REPORT DOCUMENTATION |L ***** HO.
PAGE
«. Recipient"* Accession No.
4. TJM* •nd fkibtm*
CADMIUM: Position Document 4
5. Report Oat*
October 1986
AuMiortt)
EPA, OPP, REGISTRATION DIVISION
«. Partormlne Organization Rept. No.
540/09-96-098
Porformiac Organization Him* and Addratt
ENVIRONMENTAL PROTECTION AGENCY
OFFICE OF PESTICIDE PROGRAMS
WASHINGTON, D.C. 20460
10. Profact/Tatk/Worfc Unit No.
11. Contract(C) or Grant(G) No.
(C)
(G)
12. Sponwxlug Ort«nLi«tlon Nam* and Addr«*t
SAME AS #9
11. Tjrpc of Report 4 Pwrtod Covered
14.
IS. Supplementary Notei
16. Aovtract (Limit: 200 words)
This Position Document addresses the risks and benefits of pesticide products
containing the subject active ingredient. The Agency has determined that the use
of products containing the subject active ingredient may meet or exceed a risk
criterion described in 40 CFR Part 154. Potential hazards will be examined
further to determine the nature and extent of the risk, and considering the
benefits of the subject active ingredient, whether such risks cause unreasonable
adverse effects on the environment.
17. Document Analyvl* a. Descriptors
PESTICIDES, STANDARDS, REGULATIONS, MANUFACTURING, CHEMISTRY, TOXICOIOGY,
RESIDUES, ECOLOGY, PATH OF POLLUTANTS
b. M*«itin«n/Open-Cnded Terms
.c. CO.
5LE
19. Security Class (This Report)
UNCLASSIFIED
20. Security Clast (This Page)
UNCLASSIFIED
21. No. of Pages
39
22. Price
S*« ImttrucKont on Jtowar**
OPTIONAL FORM 272 (4-77)
(Formerly NTIS-35)
Department of Commerce
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540/09-90-098
" ENVIRONMENTAL PROTECTION AGENCY
OFFICE OF PESTICIDES AND TOXIC SUBSTANCES
[OPP-30000/20D]
CADMIUM; INTENT TO CANCEL REGISTRATIONS OF PESTICIDE PRODUCTS
CONTAINING CADMIUM; DENIAL OF APPLICATIONS FOR REGISTRATION
OF PESTICIDE PRODUCTS CONTAINING CADMIUM; CONCLUSION OF
SPECIAL REVIEW
AGENCY: Environmental Protection Agency (EPA)
ACTION: Notice of Final Determination and Intent to Cancel.
SUMMARY: On October 26, 1977, EPA initiated a Special Review
of all pesticide products that contain cadmium compounds
(salts of chloride, sebacate, succinate, carbonate and
anilino cadmium dilactate) as active ingredients and that are
registered for use on turf of golf courses and home lawns.
On September 10, 1936, EF\ issued a Preliminary Determination
(PD 2/3) proposing to cancel registrations ^nd deny applications
for all uses of cadmium products on turf sites. The proposed
cancellation action v/as based on the Agency's determination
that the use of cadmiura fungicides would result in unreasonable
adverse effects -to applicators of these products for these
uses. A FEDERAL REGISTER Notice was published concerning
these actions on October 10, 1986 (51 FR 36524).
This Notice concludes the Special Review and announces
EPA's final determination to (1) cancel registrations and
deny applications of all pesticide products containing any of
the five cadmium compounds as active ingre-lients that are
87P-879
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registered for use on golf course fairways1'and home lawns, and
(2) to modify the terms and conditions of registration "of .
cadmium products for use on golf course greens and tee areas.
DATE: A request for a hearing by a registrant or applicant
must be received by [INSERT DATE 30 DAYS FROM DATE OF PUBLICATION
IS FEDERAL REGISTER] or 30 days from receipt by mail of this
Notice, whichever is the later applicable deadline. A request
for a hearing from any other adversely affected person must
be received by: [INSERT DATE 30 DAYS FROM DATE OF PUBLICATION
IN FEDERAL REGISTER].
ADDRESS: Requests cor a hearing must be submitted to:
Hearing Clerk (A-110),
Environmental Protection Agency,
401 M St., S.W.,
Washington, DC 20460.
Other relevant addresses are found under Unit IV and Unit
V.D. 1.
FOR FURTHER INFORMATION CONTACT:
By mail:
Valerie Meredith Bael
Special Review Branch,
Registration Division (TS-767C),
Office of Pesticide Programs,
Environmental Protection Agency/
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401 M St. S.W..
Washington, DC 20460.
Office location and telephone number:
Room 1006, Crystal Mall Building #2,
1921 Jefferson Davis Highway,
Arlington, Virginia 22202,
(703) 557-2314
SUPPLEMENTARY INFORMATION: This Notice is organized into six
units. Unit I is the Introduction. It provides the background
information concerning this regulatory action. Units II and
III summarize the applicator risks and the benefits associated
with the use of cadmium on golf courses and home lawns. They
also contain a review and evaluation of comments received by
tne Agency in response to the PD 2/3. Unit IV contains the
comments of the Scientific Advisory Panel, the Secretary of
Agriculture, and other public comments and EPA's response to
those comments. Unit V describes the Agency's final determina-
tion, the regulatory actions required by this Notice, and
the procedures which will TDC followed in implementing the
regulatory actions EPA is announcing in this Notice. Unit
VI is the bibliography.
I. INTRODUCTION
A. REGULATORY HISTORY
On October 26, 1977, a FEDERAL REGISTER Notice (42 FR 56574)
was published concerning the Special Review of all pesticide
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products that contain as an active ingredient cadmium compounds'
(salts of chloride, sebacate, succinate, carbonate and anilinoi'
cadmium dilactate) and that are registered for use on turf of
golf courses and home lawns. This action was based on the
determination that cadmium pesticide products exceeded risk
criteria relating to oncogenicity, mutagenicity, teratogenicity,
and fetotoxicity.
Following review of public comments and available data,
a Preliminary Determination was issued on October 10, 1986,
in which the Agency determined that the risk concerns relating
to oncogenicity remained and risk concerns for kidney effects
were added. Risk concerns for mutagenicity, teratogenicity
and fetotoxicity no longer remain. A review of the many
mutagenicity tests provided conflicting r^salts because of
the many end points and protocols used. The Agency concluded
that the weight of evidence from the composite of the many
studies does not support the risk criteria for mutagenicity.
Based on the Agency's review of animal studies, cadmium has
been shown to produce developmental toxicity (embryotoxicity,
fetotoxicity and teratogenicity) at high dose levels. The
available data are not considered adequate to support the
risk criteria for teratogenic and fetotoxic effects at exposure
levels encountered by pesticide applicators.
The October 10, 1936 Notice announced (1) the Preliminary
Determination proposing to cancel registrations for all
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pesticide products that contain cadmium compounds as active
ingredients that are used on turf of golf courses and home
lawns based on oncogenic and kidney risks, and (2) the avail-
ability of the Support Document. The Support Document
(Ref. 1) contains the background information which supported
the Agency's actions. This information included an assessment
of the hazard to applicators, the benefits of use on golf
courses and home lawns, and a discussion of measures to
reduce exposure to applicators. In consideration of the
toxicological effects of cadmium compounds, the estimated
potential risks of these effects to applicators, the lack of
effective measures to mitigate these unacceptable risks, the
availability of effective alternatives and an estimated minor
economic impact to users, the Agency concluded that the risks
of continued use of cadmium pesticide products outweighed the
benefits. Therefore, the Agency proposed cancellation of all
pesticidal uses of cadmium compounds.
This Notice concludes the Special Review and announces
"EPA's final determination to cancel registrations and deny
applications of all registered uses of cadmium on golf course
fairways and home lawns and to modify the terms and conditions
of registration for products us 3 on golf course greens and
tee areas. The weight of evidence continues to lead the
Agency to conclude that the oncogenic and kidney risks associated
with the use of cadmium on golf course qreens and +f*a at-~as
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(with hand-held sprayers), and the kidney risks associated
with the use of cadmium on golf course fairways by ground
boo* sprayers and on home lawns outweigh the low benefits.
The use of cadmium on golf course fairways and home lawns may
also pose some oncogenic concern. During development of the
PD 2/3, the Agency assumed that heavy mechanical power spray
equipment could not be used on greens and tee areas. Therefore,
exposure estimates used in the Agency's risk assessment for
greens and tee areas were based on hand-held spray equipment
only. Since publication of the PD 2/3, the Agency received
new information indicating that most golf course applicators
use power spray equipment (i.e., mini-boom sprayers and
walking boom sprayers) rather than hand-held sprayers to
apply cadmium to greens and tee areas. The Agency defines'a
"mini-boom" sprayer as a boom that can be drawn by a small
vehicle. The Agency reviewed its existing data base and
determined that it lacks adequate data on this application
method. In order to assess the risk of oncoqenic and kidney
effects from the .use of this equipment, the Agency has required
applicator exposure data through a FIFRA section 3 (c)(2)(B)
Data Call in Notice. Deadline for submissio-i of these data
is July, 1988. The Agency will allow continued use
of cadmium on golf course greens and tee ar.-MS with the
following modifications in the terms and conditions of regis-
tration: CD "Restricted Use" for retail sale to and use
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ouly by certified applicators and only for those uses covered
by the Certified Applicator's certification, (2) application
ta goLf course greens and tees only, (3) application by mini-
boom sprayers only, and (4) use of protective clothing during
nixing, loading and application (chemical resistant gloves at
all times and chemical resistant apron during mixing and
loading). If exposure data on mini-boom sprayers indicate
unreasonable risks to applicators, further regulatory action
will be taken.
B. LEGAL BACKGROUND
In order to obtain a registration for a pesticide under
the Federal Insecticide, Fungicide and Rodenticide Act (FIFRA),
as amended, an applicant for registration must demonstrate
that the pesticide satisfies the statutory standard for
registration, section 3(c)(2)(B) of FIFRA. That standard
requires, among other things, that the pesticide performs its
intended function without causing "unreasonable adverse
effects on the environment." The term "unreasonable adverse
effects on the environment" is defined under FIFRA section
2(bb) as "any unreasonable risk to man or the environment,
taking into account the economic, social, and environmental
costs and benefits of the use of any pesticide." This standa: '
requires a finding that the benefits of the use of the pesti-
cide exceed the risks of use, when the pesticide is used in
compliance with the terms and conditions of registration or
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in accordance with commonly recognized practices.
The burden of proving that a pesticide satisfies the
standard for registration is on the proponents of registration
and continues as long as the registration remains in effect.
Under FIFRA section 6, the Administrator may cancel the
registration whenever it is determined that the pesticide
causes unreasonable adverse effects on the environment. The
Agency created the RPAR process, now known as the Special
Review process, to facilitate the identification of pesticide
uses which may not satisfy the statutory requirements for
registration and to provide an informal procedure to gather
and evaluate information about the risks and benefits of
these uses.
A Special Review is initiated if a pesticide meets or
exceeds the risk criteria set out in the regulations at 40
CFR 154.7. The Agency announces that a Special Review is
initiated by issuing a notice for publication in the FEDERAL
REGISTER. Registrants and other interested persons are
invited to review the data -upon which the review is -based and
to submit data and information to rebut the presumption by
showing that the Agency's initial determination of risk was
in error, or by showing that use of the pesticide is not
likely to result in any significant risk to humans or the
environment. In addition to submitting evidence to rebut the
risk presumption, commenters may submit evidence as to whether
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the economic, social, and environmental benefits of the use
of the pesticide outweigh the risk of use. Unless all pre-ump-
tions of risk are rebutted, the Special Review is concluded
by issuance of a Notice of Intent to Cancel.
In determining whether the use of a pesticide poses
risks which are greater than the benefits, the Agency considers
possible changes to the terms and conditions of registration
which can reduce risks, and the impacts of such modifications
on the benefits of use. If the Agency determines that such
changes reduce risks to the level where the benefits outweigh
the risks, it may require that such changes be made in the
terms and conditions of registration. Alternatively, the
Agency may determine that no changes in the terms and condi-
tions of the registration will adequately oasure that use of
the pesticide will not pose any unreasonable adverse effects.
If the Agency makes such a determination, it may seek cancel-
lation and, if necessary, suspension. In either case, the
Agency may issue a Notice of Intent to Cancel the registration.
If the Notice -requires changes in the terms and conditions of
registration, cancellation may be avoided by making the
specified corrections set forth in the Notice, if possible.
Adversely affected persons may also request a hearing on the
cancellation of a specified registration an3 use, and if they
do so in a legally effective manner, that registration and
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use will be maintained pending a decision at the close.of an
•
administrative hearing.
II. SUMMARY OF THE AGENCY'S RISK ASSESSMENT AND
RESPONSE TO COMMENTS
In this unit the Agency provides a summary of the oncogenic
and kidney hazards associated with the use of cadmium on golf
courses and home lawns. This includes information discussed
in the PD 2/3, as well as a review and discussion of comments
received by the Agency after the Preliminary Determination to
Cancel all cadmium registrations was issued.
A. SUMMARY OF THE APPLICATOR RISK ASSESSMENT IN THE PD 2/3
In the PD 2/3 the Agency evaluated laboratory animal and
human epidemiological studies and concluded that cadmium
compounds are oncogenic and can cause kidney effects.
Based upon results of the studies in which (1) rats
exposed to cadmium chloride aerosol by inhalation developed
lung tumors, (2) rats and mice injected with cadmium or
•cadmium salts-developed injection-site, testvcular-and pan-
creatic islet tumors, and (3) workers exposed to airborne
cadmium and cadmium compounds experienced 4 dose-related
increase in lung tumors, the Agency has classifed cadmium as
a "probable" human carcinogen (Group Bl substance) according
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to the Agency's Cancer Assessment Guidelines, 51 FR 33992
(September 24, 1986).
The Agency prepared a risk assessment of the oncogenic
risks of persons applying cadmium fungicides to golf courses
and home lawns based on inhalation exposure studies. Only
inhalation exposure (rather than inhalation and dermal exposures)
was considered pertinent because the toxicological data base
supported the formation of lung tumors following inhalation
exposure by laboratory animals and smelter workers. The
oncogenic risks (via inhalation) for golf course applicators
range from 10"^ (applying cadmium to greens and tee areas by
hand-held sprayers) to 10~6 (applying cadmium to fairways by
ground boom sprayers). The oncogenic risks for home lawn
applicators is 10"^. Although the oncogenic risks could be
reduced by one order of magnitude by the ube of half-tace
respirators, the Agency does not believe this equipment would
be rigorously utilized by golf course applicators or home
lawn appi.cators. Hence, a label requirement for respiratory
protection is not likely to provide risk reduction in actual
practice.
The Agency further concluded that the risk criteria for
kidney effects has been met based on results of (1) animal
studies which showed that high doses of cadmium resulted in
formation of fatty bodies and degeneration of renal tubules,
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and (2) human studies in which chronic inhalation exposure to
cadmium was associated with renal tubular proteinurea (which
is symptomatic of increasingly severe irreversible kidney
damage). Friberg et al. (1974) estimated that the lowest
observed effect level (LOEL) associated with humans is 5
ug/kg/d (Ref. 2). A no observable effect level (NOEL) has
not been established.
In order to assess the risks of exposure to pesticidal
cadmium on the human kidney, the Agency conducted a quantita-
tive assessment of the ratio of the low effect level (LOEL)
derived from the Friberg study to the estimated inhalation
and dermal exposures from registered uses. These comparisons
are expressed as "Effect Ratios" (ERs). Although the LOEL is
a chronic dose, the Agency feels it is appropriate to use
this value in its risk assessment because: (1) cadmium is a
cumulative toxicant whose half-life in the body is unusually
long (10-30 years in man), (2) excretion via urine and the
gastrointestinal tract is extremely low, and (3) its consequent
adverse .health effects appear to be essentially irreversible.
In order to accurately assess risks to workers having inter-
mittant, acute exposure, the Agency used an "ar.nualized" LOEL
of 0.18 mg/kg/yr based on the human inhalation data. To
estimate inhalation ERs, the annualized LOEL was divided by
inhalation exposure estimates for each application scenario.
To estimate dermal ERs, the LOEL was multiplied by the ratio
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of absorption rates for inhalation (40 percent) to dermal
(1 percent) exposure and then divided by dermal exposure
estimates.
The following table presents dermal and inhalation ERs
for golf course (greens and tee areas and fairways) and home
lawn applicators. Also included are dermal ERs assuming
proper use of protective gloves for golf course applicators.
Dermal ERs with protective gloves are not given for home lawn
applicators because protective gloves are not considered to
be rigorously utilized by this population due to cost and
inconvenience.
In calculating the ERs, the Agency made the following
assumptions: (1) cadmium is applied to golf course greens and
tee areas by hand-held sprayers, to golf coarse fairways by
ground boom sprayers, and to home lawns by hose-end sprayers,
(2) cadmium is applied to golf course turt and home lawns at
the rate of 0.2 oz ai/lOOOft^, and (3) cadmium is typically
applied to golf course turf 8-12 times per year and to home
lawns 3 times per year.
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Cadmium Effect Ratios for Kidney Effects
Applicator
Golf Course
* Greens and tees
dermal
Application
Equipment
Hand-held
spray gun
ERs
0.1
ERs with
Protective Gloves
inhalation
4.3
n/a
* Fairways
dermal
inhalation
Home Lawns
dermal
inhalati' :
Ground boom
sprayers
Hose-end
sprayers
45
418
01
6666
91
n/a
n/a
n/a
B. NEW INFORMATION CONCERNING APPLICATION
Since publication of the PD 2/3, the Agency received
information indicating that power spray equipment ("mini-boom"
sprayers) are commonly used"to'apply cadmium to golf course
greens and tee areas. During development ot the PD 2/3, the
Agency assumed that heavy mechanical power spray equipment
could not be used on greens and tee areas. Therefore, exposure
estimates for greens and tees were based on hand-held spray
guns only.
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In a telephone conversation with a representative of the
Golf Course Superintendents Association of America the Agency
was informed that the majority of golf course applicators use
power spray equipment (i.e., "mini-boom") to apply cadmium to
greens and tee areas (Ref. 3). Smaller golf courses are
still likely to treat greens and tee areas with hand-held
sprayers.
Results of a published study submitted to the Agency by
a major registrant indicate that dermal exposure to the limbs
and torso during mini-boom application is lower than during
hand-held spraying (Ref. 4). In the study several fungicides
(benomyl, cycloheximide, cadmium succinate, thiophanate-ethyl)
and insecticides (carbaryl and trichlorfon) were applied to
golf course turf by various application methods: (1) hand-
held spray guns, (2) a boom carried on a small vehicle
("mini-boom"), and (3) a boom sprayer push»»«l by hand. Cadmium
succinate applied without protective clothing by a hand-held
sprayer at a rate of 0.5 oz/lOOOft^ yielded the highest
dermal exposures levels recorded of all the other pesticides.
Dermal pads placed outside the clothing of applicators applying
benomyl by mini-boom sprayers showed levels of residue below
detection limits (10 ug/100cm2). Similar .results were observed
with the application of thiophanate-ethyl and trichlorfon
(detection limit not given) by hand pushed boom; however,
when thiophanate and carbaryl were applied with the same
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eguipment, detectable residues were found. An explanation of
these different results was not provided. v The major deficiency
in the study was that hand exposure was not measured, which
can account for a significant percentage of total dermal
exposure. Although the study was found to be inadequate for
regulatory purposes, it does provide qualitative data regarding
exposure during application by mini-boom spraying.
C. CONCLUSIONS CONCERNING APPLICATOR RISKS
Based on the hazard assessment described in the Support
Document and on the new information, the Agency concludes that
the weight of evidence demonstrates that (1) unreasonable
oncogenic and kidney risks are associated with the use of
cadmium on golf course greens and tee areas (with hand held .
sprayers) and, (2) unreasonable kidney risks are associated
with use of cadmium on golf course fairways and home lawns.
Due to the absence of adequate exposure data, the Agency is
currently unable to calculate oncogenic and kidney risks to
applicators applying cadmium to greens and tee areas by power
spray ("mini-boom") equipment. The use of cadmium on golf
course fairways and home lawns may also pose some oncogenic
concern. Nevertheless, based on application rates, application
pressure levels, and the small acreage of greens and tees,
the Agency believes that oncogenic and kidney risks may be
lower with mini-boom sprayers than with hand-held sprayers.
In order to consider appropriate regulatory action for this
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application method, the Agency has required applicator exposure
data through a Section 3(c)(2)(B) Data Call in Notice.
Deadline for submission of these data is July, 1983.
Once these data are received and reviewed, oncogenic and
kidney risks will be reassessed for golf course greens and
tee uses.
III. SUMMARY OF THE AGENCY'S BENEFITS ANALYSIS
AND RESPONSE TO COMMENTS
In this unit the Agency provides a summary of the benefits
associated with the use of cadmium on golf courses and home
lawns. This includes information discussed in the PD 2/3, as
well as a review and discussion of comments received by the
Agency after the PD 2/3 proposing to cancel all cadmium
registrations was issued.
A. SUMMARY OF THE BENEFITS ANALYSIS IN THE PD 2/3
Cadmium is a low volume pesticide used primarily in the
mid-western states of Michigan, Ohio, Indiana, Illinois and
Minnesota for control of copper spot, red thread and cjrey
.snow mold turf diseases on golf courses and home lawns. The
benefits of cadmium were assessed in the PD 2/3 in terms of
the economic impact which would result if cadmium were cancelled
and users chose to use other registered pesticides as alterna-
tives. Eleven alternatives were evaluated a-5 to their known
toxicological risks. The Agency has initiated or completed
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Special Reviews and/or Registration Standards on a number.of
the alternatives. Triadimefon is one alternative that has
shown no adverse oncogenic, mutagenic or reproductive effects.
Although it does show a positive teratogenic effect, the
Margins-of-Safety (NOEL/estimated exposures) are larger than
100.
Although several fungicides are available to control the
aforementioned turf diseases, only cadmium and triadimefon
are registered to control all three diseases. Because triadimefon
is the only fungicide which is registered to control each of
the turf diseases controlled by cadmium, it was assumed that
all golf course acreage historically treated with cadmium
would be treated with triadimefon if cadmium were unavailable.
Based on this assumption, the economic impact of the cancel-
lation of cadmium fungicides tor use on golf courses is
estimated to be $240,000 annually. The increased cost of
substituting triadimefon would be approximately $500 annually
for each of the affected golf courses. Because cadmium
fungicides are not sufficiently effective against diseases
which are of primary concern to the average homeowner, very
little cadmium is used by home lawn applicators. Therefore,
practically no economic impact would result from cancellation
of cadmium use on home lawns.
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B. NEW INFORMATION CONCERNING THE BENEFITS
In response to the PD 2/3, the Agency received two
written comments (as attachments to a comment received from a
registrant) regarding the benefits of continuing registrations
of cadmium pesticides and one personal communication. The
first commenter was a turfgrass pathologist from the University
of Rhode Island who commented that although cadmium compounds
are no longer widely used, they are of value in disease
resistant programs (Attachment A To Ref. 5). The Agency
agrees with the commenter that having a variety of available
fungicides is significant for turfgrass resistance suppression
although it is difficult to measure this impact in economic
terms. However, the Agency does not believe that the cancel-
lation of cadmium for the golf course fairway use will create
a resistance problem because of the many alternatives available.
The second commenter, a representative of the Golf
Course Superintendent's Association of America (GCSAA),
reported that in a survey of 300 golf course superintendents
cadmium usage on golf course turf was very low. None of the
superintendents in the survey reported usinj the product more
than twice a year. Nevertheless, the majority of the super-
intendents polled stressed the value of having cadmium available
to their pest managers to control disease resistant pathogens.
GCSAA recommended to the Agency that cadmi art oe a restricted
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use chemical and sold as a liquid or dry flowable to decrease
applicator exposure (Attachment B. To Ref. 5). The Agency
is, in fact, restricting the use of cadmium on golf course
greens and tee areas (Unit V.B.), rather than cancelling this
use.
The third comment was a personal communication between a
representative of tne GCSAA and the Agency. In the conversa-
tion, the Agency was informed that cadmium is used mostly on
golf course greens and tee areas; very little, if any, is
used on fairways (Rsf. 3). The commenter stated that the
\
greens and tee areas account for approximately 2 acres while
fairways account for over 40 acres of the golf course acreage.
He further noted that use on greens and tee areas is a high
priority activity for golf course superintendents. This
information supports the Agency's conclusion that the benefits
of use of cadmium on golf course fairways is very low/ and
that cancellation of this use is not expected to have any
significant economic impact.
C. CONCLUSIONS CONCERNING THE BENEFITS
The impact of cancellation estimated in the Support
Document did not change as a result of the lew information.
Based on the new information, the Agency concludes that
although the majority of golf course superintendents polled
agree that cadmium is a valuable component in turfgrass
resistance programs, the use of cadmium may be lower than
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originally estimated in the PD 2/3. Therefore, the Agency's
estimate of the cost impact of cancellation may have been
overstated.
IV. COMMENTS OF THE SCIENTIFIC ADVISORY PANEL, THE SECRETARY
OF AGRICULTURE, AND THE PUBLIC
The Agency transmitted the Support Document to the
United States Department of Agriculture (USDA) and the Scien-
tific Advisory Panel (SAP) for review and requested comment.
The Agency also submitted additional information (Ref. 6) to
the SAP. Unit IV A and B contain the SAP and USDA comments
and the Agency's response. The Agency also received public
comments In response to the public comment period for the
FEDERAL REGISTER Notice. These comments along with the
Agency's response are summarized in Unit IV.C.
Copies of all comments, minutes of meetings with and corres-
pondence among various interested parties are contained in a
docket maintained for this Special Review, -as provided in EPA's
Special Review regulations under 40 CFR Part 154, published
in the FEDERAL REGISTER of November 27, 1985 (50 FR 49003).
The docket is available for public inspection from 8 a.m.
to 4 p.m., Monday through Friday, excluding legal holidays
in: Rm. 236, Crystal Mall *2, 1921 Jefferson Davis Highway,
Arlington, VAi
A. COMMENTS OF THE SCIENTIFIC ADVISORY PANEL
EPA presented its proposed decision to the SAP in a
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public meeting held on November 19, 1986. On November 25, 1986
the Panel responded to EPA. The Panel's comments are reproduced
in their entirety.
FEDERAL INSECTICIDE, FUNGICIDE
AND RODENTICIDE ACT (FIFRA)
SCIENTIFIC ADVISORY PANEL
A Set of Scientific Issues Being
Considered by the Agency in Connection
with the Special Review of Cadmium Fungicides
The Federal Insecticide, Fungicide, and
Rodenticide Act (FIFRA) Scientific Advisory
/
Panel (SAP) has completed review of the data
base supporting the Environmental Protection
Agency's (EPA) decision to cancel registrations
and to deny applications for pesticide products
containing cadmium compounds for use on turf.
The review was conducted in an open meeting held
.in Arlington, Virginia, on November 18, 1986.
All panel members, except Dr. Harold L. Bergman,
Dr. John J. Lech and Dr. Thomas W. ClarXson,
were present for the review.
Although Dr. Clarkson was not present at
the Panel meeting on November 19, 1986, he was
present at the meeting on November 20 1986.
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Dr. Clarkson provided his comments to the Panel
on November 20, 1986, and agreed with the Panel's
recommendations.
Public notice of the meeting was published
in the FEDERAL REGISTER on Friday, October 24, 1986.
Oral statements were received from staff
of the Environmental Protection Agency and from
Mr. Martin W. McGinn and Dr. Paul Sartoretto
of W.A. Cleary Chemical Corporation.
In consideration of all matters brought
out during the meeting and careful review of all
documents presented by the Agency, the Panel
unanimously submits the following report.
REPORT OF PANEL RECOMMENDATIONS; CADMIUM
The Agency requested the Panel to focus
its attention upon a set of scientific issues
relating to the Special Review of Cadmium
Fungicides. There follows a list of the
issues and the Panel's response to each issue:
ISSUE:
Friberg, et. al., (1974), concluded that
the critical concentration of ca-imium in the
renal cortex of humans, associate 1 with renal
dysfunction, is 200 ug/g. Since cadmium is
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J^B^*«I^B— i oir !.• • i • i rr i .' «> • »*»•»>
a cumulative poison (acute exposure -will add
to the body burden) and the half-life for
elimination of cadmium is very long, the Agency
requests any comments that the Panel may wish
to make regarding the use of the Friberg data
to assess the risks to workers having inter-
raittant, acute exposure to cadmium fungicides.
Panel Response:
The Panel believes that the Friberg, et.
al., (1974) report contains reliable and
dependable scientific data that can be used
to assess the risks to workers having inter-
mit tant, acute exposure to cadmium fungicides.
The Panel further believes that the small
quantity of cadmium that is used -as a fungi-
cide would not constitute a threat to man or
the environment. Thus, the restricted use
of cadmium that was suggested to the Panel
becomes a risk-benefit decision outside the
purview of this committee.
FOR THE CHAIRMAN
Certified as an accurate report of the Findings:
Stephen L. Johnson
Executive Secretary
FIFRA Scientific Advisory Panel
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Date: November 25, 1986
The SAP's comments support the scientific basis for the
•
Agency's conclusions concerning kidney effects from cadmium
application to golf courses and home lawns. The SAP commented
that the small amount of pesticidal cadmium would not consti-
tute a threat to man or the environment. The Agency agrees,
that compared to occupational exposure (approximately 1.5
million workers), pesticidal exposure to cadmium is minimal.
Nevertheless, the oncogenic and kidney risks to applicators
applying cadmium pesticides to golf course turf and the
kidney risks to home lawns applicators are unacceptable in
light of the low benefits and inadequacy of reasonable protec-
tive measures for the use pattern of this pesticide.
3. USDA's COMMENTS
The USDA's comments on the Special Review and the proposed
cancellation are printed in full below:
Mr. Douglas D. Campt, Director
Office of Pesticide Programs
U.S. Environmental Protection Agency
Washington, DC 20460
Dear Mr. Campt:
This is the Department of Agriculture's response to
EPA's preliminary decision to cancel the registrations and
deny applications for all products containing cadmium regis-
tered for use on turf.
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We do not have any objection to;your proceeding,with your
proposal as indicated.
Sincerely,
Charles L. Smith, Coordinator,
Pesticides and Pesticide Assessment
C. PUBLIC COMMENTS RECEIVED IN RESPONSE TO THE SPECIAL REVIEW
The Agency received 3 comments relating to the preliminary
determination to cancel all registrations of cadmium for use
on golf courses and home lawns. Two comments received were
from registrants and one was from Public Citizen Health
Research Group.
One registrant proposed the following label changes which
it claimed would reduce pesticidal exposure to applicators:
(1) Restricted Use Pesticide for use only by Certified Golf
Course Superintendents, (2) use on golf course greens, tees
and aprons only, (3) application by power spraying equipment
only, and (4) requirement for the use of protective clothing
(rubber gloves, long sleeve shirts, pants, apron, and body-
covering clothing) (Ref. 5). Along with these proposed
changes, the registrant included letters from a turfgrass
pathologist from the University of Rhode Island and the Golf
Course Superintendents Association of America. These comments
are discussed in Unit III.B. The same registrant later
submitted a formal written request to the Agency for the
aforementioned label changes (Ref. 7). These proposed changes
are in fact included in this Notice.
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Another registrant stated that cadmium products are
applied at a lower application rate per year (2.56 Ib/A/yr)
than the estimate which was stated in the Draft Notice of
Intent to Cancel and therefore yield lower risks to applicators
(Ref. 8). Contrary to the contention of this commenter, the
estimate of 30 Ib/A/yr stated in Unit IV of the Draft Notice
of Intent to Cancel was based on the maximum allowable label
rate. This estimate was not used for the Agency's risk
assessment purposes. Oncogenic and kidney risk estimates
were based on annual application rates of 2.4 to 4.8 oz
ai/1000ft2 (golf course greens and tees), 0.9 oz ai/1000ft2
(golf course fairways) and 0.6 oz ai/lOOOft? (home lawns).
Public Citizen supported the Agency's proposal to cancel
all cadmium registrations based on oncogenic and kidney risks
to applicators. They also contended that the Agency's risk
assessments are likely to understate the risks for cancer and
kidney damage since they fail to take into account additional
exposure from skin absorption and ingestion (Ref. 9). The
Agency believes that the regulatory measures set forth in
this Notice will provide adequate protection to applicators.
The Agency's risk assessments for oncogenicity and kidney
effects were based on applicator inhalation and dermal exposure
to pesticidal cadmium. However, the Agency also considered
additional potential exposures from ambient sources (including
food and water) and concluded that for certain sensitive
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individuals any additional cadmium accumulation over a long
period of time may be sufficient to cause adverse health v
effects. As noted above, even without these additional
factors, the risks calculated for oncogenicity and kidney
damage were unreasonable in light of the low benefits of use
for golf course fairways and home lawn uses, and for the golf
course greens and tee area uses without the protective measures
required by this Notice.
V. INITIATION,OF REGULATORY ACTION
This unit has several sections. The first section
summarizes EPA's reasons for concluding that products containing
the active ingredient cadmium be cancelled for all registered
uses on golf course fairways and home lawns. The second
section describes the Agency's final determination and the
regulatory actions required by this Notice. The third section
establishes provisions concerning the sale, distribution, and
use of existing stocks of cancelled products. The last
section outlines procedures which will be followed in imple-
menting the regulatory actions set .forth in this -Notice.
A. AGENCY'S CONCLUSIONS
Based on the Agency's analysis in the Support Document
and the information reviewed after the Notice of Special Review
was issued, the Agency has concluded that t'ie risk of oncogenic
and kidney effects to applicators outweighs the benefits of
use of cadmium on golf course gree-s and tee areas (with hand-
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held sprayers), and that the risk of kidney effects outweighs
the benefits of use for fairways and home lawns. The use of
cadmium on golf course fairways and home lawns may also pose
some oncogenic concern. Oncogenic and kidney effects associated
with applying cadmium to golf course greens and tee areas
(with mini-boom sprayers) cannot be assessed due to the lack
of adequate exposure data. Nevertheless, as discussed in
Dnit II.C., the Agency believes that oncogenic and kidney
risks on greens and tee areas may be lower with mini-boom
sprayers than with hand-held sprayers.
In evaluating the hazards, the Agency considered cadmium's
chronic toxicity, estimated exposures to applicators, and
application practices. In evaluating the benefits, the Agency
considered the user cost impact of cancellation and the
efficacy of cadmium and its major alternatives.
The Agency also considered requiring protective clothim}
(i.e., elbow length gloves and half-face respirators) and
prohibiting use of hand-held sprayers -as alternatives to
cancellation and concluded the following:
1. For golf course greens and tee areas (hand-held
sprayers), protective clothing (i.e., elbow length gloves)
would not sufficiently reduce the risks of kidney effects.
Dermal ERs would increase from 0.1 to 3. Repairing half-face
respirators could reduce oncogenic risks from 10~4 to 10"5
but the Agency believes that this equipment would not be
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rigorously utilized for the golf course use. Prohibiting the
use of hand-held spray equipment is expected to reduce both
oncogenic and kidney effects to reasonable levels, based on
currently available data.
2. For golf course fairways, elbow length gloves
•
would not sufficiently reduce kidney risks. Dermal ERs
would increase from 45 to 91.
3. For home lawns, kidney risks would not be
sufficiently reduced by requiring protective gloves, as the
Agency believes this equipment would not be rigorously utilized
for the home lawn use pattern. Prohibiting the use of hand-
held sprayers on home lawns would be tantamount to cancellation
due to a lack of suitable alternative application equipment.
The weight of evidence leads the Agency to conclude that
the risks associated with application of cadmium to home
lawns, golf course greens and tee areas (by hand-held sprayers)
and golf course fairways, outweigh the minor benefits and
that cancellation of these uses is the only appropriate
action. The Agency intends to cancel all current uses of
cadmium on home lawns and golf course fairways. The risks
associated with application of cadmium to golf course greens
and tee areas (by mini-boom sprayers) cannot be quantitatively
assessed due to the la :k of adequate exposure data. Therefore,
the Agency is requiring applicator exposure.data on this
application method. The Agency intends to continue registrations
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of cadmium on golf coarse greens and tee areas with label
modifications as outlined in Unit v.c. of this document.
B. FINAL DETERMINATION AND REQUIREMENTS FOR COMPLYING WITH
THIS NOTICE
1. The Agency has determined to cancel the registrations
and deny applications for registration for all products
containing cadmium compounds (salts of chloride, sebacate,
succinate, carbonate, and anilino cadmium dilactate) and
registered for use on golf course fairways.
2. The Agency has determined to cancel the registrations
containing cadmium compounds (salts of chloride, sebacate,
succinate, carbonate, and anilino cadmium dilactate) and
registered for use on home lawns.
3. The Agency has determined that modifications to the
terms and conditions of registration are necessary for all
products containing cadmium compounds (salts of chloride,
sebacate, succinate, carbonate, and anilino cadmium dilactate)
and registered for use on golf course greens and tees. In
order to avoid cancellation, registrants of-cadmium products
labeled for use on golf course greens and tees must make the
modifications specified below to the labeling of their products
within 30 days of publication of this Notice in the FEDERAL
REGISTER or within 30 days of receipt of this Notice, whichever
is later, as set forth in Onit V.D. of this Notice:
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a. RESTRICTED USE pesticide for retail sale to and
use only by certified applicators or persons
under the direct supervision of a certified
applicator and only for those uses covered by
the Certified Applicator's certification.
b. Cadmium has been shown to produce kidney toxicity
in humans and tumors in laboratory animals.
c. This product is only to be applied by power boom
spraying equipment to golf course greens and tee
areas only. Do not apply through portable, manned
or hand-held pump sprayers.
d. Wear chemical resistant gloves, long sleeve shirts,
and long legged pants. In addition, wear a chemical
resistant apron during mixing and loading.
e. Wash gloves with soap and water before removing.
Launder all clothing worn during use before reusing
and launder separately from household articles.
For a cadmium .product .which is currently labeled for
multiple uses subject to this Notice, the registrant must amend
the label, within the time specified by Unit V.D. of this Notice,
to delete the cancelled uses and modify the other uses in
accordance with the requirements of this Notice in order to avoid
cancellation of the product.
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C. EXISTING STOCKS
The following paragraphs describe the conditions under
which registrants and others may sell and distribute exist-
ing stocks of cancelled cadmium products. Existing stocks may
not be sold and distributed except as provided below:
1. No manufacturer may release for.shipment after
January 31, 1988, any cadmium product subject to this Notice
unless the product bears an amended label or has supplemental
labeling affixed which complies with Unit V.B.
*
2. No cadmium product subject to thi Notice may be
distributed or sold by a retailer or other person after
April 30, 1988, unless the product bears an amended label
or has supplemental labeling affixed which complies with Unit
V.B.
D. PROCEDURAL MATTERS
This Notice announces EPA's determination .to cancel the
registrations of products that contain cadmium and that are
used on golf course fairways and home lawns. This Unit .also
explains how registrants may apply to amend their registrations
for cadmium products registered for use on golf course greens
and tee areas to comply with the terms and conditions discussed
in Units V.B. and C. above.
Under sections 6(b) and 3(c)(6) of FIFRA, applicants,
registrants, and certain other adversely affected persons are
also entitled to respond to this Notice by requesting a
hearing on the actions that EPA is initiating. Unless a
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hearing is properly requested with' regard to-a-. particu:laT
registration or application/ this action will become-final
by operation of law.
This section of the Notice explains how such persons may
request a hearing on EPA's final cancellation and denial
Notice (and the consequences of requesting a hearing and
failing to request a hearing in accordance with those pro-
cedures).
1. Procedure for Amending the Terms and Conditions of
Registration to Avoid Cancellation or Denial of Application.
Registrants affected by the cancellation actions set forth in
this Notice may avoid cancellation by filing for an application
for an amended registration which contains the label modifications
detailed in Unit V.B. of this Notice. This application must be
filed within 30 days of receipt of this Notice or within 30
days from the publication of this Notice/ whichever occurs
later. Applicants for a registration subject to this Notice
must file an amended application registration within the applicable
30-day period to -avoid denial of -their pending application.
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Applications mast be submitted to:
Lois Rossi,
Product Manager 21,
Registration Division (TS-767C),
Office of Pesticide Programs,
Environmental Protection Agency,
401 H St., S.W.,
Washington, DC 20460,
(703-557-1900).
2. Procedures for Requesting a Hearing. To contest the
cancellation actijn set forth in this Notice, Federal registrants
or applicants may request a hearing within 30 days of receipt
of his Notice, or within 30 days from publication of this
Notice, whichever occurs later. Any other person adversely
affected by the action described in this Notice may request a
hearing within 30 days of publication of this Notice in the
FEDERAL REGISTER.
A registrant or other adversely affected party who
requests a hearing must file the request in accordance with
the procedures established by FIFRA and EPA's Rules of Practice
Governing Hearings under 40 CFR Part 164. These procedures
require, among other things, that all requests must identify
the specific pesticide product(s) for which a hearing is
requested, and that all requests must be received by the
Hearing Clerk within the applicable 30-day period. Failure
to comply with these requirements will result in a denial of
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the request for a hearing. Requests for a hearing should
also be accompanied by objections that are specific for each
use of each pesticide product(s) for which a hearing is
requested.
Requests for a hearing must be submitted to:
Hearing Clerk (A-101),
Environmental Protection Agency,
401 M St., S.W.,
Washington, DC 20460.
a. Consequences of filing a timely and effective hearing
request. If a hearing on the action initiated by this Notice
is requested in a timely and effective manner, the hearing
will be governed by EPA's Rules of Practice for hearings
under PIPRA section 6 (40 CFR Part 164), as modified below.
The hearing will be limited to the specific uses and specific
product registrations for which the hearing is requested.
In the event of a hearing, the specific use or uses of
•the specific registered product which is the subject of the
hearing will not be cancelled except pursuant to an order of
the Administrator at the conclusion of the hearing.
b. Consequences of failure to file in a timely and
effective manner. If a hearing concerning the registration
of a specific pesticide product subject to this Notice is not
requested by the end of the applicable 30-day period, registra-
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tion of that product will be cancelled, unless the registrant
files a request for an amended registration within the statutory
period provided herein (See Unit V.D.I).
If the registration of a product covered by this Notice
is cancelled by operation of law, the sale and distribution
of existing stocks is governed by the provisions of Unit V.C.
of this Notice.
3. Separation of functions. EPA's Rules of Practice
forbid anyone who may take part in deciding this case, at any
stage of the proceeding, from discussing the merits.of the
proceeding ex parte with any party or with any person who has
been connected with the preparation or presentation of the
proceeding as an advocate or in any investigative or expert
capacity, or with any of their representatives (40 CFR 164.7).
Accordingly, the following EPA offices, and the staffs
thereof, are designated as the judicial staff to perform the
judicial function of EPA in any administrative hearing on
this Notice of Intent to Cancel: the Office of the Adminis-
trative Law Judge, the Office of the Judicial Officer, the
Administrator, the Deputy Administrator, and the members of
the staff in the immediate office of the Administrator and
Deputy Administrator. None of the persons designated as the
judicial staff may have any ex parte communication with the
trial staff or any other interested person not employed by
EPA on the merits of any of the issues involved in this
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proceeding, without fully complying with the applicable^
regulations.
VII. REFERENCES
The references in this FEDERAL REGISTER Notice are as
follows:
(1) U. S. Environmental Protection Agency. "Cadmium
Technical Support Document," U.S. Environmental Protection
Agency, 1986, Public Docket No. D-5838A.
(2) Friberg, L., Piscator, M., Nordberg, G.F.,
Kjellstrom, T. "Cadmium In The Environment", 2nd. ed.,
CRC Press, Inc., Boca Raton, Florida, 1974, Public Docket No.
D-05783, Att. 23.
(3) Golf Course Superintendents Association of America.
Personal communication (telephone) between Jerry Faubel, Golf
Course Superintendents Association of America and Valerie
Bael, EPA, January 30, 1987, Public Docket No. D-7644.
(4) Daniel, W.H., Freeborg, R.P., and Knopinski, V.J.
"An On-Course Look At Pesticide Exposure," Golf Course Management,
March, 1984, j>p. 71-85, Public Docket No. D-7645.
(5) W. A. Cleary Chemical Corporation. Response of
W. A. Cleary Chemical Corporation to the Special Review and
Proposed Cancellation of cadmium, W.A. Cleary Chemical
Corporation, November 24, 1966, Public Docket No. D-6607,
submitted to USEPA December 2, 1986, with attachments:
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A. University of Rhode Island. Response to
the Special Review and Proposed Cancellation of Cadmium.
A letter to Mr. Martin McGinn of the W.A. Cleary Chemical
Corporation, University of Rhode Island, Kingston, RI.
B. Golf Course Superintendents Association
of America. Response to the Special Review and Proposed
Cancellation of Cadmium. A letter to Mr. Martin McGinn of
the W. A. Cleary Chemical Corporation.
(6) U.S. Environmental Protection Agency. Materials
submitted to the Scientific Advisory Panel in consideration
of the Special Review of Cadmium, USEPA, November 7, 1936,
Public Docket No. D-7754.
(7) W.A. Cleary Chemical Corporation. Proposed label
change, W.A. Cleary Chemical Corporation, January 12, 1987,
Public Docket No. D-7753, submitted to USEPA January 16,
1987.
(8) Seacoast Laboratories. Response of Seacoast
Laboratories to the Special Review .and Proposed Cancellation
of Cadmium, Seacoast Laboratories, November 3, 1986, Public
Docket No. D-6034, submitted to USEPA November 14, 1986.
(9) Public Citizen. Response of Public Citizen to the
Special Review and Proposed Cancellation of Cadmium, Public
Docket No. D-6115A, submitted to USEPA November 21, 1986.
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All references with Public Docket numbers are available'
for inspection in Rm. 236, Crystal Mall Building 12,'1921
Jefferson Davis Highway, Arlington, VA., from 9 a.m. to
4 p.m., Monday through Friday excluding legal holidays.
Dated:
JobrnX. Moore
Assistant Administrator
for Pesticides and
Toxic Substances
CERTIFIED TO IE * TROI
COPY Of THE OWGIMAl
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