![](media/image1.bmp)

Florida Department of Agriculture and Consumer Services

CHARLES H. BRONSON, Commissioner

The Capitol • Tallahassee, FL 32399-0800

> Please Respond to:

**Bureau of Pesticides**

**3125 Conner Boulevard (Bldg. 6)**

**Tallahassee, Florida 32399-1650**

> **(850) 487-0532; fax (850)488-8497**
>
> **howardd@doacs.state.fl.us**

August 16, 2005

Public Information and Records Integrity Branch (PIRIB)

Information Resources and Services Division (7502C)

Office of Pesticide Programs (OPP)

Environmental Protection Agency

1200 Pennsylvania Ave., N.W.

Washington, D.C. 20460

**Subject: Comments on the Screening Level Ecological Risk Assessment
for Aldicarb**

**RE: Docket ID Number OPP-2005-0163**

To Whom It May Concern:

The Florida Department of Agriculture and Consumer Services appreciates
the opportunity to comment on the screening level ecological risk
assessment for aldicarb. The Department, as a regulatory partner with
the Environmental Protection Agency (EPA), is committed to using sound
science and effective management to protect human health and the
environment from unreasonable adverse effects of pesticides. We are also
interested in efforts to refine risk assessments and mitigation measures
for pesticides that fill critical needs for pest control in Florida. The
Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) requires EPA
to balance the risk and benefits of a pesticide in making registration
decisions. This assessment of both risk and benefits of aldicarb is
especially important for Florida since our growers (particularly citrus
and potato producers) use a significant portion of aldicarb nationally
and consider it an essential tool for pest management. Florida is also
diverse in wildlife with many unique species, including threatened and
endangered species. Overall, it is essential to have an accurate
assessment of risk before making the risk/benefit decision. Therefore,
we would like to provide EPA with comments and information that will aid
the Agency in both refining the ecological risk assessment to properly
characterize the risk to non-target species and in understanding the
role of aldicarb in Florida agriculture.

Aldicarb has been used in Florida for over 35 years in crops such as
citrus and potatoes. Over these 35 years, the Department has received no
reports of wildlife mortality that was directly linked to legal use of
aldicarb. There have been incidents involving the use of baits (e.g.,
hotdogs, sardines, deer carcasses, etc.) containing aldicarb by
unscrupulous individuals for the purpose of killing dogs, cats, or
wildlife. These particular uses of aldicarb are, of course, illegal and
often result in secondary toxicity to predatory and scavenging wildlife.
The Department's Bureau of Compliance Monitoring has worked with both
U.S Fish and Wildlife Service and the Florida Fish and Wildlife
Conservation Commission to aggressively investigate these incidents and
prosecute those responsible under federal and state law. Attached is a
summary of investigations involving illegal aldicarb use in Florida.

While the Department agrees that aldicarb does pose a risk to wildlife
as evident from the toxicity data and illegal use (e.g., baiting to kill
wildlife), the lack of reported wildlife mortality incidents from
legitimate use of aldicarb in Florida indicates that the actual risk to
wildlife is likely to be substantially less than what is suggested in
the screening level risk assessment. The Department assumes that since
this is a screening level ecological risk assessment, EPA will complete
a more thorough and refined ecological risk assessment -- one that more
accurately portrays risk that is actually occurring in the field under
conditions allowed on the label. However, in many portions of the
document, the reviewers claim that this assessment may actually
underestimate risk to wildlife such as birds. This screening level
assessment clearly uses very conservative assumptions concerning both
exposure and toxicity effects to birds. The combined assumption
concerning granules exposed on the surface and birds feeding exclusively
on granules atop pesticide treated bands, while ignoring other factors
that influence the likelihood that birds will ingest the granules,
grossly overestimates risk to birds and very likely goes beyond what one
would consider a worst case scenario under conditions allowed on the
label. We believe that EPA should have made it clear that a screening
level assessment uses conservative assumptions that tend to overestimate
risk or, at best, represent worst case scenarios that are not likely to
occur for the overwhelming majority of situations expected in the field.

The screening level assessment overestimates risk in the estimate of
percentage of granules unincorporated and exposed on the soil surface.
Although the Agency uses a default value of 15% granules unincorporated
for broadcast applications, they provide no data that supports this
assumption (previous registrations of granular products point to
research conducted in 1983). The main problem with this assumption is
that applications of aldicarb in Florida are not broadcast but are made
in-furrow for both potatoes and citrus. Because in-furrow application
using positive flow is very effective in limiting the amount of granules
that are unincorporated, the proposed 15% exposed granule value greatly
overestimates risk of aldicarb to wildlife. While the 1% default value
used for in-furrow applications is also a conservative assumption, this
value is more appropriate for the screening level assessment than the
15% used for broadcast applications. Overall, this particular parameter
has the greatest effect on the estimated risk to birds and mammals, so
it is crucial to apply the appropriate value. For example, assuming that
1% of the granules are unincorporated, the calculated RQs, using the
mallard (EC~50~ = 1.0 mg/kg) as the surrogate species, would range from
0.57 (large bird) to 52 (small bird). Using the 15% unincorporated value
results in RQs of 8.6 and 771, respectively.

The above values were calculated using EPA's default avian toxicity
scaling factor of 1.15 (based on the slope regression of log LD~50~
versus log weight of the bird). This assumes that smaller birds are more
sensitive to aldicarb toxicity than larger birds. Using this value,
therefore, greatly increases the calculated RQ for small birds. However,
based on the avian toxicity data for birds submitted for registration of
aldicarb, there appears to be no relationship between toxicity of
aldicarb and body weight. In other words, LD~50~ values for the smaller
birds tested (i.e., red-winged blackbird and European starling) are very
similar (or even slightly greater) to the values for the larger birds
(i.e. pheasant and mallard). In fact, the mallard is one of the most
sensitive species tested using aldicarb. Overall, the LD~50~/ft^2^
method, which EPA uses in their risk assessment for aldicarb, is already
scaled for weight since it takes fewer granules to kill smaller birds
than larger birds. The resulting RQ is higher for small birds even
without the scaling factor. However, when using the toxicity scaling
factor for weight, EPA greatly overestimates risk to small birds,
essentially doubling the RQ for the small bird category. Therefore,
unless there is data to suggest otherwise, the use of a toxicity scaling
factor for birds is inappropriate for aldicarb.

Overall, the LD~50~/ft^2^ is a simple and effective tool for
characterizing toxicity, but it is much less effective for determining
actual risk since the exposure component is based on an arbitrarily
chosen unit area. The Department would prefer that EPA refine the risk
assessment by using toxicity data for the formulated product and the
appropriate estimates of the availability (unincorporated granules for
in-furrow application) and likelihood of birds ingesting granules in the
field. In addition, the availability of the granules should be evaluated
for the whole field or grove, as opposed to just the application band.
These factors all have a significant effect on the overall risk
characterization and will provide a more realistic estimate of both the
probability and magnitude of effects to wildlife. As it currently
stands, the screening level assessment does not provide any indication
of the probability or magnitude of risk to wildlife from the use of
aldicarb other than to suggest that practically 100% of the birds
feeding within the treated fields or groves will likely die.

There are many other routes of exposure for aldicarb, or any other
pesticide, that should be considered when determining risk to wildlife,
including residues in/on food sources, drinking water, dermal and
inhalation exposure. However, given the acute toxicity of aldicarb to
birds and mammals and the potential for exposure through ingestion of
unincorporated granules, EPA has focused the screening level ecological
risk assessment on this route of exposure. The Department agrees with
the Agency that oral ingestion of granules represents the most likely
route for adverse effects to wildlife. The Department would like to
provide assistance in refining the risk assessment to include any of
these addition routes of exposure that may impact non-target wildlife.

In the screening level ecological risk assessment, EPA determined that
all uses of aldicarb (including citrus and potatoes) pose significant
risk to fish and aquatic invertebrates. However, this assessment was
based on modeling 15% of the labeled seasonal application rate rather
than soil incorporation in the top 2 cm. Considering that the likely
percentage of unincorporated granules is likely much less than 15% (from
the use of in-furrowed application using positive flow), the Department
believes that EPA should run the PRZM model only using the
soil-incorporated setting, as this more closely represents field
conditions as required on the label. In addition, aldicarb, the parent
compound, is very unstable in water. The parent compound is rarely
detected in surface water monitoring in our state. Our data comports
with NAWQA monitoring studies in that the sulfone and sulfoxide
degradates tend to be found only infrequently and at very low
concentration in our state. Overall, we agree with EPA that impacts to
aquatic organisms, if they occur at all, are likely to be limited to
shallow water systems in high use areas.

The Department has accumulated considerable Florida ground and surface
water quality data which includes analyses for aldicarb and its
degradates. The Agency is encouraged to contact us regarding these data
as we believe they will assist in refining assessments for exposure by
humans and other non-target organisms (contact: Dr. Davis Daiker;
<daikerd@doacs.state.fl.us>; 850.487.0532). We also are attaching a copy
of Florida's aldicarb rule (5E-2.028 FAC), which imposes a variety of
mitigation measures to prevent the contamination of drinking water
supplies with aldicarb. Over the years, the results of permitting and
monitoring programs indicate that these mitigation measures are
effective.

Finally, the Department is aware that EPA has initiated informal
consultation with U.S. Fish and Wildlife Service (FWS) to address risks
to threatened and endangered species from the use of aldicarb. The
Department continues to support the cooperative effort by EPA, FWS, and
National Marine Fisheries Service in creating the counterpart
regulations to ensure that regulatory actions under FIFRA are in
compliance with the requirements of section 7 of the Endangered Species
Act. EPA has determined that aldicarb "may affect" federally listed
species, both terrestrial and aquatic, throughout the United States,
including several listed species in Florida. It is expected that EPA
will require a more refined, species-specific assessments to determine
if aldicarb is "not likely to adversely affect" listed species. A
variety of information will be required to perform the species-specific
assessments including information on biological requirements and habits
of the listed species, sub-county commodity information, pesticide use
patterns, land use practices, and monitoring data.

As the state lead agency for pesticide regulation, the Department has a
unique knowledge of agricultural and other pesticide-related activities,
either directly or through partnerships with growers, cooperative
extension personnel, and other state agencies -- information valuable
for determining risks to listed species. For example, through our
working relationships with other state agencies and federal offices we
have access to valuable sources of data and information including
endangered species data from the Florida Natural Areas Inventory (FNAI),
GIS land-use data from the Water Management Districts, and pesticide use
and crop profiles from the Institute of Food and Agricultural Sciences
(IFAS). Therefore, we request that our Department be given the
opportunity to actively participate in discussions involving mitigation
measures for aldicarb aimed at protecting federally listed species
within Florida. As the state lead agency we are ultimately responsible
for enforcement under the misuse provisions of FIFRA for those pesticide
users who fail to follow provisions relating to their pesticide
application, including provisions either on the label or in county
bulletins, regardless of whether that failure results in harm to a
listed species. Given this responsibility, our involvement is crucial
for successful implementation of the program as a whole, and
specifically, for the development of mitigation measure measures for
aldicarb that are scientifically defensible, protective, enforceable,
reasonable, and fair.

We appreciate the opportunity to provide comments on the screening level
ecological risk assessment for aldicarb and look forward to working with
you in the future to further refine the assessment and to review
mitigation measures.

Sincerely,

**CHARLES H. BRONSON**

**COMMISSIONER OF AGRICULTURE**

![](media/image3.jpeg){width="1.9993055555555554in"
height="0.3770833333333333in"}

Dennis F. Howard, Ph.D.

Chief, Bureau of Pesticides

DFH/sjr/dhd/maf

CC: Mr. Steve Rutz

Dr. Davis Daiker

Mr. Max Feken

Mr. Charlie Clark

**ATTACHMENT 1 -- Florida Investigations of Aldicarb-Animal Poisonings**

  ------------------------------------------------------------------------------
  File Number    Date assigned Allegation or       Conclusion
                               complaint           
  -------------- ------------- ------------------- -----------------------------
  102-066-3429   4/2/2002      Dogs and cats were  Several tin cans of sardines
                               found poisoned with mixed with Temik had been
                               aldicarb.           used to kill dogs and cats in
                                                   Jackson County, Florida. Four
                                                   samples of the contents of
                                                   the cans were analyzed by the
                                                   FDACS Pesticide Laboratory.
                                                   Aldicarb was detected in each
                                                   of the samples. Enforcement
                                                   action is pending.

  199- 110-2982  6/14/1999     Birds, turtles and  Analysis of samples of the
                               an alligator were   dead birds and turtles
                               found dead or dying indicated detectable levels
                               in and around the   of aldicarb sulfoxide in the
                               retention pond of   GI tract of the birds and
                               mobile home park.   turtles. No pesticides were
                                                   detected in water and
                                                   sediment samples collected
                                                   from areas around the
                                                   retention pond. The aldicarb
                                                   user was not identified.

  102- 377- 2074 12/5/2002     Black bear found    The investigation determined
                               dead near honey bee that the bear's death was
                               hives.              caused by the ingestion of
                                                   aldicarb that was probably
                                                   hidden in a bait. The source
                                                   of the aldicarb could not
                                                   identified.

  199-005-1913   1/20/1999     Dogs were poisoned  Animal tissue analysis
                               with aldicarb.      indicated the presence of
                                                   aldicarb and the FDACS
                                                   identified three violations
                                                   and fines for misuse of
                                                   aldicarb

  100-319-3771   Ca.12/22/00   Use of aldicarb as  The FDACS assisted in an EPA
                               bait to kill        investigation of an
                               coyotes.            individual who applied a fine
                                                   black, granular material to
                                                   three deer carcasses to kill
                                                   coyotes. A fine was levied by
                                                   EPA.

  105-139-1378   5/3/2005      Aldicarb mixed in   Laboratory analysis of feed
                               feed corn to poison samples confirmed the
                               44 head of cattle   presence of aldicarb. The
                                                   case is open.

  104-159-1018   8/31/2004     Aldicarb-baited     Laboratory analysis of feed
                               corn used to kill   corn samples confirmed the
                               feral pigs          presence of aldicarb. The
                                                   case is pending.
  ------------------------------------------------------------------------------

**ATTACHMENT 2 -- Florida's Aldicarb Rule (5E-2.028 FAC)**

**5E-2.028 Restrictions on Use and Sale of Aldicarb; Permit Requirements
and Procedures; Department Approval; Records; Penalties.**

\(1\) Use and Sale Restrictions. The use of aldicarb in accordance with
label directions is authorized statewide, with the following
restrictions:

> \(a\) Aldicarb shall be applied only during the time period for which
> written authorization is issued by the department by means of an
> aldicarb permit.
>
> \(b\) Aldicarb shall be applied only at the site for which written
> authorization is issued by the department by means of an aldicarb
> permit.
>
> \(c\) Experimental use must be authorized by the United States
> Environmental Protection Agency or the department.
>
> \(d\) Aldicarb shall not be applied within 300 feet of any well in
> this state, with the exception of wells that meet the provisions of
> paragraph (1)(e). Aldicarb shall not be used on Florida citrus within
> 1000 feet of any well when any soil series within the intended site of
> application is identified by the U.S.D.A. Soil Conservation Service as
> highly permeable well-drained sand, unless the applicator furnishes
> the department with construction documentation confirming that the
> well is properly cased to a depth of 100 feet below ground surface or
> a minimum of 30 feet below the water table. The 1000-foot setback
> requirements shall not apply to any wells that meet the provisions of
> paragraph (1)(e). Soils series which have been identified by the
> U.S.D.A. Soil Conservation Service as highly permeable well-drained
> sand include, but are not limited to, the following:
>
> Adamsville
>
> Archbold
>
> Astatula
>
> Candler
>
> Cassia
>
> Lake
>
> Neilhurst
>
> Orsino
>
> Palm Beach
>
> Paola
>
> Satellite
>
> St. Lucie
>
> Tavares
>
> Well construction documentation shall consist of either a copy of the
> well completion report issued by the appropriate water management
> district or a statement certified as to accuracy by a licensed well
> contractor.
>
> \(e\) Any well that meets the following provisions is exempt from the
> setback requirements specified in paragraph (1)(d):
>
> 1\. The well is not used for human consumption;
>
> 2\. The well has been posted with a conspicuous warning notice stating
> "NOT FOR HUMAN CONSUMPTION"; and
>
> 3\. If the well is situated on property under different ownership from
> the property where the aldicarb application is to be made, a signed
> statement has been obtained from the well owner authorizing the
> posting of the warning notice specified in subparagraph (1)(e)2.
>
> \(f\) Warning notices specified in subparagraph (1)(e)2. of this
> subsection shall remain in place subsequent to the aldicarb
> application until sampling and analysis of the well water performed or
> approved by the department indicate an aldicarb residue level in
> compliance with the standards established by the Florida Department of
> Environmental Protection in Chapter 62-550, F.A.C.
>
> \(g\) Citrus grove use is limited to one application per year. Such
> application may be made only during the period January 1 -- April 30.
> Application shall not exceed the rate of 5 pounds active ingredient or
> 33 pounds of 15 G formulation per acre.
>
> \(h\) Any drinking water well found to contain aldicarb residues in
> excess of the standards established by the Florida Department of
> Environmental Protection in Chapter 62-550, F.A.C., shall have further
> use of the chemical within 1,000 feet of the well suspended
> immediately. The suspension shall remain in effect until the well has
> undergone remedial treatment in a manner acceptable to the department
> or until subsequent sampling and analyses of the well water performed
> or approved by the department
>
> indicate residue levels in compliance with standards established by
> the Florida Department of Environmental Protection.
>
> \(i\) Sales documents from any person selling or distributing aldicarb
> in Florida shall state: "For use only as authorized by Rule 5E-2.028,
> F.A.C."

\(2\) Reporting Requirements and Procedures.

> \(a\) At least 10 days prior to applying aldicarb in this state, the
> licensed applicator shall obtain a permit to apply aldicarb in
> Florida. Permits may be obtained by filing an application for permit
> with the department and meeting all permit requirements. Applications
> shall be filed either electronically on the web site
> www.temikintent.com or in hard copy by delivery of a completed
> Application for Permit to Apply Aldicarb (Temik), Form DACS-13317,
> revised 1/02, to the address listed on the form. For the purposes of
> this rule, filing means received by the department. Licensed pesticide
> applicators may obtain a username and password to use the electronic
> process by submitting a completed Request for Username and Password
> for Electronic Temik Permit Application, Form DACS-13356, new 2/02, to
> the address listed on the form.
>
> \(b\) Licensed applicators conducting research with aldicarb and
> making application to no more than 10 acres per site shall be exempt
> from the 10-day pre-application requirement, provided a signed
> statement attesting the application is for research purposes is filed
> with the permit application and provided a permit is obtained before
> the application is made.
>
> \(c\) Each intended application site shall be listed as a separate
> entry on the permit application. Application sites situated in more
> than one township, range, and/or section must be submitted as multiple
> sites, with each site identified as one entry with a distinct
> township, range, and section.
>
> \(d\) Form DACS-13317, Application for Permit to Apply Aldicarb
> (Temik), revised 1/02, hereby adopted and incorporated by reference,
> may be obtained from the web site www.safepesticideuse.com or from the
> Pesticide Certification Section, Florida Department of Agriculture and
> Consumer Services, 3125 Conner Boulevard, Building 8 (L29),
> Tallahassee, Florida 32399; telephone (850) 488-3314. Form DACS-13356,
> Request for Username and Password for Electronic Temik Permit
> Application, new 2/02, hereby adopted and incorporated by reference,
> may be obtained from the web sites www.temikintent.com or
> www.safepesticideuse.com or from the Pesticide Certification Section,
> Florida Department of Agriculture and Consumer Services, 3125 Conner
> Boulevard, Building 8 (L29), Tallahassee, Florida 32399; telephone
> (850) 488-3314.

\(3\) Department Authorization; Permit.

> \(a\) No person shall apply aldicarb in this state unless written or
> electronic authorization has been issued by the department by means of
> an aldicarb permit.
>
> \(b\) No person shall apply aldicarb in this state to any site for at
> least 10 days after an aldicarb permit has been approved for that
> site. This subsection shall not apply to licensed applicators who
> apply aldicarb for research purposes to 10 acres or less per site and
> who otherwise meet the requirements set forth in this chapter.
>
> \(c\) The department shall designate on the permit application the
> dates during which aldicarb is approved for application in this state.
> The time period authorized for application shall not exceed six (6)
> months.
>
> \(d\) Department authorization is not transferable.

\(4\) Records. Each applicator shall maintain a copy of all aldicarb
permits approved by the department for that applicator, including all
attachments, for a minimum of 2 years. These records shall be made
available upon request by an authorized representative of the
department. For permit approvals issued to the applicator via the web
site www.temikintent.com, upon request by an authorized representative
of the department, the applicator must either provide a printed copy of
the permit information from the web site or make the permit information
available by computer screen for review and printing by the department
representative

\(5\) Penalties. The use, sale, distribution or application of aldicarb
by any person in a manner inconsistent with the provisions of this rule
is a violation of Chapter 487, F.S., and subject to the penalties
described therein.

*Specific Authority 487.042, 487.051, 570.07(23) FS. Law Implemented
487.051, 487.160 FS. History--New 1-1-84, Amended 4-8-84,
5-8-85,Formerly 5E-2.28, Amended 2-9-93, 7-18-95, 9-21-98, 3-28-02.*