Page images
PDF
EPUB

18 (§ 162.116). Cautions to protect food (i) Unwarranted claims. These prod. and food handling utensils from con- ucts are not effective against all housetamination are often specified and are hold insects and claims for effectiveness appropriate in any case. These products against insects generally or all insects should be kept out of the reach of chil- are unwarranted and should not be made. dren and pets. Many of these products While these products may have considwill stain or discolor wallpaper, textiles, erable residual insecticidal value when and other finished surfaces or articles. properly applied, it is usually desirable Appropriate label cautions or warnings to avoid any specific claim that residual should be included in all such cases. protection will last for any particular

(2) Liquid and powdered insecticides. length of time. The conditions of use In all cases where petroleum distillate and types of surfaces that may be treated or other combustible formulations are are so diversified that directions for reinvolved, warnings against use in the peated applications as necessary are depresence of open flame and sparks are sirable in all cases. Claims for extermirequired.

nations are not warranted and should (3) Pressurized products. Since many not be made. Products of this type are of these products contain significant frequently injurious under some condi. amounts of petroleum distillate, or other tions to both man and animal and may combustible substances in the presence contaminate food when improperly used. of open flames or heated surfaces and Therefore, their labels must ordinarily since bursting or leakage of contents not include any unqualified claim such may occur at high temperatures, all as “Non-toxic,” “Non-poisonous," "Non. pressurized products (except as specified injurious" or "Harmless to man and hereafter) should bear the following animals." Such products are of no value warning or its practical equivalent: in disinfecting and will not prevent dis

WARNING: Contents under pressure. Do ease and claims to that effect should not puncture. Do not use or store near heat not be made. or open flame. Exposure to temperatures (j) Registration. All applications for above 130° F. may cause bursting. Never registration should include duplicate throw container into fire or incinerator.

copies of all labels, circulars or other Pressurized products which have ex

literature which may be associated with treme fiammability or explosive hazards or accompany the product at any time. will be considered separately and addi- Complete information concerning the tional precautionary labeling prescribed. composition of the product should also Methods for determining the need for

be furnished with the application. If such additional precautionary labeling

the product does not conform to a conmay be obtained from the Director,

ventional pattern of pesticidal usage Pesticides Regulation Division, Environ

against household pests, data shouid be mental Protection Agency, Washington,

furnished to demonstrate the practical D.C. 20250. It is the responsibility of the

value of the product for the various pests registrant to provide precautionary label

named in the labeling. Consultation ing which will be adequate to prevent

with applicants is solicited at all times injury to persons using or handling his

in order to eliminate possible misunderproduct.

standing. (h) Deterioration. Some of these

(k) Other interpretations. This informulations deteriorate quite rapidly in

terpretation supplements interpretations storage. Also, certain types of packag.

7, 15, and 18 as revised (7 CFR 162.105, ing tend to accelerate this deterioration.

162.106, and 162.116). It is the responsibility of the registrant $ 162.122 Interpretation with respect and marketer of the particular pesticide

to claim for safety and nontoxicity on to so formulate, package and market his labeling of economic poisons. products that they will always contain the amounts of active ingredients which

(a) Requirements of the act and reg

ulations. The act provides that an ecowere represented in the information furnished at the time of registration. If

nomic poison or device is misbranded if products are known to deteriorate, a date

its labeling bears any statement, design, may be placed on the label advising

or graphic representation relative thereagainst use after a stipulated period of

to or to its ingredients which is false or time. Products which have deteriorated

misleading in any particular (7 U.S.C. are adulterated and should be withdrawn (z) (1)). Section 162.14(a) (5) prohibits from the market.

the use of unwarranted claims as to the safety of the economic poison or its in

Maximum gredients, including statements such as

type size "safe,” “non-poisonous," "non-injuri

Size of label panel

permitted

Less than 60 square inches.------- 12 point. ous," or "harmless" with or without such

60 square Inches and above.------ 18 point. a qualifying phrase as "when used as directed.” This section does provide for

Repetition of claims for non-toxicity limited claims for non-toxicity on those permitted by paragraph (c) of this secproducts which are determined by the

tion shall be held to a minimum and Director to be non-toxic to humans and will not be permitted when, in the opinpets.

ion of the Director, such repetition is (b) Economic poisons not permitted to likely to encourage misuse of the prodhave any claims for non-toricity. (1) uct, or tend to crowd or obscure other No claim for non-toxicity to man or information required by the act and animals shall be made for any economic regulations to appear on the labeling. poison that is required to have any

$ 162.123 Interpretation with respect precautionary labering relative to the

to labeling of sodium arsenite or toxicity of the product. (2) No new arsenic trioxide products. economic poison will be permitted to bear claims of non-toxicity until con

(a) Home use unacceptable. Labeling vincing evidence based on practical ex

for economic poisons submitted in conperience has shown that such claims are

nection with registration under the Act warranted.

bearing directions for use of products (c) Economic poisons permitted to

containing more than 2 percent sodium bear limited claims for non-toxicity.

arsenite or more than 1.5 percent arsenic

trioxide in or around the home is not An economic poison may have such labeling claims as “non-toxic to humans

acceptable. and pets" when: (1) Use of such claims

(b) Required warning against home is not precluded by paragraph (b) of

use. In addition to other warning and

caution statements required by the regthis section, and (2) such claims are supported by (i) adequate toxicity data

ulations and interpretations under the on the specific product including active

Act, labels for such products with acand inert ingredients to show that no

ceptable directions for agricultural, comwarning or caution statements

mercial, or industrial use inust bear, in

are necessary, (ii) subacute and chronic tox

a prominent position, the warning stateicity data on test animals sufficient to

ment(s) as indicated below: demonstrate that an adequate margin of

(1) All products; “Do Not Use or Store

in or Around the Home.” safety exists between the dosages causing detectable effects and those recom

(2) Products intended for area treatmended for effective use (up to 100 fold

ments such as herbicide use; “Do Not margin of safety may be required), and

Allow Domestic Animals to Graze Treat(iii) human and/or animal experience

ed Areas.” data demonstrating that humans and/or $ 162.124 Interpretation with respect animals are not likely to be injured by to labeling of phosphorus paste the chemical under any reasonably products. foreseeable conditions.

(a) Home use unacceptable. Labeling Products meeting these requirements for economic poisons submitted in conmay be exempted from the provisions of nection with registration under the Act $ 162.9(a) with respect to the statement bearing directions for use of products “Keep Out of Reach of Children.” containing phosphorus paste in or

(d) Prominence of claims for non- around the home is not acceptable. toxicity. Claims for non-toxicity per- (b) Acceptable directions for use by mitted by paragraph (c) of this section Government agencies or professional may appear anywhere in the labeling pest control operators. Products bearing provided they do not appear in such & acceptable directions for commercial or manner as to be misleading to the pub- industrial use and marketed in channels lic. They must be printed in type of of trade which are limited to Governa size and style bearing a reasonable ment agencies or pest control operators relationship to other print on that part will continue to be registered. In addition of the label on which they appear and to other warning and caution statements comply with the following maximum required by the Act and regulations, type sizes.

labels for such products must bear the

.

following statement in a prominent position: "Do not use or store in or around the home." f 162.125 Interpretation with respect

to the term "germ proof” and related terms used in labeling of eco

nomic 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.

[ocr errors]

PART 163–CERTIFICATION OF USEFULNESS OF PESTICIDE CHEMICALS

$ 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 "ray agricultural commodity" shall have the same meanings as they have in paragraphs (a) 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. § 163.4 Filing of requests for certifica

tion. All requests for a certification shall be made in writing to the Director. Action upon such a request will not be undertaken unless (a) the person making the request has, pursuant to the provisions of the Federal Insecticide, Fungicide, and Rodenticide Act, registered or submitted an application for the regis. tration of an economic poison consisting of or containing the pesticide chemical

Sec. 163.1 Words in the singular form. 163.2 Definitions. 163.3 Administration. 163.4 Filing of requests for certification. 163.5 Material in support of the request

for certification. 163.6 Certification limited to economic

poison uses. 163.7 Factors considered in determining

usefulness. 163.8 Basis for determination of usefulness. 163.9 Proposed certification; notice; re

quest for hearing. 163.10 Withdrawal of request for certifica

tion pending clarification or com

pletion. 163.11 Registration under the Federal In

secticide, Fungicide, and Rodenti

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 forma shall be deemed to import the plural, and vice versa, as the case may demand.

to

eco

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 re

quest 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. If the product for which a certification is sought is intended for both economic poison and noneconomic poison uses, any certification relative to the usefulness of such product will refer only to economic poison uses. No action will be taken with respect to the noneconomic poison uses of such product. $ 163.7 Factors considered in deter

mining usefulness. In determining whether a pesticide chemical is useful for the purposes for which a tolerance or exemption is sought, consideration will be given, among other things, to:

(a) 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) Reports of other experimental work before the Director in publications, the official files of the Agency, or otherwise.

(d) Opinions of experts qualified in the fields involved.

$ 163.8 Basis for determination of use

fulness. Usefulness of a pesticide chemical for the purposes intended will be determined upon the basis of its practical 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 use- (3) Opinions of experts qualified in fulness. In such cases the petitioner the fields involved. may withdraw his request for certifica- (b) If a tolerance proposed by the tion pending its clarification or the petitioner is reasonably to reflect the obtaining of additional data, and no fur- amount of residue likely to result when ther action will be taken with respect to a pesticide chemical is used, it must be the making of the certification until the large enough to include all residue which request for certification is resubmitted. is likely to result when the pesticide Upon the resubmission of the request for chemical is used in the manner proposed certification, the time limitation within by the petitioner, but not larger than which final certification is required to be needed for this purpose. The tolerance made will begin to run anew from the proposed by the petitioner may take into date of the resubmission.

account reduction of residue by washing, $ 163.11 Registration under the Fed.

brushing, or other applicable method. eral Insecticide, Fungicide, and Ro

(c) If there is insufficient information denticide Act.

before the Director to support an opinion

as to whether the tolerance proposed (a) Since in most cases where &

by the petitioner reasonably reflects the pesticide chemical may leave a residue

amount of residue likely to result, the in or on a raw agricultural commodity

opinion will so state. there can be no determination of the adequacy of the directions for use or the warning or caution statements appearing

PART 164-RULES GOVERNING THE on the labeling of an economic poison APPOINTMENT, COMPENSATION, until a tolerance or exemption has been AND PROCEEDINGS OF AN ADestablished for the pesticide chemical

VISORY COMMITTEE; AND RULES which is, or is a part of, such economic

OF PRACTICE GOVERNING HEARpoison, it will not ordinarily be possible to register the economic poison under the

INGS UNDER THE FEDERAL INSECFederal Insecticide, Fungicide, and Ro- TICIDE, FUNGICIDE, AND RODENdenticide Act until such tolerance or TICIDE ACT exemption has been established. (b) Factors other than pesticidal, or

Subpart A-General

Sec. biological, effectiveness are considered

164.1 Meaning of words. in the granting of registration under the

164.2 Definitions. Federal Insecticide, Fungicide, and Ro- 164.3 Scope and applicability of this part denticide Act. Therefore, the criteria 164.4 Submission of a determination refor registration are not all applied in

specting an economic poison to an considering the certification of useful

adivsory committee, and instituness, and the fact that such a certifica

tion of a hearing regarding the tion has been made does not mean that

application for registration or can.

cellation or suspension of an ecothe economic poison can be registered

nomic poison under the Act. for the uses concerned.

Subpart B-Rules Governing the Appointment, § 163.12 Opinion as to residue.

Compensation, and Proceedings of an Advisory (a) In forming an opinion whether the Committee tolerance or exemption proposed by the 164.10 Appointment of advisory committee. petitioner reasonably reflects the amount 164.11 Procedure for advisory committee. of residue likely to result when the pes

Subpart C— Rules of Practice Governing Hearings ticide chemical is used in the manner

Sec. proposed, consideration will be given,

164.20 Docketing of request for hearing. among other things, to:

164.21 Contents of document setting forth (1) Data furnished by the petitioner

objections. showing (i) the results of tests to ascer- 164.22 Filing copies of notification respecttain the amount of residue remaining,

ing registration, including a description of the analytical 164.23 Answer to objections. methods used, and (ii) practicable meth

164.24 Motions and requests.

164.25 Intervention. ods for removing residue which exceeds

164.26 Depositions. any proposed tolerance;

164.27 Fees of witnesses. (2) Reports of other experimental

164.28 Consolidation. work before the Director in publications, 164.29 Prehearing conference. the official files of the Agency, or other- 164.30 Qualifications and duties of exwise;

aminer.

« PreviousContinue »