Document OZdQYMrmYMN7Ya6OdmodeJLw
Interoffice Communication
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FROM: DATE: SUBJ:
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T. G. Grumbles
uiiry 17, 1990
VIS1A
TSCA ALCOHOL REREGISTRATION CONSORTIUM MEETING OF JANUARY
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The subject meeting was attended by representatives from Cochran, Drexel, Fair Products, Coastal Chemical, Uniroyal, Ethyl, and Vista. Helena, P & G, and Henkel were not present. P & G and Henkel had indicated that they would technically support the effort but would not attend the meeting. No one had heard from Helena so it is not clear what they plan to do. Below are highlights of the meeting.
1. A consortium will be formed to develop the data needed to reregister 8 and 10 alcohols at least. Cochran expressed a desire to obtain a reregistration that would cover a C6-C12 range. Most others present felt this would be difficult but Cochran can use the 8 and 10 data developed in any way they wish.
2. An 810 blend will probably be used for testing and an attempt made to demonstrate that this data adequately represents both.
3. Gene Cochran was elected chairman and Hurley Hathaway (Cochran) and Louis Haefele (Drexel) will function as the technical committee.
4. Uniroyal is still undecided as to whether they will join the consortium or not. They may claim a forraulators exemption and "pay the price" in the future if they wish to use consortium data.
5. The consortium signed our document reserving our data use right, however this was done outside the meeting with no open discussion on the matter.
6. The consortium asked that we not cancel our registration but
transfer it to the consortium, or if the consortium is not yet
a legal entity, a consortium member (probably Coastal) who would
transfer it to the consortium of a later date. They wish this
to happen just in case they need a technical (active ingredient)
as well as a formulated product registration. In effect, they
would then reregister our "labels" as well.
I don't fully
understand their concern but told them we could do that if I can
figure out how to do it and meet our January 24th filing deadline.
Regardless, we would provide them with the use of any of our original data they need to support reregistration.
VVV 0000X0955
Distribution
January 17, 1990 Page 2
7. Louis Haefele reviewed his assessment of the data needs with the group. This is attached for your reading pleasure. Bottom line is a cost ranging from 350,000 to 1,500,000 depending how persuasive we are on the "conditionally required" tests arguments.
Also, some interesting issues were discussed.
Some test
requirements are determined by the results of an octanol/water
partition coefficient.
Obviously, octanol is very soluble in
octanol and tests results would be indicative of the need for more
testing.
Another similar problem is the testing requirement for vegetative vigour or growth inhibition. TSCA alcohols are growth inhibitors by design and will "flunk" these tests.
We (they) will make technical arguments against the applicability of these test and hope reason prevails.
8. In summary, Vista will be asked for the following:
a. Transfer registrations to Consortium vs. a voluntary cancellation
b. Alcohol samples
c. Physical and chemical measurements on the samples and possibly the blend to be tested.
d. Use (without compensation) of existing registration data if needed.
e. General technical assistance such as reviewing toxicology testing results.
I did make the point that we were depending on the consortium to do the reregistration well and successfully because we were all at risk if they didn't. I think the members have the experience to do this and along with our technical help they can.
T, u. crumbles dlj Attachment cc: M. Sweet, R. Swantkowski, M. Clark, P. Hitchcock
VVV 0000109S6
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Cvldrllnt Rtftnnct Number
Title of Study
6M Chemical identity
61-2U) 612(b)
Begin, mat 6 mrjjt. pnx Dixiwlon of Impurillo
62-1 Preliminary Analysis
62-2 Certifiestlon oF limit* 62-3 Analytical Method
63-2 Color
63-3 Physical State
63-4 Odor
63-5 Mrittng Point
63-6 Boiling Point
63-7 Deroity
63-1 Solubility
63-9 Vapor Pressure
63-10
Dissociation Constant
63-11
Oct/Watcr partition Corf.
DATA REQUIREMENTS
non food crop
Conditions Under Which it A online
R R R CR These data apply to all Manufacturing- use Products (MPs) R R R R R R R R R R R CR These data apply if the Technical is organic and non-polar.
This data
How 1 will comply
Rrq`ml
with this data
8
5
.*0
applies to my fhcmlul
requirement
Time permitted lor aubmitsion
E YES NO 1 2 3 4 5 6 7 ft 9 to CPA
8 (in Years)
M x_
MX MX MX MX
MX MX
Mx Mx
X
MX
MX MX
MX MX
J2--
X
X X X
X
X
X X
x
X
X X X X X
X
1 1 1 I 1 1 J 1 1 1 1 1 1 1 1
cost
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Cildliiti Rrftroncr Mimktr
Tide of Slody
DATA REQUIREMENTS
non food
crop Conditions Under Which iLAppliea
compliance
This dit* Rrq'ml apptira lo my chemical
YES NO 1 2
llow 1 will comply with thia dila requirement
3 4 5 6 7
V
Time
prrmlltfd
for u^
9
miifion lo ErA
(in Yun)
cost
63-12 63-13 63-14
P"
Stability
Oiicliiiiig/Rtdudiig Action
CR Thesedataapplyifthe test substance is dispersible with water. M J_
R MX
CR These data apply it the product contains oxidizing or reducing
X
K. X
63-15 63-16 63-17 63-11 63-19
Flammability F.aplodabiiity Storage stability Viaccaily Misdbillty
CR Thesedauappiyifthe product contains combustible liquids.
M
R JX
R M _XJ
CR These data apply if the product is a liquid.
MX
CR emulslfiable liquid and is to be diluted with petroleum solvents
X
i.
Xj X
1
t
63-20 63-21 71-lla) 7i-mi 71-2(a) 71 -7(b) 71-3
7!-4(a)
Comtafem characteristics DirIretrie breakdown veil Acute avian oral quaU/duck Acute avian oral qual)/duek-TE Acute avian dirt, quail Acute avian dirt, duck Wild mammal tmidty Avian repra, quail
R CR
R CR
R R CR CR
liquid to be used around electrical equipment. products formulated as granulars, pellets and baits
predadde or rodenticide.
results of lower tier studies
ifone ormoreofthe criteria are met
1
MX
X
CX
?1
JLC ?? o ??
X
wX
X X
2
1 I 3,200
1
1 2.800 I 2.800 1
2
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DATA REQUIREMENTS
Cuidtllti* Rtltrtnc* Number
Till* of Study
naif
lead
crop
Conditions tinder Which It Applies
7l-4(W
71 5<W 771(a) 72-MW 771(e) TJ-Kd) 77 2(a) 72 2(b) 770(a) 77 3(b) 720(0 720(d) 720(0 720(0 72-4U)
Avian rtpro. duck Siimiltlid field ttudy
CR CR
Actual field vtudjr ftih l<Ridtybluj(ill Fish Imkily bhitgill - TEP Fish Icraktty rainbow (rout
CR
n
CR
R
Hah toaldty rainbow trout - TET Invcrirbnla (onJcity
CR R
In*ffibri1* losicity - TET Estu/marl Ion. fish
CR CR
Fshi/mari toi. irdlusk Eatu/rn*ri tea. shrimp Fjhi/airl to*, fish* TET Fjhi/mari toa. molltuk - TEP Fshi/mari loa. shrimp TEP
CR CR CR CR CR
Early Ufetujttfbh
CR
ifoneormoreofthe criteria are met depending on the results of lower tier studies depending on the results of lower tier studies
end-use product which meets conditions
end-use product which meets conditions.
end-use product which meets conditions: if the pesticide is expected to enter this environment in signifies concentrations because of its expected use or mobility pattern. To assist the registrant in determining whether the pesticide may enter estuarine and marine environments in signi 'cant concentrations, the following sites are those that EPA
tobacco pestklde is applied to water
1 hi* data
Rrq'mt applie* lo
B my
G rhrmlcal
llow | will comply
with (hi* dala rrquirrmrnl
Tim* prrmlHrd
Q. (ol iub-
8
YES NO 1 2 3 4 S 7 9 ioCPA
(in Yr*l
cost
w . _XJ X
X
cX
??
X
c jU
99
X
c.
WX wX
W- X
X
X
X
X
x_
X]
X X X
2 (55.0001 3 3
1 1 ,800 1 I 1.800 1 1 6,000 1 I (6,500) 1 (6,500) 1 (6,500) 1
1
1
1
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DATA REQUIREMENTS
CiMtlini Rtltttnct Number
Till* of Study
72-4(b) 71-5 77-4 72-7|a) 72-7(b) 111 1-7 1) SI-4 81-5 81-8 81-7 82-Ha) 82-llb) 82-2 2-3
Ufe eyeW Invertebrate life cycle fish Aquatic rg. accumulation Slmul. fi1d-aquatk orgs. Actual field-aquatic oege. Acute ora] tor. rat Acute dermal lor. rabbit/rat Acute Inhal. lor rat PKmiiy eye Irritation-rabbit Primary dermal Irritation Dermal aereitization Acute delayed neurotor ben 90-day feeding-rodent 90-day fredlng-nonrodent 21-day dermal-rabblt/rat 90-day derma)-rodent
non
food Conditions Under Which it Applies
crop
CR pestidde is applied to water at pesticide is applied directly to water at likely o occur in aquatic environments at depending on the results of lower tier studies at depending on the results of lower tier studies
it
R
It
R
R
R
at , organophosphate,
at the intended use is expected to result in human exposure
CR the intended use is expected to result tn human exposure
aat if subchronic90- daydermalstudy(82-3)isnotrequired.
**CR dermal exposure
primary route of exposure.
8
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6 8
c. r. C. r. c c.
w W
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Thia dala Rrq'ml appliaa lo my chrmlcal
Hour 1 will comply wiib tbladaia rrqvlrr mrnt
4YES NO 1 2 ) 4 >
7
X X
X
X
X
X 77 X 77 X 77
X 77
X 77
X
X
X
X
x
X
5
X
X X
Tima
prrmlHrd
lor aub-
*
minion lo EPA
/in Yrui)
cost
l
3 1
3 3
2 i .non
7 1.000 7 2,500
1 500 1 500 1 2,500
7
2 (50.0001
2 (90.000)
7 (20,000)
7
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Zaideline 4amWi
Tilt# of Study
82-4
6)-S4b> 0-1(aJ 8M<b> 0-21.) 83.2(b) 83-3U) 83-3(b> 83-4
M-Ha)
84-2<bi
M-4
85-1 85-2
18-1
90-dy InhiL-nl 'fO-Aty ncurotoa-hrn 90-dap Munlm mimmi] Qunlc loi-radtrl CKm4e (os - rorv-rodml OncoRmidtT Ml Oncocvnkihr mouw Ttwtojf nidty-rt T(TtlogtrkH7 - rabbit 2-gntntlon repro. nl
Ctrf mutation -emen
Struct chram. tbmllan Olhrr protwlt (ffrcb Gtnml maUbolism Dfnnil pvrftritton
Domntk animal safety
DATA REQUIREMENTS
food crop
1 hi* data Req'mt
Him i wm com p'y with ihii data
ippliH to
requirement
8
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.fl
my chemical
(X
Time permitted (or tub-
ftG YES NO 1 2 3 4 3 4 7 8 * to ERA (in Yean) vixj
cost
CR A test with duration of 21 days if pestiddeisusedon tobacco. c
CR studies showed neuropathy or neurotoxirity
X X
x
2 50,000 2
CR test showed neuropathv or neurotoxidty.
X
2
CR repeated human exposure to the product over a significant CR portion of the human life-span CR exposure over a portion of the human life-span CR which is signifi cant
w w u w
X X X
X
x 4 '500,000
X 4 :600,000
x4
X 4 '500.000
CR X 2 40,000
CR
CR human exposure over a portion of the human life span
R R R
CR applies if chronic feeding or oncogenicity studies apply
_x_
w X_
c. X
X c J_ wX
X
x x
X X
2
4 r ] 00,000 1 1 .500
t 6.500
1 10,000
2
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CO
CR
l CR
applies for chemicals havine a serious toxiceffect as determined by EPA-
_x_ X
2 2
DATA REQUIREMENTS
CU<liot Mink* Number
Tide of Study
non food crop
Conditions Under Which it Applies
tznu) M g(m/mdling (iwig
Vegetative vigor
mi
Aqutllc plant growth
Seed gcrm/aeedling rmetg
123-lfb) Vegetative vigor
123-2
Aquatic plant growth
124-1 124-2
Termtrlal field Aquatic l)id
13M() 132-Kb)
Foliar mldtM dissipation Sod rnldur dissipation
133-3 133-4 141-1
Dermal passive dosimetry erpo Inhal. passive dosimetry evpo 1 lorry bee acute contact
141-2
1 lorry bee residue on foliage
141-5
Field test (or pollinators
1603
Chemical Identify
r
R R CR CR CR CR CR CR CR CR CR CR CR CR R
previous tier previous tier previous tier previous tier previous tier' Use conditions of end-use product
Use conditions of end-use product Use conditions of end-use product
Use conditions of end-use product if the end-use vvill mult in exposure of honey bees. previous tier'
previous tier as required in 61-1
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Thi# data
Hew | will comply
Req'ml
with Ihiedala
applies to
requirement
my chemical
Time permitted
loraub-
YES NO
12
3 4 1 6 7a
mieeion to ErA
(in Years)
rX rX C. X
X X
X
X X X
X X
X
X X
x
X
X
X
X
X
1 8.500 1 9,000 1 6,000
t
1
1
2 2 2 2 2 2 1 1,000
I
2
1
DATA REQUIREMENTS
Guideline
Reference
Nink*f
Till* of Stud;
161-1 161-3 1614 161-4 163-t 163-3 1634 1634 163-1 163-2 163-3 164-1 164-2 164-3 164-5 165-1
Hydrolysis rholcdf{ridition-wi1f rholodegradatlon-Mil I'hotodegradatkwvaJr Aerobic toil metabolism Anaerobic soil metabolism Aiumtilc aquatic metab. Aerobic aquatic metab. I-aach/adsorp/desoeptfon Volatility - lab Volatility- field Terrestrial Reid dissipation Aquatic field dissipation Forest Reid dissipation Long term soil dissipation Confined rotational crop
non food
crop Conditions Under Which it AroZies
R R
R CR The vapor pressure of the technical is> 10-4 torr.
R
R R
R
R
1 CR
Ljl
materialhas not dissipated withinone year
8
a.
6 8 c
c c c c
r.
c
c
c
this data
How 1 win comply
Rrq'mt
with Ihia data
applies 1o
requirement
my chemical
Time \
permitted
for aub-
YES NO 1 2 3 4 5 6 7 9 minion
a:ifit # It: W-
rloEPA
It p (in Yearsl
_x_ X 1 10.000
X, X 1 15,000 X X 1 15,000
X_ XX_
X X
X X X
X
1 25,000 2 25.000 7 30.000 2
2 1 20,000 I
Ljl_
1
X-
J_ X
X
2 30,000
2 2
X
X
X
4 2 20,000
Cwidrlin* Rtltrrncr Nambtr
Till* ol Study
14S-2 165-3 1*5-4 165-5 164-1 164-? 164-3
Firld relational crop Accumulation - Irrig crop {Uoacnonulatlon In Ash ftloacnun -aquatic non-Urget GnJ ntfMmill prpspwl Grd wiirrsm. tHiotpwl Gref watrr-lrn retrcapecl.
wit
7071
171-7
Dropltl six* spectrum
DriA DfM mluiten Chemical identity
171-3
Direction* for use
171-5
Reduction of residues
171-4<) Nature of residue - plants
171-4ft.) Nature of residue - livestock
ITMIc) Res. arwlyl method - plant
171-4(d) Res. analyt. method animal
DATA REQUIREMENTS
R9A*
fwtd
crop Conditions Under Which it Applies
s'
I
cu
8
CH determined by the resuits of the confined rotational crop study
1 hi* data
Rrq'ml applie* to mj chemical
now l wilt comply with ihia data requirtmrnt
YES NO 1 i 1 S 4 7 *
S:!-;:,: --
JL_
ff
?t
CR unless theoctanol/ water partition coefficient is less lhan 1000, W CR depending on the outcome of accumulation studies in fish
J
X X
X
CR pesticide or the major degradales demonstrate persistence CR pesticide residues demonstrate persistence and mobility
JL_ J_
CR This study may apply
CR Conditionally Required -These studies apply unless it can be
CR demonstrated that a detrimental effect will not occur under rea
aonable conditions of use. RX
_X_
X
JX
X
R X . _x
rime pfrmitlM
fonaub mlaaaon
(in YtaVa)
cost
3
\ 3
.30.000
4
4
4
1 2 1 1 2 2
2 1 2
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