Pesticide Registration (PR) Notice 87-1

March 11, 1987

NOTICE TO MANUFACTURERS, FORMULATORS, PRODUCERS AND REGISTRANTS OF PESTICIDE PRODUCTS

Attention:  Persons Responsible for Registration of Pesticide Products
Subject:  Label Improvement Program for Pesticides Applied through Irrigation Systems (Chemigation)

This Notice requires registrants of pesticide products registered under FIFRA and applied through irrigation systems to revise the labeling for such products to include additional use directions and other statements described in this Notice.

No end-use pesticide products labeled for agricultural, nursery, turf farm, golf course or greenhouse uses may be released for shipment by a registrant or producer of that product after April 30, 1988 unless the product bears an amended label which complies with the LIP.

I. The Label Improvement Program

On June 5, 1980, the Agency announced the establishment of a Label Improvement Program under which labels of products were to be upgraded, improved, or revised to meet current labeling standards. Notice of this program was issued in the Federal Register and provided to all registrants as PR Notice 80-01. This Notice is issued under that LIP.

Pesticide labels are required to contain directions for use which are necessary for effecting the purpose for which the product is intended and are adequate to protect health and the environment. The label revisions required by this Notice, if adhered to by the users, will decrease environmental risks of pesticide contamination of ground water and will decrease direct human exposure to pesticide-treated irrigation water by providing appropriate use directions and restrictions or prohibitions. Although the Agency has received indirectly only very limited accounts of water source contamination or personal injury resulting from pesticide application through irrigation systems (chemigation), there is potential for such situations due to the increasing popularity of this application method, lack of public awareness that pesticides may be contained in irrigation water, lack of broad-based or uniform regulation by individual states, and the absence of directions for use on pesticide labels. This last factor is due in part to the recent development of this application technology and equipment, and in part to FIFRA sec. 2 (ee)(3) which allows "any method of application not prohibited by labeling".

The Agency has received accounts of members of the general public intentionally using irrigation water in a variety of ways which could result in direct human exposure to pesticides if the system was being used for chemigation. The required label revisions, particularly those requiring posting to inform persons that irrigation water may contain pesticides, will decrease the likelihood of direct human exposure.

The required labeling will benefit users by providing them use directions for this relatively new method of application or will indicate that certain pesticides or application equipment should not be used and do not have the support of the registrant. In addition there will be uniform label requirements at the Federal level to address environmental concerns for this method of pesticide application. The Agency will also enhance its ability to enforce the requirements under the misuse provisions of FIFRA sec. 12(a)(2)(G) which will encourage compliance by users.

The Agency believes that some of this safety equipment is already in use on more recently installed irrigation systems. Several states have regulations in place requiring similar equipment. There will be an economic impact on users who may have to install additional safety equipment. However, incremental costs of any additional equipment are small compared with the overall costs of the complete irrigation system itself. Another type of cost may be felt by users in the loss of availability of certain pesticides for chemigation because registrants elect to prohibit use rather than add use directions. Costs to registrants will be the cost of revising the labels for those who must add the label prohibition or elect to add use directions for chemigation.

In all cases, the Agency believes that incremental costs will be outweighed by the benefits of having comprehensive and appropriate label use directions, of affording greater protection of the environment including ground water, and of greater enforcement capability to ensure compliance.

II. Pesticide Products to Which This Notice Applies

A.The requirements of this Notice apply to any pesticide product which:

  1. May legally be applied through any type of irrigation system including any sprinkler, flood, furrow, drip or greenhouse system (pesticide products whose labels are silent on chemigation, i.e., neither recommend nor prohibit this application method, do legally allow this use); and
  2. Is labeled for agricultural uses, nursery uses, turf farm uses, golf course uses or greenhouse uses; and
  3. Is subject to FIFRA sec. 3 Registration, sec. 5 Experimental Use Permit, sec. 18 Emergency Use, or sec. 24(c) Special Local Need regulation.

B. The requirements of this Notice do not apply to any pesticide product which:

  1. Is intended solely for residential use (such as indoor, yard or garden);
  2. Is intended solely for direct injection into plants;
  3. Is intended solely for post harvest application to produce; or
  4. Is intended to be applied only as a gas or only as a solid, such as a pellet, tablet, granule or dust formulation.

C. This notice is not intended to limit chemigation practices to the types of irrigation systems given as examples above to the detriment of developing new technologies, nor is It intended to limit the Agency's concerns to those types of systems named as examples. If chemigation through other types of systems is Intended, registrants must submit a detailed description of the system with proposed labeling for Agency review.

D. It is the Agency's intention to maintain as much flexibility as practicable in administering this LP relative to FIFRA sec.24(c) registrations. A label prohibition against chemigation of a product under FIFRA sec. 3 will not prohibit states from issuing a sec. 24(c) registration for chemigation of that same product as long as labeling according to this LIP is incorporated into the sec. 24(c) registration.

III. If Chemigation is Not Intended

If it is your intention that your product not be applied through any type of chemigation system, add to your label the following prohibition statement: "Do not apply this product through any type of irrigation system." Skip to Section XI of this Notice.

If at any time in the future you wish to replace the prohibition statement with the prescribed use directions and precautions in Sections IV. through IX.,you must submit an application for amended registration to the appropriate Product Manager in the Registration Division. Application for amended registration are not subject to the requirements of FIFRA sec. 3(c)(1)(D) pertaining to data compensation procedures.

IV. Generic Label Statements Required for Chemigated Products

If you intend that your product be applied by any type of chemigation system, all the following generic statements must be included on your label together with the specific requirements from one or more of Sections V. through IX.

V. Label Statements for Chemigated Toxicity Category I Products

In addition to generic label statements in Section IV., and specific label statements in  one or more of Sections VI., VII., VIII., or IX., the labels of Toxicity Category I products (those with the label signal word DANGER) which allow chemigation must include the statements:

"Posting of areas to be chemigated is required when 1) any part of a treated area is within 300 feet of sensitive areas such as residential areas, labor camps, businesses, day care centers, hospitals, in-patient clinics, nursing homes or any public areas such as schools, parks, playgrounds, or other public facilities not including public roads, or 2)when the chemigated area is open to the public such as golf courses or retail greenhouses."

"Posting must conform to the following requirements. Treated areas shall be posted with signs at all usual points of entry and along likely routes of approach from the listed sensitive area. When there are no usual points of entry, signs must be posted in the corners of the treated areas and in any other locations affording maximum visibility to sensitive areas. The printed side of the sign should face away from the treated area towards the sensitive area. The signs shall be printed in English. Signs must be posted prior to application and must remain posted until foliage has dried and soil surface water has disappeared. Signs may remain in place indefinitely as long as they are composed of materials to event deterioration and maintain legibility for the duration of the posting period."

"All words shall consist of letters at least 2 1/2 inches tall, and all letters and the symbol shall be a color which sharply contrasts with their immediate background. At the top of the sign shall be the words KEEP OUT, followed by an octagonal stop sign symbol at least 8 inches in diameter containing the word STOP. Below the symbol shall be the words PESTICIDES IN IRRIGATION WATER." A small-scale illustration of an acceptable sign is attached at the end of this Notice.

Posting required for chemigation does not replace other posting and reentry interval requirements for farm worker safety.

VI. Label Statements for Chemigation Systems Connected to Public Water Systems

In addition to generic label statements in Section IV., and specific label statements in one or more of Sections VII, VIII or IX., the labels of pesticide products which allow chemigation through systems connected to public water systems must include the statements:

A.Specific Required Label Statements

  The following statements must be used verbatim:

  1. "Public water system means a system for the provision to the public of piped water for human consumption if such system has at least 15 service connections or regular serves an average of at least 25 individuals daily at least 60 days out of the year."
  2. "Chemigation systems connected to public water systems must contain a functional,reduced-pressure zone, back flow preventer (RPZ) or the functional equivalent in the water supply line upstream form the point of pesticide introduction As an option to the RPZ, the water from the public water system should be discharged into a reservoir tank prior to pesticide introduction. There shall be a complete physical break (air gap)between the flow outlet end of the fill pipe and the top or overflow rim of the reservoir tank of at least twice the inside diameter of the fill pipe."
  3. "The pesticide injection pipeline must contain a functional, automatic, quick-closing check valve to prevent the flow of fluid back toward the injection."
  4. "The pesticide injection pipeline must contain a functional, normally closed, solenoid-operated valve located on the intake side of the injection pump and connected to the system interlock to prevent fluid from being withdrawn from the supply tank when the irrigation system is either automatically or manually shut down."
  5. "The system must contain functional interlocking controls to automatically shut off the pesticide injection pump when the water pump motor stops, or in cases where there is no water pump, when the water pressure decreases to the point where pesticide distribution is adversely affected."
  6. "Systems must use a metering pump, such as a positive displacement injection pump (e.g., diaphragm pump) effectively designed and constructed of materials that are compatible with pesticides and capable of being fitted with a system interlock."
  7. "Do not apply when wind speed favors drift beyond the area intended for treatment."

B.  Nonspecific Required Label Statements

The following subjects must by addressed using the registrants own wording:

  1. Indicate whether agitation is or is not recommended in the pesticide supply tank. If it is not always recommended, identify the situations when it is recommended (e.g. when tank mixing with other pesticides or fluid fertilizers).
  2. Indicate if the pesticide is to be applied continuously for the duration of the water application. If not, indicate when during the water application the pesticide is to be applied.
  3. Provide mixing instructions for dilution of the pesticide in the supply tank.

C. Optional Label Statements

   The following subject is not required, but may be addressed at the registrants choosing:

  1. Indicate the quantity of water to be applied per acre to achieve efficacy, but not cause runoff or excessive leaching. A range of quantities may be appropriate.

VII. Label Statements for Sprinkler Chemigation

A.Specific Required Label Statements

  The following statements must be used verbatim:

  1. "The system must contain a functional check valve, vacuum relief valve, and low pressure drain appropriately located on the irrigation pipeline to prevent water source contamination from back flow."
  2. "The pesticide injection pipeline must contain a functional, automatic, quick-closing check valve to prevent the flow of fluid back toward the injection pump."
  3. "The pesticide injection pipeline must also contain a functional, normally dosed, solenoid-operated valve located on the intake side of the injection pump and connected to the system interlock to prevent fluid from being withdrawn from the supply tank when the irrigation system is either automatically or manually shut down."
  4. "The system must contain functional interlocking controls to automatically shut off the pesticide injection pump when the water pump motor stops."
  5. "The irrigation line or water pump must include a functional pressure switch which will stop the water pump motor when the water pressure decreases to the point where pesticide distribution is adversely affected."
  6. "Systems must use a metering pump, such as a positive displacement injection pump (e.g., diaphragm pump) effectively designed and constructed of materials that are compatible with pesticides and capable of being fitted with a system interlock."
  7. "Do not apply when wind speed favors drift beyond the area intended for treatment."

B.  Nonspecific Required Label Statements

The following subjects must be addressed using the registrants own wording:

  1. Indicate whether agitation is or is not recommended in the pesticide supply tank. If it is not always recommended, identify the situations when it is recommended (e.g., when tank mixing with other pesticides or fluid fertilizers).
  2. Indicate if the pesticide is to be applied continuously for the duration of the water application. If not, Indicate when during the water application the pesticide is to be applied.
  3. Provide mixing instructions for dilution of the pesticide in the supply tank.

C. Optional Label Statements

   The following subject is not required, but may be addressed at the registrant's choosing:

  1. Indicate the quantity of water to be applied per acre to achieve efficacy, but not cause runoff or excessive leaching. A range of quantifies may be appropriate.

VIII. Label Statements for Floor (Basin), Furrow and Border Chemigation

A. Specific Required Label Statements

   The following statements must be used verbatim:

  1. "Systems using a gravity flow pesticide dispensing system must meter the pesticide into the water at the head of the field and downstream of a hydraulic discontinuity such as a drop structure or weir box to decrease potential for water source contamination from back flow if water flow stops."
  2. "Systems utilizing a pressurized water and pesticide injection system must meet the following requirements:"

    3. a. "The system must contain a functional check valve, vacuum relief valve, and low pressure drain appropriately located on the irrigation pipeline to prevent water source contamination from back flow."

    b. "The pesticide injection pipeline must contain a functional, automatic, quick-closing check valve to prevent the flow of fluid back toward the injection pump."

    c. "The pesticide injection pipeline must also contain a functional, normally closed, solenoid-operated valve located on the intake side of the injection pump and connected to the system interlock to prevent fluid from being withdrawn from the supply tank when the irrigation system is either automatically or manually shut down."

    d. "The system must contain functional interlocking controls to automatically shut off the pesticide injection pump when the water pump motor stops."

    e. "The irrigation line or water pump must include a functional pressure switch which will stop the water pump motor when the water pressure decreases to the point where pesticide distribution is adversely affected."

    f. "Systems must use a metering pump, such as a positive displacement injection pump (e.g., diaphragm pump) effectively designed and constructed of materials that are compatible with pesticides and capable of being fitted with a system interlock."

B.Nonspecific Required Label Statements

  The following subject must be addressed using the registrants own wording:

  1. Indicate whether or not a pesticide supply tank is recommended for the application. If it is recommended, provide mixing instructions for dilution of the pesticide In the tank. If agitation s not always recommended, identify the situations when it is recommended (e.g., when tank mixing with other pesticides or fluid fertilizers).
  2. Indicate if the pesticide is to be applied continuously for the duration of the water application. If not, indicate when during the water application the pesticide is to be applied.

C. Optional Label Statements

   The following subject is not required, but may be addressed at the registrant's choosing:

  1. Indicate the quantity of water to be applied per acre to achieve efficacy, but not cause runoff or excessive leaching. A range of quantities may be appropriate.

IX. Label Statements for Drip (Trickle) Chemigation

A. Specific Required Label Statements

   The following statements must be used verbatim:

  1. "The system must contain a functional check valve, vacuum relief valve and low pressure drain appropriately located on the irrigation pipeline to prevent water source contamination from back flow."
  2. "The pesticide injection pipeline must contain a functional, automatic, quick-closing check valve to prevent the flow of fluid back toward the injection pump."
  3. "The pesticide injection pipeline must also contain a functional, normally closed, solenoid-operated valve located on the intake side of the injection pump and connected to the system interlock to prevent fluid from being withdrawn from the supply tank when the irrigation system is either automatically or manually shut down."
  4. "The system must contain functional inter-locking controls to automatically shut off the pesticide injection pump when the water pump motor stops."
  5. "The irrigation line or water pump must include a functional pressure switch which will stop the water pump motor when the water pressure decreases to the point where pesticide distribution is adversely affected."
  6. "Systems must use a metering pump such as a positive displacement injection pump (e.g., diaphragm pump) effectively designed and constructed of materials that are compatible with pesticides and capable of being fitted with a system interlock."

B. Nonspecific Required Label Statements

   The following subjects must be addressed using the registrant's own wording:

  1. Indicate whether or not a pesticide supply tank is recommended for the application. If it is recommended, provide mixing instructions for dilution of the pesticide in the tank and indicate whether agitation is or is not always recommended in the tank. If agitation is not always recommended, identify the situations when it is recommended (e.g., when tank mixing with other pesticides or fluid fertilizers).
  2. Indicate if the pesticide is to be applied continuously for the duration of the water application. If not, indicate when during the water application the pesticide is to be applied.

C. Optional Label Statements

   The following subject is not required, but may be addressed at the registrants choosing:

  1. Indicate the quantity of water to be applied per acre (or other measure of surface, volume etc.) to achieve efficacy, but not cause runoff or excessive leaching. A range of quantities may be appropriate.

X. Format of Label Information

If all information is included on the label itself, the label must meet the format requirements of 4O CFR 162.10. If chemigaton label requirements are included in supplemental labeling rather than on the pesticide container label, the container label must contain the referral statement:

"CHEMIGATION: Refer to supplemental labeling entitled (fill in title) for use directions for chemigation. Do not apply this product through any irrigation system unless the supplemental labeling on chemigation is followed."

Note that supplemental labeling accompanying the pesticide product or referred to on the container label is considered to be labeling under FIFRA and is subject to review and approval by the Agency.

XI. What You Must Do to Comply

If you are the registrant of a pesticide product that is Federally registered under FIFRA sec 3:

A. First ascertain by examination of each product label whether or not each product is subject to this Notice according to the use patterns, sites, and formulations outlined in Section II. A. and B. above. For products not subject to this Notice no further action is required.

B. If you believe, for reasons other than those listed in Section II. A. and B. that your product should not be subject to the requirements of this Notice, you must submit a copy of the most current approved label and written justification supporting your position for Agency review by July 31, 1987. Claims for relative non-toxic status of a pesticide are not considered sufficient justification to warrant an exclusion from this LIP. Once this information has been submitted to the Agency through the appropriate Product Manager, you need not take any further action to comply with this Notice until a response is received from the Agency.

C. If your product is subject to this Notice you must take one of the following actions:

  1. Revise your product labels in accordance with this Notice by either adding the prohibition statement in Section III. or the generic and specific label statements in Sections IV. through IX. No application for amended registration is required if the wording if Sections III. through IX is used as given and information required to be provided by the registrant is included. If you choose this option, submit the following to the Agency:
  2. If you wish to modify the required LIP statements in any substantive manner submit an application for amended registration, together with five copies of proposed labeling no later than July 31, 1987. Applications are not subject to the requirements of FIFRA see. 3(c)(1)(D) pertaining to data compensation procedures. Applications must be submitted to the appropriate Product Manager at EPA for all Federally registered products.

If you are or will be the producer of a pesticide product subject to FIFRA sections 5, 18, or 24(c):

A. There is no need to amend currently approved labeling of products subject to FIFRA sec. 5 or 18.

B. The Agency will not, however, accept labeling submitted later than April 30, 1988 unless that labeling complies with the requirements of this LIP, i.e., either contains the prohibition or appropriate chemigation use directions.

C. Producers of pesticide products subject to FIFRA sec. 24(c) shall revise existing labels as per this LIP by April 30, 1988. Revised labeling and, if appropriate, a letter of certification shall be submitted to the state agency responsible for issuance or renewal of FIFRA sec. 24(c) registrations.

XII. Compliance Dates

All subject products released for shipment after April 30, 1988 must bear the revised labeling.

Products not in compliance as of this date will be deemed to be misbranded in violation of FIFRA sec. 12(a)(1)(e). The Agency may take enforcement action, issue Notices of Intent to Cancel the product's registration in accordance with FIFRA sec. 6, or both.

Registrants are reminded that:

XIII. For Further Information

If you have questions regarding this Notice, or do not understand what you must do to comply, contact Dr. Thomas Ellanger, Registration Division, Fungicide-Herbicide Branch at (703) 557-1700.

If you have questions concerning the registration or amendment of a specific product, you must contact the Product Manager for that specific product.

The Agency address for correspondence and submission of applications is as follows:

Registration Division (TS-767C)
Environmental Protection Agency
401 M Street., S.W.
Washington, D.C. 20460

The Notice was signed:
Edwin F. Tinsworth,
Director Registration Division

MEMORANDUM May 21, 1987

SUBJECT: Decisions Relevant to PR Notice 87-01

TO: Branch Chiefs, Deputy Chiefs, Product Managers
and Section Heads Registration Division (TS-767C)

FROM: Thomas C. Ellwanger, Jr., Head
Technical Support Section

Fungicide-Herbicide Branch Registration Division (TS-767C)

The following decisions have been made in response to registrants' questions concerning PR 87-01. To be consistent throughout RD, similar questions should be answered using the following guidance. Any other questions should be referred to Tom Ellwanger 557-1700, room 241.

  1. What labeling is appropriate for a product which has chemigation for some crops/sites but not all? See the attached letter to Chevron.
  2. PR 87-01 is not applicable to nonagricultural uses. Some examples where 87-01 is not applicable included: A. 87-01 labeling would not be appropriate for the use of calcium hypochlorate used as a disinfectant in wells. B. products labeled only for non-crop area such as rights of way, industrial sights etc. C. 87-01 labeling would not be appropriate for acrolein applied to irrigation canals by irrigation district personnel. D. gaseous methyl bromide products.
  3. Container labels must have either the prohibition, use directions or a referral statement.
  4. What labeling is appropriate for registered but inactive products? Final printed labeling is not necessary, but typed label text is required.
  5. What Sec. 24(c) labeling is acceptable? It is acceptable for 24(c) labeling to refer to Sec. 3 labeling for chemigation use directions. Such a reference should contain Sec. 3 product name and EPA Registration Number. If 24(c) chemigation is prohibited, the prohibition statement must be located on the 24(c) label.
  6. If the prohibition statement is appropriate for a Sec. 3 label, it must be located within the directions for use section of the container label.

Attachment

Letter of May 15, 1987    

Ms. Jackie DiMaggio
Chevron Chemical Co.
Post Office Box 4010
Richmond, CA 94804-0010


Dear Ms. DiMaggio,

This is in response to your May 14, 1987 phone call concerning labeling relevant to PR Notice 87-01. In the case where some but not all crops or sites on a label are to be chemigated, appropriate chemigation labeling would include the statement
"Apply this product only through irrigation systems. Do not apply this product through any other type of irrigation system." This generic statement would be followed by either: 1) a short list "Apply to corn only by irrigation systems. Apply to soybeans only by irrigation systems" and "Do not apply by chemigation to any other crop, or to these crops using any other type of irrigation system"; or 2) "See further restrictions on types of irrigation systems under labeling for each crop" and "Do not apply by chemigation to these crops using any other type of irrigation system." With option 2) each crop would have to include under a "Chemigation' heading "Apply to corn only by irrigation systems" or "Do not apply by Chemigation." My dear preference is to have all the chemigation information in one place under a "Chemigation" heading rather than having it spread out under each crop. Under option 1) a table may be acceptable listing crops and irrigation systems under a title such as "Apply by chemigation only to the following crops using only the following irrigation systems. Do not apply by chemigation to any other crop or to these crops using any other type of irrigation system."

corn - center pivot, lateral move
rice - flood, furrow
citrus - flood, solid set

If you have further questions in this regard please give me a call on (703) 557-1700.    

Sincerely,    

Thomas C. Ellwanger, Jr.,
Head Technical Support Section
Fungicide-Herbicide Branch Registration Division (TS-767C)

MEMORANDUM DATE: May 14,1987

SUBJECT: Tracking and Follow-up for PR Notice 87-01 Chemigation

TO: Registration Division Branch Chiefs, PMs, Sections Heads

FROM: Edwin F. Tinsworth, Director Registration Division (TS-767C)

Following is an outline of registrant and Agency anions for accommodating PR Notice 87-01 on chemigation.

Scheduled Actions Directed by 87-01

I. Registrants of products not subject to PR Notice - need take no action.

II. Registrants of products not exempted but believed by registrant should not be subject - must submit by July 31, 1987, latest accepted label and written justification: then wait for Agency response.

III. Registrants of products which are subject:

IV. Sec 5s and 18s - Agency will accept only labeling revised according to PR 87-01 after April 30, 1988.

V. Sec 24(c)s - Registrants must submit labeling revised according to PR 87-01 to States by April 30, 1988. Agency Activities

I. Green cards (from certified mail) are being entered onto computer program by RSERB for future reference.

II. Phone calls and letters with questions are being answered by Ellwanger.

III. Letters of intent are being routed to PMs.

IV. First deadline is July 31, 1987 when registrants whose products are subject must either submit a letter of intent (those who will use PR-1 language) or an amended registration (those using different language). Those not responding as of that date must be assumed to be either not subject or not in compliance with PR 87-01. At that point we won't know which is the case since it is up to the registrant to decide if his product is subject.

V. Letter of intent will be sent to appropriate PMs to be placed in registration jackets. PM Teams should keep a running list of letters of intent.

VI. Chemigation amendments will be processed in the usual way except that TSS efficacy reviewers will be included in the process to evaluate appropriateness of proposed label language.

VII. Second deadline is April 30, 1988 for submittal of certification and final printed labeling from registrants who indicated they would use PR 87-01 language. This labeling should not need to be reviewed.

III. A comparison can be made of letters of intent (from July 31, 1987) and those responding to April 30, 1988 deadline. Labels and certification will be placed in registration jackets by PM Teams. PM Teams should check off the running list those which submit certifications and labels. Those indicating intent but not submitting certifications and labels will be forwarded to Compliance Monitoring by PMs. The green card return list will be made available to enforcement to check which registrants received 87-Ol.e appropriate Product Manager at EPA for all Federally registered products.

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