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rector may permit a reasonable time for trant shall be so notified and afforded the the disposition of stocks of the discon- opportunity to make the necessary cortinued product, if in his opinion such an rections. If the corrections are not extension would not endanger the public. made, registration will be cancelled as

(h) Claims must conform to registra- provided in section 4.c. of the Act. tion. Claims made for an economic (k) Limitations on registrations. The poison must not differ from representa- Director may refuse to register any ecotions made in connection with registra- nomic poison or any specific use thereof tion, including representations with if, in his opinion, directions and warnrespect to effectiveness, ingredients, di- ings cannot be written which will prerections for use, or pests against which vent injury to the general public when the product is recommended.

the product is used in accordance with (i) Duration of registration. If at any warnings and directions or in accordance time it does not appear to the Director with commonly recognized practices. that the economic poison is such as to If, however, such an economic poison is warrant the proposed claims for it or if

proposed for certain acceptable uses, the the economic poison and its labeling and

Director may require the label to bear a other material required to be submitted

warning against specific unacceptable do not comply with the provisions of the

uses such as in the home or home garden. Act, the Director shall notify the registrant of the facts involved and afford

136 F.R. 22496, Nov. 25, 1971, as amended

at 36 F.R. 24802, Dec, 23, 1971) him an opportunity to bring the product and its labeling into compliance with the

GUARANTEES Act. If after a reasonable period of time,

$ 162.11 Guarantee of economic poison. the registrant has not made such corrections, the Director may cancel the regis- (a) By whom given; effect of guarantration under the provisions of section tee. Any manufacturer, distributor, 4.c. of the Act. Unless cancelled in ac- wholesaler, or other person residing in cordance with this paragraph or with the the United States may furnish to any acquiescence of the registrant, or unless

person to whom he sells an economic continued in effect in accordance with

poison a guarantee that the economic the provisions of paragraph (1) of this

poison was lawfully registered at the time section, the registration of an economic

of sale and delivery to such person, and poison shall be cancelled at the end of a

that the economic poison complies with period of five years following the date of

all the requirements of the Act and of registration of such economic poison, or at the end of five years following the date

the regulations in this part. The Act of any subsequent registered change in

provides that penalties for violation of formula or labeling, or at the end of five

section 3.a. of the Act shall not apply to years following the date of any continu

a person who establishes that he has reance of registration pursuant to para

ceived a guarantee as specified in the graph (j) of this section: Provided, how

Act. ever, That prior to any such cancellation (b) Reference to guarantee. No ref. the Pesticides Regulation Division shall

erence to a guarantee or suggestion that send to the registrant a notice of intent such a guarantee has been given shall be to cancel, and, in the event such notice

made in the labeling of any economic 1s not sent to the registrant 30 days prior

poison. to the expiration of the five-year period,

(c) Contents of guarantee. In order the registration shall remain in effect

to afford effective protection, each guaruntil 30 days following the date such

antee must: notice has been sent to the registrant at (1) Be signed by and contain the name his latest address submitted to the Pesti- and address of the person giving it; and cides Regulation Division.

(2) State that the economic poison (1) Continuance of registration. If a was lawfully registered at the time of sale registrant desires to continue the regis

and delivery and that it complies with tration in effect, he shall notify the Pes

all other requirements of the Federal Inticides Regulation Division in writing and

secticide, Fungicide, and Rodenticide

Act. it shall be continued in effect under the

(d) Scope of guarantee. A guarantee same terms as the original registration:

may be (1) limited to a specific shipment Provided, however, That if, on the basis

or other delivery of a product, in which of information available at the time, it case it may be a part of or attached to appears that the product or its labeling the invoice or bill of sale covering such fails to comply with the Act, the regis- shipment or delivery, or (2) general and

continuing, in which case, in its application to any shipment or other delivery of & product it shall be considered to have been given at the date when such product was shipped or delivered by the person giving the guarantee.

(e) Expiration of guarantee. Any guarantee shall expire when the product is repacked or relabeled by the purchaser or when it becomes in violation of the Act or the regulations in this part after shipment or other delivery by the person giving the guarantee.

(f) Forms of guarantee. The following are suggested forms of guarantee:

(1) Limited form for use on invoice or Bill of sale.

hereby guarantees (Name of guarantor) that the economic poison herein listed 18 lawfully registered with the Secretary of Agriculture and that the same complies with all requirements of the Federal Insecticide, Fungicide, and Rodenticide Act.

(Signature and post office

address of guarantor)

(Date)
(2) General and continuing form.

The economic polsons comprising each shipment or other delivery hereafter made by

--, to or on the order of (Name of guarantor)

are hereby (Name and address of person

receiving guarantee) guaranteed to be lawfully registered with the Secretary of Agriculture and to comply with all requirements of the Federal Insecticide. Fungicide, and Rodenticide Act, As of the date of such shipment or delivery.

ified in the regulations in this part dur. ing ordinary conditions of marketing or storage, and must not cause the product to be ineffective or result in its causing damage when used as directed.

(b) Arsenicals and barium fluosilicate. Standard lead arsenate, basic lead arsenate, calcium arsenate, magnesium ar. senate, zinc arsenate, zinc arsenite, and barium fluosilicate shall be colored any hue, except the yellow-reds and yellows, having a value of not more than 8 and a chroma of not less than 4, or shall be discolored to a neutral lightness value not over 7.

(c) Sodium fluoride and sodium fluosilicate, Sodium fluoride and sodium fiuosilicate shall be colored blue or green having a value of not more than 8 and a chroma of not less than 4, or shall be discolored to a neutral ughtness value not over 7.

(d) Exceptions. (1) Notwithstanding the provisions of paragraphs (b) and (c) of this section, the Director, after opportunity for hearing, may permit other hues to be used for any particular purpose if he determines that use of the prescribed hues is not feasible for such purpose and that such action will not be injurious to the public.

(2) Any economic poison specified in this part which is intended solely for use by a textile manufacturer or commercial laundry, cleaner or dyer as a mothproofing agent, which would not be suitable for such use if colored and which will not come into the hands of the public except when incorporated into & fabric may be exempted by the Director from the requirements of section 3.8.(4) of the Act and the requirements of this section.

(3) The economic poison sodium fluoride shall be exempt from the require. ments of section 3.a.(4) of the Act and paragraph (c) of this section when (1) it is intended for use as a fungicide solely in the manufacture or processing of rubber, glue, or leather goods; (u) colorgtion of the economic poison in accordance with said requirements will be likely to impart objectionable color character. Istics to the finished goods; (10) the economic poison will not be present in such finished goods in suficient quantities to cause injury to any person; and (iv) the economic poison will not come into the hands of the public except after incorporation into such finished goods.

(Bignature and post office

address of guarantor)

(Date)

COLORATION OF ECONOMIC POISONS 8 162.12 Coloration and discoloration.

The white economic poisons hereinafter named shall be colored or discolored in accordance with this section. The hues, values, and chromas specified are those contained in the Munsell Book of Color, Munsell Color Company, 10 East Franklin Street, Baltimore, Md.

(a) Coloring agent. The coloring agent must produce a uniformly colored product not subject to change in color beyond the minimum requirements spec

ADULTERATION AND MISBRANDING $ 162.13 Adulteration.

An economic poison is adulterated it its strength or purity falls below the professed standard or quality as expressed on its labeling or under which it is sold, or if any substance has been substituted wholly or in part for the article, or if any valuable constituent of the article has been wholly or in part abstracted.

(a) A valuable constituent will be considered as wholly abstracted when. ever the designation or representation of the product imports its presence therein and such constituent has been wholly omitted therefrom in the preparation of the product or has been wholly removed from the completed product.

(b) A valuable constituent will be considered as partly abstracted whenever the designation or representation of the product imports its presence therein, and such constituent is not present in the usual or customary amount or in the amount indicated in the labeling. $ 162.14 Misbranding.

An economic poison or device is misbranded if the article or its labeling is false or misleading to the public in any particular.

(a) Examples of statements or representations in the labeling of an economic poison or device which render it misbranded are the following:

(1) A false or misleading statement concerning composition of the product.

(2) A false or misleading statement concerning the effectiveness of the product as an economic poison or device.

(3) A false or misleading statement about the value of the product for purposes other than as an economic poison or device.

(4) A false or misleading comparison with other economic poisons or devices.

(5) Unwarranted claims as to the safety of the economic poison or its ingredients, including a statement such as "safe,” “non-poisonous," "non-injurious," or "harmless" with or without such & qualifying phrase as "when used as directed”: Provided, however, That the Director may permit a truthful statement such as "non-toxic to humans and pets" on those products which are determined by the Director to be non-toxic to humans and pets.

(6) Any statement directly or indirectly implying that the economic poison or device is recommended or endorsed by any agency of the Federal Govern. ment.

(7) The name of an economic poison which contains two or more principal active ingredients if it suggests the name of one or more but not all such principal active ingredients even though the names of the other ingredients are stated elsewhere in the labeling.

(8) Prominent reference in the labeling to one or more active ingredients without giving their percentages in immediate proximity thereto or without giving equal prominence to the other active ingredients or to the inert ingredients.

(9) A true statement used in such a way as to give a false or misleading im. pression to the purchaser.

(b) Justification of false and misleading statements not permitted. (1) The use of any false or misleading statement on any part of the labeling, given as the statement or opinion of any person or based upon such statement or opinion, shall not be justified by the fact that the statement or opinion is actually that of such personl.

(2) The use of a false or misleading statement in the labeling cannot be justlfied by an explanatory statement.

ENFORCEMENT 8 162.15 Enforcement.

(a) Collection of samples. Samples of economic poisons and devices shall be collected by official inspectors or by any employee of the Federal Government, or of a State or Territory, or political subdivision thereof who has been duly authorized by the Director to collect samples.

(b) Examination of samples. Methods of examination of samples shall be those adopted and published by the Association of Official Agricultural Chemists, where applicable, or such other methods as the Director may find necessary to determine whether the product complies with the law.

(c) Notice of apparent violation. (1) If, from an examination or analysis, an economic poison or device appears to be in violation of the Act, & notice in writing shall be sent to the person against whom criminal proceedings are contemplated, giving him 20 days within which

97-025_73-84

841

to offer such written explanation as he (b) Articles for which permit is remay desire. The notice shall state the quired. (1) An economic poison shipped manner in which the sample fails to meet or delivered for experimental use by the requirements of the Act and the reg- qualified persons but not under the ulations thereunder.

supervision of a Federal or State agency (2) Any such person may, in addition authorized by law to conduct research in to his reply to such notice, file within 20 the field of economic poisons, for which days of its receipt a written request for a permit has been issued by the Director an opportunity to present his views orally pursuant to the provisions of this section, in connection therewith.

shall otherwise be exempt from the pro(3) No notice or hearing is required visions of the Act and of the regulations prior to the seizure of any economic in this part. Permits will be of two poison or device.

types, specific and general. A specific $ 162.16 Notices of judgment.

permit will be issued to cover a particular

shipment on a specified date to a named Publication of notices of judgments person. A general permit will be issued of the courts in cases arising under the

to cover more than one shipment over a criminal or seizure provisions of the Act period of time to the same or different shall be made in the form of notices, persons. circulars, or bulletins as the Director (2) If an economic poison is to be may prescribe.

tested in such a manner that residues

may result in or on food or feed, a permit TEMPORARY PERMITS

for shipment will not be issued unless: $ 162.17 Limited shipments for experi- (i) Suficient data are submitted to the mental purposes.

Director to show that no residue will be Temporary permits not to exceed a present on food or feed involved in the period of one year may be issued for ship- experimental program or ment of limited amounts of a product

(u) A tolerance or exemption from the which is to be tested further, usually on

need of a tolerance or a temporary tola larger scale, to determine its limita- erance or exemption from the need of a tions. Permits will be issued only for

temporary tolerance, has been estabbona fide experimental programs under

lished by the Environmental Protection the supervision of qualified persons.

Agency to cover any detectable residue The Director may require the submission which may be present on food or feed Inof such information and data concern

volved in the experimental program and ing the product and the program which

sufficient data are submitted to the he deems necessary for the protection of

Director to show that such program will the public. If, in the opinion of the

not result in any residue in excess of any Director, such information has not been

such tolerance or submitted he may, for the protection of

(ul) The food or feed derived from the public, refuse to issue the permit. the experimental program will be de(a) Articles for which no permit is re

stroyed or fed only to laboratory animals quired. (1) A substance or mixture of

or otherwise disposed of in a manner substances being put through tests in

which will protect the public and which which the purpose is only to determine

is approved by the Director. its value for economic poison purposes or

(3) A permit for shipment of any exto determine its toxicity or other prop

perimental economic poison for testing erties, and where the user does not ex

in any place likely to be frequented by pect to receive any benefit in pest con

people will be granted only if it is clearly trol from its use, not considered an

shown in the application for such pereconomic poison within the meaning of

mit that the applicant's instructions for section 2a of the Act. Therefore, no per

use reasonably assure the avoidance of mit under the Act is required for its

injury to all persons concerned.

(4) All applications for permits covershipment.

ing shipments for experimental use shall (2) An economic poison shipped or de

be filed in duplicate with the Pesticides livered for experimental use by or under

Regulation Division, Environmental Prothe supervision of any Federal or State

tection Agency, Washington, D.C. 20250, agency authorized by law to conduct re- and must be signed by the shipper and search in the field of economic poisons must contain the following: shall not be subject to the provisions of (1) A certification to the effect that the Act and the regulations in this part. food or feed derived from the experimen.

tal program will not be used or offered for consumption or sale for consumption, except by laboratory or experimental animals if Wlegal residues are present in or on such food or feed.

(ii) Name and address of the shipper and place or places from which the shipment will be made.

(iii) Proposed date of shipment or proposed shipping period not to exceed one year.

(iv) A statement of the composition of material to be covered by the permit which should apply to a single material or group of closely allied formulations of the material.

(v) A statement of the approximate quantity of material to be shipped.

(vi) Available data or information, or reference to available data or information, on the toxicity of the economic poison.

(vii) A statement of the nature of the proposed experimental program, including designation of the type of pests or organisms to be experimented with, the crops or animals on which the economic poison is to be used, a statement of the dates during which the proposed experimental program will be conducted, and the states or geographical areas where it is proposed to conduct the program, and including the results of previous tests where necessary to justify the issuance of a permit for the quantity requested.

(viii) The percentage of the total quantity of material specified under subdivision (v) of this subparagraph which will be supplied without charge to the user.

(ix) A statement that the economic poison is intended for experimental use only.

(x) Proposed labeling which must bear (a) the prominent statement “For Experimental Use Only” on the container label and any accompanying circular or other labeling, (b) a warning or caution statement if in the opinion of the Director it is necessary, which statement shall, if complied with, be adequate in his opinion, for the protection of those who may handle or be exposed to the experimental formulations, (c) the name and address of the applicant for the permit, (d) the name or designation of the formulation, (e) an ingredient statement as prescribed in $ 162.7, and (f) necessary directions for use including crops or sites to be treated, limitations on dosage to be used, and if the economic polson is to be tested on food or feed

crops the number of days required between last application and harvest.

(5) The Director may limit the quantity of economic poison covered by a permit to such less quantity than requested as he may determine if the available information on effectiveness, or toxicity or other hazards, is not suficient to justify the scope of experimental use proposed in the application, or may make such other limitations in the permit as he may determine to be necessary for the protection of the public.

(6) Reports on experimental program: During the period in which a permit is effective, the holder shall submit to the Director periodic reports regarding the status of the experimental program. Reports shall be submitted at 3-month intervals and at the end of the experimental program. These reports shall include the following information:

(i) Amount of the economic poison shipped during reporting period.

(1) Name and address of consignee of each shipment.

(iii) A summary of data on effectiveness, phytotoxicity, or other pertinent information obtained during the reporting period.

(iv) Any additional data on residues or analytical methods obtained during the reporting period.

(v) Any additional data on toxicity obtained during the reporting period.

(vi) Such other information and data as the Director may require. The Director may at any time request additional reports on the experimentai program if, in his opinion, such reports are necessary for the protection of the public.

(7) An economic poison shipped under a permit shall not be offered for general retail sale.

(c) General permit for economic potsons for experimental use which are also subject to the new drug requirements of the Federal Food, Drug, and Cosmetic Act. (1) Notwithstanding the provisions of paragraph (b) of this section, a general permit is hereby issued under section 7.a.(4) of the Act to the manufacturers and shippers of economic potsons for experimental use only, to ship such economic polsons: Provided, (1) That the product is a "new drug" within the meaning of section 201(p) and 505 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. sec. 321(p) and sec. 355); (ii) that it is subject to, and the manu

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