Document ID: EPA-HQ-OPP-2007-0400-0013
Agency: epa
Document Type: Supporting & Related Material
Title: 
Posted Date: 2007-06-01T04:00Z

AVITROL CORPORATION COMMENTS RE:  ENVIRONMENTAL FATE AND EFFECTS RISK
ASSESSMENT FOR THE 4-AMINOPYRIDINE REREGISTRATION ELIGIBILITY DECISION
FORWARDED TO AVITROL CORPORATION BY KATIE HALL, 4-AMINOPYRIDINE CHEMICAL
REVIEW MANAGER, SPECIAL REVIEW AND REREGISTRATION DIVISION, BY HER
LETTER OF APRIL 3, 2007

Following are comments on the Memorandum of February 27, 2007 to Katie
Hall from Lucy Shanaman and Pamela Hurley et al.  , referred to by Ms.
Hall as, “Transmittal of the Environmental Fate and Effects
Division’s (EFED) Re-registration Science Chapter for the Ecological
Risk Assessment of the Restricted Use Avicide, Avitrol, Dated February
27, 2007.  These comments are generally applicable to the
Re-registration Ecological Risk Assessment for, Avitrol
(4-aminopyridine) End Use Products, dated February 7, 2007, and
Appendices A through I.

GENERAL COMMENTS:  The term Avitrol is, in error, used as an equivalent
of 4-aminopyridine.  This has caused untold confusion.  There was a
report of several persons being poisoned by “Avitrol” when actually
they ordered 4-aminopyridine from a reagent supplier thinking it to be
an aphrodisiac.  They consumed it and found that it was not an
aphrodisiac.  Avitrol is actually the trade name of the Avitrol
Corporation and is not 4-aminopyridine.  

1) Page 2. Para. 1.  Line 1.  -  Avitrol Corporation has no “pelleted
corn” products.  To correct this error, change “pelleted corn” to
“cracked corn.” 

2) Page 2. Para. 1 .  Line 2.  -  The sentence beginning “Individual
birds ---, contains errors.“  Please note that the reaction of a dosed
bird varies widely from species to species.  To correct the errors in
this sentence, a more accurate statement would be.  “Individual birds
which have been dosed will have a range of reactions depending on the
species.  This range may include vocalization, loss of motor control,
erratic flight, flapping wings, which are instinctive distress and alarm
reactions.  These reactions tend to frighten away the remainder of the
flock.” 

3) Page 2. Para. 2.  Line 1.  -  House sparrows were not included in the
recitation of birds contained on Avitrol labels, and the all inclusive
term “blackbirds” was used.  To correct these errors, house sparrows
should be added to the recitation of target species found on Avitrol
product labels and blackbirds should be qualified using the word
“certain.”

4) Page 2. Para. 2.  Line 2.  -  This line begins “blackbirds in and
around---” “on” should be inserted after “in” to correct the
error of omission.

5) Page 2. Para. 2.  Line 7.  -   The sentence, “The national labels
require that, when baiting at ground level, unconsumed treated bait be
removed at nightfall to prevent exposure to non-target species.” , is
incorrect.  The Federal label actually reads, “Where uneaten bait may
be a hazard to other birds or animals, it should be picked up at the end
of each day.”  This error should be corrected.

6) Page 3. Para. 1.  Line 6. -  Active ingredient “distributed per
unit area” is not a meaningful parameter for products such as Avitrol
baits.  It is an error to use such a parameter for Avitrol baits. 
Avitrol Corporation has provided input to LTJG Scott Miller on this
matter and would be pleased to discuss this issue further.

7) Page 3.  Insert Para. Federal Migratory Bird Permit:  Avitrol
Corporation has no objection to including scientific names on Avitrol
labels for target species.  

House sparrows (Passer domesticus), Rock Dove (Columba livia) and
European Starlings (Sturnus vulgaris) are exotics and have no Federal
protection.  They may be taken in any numbers, by any legal means,
including Avitrol baits.  It would be an error and inconsistent with
Federal law to require obtaining a Federal permit before “taking”
these species with Avitrol baits.

It should be noted that Federal permits are not required for certain
species on the migratory bird list as specified in 50 CFR 21 and it
would be an error to imply that such permits are required.  The only
bird on an Avitrol label for which a Federal permit is required is
gull(s).  Because of the problems they cause, permits are not required
for the other species.  Standing “Depredation Orders” have been in
place for many years for all other species on the Avitrol labels
including those on the two California labels.  Please see below:

“50 CFR 21.43 Depredation order for blackbirds, cowbirds, grackles,
crows and magpies.

	A Federal permit shall not be required to control yellow-headed,
red-winged, rusty, and Brewer’s blackbirds, cowbirds, all grackles,
crows, and magpies, when found committing or about to commit
depredations upon ornamental or shade trees, agricultural crops,
livestock, or wildlife, or when concentrated in such numbers and manner
as to constitute a health hazard or other nuisance. ---“

“50 CFR 21.44 Depredation order for designated species of depredating
birds in California.

	In any county in California in which horned larks, golden-crowned,
white-crowned and other crowned sparrows, and house finches are, under
extraordinary conditions, seriously injurious to agricultural or other
interests, the Commissioner of Agriculture may, without permit, kill or
cause to be killed under his/her general supervision such of the above
migratory birds as may be necessary to safeguard any agricultural or
horticultural crop in the county:--“

To the best of our memory, the two California crop labels were requested
by the State of California.  Except for gulls, it would be an error to
require Federal permits for any other species found on Avitrol labels.

8) Page 4. First indented Para. The current labels state:  -  This
section considers mandating  contacting local, state and Federal game
authorities prior to using Avitrol baits.  The current label language
reads, “Avitrol must not be exposed in any manner that may endanger
desirable and protected bird species.  If there is a question of such
hazard, consult local state and Federal game authorities before
undertaking bird management with Avitrol.”  Part B of Appendix F -
Incidence Summary Reports of Re-Registration Ecological Risk Assessment
for Avitrol (4-aminopyridine) End Use Products, reports incidents of
bird mortality dating back to 1971.  There were one- hundred-ten (110)
reported incidents of target kills; twelve (12) claims of non-target
kills in which residue analysis was performed; and seven (7) claims of
non-target kills in which residue analysis was not performed.  Avitrol
Corporation is familiar with these claims and questions several of the
claimed non-target kills.

Avitrol Corporation does not understand why target kills are reported
and even less so why they are recorded by the agency.  Of the total
reports of kills, one hundred-two (102) of the one-hundred-twenty-seven
(127) come from New York State.  This is disproportionate considering
the relatively small amount of Avitrol products used in New York State.
The reason for the disproportionate number of claims coming from New
York is one aggressive state employee, who in 1999 told Kelly Swindle,
“We may not get you this time but we will get you.”  Avitrol
Corporation has never before nor since had a government employee
demonstrate such a personal vendetta.  We believe that most of the
one-hundred two (102) kill reports originating in New York State come
from this individual.  We consider reports from this source should be
viewed with some skepticism.  

With that said we do not believe that label changes should be lightly
made.  Dating back to 1971, possibly nineteen (19) non-target incidents
have been reported with the current language in effect.  Avitrol
Corporation considers that it would be a major error to make label
changes based on this history.  Further, while Avitrol baits do elicit
the alarm and distress reactions in varying degrees from target species,
there is no label restriction on the percentage of kill allowed for a
target species.  New York Supplemental labels recognize that Avitrol
Federal labels are advisory in nature and require additional
restrictions for the use of these products in New York State,
restrictions not found on the Federal labels.  

9) Page 4. Second indented Para.  Airport use:  -  Currently there are
not, nor ever have there been, restrictions on the type of “airport”
facility at which Avitrol products could be used.  Avitrol Corporation
considers it would be an error to institute such restrictions now, since
they might result in safety and maintenance problems.

10) Page 4. Third indented Para.  Timing and duration:  -  We concur
wholeheartedly that timing and duration can be important in reducing
hazards to non-targets.  Our training presentations discuss precisely
this.  Because of the added unnecessary expense that would be incurred,
in most cases, Avitrol Corporation considers that it would be an error
to mandate timing and duration of baiting for all applications.  We
would propose language such as, “Where exposed bait might be a hazard
to other birds or animals, baiting should be performed at the birds’
first feeding and be removed and/or replaced with untreated bait after a
few hours.  Repeat this cycle as required to gain control.”

11) Page 4. Fourth indented Para.  Monitoring the bait:  -  We believe
that it would be an error to require for all applications that a
technician remain present during the entire period that the treated
blend is exposed.  However, with the caveat “In areas where non-target
species are likely to be present in higher numbers, ---“ we concur and
teach this in our seminars.

12) Page 4. Fifth indented paragraph.  Monitoring for dead birds:  - 
The label currently states, “Pickup and dispose of dead birds by
burial.”  We concur with clarifying by adding “daily.”  However,
we believe that it would be an error to require continuous monitoring. 
Our long history does not indicate that there should be a concern
meriting this level of monitoring.  However, in sensitive areas, it
might be desirable to have a technician, or customer’s employee,
remain on site to continually dispose of dead or dying birds and we
recommend this in our seminars. 

13) Page 5. First indented full Para.  Use of bait trays and placement
of bait:  -  It would be an error to require use of bait trays in all
situations because birds are neo-phobic and in most cases bait trays
increase the time required for bait acceptance.  It is problematic
whether or not some species can be induced to feed at elevated sites
such as roof tops.  Requiring elevated baiting sites for all species
would be an error.  However, elevated baiting sites should be used for
pigeons whenever feasible.  Flat roof tops are ideal for pigeons, and
contrary to statements made in the “Re-registration Ecological Risk
Assessment for Avitrol (4-aminopyridine) End-Use Products”, dated
January 5, 2007, incorrectly states that most Avitrol bait applications
are made by broadcasting on the ground.  This is incorrect.  A high
percentage of Avitrol Whole Corn, EPA Reg. # 11649-7, applications are
made on roof tops.

14) Page 5. Second indented full Para.  Removal of bait:  -  Avitrol
Corporation is unaware of a problem with nocturnal species.  We have
addressed this issue already and believe that in the absence of a known
problem that it would be an error to have such a requirement.

15) Page 5. Third indented full Para.  Documentation of feeding habits 
-  Avitrol Corporation considers that the current label language is
clear and that it would be an error to add clarifying statements to a
label that is already perfectly clear.  This is akin to EPA’s
assertion that there is nothing ambiguous in the statement, “KEEP OUT
OF REACH OF CHILDREN.” 

16) Page 5. Fourth indented full Para.  Minimization of mortality:  - 
It is possible that my previous response needs clarification.  It is
perfectly legal, and in some cases, may even be desirable to kill large
numbers of pigeons, house sparrows and starlings.  Although, because of
their reaction and the response of non-affected birds to the reaction,
it is not possible to kill large percentages of a sizable starling
flock.  Under Federal law, pigeons, house sparrows and starlings have no
protection and may be taken in any numbers.

Page 2. Para. 2.  Line 11, Correctly states “Labels outline
recommended ranges for ratios of treated to untreated.”  Avitrol
labels are in fact largely “advisory” in nature.  This is why New
York State has Supplemental Labels applicable to use of Avitrol products
in that state.  Any requirement to minimize mortality, blend ratios
allowed and application rates are particularly ambiguous because of the
nature of this very different product.  

As a practical matter, gulls, cowbirds, blackbirds, grackles and crows
are excellent reactors and respond quickly to the reactions of their
fellow brethren.  Obtaining a high percentage of mortality for these
species (for a flock of any size) using Avitrol baits would be very
difficult.

While good reactors, Starlings do not respond to other reacting
starlings as well as gulls, cowbirds, blackbirds, grackles and crows do
to their own reacting species.  Consequently, when using Avitrol baits
to control starlings, mortality will be relatively higher, in a similar
situation, than for gulls and the blackbird  species.

Pigeons do not react or respond to their fellow pigeons as well as do
starlings to the reactions of other starlings.  Consequently, when using
Avitrol baits to control pigeons, mortality will be relatively higher,
in a similar situation, than is the case for starlings.  You will recall
my previous response indicated that it is possible, but not required, to
keep the mortality of pigeons as low as 4% when using Avitrol baits. 

On the lower end of reactivity and response is the house sparrow. 
Consequently, when using Avitrol baits, mortality will be relatively
higher, in a similar situation, than is the case for pigeons.  I have
known of mortality rates up to fifty percent (50%) for house sparrows
when baiting at a site that was not mortality sensitive.  House sparrows
may be controlled with a lesser mortality but, mortality will be
relatively higher than for other species on Avitrol labels.

On a scale of one (1) to ten (10) with ten the most reactive and
responsive target birds on Avitrol product labels would be approximately
as follows:

	10.	Cowbirds

	  9.	gulls, blackbirds and grackles 

	  8.	starlings

	  7.	

	  6.	pigeons

	  5.	

	  4.	house sparrows

	  3.  

It should be noted that for “small” flocks the percentage of
mortality for all species will be higher than for “large” flocks.

Birds for which there is no Federal protection, (starlings, pigeons and
house sparrows) will have somewhat higher mortality than the other
species with starlings being on the lower end of mortality, pigeons in
the middle, and house sparrows higher.  Avitrol baits have provided
excellent control of these species for over thirty-five years.  These
species are the birds that most frequently inhabit man’s close
environment.  It would be a major error to restrict use of Avitrol baits
on these species and deny society of a valuable pubic health tool needed
to protect the environment from these pest species.

Avitrol Corporation believes that it would be an error to “revisit the
usefulness of Avitrol baits for the control of starlings, pigeons and
house sparrows.”  Avitrol baits are relatively self regulating.  Birds
for which there are some forms of Federal protection, gulls, cowbirds,
blackbirds, grackles and crows, usually respond and leave with low
mortality.  Avitrol Corporation has no objection to label language
requiring control of species other than starlings, house sparrows and
pigeons with minimum mortality.

17) Page 5. Fifth indented full Para.  -  One of the major deficiencies
---  As pointed out in this paragraph, “these are not typical products
that are applied on a “per acre” basis.”  This is precisely the
reason that it would be an error to attempt to fit these products into
that mold.  We have provided information to LTJG James S. Miller on this
subject.  We would recommend that the agency might consider language
similar to, “The treated blend of bait should be applied by label only
at active feeding sites and only in the quantities necessary to control
the flock.”  The quantity of bait applied will therefore vary with the
size of the flock, and any remaining bait should be removed when the
application is complete.

This paragraph, again in error, implies that there is an objective to
minimize mortality of a target flock.  In the case of starlings, house
sparrows and pigeons this may or may not be correct, and certainly is
not required by Federal law.  The sensitivity of a given application
site will determine the amount of mortality that is acceptable.

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