[Federal Register Volume 60, Number 240 (Thursday, December 14, 1995)]
[Rules and Regulations]
[Pages 64282-64295]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 95-30503]
[[Page 64281]]
_______________________________________________________________________
Part V
Environmental Protection Agency
_______________________________________________________________________
40 CFR Part 156
Worker Protection Standard; Labeling Revisions Required for Pesticide
Products Within the Scope of the Worker Protection Standard; Policy
Statement; Final Rule
Federal Register / Vol. 60, No. 240 / Thursday, December 14, 1995 /
Rules and Regulations
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[[Page 64282]]
ENVIRONMENTAL PROTECTION AGENCY
40 CFR Part 156
[OPP-250111; FRL-4988-5]
Worker Protection Standard; Labeling Revisions Required for
Pesticide Products within the Scope of the Worker Protection Standard
AGENCY: Environmental Protection Agency (EPA).
ACTION: Policy Statement.
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SUMMARY: EPA is issuing a final policy statement on labeling revisions
required by the Worker Protection Standard (WPS) for sale or
distribution of certain agricultural pesticides after October 23, 1995.
This policy addresses pesticide products that are within the scope of
the WPS, do not bear full WPS labeling, and are being sold or
distributed by any person, other than the registrant. Certain
statements are required to be placed on the labeling of all pesticide
products within the scope of the WPS. These statements reference the
WPS and certain practices intended to reduce or eliminate human
exposure to pesticides. In most instances, these statements were
required to appear on all WPS products by April 21, 1994. Wholesalers
and dealers may have stocks of product that do not have WPS complying
labeling. This policy presents options for the registrant to relabel
the product or authorize the person(s) holding the product for
distribution or sale to relabel the product. This policy statement does
not apply to growers, custom applicators, or other persons holding
product for their own use, unless they also distribute and sell
pesticides or are registrants.
EFFECTIVE DATE: This policy became effective on September 28, 1995. The
contents of this statement were issued on September 28, 1995, as
Pesticide Regulation (PR) Notice 95-5.
FOR FURTHER INFORMATION CONTACT: James Tompkins, Office of Pesticide
Programs (7505C), Environmental Protection Agency, 401 M St., SW.,
Washington, DC 20460. Office location, telephone number, and e-mail
address: 1921 Jefferson Davis Highway, Crystal Mall #2, Rm. 239,
Arlington, VA, 703-305-5697, e-mail: tompkins.james@epamail.epa.gov.
SUPPLEMENTARY INFORMATION: The Agency is issuing a final policy
statement that allows registrants or their authorized representatives
that sell or distribute pesticides to relabel non-complying pesticide
products in their possession. The policy provides examples of
mechanisms to bring labels into compliance with WPS requirements, so
that such products may be legally sold and distributed after October
23, 1995. The required actions for registrants, wholesalers, and
retailers to relabel products are discussed to aid compliance with the
policy. All products within the scope of WPS must bear final, printed
WPS replacement labeling after October 23, 1996. Except for products
that have been canceled, products accompanied only by generic
supplemental labeling, as outlined in PR Notice 93-11, are not
considered labeled in compliance with the WPS provisions after October
23, 1995.
I. Summary of the Policy
EPA will permit registrants or their authorized representatives to
relabel non-complying stocks of products that do not bear full WPS
labeling. Under this policy, the registrant has the option to either
relabel the product or provide written authorization to the person(s)
holding the product for distribution or sale to relabel the product.
Both the registrant and the person(s) holding such pesticides are
responsible for relabeling these products in accordance with the WPS
and this policy statement. This policy statement does not apply to
growers, custom applicators, or other persons holding products for
their own use, unless they also distribute and sell pesticides or are
registrants.
Using the decision diagram presented in this policy statement,
registrants may determine if they hold non-complying products that
require amended labeling. If a product requires amended labeling, the
registrant may conduct or provide written authorization for wholesalers
or retailers to do relabeling, and provide product-specific WPS
labeling. Options for amended labeling include: a final printed WPS-
complying replacement label and supplemental product-specific labeling.
Supplemental labeling must be provided to the end-user whenever the
product is offered for sale and a ``STOP sticker'' is affixed to the
existing label. Pesticide-specific relabeling may occur at any site
without registration of the site as a pesticide-producing
establishment. Under the provisions of this policy, relabeling of
stocks of products with non-complying labels may be carried out by
person(s) acting under the authority of the registrant as an
``authorized agent'' of the registrant. The policy also addresses how
to revise labels of orphaned and deleted use products, products that
have been transferred, and dormant products.
II. Background
The 1992 WPS requires that certain statements be placed on the
labeling of all pesticide products within the scope of the standard.
These statements reference the WPS and certain practices intended to
reduce or eliminate human exposure to pesticides. The WPS also
established a schedule for meeting these labeling requirements. The
schedule required that, by April 21, 1994, all registrants of
pesticides covered by the WPS had to amend product labeling in
accordance with PR Notice 93-7 and 93-11. Most products sold or
distributed by registrants since April 21, 1994, should have WPS-
complying labeling. In some instances, wholesalers and retailers may
have stocks of products that do not have WPS complying labeling. These
stocks could have originated from these sources: (1) Products shipped
by registrants before the April 21, 1994 date; (2) products distributed
or sold by registrants under the ``released for shipment'' option
allowed under PR Notice 93-11; or, (3) ``deleted use'' products, for
which the registrant has amended the registration to delete certain
uses and these deletions place the product outside the scope of the
WPS. After April 21, 1994, under the ``release for shipment'' option,
registrants could sell or distribute products without the WPS label if
the registrant agreed to either recall and relabel, or relabel products
at wholesaler sites through an ``authorized agent'' by April 1996.
The WPS provides that any person other than a registrant (e.g.,
pesticide retailers or wholesalers) who has under their ownership,
custody or control existing stock of product that is within the scope
of the WPS, but does not bear WPS labeling, may not legally sell or
distribute the product after October 23, 1995. The primary purpose of
this policy statement is to describe the process for relabeling to
bring products into compliance.
III. Definitions
The following definitions apply for the purposes of this policy
statement:
Distribute or sell means to distribute, sell, offer for sale, hold
for distribution, hold for sale, hold for shipment, ship, deliver for
shipment, release for shipment, or receive and (having so received)
deliver or offer to deliver. The term does not include the holding or
application of registered pesticides or use dilutions thereof by any
applicator who provides a service of controlling pests without
delivering any unapplied pesticide to any person so served.
[[Page 64283]]
Label means the written, printed, or graphic matter on, or attached
to, the pesticide or device or any of its containers or wrappers.
Labeling means all labels and all other written, printed, or
graphic matter (a) accompanying the pesticide or device; or (b) to
which reference is made on the label or in literature accompanying the
pesticide or device.
Registrant means any person who has registered any pesticide
pursuant to the provisions in FIFRA (Federal Insecticide, Fungicide,
and Rodenticide Act).
Retailer means any person, other than a registrant, who distributes
or sells pesticides to end-users.
Wholesaler means any person, other than a registrant, who
distributes or sells pesticides to persons other than end-users.
IV. Policy Provisions
A. Recognition of Product Labels Requiring Amendment to Comply With WPS
If a product has labeling required under the WPS, the labeling will
have an Agricultural Use Requirements box and can be sold or
distributed after October 23, 1995, without further action. Products
accompanied only by generic supplemental labeling as outlined in PR
Notice 93-11 are not considered labeled in compliance with the WPS
provisions after October 23, 1995. Products that do bear complying WPS
labeling include those relabeled in accordance with Supplement D of PR
Notice 93-11 (by using a sticker or similar modification to an existing
label and full product-specific labeling referenced by the sticker). An
example of an Agricultural Use Requirements box follows:
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AGRICULTURAL USE
REQUIREMENTS
Use this product in accordance with its labeling and with
the Worker Protection Standard, 40 CFR 170. This
standard contains requirements for the protection of
agricultural workers on farms, forests, nurseries, and
greenhouses, and handlers of agricultural pesticides. It
contains requirements for training, decontamination,
notification, and emergency assistance. It also contains
specific instructions for exceptions pertaining to the
statements in this labeling about personal protective
equipment, restricted-entry intervals, and notification
to workers. The requirements in this box only apply to
uses of this product that are covered by the Worker
Protection Standard (WPS).
Do not enter or allow worker entry into treated areas
during the restricted entry interval (REI) of 48 hours.
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:
Chemicals over long-sleeved shirt and long pants
Chemical-resistant gloves such as barrier laminate or
viton
Chemical-resistant footwear plus socks
Protective eyewear
Chemical-resistant headgear for overhead exposure
Notify workers of the application by warning them orally
and by posting warning signs at entrances to treated
areas.
------------------------------------------------------------------------
If a product label does not have an Agricultural Use Requirements
box, it is necessary to determine whether the product is within the
scope of the WPS and, therefore, requires WPS labeling. In some
instances, it may be easy to identify a product that requires WPS
labeling; the newest shipment of containers of the same product may
bear the following: (1) Labeling with an Agricultural Use Requirements
box that refers to the WPS; or (2) stickers referring to supplemental
replacement labeling which contains such an Agricultural Use
Requirements box.
The Agricultural Use Requirements box references the WPS and
requires certain practices intended to reduce or eliminate worker and
handler exposure from pesticides. The box includes restricted entry
intervals, personal protective equipment and the notification
requirement for pesticide-treated areas. Retailers and wholesalers may
determine whether modifying a product label is necessary by calling the
registrant of the product or by using the following diagram and
criteria presented in Section B to evaluate each product. For
additional assistance, contact the industry-sponsored ``WPS Task
Force'' at 1-800-713-2291.
BILLING CODE 6560-50-F
[[Page 64284]]
[GRAPHIC][TIFF OMITTED]TR14DE95.009
BILLING CODE 6560-50-C
[[Page 64285]]
B. Scope Criteria and Determining WPS Applicability to Individual
Products
In PR Notice 93-7, registrants were to answer a series of questions
to determine if their product fell within the scope of WPS. To
determine whether pesticide products fall within the scope of this
policy (i.e. those that do not already bear labeling containing WPS
requirements in an Agricultural Use Requirements box), the following
questions must be answered:
Begin here for each product:
1. Does the labeling contain directions for application to:
Plants grown to produce food, feed, or fiber?
Turfgrass?
Ornamental plants, trees, or shrubs?
Plants grown to produce seedlings or transplants?
Plants grown to produce cut flowers or cut ferns?
Trees grown to produce timber?
Areas where any such plants are growing?
Areas where such plants will soon be grown (i.e., pre-
plant or at-plant application)?
Areas from which such plants have just been harvested?
If you answered ``Yes'' to any of these questions, this product may
be within the scope of this policy. Go on to question 2.
If you answered ``No'' to all of these questions, this product is
not within the scope of this policy statement. Begin again with
question 1 for your next product.
2. Does the labeling explicitly limit application only to plants
intended for aesthetic purposes or climate modification and growing in
interior plantscapes, ornamental gardens or parks, or on golf courses
or lawns and grounds?
If you answered ``Yes'' to this question, this product is not
within the scope of this policy statement. Begin again with question 1
for the next product.
If you answered ``No'' to this question, this product may be within
the scope of this policy statement.
Go on to question 3.
3. Does the labeling explicitly limit uses only to those not
directly related to the production of food, feed, fiber, timber,
turfgrass, or ornamentals, such as the following:
Use on pasture or rangeland?
Use on rights-of-way or other non-crop areas?
Use for structural pest control?
Use for mosquito abatement, Mediterranean fruit fly
eradication, or in other wide-area government-sponsored pest control
programs?
If you answered ``Yes'' to this question, this product is not
within the scope of this policy. Begin again with question 1 for the
next product.
If you answered ``No'' to this question, this product may be within
the scope of this policy. Go on to question 4.
4. Does the labeling contain directions only for one or more of the
following:
Control of vertebrate pests?
Use as an attractant in traps?
Use on the portions of agricultural plants that have been
harvested, including harvested timber?
Application using a point-source pheromone dispenser of a
size easily retrieved from the field, such as a ``twist-tie''?
If you answered ``Yes'' to this question, this product is not
within the scope of this notice. Begin again with question 1 for the
next product.
If you answered ``No'' to this question, this product may be within
the scope of this policy. Go on to question 5.
5. Is the product labeled primarily for use in production of plants
in homes, home flower or vegetable gardens, home lawns, or home
greenhouses? Answer ``yes'' to this question only if the current
labeling meets all the following tests:
a. The labeling indicates that the product is intended for use in
or around the home, home flower or vegetable garden, home lawn, or home
greenhouse.
b. The labeling does not include any of the following directions or
phrases:
Skull and crossbones symbol and word ``Poison.''
A requirement for users to wear a respirator.
A requirement for users to wear chemical-resistant,
waterproof, or liquid-proof suits or coveralls or ``rainsuits.''
The phrase ``for professional use.''
The phrase ``for commercial use.''
Directions for use on farms, sod farms, forests,
nurseries, or greenhouses except home greenhouses.
Directions for use including the phrases ``for crop
production'' or ``for sod production.''
Application rates expressed per acre.
Dilution rates expressed per hundred gallons.
Directions for application by aerial, ground-boom,
airblast, or other motor-driven vehicles or equipment.
Directions for use of a ``surfactant,'' ``buffer,'' or
``adjuvant,'' using those words.
Any reference to chemigation.
Directions for mechanical agitation.
Instructions or restrictions concerning livestock grazing.
c. The product is packaged in a container holding no more than 40
pounds if the product is a solid, or 2 gallons if it is a liquid, or 2
pounds if it is an aerosol.
If all three tests (5a, 5b, 5c) above are fully satisfied, this
product is not within the scope of this policy. Begin again with
question 1 for the next product.
If any of these three tests is not fully satisfied, this product is
within the scope of this policy statement. (If the product does not
satisfy all these three tests but you believe it is nonetheless
intended primarily for home use or is otherwise limited to use on
plants grown for other than commercial or research purposes, check with
the registrant. Start again with question 1 for the next product.
C. Registrant Responsibilities in the Revision of Product Labels to
Comply with the WPS
Registrants must conduct or authorize any relabeling. If a retailer
or wholesaler will relabel products, the registrant must provide a
written authorization and provide product-specific WPS labeling.
In conducting or authorizing relabeling, registrants are
responsible for ensuring that relabeling of non-complying products
takes place in accordance with the WPS and this policy statement. They
may choose to conduct relabeling by recalling the product and
relabeling with final printed replacement labeling at a registered
establishment or relabeling at the location of the product; or
authorize a wholesaler or retailer to relabel in accordance with this
policy. Options and required specifications for relabeling are outlined
in Unit IV.F. of this document.
The registrant must provide a written authorization to any
wholesaler or retailer who agrees to relabel non-complying products.
The authorization should outline the specific roles of the retailer,
wholesaler, and registrant in relabeling. Registrants are fully
responsible for ensuring that labeling modifications are carried out
correctly by any person or company they authorize. Any limitations on
who may be authorized to carry out relabeling under this policy
statement must be explicit in the authorization document. The
authorization cannot change the responsibilities of any of the parts of
terms of this policy statement. Any relabeling of products with WPS
labels must be done in cooperation with all involved parties and under
the written authorization of the registrant.
The registrant must provide labeling to those they authorize to
conduct
[[Page 64286]]
relabeling. The labeling must comply with the WPS and this policy
statement. This also includes ``STOP stickers'' if supplemental
labeling is used. A description and specifications for the ``STOP
stickers'' are given in Unit IV.F. of this document.
D. Wholesaler Revision of Product Labels to Comply with the WPS
Wholesalers must take the following actions in order to revise
product labels to comply with the WPS: gain registrant authorization
for any relabeling at the wholesaler establishment, and distribute non-
complying products only as permitted by this policy statement.
Wholesalers may use industry-sponsored assistance to identify which
specific products require WPS-complying labels.
Wholesalers may gain registrant authorization for relabeling at the
wholesaler establishment. The registrant may authorize a wholesaler,
retailer or other person(s) to perform relabeling. Any relabeling of
products must be performed under the written authorization of the
registrant. If the registrant will not perform relabeling or authorize
the wholesaler or another party to relabel, the wholesaler should
contact EPA's Registration Division (703-305-6250) for instructions on
how to proceed with these products. Wholesalers must follow the options
and required specifications for relabeling in this policy statement.
Wholesalers must not distribute non-complying products, except as
permitted by this policy statement. Products within the scope of the
WPS that do not bear WPS labeling may not be legally distributed or
sold after October 23, 1995. This policy statement, however, allows the
wholesaler to ship non-complying product prior to relabeling, if the
following conditions are satisfied: (1) The wholesaler has notified and
obtained agreement of the receiving person(s) to ensure that WPS
relabeling will occur before the product is ``offered for sale'' or
distribution to the end user; and, (2) the registrant will either
conduct or has authorized relabeling. For the purposes of this policy
statement, pesticides are considered ``offered for sale'' whenever they
are available in areas accessible to customers, unless they are clearly
identified as products that may not be sold until relabeled.
Industry-sponsored assistance is available to wholesalers in order
to bring products into compliance with WPS. Wholesalers may contact the
``WPS Task Force'' at 1-800-713-2291. This service will help identify
which specific products are covered by the WPS and need WPS-complying
labeling and distribute ``STOP stickers'' and required WPS supplemental
labeling for registrants participating in the service. Other requests
will be referred to other organizations.
E. Retailer Responsibilities in Revision of Product Labels to Comply
with the WPS
Retailers must take the three following actions in order to bring
products into compliance with WPS: do not offer for sale or distribute
any non-complying products after October 23, 1995. Retailers must
obtain registrant written authorization for relabeling at the retailer
establishment. Retailers may use industry-sponsored assistance to bring
products into compliance.
Retailers must not offer for sale products that do not comply with
the WPS after October 23, 1995, except as allowed by this policy
statement. This policy statement allows products to be relabeled under
certain specifications prior to being ``offered for sale.'' For the
purposes of this policy statement, pesticides are considered ``offered
for sale'' whenever they are available in areas accessible to
customers, unless they are clearly identified as products that may not
be sold until relabeled.
Retailers may gain registrant authorization for relabeling at the
wholesaler establishment. The registrant may authorize a wholesaler,
retailer or other person(s) to perform relabeling. Any relabeling of
products must be performed under the written authorization of the
registrant. If the registrant will not perform relabeling or authorize
the retailer or another party to relabel, the retailer should contact
EPA's Registration Division (703-305-6250) for instructions on how to
proceed with these products. Retailers must follow the options and
required specifications for relabeling in this policy statement.
Industry-sponsored assistance is available to retailers in order to
bring products into compliance with WPS. Retailers may contact the
``WPS Task Force'' at 1-800-713-2291. This service will help identify
which specific products are covered by the WPS and need WPS-complying
labeling and distribute ``STOP stickers'' and required WPS supplemental
labeling for registrants participating in the service. Other requests
will be referred to other organizations.
F. Options for Relabeling
The following options apply to the majority of products covered by
this policy statement, i.e. stocks of registered products subject to
WPS which lack required WPS labeling. The options available to bring
non-complying product labels into compliance are: final printed WPS-
complying replacement labeling and supplemental product-specific
labeling with ``STOP stickers.'' Other products, referred to as
``Special Products,'' are described and discussed in Unit IV.H. of this
document.
1. Final printed WPS-complying replacement labeling. Products may
be relabeled by replacing existing labels and labeling with final
printed WPS-complying replacement labeling that is securely affixed to
the pesticide container. The final printed WPS-complying replacement
labeling must be supplied by the registrant of the product. Such
labeling must be printed or affixed to the product package. If affixed,
it must be difficult to remove without residue or damage to the
underlying packaging or labeling it is replacing. If final printed
replacement labeling is used, it must meet the above standards as well
as those required in the WPS.
Replacement labeling could also be designed only to modify existing
labeling by adding the required WPS labeling statements without
replacing the entire existing labeling. Although we do not expect this
option to be used often, it may provide additional flexibility. If this
option is chosen, the replacement labeling must be designed and affixed
in such a way that it will not alter or obscure the other portions of
the label text that remain unchanged. Under this option, an additional
supplement containing WPS requirements cannot be developed.
Additionally, replacement labeling must be affixed in such a manner
that any existing labeling statements or requirements that are
superseded by WPS requirements are no longer visible so there is no
confusion as to the appropriate use restrictions for the end user.
If the product bears existing labeling on both an outer packaging
or supplement and an immediate container, the replacement labeling must
be affixed to both. For inner water soluble packages, the outer
package, but not the immediate container, will require replacement
labeling.
2. Supplemental product-specific labeling. Alternatively, products
may be relabeled by using supplemental product-specific labeling that
is provided when the product is offered for sale to the end user,
provided that a ``STOP sticker'' is affixed to the label and the
sticker meets the requirements as specified below. The supplemental
product-specific labeling must be supplied by the registrant of the
product.
[[Page 64287]]
a. Format of supplemental product-specific labeling.--Supplemental
labeling can be presented in two formats:
1. Single-product supplement that contains labeling information for
only the specific product the end-user is buying. This labeling must
display the (1) full text of current product labeling, or (2) partial
text that includes complete WPS-complying labeling (as EPA accepted or
registrant-verified). An example of a single-product supplement follows
the supplemental labeling specification discussion in Unit IV.F.2.b. of
this document.
2. Multi-product supplement that contains labeling information for
all products for a specific registrant. WPS information required to
appear on all product labels may appear in the brochure only once,
along with product-specific WPS information presented for each product
covered by the brochure. This option is not available for fumigant
products because of the specialized nature of the fumigant label. An
example of a brochure follows the supplemental labeling specification
discussion in Unit IV.F.2.b. of this document.
b. Supplemental product-specific labeling specifications.--
Supplemental replacement labeling must meet the following
specifications:
Title. The supplemental labeling must prominently bear the
words ``SUPPLEMENTAL LABELING WITH WORKER PROTECTION REQUIREMENTS'' at
the top of the first page or be in a pouch prominently displaying the
words ``SUPPLEMENTAL LABELING WITH WORKER PROTECTION REQUIREMENTS,''
attached to the container.
Content. Supplemental labeling can be presented in a
single product supplement or a multi-product brochure.
Single-product supplements include labeling information for only
the product the end-user is buying. These supplements will contain
either: (1) The full text of current product labeling, or (2) the
partial text that includes only the complete WPS product labeling
information, a contact phone number for the registrant, and no
information unrelated to the products' labeling. An example of a
single-product supplement follows:
SINGLE-PRODUCT, PRODUCT-SPECIFIC
(Example)
``Supplemental Labeling With Worker Protection Requirements''
Product Name, Company Name, EPA Reg. No.
For compliance with the Worker Protection Standard (40 CFR Part 170).
Important: This supplemental labeling does not apply (1) to soil or
space fumigant products, (2) to products containing ethyl parathion, or
(3) if elsewhere on the product labeling an Agricultural Use
Requirements box requires compliance with the Worker Protection
Standard (40 CFR Part 170).
When this product is used on an agricultural establishment (farm,
forest, nursery, or greenhouse) for the commercial or research
production of agricultural plants, users must comply with the
instructions in this supplemental labeling. Users who must comply with
these instructions include owners/operators of the agricultural
establishment and owners/operators of commercial businesses that are
hired to apply pesticides on the agricultural establishment or to
perform crop-advising tasks on such establishments. Failure to comply
with the requirements on this supplemental labeling and with the Worker
Protection Standard (40 CFR Part 170) is a violation of Federal law,
since it is illegal to use a pesticide product in a manner inconsistent
with its labeling.
[[Page 64288]]
------------------------------------------------------------------------
AGRICULTURAL USE
REQUIREMENTS
Use this product in accordance with its labeling and with
the Worker Protection Standard, 40 CFR 170. This
standard contains requirements for the protection of
agricultural workers on farms, forests, nurseries, and
green houses, and handlers of agricultural pesticides.
It contains requirements for training, decontamination,
notification, and emergency assistance. It also contains
specific instructions for exceptions pertaining to the
statements in this labeling about personal protective
equipment, restricted-entry intervals, and notification
to workers. The requirements in this box only apply to
uses of this product that are covered by the Worker
Protection Standard (WPS).
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.
Entry-Restrictions: Do not enter or allow worker entry
into treated areas during the restricted entry interval
(REI) of 48 hours/days.
Notification Instructions: (If required) Notify workers
of the application by warning them orally and by posting
warning signs at entrances to treated areas.
Personal Protective Equipment (PPE) Requirements:
Handler PPE: Applicators and other handlers must wear:
Coveralls over long-sleeved shirt and long pants
Chemical-resistant gloves such as barrier laminate or
viton
Chemical-resistant footwear plus socks
Protective eyewear
Chemical-resistant headgear for overhead exposure
Chemical-resistant apron when cleaning equipment,
mixing, or loading
Early Entry PPE: 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:
Chemicals over long-sleeved shirt and long pants
Chemical-resistant gloves such as barrier laminate or
viton
Chemical-resistant footwear plus socks
Protective eyewear
Chemical-resistant headgear for overhead exposure
Conflicting Instructions: If the requirements of the WPS
conflict with instructions listed elsewhere on this
product label, users must obey the more protective
requirements.
------------------------------------------------------------------------
[[Page 64289]]
Multi-product brochures must contain complete WPS product labeling
information for all products that are within scope of the WPS for the
registrant, a contact phone number for the registrant, and no
information unrelated to the products' labeling. If a brochure includes
multiple products with similar names (e.g., Weed Killer 4EC, Weed
Killer 10WP), the brochure must contain an advisory statement located
near such a grouping reminding users to carefully match the WPS
requirements in the brochure with the particular product they are
using. This option is not available for fumigant products. An example
of a multi-product brochure is provided.
MULTI-PRODUCT, PRODUCT-SPECIFIC
(Example)
``Supplemental Labeling With Worker Protection Requirements''
For compliance with the Worker Protection Standard (40 CFR Part 170):
Important: This supplemental labeling does not apply (1) to soil or
space fumigant products, (2) to products containing ethyl parathion, or
(3) if elsewhere on the product labeling an Agricultural Use
Requirements box requires compliance with the Worker Protection
Standard (40 CFR Part 170).
When this product is used on an agricultural establishment (farm,
forest, nursery, or greenhouse) for the commercial or research
production of agricultural plants, users must comply with the
instructions in this supplemental labeling. Users who must comply with
these instructions include owners/operators of the agricultural
establishment and owners/operators of commercial businesses that are
hired to apply pesticides on the agricultural establishment or to
perform crop-advising tasks on such establishments. Failure to comply
with the requirements on this supplemental labeling and with the Worker
Protection Standard (40 CFR Part 170) is a violation of Federal law,
since it is illegal to use a pesticide product in a manner inconsistent
with its labeling.
WPS Product Summary for Company XYZ:
----------------------------------------------------------------------------------------------------------------
Advisory: Similar names. Match WPS Weed Killer 10 G Weed/Insect Killer
requirements carefully with products. Granules Weed Killer 10 WP Super 8EC
----------------------------------------------------------------------------------------------------------------
Active Ingredient(s) dicarbamon tribamocarb dicarbamon
tribamocarb tribamocarb
oxyethylion
----------------------------------------------------------------------------------------------------------------
EPA Reg. No. 9999-1 9999-2 9999-3
----------------------------------------------------------------------------------------------------------------
REI (hours) 12 48 48 (72 in arid areas)
----------------------------------------------------------------------------------------------------------------
PPE for Handlers Long sleeved shirt Mixers and loaders: Applicators:
Note: ``CR'' = Chemical Resistant Long pants Coverall over short Coverall over long
Waterproof gloves sleeved shirt, short sleeved shirt, long
Shoes, socks pants pants
Protective eyewear CR footwear, socks CR gloves such as
CR headgear for barrier laminate or
overhead exposure viton
CR apron CR footwear
Dust/mist filtering CR headgear for
respirator (TC-21C) overhead exposure
Protective eyewear
Applicators and other For exposures in
handlers: enclosed areas, either
Coverall over short an organic vapor
sleeved shirt, short removing cartridge
pants respirator (TC-23C) or
Waterproof gloves canister approved for
CR footwear, socks pesticides (TC-14C)
CR headgear for
overhead exposure
CR apron when cleaning
equipment
Outdoor exposures:
dust/mist respirator
(MSHA/NIOSH TC-21C)
----------------------------------------------------------------------------------------------------------------
[[Page 64290]]
PPE for Early Entry Workers Coverall Coverall over short Coverall over long
Waterproof gloves sleeved shirt, short sleeved shirt, long
Shoes, socks pants pants
Protective eyewear Waterproof gloves CR gloves
CR footwear, socks CR footwear, socks
CR headgear for CR headgear for
overhead exposure overhead exposure
Protective eyewear
----------------------------------------------------------------------------------------------------------------
Double Notification Required? No No Yes
Only Oral Only Oral Oral and posting
----------------------------------------------------------------------------------------------------------------
Supplemental distributors must develop separate brochures because
product names will be different. However, ``buyout/transferred,''
``orphaned/canceled,'' and ``dormant'' products for which WPS label
language has been approved by EPA (all described in Unit IV.H.) may be
included in the same brochure if the following conditions are met.
``Buyout/transferred'' products can be included only if (1) both
registration numbers are listed in the reference table, and (2) the
brochure cover specifies previous registrants' names represented on the
``transferred'' products' labels and that these products have been
transferred to the existing registrant. (i.e., this brochure also
contains products previously owned by companies B, C, and D but now
owned by company A. . .) This will facilitate end users locating the
correct brochure that corresponds to each product. If ``orphaned/
canceled'' products are included, then the reference table should
specify ``canceled: generic instructions'' for each such product and
should indicate the specific generic requirements for each particular
pesticide's label.
Optional information for both single-product supplements and multi-
product brochures includes: complete registrant identification,
including company logo; statements clearly connecting the brochure with
the ``STOP stickered'' product; footnotes explaining chemical resistant
categories for gloves, respirators, etc.; statements to clarify
information given in the brochure; and statements concerning:
discarding, washing, or maintenance of personal protective equipment,
user safety recommendations, Spanish language warnings, REI's that are
longer than those prescribed by the WPS, and Engineering Control
Statements.
Highlighting. If the registrant has chosen to use a multi-
product brochure, instead of a single-product supplement, as described
in the next sections, EPA strongly encourages that the wholesaler or
retailer highlight or clearly identify in the brochure the specific
product(s) being sold or distributed to the end user. This will assist
the end-user in quickly identifying the requirements for the specific
product before pesticide application.
Location. EPA strongly encourages physically attaching the
supplemental labeling to product containers to ensure end-users receive
the supplemental labeling. (Note: It is a violation of the WPS and this
policy statement to sell or distribute products with non-complying
labels or ``offer such products for sale,'' to the end-user without
providing the appropriate supplemental labeling.) If the labeling is
not attached, it must be located in close physical proximity (e.g.,
immediately adjacent or next to) and accompany the product when the
product is offered for sale to the end-user. When products are
``offered for sale'' to the end user, the supplemental labeling must be
placed in such a way that it is clear which labeling corresponds to
which product. Therefore, single-product supplemental labeling for
different products and multi-product brochures for different
registrants should not be mixed. Whenever feasible, supplemental
labeling should accompany the stickered product at every stage of
distribution.
Format. The supplemental replacement labeling may be
photocopied, provided all text is legible. Illegible photocopies and
faxes are unacceptable. The User Safety Recommendations and
Agricultural Use Requirements must each be located in a clearly
separate box with lines or other graphic indicators to separate them
from the surrounding text.
3. ``STOP sticker'' specifications. If supplemental product-
specific labeling will be used (instead of final printed replacement
labeling as defined in Unit III.B.1. of this document) a ``STOP
sticker'' must be applied only to those products that bear a label
which has not been revised to comply with complete WPS requirements. If
multiple products are contained on pallets or in shipping containers,
these containers must be opened and a ``STOP sticker'' must be affixed
to each individual product's immediate container and outside container
before the product is offered for sale to the end-user. (The immediate
containers of water soluble packages do not have to be stickered.)
``Stickering'' of products must be carried out according to the
following specifications:
Required Text. ``STOP--Use this product only in accordance
with the Worker Protection Standard, 40 CFR Part 170, and the
``SUPPLEMENTAL LABELING WITH WORKER PROTECTION REQUIREMENTS,'' which
must be provided when the product is offered for sale. Otherwise, you
are in violation of FIFRA. For more copies of the labeling, contact
your dealer or call 1-800-713-2291.
Product labels that must not receive stickers. ``STOP
stickers'' must NOT be applied to product labels that already comply
with WPS requirements or that do not require a WPS label. For instance,
deleted-use products must not receive a sticker or WPS labeling.
Timing. The sticker must be affixed to the product
container prior to the time the product is offered for sale to the end-
user.
Prominence. The sticker must be legible and prominent on
the product package through use of contrasting colors or other graphic
devices and must be placed on the label of each product container.
Location. It must be printed on or affixed to the product
container. If affixed, it must be difficult to remove without residue
or damage to
[[Page 64291]]
underlying packaging or labeling. It must not be located on the bottom
of the package or any other place that will not readily be noticed by
users. If the product bears labeling on both outer packaging and
immediate container, the sticker must be affixed to both. However,
inner water soluble packages need not be modified under this approach.
Obscuring existing language. The sticker must not obscure
any information on the existing label.
Highlighting specific products in brochures. EPA strongly
encourages that the retailer highlight or clearly identify in the
brochure the specific product(s) being sold or distributed to the end
user. This will assist the end-user in quickly identifying the
requirements for the specific product before pesticide application.
G. Relabeling Sites
WPS-related relabeling under this policy statement may occur at any
site (such as wholesale or retail sites), by such persons without
registration of the site as a pesticide-producing establishment.
Relabeling of stocks of products with non-complying labels product
under this policy statement may only be carried out by persons acting
under the authority of the registrant as an ``authorized agent'' of the
registrant.
H. Amending Product Labels of Special Products to comply with the WPS
1. Orphaned or canceled products. ``Orphaned'' products are those
products where the registrants are no longer in business. Canceled
products are those products canceled pursuant to FIFRA section 4 or 6
where EPA cancels the registration without transferring it to another
person. You may have existing stock of these products that are within
the scope of the WPS and do not bear WPS labeling.
EPA will allow sale or distribution of a pesticide product which is
an orphaned or canceled product, after October 23, 1995, provided the
product labeling is first modified to comply with the requirements
below.
Labels of orphan or canceled products must be modified by using a
``STOP sticker'' and generic supplemental labeling that is provided
when the product is being offered for sale to the end-user and meets
certain requirements as specified below. WPS-related relabeling under
this policy statement, including generic supplemental labeling may
occur at any site (such as distribution or retail sites), by any
retailer or wholesaler. An example of the supplemental labeling with
the generic worker protection requirement is provided.
``Supplemental Labeling With Generic Worker Protection
Requirements''
For compliance with the Worker Protection Standard (40 CFR Part 170):
Important: This supplemental labeling does not apply (1) to soil or
space fumigant products, (2) to products containing ethyl parathion, or
(3) if elsewhere on the product labeling an Agricultural Use
Requirements box requires compliance with the Worker Protection
Standard (40 CFR Part 170).
When this product is used on an agricultural establishment (farm,
forest, nursery, or greenhouse) for the commercial or research
production of agricultural plants, users must comply with the
instructions in this supplemental labeling. Users who must comply with
these instructions include owners/operators of the agricultural
establishment and owners/operators of commercial businesses that are
hired to apply pesticides on the agricultural establishment or to
perform crop-advising tasks on such establishments. Failure to comply
with the requirements on this supplemental labeling and with the Worker
Protection Standard (40 CFR Part 170) is a violation of Federal law,
since it is illegal to use a pesticide product in a manner inconsistent
with its labeling.
[[Page 64292]]
------------------------------------------------------------------------
AGRICULTURAL USE REQUIREMENTS
Use this product only in accordance with its labeling and
with the Worker Protection Standard, 40 CFR 170. This
Standard contains requirements for the protection of
agricultural workers on farms, forests, nurseries, and
greenhouses, and handlers of agricultural pesticides. It
contains requirements for training, decontamination,
notification, and emergency assistance. It also contains
specific instructions and exceptions pertaining to the
statements in this labeling about personal protective
equipment, restricted-entry intervals, and notification
to workers. The requirements in this box only apply to
uses of this product that are covered by the Worker
Protection Standard (WPS).
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.
Entry-Restrictions: Do not enter or allow worker entry
during the restricted-entry interval (REI). The
restricted-entry interval for this product is:
the specific number of hours or days (if any)
listed elsewhere on the product labeling as the reentry
interval or entry restriction for the crop or site, if
12 hours or more;
12 hours, if no specific number of hours or days
is listed elsewhere on the product labeling as the
reentry interval or entry restriction for the crop or
site;
The restricted-entry interval for this product must be at
least 12 hours.
Notification Instructions: Follow the rules in the WPS
for notifying workers of the application. Exception: If
the instructions about notification (if any) listed
elsewhere on the product labeling require posting of
treated areas (rather than offering a choice), you must
notify workers of the application by warning them orally
and by posting signs at entrances to treated areas,
following the rules in the WPS.
Personal Protective Equipment (PPE) Requirements:
Handler PPE: Pesticide handlers must wear the
PPE listed elsewhere in the product labeling for
applicators. If specific PPE is required elsewhere on
the product label for specific handling tasks (such as
mixing or loading), it must be worn while performing
such tasks. In any case, any handler using this product
must wear no less than: long-sleeved shirt, long pants,
shoes, socks, and chemical-resistant or waterproof
gloves.
Early Entry PPE: 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 the same PPE as required elsewhere on this
product label for applicators, except that any
respirator requirement is waived. In any case, the
minimum PPE required for any early entry worker exposed
to this product is no less than: coveralls, shoes,
socks, and chemical-resistant or waterproof gloves.
Conflicting Instructions: If the requirements of the WPS
conflict with instructions listed elsewhere on this
product label, users must obey the more protective
requirements.
------------------------------------------------------------------------
[[Page 64293]]
The fumigant generic supplemental labeling must be furnished to
purchasers of agricultural fumigants. An example of a generic
supplemental label is provided. The non-fumigant generic supplemental
labeling must be furnished to purchasers of all other agricultural
pesticides, except ethyl parathion products.
``Supplemental Labeling With Generic Worker Protection Requirements
For Agricultural Fumigants''
For compliance with the Worker Protection Standard (40 CFR Part 170):
Important: This supplemental labeling applies ONLY to soil or space
fumigant products used in the production of agricultural plants. It
does not apply if elsewhere on the product labeling an Agricultural Use
Requirements box requires compliance with the Worker Protection
Standard (40 CFR Part 170).
When this product is used on an agricultural establishment (farm,
forest, nursery, or greenhouse) for the commercial or research
production of agricultural plants, users must comply with the
instructions in this supplemental labeling. Users who must comply with
these instructions include owners/operators of the agricultural
establishment and owners/operators of commercial businesses that are
hired to apply pesticides on the agricultural establishment or to
perform crop-advising tasks on such establishments. Failure to comply
with the requirements on this supplemental labeling and with the Worker
Protection Standard (40 CFR Part 170) is a violation of Federal law,
since it is illegal to use a pesticide product in a manner inconsistent
with its labeling.
[[Page 64294]]
------------------------------------------------------------------------
AGRICULTURAL USE
REQUIREMENTS
Use this product only in accordance with its labeling and
with the Worker Protection Standard, 40 CFR Part 170.
This Standard contains requirements for the protection
of agricultural workers on farms, forests, nurseries,
and greenhouses, and handlers of agricultural
pesticides. It contains requirements for training,
decontamination, notification, and emergency assistance.
It also contains specific instructions and exceptions
pertaining to the statements in this labeling about
personal protective equipment, restricted-entry
intervals, and notification to workers. The requirements
in this box only apply to uses of this product that are
covered by the Worker Protection Standard (WPS).
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.
Entry-Restrictions: Follow the applicable entry
restrictions listed elsewhere on the product labeling.
Notification Instructions: Follow the rules in the WPS
for notifying workers of the application.
Exception: If there are instructions listed elsewhere on
the product labeling that requires the posting of
specific signs at treated areas, you must notify workers
of the application by warning them orally and by posting
the signs specified on the labeling.
Personal Protective Equipment (PPE) Requirements: Follow
the applicable PPE instructions (if any) listed
elsewhere on the labeling.
Conflicting Instructions: If the requirements of the WPS
conflict with instructions listed elsewhere on this
product label, users must obey the more protective
requirements
------------------------------------------------------------------------
Supplemental generic labeling specifications
Title. The supplemental labeling must prominently bear the
words ``SUPPLEMENTAL LABELING WITH GENERIC WORKER PROTECTION
REQUIREMENTS'' at the top of the first page or be in a pouch
prominently displaying the words ``SUPPLEMENTAL LABELING WITH GENERIC
WORKER PROTECTION REQUIREMENTS'' attached to the container.
Content. As appropriate to the type of product, the
generic supplemental labeling must contain the complete text of the
labeling as provided in the example presented.
Location. EPA strongly encourages physical attachment of
the supplemental labeling to product containers to ensure end-users
receive the supplemental labeling. (Note: It is a violation of the WPS
and this policy statement to sell or distribute products with non-
complying labels or offer such products for sale, to the end-user
without providing the appropriate supplemental labeling.) If the
labeling is not attached, it must be located in close physical
proximity to and accompany the product when the product is offered for
sale to the end-user. Whenever feasible, supplemental labeling should
accompany the stickered product at every stage of distribution.
Format. The generic supplemental labeling should be
similar to that presented in this policy statement, with all text
legible. See Units IV.F. and IV.H. for examples.
Note: Ethyl Parathion Products: Holders of stocks on products without
WPS-complying labels may not use the option of generic supplemental
labeling described below and should contact the registrant of such
products or, if necessary, EPA for guidance.
``STOP Sticker'' Specifications for Generic Supplemental Labeling
``Stickering'' of orphaned or canceled products is only allowed
according to the following specifications:
Required Text. STOP--Use this product only in accordance
with the Worker Protection Standard, 40 CFR Part 170, and the
``SUPPLEMENTAL LABELING WITH WORKER PROTECTION REQUIREMENTS,'' which
must be provided when the product is offered for sale. Otherwise, you
are in violation of FIFRA. For more copies of the labeling, contact
your dealer or call 1-800-713-2291.
Timing. The sticker must be affixed to the product
container whenever the product is offered for sale or distribution to
the end user.
Prominence. The sticker must be legible and prominent on
the product package through use of contrasting colors or other graphic
devices, and placement on the label of each product container.
Location. It must be printed on or affixed to product
containers. If affixed, it must be difficult to remove without residue
or damage to underlying packaging or labeling and must not be located
on the bottom of the package or any other place that will not readily
be noticed by users. If the product bears labeling on both outer
packaging and immediate container, the sticker must be affixed to both.
(Exception: STOP stickers need not be affixed directly on inner water
soluble packages.)
Obscuring existing language. The sticker or facsimile must
not obscure any information on the existing label.
2. Buy-out or transferred products. These are stocks of products
that have been transferred to another registrant who has responsibility
for the product's registration. The existing stocks have the original
company's name and registration number.
The new registrant should choose one of the following options to
deal with these products:
Recall and relabel/repackage. Recalling the products and
repackaging them at a registered establishment with final printed
replacement labeling, or
Product-specific relabeling. Conducting or authorizing
relabeling of products with either: (i) Final printed product-specific,
WPS-complying replacement labeling or (ii) supplemental product-
specific replacement labeling and a ``STOP sticker'' that meets certain
requirements.
[[Page 64295]]
Relabeling must occur in accordance with the section entitled,
``Supplemental Product-Specific Labeling Specifications.'' This section
also contains information about including ``transferred'' products in
multi-product brochures. Generic Supplemental Labeling and STOP
stickers may NOT be used for these products.
3. Deleted-use products. These are products for which the
registrant has amended the registration to delete certain uses (e.g.,
sod) thereby putting the product outside the scope of the WPS. There
may be existing stocks of such products that still have the previous
label and are thus within the WPS scope.
The registrant should choose one of the following options to
relabel these products. Otherwise, the product may not be distributed
or sold after October 23, 1995.
Recall and relabel/repackage. Recalling the products and
relabeling/repackaging them at a registered establishment with the
current labeling that has been amended to delete WPS uses.
Product-specific relabeling. Conducting or providing a
written authorization for relabeling of products with the current
labeling that has been amended to delete any WPS uses. Products can be
relabeled by: (i) Replacing existing labeling with the current final
printed replacement labeling, or (ii) marking/blocking out all WPS uses
and references to WPS uses (e.g., use directions). If final printed
replacement labeling is used, the amended labeling must completely
obliterate the previous label so that the previous label does not show.
It must be securely affixed to the product package and be difficult to
remove without residue or damage to the underlying packing or labeling.
If the option to mark/block out of all WPS references is chosen, all
WPS uses and references to WPS uses must be completely blocked and no
other portions of the label text that remain unchanged must be altered
or obscured.
In the event that a retailer or wholesaler is unable to get a
registrant to recall and relabel these products, you should contact
EPA's Registration Division (703-305-6250) for instructions on how to
proceed with those products.
4. Dormant products. These are products where no quantity of the
product has been produced and distributed after April 21, 1994, and for
which registrants elected to defer labeling amendments. If there are
products left in the channels of trade, they must not be sold or
distributed after October 23, 1995. In this situation, the registrant
has several options:
Product-specific relabeling. Amend the product
registration to include the WPS requirements and follow all
requirements for relabeling with product-specific replacement labeling.
Relabeling with non-WPS label. Amend the product
registration to delete any WPS uses by either recalling and relabeling/
repackaging or by conducting or providing a written authorization for
relabeling of products at the product's location with the updated, non-
WPS label.
Generic labeling. Voluntarily cancel the registration and
follow all requirements for orphaned or canceled products concerning
relabeling with supplemental generic replacement labeling.
V. Deadline for Relabeling and Final Sale
By October 23, 1996, all products being distributed or sold must
bear final printed, WPS-complying, replacement labeling that conforms
to the requirements outlined in this policy statement. Supplemental
product-specific replacement labeling will not be allowed after this
date.
Retailers or wholesalers of orphan or canceled products may still
use generic supplemental replacement labeling and ``STOP stickers'' in
accordance with this policy statement after October 23, 1996.
VI. For Further Information and Assistance
If after reading this policy statement you have questions about
what you must do to bring the labeling of any product you hold into
compliance, you are encouraged to call the registrants of any such
products for assistance. If further assistance is necessary, you may
call EPA or any of its regional offices for assistance. The EPA
headquarters number for assistance is (703) 305-6250. Additional
information also may be obtained from the industry task force at 1-800-
713-2291.
List of Subjects in Part 156
Environmental protection and Worker protection.
Dated: November 30, 1995.
Daniel M. Barolo,
Director, Office of Pesticide Programs.
[FR Doc. 95-30503 Filed 12-13-95; 8:45 am]
BILLING CODE 6560-50-F
