Applications for reduced risk status should include a qualitative and quantitative comparison of risks on a per-acre-treated basis, encompassing human health, ecological effects, and impacts on beneficials and IPM systems. Registrants should be required to cover each of these categories of risk, and to explain why they believe a favorable decision by EPA will improve environmental quality and/or reduce human health risks.
EPA should carry out its own evaluation of the arguments and data presented, and seek public comment on this comparative assessment of risks. In some cases, registrants of existing products are likely to present a different perspective and/or additional supporting data, which should assist both the agency and farmers in reaching relative risk judgments. As a routine part of the application, registrants should also be asked to describe methods to document whether projected reductions in relative risk actually occur; such methods can in turn be used by EPA to define clear-cut criteria to judge the success of a given reduced risk decision. When needed and as a condition of registration, EPA should require registrants to either apply such monitoring methods, or arrange for independent researchers to carry out needed field research, submitting the results to EPA for evaluation.
We strongly oppose using relative risk criteria, or a relative "weight of the evidence" approach in justifying reduced risk status. Under such a policy, registrants will attempt to gain registration for active ingredients that are, for example, 100-fold less acutely toxic than aldicarb or carbofuran. Some "reduced risk" candidates, while less acutely toxic than aldicarb or perhaps less damaging to some organisms, are often still extremely toxic and likely to pose significant risks to farm-workers, applicators, and some non-target organisms in the field (i.e., toxicity of synthetic pyrethroids to aquatic organisms; impacts of sulfonylureas on soil microbial communities and wetland ecosystems).
While EPA traditionally has focused most on human health risks, and tends to base most reduced risk findings on reductions in human risks, it is bad public policy to fast-track registration of pesticides which pose other significant risks. Most farmers and pesticide users interpret "reduced risk" to be just that -- less risk, not less risk to some organisms but more to others. Hence, all risks posed by a reduced risk candidate must be fully evaluated by EPA before granting registrations and fast-track approval should granted only to those products that comprehensively reduce risk.
Moreover, our research shows that such pesticides are often applied more frequently and/or at higher doses, so that the net toxic load in an agroecosystem changes little if at all (i.e. several "softer" organophosphates and carbamates are often applied many more times than more toxic products). Indeed, as resistance becomes more prominent, the toxic load applied into the environment often rises.
2. Should structurally similar pesticides that may share a common mode of action with already registered active ingredients be considered?
If a pesticide is structurally similar to one already registered, the presumption should be that it shares the same mode of action until the agency has data allowing it to decide otherwise. In such cases, EPA should follow the sound, new health-protective provisions of the FQPA. When judging reduced risk status, EPA should apply the 1,000-fold Margin of Safety criteria recommended above to the combined exposure of the new reduced risk candidate plus exposure associated with currently registered uses of structurally similar products.
Such a policy is prudent and justified because structurally similar products tend to pose several similar sorts of risks, beyond the most sensitive endpoint in mammalian toxicology studies. By presuming that such products work through a common mode of action, the agency will reduce the chance that a reduced risk product, in combination with similar, already registered products will pose a threat to aquatic organisms, beneficial organisms or pose a threat to groundwater.
In the case of a reduced risk candidate similar to already registered pesticide(s), EPA should approve reduced risk status if the family of structurally similar pesticides meets the reduced risk criteria, based on all existing and proposed uses.
3. Should the scope of the reduced risk program be broadened or kept narrow?
Narrow, for the sound reasons noted by the Food Quality Protection Act advisory committee, as well as additional reasons noted below.
Given the need to keep pace with FQPA mandates, the EPA faces an enormous workload with level or declining resources. As a practical matter, if grid-lock and loss of public confidence is to be avoided, the agency must move toward policies which allow it to say "yes" more quickly for truly safe pesticides, and "no" sooner for those products that clearly pose unacceptable risks. The major portion of OPP's resources will need to be devoted to evaluating the risks of products that do not fall in either group.
Prudence is also warranted because of the structural changes in the agricultural and pesticide industries, trends which reinforce the potential for a new product to quickly command significant marketshare within a year or two of introduction. As the farm sector becomes more concentrated, larger portions of the landscape in an area are managed by the same companies and individuals. Likewise, because of consolidation in the pesticide industry, many companies are offering more narrow product lines, and choose to heavily promote new products that reach the market. There are several recent examples of active ingredients that gained significant marketshare within two years of introduction (e.g., acetochlor, imidacloprid).
The same can be expected for some reduced risk candidates. Hence, EPA needs to be sure that the products will be safe, and not just when applied to relatively small acreage in a few isolated regions. EPA must also request and evaluate data on watershed and region-wide ecological impacts, taking into account the other pesticides used in the same crops, so that the agency has a solid, scientific basis for projecting that applications of the reduced risk pesticide will, in fact, lower overall pesticide risks.
Given that it will take at least a decade for EPA to implement the FQPA, and that review of older pesticides must remain the agency's top FQPA priority, it will be many years before the agency is likely to devote many resources to carrying out special reviews of reduced risk pesticides registered since passage of the FQPA. Hence, the nation is likely to be stuck with the risk-consequences of newly registered reduced risk pesticides for a decade or more. It is preferable for EPA to proceed cautiously, granting reduced risk status only to those active ingredients about which it has compelling reasons to expect no surprises.
Last, EPA should state clearly in the PR-Notice that over time it will revisit, and progressively tighten the criteria that a reduced risk candidate must meet, in order to assure reduced risk status remains a compelling incentive. Breakthroughs in the sciences supporting biointensive IPM are making it possible for farmers to markedly lessen their reliance on pesticides. As pest pressure is reduced through improved, biologically-based IPM systems, the effectiveness of biopesticides and very low risk biopesticides will be enhanced. As this process of discovery and innovation unfolds, EPA will need to become more discriminating in granting reduced risk status in order to preserve the value of the incentive embodied in gaining reduced risk status.
4. How should EPA measure the success of its reduced risk initiative?
There should be three tests.
First, did achieving reduced risk status result in a significant reduction in the average time needed to gain registration?
We urge EPA to strive toward an average time to market for reduced risk products of one-third of the normal registration process. If the average is any more than one-half the average for the normal registration process, the policy should be judged ineffectual.
Second, were there any risk or pest management system surprises?
After two years of use, EPA should assess whether there were any surprises from uses of the reduced risk products registered in a given year. EPA should seek from states and user groups information on any adverse impacts on beneficials or IPM systems, as well as information on any worker poisoning or non-target organism problems. EPA should also screen Section 6(a)(2)(B) reports on the active ingredients to determine whether there have been any unexpected exposure or risk episodes, or new toxicological studies suggesting a new type of risk. If there are a large number of surprises, then the policy is not succeeding.
Third, have reduced risk registrations actually lowered the "toxicity units" associated with control of major target pests?
For the two to four major uses of each reduced risk pesticide on the market in a given year, EPA should assess the impacts of the availability of a reduced risk alternative on pesticide use patterns and risks. Such an evaluation should encompass acute and chronic mammalian toxicity, using relative indices such as those described in Chapter 3 of PMAC (see pages 79-84; copy attached to these comments for inclusion in the docket) as well as similar indices covering ecotoxicity and impacts on beneficials, including impacts on soil microbial communities.
For each reduced risk pesticide and other registered alternatives, a minimum of four index values should be calculated on a pound-for-pound basis: acute mammalian; chronic mammalian; ecotoxicitiy; and, impacts on beneficial non-target organisms. Then, based on actual pounds applied, these values should be used to calculate aggregate toxicity units, based on the products actually applied. In crops where reduced risk products have gained marketshare at the expense of more toxic products, the toxicity units will decline appreciably. Where reduced risk products have not gained much marketshare, or where they have not displaced toxic products, there will be modest change in aggregate toxicity units. The reduced risk program should be judged a success if reduced risk products significantly lower the average toxicity of pesticides actually applied.
5. What other incentives might EPA offer to encourage development and registration of reduced risk pesticides?
We believe that fast-track registration, coupled with data waivers when and as appropriate, can be a significant incentive, if EPA adopts strict and conservative criteria to assure that "reduced risk" pesticides truly reduce risks. We urge EPA to cut registration times to as short as 6 months, and believe such quick reviews are possible given the relatively small number of new pesticides that are moving through the registration process. But we feel EPA can and should do more to reward the companies offering such products to the marketplace --
* EPA should issue a press release upon registration of a biopesticide or reduced risk product, explaining the basic properties of the pesticide and why EPA has concluded it will reduce risks.
The press release should be accompanied by a simple fact sheet setting forth the use patterns, and basic toxicological and environmental fate properties of the newly registered product. The fact sheet should include simple, clear comparisons to the major currently registered products that the new pesticide is designed to replace. A matrix or table should present basic comparative data, focusing on those properties or areas of toxicity which EPA judges to be most important in reducing risks.
* Publish a database on the EPA web page of the toxicological and environmental fate properties of pesticides, with a special section highlighting impacts on beneficials, bees, worms and other economically significant non-target organisms. The database should include easy to understand indices like the "Toxic Effect" and "Selectivity Ratio" used to assess impacts on beneficials, and compatibility with biointensive IPM and reduced risk products (for discussion of these indices, see pages 60-63 of PMAC; copy attached to these comments for inclusion in the docket).
Many farmers, pest management consultants, consumers, and organizations responsible for pest management (e.g. PESP partners, etc.) are searching for reduced-risk alternatives, yet often find it difficult to place reasoned relative risks judgements across all the potential categories of risk. Accordingly, to augment the press release issued upon registration of a biopesticide or reduced risk product, EPA should develop and place on its web page a profile of pesticide properties and toxicity, on a pound for pound basis. This database should be designed for easy use in comparing relative risks, and in the construction of multiattribute relative risk indices. As part of this service, EPA should include a basic description and review of multiattribute ranking schemes, and include information on where individuals can obtain further assistance in applying a method or where they can get results from other applications.
Policies Governing Plant-Pesticides and Herbicide-Tolerant Plants
At the present time, there appears to be a presumption on EPA's part that any application to register a plant pesticide deserves treatment as a reduced risk pest management technology. We oppose this presumption, since it is clear that the basic purpose of some plant pesticides is to increase and/or perpetuate reliance on pesticides -- hardly the best way to reduce pesticide risks. Accordingly, we recommend that --
- EPA establish the criteria applicants must meet to gain reduced risk, fast track approval for a plant pesticide, and that EPA state this clearly in its final PR-Notice that such criteria must be met in order for expedited review of a plant pesticide technology.
- The final reduced risk PR-Notice include criteria that EPA will apply in acting upon applications for plant pesticides to be reviewed on a fast-track as a reduced risk pest management technology.
- The criteria should reserve reduced risk status for plant pesticides which enhance a plant's natural immune and defense mechanisms and response capability, or otherwise promotes the effectiveness of biointensive IPM systems through a non-toxic mode of action that targets and alters pest reproduction, development, behavior, or physiology in a way which places the pest in a less competitive position relative to the plant and other organisms within the ecosystem.
- Any plants that are engineered to tolerate application of a synthetic pesticide (e.g. herbicide-tolerant plants) should not be eligible for reduced risk status under any circumstances.
Other Issues
In some recent cases involving pesticides derived from and containing only natural ingredients, EPA has slowed down review and approval of reduced risk and biopesticide applications because of uncertainty over the exact nature and identity of the active agents, and uncertainty over the mode or modes of action through which such products work. Delays of one to three years have occurred in cases where there has been few if any questions over safety.
Such cases are likely to occur with increasing regularity as companies seek registrations for biopesticides derived from soil microorganisms, plant extracts, and other natural constituents of plants, pests, or other organisms. By requiring registrants to carry out the basic plant research needed to prove what the active agents are -- many of which work in the parts per billion range -- and the modes of action through which they influence plant defense mechanisms, root health, or soil microbial community structure and performance, EPA is placing a wholly unreasonable and unjustifiable burden on such companies.
Accordingly, in the case of natural products and other biopesticides that are derived from nature, EPA should require identification of just the major active agents in a product ("major" defined by concentration), and should allow registrants to state hypotheses regarding principle modes of action. First-tier toxicity tests and safety evaluations should be based on the formulated product; if no signs of toxicity are found, no further tests should be required. The agency should accept plausible explanations of modes of action, and leave it to the marketplace to determine whether farmers are able to find cost-effective applications of such products.
Under section V., "Characteristics of Acceptable and Unacceptable Submissions for the Reduced-Risk Initiative," we recommend --
- EPA clearly state in another PR-Notice or rule-making data and criteria that will be relied upon in reaching relative risk judgements and public interest findings.
- Reduced risk status should be granted for no more than five years.
- EPA add a provision regarding how it is going to track whether a reduced risk product actually displaces a higher-risk product registered for the same use, and what EPA will do in cases where such projected displacement does not occur.
- If a pesticide is approved as a reduced risk product because of lesser risks than a registered alternative, what will EPA do if the higher-risk product is no longer on the market because of, for example, an action under the FQPA or development of resistance? At a minimum in such a case, EPA should revoke the product's reduced risk status.
- A new section of data and comparative assessment should be added -- "Impacts on Beneficial Non-target Organisms" where data would be required on impacts on bees, beneficial arthropods, soil microorganisms, worms, and other economically important non-target species.
We find the parenthetical phrase in the resistance criteria to be unsupportable. As stated, the criterion reads -- "low pest resistance potential (i.e. a new mode of action)". We accept that low resistance potential should be listed as a desirable criterion, but do not agree that if a pesticide works through a new mode of action, it will, by definition, reduce problems with resistance. Many pest species are now cross- and multiple-resistant to may active ingredients. The time required for pests to develop resistance to a product with a new mode of action may be very short. Hence, EPA has to consider additional factors before granting reduced risk status because of resistance management benefits.
We strongly approve of the criteria "highly compatible with IPM", but urge it be revised to read -- "Highly compatible with biologically based IPM systems and approaches." In all other parts of the notice where the term "IPM" is used, it should be prefaced by "biologically based", "biointensive", or some other comparable term. In addition, EPA should discuss in the final notice how it will determine whether a product is compatible with biologically based IPM, and what constitutes "highly" compatible, as opposed to just "compatible." In doing so, we urge EPA to compare the "Toxic Effect" and "Selectivity Ratio" index values, along with other pertinent measures of ecological impacts, for the reduced risk candidate, in contrast to currently registered products. Until EPA and/or USDA develop a better methodology, reduced risk status should be reserved for active ingredients in the "soft" one-third of both indices (i..e., for active ingredients that are as soft, or softer than two-thirds of the products registered for the same uses).
Thank you for the opportunity to submit these comments. We look forward to review of the final PR-Notice.
Sincerely,
Charles M. Benbrook, Ph.D.
Consultant
Pesticide Policy Project
Michael K. Hansen, Ph.D.
Research Associate
Consumer Policy Institute
