-. .•• •, . -s- -^> • •-• .«-' *' '-•.<• » ' •; •i.i'11 ' -a . ; • *•, -.-. .i -'* .tffsf- •; '- •«.-*. • ..... ••- .,••.-.'-,> * • - . . '^x*- S«^iv'i;J:J^%^^^ ,"-' '•.^?*?-£i''#r*-:*'&&*ji!i&f : •*.•. SEPTEMBER 30, 1992 ... -*T. ^-'d^ft^-f^rjKrrW- 'S'-rlf ; :^r • ; ------- ------- •;v#r Z&jl' 3Ssf®^-*-i:};'. •-• ••&.±.&ifc£&*!*:#- ••'•' " •" -T-'''' . ''"'"''' "" * * ' * ' "' *" "' l*"'' '" Inspector General Division Conducting the Audit: Northern Audit Division Program Offices Involved: Pesticides ^nd Toxic _ ------- ------- UNITED STATES ENVIRONMENTAL PROTECTION AGENCY WASHINGTON, D.C. 20460 SEP 30 1992 OFFICE OF THE INSPECTOR GENERAL KEMORANDUM SUBJECT: Audit Report No. E1EPF1-05-0429-2100613 Labeling of Pesticides FROM: TO: /,Kenneth A. Konz if'Assistant Inspec General for Audit Linda J. Fisher Assistant Administrator for Prevention, Pesticides and Toxic Substances Attached is a copy of the subject report. This report provides important findings and corrective actions regarding the labeling of pesticides. This audit report contains findings that describe problems th<3 Office of Inspector General (OIG) has identified and corrective actions the Agency has agreed to take. This audit report represents the opinion of the OIG. Final determinations on matters in this audit report vill be made by EPA managers in accordance with established EPA audit resolution procedures. Accordingly, the findings described in the audit report do not necessarily represent the final EPA position. ACTION REQUIRED In responding to the draft report, your office provided action plans and milestone dates for correcting the findings. As a result, your response to the report is adequate in accordance with EPA Order 2750. Therefore, we are closing out this report in our tracking system, effective September 30, 1992. Please track all action plans and milestone dates in the Management Audit Tracking System. We have no objections to the further release of this report to t/ie public. i o Cvj s HEADQUARTERS ENViWWENTAL PROTECTION AGF.NCY WASHINGTON, D.C. 20460 ------- Should you or your staff have any questions or need additional information, please contact Anthony C. Carrollo, Divisional Inspector General, Northern Audit Division on (312) 353-2503. Attachment cc: Douglas D. Campt, Director Office of Pesticide Programs (H7501C) Michael M. Stahl, Director Office of Compliance Monitoring (EN-342) Joyce Hay, Audit Liaison (TS-788) Anthony C. Carrollo, DIGA-NAD ------- Labeling of Pesticides EXECUTIVE SUMMARY PURPOSE The Office of Inspector General has completed an audit of the U.S. Environmental Protection Agency's (EPA) process for reviewing and approving pesticide labels. We decided to perform this audit because the label provides the user with important information on how to safely use pesticides. Our specific objectives were to determine whether: o EPA's process for reviewing and accepting pesticide labeling is adequate to protect human health and the environment, and o EPA uses the information obtained from pesticide incident reports to protect against further pesticide problems. BACKGROUND Pesticides are poisons that are designed to kill or repel c.nimals, plants, or bacteria that are considered to be pests. However, some pesticides can have unintended effects on people, pets, wildlife and the environment. Most pesticide accidents result from careless use or lack of knowledge about proper handling of pesticides. The pesticide label plays a critical role in providing the user with information on how to use the pesticide safely. Before EPA registers a pesticide, EPA must determine that (1) the label complies with the requirements of the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA), and (2) the pesticide will not cause unreasonable adverse effects on the environment. The decision to register a pesticide is based on EPA's evaluation of the test data that registrants provide. Testing is needed to determine whether a pesticide has the potential to cause adverse effects on humans, wildlife, fish and plants. The* precautionary statements are one of the most important parts of the pesticide label. Precautionary statements include human hazard signal words, child hazard warning, statement of practical treatment, statement of hazards to humans and domestic animals, environmental hazard statements, Report NO. E1EPF1-05-0429-2100613 ------- Labeling of Pesticides and physical and chemical hazard statements. EPA determines what statements the registrant needs to include on the pesticide label based on the registrant's test data. RESULTS-IN-BRIEF EPA cannot provide the public with assurance that precautionary statements on many pesticide labels are adequate to protect humans and the environment from unreasonable adverse effects. The Office of Pesticide Program's (OPP) process for reviewing and accepting pesticide labels did not include verifying that toxicity studies existed prior to accepting pesticide labels. In many cases, the toxicity studies would not have been available even if OPP had attempted to use them. Due to certain provisions of FIFRA, pesticides were registered without requiring a complete set of toxicity studies. OPP officials stated that this problem will be corrected during its pesticide reregistration process. However, reregistration is not expected to be completed until the year 2002. The precautionary statements on many pesticide labels may not be adequate to protect the user and the environment. Almost half the pesticide labels evaluated had missing or inaccurate precautionary statements. Other pesticides were missing statements restricting usage of the pesticide to certified applicators. OPP placed little importance on the information in the incident reports that it received. However, the incident reports contained important information on the consequences of pesticide use. Incident reports include information on human and animal deaths and adverse reactions to pesticides. OPP was not analyzing the incident reports to identify additional restrictions which may be needed to protect users and the environment from adverse effects of pesticides. ii Report No. E1EPF1-05-0429-2100613 ------- Labeling of Pesticides PRINCIPAL FINDINGS EPA Missing Toxicity Studies To Support Precautionary Label Statements EPA did not have either the toxicity studies, or the documentation of its review of those studies, to assure that correct precautionary statements were printed on many pesticide labels. This occurred because the (1) conditional registration provisions of FIFRA allowed the registration of substantially similar pesticides without a complete set of toxicity studies, and (2) reregistration process was not completed. Because of this, product managers were not expected to verify whether toxicity studies were available to support individual registrations. As a result, there was little assurance that pesticide labels contained correct warning and practical treatment statements. FIFRA requires EPA to determine whether individual pesticides can be used without causing unreasonable adverse effects on the environment. Without toxicity studies, OPP's ability to fulfill its obligation to protect against adverse effects of pesticides is diminished. Toxicity studies were unavailable for 58 of 95 pesticides reviewed. For 33 pesticides, the toxicity studies could not be located, but may exist. In other cases, the pesticides, or similar pesticides, were registered before EPA required a fall set of toxicity studies. According to OPP officials, the missing studies will be obtained during reregistration. EPA Accepted Labels With Inaccurate Precautionary Statements Precautionary stacements for many pesticide products we reviewed did not meet regulatory requirements. This occurred because the OPP did not have procedures to be sure product managers were consistent in their reviews of pesticide labels. As a result, the labeling statements on pesticides may not adequately protect humans and the environment from unnecessary adverse effects. pesticide labels reviewed were missing various statements. For almost half the labels evaluated, there were precautionary stat«jments which were missing or inaccurate. For example, several pesticides were missing the statement "Harmful if absorbed through skin." Another pesticide was missing a statement, of practical treatment for eye irritation. Two labels reviewed were missing restricted use Report NO. E1EPF1-05-0429-2100613 ------- Labeling of Pesticides statements. Also, some label statements did not meet the labeling instructions in registration standards. Registrants Did Not Submit Final Printed Labels EPA did not have complete copies of final printed labels for many pesticides. This occurred because OPP did not regularly follow-up on whether registrants submitted final printed labels. Without the registrants submitting final printed labels, OPP had little assurance that the registrant had made the required changes to the label. Also, enforcement personnel need an accurate copy of the accepted label to use during inspections to determine whether pesticide products are properly labeled. OPP relied upon the registrant to make requested changes to the labels and to submit a copy of the final printed label before distributing the pesticide. We found cases where registrants did not make changes OPP requested. In one case, OPP accepted a draft label after the registrant did not (1) make previously requested changes and (2) submit a final printed label. In another case, the registrant submitted a label to the state which did not include OPP requested changes. The label was missing the statement "Causes irreversible eye damage." EPA Needs To Make Better Use Of Information In Incident Reports OPP needs to follow-up on significant incidents involving a pesticide or after a series of incidents indicates a pesticide is adversely affecting the environment. However, OPP was not collecting or analyzing pesticide incident reports. This occurred because, until recently, OPP placed little importance on the information contained in incident reports. As a result, OPP may not have been aware of pesticides for which registrants need to take additional action, such as changing label precautions or directions, to protect the environment. In July 1992, OPP completed a system for tracking and analyzing incident reports which may correct many of the deficiencies that we found. At the time of our fieldwork, OPP did not (1) centrally collect, (2) organize, or (3) follow-up on incident reports it received. However, the incident reports contained important information on the consequences of pesticide use. For example, of 50 incident reports reviewed, 5 described iv Report MO. E1EPF1-05-0429-2100613 ------- Labeling of Pesticides deaths to adults. OPP also infrequently used information on incident reports it could obtain from a contractor. It was only after 200 incidents in one year, including 26 animal deaths, that OPP required the registrant to make label changes to a flea and tick pesticide. AGENCY ACTIONS AND COMMENTS The Assistant Administrator stated that this audit was quite important since labeling is one of the critical functions in pesticide regulation. She agreed to improvements in both labeling and incident information that will address our concerns. The Agency is already implementing, or planning to implement, a number of improvements to strengthen the labeling program. For example, OPP: o is organizing all new toxicity studies it receives in such a way that the studies which support specific registrations can be identified; o will prepare a guide for product managers to use during label reviews; o will reinstitute selective audits of final printed labels and has requested additional funding to facilitate making the accepted labels available to enforcement personnel; and o has completed a system for tracking and analyzing incident reports. Ihe Assistant Administrator stated that an essential element in evaluating the Agency's data and labeling programs is an accurate characterization of the factors contributing to the problems with labeling. She believes that the difficulty the report identifies, in reconciling the Agency's labeling decisions with supporting toxicity studies, is an undesirable, but predictable consequence of the conditional registration, data compensation and reregistration programs established by Congress. The Assistant Administrator stated that without adequate funding of the reregistration program, the acquisition of the needed data and labeling decisions will be delayed beyond the projected completion date of 2002. v Report No. E1EPF1-05-0429-2100613 ------- Labeling of Pesticides PIG EVALUATION While preparing our report, we met several times with OPP on the conditional registration and reregistration provisions of FIFRA. We incorporated the effect these provisions have had upon the labeling program to the extent we considered appropriate. We agree with the Assistant Administrator that these FIFRA provisions have impacted OPP's process for reviewing and accepting labels. While we recognize these constraints, additional causes, as described in our report, also exist. Notwithstanding these differences, we are in substantial agreement regarding corrective actions. As discussed at the end of each chapter, the Assistant Administrator has proposed actions that, when implemented, will substantially resolve our concerns. vi Report NO. E1EPF1-05-0429-2100613 ------- Labeling of Pesticides TABLE OF CONTENTS EXECUTIVE SUMMARY i CHAPTERS 1 INTRODUCTION 1 PURPOSE 1 BACKGROUND 1 SCOPE AND METHODOLOGY 5 PRIOR AUDIT COVERAGE 8 2 EPA MISSING TOXICITY STUDIES TO SUPPORT PRECAUTIONARY LABEL STATEMENTS 9 EPA BASES PRECAUTIONARY STATEMENTS ON TOXICITY STUDIES 10 TOXICITY STUDIES WERE NOT LOCATED OR OPP'S REVIEW NOT DOCUMENTED 10 PRODUCTS REGISTERED WITHOUT TOXICITY STUDIES ... 14 TOXICITY STUDIES WERE FOR A DIFFERENT PRODUCT FORMULATION 14 CONCLUSION 15 AGENCY COMMENTS AND ACTIONS 16 OIG EVALUATION 17 3 EPA ACCEPTED LABELS WITH INACCURATE PRECAUTIONARY STATEMENTS 19 LABELING REGULATIONS REQUIRE PRECAUTIONARY STATEMENTS 19 PRECAUTIONARY STATEMENTS WERE INADEQUATE 20 RESTRICTED USE STATEMENTS MISSING FROM PESTICIDE LABELS 23 vii Report MO. E1EPF1-05-0429-2100613 ------- Labeling of Pesticides TABLE OF CONTENTS (continued^ LABELING CHANGES IN REGISTRATION STANDARDS NOT ENFORCED 24 ADDITIONAL OPP CONCERNS 26 CONCLUSION 27 AGENCY COMMENTS AND ACTIONS 27 OIG EVALUATION 28 4 REGISTRANTS DID NOT SUBMIT FINAL PRINTED LABELS . . 31 REGISTRANTS REQUIRED TO SUBMIT A COMPLETE COPY OF LABELS 31 REGISTRANTS OFTEN DID NOT SUBMIT FINAL PRINTED LABELS 32 ENFORCEMENT PERSONNEL NEED ACCURATE COPIES OF ACCEPTED LABELS 35 CONCLUSION 37 AGENCY COMMENTS AND ACTIONS 37 OIG EVALUATION 38 5 EPA NEEDS TO MAKE BETTER USE OF INFORMATION IN INCIDENT REPORTS 39 INCIDENT REPORTS CONTAIN VALUABLE INFORMATION . . 39 OPP'S HANDLING OF INCIDENT REPORTS IT RECEIVED WAS NOT ADEQUATE 41 OPP INFREQUENTLY USED VALUABLE INFORMATION ON PESTICIDE INCIDENTS 45 CONCLUSION 47 AGENCY COMMENTS AND ACTIONS 47 OIG EVALUATION 48 viii Report NO. E1EPP1-05-0429-2100613 ------- Labeling of Pesticides TABLE OF CONTENTS (continued1 EXHIBIT EXHIBIT 1 PESTICIDE INCIDENT REPORTS REVIEWED .... 49 APPENDIX APPENDIX 1 ASSISTANT ADMINISTRATOR FOR PREVENTION PESTICIDES AND TOXIC SUBSTANCES RESPONSE TO THE DRAFT REPORT 51 APPENDIX 2 ABBREVIATIONS 63 APPENDIX 3 DISTRIBUTION 64 IX Report NO. E1EPF1-05-0429-2100613 ------- Labeling of Pesticides [This page was intentionally left blank.] x Report HO. E1EPF1-05-0429-2100613 ------- Labeling of Pesticides CHAPTER 1 INTRODUCTION PURPOSE The Office of Inspector General has completed an audit of EPA's process for reviewing and approving pesticide labels. We decided to perform this audit because the label provides the user with important information on how to safely use pesticides. Our specific objectives were to determine whether: o EPA's process for reviewing and accepting pesticide labeling is adequate to protect human health and the environment, and o EPA uses the information obtained from pesticide incident reports to protect against further pesticide problems. BACKGROUND Pesticides are chemical or biological substances used to control unwanted plants, insects, fungi, rodents, or bacteria. Pesticide use has contributed to increased agricultural prodxiction and improved public health through control of disease-carrying pests. However, acute and chronic human health and environmental risks also can be associated with the use of many of these chemicals. In determining whether to permit the marketing of a pesticide and how to regulate its use, EPA balances such potential risks against the benefits that may be derived from use of the chemical. The goal of EPA's Pesticide Program is to protect human health and the environment from unreasonable adverse effects of pesticides. FIFRA authorized EPA to regulate pesticides and their uses. FIFRA states that EPA can register a pesticide after EPA dettjrmines that: o the pesticide's; label, and other material required to be submitted, comply with the requirements of FIFRA; Report NO. E1EPF1-05-0429-2100613 ------- Labeling of Pesticides o the pesticide will perform its intended function without unreasonable adverse effects on the environment; and o when used in accordance with widespread and commonly recognized practice, the pesticide will not generally cause unreasonable adverse effects. The decision to register a pesticide is based on EPA's evaluation of the test data that registrants provide. Tests are performed to determine whether a pesticide has the potential to cause adverse effects on humans, wildlife, fish and plants. Potential human risks are identified by using results of laboratory tests. Human risks include acute toxic reactions, such as poisoning and skin and eye irritation, as well as possible long term effects like cancer, birth defects, and reproductive disorders. Test data on how a pesticide behaves in the environment are required so that EPA can determine, among other things, whether a pesticide poses a threat to ground or surface water. EPA defines a pesticide product to be misbranded if it does not include the following information on the label: (1) ingredient statement, (2) name, brand or trademark, (3) precautionary statements, (4) directions for use, (5) name and address of the manufacturer, (6) net contents, (7) EPA registration number, (8) EPA establishment number, and (9) use classification. The precautionary statements are one of the most important parts of the pesticide label. Precautionary statements include human hazard signal words, child hazard warning, statement of practical treatment, statement of hazards to humans and domestic animals, environmental hazard statements, and physical and chemical hazard statements. EPA determines what statements the registrant needs to include on the pesticide label based the registrant's test data. The human hazard signal words indicate the level of the product's toxicity. Report No. E1EPF1-05-0429-2100613 ------- Labeling of Pesticides Figure 1: Example of a Pesticide Label PRECAUTIONARY STATEMENTS HAZARDS TO HUMANS t DOMESTIC ANIMALS CAUTION ENVIRONMENTAL HAZARDS PHYSICAL OR CHEMICAL HAZARDS DIRjJCTIONS FOR USE It ii ii violation of Federal liw to UK thii product in a tnann;r inconiittem with in labeling. RE-EHTRY STATEMENT (IF APPLICABLE) CROP: CROP: CROP: PRODUCT NAME ACTIVE INGREDIENT: * INERT INGREDIENT: % TOTAL: 100 % KEEP OUT OF REACH OF CHILDREN CAUTION STATEMENT OF PRACTICAL TREATMENT IF SWALLOWED IF INHALED IF ON SKIN IF IN EYES SEE SIDE PANEL FOR ADDITIONAL PRECAUTIONARY STATEMENTS CROP: CROP: CROP: CROP: STORAGE AND DISPOSAL STORAGE DISPOSAL WARRANTY STATEMENT MFGBY TOWN, STATE ESTABLISHMENT NO. EPA REGISTRATION NO. NET CONTENT Report NO. E1EPF1-05-0429-2100613 ------- Labeling of Pesticides Figure 2: Product Toxicity Signal Word Level of Product Toxicity Danger Extremely toxic or corrosive. A taste to a teaspoon taken by mouth could kill an average-sized adult. Warning Moderately toxic or irritating. A teaspoon to an ounce taken by mouth could kill an averaged-sized adult. Caution Minimally toxic or mildly irritating. An ounce or more taken by mouth could kill an averaged-size adult. The 1972 FIFRA amendments provided EPA with new authority over the use of pesticides. EPA's enforcement of pesticide usage is based primarily on the pesticide label. The 1972 amendments made it a violation of the law to use a product in a manner inconsistent with the label. It is also a violation of FIFRA to distribute a pesticide that is misbranded, meaning that it does not include the nine statements mentioned above. Pesticide Program History With the 1972 amendments to FIFRA, Congress mandated that EPA assess the safety of all previously registered products. Prior to this, pesticides had been registered using less stringent scientific testing requirements. This comprehensive reevaluation of pesticide safety in light of modern standards was critical to protecting health and the environment, and to maintaining public confidence in our food supply. In 1980, EPA began a registration standard process. The registration standard summarizes the Agency's evaluation of the available data on an existing active ingredient, and identified and required submission of additional data. The registration standard also set forth the conditions a registrant had to meet in order for EPA to reregister pesticide products containing the active ingredient. These conditions included modifications to registrations and labels. Report No. E1EPF1-05-0429-2100613 ------- Labeling of Pesticides By the late 1980's, it became increasingly apparent that, under the registration standards program, EPA would not be able to complete reregistation of existing pesticides as quickly as Congress originally envisioned. At the pace of issuing 25 registration standards per year, reregistration could not have been completed until about 2000. Growing public concern about how long it would take to reassess existing pesticides spurred Congress to act in 1988 to substantially change EPA's approach. The reregistration provisions of the 1988 amendments established mandatory timeframes and duties for reregistration of pesticides. EPA was required to review for reregistration each product containing any active ingredient registered before November 1, 1984. If EPA would have met all the deadlines Congress established, reregistration would have been completed by 1997. EPA currently estimates completing reregistation around the year 2002. To ensure the equitable treatment of new pesticides which were substantially similar to products which were part of reregistration, in 1978 Congress allowed conditional registration. FIFRA Section 3(c)(7) states that EPA may conditionally register a pesticide if it determines that (1) the pesticide and its proposed use are identical or substantially similar to any currently registered pesticide, and (2) approval of the registration will not significantly increase the risk of any unreasonable adverse effect on the environment. In addition, FIFRA Section 3(c)(l)(F) allows registrants to, instead of performing tests on a pesticide, roly on previously submitted data or public literature to support the product registration. These two sections of FIFRA contributed to the findings discussed in Chapter 2. SCOPE AND METHODOLOGY Our first objective was to determine whether EPA's process for reviewing and accepting pesticide labeling was adequate to protect human health and the environment. To accomplish th:.s objective, we reviewed the FIFRA law and OPP's regulations, policies, and procedures for registering pesticides and the review and approval of pesticide labels. We also discussed with OPP Headquarters officials in Washington, DC, the process for reviewing and accepting pesticide labels. 5 Report No. E1EPF1-05-0429-2100613 ------- Labeling of Pesticides To determine whether OPP was following its policies and procedures when reviewing labels, we randomly selected a sample of 100 active pesticide registrations. To select our sample, we obtained a list of pesticide active ingredients from the Pesticide Product Information System (PPIS), dated December 10, 1991. We randomly selected 20 active ingredients. At the request of program management, to distribute the active ingredients selected among OPP's 14 product managers, we agreed to replace two active ingredients originally selected. We obtained a listing from PPIS, dated December 18, 1991, of the active registrations which contained the 20 active ingredients. For each of the 20 active ingredients, we selected 5 registrations, for a total of 100 registrations.1 We did not perform any tests of the controls over the PPIS database. For each of the 100 registrations, we reviewed pesticide registration and toxicity study files to determine whether OPP was following its policies and procedures when reviewing pesticide labels. We limited our review to the following label statements: warning, human hazard precautionary, environmental hazard precautionary, practical treatment, flammability, restricted use, worker protection, and storage and disposal. We performed a cursory review of the rest of the label to verify that all statements were included on the label, but did not evaluate the adequacy of these statements. As criteria for our review, we used the current labeling regulation (40 Code of Federal Regulations (CFR) 156) and applicable pesticide regulation (PR) notices in effect at the time the label was accepted. To verify our results, we discussed them with the responsible OPP product manager. In many cases we also provided the product managers with written questions concerning the pesticide labels. Our second objective was to determine whether EPA uses the information from pesticide incident reports to protect against further pesticide problems. To accomplish this objective, we discussed with OPP's pesticide incident response officer, product managers, and regional personnel their process for receiving, filing and following-up on pesticide incident reports. We reviewed a sample of 50 'We deleted five registrations from our sample, all including the same active ingredient, because EPA was canceling the registrations for each of the products. We did not replace the five registrations. 6 Report NO. E1EPF1-05-0429-2100613 ------- Labeling of Pesticides incident reports EPA received between January 1989 and December 1991. Because the incident reports were not organized (see Chapter 5), we could not (1) determine the universe of incident reports received during the time period or (2) select & random sample. We also visited an EPA contractor in Texas, who operates the National Pesticide Telecommunications Network (NPTN), and discussed its procedures for providing information to callers concerning pesticides, and collecting information on pesticide incidents. We discussed our audit methodology with OPP management. Subsequent to the entrance conference on November 19, 1991, we met with program management three tinges to discuss our audit methodology: November 21, 1991; December 11, 1991; and January 14, 1992. We distributed position papers to OPP and "he Office of Compliance Monitoring (OCM) management on June ;J6 and July 29, 1992. The position papers included the registration numbers of all products referred to in the report. We discussed the position papers with OPP and OCM on July 30 and August 10 and 12, 1992. We also received written, unsigned, comments from OPP on August 5, 1992. The comments were included in the report. On August 19, 1992, we issued our draft report. We held an e:cit conference with the Assistant Administrator for Prevention, Pesticides and Toxic Substances on September 25, IS'92. The Assistant Administrator responded to our draft report on September 29, 1992. After reviewing the response and conducting th«i exit conference, we made appropriate changes and finalized our report. The Assistant Administrator's response is included as Appendix 1. Our draft report contained recommendations to address the issues in each finding. The Assistant Administrator's response proposed acceptable corrective actions. As a result, the final report does not contain additional recommendations. We performed our audit in accordance with the Government Auditing Standards issued by the Comptroller General of the United States (1988 revision). Our fieldwork was conducted from December 2, 1991 to August 3, 1992. We reviewed OPP's internal controls over the approval of pesticide labels and evaluation of incident reports. We also reviewed OPP's fiscal year 1990 and 1991 annual reports on internal controls. These reports did not identify any weaknesses in the internal controls over pesticide labeling. 7 Report No. E1EPF1-05-0429-2100613 ------- Labeling of Pesticides PRIOR AUDIT COVERAGE There were no previous audits of pesticide labeling which applied to our audit objectives. 8 Report MO. E1EPF1-05-0429-2100613 ------- Labeling of Pesticides CHAPTER 2 EPA MISSING TOXICITY STUDIES TO SUPPORT PRECAUTIONARY LABEL STATEMENTS EPA did not have either the toxicity studies, or the documentation of its review of those studies, to assure that correct precautionary statements were printed on many pesticide labels. This occurred because the (l) conditional registration provisions of FIFRA allowed the registration of substantially similar pesticides without a complete set of toxicity studies, and (2) reregistration process was not completed. Because of this, product managers were not expected to verify whether toxicity studies were available to support individual registrations. As a result, there was j.ittle assurance that pesticide labels contained correct warning and practical treatment statements. FIFRA requires EPA to determine whether individual pesticides can be used without causing unreasonable adverse effects on the environment. Without toxicity studies, OPP's ability to fulfill its obligation to protect against adverse effects of pesticides is diminished. Tcxicity studies were unavailable for 58 of 95 pesticides reviewed. Some studies were not available because, the pesticides, or similar pesticides, were registered before EPA required a full set of toxicity studies. According to OPP officials, the missing studies will be obtained during reregistration. Figure 3: Toxicitv Studies Not Available Products for which toxicity studies were not found, but may exist 33 Products for which toxicity studies were found, but not OPP's review 6 Products for which toxicity studies do not exist 14 Toxicity studies were for a different formulation 5 Total 58 Report NO. E1EPF1-05-0429-2100613 ------- Labeling of Pesticides EPA BASES PRECAUTIONARY STATEMENTS ON TOXICITYSTUDIES OPP determines the precautionary statements required on pesticide labels based on toxicity studies. FIFRA requires registrants to submit, or cite references to, these studies along with their application for registration. OPP uses the results of five acute toxicity studies (oral, skin absorption, skin irritation, inhalation, and eye) to determine the precautionary statements needed on pesticide labels. OPP's Precautionary Review Section, at the product manager's request, interprets the study results, placing pesticides in one of four toxicity categories for each of the five test areas. The product manager uses this review as the basis for accepting pesticide labels. For each toxicity category, labeling regulations2 outline the required precautionary statements which must appear on the pesticide label. OPP bases the signal word on the highest toxicity category assigned, as shown in Figure 4. Figure 4: Pesticide Label Signal Words i Toxicity Category 2 3 4 Word Danger Warning Caution Caution (a) Categories are listed from highest to lowest toxicity. TOXICITY STUDIES WERE NOT LOCATED OR OPP'S REVIEW NOT DOCUMENTED OPP personnel were unable to locate the toxicity studies, or their review of the toxicity studies, for over one-third of the labels reviewed, as shown in Figure 5. Without toxicity studies, we were unable to verify the accuracy of the precautionary statements on the pesticide labels. 240 CFR 156 "Labeling Requirements for Pesticides and Devices". 10 Report No, E1EPF1-05-0429-2100613 ------- Labeling of Pesticides Figure 5: Toxicitv StudiesNot Located Or Reviewed Toxicity studies not located, but may exist 33 Reviews of toxicity studies not found 6 Total ^9 Toxicity Studies Not Located Product managers did not ensure that registrants submitted toxicity studies before accepting pesticide labels. We were unable to locat«i the toxicity studies for 33 of 95 labels. In some cases, EPA may not have the toxicity studies and is requiring registrants to submit them during reregistration. In other cases, this occurred because the product managers did not verify that there were toxicity studies to support the referenced product. In still other cases, the registrant may have submitted the studies, but product managers did not record a coding system number in the file, and thus could no longer match the registration to the study. As a result, we could not verify, and OPP has little assurance, that one- third of the pesticide labels reviewed contained adequate pirecautionary statements. F1FRA allows registrants to rely upon the toxicity studies other registrants submit. To do this, the product must be identical or substantially similar to another registered pesticide. OPP refers to this as a "me-too" registration. If OPP determines that, based on the product chemistry, the pesticide is identical or substantially similar to another registered pesticide, OPP can register the product without requiring a complete set of toxicity studies. When a registrant claimed to have a substantially similar product, product managers relied upon the label of the referenced product, rather than toxicity studies, to review the label. As a result, one set of toxicity studies may support several pesticides. However, product managers did not ensure there were toxicity studies to support the referenced product. In those cases where the registrant identified the substantially similar product, we reviewed the referenced product to determine the appropriate toxicity categories. In many cases, we were unable to identify the toxicity studies which supported the referenced product. Rather than reviewing referenced products' toxicity studies, product managers used the referenced products' labels to 11 Report Ho. E1EPF1-05-0429-2100613 ------- Labeling of Pesticides determine the precautionary statements needed. Without reviewing the toxicity studies, project managers cannot be sure that the precautionary statements on the referenced product are adequate. In some cases, we were unable to identify the specific studies which supported the registration because OPP did not include a coding system number in the product registration file. OPP assigns each study a Master Record Identification Document (MRID) number. OPP files toxicity studies by MRID numbers, separate from the product's registration file. When the registration file did not contain the MRID number, neither the product managers or our auditors could locate the toxicity studies. Without the studies, we were unable to verify the accuracy of the precautionary statements. Some Missing Studies Will Be Obtained During Rereaistration OPP officials stated that under the conditional registration provisions of FIFRA (see Pesticide Program History on page 3), each individual product is not required to be supported by a complete set of toxicity studies. Ultimately all products will be supported by appropriate toxicity studies at reregistration. A core set of data will serve labeling needs of a number of substantially similar products. Until reregistration is completed around 2002, EPA will continue to determine labeling statements for substantially similar products based upon a core database. During reregistration, EPA will group substantially similar products and request registrants to submit one set of toxicity studies for each group of substantially similar products. We recognize that the slow pace of reregistration has resulted in OPP not yet having toxicity studies for some pesticides (see page 4). However, many of the toxicity studies that we could not find may exist. Where EPA does have toxicity studies, EPA should use the studies when reviewing the precautionary label statements. OPP accepted precautionary statements for substantially similar products based on other labels and not on toxicity studies. OPP officials justified this practice by stating that there is generally more than one substantially similar product which the product manager can rely upon. However, as discussed in Chapter 3, we found almost half the pesticides we reviewed had missing or inaccurate precautionary statements. Based on our review, OPP should not rely on the 12 Report No. E1EPF1-05-0429-2100613 ------- Labeling of Pesticides labels of other products to determine the accuracy of precautionary statements when toxicity studies are available. Reviews Of Toxicity Studies Could Not Be Located For 6 of 95 labels reviewed, we were able to locate the toxicity studies, but not OPP's review. The studies contain the results of the testing the registrants performed. The Precautionary Review Section assigns a toxicity category to a pesticide based on its review of the study. In six cases we were unable to Locate documentation of this review. Without documentation of the study results, we were unable to determine how, or if, OPP determined the accuracy of the precautionary statements. Improvements Needed In The Documentation Of Studies And Reviews £»ome of the studies, and summaries of OPP reviews, that we were unable to locate may exist. However, we were unable to locate them, even with the assistance of product managers. The Federal Managers' Financial Integrity Act requires that U. S. General Accounting Office internal control standards be followed when establishing and maintaining systems of internal control. The standard on documentation states that: Internal control systems and all transactions and other significant events are to be clearly documented, and the documentation is to be readily available for examination. OPP requires precautionary statements on pesticide labels to protect humans and the environment from harmful effects of pesticides. Consequently, OPP's process for ensuring the accuracy of the precautionary statements is significant in the-, registration of pesticides. OPP needs to maintain documentation of how it determined the accuracy of precautionary statements on pesticide labels. Toxicity studies, and OPP's review of the toxicity studies, are vital to ensuring the adequacy of precautionary statements. In June 1992, OPP drafted a strategy for improving information management. OPP officials stated that the implementation of this strategy will significantly enhance OPP's ability to retrieve and use toxicity studies and reviews. Until OPP provides further details regarding the implementation of the strategy, we cannot evaluate whether 13 Report MO. E1EPF1-05-0429-2100613 ------- Labeling of Pesticides OPP's intended actions will improve the documentation of toxicity studies and reviews of toxicity studies. PRODUCTS REGISTERED WITHOUT TOXICITY STUDIES For 14 of 95 labels reviewed, OPP had not required the registrants to submit toxicity studies. At least nine of these products were registered before EPA required a full set of toxicity studies. OPP intends on obtaining many of these studies during reregistration, which is not scheduled to be completed until 2002. In the 14 cases cited: o Five products, each of which contained the active ingredient sodium cyanide, did not have toxicity studies. The product manager stated that toxicity studies were not required because OPP knew sodium cyanide was very toxic. o The other nine products contained ethylene oxide (4) or coal tar creosote (5) as the active ingredient. Product managers stated that these long-used active ingredients were registered before toxicity studies were required. OPP will collect toxicity information on these products during reregistration. Reregistration has been a massive undertaking for OPP and has proceeded slowly. In 1972 Congress required OPP to reregister existing pesticides that were originally registered before formal scientific and regulatory standards were established. In 1988, Congress established for EPA an accelerated reregistration process. As of April 1992, OPP had determined that 14 of 400 active ingredients were eligible for reregistration. Neither ethylene oxide nor coal tar creosote are among the ingredients that have been reviewed for reregistration eligibility. Until reregistration is complete, the precautionary statements on the labels of products like these will not be supported by toxicity studies and the label statements may not indicate the dangers of the pesticide. TOXICITY STUDIES WERE FOR A DIFFERENT PRODUCT FORMUIATIOK Of the 95 labels reviewed, in five cases the product formulation used in the toxicity studies was different from the current formulation. 14 Report No. E1EPF1-05-0429-2100613 ------- Labeling ofPesticides o In one case, one of the ingredients in the pesticide was methanol. However, the toxicity studies for the referenced product were based on a formulation that did not contain methanol. The sole presence of methanol should have resulted in more restrictive precautionary statements. o In another case, the referenced product was not substantially similar to the product being registered. One product was 5 percent resmethrin, while the referenced product was 40 percent resmethrin. The product manager did not reguire the registrant to reference a substantially similar product or submit toxicity studies. o In three 'cases, the registrants revised the precautionary statements to reflect the removal of a toxic inert ingredient. However, the product manager did not reguire the registrants to submit toxicity studies to support the change in precautionary statements. EPA registration guidance requires registrants to submit acute toxicity data when proposing changes to precautionary statements. opp bases the precautionary statements on the results of five tDxicity studies. The results of toxicity studies may change based on the product's formulation. OPP needs to be sure that it relies on products that are in fact substantially similar or requests the registrants to submit toxicity studies on the correct product formulation. CONCLUSION Before registering a pesticide, FIFRA requires EPA to determine whether the pesticide can be used without causing unreasonable adverse effects on the environment. Toxicity studies play an important role in establishing the precautionary statements that pesticide labels must contain. OPP needs to ensure that toxicity studies are (1) submitted, (2) reviewed, and (3) serve as the basis for precautionary statements on pesticides. When this is not done, EPA cannot be sure that precautionary statements on pesticide labels are protecting humans and the environment. Toxicity studies for some registered products are older than EPA. According to OPP officials, many of the older studies 15 Report NO. E1EPF1-05-0429-2100613 ------- Labeling of Pesticides have become obsolete. Others are in EPA files, but not organized in such a way that they can be easily matched to the products that they support. As a result, EPA practice is to have the product managers look at the label, not the toxicity studies, when reviewing label statements on substantially similar products. If they want to find the studies, they face an intensive search. EPA intends on correcting this during reregistration. EPA needs to organize the toxicity studies that it has, so that it can use them to determine the accuracy of precautionary labeling statements. However, we recognize that this would be a massive undertaking. Because of the resource intensive nature of this process, the Agency's actions need to emphasize organizing future toxicity studies that it receives. While not making recommendations about the current problem, we do not agree with EPA's current process of relying on labels rather than studies to register products. AGENCY COMMENTS AND ACTIONS The Assistant Administrator agreed to act to resolve the issues described above. She added, however, that this finding does not adequately consider the statutory framework of conditional registration and reregistration. According to the Assistant Administrator, it is these provisions of FIFRA that allow the apparent weakness of the data base of toxicity studies to continue. Only the completion of reregistration will correct the problem. The Assistant Administrator agreed that each precautionary labeling decision should be supported by product-specific data. Currently, the Agency does not have such a data base; data on each product are not available and the data that are available are often old or obsolete. According to the Assistant Administrator, this weakness stems from the conditional registration provisions of FIFRA which Congress directed EPA to administer. The Assistant Administrator further explained that: o Reregistration was established to systematically collect data and review pesticide product regulatory decisions, including labeling decisions. 16 Report NO. E1EPF1-05-0429-2100613 ------- Labeling of Pesticides o Congress recognized that the ongoing registration process cannot equitably refuse registration of new products, which are substantially similar to existing products, while EPA was conducting reregistration. This was the basis for conditional registration. o Data compensation provisions of FIFRA explicitly permit registrants to use data from other sources to support their registrations. The Assistant Administrator agreed with our emphasis on better organizing and documenting the studies EPA receives in the future. ThtJ Assistant Administrator described changes to OPP's process for organizing toxicity studies and EPA reviews of these studies. These changes were not in place for many of the registrations we reviewed. She stated that OPP will :ae able to document whether and what type of toxicity studies »2xist to support particular registrations. (See Appendix l, pages 54 and 55, for details.) OIG EVALUATION To the extent we considered appropriate, we incorporated the Agency's position that the statutory framework of FIFRA has greatly impacted the availability of toxicity studies and the labeling of pesticides. The reason toxicity studies were not available is a combination of FIFRA provisions and data management problems which OPP can address. In fact, OPP has already begun to address the problem of linking toxicity studies with pesticide registrations. As stated in our conclusion, no reasonable actions, besides reregistration, could be taken on toxicity studies previously received. For future toxicity studies OPP receives, the Assistant Administrator's actions will assure that, for new pesticide registrations, OPP can identify toxicity studies to support them. 17 Report No. E1EPF1-05-0429-2100613 ------- Labeling of Pesticides [This page was intentionally left blank.] 18 Report NO. E1EPF1-05-0429-2100613 ------- Labeling of Pesticides CHAPTER 3 EPA ACCEPTED LABELS WITH INACCURATE PRECAUTIONARY STATEMENTS Precautionary statements for many pesticide products we reviewed did not meet regulatory requirements. This occurred because the OPP did not have procedures to be sure product managers were consistent in their reviews of pesticide labels. As a result, the labeling statements on pesticides may not adequately protect humans and the environment from unnecessary adverse effects. The pesticide labels reviewed were missing various statements. For almost half the labels evaluated, there were precautionary statements which were missing or inaccurate. For example, several pesticides were missing the statement "Harmful if absorbed through skin." Another pesticide was missing a statement of practical treatment for eye irritation. Two labels reviewed were missing restricted use statements. Also, some label statements did not meet the labeling instructions in registration standards. LABELING REGULATIONS REQUIRE PRECAUTIONARY STATEMENTS Labeling regulations, as contained in 40 CFR Part 156 "Labeling Requirements for Pesticides and Devices," give guidelines for the information needed on pesticide labels. FIFRA requires precautionary statements on pesticides to better protect humans, animals and the environment from harmful effects of pesticides. EPA bases the level of the precautionary statement on the results of the registrant's toxicity studies. Toxicity categories range from 1 (highest) to 4 (lowest). Figure 6 gives an example, taken from 40 CFR 156.10, of how eye precautionary statements would vary for each toxicity category. 19 Report No. E1EPF1-05-0429-2100613 ------- Labeling of Pesticides Figure 6: Exampleof Precautionary Statements Toxicity Category l 2 3 4 Precautionary Statement Corrosive, causes eye damage. Do not get in eyes. Wear goggles or face shield when handling. Harmful or fatal if swallowed. [Appropriate first aid statement required.] Causes eye irritation. Do not get in eyes. Harmful if swallowed. [Appropriate first aid statement required. ] Avoid contact with eyes. In case of contact immediately flush eyes. Get medical attention if irritation persists. [No precautionary statements required. ] PRECAUTIONARY STATEMENTS WERE INACCURATE The precautionary statements OPP accepted on almost half the labels evaluated were inaccurate. This occurred because OPP did not have procedures for product managers to use when reviewing pesticide labels. Instead, product managers used past experience and a combination of pesticide regulations and policies when reviewing pesticide labels. Also, OPP had not finalized some of the regulations the product managers were using. This resulted in (1) labels not including accurate precautions, and (2) inconsistencies between labels of similar products. We found deficiencies with the following types of statements: (1) human hazard precautionary, (2) environmental hazard precautionary, and (3) practical treatment.3 * Because toxicity studies were missing (see Chapter 2), we were only able to evaluate the precautionary statements for 37 of 95 labels reviewed. 3In this Chapter, we will refer to the three types of statements as precautionary statements. *The other statements we reviewed for which we did not find deficiencies were: signal word, flammability statement, worker protection statement, and statements on storage and disposal. 20 Report MO. E1EPF1-05-0429-2100613 ------- Labeling of Pesticides Figure 7: Results of Our Evaluation of Precautionary Label Statements Statements were accurate Statements were inaccurate Total Labels Percent 20 54 22 100 As shown in Figure 7, one or more precautionary statements on 17 of 37 labels evaluated were not accurate. For example: o The labels for six products did not contain a human hazard precautionary statement for skin toxicity. Each of the products were toxicity category 3 and should have included a statement such as "Harmful if absorbed through skin." o The labels for five products, each containing the same active ingredient, did not include statements of practical treatment for inhalation hazards. The products were toxicity category 3, for which the regulations require such a statement. o Two products were missing environmental hazard statements. The products should have contained a statement such as "This pesticide is toxic to fish."5 o One product did not have a statement of practical treatment for eye irritation. The product was toxicity category 2, for which the regulations require a statement of practical treatment. An example of a practical treatment statement would be "If in eyes: Hold eyes open and flush with a steady, gentle stream of water for 15 minutes." We discussed our evaluation of the labels with product managers. Product managers agreed that the statements were missing from the labels. Some product managers stated that they would act immediately to correct the label, while others stated that OPP would correct the label during reregistration. Considering that OPP does not plan to complete reregistration until 2002, more immediate action should be taken to correct the labels. sThe label for one product was corrected during our review. 21 Report Mo. E1EPF1-05-0429-2100613 ------- Labeling of Pesticides Even though product managers agreed with our evaluation of the precautionary statements, OPP officials gave several additional reasons why precautionary statements may not conform to current policies. First, product managers have the discretion to approve a variety of precautionary statements that may differ from the typical statements contained in the regulations. Second, because products are approved over a long period of time, there is an inherent inconsistency created as new products are registered if older products are not updated. We agree that these issues may account for why precautionary statements differ from what is contained in OPP regulations, however, neither of these issues contributed to the inaccurate statements found during our review. Combination of Policies Used In Label Reviews EPA product managers used a combination of current regulations, proposed regulations, and pesticide regulation notices when reviewing and accepting pesticide labels. Not finalizing the regulations creates the potential for uncertainty for the registrants and makes it difficult for them to understand the wording needed on a pesticide label. Pesticide regulation notices are issued to registrants when OPP wants to make changes in the registration process. One way OPP used regulation notices was to carry out a label improvement program. OPP began the label improvement program in 1980 to upgrade pesticide labeling to further protect human health and the environment. OPP has recently issued label improvement program notices for such things as revising label statements for products containing Deet (a particular active ingredient) and false and misleading statements on labels. However, with regulation notices and all other labeling instructions and regulations, OPP must rely on the registrants for voluntary compliance, or use the cancellation process to compel compliance. In 1984, OPP proposed to revise and expand the labeling regulations included in 40 CFR Part 156, but never finalized the revisions. OPP management believed that the revision was needed to provide a more comprehensive description of pesticide labeling requirements. The planned revisions would also result in better quality labeling for users. In the areas of precautionary statements, OPP proposed to revise criteria used to place pesticides in toxicity categories, expanded the human hazard precautionary statements, and added 22 Report NO. E1EPP1-OS-0429-2100613 ------- Labeling of Pesticides recommended practical treatment statements. According to OPP officials, they did not finalize the regulations because of other priorities. Even though OPP did not finalize the revisions to the regulations, product managers used the proposed revisions when reviewing pesticide labels. Registrants were aware that OPP used the proposed regulations and generally followed them in order to get product managers to approve registrations and amendments. OPP officials agreed that revising the regulations may result in improved labeling because (1) registrants are more apt to comply with regulations, (2) enforcement actions will be easier to sustain if requirements are regulatory, and (3) courts generally give greater deference to regulations than policies. Procedures Needed For Label Reviews There were no procedures for product managers to use when reviewing pesticide labels. Not having procedures can result in inconsistencies in how product managers review labels. Also, product managers may be giving conflicting instructions to registrants on labels. In the past, product managers used a checklist for the review of registrations, including the label review. However, as pesticide products became more complex, the checklist fell into disuse. OPP has recognized the value of having procedures for label reviews. During 1992, OPP planned to develop a procedures manual for label reviews. RESTRICTED USE STATEMENTS MISSING FROM PESTICIDE LABELS Of the 95 labels reviewed, EPA had determined that 16 should be classified as restricted use pesticides. Two of the 16 labels reviewed were missing restricted use statements. FIFRA states that if EPA determines that a particular pesticide, or uses of a pesticide, may generally cause unreasonable adverse effects on the environment, the pesticide may be classified as restricted use. Restricted use pesticides can only be used by certified applicators or undtsr the direct supervision of a certified applicator. Labcding regulations require restricted use pesticides to have the following statements on the front of the label: 23 Report NO. E1EPF1-05-0429-2100613 ------- Labeling of Pesticides RESTRiCTEE) USE PESTICIDE . ,. . only lay • ,•-••• . •• :'•.. \ .-;Cer*ified Applicators or persons under tiheir :: .; direct supervision and only for those uses covered ' " '' Of the 16 pesticides EPA had determined should have restricted use statements: o One product containing coal tar creosote as the active ingredient did not have a restricted use statement. Other products with coal tar creosote were properly labeled as restricted use pesticides. o One product contained the statement MFor use by only professional or certified applicators ...", but was not clearly labeled as a restricted use pesticide. The product manager agreed that the product was a restricted use pesticide.6 OPP classifies products as restricted use pesticides when it determines the product will cause unreasonable adverse effects if it is used without this restriction. OPP needs to take the necessary steps to be sure that registrants properly label all restricted use pesticides. LABELING CHANGES IN REGISTRATION STANDARDS NOT ENFORCED OPP is waiting until products are reregistered to implement labeling changes identified in registration standards. OPP issued the registration standards during the 1980's. The registration standards summarized OPP's review of available data on the active ingredient and identified the label statements which were needed based on the available data. When registrants request label changes for products which 'The registrant was disputing with EPA over the restricted use statement. 24 Report MO. E1EPF1-05-0429-2100613 ------- Labeling of Pesticides have registration standards, product managers do not verify that labels comply with the standards. Since reregistration will not be completed until about 2002, OPP should not wait to implement label changes identified in the registration standards, Product managers do not always verify that labels comply with registration standards when accepting pesticide labels. As discussed in Chapter 2, toxicity studies were not available for 58 of 95 products reviewed. OPP had issued registration standards for 27 of the 58 products without toxicity studies. Of the 27 products, the precautionary statements on 12 of the labels did not comply with the registration standard. Product managers stated that they had not checked for compliance with the registration standard because the standard was applicable only to manufacturing use products7. T.ie product managers stated that those labels which did not comply with the registration standard would be corrected during reregistration, when all product labels are updated. During the 1980's OPP was systematically reevaluating older existing pesticides through a registration standards program. By 1988, OPP issued 194 registration standards8. The registration standard summarized OPP's evaluation of available data on an existing chemical, identified and required registrants to submit additional data, and set forth conditions the registrant needed to meet in order to reregister a product. The registration standard typically included modifications to labels. Some standards were only applicable to manufacturing use products, while other standards were applicable to both manufacturing use and end use products. The registration standards contain conflicting information on their applicability to end use products. For the products reviewed against the registration standards, the section "Products Subject To This Standard" said that end use products were subject to the labeling changes. Also, the 7Meinufacturing use products are pesticides used solely to manufacture other pesticides. *The 1988 FIFRA amendments revised EPA's process for reevaluciting existing pesticides. Those pesticides with registration standards became List A in the reregistration process. 25 Report No. E1EPF1-05-0429-2100613 ------- I Labeling of Pesticides section of the standard concerning labeling often included specific label language for end use products. The product manager's statement that the standard was not applicable to end use products was taken from the introduction to the standard which states "The Agency will apply the provisions of the Registration Standard to end use products if necessary to protect man and the environment." When EPA issued the registration standards, it recognized that additional label precautions may be necessary to protect human health and the environment. EPA issued the registration standards during the mid-1980's. EPA's current estimate for completing reregistration is around 2002. At least ten years will have passed from when EPA issued the standard to when EPA completes reregistration. This is a long time for products to remain in use when EPA had indications that the label precautions were not adequate. Registrants continually submit label revisions for products subject to the registration standards. Correcting the label statements now will further protect the public and environment until EPA completes reregistration. ADDITIONAL OPP CONCERNS OPP officials stated that the lack of direct authority to enforce compliance with labeling regulations makes enforcement difficult. It is not a violation of FIFRA for registrants not to comply with OPP regulations. However, OPP has two other options for taking an enforcement action when a registrant does not revise its pesticide label: Under FIFRA Section 6(b), OPP can cancel the registration for products that do not make requested label changes. To do this, OPP must prove not making the label changes will cause unreasonable adverse effects. In addition, the law allows a registrant to request a hearing. Under FIFRA Section 12, OPP can bring a misbranding action against any one who distributes or sells a pesticide that does not contain proper precautionary statements. To bring a misbranding action, OPP must prove that the product was distributed without required changes and that the label changes were necessary to adequately protect the public health or the environment. 26 Report Ho. E1EPF1-05-0429-2100613 ------- Labeling of Pesticides According to OPP officials, both of these enforcement actions can be cumbersome and resource intensive. As a result, OPP generally tries to obtain registrant compliance without taking formal enforcement actions. OPP is working with Congress to give EPA the authority to directly enforce compliance with any regulation, including labeling regulations. CONCLUSION FIFRA requires OPP to ensure that registered pesticides, when used according to label directions, will not generally cause unreasonable adverse effects. OPP uses precautionary statements to warn users of the potential harmful effects of pesticides. Yet, almost half of the pesticide labels that we reviewed did not have accurate precautionary statements. Also, important restricted use statements were missing from some pesticides. OPP needs to be sure the precautionary statements are accurate and will protect human health and the environment. AGENCY COMMENTS AND ACTIONS The Assistant Administrator agreed to act to resolve the issues described above. The Assistant Administrator acknowledged that product precautionary labeling may not precisely conform to the labeling regulations. OPP agreed that it lacks clear written procedures for product managers to use in reviewing and accepting labeling statements. However, according to the Assistant Administrator, this was not the most significant reason for labeling inconsistency, and its correction will not necessarily ensure a constant and strict conformity with labeling guidelines in the future. According to the Assistant Administrator, the difficulty lies in compelling registrants to make label changes. After initial registration, the Agency's ability to compel label changes is constrained because FIFRA Section 12 does not give EPA the authority to directly enforce labeling regulations. This weakness in FIFRA is a major consideration driving program choices. EPA must enforce its labeling regulations throagh either cancellation of the product's registration or a missbranding enforcement action. While it does not absolutely prohibit obtaining label changes, the statutory mechanisms are cumbersome and time-consuming. The Assistant 27 Report NO. E1EPF1-05-0429-2100613 ------- Labeling of Pesticides Administrator stated that the Administration continues to propose legislation to obtain changes in FIFRA which would enhance EPA's ability to ensure labeling is accurate and consistent. To address the issues raised in this chapter, the Assistant Administrator stated that OPP: 1. had established the Center for Excellence for Labeling to focus on labeling problems. The Center plans to develop, by September 1993, a labeling review guide for product managers. 2. will issue by October 30, 1992, a memorandum to branch chiefs regarding verifying compliance with registration standards. This will be done for new products and amendments to the extent that the requirements in the registration standards are applied to end use products. 3. will request registrants of the products with labels we found to be inaccurate to correct their labels. OPP will issue letters to the registrants by October 31, 1992.9 The Assistant Administrator stated that before EPA revises its labeling regulations (40 CFR Part 156) to reflect what is currently required on labels, it is important to collect, analyze, and disseminate current labeling policy. The Center for Excellence for Labeling expects to complete this task by March 31, 1993. At that time, OPP will decide whether and when the labeling regulations will be revised. PIG EVALUATION He agree that the difficulty in requiring labeling changes can contribute to label inconsistencies. In the cases we reviewed, however, we did not find that the lack of authority to compel registrants to modify their labels was the cause of the inaccuracy in the labels. These were not cases where EPA requested a change and the registrant refused. Instead, in these cases, statements were missing from the labels and EPA had not informed the registrants of these deficiencies. *We provided OPP with a listing of the registration numbers for the labels referred to in this chapter on June 26, 1992. 28 Report NO. E1EPF1-05-0429-2100613 ------- Labeling of Pesticides The Assistant Administrator has proposed actions that, when implemented, will substantially resolve the issues presented in this chapter. 29 Report NO. E1EPF1-05-0429-2100613 ------- Labeling of Pesticides [This page was intentionally left blank.] 30 Report No. E1EPF1-05-0429-2100613 ------- Labeling of Pesticides CHAPTER 4 REGISTRANTS DID NOT SUBMIT FINAL PRINTED LABELS EPA did not have complete copies of final printed labels for many pesticides. This occurred because OPP did not regularly follow-up on whether registrants submitted final printed labels. Without the registrants submitting final printed labels, OPP had little assurance that the registrant had made the required changes to the label. Also, enforcement personnel need an accurate copy of the accepted label to use cturing inspections to determine whether pesticide products are properly labeled. OPP relied upon the registrant to make requested changes to t:^e labels and to submit a copy of the final printed label before distributing the pesticide. We found cases where registrants did not make changes OPP requested. In one case, OPP accepted a draft label after the registrant did not (1) make previously requested changes and (2) submit a final printed label. In another case, the registrant submitted a label to the state which did not include OPP requested changes. The label was missing the statement "Causes irreversible eye damage." REGISTRANTS REQUIRED TO SUBMIT A COMPLETE COPY OF LABELS FIFRA Section 3(c) requires that, as a condition of registration, the registrant submit a complete copy of the pesticide label. EPA's labeling regulations (40 CFR Part 156.) also require that registrants submit copies of final printed labels. Prior to 1982, OPP required that both draft and final printed labels be reviewed and approved before a registration was granted.10 The registrant could not market the product until OPP approved the final printed label. This resulted in delays in marketing pesticide products. In 1382, OPP issued a regulation notice (Pesticide Regulation Notice 82-2) changing its procedures for approving pesticide registrations. Prior to this, registrants had indicated that they were prepared to assume responsibility for producing l°References to pesticide registrations also include amendments to registrations. 31 Report No. E1EPF1-05-0429-2100613 ------- Labeling of Pesticides accurate final printed labels if it would result in OPP making faster registration decisions. With the issuance of the regulation notice, OPP no longer routinely required registrants to submit final printed labels before approving the registration. However, as a condition of registration, OPP required the registrant to (1) make the label changes OPP requested and (2) submit a final printed label before the product was released for shipment. In the regulation notice, OPP stated that it would selectively audit final printed labels to ensure registrants' compliance. Also, OPP would require a final printed label before approving the registration if the registrant had previously not made the required changes". REGISTRANTS OFTEN DID NOT SUBMIT FINAL PRINTED LABELS In many cases, the registrants had not submitted final printed labels, as shown in Figure 8. 11 EPA subsequently formalized its policy to review draft labeling and included it in 40 CFR 152.108. 32 Report Mo. E1EPF1-05-0429-2100613 ------- Labeling of Pesticides Figure 8: Most Current Label in OFF Files Number Percent Final printed label 54 57 Draft label with no additional changes to be made12 17 18 Total cases with final printed label or complete draft label 71 No final printed label: Draft label with additional OPP requested changes 15 16 Draft label with changes inserted 9 9 Total cases with no final printed label 24 Total labels reviewed £5 100 OPP did not systematically follow-up to be sure that registrants submitted final printed labels. Product managers stated that (l) they did not check for final printed labels or (2) Pesticide Regulation Notice 82-2 did not require registrants to submit final printed labels. We do not agree with the product managers' interpretation of the regulation notice. The regulation notice does allow for approval of a registration based on a draft label, but does require that the registrant submit a final printed label. Without the registrants submitting final printed labels, OPP has little assurance that registrants make requested changes to labels. In some cases, the product managers stated that if the files did :iot contain final printed labels it was because the registrant had not released the product for shipment. When OPP accepted changes to pesticide labels, it did not give a time frame for when ithe registrant must change its labels. Even though OPP may not specify a deadline for registrants to revise their labels, 40 CFR 152.130(c) states that when registrants initiate a label change, they may distribute the 12 According to OPP officials, when a registrant has submitted a draft label for which no additional changes are needed, the importance of obtaining the final printed label is reduced. 33 Report Mo. E1EPF1-05-0429-2100613 ------- Labeling of Pesticides product under the previously approved labeling for 18 months. For changes OPP initiates to further protect users or the environment, the regulations allow OPP to establish a deadline for using a revised label. When label changes are made to protect human health and the environment, OPP needs to give the registrant a deadline for making the label changes. We found cases where registrants did not make changes OPP requested. For example, in one case, OPP accepted a draft label after the registrant did not (1) make previously requested changes and (2) submit a final printed label. In 1988, OPP accepted a draft label with a use on cockroaches deleted as follows: PERIMETER TREATMENT: To prevent infestation of buildings by Ants, Crickets, Earwigs, and Sowbugs (Pillbugs), ... In the letter approving the registration, OPP required the registrant to submit a copy of the final printed label before shipping the product. The registrant did not submit a final printed label. In 1990, the registrant submitted a draft label which looked as follows: PERIMETER TREATMENT: To prevent infestation of buildings by Ants, Cockroaches, Crickets, Earwigs, and Sowbugs (Pillbugs), ... In a letter to the company, OPP stated that the label was unacceptable, and that the use on cockroaches was to be deleted. The registrant resubmitted a draft label with the use on cockroaches again deleted as follows: PERIMETER TREATMENT: To prevent infestation of buildings by Ants, Crickets, Earwigs, and Sowbugs (Pillbugs}, ... On September 24, 1990, OPP accepted the draft label. Again, the registrant did not submit the final printed label. Because EPA does not follow-up on submission of final printed labels, EPA cannot be sure that the final label will not include a use on cockroaches. When asked about submission of the final label, the product manager stated that it was not his responsibility to check to see if the registrant submitted a final printed label. 34 Report Ho. E1EPF1-05-0429-2100613 ------- Labeling of Pesticides Contrary to the product manager's statement, OPP needs to be sure that registrants submit copies of the final printed labels. The 1982 regulation notice, and 40 CFR 152.108, stated that OPP would selectively review final printed labels to ensure that registrants submitted final printed labels and made all OPP requested changes. However, OPP has not been performing this type of review. A selective review of final printed labels would give OPP assurance that registrants (1) submit •:he final printed labels, and (2) make all changes OPP requests. In those cases where there was no final printed label, OPP did not always notify the registrant that (1) they were required to submit a final printed label and (2) enforcement action could be taken if the label was not submitted. Figure 9: Registrant Notified to Submit Final Printed Label Registrant notified to submit a final printed label and of the potential for enforcement action 15 Registrant notified to submit a final printed label, but not of the potential for enforcement action 8 Registrant not notified to submit a final printed label 18 Total The registrant was responsible for submitting a final printed label, even if there were no additional changes needed to the draft label. When OPP notifies the registrant that the draft label is accepted, OPP needs to remind registrants of their responsibility to submit final printed labels. OPP stated in the regulation notice that if the registrant does not submit a final printed label prior to the product's release for shipment, FIFRA section 6(e) allows OPP to propose to cancel the registration. ENFORCEMENT PERSONNEL NEED ACCURATE COPIES OF ACCEPTED LABELS ;Final printed labels, or accurate copies of EPA accepted labels, would assist enforcement personnel in ensuring 35 Report NO. E1EPP1-05-0429-2100613 ------- Labeling of Pesticides registrants' compliance with labeling requirements. Headquarters and regional enforcement personnel stated that the lack of final printed labels or accepted labels created an enforcement problem. The states, which have primary enforcement responsibility, need accurate copies of EPA accepted labels to use during inspections. Accurate copies of accepted labels are needed to conduct producer establishment and marketplace inspections. EPA's pesticide inspection manual lists as the first objective of producer establishment inspections is to "ensure industry compliance with ... labeling requirements before the products are distributed—" Also, the first objective of marketplace inspections is "to detect and obtain samples of unregistered or misbranded pesticides being marketed."13 State Inspectors Did Not Have Accepted Pesticide Labels State personnel generally perform pesticide inspections. Generally, the states get copies of the pesticide labels from the producers who sell pesticides in their state. Our review found that the states may not have the same pesticide labels that EPA has accepted. As a result, the states are not using the EPA accepted labels to ensure compliance with labeling requirements. He obtained 17 pesticide labels from various states and compared the state label with the EPA accepted label. Seven of 17 (41 percent) state labels were different from the EPA accepted label. Some of the differences were significant. o For one pesticide, OPP recommended in February 1991 significant label changes based on new studies to support reregistration. The label changes included (1) restricting usage to professional turf maintenance personnel, landscaping, or commercial applicators, and (2) revising the precautionary statement to read: "Causes irreversible eye damage." OPP accepted the draft label on May 6, 1991. The registrant did not submit a final printed label. The registrant renewed its license with the state of Oregon in December 1991. The label the registrant 13A pesticide is misbranded if it does not display a proper label or if the label contains false or misleading information. 36 Report NO. E1EPF1-05-0429-2100613 ------- Labeling of Pesticides submitted to the state did not include the revisions OPP had requested ten months earlier. The state's label neither restricted the usage of the pesticide nor warned the user of irreversible eye damage. Instead, for eye irritation, the state's label read: "Causes eye ... irritation." o For another pesticide, the EPA accepted label read "Keep pets and grazing animals out of treated area for 24 hours following application." The state of Missouri's label for this product does not include the statement. EPA needs to ensure that the states have copies of the EPA accepted labels to use during enforcement inspections. CONCLUSION Registrants are required to submit a complete copy of the posticide label. OPP needs to be sure that registrants submit final printed labels that include all warning and precautionary statements. Inspectors also need an accurate copy of the EPA accepted label during inspections. OPP needs a systematic way of verifying that registrants submit copies of the final printed labels. If OPP does not verify that registrants submit final printed labels, OPP cannot be sure that registrants are revising their labels. AGENCY COMMENTS AND ACTIONS The Assistant Administrator agreed to act to resolve the issues discussed above. She also agreed that OPP's current policies and rules require the submission of a final printed label prior to marketing, and that OPP has not been conssistent either in assuring that this was done, or in selectively reviewing such labeling for compliance with necessary changes. The Assistant Administrator stated that OPP: 1. will reinstitute its selective audit of final printed labels. By January 31, 1993, OPP will develop a Standard Operating Procedure describing how it will conduct the process. During fiscal 1993, OPP intends to review and verify accuracy of at least 50 product labels under the new process. Thereafter, OPP will evaluate 37 Report NO. E1EPF1-05-0429-2100613 ------- I Labeling of Pesticides the results of the selective review to determine whether any changes are needed in the audit process. 2. will issue a memorandum to branch chiefs and product managers requiring OFF to give registrants a specific date for making label changes when the changes may affect human health and the environment and are not covered by OPP's existing stocks policy. OPP will issue the memorandum by October 30, 1992. 3. has requested funding to facilitate making EPA accepted labels available to EPA and state enforcement personnel. At the time of the response, decisions on funding had not yet been made. If funding is not available, OPP will continue its current practice of supplying microfiche copies of labels to the Regions. 4. will require registrants to submit final printed labels for those products where we found OPP did not have final printed labels.14 OPP will issue letters to registrants by October 31, 1992. PIG EVALUATION The Assistant Administrator has proposed actions that, when implemented, will substantially resolve the issues presented in this chapter. 14We provided OPP with a listing of the registration numbers for the labels referred to in this chapter on June 26, 1992. 38 Report NO. E1EPF1-05-0429-2100613 ------- Labeling of Pesticides CHAPTER 5 EPA NEEDS TO MAKE BETTER USE OF INFORMATION IN INCIDENT REPORTS OPP needs to follow-up on significant incidents involving a pesticide or after a series of incidents indicates a pesticide is adversely affecting the environment. However, OPP was not collecting or analyzing pesticide incident reports. This occurred because, until recently, OPP placed little importance on the information contained in incident reports. As a result, OPP may not have been aware of pesticides for which registrants need to take additional action, such as changing label precautions or directions, to protect the environment. In July 1992, OPP completed a system for tracking and analyzing incident reports which may correct many of the deficiencies that we found. A'- the time of our fieldwork, OPP did not (1) centrally collect, (2) organize, or (3) follow-up on incident reports it received. However, the incident reports contained inportant information on the consequences of pesticide use. For example, of 50 incident reports reviewed, 5 described deaths to adults. OPP also infrequently used information on incident reports it could obtain from a contractor. It was only after 200 incidents in one year, including 26 animal deaths, that OPP required the registrant to make label changes to a flea and tick pesticide. INCIDENT REPORTS CONTAIN VALUABLE INFORMATION FIFRA Section 6(a)(2) requires registrants to notify EPA whenever they obtain information that a pesticide may cause unreasonable adverse effects on the environment. In addition, the generail public and medical personnel voluntarily report to EPA incidents involving pesticides. FIFRA allows the Agency to register pesticide products only if they will not adversely affect man and the environment. FIFRA, Section 3(c}(5) states that EPA is to consider when registering a pesticide whether: it will perform its intended function without unreasonable adverse effects on the environment; eind 39 Report NO. E1EPF1-05-0429-2100613 ------- Labeling of Pesticides when used in accordance with widespread and commonly recognized practice it will not generally cause unreasonable adverse effects on the environment. Incident reports sometimes describe serious consequences of pesticide use and misuse. For example, we reviewed a sample of 50 incident reports the response officer received between January 1989 and December 1991. As shown in Exhibit 1, most of the incidents describe human or animal deaths or adverse reactions. For example, the 20 human cases included 5 adult deaths, 1 child death, and 1 miscarriage. Nineteen cases described pet deaths or adverse reactions. Some cases involved multiple deaths, including one case involving the death of a cat and her litter of kittens. The cases describing bird and fish kills again involved multiple deaths. For example, two of the bird kills involved about 20 birds each; the fish kill was estimated at several thousand pounds. Some of the adverse reactions resulted from intentional or accidental misuse of the product. For example, one of the adult deaths was a suicide. The child death resulted from the child drinking a pesticide left in a bucket. Other cases, though, may indicate problems with a pesticide or its label. For example, one pet owner wrote that a product's label directions did not match the directions in the box. Even though OPP did not regularly analyze incident reports, in some cases EPA had decided to require registrants to place additional precautions on the pesticide label based on reported incidents. However, OPP took action only after there were significant incidents. For example: o During 1987, the National Animal Pollution Control Center, an EPA subcontractor, received almost 500 incident reports of dogs and cats having adverse reactions to a flea and tick pesticide. The incidents included 75 animal deaths. Because of the high number of incidents, OPP required additional testing of the pesticide. In 1988, the registrant stopped distributing the pesticide. The registrant reintroduced the pesticide in 1989 with additional label precautions. o From incident reports, OPP found that adverse reactions were occurring from the use of flying insect sprays containing the active ingredient DEET. The adverse 40 Report NO. E1EPF1-05-0429-2100613 ------- Labeling of Pesticides reactions resulted from accidental exposure by spraying the pesticide into the eye and by applying the pesticide too often. As a result, in 1991, OPP required additional labeling statements for some end-use products containing the active ingredient DEBT. o In July 1991, a train derailed and spilled metam sodium into a California river. The spill killed all plants and fish in a 40 mile stretch of the river. As a result of this incident and EPA's review of the registrant's studies, EPA and a number registrants worked together to revise the pesticide label, and canceled all home-use products containing metam sodium. These examples illustrate that incidents can point out needed label changes, and that OPP has acted based on incidents in the past. OPP's pesticide incident response officer and OPP's product managers are responsible for collecting information on incidents and ensuring that pesticides are not causing unreasonable adverse effects. In 1978, OPP appointed a person as the pesticide incident response officer. The incident response officer is to serve as the focal point for receiving, tracking, and monitoring all pesticide incidents. OPP product managers are responsible for identifying chemicals that pose unreasonable adverse effects and arranging for reviews of pesticide labels to ensure that they are adequate to protect human health and the environment. OPP'S HANDLING OF INCIDENT REPORTS IT RECEIVED WAS NOT ADEQUATE The incident response officer was not (1) collecting, (2) organizing, or (3) following-up on all incident reports. This occurred because OPP had (1) no procedures for handling incident reports, and (2) placed little importance on the information in incident reports. Without adequate processing of incident reports, OPP cannot use the information to identify pesticides that may be adversely affecting the environment. Incidents Reports Not Centrally Collected Various OPP divisions, regional offices, and state agencies may receive incident reports. However, the various offices 41 Report NO. E1EPP1-05-0429-2100613 ------- Labeling of Pesticides do not routinely forward the information to the incident response officer. The incident response officer needs to be aware of all incidents involving a pesticide to have an accurate record of incidents. This will allow OPP to identify significant trends in incident reports and possible label deficiencies. Without centralized collection, OPP had only a limited picture of how pesticides were adversely affecting the environment. OPP did not have procedures which required its product managers to forward incident reports to the incident response officer. Some product managers reviewed incident reports before sending the information to the incident response officer. Others forwarded the incident report to the incident response officer without reviewing the information. One product manager placed the reports directly in the registration file without sending the information to the incident response officer. Without a central receiving point, OPP was not aware of all incidents reported for a particular pesticide. Regional and state offices also receive reports of pesticide incidents. However, the incident response officer generally did not receive information on pesticide incidents from the regions and states. The regions report some incidents to OCM, but this information was not forwarded to the incident response officer. Regions and states need to forward reports to the incident response officer in order to have a complete record of pesticide incidents. Incident Reports Not Organized For more than 10 years, OPP had not organized incident reports in any useable manner. Some of the reports the incident response officer received were placed in unmarked folders. Others were stored in file cabinets, but not necessarily in any specific order. Still others were stored loosely in boxes or on top of desks and file cabinets in the incident response officer's office. The files did not contain unique identification numbers. There was no way to identify all incidents relating to a specific active ingredient or product. Because OPP did not organize the incident reports, it could not use the incident reports to identify pesticides that may be adversely affecting humans and the environment. 42 Report Mo. E1EPF1-05-0429-2100613 ------- Labeling of Pesticides OPP previously entered incidents into the Pesticide Incident Monitoring System. During the mid 1970's, OPP discontinued the system because of a shortage of staff and funding. By not organizing the incident reports in a centralized system, OPP was left without the capability of obtaining accurate incident information. Product managers consistently told us that a computer system capable of sorting and tracking incidents would be a great benefit during label reviews. With such a system OPP could identify pesticides that were frequently mentioned in incident reports. Because OPP did not organize incident reports, product managers could not use the reports to identify potential weaknesses in labeling statements. GPP has taken stejps to improve the organization of new incident reports it receives. Since September 1991, OPP has placed all incidents received from registrants and others on microfiche. In July 1992, OPP also implemented a computerized incident report system15. Based on the ir,formation in the system, OPP can produce statistical reports concerning incident reports. Incident Reports Not Followed-up Although incident reports can involve human and animal deaths and adverse reactions, the incident response officer and product managers did not routinely follow-up on incident reports. OPP had no requirements that the incident response officer or product managers obtain additional information on reported incidents. Without adequate follow-up of reported incidents, OPP did not have accurate information on how pesticides adversely affected man and the environment. Some incident reports contain detailed information on the incident, while others may include only limited information. As a result, OPP needs to follow-up on information in incident reports where the registrant or public provided too little information for OPP to determine the extent of the problsm. The incident response officer can refer cases to the Registration Division, the Special Review and Reregz.stration Division, and the Office of Compliance 15 We did not evaluate the information in the incident report system because it was not implemented until the end of our fieldworK. 43 Report Mo. E1EPP1-05-0429-2100613 ------- Labeling of Pesticides Monitoring. However, the incident response officer seldom referred incident reports for further action. In those cases where the incidents were referred for further action, there was little documentation in OFF files as to the actions taken. OPP does not necessarily need to follow-up on each pesticide incident. OPP needs to follow-up on significant incidents or after a series of incidents indicates a significant problem. However, because OPP did not centrally collect or organize incident reports, it could not determine when a pattern had developed that pointed out a problem that needed further investigation. Recent Actions To Improve Handling of Incident Reports After the July 1991 metam sodium spill in California, Congress held hearings16 concerning EPA's review of information on adverse effects of pesticides received from registrants. As a result, OPP began to establish procedures for reviewing adverse effect information received from registrants and incident reports received from other sources. In October 1991, OPP established a workgroup, referred to as a SWAT team, to address the problems in the handling of adverse effect and incident information. OPP identified similar problems with handling incident reports as discussed in this report. In July 1992, OPP completed procedures for handling incident reports. The procedures included: o A flowchart for handling incident reports, including identification of responsible persons or offices. o criteria for screening incident reports in order to identify incidents needing additional review or OPP action. o Format for recording information obtained over the telephone on incident reports. OPP has also developed and implemented a computerized incident reports system. All incident reports are now input into the computer system. Based on the information in the "Joint hearing before the House Committees on Government Operations and Agriculture on October 31, 1991. 44 Report NO. E1EPF1-05-0429-2100613 ------- Labeling of Pesticides system, OPP can produce statistical reports concerning incident reports. These new procedures and the incident reports system should correct the deficiencies found during our review. OPP INFREQUENTLY USED VALUABLE INFORMATION ON PESTICIDE INCIDENTS OPP infrequently used information on pesticides incidents available from its contractor. The contractor's information indicated trends in pesticide incidents. Because OPP infrequently requested the contractor's information, the information was not used to identify pesticides for which action was needed to further protect the environment. CPP has a five year contract, worth about $825,000 per year, with Texas Tech University (Lubbock, Texas) to operate NPTN. N.PTN is a 24-hour pesticide hotline that provides callers with information on the use and effects of pesticides. Calls rsmge from routine requests for information about a pesticide to emergencies involving humans or animals. NPTN receives calls from all over the United States. NPTN inputs information on all calls into a computer system. When the call involves a pesticide incident, NPTN records information such as the pesticide used; whether it affected humans, animals or the environment; extent of adverse affects; and how the pesticide was used. NPTN provides OPP with quarterly reports on the number and nature of the calls they receive. For incidents, NPTN provides information on the active ingredient involved and whether it affected humans, animals, or the environment. NPTN maintains statistics on calls received on a particular active ingredient or product for at least the past eight years. NPTN statistics show that the pesticide active ingredients used in most incidents have generally remained the same over the past eight years, as shown in Figure 10. 45 Report No. E1EPF1-05-0429-2100613 ------- Labeling of Pesticides Figure 10: Number of Incident Reports Bv Active Ingredient 1984-1991 Third Quarter Fiscal Year 1991 Active Ingredient Chlorpyrifos Chlordane" Diazinon17 Malathion Carbaryl 2,4-D17 Pyrethrins Glyphosate Lindane17 fiendiocarb Number of Incidents 3642 3166 2517 1472 737 673 591 569 558 508 Ranking 1 2 3 4 5 6 7 8 9 10 Number of Incidents 191 54 129 58 39 30 12 26 (not 12 Ranking 1 4 2 3 5 6 14 8 listed) 14 These statistics reflect only those incidents reported to NPTN. This may be only a small fraction of the pesticide incidents that occur. These chemicals also represent some of the most frequently used home-use pesticides. From this information there does appear to be a trend in the active ingredients that commonly cause adverse effects on humans and the environment. Information on specific incidents is readily available from NPTN. However, prior to fiscal year 1992, NPTN received only 13 requests from EPA for additional information. OPP had taken action on some active ingredients because of a large number of incidents. One example of where OPP has taken action on the chemicals listed above is Chlorpyrifos. In 1984, OPP requested the registrant to perform additional testing on Chlorpyrifos, the chemical most frequently mentioned in NPTN incident reports. OPP's review of these tests did not show that there was enough of a problem to require additional labeling changes. Even though OPP did not find any problems with the first set of tests, OPP requested additional testing in 1991 because there was still additional 17OPP is reviewing or had reviewed each of these chemicals as part of the special review process. Special review is EPA's process for determining whether the use of a pesticide poses unreasonable adverse effects to humans or the environment. 46 Report MO. E1EPF1-05-0429-2100613 ------- Labeling of Pesticides information needed to evaluate the safety of the chlorpyrifos. EPA is awaiting the results of this testing. As noted in the chart, OPP is taking action on several other chemicals through the special review process. OPP pays NPTN to provide information to the public concerning pesticides. As part of this, NPTN collects and summarizes information on incident reports. However, EPA infrequently used the information from NPTN. As a result, certain pesticides may persist in adversely affecting the environment. EPA needs to act more often upon the information NPTN collects. CONCLUSION EPA is entrusted with the responsibility to protect the public and environment from unreasonable adverse effects of pesticides. The public reports to EPA real life incidents of when pesticides may be adversely affecting the environment. These reports can be of great value to the Agency. However, OPP did not routinely analyze the incident reports it received, or use the information its contractor provided. OPP has recently improved its ability to collect and analyze incident reports. OPP now needs to use the information it collects to identify problem pesticides, and to protect the public and environment from unreasonable adverse affects of thiise pesticides. AGENCY COMMENTS AND ACTIONS During our review, the Agency took action to improve its ability to collect and analyze incident reports. In responding to the draft report, the Assistant Administrator stated that OPP has requested NPTN to collect more precise information from callers concerning potential incidents. Although agreeing with our recommendations, the Assistant Administrator also discussed limitations associated with incident report data. The Assistant Administrator stated that the report focused on incidents reported voluntarily and not those registrants are required to report under FIFRA Section 6(a)(2). According to the Assistant Administrator, •the type of information obtained from voluntarily reported incidents is unlikely to sustain a regulatory decision. The quality and quantity of information needed is significantly 47 Report NO. E1EPF1-05-0429-2100613 ------- Labeling of Pesticides greater than that unverified, poorly documented incident reports provide. In regards to NPTN, the Assistant Administrator stated that it is primarily intended to provide information to the public rather than to receive incident reports. OPP has verbally requested NPTN to collect more precise information from callers about potential incidents. OPP will provide written procedures, including what data elements to collect, to NPTN by the end of October 1992. Even though NPTN will be collecting additional information, it will not substitute for OPP follow-up, and will not reduce the resources needed for integrating incident information into regulatory decision making. OIG EVALUATION The Assistant Administrator has proposed actions that, when implemented, will substantially resolve the issues presented in this chapter. 48 Report NO. E1EPF1-05-0429-2100613 ------- Labeling of Pesticides EXHIBIT 1 Page 1 of 1 PESTICIDE INCIDENT REPORTS REVIEWED Cases Human reactions Adult deaths Child deaths Adult adverse reactions Child adverse reactions Miscarriages Total human reactions Pet reactions Cat deaths Dog deaths Cage bird deaths Dog adverse reactions Unidentified pet reaction Total pet reactions Wildlife reactions Bird kill Fish kill Total wildlife reactions Other Fire Plant kill General Total other Total incidents reviewed Incidents 5 l 10 3 1 20 9 3 1 5 1 19 5 I 6 1 1 3_ 5 50 49 Report MO. E1EPF1-05-0429-2100613 ------- Labeling of Pesticides [This page was intentionally left blank.] SO Report NO. E1EPF1-05-0429-2100613 ------- Labeling of Pesticides APPENDIX 1 Page 1 of 11 UNITED STATES ENVIRONMENTAL PROTECTION AGENCY WASHINGTON, D.C. 20460 PREVENTION. PESTCiOES AMD TQIC SUBSTANCES SEP 29 1992 MEMORANDUM SUBJECT: Draft Report on jf^be^ing FROM: TO: her Assistant Administrator Kenneth A. Konz Assistant Inspector General for Audit My office has reviewed the draft report entitled Labeling of Pesticides, which has evaluated certain aspects of the Office of Pesticide Program's (OPP) process for reviewing data and labeling for adequacy under the Federal Insecticide, Fungicide and Rodenticide Act (FIFRA). The report also evaluated the program's incident reporting systems. This review is quite important since labeling is one of the critical functions in the regulation of pesticides, serving as both an enforcement and an information vehicle to reduce the risks posed by pesticide use. Incident information serves to highlight trends in pesticide use and effects that merit particular attention by EPA. The report recommends a number of improvements in both labeling and incident information that are sound, and for the most part achievable. In fact, the recommendations are by no means surprising or unexpected, and, as we indicate below, we are planning or already implementing a number of improvements in our processes to strengthen our labeling programs. It should be recognized, however, that the improvements recommended in the report would impose a heavy resource burden on the program. Allocation of resources to these specific areas would have to be considered in the light of broader program priorities. He welcome the recommendations of the report as a means of focussing on these problems and on the resources needed to rectify them. My staff have worked extensively with yours, and, as the report indicates, we have provided them with substantial comment on several occasions. He appreciate their willingness to meet with us and hear our concerns. In this report, these discussions have measurably improved the accuracy and quality of the report and allowed both the IG and OPP to arrive at a mutual 51 Report NO. E1EPF1-05-0429-2100613 ------- Labeling of Pesticides APPENDIX 1 Page 2 of 11 understanding of the nature of the problems. I believe that, in future audits, the IG should seek substantive discussions with the program even earlier in the process. GENERAL OBSERVATIONS An essential element in evaluating the Agency's data and labeling programs is an accurate characterization of the factors contributing to the problems with labeling. In particular, the report should emphasize even more that the FIFRA mandates are in large measure responsible for the situation that the report identifies. If these are not accurately reflected, the report could appear to call into question the adequacy of the Agency's labeling program for protection of public health. By explaining how the fundamental statutory directives of FIFRA affect the labeling program, the problems with labeling and its underlying databases are cast in the proper perspective. We believe that the difficulty the report identifies in reconciling the Agency's labeling decisions with a supporting database are an undesirable, but predictable consequence of the conditional registration, data compensation and reregistration programs established by Congress. And while reregistration is the Congressionaliy mandated program intended to correct the "lack of data" problem, and reregistration is well underway, our resources for this program must be taken into account in determining how rapidly the correction can be accomplished. Without adequate funding of the reregistration program, the acquisition of the needed data and the labeling decisions will be delayed well beyond the FIFRA projected completion date for reregistration. Moreover, the report should emphasize the statutory constraints upon EPA's ability to compel registrant compliance with labeling decisions. The cumbersome means of effecting label changes is a key factor that influences how we administer the labeling program now, and, ultimately, a large factor in how well we will be able to accomplish some of the improvements the report recommends, in assessing the program's use of incident information, the report clearly identifies an area which deserves and has received greater attention, but where the remaining hurdle to a comprehensive program is funding for information management systems. In sum, while we agree with the types of problems the report identifies, we believe that they are not generally indicative of program management or administrative weaknesses. The solutions rest largely on legislative changes to FIFRA and increased funding for the current reregistration and information management programs. 52 Report NO. E1EPF1-05-0429-2100613 ------- Labeling of Pesticides APPENDIX 1 Page 3 of 11 CHAPTER 2. EPA MISSING TOXICITY STUDIES TO SUPPORT PRECAUTIONARY STATEMENTS. CONCLUSIONS: The report, in several subsections, claims that OPP could not locate its toxicity studies, or its reviews of toxicity studies, in support of precautionary labeling. The report goes on to conclude that OPP improperly registered products without such studies, or by improperly relying on studies on a different product formulation. The report attributes this problem to OPP's failing to verify study existence and location at the time of registration. As my staff has previously explained in meetings and comments, the report does not adequately describe how the statutory framework of conditional registration and reregistration apply to its findings on the availability of toxicity data. The explanation under Pesticide Program History of reregistration, conditional registration, and data compensation, does not consider the implications of these provisions for OPP's regulatory programs. In fact, in administering the reregistration, conditional registration and data compensation provisions of FIFRA as it has, EPA is operating consistently under longstanding Congressional directives, which have been reiterated in successive FIFRA amendments. As a result, Chapter 2 conclusions misidentify the problem and its causes. Tide report concludes that EPA should "ensure that toxicity studies are (1) submitted, (2) reviewed, and (3) serve as the basis for precautionary statements on pesticides." However, under the reregistration mandate of FIFRA sec. 4, the conditional registration scheme of FIFRA sec. 3(c)(7) and the data compensation provisions of FIFRA sec. (3)(c)(1)(F), toxicity studies are not necessarily required to be submitted or reviewed prior to registration, and therefore cannot always serve as the basis for precautionary statements of currently registered products. We agree that each precautionary labeling decision should be supported by product-specific data which the Agency could identify as the basis for that decision. Currently, we do not have such a data base; data on each product are not available and the data that are available are often old or obsolete. This weakness, however, stems from the conditional registration scheme which Congress statutorily directed us to administer: •Reregistration was established to rectify this situation: to systematically collect data and review pesticide product regulator!' decisions (including labeling decisions). This is a lengthy process, as the report acknowledges in citing the length 53 Report NO. E1EPF1-05-0429-2100613 ------- Labeling of Pesticides APPENDIX 1 Page 4 of 11 of time it has taken the Agency to complete the preliminary data call-in portions of reregistration. •Congress also recognized that the ongoing registration process cannot equitably refuse registration to new products that are substantially similar to existing products while EPA is awaiting new data, and thus authorized conditional registration while data are being developed. •Finally, Congress recognized that because many products are substantially similar to one another, requiring data on each individual product would be duplicative and wasteful of both data development and review resources. Data compensation provisions explicitly permit registrants to cite data from other sources that support their registrations. It is the meshing of these three provisions that allows the apparent weakness of the data base to continue, and it is only the completion of reregistration that will cure the problem. Reregistration is a lengthy process. As the report states, the current estimate for accomplishing reregistration is 2002; the program has been hindered by lack of funding which could speed our task. I have testified before Congress on the shortfall in resources to meet our statutory targets. Without additional funding, reregistration will take longer than Congress projected. RECOMMENDATIONS - CHAPTER 2. The report recognizes the resource-intensive nature of attempting to locate, organize, document, and link existing toxicity studies to existing products for the purpose of verifying labeling decisions. Consequently the report makes no recommendations about existing studies but focusses on better organization and documentation of studies to be received in the future. We agree generally with this emphasis. RECOMMENDATIONS 2.1 AND 2.2: The report recommends that OPP "organize toxicity studies, starting in fiscal year 1993, in such a way that OPP can easily locate and use the studies when making labeling decisions regarding substantially similar products." The report recommends that OPP record the location of each toxicity study, and further document the results of the review. OPP currently organizes its data by Master Record Identification Number in the Pesticide Data Management System. The MRID number is placed on the data itself, and in the review of the data by scientists. In the past, reviews were located in registration files, and were difficult to locate for use with subsequent products, storage in registration files also meant that a study review could be lost for all practical purposes if the registration file was retired. Since 1991, OPP has instead been storing paper copies of reviews separate from product files. 54 Report No. E1EPP1-05-0429-2100613 ------- Labeling of Pesticides APPENDIX 1 Page 5 of 11 We have also been cataloging the reviews on a d-base system which stores all study reviews and is searchable by registration number. Finally, since 1990 the results of toxicity study reviews (the toxicity category information by route of exposure) have been included on the Pesticide Registration Action Tracking System (PRATS) which allows a reviewer to determine by registration number the acute toxicity characteristics of the product for use in determining whether another product is substantially similar. We believe that the combination of these systems addresses the iG's concern about linkage of supporting data to individual precautionary labeling decisions. OPP will be able to document whether and what type of database exists in support of a particular set of precautionary statements. CHAPTER 3. EPA ACCEPTED LABELS WITH INACCURATE PRECAUTIONARY STATEMENTS. CONCLUSIONS: The report identified 17 products that were not accurately labeled when compared with our labeling regulations. This is not an unexpected finding; OPP acknowledges that product precautionary labeling may not precisely conform to the labeling regulations. Further, inconsistencies among similar products become apparent when compared systematically rather than product by product. These findings, however, are less significant than the underlying causes of the reasons for inaccuracy and inconsistency. The report attributes the discrepancies to the lack of procedures for Product Managers to use in making labeling decisions and to the fact that EPA has not finalized a set of labeling regulations that Product Managers use. OPP agrees that it lacks clear written procedures for Product Managers to use in reviewing and accepting labeling statements. By providing such instructions, one source of inaccuracy and inconsistency should be eliminated. Some of the products identified in the report as having inaccurate labeling undoubtedly could be attributed to this cause. However, this is not the most significant reason for labeling inconsistency, and its correction will not necessarily ensure a constant and strict conformity with Agency specifications for labeling of future products. The more intractable problem, mentioned but not highlighted in the report, is the difficulty of compelling labeling changes. We recognize the need to correct or update labeling, both because products are reviewed over time and because policies and guidance evolve over time. A licensing based statute, by the very nature of its product-by-product review, fosters inconsistency. It is in riFRA that the difficulty lies. 55 Report NO. E1EPF1-05-0429-2100613 ------- Labeling of Pesticides APPENDIX 1 Page 6 of 11 Except during initial registration, the Agency's ability to compel changes in labeling that registrants do not agree to make is constrained by the fact that FIFRA does not provide for directly enforceable labeling regulations under section 12. EPA must enforce its labeling regulations in the same manner that it requires labeling changes not prescribed by regulation (cancellation or nisbranding enforcement). This weakness in FIFRA is a major consideration driving program choices. While not an absolute bar to obtaining label changes, the statutory mechanisms are cumbersome and time-consuming. Thus, in most situations where OPP issues a policy document affecting the labeling of a large number of products at one time, we rely on a voluntary compliance strategy rather than a cancellation-based strategy or enforcement of nisbranding provisions. As a result, the program chooses to issue its labeling standards by a less costly and faster method. The report identifies accurately the result—a variety of non-regulatory documents such as PR Notices and Registration standards—but ascribes to regulations greater weight than they actually possess under FIFRA. The Administration has proposed in the past, and had rejected, a legislative proposal that would give EPA direct authority to compel compliance with regulations, including labeling regulations. A second legislative solution, contained in the Administration's current proposal, is to streamline the cancellation process to make it faster and less cumbersome. Speeding up the cancellation process would allow OPP to use it more effectively as a tool to obtain compliance. Either legislative change would enhance our ability to ensure that labeling is accurate and consistent. RECOMMENDATION 3.1: OPPTS should continue to develop and implement procedures for reviewing pesticide labels. The procedures should include verifying compliance with appropriate registration standards. RESPONSE: in December 1991, EPA established a Center for Excellence for Labeling to focus on labeling problems. The charge of the group was to collect, evaluate and update policies and procedures; to provide training materials; and to improve consistency and quality in the label review process. As its first project, the group is collecting all available policies and procedures and developing labeling review guide for Product Managers. The guide will review the different parts of the label It should be noted, however, that the Office of General Counsel is currently researching whether the misbranding provisions of FIFRA can be interpreted to limit challenges to natters resolved in rulemaking. If so, OPF may reassess the value of issuing labeling standards through regulation. 56 Report No. B1BFF1-05-0429-2100613 ------- Labeling of Pesticides APPENDIX 1 Page 7 of 11 step-by-step and will refer readers to the sources of information and policy affecting their decisions in each area. This effort is planned for completion by September 1993. With respect to verifying compliance with Registration Stardard labeling requirements, OPP will do so for new products and amendments to the extent that the requirements applied to end use products. A memo to Branch Chiefs to this effect will be issued by October 30, 1992. RECOMMENDATION 3.2: OPPTS should revise 40 CFR Part 156, "Labeling Requirements for Pesticides and Devices," to reflect what it is currently requiring on pesticide labels. RESPONSE: OPP believes that the efforts by the Labeling Center for Excellence to collect, analyze and disseminate current policy is a necessary first step before revising its labeling regulations. The program expects to complete this initial task by March 31, 1993. Thereafter, we will decide whether and when to revise labeling regulations. However, until the benefits of regulations are demonstrably greater than other labeling standard documents, considering the time and resources needed to promulgate them, they will not be a high priority for the program among other competing activities. RECOMMENDATION 3.3: OPPTS should require registrants to correct the precautionary and restricted use statements, or document why changes were not needed, for those labels referred to in this chapter. RESPONSE: OPP agrees with this recommendation, and will issue letters by October 30, 1992, to affected registrants requesting them to correct their labels. CHAPTER 4. REGISTRANTS DID NOT SUBMIT FINAL PRINTED LABELS. CONCLUSION: The report concludes that EPA did not have complete copies of final printed labels for many pesticides, contrary to its policy as expressed in PR Notice 82-2. (Regulations in 40 CFR 152 do not require submission of final printed labeling, but current labeling regulations in 40 CFR 156 do). The report cites a need for final printed labeling to ensure that directed corrections are actually made. The report cites instances in which OPP registration files did not contain a final printed label, or contained only a draft accepted label with changes. The report suggests that, since OPP only selectively reviews final printed labeling for compliance, it should at a minimum set compliance deadlines for registrants to make changes that affect health and safety. 57 Report NO. E1EPP1-05-0429-2100613 ------- Labeling of Pesticides APPENDIX 1 Page 8 of 11 Further, the report concludes that opp was not consistently providing final printed or accepted labels to enforcement personnel, such as State inspectors who needed to verify compliance in the field. The report finds that in some cases registrants submitted to States (who also conduct registration programs at the State level) labels that did not comport with the OPP accepted label. However, the report correctly recognizes that it is not the particular form of the label that is critical for enforcement, but that fact that the label is documented as accepted by the Agency. opp agrees that its current policies and rules require the submission of a final printed label prior to marketing, and that OPP has not been consistent either in assuring that this was done, or in selectively reviewing such labeling for compliance with necessary changes. RECOMMENDATION 4.1: OPPTS should implement a system, similar to what the Office of Pesticides outlined in PR Notice 82-2, to ensure that registrants submit final printed labels. The system should include notification of registrant's obligation to submit final printed labels, establishment of timeframes for health and environment-related changes, and a verification of compliance with needed changes. RESPONSE: OPP believes that registrants have adequate notice of their obligation to submit final printed labeling. PR Notice 82- 2, describes the Agency's policy of requiring the submission of final printed labeling, which the Agency will selectively review. Moreover, the Notice of Registration issued at the time of registration contains a statement to this effect. With respect to the establishment of timeframes for label revisions, we agree that such policies are necessary, and have established them. As the report notes, registrant-initiated requests to revise human or environmental hazard precautionary statements are subject to 40 CFR 152.130, which sets an 18-month timeframe for the use of old labeling. In addition, in June 1991, EPA issued in the Federal Register a Statement of Policy on Existing Stocks of Pesticides (56 FR 29362), which sets out when and how the Agency will establish timeframes for labeling changes under various circumstances, including Agency-initiated health and safety labeling. When OPP identifies a label revision that may affect human health or the environment, OPP will notify the registrant of the needed label change and specify a date by which the registrant must respond. RD will issue a memorandum to this effect to Branch Chiefs and Product Managers by October 30, 1992. 58 Report MO. E1EPF1-05-0429-2100613 ------- Labeling of Pesticides APPENDIX I Page 9 of 11 With respect to verifying that registrants submit final printed labels and make the changes requested, OPP will reinstitute its selective audit of final printed labels. By January 31, 1993, OPP will develop a Standard Operating Procedure describing how it will conduct the process. During FY 93, OPP intends to review and verify accuracy of at least 50 product labels under the new process. Thereafter, OPP will evaluate the results of the selective review to determine whether any changes are needed in the audit process. RECOMMENDATION 4.2: OPPTS should make EPA accepted labels available to EPA and State enforcement personnel. RESPONSE: On a quarterly basis, OPP provides an updated version of the Compact Label File on microfiche to the Regional Offices. OPP does not provide this microfiche directly to States because of the cost of reproducing the microfiche. However, States have access to accepted labeling through the Regional Offices. OPP has conducted a feasibility study on the possibility of supplying the Compact Label File using CD-ROM technology. The study concluded that it is feasible to do so, and once a complete set of accepted labels is developed the cost of updating via CD-ROM technology would be considerably less than using microform technology. The Program Management and Support Division (PMSD) of OPP has proposed $200,000 in funding for this conversion for FY93. OPP has also identified as an FY 93 priority in the Information Management Strategy other priorities that would lay the foundation for enhanced future availability of labels and label information within the pesticide regulatory community, which includes states: •Under the goal of Minimizing Barriers to Pesticide Information Sharing Within the Regulatory Community, OPP has identified the task of providing access to the OPP/OCM IAN by Regions and other regulatory partners. PMSD has proposed $25,000 in intramural funding to begin this work, which would link regions directly to Headquarters systems containing product and label information. •Under the goal of Managing Information for Maximum Feasible Reliability, OPP has included the objective of defining a rigorous structure for electronic submission and dissemination of full label content. PMSD has proposed 0.2 FTE, but no funding, in FY93 for this project. This task would pave the way for future electronic transmission of label content (but not imaging) to the enforcement community. No decisions on funding or resources for Information Management in FY93 have yet been made. If funding is not available for these projects in FY93, OPP will continue its 59 Report No. E1EPF1-05-0429-2100613 ------- Labeling of Pesticides APPENDIX 1 Page 10 of 11 10 current practice of supplying microfiche copies to Regions. Although cumbersome, the current system does provide a basic level of access to labels. RECOMMENDATION 4.3: OPPTS should require registrants to submit final printed labels for those products referred to in the report. RESPONSE: OPP agrees, and will issue such letters to registrants by October 30, 1992. CHAPTER 5. EPA NEEDS TO MAKE BETTER USE OF INFORMATION IN INCIDENT REPORTS. CONCLUSION: The report concludes that OPP did not in the past centrally collect, organize, follow-up, or use information reported to the program by the public. The report claims that OPP placed little importance on such information, which, it asserts, could identify problem pesticides where OPP could direct registrants to change label precautions. The report acknowledges a number of recent improvements in OPP's administration of its incident information systems which correct most of the deficiencies the report cites. The report focussed on OPP's handling of incident reports available from the National Pesticide Telecommunication Network (NPTN) system, and not those provided through the mandatory 6(a)(2) program. Voluntary incident information is important to our regulatory programs, but the report should fully describe the value and limitations of such data for regulatory purposes. The type of information gained from such reports is unlikely independently to sustain a regulatory decision. The quality and quantity of information needed is significantly greater than that provided by unverified, poorly documented incident reports. Because the NPTN is primarily intended to provide information to the public rather than receive incident reports, it is not asked to perform the intensive follow up needed to yield useful incident information, opp must assess the significance of NPTN information and conduct follow up with NPTN callers, a resource-intensive process of uncertain success, reserved only for incident reports of serious adverse effects. For those which do not warrant followup or where followup provides insufficient information, however, the aggregation of incident reports can indicate trends in pesticide effects, exposures, or particular chemicals that should be further evaluated for regulatory action, including improved labeling. 60 Report NO. E1EPF1-05-0429-2100613 ------- Labe1lag of Pesticides APPENDIX 1 Page 11 of 11 11 RECOMMENDATION 5.1: OPPTS should review information from the National Pesticide Telecommunication Network when determining whether incident reports indicate a need for Agency action. RESPONSE: OPPTS agrees with this recommendation, and has already implemented information management systems which will permit it to readily access such data for review and consideration in regulatory decisionmaking. We have requested NPTN to collect more precise information from callers with potential incident information. Oral guidance has been provided on the types of information to collect. Written procedures including what data elements to collect will be provided by the end of October. It should be emphasized that this additional information collection by NPTN will primarily assist OPP in determining which incidents warrant followup and make followup easier, but does not substitute for OPP followup, and will not reduce the resources needed for integrating incident information into regulatory decisionmaking. In addition, as the report acknowledges, OPP has implemented improved procedures for processing and evaluating incident reports?. Among them is the Incident Data System (IDS). Incident reports arriving since June 1992 have been loaded into the system. Among other functions, IDS serves as a tool to aggregate incident reports by chemical, product, location, effect, etc. to determine if trends of concern are emerging. It can identify areas that may warrant more detailed data generation or investigation. These may lead to label changes. While NPTN data also yield aggregate reports of interest, IDS is expected to provide more and better aggregate report capabilities. In order to increase the size of the data base of incident reports to support aggregate reporting, OPP management is considering the feasibility of loading the backlog of existing paper records of incident reports into IDS. This effort is estimated to cost $250,000 and is under consideration in the OPP resource allocation process. While cost is not the only factor in analyzing the feasibility of loading the paper records, it is important to recognize the substantial expense related to acquisition, entry and maintenance of quality information. 61 Report NO. E1EPF1-05-0429-2100613 ------- Labeling of Pesticides [This page was intentionally left blank.] 62 Report NO. E1EPF1-05-0429-2100613 ------- Labeling of Pesticides APPENDIX 2 Page 1 of 1 ABBREVIATIONS CFR Code of Federal Regulations EPA Environmental Protection Agency ?IFRA Federal Insecticide, Fungicide, and Rodenticide Act MRID Master Record Identification Number KPTN National Pesticide Telecommunications Network OCM Office of Compliance Monitoring OPP Office of Pesticide Programs PPIS Pesticide Product Information System 63 Report No. E1EPF1-05-0429-2100613 ------- Labeling of Pesticides APPENDIX 3 Page 1 of 1 DISTRIBUTION Inspector General (A-109) Assistant Administrator for Prevention, Pesticides and Toxic Substances (TS-788) Agency Followup Official (PM-208) Attention: Assistant Administrator for the Office of Administration and Resources Management Agency Followup Coordinator (H-3304) Attention: Director, Resource Management Division Audit Followup Coordinator Office of Program Management Operation (TS-788) Associate Administrator for Regional Operations and State/Local Relations (H-1501) Associate Administrator for Communications and Public Affairs (A-100) Associate Administrator for Congressional and Legislative Affairs (A-103) Headquarters Library (PM-211A) 64 Report MO. 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