United States
Environmental Protection
Agency
Prevention, Pesticides
And Toxic Substances
(7508W)
EPA-738-F-95-010
January 1995
R.E.D. FACTS
Pesticide
Reregistration
Use Profile
Bromohydroxy-
acetophenone (BHAP)
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 years ago 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 imposes
any regulatory controls that are needed to effectively manage 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 announces this and
explains why in a Reregistration Eligibility Decision (RED) document. This
fact sheet summarizes the information in the RED document for
reregistration case 3032, bromohydroxyacetophenone or BHAP.
Bromohydroxyacetophenone, also known as BHAP, is a microbicide
or microbistat used to inhibit the growth of bacteria and fungi that cause the
microbiological degradation of papermaking chemicals. Two of the three
registered pesticide products containing this active ingredient are also used
to inhibit the growth of bacteria that cause loss of viscosity in emulsions,
paints, adhesives, waxes and polishes. BHAP products, which are marketed
under the trade name Busan, are formulated as a soluble concentrate/liquid.
Treatments are made using a variety of types of equipment including drip-
feed devices, measuring containers and metering pumps.
Use practice limitations include an equipment precleaning
requirement; a warning not to expose the product to extreme temperatures;
and a prohibition against discharging effluent into sewage systems without
notifying the sewage treatment plant authority, or into public waters except
under an NPDES permit.
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Regulatory BHAP was first registered as a pesticide in the U.S. in 1964 for use as
History a micr°bicide/microbiostat. Currently, three Busan products are registered
for various industrial water treatment uses.
Human Health
Assessment
Toxicity
BHAP generally is of moderate acute toxicity but is corrosive to the
eyes and has been placed in Toxicity Category I (the highest of four levels)
indicating the greatest degree of primary eye irritation effects. BHAP is
moderately toxic by the oral and inhalation routes (Toxicity Category II). It
is slightly toxic by the dermal route and is a mild irritant to the skin
(Toxicity Category III). BHAP also is a skin sensitizer.
A subacute dermal toxicity study using rabbits resulted in no systemic
toxicity, but BHAP induced dermal irritation at all dose levels. Since use of
BHAP will not result in human exposure over a significant portion of a
human life span, chronic toxicity, carcinogenicity and reproduction studies
were not required. BHAP does not cause developmental toxicity or
mutagenic effects.
Dietary Exposure
A food additive tolerance, or maximum residue limit, has been
established for BHAP residues remaining in food contact paper and
paperboard. However, this tolerance is under FDA's regulatory purview.
Occupational and Residential Exposure
Based on current use patterns, workers may be exposed to BHAP
during and immediately after water treatment in pulp and paper
manufacturing, paint manufacturing and industrial solution preparation.
However, the toxicological endpoints of concern for workers (eye irritation
and inhalation toxicity) can be mitigated through use of personal protective
equipment (PPE). The PPE recommended for handlers using BHAP in
industrial/manufacturing settings is: goggles or faceshield to prevent eye
contact, chemical resistant gloves, and a NIOSH/MSHA approved organic
vapor removing cartridge respirator with prefilter (TC-23). Since BHAP
has low vapor pressure, inhalation by workers immediately after BHAP use
is likely to be negligible.
People also could be exposed to BHAP when using substances that
contain BHAP residues such as paints, waxes, polishes and adhesives.
However, the amount of BHAP in these substances is minimal, so both
exposure and risk are expected to be negligible.
Human Risk Assessment
BHAP is corrosive to the eyes (Toxicity Category I for primary eye
irritation effects) and is moderately toxic by the oral and inhalation routes
(Toxicity Category II). It has no significant food uses; a single food
additive tolerance for residues in food contact paper and paperboard is
regulated by FDA. Although workers may be exposed to BHAP during and
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Environmental
Assessment
immediately after water treatment, risks of severe eye irritation and
inhalation exposure can be mitigated through use of the recommended PPE.
Exposure and risk to the public from using paints, waxes, polishes and
adhesives containing BHAP residues are believed to be negligible.
EPA has sufficient data at this time to conduct only a qualitative
environmental fate assessment of BHAP. Additional data requirements for
the pulp and papermill use still must be satisfied.
Environmental Fate
BHAP appears to be nonpersistent, and photolysis plays a major role
in its degradation pathway. BHAP photodegrades in water with a half-life
of less than two days. It appears to be immobile to moderately mobile in
clay and loam soils, but very mobile in sandy soils.
BHAP's indoor, nonfood use pattern involves no direct exposure to
the environment. However, its industrial uses result in indirect
environmental exposures from discharges to water. These discharges are
regulated by EPA's Office of Water and the states through the National
Pollutant Discharge Elimination System (NPDES) permit program.
Ecological Effects
BHAP is moderately toxic to birds on an acute oral basis, but is no
more than slightly toxic to birds on a subacute dietary basis. BHAP is
moderately to highly toxic to freshwater fish, and is moderately toxic to
freshwater invertebrates.
Ecological Effects Risk Assessment
BHAP's acute ecological risk is based on the residue levels in natural
water receiving effluent from facilities using the pesticide. If residues
should exceed one-half of the established EC50 levels for aquatic
invertebrates or freshwater fish, these organisms would be acutely at risk.
By their nature, industrial biocides are often toxic to aquatic
organisms. While the use of BHAP as a pesticide is regulated by EPA's
Office of Pesticide Programs (OPP) under the federal pesticide law, FIFRA,
the discharge of effluent containing DCDIC to surface waters is regulated
under the NPDES permit program administered by EPA's Office of Water
(OW) with the states. The NPDES process takes local conditions into
account in issuing permits for the discharge of pollutants to bodies of water.
EPA's OPP and OW will share information and cooperate in overseeing the
use of biocides such as BHAP.
Additional Data
Required
EPA is requiring several additional generic environmental fate studies
for BHAP to confirm its regulatory assessments and conclusions. The
Agency also is requiring product-specific data including product chemistry
and acute toxicity studies, revised Confidential Statements of Formula
(CSFs) and revised labeling for reregistration.
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Product Labeling
Changes Required
Regulatory
Conclusion
All BHAP end-use products must comply with EPA's current pesticide
product labeling requirements, and with the following:
Labeling Requirements - For end-use products intended primarily for
occupational use:
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."
Sensitization Statement: Required in the "Hazards to Humans (and
Domestic Animals)" section of Precautionary Statements on the
labeling of all end-use products, because BHAP is a skin sensitizer:
"This product may cause skin sensitization reactions in some people."
Effluent Discharge Labeling Statements - All BHAP products that may
be contained in an effluent discharged to the waters of the U.S. or municipal
sewer systems must bear the following statement:
"This pesticide is toxic to fish. Do not use in facilities discharging
directly or indirectly to the estuarine or marine environment. Do not
discharge effluent containing this product into freshwater lakes,
streams and ponds unless in accordance with the requirements of a
National Pollutant Discharge Elimination System (NPDES) permit,
and the permitting authority has been notified in writing prior to
discharge. Secondary biological treatment of BHAP effluent
discharging to freshwater environments is required for all uses except
for use in secondary oil recovery systems discharging to freshwater
environments. Do not discharge effluent containing this product to
sewer systems without previously notifying the local sewage treatment
plant authority. For guidance contact your State Water Board or
Regional Office of the EPA."
The use of currently registered products containing BHAP in
accordance with approved labeling will not pose unreasonable risks or
adverse effects to humans or the environment. Therefore, all uses of these
products are eligible for reregistration.
Discharge of effluent containing BHAP from industrial facilities using
this pesticide generally will not cause unreasonable adverse effects on the
environment. EPA's OPP and OW will share information to improve the
regulation of BHAP's use at specific sites across the country.
Products containing BHAP will be reregistered once the required
product-specific data, revised Confidential Statements of Formula and
revised labeling are received and accepted by EPA.
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For MorG EPA is requesting public comments on the Reregistration Eligibility
Information Decision (RED) document for BHAP 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 Reregistration 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 BHAP 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 BHAP RED, or reregistration of individual products containing BHAP,
please contact the Special Review and Reregistration 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 8:00 am and 6:00 pm Central Time, Monday
through Friday.
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