PRN 97-5: Use of Common Names for Active Ingredients on Pesticide Labeling

Notice To: Manufacturers, Producers, Formulators, and Registrants of Pesticide Products

Attention: Persons Responsible for the Registration of Pesticides

Subject: Use of Common Names for Active Ingredients on Pesticide Labeling

This notice announces EPA policy to expand the use of common names on pesticide labeling. EPA will permit the use of common names approved by the American National Standards Institute (ANSI) in the label ingredients statement without the accompanying scientific chemical names, and will permit the use of other common names listed in this notice without the accompanying scientific chemical name. EPA also recommends the inclusion on labels of Chemical Abstracts Service (CAS) numbers to identify ingredients definitively.

A registrant is not required to revise a product label in this manner; chemical names may be retained in the ingredients statement. EPA urges registrants of consumer products in particular to modify their labels to use common names.

Label revisions in response to this notice may be done by notification.

1. Background
2. The Consumer Labeling Initiative
3. Naming Active Ingredients In Pesticide Products
4. Policy
5. Procedure
6. Compliance
7. Addresses
8. Appendix A
9. Appendix B
10. Appendix C

1. Background

   Chemicals (including pesticide ingredients) have scientific names based upon their chemical structure. In many instances, these names are long, complicated and understandable only by those with a scientific or technical background. Chemical naming systems have been developed, but a single chemical structure may have several chemical name variants. Historically, some chemicals have been identified by shorter, acronym-like names, often based upon combinations of the chemical name or chemical family to which the chemical belongs. These are called "common names" and are widely used in lieu of the chemical names on a day-to-day basis, particularly in the agricultural pesticide community.

   In the past, common names for pesticide active ingredients were established by the now-defunct Intergovernmental Committee on Pest Control (e.g., captan), or by the Food and Drug Administration. Others may have become well-known merely by common usage through the years. Typically, these were agricultural chemicals whose use predates standardization processes. Newer common names are generally developed through an established approval process, such as one of the national standards organizations. In the United States, common names for pesticide active ingredients are established by the K-62 Committee of the American National Standards Institute (ANSI). Other national standards organizations (British, Canadian) and the International Standards Organization also coordinate standardization of common names.

   EPA encourages the development and use of common names. Common names promote user understanding of chemical-based products, provide a ready reference for persons without technical or scientific background, and can foster informed choice in purchasing and using products, both pesticide and non-pesticide.




2. The Consumer Labeling Initiative

   In 1996, EPA began a Consumer Labeling Initiative (CLI), which has as its goal the improvement of consumer labeling in general (focusing on pesticide products). In the first phase of the CLI, individual interviews were conducted with users of household pesticides (both indoor and outdoor) and pesticide and non-pesticide cleaning agents. Interviews with consumers and comments submitted to EPA indicated that average consumers have very little knowledge of technical chemical names and found them uninformative and difficult to use. Based on these comments, the Consumer Labeling Initiative Phase I Report recommended that EPA increase the use of common names on labels.

   Although users of pesticides are the primary audience of the pesticide label, others rely on the label for information about the pesticide. In particular, medical personnel and poison control centers may need to know the identity of the active ingredients in order to provide proper treatment in an emergency. Persons suspecting pesticide exposure or poisoning are instructed to bring the labeled container with them when they seek treatment. Hazardous materials personnel may require a full chemical name in case of a spill, leakage, or transportation incident. Consequently, EPA must balance the desire by consumers and users for simplicity in chemical names with the potential need for more technical information for others.

   EPA believes that it can forego scientific chemical names on the labels of many products where a common name has been established either by a standards organization, by the Agency itself, or through long usage. EPA also believes that medical personnel and others who may need a more specific chemical name have numerous resources at their disposal to translate a common name into its chemical name and are knowledgeable or trained enough to do so quickly and easily.




3. Naming Active Ingredients In Pesticide Products

   FIFRA sec. 2(q)(2)(A) requires that each pesticide product bear an ingredients statement, which must include the name and percentage of each active ingredient. Labeling regulations in 40 CFR 156.10(g) require that the name used in the ingredient statement be:

   ". . the accepted common name, if there is one, followed by the chemical name. The common name may be used alone only if it is well-known. If no common name has been established, the chemical name alone shall be used."

   The regulations do not define "accepted common name." Currently, the Agency uses a chemical vocabulary list that includes identifiers for a common name (both ANSI-approved names and other common names), the Chemical Abstracts Service Registry number (the CAS number), multiple chemical names and multiple trade names. Moreover, EPA has not specified which common names are "well-known" enough that a common name alone suffices for the ingredients statement. Today's notice states a new Agency position which allows the use of ANSI-approved common names and certain other common names alone in label ingredients statements.

   When required, the chemical name that must be used in ingredients statements is that established by the Chemical Abstracts Service. The CAS name corresponds to a unique CAS Registry number (CAS number) by which the chemical may be identified regardless of what chemical name variant, common names, synonyms or trade names the chemical may also have.




4. Policy

   This policy applies only to pesticide active ingredients; inert ingredients are not eligible.

   1. ANSI common names. A common name that is approved by ANSI may be used in the label ingredients statement without the accompanying chemical name. A registrant who is unsure whether a common name has been approved by ANSI, and thus may be used alone in the ingredients statement may contact Kerry Leifer of EPA at 703-308-8811, or Mr. Glenn Hanes of the K-62 Committee, at the address at the end of this notice. Appendix A of this notice lists all pesticide active ingredient names currently approved by ANSI for which a product is registered. EPA believes this list to be comprehensive, but if an ANSI-approved common name has been omitted, it may still be used alone in the ingredients statement.
   
   
   2. Other acceptable common names. Appendix B to this notice lists other names, not established by ANSI, which may also be used alone in the ingredients statement without an accompanying chemical name. These names may be:
       

      Names adopted by EPA for use on labels Shorter and more familiar chemical name variants Names that have become well-known through wide usage Names that have been approved by another recognized standards-setting organization.

      Most of these additional common names are those approved by the International Standards Organization (ISO) or the British Standards Institute (BSI). This list may be expanded in the future. EPA welcomes suggestions for additional common names that could be included on this list. Currently the list does not include biochemical or microbial active ingredients. EPA is exploring how such names may be best expressed for user understanding.

      Finally, EPA intends to modify its new OPUS-based chemical vocabulary database system to include a specific field for the label ingredients name which would identify the acceptable name for use in the ingredients statement, whether that name is a common name alone, a chemical name alone, or a combination of common and chemical name.

   
   
   3. Seeking ANSI approval. EPA prefers that common names for chemicals be established through standards-setting organizations such as ANSI. Registrants are strongly encouraged to seek ANSI approval of additional common names for chemicals for which common names are not yet available. Appendix C to this notice is an information sheet issued by the K-62 Committee on how to apply for ANSI common names.
   
   
   4. CAS numbers. When a common name alone is permitted on the label, registrants should include the CAS registry number of the active ingredient to provide a reference for those who need to know the chemical name. The CAS number need not figure prominently in the ingredients statement, but may appear as a substatement or footnote to the ingredients statement.
       

      This policy applies solely to label declarations of ingredients. This policy does not supersede or modify requirements for identifying ingredients in applications, documents, studies, or reports to EPA, including the Confidential Statement of Formula. These must continue to identify fully, as applicable, chemical names, common names, synonyms, trade names and numerical identifiers of each chemical.

      EPA will initiate rulemaking to revise its labeling regulations in 40 CFR 156.10 to conform to this policy change; however, in the interest of improving pesticide labeling, EPA is proceeding immediately to permit registrants to make this change voluntarily. No registrant is required to revise its labels in response to this notice; however, EPA encourages registrants to do so when labels are routinely revised for other reasons.




5. Procedure

   To make it convenient and easy for this policy to be implemented, EPA will allow the change to be made by notification to the Agency, as follows:

   1. Products currently bearing both a common name and a chemical name. Registrants who wish to modify a label to delete the chemical name of an active ingredient with an ANSI or EPA-approved common name may do so by notification to EPA. The registrant should:
      
      
      1. Submit an Application for Amended Registration, listing in section II, "Notification to modify ingredients statement to delete chemical name."
      
      
      2. Submit two copies of the modified labeling.
      
      
      3. Submit a modified Confidential Statement of Formula if the current CSF does not already include the common name.
   
   
   2. Products currently bearing only a chemical name. A registrant who wishes to modify a label to substitute an ANSI- or EPA-approved common name for the chemical name of an active ingredient should:
      
      
      1. Submit an Application for Amended Registration, listing in Section II, "Notification to modify ingredients statement to substitute common name for chemical name";
      
      
      2. Submit two copies of the modified labeling; and
      
      
      3. Submit a modified Confidential Statement of Formula if the current CSF does not already include the common name.
          

         Each notification under under V.A. or B. should include the following certification statement:

         This notification is consistent with the provisions of PR Notice 97-5 and EPA regulations at 40 CFR 152.46, and no other changes have been made to the labeling or the confidential statement of formula of this product. I understand this it is a violation of 18 U.S.C. 1001 to willfully make any false statement to EPA. I further understand that if this notification is not consistent with the terms of PR Notice 97-5 and 40 CFR 152.46, this product may be in violation of FIFRA and I may be subject to enforcement action and penalties under sections 12 and 14 of FIFRA.

      
      
      
      
      
       
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   3. To add a CAS Registry number. Registrants who wish to add CAS numbers for ingredients to their ingredients statement may do so without notification to EPA (a "non-notification" under 40 CFR 152.46).
   
   
   
   
   
    
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6. Compliance

   No registrant is required to make this change; a registrant may continue to include both the common name and the chemical name of the active ingredient(s) in the ingredients statement. EPA will not consider a product bearing a permitted common name without the accompanying chemical name to be misbranded within the meaning of FIFRA sec. 12 solely because of that change.




7. Addresses

   Notifications should be sent to:

   For US Postal Service submissions:

   Document Processing Desk (NOTIF)
   Office of Pesticide Programs (7504C)
   U.S. Environmental Protection Agency
   401 M Street, S.W.
   Washington, D.C. 20460-0001

    

   For Courier Deliveries:

   Document Processing Desk (NOTIF)
   Office of Pesticide Programs (7504C)
   U.S. Environmental Protection Agency
   Room 266A, Crystal Mall 2
   1921 Jefferson Davis Highway
   Arlington, VA 22202

8. Appendix A PR Notice 97-5

   Common names for use on pesticide labels approved by The American National Standards Institute




9. Appendix B PR Notice 97-5

   Common names for use on pesticide labels approved by The Environmental Protection Agency




10. Appendix C PR Notice 97-5

    Procedures to be Followed by Sponsors of Proposed Common Names for Pest Control Chemicals

    The basic instructions to complete the application are contained in the document K62.1-1985, Common Name for a Pest Control Chemical - Procedure for Acceptance. Another document useful in selecting a common name is ISO 257. Both are available from ANSI's Sales Department, 11 West 42nd Street, New York, New York 10036 (telephone number 212-642-4900).

    Some of the information needed in the application is the Chemical Abstracts (CA) chemical name, the Chemical Abstracts Service Registry Number, and both molecular and structural formulae. Prior to submit the application, a copy of the chemical information should be sent to the K62 committee contact with the Chemical Abstracts Service:

    Dr. Dan Stossel
    Chemical Abstracts Service
    Department 64
    P.O. Box 3012
    Columbus, Ohio 43210

    Phone: 614-447-3600, ext. 2950
    FAX: 614-447-3713, Attn: Dr. Dan Stossel, Dept 64

    He will verify the CAS nomenclature, drawing of the structures, and the CAS registry numbers that are cited. He is also the person to contact if a CAS registry number assignment is needed. Often, Dr. Stossel can supply helpful comments on the use of ISO Recommended Syllables and give an opinion as to the likelihood of acceptance of the selected common name. His letter of response/approval should then be included in the submission.

    It is a principle that common names shall not be liable to confusion with commercial trademarks. To check this as far as is practicable, sponsors of common names are required to obtain, pay for, and submit to the Secretariat, reports of trademark searches in classes 1 and 5 of the following registers.

    If for U.S. use only, ANSI requires a search from:

    (a) The United States of America. This includes a Patent and Trademark Office (PTO) and common law search.

    If for international use, ISO requires a trademark search from:

    1. International listings
    2. The United States of America (as above)
    3. The United Kingdom
    4. The sponsor's country (same as (b) if U.S.A. submission)
     

    If the proposed common name is already established as an International Nonproprietary Name (INN) for the same pesticide or other agrochemical, only a United States of America trademark search is required. Additional information on trademark searches is available.

    Note: It is permissible for the name that is being proposed as a common name to be registered as a trademark in order to protect it until the common name has been adopted by ISO. All such rights have, however, to be relinquished as soon as the common name has been so adopted.

    It should be noted, however, that if a proposed common name be unacceptable at any stage for any reason, and a replacement common name considered, it is usually necessary for further trademark reports to be submitted. The reports are not required for common name proposals formed by attaching suffixes to common names for which trademark reports have previously been submitted.

    Submit 25 copies of each document you submit. This is indicated in ANSI K62.1-1985. Be sure to include 25 copies of any required trademark searches. All of these requested copies can be photocopies of the original materials.

    ANSI charges an application fee of $900. When making your formal submission, a check should be made out to, and sent directly to: ANSI, c/o Fran Schrotter (Re: K62 Application Fee), 11 West 42nd Street, New York, New York 10036. Your cover letter should indicate the proposed common name for which the fee applies. Please courtesy copy Glenn Hanes. Only the check is to go to Ms. Schrotter. The formal submission and all correspondence is to be sent to Mr. Hanes at the address below.

    In summary, to complete the application:

    1. Obtain CA names, CAS registry numbers, structures.
    
    
    2. Have Dr. Stossel verify the chemical information.
    
    
    3. Send application as stated in ANSI K62.1-1985 document.
    
    
    4. Include Dr. Stossel's letter of response in the submission.
    
    
    5. In the application or in a cover letter, clearly indicate if the proposed name is approved, or is pending approval, as an ISO name. If a U.S. trademark search was done as part of a recent ISO submission, that search is probably sufficient to accompany this application.
    
    
    6. Include the U.S. trademark search. Also include U.K. and international (WIPO) trademark searches if consideration as an international common name is requested.
    
    
    7. Send 25 copies (photocopies) of the entire submission to Mr. Glenn Hanes, Chairman, K62 Committee, at USDA, ARS, PRS, Bldg 1072, BARC-East, 10300 Baltimore Avenue, Beltsville, Maryland 20705-2350.
    
    
    8. Only the application fee should be sent to: ANSI, c/o Fran Schrotter (Re: K62 Application Fee), 11 West 42nd Street, New York, New York 10036.
     

    If you have procedural questions, please direct them to Mr. Glenn Hanes. Voice: 301-504-8137, FAX: 301-504-8142, Attn: G. Hanes).