecticide tools, address minor uses and encourage the development of non-organophosphate alternatives. We could make decisions on the organophosphates by August 1999.

For cotton, there are some viable alternatives to organophosphate insecticides. Bt cotton is currently planted on 20 percent of your cotton acreage and it appears that it may have good potential. Unfortunately, like many of the newer chemicals and biologicals, it can represent an added expense to you. And we are worried about monitoring for and managing resistance to Bt endotoxin.

There are some upcoming pesticides. Another good reduced risk insecticide is spinosad, or Tracer, which EPA registered last February. Another pesticide, called Steward [Indoxacarb], manufactured by Dupont, is currently is being reviewed as a candidate for reduced risk, safer status. It's promising. We also anticipate a mid-1998 registration of a reduce risk insecticide, pyriproxyfen or Knack, for whiteflies, which has an good human health profile as far as we know now and low use rates.

We also recently granted a reduced risk status to an insecticide, pymetrozine or Fulfil, to control aphids and whiteflies, which has potential for cotton. The registrant said it intended to submit a registration application for cotton in September of this year. This chemical has a unique mode of action: Insects stop feeding shortly after exposure and die of starvation in two to four days. Its overall profile also looks good, and we could make a registration determination on it as early as December 1999.

We also plan to make a Sec. 18 decision in March on the use of chlorphenapyr, or Pirate, for cotton again this growing season and a Section 3 decision for its use on cotton in May.

Rice: Is There Anyone Interested in Hearing About Rice?

Rice is another crop important to Louisiana growers. Louisiana is the second largest rice producer in the United States, with 550,000 acres. Carbofuran, or furadan, is an important pesticide for you in controlling the rice water weevil. As you know, its uses have been phasing down and may be phased out. Currently, it is being applied to between 40 and 50 percent of your rice acreage here in Louisiana. My mind is completely open on this issue until we have had a chance to complete the review, and I promise to look at the issues personally if a denial is proposed.

EPA's decision on whether to increase the production cap for carbofuran use on rice in the 1998 growing season is expected in mid-February to mid-March. Based on the risk data we have analyzed to date, EPA would be forced to deny the request to raise the production cap because we could not make a "reasonable certainty of no harm" determination. The registrant, FMC, has submitted an additional risk analysis, however, and we are reviewing it carefully.

The Agency is working on alternatives to carbofuran. Soon the EPA will make a registration decision on Fipronil for the 1998 growing season. If the cap on carbofuran is not increased, there may be problems this growing season, depending on the activity level of the rice water weevil. The major issue remaining on Fipronil, is like with furadan, whether it meets the new safety standard.

Karate, the only registered alternative, is not as effective as carbofuran on Louisiana's water seeded rice. A new formulation of Karate to improve its water fastness and increased experience with its application timing could make this chemical more useful in the long-term. For Karate, however, there is concern about applying it to the 20 percent of the state's rice fields that are used for crawfish breeding ponds.

On the positive side, a registration decision is pending for Azoxystrobine, also known as Heritage or Abound, a reduced risk chemical that effectively controls fungal diseases.

Sugar cane: Are There Any Sugar Cane Growers Here?

The use of Azinphos-methyl, used to control the sugar cane borer, has been greatly reduced, and is now used only as a last resort. It was used on only 1,200 acres in the state last year. The insecticide caused large fish kills in 1991 and 1993. In 1993, EPA Region 6 and the Louisiana Department of Agriculture and Forestry developed a state-wide plan for its prescriptive use. The plan required growers to get written authorization from the department prior to applying the insecticide. Growers turned to Bathroid [Error? perhaps cyfluthrn's Baythroid], a synthetic pyrethroid, as the alternative, and we hope that growers now see this alternative as their best defense. EPA will make a final determination on usage of Azinphos-methyl through the re-registration process by about September 1998.

Meanwhile, sugar cane is a pending new use for tebufenozide, or Confirm, an insecticide already registered under the reduced risk initiative for other crops. It targets lepidoptera larvae, which includes sugar cane borers. This insecticide effectively controls the borer without causing aphid outbreaks. It has good efficacy, an excellent human health profile, good ecological toxicity, and a favorable environmental health profile.

Meeting the Challenge: EPA's Role

Clearly, we need to develop safer pesticides and pesticide alternatives, and EPA is committed to encouraging safer new pesticides by expediting their registration. By giving priority attention to biopesticides and others that reduce pesticide risks to health or the environment, we have cut down review time to an average of 14 months, compared to an average of 38 months for a conventional pesticide. As I mentioned, of the 28 registration decisions we have made since the new food quality law was enacted, four have been for reduced risk conventional pesticides and 15 have been for biologicals.

EPA is moving quickly to establish a regulatory framework for biotechnology. We began to see products for this new industry 15 years ago and have approved many experimental use permits and registrations. This field is developing promising innovations and advancements -- advancements that hold tremendous promise for improving the safety, the quantity and the quality of the world's food supply. EPA has sought to nurture this trend. On one hand, we are taking steps to foster their continued research and development while, on the other hand, ensuring there is enough oversight to maintain the safety of these products and, with it, the confidence of the consuming public. I applaud you for taking advantage of the opportunities that biotechnology as well as biological pesticidal offer. Some of your growers' hard work and persistence in using Bt cotton is an example of how this new generation of pesticide can replace conventionals if growers are willing to put in the time and effort required to learn how they act in the field.

I would like to stress that we are fully committed to learning from industry and our other stakeholders, like yourselves. The Food Safety Advisory Committee of diverse stakeholders was instrumental in helping EPA in its approach to implementing the new law. Although this committee has finished its work, we are continuing our partnership with growers, chemical manufacturers, and food processors. We receive advice formally through panels, such as the Pesticide Program Dialogue Committee and our standing scientific panels, and through meetings like this one. On that score, I would like to note that if a pesticide with multiple uses exceeds the negligible standard, an impact analysis could help determine which uses should be retained within the risk cup. When EPA must reduce risk posed by a certain pesticide or group of pesticides in this way, we will use an open process with stakeholders' involvement.

Your Role: PESP and Beyond

EPA has benefited and enjoyed working with Louisiana growers on their pesticide and safety issues. An EPA team met with researchers last August to fully evaluate the rice situation. We continue to work on resistance issues. Strategies like the prescriptive program we worked out together for the selective use of azinphos-methyl is indicative of the types of creative solutions that we need as we feel the full effect of the new food safety law. I know that you are very familiar with our Pesticide Environmental Stewardship Program -- you practically invented many of the methods its members use. I would like once more to invite you to join. Your contribution would be invaluable, and we think that you would benefit too. As you know, the 78 partner organizations that have signed on to this program have made an important commitment: to promote the safest, most effective pest management practices available -- to do whatever they can to reduce the use and the risk of pesticides. It sounds a lot like the cotton growers. And EPA values these partnerships because they help us work smarter.

In closing, I would like to reiterate our message to all of you: As EPA reviews new and existing pesticide registrations under the new law, we will find that some -- considering their aggregate exposures and cumulative effects on children -- exceed the "reasonable certainty of no harm" standard. EPA and others will be making tough decisions and tough choices, but they are for the right reasons -- protection of public health and the environment. As you know the Food Quality Protection Act passed Congress unanimously, and Americans are vitally concerned about the safety of the food they eat and the water they drink. Congress is keeping a close eye on how EPA implements this law. So I encourage you to act now to prepare for the upcoming decisions that will affect you. Your work now will bear fruit by making room in the risk cup for some of your uses for some chemicals. But you will need to go further, embracing research into chemical and non-chemical alternatives, collaboration with state and federal agencies, and experimenting with new biological controls. We need you to continue to be pioneers in IPM. We need you to continue to be leaders and innovators. And make no mistake --those in agribusiness that develop reduced-risk chemicals and seek creative solutions will reap the greatest financial benefits. And it will be far better to act now rather than react after a regulatory decision that affects one of your key pest management tools.

Our task is to seek alternatives. We need to look hard at them because they will guide us into the future we want. There is an old adage that an optimist sees every calamity as an opportunity. Well, I do not think that Louisiana growers are facing a calamity, but I do think we need to have optimists who can view the future in terms of new opportunities. EPA's goal is to ensure that our environmental standards put the public's health first and that we have safe and abundant crops. I think we can have it all, if we work together. Thank you, and I would be glad to answer questions.

From: http://www.epa.gov/opptsfrs/home/louisifi.htm

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