August 4, 1998
PESTICIDE REGISTRATION NOTICE 98-4
NOTICE TO MANUFACTURERS, FORMULATORS, PRODUCERS, DISTRIBUTORS
AND REGISTRANTS OF PESTICIDE PRODUCTS
ATTENTION: Persons Responsible for Federal Registration of Pesticides
SUBJECT: Additional Guidance on Final FIFRA Section 6(aX2) 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(aX2) 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 of FIFRA section 6(aX2), actionable under FIFRA sections 12(aX2XBXH) and
12(aX2)(N)- This rule became effective June 16, 1998, and superseded all previous policy
statements pertaining to section 6(aX2).
EPA has been working with registrants to prepare them for effective implementation of
the new FIFRA 6(aj(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 hew 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 hi the Federal
Register which deferred the compliance date of the regulations from June 16, 1998 to August 17,
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,:^f: ^P/R ^1|2)? ;Bl§ was done because the Final Rule and Technical Corrections were not
^"JS'SSSSHPtil after the original effective date of the regulations. Finally, through a series of
reS!strant-sponsored workshops and other discussions, additional issues were raised which the
f has decided to address in this PR notice. In addition to providing guidance on the
*U~ IWjL9'1998 Final Rule: and, Technical Corrections and other matters, this PR
" ^s|Jr^s °t^e elimination of a reporting requirement for at least one year.
^.0MP?
H. PURPOSE
III? ..... '. ..... II :«i .....
. ..... Im
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..... PB50^ of this PR notice is to announce the availability of the attached document
';!YteftiM;Provid? ...... Eegistrants guidance on the June 19, 1998 Final Rule and Technical
£^&m^, August 3, 1998 Federal ^ Register notice that deferred the compliance date of the
regulations; address additional issues raised by registrants since publication of PRN 98-3- and
notify registrants of the elimination of a specific reporting requirement for a period of at least one
y^'- ^ Stance « this document has been organized alphabetically by subject area and a
table of contents has been provided for ease of reference.
HI, FOR FURTHER INFORMATION
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wiJ111 i1: ,i,"in,'"'in ,. 'in;., Hi , i f « I
Registrants may contact Kathryn Bouve for information or questions concerning this PR
*n4 aftached guidance document at: Office of Pesticide Programs (75 02C) US
'S ^^TteS^H ?!P!lSt!on Agency, 401 M St., SW, Washington, DC 20460. Office location
^^^rjS?"' ^l^^^ail address: Crystal Mall #2, Rm. 224, 1921 Jefferson Davis Highway,
W^-'^W^^y^^70?). 305-5032' e-mail: Bouve.Kate@epa.gov.
MarciaE.Mu.lk^mector'
Office of Pesticide Programs
Environmental Protection Agency
s
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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
v>EPA
Environmental Protection Agency
Office of Pesticide Programs
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Attachment to PR Notice 98-4 ''-.. '
Additional Guidance oh Final FIFRA 6(a)(2) Regulations
TABLE OF CONTENTS
(alphabetical by topic)
I. Introduction.. .., i
II. Deferral of Compliance Date -...". 2
HI. Definition of Registrant .....^ .... 2
IV. Elimination of Reporting Requirement-'May Suffer'Incidents ; : 3
V. Information about MGL's and HAL's for Chemicals >.............,..... 4
VI. Modification of Reporting Timeframe-August 17-31 , 5
VII. Reporting of Information Obtained Before Promulgation 5
VIE. Technical Corrections - Reportable Information................;. v. g
DC. Technical Corrections - Reporting Timeframes ... 7
X. Voluntary Incident Reporting Forms.... .; . g
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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 12(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 Technical1 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, of the requirement to report
. incidents in which adverse effects have not occurred, but exposed individuals may suffer
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Attachment to PR Notic? 98-4
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adverse effects in the future.
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.
U. DEFERRAL OF COMPLIANCE DATE
;, " , ,;,;! . , , , .'» '.'.'..'.'
In the August 3, 1998 Federal Register notice, the Agency announced that the compliance
daje of the 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 hi 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.
HI. DEFINITION OF REGISTRANT
IntheJunei9, 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 hi PRN 98-3 is still in effect.
Supplemental distributors are defined hi 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 1 59, 155(a) states that; "EPA may,^ in its discretion, , ..... .eliminate reporting
requirements entirely," This is accomplished by providing registrants with written notation 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
^formation. By this PR Notice, beginning oh the effective date of the regulLns ofTugtt 17
egi«^
> . SUer a or
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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 Enforcement 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.
"' " " ' '' , ''' " ; ' ', ','''.,, ",,', ', '' ".I1'1,.
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:
x .- . /''
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.
.:: ' . , . i "L, , " . . ^ . 'i ,; ' ' '
This is a one-time modification of reporting timeframes and applies to the period August
17-31, 1998 only. This modification of reporting 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.
1,' ,', ' , 'L':I '' ' ' ' ' ' ' ' '' '; ' '' ', ' ' ! ' ' '
Vn. 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.
VIIL 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)(l), (2), and~p)
Incident Specific Information in 159.184(c)(4)(iv)
(E) Sample type (grab, composite)
(F) Sampling times/frequency
i (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 15 9.184(c)( 1), (2), and (3)
' , ' ' " '-''., . >
For detections in surface water - mcident 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
>'".",;
"I'iii iii'i
) Pesticides and degradates analyzed for, the detection limits, and amount
detected. .
(H) Method of analysis.
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For detections in groundwater - Incident Specific Information in 159.184(c)(4)(v)
, " . ,,, ' ll'l ' , . '"",': ' ' '' " ' ' ' ,
(A) Pesticide and degradates analyzed for, the analytical method used, the
detection limits, and amount detected.
(B) Sample date.
(C)Amount pesticide applied (Ibs-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/unconfhied).
(J) Method of application.
(K) Years pesticide used.
(L) Well use and well identifier.
(M) Screened interval.
(N) Annual cumulative rainfall (niches).
(O) 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
DC. TECHNICAL CORRECTIONS - REPORTING TIMEFRAMES
Among the technical corrections in the June 1 9, 1 998 FR Notice, the Agency specified
the reporting timeframes for all categories of reportable adverse effects information. What
follows is a summary of those requirements:
ASAP - No later Allegation of human death - H-A
than 15 calendar
days
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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 ,
Accumulate for
three months/
submit by end of
second month
after accumulation
period
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 V
Failure of performance 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)
Minor human incident - H-D
Human incident - symptoms unknown or not specified - H-E
Domestic animal death - D-A
Major domestic animal incident - D-B
Moderate domestic animal incident - D-C
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 trie forms will be accepted by
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Attachment to PR Notice 98-4
the 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:
Ameripan 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
,! I" ' M, *P ,
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, EL 60646
Staff contact - Bill Balek
Phone - 847-982-0800
Fax- 847-982-1922
Web site - www.issa.com
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
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