Docket EPA HQ OPP 2004 0404 Page 1 of 14 8/ 2/ 2006 Response to Comments This document responds to issues raised in comments on the July 13, 2005 Notice of Proposed Rulemaking that were not addressed in the Notice of Final Rule making establishing procedures for the Registration Review Program. That notice is available elsewhere in this docket.

EPA received 23 comments on the proposed rule, as follows:

  one individual   two consultants   one public interest group   four registrants   one state pesticide safety coordinator   three state lead agencies for pesticides   five California water sanitation agencies   six trade associations I. Generic Issues Relating to Licensing of Pesticides A. Review of Product Registrations 1. Product specific data Comments from industry expressed concern about the Agency's requirements for product specific data, as follows:

o Comment: Industry comments asserted that the Agency should be more selective in determining when new productspecific data are needed. EPA should create broader groups or clusters for end use products, bridge more data  especially storage stability   in order to avoid unnecessary data requirements, and expedite product chemistry and acute toxicity data reviews. Industry asserted that storage stability studies for end use products are very timeconsuming and a review of state enforcement analytical results may show that additional GLP storage stability studies are unnecessary and would not add new information.

Response: EPA agrees that bridging data may be appropriate in some circumstances and is addressing this issue through pilot projects in the product reregistration program. In one project involving an active ingredient with hundreds of registered products, EPA found that the existing storage stabilities studies are adequate. EPA finds that storage stability data are needed to establish proper storage conditions and to assure that products are properly Docket EPA HQ OPP 2004 0404 Page 2 of 14 8/ 2/ 2006 labeled with respect to storage conditions. This is especially important because some pesticides have increased in toxicity from degradates when improperly stored.

o Comment: Industry comments asserted that there is insufficient laboratory capacity to conduct replacement efficacy studies for public health pesticides.

Response: EPA believes that the issue of insufficient laboratory capacity for efficacy studies is unlikely to arise until the Agency adopts new efficacy testing methods and requires existing studies to be replaced with new tests. If laboratory capacity appears to be a problem, the Agency and its stakeholders will develop a strategy for managing it.

2. Label changes for products with multiple active ingredients Comment: An industry trade association stated that label changes for end use products are costly and recommended that the Agency postpone label changes for products with multiple active ingredients until the last active ingredient has undergone registration review.

Response: As with the Agency's reregistration program, products containing multiple active ingredients can belong to more than one registration review case. Accordingly, such pesticide products may undergo registration review two or more times during the 15 year registration review cycle. The procedural rules for registration review give the Agency flexibility to develop appropriate approaches for such situations when they arise.

3. Accept data that were not conducted under EPA's Good Laboratory Practice ( GLP) regulations to support product chemistry requirements Comment: An industry trade association asked EPA to accept both GLP and non GLP studies currently on file to fulfill product chemistry requirements regardless if studies now are required to be run by GLP.

Response: The issue of the acceptability of product chemistry studies that do not meet GLP requirements is of concern in the registration of new products and in reregistration as well as in registration review. Accordingly, it is being handled outside of the Docket EPA HQ OPP 2004 0404 Page 3 of 14 8/ 2/ 2006 rule making for registration review. For example, this GLP issue was recently discussed in the July 2006 meeting of the Pesticide Program Dialogue Committee ( PPDC) workgroup on product chemistry.

4. End use products in the U. S. should be exempt from the Global Harmonization System ( GHS)

Comment: A trade association commented that because initiatives such as GHS mandated changes would complicate the process of updating labels in the registration review program, enduse products in the US should be exempt from GHS requirements.

Response: GHS is explained on EPA's website: http:// www. epa. gov/ oppfead1/ international/ globalharmon. htm. EPA is planning a public meeting in the fall of 2006 to discuss issues, such as this one, that were raised in comments on its 2004 White Paper on GHS. The Agency may consider options for implementing GHS label changes.

5. Label Review Manual Comment: A trade association commented that EPA should revise its Label Review Manual before implementing the registration review program. A state pesticide safety coordinator commented that EPA must directly incorporate label language improvements via updates to Label Review Manual.

Response: EPA publishes a Label Review Manual as guidance for EPA reviewers and updates it from time to time to reflect changes in labeling policy. The Label Review Manual does not establish labeling requirements or announce new policies. As label policies change, EPA will update the Manual for its use in the registration and registration review programs.

B. Announcing pending registration actions Comment: A trade association commented that EPA should not include information about pending registration decisions in the registration review case docket unless the Agency is required to announce such pending actions in the Federal Register.

Response: EPA agrees. Docket EPA HQ OPP 2004 0404 Page 4 of 14 8/ 2/ 2006 II. Risk assessment procedures A. Timeliness of EPA's data reviews Comment: A trade association commented that EPA should be required to promptly review and reflect in its regulatory decisions results of studies submitted in response to data call ins. The comment alleges that EPA has not completed data reviews of studies called in and submitted many years earlier. In the meantime, study guidelines have changed and some studies may not meet Agency requirements. This has wasted resources and caused needless animal sacrifice. Data submitters have been deprived of their rights for data compensation because the period of compensability elapsed before the Agency completed its review of data submitted pursuant to data call ins.

Response: EPA believes that this situation should not arise in the registration review program. In registration review, EPA will call in only those data that it believes are likely to affect its regulatory position on the pesticide. Because these data are critical, EPA will review them as quickly as possible to complete the registration review decision. .

B. Inert ingredients Comment: A trade association asked what process EPA will use to characterize List 3 inert ingredients. Another trade association suggested that EPA could use the low toxicity methodology adopted for tolerance reassessment when it reviews inert ingredients for which no tolerances or exemptions from tolerance have been established. A registrant advised that clearance of new inerts can be accomplished most efficiently through a dedicated team specializing in lower toxicity evaluations.

Response: EPA's activities on inert ingredients are described in http:/ www. epa. gov/ opprd001/ inerts/. The commenters are referring to EPA's " Guidance Document on Methodology for Determining the Data Needed and the Types of Assessments Necessary to Make FFDCA Section 408 Safety Determinations for Lower Toxicity Pesticide Chemicals" that is posted on EPA's website. It generally describes the screening level assessments that EPA is using to reassess inert ingredient tolerance exemptions. EPA agrees that the processes described in this guidance document may prove useful in evaluating inert ingredient that are used only in non food pesticide products and therefore do not have tolerance exemptions. Docket EPA HQ OPP 2004 0404 Page 5 of 14 8/ 2/ 2006 C. Risk Assessment 1. Risk assessment methods Comment: A public interest group suggested that EPA publish guidance explaining how the risk assessment process will function in the registration review program. A registrant commented that EPA should propose a process to establish guidelines for completion and interpretation of studies on immunotoxicity, cumulative risk, and endocrine disruption. The registrant and a trade association also commented that EPA should establish a transparent process for deciding when to require endangered species data. A water sanitation agency recommended that EPA should change the defaults it uses in estimating exposures from water when monitoring data are not available.

Response: EPA's risk assessment process remains the same whether EPA is reviewing a new registration action or conducting a review of a registered pesticide. EPA involves the public in the development of risk assessment procedures, including procedures for estimating exposures from water, cumulative risk assessments or endangered species assessments. EPA may hold public workshops to develop approaches, consult with experts, convene advisory committees under the Federal Advisory Committee Act, or ask the FIFRA Scientific Advisory Panel ( SAP) authorized by FIFRA to peer review proposed risk assessment procedures. EPA has established a guideline for immunotoxicity studies; it is available on the Agency website website at: http:// www. epa. gov/ opptsfrs/ publications/ OPPTS_ Harmonized/ 87 0_ Health_ Effects_ Test_ Guidelines/ Series/. EPA has a public procedure for developing endocrine disruptor testing methods ( see http:// www. epa. gov/ scipoly/ oscpendo/ pubs/ assayvalidation/ index. htm).

2. Use of methodology for assessing lower toxicity chemicals Comment: When deciding on the scope and depth of reviews, EPA could rely on the experience gained in the reassessment of inert ingredients and the development of the methodology for assessing lower toxicity chemicals.

Response: EPA agrees with this comment.

3. Will EPA relax its standards?

Comment: A statel lead agency commented that EPA should recognize the extent to which state agencies rely on EPA's risk assessments and should avoid weakening the data requirements Docket EPA HQ OPP 2004 0404 Page 6 of 14 8/ 2/ 2006 and summaries associated with risk assessments. This commenter implied that under the proposed registration review process, EPA will relax its standards regarding the data needed to support a registration decision. The commenter advised EPA to limit the use of data requirement waivers which he believes have contributed significantly to the gaps in reregistration risk assessments.

Response: EPA's risk assessments account for each applicable data requirement. These documents explain the basis for any decision to waive a requirement. In registration review, the public will generally have opportunity to review draft risk assessments and may comment on the completeness or thoroughness of the draft risk assessment.

4. Will EPA's risk assessments account for regional or local environmental conditions?

Comment: A state lead agency commented that when conducting risk assessments or evaluating risk management approaches, EPA should remain aware of variations among states with regard to climates, topographies, soils, and water resources. States do not have resources to evaluate or customize state registrations to protect local environments from impacts not anticipated or evaluated during federal registration review.

Response: EPA agrees that its risk assessments should consider, to the extent practicable, a range of regional and local variations in climate, topography, soils, and water resources. However it is generally not possible to routinely conduct risk assessments that capture each variation in environmental conditions. To assure that its risk management decisions will be protective of sensitive environments, EPA assesses the effects of the pesticide in environments that it believes to be the most vulnerable to the potential effects of the pesticide.

5. EPA's definition of " sound science"

Comment: A public interest group commented that EPA should avoid adopting a definition of " sound science" that would cause the Agency to delay restricting or banning the use of a dangerous pesticide until harm is " proven." This comment stated that replicable, reliable studies conducted by government or independent researchers that show a strong association between a pesticide's use and harm to public health or the environment should qualify as sound science. An individual commented that EPA's risk assessments must include the latest scientific information on health and safety. Docket EPA HQ OPP 2004 0404 Page 7 of 14 8/ 2/ 2006 Response: In accordance with the Data Quality Act, EPA has issued guidance regarding the quality of information it relies upon for regulatory decisions. This guidance is available at EPA's website at: htpp:// www. epa. gov/ quality/ informationguidlines/. Under these guidelines, EPA may base a regulatory decision on data developed by the government or independent researchers.

6. Are exposure assessment models compensable data?

Comment: A trade association asserted that if exposure assessment models are improved by compensable data, such as those generated by task forces and joint ventures, then these models themselves should be subject to compensation. They believe that EPA should develop a plan to assure that data generators' contributions are recognized and compensated under FIFRA.

Response: The issue of how to compensate data generators for data used in models is a generic issue arising in registration as well as in registration review. Under FIFRA section 3( g), data compensation applies to data submitted to support or maintain registrations in connection with registration review. EPA regulations at 40 CFR Part 152.80 through 152.99 and the preamble to those 1984 regulations explain the circumstances under which data submitted in support of registration and continuing registration activities are protected by EPA. We believe Congress intended that the same protections be extended to data that EPA relies upon to support decisions made in registration review.

D. Data requirements and risk assessment methods for antimicrobial pesticides 1. EPA lacks data requirements for antimicrobial pesticides Comment: A trade association asserted that FIFRA section 3( h)( 3) required EPA to issue final regulations establishing data requirements for registration of antimicrobial pesticides. EPA missed this deadline and still hasn't published these regulations. The publication in 2005 of proposed draft guidance on data requirements for antimicrobial pesticides doesn't relieve EPA of its obligation to establish data requirements by regulation.

Response: As explained in the preamble to the final rule, as a standard program practice in the absence of updated part 158 rules, the Agency makes case by case determinations in the registration, Docket EPA HQ OPP 2004 0404 Page 8 of 14 8/ 2/ 2006 reregistration and tolerance assessment programs. The Agency believes that the registration review program can operate effectively in the absence of updated part 158 rules. The Agency is developing revised part 158 rules for antimicrobial pesticides and will release its rule making schedule in the Regulatory Agenda to be published in the Federal Register in October.

2. EPA's application of policy on antimicrobial data requirements Comment: A trade association commented that although EPA has published policies regarding data requirements and risk assessment methodologies for antimicrobial pesticides, the Agency frequently and arbitrarily departs from these policies. Data requirements for antimicrobial pesticides are less clear than they were when FQPA was enacted.

Response: EPA uses its published data requirement and risk assessment policies to guide decisions on individual pesticide cases. Based on the available information in a particular case, EPA may determine that aspects of a policy do not apply to that case. Departures from published policy are infrequent and are taken on a case by case basis, but when they do occur, they are explained and documented.

3. Applicability of " new decision paradigm" to registration or reregistration decisions Comment: A trade association commented that EPA currently does not apply the " new decision paradigm" in its current activities with respect to antimicrobial pesticides. EPA still requires data to " complete the data base." EPA requires data even when risk estimates that are based on worst case default assumptions ( used when there are no data) show acceptable margins of exposure.

Response: EPA has used the term " new decision paradigm" to describe the process that it will use in registration review to decide whether it can continue to rely on existing risk assessments. In registration review it is appropriate to focus on what has changed since the last risk assessment and registration or reregistration decision. Pesticides undergoing registration review already meet or exceed requirements for registration that were established in 1984. In registration of new pesticides or reregistration of pesticides that were registered before 1984, EPA focuses on having registrants meet data requirements before it conducts a risk assessment. Accordingly, the " new decision paradigm" would not apply to such actions. Docket EPA HQ OPP 2004 0404 Page 9 of 14 8/ 2/ 2006 E. Scope of risk assessments 1. Consider risks posed by formulated products, inert ingredients and degradates Comment: Water sanitation agencies commented that EPA should not evaluate individual pesticide ingredients and degradates separately  EPA should consider effects of pesticide formulations, inert ingredients, degradates and cumulative effects. The comment further stated that, when considering the risks of formulated products, EPA should not confine review to acute toxicity but consider all risks. A state lead agency commented that EPA should characterize environmental fate and toxicity of inert ingredients.

Response: EPA agrees that it should evaluate the risk posed by pesticide products, including the active ingredient, other ingredients in the pesticide product, and degradates and metabolites of these ingredients. To the extent practicable, the Agency's test guidelines take these aspects into account. In addition to data on the active ingredient, EPA requires, where applicable, information regarding environmental fate, residue chemistry and toxicological effects of typical end use products.

2. Consider endocrine disruption effects Comment: A state lead agency commented the EPA should consider states' concerns related to pesticides and endocrine disruption.

Response: As required under section 408( p) of the Federal Food, Drug and Cosmetic Act, EPA is developing a program to assess endocrine disruption potential of pesticides. As explained in the preambles to the proposed and final rules, EPA intends to use registration review as the framework for managing the endocrine screening and testing program for pesticides.

3. Scope of review under EPA's " new decision paradigm"

Comment: A trade association commented that EPA proposed a " new decision paradigm" for registration review and is premising the program in part on the assumption that for a significant proportion of cases reviewed each year, there will be no need for new data. However, they believe that this assumption is inconsistent with the results of the pilot study. Another trade association asserted that EPA will not be able to complete 50 registration review cases per year if it asks for a lot of data. Docket EPA HQ OPP 2004 0404 Page 10 of 14 8/ 2/ 2006 Response: The Agency does not agree with this interpretation. The Agency is premising the program on its finding, based on the results of the feasibility study, that it is possible to determine reasonably quickly whether it can continue to rely on existing risk assessments, and if not, whether it can update them with available data. After the Agency determines the scope and depth of a pesticide's registration review ( including any needs for new data), it will develop schedules for completing the work that take into account time needed to develop any new data. EPA plans to complete registration review decisions on about 45 cases per year. However, many of these cases will be cases that were carried over from previous years as data are developed and submitted and risk assessments are completed. Many of the cases opened in a given year will be completed in subsequent years.

III. Risk/ benefit decisions A. Assessing risks and benefits in endangered species assessments Comment: A registrant commented that the challenge for EPA is to provide adequate protection for non target organisms while minimizing economic losses or negative impacts on agricultural production or pest control. For endangered species, it was Congress' intent that mitigation measures should minimize impact on agriculture ( Section 1010 of Public Law 100 478, October 7, 1988).

Response: EPA agrees that finding this balance in registration review will be a challenge. Accordingly, the final rule provides EPA the flexibility to expand opportunities for public participation in the development of risk mitigation measures.

B. Assessing risks of potential substitutes Comment: Water sanitation agencies commented that when EPA looks at alternatives to a pesticide that must be phased out, it should consider risks from the urban uses of the alternative pesticide, including the costs incurred by publicly owned water treatment facilities when expanded use of the alternative pesticide would result in impairment of water bodies or cause these facilities to violate NPDES permits.

Response: EPA agrees that it should evaluate the risks posed by urban uses and on a case by case basis it would consider water treatment facilities' costs in assessing various options for risk management of a pesticide that poses risks of concern. Docket EPA HQ OPP 2004 0404 Page 11 of 14 8/ 2/ 2006 IV. Risk Mitigation A. Timeliness Comment: A trade association asked EPA to consider the time that registrants need to obtain state approvals of new labels when EPA sets timeframes for implementing risk mitigation. Water sanitation agencies commented that phase outs should be accelerated as much as possible, especially if safer pesticides are available.

Response: EPA agrees that mitigation should be implemented as promptly as possible.

B. Effectiveness 1. Implementation of new measures Comment: A registrant asserted that EPA should assure that risk mitigation measures are implemented and maintained by all the registrant community, not just the technical registrants. A pesticide safety coordinator commented that EPA should reduce the number of multiple labels for the same product because having multiple labels complicates education and enforcement.

Response: EPA agrees that risk mitigation measures should be adopted for all products for which the measures apply. The Agency acknowledges that having multiple labels for the same product might pose problems for some stakeholders.

2. Disposal of phased out products Comment: Water sanitation agencies commented that retailers and the public need guidance on appropriate disposal of phased out pesticides. They reported that after diazanon was cancelled, people apparently immediately discontinued use of the product and disposed of it dumping it into wastewater which adversely affected water quality. Municipalities found that retailers were unaware of disposal options for unsold diazanon products. The water sanitation agencies asserted that EPA should provide funds to help municipalities collect and dispose of phased out pesticides.

Response: EPA agrees that phased out products should be disposed of appropriately. Municipalities should not have the burden of collecting and disposing of unsold phased out pesticides. Docket EPA HQ OPP 2004 0404 Page 12 of 14 8/ 2/ 2006 V. Financing the Registration Review Program A. Agency funding Comment: Several trade associations and a public interest group expressed concern about the Agency's capacity and resources to conduct the program described in the preamble to the proposed rule. One trade association commented that the registration review program should be funded through appropriations, not user fees for industry.

Response: Unless Congress authorizes user fees, the registration review program will be funded through appropriations.

B. States' costs Comment: Water treatment agencies commented that EPA or registrants should fund collection of water quality data. A state lead agency stated that states need federal support to quantify local impacts and for enforcement.

Response: When a chemical poses a significant water quality concern EPA may require registrants to conduct monitoring, or to conduct analyses of samples collected by states. For example, EPA required registrants to monitor vulnerable watersheds for atrazine, and required the registrant of a new chemical  isoxaflutole  to conduct sample analyses for states. Although the Agency does not have the resources to support each state's efforts to assess water quality impacts, OPP has recently entered into an agreement with the U. S. Geological Survey to jointly plan for additional projects to assess pesticide impacts on water quality.

C. Registrants' costs Comments: A registrant and an industry consultant commented that application of FIFRA requirements for small business and large international conglomerates is inherently unequal because small businesses have to comply with the same regulatory requirements and registration fees as large businesses. They suggested that small businesses should have a special rate and that there should be a separate fee category for non dangerous products. A trade association expressed its concern that small businesses could be adversely affected if the public perceives that EPA review means the product is dangerous.

Response: EPA does not have authority to adjust registration fees for small businesses or to establish a fee category for less toxic products. EPA acknowledges that economies of scale may favor large business. Where possible, EPA accommodates the needs of small business with respect to implementing data requirements. Docket EPA HQ OPP 2004 0404 Page 13 of 14 8/ 2/ 2006 EPA acknowledges that public perception can affect a product's marketability. Accordingly, along with continuing efforts to explain the registration review program to the public, the Agency has adopted a transparent process for conducting registration review. The Agency hopes that these efforts are sufficient to assuage small business concerns in this regard.

VI. Issues Relating to Specific Cases Comment: A registrant commented on the composition of the copper oxides reregistration case. They asked EPA to differentiate between metallic copper and cuprous or cupric oxides because metallic copper is safe for human consumption whereas the cuprous or cupric oxides are toxic. Because EPA failed to make this distinction in reregistration, EPA evaluation of copper containing antifoulant paint mischaracterized the leaching potential of their product.

Response: The reregistration case and the anticipated registration review case for copper compounds includes copper oxide, cuprous oxide, cupric oxide and metallic copper. While individual products may have one specific compound as the active ingredient, once the product is in service, the substance of interest is the copper ion which is released into the surrounding soil or water and is primarily responsible for the toxicity of copper compounds to wildlife and aquatic organisms.

VII. Registrant Support of Registration Review Cases Comment: A trade association noted that EPA prefers to determine as early as possible whether a given product will be supported in registration review and suggested that EPA could send a questionnaire to registrants informing them of anticipated issues or data requirements and asking them whether they intend to support their product.

Response: The questionnaire contemplated in this comment is similar to an application for registration review. The NPRM explained that the Agency had considered adopting an application procedure for the registration review program but dropped this idea because, among other things, stakeholders objected to it.

VIII. GPRA Goals Comment: Regarding the preamble discussion of measuring environmental outcomes as required under the Government Performance and Results Act ( GPRA), an industry trade association commented that EPA must consider and articulate the need to protect the nation's food supply, property and public health from pests and develop measures of the program's effectiveness. They suggested that EPA should seek input on the criteria used to measure environmental outcomes of registration review to ensure a clear cause and effect relationship. Docket EPA HQ OPP 2004 0404 Page 14 of 14 8/ 2/ 2006 Response: The Agency's Strategic Plan ( available at: http:// www. epa. gov/ ocfo/ plan/ 2003. pdf) describes the Agency's goals and the criteria for measuring success in achieving these goals. The social benefits of pesticide use are discussed in Appendix 1 of the Agency's Strategic Plan for 2003 2008. The Agency invites public comment on its draft strategic plans.