United States
                 Environmental Protection
                 Agency	
                      Prevention, Pesticides
                      And Toxic Substances
                      (7508W)	
EPA-738-F-96-028
September 1995
                 R.E.D.   FACTS
     Pesticide
Reregistration
   Use Profile
   Regulatory
       History
Bis(trichloromethyl)


sulfone	
    All pesticides sold or distributed in the United States must be
registered by EPA, based on scientific studies showing that they can be used
without posing unreasonable risks to people or the environment. Because of
advances in scientific knowledge, the law requires that pesticides which
were first registered before November 1, 1984, be reregistered to ensure that
they meet today's more stringent standards.
    In evaluating pesticides for reregistration, EPA obtains and reviews a
complete set of studies from pesticide producers, describing the human
health and environmental effects of each pesticide. The Agency develops
any mitigation measures or regulatory controls needed to effectively reduce
each pesticide's risks. EPA then reregisters pesticides that can be used
without posing unreasonable risks to human health or the environment.
    When a pesticide is eligible for reregistration, EPA explains the basis
for its decision in a Reregistration Eligibility Decision (RED) document.
This fact sheet summarizes the information in the RED document for
reregistration case 2055, bis(trichloromethyl) sulfone.

    Bis(trichloromethyl) sulfone is used to control microbes, algae, and
fungi in cooling water systems,  waste disposal systems, pulp and paper mill
water systems, oil extraction systems, and other industrial settings
(adhesives, industrial coatings, industrial emulsions, etc.). Formulations
include soluble concentrated liquids, ready-to-use liquids, and soluble
concentrated solids. These products are added to systems and industrial
products using pouring and pumping methods.  Product labeling includes
National Pollutant Discharge Elimination System (NPDES) license
requirements.

    Bis(trichloro)methyl sulfone was first registered in the U.S. in 1967 as
a fungicide. In 1968, another registration was issued for a
bis(trichloromethyl) sulfone product with additional biocide uses.  Currently
there are five companies with fourteen products.  One of these products is
registered as a technical with an active ingredient declaration of 98%.  The

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                    others are end-use products containing from 2.5% to 49%
                    bis(trichloromethyl) sulfone.
                          In 1987 the Agency issued the Antimicrobial Data Call-in Notice to
                    obtain additional chronic and subchronic toxicity data for this and other
                    antimicrobial chemicals.

Human  Health   Toxicity
  Assessment         Bis(trichloromethyl) sulfone is slightly toxic to non-toxic in acute oral
                    and dermal toxicity tests. However, it is highly toxic in eye irritation,
                    dermal irritation, and inhalation acute toxicity studies.
                          In an acute neurotoxicity study with rats, decreased food
                    consumption, body weights, core body temperatures, and motor activity
                    were observed in the low dose animals. In a subchronic dermal rabbit
                    toxicity study changes in the blood and clinical  chemistry values  occurred.
                    In developmental studies in the rat and rabbit, signs of maternal toxicity
                    included decreased body weight gains and reduced food consumption.
                    Incidences of clinical toxicity were observed in maternal rabbits at the mid-
                    dose.  Although no developmental treatment-related effects were  noted in
                    rabbits,  decreased fetal body, skeletal, and external abnormalities were
                    identified in the mid-dose animals.  Evidence of mutagenicity was observed
                    in several studies.  Because the findings were equivocal in the  gene
                    mutation study, an assay that involves animal germ cells is required.
                    Dietary Exposure
                          Tolerances or residue limits are established for bis(trichloromethyl)
                    sulfone  in adhesives, paper and paper products which may contact food.
                    These uses of bis(trichloromethyl) sulfone in the manufacture of paper,
                    paperboard (21 CFR §176.300) and adhesives (21  CFR §175.105) which
                    may contact food are regulated by the U.S. Food and Drug Administration
                    (FDA).  There are no other registered food uses of bis(trichloromethyl)
                    sulfone.
                    Occupational and Residential  Exposure
                          Based on the current use patterns, handlers (mixers, loaders, and
                    applicators) may be exposed to bis(trichloromethyl) sulfone during and after
                    normal use of the liquid and solid soluble concentrates and the ready-to-use
                    liquid formulations. An exposure assessment is appropriate based on the
                    toxicological endpoints from the  subchronic dermal and developmental
                    toxicity studies in the rat.
                          Several exposure scenarios  were considered in the Agency's exposure
                    assessment, including both open and closed  application systems.  Data
                    suggest that for the estimation of dermal exposures were appropriate. As
                    expected, exposures to handlers were greatest from open systems,
                    particularly in cooling water and  oil drilling muds/packer fluid  applications.
                    For these scenarios, margins of exposure (MOEs)  were less than 100 for

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Environmental
  Assessment
both the short-term and intermediate term exposures. An MOE of less than
100 is of concern to the Agency.
     To mitigate these risks to handlers, EPA is requiring use of a closed
system for loading and application in water cooling systems and oil drilling
muds/packer fluid scenarios. For all other uses of bis(trichloromethyl)
sulfone, baseline personal protective equipment (PPE) equivalent to those
worn in the exposure study are required.
     Although exposures to workers in areas where bis(trichloromethyl)
sulfone has recently been applied are expected, EPA believes that these
exposures would be significantly less than those for handlers applying the
pesticide.
     There are no bis(trichloromethyl) sulfone products labeled for
homeowner use. Exposures to homeowners may occur from products, such
as adhesives or paper products, treated with bis(trichloromethyl) sulfone.
Again, the Agency believes that these exposures would be minimal.
Human Risk Assessment
     Bis(trichloromethyl) sulfone was determined to be highly toxic in eye
irritation, dermal irritation and inhalation acute toxicity studies, but was
slightly toxic to non-toxic in other acute toxicity tests.
     The use of bis(trichloromethyl) sulfone in the manufacture of paper,
paperboard, and adhesives  which may contact food are regulated by FDA.
There are no other registered food uses.
     The Agency is concerned for exposures to bis(trichloromethyl)
sulfone in the workplace, especially for handlers open-pouring the pesticide
in cooling water and oil drilling mud/packer fluid applications.  To protect
these workers, the Agency is requiring closed system loading and
application methods.  Baseline PPE is required for other uses of
bis(trichloromethyl) sulfone.

Environmental  Fate
     Marginal data are available to estimate the environmental fate of
bis(trichloromethyl) sulfone. These data suggest that the primary route of
dissipation is through microbial action, with a half-life of less than 0.5 days.
Ecological  Effects
     Bis(trichloromethyl) sulfone is practically non-toxic to birds, and
highly to very  highly toxic to freshwater and estuarine/marine organisms.
Ecological  Effects Risk  Assessment
     While the hazard to aquatic organisms from bis(trichloromethyl)
sulfone has been characterized, a quantitative risk assessment has not been
conducted.  The risks to aquatic environments from this use are regulated
under the NPDES  permitting program of EPA's Office of Water.  The
Agency currently requires that labels for all bis(trichloromethyl) sulfone

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                         products require that discharges to aquatic environments comply with an
                         NPDES permit.
    Risk Mitigation
   Additional  Data
           Required
  Product Labeling
            Changes
Required
     To lessen the risks posed by bis(trichloromethyl) sulfone, EPA is
requiring the following risk mitigation measures.
•   EPA is requiring meter-pump loading and application of
     bis(trichloromethyl) sulfone for the following uses:
     pasteurizer/warmer/cannery cooling water systems, commercial/
     industrial water cooling systems, evaporative-condenser water
     systems, heat-exchanger water systems, and oil recovery drilling
     muds/packer fluids.
•   The Agency is establishing active ingredient based minimum PPE
     requirements for primary occupational handlers. Since all the MOEs
     generated are based on units of exposure from the Chemical
     Manufacturers Association exposure study in which handlers wore
     chemical resistant gloves, such chemical-resistant  gloves are required
     for occupational handlers of bis(trichloromethyl) sulfone.

     EPA is requiring additional generic information for
bis(trichloromethyl) sulfone to confirm its regulatory assessments and
conclusions, including an acute neurotoxicity study in rats, gene mutation
study, and a sister chromatid exchange study.
     Data generated by the Antimicrobial Task Force of the Chemical
Manufacturers Association have been used to address these exposures in the
bis(trichloromethyl) sulfone RED document; however, the Agency requires
offers of compensation be made for the use of these data or new, adequate
data be submitted. A Data Call-in has been  issued to the registrants of
bis(trichloromethyl) sulfone requiring these  actions.

     All bis(trichloromethyl) sulfone end-use products must comply with
EPA's current pesticide product labeling  requirements and with the
following.
•   PPE/Engineering Control Requirements for Pesticide Handlers
     For sole-active-ingredient end-use products that contain
     bis(trichloromethyl) sulfone, the product labeling must be revised to
     adopt the handler personal protective equipment (PPE)t/engineering
     control requirements set forth below. Any conflicting
     PPE/engineering control requirements on the current labeling must be
     removed.
     For multiple-active-ingredient end-use products  that contain
     bis(trichloromethyl) sulfone, the PPE/control requirements set forth in
     this section must be  compared to the requirements on the current

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labeling and the more protective must be retained. For guidance on
which requirements are considered more protective, see PR Notice
93-7.
(1)  Minimum (Baseline) Engineering Control Requirements
     Products with bis(trichloromethyl) sulfone must be labeled to
     require pump engineering controls during loading and
     application for the following uses: oil recovery drilling
     muds/packer fluids, pasteurizer/warmer/cannery cooling water
     systems, commercial/industrial water cooling systems,
     evaporative-condenser water systems, and heat exchanger water
     systems.
     In the "Directions For Use" portion of the label referring to
     these uses, registrants must insert the following language:
         "This product must be loaded and applied only using a
         meter-pump system or a closed loading/application system
         for the following uses:  (list uses}.  Open pouring is
         prohibited."
(2)  Minimum (Baseline) Personal Protective Equipment
     Requirements
     EPA is establishing active-ingredient-based minimum (baseline)
     PPE for bis(trichloromethyl) sulfone end-use products that are
     intended for occupational use.  Product labels must be amended
     to include the following statement:
         "Applicators and other handlers must wear: chemical
         resistant gloves, long pants, a long sleeved shirt, shoes and
         socks."
Placement in labeling: The PPE must be placed on the end-use
product labeling in the location specified in PR Notice 93-7 and the
format and language of the PPE requirements must be the same as is
specified in PR Notice 93-7.
Determining PPE Requirements for End-Use Product Labels:
The PPE that would be established on the basis of the acute toxicity
category of the end-use product must be compared to the active-
ingredient-based minimum (baseline) PPE specified above. The more
protective PPE must be placed on the product labeling. For guidance
on which PPE is considered more protective, its placement, format,
and wording refer to PR Notice 93-7. NOTE: If the end-use product
is classified as toxicity category I or II for  eye irritation potential,
protective eyewear is also required.
The Agency is requiring the following labeling statements to be
located on all end-use products containing bis(trichloromethyl)
sulfone that are intended primarily for occupational use.
     Application Restrictions

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     "Do not apply this product in a way that will contact
     workers or other persons."
     User Safety Requirements
     —Registrants:  add the following statements if coveralls are
     required for pesticide handlers on the end-use product label:
         "Discard clothing or other absorbent materials that have
         been drenched or heavily contaminated with this product's
         concentrate. Do not reuse them."
     —Registrants: add the following statements always:
         "Follow manufacturer's instructions for
         cleaning/maintaining PPE. If no such instructions for
         washables, use detergent and hot water. Keep and wash
         PPE separately from other laundry."
     User Safety Recommendations
     •  "Users should wash hands before eating, drinking, chewing
         gum, using tobacco,  or using the toilet."
     •  "Users should remove clothing immediately if pesticide
         gets inside.  Then wash thoroughly and put on clean
         clothing."
     •  "Users should remove PPE immediately after handling this
         product. Wash the outside of gloves before removing. As
         soon as possible wash thoroughly."
To clarify the intent of the oil  recovery drilling muds/packer fluids use
(as an indoor or outdoor use pattern) the following statement must be
added to the labels for terrestrial non-food oil/gas drilling muds and
packer fluids:
     "For use on terrestrial oil wells only."
And the following statement must be added to the precautionary
labeling:
     "Do not apply in marine and/or estuarine oil fields."
The following statement must be added to the labels for aquatic non-
food industrial drilling muds and packer fluids:
     "For use on offshore oil  wells only."
For use in both terrestrial and  offshore oil drilling muds and packer
fluids, the following statement must be added:
     "This product may be used for terrestrial and offshore oil
     drilling muds and packer fluids."
Registrants must specify on labeling the complete directions for use
for each use pattern:  site of application, type of application, timing of

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                      application, equipment used for application, and the rate of
                      application (dosage).
                 •    To clarify that water cooling uses do not include once-through
                      systems, the following statement must be added:
                           "This product may not be used in once-through cooling
                           systems."
                      For a comprehensive list of labeling requirements, please see the
                 Bis(trichloromethyl) sulfone RED document.
 Regulatory
Conclusion
   For More
Information
     The use of currently registered products containing
bis(trichloromethyl) sulfone in accordance with approved labeling and as
described in the Reregi strati on Eligibility Document will not pose
unreasonable risks or adverse effects to humans or the environment.
Therefore, all uses of these products are eligible for reregi strati on.
     Bis(trichloromethyl) sulfone products will be reregistered once the
required product-specific data, confirmatory generic data, revised
Confidential Statements of Formula, and revised labeling are received and
accepted by EPA.

     EPA is requesting public comments on the Reregi strati on Eligibility
Decision (RED) document for bis(trichloromethyl) sulfone during a 60-day
time period, as announced in a Notice of Availability published in the
Federal Register. To obtain a copy of the RED  document or to submit
written comments, please contact the Pesticide Docket, Public Response
and Program Resources Branch, Field Operations Division (7506C), Office
of Pesticide Programs (OPP), US EPA, Washington, DC 20460, telephone
703-305-5805.
     Electronic copies of the RED and this fact sheet can be downloaded
from the Pesticide Special Review and Reregi strati on Information System
at 703-308-7224. They also are available on the Internet on EPA's gopher
server, GOPHEREPAGOV, or using ftp on FTP.EPAGOV, or using
WWW (World Wide Web) on WWW.EPAGOV.
     Printed copies of the RED and fact sheet can be obtained from EPA's
National  Center for Environmental Publications and Information
(EPA/NCEPI), PO Box 42419, Cincinnati, OH  45242-0419, telephone 513-
489-8190, fax 513-489-8695.
     Following the comment period, the [name] RED document also will
be available from the National Technical Information Service (NTIS),  5285
Port Royal Road, Springfield, VA 22161, telephone 703-487-4650.

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     For more information about EPA's pesticide reregi strati on program,
the bis(trichloromethyl) sulfone RED, or reregi strati on of individual
products containing bis(trichloromethyl) sulfone, please contact the Special
Review and Reregi strati on Division (7508W), OPP, US EPA, Washington,
DC 20460, telephone 703-308-8000.
     For information about the health effects of pesticides, or for assistance
in recognizing and managing pesticide poisoning symptoms, please contact
the National Pesticides Telecommunications Network (NPTN).  Call toll-
free 1-800-858-7378, between 9:30 am and 7:30 pm Eastern Standard Time,
Monday through Friday.

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