Document ID: EPA-HQ-OPP-2004-0032-0039
Agency: epa
Document Type: Supporting & Related Material
Title: 
Posted Date: 2006-12-21T05:00Z

Labeling Changes Summary Table				[Attachment III]	

In order to be eligible for reregistration, amend all product labels to
incorporate the risk mitigation measures outlined in Section IV.  The
following table describes how language on the labels should be amended.

  Table 12: Summary of Labeling Changes for Formetanate Hydrochloride

Description	

Manufacturing Use Products	

Placement on Label

For all Manufacturing Use Products	

“Only for formulation into an insecticide for the following use(s)
nectarines, peaches, pome fruits, citrus, and alfalfa grown for seed.”

“This product may be used only to formulate wettable powder end use
products that are packaged in water soluble packets”.

	

Directions for Use

One of these statements may be added to a label to allow reformulation
of the product for a specific use 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 	

"This pesticide is toxic to fish and aquatic invertebrates.  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. Do not contaminate water when disposing of
equipment washwaters.”	

Precautionary Statements

End Use Products Intended for Occupational Use

PPE Requirements Established by the RED1 For Wettable Powder

Formulations

(Note: Only products packaged in water soluble bags will be eligible for
reregistration)

	

“Personal Protective Equipment (PPE)

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."

“Mixers, loaders, applicators, flaggers, and other handlers must wear:

> Long-sleeved shirt and long pants, 

> Shoes plus socks,

> Chemical resistant gloves and apron for mixers and other handlers
exposed to the concentrate.  

> Applicators using groundboom and air-blast equipment must wear a
NIOSH-approved respirator with:

-- a dust/mist filter with MSHA/NIOSH approval number prefix TC-21C or 

-- any N, R, P, or HE filter”

“See Engineering Controls for Additional 

Requirements”

Instruction to Registrant: Drop the “N” type prefilter from the
respirator statement, if the pesticide product contains, or is used
with, oil.

	

Immediately following/below 

Precautionary Statements:  Hazards to Humans and Domestic Animals

User Safety Requirements	

“Discard clothing and other absorbent materials that have been
drenched or heavily contaminated with this product’s concentrate.  Do
not reuse them.”

“Follow manufacturers’ instructions for cleaning and maintaining
PPE.  If no such instructions for washables exist, use detergent and hot
water.  Keep and wash PPE separately from other laundry.”	

Precautionary Statements:  Hazards to Humans and Domestic Animals
immediately following the PPE requirements

Engineering Controls 

for wettable powder formulations	

“Engineering Controls

“Water-soluble packets when used correctly qualify as a closed
mixing/loading system under the Worker Protection Standard for
Agricultural Pesticides [40 CFR 170.240(d)(4)].  Mixers and loaders
using water-soluble packets must :

-- wear the personal protective equipment required in the PPE section of
this labeling for mixers and loaders, and

-- be provided and must have immediately available for use in an
emergency, such as a broken package, spill, or equipment breakdown: 
chemical-resistant footwear and the respirator as specified in the PPE
section of this label.”

Pilots must use enclosed cockpit that meets the requirements listed in
the Worker Protection Standard (WPS) for agricultural pesticides [40 CFR
170.240(d)(6)].”	

Precautionary Statements:  Hazards to Humans and Domestic Animals  
(Immediately following PPE and User Safety Requirements.) 

User Safety Recommendations	

“User Safety Recommendations

Users should wash hands before eating, drinking, chewing gum, using
tobacco, or using the toilet.

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.”	

Precautionary Statements under:  Hazards to Humans and Domestic Animals
immediately following Engineering Controls

(Must be placed in a box.)

Environmental Hazards 	

“This product is toxic to aquatic invertebrates.  Do not apply
directly to water, to areas where surface water is present or to
intertidal areas below the mean high water mark.  Drift and runoff may
be hazardous to aquatic organisms in water adjacent to treated areas. 
Do not contaminate water when disposing of equipment washwaters or
rinsate.”

“This chemical can contaminate surface water through spray
applications.  Under some conditions, it may also have a potential for
runoff into surface water after application.”   

“This product is toxic to bees exposed to direct treatment.  Do not
apply this product while bees are actively visiting the treatment area.
Do not allow animals to graze in treated orchard areas.”

	

Precautionary Statements immediately following the User Safety
Recommendations

Restricted-Entry Interval  (REI)	

“Do not enter or allow worker entry into treated areas during the
restricted entry interval (REI) of:   

9 days for citrus

5 days for pome and stone fruits

4 days for alfalfa grown for seed”	

Directions for Use, Under Agricultural Use Requirements Box

Early Entry Personal Protective Equipment 	

“PPE required for early entry to treated areas that is permitted under
the Worker Protection Standard and that involves contact with anything
that has been treated, such as plants, soil, or water, is:

coveralls,

shoes plus socks

chemical-resistant gloves made of any waterproof material”

“Notify workers of the application by warning them orally and by
posting warnings signs at entrances to treated area.”	

Direction for Use

Agricultural Use Requirements box

General Application Restrictions	

“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.”	

Place in the Direction for Use directly above the Agricultural Use Box. 

Other Application Restrictions (Risk Mitigation)	

“Late season applications to apples is prohibited; Only apply at petal
fall”

“Aerial applications to orchard crops is prohibited”

“Hand harvesting for alfalfa is prohibited”

	

Directions for Use in the appropriate site/crop instructions

1 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.

2 Label requirements in quotes are to be specified on the label.