EPA 730-N-03-001
\ UNITED STATES ENVIRONMENTAL PROTECTION AGENCY
\ V27V * WASHINGTON, D.C. 20460
PESTICIDE REGISTRATION (PR) NOTICE 2003-1
NOTICE TO MANUFACTURERS, FORMULATORS, PRODUCERS AND
REGISTRANTS OF PESTICIDE PRODUCTS
ATTENTION: Persons Responsible for Registration of Pesticide Products
SUBJ1ECT: Labeling of Pesticide Products under the National Organic Program
I. PURPOSE
This notice describes how registrants can obtain Environmental Protection Agency (EPA)
approval of label language indicating that all ingredients (active and inert) in a pesticide product
and all uses of that pesticide meet the criteria defined in the United States Department of
Agriculture's (USDA) National Organic Program (NOP) Rule. This PR Notice provides an
example of acceptable label language and the procedures for adding such identification to
product labels. The information on the pesticide label will assist organic growers and those
persons certifying organic production methods in knowing which pesticide products meet the
requirements of the NOP Rule for use in organic agriculture. According to USDA's rules,
organic growers are required to rely on their certifier for compliance with the NOP (7 CFR
Sections 205.400 - 406). Any label language on a pesticide product as described in this notice is
to assist the grower and certifier. Label language'on a pesticide product stating that the pesticide
meets the NOP Rule criteria is not required for an organic producer to utilize a pesticide product
which the producer and/or certifier ascertains meets the requirements of the NOP. Registrants of
pesticide products are not required to add such NOP language to their products for the products
to be used in organic agriculture. Use of products with NOP language does not modify the
requirement that growers rely on their certifier for compliance with the NOP.
This notice provides guidance to pesticide registrants who may consider participation in
this voluntary program.
II. BACKGROUND
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On December 21, 2000 (65 FR 80548), the USDA's Agricultural Marketing ';
Service (AMS) published its final rule for the National Organic Program. The final rule
establishes national standards for the production and handling of organically produced products,
including a National List of substances approved and prohibited for use in organic production
and handling. The rule became effective on October 21, 2002.
The National List is divided roughly into 3 categories, substances permitted in crop
production (7 CFR 205.601), substances permitted in animal production (7 CFR 205.603), and
substances permitted in food processing (7 CFR 205.605 & 606). Specific prohibitions are also
included (7 CFR 205.602 & 604), as are procedures to amend the National List (7 CFR
205.607). The National List includes, among other things, substances that are pesticides or
pesticide inert ingredients as defined and regulated under the Federal Insecticide, Fungicide and
Rodenticide Act (FIFRA). The Secretary of Agriculture determines, upon recommendation by
the National Organic Standards Board (NOSB), which substances, including active ingredients
and inert or other ingredients, are allowable for use in organic production and handling.
At present, the National List only specifies by name certain synthetic active ingredients
which are allowed and non-synthetic materials which are prohibited. EPA intends to rely on the
expertise of USD A in all determinations regarding whether an active ingredient qualifies under
the approach set forth in the National List. Therefore, until USDA identifies for EPA those
specific active ingredients that meet the conditions of the List, EPA may not be able to approve
NOP labeling for products containing such ingredients. A list of all allowable non-synthetic
materials can not be complete. Innovative individuals will continue to research pesticidal
properties in plants and microbes and develop ways within the constraints of the National
Organic Program to utilize them as pesticides. Therefore, EPA expects to have a continuous
working relationship with USDA about which active ingredients meet the criteria.
Pesticide manufacturers and organic farmers have indicated to EPA that it would be
useful to have some identification on pesticide labels regarding those pesticide products that are
acceptable for organic production. In response to this request, EPA has consulted with
USDA/AMS National Organic Program Staff and with the NOSB on the procedures for
registrants of pesticide products submitting product registration amendments to EPA. These
amendments will allow pesticide product labels to carry identification language denoting that the
product meets the criteria allowable under the NOP. If the ingredients and label language meet
the criteria for organic production and handling, and the product and its labeling meet the
pesticide registration requirements, they will be accepted by EPA. USDA will provide EPA with
a current version of the National List whenever it is updated.
III. PESTICIDE LABELING UNDER FIFRA
Under FIFRA, unless otherwise exempted, each pesticide product must be registered with
EPA, and its labeling accepted before it may be distributed or sold for use. FIFRA establishes
standards for pesticide labeling, among which is the requirement that labeling not be false or
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misleading in any manner, and that products and use(s) not pose unreasonable adverse effects on
the environment. Users are required to use; a registereo. pesticide product only in accordance \vith
its labeling, or face possible penalties under FIFRA.
EPA has generally regarded statements such as "organic" to be forms of false or
misleading safety claims prohibited by statute and EPA's labeling regulations. The Agency
believed such claims could not be well defined, in part because there are a variety of definitions
of organic. EPA has evaluated its policy in light of the Federal Organic Foods Production Act of
1990 and USDA's associated NOP and has determined, for reasons explained below, that a
statement "for organic production" is an acceptable labeling statement under certain conditions.
Prior to the Federal Organic Foods Production Act of 1990 and USDA's promulgation of
the associated National Organic Program rule, EPA regarded the term "organic" as misleading
because there was no specific standard to which "organic" clearly referred and a variety of
"organic"- type standards existed. For example, using a dictionary, various definitions of the
term "organic" could be found including "any chemical compound containing carbon:" "of,
relating to, yielding or derived from living organisms;" and "grown only with animal or
vegetable inputs, such as, manure, bone meal, compost, and various animal or vegetable pest
management materials." In addition, a number of organizations and States had their own
(sometimes different) definitions of "organic." Furthermore, partly because of the variety of
definitions, EPA believed that the term "organic" could give users misleading impressions
regarding safety of the product.
Under the Federal Organic Food Production Act (7 U.S.C. section 650let seq.) and
associated NOP Rule, consistent Federal standards for "organic" now exist so that confusion over
the meaning of "organic" with respect to crop and animal production (or "food" production) has
been minimized. Further the phrase "for organic production" provides information about the use
of the product in USDA's program and would not be likely to be perceived as safety information.
EPA believes that the minimal potential for such claims to mislead consumers is outweighed by
the benefit to the regulated community in adapting EPA's policy to mesh with the regulations,
policies, and programs of other regulatory agencies such as USD A. Identification of NOP
allowed products should greatly assist organic producers and handlers in making an informed
choice when selecting pesticide products that may be used under the Federal Organic Foods
Production Act of 1990 and the associated NOP Rule. Therefore, EPA has concluded that using
the phrase "for organic production" when referring to pesticide products that may be used for
organic production would not be considered false and misleading.
IV. GUIDANCE FOR ACCEPTABILITY OF PRODUCTS FOR NOP LABELING
UNDER FIFIRA
This section contains a discussion of existing requirements of: the Federal Organic Foods
Protection Act of 1990, the National Organic Program, the Federal Insecticide, Rodenticide and
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Fungicide Act, EPA regulations and the Federal Food, Drug and Cosmetic Act. In order to be
acceptable for use under the NOP, the product must meet the following:
A. Product Composition
-In order for a product to meet the requirements of the NOP, each ingredient in the
product, including active and inert ingredients, must be allowable under The National List of
Allowed and Prohibited Substances (National List) contained in 7 CFR part 205. !
- The National List does not specifically list each allowable material but rather criteria for
allowable materials. (However, specific allowed synthetics are included on the National List.)
The National List is available at: www.usda.gov/nop/nop/NationalList/FmalRule.htail. Inert
ingredients (including List 4), (specifically allowable for use in crop and livestock production in
the National List) are available at: http://www.epa.gov/opprd001/inerts/list4inerts.htail. Both, of
these lists will change as new materials are added and materials are deleted.
B. Product Uses
1. A product with use instructions that are inconsistent with the instructions specified by
the NOP cannot claim compliance with the NOP on its label. Thus, if the National List includes
restrictions on the use of a substance, the pesticide product's uses and use directions must
conform to those restrictions. If a product bears multiple uses, some of which are within the
National List restrictions and others not, the product should not be labeled with a NOP statement.
In this instance the registrant may consider applying to register a new product which is fully .
compliant with the NOP. (see Section V). '•
Example: EPA List 4 inert ingredients are permitted under the NOP rule at Part 205.601 and Part 205.603
for use in crop and animal production only, not processed food production. A disinfectant/sanitizer pesticide product
containing a List 4 inert bears directions for use in sanitizing both in animal facilities and in food processing areas or
which bears only non-specific instructions for disinfection/sanitizing is not eligible for a NOP statement as such a
claim regarding the product as a whole would be false since its label language covers uses not allowed under the
NOP.
2. There are NOP use restrictions where it is unclear how to comply. An example would
be "...copper-based materials must be used in a manner that minimizes accumulation in the soil
and shall not be used as herbicides" where, in order for EPA to determine whether the product is
consistent with the NOP criteria, the Agency would need to have sufficient information from a
registrant demonstrating that the product does in fact comply with the NOP.
C. Food Uses
All ingredients of pesticide products registered (or exempted from regulation under
FIFRA) for use on foods must have either a tolerance or an exemption from the requirement of a
tolerance if residues of such ingredients result in or on the food from such use. If no tolerance or
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exemption has been granted, foods containing such residues may not be lawfully sold in
commerce. (Title 21 U.S.C. Section 408).
D. Alternate Formulations
All formulations of a pesticide product which have the NOP allowed wording must
comply with the requirements of the NOP. We would not allow alternate formulations for
products which are not fully compliant with the NOP requirements where the basic formulation
has NOP labeling language (40 CFR 1 52.43 (b)(3)).
V. PRODUCTS EXEMPTED FROM REGULATION UNDER FIFRA.
EPA will only review labeling submissions for pesticide products that are registered or
proposed to be registered. There are pesticide products which are exempted from regulation
under 25(b) of FIFRA. EPA does not, however, review product labels of pesticides exempt
under 25(b) and, therefore, EPA cannot approve the use of NOP language on 25(b) product
labels. Products exempted under FIFRA section 25(b) are not precluded from identifying
whether they meet the requirements of the National Organic Program. However, producers of
such products are reminded that it is their responsibility to: :
Ensure the products contain only ingredients permitted under the National List (7 CFR
205.600-607)
Ensure that they conform in all respects with the criteria of the National List
Ensure they conform in all respects with the criteria for exemption from regulation under
FIFRA [40 CFR 152.25 (a) - (f)] .
Be aware that certain exempted products may be in violation of FIFRA if they
misrepresent on the label their status under the NOP. [See for example 40 CFR
Also note that some of the active and inert ingredients exempted from regulation
currently do not have a tolerance or exemption from the requirement of a tolerance for
residues of these pesticide chemicals on food.
VI. ACCEPTABLE FORMS OF LABELING STATEMENT
The phrase, "For Organic Production," located on the front panel of the label in close
proximity to the product name is an example of an acceptable labeling statement. The phrase
should not appear above the product name (in the location normally reserved for a Restricted Use
Statement). For example, the following would be acceptable:
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Sam's Insecticide
For Organic Production
The Agency has determined that this label statement would be acceptable under Part 156
labeling requirements. To avoid being misleading, this statement should be in a font size
comparable to that of other type and not highlighted by size, color, contrast or placement.
EPA has worked with USDA and the NOSB to develop this suggested labeling language.
The Agency believes that it would be useful for registrants to use a consistent labeling statement
to avoid any confusion on the part of individuals wishing to use products for organic crop
production. The language was also developed to avoid creating label language which could be
viewed as an endorsement by a Federal agency; such statements are generally considered false
and misleading. See 40 CFR 156.1 0(a)(5)(v). |
The Agency is aware that other groups may have reviewed materials proposed for use in
organic agriculture for a number of years and have determined that they meet the requirements of
USDA's NOP rule. This Agency will also consider accepting use of label language and/or logo
of the other groups for use on pesticide products in lieu of the phrase "for organic production"
providing the registrant submits a letter from that group stating that the product does, in the
opinion of such group, meet the NOP requirements, and the Agency concurs with the opinion.
EPA will also consider whether such labeling could be false or misleading.
VII. HOW REGISTRANTS MAY APPLY FOR APPROVAL OF A NOP STATEMENT
A. Currently registered products that conform fully to NOP criteria
Submit an application for amended registration that should include:
An application for Amended Registration (EPA Form 8570-1).
Draft labeling, bearing the proposed changes, and including an acceptable NOP phrase or
statement (see Section VT).
In order to substantially shorten the time for EPA approval of the new label language,
registrants should consider also submitting a new Confidential Statement of Formula (EPA Form
8570-4), which includes a brief annotation describing how each product ingredient is consistent
with the NOP; the brief description could include references to listed ingredients or categories in
the National List. The registrant could also cite the EPA List of Other (Inert) Pesticide
Ingredients Inert - List 4, for each ingredient in the product, where applicable.
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In order to further expedite EPA approval, registrants should also submit a request to
amend their registration to add the following term and condition: "This registrant acknowledges
that its product will be misbranded if one or more of this product's ingredients, active and/or
inert, is removed (delisted) from the National List. If one or more of the ingredients in this
pesticide product are removed (delisted) from the National List, the registrant will submit a label
amendment to the Agency within 30 days requesting deletion of the NOP related labeling
.language. If the registrant does not submit such a request within 30 days of delisting, EPA may
cancel or suspend this product pursuant to procedures in or similar to those in FIFRA Section
B. Currently registered products that do not fully conform to NOP criteria.
Submit a completed Application for Registration (EPA Form 8570-1) of a new product
which fully complies with the requirements of the National List along with all forms and data
requirements for a pesticide product registration. Additional data may be required if active or
inert ingredients in the product change. If the new product merely contains more restrictive label
language to have all label uses fully conform with the NOP requirements, no additional data will
likely be required. Once you have received your fully conforming NOP label, you may wish to
continue to market the currently registered product for the non-organic market or you may decide
to cancel the registration of the currently registered product.
Include draft labeling, bearing the proposed label language, and including an acceptable
NOP phrase (see Section VI). ..
In order to substantially shorten the time for EPA approval of the new label language,
registrants should consider also submitting a brief annotation describing how each product
ingredient is consistent with the NOP; the brief description could include references to listed
ingredients or categories in the National List. The registrant could also cite the EPA List of
Other (Inert) Pesticide Ingredients Inert - List 4, for each ingredient in the product, where
applicable. •
In order to further expedite EPA approval, registrants should also submit a request to
amend their registration to add the following term and condition: "Registrant acknowledges that
its product will be misbranded if one or more of this product's ingredients, active and/or inert, is
removed (delisted) from the National List. If one or more of the ingredients in this pesticide
product are removed (delisted) from the National List, the registrant will submit a label
amendment to the Agency within 30 days requesting deletion of the NOP related labeling
language. If the registrant does not submit such a request within 30 days of delisting, EPA may
cancel or suspend this product pursuant to procedures in or similar to those in FIFRA Section
C. Pending Applications
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Resubmit an application for registration which notifies EPA of changes in your
application to conform to the NOP. If the amendment involves changes in the ingredients of the
pesticide product, any required additional data as discussed above may involve a delay in the
Agency's decision regarding registration.
Provide draft labeling, bearing the proposed changes, including an acceptable NOP
phrase or logo (see Section VI).
Follow the above procedures suggested in Section B.
D. New Product Registrations
Submit an application for registration of a pesticide product including all required EPA
forms and supporting information.
Provide draft labeling, including an acceptable NOP phrase or statement (see Section VT).
In order to substantially shorten the time for EPA approval of the new label language,
registrants should also consider submitting a brief annotation describing how each product
ingredient is consistent with the NOP; the brief description could include references to listed
ingredients or categories in the National List. The registrant could also cite the EPA List of
Other (Inert) Pesticide Ingredients Inert - List 4, for each ingredient in the product, where
applicable. .
In order to further expedite EPA approval, registrants should also submit a request to
amend their registration to add the following term and condition: "Registrant acknowledges that
its product will be misbranded if one or more of this product's ingredients, active and/or inert, is
removed (delisted) from the National List. If one or more of the ingredients in this pesticide
product are removed (delisted) from the National List, the registrant will submit a label
amendment to the Agency within 30 days requesting deletion of the NOP related labeling
language. If the registrant does not submit such a request within 30 days of delisting, EPA may
cancel or suspend this product pursuant to procedures in or similar to those in FIFRA Section
E. When to Make Submission
EPA will begin processing applications for review of new or amended product labels
bearing statements indicating that the pesticide meets the NOP Rule criteria (see example
statement in Section VI) when this PR Notice goes into effect. EPA is working with USDA to
develop this list of active ingredients which are allowable under the National List. EPA will post
this list on the Office of Pesticide Programs Web site (http://www.epa.gove/pesticides/) in the
What's New section when this list of allowable active ingredients is available. Until this list is
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developed, registrants may experience delays in Agency approval of pesticide labels with this
language until this list is completed.
VIII. DISTRIBUTOR PRODUCTS
It is a registrant's responsibility to ensure that his distributor products (supplemental
distribution) continue to conform to Agency requirements. A registrant who amends his product
and product labeling would be obligated to ensure that any distributor products under the basic
registration are also amended (40 CFR 152.132).
EPA believes it likely that distributor products will be eligible for NOP labeling if the
underlying registered product is eligible. Under EPA requirements, a distributor product may
vary from the underlying registered product only in minor ways. The composition may not vary,
so that the NOP composition criteria should be met. Uses may vary only by omission of uses
(the distributor product is not required to include all uses on the basic registered product), so that
the use criteria should also be met. Note: The acceptable label statement must be on the basic
registered product if it is on a distributor product (40 CFR 152.132). A distributor may not add
an NOP statement independently.
IX. R3EGISTRANT/APPLICANT RESPONSIBILITIES
It is the registrant's/applicant's responsibility to demonstrate to the Agency that their
product conforms fully with all requirements of the NOP and that their NOP labeling statements
are therefore true. EPA will not be able to approve an application that fails to provide sufficient
information to allow the Agency to make this determination. It should be pointed out that certain
types of restrictions under the NOP are difficult to verify, and the Agency may not be able to
approve the application for NOP labeling without additional justification provided by the
applicant.
Example 1: Under 7 CFR 205.601, certain copper products are permitted provided that
materials are used in a manner that "minimizes accumulation in the soil." This criterion is non-
quantified. An applicant must justify how the use directions for the product will minimize
accumulation in the soil.
Example 2: Certain chlorine-containing products are approved for use as disinfectants
and sanitizing agents in agricultural, animal and food processing production, provided that
residual chlorine at the use level does not exceed limits set under the Safe Drinking Water Act.
An applicant who seeks an NOP label for a chlorine product must ensure that the use directions
are adequate so that the user who follows label instructions will remain within the Safe Drinking
Water limit.
X. RELATIONSHIP OF THE NATIONAL LIST TO EPA PESTICIDE INGREDIENTS
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Inclusion of an ingredient on the National List is independent of approval of ingredients
for use in pesticide products under FIFRA or FFDCA. The National List may include substances
that are not currently found in any registered pesticide product.
For example, inclusion on the EPA List 4 Inerts list is sufficient to identify a pesticide
inert ingredient as NOP-allowed, but the opposite is not true. Inclusion on the National List does
not allow an applicant to presume that an ingredient (active or inert) is acceptable to EPA for use
in a pesticide product.
Each ingredient in a pesticide product must be approved by the Agency, and, if for food
use, must have a tolerance or exemption from the requirement of a tolerance for residues on food
under the Federal Food, Drug and Cosmetic Act. Applicants who wish to obtain clearance for an
ingredient on the National List for use in pesticide products are advised to consult with the
Agency.
XI. DELISTING
USDA may on occasion prohibit use of previously allowed materials. If USD A prohibits
use of a previously allowed material, use of this material after the delisting may endanger an
organic producer's organic certification. Such prohibitions would be made as amendments to the
National List through rule making with public comment. Organic certifiers normally provide for
a period of time where a producer can use up existing stocks of a delisted material. Registrants
and users are advised to keep abreast of any such delistings, and not to rely solely on the
pesticide label for approval status under the NOP.
A. EPA cannot unilaterally modify registrations to keep abreast of changes in the
National List and EPA List 4 inerts which could have the effect of making continued use of the
NOP language unacceptable. Further, there may be delays in the revision of pesticide labeling.
Thus produces) in channels of trade and in the hands of users may not accurately reflect NOP
status if an ingredient is delisted. Therefore, use of the product, though not in violation under
FIFRA5 s misuse provisions, may jeopardize the user's organic production certification.
B. If delisting results in the loss of NOP approval for a pesticide product, EPA will
permit the removal of the NOP statement by notification according to PR Notice 98-10, so that
product labels can be revised rapidly. Registrants should submit such notifications and make
label changes as soon as possible, to avoid having the product label deemed to be false and
misleading under FIFRA.
C. If the registrant wishes thereafter to continue to market a product for the organic
market, he should submit an application for a new product which is compliant with the NOP.
D. If a registrant does not take actions to remove information on a product label
indicating a product meets the requirements of the NOP, the Agency may take action pursuant to
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FIFRA Section 2(q), 6(e), 40 CFR 156.10(a)_(5) and/or any other appropriate provision of FIFRA
and the associated regulations.
XII. OTHER INFORMATION
We encourage registrants who want their pesticide products to be marketed for organic
production to list all product ingredients on the pesticide label, including inert or other
ingredients. This will make it easier for an organic farmer or the farmer's certifier to verify that
the product is allowable for use in organic production, especially where changes to the NOP are
made.
XHI. WHERE SHOULD REGISTRANTS SUBMIT AN APPLICATION
A. In order to properly process applications, registrants should send applications for a label
amendment as described above to the appropriate following address:
U.S. Postal Service Deliveries
The following official mailing address must be used for all correspondence or data
submissions sent to OPP by "mail:
Document Processing Desk (AMEND) or (APPL)
Office of Pesticide Programs (7504-C)
U.S. Environmental Protection Agency
Ariel Rios Building
1200 Pennsylvania Ave., NW
Washington, D.C. 20460-0001 .
Personal/Courier Service Deliveries
The following address should be used for all correspondence or data submissions that are
hand-carried or sent by courier service Monday through Friday, from 8:00 AM to 4:30
PM, excluding Federal holidays:
Document Processing Desk (AMEND) or (APPL)
Office of Pesticide Programs (7504-C)
U.S. Environmental Protection Agency
Room 266A, Crystal Mall 2
1921 Jefferson Davis Highway
Arlington, Virginia 22202
XIV. NON-BINDING STATEMENT
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This PR Notice provides guidance to EPA and to pesticide registrants. This notice is not
binding on either EPA or pesticide registrants, and EPA may depart from the guidance provided
in individual circumstances. Likewise, pesticide registrants may assert that the guidance is not
appropriate for a specific pesticide or situation.
XV. FOR FURTHER INFORMATION
For information on this notice, contact:
• Robert Torla, Biopesticides and Pollution Prevention Division, at 703-308-8098, or by email
to: torla.robe'rt@epa.gov.
• Linda Arrington, Registration Division, at 703-305-5446, or by email to: ;
arrington.linda@epa. gov.
• Michael Hardy, Antimicrobial Division, at 703-308-6432, or by email to:
hardy.michael@epa.gov. ]
Marcia E. Mufkey, Director
Office of Pesticide Programs, (75(JlC)
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