Proposed Process Improvements from Industry
Note: EPA no longer updates this information, but it may be useful as a reference or resource.
The low number of new inerts approved in recent years, the backlog of new inerts seeking approval, and the large work load in tolerance reassessment of existing inerts are evidence of the need for additional resources for approval of inerts, as provided in PRIA. The work plan for approval of new inerts and for tolerance reassessment of inerts needs to be more transparent, in line with the tolerance reassessment work plan on EPA’s web site. There is also a need for FEAD and RD to work toward establishment of a data compensation scheme for inerts, as called for in FQPA. We are aware that EPA is taking steps to address these issues through formation of a separate branch for inerts work within the Registration Division. The comments below regarding the new branch were previously communicated comments to EPA by the Inert Steering Committee.
Inert Branch Ideas
Inert Steering Committee / April 8, 2004
- Inert Branch should be modeled after BPPD ‘in-house expertise’ approach.
- May not be able to build resource large enough to do everything in-house or via contract support but should have internal skill set to help continue to build and frame the Lower Toxicity Methodology as a minimum.
- Suggest not designing the branch to handle safeners, Tier 3 compounds as these will be the exceptions, not the majority of the work. Suggest handling safeners, Tier 3 compounds on a case by case basis.
- HED expertise / background needed to implement PIRAT, develop dietary exposure model for inerts, continue development of Lower Toxicity Methodology.
- Tom Brennan’s stay in the Inert area was too short but it showed what could be done by someone with this skill set.
- RD PM team experience needed, especially with implementation of data compensation.
- Someone with experience in HED & RD could be a valuable member of this unit as they have experience in how data reviews are done in HED and how these reviews / decisions are used in RD.
- List of approved inerts needs to be kept in this branch.
- The group / person responsible for keeping this list updated should have a dotted-line responsibility to the Technical Support Branch (Deb McCall’s branch) as they are the primary users of this information. Lot of issues with end-use product approvals have been created by the lack of a strong link between the holder of the inert approved list and TSB.
- Some linkage with SRRD product reregistration may also be needed.
- Strongly suggest that this list be posted on EPA website or otherwise publicly available.
- A peer review panel with representatives from HED, EFED, RD Deputy Director should be maintained in assist in the inert decision-making process with the goal of making consistent decisions particularly in the initial life of the branch.
- We believe there has been a group like this working in the past with Pete Caulkins serving as a member. This group should be continued but their role adapted as more resource becomes available to the Inert Branch.
- Chairperson or the secretariat of this panel should be within the Inert Branch.
- Consider a source of expertise or new hires / contractor resource that have some industry experience with inerts.
- For example, an early retiree from an inert supplier / registrant with formulation development experience.
- Establish an official NAFTA coordinator for inerts to interface particularly with PMRA.
- This concept could be expanded to include an international component such as working with the Global Harmonization System.
- Some thought should be given to establishing a coordinator for chemical clusters that are going through tolerance reassessment.
- This has the advantage of establishing a consistent approach and a single EPA point of contact to a group of inerts.
- We urge the continuation of the interaction with the Inert Steering Committee as the Inert Branch moves forward.
Registrants' access to data evaluation records (DERs) for science studies, minutes from FQPA meetings, and risk assessments is an ongoing concern for RD, AD, and, to some extent, BPPD. A registrant may not receive the DERs, even after the registration is granted. Companies often have to resort to FOIA requests or rely on the Product Manager for these documents. The FOIA route takes at least 1 to 3 months and places a significant burden on EPA personnel that should be unnecessary.
In BPPD, DERs are not handled consistently among Regulatory Action Leaders. Some attach DERs to deficiency letters sent to the registrant, while others do not. If the registration is approved, the registrant may receive only the Registration Notice with no DERs.
These documents should be provided to registrants promptly and routinely, as they are vitally important for a variety of reasons:
The registrant must have the DER to determine whether and how to challenge an adverse decision regarding the acceptability of a study.
- A company considering the purchase of an existing product registration from another registrant must be able to review the status of that registration. The DERs provide important insights into that status.
- In preparing to apply for additional product uses, the registrant must review the DERs for the data that support already registered uses.
- DERs provide evidence to state lead agencies and foreign regulatory authorities that EPA has reviewed and accepted the data in support of the product registration. New York and California require submission of EPA’s DERs before they will register a product for use in their respective states.
- DERs, FQPA meeting minutes, and risk assessments document shifts in EPA’s preferred study designs and protocols, policy directions, and registration processes. Registrants need this information to continually improve the quality of their data submissions.
There is a need for better communication to registrants of status of applications, information on the application, who working on an application, and notification of important milestones in the regulatory process.
July 20, 2004
Once a registration application is processed by the Document Processing Desk/Front End it is routed to the appropriate Product Manager (PM) in the Registration Division (RD) or Antimicrobial Division (AD), or Branch Chief in the Biopesticide Division (BPPD). Subsequently the application is routed to an EPA staffer that is assigned to it.
Assignments to staffers often depends on workload and experience, so different staffers may work on a given company’s applications, or in some divisions not work on the same active ingredients. The registrant may not know in advance which staffer will handle his application.
The staffer is typically the main contact for the registrant, the person with whom the registrant will ascertain status and communicate with on any issues. PMs and Branch Chiefs do not routinely notify the registrant of the staffer assignment. Typically for registrants, the only way to identify the staffer assigned is to contact the PM or Branch Chief directly.
For a time, both RD and BPPD were sending emails to notify registrants of receipt of their applications and assignment to the designated staffer; however, this practice has been sporadic within RD and has stopped completely within BPPD.
Routinely notifying the registrant of receipt of the application by the PM or Branch Chief, identifying the staffer assignment, would significantly decrease the number of registrant inquiries about the status of applications.
Speed of MRID Receipt
It appears that there has been a slow down in the notification of registrants of important information in the front end-screen in recent months, even before the implementation of PRIA. In many cases, it is taking 2 to 3 months for the registrant to receive MRID numbers or file symbols for new registration applications.
Fee Payment Acknowledgement / Notification of Milestones
With the implementation of PRIA, an automatic notification system has been created to invoice registrants by e-mail for their applications. Generally this system has been working well; however, it would be helpful to add to the invoice a short description of the action, as a registrant may submit multiple similar actions almost simultaneously. Registrants need a similar notification when the paid fee acknowledgement is entered into the OPPIN system, officially starting the decision time review period under PRIA.
There are other important milestones of significant interest to registrants, for which timely notification should be sent routinely:
Milestones for EPA Workplan / Registrant Notification
- Start of decision time review period (acknowledgement of certification of check).
- Date that submission passed chemical screening and was sent to Science Divisions, Technical Review Branch/RD, ARIA/RD
- Date of completion of primary reviews by HED, EFED, Technical Review Branch/RD, ARIA/RD, contractors
- Date of completion of secondary reviews by HED and EFED
- Dates for Peer Review Committees (HEXARC, MARC, CARC, RARC, etc.)
- Date of completion of risk assessments (HED, EFED, Endangered Species, etc.)
- Date of risk assessment outcome, HED/EFED reviews returned to the PM
- Date of EPA registration decision
- Date for publication of Notice of Filing and Federal Register Notice for tolerance petitions
- Date for completion of label review
PMs Changing the Fee Category after an invoice had been received and the fee has been paid by the registrant.
There have been a few instances where the expert team that determined the fee category during the front-end screen has been overruled by the PM after the invoice has been sent to the registrant and the fee has been paid. Given the implications for decision time review periods and, to a lesser degree, for the fee cost, it is important to establish a process where this ‘double jeopardy’ does not occur. Otherwise, it could adversely affect PEA’s ability to meet decision time review periods.
Registrants have a limited number of points of contact for settling fee category questions.
In the start-up phase of PRIA, the onslaught of questions regarding fee categories has overwhelmed the Agency’s resources to deal with them. There is an urgent need to provide additional resources (1) to provide assistance for pre-submission discussions of fee category assignments, particularly for actions where there is uncertainty about the appropriate category; (2) to follow up after submission of applications on registrants’ open questions on fee category assignments; and (3) to resolve disagreements over fee category assignments. As more experience is gained and precedent-setting decisions are made on PRIA issues, these need to be posted in the PRIA guidance on EPA’s website in an expedited fashion.
Particularly, there needs to be an improved process for resolution of decisions that the PRIA expert committee is not able to make quickly. There will always be "special cases" that do not fit clearly in the established categories. In many cases, the Product Manager could resolve these through discussion with the registrant, but the registrant is not usually brought into the loop at this early stage.
EPA mandated actions are being invoiced under PRIA
RD is invoicing registration submissions that have been required by SRRD, even though EPA-mandated submissions are not subject to fees. Better coordination by EPA is clearly needed on this issue, especially as this has occurred on extremely time-sensitive actions that involve many registrants.
EPA work plan
There has been an increasing need for EPA to publish a new ‘revolving’ work plan including, at a minimum, new active ingredients, new uses, and new inert approvals. This work plan should be updated on a routine basis to include new applications as they are processed and pending actions added after payment of voluntary fees.
Resolution of the fee waivers for IR 4 / minor use applications
Guidance is needed on how waivers for minor uses should be requested and who should file them, both when IR-4 is involved and when it is not.
Resolution of the multiple-product applications
Clarification is needed on the fee structure and submission procedures for applications that involve multiple products supported by a common data set.
Revision of PR 98-10
PRIA has brought additional complexity to the notification process that was clarified most recently with PR Notice 98-10. While updating PR Notice 98-10, EPA should consider expanding the list of minor amendments that can be submitted as notifications.
Endangered species concerns are receiving increased emphasis due to litigation and the imminent implementation of the Counterpart Regulation and the Endangered Species Protection Program. Although a process has been promulgated through rulemaking, it is still not clear who within the OPP is doing the various required steps in the risk assessment process for endangered species. There is also a need to clarify the required format for registrants’ submissions of use information and existing protections, and how EPA could utilize refined risk assessments submitted by registrants.
OPP should communicate a clear defined process to registrants. EPA should always provide the registrant with draft copies of the risk assessments and DERs as early as possible in the process, prior to negotiations of the conditions of registration or mitigation measures that involve endangered species issues. Given the difficulties seen to date in dealing with litigation and in implementing ESA protections, it is imperative to identify and resolve potential issues early in the registration process.
It is extremely important that registrants and EPA personnel understand the work flow and coordination between EFED and FEAD in conducting endangered species assessments during the normal registration and reregistration processes. EPA’s risk managers must be integrally involved in recommending mitigations to deal with endangered species concerns that may arise.
It is also important that EPA’s risk managers become familiar with the tools involved in endangered species assessments, such as the Information Management System (IMS) being developed by the FIFRA Endangered Species Task Force. Given that proximity analyses are being required in recent reregistration actions, it is imperative that risk managers understand how the IMS, county bulletins, landowner agreements, and existing protections interact and to determine and fulfill the need for risk mitigation. Practical experience with case study examples and improved interaction with USDA and commodity groups would give risk managers a better understanding of what constitutes practical mitigation of endangered species concerns, consistent with real agricultural production conditions. (A recent proposal by EPA to impose a 100-mile buffer exceeds the definition of “practical.” Requiring a vegetative filter strip for avocados grown in CA is not an effective mitigation where there is not enough water to grow filter strips.)
A large number of recycles occur in the product chemistry review area. Examples include:
- The reviewers ask for inert ingredient information that is already on file, even for inerts that have been used for many years. Further, there is inordinate confusion and lack of clarity over the status of inerts that are approved for use in formulations. There is a clear need to have better access to and visibility of the approved inert list and a better pathway for resolution of these inert approval issues.
- Product chemistry studies appear to be rejected because there are open questions and the due date for the review is approaching. A recycle could be avoided if the registrant is contacted in advance of the due date in an attempt to resolve these open questions. A call to the registrant to correct minor errors (e.g., incorrect pH on a CSF) and answer simple questions would be a better approach than rejection of the application, resubmission of the package, and another round of review.
- Registrants and reviewers may calculate the percentage of active ingredient incorrectly. Even though the nominal concentration of the TGAI is on the CSF, they may compare the amount of TGAI used in the product with the label, forgetting that the TGAI is almost never 100% pure. Regardless of who makes such an error, it should be corrected without another cycle or resubmission
- EPA reviewers have asked for documentation on the source of petroleum distillate mentioned on the label, especially when it is a component of another ingredient (such as a registered manufacturing concentrate) and not listed separately on the product’s CSF. The reviewers should have ready access to the CSF for the corresponding source products to verify the petroleum distillates, or contact the registrant for explanation and background information, instead of rejecting the package, leading to another round of review.
- EPA has rejected storage stability studies (run a number of years ago) that were not evaluated at the prescribed monthly intervals, even though stability was still checked 4-5 times during the year. Reviewers require replacements studies because of these and similar shortcomings, even though they acknowledge that the product appears to be stable. Such rework triggered by administrative reasons rather than genuine technical needs are wasteful and take resources away from more productive activities for both EPA and registrants.
- Approvals of alternate formulations are routine regulatory actions. PR Notice 98-10 provides a means to make minor formulations changes to an existing CSF and qualify for accelerated review. Generally speaking, if an inert does not invalidate product-specific chemistry, is found on list 3 or 4, has a cleared food use, and is used for the same purpose in the formulation, it qualifies for accelerated review under PR Notice 98-10. However, many times such applications are not routed to the Minor Formulations Coordinator (in RD) and end up on the PM’s desk where they lose the accelerated status.
- There is a clear need to provide a current public listing of approved inerts and proprietary blends, or at least to have this information easily accessible within EPA. For proposed revisions to a CSF, a reviewer may raise concerns about an already approved ingredient for which no change is proposed. If the CSF lists a proprietary blend, the reviewer must physically retrieve the manufacturer’s file for that blend to verify its components. Often the reviewer claims that the inert is not on file or not cleared for food use. The inert supplier must then produce supporting documentation that already resides in EPA’s Master File. EPA apparently has no mechanism for EPA to record when an inert manufacturer changes the name of a proprietary formulation.
There are many examples where registrants for SRRD, RD and AD actions have provided refined risk assessments, which EPA reviewers have systematically ignored. EPA does often not review the summary documents registrants provide, including risk assessments since they are not considered responsive to a formal requirement. This results in situations where EPA performs and publishes overall evaluations/risk assessments that are scientifically debatable, for example, they do not consider all the data in a comprehensive fashion or are not sufficiently refined.
FQPA and some other paradigms & procedures have been implemented by relying on publicly available policy documents and SOP procedures. The agency should adopt a similar approach on guidance for registrant-supplied risk assessments. Relying on such guidance, EPA and the applicant, before the risk assessment phase begins, could discuss and agree on risk assessment input parameters (particularly where a refined assessment may be needed).
Also a formal requirement for exposure risk assessments in conjunction with a clearly laid out process for stepwise refinements would be extremely helpful in the development of refined risk assessments. This process is not routinely utilized in EPA with the exception of refinement of dietary assessments. In certain cases (particularly in the ecotoxicology area), SAP meetings that have provided guidance on the completion of modeling, probabilistic risk assessments, and risk assessment tiers that are not being routinely followed due to resource constraints and other issues. While we do not support the expansion of Tier summary documents to EPA as they are listed in the OECD dossier guidance, it does show that regulatory systems can benefit from risk assessments provided by the registrant.
Under PRIA and its set timelines for decisions, EPA will have to monitor its resource usage even more intently than in the past. Further, the full implementation of the Endangered Species Act under the proposed counterpart regulations will likely require more sophisticated analysis and refined risk assessments, creating more of a need for consideration of registrant-generated risk assessments. One option to consider is to request from registrants an electronic risk assessment format that could then be modified as needed by EPA, particularly where a resource-intensive refined risk assessment is needed.