Achieving a Safe and Reliable Product: A Guide to Liability Prevention


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Commercial insurance by its very nature is complex. However, it is possible with the assistance of a competent licensed broker-agent to steer clear of the pitfalls and make good decisions when purchasing insurance for your business. This brochure is meant to be a starting place for the small business owner investigating commercial insurance coverages. Throughout the brochure general information has been given on the greatest areas of concern when dealing with commercial insurance. Specifically, these efforts - both by Department staff and the Commissioner-appointed Insurance Diversity Task Force - are meant to encourage increased procurement from California's diverse suppliers and diversity amongst insurer governing boards.

This Initiative represents an open door to increased business opportunities for California's minority, women, disabled veteran, and LGBT owned businesses. The Department accomplishes these goals by conducting surveys to collect and make public information about the diversity efforts of insurers, as well as through outreach, partnerships, and Department-hosted events. The first action of the Commissioner was a Voluntary Survey sent to the state's top insurers to understand the state of supplier diversity and governing board diversity in the industry.

Since then, the Initiative has administered annual surveys to ensure transparency around these important issues of diversity. MIDS will now build on California's success by taking a look at diversity issues across the nation's insurance industry. Supplier diversity, as seen in other industries, is a win-win for both diverse businesses and insurers.

For insurers, increased partnerships with diverse suppliers can result in decreased costs and more competition for bids, in addition to enhanced quality, creativity, and innovation from those suppliers — giving insurers the edge they need in a competitive market with rapidly changing demographics. For the first time ever, information about insurer procurement practices is being collected and made available to the public.

For more information about the Insurance Diversity Initiative, visit: www. The Fair Market Value of an item is the dollar amount that a knowledgeable buyer under no unusual pressure is willing to pay and a knowledgeable seller under no unusual pressure is willing to accept. A licensed individual or organization authorized to sell and service insurance policies for an insurance company.

The maximum dollar amount of coverage in force for a property damage policy or liability policy. This maximum amount can be figured on a per occurrence basis or as a general aggregate for the complete policy term. A method of loss valuation where the insured and the insurer list an agreed upon amount to be paid in case of loss. This valuation method is most common in property insurance when insuring valuable artwork, antiques, or classic autos. A professional appraisal is usually required. A clause in an insurance policy that allows the insured and the insurer to each appoint an arbitrator if they cannot agree upon an appropriate claim settlement.

Once the arbitrators have been selected, they in turn appoint an independent umpire. If the arbitrators disagree, then the umpire decides which claims settlement to support. The final decision is binding. A situation that occurs in a loss when an old piece of property is replaced by a brand new item. The insured is put in a better financial position than they were before the loss occurred, and consequentially may have to pay the difference in price for the betterment. A short-term agreement that provides temporary insurance coverage until the policy can be issued or delivered.

A licensed individual who can act as an agent representing one or more insurers, and also as a broker dealing with one or more insurers representing your interests. The termination of an in-force insurance contract by either the insured or the insurer before its normal expiration date.

Notice to an insurance company that a loss has occurred that may be covered under the terms and conditions of the policy. The person who evaluates the damage caused by a covered loss and determines the amount to be paid under the policy terms. A liability insurance policy where coverage applies to claims filed during the policy period no matter when the loss occurred subject to a retroactive inception date. An insurance clause that defines the amount of each loss that the company pays according to the amount of insurance carried, divided by the amount of insurance required.

This basic formula relates to a contracted percentage of coverage that must be required to prevent a coinsurance penalty. When bodily injury liability and property damage liability is expressed as a single sum limit of coverage. Insurance coverages for businesses, commercial institutions, and professional organizations, as contrasted with personal insurance. Occurs when two or more perils cause a loss. When only one of these perils is covered by the insurance policy, the court generally rules that the entire loss is covered.

Many insurance companies have reworded their policies to clarify that only a loss attributed to a covered peril is indeed covered. The portion of an insurance contract that sets forth the rights and duties of the insured and the insurer. In Workers Compensation, special circumstances can arise when a work-related injury causes some sort of non-work related injury. Usually the first page of an insurance policy that contains the full legal name of the insurance company, the policy number, effective and expiration dates, premium payable, the amount and types of coverage, and the deductibles.

The amount of the loss that the insured is responsible to pay before benefits from the insurance policy are payable. The actual or accounting recognition of the decrease in value of property over a period of time according to a predetermined schedule. In Workers Compensation, an employer may be liable two ways to an employee who incurs bodily injury on the job as a result of using a product or service produced by that employer. The employee is eligible for Workers Compensation benefits and may also sue the employer because of the defectiveness of the injuring product or service.

A written agreement that changes the terms of an insurance policy by adding or subtracting coverage. A contractual provision in an insurance policy that denies or restricts coverage for certain perils, persons, property, or locations. The adjustment of premium resulting from the use of experience rating.

Cancellation that takes place on the policy effective date. No premium charge is made; however, other charges i. An intentionally deceptive act committed to obtain an unfair or unlawful advantage. Fraud usually involves monetary gain. In a property and casualty contract, the objective is to restore an insured to the same financial position after the loss that the insured had prior to the loss.

In the most basic sense, indemnity is compensation for a loss. A person or organization that provides claim adjusting services to different insurers on a contract basis. Any interest most commonly ownership that a person, company, or corporation has in a subject of insurance such as a business, building, or auto, which can be damaged and may cause the person, company, or corporation financial loss or other tangible deprivation.

Generally, an insurable interest must be demonstrated when a policy is issued and must exist at the time of loss. A method of shifting risk from a person, business, or organization to an insurance company in exchange for the payment of premium. The insurance company commits to be responsible for covered losses. The insurance company who issues insurance and agrees to pay for losses and provide covered benefits.

The portion of an insurance contract that describes what is covered. A rating modification either decrease or increase that is based on the underwriters experience, best judgment, and analysis in classifying and underwriting a particular type of risk. In property and casualty insurance a lapse in the termination of a policy because of a failure to pay premium when due. A certificate of authority issued by the CDI to an insurer, agent, broker, or broker-agent to transact insurance business. The maximum amount of benefits the insurance company agrees to pay in the event of a loss.

A potential situation in any bodily injury claim including Workers Compensation claims where a spouse contends that the bodily injury of their partner deprives them of the natural affection spousal duties , help, and companionship of said spouse. A provision that authorizes the insurer to make a loss payment to a person, company, or organization loss payee other than the insured. The loss payee must have an insurable interest such as a lienholder for business personal property or a mortgagee on real property.

An MGA can manage the marketing, underwriting, policy issuance, premium collection, appointing and supervision of other agents, claims payments, and reinsurance negotiations of an insurance company. A factual falsification made in such a manner that the insurance company would have refused to insure the risk if the truth had been known at policy issuance. A material misrepresentation gives an insurance company grounds to rescind a contract. Failure by the policyholder to pay the premium on a policy or pay the installment premium payments due on a policy.

A liability insurance policy that covers claims arising out of occurrences that take place during the policy period, regardless of when the claim is filed. Insurance written on the personal and real property of an individual or individuals to include such policies as homeowners insurance and personal auto insurance, as contrasted with commercial lines.

The monetary payment that an insured makes to an insurance company in exchange for the contract indemnifying the insured against potential loss. Simply put this is the payment made by the insured to keep an insurance policy in effect. A cancellation of a policy by an insurance company that returns the unearned premium to the policyholder the portion of the premium for the remaining time period that the policy will not be in force. A licensed person or organization that represents the policyholder by contract in property damage claims negotiations with an insurance company.

An estimate of the cost of insurance based on the information supplied to the agent, broker, broker-agent, or the insurance company. The cancellation of an insurance policy back to its effective date resulting in a return of all premium charged. Requirements developed by the CDI that implement laws passed by the legislature. Regulations go through a public comment process and must be approved by the state Office of Administrative Law. The continuation of an insurance policy offer of renewal into a new term from the same insurance company that issued the existing policy.

The amount that it costs to replace lost or damaged property with new property of like kind or quality in the local market. A method of pricing property and liability insurance. Schedule Rating uses debits and credits to modify a base rate figured by the special characteristics of the risk exposure. Insurers develop Schedule Rating because actuarial experience shows a direct relationship between certain physical characteristics and the possibility of loss.

Most schedule rating plans must be filed and approved by the CDI. A cancellation initiated by policyholder request in which the premium returned is subject to an administrative penalty. Exists when a manufacturer refuses to withdraw a product as ordered by a government agency or company management. Once a defective product has been identified and recalled, an insurance company excludes all other claims arising from the defective product due to the negligent failure of the company to take the product off the market.

The technique for expressing limits of liability coverage under a particular insurance policy by stating separate limits for different types of claims growing out of a single event or combination of events. Coverage can be split limited per person, per occurrence, between bodily and property damage, or in other ways. The process of recovering the amount of claim damages paid out to a policyholder from the legally liable party.

An individual other than the policyholder or the insurance company who has suffered a loss and may be able to collect compensation under the policy due to the negligent acts or omissions of the policyholder. The legal doctrine that involves an injured employee bringing suit against a third party who for one reason or another is able to bring an action against the employer. The process to evaluate the insurance application and independent sources in order to verify the information provided and to determine the acceptability of the risk.

The person who performs the underwriting process to accept, reject, or modify risks on behalf of the insurer. The portion of the written premium applicable to the unexpired or unused part of the policy period for which the premium has been paid. The total premium on all policies written by an insurer during a specified period of time, regardless of what portion has been earned.

Do you have a question, comment or concern? There are several ways to talk to us:. The Department of Insurance is unable to guarantee the accuracy of this translation and is therefore not liable for any inaccurate information resulting from the translation application tool. The Department of Insurance is also unable to guarantee the same page layout for all the languages. Depending on the languages, the page layout may look strange from the original. Please consult with a translator for accuracy if you are relying on the translation or are using this site for official business.

A copy of this disclaimer can also be found on our Disclaimer page. Contacting a Broker-Agent One of the first steps in purchasing small business insurance is to contact a licensed insurance broker-agent who specializes in commercial coverages. Valuation Types Commercial property coverage will include a provision to determine what valuation method is to be used to pay the loss. Coverage Forms and Endorsements There are various coverage forms and endorsements in addition to the basic property coverages already discussed that can customize coverage in a commercial property insurance policy.

The following are the most common coverage forms and endorsements used in commercial property insurance: Builder's Risk — Added to a policy for a one-year minimum term to cover a new building or structure under construction or an existing structure undergoing additions, alterations, or repairs. Cancellation is allowed on a pro rata basis upon project completion; however, midterm cancellation will result in a short rate penalty.

A reporting form or renovations form allows coverage to be carried according to the stage of completion i. The loss or damage must be caused by a covered peril including loss of use. The loss must be accidental and the coverage most often is purchased for tenants in commercial buildings.

Building Ordinance or Law — Provides coverage if the enforcement of any building, zoning or land use law results in loss to the undamaged portion of the building Coverage A ; demolition and removal costs of undamaged parts of the structure Coverage B ; or any increased cost of repairs or reconstruction Coverage C. Replacement cost must be in effect for Coverage C to be applied. Improvements and Betterments — Usually added by a lienholder. Covers all permanently installed improvements and betterments, which cannot be removed when a tenant vacates the building.

Glass — Basic specified perils for glass coverage include any resulting damage to other property from broken glass due to vandalism and also vandalism to glass building blocks. A glass form must be added for scheduled glass coverage when there is a significant glass exposure to insure. The glass form includes the number of panes, dimensions, location, lettering, and ornamentation. A separate glass deductible may be scheduled as well. Peak Season — An endorsement that provides additional limits on personal property inventory during a designated period of time.

This is specifically used to cover fluctuating inventory values before and during peak shopping seasons. Inflation Guard — Automatically adjusts the limits of insurance to keep up with inflation. The adjustment can be tied to the construction cost index in a regional area or a specified percentage per year. This endorsement can be very important in helping to maintain adequate coverage limits, which can protect against potential coinsurance penalties in a property loss.

Time Element — Insurance that covers other losses stemming from a direct loss by a covered peril to business property. Business interruption, extra expense, and loss of rents and rental value are the most common time element coverages. Business interruption coverage replaces lost business income after a covered loss. Certain key employees can be named, allowing the employer to continue to pay their salaries until the business restarts operations after a loss.

Extra expense can pay for office space, equipment rental, advertising, or most costs considered reasonable for keeping the company operating after a covered loss. Loss of rents and rental value cover loss of rental income to the property owner caused by damage or destruction of a building rendering it unfit for occupancy. Covered Causes of Loss Standard perils in Inland Marine may include fire, lightning, windstorm, flood, earthquake, landslide, theft, collision, derailment, overturn of the transporting vehicle, and bridge collapse.

Boiler and Machinery Boiler and machinery insurance can add an important layer of coverage to an insurance policy. Crime Crime insurance provides protection for the assets of your business including merchandise for sale, real property, money and securities. Commercial Automobile Coverage, Classification and Limits of Insurance Commercial automobile coverage is similar to the coverage you may carry on your personal auto; however, commercial automobile exposures can be more complex requiring specialty coverages to be considered based on the individual needs of your business.

Commercial General Liability Coverage One of the key concepts of liability coverage is that it is comprehensive in nature. Classification The type of business you run determines how a CGL policy is classified. Limits of Insurance The CGL policy has separate limits of insurance for general liability, fire legal liability, products and completed operations liability, advertising and personal liability, and medical payments.

Commercial Umbrella When a liability claim goes above the aggregate limit of liability, the policy limits are exhausted. Workers Compensation When an employee suffers a work related injury or illness, workers compensation insurance steps in to provide benefits based on the type of illness or injury sustained. Coverage Sections Workers compensation insurance is divided into two coverage sections. Back to Top Classification and Rating Classification of workers compensation insurance is based upon the specific duties that your employees perform in the course of their employment with your company.

Claims It is important to note that workers compensation claims do not come under the jurisdiction of the CDI. What Is a Business Owners Policy? Deductible The deductible on a commercial policy is the part of the loss that you pay up-front before your insurance company pays a claim. Surplus Line Insurance When you have had three applications turned down from a licensed commercial insurance carrier and have written documentation of the declination to insure you can proceed to obtain insurance from the surplus line market.

In Summary Commercial insurance by its very nature is complex. Agent A licensed individual or organization authorized to sell and service insurance policies for an insurance company. Aggregate Limit The maximum dollar amount of coverage in force for a property damage policy or liability policy. Agreed Value A method of loss valuation where the insured and the insurer list an agreed upon amount to be paid in case of loss. Arbitration Clause A clause in an insurance policy that allows the insured and the insurer to each appoint an arbitrator if they cannot agree upon an appropriate claim settlement.

Betterment A situation that occurs in a loss when an old piece of property is replaced by a brand new item. Binder A short-term agreement that provides temporary insurance coverage until the policy can be issued or delivered. Broker A licensed individual or organization who sells and services insurance polices on your behalf. Broker-agent A licensed individual who can act as an agent representing one or more insurers, and also as a broker dealing with one or more insurers representing your interests.

Cancellation The termination of an in-force insurance contract by either the insured or the insurer before its normal expiration date. Claim Notice to an insurance company that a loss has occurred that may be covered under the terms and conditions of the policy. Claim Adjuster The person who evaluates the damage caused by a covered loss and determines the amount to be paid under the policy terms.

Claims Made A liability insurance policy where coverage applies to claims filed during the policy period no matter when the loss occurred subject to a retroactive inception date. Coinsurance An insurance clause that defines the amount of each loss that the company pays according to the amount of insurance carried, divided by the amount of insurance required. Combined Single Limit When bodily injury liability and property damage liability is expressed as a single sum limit of coverage.

Commercial Lines Insurance coverages for businesses, commercial institutions, and professional organizations, as contrasted with personal insurance. Concurrent Causation Occurs when two or more perils cause a loss. Conditions The portion of an insurance contract that sets forth the rights and duties of the insured and the insurer.

Consequential Bodily Injury In Workers Compensation, special circumstances can arise when a work-related injury causes some sort of non-work related injury. Coverage Protection that is provided under an insurance policy. Declarations DEC Page Usually the first page of an insurance policy that contains the full legal name of the insurance company, the policy number, effective and expiration dates, premium payable, the amount and types of coverage, and the deductibles.

Deductible The amount of the loss that the insured is responsible to pay before benefits from the insurance policy are payable. Depreciation The actual or accounting recognition of the decrease in value of property over a period of time according to a predetermined schedule. Dual Capacity In Workers Compensation, an employer may be liable two ways to an employee who incurs bodily injury on the job as a result of using a product or service produced by that employer.

Endorsement A written agreement that changes the terms of an insurance policy by adding or subtracting coverage. Effective Date The starting date of an insurance policy: the date the policy goes in to force. Exclusion A contractual provision in an insurance policy that denies or restricts coverage for certain perils, persons, property, or locations. Experience Modification The adjustment of premium resulting from the use of experience rating. Expiration Date The termination date of coverage as indicated on an insurance policy.

First Party The policyholder insured in an insurance contract. Flat Cancellation Cancellation that takes place on the policy effective date. Fraud An intentionally deceptive act committed to obtain an unfair or unlawful advantage. Frequency The number of times a loss occurs. Hazard A circumstance that increases the likelihood or potential severity of a loss. Indemnity In a property and casualty contract, the objective is to restore an insured to the same financial position after the loss that the insured had prior to the loss.

Independent Adjuster A person or organization that provides claim adjusting services to different insurers on a contract basis. Insurable Interest Any interest most commonly ownership that a person, company, or corporation has in a subject of insurance such as a business, building, or auto, which can be damaged and may cause the person, company, or corporation financial loss or other tangible deprivation. Insurance A method of shifting risk from a person, business, or organization to an insurance company in exchange for the payment of premium.

Insured The policyholder s entitled to coverage under an insurance policy. Insurer The insurance company who issues insurance and agrees to pay for losses and provide covered benefits. Insuring Agreement The portion of an insurance contract that describes what is covered. Judgment Rating A rating modification either decrease or increase that is based on the underwriters experience, best judgment, and analysis in classifying and underwriting a particular type of risk. Lapse In property and casualty insurance a lapse in the termination of a policy because of a failure to pay premium when due.

License A certificate of authority issued by the CDI to an insurer, agent, broker, or broker-agent to transact insurance business. Loss of Consortium A potential situation in any bodily injury claim including Workers Compensation claims where a spouse contends that the bodily injury of their partner deprives them of the natural affection spousal duties , help, and companionship of said spouse. Loss Payable Clause A provision that authorizes the insurer to make a loss payment to a person, company, or organization loss payee other than the insured.

Material Misrepresentation A factual falsification made in such a manner that the insurance company would have refused to insure the risk if the truth had been known at policy issuance. Misquote An incorrect estimate of an insurance premium. Nonpayment of Premium Failure by the policyholder to pay the premium on a policy or pay the installment premium payments due on a policy.

I. Introduction

Nonrenewal The termination of an insurance policy on its normal expiration date. Occurrence A liability insurance policy that covers claims arising out of occurrences that take place during the policy period, regardless of when the claim is filed. Peril Cause of loss. Personal Lines Insurance written on the personal and real property of an individual or individuals to include such policies as homeowners insurance and personal auto insurance, as contrasted with commercial lines.

Policy A contract that states the rights and duties of the insurance company and the insured. Premium The monetary payment that an insured makes to an insurance company in exchange for the contract indemnifying the insured against potential loss. Producer A term used by the insurance industry to refer to agent, brokers, broker-agents, and solicitors. Pro Rata Cancellation A cancellation of a policy by an insurance company that returns the unearned premium to the policyholder the portion of the premium for the remaining time period that the policy will not be in force.

Provisions The statement of policy conditions in an insurance policy. Public Adjuster A licensed person or organization that represents the policyholder by contract in property damage claims negotiations with an insurance company. Quotation An estimate of the cost of insurance based on the information supplied to the agent, broker, broker-agent, or the insurance company.

Recision The cancellation of an insurance policy back to its effective date resulting in a return of all premium charged. Regulations Requirements developed by the CDI that implement laws passed by the legislature. Reinstatement The restoration of a lapsed or canceled policy. Renewal The continuation of an insurance policy offer of renewal into a new term from the same insurance company that issued the existing policy.

Replacement Cost The amount that it costs to replace lost or damaged property with new property of like kind or quality in the local market. Schedule Rating A method of pricing property and liability insurance. Second Party The insurance company in an insurance contract. It has been the agency's policy not to allow the use of terms such as "total" or "complete" as part of product names because such use may be false or misleading. Use of terms such as "total" or "complete" may be allowed as part of a brand name so long as the brand name is presented in a non-misleading way.

The Agency will work with registrants to fit potentially misleading brand names into the context of a label so that they are not misleading. The name may be considered to be false or misleading unless it is sufficiently different to enable a user to distinguish one product from another and the exact same name cannot be used by any one registrant for different registered products. The Agency would consider the same name for two different products under the same company name to be misleading regardless of whether the registration numbers are different due to multiple company numbers.

A similar question was previously answered, LC We believe the best reading of the statute and regulations is that each product must have a unique name taking into account the name, brand or trademark in context. Thus, a company could not have two products with the same name but two different companies could potentially have a product with the same name because they would be distinguishable based on their company name. Already-approved use sites and use directions can be incorporated onto an alternate brand name label without notification to the agency.

The requirement allows that the name appearing on the label can be qualified in several ways. For the example above, using XYZ Company would be acceptable. EPA does, however, need to be able to link the company names appearing on labels with company names appearing on registration documents. Therefore, EPA asks that companies change their registration documents to reflect the company names used on labels. See Chapter 15 of the Label Review Manual for more information. The regulations are clear that an unqualified name and address is considered the name and address of the producer.

The agency agrees that a zip code that is unique to a given registrant and adequate for the delivery of mail would meet the requirement of "address" as discussed in 40 CFR In accordance with the regulations at 40 CFR That regulation states that a registrant must provide EPA with a current address that will be used by the Agency for corresponding with the registrant.

It is also sufficient to provide company name, city, state, and a unique zip code where the zip code includes a PO box as part of the suffix. Under Federal Law, only a federal registration is required to sell and distribute a pesticide. All states, under individual state laws, require that pesticides be registered in their state before they can be sold and distributed. The laws of the state where a sale or distribution occurs will determine who is responsible for any required state registration.

Under section 18 of the Federal Insecticide, Fungicide and Rodenticide Act the Administrator may authorize the use of an unregistered pesticide or unregistered use of a registered pesticide including an unregistered pesticide product if an emergency condition exists as described under 40 CFR Part Some products authorized for use under section 18 have been submitted for registration and have therefore received an EPA file symbol. The agency has not taken final action with respect to registering the product but has authorized its use under section These products could have an EPA file symbol assigned to them and that symbol may be included on a label, however, the product may only be used in accordance with a section 18 exemption granted by the Agency.

According to 40 CFR An EPA Establishment Number coded on a container, in the absence of any pesticidal claims by the product labeling or advertising, would not make the product subject to FIFRA in most circumstances. If the presence of an establishment number is intended to imply the product has pesticidal effect or if consumers are misled by the establishment number to believe the product has a pesticidal effect, the product may be subject to FIFRA. Note that pesticide device packaging must bear the EPA establishment number for the place where the device was produced, so some unregistered products that bear establishment numbers may be devices.

Further, labeling for all products are subject to the requirements of the Federal Trade Commission, which can take action against false or misleading claims. In the instance of an aerosol can filled at one establishment and packaged at a second establishment, the immediate container the aerosol can must bear the establishment number of the establishment where filled Est. The box that the aerosol can is placed in must bear the establishment number of the facility where the repackaging occurred Est.

Both establishment numbers may appear because they can be easily associated with different steps in the packaging of the product. Please also note that if the full label of the aerosol can cannot be read through the outer package, the full label of the product must appear on the outer package. The definition of produce includes not only the manufacturing of pesticides but also packaging and repackaging of pesticides. If a pesticide container is placed in a blister card or box the packaging must take place in a registered establishment and the establishment number of the establishment appear on the package.

If the packaging in the blister card or box takes place in a different establishment than where the original container was filled, the establishment numbers on the immediate container and the blister pack or box will be those of different establishments. The blister card or box may list more than one establishment number as long as the correct establishment number where the last production step occurred is clearly visible on or through the outer container or wrapper and there is some designation to distinguish which establishment number applies.

If the lot number is used to designate the appropriate establishment number, the label must explain how to interpret the lot number; i. Since the establishment number does not have to be on the printed label, but may be placed on, printed on, or embossed onto the container itself, it is not necessary for the establishment number to be on the master label. The EPA Establishment number can be placed on either the label or the product container. PR Notice allows under Non-Notification, factual statements about where the product is made, which could include the Establishment Number.

Therefore, the number can be changed without notification. The product must indicate the Establishment Number of the final establishment at which the product was produced. If the terminal is transferring pesticides as part of the distribution of the product, it is not required to register as an establishment. The transfer is considered part of the process of shipping the pesticide to the retailer and ultimately the end-user.

The registration and establishment number are not required to appear on the master case if the pesticide product is removed from the master case before being sold to the end-user. If the master case is the outer container as customarily distributed or sold to the user, 40 CFR As a matter of general practice, EPA recommends that the master outer case bear identification of the product within to allow quick identification of the product in the case of an accident or spill. In addition, the person shipping the pesticide must ensure that the shipment meets all applicable Department of Transportation DOT regulations.

In most cases, the misuse statement should not be included on the labeling of unregistered products being sold, imported or otherwise distributed in the U. The violation referred to in the misuse statement is a violation of section 12 a 2 G , which only prohibits misuse of registered products. Generally, it is not a violation of FIFRA section 12 to use an unregistered pesticide in a manner inconsistent with its labeling.

Exceptions may exist based on an EPA order that imposes restrictions on the use of a particular unregistered product e. Further, misbranded products generally cannot qualify for legal sale or distribution through the above-listed exceptions at section However, after further consideration, EPA determined that while the ATCC numbers are necessary for the Agency microbiology reviewers as identifiers for the microorganisms tested and listed on product labels, they may not have the same level of significance to the end-users of the products.

As described in the question, the pesticide within the bag is a liquid, suggesting that the net contents must be expressed in terms of liquid measure under 40 CFR Additionally, the bag is contained within a pressurized canister, suggesting that the net contents must be expressed in terms of weight under 40 CFR Because the pesticide is both liquid and pressurized, the net contents of BOV pesticide products must be expressed in terms of both liquid measure and weight.

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Microorganisms are often strong sensitizers, and this precautionary label statement is required on microbial pesticides on a case-by-case basis to mitigate the potential risk of allergenicity from repeated inhalation exposure to airborne microbial particles. This statement was first used during the Bt reregistration process. Therefore, in general, the Agency requires protective equipment to lessen exposure to microbial agents for applicators with a high likelihood of repeated exposures.

Information showing a specific microbial pesticide is not a respiratory sensitizer would be considered and may lead EPA to determine this precautionary statement is not necessary for that specific pesticide. All words, statements, graphic representations, designs or other information required on pesticide labeling must be set in no smaller than 6 point font.

In addition, required content must appear on a clear contrasting background, not be obscured or crowded and be rendered so that it is likely to be read and understood by the ordinary individual under customary conditions of purchase or use. Precautionary statements must abide by the same 6-point font minimum, except when larger fonts are required for front panel precautionary statements such as signal words and child hazard warnings.

To request variation from the standard requirement, a registrant must explain to EPA why they believe it would be more practical for the information to appear elsewhere. First, "dermal sensitizer" and "dermal irritant" are not signal words. Signal words are described in 40 CFR These numbered toxicity categories correspond to the following tests: oral and dermal LD50, inhalation LC50, eye and dermal irritation. These tests are based on a single exposure to a substance.

In contrast, dermal sensitization is an immunologically mediated cutaneous reaction to repeat exposures to a substance. Dermal sensitization is not part of the numbered toxicity categorization scheme. Pesticides either are or are not dermal sensitizers. You are correct that the two endpoints dermal irritant and dermal sensitization correlate; and that is why the OPPTS While no signal word is associated with dermal sensitization, products that test positive for dermal sensitization may be required to bear precautionary label language for this endpoint such as: "Prolonged or frequently repeated skin contact may cause allergic reactions in some individuals.

These statements, as applicable, must remain on labels that choose to in addition use the GHS symbols. Further, 40 CFR The GHS flammability symbol is equivalent and may replace the example provided. GHS symbols may be added by a label amendment and may not be added through notification. The GHS symbols allowed are:. As pointed out in the Chapter 8.

The ground water advisory is a case-by-case basis determination depending on the use site and available data. Termiticides uses are generally considered indoor uses because applications involve injection through drilled holes in slabs of constructed houses, or for pre-construction, the soil is sprayed just before the foundation is poured. Under such circumstances, OPP has not generally required ground water advisories. It is not permissible to list a specific application rate on the distributor product labeling when the application rates on the registered primary product appear in a range. In order for a specific rate to be listed on the distributor product labeling, that one specific rate must appear on the registered primary product master labeling.

Spreader settings are not required to appear on the label of granular pesticide products. Registrants may provide accurate information if they choose. The label language cited or similar labeling appears on many labels with non-agricultural uses and must be read carefully in the context of the entire labeling of the product. There are many variations of the statements cited above and based on the wording of the statements they may have different meanings.

On some labels the prohibitions against entry are specific to certain uses. On other labels the prohibitions are expressed in such a way that the prohibition applies to a broad array of uses. The prohibition in the language cited above applies specifically to the applicator of the pesticide. The first sentence requires the applicator to keep people or pets from entering the treatment area during application. While the applicator may not be able to control the movement of people or pets into the area, the applicator can and must stop applying the pesticide if people or pets enter the area being treated.

The second sentence prohibits the applicator from entering the treated area until sprays have dried. Neither sentence would require the applicator to have a continuing obligation to keep people or pets out of the treated area after application of the pesticide. Under 40 CFR If you are unsure whether your product is a pesticide, it would be prudent to contact the Office of Pesticide Programs. The lack of pesticidal claims on a product does not necessarily mean the product does not need to be registered. The Federal Insecticide Fungicide and Rodenticide Act defines a pesticide in part as "1 any substance or mixture of substances intended for preventing, destroying, repelling, or mitigating any pests, 2 any substance or mixture of substances intended or used as a plant regulator, defoliant, desiccant, and 3 any nitrogen stabilizer.

Intent for a pesticidal purpose is considered on a case-by-case basis and the Agency may determine a product is a pesticide, and therefore requires a registration, regardless of the product's label claims. EPA has not established an "official" definition of "orchards" as used on product labels. An orchard is considered a distinct use site.


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Generally, one would take a common sense approach to determining where a product labeled for use in an orchard might end. Normally, one would determine that the orchard would end at the outer edge of the drip line of the last row of trees. The statutory basis for this PR notice is section 2 ee of FIFRA, which defines the term "to use any registered pesticide in a manner inconsistent with its labeling" i.

PR notice states, in pertinent part:. Mandatory statements, which commonly use imperative verbs such as "must" or "shall," either require action or prohibit the user from taking certain action. Advisory statements generally provide information, either in support of the mandatory statements or about the product in general.

To ensure that the intent of each labeling statement is clear, mandatory statements need to be clearly distinguishable from advisory statements. Currently, labeling provisions are enforced by taking into consideration all of the information presented on the label and by reading advisory statements in the context of the entire label. Problems can arise when advisory statements are either vague or ambiguous in meaning, or are inconsistent with mandatory labeling statements.

In the past, advisory statements have commonly used suggestive verbs such as "should," "may" or "recommend" to encourage the user to achieve the directed behavior, but often these statements can be unclear as to whether they are mandatory or advisory. Advisory language using terms such as "should," "may" and "recommend" can create ambiguities as to the intent of the direction or precaution. Too often, common everyday speech using the word "should" creeps into mandatory label statements where the imperative tense is needed to communicate that certain action is required.

Another problem is contradictory headings and statements. A set of mandatory directions preceded by an advisory heading such as "Use Recommendations" potentially conflicts with the nature of the intended action.

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Lastly, the use of words such as "should" in advisory language can mistakenly imply that an unaccepted use is permissible. For example, the direction "you should remove all food articles prior to use" on a product that is not registered for any food uses could be mistakenly read to suggest that it is not mandatory to remove all food from the area to be treated. Consequently, such a statement would not be acceptable. The Agency seeks to improve mandatory and advisory labeling statements by providing guidance see Appendix on how they can best be written.

Mandatory statements are generally written in imperative or directive terms such as "shall," "must," "do this," "do not" so that a typical user will understand that these statements direct the user to take or avoid certain actions, and that failure to follow these instructions is a misuse of the product. Advisory statements are generally best written in descriptive or nondirective terms to support the mandatory statements or provide information. Suggestive terms such as "should," "may" or "recommend" may be confusing or ambiguous, or potentially conflict with mandatory labeling statements; thus, they are to be avoided.

EPA realizes that the use of descriptive terms for advisory statements is not appropriate for every situation and that there are times where it may be necessary to use "should," "may," "recommend" or similar words. Traditionally the Agency considers the day of treatment to be Day 0.


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The 7-day restriction pre-harvest interval would start with Day 1 which is the day after the initial treatment with subsequent days to follow in order. The Agency has not required the exact time of treatment to be recorded but if someone were to appropriately document treatment ending at, for example a. Under the Federal Insecticide, Fungicide and Rodenticide Act FIFRA there is no minimum labeling required for shipping containers unless the shipping container is the unit customarily sold to the end user, in which case full labeling is required. The Agency suggests that at a minimum, shipping containers bear enough information to identify the contents of the container in the event of an accident or spill; usually product name, active ingredient s , EPA Registration Number, and any pertinent precautionary labeling.


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  5. Other regulatory agencies, such as the Department of Transportation, may have requirements concerning the labeling of shipping containers generally, which may apply to the shipping of pesticide products. General Use products may be sold to any person without restriction. Products classified for Restricted Use may only be sold to and used by certified applicators or persons under their direct supervision and are therefore prohibited from sale to the general public. The Agency has in certain cases limited the use of products to certain groups of users without classifying the product for Restricted Use.

    Three examples where this occurs are use by veterinarians, mosquito control officials and persons licensed or certified by a state to apply termiticide products. In these cases, the users are individuals identifiable either by a state credential or by being employed by certain public agencies. Individuals who are not members of these groups may still purchase these products but they are prohibited from using such products.

    The expectation is that the user will read this section of the label, be made aware that this product can move into groundwater, and will carefully follow label directions when using the product to prevent groundwater contamination. The phrase "unused product" should be interpreted as opened product containers as well as unopened containers.

    Institutional use is defined in 40 Code of Federal Regulations The product can't be applied if one or more occupants are present in the immediate area where the product is to be applied. EPA has not established a standard depth to define shallow ground water. Hydrologic characteristics differ between regions of the country so shallow ground water is usually defined on a local or regional basis.

    Can pesticides that are labeled only for use on commercially grown tree fruit such as apples and are not Federal Restricted Use Products RUPs be applied by homeowners to control pests in backyard noncommercial apple orchards? A homeowner could legally apply the pesticides if they intended to make a profit from the fruit.

    Since the word "commercial" is commonly defined as engaged in commerce or intending to make a profit, the home owner would only have to show he or she intended to make a profit from the fruit in order to be within the bounds of the uses allowed on the label. Use in a noncommercial orchard would be inconsistent with the product's labeling and a violation of FIFRA. If the label carries WPS requirements such as PPE or REI and use is limited to commercial applications all applicators including homeowners would have to comply with them.

    If the homeowner cannot apply these pesticides, then could they hire a commercial applicator to treat their apple orchard with these products? The homeowner could always hire a commercial applicator, but the answers to questions 1 and 2 apply since the labeling deals with pesticides labeled for use on commercially grown tree fruits versus a restriction requiring a commercial applicator to apply the product. The hired commercial applicator could only apply the pesticide to the homeowner orchard if the fruit it is intended for commerce and the commercial applicator would need to follow WPS requirements.

    The homeowner as "owner of [an] agricultural establishment" would be required to follow all WPS requirements if the commercial applicator is not a member of the homeowner's immediate family. A guideline a, principle, or piece of advice is neither mandatory nor enforceable but rather is included on the label for the user's guidance. A requirement e. Directions for Use are required to be on all pesticide labels. Certain statements in the Directions for Use section may be advisory and others are mandatory. Requirements or mandatory statements are written in a directive manner. The following are examples of language used in the Directions for Use to alert the user to a mandatory duty: such as 1 "Do not use It is important to note that if any requirement under the Directions for Use is not followed, the user is using the product in a manner inconsistent with its labeling and is in a violation of FIFRA.

    It refers to either. There is no reason for applying a lower concentration of termiticide active ingredient in the spray mix or a lower dosage than is specified by the label. Less volume of the end-use dilution may be applied as directed by the label. This language is found on the labels of all soil applied termiticide products. At the finished grade, soil movement and manipulation is completed on the site and the house is build. As you know, sub-slab treatments take place according to label instructions before the "interior slab" is poured but after all interior grading is completed.

    Exterior perimeter applications should take place after final grading of the soil outside the foundation to insure that treated soil, hence the barrier or treated zone, is not disturbed. However, EPA has not defined the term "finished grade" on the label. If the product label lists only specific ornamental species, then only those species are the labeled use sites crops.

    If however, a label should state: "For use on ornamentals, such as [listing of several specific species]. Regarding food crops, we must consider established tolerances for the active ingredient pesticide. A pesticide label will only list food crops for which a tolerance or an exemption from the requirement of a tolerance has been established. Sometimes, if a crop grouping has an established tolerance or exemption from tolerance, the label might list the crop group, for example, "For use on stone fruits, such as cherries, nectarines, peaches and plums. Therefore, if the label does not list a crop group, then application of the pesticide product is limited to only those food crop species listed on the label.

    If a pesticide is registered on an agricultural crop s and there are no restrictions on the product label concerning when rotational crops may be planted or any other planting restriction intervals, such as crop failure, then it would not be a violation of FIFRA to plant new crops at any time. It is not a Federal violation for an unlicensed individual to purchase a registered general-use product that bears the labeling referenced.

    It is a violation of FIFRA 12 a 2 G for an individual who is not licensed by the state to use a product that bears the labeling referenced. In addition, it may be a violation of state law for an unlicensed individual to purchase products that include that labeling. Note that for termiticide products, PR Notice includes the preferred statement that should be used on termiticide labels:. States may have more restrictive requirements regarding qualifications of persons using this product. Consult the structural pest control regulatory agency of your state prior to use of this product.

    A registrant may distribute or sell a product under labeling bearing any subset of the approved directions for use, provided that in limiting the uses listed on the label, no changes would be necessary in the precautionary statements, use classification or packaging. EPA generally would allow a registrant to voluntarily impose restrictions beyond what EPA has required where additional restrictions reduce risk. There may be cases where imposing additional restrictions would have no impact on the risks associated with use of a pesticide and, in those cases, additional restrictions may be considered misleading and therefore not allowed.

    While EPA may allow additional restrictions, they must be presented in a way that does not mislead the user. Further, having varying PHIs for the same use on one registration is potentially misleading. EPA allows marketing a subset of approved uses on labels that differ from the master label often referred to as sub-labels or split labels so long as no changes would be necessary to precautionary statements, use classifications or packaging. EPA would not approve a master label containing two conflicting PHIs, and because sub- or split labels are pulled directly from the master label, a registrant would not be able to create a sub- or split label with a different PHI for the same use.

    The lettered groups are used by pesticide users to select the appropriate type Personal Protective Material from the chart. Label notification changes submitted by the registrant are label amendments and subject to the same month provision for existing stocks. In the case of a notification of a change to an antimicrobial label, the month period begins upon acceptance of the notification. There are no standard alternative "Container Disposal" statements specific to antifouling paint products.

    EPA agrees that it may not be prudent to triple rinse containers that hold pesticides that are ready-to-use products. In those cases, the rinsate cannot be incorporated into the pesticide application because there is no pesticide mixture. Therefore, rinsing the container would require the end user to properly dispose of the rinsate in addition to properly disposing of or recycling the container. Likewise, PR Notice also provided that registrants might propose alternative container disposal statements if the statements recommended in the PR Notice and Chapter 13 of the Label Review Manual were not appropriate.

    Registrants may revise the container disposal statement for a specific product by submitting an amendment to EPA with the revised container disposal instruction. The best method for using up opened and unused pesticides or unused diluted spray is use according to label directions. Oftentimes, the unused product or diluted spray can be applied to another site listed on the label. The Agency does not recommend pesticide disposal in the trash or by burying.

    See additional guidance on pesticide disposal. See 40 C. Specific directions concerning the storage and disposal of the pesticide and its container, meeting the requirements of 40 CFR part Although the regulation originally may have been intended to protect users in their largely unregulated disposal of pressurized containers, such disposal practices have been replaced by a more centralized and highly regulated waste management industry. EPA believes that the hazards associated with recycling aerosol pesticide containers are adequately, and more appropriately, addressed under federal, state and local laws concerning solid and hazardous wastes and occupational safety and health.

    While EPA believes that these hazards are already adequately addressed through other authorities, EPA believes that any remaining risk that might arguably be subject to FIFRA is small and outweighed by the benefits of recycling the aerosol containers. Therefore, EPA has determined that the puncturing of disposed aerosol pesticide containers for recycling is consistent with the purposes of FIFRA, provided that:.

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    Failure to comply with all these conditions when puncturing aerosol pesticide containers would constitute use of a pesticide product in a manner inconsistent with its labeling and may result in the imposition of penalties under FIFRA. FIFRA, for the most part, regulates sale and distribution of pesticides in commerce. FIFRA's reach to pesticide users is primarily focused on requiring users to follow pesticide labels and other instructions related to use. See e. Relabeling pesticides for sale and distribution is considered a production activity under 40 CFR But, an end-user who restores a pesticide label solely for his own use and not for sale or distribution would not be engaging in production of a pesticide that is subject to the requirements of 40 CFR Part So long as the end user is only replacing a damaged label with an intact label that is exactly the same as the original label and that fully conforms to the EPA-approved label, the end user is neither altering nor defacing the label in violation of FIFRA section 12 a 2 A.

    For the situation posed in this question, the manufacturer may provide a replacement label and the end-user may attach that label over the damaged label so long as the label provided is identical to the damaged label and the product will not be sold and distributed beyond the end-user. Note that shipment of a pesticide with a damaged label may be a violation of FIFRA 12 a 1 E because the damage to the label may make the pesticide misbranded.

    Shippers should take all steps possible to ensure the safe handling and shipment of pesticide products so that the labeling remains intact.

    When a product makes a claim that it disinfects, it is making a pesticidal claim and must be registered by EPA to be legally sold and distributed in the United States. The label consists of the "written, printed, or graphic matter on, or attached to, the pesticide or device or any of its containers or wrappers. When accompanying or referenced materials do exist: 1 they are subject to review and approval; 2 may not be false or misleading; and 3 may not contain any claims that substantially differ from those that are approved for the registration.

    EPA recommends that any associated materials contain the product name and product registration number so that the user can relate that material back to the product label. A booklet that contains information required by 40 CFR Part to be part of the product labeling must either accompany the product or be referenced on the label or in literature accompanying the pesticide.

    If the booklet is not referenced on the container label or accompanying literature, the booklet must accompany the product at the time of sale and may be distributed to dealers by attaching it to the shipping papers so long as there are an equal number of booklets and containers so that a booklet accompanies each container that is sold. If the labeling information is referenced on the container it need not be provided in equal numbers so long as the user can obtain the information in some format.

    However, certain information required in Part must be contained on the actual product label versus on attached or unattached labeling. The label must be "securely attached" to the product and EPA would not consider attaching paper with a rubber band to be securely attached. A Quick Response QR code that allows easy access to websites or other text from portable devices can be added to a pesticide label.

    Therefore, if a QR code is added to a label, the content it references is considered labeling and is subject to review by the Agency. H, which allows the use of graphics in conjunction with approved text to be added through notification. If the URL is not already present on the approved labeling, the QR code needs to be added by an amendment.

    EPA directs users to follow the use directions found on the label of the container and in any EPA-approved supplemental labeling of the pesticide they are applying that accompanies the pesticide. Labels acquired from web sites may not be the most current label or may conflict with the label on the container. Because the label on the container is the label that must be followed along with any EPA-approved supplemental labeling which must accompany the user at the time of application, users should not download entire section 3 labels for use.

    The Globally Harmonized System of Classification and Labeling of Chemicals GHS is a internationally agreed-upon system for classifying and labeling chemicals in a consistent manner. There is limited guidance available at this time regarding the use of fragrances in pesticides. In December , EPA published guidance for registrants seeking to add new or modify existing fragrances by the notification process. The guidance indicates the requirements necessary to qualify under this program. InertFinder includes the latest Fragrance Ingredient List.

    If you need guidance in that area, you should contact the appropriate PM team. Neem Oil is not an exempt active ingredient under OMRI certification is only relevant to Agency consideration when a registrant seeks to make an organic label claim on a registered pesticide product. The act of applying a pesticide label to an empty container, for the purposes of sending it to another location for filling, does not constitute production of a pesticidal product because there is no pesticide, active ingredient or device involved. Therefore labeling an empty container as described does not have to be done in a registered establishment.

    In contrast, applying a label to a container that has been filled with a pesticide is considered production and must be done in a registered establishment. Also note, that empty pesticide containers may be subject to other FIFRA requirements under some circumstances, such as, distribution of used pesticide containers that contain pesticide residues or where the prospective buyers expect to receive full containers. For products such as bait stations, the immediate container of the pesticide product is considered by the Agency to be the bait station itself because EPA expects the outer container holding the individual bait station s prior to use to likely be disposed of once the bait stations have been removed from the outer container to then be put out for use.

    Therefore, the batch code would need to go on the bait station which would in this instance be the immediate container, either directly on the bait station or on a label that is attached securely to the bait station, rather than on a secondary outer container that would likely be discarded before the actual bait station is used or during its use. The intent of the batch code requirement is to allow for the tracing of defective products back to the place of manufacture, and identification of other products manufactured as part of the same batch.

    All pesticides sold in the U. The pesticide producing establishment must appear on the container of the pesticide. The pesticide producing establishment number is the company number of the producing establishment, followed by the code of the state or country where the establishment is located, followed by the number of the establishment located in that state or country. As an example, for the establishment number NY, is the company number of the establishment, NY indicates that the establishment is located in New York state, and 02 indicates that the establishment is the second establishment of that company registered in New York state.

    Pesticides that are produced in the U. Foreign country codes may be found at the Enforcement website. The establishment number on a product is the number of the last establishment where production activity took place. Production activity may have occurred in several previous establishments. Beyond the requirement to include the last establishment, EPA has no requirement to list the country of origin on pesticide labeling. Pesticide groups such as Group 4A refer to resistance management of target pests. Each group identity is based on the mode or target site of action of the pesticide on the pest.

    Pesticide companies are not required to include resistance management labeling and mode-of-action group identification on their product labels, however, they are strongly encouraged to do so. More detailed information on pesticide resistance management labeling guidelines may be found on EPA's web site.

    However, the CFR does not restrict additional information about the net contents other than providing that the net contents may also be stated in metric units in addition to the required units specified. Therefore, it would be permissible to include both volume and weight so long as it is not done in a false or misleading manner.

    The Agency also allows other languages to optionally be included in labeling if they are true and accurate translations of the English. See PR-N When non-English text is included optionally, there are no requirements on how it is presented, but EPA recommends that it be no smaller than 6-point type to allow legibility. If, however, the MSDS accompanies the pesticide at any time, it is considered labeling and must not conflict with the labeling EPA has approved for the pesticide product.

    Generally, however, the PPE requirements on a product's label must be followed and overrule any differing requirements that may appear on an MSDS. If you have a case such as this, please inform the Agency and we will investigate whether corrections are necessary. EPA interpretation of the statutory and regulatory requirements is that the label must state the total weight for the entire contents as sold and distributed. In addition, the label may indicate the net weight and quantity of individual units within the carton.

    For example, "Net Weight 6. Whether EPA can require labeling language about state, local or tribal restrictions depends upon specific facts related to individual products and the applicable bans. The regulations concerning the labeling of pesticides for export 40 CFR In order for the pesticide to be treated as registered for purposes of FIFRA section 17 a 1 , among other requirements, the label and labeling approved under a current FIFRA section 3 registration must be attached to the immediate product container or accompany the product at all times.

    Currently there are no data submission requirements specified for claims related to plant health or yield increases. EPA considers these types of claims to be efficacy claims and does not routinely require applicants to submit efficacy data for pesticides intended to control plant pathogens, non-public-health insect pests or weeds. EPA may, on a case-by-case basis, require submission of such efficacy data for non-public-health pesticides when necessary to evaluate whether the pesticide meets the standard for registration.

    This registration evaluation includes determining whether the composition of the pesticide warrants the proposed claims for it, the pesticide's labeling complies with all applicable requirements e. See 29 CFR All labeling — all written, printed or graphic matter attached to, accompanying or referenced on a pesticide product — must be approved by EPA.

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    If a manufacturer wishes to add additional worker health and safety information to labeling beyond that which is required by FIFRA, he must submit the information to EPA for approval. The additional information may not be false or misleading or detract from the information required by FIFRA and must be part of the draft labeling submitted as part of an application for a new registration or as an amendment to an existing registration.

    Only when EPA approves the labeling may the information appear on the label of the product. A one-year storage stability study is one of the product chemistry data requirements that a pesticide product must satisfy in order to obtain a registration 40 CFR If the results of this study show that the product will not remain stable for a one-year period, then an expiration date may be required. Stickering-over an incorrect EPA Reg. See 40 CFR Part for more information on registered establishments and reporting requirements for them.

    EPA, under FIFRA and its associated regulations, does not generally regulate labeling of blending tanks and associated piping used in the production of a pesticide by a registrant. Therefore, unless one of the tanks holds a registered pesticide no labeling would be necessary for the blending tanks and piping under FIFRA. If one of the tanks holds a registered pesticide, the tank would have to bear the label of the product. Labeling for the end product must be present when the end product is released for shipment. Note that this answer addresses blending tanks in a manufacturing setting to produce a registered end-use pesticide and is not intended to address custom blenders or refilling establishments.

    See the Aug. The label review manual LRM provides guidance that the term may be used on labeling of a product of new composition for a period of 6 months following approval of the label. Section 26 of FIFRA designates a state as having primary enforcement responsibility for pesticide use violations when the state has met certain criteria including adopting and implementing adequate procedures for enforcement.

    In some cases, the State Lead Agency may work with local levels of government to enforce the use of pesticides or may delegate enforcement authority to local agencies. We are concerned about the terms "dermatologist-tested" and "hypo-allergenic. OPP would not allow such a statement unless it was properly qualified so that it is not misleading and adequately substantiated with data. We currently do not require or have protocols dealing with dermatology studies so acceptance of such data would be on a case-by-case basis.

    Similarly with respect to the term "hypo-allergenic," such a claim would have to be substantiated with data and appropriately qualified so that it does not misleadingly imply safety. Currently, there are no data requirements to validate such a claim on a pesticide label. Such claims whether on the label or labeling collateral promotional items tied to the product would be subject to 40 CFR There is no specific citation either in FIFRA or the 40 CFR that forbids the use on labeling of quantities of pesticide product that are greater than the package container.

    However, such practice may be misleading to the consumer and, therefore, could be subject to the false and misleading provisions found in 40 CFR The agency often certifies that a product is registered under the Federal, Insecticide, Fungicide and Rodenticide Act and as such may be sold and marketed in the United States. A true and correct copy of the product label in question accompanies the certifying letter. It is used by registrants to show to requiring foreign countries that their product is registered in the United States.

    This certification is often referred to as a "Gold Seal" letter it carries a gold seal embossed with the EPA logo. You may send a letter requesting a copy to the Product Manager for the registration in question. If you do not know the Product Manager you may send it to the registering division. The general rule that the Agency uses in addressing use of previously approved labeling can be found in 40 CFR As to situations where the registrant initiates the amendment, 40 CFR While this section does not specifically address printing of product labels, one can factor that in when determining the 18 month date and anticipated approval by state agencies.

    The collection contains the initially approved label for pesticide products registered under FIFRA as well as subsequent versions of labels which have changed via amendment or notification. The label images are indexed by EPA registration number and the date on which the label was initially registered or amended. In addition to the stamped approved labels this collection contains any associated correspondence about the terms of registration, specifying any changes which the registrant was required to make in the final printed label.

    Because some label amendments address only portions of the label, you may have to review several labels for a single product to determine the complete terms of registration. The collection does not identify those products which have been subsequently canceled or transferred, but rather identifies each pesticide label as it appeared at the time that it was approved.

    While torn or ripped bags are not covered per se in the act or regulations there are several parts of the Act that could be applicable depending on the circumstances. It could also be misbranded if the amount remaining in the bag is significantly different from what is listed on the label. In addition, FIFRA 12 a 2 makes it unlawful for any person to detach, alter, deface or destroy in whole or in part, and labeling required under the Act.

    For state-specific requirements, contact the applicable state agency. In general, an EPA registration is a national license to market a pesticide product, and thus, under federal law, may be marketed in any state. However, in most cases, states also require registration of pesticide products under state law as a condition of sale and use. Thus, marketing a pesticide usually requires a state registration in addition to the EPA registration. The agency responsible for pesticide regulation in each state is the best source of information on their current requirements. Links to these state agencies can be found on EPA's pesticide program website.

    After a label has been approved, misspelled words may be corrected without notifying EPA. Any corrections which result in changes in use directions, use precautions or the ingredient statement must be submitted as a notification or an amendment as described in this PR Notice.

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    Flypaper and glue boards are typically considered devices. In addition, devices must bear the EPA Establishment Number of the establishment where they were produced. In the example you cited, the glue does not need to be listed as an ingredient. Normally, it would be a violation of FIFRA to break up a registered pesticide product and sell and distribute individual doses. This policy provides that veterinarians may dispense pesticides for treatment provided certain minimal conditions described in the notice are met.

    The conditions are paraphrased below, for full details see the policy statement:. Provided the conditions listed in the notice are met, a veterinarian may break up a 3- or 6-pack and sell individual doses. Further, EPA urges veterinarians to discuss the labeling directions with the client at the time the pesticide is dispensed. Unless the EPA registration allows and the registrant has authorized the do-it-yourself pest store to sell the bottles individually and to copy the label and provide it to the customer, the act of copying the label and providing it to the customer along with the individual bottle is considered production and sale of an unregistered pesticide.

    If the registrant authorizes the do-it-yourself pest store to open a box and sell individual bottles along with a copy of the full label and such sale is permitted under the registration, the do-it-yourself store would have to register as a producing establishment and file annual reports of their production. In addition, the individual bottles, if sold separately without the full labeling, are considered misbranded and it is a violation of section 12 a 1 F of the Federal Insecticide, Fungicide and Rodenticide Act FIFRA to sell or distribute a misbranded pesticide.

    If the approved label s is visible through the outer packaging e. If, however, the kit is sold under a separate name from its previously registered contents, the kit must be registered as a separate product and the kit label must be reviewed. Therefore if the kit is considered anything more than the combination of separately named products i. Thus if the kit is being sold as a unique product requiring separate registration or the individual product labels are not visible from the outer container or the previously approved labels are not used on the outer container in their entirety without modification, EPA must review the labeling through the registration in the case of a new product or registration amendment process.

    The Agency may allow, if appropriate, a subset of the approved label to appear on the outer container. In all cases, the following items are required to be fully visible either through the outer packaging or on the outer container:. If review is necessary and multiple pesticide products are contained within the kit, the outer container label must be reviewed by the particular team for each individual pesticide product contained inside. To help coordinate this review, it would be helpful to include a cover letter identifying the teams that will be reviewing the outer container label.

    If label review is necessary, the amended label must be submitted as a registration amendment. If no label review is necessary because approved labeling is visible either through the outer packaging or reprinted in total and the packaging changes meet the criteria found in PR II. EPA has the responsibility to ensure that pesticide labeling — written, printed, or graphic matter accompanying the pesticide at any time — is not false or misleading before it is approved.

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