[Federal Register Volume 59, Number 128 (Wednesday, July 6, 1994)]
[Unknown Section]
[Page 0]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 94-16334]
[[Page Unknown]]
[Federal Register: July 6, 1994]
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ENVIRONMENTAL PROTECTION AGENCY
[OPP-66194; FRL-4896-5]
Notice of Intent to Cancel the Registrations of Nuclo Dry
Granular Algaecide, Nuclo Dry Algaecide 90, Winterizing Algaecide, and
Algicil Plus
AGENCY: Environmental Protection Agency (EPA).
ACTION: Notice of Intent to Cancel (NOIC).
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SUMMARY: Pursuant to section 6(b) of the Federal Insecticide,
Fungicide, and Rodenticide Act (FIFRA), this Notice announces EPA's
intent to cancel the following pesticide registrations for simazine
products used in swimming pools, hot tubs, and whirlpool baths: Nuclo
Dry Granular Algaecide (EPA Reg. No. 7124-32) and Nuclo Dry Algaecide
90 (EPA Reg. No. 7124-93), produced by Alden Leeds, Inc.; and
Winterizing Algaecide (EPA Reg. No. 3432-33) and Algicil Plus (EPA Reg.
No. 3432-54), produced by N. Jonas Company. EPA is taking this action
because it believes that the use of the products, in accordance with
widespread and commonly recognized practice, generally causes
unreasonable adverse effects on the environment. Specifically, EPA is
concerned with potential cancer and non-cancer effects resulting from
exposure to simazine in swimming pools. EPA believes that the risks
from this particular simazine use exceed the benefits derived from this
use. Effective the date of final cancellation, EPA will not allow
further sale, distribution, or use of existing stocks of these
products, as described in this Notice. Holders of existing stocks are
subject to FIFRA section 6(g) reporting requirements.
DATES: Requests for a hearing by a registrant must be received by the
Office of the Hearing Clerk at the address given below on or before
August 5, 1994, or on or before 30 days from receipt of this Notice by
the registrant, whichever occurs later. Requests for a hearing by other
adversely affected parties must be received by the Office of the
Hearing Clerk on or before August 5, 1994.
ADDRESSES: Requests for a hearing must be submitted to: Hearing Clerk
(1900), U.S. EPA, 401 M St., SW., Washington, DC 20460. Additional
information supporting this action is available for public inspection
from 8 a.m. to 4 p.m., Monday through Friday, except legal holidays in:
Information Services Branch, Program Management and Support Division
(7502C), Office of Pesticide Programs, Environmental Protection Agency,
Rm. 236, Crystal Mall #2, 1921 Jefferson Davis Highway, Arlington, VA.
FOR FURTHER INFORMATION CONTACT: By mail: Jeff Morris, Special Review
and Reregistration Division (7508W), Office of Pesticide Programs,
Environmental Protection Agency, 401 M St., SW., Washington, DC 20460.
Office location and telephone number: 3rd Floor, Crystal Station #1,
2800 Crystal Drive, Arlington, VA. Telephone: 703-308-8029.
SUPPLEMENTARY INFORMATION:
I. Introduction
This Notice announces EPA's intent to cancel the following
pesticide registrations for simazine products used in swimming pools,
hot tubs, and whirlpool baths: Nuclo Dry Granular Algaecide (EPA Reg.
No. 7124-32), Nuclo Dry Algaecide 90 (EPA Reg. No. 7124-93),
Winterizing Algaecide (EPA Reg. No. 3432-33), and Algicil Plus (EPA
Reg. No. 3432-54). For the reasons set forth below, the Administrator
has made the determination that these products, when used in accordance
with widespread and commonly recognized practice, generally cause
unreasonable adverse effects on the environment.
A. Organization of this Notice
This Notice is divided into 13 units. This unit provides
introductory information and describes the legal authority for this
action. Unit II gives the background information on how EPA arrived at
its decision to cancel these products. Unit III summarizes EPA's
toxicology concerns. Unit IV outlines the exposure assessment. Unit V
discusses EPA's risk concerns. Unit VI examines the benefits of these
products and the impact of this proposed cancellation action. Unit VII
provides the risk/benefit analysis. Unit VIII describes the role of the
Scientific Advisory Panel and the Secretary of Agriculture. Unit IX
discusses disposition of existing product stocks. Unit X provides the
required notification for possession of canceled products. Unit XI
outlines the procedures for implementing the actions required by this
Notice, as well as the procedures for requesting a hearing. Unit XII
lists the references to the supporting documentation. Unit XIII gives
information on the public docket.
B. Legal Authority
Before a pesticide product may be lawfully sold or distributed in
either intrastate or interstate commerce, the product must be
registered by EPA pursuant to FIFRA section 3(a) (7 U.S.C. 136a(a)). A
registration is a license allowing a pesticide product to be sold and
distributed for specified uses in accordance with use instructions,
precautions, and other terms and conditions of the registration.
In order to obtain a registration for a pesticide under FIFRA, an
applicant must demonstrate that the pesticide satisfies the statutory
standard for registration, section 3(c)(5) of FIFRA (7 U.S.C.
136a(c)(5)). 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'' (7 U.S.C. 136(bb)). This standard requires a finding
that the benefits of the use of the pesticide exceed the risks of use,
when the pesticide is used in compliance with the terms and conditions
of registration or in accordance with commonly recognized practices.
The burden of demonstrating that a pesticide product satisfies the
statutory criteria for registration is at all times on the proponents
of registration, and continues as long as the registration is in effect
(Industrial Union Dept. v. American Petroleum Institute, 448 U.S. 607,
653 n.61 (1980); Environmental Defense Fund V. EPA, 510 F. 2d 1292,
1297 (D.C. Cir. 1975)).
Under FIFRA section 6(b), EPA may issue a notice of intent to
cancel the registration of a pesticide product whenever it appears to
the Administrator that the product, when used in accordance with
widespread and generally recognized practice, generally causes
unreasonable effects (7 U.S.C. 136d(b)).
Registrants and other adversely affected persons may request a
hearing on the cancellation of a specified registration and use. If
they do so in a legally effective manner, the registration and use will
be continued pending a decision at the conclusion of an administrative
hearing.
II. Background
In 1989, EPA classified simazine as a possible human carcinogen
(Ref. 1). Simazine is used primarily as an agricultural herbicide;
swimming pool use accounts for less than 2 percent of total simazine
usage. In August 1993, EPA conducted a risk assessment for the swimming
pool use (Ref. 2). The risk assessment revealed high potential cancer
and non-cancer health risks to children and adults exposed to water
treated with simazine algaecides.
Because of its risk concerns, EPA requested that the 13 registrants
of the simazine swimming pool algaecides cease product formulation and
voluntarily cancel their product registrations (Refs. 3 and 4). In
response to EPA's request, nine of the registrants--A & V, Great Lakes
Biochemical, Applied Biochemists, Aqua Clear Industries, Western Purity
Biochemical, Poolmaster, Leslie's Pool Supplies, York Chemical, and
Quantum Biochemical--requested a FIFRA section 6(f) voluntary product
cancellation. Also, pursuant to FIFRA section 4(i)(5)(D), EPA canceled
two registrations held by EZ-Clor Systems and one held by N. Jonas
Company, for failure to pay the annual registration maintenance fees
for those registrations. The cancellation order for the registrations
held by these 11 registrants was published on April 15, 1994 (59 FR
18120). A separate order, cancelling the registration of Aladdin Winter
Care (EPA Reg. No. 11329-17) for failure to pay the annual registration
maintenance fee for that product registration, was signed on May 16,
1994. The order was published in the Federal Register and became
effective on May 25, 1994 (59 FR 27016).
Alden Leeds and N. Jonas Co. still hold the following registrations
for the following simazine products: Nuclo Dry Granular Algaecide (EPA
Reg. No. 7124-32), Nuclo Dry Algaecide 90 (EPA Reg. No. 7124-93),
Winterizing Algaecide (EPA Reg. No. 3432-33), and Algicil Plus (EPA
Reg. No. 3432-54).
The three registrants of technical simazine--Ciba-Geigy, Drexel
Chemical, and Oxon-Italia--are not supporting the swimming pool
simazine use. That is, these manufacturers of the simazine active
ingredient do not have their simazine products registered for swimming
pool-related uses. None of Drexel Chemical's products were registered
for aquatic use, and Ciba-Geigy and Oxon-Italia had ceased supporting
all aquatic uses before EPA conducted its risk assessment. The aquatic-
use cancellation for Ciba-Geigy, the supplier of technical simazine for
the swimming pool products, was published in the Federal Register on
July 1, 1992 (57 FR 29309) and became effective on October 9, 1992. The
notice of Oxon-Italia's request for aquatic use cancellations was
published in the Federal Register on February 9, 1994 (59 FR 6021), and
became effective 90 days from that publication date. At EPA's request,
Ciba-Geigy and Oxon-Italia have amended their product labels to
explicitly prohibit reformulation of their products into swimming pool
products; Drexel has amended its technical simazine label to prohibit
formulation into aquatic-use products. Because manufacturers of
simazine swimming pool products must formulate their products from
technical simazine, the effect of these actions is that there is no
legal source of simazine active ingredient from which the swimming pool
product manufacturers may formulate any simazine products.
III. Summary of Toxicological Concerns
Based on toxicological studies in laboratory animals, EPA has
determined that simazine may pose cancer and non-cancer risks to
individuals exposed to this pesticide. The results of these studies, as
well as the EPA classification of the carcinogenic potential of
simazine, are described below.
A. Carcinogenicity
EPA reviewed the simazine toxicological data base, including rat
and mouse chronic feeding/carcinogenicity studies, in its evaluation of
the carcinogenic potential of simazine.
1. Rat study. In a 2-year chronic feeding carcinogenicity study,
simazine technical was administered in the diet of 340 male and 340
female Sprague-Dawley (SD) rats (MRID No. 40614405). The study had two
phases: a carcinogenicity phase and a chronic phase. An equal number of
male and female rats were randomly divided into four major groups; 50
animals/sex/group were used in the carcinogenicity phase, and 30 to 40
animals/sex/group were used in the chronic phase. Animals were dosed at
0 (control), 10, 100, or 1,000 ppm of simazine for 2 years
(corresponding to 0.41, 4.17, or 45.77 mg/kg/day in males; and 0.52,
5.34, or 63.10 mg/kg/day in females).
For the carcinogenicity phase, results in the female SD rats
indicated that there was a statistically significant dose-related trend
in mammary gland carcinomas, as well as in combined adenomas and
carcinomas. The incidence of mammary gland carcinomas was statistically
significantly increased at both the 100 and 1,000 ppm groups, as
compared to the controls. Also, the incidence of combined adenomas and
carcinomas was statistically significantly higher in the highest dose
tested (HDT) group, as compared to the controls. Mammary gland
carcinomas in the main study contributed to increased mortality in the
HDT animals. A higher incidence of mammary gland carcinomas was also
seen in the recovery study (52 weeks of treatment at 1,000 ppm,
followed by 52 weeks of recovery) for the control (1/10) and the HDT
(4/10) animals.
The incidence of hyperplastic changes (cystic glandular
hyperplasia) in the mammary glands of female rats was statistically
significantly higher in the HDT animals than in the controls. This
finding correlates with the observed high incidence of tumors in the
HDT group. It is generally understood that the higher tumor incidence
correlates directly with a higher incidence of hyperplastic changes.
In the female rats, the incidence of pituitary carcinomas was found
to be statistically significantly higher in the HDT animals than in the
controls. The incidence of pituitary adenomas was found to be extremely
high in all groups. Further statistical analysis of these tumors (total
tumor analysis) indicated that the incidence of combined adenomas/
carcinomas in the mid- and high-dose groups was statistically
significantly higher than in the controls, and also exhibited a
significant increasing dose-related trend.
There was a statistically significant dose-related trend for the
incidence of kidney tubular adenomas in female rats. However, the
tumors occurred only at the HDT, and the incidence was not
statistically significant as compared to the control animals.
In the male SD rats, the incidence of hepatocellular adenomas or
carcinomas was very low in all treated and control groups. The
incidence of combined hepatocellular adenomas and carcinomas was
statistically significantly higher in the HDT group, as compared to the
control group. These incidences fell within the historical control
range for this testing facility.
A very low incidence of kidney tubular adenomas and carcinomas was
seen in male rats. A statistically significant dose-related trend was
observed for the incidence of carcinomas, as well as for the incidence
of combined adenomas and carcinomas. However, tumors occurred only at
the HDT, and tumor incidences were not statistically significantly
elevated as compared to concurrent controls.
For this study, the Health Effects Division (HED) of the Office of
Pesticide Programs Cancer Peer Review Committee concluded that the
highest dose exceeded the Maximum Tolerated Dose (MTD) for female rats,
based on excess deaths and body-weight-gain reductions. The Committee
also agreed that the highest dose in male rats appeared to have
exceeded the MTD, based on a significant decrease in body-weight gain.
However, the mid-level dose was well below the MTD, and mammary gland
tumors in the female rat were statistically significantly increased at
both the mid- and high-dose levels. In addition, the Committee
concluded that there was too great an interval between the mid (100
ppm) and high (1,000 ppm) doses. These factors were taken into account
in the weight-of-evidence considerations that led the Committee to
classify simazine as a possible human carcinogen (Ref. 2).
2. Mouse study. There is no evidence of a relationship between
simazine exposure and carcinogenicity in the mouse. In a 1988 chronic
feeding/carcinogenicity study in mice, simazine technical was
administered in the diet to a group of 60 male and 60 female CD1 (ICR)
BR mice at 0 (control), 40, 1,000, or 4,000 ppm for 95 weeks (MRID No.
40614404). There were no increases in neoplasms reported for any dosed
group and no evidence of compound-related effect on survival or target
organ toxicity.
3. Classification of carcinogenic potential. Based on the weight-
of-evidence, the HED Cancer Peer Review Committee concluded that
simazine should be classified as a Group C possible human carcinogen
(Ref. 2). This determination was primarily based on results from the 2-
year chronic feeding/carcinogenicity study in rats. Based on EPA's
evaluation of the data presented in this study, EPA concluded that
technical-grade simazine is carcinogenic in female SD rats, inducing
the formation of mammary gland carcinomas. There is evidence in the
published literature that simazine has genotoxic activity, and this was
considered in the weight-of-evidence evaluation of simazine's
carcinogenicity classification.
B. Systemic Effects
1. Rat study. EPA determined that the 2-year rat chronic feeding
study, described in unit III. A.1. of this notice, was appropriate for
assessing non-cancer risks for ``competitive'' exposure to simazine. A
No Observed Effect Level (NOEL) of 0.52 mg/kg/day was established based
on decreased body weight gain and depression of hematological
parameters that occurred at 5.34 mg/kg/day. These effects, which
include depressed red-blood-cell count, hemoglobin, and hematocrit, are
considered to be reversible when exposure is terminated.
2. Rabbit study. For evaluation of non-cancer risks from
``recreational'' exposure to simazine, EPA based its risk assessment on
the results of a rabbit developmental toxicity study (MRID No.
001611407).
In this study, 19 female New Zealand White rabbits per dose level
were artificially inseminated and administered technical grade simazine
once daily by gastric intubation at doses of 5 mg/kg, 75 mg/kg, and 200
mg/kg of body weight. A significant reduction in mean fetal weight and
a significant increase in the incidence of fetuses with skeletal
variations were observed at the 200 mg/kg dose level. Therefore, the
developmental NOEL for this study is 75 mg/kg of body weight. In the
mothers, significant decreases in body weight gain, tremors, and
abortions were observed in the mid- and high-dose groups (75 and 200
mg/kg dose levels). The maternal NOEL was therefore established at 5
mg/kg of body weight.
IV. Exposure Assessment
EPA developed four exposure scenarios based on the frequency and
duration of exposure (competitive versus recreational swimming), and on
the age and weight of the swimmer (6-year-old child versus 35-year-old
male). The assessment assumed exposure to the entire body through
dermal, oral, buccal and sublingual, orbital and nasal, aural, and
inhalation routes. High-exposure frequency, or ``competitive,'' 6-year-
old and 35-year-old swimmers are assumed to have daily exposures of 3
and 5 hours, respectively, for 150 days per year (Ref. 5). Based on
these assumptions, EPA estimates that ``competitive'' swimmers are
exposed to an Actual Daily Exposure (ADE) of 0.12 mg/kg/day for
children, and 0.07 mg/kg/day for adults. Low-exposure frequency, or
``recreational,'' swimmers of both age groups are assumed to be exposed
for 30 minutes per day, 5 days a year. This low exposure results in an
ADE of 0.02 mg/kg/day for children and 0.0073 mg/kg/day for adults. EPA
assumed that lifetime exposure constitutes 30 years of exposure over a
75-year lifetime.
Simazine concentrations in swimming pool water were calculated
based on label application rates. Although simazine is soluble to only
3.5 parts per million (ppm) in water at 68 deg.F, EPA assumed that
swimmers could be exposed to average simazine concentrations of 5 ppm,
because solubility could increase at temperatures above 68 deg.F.
EPA has concluded that it is not necessary to conduct a separate
exposure assessment for the simazine product that is used to control
algae in swimming pools during the off-season or winter months. A
separate assessment is unnecessary because the exposure levels for the
winter-use (winterizer) product are comparable to the exposure levels
for the non-winterizer simazine swimming pool products. Label
application rates for winterizer and non-winterizer products are
similar. In addition, label directions do not require swimming pools
that have been treated with winterizer products to be drained before
they are used by swimmers. Because EPA has no data concerning simazine
dissipation, EPA must assume that following initial or subsequent
winterizer treatment, simazine does not dissipate from swimming pool
water. Consequently, swimmers could be exposed to unacceptable levels
of simazine when winterized swimming pools are opened for use.
Therefore, EPA believes that the individual risk posed to swimmers from
exposure to simazine used as a winterizer is not significantly
different from other exposure scenarios.
V. Risk
A. Cancer
1. Potency factor (Q1*). EPA calculated the cancer potency, or
Q1*, for simazine as 1.20 x 10-1 (mg/kg/day)-1, based
on mammary gland cancer in laboratory animals. The Scientific Advisory
Panel (SAP) reviewed the carcinogenicity of simazine in September 1989
and, while agreeing with the Group C classification, did not recommend
the use of a quantitative risk assessment (Ref. 6). The SAP noted that
certain pesticides, such as simazine, may alter endocrine physiology in
the rat and influence the incidence of mammary gland tumors; the SAP
therefore recommended that EPA formulate a position on the regulation
of chemicals with this mechanism.
At a subsequent OPP Cancer Peer Review Committee meeting, the Peer
Review Committee evaluated the SAP's recommendation and concluded that
it is appropriate to use the Q1* to quantify the carcinogenic
risks from exposure to simazine until data are provided showing a
hormonally mediated mechanism (Ref. 7). EPA has not received data
adequate to support this hypothesis.
2. Cancer risk. The excess individual lifetime cancer risk is
calculated by multiplying the Q1* by the Lifetime Average Daily
Exposure (LADE), expressed in mg/kg/day. EPA estimates that the excess
risk to an individual exposed to simazine over a 75-year lifetime
(i.e., 30 years of exposure) ranges from 4.8 x 10-6 to 1.4 x
10-3. Risk to most competitive and recreational swimmers is
estimated to fall within this range, although in some instances the
risks could be higher or lower. EPA generally considers any risk to the
general public greater than 1 x 10-6 to be unacceptable.
B. Non-Cancer
EPA measures non-cancer risks by calculating a margin of exposure
(MOE), which is a comparison of the NOEL to actual daily exposure, both
of which are expressed in milligrams of chemical dose per kilogram of
body weight per day. An MOE less than 100 generally represents an
unacceptable risk.
1. Non-cancer risk to swimmers from high exposure frequency. The
high exposure frequency assumed for the competitive swimmer categories
necessitated the use of a long-term toxicity study to calculate non-
cancer risk. The 2-year chronic rat feeding study was therefore used to
calculate the MOEs for competitive swimmers. The risks to swimmers for
the non-cancer effects seen in the chronic study--reduction in body
weight gain and depression of hematological parameters (anemia)--are
reflected in MOEs of 4.3 for children and 7.4 for adults. The MOEs for
swimmers in the competitive category, based on effects seen in the
chronic feeding study, are well below 100 and therefore indicate an
unacceptable risk.
2. Non-cancer risk to swimmers from low exposure frequency. EPA
does not consider swimmers exposed at a low exposure frequency (i.e., a
few short exposures per year) to be at risk of exhibiting non-cancer
effects (Ref. 8). Because of the low exposure frequency assumed for the
recreational swimmer categories, the rabbit developmental toxicity
study was used to calculate MOEs. The effects of reduction in maternal
body weight gain, abortions, and tremors were manifested at very high
dose levels and are considered signs of general systemic toxicity in
the test animals. EPA calculated MOEs of 250 for children and 685 for
adults exposed to simazine in swimming pools. This indicates that
recreational swimmers are not at risk from the effects seen in the
developmental toxicity study.
The following table summarizes the risk numbers derived from the
assessment:
------------------------------------------------------------------------
Swimmer Category Cancer Risk Non-Cancer Risk (MOE)
------------------------------------------------------------------------
Competitive 6-year-old (3 2.4 x 10-3 4.3\1\
hours/day, 150 days/year).
Competitive 35-year-old 1.4 x 10-3 7.4\1\
male (5 hours/day, 150
days/year).
Recreational 6-year-old 1.4 x 10-5 250\2\
(0.5 hour/day, 5 days/
year).
Recreational 35-year-old 4.8 x 10-6 685\2\
male (0.5 hour/day, 5
days/year).
------------------------------------------------------------------------
\1\ 2-year chronic feeding study in rats, MRID 40614405. NOEL = 0.52 mg/
kg/day, based on decreased body weight gain and depression of
hematological parameters at 5.34 mg/kg/day.
\2\ Developmental toxicity study in rabbits (13-day length of exposure),
MRID 00161407. NOEL = 5.0 mg/kg/day, based on tremors, abortions, and
decreased body weight gain (all maternal toxicity effects) at 75 mg/kg/
day.
VI. Benefits and Impact of Cancellation
Under FIFRA, a pesticide registration may only be maintained if the
benefits of the use of the pesticide exceed the risks of use. EPA has
found that at least some of the registered alternative algaecides
provide comparative control at comparative prices, during summer season
use. EPA has concluded that the benefits associated with Nuclo Dry
Granular Algaecide, Nuclo Dry Algaecide 90, and Algicil Plus are
negligible when compared to the total operating costs on a per-pool
basis. The cancellation of these products for summer use will have a
negligible impact on the pool industry and the public.
EPA has also found that the benefits associated with Winterizing
Algaecide are relatively small. This information is based on the fact
that there are a number of alternatives to simazine winterizing
products on the market, and the labels of many of these alternative
products indicate that they are used at a similar frequency as
simazine. Although EPA has anecdotal information that suggests simazine
may have a longer duration of activity, which could, if true, result in
a cost savings, there are no data to support this. Therefore, EPA
concludes that the loss of simazine winterizing products would have
only a small impact on the swimming pool industry and the public.
The cancellation of the four products subject to this Notice will
not have a significant economic impact in part because they account for
only a small share of the algaecide market for swimming pool use. EPA
estimates that all 22 simazine products account for less than 10
percent of the market for algaecides for swimming pool use. Registrants
of 18 of these products have already requested voluntary cancellation
of their registrations, or have had their registrations canceled for
maintenance fee non-payment. The remaining four products subject to
this Notice account for less than 1 percent of the total swimming pool
algaecide market.
The economic impact of cancelling these four products is minimized
by the availability of registered alternative algaecides for swimming
pool use. Because these alternatives have a substantially greater
market share than simazine, the cancellation of the four products
subject to this Notice should not result in significant price increases
in the non-simazine products. For the same reasons, EPA does not expect
market dislocations due to the inability to produce the alternative
algaecides to meet demand.
Alden Leeds and N. Jonas Co. indicated to EPA that they have
accounted for approximately 25,000 gallons of liquid product in their
possession or in the channels of trade, and 14,000 pounds of
unformulated Ciba-Geigy simazine product that Ciba-Geigy has agreed to
buy back. Given the small amount of these products and the over 3
million swimming pools in the United States that could use simazine
pool products, cancellation of these products would have little impact
on the swimming pool industry. Section 6(b) of FIFRA requires EPA to
consider the impact of cancellation upon the agricultural economy (7
U.S.C. 136d(b)). EPA has determined that the cancellation of these
products will have no impact upon the agricultural economy because
these products are registered for swimming pool use, and not for
agricultural uses.
VII. Risk/Benefit Assessment
Under section 6(b) of FIFRA, the Administrator may cancel a
pesticide due to unreasonable adverse effects, if the pesticide
generally causes an ``unreasonable risk to man or the environment,
taking into account the economic, social, and environmental costs and
benefits'' of the pesticide's use (7 U.S.C. 136d(b)).
As discussed in the preceding sections of this Notice, the cancer
and non- cancer risks to human health from continued registration of
Nuclo Dry Granular Algaecide, Nuclo Dry Algaecide 90, Winterizing
Algaecide, and Algicil Plus are significant, while the benefits of
continued registration are negligible for summer use, and are
relatively small for the winterizing use. EPA believes that the risks
posed by continued registration are unreasonable when compared to the
benefits, and that simazine use in swimming pools should be canceled.
In making its determination to propose cancellation, EPA has also
examined whether any measures short of cancellation exist to reduce
exposure to acceptable levels, and has concluded that there are none.
For the summer use, no measures could be identified to reduce risk to
an acceptable range. For the winterizer use, EPA considered allowing
registrants to retain that use, if data were submitted that showed that
superchlorination of pools following simazine use eliminated the
product from treated water. No such data were submitted to EPA.
Therefore, EPA has determined that for both the summer and winter use,
there are no acceptable measures short of cancellation.
VIII. Role of the Scientific Advisory Panel and the Secretary of
Agriculture
Sections 6(b) and 25(d) of FIFRA provide certain opportunities for
the FIFRA Scientific Advisory Panel (SAP) and the Secretary of the
Department of Agriculture (USDA) to review and comment upon a draft
NOIC, and in the case of USDA, an analysis of the impact of the
proposed action on the agricultural economy. These reviews may be
waived, and when they are, the Notice may be published without delay.
On April 5, 1994, EPA asked the SAP and Secretary of USDA to waive
their rights to review and comment on this Notice (Refs. 9 and 10). On
April 12, 1994, Nancy Ragsdale, Director, National Agricultural
Pesticide Impact Assessment Program, USDA, notified EPA that the
Secretary would waive review of this action (Ref. 11). On May 25, 1994,
the SAP notified EPA that it waived its review of this action (Ref.
12). Because the SAP and USDA have waived their review of this action,
EPA is issuing this Notice without delay.
IX. Disposition of Existing Stocks
For purposes of this Notice, existing stocks are defined as those
stocks of simazine products for use in swimming pools that were in the
United States and were packaged, labeled, and released for shipment
prior to July 6, 1994.
EPA has an established policy for determinations concerning the
sale, distribution, and use of existing stocks of canceled pesticides
(56 FR 29362, June 26, 1991). That policy states that in cases where
EPA has identified a significant risk concern and the registration is
canceled, EPA will make existing stocks determinations on a case-by-
case basis. In most cases EPA will not permit the continued sale,
distribution, or use of existing stocks of a canceled product raising
risk concerns unless it can be demonstrated that the benefits exceed
the risks. EPA reserves the right to amend this existing stocks
provision, should conditions warrant such amendment.
The swimming pool use of simazine poses unreasonable cancer and
non- cancer risk. As discussed in units VI and VII of this Notice, the
benefits of continued sale, distribution, and use of existing stocks
are negligible and do not outweigh the risks. Finally, EPA has taken
steps to minimize the amount of stocks that are currently in the hands
of registrants, retailers, and distributors. In December 1993, EPA
notified registrants of the risks associated with the products and
asked them to stop formulating, selling, and distributing their
products (Ref. 4).
EPA has determined that no person may sell, distribute, or use the
existing stocks of any product subject to this Notice except for: (1)
Sale or distribution up through the chain of distribution to the former
registrant of that product, or (2) for lawful disposal. It is the
responsibility of the basic registrants to notify any and all
supplementally registered distributors of their product(s) that this
Notice also applies to their supplementally registered products.
Registrants may be held liable for violations committed by their
distributors. Any sale, distribution, or use of existing stocks of
canceled products other than as provided in this Notice will be
considered a violation of FIFRA 12(a)(2)(J).
Notwithstanding any other provision of this Notice, the
distribution or sale of canceled products will be allowed if such
distribution or sale is for the purpose of collecting products for
relabeling, reformulation, disposal, or export to a country where the
use of simazine is not prohibited, or any other lawful purpose not
inconsistent with the provisions of this Notice. In order for exported
existing stocks of canceled simazine to qualify for this exception,
such stocks must comply with all the labeling requirements identified
in FIFRA section 17(1)(a) and the foreign purchaser acknowledgement
requirements identified in FIFRA section 17(a)(2). In order to be
considered to be in compliance with these provisions, the exporter must
follow the procedures specified in the EPA's Export Policy and
Procedures for Exporting Unregistered Pesticides at 40 CFR part 168,
subpart D.
X. Required Notification of Possession of Canceled Products
Pursuant to FIFRA section 6(g), any producer or exporter,
registrant, applicant for a registration, applicant or holder of an
experimental use permit, commercial applicator, or any person who
distributes or sells any pesticide, who possesses any stocks of
pesticide products containing simazine subject to this Notice that are
canceled by a final order issued either in the absence of or following
a hearing on cancellation (hereafter, referred to as ``affected
persons,'' which includes affected individuals, partnerships,
associations, corporations, or any organized group of persons whether
incorporated or not) must notify the EPA and appropriate State and
local officials of: (1) Such possession; (2) the quantity of canceled
simazine pesticide product possessed; and, (3) the place at which the
canceled simazine pesticide product is stored. Notification by affected
persons to EPA and designated State and local officials pursuant to
FIFRA section 6(g) shall be in accordance with the procedures, time
frames, and requirements set out in this Unit. End users, except
commercial applicators, are not required to report their stocks of
canceled simazine products.
A. Pesticides Required to be Reported
Affected persons must report, pursuant to FIFRA section 6(g), the
information described below for canceled simazine pesticide products
that are in their possession, regardless of the ownership of that
canceled simazine pesticide product. Canceled simazine product that is
owned by one affected person, but is in the physical possession of
another affected person who is subject to section 6(g) reporting, is to
be reported by the person in physical possession of the pesticide.
The Office of Management and Budget (OMB) has given approval for
the collection of information under FIFRA section 6(g), and has
assigned the OMB control number 2070-0109.
B. Information that Must be Included in the Submission
To be in compliance with FIFRA section 6(g), affected persons must
submit to the designated EPA and State and local officials the
following information certified by a responsible company official as
true and correct:
1. The identity and address of the affected person (company).
2. Name and phone number of a contact person (in the company).
3. Indication that the FIFRA section 6(g) information is being
submitted for canceled pesticide products containing simazine.
4. The relationship of the affected person (company) to the
canceled simazine pesticide products being reported under FIFRA section
6(g) (i.e., exporter, producer, registrant, applicant for registration,
applicant for or holder of an experimental use permit, commercial
applicator, distributor, retailer, etc.).
5. The street address of each location owned, leased, or operated
in the United States by the submitter where the canceled simazine
pesticide product is held.
6. For each location listed, the quantity (pounds, gallons, or
other appropriate measure) of canceled simazine pesticide product
listed by the number of units of each size container (pound, gallons,
or other appropriate measure) and by EPA registration number (e.g., x
units of 5 gallon containers of EPA registration number xxx-xxx).
C. When to Report
Affected persons are advised not to report until the effective date
of the final order issued either in the absence of or following a
hearing on cancellation. Reports of existing stocks submitted before
the effective date of the cancellation are not considered to meet the
reporting requirements of FIFRA section 6(g). Upon the effective date
of cancellation, affected persons must submit FIFRA section 6(g)
information according to the following time frames:
1. Registrants of canceled simazine must report within 30 days of
the effective date of the final order.
2. Producers, exporters, applicants for a registration, applicants
or holders of an experimental use permit, dealers, distributors,
retailers, and commercial applicators must report within 45 days of the
effective date of the final order.
3. End users are not required to report their possession of
canceled products containing simazine.
D. Where to Submit Section 6(g) Information
The FIFRA section 6(g) information is to be sent to each of the
following locations:
1. EPA. Chief, Agricultural Branch, Agricultural and Ecosystems
Division, Office of Compliance, Office of Enforcement and Compliance
Assurance, U.S. Environmental Protection Agency, 401 M St., SW.,
Washington, DC 20460, ``Attention: FIFRA Section 6(g) Information.''
2. State. Chief Pesticide Regulatory Official of the agency in the
State government that enforces the State pesticide laws where the
canceled simazine pesticide product is stored. Envelopes must be marked
``Attention: FIFRA Section 6(g) Information.''
3. Local. Chair of the Local Emergency Planning Committee (LEPC)
for the location where the canceled pesticide is stored. Envelopes
should be marked ``Attention: Notification of Possession of Canceled
Pesticides.'' To identify the name and address of the chair of the
LEPC, contact the State Emergency Response Commission (SERC) or call
the Emergency Planning and Community Right-to-Know (EPCRA) information
Hotline at 1-800-535-0202.
E. Confidentiality of FIFRA Section 6(g) Information
EPA does not consider FIFRA section 6(g) information to be
confidential business information (CBI) under the provisions of FIFRA
section 10. Such information may be made available by EPA to the public
without further notice.
F. Enforcement
Failure to submit complete and accurate FIFRA section 6(g)
information, and/or failure to submit accurate section 6(g) information
in the required time frames, is a violation of FIFRA section
12(a)(2)(K), and violators may be subject to civil penalties up to
$5,000 per offense. Affected persons who possess canceled or suspended
pesticide in multiple locations may be fined up to $5,000 per offense
for each location for which the FIFRA section 6(g) information is not
submitted, submitted late, incomplete, or inaccurate. Persons who
knowingly submit false section 6(g) reports are in violation of FIFRA
section 12(a)(2)(M) and may also be subject to civil penalties up to
$5,000 per offense. Knowing violations of the requirements of FIFRA
section 6(g) may also result in criminal penalties under section 14(b)
of FIFRA, or 18 U.S.C. 1001.
For additional information regarding FIFRA section 6(g)
requirements, contact Phyllis Flaherty or David Stangel of the
Agriculture Branch, Agriculture and Ecosystems Division, Office of
Compliance, at (703) 308-8383.
XI. Procedural Matters
This Notice announces EPA's intent to cancel the registrations of
Nuclo Dry Granular Algaecide (EPA Reg. No. 7124-32), Nuclo Dry
Algaecide 90 (EPA Reg. No. 7124-93), Winterizing Algaecide (EPA Reg.
No. 3432-33), Algicil Plus (EPA Reg. No. 3432-54), and any products
with these registration numbers that are supplementally distributed.
This action is taken pursuant to authority in section 6(b) of FIFRA.
Under FIFRA section 6(b)(1), registrants and other adversely affected
parties may request a hearing on the cancellation actions that this
Notice initiates. Any hearing concerning cancellation of the
registration for any affected pesticide product will be held in
accordance with FIFRA section 6(d). Unless a hearing is properly
requested in accordance with the provisions of this Notice, the
registrations will be canceled. This unit of the Notice explains how
such persons may request a hearing in accordance with the procedures
specified in this Notice, and the consequences of requesting or failing
to request a hearing.
A. Procedures for Requesting a Hearing
Requests for a hearing by a registrant must be received by the
Office of the Hearing Clerk at the address given below on or before
August 5, 1994, or on or before 30 days from receipt of this Notice by
the registrant, whichever occurs later. Requests for a hearing by other
adversely affected parties must be received by the Office of the
Hearing Clerk on or before August 5, 1994. All registrants and other
adversely affected persons who request a hearing must file the request
in accordance with the procedures established by FIFRA and EPA's Rules
of Practice Governing Hearings (40 CFR part 164). These procedures
require that all requests identify the specific registration by
Registration Number and state the basis for objecting to the
cancellation of the product for which a hearing is requested. Requests
must be received by the Hearing Clerk within the applicable 30-day
period. Failure to comply with these requirements will result in denial
of the request for a hearing. Requests for a hearing must be submitted
to: Hearing Clerk (1900), Environmental Protection Agency, 401 M
Street, SW, Washington, DC 20460.
1. Consequences of filing a timely and effective hearing request.
If a hearing on any action initiated by this Notice is requested in a
timely and effective manner, the hearing will be governed by EPA's
Rules of Practice Governing Hearings under FIFRA section 6 (40 CFR part
164). All hearings will be held in Washington, DC. In the event of a
timely and effective request for a hearing, each cancellation action
concerning the specific use of the specific registered product that is
the subject of the hearing request will not become effective except
pursuant to an order of the Administrator at the conclusion of the
hearing.
2. Consequences of failure to file in a timely and effective
manner. If a hearing concerning the cancellation of a specific product
subject to this Notice is not requested in a timely and effective
manner by the end of the applicable 30-day period, registration of that
product will be canceled automatically.
B. 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 his/her representatives (40 CFR 164.7).
Accordingly, the following EPA offices, and the staffs thereof, are
designated as the judicial staff of EPA in any administrative hearing
on this Notice of Intent to Cancel: the Office of Administrative Law
Judges, the Environmental Appeals Board, the Deputy Administrator and
the members of the staff in the immediate office of the Deputy
Administrator, and the Administrator and the members of staff in the
immediate office of the Administrator. The following offices are
designated as the trial staff in any proceeding which may arise under
this Notice: the Office of General Counsel, the Assistant Administrator
for the Office of Prevention, Pesticides, and Toxic Substances and
immediate staff, the Office of Pesticide Programs, and the Office of
Compliance Monitoring. None of the persons designated as the judicial
staff may have any ex parte communications with the trial staff or any
other interested person not employed by EPA on the merits of any of the
issues involved in these proceedings, without fully complying with the
applicable regulations.
XII. References
1. June 16, 1989, ``Peer Review of Simazine.'' HED Peer Review
Committee review of the weight of the evidence on simazine with
particular reference to its oncogenic potential.
2. August 18, 1993, memo from Henry Spencer, HED/OPP, to Joanne
Miller, RD/OPP. RE: exposure assessment and subsequent assessment of
cancer risk from simazine-treated swimming pools.
3. November 29, 1993, letter from Daniel Barolo, SRRD/OPP, to the
simazine algaecide registrants. RE: EPA's risk concerns and invitation
to December 6, 1993 meeting.
4. December 8, 1993, letter from Daniel Barolo to the simazine
algaecide registrants. RE: request for voluntary cancellation.
5. July 28, 1993, memo from Judy Smith, HED/OPP, to Henry Spencer.
RE: request for swimmer exposure assessment for simazine-treated pools.
6. October 16, 1989, Scientific Advisory Panel (SAP), ``A Set of
Scientific Issues Being Considered by the Agency in Connection with the
Peer Review Classification of Simazine as a Class C Oncogen.''
7. May 24, 1990, ``Peer Review of Simazine Following SAP Review.''
HED Peer Review Committee met to reconsider the evaluation of simazine
following the presentation to the SAP.
8. November 23, 1993, memo from Henry Spencer to Joanne Miller. RE:
addendum to assessment of non-cancer health risk from simazine-treated
swimming pools.
9. April 5, 1994, memo from Douglas Campt, OPP, to Bruce Jaeger,
SAP. RE: Request for waiver of SAP's right to review the NOIC.
10. April 5, 1994, letter from Douglas Campt to Nancy Ragsdale,
USDA. RE: Request for waiver of USDA's right to review the NOIC.
11. April 12, 1994, letter from Nancy Ragsdale to Douglas Campt.
RE: USDA waiver of NOIC review.
12. April 25, 1994, memo from R. Bruce Jaeger to Douglas Campt. RE:
SAP waiver of NOIC review.
XIII. Public Docket
The public docket containing the above supporting documentation is
located at 1921 Jefferson Davis Highway, Room 1128, Arlington,
Virginia. The references can be viewed from 8 a.m. to 4 p.m., Monday
through Friday, except legal holidays.
Dated: June 24, 1994.
Lynn R. Goldman,
Assistant Administrator for Prevention, Pesticides and Toxic
Substances.
[FR Doc. 94-16334 Filed 7-5-94; 8:45 am]
BILLING CODE 6560-50-F