1. MANAGING RETAILER'S OWNED
BRANDS UNDER FIFRA

2. Wade Miller, CHMM, CPEA, PMP
Sr. Compliance Consultant
Wenck Associates, Inc.

3. FIFRA 101
• What is FIFRA?
• How does EPA regulate pesticides?
– Pesticide labels
– Information sources
• Responsibilities of a pesticide registrant
• Supplemental distribution

4. Definitions
• FIFRA: Federal Insecticide, Fungicide and
Rodenticide Act
• Pesticide: “Any substance or mixture of
substances intended for preventing, destroying,
repelling, or mitigating any pest.”
• Pest: Any insect, rodent, nematode, fungus,
weed, or any other form of terrestrial or aquatic
plant or animal life or virus, bacteria or other
micro-organism.” [Definition doesn’t apply to the
last three in/on living people or animals.]

5. Examples of Pesticides

6. Pesticide Regulation
• EPA has authority to collect data
– Industry fulfills data requirements
• EPA reviews and evaluates data
– Risk assessment and risk management
• EPA registers a pesticide if it meets FIFRA
standard:
– When used in accordance with widespread and commonly
recognized practice, the pesticide generally will not cause
unreasonable adverse effects on human health or the
environment

7. Registered Pesticide
• Decision to register includes:
– Product composition and packaging
– Product labeling: directions for use; limitations on
where, how & when a pesticide can be applied
• Registration number:
– EPA Reg. No.: 1234-56
• Registrant: Person who has registered any
pesticide under FIFRA

8. Pesticide Labels and Labeling
Elements included on
pesticide labels include:
• Product identification
• Ingredient information
• EPA Reg. No.
• Signal word and symbol
(if required)
• Precautionary statements
• Directions for use
• Storage & disposal
instructions

9. Pesticide Labels and Labeling
• Label: written, printed or graphic matter on or
attached to the pesticide or its container
• Labeling: all labels and all other written,
printed or graphic matter accompanying the
pesticide or that is referenced on the label
• “Label is the law” principle under FIFRA
– Label incorrect: misbranded (registrant violation)
– User doesn’t follow label: misuse (user violation)

10. Pesticide Regulation
Mandatory Guidance
• Pesticide Registration
Notices (PR Notices)
• Pesticide Registration
Manual
http://www2.epa.gov/
pesticide-registration
• Label Review Manual
http://www2.epa.gov/
pesticide-registration/label-
review-manual
FIFRA
16,000 Labels

11. Pesticide Registrant Responsibilities
Registrants are entirely responsible for their pesticide and pesticide
labeling and must:
• Ensure each production facility is registered
• Maintain a U.S. mailing address
• Notify EPA of name and/or address changes
• Notify EPA if the authorized agent changes
• Provide info on adverse effects of the pesticide
• Ensure their product labeling is in compliance
• Ensure that supplemental distributor products & their distributor
product labeling are in compliance
• Obtain permission to transfer registration of a product and/or data
to another person
• Pay the annual pesticide registration maintenance fees.

12. Pesticide Regulation (FIFRA section 7)
Any facility where pesticides are produced
(includes putting on labels and repackaging) must:
• Register the facility with EPA as a pesticide
producing establishment and obtain an EPA
establishment number (40 CFR Part 167)
• Report annual production volume to EPA (40 CFR
Part 167)
• Maintain records of production (40 CFR Part 169).

13. Retailer Owned Brands of Pesticides
• Register the product
• Original registrant registers an alternate brand name
– Enter into contract with registrant for relevant activities
(sale, distribution, labeling, repackaging, etc.)
• Supplemental distributor. Both parties must:
– Enter into contract
– Complete & file the form Notice of Supplemental
Distribution of a Registered Pesticide Product (EPA Form
8570-5) with EPA
– Comply with requirements in 40 CFR 152.132

14. Supplemental Distribution (§152.132)
• Distributor product must be produced, packaged
and labeled by the same producer who produces,
packages, and labels the registered product (or
under contract with the registrant).
• The distributor product cannot be repackaged
(remain in the producer’s unopened container).
– If you repackage, your contract with the registrant
must specifically include that. [Supplemental
distribution + contract packaging/repackaging.]

15. Supplemental Distribution (continued)
The label of the distributor product must be the same as that
of the registered product, except that:
• The distributor product name may be different.
• The name & address of the distributor may appear instead
of the registrant’s name & address.
• The registration number must include the distributor’s
company number, e.g., EPA Reg. No. 1234-56-987, where
987 is the distributor’s company number.
• The establishment number must be that of the final
establishment where the product was produced.
• Specific claims may be deleted, provided no other changes
are necessary.

16. Federal Insecticide, Fungicide,
Rodenticide Act (FIFRA)
Introduction:
• EPA vs FDA
• Federal Registration
• State-Specific Registration
• Articles
• 25(b) products
• Devices
• Labeling
• Branding
• Importing
• Resources

17. EPA vs FDA
• Two different agencies; two different sets
of regulations.
• Products may be regulated under either,
neither or both, based on claims.
• FDA for products designed for on/in a
person; EPA for other products.

18. EPA Registration
18
• Pesticides are Regulated by US EPA and must
be registered AND produced in a registered
facility.
• If a claim is made (disinfects, sanitizes, kills,
repels, etc.), then registration is required.
• Use must match registration: Treatment of an
article, for example, must be included on the
EPA stamped label before it may be used for
that purpose.

19. What Claims?
Examples of Claims That the Agency Considers to be Pesticidal
Cleaning products with claims such as those described below are considered by the
Agency to be intended for a pesticidal purpose because the claims imply or express
that the product mitigates a pest, directly or indirectly, either by itself or by removing
the pest’s food, food source or its habitat. These examples represent claims or types
of claims for a cleaning product that would trigger a requirement to register the
product under FIFRA.
• Cleans away, washes away or removes any pest covered by 40 CFR §152.5.
• Cleans away, washes away or removes biofilm or scum (unqualified).
• Cleans away, washes away or removes allergens (unqualified).
• Cleans away or removes allergens associated with a pest (e.g., dust mite allergens,
cockroach allergens).
• Removes pests by suffocating or drowning.
• Cleans or removes pest habitats or breeding sites.
• Cleans, precipitates or removes contaminants, nutrients or matter that provide
food or habitat for pests.

20. What Claims? (cont.)
• Cleans, reduces or removes scum or sludge where pests breed, feed or
live.
• Out-competes or displaces a pest for nutrition or habitat.
• Cleans or removes the habitat where biofilm, germs, allergens or
microorganisms can hide, thrive or grow.
• Prevents, blocks, removes, neutralizes or controls bacteria or other pests
that cause odors.
• Sanitizes, disinfects or sterilizes.
• Images of pests or pest habitats (e.g., nest, hive or web) that imply
cleaning or removal of pest habitats, or of nutrition or sources of nutrition
for pests.
• A banner, logo, design, header or any claim on a label or labeling, or
through other means such as web sites, advertising, etc. that specifically
links the cleaning product to pest control, Integrated Pest Management
(IPM), pests or a specific kind of pest.

21. Additional Brand
21
Additional Brand Amendments occur when the initial registrant (vendor)
submits an amendment to EPA to have another brand included with the
initial registration.

22. Supplemental Distribution
22
• Occurs when registering entity doesn’t
own the formulation
• The product is registered so long as
the initial registration is valid or until
one of parties (producer or initial
registrant) of the agreement notifies
EPA that the product will no longer be
sold under the distributor’s brand.
• Cannot have two supplementally
distributed products with the same
name.

23. State Registrations
23
State Registration of Pesticides
After a pesticide is registered by EPA, states require registration of
pesticides under specific state pesticide registration laws. A State
may have more stringent requirements for registering pesticides
for use in that state. Ultimately, states have primary responsibility
(called primacy) for pesticides distributed within state borders.
• States may also require registration of pesticides that are
exempt under US EPA regulations. For retailers, these are the
25(b) exempt pesticides (25(b) stands for the section in FIFRA
where this exemption is found).
• States require annual or biennial registration renewals (which
includes a per-product registration fee).
• States typically require that products continue to be registered
for a period of time (one or two years) after the product has
been discontinued.

24. California Example
California provides a guidance document for
registrants similar to EPA’s Label Review
Manual.
California guidance includes requirements
around supplemental distribution (may not
have two products with same
name/different manufacturers), product
names (read consecutively left to right and
top to bottom), and 25(b) registration in
addition to what EPA’s manual provides.
http://www.cdpr.ca.gov/docs/registration/manual/guidance.pdf

25. Article Exemption
25
There are two exemptions that affect Retailers:
1. Article Exemptions
An article or a substance treated with or containing a pesticide to protect
the article or substance itself is exempt from registration.
• The antimicrobial chemical must be registered for that use
• The article/packaging/labeling can make no health claims
• The markings/labeling calling attention to the treatment has to clearly
note that the treatment is for protection of the article, and not to
prevent the spread of germs.
• Example: The Antimicrobial Shower Curtain: “these heavy duty
shower curtains are treated to resist mold, mildew, and bacteria. They
contain the anti-microbial agent Vinyzene, a proven mildew-resistant
chemical that keeps the curtains hygienic at all times. Vinyzene also
prevents unsightly stains caused by bacteria build-up. The mildew
resistance remains effective for the life of the curtains.”

26. Use Consistent with Label….

27. Nano Silver: Not Approved!
• Columbia Sportswear Company has reached a
settlement with the U.S. Environmental Protection
Agency for distributing mislabeled clothing containing
insect repellent and violating federal insecticide laws:
$100,800 penalty .
• The U.S. Environmental Protection Agency issued an
order to the Pathway Investment Corp. of Englewood,
New Jersey to stop the sale of plastic food storage
containers with claims.
• EPA Conditionally Approved NanoSilva in Aug. 2013,
but Ninth Circuit vacated shortly after (Nov. 2013); so
no silver nano particles approved as pesticide.

28. 25(b) Exemption
28
2. Minimal Risk Pesticides
To satisfy the conditions required for federal minimum risk status, all five of
the following conditions must be met:
• Condition 1: The product must contain only ingredients listed.
• Condition 2: The product must contain only those inert ingredients that
have been classified by EPA as List 4A “Inert Ingredients of Minimal
Concern.”
• Condition 3: All of the ingredients (both active and inert) must be listed on
the label. The active ingredient(s) must be listed by name and percentage
by weight. Each inert ingredient must be listed by name.
• Condition 4: The label cannot include any false or misleading statements,
and claims that minimum risk pesticides protect human or public health
are prohibited.
• Condition 5: In general, public health claims are prohibited.

29. List of 25(b) products
29
Castor oil (U.S.P. or equivalent) Linseed oil
Cedar oil Malic acid
Cinnamon and cinnamon oil Mint and mint oil
Citric acid Peppermint and peppermint oil
Citronella and Citronella oil 2-Phenethyl propionate (2-phenylethyl propionate)
Cloves and clove oil Potassium sorbate
Corn gluten meal Putrescent whole egg solids
Corn oil Rosemary and rosemary oil
Cottonseed oil Sesame (includes ground sesame plant) and sesame oil*
Dried Blood Sodium chloride (common salt)
Eugenol Sodium lauryl sulfate
Garlic and garlic oil Soybean oil
Geraniol* Thyme and thyme oil
Geranium oil White pepper
Lauryl sulfate Zinc metal strips (consisting solely of zinc metal and impurities)
Lemongrass oil
Active ingredients that can be used for exemption

30. Devices
• An instrument or contrivance (other than
a firearm) that is used to destroy, repel,
trap or mitigate (lessen the severity of)
any pest such as insects, weeds, rodents,
certain other animals, birds,
mold/mildew, bacteria and viruses.
• Not registered, but cannot make false or
misleading statements.
• Must carry warnings and directions for
use on label.
• Must be produced in a registered
establishment (establishment # on label).

31. Labeling of Pesticides
What are we looking at?
A pesticide is any substance or mixture of substances intended for:
• preventing,
• destroying,
• repelling, or
• mitigating any pest.
• Purpose of a Pesticide Label
– “Provide clear directions for effective product performance while
minimizing risk to human health and the environment”
– Legally binding document for correct use
• EPA Approval
• Label Requirements

32. Required Information
• Name and address of the producer or registrant
• Restricted Use Statement (if applicable)
• Product Name, Brand or Trademark
• Ingredient Statement and net weight or measure of contents
• EPA Registration Number and EPA Establishment Number
• Signal Word, including Skull & Crossbones, if either are required
• "Keep Out Of Reach Of Children" statement
• Precautionary Statements, including Hazards to Humans & Domestic
Animals and First Aid (Statement of Practical Treatment), Environmental
Hazards, and Physical/Chemical Hazards
• Storage and Disposal Statements
• Directions for Use
• Warranty Statement

33. Front Panel
• Found at:
http://www.epa.gov/pesticides/regulating/labels/labels_faq/lr_faq_10.ht
ml)
• “The front panel is generally regarded as the part of the label that is
(normally) visible to the user, consumer, etc. when the product is in a retail
environment. At a minimum, the front panel must contain the following
information:
– Restricted Use Product statement (if applicable)(40 CFR 156.10(j))
– Product Name, Brand or Trademark (40 CFR 156.10(b))
– Ingredient Statement (unless permission is granted to place it elsewhere due to
impracticability) (40 CFR 156.10(g)(2))
– Keep Out of Reach of Children Statement (40 CFR 156.60)
– Signal Word (40 CFR 156.64)
– First Aid (or referral statement if First Aid is allowed on other parts of the label) (40 CFR
156.68(d))
– Skull & Crossbones Symbol and the word Poison (if applicable) (40 CFR 156.64(a)(1))”

34. Compliant or Not?
EPA’s regulation requires that words,
statements, graphic representations,
designs or other information that are
legally required to appear on a label
be clearly legible, and readily
understood. In addition, all required
label text must appear on a clear
contrasting background and not be
obscured or crowded.
40 CFR 156.10(a)(2)
clearly legible

35. Owned Brand
35
• Registered Label and Retailer’s Label must match-up.
– There is some flexibility within the Registered Label
• Each registered label will offer a menu of claims, uses and other
language (found in italics in the label)
• Can have fewer claims than the Registered Label, but not more.
• All of the required label sections must be complete and consistent
with the Registered Label
– If there is multi-packs, the inner AND outer packaging must have
all the label information. The net weights need to match (inner
and outer packaging).
– ANY new formulations, or deviations, in the product formula will
result in significant registration actions by the vendors. Even
exempt products may shift to where registration is required –
particularly with respect to States.

36. Importing
Importation of Pesticides and Devices
• All pesticides and devices imported into the
United States must: Comply with U.S. pesticide
law
• Be registered with EPA, except where exempted
by regulation or statute
• Not be adulterated or otherwise violative
• Properly labeled
• Produced in an EPA-registered establishment that
files annual reports with the Agency

37. Electronic Resources and Registration
• ALSTAR http://npirspublic.ceris.purdue.edu/alstar.htm
• KellySolutions http://www.kellysolutions.com/
• State Pesticide Agencies
http://npic.orst.edu/reg/state_agencies.html
• Cornell University
http://psep.cce.cornell.edu/Tutorials/pesticide_labels.
aspx
• NPIRS http://npirspublic.ceris.purdue.edu/state/
• EPA Label Database
http://oaspub.epa.gov/apex/pesticides/f?p=PPLS:1

38. EPA’s Interim Policy on Pesticide Container
Repair (“Bag Patch” Policy)
• Produce means to manufacture, prepare,
propagate, compound or process any
pesticide, active ingredient or device, or to
package, repackage, label, relabel, or
otherwise change the container of any
pesticide or device. (40 CFR 167.3)
• With limited exceptions, EPA’s position is that
any packaging or labeling activity constitutes
“production” under FIFRA.

39. Bag Patch Policy
• EPA will consider whether individual proposals for
“minor repair programs” constitute production
and whether minor damage can be repaired and
the product sold or distributed under the terms
of its existing registration.
• A company’s minor repair program must
maintain:
– Label integrity: entire label is legible
– Product integrity: not adulterated; loss of contents
– Container integrity: patch, how to repair, training.

40. Bag Patch Program Process
• Send proposed container repair programs to
the Director of the Office of Pesticide
Programs (OPP) via Nancy Fitz.
– fitz.nancy@epa.gov; 703-305-7385
• Reviewed by EPA workgroup; usually some
back and forth discussion.
• OPP Office Director sends letter when
approved.

41. Bag Patch Program
• The interim policy does not exempt all
facilities from the Section 7 requirements
(establishment registration, production
reporting and records) – only those who have
an approved program.

42. Questions?
Contact US
Wade Miller
Wenck Associates, Inc.
651-395-5222
wmiller@wenck.com