United States
Environmental Protection
Agency _^
Prevention, Pesticides
And Toxic Substances
(7508WJ
EPA-738-F-95-030'
January 1996
R.E.D. FACTS
Nabam
Pesticide
Reregistration
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?19fea,4Y^^S^itlmtif^ knowledge, the law requires that'
pesticides^whiclirw3|re!g.r§t£r1fgis|e^d 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 decisipn in a Reregistration Eligibility Decision (RED) document.
This fact sheet summarizes the information in the RED document for
reregistration case 0641, Nabam.
Nabam is a fungicide/bactericide/algicide used in aquatic 'nonfood
industrial, indoor nonfood, terrestrial nonfood and indoor food use sites.
Nabam is currently registered for the control of algae, slime-forming
bacteria and slime-forming fungi in the following: air washer water
systems, commercial/industrial water cooling systems (includes shipboard
. seawater cooling systems), evaporative condenser water systems, oil
recovery drilling muds/packer fluids, pulp/paper mill water systems,
secondary oil recovery injection water, fuels/oil storage tank bottom water
additive, pasteurizer/warmer/cannery cooling water systems, specialty
industrial products (flue gas desulfurization thickeners), and food
processing water systems (cane and beet sugar mill processing water -
regulated by the Food and Drug Administration (FDA)).
Reg U latQry Nabam .was first registered in the United States in 1948 as a broad
History spectrum fungicide used to prevent crop damage by fungi, to protect
harvested products from deterioration, and as an industrial microbiocide..
Nabam and the other LKBC pesticides, mancozeb, maneb and metiram
have been the subject of twa Special Reviews based on the presumption
Use Profile
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that the EBDCs and their common metabolite, ETU, posed potential risks to
. human health and/or the environment in the following areas:
. carcinogenicity, developmental toxicity, and acute toxicity to aquatic
organisms. Three additional areas of concern identified were thyroid
toxicity, mutagenicity, and skin sensitization.
EPA initiated the first Special Review in 1977 and concluded it in
1982, issuing a Final Position Document (PD 4) that required risk reduction
measures to prevent unreasonable adverse effects pending development of
additional data needed to better assess the risks. An additional label
, statement was required to warn users of hazards to fish, and additional
, protective clothing was required to mitigate potential risks of
developmental and thyroid effects to applicators. Additional exposure data
, . • ' were required to address mutagenic effects,, but it was determined that the
• .- skin sensitization effect did aot ultimately "meet the. criteria for a Special
• ..' . ., - " . • -~* ^^mp^^prr. yt_ .'.J.)*w> -tieowtner "•••-'->v^->« !•.'Xr^r^3^*^S-3^^*s^iA^^;^^^"^*'K!fi*?a?s.!jt' «f«i*sgTrf jffj.i.'or f-Ar Rt^^taor?
. a Group B2 carctnogerrsfiortry afterthe cfassincatrxifi system was ^>lhM
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Dietary Exposure
Dietary exposure to residues of nabam from EPA-regulate'd uses is
not expected. -...--'" ,
Occupational and Residential Exposure
The toxicological endpoint of concern for occupational and residential
exposure to nabam is systemic tbxicity based on a rabbit developmental
study and from exposure to ETU. The calculated Margins of Exposure
(MOE = NOEL/exposure) for nabam are acceptable (greater than 100) for
all uses except two. Exposures to handlers using open pour liquid
, _ formulations in cooling water systems (e.g. towers) and open pour solid
formulations to drilling muds & packing fluids and secondary & tertiary oil
recovery water systems are unacceptable (less than 100) without the
additionarrisk mitigation requirements imposed in the nabam RED.
Human Risk Assessment.
' Human risk from dietary exposure was not assessed because nabam
has no registered'food uses under EPA purview.
Risks to handlers (mixers/loaders/applicators) of nabam and its
contaminant ETU are acceptable except for open-pour liquid applications in
- . . - ' water cooling systems and open-pour solid applications to drilling muds
and packer fluids. To minimize the risks to handlers from these scenarios,
. • - EPA is requiring liquid formulations in water cooling systems (e.g. towers)
to be applied by mechanical loading delivery systems (such as metering
pump, gravity fed, manual pump, pressurized, probe, etc.) and is
prohibiting open-pour applications. The Agency is also requiring that dry
formulations of nabam be placed in water-soluble packaging. Additipnally,
since all the exposure studies were conducted with handlers wearing
chemical-resistant gloves and there were not sufficient data to predict the
probable exposure without chemicalrresistant gloves, EPA is requiring use
of baseline PPE (chemical-resistant gloves) for all nabam end-use product
labeling.
Environmental Environmental Fate
Assessment The Agency requires only a limited set of ecotoxicology and
environmental fate studies for microbiocides. While the hazard to aquatic
organisms from nabam has been characterized, a quantitative risk
assessment has not been conducted. Risks to aquatic organisms resulting
from the discharge of effluent containing nabam are regulated under the
NPDES permitting program of the Agency's Office of Water. Labels for all.
, nabam pesticide products must require that discharges to aquatic
, environments comply with an NPDES permit . '
Ecological Effects
. Existing studies show that nabam was found to be practically
nontoxic to birds on an acute oral and subacute dietary basis.and practically
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Risk Mitigation
Additional Data
Required
Product Labeling
Changes Required
nontpxic to bees. Available data indicate that nabam is slightly to
moderately toxic to both cold and warm water fish and. moderately toxic to
freshwater invertebrates. Additionally, nabam ranged from being highly
toxic to practically nontoxic to estuarine/marine organisms. Ecological
effects testing of ETU previously had been required; however, because of
the current limited uses of nabam,.these tests are not required at this time.
Ecological Effects Risk Assessment
The Agency does not anticipate any exposure of concern to fish and
wildlife, providing that all nabam products require that discharges to the
environment comply with, all disposal laws or a NPDES permit.
Xo lessen the risks of nabam to handlers, EPA is requiring the
following risk mitigation measures. - • ,
o All liquMfdrMmf&WMn^^
applied by mechaiiieafiMidM^ M&v®fyz®y$i®ffi$! (such?asj-sretering'pump,
gravity fedi, manual pump, pressurized, probe, etc.).
o Open-pour applications are prohibited.
o Dry formulations of nabam must be marketed in water-soluble packaging.
o Use of baseline PPE (chemical-resistant gloves) is required for all nabam
end-use products.
EPA is not requiring any additional generic studies for nabam
however, several previously required studies still have data deficiencies.
These studies are upgradable with the submission of acceptable data. See
Appendix B of the Nabam RED for specific data deficiencies.
. For the reregistration of nabam products, the Agency is requiring
product-specific data including product chemistry and acute toxicity
studies, revised Confidential Statements of Formula (CSFs), and revised
labeling. : "
All nabam end-use products must comply with EPA's current
pesticide product labeling requirements,^ arid with the following labeling
requirements. For the complete text of labeling changes required, please
see the nabam RED document.
Minimum (Baseline) PPE/Engineering Control Requirements
The minimum (baseline) PPE for all occupational uses of nabam end-use
products is:
Minimum PPE:
"Applicators and other handlers must wear:
—long-sleeve shirt and long pants
--chemical-resistant gloves*, '
..;••,:,;'*;''t§og|cs plus-shoes . ' .•••'.-..'••.'
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*For the glove statement, use the statement established for nabam
through the instructions in Supplement Three of PR Notice 93-7.
Engineering Control Requirements
For liquid formulations; ,' • '
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 transferred only using a
metering-pump system or a closed loading/application system
, for the following uses: (list each of the following uses for
which the end-use product is labeled: air washer water systems;
-commercial/industrial water cooling systems (includes
shipboard seawater cooling systems); evaporative condenser
. water systems; pasteurizer/warm er/cannery cooling water-
, ., -;i.m,p.ia;.nJt/ e.i^xi'.<.,"i-,j,-l!ut aiu-aiikeiV autci ia«-t;r.tsria Sir a^jed-ii '
systems; and jleat,exchanger wateisyaterns.}. Open pouring is
oroiiibjited " •- t——^-f- fti^sti^i^ii.*^^-.^ i.'f.^-.^--^^^.^--. ••• .. ...
• — .f*~-*f>v?AVr?T0-pn ?nort!v it^r^Tf" r'-J5«nri<^irion cn'-f^-m ---^f • •
For dry formulations:
All nabam end-use products formulated as a dry formulation
must be placed in water-soluble packaging.
Other Labeling Requirements
Registrants must specify on labeling the complete directions for use for
each use pattern: site of application, type of application, timing of
application, equipment used for application, and the rate of application
(dosage).
"- i . - .. " - '
Products Intended Primarily for Occupational Use
The Agency is requiring that the following statements be located on labels
of all end-use products containing nabam that are. intended primarily for
occupational use.
Application Restrictions
"Do not apply this product in a way that will contact workers or other
persons." ,
User Safety Requirements .
1. Registrant: place the following statement on the end-use product
label if coveralls are required for pesticide handlers:
"Discard clothing or other absorbent materials that have been
drenched or heavily contaminated with this product's concentrate. Do
not reuse them."
2. Registrant: place the following statement on the end-use product
label:
"Follow manufacturer's instructions fqrcleaning/maintaining
PPE. If no such instructions exist for washables, use detergent
and hot water. Keep and wash PPE separately from other
'"
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Regulatory
Conclusion
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 arid change into clean clothing."
Skin Sensitizer Statement .
"This product may cause skin sensitization reactions in some people."
Clarification of Oil Drilling Mud Use
The following statement must be added to the labels for terrestrial non-food-
oil/gairftiSfe fluids:
"For uselntt^i*e"stfi-atWel$^oril^.'te «as not assessed oecd.uac nauam
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 oil/gas drilling muds and packer fluids:
"For use in offshore wells only."
For use in both terrestrial arid offshore oil/gas drilling muds and packer
fluids, the following statement must be added:
"This product niay be used for terrestrial and offshore oil/gas drilling
muds and packer fluids."
The use of currently registered products containing nabam in
accordance with approved labeling will not pose unreasonable risks or
adverse effects to humanjs or the environment. Therefore, all uses of these
products are eligible for reregistration.
Nabam products will be reregistered once the required product-
specific data, revised Confidential Statements of Formula, and revised
labeling are received and accepted by EPA.
For More
Information
EPA is requesting public comments on the Reregistration Eligibility-
Decision (RED) document for nabam 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 Rerigistratiott Information System
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at 703.-308-7224. They also are available on the Internet on EPA's gopher
server, GOPHER.EPA.GbV, or using ftp on FTP.EPA.GOV, or using
WWW (World Wide Web) on WWW.EPA. GO V.
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 nabam RED document also will
be available from the National Technical Information Service (NTIS), 5285
Port Royal Road, Springfield, VA 22161, telephone 703-487-4650.
For more information about EPA's pesticide reregistration program,
the nabam RED, or reregistration of individual products containing nabam,
please contact the Special Review and Reregistration Division (7508W),
OPP, US' BPAirMasM-agtOFr?fiC"2046Qr teteptorielOS-SiQS-^SOeOs' --
-- For-lriftjrMMHW WSS£tfte%^«f!^^^
in recognizing and managing pesticide poisoning symptoms, please contact
the National Pesticides Telecommunications Network (NPTN). Call toll-
free i-800-858-7378, between 9:30 am and 7:30 pm Eastern Standard
Time, Monday through Friday. •
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