United States
Environmental Protection
Agency
Prevention, Pesticides
And Toxic Substances
(7508W)
EPA-738-F-96-008
January 1997
R.E.D. FACTS
Pesticide
Reregistration
p-Chloro-m-cresol
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 reregi strati on, 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 reregi strati on, EPA explains the basis
for its decision in a Reregi strati on Eligibility Decision (RED) document.
This fact sheet summarizes the information in the RED document for
reregi strati on case 3046, p-chloro-m-cresol.
Use Profile
Regulatory
History
p-Chloro-m-cresol is a microbicide used to control slime-forming
bacteria and fungi that might develop in industrial adhesives, industrial
coatings, emulsions, leather processing liquors, metal cutting fluids, paints
(in can), specialty industrial products, oil drilling muds/packer fluids, and
wet-end adhesives/industrial processing chemicals. Products are applied by
open pouring.
Use practice limitations prohibit discharging effluent containing p-
chloro-m-cresol to bodies of water without an NPDES license and/or into
treatment plants without first notifying the sewage treatment plant authority.
p-Chloro-m-cresol was first registered as a pesticide in the U.S. in
1968. Currently, three p-chloro-m-cresol products are registered including
two manufacturing-use products and one end-use product. Through the
Antimicrobial Data Call-In (DCI) of 1987 and the Reregi strati on Phase IV
DCI of 1991, EPA required additional data to complete p-chloro-m-cresol's
data base for reregi strati on. The U.S. Food and Drug Administration has
established tolerances or maximum residue levels for p-chloro-m-cresol in
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food grade adhesives and paper coatings which may contact foods. These
tolerances are specified in the 21 CFR.
Human Health
Assessment
Toxicity
In most acute and subchronic toxicology studies using laboratory
animals, p-chloro-m-cresol has been shown to be slightly toxic to
practically non-toxic. It is, however, very highly toxic (Toxicity Category
I) when applied to the skin or the eye. It is not a skin sensitizer, and
inhalation exposure is not expected since p-chloro-m-cresol is a chunky
solid and respirable particles are unlikely. In a developmental toxicology
study using rats decreases of body weight and food efficiency, increased
water intake, decreased urinary protein, and changes in organ weights were
noted at the highest dose level. In a chronic feeding study using rats
decreases in body weight and food efficiency, increased water intake,
decreased urinary protein, and changes in organ weights were noted at the
lowest dose. Carcinogenicity and mutagenicity studies were negative for
effects. The Agency thus classified p-chloro-m-cresol as a Group D
carcinogen, that is, a chemical with insufficient or no information to be
classified.
Dietary Exposure
There is no direct application of p-chloro-m-cresol to food; however,
indirect exposure may occur from its use in paper coatings and adhesives.
Tolerances are established by FDA for these indirect food additive
exposures.
Occupational and Residential Exposure
Based on current use patterns, handlers (mixers, loaders, and
applicators) may be exposed to p-chloro-m-cresol during and after use of
products containing this active ingredient. Occupational exposures may
occur to workers from open-pouring the solid end-use product.
Assessments for short- and intermediate-term and chronic exposures are
appropriate because of the toxicological endpoints from the developmental
toxicology and chronic feeding studies.
EPA's exposure assessment included dermal and inhalation
exposures for handlers applying product used in industrial preservatives and
metal-working/cutting fluids. The Agency also considered exposures to
other workers in industrial settings and people in residential settings who
handle products treated with p-chloro-m-cresol. The Agency believes that,
with the exception of workers using metal-working/cutting fluids and
paints, these secondary exposures are not greater than the handler exposures
described above.
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Exposures are likely to workers in industrial settings and to people in
residential settings where p-chloro-m-cresol-treated products have been
applied, for example, exposures from working in a recently-painted room.
These post-application exposures are expected to be of short duration and
result from products with diluted concentrations (0.02 to 5.0%) of p-chloro-
m-cresol. These exposures are expected to be less than those described for
the handler of the concentrated p-chloro-m-cresol end-use product.
For estimating short- and intermediate-term risks to workers, EPA
compared the no observed effect level from the developmental study to the
worker exposure estimates. The margins of exposures (MOEs) for short
and intermediate term exposures to workers, except painters, are not of
concern to the Agency. The calculated MOEs are well above 100, a level
the Agency generally considers adequate protection.
Chronic risk was estimated for the handler applying the end-use
product as a general preservative. This MOE was greater than 300 and
therefore is not of concern to the Agency.
Risks to commercial painters from short- and intermediate-term and
chronic exposures were of concern to the Agency. To minimize these risks,
the registrant has agreed to reduce the concentration of p-chloro-m-cresol in
finished paints to 0.05%.
The Agency has concerns for the metal-working/cutting fluid worker,
and has made this document available to OSHA for their use in regulating
these workers.
Human Risk Assessment
p-Chloro-m-cresol is very highly toxic to the skin and eyes (Toxicity
Category I), but otherwise is of low acute toxicity. No dietary exposure is
expected as a result of its pesticide uses. Food additive uses, in paper
coatings and adhesives, are regulated by FDA.
To minimize risks to commercial painters, the registrant has agreed to
reduce the concentration of p-chloro-m-cresol in finished paints to 0.05%.
Personal protective equipment (PPE), including chemical-resistant gloves
and protective eyewear, is required for occupational users.
Environmental Ecological Effects
AsSGSSrnGnt p-Chloro-m-cresol is slightly toxic to avian species in both acute oral
and subacute dietary toxicity studies. It is highly toxic to freshwater fish
and moderately toxic to freshwater invertebrates in acute studies.
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Environmental Fate
The currently registered uses of p-chloro-m-cresol are not likely to
result in significant environmental exposures. Therefore, the Agency
required only limited data to describe dissipation in the environment.
Risk Mitigation
Ecological Effects Risk Assessment
Current uses of p-chloro-m-cresol are expected to result in minimal
exposure or risk to the environment, and effluent from these uses is
regulated under the NPDES program. Therefore, no environmental risk
mitigation measures are imposed at this time.
EPA is requiring the following risk mitigation measure to lessen the
risks posed by p-chloro-m-cresol:
• Reduction of maximum application concentration of p-chloro-m-
cresol in paints to 0.05%.
• Personal protective equipment (PPE) for handlers as described below.
Additional Data All p-chloro-m-cresol end-use products must comply with EPA's
Required current pesticide product labeling requirements and with product-specific
data requirements including product chemistry and acute toxicity studies,
and revised Confidential Statements of Formula for product reregi strati on.
Product Labeling
Changes
Required
The Agency is requiring revised labeling for reregi strati on of end-use
products:
• 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.
• The maximum application concentration of p-chloro-m-cresol in
paints must be revised to 0.05%.
• The following statement is required to appear in the Environmental
Hazards section of the label, in accordance with 40 CFR 156.10:
"This pesticide is highly toxic to fish."
• To clarify the intent of the oil recovery drilling mud/packer fluid use
(as an aquatic or terrestrial site), the following statement must be
added to the labels for terrestrial oil drilling muds and packer fluids:
"For use in (terrestrial or aquatic) wells only."
PPE Requirements for Pesticide Handlers
For sole active-ingredient end-use products that contain p-chloro-m-
cresol, the product labeling must be revised to adopt the handler personal
protective equipment requirements set forth in this section. Any conflicting
PPE requirements on the current labeling must be removed.
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For multiple active-ingredient end-use products that contain p-chloro-
m-cresol, the handler PPE requirements set forth in this section must be
compared to the requirements on the current labeling and the more
protective must be retained. For guidance see PR Notice 93-7. Although
this PR Notice addresses products within the scope of the Worker
Protection Standard (WPS), that is products that are generally for
agricultural use, certain parts of the guidance in this PR Notice are
applicable to all pesticide products.
The Agency is establishing the following active ingredient-based
minimum (baseline) PPE requirements for p-chloro-m-cresol end-use
products that are intended primarily for occupational use:
Applicators and other handlers must wear:
• long-sleeved shirt, long pants,
• socks and shoes, and
• chemical-resistant gloves
Any necessary PPE for each p-chloro-m-cresol occupational end-use
product will be established on the basis of the end-use product's acute
toxicity category. 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, and the
more protective PPE must be placed on the product labeling.
• The Agency is requiring the following labeling statements to be
located on all end-use products containing p-chloro-m-cresol:
"Do not apply this product in a way that will contact workers or
other persons."
"Follow manufacturer's instructions for cleaning/maintaining
personal protection equipment (PPE). If no such instructions
exist for washables, use detergent and hot water. Keep and
wash PPE separately from other laundry."
The use of currently registered products containing p-chloro-m-cresol,
Conclusion used m accordance with required labeling, 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.
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p-Chloro-m-cresol 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 EPA is requesting public comments on the Reregi strati on Eligibility
Information Decision (RED) document for p-chloro-m-cresol 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, GOPHER.EPA.GOV, or using ftp on FTP.EPA.GOV, or using
WWW (World Wide Web) on WWW.EPA.GOV.
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 p-chloro-m-cresol 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 reregi strati on program,
the p-chloro-m-cresol RED, or reregi strati on of individual products
containing p-chloro-m-cresol, 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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