## Attachment D

PesticideRegistrationNotice 98-4 Additional Guidance on Final FIFRA Section 6(a)(2) Regulations for Pesticide Product Registrants (w/ Attachment) (available electronically at http://www.epa.gov/opppmsdl/PR Notices/pr98-4.pdt)August 4, 1998 PESTICIDE REGISTRATION NOTICE 98-4 NOTICE TO MANUFACTURERS, FORMULATORS, PRODUCERS, DISTRIBUTORS AND REGISTRANTS OF PESTICIDE PRODUCTS ATTENTION: SUBJECT: Persons Responsible for Federal Registration ofPesticides Additional Guidance on Final FIFRA Section 6(a)(2) Regulations for Pesticide Product Registrants
I. BACKGROUND On September 19, 1997, EPA published in the Federal Register the final rule codifying EPA's interpretation and enforcement policy regarding section 6(a)(2) ofthe Federal Insecticide, Fungicide and Rodenticide Act (FIFRA), which requires pesticide registrants to report information concerning unreasonable adverse effects oftheirproducts to EPA (62 FR49370). The purpose ofthe rule is to clarify what information to submit, how and when to submit it, as well as which failures to report information, ordelays in reporting, will be regarded by EPA as violations ofFIFRA section 6(a)(2), actionable under FIFRA sections 12(a)(2)(B)(ii) and 12(a)(2)(N). This rule became effective June 16, 1998, and superseded all previous policy statements pertaining to section 6(a)(2). EPA has been working with registrants to prepare them for effective implementation of the new FIFRA 6(a)(2) regulations. As a result ofthose efforts, the Agencyhas taken several actions. On April 3, 1998, the Agency issued Pesticide Registration Notice 98-3 which provided registrants guidance on implementing the new regulations. 

### Itaddressed questions and issues raised by registrants and otherparties subsequent to the publication ofthe final rule. On June 19, 1998, the Agency published a Final Rule and Technical Corrections to amend and correct the final regulations (63 FR 33580). The action changed the definition ofa registrant to make it consistent with the statutory definition and thus clarified the scope ofthe registrant's responsibilities and liabilities under section 6(a)(2). The corrections included omitted, yet implied, reporting time frames andrequiredreportable information, missing conjunctions, and minor editorial changes. On August 3, 1998, the Agency published a notice in the Federal Register which deferred the compliance date ofthe regulations from June 16, 1998 to August 17, 1998 (63 FR41192). This was done because the Final Rule and Technical Corrections were not published until after the original effective date ofthe regulations. Finally, through a series ofregistrant-sponsored workshops and other discussions, additional issues were raised which the Agency has decided to address in this PRnotice. In addition to providing guidance on the details ofthe June 19, 1998 Final Rule and Technical Corrections and other matters, this PRnotice notifies registrants ofthe elimination ofa reporting requirement for at least one year.

### II. PURPOSE The purpose ofthis PRnotice is to announce the availability ofthe attached document which will provide registrants guidance on the June 19, 1998 Final Rule and Technical Corrections; the August 3, 1998 Federal Register notice that deferred the compliance date ofthe regulations; address additional issues raised by registrants since publication ofPRN 98-3; and notify registrants ofthe elimination ofa specific reporting requirement for a period ofat least one year. The guidance in this documenthas been organized alphabetically by subject area, and a table ofcontents has been provided for ease ofreference. 

### III. FOR FURTHER INFORMATION Registrants may contact Kathryn Bouve for information or questions concerning this PR notice and attached guidance document at: Office ofPesticide Programs (7502C), U.S. Environmental Protection Agency, 401 M St., SW, Washington, DC 20460. Office location, telephone number and e-mail address: Crystal Mall #2, Rm. 224, 1921 Jefferson Davis Highway, Arlington, VA, (703) 305-5032, e-mail: Bouve.Kate@epa.gov.

Marcia E. Mulkey, Director Office ofPesticide Programs Environmental Protection AgencyAttachment to PR Notice 98-4



### Attachmentto PRNotice 98-4 

### Additional Guidance on FinalFIFRA 6(a)(2) Regulations for Pesticide ProductRegistrants August4, 1998



# &EPA

Environmental Protection Agency Office ofPesticide ProgramsAttachment to PR Notice 98-4 Additional Guidance on Final FIFRA 6(a)(2) Regulations TABLE OF CONTENTS

(alphabetical by topic)


### I. Introduction ........................................................................................................ II. Deferral ofCompliance Date

....................... .... . ..... ... .... . .... .... ....... .... . . . . ..... . . . . ...... 2 III. Definition ofRegistrant

. ............. . .... ...... .... . . ........ .... . .......... .......... . . ......... ... . . ... ... . 2 IV. Elimination ofReporting Requirement- 'May Suffer' Incidents.......................... 3 V. Information about MCL's and HAL's for Chemicals........................................... 4 VI. Modification ofReporting Timeframe

- August 17

- 31..

.... . . . . . . . . .......................... 5 VII. Reporting oflnformation Obtained Before Promulgation..................................... 5 VIII. Technical Corrections- Reportable Information................................................... 6

IX. Technical Corrections- Reporting Timeframes..................................................... 7 X. Voluntary Incident Reporting Forms................................................................... 8Attachment to PR Notice 98-4 

### I. INTRODUCTION On September 19, 1997, EPA published in the Federal Register the final rule codifying EPA's interpretation and enforcement policy regarding section 6(a)(2) ofthe Federal Insecticide, Fungicide and Rodenticide Act (FIFRA), which requires pesticide registrants to report information concerning unreasonable adverse effects oftheirproducts to EPA. The purpose ofthe rule is to clarify what information to submit, how and when to submit it, as well as which failures · to report information, or delays in reporting, will be regarded by EPA as violations ofFIFRA section 6(a)(2), actionable under FIFRA sections 12(a)(2)(B)(ii) and l2(a)(2)(N). In comparison to previous EPA policy statements, some reportingrequirements have been expanded, and others reflect increased flexibility or exemptions for reporting specific types ofinformation. This rule became effective June 16, 1998, and superseded all previous policy statements pertaining to section 6(a)(2). EPA has been working with registrants to prepare them for effective implementation of the new FIFRA 6(a)(2) regulations. As a result ofthose efforts, the Agency has taken several actions. OnApril 3, 1998, the Agency issued Pesticide Registration Notice 98-3 which provided registrants guidance on implementing the new regulations. Itaddressed questions and issues raised byregistrants and otherparties subsequent to the publication ofthe final rule. OnJune 19, 1998, the Agency published a Final Rule and Technical Corrections to amend and correct the final regulations (63 FR 33580). The action changed the definition ofa registrant to make it consistent with the statutory definition and thus clarified the scope of the registrant's responsibilities and liabilities under section 6(a)(2). The corrections included omitted, yet implied, reporting time frames and required reportable information, missing conjunctions, and minor editorial changes. On August 3, 1998, the Agencypublished a notice in the Federal Register which deferred the compliance date ofthe regulations from June 16, 1998 to August 17, 1998 (63 FR 41192). This was done in response to a petition from seven trade associations asking for deferral ofthe compliance date ofthe regulations. The Agency agreed to the request because the Final Rule and Technical Correctionswere not publisheduntil afterthe original effective date ofthe regulations. The Agency acknowledged that the deferral will give registrants sufficient time to implement compliance programs. Finally, through a series ofregistrant-sponsored workshops and discussions, additional issues were raised which the Agency has decided to address in this PRnotice. This includes elimination, for a period ofat least one year, oftherequirement to report incidents in which adverse effects have not occurred, but exposed individuals may suffer adverse effects in the future.
1Attachmentto PR Notice 98-4

For further information, contact Kathryn S. Bouve, Office ofPesticide Programs (7502C), U.S. Environmental Protection Agency, 401 M St., SW, Washington, DC 20460. Office location, telephone number and e-mail address: Crystal Mall #2, Rm. 224, 1921 Jefferson Davis Highway, Arlington, VA, (703) 305-5032, e-mail: Bouve.Kate@epa.gov. 

### II. DEFERRAL OF COMPLIANCE DATE In the August 3, 1998 Federal Register notice, the Agency announced that the compliance date ofthe 6(a)(2) regulations is deferred until August 17, 1998. EPA is aware that some registrants may wish to comply with the new regulations immediately rather than continue to comply with the pre-existingrequirements for another two months. Any registrant that wishes to comply with the new regulations immediately may do so provided that the registrant first informs the Agency in writing ofits desire to be bound by the new regulations effective June 16, 1998. Such notice should be submitted to Kathryn Bouve, the Agency contact person, at the address given above. Please see VI. and VII. below for additional guidance related to the deferral ofthe compliance date ofthe regulations. 

### III. DEFINITION OF REGISTRANT In the June 19, 1998 FR Final Rule and Technical Corrections, the Agency changed the definition ofregistrant to make it consistent with the definition ofregistrant in FIFRA. Registrant is now defined as "

..any person who holds, oreverheld, a registration for a pesticide product issued underFIFRA section 3 or 24(c)." The language about employees and agents has been removed from 159.153(b) and is incorporated into 159.155(b). The effect ofthis change is to make clearthat onlyregistrants are obligated to submit adverse effects information to the Agency. Employees and agents, with the exception ofsupplemental distributors, have no independent obligation to submit adverse effects information to the Agency. Registrants are, however, responsible for information possessed by their employees and agents. Regarding supplemental distributors, guidance provided in PRN 98-3 is still in effect. Supplemental distributors are defined in 40 CFR section 152.132 as agents ofthe registrant and both the supplemental distributor and underlying section 3 registrant are liable for violations pertaining to the distributorproduct. Nevertheless, regarding the submission ofadverse effects information under 6(a)(2), the Agency prefers that supplemental distributors deliver reportable information to the underlying registrant (in sufficient time for registrant to report) and not directly to EPA.

2Attachment to PR Notice 98-4 

### IV. ELIMINATION OF REPORTING REQUIREMENT- 'MAY SUFFER' INCIDENTS Section 159.155(a) states that: "EPA may, in its discretion,
.......eliminate reporting requirements entirely." This is accomplishedby providing registrants with written notification of the change in reporting requirements. As the Preamble to the regulations explains, EPA may eliminate a reporting provision ifthe Agency believes the provision will notprovide useful information. By this PRNotice, beginning on the effective date ofthe regulations ofAugust 17, 1998, the Agency eliminates for all registrants the requirement to report incidents in which a registrant hasbeen informed that a person or non-target organism may suffer a delayed orchronic adverse effect in the future. This requirement is found in section 159.184(a)(2). The elimination ofthis requirement will remain in effect for at least one year and for any further period until the Agency provides written notice to registrants that the requirement has beenreinstated. To summarize, with this change, the general conditions for reporting toxic or adverse incidents reports are as follows: (1) The registrant is aware, orhas been informed that a person or non-target organism may have been exposed to a pesticide. (2) The registrant is aware, orhas been informed that the person ornon-target organism suffered a toxic or adverse effect. (3) The registrant has orcould obtain information concerning where the incident occurred, the pesticide orproduct involved, and the name ofa person to contact regarding the incident. The elimination ofthe requirement to report incidents in which a person ornon-target organism may suffer a delayed orchronic adverse effect in the future results in a slight change in the definition ofincident exposure type/severity category H-E found in 159.184(c)(5)(i)(E). Included in that category were incidents in which future ordelayed effects are reported. With this change, incidents in that category are limited to those in which symptoms are unknown or unspecified. The Agency has eliminated this requirement for at least a one yearperiod in response to information provided by registrants and otherparties during the implementation workshops and meetings held since the final regulations were published in September 1997. Registrants pointed out that many individuals contact them to inquire ifadverse effects may occur as a result of exposure orpossible exposure totheirpesticide. Underthe final regulations, such incidents appearto be reportable. After consultation with Agency scientists in OPP's Health Effects Division and staffat a majorpoison control center, it was agreed that the very small number of potentially useful incidents reports couldbeburied in the much larger number ofreports that were 

### 3Attachment to PR Notice 98-4 essentially inquiries about possible effects. In order for registrants and the Agency to remain focused on a manageable volume ofuseful adverse effects information, the Agency has eliminated the requirement for at least one year. On the otherhand, incidents ofvery significant or unexpectedly high exposure to pesticides whose primary toxic properties are chronic ordelayed should be reported. The same is true for reports ofunexpectedly high exposure to very toxic pesticides regulated to ensure very low exposure although no adverse effects occurred. Such information would be reportable under 159.195 oftheregulations because such information could have impact on continuedregistration ofthe product or on terms and conditions ofregistration. During the first year the 6(a)(2) regulations are effective, the Agency will monitor to evaluate reporting pursuant to 159.195 in an effort to determine whetherthese kinds ofincidents appear to be properlyreported through that provision. 

### V. INFORMATION ABOUT MCL's AND HAL's FOR CHEMICALS Sections 159.178(b) and 159.184(c)(5)(vi) describe the requirements for reporting contamination ofwaterbypesticides. Section 159.153(b) includes definitions ofthe water reference levels that triggerreporting. Forhuman health concern, the regulations refer to the maximum contaminant levels (MCL) and the health advisory levels (HAL) which are the drinking water regulations and health advisories developed byEPA's Office ofWater. The standards are set for many chemicals some ofwhich are pesticides. Ifan MCL has been established for the pesticide detected, 10% ormore ofthe MCL is the reporting trigger. Ifan MCL has not been established, but an HAL has been established for the detected pesticide, 10% ormore ofthe HAL is the reporting trigger. HAL's are set for different exposure durations and weights ofexposed individuals. Whenrelying on an HAL as a trigger for reporting a pesticide in water, the lifetime adult level- the most conservative level

- should be used. Registrants have asked how to find the MCL's and HAL's for chemicals. Copiesofthe Drinking Water Regulations and Health Advisories maybe ordered free ofcharge from the: SAFE DRINKING WATER HOTLINE 1-800-426-4791 Monday thru Friday, 9:00A.M. to 5:30P.M. EST They are also available on the Internet at the following URL:
www.epa.gov/OSTIT ools/dwstds.htrnl

4Attachment to PR Notice 98-4 

### VI. MODIFICATION OFREPORTING TIMEFRAME- AUGUST 17-31, 1998 As noted above, with publication ofthe August 3, 1998 Federal Register notice, the 6(a)(2) regulations become effective on August 17, 1998. Consequently, August 17, 1998 marks the transition from the old reporting requirements

- the 1979 Enforcement Policy

- to the new regulations. Part ofthe transition is the shift from the 1979 EJ?forcement Policy's 30-day reporting timeframe for all information to the new regulations' variable reporting timeframes for different categories ofinformation. For some categories ofinformation, information may be accumulated for one month and may be submittedby the end ofthe month following the accumulation period. For other categories ofinformation, information may be accumulated for three months and may be submitted by the end ofthe second month following the accumulation period. In the interest of simplicity, the Agency would like registrants to use the last day ofa month as the deadline for reporting adverse effects information as applicable to the Agency. Registrants have raised the question ofhowto handle submission ofadverse effects information that comes into a registrant's possession during the period August 17

- 31, 1998. To address that concern, by this PRNotice, the Agency is permitting registrants to include reportable information that arises during the period ofAugust 17

- 31, 1998 in the following way: Forcategories ofinformation that may be accumulated for one month and submitted by the end ofthe month following the accumulation period, information arising between August 17 and 31, 1998 may be accumulated with information arising during the month of September 1998. Such reports will be due to the Agencybythe end ofOctober, 1998. Forcategories ofinformation that maybe accumulated for three months and submitted by the end ofthe second month following the accumulation period, information arising between August 17 and 31, 1998 may be accumulated with information arising during the months ofSeptember, October, and November, 1998. Such reports will be due to the Agency by the end ofJanuary, 1999. This is a one-time modification ofreporting timeframes and applies to the period August 17-31, 1998 only. This modification ofreportingtimeframes is done per section 159.155(a) which provides EPA the discretion to notify registrants in writing ofa different reporting period for specific information. 

### VII. REPORTING OF INFORMATION OBTAINED BEFORE PROMULGATION Section 159.159 ofthe regulations specifies the requirements regarding information obtained before June 16, 1998 which is reportable under the regulations but was not reportable 5Attachment to PR Notice 98-4 under the 1979 Enforcement Policy. The September 19, 1997 regulations required that information ofthis type be submitted to the Agency by June 16, 1999. This has beenreferred to as the 'look back' provision. Notwithstanding the deferral ofthe compliance date ofthe regulations, reportable information under 159.159 is still required to be submittedbyJune 16, 1999. Registrants have been aware ofthe requirement since September 1997 which has given them 21 months to review records and prepare the summary report specified in the regulations. 

### VIII. TECHNICAL CORRECTIONS
- REPORTABLE INFORMATION Among the technical corrections in the June 19, 1998 FRnotice, the Agency specified the information items to be provided with reports ofadverse effects information. The technical corrections linked requirements to report to the lists ofdata elements in section 159.184. What follows is a summary ofthose requirements: Fordetection ofpesticides in food or feed- 159.178(a) Administrative, Pesticide, and Circumstance information in 159.184(c)(1), (2), and (3) Incident Specific Information in 159.184(c)(4)(iv) (E) Sample type (grab, composite) (F) Sampling times/frequency (G) Pesticides and degradates analyzed for, the detection limits, and the amount detected. (H) Method ofanalysis Fordetection ofpesticides in water

- 159.178(b) Administrative, Pesticide, and Circumstance information in 159.184(c)(l), (2), and (3) For detections in surface water- Incident Specific Information in 159.184(c)(4)(iv) (A) Ifraw water samples, waterbodies sampled and approximate locations in each waterbody. (B) Ifraw water samples, proximity ofsampling locations to drinking water supply intakes and identities ofsystems supplied. (C) Iffinished water samples, water supply systems sampled. (D) Iffinished water samples, percent surface water source by specific surface water sources to water supply system(s). (E) Sample type (grab, composite). (F) Sampling times/frequency.
6Attachment to PR Notice 98-4 (G) Pesticides and degradates analyzed for, the detection limits, and amount detected. (H) Method ofanalysis. Fordetections in groundwater- Incident Specific Information in 159.184( c)( 4)(v) (A) Pesticide and degradates analyzed for, the analytical method used, the detection limits, and amount detected. (B) Sample date. (C)Amountpesticide applied (lbs-ai/acre). (D) Date oflast application. (E) Depth to water. (F) Latitude/longitude. (G) Soil series and texture(sand/silt/clay). (H) Frequency ofapplications peryear. (I) Aquifer description (confined/unconfined). (J) Method ofapplication. (K) Years pesticide used. (L) Well use and well identifier. (M) Screened interval. (N) Annual cumulative rainfall (inches). (0) Maximumrainfall and date. (P) Cumulative irrigation (inches). (Q) Hydrologic group. (R) Hydraulic conductivity. (S) pH. {T) Organic matter ororganic carbon (percent). Also (5)(vi)

- Severity Category 

### IX. TECHNICAL CORRECTIONS
- REPORTING TIMEFRAMES Among the technical corrections in the June 19, 1998 FRNotice, the Agency specified the reporting timeframes for all categories ofreportable adverse effects information. What follows is a summary ofthose requirements:

ASAP

- No later than 15 calendar days Allegation ofhuman death- H-A

7Attachment to PR Notice 98-4 No later than 30 calendar days

Accumulate for one month/submit by end ofnext month Scientific studies- section 159.165 Information about discontinued studies- section 159.167 Human epidemiological and exposure studies

- section 159.170 Detection ofpesticide in or on food or feed- section 159.178(a) Detection ofmetabolites, degradates, contaminants, impurities

- section

159.179 Failure ofperformance studies- section 159.188(a)(2), (b)(2), and (c) Other information

- 159.195 Majorhuman incident- H-B Moderate human incident- H-C Major wildlife incident

- W-A Majorplantdamage incident- P-A Major water incident

- G-A Efficacy failure incident- section 159.188(a)(l) and (b)(l) Accumulate for Minorhuman incident

- H:D three months/ Human incident- symptoms unknown or not specified- H-E. submit by end of Domestic animal death

- D-A second month after Major domestic animal incident- D-B accumulation Moderate domestic animal incident

- D-C period Minordomestic animal incident- D-D Domestic animal incident- symptoms unknown or not specified- D-E Minor wildlife incident- W-B Minorplant damage incident

- P-B Incidents involving all othernon-target organisms

- ONT Moderate water incident

- G-B Minor water incident

- G-C 

### X. VOLUNTARY INCIDENT REPORTING FORMS A work group comprisingrepresentatives ofregistrant companies and trade associations, with input from OPP staff, designed forms for capturing and submitting individual and aggregate incident reports. The individual incident form is designed to capture the basic information about the incident in orderto determine ifit is reportable (exposure, adverse effect, contactperson, pesticide identification, and where it occurred). In addition, it will foster the process by which registrants categorize each incidentbyexposure type and severity category and determine how much information is to be reported and when to submit the reports. An aggregate report format is also being designed. Detailed instructions accompany both forms. This will support aggregate reporting ofappropriate categories ofexposure types and severity as specified in the regulations. Use ofthese forms is voluntary and information submitted using the forms will be accepted bythe 8Attachment to PR Notice 98-4 Agency. Otherformats that meet the requirements ofthe regulations will be acceptable to the Agency as well. The forms and instructions are available to any interestedparty from the participating trade associations that follow:

American Crop Protection Association 1156 15th Street, N.W. Suite 400 Washington, DC 20005 Staffcontact

- RayMcAllister Phone- 202-296-1585 Fax- 202-463-0474 Web site- www.acpa.org Chemical Producers and Distributors Association 1430 Duke Street Alexandria, VA 22314 Staffcontact- Warren Stickle Phone

- 703-548-7700 Fax- 703-548-3149 Web site- www.cpda.com International Sanitary SupplyAssociation 7373 North Lincoln Ave. Lincolnwood, IL 60646 Staffcontact

- Bill Balek Phone- 847-982-0800 Fax- 847-982-1922 Web site- www.issa.com

9 Chemical Manufacturers Association 1300 Wilson Blvd. Arlington, VA 22209 Staffcontact

- Has Shah Phone- 703-741-5000 Fax- 703-741-6091 Web site- www.cmahq.com
Chemical Specialties Manufacturers Association 1913 Eye Street, N.W. Washington, DC 22206 Staffcontact

- Steve Kellner Phone

- 202-872-8110 Fax- 202-872-8114 Web site- www.csma.org