Attachment D 

Pesticide Registration Notice 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 of Pesticides 

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) of the Federal Insecticide, 

Fungicide and Rodenticide Act (FIFRA), which requires pesticide registrants to report 

information concerning unreasonable adverse effects of their products to EPA (62 FR 49370). 

The purpose of the 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 

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 This rule became effective June 16, 1998, and superseded all previous policy 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 of those efforts, the Agency has taken several 

actions. On April 3, 1998, the Agency issued Pesticide Registration Notice 98-3 which provided 

registrants guidance on implementing the new regulations. It addressed questions and issues 

raised by registrants and other parties subsequent to the publication of the 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 of a 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 Agency published a notice in the Federal Register which deferred the 

compliance date of the regulations from June 16, 1998 to August 17, 1998 (63 FR 41192). This 

was done because the Final Rule and Technical Corrections were not published until after the 

original effective date of the regulations. Finally, through a series of registrant-sponsored 

workshops and other discussions, additional issues were raised which the Agency has decided to 

address in this PR notice. In addition to providing guidance on the details of the June 19, 1998 

Final Rule and Technical Corrections and other matters, this PR notice notifies registrants of the 

elimination of a reporting requirement for at least one year. 
II. PURPOSE 

The purpose of this PR notice is to announce the availability of the 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 of the elimination of a specific reporting requirement for a period of at least one 

year. The guidance in this document has been organized alphabetically by subject area, and a 

table of contents has been provided for ease of reference. 

III. FOR FURTHER INFORMATION 

Registrants may contact Kathryn Bouve for information or questions concerning this PR 

notice and attached guidance document at: Office of Pesticide 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 of Pesticide Programs 

Environmental Protection Agency 
Attachment to PR Notice 98-4 

Attachment to PR Notice 98-4 

Additional Guidance on Final FIFRA 6(a)(2) Regulations 

for Pesticide Product Registrants 

August 4, 1998 

&EPA 

Environmental Protection Agency 

Office of Pesticide Programs 
Attachment to PR Notice 98-4 

Additional Guidance on Final FIFRA 6(a)(2) Regulations 

TABLE OF CONTENTS 

(alphabetical by topic) 

I. Introduction ....................................................................................................... . 

II. Deferral of Compliance Date . ...... ... . ....... .. .. . . .. . . . .. .. .. . . .. . . . .. . . .. . . .. ... . . .. . . . . . . ... . . . . . . .. .. . 2 

III. Definition of Registrant . . .. .. .. .. . .. . . . .. . . .. .. . . .. . . . . .. .. .. . . .. . . . .. ... . .. . . .. .... .. . . . . .. . .. . .. .. . . . . .. .. . . 2 

IV. Elimination of Reporting Requirement- 'May Suffer' Incidents.......................... 3 

V. Information about MCL's and HAL's for Chemicals........................................... 4 

VI. Modification of Reporting 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................................................................... 8 
Attachment 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) of the Federal Insecticide, 

Fungicide and Rodenticide Act (FIFRA), which requires pesticide registrants to report 

information concerning unreasonable adverse effects of their products to EPA. The purpose of the 

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 of FIFRA 

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 reporting requirements have been expanded, and others 

reflect increased flexibility or exemptions for reporting specific types of information. 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 of those efforts, the Agency has taken several 

actions. 

On April 3, 1998, the Agency issued Pesticide Registration Notice 98-3 which provided 

registrants guidance on implementing the new regulations. It addressed questions and 

issues raised by registrants and other parties subsequent to the publication of the 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 of a 

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 Agency published a notice in the Federal Register which deferred 

the compliance date of the 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 of the compliance date of the regulations. The Agency agreed to the request 

because the Final Rule and Technical Corrections were not published until after the 

original effective date of the regulations. The Agency acknowledged that the deferral will 

give registrants sufficient time to implement compliance programs. 

Finally, through a series of registrant-sponsored workshops and discussions, additional 

issues were raised which the Agency has decided to address in this PR notice. This 

includes elimination, for a period of at least one year, ofthe requirement to report 

incidents in which adverse effects have not occurred, but exposed individuals may suffer 

adverse effects in the future. 

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Attachment to PR Notice 98-4 

For further information, contact Kathryn S. Bouve, Office of Pesticide 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-existing requirements 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 of its 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 of the 

compliance date of the regulations. 

III. DEFINITION OF REGISTRANT 

In the June 19, 1998 FR Final Rule and Technical Corrections, the Agency changed the 

definition of registrant to make it consistent with the definition of registrant in FIFRA. Registrant 

is now defined as " .. any person who holds, or ever held, a registration for a pesticide product 

issued under FIFRA 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 of this change is to 

make clear that only registrants are obligated to submit adverse effects information to the Agency. 

Employees and agents, with the exception of supplemental 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 of the registrant and 

both the supplemental distributor and underlying section 3 registrant are liable for violations 

pertaining to the distributor product. Nevertheless, regarding the submission of adverse 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. 

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Attachment 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 accomplished by providing registrants with written notification of 

the change in reporting requirements. As the Preamble to the regulations explains, EPA may 

eliminate a reporting provision if the Agency believes the provision will not provide useful 

information. By this PR Notice, beginning on the effective date of the regulations of August 17, 

1998, the Agency eliminates for all registrants the requirement to report incidents in which a 

registrant has been informed that a person or non-target organism may suffer a delayed or chronic 

adverse effect in the future. This requirement is found in section 159.184(a)(2). The elimination 

of this 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 been reinstated. 

To summarize, with this change, the general conditions for reporting toxic or adverse 

incidents reports are as follows: 

(1) The registrant is aware, or has been informed that a person or non-target organism 

may have been exposed to a pesticide. 

(2) The registrant is aware, or has been informed that the person or non-target organism 

suffered a toxic or adverse effect. 

(3) The registrant has or could obtain information concerning where the incident 

occurred, the pesticide or product involved, and the name of a person to contact regarding 

the incident. 

The elimination of the requirement to report incidents in which a person or non-target 

organism may suffer a delayed or chronic adverse effect in the future results in a slight change in 

the definition of incident exposure type/severity category H-E found in 159.184(c)(5)(i)(E). 

Included in that category were incidents in which future or delayed 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 year period in response to 

information provided by registrants and other parties 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 if adverse effects may occur as a result of 

exposure or possible exposure to their pesticide. Under the final regulations, such incidents 

appear to be reportable. After consultation with Agency scientists in OPP's Health Effects 

Division and staff at a major poison control center, it was agreed that the very small number of 

potentially useful incidents reports could be buried in the much larger number of reports that were 

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Attachment 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 other hand, incidents of very significant or 

unexpectedly high exposure to pesticides whose primary toxic properties are chronic or delayed 

should be reported. The same is true for reports of unexpectedly 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 ofthe regulations because such information could 

have impact on continued registration of the product or on terms and conditions of registration. 

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 whether these kinds of incidents appear to 

be properly reported 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 of water by pesticides. Section 159.153(b) includes definitions of the water 

reference levels that trigger reporting. 

For human 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 by EPA's Office of Water. The standards are set for many chemicals some 

of which are pesticides. If an MCL has been established for the pesticide detected, 10% or more 

of the MCL is the reporting trigger. If an MCL has not been established, but an HAL has been 

established for the detected pesticide, 10% or more of the HAL is the reporting trigger. HAL's 

are set for different exposure durations and weights of exposed individuals. When relying 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. Copies of the 

Drinking Water Regulations and Health Advisories may be ordered free of charge from the: 

SAFE DRINKING WATER HOTLINE 

1-800-426-4 791 

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/OST IT ools/ dwstds.htrnl 

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Attachment to PR Notice 98-4 

VI. MODIFICATION OF REPORTING TIMEFRAME- AUGUST 17-31, 1998 

As noted above, with publication of the 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 of the 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 of information. 

For some categories of information, information may be accumulated for one month and 

may be submitted by the end of the month following the accumulation period. For other 

categories of information, information may be accumulated for three months and may be 

submitted by the end of the second month following the accumulation period. In the interest of 

simplicity, the Agency would like registrants to use the last day of a month as the deadline for 

reporting adverse effects information as applicable to the Agency. 

Registrants have raised the question of how to handle submission of adverse effects 

information that comes into a registrant's possession during the period August 17 - 31, 1998. To 

address that concern, by this PR Notice, the Agency is permitting registrants to include reportable 

information that arises during the period of August 17 - 31, 1998 in the following way: 

For categories of information that may be accumulated for one month and submitted by 

the end of the 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 Agency by the end of October, 1998. 

For categories of information that may be accumulated for three months and submitted by 

the end of the second month following the accumulation period, information arising 

between August 17 and 31, 1998 may be accumulated with information arising during the 

months of September, October, and November, 1998. Such reports will be due to the 

Agency by the end of January, 1999. 

This is a one-time modification of reporting timeframes and applies to the period August 

17-31, 1998 only. This modification ofreporting timeframes is done per section 159.155(a) 

which provides EPA the discretion to notify registrants in writing of a different reporting period 

for specific information. 

VII. REPORTING OF INFORMATION OBTAINED BEFORE PROMULGATION 

Section 159.159 of the regulations specifies the requirements regarding information 

obtained before June 16, 1998 which is reportable under the regulations but was not reportable 

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Attachment to PR Notice 98-4 

under the 1979 Enforcement Policy. The September 19, 1997 regulations required that 

information of this type be submitted to the Agency by June 16, 1999. This has been referred to 

as the 'look back' provision. Notwithstanding the deferral of the compliance date of the 

regulations, reportable information under 159.159 is still required to be submitted by June 16, 

1999. Registrants have been aware of the 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 FR notice, the Agency specified the 

information items to be provided with reports of adverse effects information. The technical 

corrections linked requirements to report to the lists of data elements in section 159.184. What 

follows is a summary of those requirements: 

For detection of pesticides 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 of analysis 

For detection of pesticides 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) If raw water samples, water bodies sampled and approximate locations in each 

water body. 

(B) If raw water samples, proximity of sampling locations to drinking water supply 

intakes and identities of systems supplied. 

(C) If finished water samples, water supply systems sampled. 

(D) If finished 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. 

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Attachment to PR Notice 98-4 

(G) Pesticides and degradates analyzed for, the detection limits, and amount 

detected. 

(H) Method of analysis. 

For detections 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)Amount pesticide applied (lbs-ai/acre). 

(D) Date of last application. 

(E) Depth to water. 

(F) Latitude/longitude. 

(G) Soil series and texture(sand/silt/clay). 

(H) Frequency of applications per year. 

(I) Aquifer description (confined/unconfined). 

(J) Method of application. 

(K) Years pesticide used. 

(L) Well use and well identifier. 

(M) Screened interval. 

(N) Annual cumulative rainfall (inches). 

(0) Maximum rainfall and date. 

(P) Cumulative irrigation (inches). 

(Q) Hydrologic group. 

(R) Hydraulic conductivity. 

(S) pH. 

{T) Organic matter or organic carbon (percent). 

Also (5)(vi) - Severity Category 

IX. TECHNICAL CORRECTIONS - REPORTING TIMEFRAMES 

Among the technical corrections in the June 19, 1998 FR Notice, the Agency specified the 

reporting time frames for all categories of reportable adverse effects information. What follows is 

a summary of those requirements: 

ASAP - No later 

than 15 calendar 

days 

Allegation of human death- H-A 

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Attachment to PR Notice 98-4 

No later than 30 

calendar days 

Accumulate for 

one month/submit 

by end of next 

month 

Scientific studies- section 159.165 

Information about discontinued studies- section 159.167 

Human epidemiological and exposure studies - section 159.170 

Detection of pesticide in or on food or feed- section 159.178(a) 

Detection of metabolites, degradates, contaminants, impurities - section 

159.179 

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

Other information - 159.195 

Major human incident- H-B 

Moderate human incident- H-C 

Major wildlife incident - W -A 

Major plant damage incident- P-A 

Major water incident - G-A 

Efficacy failure incident- section 159.188(a)(l) and (b)(l) 

Accumulate for Minor human 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 Minor domestic animal incident- D-D 

Domestic animal incident- symptoms unknown or not specified- D-E 

Minor wildlife incident- W-B 

Minor plant damage incident - P-B 

Incidents involving all other non-target organisms - ONT 

Moderate water incident - G-B 

Minor water incident - G-C 

X. VOLUNTARY INCIDENT REPORTING FORMS 

A work group comprising representatives of registrant 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 order to determine if it is reportable (exposure, adverse effect, contact person, 

pesticide identification, and where it occurred). In addition, it will foster the process by which 

registrants categorize each incident by exposure 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 of appropriate categories of exposure types and severity as specified in the regulations. 

Use of these forms is voluntary and information submitted using the forms will be accepted by the 

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Attachment to PR Notice 98-4 

Agency. Other formats that meet the requirements of the regulations will be acceptable to the 

Agency as well. The forms and instructions are available to any interested party from the 

participating trade associations that follow: 

American Crop Protection Association 

1156 15th Street, N.W. Suite 400 

Washington, DC 20005 

Staff contact - Ray McAllister 

Phone- 202-296-1585 

Fax- 202-463-0474 

Web site- www.acpa.org 

Chemical Producers and Distributors 

Association 

1430 Duke Street 

Alexandria, VA 22314 

Staff contact- Warren Stickle 

Phone - 703-548-7700 

Fax- 703-548-3149 

Web site- www.cpda.com 

International Sanitary Supply Association 

7373 North Lincoln Ave. 

Lincolnwood, IL 60646 

Staff contact - Bill Balek 

Phone- 847-982-0800 

Fax- 847-982-1922 

Web site- www.issa.com 

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Chemical Manufacturers Association 

1300 Wilson Blvd. 

Arlington, VA 22209 

Staff contact - 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 

Staff contact - Steve Kellner 

Phone - 202-872-8110 

Fax- 202-872-8114 

Web site- www.csma.org