safety of the economic poison or its ingredients, including statements such as "safe," "non-poisonous," "non-injurious," or "harmless" with or without such a qualifying phrase as "when used as directed." This section does provide for limited claims for non-toxicity on those products which are determined by the Director to be non-toxic to humans and pets. (b) Economic poisons not permitted to have any claims for non-toxicity. (1) No claim for non-toxicity to man or animals shall be made for any economic poison that is required to have any precautionary labeling relative to the toxicity of the product. (2) No new economic poison will be permitted to bear claims of non-toxicity until convincing evidence based on practical experience has shown that such claims are warranted. (c) Economic poisons permitted to bear limited claims for non-toxicity. An economic poison may have such labeling claims as "non-toxic to humans and pets" when: (1) Use of such claims is not precluded by paragraph (b) of this section, and (2) such claims are supported by (i) adequate toxicity data on the specific product including active and inert ingredients to show that no warning or caution statements are necessary, (ii) subacute and chronic toxicity data on test animals sufficient to demonstrate that an adequate margin of safety exists between the dosages causing detectable effects and those recommended for effective use (up to 100 fold margin of safety may be required), and (iii) human and/or animal experience data demonstrating that humans and/or animals are not likely to be injured by the chemical under any reasonably foreseeable conditions. Products meeting these requirements may be exempted from the provisions of § 162.9 (a) with respect to the statement "Keep Out of Reach of Children." (d) Prominence of claims for nontoxicity. Claims for non-toxicity permitted by paragraph (c) of this section may appear anywhere in the labeling provided they do not appear in such a manner as to be misleading to the public. They must be printed in type of a size and style bearing a reasonable relationship to other print on that part of the label on which they appear and comply with the following maximum type sizes. Maximum type size permitted 12 point. 18 point. Size of label panel Less than 60 square inches.60 square inches and above------Repetition of claims for non-toxicity permitted by paragraph (c) of this section shall be held to a minimum and will not be permitted when, in the opinion of the Director, such repetition is likely to encourage misuse of the product, or tend to crowd or obscure other information required by the act and regulations to appear on the labeling. § 162.123 Interpretation with respect to labeling of sodium arsenite or arsenic trioxide products. (a) Home use unacceptable. Labeling for economic poisons submitted in connection with registration under the Act bearing directions for use of products containing more than 2 percent sodium arsenite or more than 1.5 percent arsenic trioxide in or around the home is not acceptable. (b) Required warning against home use. In addition to other warning and caution statements required by the regulations and interpretations under the Act, labels for such products with acceptable directions for agricultural, commercial, or industrial use must bear, in a prominent position, the warning statement(s) as indicated below: (1) All products; "Do Not Use or Store in or Around the Home." (2) Products intended for area treatments such as herbicide use; "Do Not Allow Domestic Animals to Graze Treated Areas." § 162.124 Interpretation with respect to labeling of phosphorus paste products. (a) Home use unacceptable. Labeling for economic poisons submitted in connection with registration under the Act bearing directions for use of products containing phosphorus paste in or around the home is not acceptable. (b) Acceptable directions for use by Government agencies or professional pest control operators. Products bearing acceptable directions for commercial or industrial use and marketed in channels of trade which are limited to Government agencies or pest control operators will continue to be registered. In addition to other warning and caution statements required by the Act and regulations, labels for such products must bear the following statement in a prominent position: "Do not use or store in or around the home." § 162.125 Interpretation with respect to the term "germ proof" and related terms used in labeling of economic poisons. For the purposes of the Act, the following terms shall have the meanings stated below: (a) The terms "germ proof" and "germ proofed", referring to any surfaces, materials or articles, indicate the existence of actively germicidal or self disinfecting properties. (b) The terms "germ proofs" and "germ proofer" mean that, when applied as directed, the economic poison will provide a germicidal or disinfecting result, and also provide treated surfaces, articles or materials with germ proof or germ proofed properties. (c) The term "germ proofing" means a process that will, when followed, disinfect and provide germ proof and germ proofed surfaces, materials and articles. PART 163-CERTIFICATION OF USEFULNESS OF PESTICIDE CHEMICALS Sec. 163.1 163.2 163.3 163.4 163.5 163.6 163.7 163.8 163.9 Words in the singular form. Definitions. Administration. Filing of requests for certification. Material in support of the request for certification. Certification limited to economic poison uses. Factors considered in determining usefulness. Basis for determination of usefulness. Proposed certification; notice; request for hearing. 163.10 Withdrawal of request for certification pending clarification or completion. 163.11 Registration under the Federal Insecticide, Fungicide, and Rodent!cide Act. 163.12 Opinion as to residue. AUTHORITY: The provisions of this Part 163 issued under sec. 3, 68 Stat. 511; 21 U.S.C. 346a. SOURCE: The provisions of this Part 163 appear at 36 F.R. 22533, Nov. 25, 1971, unless otherwise noted. § 163.1 Words in the singular form. Words in this part in the singular form shall be deemed to import the plural, and vice versa, as the case may demand. § 163.2 Definitions. Unless the context otherwise requires, the following terms shall be construed, respectively, to mean: (a) "Act" means the Federal Food, Drug, and Cosmetic Act (21 U. S. C. 301 et seq.), as amended by Public Law 518, 83d Congress, 2d Session, "An Act to amend the Federal Food, Drug, and Cosmetic Act with respect to residues of pesticide chemicals in or on raw agricultural commodities" (68 Stat. 511). (b) "Director" means the Director of the Pesticides Regulation Division, Environmental Protection Agency, Washington, D.C. (c) "Agency" means the Environmental Protection Agency. (d) "Pesticide chemical" and "raw agricultural commodity” shall have the same meanings as they have in paragraphs (q) and (r), respectively, of section 201 of the act. (e) "Economic poison" shall have the same meaning as it has under the Federal Insecticide, Fungicide, and Rodenticide Act (7 U. S. C. 135–135k) and the regulations issued thereunder (Part 162 of this chapter). (f) "Person" means individuals, partnerships, corporations, and associations. (g) "Certification" means a certification by the Director that a pesticide chemical is useful for the purpose for which a tolerance or exemption is sought under the act. (h) "Petition" means a petition filed with the Administrator, Environmental Protection Agency pursuant to section 408(d) (1) of the act. § 163.3 Administration. The Director is authorized to take such action as, in his discretion, may be necessary to carry out the provisions of sections 408 (i) and 408 (1) of the act and the regulations in this part. for which the certification is sought and (b) the request is accompanied by a copy of the petition. The person requesting certification may at any time withdraw such request for certification. § 163.5 Material in support of the request for certification. In addition to the data required by section 408 (d) (1) of the act to be included in the petition, the request for certification should be supported by the following material, to the extent it is relied upon by the petitioner: (a) A complete report of the results of any experimental work by the petitioner on the effectiveness of the pesticide chemical for the purposes intended; (b) Data relating to the usefulness of the pesticide chemical obtained by other qualified investigators; (c) Any other material which the petitioner believes will justify a finding of usefulness. If such material is fully shown in the petition, it need not be set forth separately in the request for certification. § 163.6 Certification limited nomic poison uses. to eco § 163.8 Basis for determination of usefulness. Usefulness of a pesticide chemical for the purposes intended will be determined upon the basis of its praċtical pesticidal, or biological, effectiveness. Pesticidal effectiveness may be established in terms of percentage reduction or control of pests or, when appropriate, increase in yield or quality of crop following application of the specified pesticide under the conditions prescribed, compared with the results from adequate controls. Consideration may also be given to other economic gain or practical benefit, including: Economy or ease of production, harvest, or storage of crop; flexibility as regards the time of planting or harvest, even at the possible sacrifice of yield; and general benefit to livestock, plants, or human welfare. § 163.9 Proposed certification; notice; request for hearing. (a) If, upon the basis of the data before him, it appears to the Director that the pesticide chemical is not useful for the purpose or purposes for which a tolerance or exemption is sought, or is useful for only some of the purposes for which a tolerance or exemption is sought, the Director shall notify the person requesting the certification of his proposal to so certify. Notice of such proposed certification will be given by registered mail. (b) Within one week after receipt of such notice of proposed certification the person requesting the certification may, by filing a request with the Director, (1) request that the certification be made on the basis of the proposed certification; (2) request a hearing on the proposed certification or the parts objected to; (3) request both such certification and such hearing; or (4) withdraw the request for certification as provided for in § 163.10. If no such request or withdrawal is filed with the Director within such time, the certification will be made as proposed. § 163.10 Withdrawal of request for certification pending clarification or completion. In some cases it may be necessary for the Director to notify the petitioner of his proposal to certify that the pesticide chemical does not appear to be useful for some or all of the purposes for which a tolerance or exemption is sought only because the data submitted by the petitioner are not sufficiently clear or complete to justify a finding of usefulness. In such cases the petitioner may withdraw his request for certification pending its clarification or the obtaining of additional data, and no further action will be taken with respect to the making of the certification until the request for certification is resubmitted. Upon the resubmission of the request for certification, the time limitation within which final certification is required to be made will begin to run anew from the date of the resubmission. § 163.11 Registration under the Federal Insecticide, Fungicide, and RoIdenticide Act. (a) Since in most cases where a pesticide chemical may leave a residue in or on a raw agricultural commodity there can be no determination of the adequacy of the directions for use or the warning or caution statements appearing on the labeling of an economic poison until a tolerance or exemption has been established for the pesticide chemical which is, or is a part of, such economic poison, it will not ordinarily be possible to register the economic poison under the Federal Insecticide, Fungicide, and Rodenticide Act until such tolerance or exemption has been established. (b) Factors other than pesticidal, or biological, effectiveness are considered in the granting of registration under the Federal Insecticide, Fungicide, and Rodenticide Act. Therefore, the criteria for registration are not all applied in considering the certification of usefulness, and the fact that such a certification has been made does not mean that the economic poison can be registered for the uses concerned. § 163.12 Opinion as to residue. (a) In forming an opinion whether the tolerance or exemption proposed by the petitioner reasonably reflects the amount of residue likely to result when the pesticide chemical is used in the manner proposed, consideration will be given, among other things, to: (1) Data furnished by the petitioner showing (i) the results of tests to ascertain the amount of residue remaining, including a description of the analytical methods used, and (ii) practicable methods for removing residue which exceeds any proposed tolerance; (2) Reports of other experimental work before the Director in publications, the official files of the Agency, or otherwise; (3) Opinions of experts qualified in the fields involved. (b) If a tolerance proposed by the petitioner is reasonably to reflect the amount of residue likely to result when a pesticide chemical is used, it must be large enough to include all residue which is likely to result when the pesticide chemical is used in the manner proposed by the petitioner, but not larger than needed for this purpose. The tolerance proposed by the petitioner may take into account reduction of residue by washing, brushing, or other applicable method. (c) If there is insufficient information before the Director to support an opinion as to whether the tolerance proposed by the petitioner reasonably reflects the amount of residue likely to result, the opinion will so state. 164.2 164.3 164.4 Scope and applicability of this part. Submission of a determination respecting an economic poison to an adivsory committee, and institution of a hearing regarding the application for registration or cancellation or suspension of an economic poison under the Act. Subpart B-Rules Governing the Appointment, Compensation, and Proceedings of an Advisory Committee 164.10 Appointment of advisory committee. 164.11 Procedure for advisory committee. Subpart C-Rules of Practice Governing Hearings Sec. 164.20 Docketing of request for hearing. 164.21 Contents of document setting forth objections. 164.22 Filing copies of notification respecting registration. 164.23 Answer to objections. 164.24 Motions and requests. 164.37 164.38 164.39 164.40 164.41 164.42 Exceptions, objections, request for Argument before the Administrator. Ex parte discussion of proceeding. Procedure for disposition of petitions. 164.43 Filing and service. 164.44 Computation and extensions of time. AUTHORITY: The provisions of this Part 164 issued under secs. 4, 6, 61 Stat. 167-168, as amended; 7 U.S.C. 135b, 135d. Subpart A-General SOURCE: 36 FR 22535, Nov. 25, 1971, unless otherwise noted. § 164.1 Meaning of words. As used in this part, words in the singular form shall be deemed to import the plural, and vice-versa, as the case may require. For the purposes of this part, the following terms shall be construed, respectively, to mean: (a) The term “Act” means the Federal Insecticide, Fungicide, and Rodenticide Act (61 Stat. 163, et seq. as amended, 7 U.S.C. 135-135k). (b) The term "person" includes any individual, partnership, association, corporation, or any organized group of persons, whether incorporated or not. (c) The term "Administrator" means the Administrator of the Environmental Protection Agency of the United States, or any officer or employee of the Environmental Protection Agency to whom authority has heretofore been delegated, or to whom authority may hereafter be delegated, to act in his stead, including the Judicial Officer of the Environmental Protection Agency. (d) The term "Hearing Clerk" means the Hearing Clerk, Environmental Protection Agency, Washington, D.C. 20250. (e) The term "Examiner" means an examiner in the Office of the Hearing Examiners, Environmental Protection Agency. (f) The term "Examiner's Report" means the report made by the Examiner to the Administrator with respect to proposed: (1) Findings of fact and conclusions regarding all material issues of fact, law or discretion, as well as the reasons or basis therefor, and (2) Order. (g) [Reserved] (h) The term "Director" means the Director, Pesticides Regulation Division, Environmental Protection Agency, or any official or employee of the Environmental Protection Agency to whom authority has heretofore been delegated, or to whom authority may hereafter be delegated, to act in his stead. (i) The term "Division" means the Pesticides Regulation Division, Environmental Protection Agency. (j) The term "applicant" means any person who has made application to have an economic poison 1 registered pursuant to the provisions of the Act. (k) The term "registrant” means any person who has registered an economic poison1 pursuant to the provisions of the Act. (1) The term "petitioner" means any person who has been notified that his application for registration of an economic poison' has been refused or any person who has received a notice of cancellation or suspension of the registration of an economic poison1 under the Act, and who has filed a petition requesting that the matter be referred to an advisory committee. (m) The term "advisory committee" means a group of qualified experts designated to submit an independent report to the Administrator regarding the registration of an economic poison.1 (n) The term "hearing" means any action arising under the Act, in which it is required by law that relevant and material evidence be received at a public hearing. (o) The term "final order" includes the Administrator's findings, conclusions, order and rulings on motions, exceptions, statements of objections and proposed findings, conclusions and orders submitted by parties and not theretofore ruled upon. 1 See definition of "economic poison" and related terms contained in section 2 of the Act (7 U.S.C. 135b) and § 162.2 of the regulations for the enforcement of the Act (7 CFR 162.2). |