Fifra compliance program policy


















The Texas Department of Agriculture will issue advisory approvals of Section 2 ee recommendations in printed form for distribution in Texas subject to the following conditions:. Section 2 ee recommendations that have received advisory approvals from the department will be presumed by the department to be in compliance with Tex. Any changes to the Section 2 ee recommendation after approval will cancel the notification. Those not receiving an advisory approval from the department will bear the risk of being found in violation of Tex.

Pesticide Registration 2ee Policy. The Texas Department of Agriculture will issue advisory approvals of Section 2 ee recommendations in printed form for distribution in Texas subject to the following conditions: 1.

Recommendations s in printed form shall be distributed as "Product Information Bulletin s ", "Pesticide Fact Sheet s ": etc. In many cases, aggregate yearly data which does not Identify Individual producers may not be confidential. However, there Is a risk, In some cases, that the requestor may ascertain the Identities of Individual producers when combining the aggregate data with other Information 1n his possession.

Sears Roebuck. Agg'regatlon of pesticide production data submitted to EPA 1s clearly the creation of new records. It has decided not to do so due to the risk of unintended disclosure of confidential data. Docket Nos. Pol icy; registered or experimental use not authorized by the label or A person may legally use a registered or experimental use pesticide for testing purposes in a manner not authorized by the label or the permit 1f: 1.

The purpose of the use is only to determine the pesticidal value of the substance or its toxicity or other properties, and 2. No one conducting the test expects to obtain any benefit in pest control from Its use. In addition, other specific conditions must be met for pesticide uses as described in 40 CFR Part The regulations at 40 CFR Part These crops include crops subsequently grown on such land which may reasonably be expected to contain residues of such substances or mixtures of substances.

Therefore, It 1s also not a violation to use a substance with an EUP in a manner contrary to the provisions of the permit, if the use is In tests which meet the conditions at 40 CFR Parts They stated that the pesticide label directs safety requirements at the most hazardous pesticide use situations without considering less hazardous situations.

Further, the Nay policy may actually hinder the development of new equipment designed to safely handle pesticides. The Agency's position 1s that wearing the personal protective equipment required by the pesticide label provides the greatest level of user protection. However, the Agency recognizes that technological and engineering advancements have made significant contributions In the field of pesticide use safety. One such advancement Is the development of closed systems.

Preliminary field experiences Indicate that the Incidents pesticide exposure to persons operating a closed system gen- illy arise due to one of the following conditions: o Pesticide leaks at seals, gaskets, hoses, or seams caused by worn or poor quality parts, or by parts eroded when the chemicals are allowed to stand In the container. There are, however, many documented Instances when a closed System has been used without resulting 1n an exposure from Its use.

Therefore, the Agency will amend Us Hay 10, , policy and will not take an enforcement action 1f the operator can show the following: o Records are available for the current operating year which show that a cleaning schedule and maintenance program which Includes flushing the system so that pesticides are not allowed to stand In the system for more than one work day has been developed and 1s administered.

Notwithstanding the requirements of this policy, If all of the personal protective equipment required by the label 1s not worn while using a closed system and a pesticide exposure occurs, the Agency may take an enforcement action under FIFRA Section 12 a 2 G against the operator of the closed system. October 12, letter from Ms. July 1, letter from Mr. Phillip C. References; "Closed System Update" by R. Brazelton, N. Akesson, and K. Maddy, January Upon a showing that there is reason to believe that the provisions of FIFRA have been violated, EPA inspectors may obtain warrants to inspect such establishments pursuant to section 9 b.

This Section makes It unlawful to use a pesticide in a manner inconsistent with Its labeling. To enforce this subsection and to prevent pesticide misuse, EPA may routinely undertake "use inspections", as part of a neutral administrative inspection scheme. However, inspectors roust obtain the consent of the owner or person In charge of the premises to be Inspected. Well established Fourth Amendment principles require that the consent be knowing and voluntary. Within the framework outlined above, EPA inspectors may also obtain samples of pesticides or devices, and samples of any con.

Any such samples must be obtained in accordance with the receipt procedure described in Section 9 a. EPA take enforcement action against pesticide deale-s who make restricted use pesticides RUP available to persons who are not certified applicators?

Section 12 a 2 F of FIFRA states: It shall be unlawful for any person to make available for use, or to use, any registered pesticide classified for restricted use for some or all purposes other than In accordance with section 3 d and any regulations thereunder; Provided, That 1t shaU not be unlawful to sell, under regulations Issued by the Administrator, a restricted use pesticide to a person who 1s not a certified applicator for application by a certified applicator.

These regulations apply only to States with federally operated certification and training programs. This new policy Other States may presently allow the sale of RUP's to a person who 1s not a certified applicator 1f they have a plan approved by the Administrator containing the minimum standards listed in 40 CFR If the label specifies a substance as the product's diluent, the use of any other substance as a diluent 1s considered a use In- consistent with the label and constitutes a misuse violation under Section 12 a 2 G.

In instances where no diluent 1s specified on the label, water must be used as the diluent. Discussion: This policy applies to the use of any substance as a diluent, which is not specified on the label e. This policy also applies to ultra-low, low volume, or conventional application systems. The Agency 1s Issuing this policy 1n response to the practice of some applicators to use diluents not specified on the label.

Specifically, the use of vegetable oil by some applicators as a diluent because of Its slow evaporation properties. The Agency is concerned that this practice will have adverse health effects if the pesticide does not evaporate at the anticipated rate I.

In addition, there may be adverse safety Impacts to farmworkers who are exposed to a pesticide that does not evaporate as rapidly as anticipated. The applicators state that the use of vegetable oil as the diluent results In a pesticide dosage less than that specified on the label. In the opinion of the applicators, the use of vegetable oil as the diluent can there- fore be justified in ultra-low volume ULV applications under Sec- tion 2 ee l and the March 3,!

The March, Advisory Opinion permits the use of a product at a dosage less than the specified label in ULV applications, provided such use is recommended by an appropriate State or Federal agency, and the use pattern is submitted to and approved sy EPA. The provisions of Section 2 ee l and the March, " Advisory Opinion apply on! Neither Section 2 ee nor the March, Advisory Opinion permits a discretionary choice of diluent.

The use of a diluent not specified on the label, regardless of resulting dosage or application method, constitutes a misuse under Section 12 a 2 G To determine a legal choice of product diluent, applicators must consult the pesticide labeling, pesticide exemptions, 24 c registrations, or other pertinent EPA policy documents. Environmental Protection Agency take an enforcement action under FIFRA section 12 a 2 G against the applicator who uses an appropriate enclosed cab to apply ' pesticides without wearing the personal protective equipment required by the pesticide product labeling?

Policy; The Agency will not take an enforcement action under FIFRA section 12 a 2 G against an applicator for using an enclosed cab instead of personal protective equipment required by the pesticide product labeling, provided the conditions outlined in this interim policy are met. This policy applies to ground methods of application only. There is documented evidence that certain enclosed cabs can provide applicator protection equivalent or superior to that provided by personal protective clothing and equipment PPE.

However, for these enclosed cabs to be used in lieu of PPE, certain potential problems must be addressed. It is of particular importance that these problems be addressed for enclosed cabs used for protection from respiratory hazards. Problems observed during field observations include: Insufficient data on the effectiveness of protection provided. Insufficient operating and maintenance instructions that allow the user to maintain effectiveness.

Insufficient records showing the user is following manufacturer's recommendations. Insufficient training and documentation of training.

Insufficient instruction on user protection if exit is necessary during use and how to avoid contamination of equipment. During ground methods of pesticide application an enclosed cab may be used instead of the personal protective equipment required by the product labeling provided the following conditions are met.

To ensure protection equivalent or superior to that provided by label-required personal protective equipment, enclosed cabs and users must meet all the following minimum requirements for purposes of this policy: 1 For labeling instructions that require dermal or eye protection, an enclosed cab must provide a nonporous barrier totally surrounding the occupants of the cab that prevents contact with the spray mist, dust, or treated surfaces.

Uncontaminated personal protective clothing and equipment, including a properly functioning and maintained respirator, required by the product labeling to be used during application must be available inside the enclosed cab.

PPE must be removed before reentering the cab and stored outside the cab. PPE may be taken into the cab only if it is enclosed in a chemical resistant container, such as a plastic bag. Cabs used in lieu of respiratory protection must be approved by the State in which the pesticide is being applied. If there is no established permissible exposure limit PEL , the protection provided must meet the protection factor provided by the respiratory protection equipment required by the labeling.

If a State does not set up such an approval program, the respiratory protection device required by the labeling must be worn. Note: Those States wishing to do so may use California's list of approved cabs. States are cautioned that this policy does not apply to fumigants unless, as part of their approval program, the State, after review of research presented, makes the determination that the enclosed cab provides protection equivalent to an applicable PEL or labeling required PPE, as outlined above.

In addition to all of the above requirements, the operator must make available at the request of the inspector: - Operating and maintenance instructions to be followed in order to maintain required air levels and a cab interior free from contamination.

Respirators, JoKrt J. NeylajJ IIl'. The coyer. The policy will remain in effect until OPP has completed decision making and such decisions are implemented. If you have any questions, please contact me at Attachment cc: Anne E. Lindsay Douglas. This policy addresses the enforcement of the label provisions which were required in PR Notice A Chemigation Committee established by OPP has the respon- sibility for preparing and updating the list of approved, comparable equipment.

The attached list is the first, preliminary identification of comparable systems prepared by OPP. Because this list is subject to updates and modifications, it has not been made a part of this policy. Rather, the policy refers to "a current list of comparable systems," and provides information on how to obtain the list. This is an interim final policy which will be in effect for year from the date of this policy.

During that year, OPP will. Depending on the conclusions of this review, thfs interim policy may be withdrawn, modified, or extended. The States and the regulated community have indicated that other comparable systems'exist and have requested EPA to allow such systems to be used instead of what is specified on the label. PR Notice required: 1 registrants of pesticide products which are applied through chemigation to revise their labels to include additional use directions.

EPA recognizes that other, comparable technologies exist for the application of pesticides through chemi. Such technologies have been proposed to the Agency by grower groups, equipment manufacturers, and State regulators. To evaluate such technologies, OPP has organized a Chemigation Committee consisting primarily of agricultural engineers from various parts of the country.

Based on the Committee's evaluations, a list of comparable equipment has been prepared and will be updated or modified, as appropriate. Please note as identified on be followed. EPA, that any applicable restrictions or requirements the list and all other label directions must obtain a copy of a current list of comparable the Chief of the Registration Support Branch, Registration Division,"Office of Pesticide M Street, S.

Downing, Ocean Hew Jersey Dept. Flaherty, Compliance R. Flaherty, Chief, Policy and Analysis Branch. These devices are offered as alternatives to certain required components of chemigation systems in PR Notice , the Chemigation Label Improvement Program.

I am sure you are aware of the urgency to' get this information into the hands of State and Federal regulators as soon as possible for the impending growing season. If we can be of assistance in the timely distribution, please let us know. There are several grower groups, equipment manufac- turers, committee members, and other interested parties with whom we have been working, so we would appreciate several copies of the final document.

I have been advised that there may be some further expansion of this list of alternatives upon further consideration of the Chemigation Committee. Please contact Dr. Tom Ellwanger on the status of the mailout and if there are questions on the technical aspects of the project. As a result of comments and new information received subsequent to issuance, a list of alternative devices to those included in PR Notice has been considered and approved for use.

In some cases these alternative devices may be less expensive, more reliable, or more available than some. Be advised that all of the devices originally included in PR Notice are still acceptable and that the PR Notice is, in its entirety, still in effect. Devices required in PR Notice- which have no listed alternatives are still required components of all chemigation systems.

The original devices as required in PR Notice and their corresponding alternatives are listed below: Original Device Functional normally closed, solenoid-operated valve located on the intake side of the injection pump. Alternative Device 1 Functional spring-loaded check valve with a minimum of 10 psi cracking pressure. The valve must prevent irrigation water under operating pressure from entering the pesticide injection line and must prevent leakage from, the pesticide supply-tank on system shutdown.

This valve must be constructed of pesticidally resistant materials. The control line must be connected to the main water line such that the valve opens only when the main water line is adequately pressurized.

This valve must prevent leakage from the pesticide supply tank on system shutdown. The valve must be constructed of pesticidally resistant materials. This alternative is appropriate for only those chemigation systems using a positive displacement pesticide injection pump and is not for use with venturi injection systems.

This valve must be elevated at least 12 inches above the highest fluid level in the pesticide supply tank and must be the highest point in the injection. The valve must open at 6 inches water vacuum or less and must be spring loaded or otherwise constructed such that it does not leak on closing.

It must prevent leakage from the pesticide supply tank on'system shutdown. Original Device Functional main water line check valve and main water line low pressure drain. Alternative Device 1 Gooseneck pipe loop located in the main water line immediately downstream of the irrigation water pump. The bottom side of the pipe at the loop apex must be at least 24 inches above the highest sprinkler or other type of water emitting device. The loop must contain either a vacuum relief or combination air and vacuum relief valve at the apex of the pipe loop.

The pesticide injection port must be located downstream of the apex of the pipe loop and at least 6 inches below the bottom side of the pipe at the loop apex. Original Device Positive displacement pesticide injection pump. Venturies must be constructed of pesticidally resistant materials. This valve must be located immediately adjacent to the venturi pesticide inlet.

This same supply line must also contain. In bypass systems as an option to placing both valves in the line from the pesticide supply tank, the check valve may be installed in the bypass immediately upstream of the venturi water inlet and either the normally closed solenoid or hydraulically operated valve may be installed immediately downstream of the venturi water outlet. Original Device Vacuum relief valve.

Alternative Device 1 Combination air and vacuum relief valve. Pol icy; A product which legally enters a foreign-trade zone for processing or repackaging is not subject to the requirements of FIFKA.

Discussion: Foreign-trade zones or "freeports" are areas within the United States where products may be stored, processed, manipulated, manu- factured and reshipped without being subject to the customs laws of the United States governing the entry of goods and the payment of duty.

The regulations contained in 19 CFR Part govern admission of merchandise into a foreign-trade zone; manipulation, manufactur- ing, processing, etc. In order to be. Freeports, Processing, Registration, Repackagl ng. Pol Icy; multi-use chemicals and pesticides Imported purposes obtain a waiver from "Notice of Importers of multi-use chemicals and pesticides imported for non-pestiddal purposes can be granted a waiver from "Notice of Arrival" requirements.

Section 17 c states that pesticides or devices which are adulterated, mis- branded or otherwise violate the provisions set forth in the Act or are injurious to health or the environment may be refused entry Into the country. The regulations state 1n part that pesticides and pesticide products Imported into the U. To assist in monitoring compliance with this requirement, EPA developed a checklist of frequently encountered pesticides and distributed ft to U.

Customs commodity Import specialists. Somt of the pesticide chemicals which appear on the list may be multi-use chemicals Imported for non-pestiddal uses or pesticides Imported for chemical analysis or other testing. As a matter of policy, the Agency will allow persons Importing products for such purposes to request a waiver from the Notice of Arrival requirements. Such requests must be made In writing to EPA Headquarters and must state 1 the chemical being Imported together with Its EPA registration number, If regis- tered; 2 the purpose for which the product 1s being Imported; 3 the amount of chemical being Imported; and 4 1f known, the port of entry If there Is more than one, all ports of entry should be listed.

To expedite future shipments, the Regions should encourage importers to file a copy of the waiver with Customs for each subsequent entry of the product. Pol1cy; The Agency will permit Section 24 c labeling to appear on Federal labeling under certain conditions. Discussion: Section 24 c of FIFRA states that a State may register addi- tional uses of federally registered pesticides for distribution and use within that State to meet special local needs provided that no such use has been previously denied, disapproved or cancelled by EPA.

The Agency has 90 days to review such a registration. If the use Is for a food or feed crop, a tolerance or exemption must exist for that use. Part As a matter of convenience for both the regis- trant and the user. Section 24 c use directions nay appear on a Federal label provided the directions are clearly Identified and separate from Federal labeling.

Either a distinct border around the Section 24 c uses or a sticker which does not obscure the Information on the Federal label 1s an acceptable means of con- veying Section 24 c Information. The labeling must also clearly Identify the State 1n which the Section 24 c use 1s allowed. If a specific Identical use has been registered In a number of States, the registrant may list all the States which have registered the use.

The registrant must use the statement "For distribution and use only within name of State s 11 on all Section 24 c labeling. A product bearing Section 24 c uses on the label may only be sold 1n those States listed. This policy applies only to additional State registered uses of a Federally registered product. It does not not apply to State registered products. Conroy II to Mr. Arthur F. Gohlke, Cities Service Company. Policy: Labeling a pesticide "For Agricultural Use Only" or expressing the dosage rate in pounds per acre, label language usually reserve.

One criterion is that the product is intended for use in. Expressing the use directions in terns of number of pounds per acre does not in or by itself preclude residential use. This also would not affect whether or not a product requires CRP. Therefore, where the package size is small, the product is narketed fn hone and garden stores, or the entire net contents.

CRP would be required if the C3P criteria are met regardless of whether the label also states "For Agricultural Use Only" or the dosage rate is expressed in agricultural terms, such as pounds per acre. References: 40 CFR Part Region IV. Pol Icy; Primacy authority is transferred to a State when the State formally accepts a written offer by the Administrator to convey such authority. Primacy is also transferred when a cooperative enforcement agreement is signed by the Administrator and the State, unless the terms of the agreement specify otherwise.

Discussion: Section 26 of FIFRA authorizes the Administrator to grant primacy to a State if the State has adopted adequate laws and adequate procedures for implementing such laws, or If the State has an approved certification plan that meets the adequate laws and procedures criteria. In addition, States may obtain primacy by entering into a cooperative agreement for the enforcement of pesticide use restrictions under Section 23 of FIFRA. To transfer primacy through the first two mechanisms, the Administrator will write to the Governor offering to grant primacy to the State.

The Administrator's letter will request a formal response to the offer of primacy. The transfer of primary use enforcement responsibility will not be effective until the Governor or his representative posts a written response accepting privacy. With respect to tht third mechanism, when a State signs a cooperative agreement which calls for the State to monitor and enforce compliance with pesticide ust restrictions, such Statt assumes ust enforcement primacy unless the terms of the agreement specify otherwise.

Thus tht signing of an agree- ment which specifically states that tht assumption by a State of primacy depends upon tht occurrtnct of an tvtnt dots not transfer primacy authority until tht tvtnt takes place.

Cooperative enforcement agreements which do not contain such conditions will strvt to convey primacy to a Statt upon signature of the Govtrnor and tht Administrator or their duly designated representatives. Conroy II,.



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