s
. ' . ' . ' EPA 730-N-98-009.
^ ^^ % UNITED STATES ENVIRONMENTAL PROTECTION AGENCY
! ' ' WASHINGTON, D.C. 20460 : -
OFFICE OF
PREVENTION, PESTICIDES
. AND TOXIC SUBSTANCES
, October 1998 .
' Pesticide Registration (PR) Notice 98-9
NOTICE TO MANUFACTURERS, PRODUCERS, FORMULATORS AND
REGISTRANTS OF AGRICULTURAL PESTICIDES
Attention: Persons Responsible for Registration of Pesticide Products. ;,,'.-
Subject: Modification of Respirator Statements for Pesticide Product Labels
This PR Notice-informs registrants-of technology improvements for respirators and designation
changes for certain respirator filters' required in pesticide labeling statements. Because the National -
Institute of Occupational Safety and Health has revised respirator standards'for paniculate filters,
references to filter classification types on pesticide labels are no longer accurate. Previously certified
filters for pesticide userswill no longer be available after fall 1998. EPA intends to modify the regulations
governing respirator'reauirerhents for product labels. -EPA is issuing this notice jn order to allow
registrants adequate time to make appropriate changes in product labels. -
Registrants should modify the respirator designations on those product labels that contain
language that requires pesticide handlers to wear dust/mist filtering respirators (TC-21C) orthose
'respirators that require an organic vapor-removing cartridge respirator with a prefilte'r approved for
pesticides (TC-23C). -"-..- '.>...,-
. ' ) Registrants should update the respirator language on each product label. A notification process
may be used for this change if registrants do not combine this change with other changes that require
Agency review. ". ' . ' - - , ; .'. v
This PR Notice is effective immediately. Registrants are required to remove old respirator
language-between-April 1, 2001 and April 1, 2004, while adding new respirator language should begin as
soon-as possible so that the new language is in place by April 1, 2000.
I. Background
In June 1995, the National Institute for Occupational Safety and Health (NIOSH) published a
Federal regulation for certifying nonpowered, air-purifying paniculate respirators, Part 84; Part 84 was to
replace the outdated certification standards in 30 CFR 1-1 '(Part 11) regulations. In the-new regulation,
only nonpowered air-purifying, particulate filter respirator classifications have been changed: The new
Part 84 regulation creates a total of nine classes of particulate filters; these classes apply only to
-nonpowered air-purifying, particulate filter respirators. NIOSH allowed manufacturers of respirators to .
continue selling and shipping Part 11 particulate filters as NIOSH-certified until July 10, 1998,
In reviewing the NIOSH certification changes, EPA has concluded that all 42 QFR 84 (Part 84)
respirators meet or exceed all 30 CFR 11 (Part 11) requirements and'that a respirator certified under Part
84 is an acceptable substitute for a respirator certified under Part 11. -
II. Rationale for Respirator Classification Changes
Three categories exist for filter efficiency and each category has three possible oil degradation
resistances that may be selected and matched with filter efficiency. Each'of the nine resulting respirator
categories is designated by a code in which a letter - N, R or P - represents its oil resistance and a
PRN 98-9 1
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number--95. 99 or 100 - represents filter efficiency.
The three levels of filter efficiency are:
95%, ';'","
« 99% and
99,97%, - .
The three categories of oil degradation resistance are based on the degree to which the filter
performance s impaSd by the deposition of oil. Examples of oils include: dioctyI phthalate oil glycerine,
SdrSSSSiSS^S as lubricants. For Part 84 respirators, di-octyl phthalate (OOP) oil » utilizedas; a
challenqe material- this substance will act to neutralize the electrostatic charges present on the surface of
£f,bers^nd educe respirator efficiency. In this document the term "oil" will be used to represent any
highSng point liquid hydrocarbon that will accumulate on the particulate filter of a respirator wrtn
mfnimaI evaporation. Note that the accumulation of oil may lead to filter efficiency degradation In
Slg formulated products, registrants should work closely with respirator manufacturers to assure
that the proper filter type is selected for the product.
N-series (not resistant to oil) particulate filters may be used for solid particulate or liquid
oarticulate hazards. During certification sodium chloride is used as a testing material and a very
high particulate load (200 mg) is utilized for the test. Given the rigorousness of the testing regime.
there is no recommended time limitation for an N-series filter.
R-series (oil resistant) particulate filters may be used for solid and liquid particulate hazards. For
those products containing oil, the R-series is to be used for only one work shift (an 8 hour work
period) or per manufacturer's recommendations.
p-series filters may be used for more than a single work period, but NIOSH has requested each
respirator manufacturer to establish service time, recommendations as part of their user
instructions. It has been determined that long term oil exposure could reduce the efficiency of a
P100 filter to levels below that of a P95 filter.
Oil Resistance
Filter
Efficiency
N-series particulate filters
Not resistant to oil.
R-series particulate filters
Oil-resistant.
P-series filters
Oil-proof.
95%
N95
Not resistant to oil.
Maybe used for- solid
particulate or liquid particulate
hazards
No time limitations
Moderate filter efficiency
R95
Oil-resistant.
May be used for solid and
liquid particulate hazards.
Time limitation: 8 hours or
manufacturer recommendation
Moderate filter efficiency
P95
Oil-proof. . '
Time limitation: manufacturer
recommendation, usually .
more than 8 hours,
Moderate filter efficiency
99%
N99
Not resistant to oil.
May be used for solid
particulate or liquid particulate
hazards
No time limitations
High filter efficiency.
R99
Oil-resistant.
May be used for solid and
liquid particulate hazards.
Time limitation: 8 hours or
manufacturer recommendation
High filter efficiency
P99
Oil-proof.
Time limitation: manufacturer
recommendation, usually
more than 8 hours.
High filte'r efficiency
PRN 98-9 2
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99.97%.
N1.00
Not resistant to oil.'
May be used for solid
paniculate or liquid paniculate
hazards
N.o time iimita'tions
Very high filter efficiency ,
R100
Oil-resistant.
May be used for solid and
liquid paniculate hazards.
Time limitation: 8 hours or
manufacturer recommendation
Very high filter efficiency
P100
Oil-proof.
Time limitation: manufacturer
recommendation, usually .
more than 8 hours.
Very high filter efficiency
NOTE: long-term exposure to
oil can lower efficiency to
95%. *' . ':
III. what Label Supplements Should Be.Revised?
- The labeling revision applies to any product label that currently requires a dust/mist filtering _
respirator (TC'-21C)Tand/or.ah organic vapor removing cartridge respirator with a prefilter approved for
1 pesticides (TC-23C)..; _. ". .',.';' , ' . " \ ' . '. ' ',
: Registrants should modify such a label to add Part 84 respirator designations but should retain
Part 11 respirator designations. This modification 'allows, pesticide users to continue to use and deplete
S exiSg sSes of Part 11 respirators; it also permits the use of the Part 84 respirator* to satisfy
Part 11 respirator requirements on'product labels/
IV. When Should Labels Be Revised?
- Registrants should modify labels according to the following schedule:
Complete the process of adding references to Part 84 respirator designations beginning April 1,
2000. . --( , ." , - ' - - . '.-.;.
Retain current Part 11 respirator designations until Aprill, 2001 , .
Remove Part 11 respirator designations between April 1, 2001 and April 1, 2004.
Registrants will not be required to sticker, relabel/or retrieve product from the Channels of trade
only Part 11 language. In a May 7, 1998 Federal Register Notice.entitled Labeling
r PesfckieV Respirator Compliance' Policy Statement" (63 FR 25168), the Agency has
statements on old product labels. . i ' ..'"'".',
V.
;How to add new label language for dust/mist respirators?
Use the following procedure to determine the new respirator language that should be'added'to your
product labels for dust/mist respirators. / '
IF your present label states:
"dust/mist filtering respirator
(MSKA/N1OSH approval number
prefix TC-21C" . .- -
AND...
your product contains-oil or has-
instructions that would allow
application with an oil-containing
material, '.'...
THEN your new label must state:
"dust/mist filtering respirator
(MSHA/NIOSH approval number
prefix TC-21 C), or a N1OSH
approved respirator with any R.-P
or HE filter.". .
PRN 98-9 "3
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"dust/mist filtering respirator
(MSHA/NIOSH approval number
prefix TC-21C"
your product does NOT
contain oil and bears no
instructions that will allow
application with an oil-containing
material,
Examples include: granular
formulations, dusts mixed with
water, dry powders mixed with
water '.
"dust/mist filtering respirator
(MSHA/NIOSH approval number
prefix TC-21C), or a NIOSH ,
approved respirator with any N, R,
P or HE filter."
Note: If oil is not present, an additional filter type, N, can be used.
VI. How to add new language for organic vapor respirators?
Use the following procedure to determine trie new respirator language that should be added to
your pesticide product for organic vapor respirators.
IF your present label states:
AND...
THEN your new label must state:'
"respirator with an organic-vapor
removing cartridge with a
prefilter approved for pesticides
(MSHA/NIOSH approval number
prefix TC-23C), or a canister
approved for pesticides
(MSHA/NIOSH approval number
prefix TC-14G)."
your product contains oil or has
instructions that would allow
concurrent application with an
oil-containing material,
"respirator with an organic-vapor.
removing cartridge with a prefilter.
approved for pesticides .
(MSHA/NIOSH approval number
prefix TC-23C), or a canister
approved for pesticides
(MSHA/NIOSH approval number
prefix TC-14G), or a NIOSH
approved respirator with an
organic vapor (OV) cartridge or
canister with any R, P or HE
prefilter."
"respirator with an organic-vapor
removing cartridge with a
prefilter approved for pesticides
(MSHA/NIOSH approval numbe'-
prefix TC-23C), or a canister
approved for pesticides
(MSHA/NIOSH approval number
prefix TC-14G)."
your product does NOT
contain oil and bears no
instructions that will allow
concurrent application with an
oil-containing material,
Examples include: granular
formulations, dusts mixed with
water, dry powders mixed with
water
"respirator with an organic-vapor
removing cartridge with a prefilter
approved for pesticides
(MSHA/NIOSH approval number
prefix TC-23C), or a canister
approved for pesticides
(MSHA/NIOSH approval number
prefix TC-14G), or a NIOSH
approved respirator with an
organic vapor (OV) cartridge or
canister with any N, R, P or HE
prefilter."
Clarifipation concerning HE prefilters in the preceding tables: Text entries for new label language in
the column marked "THEN your new label must state" mention "HE prefilters". "HE" stands for "high
efficiency particulate aerosol" and refers to a category of canister-type respirators with a particle filtering
efficiency well above 99,97%. "HE" can be considered to be a fourth level of particle removal efficiency.
EPA believes HE respirators will rarely be used in pesticide handling and application since they are more
. expensive than those in the 95%, 9§% and 99.97% (which is sometimes called 100%) particle removal
efficiency categories and since EPA does not require pesticide applicators and other handlers to use "HE"
filters. However, the new label language mentions "HE" filters to make the new requirements clear in the
infrequent situations where these filter types are incorporated by the respirator manufacturer in canister-
type respirators,.
VII. Procedure for Notification
' '" , .: »!, p » \ ; '' '' , ,,' : ( '
A. Notification submission
For each product to be modified, the registrant should notify EPA. 'No changes other than
PRN 98-9 4
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toe respirator statement should be included, otherwise the notification must be processed as
'
1 , An Application for Registration (EPA Form 8570-1), identified as a .
"Notification of Respirator Statement Changeper PR Notice 98-9.
2-'' One copy of the labelirig with changes-highlighted in a way that can be photocopied. This
' may be draft labeJing or final printed labeling. : . ' ,
' 3. The following certification statement: ..;,,' ':
"On behalf of __(insert Registrant's name) __, I certify that this notification is
consistent with the provisions of PR Notice 98-9 and EPA regulations at 40 CFR
152 46 and no other changes have been made to the labeling or the.confidential
statement of formula of this product. I understand that it is a violation of 18 U.S.C.
Sec 1001 to willfully make any false statement to EPA. I further understand that if
this notification is not consistent with the terms of PR Notice 98-9 and 40 CFR
152.46, this product may be in violation of FIFRA and I may be subject to
enforcement action and penalties under sections 12 and 14 of FIFRA."
. \ Notifications should be sent to: , .; . :. / :
- U.S. Postal Service Deliveries ...
Document Processing-Desk (RESPIRATOR) , ,:-... /
Office of Pesticide Programs (7504C) , .
- U.S. Environmental Protection Agency / \ .
401 MSt, S.W. : " -..'-
Washington DC 20460-0001 ' ' :,
Personal/Courier Service Deliveries " ' '. / ' ,
(Mon.-Fri., 8:00 a.m: to 4:30 p.m., except Federal Holidays) ;
Document Processing Desk (RESPIRATOR) ; " '' ,
.Office of Pesticide Programs (7504C) '".-..- "
' U.S. Environmental Protection Agency ' , /
. Room 266A, Crystal Mall 2 v ", . \" ':..;.
1921 Jefferson Davis Highway ,; ,
Arlington VA 22202 . ,'
VIII. Sale and Distribution of Pesticide Products with Revised Labeling
' ' The notification must be received by the Agency before the registrant may distribute or sell the product
with the revised labeling, 'as modified. A product distributed or sold with revised labeling before a notification
and final printed labeling are-received is in violation of FIFRA and may be subject to enforcement action.
This PR Notice does not require registrants to relabel products bearing only Part 11 respirator
language already in channels of trade. EPA will permit pesticide users to use Part 84 respirators in place of
'Part 11 respirators; the Agency has determined that a respirator certified under.Part 84 will meet or exceed
all Part 11 requirements. ' _ ' . . ' / . . '
IX. Agency Determination to Revise the Respirator Statement
If- on the basis of information received from a registrant or other sources, the Agency determines that
the respirator statement on a, productlabel must be revised, the Agency will inform the registrant of that
determination and of the new statement that should replace the existing.respirator statement on the product
falTVhe Agency will inform the registrant of actions, if any, that should be taken with respect to existing
stocks of products labeled with an incorrect respirator statement. Reregistrat.on deasions or decisions
PRN98-9 5
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resulting from other Agency review processes may supersede this notice. '
"J ' ",.'.', ,, , , , , , -
X. Compliance
Registrants are responsible for the content and accuracy of labeling and for compliance with labeling
requirements The Agency'will monitor notifications to verify that changes are accurate. Registrants who
submit notifications which do not comply with this policy or EPA's requirements may be subject to enforcement
action under FIFRA sections 12 and 14.
Registrants selling or distributing products bearing revised labeling are responsible for ensuring that
the products bearing the proposed labels .are not misbranded. In most cases, incorrectly modifying the
respirator statement would be considered misbranding as, defined under FIFRA section 2(q), and may result
in the Agency issuing slop-sale orders or civil penalties. Such misbranding may create a potential for harm
to workers, handlers, or other persons, or the environment, or may prevent the Agency from achieving the
basic goals'of the Worker Protection Standard or FIFRA.
All products released for shipment by registrants after April 1, 2000 should bear labeling that is
consistent with this notice. It is the responsibility of the registrants to submit'notificatiqns in a timely manner.
After this date, the Agency may either issue a notice of Intent to Cancel or bring enforcement action against
products not bearing required labeling. , .
Vlll. Further Information
Questions regarding this notice may be addressed to your Product Manager or Mr. Jim Tompkins
(703-305-5697), e-mail;'tompkins.jim@epamail.epa.gov. .
7
James J. Jonesir Director
Registration Division
PRN98-9-6
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