UNITED STATES ENVIRONMENTAL PROTECTION AGENCY
WASHINGTON, D.C. 20460
OFFICE OF
PREVENTION, PESTICIDES
AND TOXIC SUBSTANCES
Propylene Oxide (PPO) RED Addendum
June 2009
Richard Keigwin, Jr.
Director
Special Review and Reregistration Division
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CORRECTION TO NOVEMBER 14,2008 Propylene Oxide (PPO) RED
ADDENDUM
The Environmental Protection Agency (EPA or the Agency) is publishing a correction to
the November 14,2008 Propylene Oxide (PPO) RED Addendum. The initial PPO RED
Addendum was issued on September 25, 2008 because of an error in the PERFUM model
in the July 2006 RED. The PPO RED Addendum was revised on November 14, 2008 to
insert a missing word. These documents are posted on www.regulations.gQy, documents
EPA-HQ-OPP-2005-0253-0070 and EPA-HQ-OPP-2005-0253-0075 respectively.
Since the November 14, 2008 version, the registrant indicated that the following
language, "During the aeration period there must be a minimum of 20 air changes per
hour," is not feasible for vacuum fumigations equipped with emission control technology
because of the efficacy of the pumps and the time needed to bring the chamber to vacuum
in an hour. The registrant also asked the Agency to consider an additional mitigation
scenario (higher stack and fewer air changes) for fumigators without emission control
technology.
For vacuum chambers with emission control technology that reduces PPO emissions by
at least 95%, the Agency has determined that 20 air changes an hour is not necessary to
make a safety finding because standard ventilation procedures are adequate. The label
language will be revised as appropriate.
For vacuum chambers without emission control technology, the registrant submitted
PERFUM modeling runs (MRID 47692001) with higher stack heights and fewer air
changes per hour. The Agency has reviewed these runs and determined that this scenario
still allows the Agency to make a safety finding and additional language will be added to
the label. For a detailed review please see the following document in the PPO docket
EPA-HQ-OPP-2005-0253, "Propylene Oxide: Review of Submitted PERFUM Results
(RED Case 2560)," (Crowley, 2009).
As a result of this review, the Agency is revising the PPO RED where appropriate. These
revisions are listed below and the corresponding amended label language is included in
Table 1.
For Fumigation in Vacuum-Sealed Pressurized Chambers
• For all applications of PPO > 75 Ibs ai/1,000 ft3 (1.2 oz/ft3) and < 150 Ibs
ai/1,000 ft3 (2.4 oz/ft3), the chamber must be equipped with equipment
specifically designed to reduce PPO emissions by at least 95 percent.
• For chambers < 5,000 ft3 with PPO application rates of 75 Ibs ai/1,000 ft3 (1.2
oz/ft3) and below:
o a chamber must have a release height of at least 27 feet and during the
aeration period there must be a minimum flow rate through the stack
equivalent to at least 20 air changes per hour, OR
o a chamber must have a release height of at least 40 ft and a minimum flow
through the stack equivalent to at least 4 air changes per hour, OR
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o the chamber must be equipped with equipment specifically designed to
reduce PPO emissions by at least 95 percent.
• For chambers > 5,000 ft3 and < 10,000 ft3 with application rates of PPO 75 Ibs
ai/1,000 ft3 (1.2 oz/ft3) and below:
o a chamber must have a release height of at least 40 feet and during the
aeration period there must be a minimum flow rate through the stack
equivalent to at least 20 air changes per hour, OR
o the chamber must be equipped with equipment specifically designed to
reduce PPO emissions by at least 95 percent.
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Table 1. Revised summary of required labeling changes for PPO products
Manufacturing-Use Products
Description
Amended Labeling Language
Placement on Label
For all
Manufacturing-Use
Products
"Propylene oxide only can be formulated into end-use products containing
directions for use that include acceptable air concentration levels of 2 ppm
as an 8-hour time weighted average and other measures for ensuring that
workers and other persons are not exposed to concentrations of propylene
oxide that exceed this level unless appropriate respiratory protection is
used."
"Propylene oxide cannot be formulated into end-use products labeled for
use on edible gums or birdseed. End-use product labels must be revised to
delete all references to and use directions for edible gums or birdseed."
"Propylene oxide only can be formulated into end-use products that are
classified as and identified as Restricted Use."
Directions for Use
One of these
statements may be
added to a label to
allow reformulation
of the product for a
specific use or use-
pattern or all
additional uses
supported by a
formulator or user
group
"This product may be used to formulate products for specific use(s) not
listed on the MP label if the formulator, user group, or grower has complied
with U.S. EPA submission requirements regarding support of such use(s)."
"This product may be used to formulate products for any additional use(s)
not listed on the MP label if the formulator, user group, or grower has
complied with U.S. EPA submission requirements regarding support of
such use(s)."
Directions for Use
Environmental
Hazards Statements
Required by the
RED and Agency
Label Policies
"ENVIRONMENTAL HAZARDS
This pesticide is toxic to birds and mammals. Do not discharge effluent
containing this product into lakes, streams, ponds, estuaries, oceans, or
other waters unless in accordance with the requirements of a National
Pollution Discharge Elimination System (NPDES) permit and the
permitting authority has been notified in writing prior to discharge. 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."
Precautionary
Statements
End-Use Products Intended for Occupational Use
Description
Amended Labeling Language
Placement on Label
Restricted Use
Pesticide
"RESTRICTED USE PESTICIDE DUE TO INHALATION TOXICITY
For retail sale to and use only by Certified Applicators or persons under
their direct supervision and only for those uses covered by the Certified
Applicator's certification."
Top of Front Panel
Identify as a
fumigant all
propylene oxide end-
Prominently identify the end-use product as a "Fumigant"
Insert the word
"fumigant" as part of
the product name or
close to the product
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use products
name, either as part
of the product-type
identification or as a
separate word or
sentence
Add precautionary
language in Spanish
on propylene oxide
end-use products
Add the following Spanish signal word and statement:
"PELIGRO
Si Usted no entiende la etiqueta, busque a alquien para que se la explique a
Usted en detalle. (If you do not understand the label, find someone to
explain it to you in detail.)"
On front panel of the
label near the signal
word DANGER.
Add acceptable air
concentration
language to
propylene oxide end-
use products
"AIR CONCENTRATION LEVEL
The acceptable air concentration level for persons exposed to propylene
oxide is 2 ppm (8 mg/m3) as a time-weighted average."
In the Hazards to
Humans and
Domestic Animals
section of the
labeling immediately
following the
precautionary
statements.
PPE Requirements
Established by the
RED for propylene
oxide end-use
products*
"PERSONAL PROTECTIVE EQUIPMENT
Some materials that are chemical-resistant to this product are (registrant
inserts correct chemical-resistant material). If you want more options,
follow the instructions for category [registrant inserts
A,B,C,D,E,F,G,or H] on an EPA chemical-resistance category selection
chart.
All handlers opening propylene oxide drums or tanks, cleaning up leaks or
spills, or who otherwise may potentially contact liquid propylene oxide,
must wear:
> long-sleeved shirt and long pants,
> chemical-resistant gloves,
> chemical-resistant footwear plus socks,
> chemical-resistant apron.
> face-sealing goggles, and
> full-face shield, unless a respirator that covers the entire face is
worn.
Respirator Requirements: Once propylene oxide has been introduced
into an enclosure, the certified applicator supervising the fumigation must
make sure that all persons in the exposure area (the treatment area and the
buffer zone, if applicable) have appropriate respiratory protection or are
removed from the exposure area.
Air Concentrations 10 PPM or Greater from a Direct-read Device or
Air Concentrations Greater than 2 ppm as an 8-Hour Time Weighted
Average:
If propylene oxide air concentration level is measured to be 10 ppm or
greater at anytime when measured using a direct read device or if
propylene air concentration exceeds 2 ppm as an 8-hour time weighted
average, each person in the exposure area must wear either;
• a supplied-air respirator (MSHA/NIOSH approval number TC-
19C), or
• a self-contained breathing apparatus (SCBA) (MSHA/NIOSH
Immediately
following/below
Precautionary
Statements: Hazards
to Humans and
Domestic Animals
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approval number prefix TC-13F).
• any NIOSH-approved air purifying respirator (APR) outfitted with
an organic vapor canister/cartridge and an end-of-service-life
indicator (ESLI) certified by NIOSH for the contaminant (APR is
not approved for IDLH situations); or
• any NIOSH-approved air purifying respirator (APR) outfitted with
an organic vapor canister/cartridge for which, if there is no ESLI
certified by NIOSH for the contaminant, the employer implements
a change schedule for canisters and cartridges that is based on
documented objective information or data that will ensure that
canisters and cartridges are changed before the end of their service
life (APR is not approved for IDLH situations).
Air Concentrations lower than 10 ppm from a Direct-read Device, and
Air Concentrations at or below 2 PPM as an 8-hour Time Weighted
Average: No respirator is required if the air concentration level of
propylene oxide in the exposure area is measured to be lower than 10 ppm
using a direct-read device a«fi?the air concentration is at or below 2 ppm as
an 8-hour time weighted average."
User Safety
Requirements for all
propylene oxide end-
use products
"WORK SAFETY REQUIREMENTS
Respirator Requirements: When a respirator is required for use with this
product, the certified applicator supervising the fumigation must make sure
that:
a) Respirators must be fit tested and fit checked using a program that
conforms with OSHA's requirements (described in 29 CFR Part 1910.134);
b) Respirator users must be trained using a program that conforms with
OSHA's requirements (described in 29 CFR Part 1910.134);
c) Respirator users must be examined by a qualified medical practitioner to
ensure the physical ability to safely wear the style of respirator to be worn;
d) Respirators must be maintained according to a program that conforms
with OSHA's requirements (described in 29 CFR Part 1910.134).
~ If liquid fumigant splashes or spills on clothing, remove them at once,
and place them outdoors in an isolated place to aerate, because fumes will
be an intolerable source of irritation.
— Immediately after application remove personal protective equipment. Do
not reuse the personal protective equipment until cleaned. Keep and wash
the work clothing and personal protective equipment separately from other
laundry.
~ Discard clothing and other absorbent materials that have been drenched
or heavily contaminated with this product. Do not reuse them.
~ Follow manufacturer's instructions for cleaning/maintaining personal
protective equipment."
Precautionary
Statements: Hazards
to Humans and
Domestic Animals
immediately
following Personal
Protective Equipment
Requirements
User Safety
Recommendations
"User Safety Recommendations
Users should wash hands before eating, drinking, chewing gum, using
tobacco, or using the toilet.
Precautionary
Statements under:
Hazards to Humans
and Domestic
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Users should remove clothing/PPE 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 and change into clean clothing."
Animals immediately
following User
Safety Requirements
(Must be placed in a
box.)
Application
Restrictions
"The maximum size enclosure that is allowed to be fumigated is 10,000
ft3."
In the Directions for
Use section.
Restrictions for
Vacuum-Sealed
Pressurized
Chambers
"Fumigation in Vacuum-Sealed Pressurized Chambers
For all applications of PPO > 75 Ibs ai/1,000 ft3 (1.2 oz/ft3) and < 150 Ibs
ai/1,000 ft3 (2.4 oz/ft3), the chamber must be equipped with equipment
specifically designed to reduce PPO emissions by at least 95 percent.
For chambers < 5,000 ft3 with PPO application rates of 75 Ibs ai/1,000 ft3
(1.2oz/ft3)andbelow:
• a chamber must have a release height of at least 27 feet and
during the aeration period there must be a minimum flow rate
through the stack equivalent to at least 20 air changes per
hour, OR
• a chamber must have a release height of at least 40 ft and a
minimum flow through the stack equivalent to at least 4 air
changes per hour, OR
• the chamber must be equipped with equipment specifically
designed to reduce PPO emissions by at least 95 percent.
For chambers > 5,000 ft3 and < 10,000 ft3 with application rates of PPO 75
Ibs ai/1,000 ft3 (1.2 oz/ft3) and below:
• a chamber must have a release height of at least 40 feet and
during the aeration period there must be a minimum flow rate
through the stack equivalent to at least 20 air changes per
hour, OR
• the chamber must be equipped with equipment specifically
designed to reduce PPO emissions by at least 95 percent."
In the Directions for
Use under
"Fumigation in
Vacuum-Sealed
Pressurized
Chambers"
Restrictions for
Fumigation Not
Contained within a
Vacuum-Sealed
Pressurized Chamber
"Fumigation in a Non Vacuum-Sealed Pressurized Chamber
(atmospheric chambers or structures, railcars, trailers, air/sea
transport containers, tents, and tarps)
For any fumigation that takes place in a non vacuum-sealed pressurized
chamber the appropriate buffer zone (see below) must be established
around the treated enclosure from the time propylene oxide is introduced
into the enclosure and must remain in effect until the ah- concentration of
propylene oxide being exhausted from the treated enclosure is measured to
be lOppmor less.
• For chambers that are passively aerated the buffer zones in Table
1 are required during treatment and aeration.
Table 1.
In the Directions for
Use under the
heading: Fumigation
Not Contained
Within a Vacuum-
Sealed Pressurized
Chamber"
immediately
following
"Fumigation in
Vacuum-Sealed
Pressurized
Chambers"
Enclosure Size
< 1,000 ft3
Buffer Zone
10 feet
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> 1 ,000 ft3 and < 2,000
ft3
> 2,000 ft3 and < 5,000
ft3
> 5,000 ft' up to 10,000
ft3
50 feet
115 feet
200 feet
• During aeration if the chamber is actively aerated with 20 air
changes per hour with a 10 foot permanent or portable stack above
the product, chamber, or structure, the required buffer zone that
must be established around the treated chamber is 10 feet.
Fumigation taking place in a non vacuum-sealed pressurized chamber is
limited to a maximum concentration of 0.0448 ounces of propylene oxide
per cubic foot of fumigation enclosure.
Buffer Zone Entry Restrictions
Entry by the certified applicator supervising the fumigation, or persons
under his/her direct supervision, is permitted in the buffer zone, provided
either:
— the appropriate respirator is worn (see PPE requirements elsewhere in
this labeling); OR
-- the air concentration level for propylene oxide is at or below 2 ppm for
an 8-hour time weighted average.
The certified applicator supervising the fumigation must ensure that any
person, except the certified applicator or persons under his/her direct
supervision, is kept outside the buffer zone surrounding the treated
enclosure from the time propylene oxide is introduced into the enclosure
until the air concentration of propylene oxide being exhausted from the
treated enclosure is measured to be 10 ppm or less."
Onsite Notification
for all propylene
oxide end-use
products
"PLACARDING OF FUMIGATED ENCLOSURES
The certified applicator supervising the fumigation (or person under his/her
direct supervision) must placard all entrances to the fumigation enclosure
with signs bearing:
— skull and crossbones symbol
-- "DANGER/PELIGRO,"
~ "Area under fumigation, DO NOT ENTER/NO ENTRE,"
— "Propylene Oxide Fumigant in use,"
— the date and time of fumigation, and
~ name, address, and telephone number of the certified applicator
supervising the fumigation."
"The certified applicator supervising the fumigation must ensure that no
person, except the certified applicator or persons under his/her direct
supervision who are wearing appropriate respiratory protection, enters into
the treated enclosure until the signs are removed. Such signs must only be
removed when aeration has occurred and when the air concentration level
of propylene oxide is monitored as described in this labeling and the
monitoring indicates that workers can enter without respiratory protection.
Signs must remain legible during entire posting period.
The warning signs at entrances to fumigation enclosure may only be
removed by the certified applicator supervising the fumigation or person
In the Directions for
Use under the
heading
"PLACARDING OF
FUMIGATED
ENCLOSURES"
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under his/her direct supervision.
Vehicles must be placarded with applicable U.S. Department of
Transportation warning signs."
Environmental
Hazards Statements
"ENVIRONMENTAL HAZARDS
This pesticide is toxic to birds and mammals. Do not discharge effluent
containing this product into lakes, streams, ponds, estuaries, oceans or
other waters unless in accordance with the requirements of a National
Pollutant Discharge Elimination System (NDPES) permit and the
permitting authority has been notified in writing prior to discharge. Do not
discharge effluent containing this product to sewer systems without
previously notifying the local sewage treatment plants authority. For
guidance contact your State Water Board or Regional Office of the EPA."
Precautionary
Statements under
Environmental
Hazards
Storage and Disposal
language of for all
propylene oxide end-
use products
"Persons moving, handling, or opening containers must wear the personal
protective equipment (including prescribed respirators when necessary)
specified in the Human Hazards section of this labeling. Store containers
in a well-ventilated area."
Storage and Disposal
section of the label
Spill and Leak
Procedures of for
propylene oxide end-
use products
"SPILL AND LEAK PROCEDURES
Evacuate everyone from the immediate area of the spill or leak. For entry
into affected area to correct problem, wear the personal protective
equipment (including prescribed respirators) specified in the Hazards to
Humans section of this labeling. Move leaking or damaged containers
outdoors or to an isolated location. Observe strict safety precautions.
Work upwind, if possible. Allow spilled fumigant to evaporate. Only
correctly trained and PPE-equipped handlers are permitted to perform such
cleanup. Do not permit entry into the spill or leak area by any other person
until the air concentration level of propylene oxide is measured to be at or
below 2 ppm as an 8-hour time weighted average.
Contaminated soil, water, and other cleanup debris is a toxic hazardous
waste. Report spill to the National Response Center (800-424-8802) if the
reportable quantity of 1000 Ibs. is exceeded."
In the labeling
section titled
"Storage and
Disposal" or by
themselves under the
heading "Spill and
Leak Procedures"
General Application
Restrictions
"DIRECTIONS FOR USE
It is a violation of Federal Law to use this product in a manner inconsistent
with its labeling.
Do not apply this product in a way that will contact workers or other
persons, either directly or through drift. Only protected handlers may be in
the area during application. For any requirements specific to your State or
Tribe, consult the agency responsible for pesticide regulation."
Place in the Direction
for Use directly
below the heading
"Directions for Use"
" PPE that is established on the basis of Acute Toxicity of the end-use product must be compared to the
active ingredient PPE in this document. The more protective PPE must be placed in the product labeling.
For guidance on which PPE is considered more protective, see PR Notice 93-7.
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