Document ID: EPA-HQ-OPP-2005-0231-0027
Agency: epa
Document Type: Supporting & Related Material
Title: 
Posted Date: 2007-06-28T04:00Z

UNITED STATES ENVIRONMENTAL PROTECTION AGENCY

WASHINGTON, D.C.  20460

OFFICE OF           

PREVENTION, PESTICIDES

AND TOXIC SUBSTANCES

June 22, 2007

CERTIFIED MAIL			

Dear Registrant:

SUBJECT:  AMENDMENT TO METALDEHYDE RED

The Reregistration Eligibility Decision (RED) document for metaldehyde
was signed on July 27, 2006.  A public comment period for the RED and
supporting documents was conducted from August 9 to October 10, 2006. 
The RED documents and public comments can be found   SEQ CHAPTER \h \r 1
on the Federal docket system, available at www.regulations.gov (docket #
EPA-HQ-OPP-2005-0231).  The Agency has reviewed the public comments and
has prepared a response to comments document which addresses the
substantive comments.  The response document is available for viewing at
www.regulations.gov under the same docket number.  This amendment to the
metaldehyde RED makes changes to the original decision document based on
the Agency’s evaluation of the public comments and other information
that became available during the comment period.    This amendment
includes changes to the RED label tables for metaldehyde products
(attached).

In the discussion below, the portions of the RED that prompted the
original comment (or related comments) are cited, the comment(s)
summarized, and the appropriate revision(s) explained.

Amendments to Required Label Language

Precautionary language and storage restrictions for end-use product
labels

RED text (labels of products intended for agricultural use):  

Domestic Animal Precautionary Statement:  “This product can be fatal
to children and dogs (and other 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.”

Storage Restrictions:  “This product can be fatal to children and
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.  Do not store in any location where
children and domestic animals can access the packaging or the
product.”

RED text (labels of products intended for residential and similar uses):
 

Precautionary Statements:  “Keep out of reach of children and domestic
animals.  This pesticide may be fatal to children and dogs (and other
domestic animals) when 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.”

“IMPORTANT:  This product may be fatal to children and dogs (and other
domestic animals) if ingested.  Keep out of reach of children and
domestic animals.  Children and dogs may be attracted to metaldehyde
products and their packaging.  Keep children and dogs (and other
domestic animals) out of treated areas from the start of application
until the applied product is no longer visible.”

Storage Restrictions: “This product can be fatal to children and 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.  Do not store in any location where
children or domestic animals can access the packaging or the product.”
 

Comments:  These statements are excessive in length and the contents are
redundant.  Metaldehyde has not been associated with lethal poisonings
in children.

Amendment:  The Agency has revised the precautionary statements and
storage restrictions labeling to be more concise.  The precautionary
statements are revised to indicate that ingestion by children may be
harmful, rather than lethal. 

The graphic representation for residential product labels

RED text:  “The label of any end-use product with directions for use
on residential sites...must contain a graphic that depicts the
prohibition on allowing children and domestic animals access to treated
areas.  For example, the symbol may be a red circle with the words
“Children” and “Pets” within the circle and with a red bar
running diagonally through it.”  This statement is to appear on the
front panel of the packaging, and the RED specifically solicited comment
on what type of graphic representation would be best

Comments:  Comments on this subject were divided between supporters of
the graphic and those who opposed it.  The primary concerns of those in
opposition were:  the graphic could be misinterpreted as prohibiting use
by people with children or dogs; the graphic is confusing; no standards
exist on pesticide labels for warning of this type.  Commenters in
support of the graphic thought it would help alert dog owners, and noted
that graphic warnings have been used successfully to communicate hazards
to consumers.  The suggestion was made that educational outreach efforts
could further the objective of protecting the public.  The specific
graphic suggested in the original RED (red circle with a red slash
running diagonally across the circle from upper left to lower right; the
words “Children” and “Pets” printed within the circle) is a
universally recognized symbol connoting prohibited or undesirable
behaviors and situations; this type of graphic is most effective if
accompanied by warning statements in text.

No comments were made on alternate graphic representations.

Amendment:  The Agency continues to believe that the graphic can act as
a readily visible warning on keeping children and pets out of treated
areas.  Since no alternatives were suggested, the Agency is requiring
the red circle and slash symbol as the only acceptable graphic at this
time.  The Agency agrees to discuss educational outreach to consumers
and conveying pertinent information via websites with the registrants.

Poisoning hotline label statements

RED text (for labels of all metaldehyde end-use products):   “Seek
medical 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 when going for treatment.  For information on this pesticide
product (including health concerns, medical emergencies, or pesticide
incidents), call the National Pesticide Information Center at
1-800-858-7378.”

RED text (for labels of residential use products only):  “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 veterinarian or when taking an exposed
animal for treatment.  For treatment advice and other information about
exposures of animals to this pesticide, call [registrant enters name of
reporting service] at [registrant enters appropriate toll-free telephone
number].”

Comments:  Requiring two different reporting numbers (human and domestic
animal) is confusing to the user.  Directing incident calls to NPIC
should not be mandated.

Amendment:  The Agency’s concern for the poisoning hotline text and
toll-free number required to be placed on all metaldehyde end-use
product labels is three-fold:  1) callers should have quick access via
the hotline number to practical poisoning information (which in many
cases will be referral as follows); 2)  depending on the potential
seriousness of a poisoning incident, callers should be referred rapidly
to their human or animal health care providers, or if a provider is not
available, to an entity qualified to provide emergency care information
(such as a local poison control center or the Animal Poison Control
Center); and 3)  information on exposure and poisoning incidents must be
collected and reported to the Agency in a uniform manner so that
statistics on poisonings are comparable between hotline service
providers.  When these criteria can be satisfied, the Agency feels no
need to mandate that the registrant use a particular hotline service. 
Therefore, the Agency is allowing the registrants to use the hotline
services they select, but they will be required to collect and report
incident information and provide advice to callers reporting a poisoning
incident using a protocol substantially similar to the one employed by
NPIC and the certified poison control centers.  Data collected and
reported in this way should allow the Agency to compare incident types
and numbers between registrants.

The required protocol for incident data collection and referral is
detailed in an attachment to this amendment.

The Agency is requiring one statement that will cover both human and
domestic animal incidents.  The label table of the RED is amended so
that the hotline statements for human and animal incidents are combined.

In addition, in researching how metaldehyde poisoning incidents should 
be handled, the Agency determined that many metaldehyde end-use product
labels do not include a “Note to Physician” and a “Note to
Veterinarian” to provide key advice to health and veterinary care
professionals treating metaldehyde exposures.  Among those product
labels that do, the statements vary and some do not provide information
that will aid professionals to the extent the Agency feels is needed. 
Therefore, the Agency is requiring specific language that can be used by
physicians and veterinarians to respond quickly to patients in their
care.  The specific language is found in the label table attached to
this amendment.  To address a concern expressed by several experts in
the field during development of this language, the statements will warn
that individuals other than human and animal health professionals should
refrain from utilizing this information, because only these
professionals will be able to make judgments about specific therapies,
and improperly applied treatments may worsen the condition of the
exposed person or animal.

The notes to the veterinarian and doctor must appear directly below the
first aid box on the product label.  The first aid box will cover
actions that non-professional responders may undertake after an
accidental exposure, such as directions to remove the exposed individual
from the treatment area, rinse eyes and skin, and contact a medical or
veterinary health care provider as soon as possible.

 

Environmental hazard statements for end-use products

RED text (labels of products intended for agricultural use):   “This
pesticide is toxic to fish and aquatic invertebrates.  Do not apply
directly to water, to areas where surface water is present, or to
intertidal areas below the mean high water mark except as noted on
appropriate labels.  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.”

RED text (labels of products intended for residential and similar uses):
 “This product is toxic to fish and aquatic invertebrates.  Do not
apply product near water 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.  Sweep up or collect and remove any
product that lands on the driveway, sidewalk, or other hard surface on
which it is spilled.”

Comments:  Metaldehyde applied as a spot treatment is not likely to be
present on impervious surfaces after residential applications, so the
labeling, “…[s]weep up or collect and remove any product that lands
on the driveway, sidewalk, or other hard surface on which it is
spilled” is not needed.  Metaldehyde does not meet the LC50 threshold
for aquatic hazard statement. 

Amendment:  In the interest of reducing the volume of label text, the
Agency will require abbreviated text for the hazard statement on
pelletized, residential-use products, without the phrase relating to
hard surfaces.

EPA believes the aquatic hazard statement is warranted, regardless of
metaldehyde’s LC50 , since it is a molluscicide, for which toxicity to
nontarget mollusks is likely.  The Agency will amend the aquatic hazard
statement for both the agricultural and residential use labels to
reflect the concern for these types of organisms.

Application of residential use products resulting in piles of pellets

RED text:  NA

Comment:  Residential metaldehyde products applied in a manner that
results in piles of granular materials on the treated surface present a
hazard by concentrating material that might be ingested by pets.

Amendment:  The labeling is amended to require that users avoid applying
residential products in ways that result in piles of pellets.

Cultural practices statement for residential product labels

RED text:  “Certain cultural practices may reduce damage from snails
and slugs, and may make metaldehyde applications more effective. 
Examples of cultural methods to reduce snail and slug populations
include: 

-- removing leaf litter and debris to eliminate places for slugs and
snails to hide during the day; 

-- looking for and removing slugs and snails during daylight hours in
leaf litter, mulch, or other protected areas adjacent to plants they
feed on; 

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

Comments:  Comments were received in support and in opposition of this
language.  Labels should refer users to garden experts for information
on complementary cultural practices.  Outreach materials could be
developed to communicate additional cultural control information.

Amendment:  The Agency continues to believe that information on relevant
cultural practices can help consumers reduce damage by target pests
while also reducing potentially hazardous exposures to metaldehyde. 
However, the Agency sees an opportunity to address the concern
articulated in the public comments about the volume of text on the
residential product labels, and is requiring an abbreviated cultural
practices statement, one with specific, easy-to-implement practices.  In
addition, the Agency will discuss options in public outreach, including
additional information on cultural practices, with the metaldehyde
registrants.

Application methods and equipment

RED text:  “Broadcast or foliar applications of this product are
prohibited.”

Comment:  Broadcast applications are needed for grass grown for seed.  

Amendment:  Broadcast applications were the basis for the Agency’s
risk assessment for grass grown for seed, and are the norm for that
crop.  Labeling will be revised to allow broadcast applications for
grass grown for seed. 

 

RED text: NA

Comments:  Allowable uses must be listed on all product labels. 
Allowable application methods and equipment and special application
instructions should be listed on the product label.

Amendment:  In addition to previous requirements for labeling that
completely describes the maximum application rate, maximum number of
applications per growing season, and minimum retreatment intervals for
each use site, labels must also incorporate information on application
methods, equipment, and any specialized application instructions.

Differentiation of formulation types

RED text:  “Do not apply this product in a way that will contact other
persons or pets either directly or through drift.  Keep people and pets
out of the area during application.”

Comment:  The General Application Restrictions for residential use
products contains a drift statement that is not applicable to granular
formulations.

Amendment:  The drift statement is amended to be more applicable to such
formulations.

Grouping nonresidential sites with other nonagricultural, nonresidential
sites 

RED text:   The following phrase appears in several places within the
metaldehyde label table:  “…residential sites (i.e., in yards or
gardens, around homes, apartments, schools, daycare facilities, athletic
fields, playgrounds, parks, recreation areas, etc.)…”  

Comment:  Residential use sites should not include athletic fields,
playgrounds, parks, and recreation areas.

EPA response:  The intent of this language is to impose the same
requirements on residential uses and use on the listed sites, which are
not truly examples of residential sites, but sites for which the Agency
believes the potential for exposure (esp. to children, pets, and
wildlife) is similar.  The RED is amended so that these use sites are
not named as types of residential use sites, but retains the same
labeling requirements for both.

Setback for fruit and vegetable plants

RED text (residential product labels):  “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.”

Comment:  The setback statement for residential labels should be
emphasized.

Amendment:  Residential product labels are required to incorporate these
two sentences in a way that will draw the attention of users to the
change in use practices, i.e., in boldface type or another contrasting
color that is readily distinguishable from the surrounding text.

Misleading statements on existing end-use product labels

RED text:  NA

Comment:  Phrases such as “ideal for vegetable gardens” and “can
be used around fruit and vegetable plants, lawns and ornamental
plants” on metaldehyde product labels may be construed to allow use on
a broad range of use sites (including sites not appearing on the
labels).

Amendment:  Label submissions will be rejected if they are found to bear
inappropriate or misleading statements.

Application parameters for blueberries

RED text:  The RED requires that labels specify that the maximum
application rate and number of application for blueberries must be no
more than 0.8 lb ai/A per individual application and two
applications/year.  The minimum retreatment interval must be no less
than 14 days.

Comment:  The number of applications/year for blueberries should be
increased to three.

Amendment:  EPA has been advised by an expert in the field that three
applications/season may be needed for blueberries in years of high
rainfall and high pest pressure, which is significantly fewer than the
assessed number of applications (five).  Labeling will be amended to
reflect a maximum of three applications per season on blueberries

Labeling for official use in eradicating invasive mollusks

RED text:  NA

Comments:  The United States Department of Agriculture’s Animal and
Plant Health Inspection Service (APHIS) uses metaldehyde as a
cornerstone in its National program for controlling exotic, invasive
snails and slugs that pose threats to plants and human health.  This
program includes treatments with metaldehyde on additional use sites not
among those identified as eligible for reregistration by the RED,
including fallow land, barrier strips; and railroad, pipeline, highway,
power, and telephone rights of way.

Amendment:  The mollusk eradication program is a high-benefit activity
which addresses not just potential plant damage, but also threats to the
public health, as some of the target species can transmit diseases to
humans.  The usage of metaldehyde in this program is relatively small. 
The Agency is requiring that any formulators who have previously
included the additional use sites on their product labeling and wish to
retain them for the use in the mollusk eradication program, or who later
supplies product for use in the program, must include instructions
within a special use box on the product label.  Text within the special
use box must include directions for use only in response to State and/or
Federal invasive mollusk eradication operations.

Metaldehyde/carbaryl combination products

RED text:  “…labels for metaldehyde-carbaryl combination products
must bear language advising users that such products must not be applied
unless both snails or slugs and target pests for carbaryl are
present.”

Comments:  New labeling is not likely to prevent misuse of these
products.  To draw attention to the new restrictions, the combination
products should be packaged differently, and prominent labeling should
warn against using the product unless both types of pests are present.

Amendment:  The Agency is amending the labeling requirements of the RED
so that the requirement for using these products only when both types of
pests are present is emphasized, both by placing the text on the front
of the label and using boldface or other contrasting type to draw
attention to subject language. 

Amendments to the RED Text other than Labeling Requirements 

Formulating metaldehyde end-use products with a blue dye 

RED text:  “Based on evidence that brightly colored granules may be
less attractive to animals, formulators must incorporate a coloring
agent into their granular formulations…  The Agency is specifically
seeking public input on this issue in the comment period after the RED
becomes available.”

Comments:  Bright non-natural colors could be effective in discouraging
ingestion of granules by birds, especially if coupled with a
taste-conditioned aversion.  Colored pellets would make it easier for
users to determine when applied material is no longer visible so that
children and pets can regain access to yards.  Blue-dyed pellets might
appeal to children who would mistake them for candy.  Conflicting
comments were submitted on whether or not the dye would affect the
appearance of produce and ornamentals.

Amendment:  The Agency is withdrawing its requirement for colored
pellets, primarily because of the possible risks to children and a body
of literature which is not conclusive about the aversion of birds to
colored pellets.

Relative costs of using metaldehyde and iron phosphate products

RED text:  “Growers may be reluctant to use iron phosphate because
they consider it to be new and untested, and because it is more
expensive ($1.55/lb vs. $1.25 for metaldehyde).”

Comment:  The discussion of relative treatment costs does not account
for the higher application rate of iron phosphate.

Amendment:  The Agency has more thoroughly explored the issue of the
relative costs of metaldehyde and iron phosphate based on maximum and
typical application rates.  The Agency agrees that there are cost
differentials for agricultural uses and higher cost differentials for
residential uses.  The RED is amended to include the following text:  

“The labeled application rate for metaldehyde for most crops is 10 to
40 lb/acre (with the exception of artichokes where application rate is
20 to 75 lb/acre).  Similarly, the label application rate for iron
phosphate is 10 to 44 lb/acre.  According to Washington State Pest
Management Resource Service, iron phosphate costs $0.36 more per pound
than metaldehyde.  At the maximum labeled rates noted above (excluding
the rate for artichokes), this amounts to a difference of about $21 per
acre.  Data from the California Department of Pesticide Regulation Data
for 2005 (http://www.cdpr.ca.gov/docs/pur/pur05rep/05_pur.htm) indicate
that actual application rates do not approach the label maximum and that
application rates for metaldehyde and iron phosphate are generally
comparable.

“Labeling directions for residential use products suggest that iron
phosphate be applied at two and a half to four times the rate of
metaldehyde.  Prices for residential use products vary, with iron
phosphate typically being slightly more expensive than metaldehyde. 
Applying metaldehyde at the rates shown in the directions for use on
residential product labels would make the use of iron phosphate
approximately two to five times more costly than the use of
metaldehyde.” 

Animal exposures via routes other than ingestion

RED text:  “Labels for residential-use products must prominently
display language advising users that…metaldehyde ingestion or other
exposures to metaldehyde can be lethal to domestic animals.” (Even
though this text includes requirements for label language, the
metaldehyde label table did not reflect such a requirement.)

Comment:  Exposure of domestic animals to metaldehyde by routes other
than ingestion is not known to be lethal.

Amendment:  Although domestic animals may be exposed to metaldehyde
through other routes (e.g., dermal), there are no data to support the
statement in the RED.  The RED is amended to exclude this statement.

Contact Information

If you have questions on the metaldehyde RED, the amendments listed in
this document, or questions about the Generic DCI, please contact the
Chemical Review Manager, Jill Bloom, at (703) 308-8019, or via email at 
 HYPERLINK "mailto:bloom.jill@epa.gov"  bloom.jill@epa.gov .

Sincerely,

Peter Caulkins

Acting Director

Special Review and Reregistration Division

Attachment:	Revised Metaldehyde Label Table

		Protocol for Incident Data Collection

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