Mancozeb Task Force Comments on:

Mancozeb Facts – September, 2005, EPA 738-F-05-XX

and the Mancozeb Reregistration Eligibility Decision

Author

Janet Ollinger, PhD

Chairperson

Mancozeb Task Force

Date

October 11, 2006

Report No. MZ200601

Submitted by:

Mancozeb Task Force

Cerexagri Inc.

Dow AgroSciences LLC

Griffin LLC (a DuPont Company)

c/o

Edward M. Ruckert

McDermott, Will & Emery

600 13th Street, N.W.

Washington, DC 20005

Mancozeb Task Force Comments on:

Mancozeb Facts – September, 2005, EPA 738-F-05-XX

and the Mancozeb Reregistration Eligibility Decision

Executive Summary

	The members of the Mancozeb Task Force applaud EPA for issuing the
mancozeb Reregistration Eligibility Decision (RED) on December 28, 2005.
 In most cases, the information presented in “Mancozeb Facts” and in
the Mancozeb Reregistration Decision (RED) is accurate.  However,
because the “Mancozeb Facts” document will be used as a reference
for a number of years, the Mancozeb Task Force wishes to point out some
errors and requests that they be corrected.

	The RED has some errors with some of the proposed tolerances and some
of the statements regarding personal protection equipment (PPE).
Therefore, this document is being provided to the EPA to outline the
discrepancies so they can be resolved.  The key issues in the RED are:

	Tolerances

Tolerances for all of the straws for the small grains should be the same
number rather than a proposed tolerance of 25 ppm for wheat straw and 20
ppm for barley, oat, and rye straw.

Small grain hay tolerances can be established at 30 ppm based on an
earlier Residue Chemistry review stating that sufficient wheat data are
available.

The pineapple listing of TBD should be withdrawn because pineapple will
be withdrawn from future labels.

The proposed carrot tolerance listed as 1 ppm in 40 CFR 180.176(a) and
0.6 ppm in 40 CFR 180.176(b) should be the same in both places.

The sweet corn kernel and popcorn grain tolerances should be identical.

It would be helpful to add a notation that fennel is in Group 4 B, leafy
vegetables, so growers can differentiate the use from the fennel that is
a spice.

	PPE

	The key PPE issue is that the registrants agreed to dust collector
equipment for the wettable powder (WP) seed treatment (except potato
seed piece treatment) and the dust application to potato seed piece
treatment for commercial operations.  The registrants did not agree to
an enclosed handling system.  The registrants agreed to a single layer
PPE with PF5 respirator and gloves for WP application to potato seed
piece treatment.  Other discrepancies between Table 49 of the RED and
the text are also described.

	Skin sensitization

	EPA indicates that the lack of skin sensitization in the dermal
sensitization study applies to the manufacturing product, whereas
reports of skin sensitization in humans are associated with end use
products.  The unusual situation for mancozeb is that the 80% wettable
powder end use product serves as the manufacturing use product because
mancozeb cannot be isolated in stable form without the formulation
additives.  Therefore, the conclusion that mancozeb is not a skin
sensitizer in animal studies applies to the 80% wettable powder end use
product and the 75% dry flowable end use product.

	Characterization of the mancozeb soil half-life and potential endocrine
disruption 	effects

	Proposed revisions and items for discussion are provided in this
response.  The response lists the page, paragraph, and sentence number,
with the original text italicized and the revised text shown in a normal
font.  Words to be changed are noted in bold.

	Label revisions

	On page 75, the corn forage comment states that the tolerance is
“contingent upon label revision to remove feeding/grazing
restrictions”.  A statement regarding this fact should be included in
Table 51 with the summary of labeling changes.

Comments on : “Mancozeb Facts – September, 2005, EPA 738-F-05-XX”

1.	Page 1, paragraph 4, line 1 (after Regulatory History)

	EPA states “Mancozeb was first registered in the United States in
1948 as a broad spectrum fungicide...”

	The sentence should read:  “Mancozeb was first registered in the
United States in 1962 as a broad spectrum fungicide...”

2.	Page 3, full paragraph 3, line 2

	EPA states “Potential residential exposure to mancozeb may also occur
from residues remaining on transplanted turf from sod farms.  However,
the reduced application rate and/or extended PHI, combined with the
logistics of transplanting turf and installation restrictions,
effectively reduced the potential contribution from this use pattern to
a level not of concern to the Agency”.

	The mancozeb seasonal rate was defined, therefore the second sentence
of this paragraph should read:  “However, refinement of the seasonal
maximum application rate, the extended PHI, combined with the
logistics....”

3.	Page 3, full paragraph 4

	EPA states “EPA has risk concerns for some workers who mix, load,
and/or apply maneb to agricultural sites and for workers who re-enter
treated areas.”

	The sentence should read:  “EPA has risk concerns for some workers
who mix, load, and/or apply mancozeb to agricultural sites and for
workers who re-enter treated areas.”

4.	Page 5 – WP Formulation, Seed Treatment

	Add that a dust collection system is required for the WP seed
treatment.

Comments on:  “Reregistration Eligibility Decision for Mancozeb”,
EPA 738-R-04-012, September 2005

1.	Page ix, paragraph 2, line 1

	Change “Mancozeb was first registered in the United States in
1948...” to “Mancozeb was first registered in the United States in
1962......”

2.	Page ix, paragraph 2, line 6

	EPA states “Approximately 5.6 million pounds of mancozeb are used
annually.”

	EPA has shown somewhat higher numbers in other places, specifically:
6.5 million pounds (Screening Level Usage Analysis for Mancozeb, March
24, 2005” or 6.3 million pounds (Quantitative Usage Analysis for
Mancozeb, Frank Hernandez, November 1, 2002).

3.	Page x, paragraph 2, line 4

	Change “Cancer risks to athletes on treated fields are of
concern...” to Chronic risks to athletes on treated fields are of
concern...”  The cancer risk is not of concern, as noted on page 44 of
the June 3, 2005 memorandum titled “Mancozeb.  Health Effects Division
(HED) Human Health Risk Assessment to Support Reregistration”.  EPA
concluded that the cancer risk was only 6.0 X 10-8, which is below the
level of concern.

4.	Page 2, paragraph 2, line 4

	In describing the data required as a result of the conclusion of the
1982 Special Review, EPA states: “These data included a market basket
survey of residues of the EBDCs and their metabolite, ETU, in foods and
additional toxicological data for ETU”.

	The data actually required as a result of the 1982 regulatory
conclusion were field trial, food processing, animal feeding and
metabolism, and plant metabolism data, in addition to some toxicology
studies.  The market basket survey data were not required until an
April, 1989 Data-Call-In Notice.

5.	Page 3, paragraph 1, line 1

	EPA states:  “The 1992 PD 4 specified that only the following
mancozeb food uses would be eligible for continued registration,
provided that specific label revisions were made and supporting residue
data were submitted:”

	The PD 4 did require specific label revisions.  However, the Terms and
Conditions of the PD4 did not include a requirement for supporting
residue data to maintain the registrations.  EPA did say it appeared
that additional residue trials might be required for some crops to
reassess the tolerances and that those data would be described in a
forthcoming Data Call-In Notice.

6.	Page 3, paragraph 1, conclusion of the paragraph

	EPA correctly lists the 9 states granted a 3 day pre-harvest interval
(PHI) for potatoes in PD 4.  It should also be noted that the 3 day PHI
was extended to 4 additional states (Delaware, Michigan, Ohio, and Rhode
Island) as a result of comments received during the PD 4 comment period
that these 4 states also suffered from late blight of potatoes.

7.	Page 3, paragraph 3, line 1

	“EPA has also received petitions for proposed new uses of mancozeb on
ginseng, mandarin oranges (import tolerance), walnuts, and tropical
fruits.”

	There is an additional petition for the cucurbit crop group, which is
discussed later in the RED.

8.	Page 3, paragraph 4, line 1

	EPA states:  The Mancozeb Task Force was formed in 1994 to represent
the interests of the Mancozeb registrants, who were then two companies:
Rhom and Haas and E.I. DuPont De Nemours”.

	The sentence should read:  The Mancozeb Task Force was formed in 1994
to represent interests of the Mancozeb registrants, who were then three
companies:  Rohm and Haas, E.I. duPont de Nemours, and Pennwalt.

9.	Page 4

	Trade name:  should be Dithane®, Manzate®, Penncozeb® and Fore®
rather than Dithane 45®, Manzate 200®, Penncozeb® and Fore.

	CAVES Registry Number is the same as the CAS Registry Number

	Molecular weight: 	 (265.3)x + (65.4)y = 271 (the = 271 is missing)

	Empirical Formula:	(C4H6MnN2S4)x(Zn)y; where X =1 and y = 1/11 (the
bold 					part is missing)

10.	Page 5, final paragraph, line 1

	EPA states:  “Proposed new uses for mancozeb on ginseng, mandarins
(import), walnuts, and tropical fruits were included in the risk
assessments as well.”

	The sentence should read:  “Proposed new uses for mancozeb on
ginseng, mandarins (import), walnuts, tropical fruits, and the cucurbit
crop group were included in the risk assessments as well.”

11.	Page 6, Food uses:

	Some listed uses are not registered for mancozeb.  They are noted with
a strike out in the following sentence:

	Apples, asparagus, cabbage, cantaloupe, cotton, cranberries, cucumber,
eggplant, garlic, grapes, onions, peanuts, pears, pecans, potatoes,
pumpkin, squash, sugar beets, sweet corn, tobacco, tomatoes,
watermelons, and wheat.

12.	Page 9, line 1

	See comment 2 regarding the number of pounds of mancozeb used annually.

13.	Page 12, paragraph 4, line 9

	With regard to the skin sensitization study, EPA states:  “Although
animal data indicate that mancozeb is not a skin sensitizer.....The
dermal sensitization study in animals is conducted on the manufacturing
use product, whereas the reports of skin sensitization in humans are
associated with end use products.”

	The mancozeb manufacturing use product is actually the 80% wettable
powder end use product.  This is the case because mancozeb cannot be
isolated in a stable form without the formulation additives.  Because
the mancozeb manufacturing product is the 80% wettable powder, the
dermal sensitization study was conducted on the 80% wettable powder end
use product.  Therefore, the 80% wettable powder end use product does
not have dermal sensitization.  In Appendix G of the RED, EPA has
batched the oral toxicity requirements of both the 80% wettable powder
and the 75% dry flowable formulation.    Thus, the animal data
indicating that mancozeb is not a skin sensitizer applies to both the
80% wettable powder and 75% dry flowable formulations.

14.	Page 30, “ETU Dietary Cancer Risk from Food and Drinking Water”.
 Line 2.  EPA states:  “Estimated dietary cancer risk from
mancozeb-derived ETU in food and water is 1.6 X 10-6 for the general US
population...”

	However, page 7 of the Mancozeb HED chapter states: “The estimated
dietary exposure for the general US population corresponds to a cancer
risk of 1.08 X 10-6”.  Because the risks from surface and ground
water, respectively, are 1 or 2 X 10-7, the aggregate food and water
risks range from 1.2 to 1.3 X 10-6 rather than 1.6 X 10-6.

15.	Page 53, line 2

	EPA states:  “Although mancozeb parent degrades quickly by
hydrolysis, the mancozeb complex appears to degrade slowly in the
environment, via biodegradation and other fate processes”.

	The Mancozeb Task Force agrees that mancozeb degrades quickly by
hydrolysis.  However, there are no data to support the conclusion
regarding a mancozeb complex that degrades slowly in the environment.
(EPA-HQ-OPP-2004-0078-0018, Mancozeb Task Force Response to U.S. EPA's
Draft Science Chapter for the Environmental Fate and Ecological Risk
Assessment for Mancozeb dated June 3, 2004)

	The EEC’s were recalculated using the Task Force half-life of <0.5
days (January 18, 2005 meeting between EPA and Mancozeb Task Force) and
included with the February 22, 2005 Mancozeb Task Force response to the
EFED chapter.  The recalculated EEC’s are shown in Table 1.  These
EEC’s are the most representative of the actual concentrations.

16.	Endocrine Disruptor Effects

	EPA stated:  “The available human health and ecological effects data
for mancozeb suggest possible endocrine effects.  Mammalian studies for
mancozeb showed thyroid effects, which may indicate potential endocrine
disruption.  EPA has considered these effects in the human health risk
assessment by selecting endpoints based on thyroid effects.  To further
characterize these effects, EPA is requiring a confirmatory comparative
thyroid toxicity study for ETU.  Mancozeb data on ecological effects
suggest possible hormonal effects to birds and mammals....”

	As noted in the Mancozeb Task Force comments, the Task Force disagrees
that data on ecological effects suggest possible hormonal effects to
birds and mammals. (EPA-HQ-OPP-2004-0078-0018, Mancozeb Task Force
Response to U.S. EPA's Draft Science Chapter for the Environmental Fate
and Ecological Risk Assessment for Mancozeb dated June 3, 2004).
Additionally, while thyroid effects were seen in rodent studies, they
are not indicative of thyroid effects in humans.  It is well known, for
example, that rats are more sensitive to thyroid effects than humans
because humans have thyroid-binding globulin, which binds T4, and stored
thyroid hormones.  This protein is missing in rodents and other
vertebrates. (Assessment of Thyroid Follicular Cell Tumors, Risk
Assessment Forum, U.S. Environmental Protection Agency, Washington, DC
20460)

17.	Page 71, paragraph 3 of Tolerance Reassessment Summary

	EPA stated the proposed tolerance expression for mancozeb under 40 CFR
section 180.176 is:

		Tolerances are established for residues of a fungicide that is a
mixture of 			5.2 parts by weight of ammoniates of
[ethylenebis(dithiocarbamate)]zinc 			with 1 part by weight ethylenebis
[dithiocarbamic acid] bimolecular and 			trimolecular cyclic
anhydrosulfides and disulfides, calculated as carbon 			disulfide, or
CS2, in or on raw agricultural commodities.

	This statement as written is the tolerance expression for metiram.  The
tolerance expression for mancozeb should read:

		Tolerances are established for residues of a fungicide which is a
coordination complex of zinc ion and maneb (manganous
ethylenebisdithiocarbamate), calculated as carbon disulfide, CS2, in or
on

		raw agricultural commodities.

18.	Page 73, paragraph 1, line 1

	EPA states:  “Additional residue data are necessary to establish
mancozeb tolerance values for the following commodities:  barley hay;
cotton gin byproducts; oat hay; and wheat hay.  The requested data for
wheat hay will be translated to barley hay and oat hay.”

	In fact, adequate residue data for wheat hay are already available.  In
a May 2, 2001 memorandum from Christine L. Olinger to Anne Overstreet,
“Reregistration of Mancozeb: Wheat Crop Field Trial Data; Chemical No.
14504; DP Barcode D255366, MRID No.: 44802501”, EPA states: “Wheat
hay:  The submitted residue data for wheat hay are acceptable.  They
suggest that a tolerance for wheat hay should be established at 50 ppm
to support the currently maximum registered use pattern.” (Item #5,
page 3 of the Dynamac review).  The cover letter states “No additional
magnitude of residue data are required to support the reregistration of
mancozeb on wheat”.

	The proposed 50 ppm tolerance is in zineb equivalents.  The tolerance
would be 30 ppm in CS2 equivalents.    Because the wheat hay tolerance
is extrapolated to the other small grains, the Mancozeb Task Force
proposes a 30 ppm tolerance for wheat, oats, and barley hay.

	Regarding cotton gin by-products, the foliar use of cotton has been
cancelled.  Thus, it is not clear if there is a need for tolerances on
cotton gin by-products.

19.	Table 49 – Tolerance Reassessment Summary for Mancozeb

	The Mancozeb Task Force has comments on carrot, barley, oat, rye, and
wheat straw, sweet corn and popcorn, wheat, oat and barley hay, and
pineapple tolerances. The crops and proposed tolerances, along with the
Task Force comments, are shown in the following table.

Comments on Table 49.  Tolerance Reassessment Summary for Mancozeb

Commodity	Reassessed

Tolerance

(ppm CS2)	Mancozeb Task Force Comment

Tolerance Listed Under 40 CFR 180.176(a)

Raw Agricultural Commodities

Barley, straw	20	Wheat data were translated to barley straw, but the
wheat straw tolerance is 25 ppm.  The barley and wheat straw tolerances
should be identical.

Carrots	1	A value of 0.6 is listed in Tolerances Under 40 CFR 180.176(b)

Corn, fresh including sweet corn (K+CWHR)

	0.1	See comment on corn, pop, grain

Corn, pop, grain	0.06	EPA said available data for sweet corn (K+CWHR)
support lowering the tolerance.  Because sweet corn data support pop
corn, grain, the two tolerances should be identical.

Fennel	2.5	Add a notation that this fennel is in Group 4B, leafy
vegetables, in order to avoid confusion with the spice fennel

Oat, straw	20	Same comment as barley straw.

Rye, straw	20	Same comment as barley straw.

Wheat straw	25	See comments on barley, oat, rye straw

Tolerances to be Proposed under 40 CFR 180.176 (a)

Raw Agricultural Commodities

Barley, hay	TBD	Establish at 30 ppm, same as wheat hay

Oats, hay	TBD	Establish at 30 ppm, same as wheat hay

Pineapple	TBD	No tolerance is required because this use has been
withdrawn

Wheat, hay	TBD	 EPA said TBD pending submission of field data for wheat
hay.  However, the review of the wheat residue trial said the hay data
were acceptable and a tolerance of 50 ppm (zineb) should be established.
 This results in 30 ppm CS2 equivalents.

20.	Page 80, paragraph 3

	Regarding the withdrawal of the mancozeb use on athletic fields, EPA
stated:  “The Agency intends to publish a Notice of Receipt of this
use deletion in the Federal Register in September, 2005.”

	The withdrawal was published in the November 2, 2005 Federal Register.

21.	Page 83, paragraph 2, line 6 (Agricultural Crops).

	EPA states:  “...the chronic MOE for small grains, cotton, and
cucurbits is 89 with the PPE described above.”

	The MOE of 89 for small grains and cotton is a short-intermediate term
MOE rather than a chronic MOE (see page 35 of the RED) for the aerial or
chemigation WP application.  And the short-intermediate term MOE for
cucurbits is 200 rather than 89.

22.	Page 83, second bullet under Turf, Ornamentals, and Agricultural
Crops

	This should read:  Applicator, all methods except aerial, groundboom &
airblast – single layer + gloves

	(add airblast to the list)

23.	Page 84, second bullet under Ornamentals and Agricultural Crops

	This should read:  Applicator, all methods except aerial, groundboom &
airblast – single layer + gloves

	(add airblast to the list)

24.	Page 87, Applicators

	The formulation type is not listed.  The formulation type must be
listed because the statement “Aerial Application Turf (sod farms) –
Use Deleted from all Labels” applies to the WP and liquid formulations
but not the DF.

25.	Page 87, Mixer/Loader/Applicators (M/L/A)

	For M/L/A WP with Low Pressure Handwand pachysandra, conifers,
ornamentals, the PPE mitigation measure for conifers and ornamentals is
“Single layer w/gloves + PF 5 respirator for other ornamentals” (add
the PF5 respirator)

26.	Page 87, Mixer/Loader/Applicators (M/L/A)

	For M/L/A WP with Turfgun Turf, the PPE mitigation measure should be
changed from “Single layer w/gloves” to “use in water soluble
packaging”.

27.	Page 89, paragraph 2

	EPA states:  “To mitigate the handler risks for potato seed-piece
treatment with dusts and wettable powder formulations, the Agency is
requiring engineering controls (closed capture equipment) for commercial
seed-piece treatment and additional PPE (single layer, gloves, and PF5
respirator) for noncommercial, on-farm seed-piece treatment.”

	The mitigation for the dusts and wettable powders must be described
separately. The Mancozeb Task Force agreed to closed capture equipment
for the commercial potato seed-piece treatment with dusts.  However, the
mitigation agreed to for the WP is a single layer PPE with PF5
respirator and gloves.  The mitigation did not include closed capture
equipment.

28.	Page 99, WP Formulation Seed Treatment

	The heading should be changed to: “WP Formulation Seed Treatment
(except potato seed piece)”

	Add a bullet:

	 “require dust collection system”

	Add a new topic:

	 “Potato seed piece treatment

single layer PPE with PF5 respirator and gloves”

29.	Page 104, Table 51.  Summary of Labeling Changes for Mancozeb

	For all Manufacturing Use Products – last item

	EPA states: Manufacturers of products formulated as dusts must require
closed systems for commercial seed-piece treatment.

	The sentence should read:  Manufacturers of products formulated as
dusts must require dust collection systems for commercial potato
seed-piece treatment.

	(changes in bold)

30.	Page 105, End Use Products Intended for Occupational Use (WPS and
non-WPS)

	Under “PPE Requirements Established by the RED for Liquid Concentrate
Formulations (For all uses except seed and seed piece treatment)”, EPA
states:

	“See engineering controls for additional requirements.”

	This line should be deleted.  There are no engineering controls
required for the liquid concentrate formulations.

31.	Page 106, PPE Requirements Established by the RED for Wettable
Powder (WP) Formulations that are not packaged in water soluble
packaging.  (For all uses except seed and seed piece treatment)

	The last line reads “See engineering controls for additional
requirements”.

	This line should be deleted.  There are no uses in this category of the
WP that require engineering controls.

32.	Page 107, PPE requirements for WP formulations that are not packaged
in water soluble packaging (For products with directions for use as a
seed treatment)

	This section states “See engineering controls for additional
requirements”.  However, the “engineering controls” section does
not list engineering controls for seed treatments, except for the potato
seed-piece treatments.  A section should be added in “engineering
controls” specifying that a dust collection system is required.

33.	Page 109, PPE Requirements Established by the RED for Dry Flowable
(DF) Formulations

	EPA states:  “See engineering controls for additional
requirements.”  This sentence should be deleted.  There are no
engineering controls required for DF formulations.

34.	Page 109, Engineering Controls:  Closed System for Commercial
Seed-Piece Treatment.  Dust Formulations and Wettable Powder
Formulations (applied dry)

	The Mancozeb Task Force disagrees with three of the items in this
section:

1)	The requirements for the WP application to potato seed pieces are
single layer PPE with PF5 respirator and gloves.  No engineering
controls are required.

2)	As currently written, both commercial and on farm applications of the
dust formulation to seed piece require engineering controls.  The
engineering controls apply only to the COMMERCIAL application.  The PPE
for ON FARM is a single layer PPE with PF5 respirator and gloves.

3)	The Mancozeb Task Force agreed to a dust collection system as the
engineering control for dust application to potato seed piece treatment.
 The Task Force did not agree to the language in the RED stating
“Loaders must use a closed system designed by the manufacturer to
enclose the pesticide to prevent it from contacting handlers or other
people while it is being handled” and disagrees with this requirement.

35.	Page 109

	A section describing engineering controls for the wettable powder seed
treatment (except potato seed piece treatment) is needed.  The required
engineering controls are a dust collection system.

36. 	Page 113, Application Restrictions for seed treatment

	The restriction to apply mancozeb “to dry seed with conventional
slurry or mist seed treating equipment” applies only to the wettable
powder formulation.  It does not apply to the dry flowable or flowable
formulations.  As currently written, the statement would apply to all
formulations.

Comment on:  Mancozeb.  Health Effects Division (HED) Human Health Risk
Assessment to Support Reregistration, From Kit Farwell to Christina
Scheltema, June 3, 2005

Page 3, final paragraph, line 7 and Page 14, Section 3.1, paragraph 6,
line 2:

EPA states “Mancozeb has been tested in a series of in vitro and in
vivo genotoxicity assays, which have shown that it exhibits weak
genotoxic potential.”  Mancozeb does not have positive genotoxicity
findings in vivo.  Therefore, the appropriate statement is:  Mancozeb
has been tested in a series of in vitro and in vivo genotoxicity assays,
which demonstrates that it exhibits weak genotoxic potential in vitro
with negative findings in vivo.

36.	Table 51 should have a statement regarding removal of the grazing
restriction in order to be consistent with the language in Table 49,
“Tolerance Reassessment Summary for Mancozeb” for corn forage.
Table 49 states the field corn forage tolerance is “Contingent upon
label revision to remove feeding/grazing restrictions”.

Table 1

Summary of Mancozeb Risk Quotients from USEPA Public Draft
Re-Registerability Eligibility Decision Document Entitled
“Environmental Fate and Ecological Risk Assessment for the
Reregistration of Mancozeb”, PC Code No. 014504, DP Barcode D305808,
Date October 20, 2004.  Values in parenthesis from Mancozeb Task Force
Comments Dated February 22, 2005.

Site/Crop Use	Birds Chronic

(short grass, Max EEC)	Mammals Chronic

(short grass, Max EEC)	Freshwater Fish Acute

(PRZM/ EXAMS)	Estuarine/ Marine Fish Acute

(PRZM/ EXAMS)	Freshwater Invertebrate Acute

(PRZM/ EXAMS)	Estuarine/ Marine Invertebrate Acute

(PRZM/ EXAMS)	Aquatic Plant Acute

(PRZM/ EXAMS)	Freshwater Fish Chronic

(PRZM/ EXAMS)	Freshwater Invertebrate Chronic

(PRZM/ EXAMS)	Mitigation/ Refinement Options

Apple, Pear, Quince	379 (20)	32 (4.0)	0.16 (0.016)	0.05 (0.0098)	0.13
(0.0041)	6.99 (1.5)	1.56 (0.33)	1.46 (0.46)	0.96 (0.30)

Asparagus	117 (5.7)	9.7 (1.1)

Banana, Plantain	223	19

Barley, Oat, Rye, Triticale, Wheat	101	8.4	0.22 (0.0059)	0.06 (0.0037)
0.18 (0.0016)	9.85 (0.56)	2.20 (0.13)	1.46 (0.14)	1.05 (0.11)

	[Citrus]a	[57]	[4.7]

Corn (Sweet)	263	22	0.15 (0.0035)	0.04 (0.0022)	0.12 (0.00092)	6.50
(0.33)	1.45 (0.074)	2.05 (0.41)	1.32 (0.14)

	Cotton	117	9.7

Cranberry	303	25

Cucumber	298	25

Fennel	199	17

Garlic, Shallot	106	8.9

Grapes	335	28

Melon, Squash	298	25

Onion	334	28

Papaya	509	42

Peanut	199	17

Potato	204	17	0.10 (0.0059)	0.03 (0.0037)	0.08 (0.0016)	4.46 (0.56)	1.00
(0.13)	1.00 (0.27)	0.59 (0.16)

	Sugar Beet	204	17

Tobaccoa	131	11

Tomato	276 (11,6.8)g	23 (2.2,1.3)g	0.46 (0.0097)	0.13 (0.0061)	0.36
(0.0026)	20.08 (0.92)	4.49 (0.21)	3.33 (0.41)	2.29 (0.18)

	Vegetable Seed Crops a,b	95	7.9

Forestry (Douglas Fir)a	179	15

Ornamental Treesa,c	179	15

Ornamentalsa	101 (6.1)	8.4 (1.2)

Ornamentals-Pachysandra	--	--

Turfa,e	1138 (73)	95 (14)

Fold Reduction in RQ (Mean, Range)	23 (16-41)	10 (7-18)	31 (10-47)	14
(5-21)	92 (31-138)	15 (5-22)	14 (5-21)	6 (3-10)	8 (3-13)	See mitigation
and refinements below.

Footnotes from USEPA Public Draft RED Document

a Maximum number of applications/year or crop cycle not specified
(assumed 3 applications)

b Beets (unspecified), Broccoli, Brussel sprouts, Cabbage, Carrots,
Cauliflower, Chard (Swiss), Collards, Coriander, Dill, Endive, Kale,
Kohlrabi, Leeks, Lettuce, Mustard, Mustard Cabbage, Parsley, Parsnip,
Radish, Rape, Roquette (Arrugula), Rutabaga, Spinach & Turnip.

c Christmas Tree plantations

d Trees, Herbaceous plants, Non-flowering plants & Woody shrubs and
Vines

e Commercial/Industrial, Golf course, Sod Farm & Residential

Additional Footnotes

f Pachysandra labelled use rate greater than typical ornamentals.

g (11,6.8) & (2.2,1.3) = RQ’s for (Tomato-East of the Mississippi,
Tomato-West of the Mississippi), respectively.

-- Not reported by USEPA in Public Draft.

Mitigations and Refinements Proposed by the Mancozeb Task Force in
Public Comments to the Draft RED (Feb 2005)

Terrestrial Risk Refinements:

Measured 90%tile foliage DT50=9.8 days from registrant crop residue, DFR
and TFR studies and published studies on foliage residues.

Avian NOEC=125 ppm, the endpoint cited by USEPA in memorandum.

Mammalian NOEC=640 ppm, endpoint from developmental toxicology study
proposed by Mancozeb Task Force as better estimate of threshold for
adverse effects for the ecological risk assessment.

Average (and range) of RQ fold reductions from terrestrial refinements:
Birds-23 (16-41); Mammals-10 (7-18)

Additional Terrestrial Risk Refinements that could be considered:

Mean initial residues on dietary items are more likely to be encountered
over the long term than peak maximum initial residues (approximately 3
fold reduction).

Time weighted average concentrations more closely approximate exposure
to the degrading active ingredient on dietary items (approximately 2
fold reduction).

Measured initial residues on short grass in orchards and vineyards (from
EU study, approximately 10-20 fold reduction from max H&K residues on
short grass)

Aquatic Risk Refinements:

Aerobic soil DT50 based on degradation of mancozeb plus
dithiocarbamate-containing degradates.

Surface water modeling of combined residues of mancozeb and
dithiocarbamate-containing degradates for aquatic RQ calculations.

Proposed studies on toxicity of soil Non-Extractable Residues in
sediment dwelling organism.

Aquatic toxicity values to rainbow trout and Daphnia based on modern,
full GLP, guideline-compliant, analytically confirmed and maintained
concentrations in flow-through systems.

Average (and range) of RQ fold reductions from aquatic refinements:
Freshwater fish acute-31 (10-47); Estuarine/Marine Fish acute-14 (5-21);
Freshwater Invertebrate acute-92 (31-138); Estuarine/Marine Invertebrate
acute-15 (5-22); Aquatic Plant acute-14 (5-21); Freshwater Fish
chronic-6 (3-10); Freshwater Invertebrate chronic-8 (3-13).

 PAGE

 PAGE   8


[Federal Register: July 22, 2009 (Volume 74, Number 139)]
[Notices]
[Page 36228]
[DOCID:fr22jy09-81]

=======================================================================
-----------------------------------------------------------------------

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2008-N-0652]

Agency Information Collection Activities; Announcement of Office
of Management and Budget Approval; Notice of Participation

AGENCY:  Food and Drug Administration, HHS.

ACTION:  Notice.

-----------------------------------------------------------------------

SUMMARY: The Food and Drug Administration (FDA) is announcing that a
collection of information entitled ``Notice of Participation'' has been
approved by the Office of Management and Budget (OMB) under the
Paperwork Reduction Act of 1995.

FOR FURTHER INFORMATION CONTACT: Jonna Capezzuto, Office of Information
Management (HFA-710), Food and Drug Administration, 5600 Fishers Lane,
Rockville, MD 20857,<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION: In the Federal Register of April 6, 2009 (74
FR 15496), the agency announced that the proposed information
collection had been submitted to OMB for review and clearance under 44
U.S.C. 3507. An agency may not conduct or sponsor, and a person is not
required to respond to, a collection of information unless it displays
a currently valid OMB control number. OMB has now approved the
information collection and has assigned OMB control number 0910-0191.
The approval expires on May 31, 2012. A copy of the supporting
statement for this information collection is available on the Internet
at http://www.reginfo.gov/public/do/PRAMain.

    Dated: July 14, 2009.
Jeffrey Shuren,
Associate Commissioner for Policy and Planning.
[FR Doc. E9-17329 Filed 7-21-09; 8:45 am]

BILLING CODE 4160-01-S


Comment Info: =================

General Comment:USCG-2008-0170-0002

Preliminary Regulatory Analysis & Initial Regulatory Flexibility Analysis, 2009

Supporting and Related Materials

85 Pages