managing retailer's owned brands under fifra rev 6
TRANSCRIPT
MANAGING RETAILER'S OWNED BRANDS UNDER FIFRA
Wade Miller, CHMM, CPEA, PMPSr. Compliance ConsultantWenck Associates, Inc.
FIFRA 101
• What is FIFRA?• How does EPA regulate pesticides?– Pesticide labels– Information sources
• Responsibilities of a pesticide registrant• Supplemental distribution
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.]
Examples of Pesticides
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
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
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
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)
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
FIFRA16,000 Labels
Pesticide Registrant ResponsibilitiesRegistrants 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.
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).
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
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.]
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.
Federal Insecticide, Fungicide, Rodenticide Act (FIFRA)
Introduction:• EPA vs FDA• Federal Registration • State-Specific Registration• Articles• 25(b) products• Devices• Labeling• Branding• Importing• Resources
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.
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EPA Registration
• 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.
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.
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.
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Additional BrandAdditional Brand Amendments occur when the initial registrant (vendor) submits an amendment to EPA to have another brand included with the initial registration.
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Supplemental Distribution• 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.
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State Registrations
State Registration of PesticidesAfter 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.
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
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Article Exemption
There are two exemptions that affect Retailers: 1. Article ExemptionsAn 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.”
Use Consistent with Label….
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.
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25(b) Exemption
2. Minimal Risk PesticidesTo 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.
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List of 25(b) productsCastor oil (U.S.P. or equivalent) Linseed oil
Cedar oil Malic acidCinnamon and cinnamon oil Mint and mint oilCitric acid Peppermint and peppermint oil
Citronella and Citronella oil 2-Phenethyl propionate (2-phenylethyl propionate)
Cloves and clove oil Potassium sorbateCorn gluten meal Putrescent whole egg solidsCorn oil Rosemary and rosemary oil
Cottonseed oil Sesame (includes ground sesame plant) and sesame oil*
Dried Blood Sodium chloride (common salt) Eugenol Sodium lauryl sulfateGarlic and garlic oil Soybean oilGeraniol* Thyme and thyme oilGeranium 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
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).
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
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
Front Panel• Found at: http://
www.epa.gov/pesticides/regulating/labels/labels_faq/lr_faq_10.html)• “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))”
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
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Owned Brand
• 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.
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
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
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.
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.
Bag Patch Program Process
• Send proposed container repair programs to the Director of the Office of Pesticide Programs (OPP) via Nancy Fitz.– [email protected]; 703-305-7385
• Reviewed by EPA workgroup; usually some back and forth discussion.
• OPP Office Director sends letter when approved.
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.
