Pesticides: EPA Should Take Steps to Improve Its Oversight of Conditional Registrations
Published: 2013-08-08T00:00:00

Fast Facts:

Highlights:
section_title: Why GAO Did This Study
paragraphs: As of September 2010, more than 16,000 pesticides were registered for use in the United States, according to EPA. EPA reviews health and environmental effects data submitted by a company and may register a pesticide or, alternatively, grant a "conditional registration" for a pesticide under certain circumstances, even though some of the required data may not have been submitted or reviewed. The company must provide the missing data within a specified time. In 2010, environmental and other groups charged that EPA had overused conditional registrations and did not appear to have a reliable system to identify whether the required data had been submitted. GAO was asked to examine issues related to EPA's use of conditional registrations for pesticides. This report examines the (1) number of conditional registrations EPA has granted and the basis for these, (2) extent to which EPA ensures that companies submit the required additional data and EPA reviews the data, and (3) views of relevant stakeholders on EPA's use of conditional registrations. GAO reviewed EPA data and surveyed stakeholders, among other things.
section_title: What GAO Found
paragraphs: The total number of conditional registrations granted is unclear, as the Environmental Protection Agency (EPA) reports that its data are inaccurate for several reasons. First, the database used to track conditional registrations does not allow officials to change a pesticide's registration status from conditional to unconditional once the registrant has satisfied all requirements, thereby overstating the number of conditional registrations. Second, EPA staff have misused the term "conditional registration," incorrectly classifying pesticide registrations as conditional when, for example, they require a label change, which is not a basis in statute for a conditional registration. According to EPA documents and officials, weaknesses in guidance and training, management oversight, and data management contributed to these misclassification problems. For example, according to EPA documents, there was limited, organized management oversight to ensure that regulatory actions were not misclassified as conditional registrations. As of July 2013, EPA officials told GAO that the agency has taken or is planning to take several actions to more accurately account for conditional registrations, including beginning to design a new automated data system to more accurately track conditional registrations.
The extent to which EPA ensures that companies submit additional required data and EPA reviews these data is unknown. Specifically, EPA does not have a reliable system, such as an automated data system, to track key information related to conditional registrations, including whether companies have submitted additional data within required time frames. As a result, pesticides with conditional registrations could be marketed for years without EPA's receipt and review of these data. In the absence of a reliable system for managing conditional registrations, EPA relies on a variety of routine program operations, such as its review of a company's changes to a pesticide registration, to discover that data are missing. However, these methods fall short of what is needed because they are neither comprehensive nor do they ensure timely submission of these data. According to federal internal control standards, EPA's lack of a reliable system for managing conditional registrations constitutes an internal control weakness because the agency lacks an effective mechanism for program oversight and decision making.
Stakeholders GAO surveyed--representatives of consumer, environmental, industry, legal, producer, science, and state government groups--generally said EPA needs to improve its conditional registration process. For example, some stated EPA should improve its data systems for tracking conditional registrations to ensure that required data are submitted and reviewed in a timely manner. However, stakeholder views varied on the benefits and disadvantages of conditionally registering pesticides. For example, some consumer, industry, legal, producer, and state government stakeholders stated that the conditional registration process promotes innovation by bringing new technologies to the marketplace more quickly. In contrast, some consumer, environmental, legal, science, and state government stakeholders voiced concerns that conditional registration allows products with safety that has not been fully evaluated into the marketplace.
section_title: What GAO Recommends
paragraphs: GAO recommends, in part, that EPA consider and implement options for an automated system to better track conditional registrations. EPA agreed with GAO's recommendations and noted specific actions it will take to implement them.

section_title: Letter
paragraphs: As of September 2010, more than 16,000 pesticides were registered for  use in the United States, according to the Environmental Protection  Agency (EPA). In addition, expenditures for pesticides—primarily for use  in agriculture—totaled $12.5 billion in 2007, the latest year for which data  are available from EPA. These pesticides—chemicals or biological  substances used to destroy or control weeds or unwanted insects, fungi,  rodents, bacteria and other pests—contribute significantly to agricultural  productivity by preventing crop damage and improving public health by  controlling disease-carrying pests. However, if used improperly,  pesticides may adversely affect human health by, for example, increasing  the risk of cancer and neurological disorders caused by pesticide  residues on food crops. Pesticides may also damage the environment by,  for example, killing or causing reproductive abnormalities in species other  than those which the pesticide is intended to kill, including fish, birds, and  other wildlife.
Under the Federal Insecticide, Fungicide, and Rodenticide Act, as  amended, (FIFRA), EPA registers pesticides distributed, sold, or   used in the United States and prescribes labeling and other regulatory  requirements to prevent unreasonable adverse effects on the  environment. To obtain a registration, a company or person (registrant)  is to submit an application containing health and environmental effects  data and other information on a pesticide for EPA’s review. After  reviewing the information, in general, EPA may (1) register the pesticide  and set a tolerance level (i.e., the maximum pesticide residue allowed) for  those pesticides used on food or animal feed, (2) notify the registrant of  deficiencies in the data or the need for additional information, or (3) deny  the application.
FIFRA section 3(c)(5) and section 3(c)(7) set forth two sets of statutory  standards under which EPA may register pesticides. EPA is authorized to  grant registrations under section 3(c)(5) if EPA determines, among other  things, that the application materials provided satisfy the requirements of  the statutes and that the information those materials contain concerning  the pesticide demonstrates that, when used in accordance with  widespread and commonly recognized practice, the product will not  generally cause unreasonable adverse effects on the environment. Such  registrations are commonly referred to as “unconditional” registrations  because they are approved without EPA imposing a requirement on the  registrant to develop additional data.
In addition, section 3(c)(7) of FIFRA provides EPA the authority to grant a  “conditional registration” for a pesticide product under certain  circumstances, although some necessary data have not been provided by  the registrant in the application. Under this authority, EPA may grant a  conditional registration for pesticide products that are identical or  substantially similar to pesticide products that are already registered or for  a new use of a currently registered product as long as EPA determines,  among other things, that the pesticide will not significantly increase the  risk of unreasonable adverse effects on the environment. This authority  also allows EPA to grant a conditional registration for pesticide products  with new active ingredients where data are missing from the application  because the requirement for the data was imposed so recently that the  registrant did not have adequate time to generate the data and EPA  determines, among other things, that the pesticide will not cause  unreasonable adverse effects on the environment during the time needed  to generate the data. According to EPA officials, registrants typically  have from 1 to 4 years to provide the missing data required by a  conditional registration.
In 2010, an environmental group questioned EPA’s use of conditional  registrations in the pesticide program, and other consumer and science  groups supported this position. The environmental group charged that  EPA had overused conditional registrations, stating that information from  EPA’s Office of Pesticide Programs Information Network (OPPIN) data  system showed that conditional registrations represented the majority of  active registrations. indicated that some pesticide products had been conditionally registered  for 20 years or more.
The group also pointed out that the OPPIN data  In this context, you asked us to examine EPA’s procedures for granting  conditional registrations. Accordingly, we examined the (1) number of  conditional pesticide registrations EPA has granted and the basis for  granting these registrations; (2) extent to which EPA ensures that  registrants submit the additional data required as part of conditional  registrations and reviews these data; and (3) views of relevant  stakeholders on EPA’s use of conditional registrations, including ways, if  any, to improve the conditional registration process.
EPA refers to registrations that are in effect (i.e., the registration has not been suspended  or canceled) as “active” registrations. For purposes of this report, unless otherwise  indicated, all registrations discussed are “active.” status and how long they have been in this status; (2) the total number of  current pesticide registrations (conditional and unconditional); and (3) for  fiscal years 1997 through 2011, the number of conditional registrations  granted for each year and the basis on which these were granted (i.e.,  identical/substantially similar pesticides, new uses, or new active  ingredients). In addition, we asked OPP to provide information on the  number of pesticides that (1) have a conditional registration, but the  registrant has not submitted the additional required data by the specified  due date; (2) have a conditional registration and the registrant has  submitted the additional required data, but EPA has not reviewed these  data; (3) still have a conditional registration, even though the registrant  has submitted, and EPA has reviewed, the additional required data; and  (4) had been changed from conditional to unconditional status. However,  after interviewing OPP officials and reviewing past GAO, Inspector  General, and EPA contractor studies examining OPP’s data  management, especially its use of OPPIN, we concluded that EPA could  not provide us with sufficiently reliable data for obtaining summary level  information on conditional pesticide registrations. In the absence of these  data, we discussed with OPP officials the data limitations they face using  OPPIN and any potential workarounds they employ or are planning. In  addition, we interviewed OPP officials and reviewed documentation they  provided to obtain further information and clarification on EPA’s  conditional registration process, including any planned responses to  internal review or external stakeholder concerns. To obtain the views of  relevant stakeholders on EPA’s conditional registration process and  ways, if any, to improve it, we used the results of a literature search and  other sources to develop a list of consumer, environmental, industry,  legal, producer, science, and state government stakeholders. From this  list, we selected a nonprobability sample of stakeholders from each  category to contact, for a total of 35 stakeholders. We then developed,  pretested, and e-mailed a questionnaire to obtain these stakeholders’  views. Twenty-four out of 35 stakeholders provided responses to our  questionnaire. We performed a content analysis of the questionnaire  responses to identify common themes regarding stakeholders’ views on  EPA’s use of conditional registrations. Appendix I provides a more  detailed description of our objectives, scope, and methodology.
We conducted this performance audit from September 2011 to August  2013 in accordance with generally accepted government auditing  standards. Those standards require that we plan and perform the audit to  obtain sufficient, appropriate evidence to provide a reasonable basis for  our findings and conclusions based on our audit objectives. We believe  that the evidence obtained provides a reasonable basis for our findings  and conclusions based on our audit objectives.
subsections: section_title: Background
paragraphs: The primary federal laws that govern how EPA regulates pesticides in the  United States are FIFRA and the Federal Food, Drug, and Cosmetic Act  (FFDCA). Under FIFRA implementing regulations, EPA is to review  applications for pesticide products and register those that it determines  will meet the FIFRA statutory standards for registration. If the use of a  pesticide would result in a residue of the substance in or on food or  animal feed, EPA may not register a pesticide under FIFRA unless it can  determine that the residue is “safe” as defined by FFDCA. Under FFDCA,  safe means that EPA has determined, among other things, that there is a  reasonable certainty that no harm will result from aggregate exposure to  the pesticide residue, including all anticipated dietary exposures and all  other nonoccupational exposures for which there is reliable information.  EPA may establish a tolerance level—the maximum permissible pesticide  residue in or on food or animal feed that is sold—that meets the FFDCA  safety standard or may choose to grant an exemption for a tolerance.
OPP—the EPA office primarily responsible for regulating the use of  pesticides—has regulatory staff in three divisions—Registration,  Biopesticides and Pollution Prevention, and Antimicrobials—that are  responsible for registering pesticides. The registration process formally  begins when a registrant submits an application to OPP for a particular  pesticide. This application is to include data to support the registration of  the pesticide. In reviewing the application, OPP is to examine, among  other things, the pesticide’s ingredients; the site or crop on which it is to  be used; the amount, frequency, and timing of its use; and storage and  disposal practices. OPP is also to review toxicity tests and studies  showing how the pesticide affects human health and the environment.  According to OPP officials, the length of time OPP takes from the initial  review of an application to the final decision on whether to register a  pesticide depends on many factors—including whether the pesticide  being reviewed is similar to any pesticide EPA has previously reviewed— and, according to OPP officials, can take from 3 to 24 months. After OPP  completes its review and approves the submitted package, EPA may  register the pesticide without imposing requirements for additional data  (unconditional registration) under FIFRA 3(c)(5) if EPA determines,  among other things, that use of the pesticide in accordance with label  directions will not have unreasonable adverse effects on the  environment.
Alternatively, FIFRA section 3(c)(7) allows EPA to grant a conditional  registration for pesticides in the following circumstances:  Identical/substantially similar pesticides (FIFRA Section 3(c)(7)(A)).  EPA may conditionally approve an application for registration or an  amended registration for a pesticide product if the agency determines  that  the pesticide and proposed use are identical or substantially  similar to any currently registered pesticide and its uses, or differ  only in ways that will not significantly increase the risk of  unreasonable adverse effects on the environment; and approving the registration or amendment in the manner proposed  would not significantly increase the risk of any unreasonable  adverse effect on the environment.
Each registration issued under 3(c)(7)(A) must submit or cite the same  data that would be required for the unconditional registration of a similar  product.
New uses (FIFRA Section 3(c)(7)(B)). A current pesticide registration  may be amended to allow additional uses, even if the data concerning  the pesticide may be insufficient to support unconditional registration,  if EPA determines that  the applicant has submitted satisfactory data pertaining to the  proposed additional use; and amending the registration would not significantly increase the risk  of unreasonable adverse effect on the environment.
Each registrant must submit or cite the same data that would be required  for the unconditional registration of a similar product.
New active ingredients (FIFRA Section 3(c)(7)(C)). A pesticide  containing a new active ingredient not found in any currently  registered pesticide can be conditionally registered for a period  reasonably sufficient for the generation and submission of required  data, if EPA determines  insufficient time has elapsed since the imposition of the data  requirement for those data to be developed and on the condition  that when the agency receives such data that they do not meet or  exceed risk criteria stated in the regulations issued under FIFRA  and other conditions issued by the agency;  the use of the pesticide during the period of the conditional  registration will not cause unreasonable adverse effect on the  environment; and  the use of the pesticide is in the public interest.
After a pesticide product is conditionally registered under FIFRA section  (3)(c)(7), the registrant receives a notice indicating the terms of the  conditional registration, including a list of any additional data that will  need to be submitted and deadlines for submitting these data. Figure 1  summarizes the pesticide registration and tolerance setting process.
According to EPA officials, once a pesticide is conditionally registered,  EPA typically grants a period of time, generally 1 to 4 years, for the  registrant to provide the required data. The registrant can ask EPA to  waive the requirement for additional information or, according to EPA  officials, extend the time frame. If the registrant does not submit the data  specified within the required time frame, EPA can cancel the pesticide  registration.
Before a pesticide can be sold or distributed in the United States, it must  be registered under FIFRA.  At any time, EPA may initiate a suspension  or cancellation proceeding for a pesticide registration if safety concerns  develop. For example, EPA began proceedings to cancel some uses of  Carbofuran—an insecticide and nematicide that was registered to  control pests in soils and on leaves in a variety of field, fruit, and  vegetable crops—after the agency determined that the dietary, worker,  and ecological risks of this pesticide were unacceptable.
Another check on the safety of registered pesticide products is the  requirement in FIFRA section 6(a)(2) and FIFRA implementing  regulations that registrants report adverse effects-related information to  EPA.  For example, registrants are required to submit certain toxicity  information concerning the product both before and after registration,  such as information on the product’s toxicity to nontarget plant species.
In addition, as required by FIFRA,registered pesticide every 15 years to help ensure that each pesticide  registration continues to satisfy the regulatory standard. In 2007, EPA   EPA is to review the safety of each  began conducting these reviews under its registration review program.As a part of this program, if EPA determines that additional data are  needed to support the continued registration of a pesticide, the agency  may issue a Data Call-In (DCI) notice, as authorized by FIFRA section  3(c)(2)(B), requiring the registrant to provide the data by a specific date.  Also, at any time after a pesticide is registered, a registrant may apply to  amend the registration and, according to OPP officials, such requests are  reviewed as though the registrant is seeking approval for a new pesticide.  While reviewing such requests, the agency may also issue a DCI notice  requiring the registrant to provide additional data by a specific date. If a  registrant fails to provide the data requested through a DCI, EPA may  suspend the pesticide’s registration under authority of FIFRA section  3(c)(2)(B).
The Pesticide Registration Improvement Act of 2003 (PRIA), Pub. L. No. 108-199, Div.  G, Tit. V, § 501, 118 Stat. 419 (2004), amended FIFRA by, among other things,  establishing pesticide registration fees for some registration actions. PRIA was  reauthorized in 2007 (Pesticide Registration Improvement Renewal Act of 2007, Pub. L.  No. 110-94, 121 Stat. 1000 (2007) or PRIA 2) and again in 2012 (Pesticide Registration  Improvement Extension Act of 2012, Pub. L. No. 112-177, 126 Stat. 1327, or PRIA 3). registrations the agency had issued, whether registrants had submitted  the additional data required by the registrations, and whether EPA had  reviewed the data submitted. OPP provided the group with information  from the OPPIN data system on the number of pesticide registrations that  had been categorized as conditional. Subsequently, in September 2010,  the environmental group raised concerns about EPA’s use of its  conditional registration authority, and several other environmental groups  and other interested parties supported this position. Among other things,  the environmental group asserted that EPA had overused conditional  registrations and did not appear to have a reliable tracking system to  identify the status of conditionally registered pesticides to ensure that  registrants submitted, and EPA reviewed, additional data in a timely  manner. In addition, the group noted that the information EPA provided  indicated that many pesticides have remained in conditional status for  many years. For example, the information showed that over 3,200  pesticides had been in conditional status since 1995 (15 years) and that  2,100 pesticides had been in conditional status since 1990 (20 years).
section_title: Total Number of Conditional Registrations Granted Is Unclear, as EPA Found Data to Be Inaccurate
paragraphs: The number of active conditional registrations EPA has granted is  unclear, according to OPP officials who, as a result of a 2011 EPA  review, found the agency’s registration data to be inaccurate and the  basis for granting some of these registrations to be inappropriately  classified. Specifically, an internal review of OPP’s conditional registration  program found that OPPIN does not allow officials to change a pesticide’s  registration status from conditional to unconditional once the registrant  has satisfied all data requirements, and the basis for many registration  decisions was mischaracterized as conditional. In addition, based on the  internal review, OPP officials concluded that several weaknesses  contributed to this misclassification problem, including insufficient  guidance and training, management oversight, and data management. As  of July 2013, OPP officials told us that the office has taken or is planning  to take several actions to more accurately account for conditional  registrations.
subsections: section_title: EPA Found Conditional Registration Data to Be Inaccurate and That the Basis for Many Registrations Was Inappropriately Classified
paragraphs: According to OPP officials, following an internal review of its conditional  registration program that it completed in March 2011, OPP concluded that  the OPPIN data on the number of conditional registrations were  inaccurate. The internal review was conducted, in part, to determine the  number of conditional registrations granted by EPA. According to  information on OPP’s website, during the internal review, OPP  determined that OPPIN contained 16,156 active pesticide registrations  and that 11,205 (69 percent) of these pesticides were conditionally  registered. However, OPP officials concluded, based on the internal  review, that the data were inaccurate, and that the number of conditional  registrations was overstated, for two reasons. First, once a registration is  classified as conditional in OPPIN, its status in this data system cannot be  changed from conditional to unconditional, when, for example, the  registrant has satisfied all data requirements imposed. According to the  internal review, OPPIN is an older system that was not designed  specifically to track conditional registrations and thus is ill-suited for that  purpose. To determine the current number of conditionally registered  pesticides, OPP officials said detailed paper files that support each  pesticide registration would need to be reviewed, which would be a very  time-consuming process. OPP officials indicated that they plan to develop  a new automated system for tracking conditional registrations and, in  fiscal year 2013, they began using a portion of the registration  maintenance fees collected annually to begin exploring the feasibility of   However, these officials were uncertain  implementing such a system.about the ultimate cost of this system, what sources they would use for  any additional funding, and when the system would be operational.
Second, as a result of the internal review, OPP found that its regulatory  staff had incorrectly categorized the basis for many program actions in  OPPIN as “conditional registrations” and that these incorrect  categorizations resulted in an overcounting of conditional registrations.  According to the internal review, OPP staff had used conditional  registrations to describe a variety of actions that fall outside of the  circumstances authorized by FIFRA Section 3(c)(7). For example,  according to OPP officials and the internal review, OPP staff had  assigned the category “conditional registration” to situations where  approval of a registration is contingent upon the “condition” that the  registrant makes a change that does not involve generating additional  data. These situations included certain changes to pesticide product  labels—such as strengthening precautionary statements—that are not  specified by FIFRA section 3(c)(7), according to the results of the internal  review. Similarly, OPP staff categorized as “conditional registrations”  situations where the agency requested registrants to provide certain  pesticide product-specific information—such as product chemistry studies  related to storage stability that are used to determine label  requirements—that do not fall under FIFRA Section 3(c)(7). The incorrect  classification of actions as conditional registrations, according to the  internal review, may leave the agency vulnerable to allegations by  environmental, industry, and other stakeholders who assert that EPA  inappropriately grants conditional registrations. However, according to  OPP officials, all of the actions that were mistakenly categorized as  conditional registrations were legitimate program actions that were lawful  under other sections of FIFRA. We were unable to verify this assertion.  Further, EPA still needs to take steps to correct these misclassifications in  order to ensure the accuracy and integrity of its data and make clear the  statutory basis for these program actions.
section_title: Several Weaknesses Contributed to Incorrect Data Entry on Conditional Registrations
paragraphs: Several weaknesses contributed to incorrect data entries into OPPIN.  First, according to OPP officials, OPP regulatory staff did not have  sufficient guidance or training to help them determine when a program  action met the criteria for conditional registration. Second, according to  OPP’s internal review, there was limited, organized management  oversight to ensure that regulatory actions not subject to the narrow  scope of section 3(c)(7) were not mischaracterized by OPP staff as  conditional registrations. As a result, as the internal review stated, the  actions that were classified as conditional registrations have varied  across OPP’s three divisions and by individual entering data into OPPIN  within each division. In addition, data management weaknesses  contributed to the misclassification of registrations or other actions as  conditional. For example, OPP officials said that OPPIN does not  generate management reports of summary data that could have alerted  managers to the excessive use of “conditional registration” due to the  inaccurate classification of actions as conditional registrations by OPP  staff. Under the federal standards for internal control, federal agencies  are to employ internal control activities, such as management reviews at  the functional or activity level, to help ensure that management’s  directives are carried out and to determine if agencies are effectively and  efficiently using resources. Without the ability to generate summary data  on conditional registrations from OPPIN, OPP managers cannot easily  conduct such reviews. However, they are still responsible for monitoring  and ensuring the accuracy of conditional registration data.
In light of the apparent widespread misclassification of regulatory actions  as conditional registration, OPP, as part of its internal review of  conditional registrations, analyzed data in OPPIN to, among other things,  determine EPA’s historical use of conditional registrations, including how  many of each of the three types of conditional registrations authorized by  FIFRA section 3(c)(7) had been granted. The OPP official primarily  responsible for conducting this analysis said the intent of the analysis was  to show that (1) as noted on the OPP website, only a small portion of the  conditional registrations granted by EPA were for new uses under section  3(c)(7)(B) or new active ingredients under section 3(c)(7)(C), as intended,  and (2) most of the conditional registrations granted were for identical or  substantially similar products under section 3(c)(7)(A). However, in  reviewing this information and related documentation, we found that the  information on the website was unclear, contained discrepancies, and  used technical terms without defining them, which could lead to  misinterpretation of the information. For example, the calculations  presented on the website to support the conclusion that the overwhelming  majority of actions identified in OPPIN as conditional registrations fall  outside the circumstances authorized by FIFRA section 3(c)(7) incorrectly  grouped conditional registrations for identical or substantially similar  products authorized by section 3(c)(7)(A) with label amendments and  other actions that fall outside the narrow scope of section 3(c)(7). After  meeting with OPP officials in November 2012 to discuss the analysis,  these officials acknowledged the website could be clearer and said that  the website would be revised to clarify any confusing language and  correct any inaccurate statements. However, OPP had no specific plan or  time frame for doing so. As of July 2013, these clarifications and  corrections had not been made.
section_title: OPP Is Taking, or Plans to Take, Actions to More Accurately Account for Conditional Registrations
paragraphs: Accurate and reliable data are essential to an efficient and effective  operating environment in the federal government. To more accurately  report on the number of pesticide products that are conditionally  registered, OPP officials told us that the office has taken or planned to  take the following actions:
Beginning in the fall of 2010, representatives of the OPP divisions that  deal with pesticide registrations began meeting with OPP  management at least quarterly to, among other things, review  proposed conditional registrations for pesticide products with new  active ingredients to ensure that (1) any new conditional registrations  granted for these products meet the circumstances outlined in FIFRA  Section 3(c)(7)(C); (2) the additional data that would be requested as  a part of the conditional registration are really needed; and (3) if the  data are needed, EPA is still able to make the determination that the  information available concerning the pesticide demonstrates that the  FIFRA safety standard will be met, which requires that the use of the  product during the time needed to generate the necessary data will  not cause unreasonable adverse effects on the environment.  According to OPP officials, since they started these quarterly reviews,  the number of conditional registrations granted for new active  ingredients generally has dropped. For example, since starting these  reviews, they have been able to preclude cases of misclassification of  new active ingredient registrations as “conditional” that had been  occurring in the past. Specifically, they noted that, prior to 2010, in  some cases, OPP staff had classified some of these registrations as  conditional when the additional data being requested of the registrant  could only be generated after the date of registration, such as data  measuring the storage stability of a commercially manufactured  version of the newly registered pesticide product. According to OPP  officials, they do not regard such data requirements as being within  the scope of FIFRA section 3(c)(7).
In 2012, OPP began revising the registration categories in OPPIN to,  among other things, more accurately reflect those circumstances  under which conditional registrations may be granted under FIFRA.  As of May 2013, OPP officials said that they had completed  development of the categories and provided training to their regulatory  staff on how to correctly assign the new categories to each type of  registration. In July 2013, OPP officials said they had completed  implementation of the new codes in OPPIN.  In addition to the  training, OPP officials noted the training materials will be available  online for regulatory staff to consult for guidance on an ongoing basis.
In fiscal year 2013, OPP began using a portion of the maintenance  fees it collects to begin development of an electronic tracking system  for conditional registrations. As discussed, OPP officials are not  certain what the total cost of the system will be or when the system  will be ready for implementation.
Table 1 summarizes the status, according to OPP officials, of key actions  taken or planned by OPP to improve the reliability of conditional  registration data.
While OPP officials acknowledged the need to ensure that registrations  are accurately classified to reflect their statutory basis and to develop an  electronic data system for tracking the status of conditional registrations,  they stated that EPA’s past practices for managing conditional  registrations have not created additional risks to the environment and  have been in compliance with applicable laws. Specifically, an EPA  attorney stated that the agency views products conditionally registered as  identical or substantially similar to currently registered pesticides under  section 3(c)(7)(A) and as new uses of currently registered pesticides  under section 3(c)(7)(B) as meeting the same safety standards as  products registered “unconditionally” under section 3(c)(5). Therefore,  according to this official, these products do not pose unreasonable  adverse effects on human health or the environment. Further, a Deputy  Director of OPP said section 3(c)(7)(A) and section 3(c)(7)(B)  registrations make up the bulk of conditionally registered pesticides. In  addition, OPP officials stressed that the program actions that were  mischaracterized as conditional registrations were nevertheless legitimate  program actions. Specifically, these officials and OPP’s website note that  most of these actions were taken pursuant to the authority of FIFRA  implementing regulations and should have been identified as such.  Moreover, the EPA attorney stated that FIFRA does not require EPA to  convert a registration from “conditional” to “unconditional” when all  additional data requirements have been satisfied. So, according to this  official, the fact that EPA has not done so in OPPIN in the past does not  raise a legal issue. However, despite these assertions, EPA should still  take steps to ensure that its data on the registration status of individual  pesticide products are current and accurate.
section_title: Extent to Which EPA Ensures That Registrants Submit Additional Required Data and EPA Reviews These Data Is Unknown
paragraphs: The extent to which EPA ensures that registrants submit the additional  data required when it grants conditional registrations or that it has  reviewed these data is unknown. In particular, OPP does not have a  reliable system, such as an automated data system, designed specifically  to track key information related to conditional registrations, including  whether registrants submitted additional data within required time frames  and OPP reviewed these data. OPP officials acknowledged this lack of a  comprehensive means to track the status of conditional registrations, and  noted, as discussed, their intention to develop such a system. However,  these officials, as well as OPP’s website, note that the conditions for most  of these registrations have likely been satisfied as a result of routine  program operations that, in the OPP officials’ view, constitute a quality  assurance check. While these program operations may help to identify  some situations where required data are missing, they fall short of what is  needed because they are neither comprehensive nor do they ensure the  timely submission of these data. This is a key reason that OPP officials  are currently conducting a manual review of the files of the more than  16,000 active pesticide registrations OPP has issued, including  conditional registrations, to identify any missing data, misclassified  registrations, or other problems.
subsections: section_title: OPP’s Lack of a Reliable System to Track Conditional Registrations Hinders Its Ability to Ensure that Data Are Submitted, Timely, and Reviewed
paragraphs: OPP lacks a reliable system specifically to track the status of conditional  registrations to ensure that additional required data are submitted and  timely, and that OPP reviews these data. As discussed, EPA currently  “tracks” conditional registrations in OPPIN, an older data system that was  not designed for this purpose and that does not have, among other  things, the capability to flag situations in which required data have not  been submitted by registrants or reviewed by OPP. Federal internal  control standards require, in part, that information should be recorded and  communicated to management and others within the entity who need it  and in a form and within a time frame that enables them to carry out their  internal control and other responsibilities. Thus, for an entity to run and  control its operations, it must obtain, maintain, and use relevant, reliable,  and timely information for program oversight and decision making.  Furthermore, the Office of Management and Budget (OMB) directs  agency managers to take timely and effective action to correct internal  control weaknesses. As measured against this internal control standard,  EPA’s lack of a reliable and comprehensive means of routinely collecting  and tracking information on conditional registrations, including the status  of registrants’ submission of required data and OPP’s review of these  data, constitutes an internal control weakness and leaves OPP without an  important management tool. For example, when registrants miss due  dates without applying for waivers or extensions, it is difficult for OPP  without a reliable tracking system to identify these cases for priority  follow-up and notify the registrants that their pesticide registrations could  be cancelled.
In addition, without a reliable tracking system, OPP may miss conditional  pesticides where, had the additional required data been submitted and  reviewed, OPP might have altered the terms of a registration. OPP  officials acknowledged there have been cases in which their  consideration of these additional data led them to make minor changes to  a registration, although they could not recall a case where these  additional data prompted them to cancel a registration. These officials  emphasized, and OPP documents state, that in issuing a conditional  registration, even though OPP may ask the registrant for additional data,  OPP has determined that the pesticide when used in accordance with  labeling and common practices will not cause unreasonable adverse  effects on the environment, and that OPP’s registration decision takes  into account the economic, social, and environmental costs and benefits  of the use of that pesticide. Nevertheless, without the ability to  systematically track conditional registrations, OPP is not well-positioned  to produce summary data to enable it to easily identify situations for  priority follow-up; enforce FIFRA and its implementing regulations; and  report to Congress and others on program status. For example, without  this tracking, it is more difficult to identify patterns of potential problems  for management attention, such as registrants that are repeatedly late in  providing additional required data for their conditional registrations, which  could be the basis for canceling these registrations.
OPP’s problems with data management have been well-documented over  the years. GAO studies dating back to 1980, 1986, 1991 and 1992 noted  problems with OPP data systems used to track the status of pesticide  registrations. For example, the 1986 study found that OPP did not have  a data system for monitoring whether registrants were submitting the data  required by conditional registrations and could only determine the status  of data submissions by performing a time-consuming manual file search.  At the time, we recommended that OPP take steps to review outstanding  conditional registrations of new active ingredients and determine what  progress is being made by registrants to submit the required data and  take appropriate action. In response to our recommendation, OPP said it  was developing a new automated system to track all outstanding data  requirements. However, as discussed, OPP does not currently have such  a system. The 1992 study noted that, after having spent $14 million over  3 years in data systems development, OPP could not easily assemble  accurate, reliable, and complete information on pesticides subject to  reregistration (now registration review). EPA Inspector General studies in  1994 and 2000 noted that OPP had not completed actions to improve  information systems that contain inaccurate, incomplete, and duplicate  data or that are not integrated. In addition, a 2007 EPA contractor study  found that many of these problems persist, especially with OPPIN.  Noting that OPPIN was launched in 2000, this study found that this  system had failed to meet the needs of OPP staff and that many of these  staff had created “one-off” (off-line) tracking systems in order to get their  jobs done, making comprehensive, reliable status updates, such as  whether required data had been submitted and reviewed, very difficult to  retrieve. The study also reported that OPPIN lacks the needed data fields  and reporting functions for detailed tracking of the status of pesticide  registrations, and that multiple OPP staff had expressed dissatisfaction  with OPPIN, stating that it is not user-friendly, data are not current or  complete, and it lacks a “report card” function to easily check the status of  pesticide registrations, including reregistration status. Although the  contractor study noted that OPPIN was to be retired in September 2008,  we found, as discussed, that OPP is still using OPPIN despite its many  limitations.
section_title: Although Helpful in Identifying Missing Information, Routine Program Operations Fall Short of What Is Needed
paragraphs: OPP officials said, and the internal review states, that the conditions for  most conditional registrations have likely been satisfied as a result of  routine program operations that, in their view, constitute a quality  assurance check. However, these operations fall short of what is needed  for quality assurance because they are neither comprehensive nor do  they ensure the timely submission of the additional data required as a  condition of the registration. The program operations mentioned by OPP  include the following: good faith submissions made by registrants to satisfy additional data  record keeping and targeted follow-up done by pesticide product  managers;  state pesticide registration actions that may bring to light missing data  required by the OPP’s conditional registration of a pesticide; missing data identified as part of OPP’s periodic reevaluation of  registrant-initiated actions, such as label change amendments, that  bring to light missing data associated with an earlier conditional  registration.
The program operations OPP officials identified may help identify some  situations where required data are missing, but they each have limitations  and fall short of what is needed, as follows:
Registrant submissions: While undoubtedly many registrants are  conscientious about their timely submission of additional data required  by their conditional registrations, OPP has found cases in the past  where required data were not submitted or were submitted late. As  discussed, once OPP issues a conditional registration, the registrant  can move the associated pesticide product into the marketplace. In  that sense, the registrant’s commercialization of that product is not  contingent on the registrant’s submission of the additional required  data. In addition, because OPPIN does not have the ability to  systematically flag missing or late data, some registrants may be  emboldened to delay or give less priority to developing and submitting  these additional data.
Product manager actions: The record keeping and targeted follow-up  done by OPP product managers also have limitations. According to  OPP officials, each of OPP’s 20 product managers is responsible for  tracking about 800 of the more than 16,000 active pesticide  registrations maintained by OPP. While OPP officials acknowledged  that each manager has a very broad span of control, there are other  OPP regulatory staff who assist these managers. Moreover, of the  approximately 800 registrations handled by each manager, conditional  registrations constitute a subset, particularly for new active  ingredients. However, we found that OPP had not provided written  guidance to product managers on how to track the status of the  pesticide registrations for which they are responsible. As a result,  according to OPP officials, product managers use a variety of  methods to track this information, including electronic spreadsheets or  reminder notices, handwritten notes, and memory. Without OPP  guidance on how product managers should maintain their pesticide  registration files, in the case of the retirement or resignation of an  experienced manager—or even the extended absence of a manager  due to illness—other managers asked to replace or fill in for this  manager may not be familiar with how he or she maintained files or  data, or the extent to which this official relied on memory versus  written records. Furthermore, requiring all product managers to track  the status of registrations in a consistent, electronic format would help  OPP meet the goals of an August 2012 OMB directive that, among  other things, directs executive agencies to the fullest extent possible  to eliminate paper and use electronic record keeping to ensure  transparency, efficiency, and accountability. The directive is  applicable to all executive agencies and all records.
State registration: While state pesticides registration activities may  help to bring to light missing data associated with conditional  registrations issued by OPP, the extent to which this happens is  unknown and should not be relied upon as a quality assurance check.  After OPP registers a pesticide, states also can register that pesticide  under specific state pesticide registration laws. A state may be more  stringent in registering a pesticide for use in that state, but its  registration requirements generally may not be less stringent than the  federal requirements. In addition, states generally have primary  responsibility (known as “primacy”) for enforcement of the proper use  of pesticides within their borders.
Periodic review of registered pesticides: As discussed, FIFRA  requires that EPA periodically reevaluate registered pesticides to  ensure that each registration continues to satisfy regulatory  standards. EPA originally did this reevaluation under its reregistration  program, applicable to pesticides registered prior to November 1984.  More recently, this reevaluation is being done under the agency’s  registration review program. According to OPP officials, this periodic  review of previously registered pesticides provides an opportunity to  identify missing data required by a conditional registration. For  example, these officials said any missing data related to section  3(c)(7)(A) (identical or similar) or (B) (new uses) can be identified  through registration review. They explained that registrations under  these sections do not impose new data requirements. Instead, these  registrations are issued when there is an outstanding DCI, or planned  DCI, for an identical or similar currently registered pesticide. Thus,  according to OPP officials, because registrations under these sections  are linked to DCIs, and OPP’s Pesticide Registration Information  System (PRISM) is used to track DCIs, they are confident in their  ability to ensure the timely submission of required data. They noted  that PRISM is a newer and more robust data system than OPPIN.  They also noted that (1) most conditional registrations are made  under sections 3(c)(7)(A) or (B), (2) the associated DCIs place a legal  obligation on the registrant to provide the requested data, and (3)  OPP may suspend a registration for failure to respond to a DCI.  However, we note that PRISM has apparent limitations as well. For  example, OPP officials said that PRISM is not designed, per se, to  track conditional registrations and therefore cannot be used to identify  the conditional registrations, if any, associated with a particular DCI.  In addition, they said while this system is useful for tracking the status  of DCIs on a case-by-case basis, PRISM lacks the capability to  produce summary reports for management attention that could  indicate, for example, the extent to which registrants are meeting the  requirement to provide an initial response to a DCI within 90 days.
Furthermore, as acknowledged by OPP officials, registration review is  not helpful in tracking the status of conditional registrations made for  new active ingredients under FIFRA section 3(c)(7)(C). For these  registrations, there is no relationship to an identical or similar,  currently registered pesticide. As a result, the potential exists that a  conditionally registered pesticide under this section would continue to  be sold and used in the United States for a number of years before  OPP discovered that the additional data required had not been  submitted and were late. In reviewing OPP documents related to the  conditional registration of new active ingredients done in the early  2000s, we noted such cases. In each case, when the associated  pesticide product came up for registration review, OPP determined  that some of the required data related to the original conditional  registration had not been submitted and were late or, if submitted, had  not been reviewed by OPP. For example, in the case of a pesticide  product containing the active ingredient Foramsulfuron, conditionally  registered in November 2002, two required studies on the effects of  this pesticide on terrestrial and aquatic plants that were due in  December 2004 had not been submitted 10 years after the conditional  registration was issued, as determined by OPP’s registration review of  this pesticide in 2012. In another case, involving a pesticide product  containing the active ingredient Acetamiprid, conditionally registered  in March 2002, OPP discovered during its registration review of this  pesticide in 2012, about 10 years later, that it had received, but not  reviewed, a study related to the effects of this pesticide on  honeybees. OPP documents indicate the registrant submitted this  study in 2001, even before OPP granted the conditional registration.  Acetamiprid belongs to a class of pesticides called neonicotinoids that  some beekeepers, environmental groups, and others suspect of  having adverse effects on honeybees.
Registrant-initiated actions: According to OPP officials, if a registrant  applies to amend a registration, such as to make a label change, this  action triggers an OPP review of the data supporting the pesticide  registration and provides an opportunity to identify missing data  associated with a conditional registration. If it is determined that data  are missing, the agency may issue a DCI requiring the registrant to  provide the data by a specific date. However, this mechanism to  identify missing data is ad hoc and only applies to cases in which a  registrant seeks to amend its registration.
In addition, OPP officials pointed to an analysis they performed as part of  OPP’s 2011 internal review that showed registrants usually meet the  additional data requirements associated with their conditional  registrations on a timely basis. Specifically, OPP examined 544  conditional registrations that it granted (1) for new uses or new active  ingredients under FIFRA sections (3(c)(7)(B) or (C), respectively, and (2)  from March 2004 to September 2010. According to OPP officials and the  office’s website, these conditional registrations were selected because, as  relatively recent registrations, they were the most likely candidates to be  missing additional required data. In contrast, according to OPP officials,  older conditional registrations were less likely to be missing data because  of the application of the cited routine program operations.
To do this analysis, OPP officials said they first identified all additional  data requirements and associated due dates for these conditional  registrations, and then manually reviewed the files for these pesticides to  determine if the required data were submitted and due dates met. When  finished, OPP concluded that registrants had completed 96 percent of “all  actions intended” for these 544 conditional registrations in a timely  manner. OPP posted this information on its website. However, in  reviewing the information on the website, as well as supporting  documents provided by OPP, we were unable to verify these calculations,  in part because OPP was unable to locate some of the supporting  documentation. In addition, some of the documentation provided did not  always make clear whether the submitted data had been timely or  reviewed by OPP. Furthermore, we found that some of the statements on  the website were confusing; used technical terms such as “registration,”  “action,” and “decision” without defining the terms; and contained other  discrepancies. Some of these problems have been cited by legal and  environmental groups who found this information confusing as well.  Although OPP officials generally agreed that revisions were needed to the  discussion on the website for clarity, OPP had no specific plan or time  frame for doing so. Regardless of any clarifications needed to the  website, an OPP Deputy Director expressed confidence in the results of  this analysis. As of July 2013, the discussion of this analysis on the  website had not been clarified.
section_title: OPP Is Manually Reviewing All of the More than 16,000 Pesticide Registrations to Identify Problems Such as Missing Data
paragraphs: In May 2012, OPP staff began manually reviewing the files for the more  than 16,000 pesticide registrations granted by EPA. The purposes of this  review include identifying all outstanding data requirements, as well as  cases where the registration action, such as a label change amendment,  was mischaracterized as a “conditional registration.” According to OPP  officials, all prior registrations are being reviewed, not just those classified  as conditional, because pesticide registrations may have long histories,  and even though a registration may have been classified initially as  unconditional, OPP may have imposed additional data requirements at a  later time.
According to OPP officials, reviewing each pesticide registration file is  time-consuming and, depending on the pesticide, may take from a few  hours to a few days to complete. This generally includes OPP regulatory  staff reviewing voluminous paper files associated with many of these  pesticide registrations. According to these officials, once this review  process is completed, OPP will have a “clean” set of data that will, among  other things, identify (1) any missing data, (2) missed deadlines for  registrants submitting these data, and (3) cases where the registration  action was mischaracterized, including the misuse of “conditional  registration.” These officials said the review results are being recorded in  an electronic spreadsheet, known as the “master file,” for future use. For  example, when a pesticide comes up for registration review, OPP officials  said that staff will refer to the master file to identify any missing data that  should be included in the DCI resulting from that review.
Although OPP’s review of prior pesticide registrations remains a work in  progress, OPP provided an excerpt from its electronic spreadsheet  showing the results for three pesticides that we asked about because  other agency documents we reviewed suggested possible registration  issues. For these pesticides, the spreadsheet indicated that most, but not  all, of the required data had been submitted by registrants; some of these  data were submitted from 2 to 12 months after the related due dates and,  for one of these pesticides, no due date was specified in the registration  notice, making it impossible to determine if the data were submitted on- time. In this last case, OPP officials stated that the lack of due dates in  the registration notice was an unintentional oversight. Since OPP has not  finished its review of all prior registrations, it has not yet developed  summary statistics on the frequency with which these types of problems  were found. OPP officials said they plan to complete their manual review  of prior registrations by the fall of 2013, but its completion by then will  depend on the amount of time OPP staff can devote to this review relative  to their other responsibilities. In addition, according to agency officials, by  the end of calendar year 2013, they plan to make public information from  the review about the number of active ingredients approved under FIFRA  section 3(c)(7)(C) for which data are overdue, and those for which data  were submitted late.
While OPP’s manual review of existing registrations may result in a clean  data set and identify some missing data and other problems not  discovered as a result of what OPP calls routine program operations, it is  an interim measure. Among other things, OPP officials said their office  needs a comprehensive automated data system for tracking conditional  registrations. As noted by one OPP division director, “no one wants to  have to track this information by hand” in the future. In addition, according  to these officials, OPP does not plan to update the master file to include  new pesticide registrations or other registration changes that occur in the  future. They noted that the master file is retrospective, and it provides a  snapshot in time. Instead, OPP officials said that new pesticide  registrations and other registration changes will be entered into OPPIN  using the new codes that OPPIN plans to introduce in June 2013. In July  2013, EPA advised us that the codes have been entered in OPPIN.  According to these officials, the introduction of these new codes, in  conjunction with staff training on how to use them, should preclude some  of the misclassification problems experienced in the past until a new  comprehensive data system is available to replace OPPIN.
section_title: Stakeholders Generally Said EPA Needs to Improve Its Conditional Registration Process and Had Mixed Views on the Value of These Registrations
paragraphs: The 24 stakeholders that responded to our questionnaire—including  representatives of consumer (3), environmental (6), industry (5), legal (3),  producer (1), science (1), and state government groups (5)—generally  indicated that EPA needs to improve its conditional registration process  and, in some cases, they offered suggestions for improving this   The issues that stakeholders raised included concerns about  process.the timely submission and review of required data and the misuse of the  conditional registration designation. In addition, stakeholders’ views  varied regarding the potential benefits and problems associated with the  conditional registration of pesticides.
subsections: section_title: Respondents Generally Reported That EPA Needs to Improve Its Conditional Registration Process
paragraphs: In responding to our questionnaire, respondents in the consumer,  environmental, industry, legal, science, and state government stakeholder  groups generally reported concerns with submission or review of required  data as follows:
Of the 19 respondents in the consumer, environmental, legal,  producer, science, and state government groups, 17 reported  concerns related to registrants not submitting additional required data  on time, including concerns about pesticides that remain in the  marketplace when their environmental and health impacts have not  been fully evaluated. In addition, 3 of the 8 respondents from  consumer groups and state government were generally concerned  that, when registrants are allowed to miss due dates without any  follow-up from EPA, there is little incentive for the registrants to submit  the additional data and take the data requirements seriously. Further,  4 of the 17 respondents from consumer, environmental, legal, and  state government groups reported that EPA should cancel  registrations for those registrants who do not submit required data on  time.
Of the 19 respondents from environmental, industry, legal, and state  government groups, 8 reported concerns about EPA’s record keeping  related to conditional registrations, including the agency’s ability to  ensure the receipt and review of required data. Specifically, one  industry stakeholder stated that EPA does not effectively track the  receipt and review of required data and said, in particular, EPA does  not always acknowledge receipt of required information and does not  always notify recipients whether the data submitted satisfied the  condition. However, 4 of the 5 respondents from industry stated the  public faced little risk when required data are not submitted or  reviewed, pointing out that before EPA conditionally registers a  pesticide, the agency must determine that the pesticide meets FIFRA  registration standards.
Stakeholders representing environmental, industry, and state government  groups generally reported concern with EPA issuing conditional  registrations for circumstances that were outside of the permissible  situations stated in FIFRA. Examples are as follows:
Of the 16 respondents representing these groups, 10 reported  concern that EPA was overusing conditional registrations. Three of  the 5 environmental stakeholders that had these concerns generally  stated that conditional registrations were originally intended to be  used in limited circumstances where a public need was established— such as the need to quickly approve the use of a pesticide to prevent  significant crop damage and economic loss—and that EPA’s current  practices for issuing conditional registrations are not in keeping with  this original intent.
Of the 5 respondents from industry, 3 stated that there are cases  when EPA grants a conditional registration for a pesticide that should  have qualified for an unconditional registration. These stakeholders  reported that, in some of these cases, EPA had granted a conditional  registration for reasons that were outside of those permissible  circumstances outlined in FIFRA, such as the need for labeling  changes and potential data requirements that could be imposed in the  future as a result of the registration review process. Of these three  industry stakeholders, two were aware of EPA’s recent efforts to  ensure that conditional registrations are granted only in appropriate  circumstances, as described on the agency’s website, and these  stakeholders were supportive of these efforts.
In keeping with these concerns, respondents from environmental,  industry, producer, and state government groups generally offered  suggestions for improving EPA’s conditional registration process.  Following are examples:
Of the 16 respondents representing environmental, industry, and state  government groups, 7 generally stated that EPA needs a better  system for tracking the status of conditional registrations, including its  review of required data.
Of the 10 respondents representing industry and state government  groups, 6 stated that it would be helpful if EPA developed a way to  share information about conditional registrations with external  stakeholders. For example, a respondent from a state government  group suggested that EPA create a notification and tracking system  for states that specifically lists the status of conditional registrations  and any pending data requirements. The stakeholder stated that this  system would facilitate the exchange of information between EPA and  the states. Also, a respondent representing an industry group stated  that EPA should develop a system similar to one used by California’s  Department of Pesticide Regulation; the respondent stated that this  system allows registrants to access information on the status of their  pesticide registration applications pending before that state and about  their conditionally registered products.
Of the 5 industry respondents, 2 suggested that EPA address  concerns about overuse of conditional registrations by taking steps to  ensure that these registrations only are used according to the explicit  criteria set forth in FIFRA section 3(c)(7).
section_title: Some Respondents Stated That Conditional Registrations Offer Benefits, and Others Stated That They Pose Serious Risks
paragraphs: Of the 17 respondents representing consumer, industry, legal, producer,  and state government groups, 14 stated that there were significant  benefits in conditionally registering pesticides. They generally noted that  the conditional registration process is an important and effective  mechanism that gives EPA the flexibility to allow pesticides to move to the  market more quickly, and that quicker movement to the market, in turn,  provides users and growers with faster access to the pesticides they  need. For example, one respondent commented that conditional  registrations are especially valuable in situations where users have a  much more limited choice of pesticides that meet their needs, such as  growers of specialty crops. Seven of these 14 respondents also  generally stated that conditional registrations promote innovation by  bringing new technologies and products to the marketplace faster.
In contrast, 13 of the 18 respondents representing consumer,  environmental, legal, science, and state government groups stated that  there were numerous negative impacts caused by conditionally  registering pesticides. For example, all 13 of the respondents concerned  with negative impacts reported that conditionally registering pesticides  can delay EPA’s ability to mitigate public health and environmental  impacts caused by pesticides. These respondents generally stated that  EPA is not conducting a full, rigorous review of conditionally registered  pesticides and therefore is allowing these pesticides into the marketplace  without complete data, such as toxicity tests and studies that demonstrate  the pesticides’ impact on the environment. Eight of these 13 respondents  who expressed concern with conditionally registering a new use of a  pesticide generally noted that, without a full, rigorous review, EPA may  miss problems caused by the new use that may not have occurred with  the original use.in the cases that involve pesticides with new active ingredients, a  conditional registration should only be granted if a critical need for the  pesticide can be demonstrated. Six of the 13 respondents stated that the  risks posed by conditionally registering new active ingredients were so  great that EPA should discontinue this type of conditional registration. In   Four of the 13 respondents also stated that, especially  elaborating on their concerns, 12 of the 18 respondents from consumer,  environmental, legal, science, and state government groups cited  examples of conditionally registered pesticides that, in their opinion,  should not have been conditionally registered. The three pesticide  products mentioned most frequently by these respondents were the  following:  Background: According to EPA documents, in 2003, EPA conditionally  registered the insecticide Clothianidin, which the agency had identified as  an alternative to older, more toxic insecticides. As one of the conditions of  the registration, EPA required the manufacturer, Bayer CropScience, to  submit a study evaluating the effects on honeybees of prolonged  exposure to Clothianidin. In 2007, the agency reviewed this study and  determined that it satisfied EPA’s field study guidelines. However, in 2010  and again in 2012, numerous entities, including consumer and  environmental groups, petitioned EPA to discontinue use of Clothianidin,  charging, among other things, that it posed an imminent hazard to  honeybees. In 2010, EPA decided to reevaluate the study and ultimately  determined that there were some deficiencies in the study but that the  registered uses of Clothianidin met the FIFRA standard for registration.  According to Bayer CropScience, the use of Clothianidin was necessary  to prevent crop damage from pesticide-resistant pests and the dying of  honeybees in 2008, which environmental groups claimed was caused by  Clothianidin, was actually a result of a variety of factors, including  incorrect application of the pesticide.
Stakeholder comments: Half (9 of 18) of the respondents representing  consumer, environmental, legal, science, and state government groups  raised concerns about the insecticide Clothianidin. For example, of the 9  respondents who raised concerns, 6 generally reported that EPA should  not have conditionally registered this pesticide in 2003 without all the data  needed to establish that the pesticide would not significantly increase  unreasonable adverse effects to pollinators, including honeybees. Two of  these 6 respondents reported that the failure to do so has allowed the  widespread use of a pesticide that, in their view, has caused the death of  honeybee colonies and irreparably damaged the environment and  livelihoods of beekeepers. Four of the 6 respondents said that it is  irresponsible for EPA to refuse to discontinue the registration of this  product when the agency eventually determined that the pollinator study  submitted by the company was inadequate.
Background: According to EPA documents, in August 2010, EPA  conditionally registered the active ingredient of the pesticide Imprelis. This  pesticide, manufactured by DuPont, was a low-toxicity herbicide used to  control weeds, vines, and grasses on nonfood use sites, such as weeds  around an office building. EPA stated that the studies originally submitted  for Imprelis were adequate to make a finding for the registration but also  concluded that two additional studies (on toxicity and reproduction) were  required to confirm the conclusions from existing data. However, in the  summer of 2011, EPA received reports from several states that this  pesticide may have caused injury to certain species of evergreen trees,  particularly Norway spruce and white pine. In a June 2011 letter, DuPont  cautioned professional applicators not to use Imperils near certain  species of trees, including Norway spruce and white pine. On August 4,  2011, DuPont voluntarily suspended sales of Imprelis and, on August 11,  2011, EPA issued a stop-sale order directing DuPont to immediately halt  the sale, use, or distribution of Imprelis. According to EPA, it issued this  stop-sale order because it had reason to believe the product was  misbranded and the agency had obtained new information, not available  during the registration process, that showed Imprelis was toxic to certain  trees.  Currently, EPA is evaluating the tree damage to determine what  caused the injuries. DuPont has since started a return and refund  program for Imprelis users.
Stakeholder comments: Of the 7 respondents representing environmental  and science groups, 4 raised concerns about the pesticide Imprelis.  According to 3 of these 4 stakeholders, EPA did not properly consider the  “unreasonable effects on the environment” of this pesticide, specifically  effects on organisms that this pesticide was not intended kill, including  trees. One stakeholder reported that the experience with this pesticide  illustrates what can happen when EPA allows a pesticide product to  proceed to the marketplace without complete information and, in this  stakeholder’s opinion, confirms that the conditional registration process  actually allows EPA to bypass statutory safeguards and rush pesticides  with unknown and unevaluated risks to market.
GAO, Nanotechnology: Nanomaterials Are Widely Used in Commerce, but EPA Faces  Challenges in Regulating Risk, GAO-10-549 (Washington, D.C.: May 25, 2010). appropriate because (1) the company had insufficient time to generate  certain required data, (2) use of the pesticide is in the public interest, and  (3) use of the pesticide during the period needed to generate and review  the required data will not cause unreasonable adverse effects. The  registration of this product is being challenged in a lawsuit by the Natural  Resources Defense Council.
section_title: Conclusions
paragraphs: EPA Office of the Inspector General, EPA Needs to Manage Nanomaterial Risks More  Effectively, Report no. 12-P-0162, Dec. 29, 2011. OPP officials noted that the Office of the  Inspector General advised EPA to develop a better internal process for sharing data  across program offices. According to these officials, EPA has implemented this  recommendation, and an Inspector General official concurred. reviewing applications submitted each year for new or amended  registrations. The pesticide products that the agency registers play a  critical role in food production by helping to minimize crop losses due to  pests and weeds. In addition, pesticide products have helped improve  public health by controlling disease-carrying pests, such as insects and  rodents. At the same time, consumers rely on OPP to ensure that  registered pesticide products do not cause unreasonable adverse effects  on the environment or human health when used according to the label  instructions approved by the agency.
OPP faces challenges in tracking key information specifically related to  conditional registrations, and, as a result, is unable to produce accurate  information on the current number of these registrations. OPP’s lack of a  reliable and comprehensive means of routinely collecting and tracking  information on conditional registrations, including the status of registrants’  submission of required data and OPP’s review of these data, leaves it  without an important management tool. Because OPP is not  systematically tracking whether registrants of conditionally registered  pesticides submitted additional required data, and whether OPP reviewed  these data, it may not be able to identify situations in which the additional  data would suggest the need to alter a registration. Furthermore, without  the ability to systematically track conditional registrations, OPP is not  well-positioned to produce summary data to enable it to easily identify  situations for priority follow-up; enforce FIFRA and its implementing  regulations; and report to Congress and others on program status.
Furthermore, OPP’s use of conditional registrations for actions other than  those that meet the criteria outlined in FIFRA Section 3(c)(7) has created  confusion for its staff, and may leave OPP vulnerable to charges by  environmental, industry, and other stakeholders who assert that it  inappropriately grants conditional registrations. According to OPP officials  and documents, weaknesses in guidance and training, management  oversight, and data management contributed to the misclassification of  other pesticide-related activities as conditional registrations. OPP has  raised the visibility of these issues by holding meetings at least quarterly  with representatives of the OPP divisions that issue pesticide registrations  to discuss any conditional registrations being considered for new active  ingredients to ensure they meet the statutory criteria outlined in FIFRA  Section 3(c)(7) and that the additional information requested is indeed  needed to unconditionally register the pesticide. In addition, OPP has  taken or plans to take other actions to ensure that staff appropriately  grant conditional registrations and registrants submit required data;  however, these are short-term solutions that do not fully address the  problems identified. As OPP officials and stakeholders recognize, OPP  needs a comprehensive automated data system to track conditional  registrations from the time the conditional registration is granted until  additional data requested is received and reviewed. However, OPP  previously stated over 25 years ago that it planned to develop an  automated system for tracking conditional registrations of new active  ingredients, but it did not follow through with this plan. OPP has secured  funding through FIFRA amendments to begin the development of such a  system, but much work remains to be done and will depend on a further  commitment of needed resources.
Moreover, OPP lacks written guidance or a consistent methodology for  how product managers are to maintain their pesticide registration files.  Allowing product managers to use disparate methods to collect and keep  information on the pesticides they are responsible for makes it more  difficult to develop summary information about the status of pesticide  registrations overall, which could be useful information for managing the  pesticide registration program. Also, as the extensive amount of time and  effort needed in OPP’s ongoing review of all registered pesticides  demonstrates, product managers’ current methods are not sufficient to  efficiently track this information. It will take time and money to develop an  automated system for tracking the progress of conditionally registered  pesticides but, in the interim, OPP is further hampered in its efforts to be  informed about the status of conditional registrations because product  managers do not use a consistent system for tracking their status,  including when data are submitted by registrants and reviewed by OPP.  Furthermore, OPP’s reliance on the institutional knowledge of its product  managers and the records they keep is problematic for other reasons,  including the loss of knowledge and experience of these employees as  they retire or are replaced by new employees.
Finally, OPP has also not clearly and concisely communicated the results  of its analyses of conditional registrations on its website. It is important for  agencies to ensure that information placed on their websites is accurate  and free of discrepancies. OPP officials have acknowledged the need to  correct the agency’s website on conditional registrations and remove any  confusing or inaccurate statements.
section_title: Recommendations for Executive Action
paragraphs: To improve EPA’s management of the conditional registration process,  we recommend that the Administrator of EPA direct the Director of the  Office of Pesticide Programs to take the following three actions:
Complete plans to automate data related to conditional registrations to  more readily track the status of these registrations and related  registrant and agency actions and identify potential problems requiring  management attention,
Pending development of an automated data system for tracking the  status of conditional registrations, develop guidance to ensure that  product managers use a uniform methodology to track and document  this information, including when data are submitted by registrants and  reviewed by EPA, in the files maintained by each pesticide product  manager.
Review and correct, as appropriate, OPP’s website on conditional  registrations to ensure that the information presented is clear,  concise, and accurate, including defining technical terms.
section_title: Agency Comments and Our Evaluation
paragraphs: We provided a draft of this report to EPA for review and comment.  In  written comments, which are included in appendix II, EPA agreed with the  report’s recommendations. Regarding the first recommendation, EPA said  that its implementation plan to automate data related to conditional  registrations includes (1) development of new codes for identifying  conditional registration decisions in OPPIN; (2) training its staff on use of  the new categories represented by these new codes, and making the  training available online for guidance; and (3) changes to its databases to  allow staff to check more easily whether there are any outstanding  requests for data on any pesticide active ingredients. EPA also said it  plans to develop a more comprehensive system for tracking conditional  registrations; however, the agency’s ability to do so depends on the  availability of funding and the complexity of incorporating changes in the  databases. Regarding the second recommendation, EPA said it is  developing a standard operating procedure for staff to follow when  entering data into the computerized tracking system about the statutory  basis for registration decisions. According to EPA, this procedure,  together with the new training for staff, should ensure that conditional  registration decisions are properly identified in the OPPIN database going  forward. The agency said it expects to complete the procedure by the end  of calendar year 2013. EPA added that the status of products previously  approved under conditional registration authority is also being reviewed  and updated, as necessary. For the third recommendation, EPA said by  the end of 2013 it will revise its website on conditional registration to both  clarify and update the information presented. In addition, EPA indicated  the website will include an outline of ongoing agency work to strengthen  its conditional pesticide registration program. EPA also provided technical  comments, which we incorporated as appropriate.
As agreed with your office, unless you publicly announce the contents of  this report earlier, we will plan no further distribution until 30 days from the  report date. At that time, we will send copies of this report to the  Administrator of EPA, the appropriate congressional committees, and  other interested parties. In addition, the report will be available at no  charge on the GAO website at http://www.gao.gov.
If you or your staff members have any questions about this report, please  contact me at (202) 512-3841 or gomezj@gao.gov. Contact points for our  Offices of Congressional Relations and Public Affairs may be found on  the last page of this report. GAO staff who made key contributions to this  report are listed in appendix III.
section_title: Appendix I: Objectives, Scope and Methodology
paragraphs: Our objectives were to examine the (1) number of conditional pesticide  registrations the Environmental Protection Agency (EPA) has granted and  the basis for granting these registrations; (2) extent to which EPA ensures  that registrants submit the additional data EPA required as part of  conditional registrations and reviews these data; and (3) views of relevant  stakeholders on EPA’s use of conditional registrations, including ways, if  any, to improve the conditional registration process. To address these  objectives, we reviewed relevant federal statutes and regulations, EPA  program and guidance documents, federal internal control standards,  and previous GAO and EPA Inspector General reports. We also  reviewed EPA’s fiscal year 2011–2015 strategic plan; EPA’s fiscal year  2011 and 2012 annual performance plans; EPA’s budget justification  documents for fiscal years 2012 and 2013; Office of Pesticide Programs’  (OPP) pesticide registration work plans for fiscal years 2001 through  2012; OPP notices of pesticide registration for conditionally registered  pesticides; and Federal Register notices related to OPP’s registration  decisions. In addition, we interviewed OPP officials and reviewed  documentation they provided to obtain further information and clarification  on EPA’s conditional registration process, including any planned  responses to internal review or external stakeholder concerns.  Furthermore, we reviewed recent literature related to pesticide  registration, including information and documents found on the websites  of a variety of consumer, environmental, industry, legal, producer,  science, and state government organizations.
To examine the number of conditional pesticide registrations EPA has  granted and the basis for them, we requested that OPP provide us with  summary data on (1) the number of pesticide registrations currently in  conditional status and how long they have been in this status; (2) the total  number of current pesticide registrations (conditional and unconditional);  and (3) for fiscal years 1997 through 2011, the number of conditional  registrations granted for each year and the basis on which these were  granted. We asked for information for 1997 through 2011 because  reviewing registrations from this period could address the concerns that  environmental and other groups raised that some pesticides may have  been in conditional status for many years and also take into account key  changes made to the pesticide registration and tolerance setting   We intended to assess the reliability  processes that occurred after 1996.of the data that we requested from EPA and conduct electronic testing on  data fields necessary for our analysis; however, after interviewing OPP  officials and reviewing past GAO, Inspector General, and EPA contractor  studies examining OPP’s data management, especially its use of the  Office of Pesticide Programs Information Network (OPPIN), we concluded  that EPA could not provide us with sufficiently reliable data for obtaining  summary level information on conditional pesticide registrations. In the  absence of these data, we discussed with OPP officials the capabilities  and limitations of OPPIN and any potential work-arounds they employ or  are planning for. In addition, we reviewed and discussed with these  officials a recent analysis of OPPIN data that OPP conducted to  determine how many of the conditional registrations granted were outside  of the permissible circumstances outlined in the Federal Insecticide,  Fungicide, and Rodenticide Act (FIFRA). The results of this analysis were  included in an OPP internal review report and posted on OPP’s website.
To address the second objective—the extent to which EPA ensures that  registrants submit the additional data required as part of conditional  registrations and reviews these data—we interviewed OPP officials about  how they manage conditional registration data requirements. We also  asked OPP to provide information on the number of pesticides that (1)  have a conditional registration, but the registrant has not submitted the  additional required data by the specified due date; (2) have a conditional  registration and the registrant has submitted the additional required data,  but EPA has not reviewed these data; (3) still have a conditional  registration, even though the registrant has submitted, and EPA has  reviewed, the additional required data; and (4) had been changed from  conditional to unconditional status. However, OPP officials said they  could not provide these data because they do not have an automated  data system that tracks this information, but that they did analyze a  subset of 544 conditional registrations to try to determine whether  registrants had submitted the required data and posted the results of this  analysis on OPP’s website.
To obtain the views of relevant stakeholders on EPA’s conditional  registration process and ways, if any to improve it, we administered a  questionnaire to 35 professionals in the consumer, environmental,  industry, legal, producer, science, and state government fields. We used  a multistage process to identify our final nonprobability sample of 35  potential respondents. This process included (1) conducting a literature  search to identify groups or individuals who had recently published  articles on registration (including conditional registration) of pesticides, (2)  asking agency and other relevant officials for recommendations of  knowledgeable parties in each of these areas, and (3) asking prospective  stakeholders for suggestions of other potential stakeholders. Through  these methods, we arrived at an initial list of 148 potential stakeholders  that were divided, based on their institutional affiliation, into the seven  categories listed above. We then narrowed this list by (1) performing  online searches of the professional affiliations of each stakeholder to  determine whether they would likely have sufficient knowledge about  EPA’s conditional registration of pesticides and (2) conducting screening  interviews, by phone and e-mail, to determine whether the individuals  were sufficiently familiar with EPA’s process for registering pesticides and  to secure their commitment to participate in our survey. After this process  was completed, we arrived at a list of 35 stakeholders to whom we sent,  via e-mail, our questionnaire.
The questionnaire asked about, among other things, (1) problems, if any,  associated with each of the permissible situations for which registrations  can be conditionally granted; (2) risks, if any, associated with registrants  not submitting data required by a conditional registration in a timely  manner; (3) pesticides with conditional registrations that stakeholders  believe should not have been conditionally registered; and (4)  suggestions for improving EPA’s conditional registration process. In  preparing to administer this questionnaire, we conducted three pretests to  ensure that the questions were clear, terminology was used appropriately,  and the questionnaire was unbiased. We used the results of our pretests  to revise the questions as needed. The questions were open-ended, and  thus issues raised by stakeholders had to be “volunteered.” We did not  ask each stakeholder to agree or disagree with particular issues.
The administration period for this questionnaire was from July through  September 2012. Of the 35 participating stakeholders, 24 provided  complete, valid questionnaire responses. The organizations that  participated as stakeholders were Akin Gump, LLP; American Chemistry  Council; American Farm Bureau Federation; Beyond Pesticides;  California Department of Pesticide Regulation; Center for Biological  Diversity; Center for Environmental Health; Center for Food Safety;  Center for Science in the Public Interest; Council of Producers and  Distributors of Agrotechnology; CropLife America; Dow Agrosciences,  LLC; Earthjustice; Environmental Working Group; Food and Water Watch;  Florida Department of Agriculture and Consumer Services; Iowa  Department of Agriculture; McDermott, Will and Emery, LLP; Natural  Resources Defense Council; New York State Department of  Environmental Conservation; Pesticide Action Network North America;  Syngenta Crop Protection, LLC; Texas Department of Agriculture; and  The Endocrine Disruption Exchange. The results of this questionnaire  cannot be generalized to all parties knowledgeable about the conditional  registration of pesticides; rather our analysis of the results of this  questionnaire identifies common themes present in the responses of  those who participated in our questionnaire.
We analyzed stakeholder responses to the questionnaire to identify  themes and develop summary findings. Two GAO analysts separately  conducted this analysis and placed users’ responses into one or more  categories, then compared these analyses. All initial disagreements  regarding the categorizations of stakeholders’ responses were discussed  and reconciled. The analysts then tallied the number of responses in each  category.
We conducted this performance audit from September 2011 to August  2013 in accordance with generally accepted government auditing  standards. Those standards require that we plan and perform the audit to  obtain sufficient, appropriate evidence to provide a reasonable basis for  our findings and conclusions based on our audit objectives. We believe  that the evidence obtained provides a reasonable basis for our findings  and conclusions based on our audit objectives.
section_title: Appendix II: Comments from the Environmental Protection Agency
section_title: Appendix III: GAO Contact and Staff Acknowledgments
subsections: section_title: GAO Contact
section_title: Staff Acknowledgments
paragraphs: In addition to the individual named above, James R. Jones, Jr., Assistant  Director; Jameal Addison; Kevin Bray; Kirsten B. Lauber; Robin Marion;  Lisa Shames; Carol Herrnstadt Shulman; Kathryn Smith; and Lisa Turner  made key contributions to this report. Colleen M. Candrl, Joyce Evans,  Dan Royer, and Kiki Theodoropoulos also made important contributions  to this report.
section_title: Related GAO Products
paragraphs: Nanotechnology: Improved Performance Information Needed for  Environmental, Health, and Safety Research. GAO-12-427. Washington,  D.C.: May 21, 2012.
Agricultural Chemicals: USDA Could Enhance Pesticide and Fertilizer  Usage Data, Improve Outreach, and Better Leverage Resources.   GAO-11-37. Washington, D.C.: November 4, 2010.
Pesticides on Tobacco: Federal Activities to Assess Risks and Monitor  Residues. GAO-03-485. Washington, D.C.: March 26, 2003.
Agricultural Pesticides: Management Improvements Needed to Further  Promote Integrated Pest Management. GAO-01-815. Washington, D.C.:  August 17, 2001.
Children and Pesticides: New Approach to Considering Risk is Partly in  Place. GAO/HEHS-00-175. Washington, D.C.: September 11, 2000.
Pesticides: Improvements Needed to Ensure the Safety of Farmworkers  and Their Children. GAO/RCED-00-40. Washington, D.C.: March 14,  2000.
GAO Products Related to Pesticide Regulation. GAO/RCED-95-272R.  Washington, D.C.: September 26, 1995.
Pesticides: Information Systems Improvements Essential for EPA’s  Reregistration Efforts. GAO/IMTEC-93-5. Washington, D.C.: November  23, 1992.
Pesticides: EPA’s Information Systems Provide Inadequate Support for  Reregistration. GAO/T-IMTEC-92-3. Washington, D.C.: October 30, 1991.
Pesticides: EPA’s Formidable Task to Assess and Regulate Their Risks.  GAO/RCED-86-125. Washington, D.C.: April 18, 1986.
Natural Resources and Environment: Delays and Unresolved Issues  Plague New Pesticide Protection Programs. GAO/CED-80-32.  Washington, D.C.: February 15, 1980.