Document ID: EPA-HQ-OPP-2005-0231-0028
Agency: epa
Document Type: Supporting & Related Material
Title: 
Posted Date: 2007-06-28T04:00Z

Labeling Changes for Products Containing Metaldehyde

Description	

Amended Labeling Language	

Placement on Label

Manufacturing-Use Products

For all Manufacturing- Use Products	“This product may be formulated
into a molluscicide for the following use(s) only: artichokes,
blueberries, caneberries (bingleberry, black raspberry, blackberry,
boysenberry, dewberry, lowberry, marionberry, olallieberry,  red
raspberry, youngberry) and other berries (currant, elderberry,
gooseberry, huckleberry, loganberry, lingonberry, juneberry, salal),
citrus, lettuce, cole crops and other leafy greens (broccoli, Brussels
sprouts, cabbage, cauliflower, cavalo, broccolo, collards, kale,
kohlrabi, mizuna, mustard greens, spinach, rape greens), grass grown for
seed, ornamentals, tomato, and strawberry (grown as perennials only),
except those use sites with directions for use in State and/or Federal
invasive mollusk eradication operations.” 

 “This product may not be formulated into end-use products for use on
turf (except grass grown for seed and those use sites with directions
for use in State and/or Federal invasive mollusk eradication
operations), dichondra lawns, or strawberries grown as annuals.” 

“This product may not be formulated into end-use granular or
pelletized products unless formulated to contain more than 35 pellets
per gram.”

“This product may not be formulated into end-use granular or
pelletized products with directions for use at residential sites (i.e.,
in yards, gardens, around homes and apartments) and other sites such as
the exterior areas around schools and daycare facilities, and athletic
fields, playgrounds, parks, recreation areas, etc., unless such products
contain the current bittering agent at 300 ppm or another bittering
agent approved by the Agency.  The bittering agent must be of sufficient
concentration to deter ingestion by children and domestic animals.”

“This product may not be formulated into end-use products with
directions for use at residential sites (i.e., in yards, gardens, around
homes and apartments) and other sites such as the exterior areas around
schools and daycare facilities, and athletic fields, playgrounds, parks,
recreation areas, etc., unless the labels of such products contain a
graphic that depicts the prohibition on allowing children and domestic
animals access to treated areas and specific warnings designed to reduce
the numbers of incidents involving children and domestic animals.”
Directions for Use

One of these statements may be added to a label to allow reformulation
of the product for a specific use or all additional uses supported by a
formulator or user group	“This product may be used to formulate
products for specific use(s) not listed on the MP label if the
formulator, user group, or grower has complied with U.S. EPA submission
requirements regarding support of such use(s).”

“This product may be used to formulate products for any additional
use(s) not listed on the MP label if the formulator, user group, or
grower has complied with U.S. EPA submission requirements regarding
support of such use(s).”	Directions for Use

Environmental Hazards

Statements Required by the RED and Agency Label Policies	"This pesticide
is toxic to birds and mammals.  This pesticide is toxic to mollusks
(e.g., clams, oysters, scallops, mussels).  Do not discharge effluent
containing this product into lakes, streams, ponds, estuaries, oceans,
or other waters unless in accordance with the requirements of a National
Pollution Discharge Elimination System (NPDES) permit and the permitting
authority has been notified in writing prior to discharge.  Do not
discharge effluent containing this product to sewer systems without
previously notifying the local sewage treatment plant authority. For
guidance contact your State Water Board or Regional Office of the EPA."
Precautionary

Statements

End Use Products Intended for Agricultural Use or Use under State and/or
Federal Invasive Mollusk Eradication Operations

For any products that will  potentially be used in State and/or Federal
Invasive Mollusk Eradication operations

NOTE:  In addition to providing application rates in terms of pounds of
active ingredient, labels also must provide application rate information
in pounds of formulated product.	“This product may be used only on the
following use sites in response to State and/or Federal invasive mollusk
eradication operations.

“Broadcast applications of this product may be made to the following
use-sites for State and/or Federal invasive mollusk eradication
operations: fallow land; barrier strips; uncultivated non-agricultural
areas; recreational areas; non-food or non-feed brush; weed or dense
vegetative areas; railroad, pipeline, highway, power and telephone
rights of way and roadsides; guardrails and fences; lumberyards; storage
areas; seaports; industrial facility sites, including yards and walkways
around industrial buildings, parking areas, parks, golf courses, other
public areas; and airport and similar industrial non-crop areas.”

“This product may be applied for State and/or Federal invasive mollusk
eradication operations at an individual application rate of no more than
2 lb ai/A, and at no more than six applications/year. “ 	Text must be
placed within a Special Use Box in the Directions for Use section of the
label

Domestic Animal Precautionary Statements	“IMPORTANT:  This product can
be harmful to children and fatal to domestic animals when ingested. 
Children and dogs may be attracted to the product. Application of this
product is prohibited unless children and domestic animals can be
excluded from the treated area from the start of the application until
applied material is no longer visible.” 	Precautionary Statements: 
Hazards to Humans and Domestic Animals

PPE Requirements Established by the RED 	 “Mixers, loaders,
applicators, and other handlers must wear:

long-sleeved shirts and long pants, and

shoes plus socks.”	Immediately following/ below Precautionary
Statements:  Hazards to Humans and Domestic Animals

User Safety Requirements	“Follow manufacturer's instructions for
cleaning/maintaining PPE.  If no such instructions for washables exist,
use detergent and hot water.  Keep and wash PPE separately from other
laundry.”

“Discard clothing and other absorbent materials that have been
drenched or heavily contaminated with this product’s concentrate.  Do
not reuse them.”	Precautionary Statements:  Hazards to Humans and
Domestic Animals immediately following the PPE requirements

User Safety Recommendations	“User Safety Recommendations”

“Users should wash hands before eating, drinking, chewing gum, using
tobacco, or using the toilet.

“Users should remove clothing/PPE immediately if pesticide gets
inside.  Then wash thoroughly and put on clean clothing.

“Users should remove PPE immediately after handling this product.  

“Wash the outside of gloves before removing.  As soon as possible,
wash thoroughly and change into clean clothing.”	Precautionary
Statements:  Hazards to Humans and Domestic Animals immediately
following Engineering Controls

(Must be placed in a box.)

Environmental Hazard

Statements	

“This pesticide is toxic to mollusks (e.g., clams, oysters, scallops,
mussels).  Do not apply directly to water, to areas where surface water
is present, or to intertidal areas below the mean high water mark. 
Drift and runoff may be hazardous to aquatic organisms in water adjacent
to treated areas.  Do not contaminate water when disposing of equipment
wash waters or rinsate.

“This pesticide is toxic to birds and mammals.  Granules on soil
surface may be hazardous to terrestrial wildlife.  Cover or collect any
such materials spilled during loading.”	Precautionary Statements
immediately following the User Safety Recommendations

Poisoning Hotline	“Seek medical care as soon as possible after
exposure.  For incidents involving animals, seek veterinary care as soon
as possible after exposure.  Have the product container or label with
you when you call a poison control center or doctor or veterinarian, or
when going for treatment.  For information on this pesticide product
(including health concerns, medical emergencies, treatment advice, or
pesticide incidents), call [enter contact name as instructed below]     
                         at 1-[enter toll-free number as instructed
below].”

Instruction to the registrant:  The registrant must enter the contact
information, including a toll-free telephone number, for the entity that
1) will provide information to callers, and as needed, refer callers for
treatment advice (including instruction to see a medical or veterinary
professional as soon as possible), and 2) collect incident information
for reporting to EPA for both animal and human incidents.  Requirements
for call centers identified on the metaldehyde labels are detailed in an
attachment to this amendment to the metaldehyde RED.	Precautionary
Statements, under “First Aid” :  Poisoning Hotline

Note to Physician; Note to Veterinarian	“Metaldehyde is a systemic
toxin. There is no antidote.  The following instructions are not
intended for laypeople.  There is no home treatment.  Exposed
individuals and animals should receive emergency care as quickly as
possible. 

“NOTE TO PHYSICIAN:  Dust inhalation is usual route of accidental
exposure; the product is rarely ingested.  Treatment is symptomatic and
supportive. Monitor severe exposures closely: seizures, electrolyte
imbalances, acidosis, dehydration, and increased body temperature have
been reported. 

“NOTE TO VETERINARIAN: Animals typically are exposed via ingestion. 
Treatment is symptomatic and supportive. If significant ingestion
suspected, and the animal is asymptomatic, consider induction of emesis
or gastric lavage and administration of activated charcoal, cathartic
and enema to limit absorption.  Monitor asymptomatic and symptomatic
animals closely. Treat seizures, electrolyte imbalances, acidosis,
dehydration, and increased body temperature.  Monitor liver function
post recovery.”

Note to the registrant:  The text appearing in boldface type above must
appear on the product label in boldface or other contrasting type that
is readily distinguishable from the surrounding text.	Precautionary
Statements, under “First Aid” :  Poisoning Hotline

Restricted-Entry Interval for products with directions for use within
scope of the Worker Protection Standard for Agricultural Pesticides
(WPS) 	“Do not enter or allow worker entry into treated areas during
the restricted entry interval (REI) of 12 hours.  Exception:   SEQ
CHAPTER \h \r 1 if the product is soil-injected or soil-incorporated,
the Worker Protection Standard, under certain circumstances, allows
workers to enter the treated areas without restriction if there will be
no contact with anything that has been treated.”

	Directions for Use, under Agricultural Use Requirements Box 

Early Entry Personal Protective Equipment for products with directions
for use within the scope of the WPS	“PPE required for early entry to
treated areas that is permitted under the Worker Protection Standard and
that involves contact with anything that has been treated, such as
plants, soil, or water, is:

* coveralls,

* shoes plus socks

* chemical-resistant gloves made of any waterproof material” 
Directions for Use,

under Agricultural Use Requirements Box

General Application Restrictions	“Do not apply this product in a way
that will contact workers or other persons, either directly or through
drift.  Only protected handlers may be in the area during
application.”	Directions for Use,

immediately above the Agricultural Use Requirements Box

Other Application Restrictions 	“This product is intended solely for
use on agricultural crops grown for commercial or research purposes, and
in State and/or Federal invasive mollusk eradication operations.  This
product may not be applied to residential sites (i.e., in yards,
gardens, around homes and apartments) and other sites such as the
exterior areas around schools and daycare facilities, and athletic
fields, playgrounds, parks, recreation areas, etc.”

 “Broadcast applications and applications of this product directed to
plant parts are prohibited except to grass grown for seed and as
specified for use in State and/or Federal invasive mollusk eradication
operations.”	Directions for Use

Crop Specific Directions for Use

NOTE:  Maximum application rates must be expressed in pounds of
formulation per acre in addition to pounds active ingredient per acre

	End-use product labels must be amended to contain directions for use
only on the following crop- and use-sites and only with the maximum
application rate, maximum number of applications per growing season, and
minimum retreatment intervals as listed below.  All other crop- and
use-sites must be removed from end-use product labels.

Artichokes:  

When grown as a perennial, the maximum application rate is 1.0 lb ai/A
per application.  A maximum of 6 applications are permitted per growing
season at a minimum of retreatment interval of 18 days.

When grown as an annual, the maximum application rate is 1.0 lb ai/A per
application.  A maximum of 2 applications are permitted per growing
season at a minimum of retreatment interval of 18 days.

Blueberries: the maximum application rate is 0.8 lb ai/A per
application.  A maximum of 3 applications are permitted per growing
season at a minimum of retreatment interval of 14 days.

Caneberries (bingleberry, black raspberry, blackberry, boysenberry,
dewberry, lowberry, marionberry, olallieberry, red raspberry,
youngberry) and Other Berries (currant, elderberry, gooseberry,
huckleberry, loganberry, lingonberry, juneberry, salal): the maximum
application rate is 0.8 lb ai/A per application.  A maximum of 3
applications are permitted per growing season at a minimum of
retreatment interval of 14 days.

Citrus: the maximum application rate is 1.0 lb ai/A per application.  A
maximum of 6 applications are permitted per growing season at a minimum
of retreatment interval of 14 days.

Lettuce, Cole Crops, And Other Leafy Greens: (broccoli, Brussels
sprouts, cabbage, cauliflower, cavalo, broccolo, collards, kale,
kohlrabi, mizuna, mustard greens, spinach, rape greens): the maximum
application rate is 1.0 lb ai/A per application.  A maximum of 3
applications are permitted per growing season at a minimum of
retreatment interval of 14 days.

Grass grown for seed: the maximum application rate is 0.8 lb ai/A per
application.  A maximum of 4 applications are permitted per growing
season at a minimum of retreatment interval of 21 days.  Applications to
turfgrass (other than grass grown for seed or in State and/or Federal
invasive mollusk eradication operations) are prohibited.

Ornamentals: the maximum application rate is 1.0 lb ai/A per
application.  A maximum of 6 applications are permitted per growing
season at a minimum of retreatment interval of 21 days.

Tomatoes: the maximum application rate is 1.0 lb ai/A per application. 
A 

maximum of 3 applications are permitted per growing season at a minimum
of 

retreatment interval of 14 days.

Strawberries (grown as perennials only): the maximum application rate is
1.0 lb ai/A per application.  A maximum of 3 applications are permitted
per growing season at a minimum of retreatment interval of 14 days. 
Applications to strawberries grown as annuals are prohibited.

Note to the registrant:  Application methods and/or types of application
equipment must be specified for each use site on the label, along with
any specialized application instructions for any of the uses.	Directions
for Use, associated with the specific crop- or use-site

Storage Restrictions	“This product can be harmful to children and
fatal to dogs and other domestic animals if ingested.  Dogs have been
known to ingest metaldehyde after opening or tearing packaging.  Store
this product in its original packaging, in a cool, secure location, and
out of reach of children and pets.” 	Storage and Disposal

Products Intended for Use at Residential Sites and Other Sites such as
exterior areas around schools and daycare facilities, athletic fields,
playgrounds, parks, recreation areas

Precautionary Statement and Graphic Depiction for Products Intended for
Use at  Residential Sites 	The label of any end-use product with
directions for use residential sites (i.e., in yards, gardens, around
homes and apartments) and other sites such as the exterior areas around
schools and daycare facilities, and athletic fields, playgrounds, parks,
recreation areas, etc. must contain a graphic that depicts the
prohibition on allowing children and domestic animals access to treated
areas.  The required graphic is in the form of a red circle with the
words “Children” and “Pets” within the circle and with a red bar
running diagonally through it from upper left to lower right. 

The following specific warning statements must be added to the label in
close association to the above graphic:

“Keep out of reach of children and domestic animals.  This pesticide
may be harmful to children and fatal to domestic animals if ingested. 
Exclude children and pets from treated areas until the applied product
is no longer visible.  For additional precautionary measures, see
“Directions for Use” and “Storage and Disposal.””	Front panel

Precautionary Language	“IMPORTANT:  This product may be harmful to
children and fatal to domestic animals if ingested.  Children and dogs
may be attracted to metaldehyde products and their packaging.  Keep
children and pets out of treated areas from the start of application
until the applied product is no longer visible.”	Precautionary
Statements:  Hazards to Humans and Domestic Animals

Poisoning Hotline	“Seek medical care as soon as possible after
exposure.  For incidents involving animals, seek veterinary care as soon
as possible after exposure.  Have the product container or label with
you when you call a poison control center or doctor or veterinarian, or
when going for treatment.  For information on this pesticide product
(including health concerns, medical emergencies, treatment advice, or
pesticide incidents), call [enter contact name as instructed below]     
                         at 1-[enter toll-free number as instructed
below].”

Instruction to the registrant:  The registrant must enter the contact
information, including a toll-free telephone number, for the entity that
1) will provide information to callers, and as needed, refer callers for
treatment advice (including instruction to see a medical or veterinary
professional as soon as possible), and 2) collect incident information
for reporting to EPA for both animal and human incidents.  Requirements
for call centers identified on the metaldehyde labels are detailed in an
attachment to this amendment to the metaldehyde RED.	Precautionary
Statements, under “First Aid” :  Poisoning Hotline

Note to Physician; Note to Veterinarian	“Metaldehyde is a systemic
toxin. There is no antidote.  The following instructions are not
intended for laypeople.  There is no home treatment.  Exposed
individuals and animals should receive emergency care as quickly as
possible. 

“NOTE TO PHYSICIAN:  Dust inhalation is usual route of accidental
exposure; the product is rarely ingested.  Treatment is symptomatic and
supportive. Monitor severe exposures closely: seizures, electrolyte
imbalances, acidosis, dehydration, and increased body temperature have
been reported. 

  

“NOTE TO VETERINARIAN: Animals typically are exposed via ingestion. 
Treatment is symptomatic and supportive. If significant ingestion
suspected, and the animal is asymptomatic, consider induction of emesis
or gastric lavage and administration of activated charcoal, cathartic
and enema to limit absorption.  Monitor asymptomatic and symptomatic
animals closely. Treat seizures, electrolyte imbalances, acidosis,
dehydration, and increased body temperature.  Monitor liver function
post recovery.”

Note to the registrant:  The text appearing in boldface type above must
appear on the product label in boldface or other contrasting type that
is readily distinguishable from the surrounding text.	Precautionary
Statements, under “First Aid” :  Poisoning Hotline

Environmental Hazard

Statement for Residential Use Products	“This product is toxic to
mollusks (e.g., clams, oysters, scallops, mussels).  Do not apply
product near water (including garden ponds) or storm drains. Do not
apply if heavy rain is expected.  Apply this product only around
gardens and ornamental plants.”

For granular or pelletized product, add:

“This pesticide is toxic to birds and mammals.  Collect and remove any
product that is spilled.”	Precautionary Statements

General Application Restrictions	“Keep people and pets out of the area
during application.”	Directions for Use under General Precautions and
Restrictions

Other Application Restrictions	“This pesticide may be harmful to
children and fatal to dogs and other domestic animals if ingested. 
Children and dogs may be attracted to metaldehyde products, both in the
package and when applied.  Children and domestic animals must be kept
out of treated areas from the start of application until the applied
product is no longer visible.”

“Application of this metaldehyde product is prohibited unless children
and domestic animals can be excluded from the treated areas from the
start of application until the applied product is no longer visible.”

“Applications to turf and dichondra are prohibited.  Application is
permitted only to non-turf areas (i.e., on soil or mulch) directly
surrounding plants listed for use on the label.”

“Broadcast and foliar applications of this product are prohibited.
Application is permitted only as a barrier around gardens or individual
plants.  Application is prohibited within one foot of vegetable plants
or fruit-bearing plants not listed on this label.”

“Avoid applying pellets in piles that may attract pets.”

“Certain cultural practices may reduce damage from snails and slugs. 
These practices include: 

-- eliminating hiding places by removing leaf litter and debris in the
garden; 

-- removing slugs and snails during daylight hours from nearby leaf
litter, mulch, and other protected areas; 

-- watering in the morning to reduce humidity during the night when
snails and slugs are active.” 

The labels of end-use products containing both metaldehyde and carbaryl
must bear this statement on the front of the container:  “Do not use
this product unless both insect pests and slugs or snails are present. 
Pests targeted by this product are listed under ‘Directions for
Use.’”

Note to the registrant:  The text appearing in boldface type above must
appear on the product label in boldface or other contrasting type that
is readily distinguishable from the surrounding text.	Directions for Use
under General Precautions and Restrictions

Crop- and Use-Site Specific Directions for Use

NOTE: Application rates must be provided in user-friendly terms, for
example, “Apply pellets as a barrier around plants by distributing
pellets evenly in a line at a rate of X tablespoons of product per X
linear foot.”  	End-use product labels must be amended to allow use
only on the crop- and use-sites identified below.  Use instructions must
be consistent with the maximum application rate, maximum number of
applications per growing season, and minimum retreatment intervals
listed below.  All other crop- and use-sites must be removed from
end-use product labels.

Artichokes:  

When grown as a perennial, the maximum application rate is 1.0 lb ai/A
per application.  A maximum of 6 applications are permitted per growing
season at a minimum of retreatment interval of 18 days.

When grown as an annual, the maximum application rate is 1.0 lb ai/A per
application.  A maximum of 2 applications are permitted per growing
season at a minimum of retreatment interval of 18 days.

Blueberries: the maximum application rate is 0.8 lb ai/A per
application.  A maximum of 3 applications are permitted per growing
season at a minimum of retreatment interval of 14 days.

Caneberries (bingleberry, black raspberry, blackberry, boysenberry,
dewberry, lowberry, marionberry, olallieberry,  red raspberry,
youngberry) and Other Berries (currant, elderberry, gooseberry,
huckleberry, loganberry, lingonberry, juneberry, salal): the maximum
application rate is 0.8 lb ai/A per application.  A maximum of 3
applications are permitted per growing season at a minimum of
retreatment interval of 14 days.

Citrus: the maximum application rate is 1.0 lb ai/A per application.  A
maximum of 6 applications are permitted per growing season at a minimum
of retreatment interval of 14 days.

Lettuce, Cole Crops, And Other Leafy Greens (broccoli, Brussels sprouts,
cabbage, cauliflower, cavalo, broccolo, collards, kale, kohlrabi,
mizuna, mustard greens, spinach, rape greens): the maximum application
rate is 1.0 lb ai/A per application.  A maximum of 3 applications are
permitted per growing season at a minimum of retreatment interval of 14
days.

Ornamentals: the maximum application rate is 1.0 lb ai/A per
application.  A maximum of 6 applications are permitted per growing
season at a minimum of retreatment interval of 21 days.

Tomatoes:  the maximum application rate is 1.0 lb ai/A per application. 
A maximum of 3 applications are permitted per growing season at a
minimum of retreatment interval of 14 days.

Strawberries (grown as perennials only) the maximum application rate is
1.0 lb ai/A per application.  A maximum of 3 applications are permitted
per growing season at a minimum of retreatment interval of 14 days. 
Applications to strawberries grown as annuals are prohibited.

Note to the registrant:  Application methods and/or types of application
equipment must be specified for each use site on the label, along with
any specialized application instructions for any of the uses.	Directions
for Use associated with the specific crop- or use-site

Storage Restrictions	“This product can be harmful to children and
fatal to domestic animals if ingested.  Dogs have been known to ingest
metaldehyde after opening or tearing packaging.  Store this product in
its original packaging, in a cool, secure location, and out of reach of
children and pets.” 	Storage and Disposal

	

 PPE established on the basis of Acute Toxicity of the end-use product
must be compared to the active ingredient PPE in this document.  The
more protective PPE must be placed in the product labeling.  For
guidance on which PPE is considered more protective, see PR Notice 93-7.