Consumer Product Safety Commission § 1702.2 CFR 1700.1(b)(2)), the term household AUTHORITY: 15 U.S.C. 1471(4), 1472, 1474, substance is defined as ‘‘any substance 1269(a), 2079(a); 21 U.S.C. 371(a). which is customarily produced or dis- SOURCE: 45 FR 13064, Feb. 28, 1980, unless tributed for sale for consumption or otherwise noted. use, or customarily stored, by individ- uals in or about the household * * *.’’ § 1702.1 Purpose and policy. The Commission has issued require- (a) Section 1700.14(a) of part 1700 lists ments for special packaging for certain household substances the Consumer hazardous substances at 16 CFR Product Safety Commission requires, 1700.14(a). Unless otherwise indicated in under section 3(a)(1) of the Poison Pre- the requirements for specific hazardous vention Packaging Act of 1970, 15 substances, the Commission interprets U.S.C. 1472, to be contained in special the term ‘‘household substance’’ as packaging to protect children from se- only applying to these hazardous sub- stances when packaged in containers rious personal injury or serious illness with a capacity of less than 5 gallons. resulting from handling, using, or in- As a result, unless otherwise specified, gesting such substances. There may be the hazardous substances at 16 CFR occasions, however, when the Commis- 1700.14(a) are not required to be in spe- sion determines that a particular sub- cial packaging when packaged in con- stance should be exempt from special tainers of 5 gallons or more. packaging requirements. (b) The Commission may, either on (Secs. 2, 5, 7, 9, Pub. L. 91–601; 94 Stat. 1670– its own initiative or upon the petition 1674 (15 U.S.C. 1471, 1474, 1476, 1478); sec. 30(a), Pub. L. 92–573, 86 Stat. 1231 (15 U.S.C. 2079(a)) of any interested person, amend the regulation at § 1700.14(a) by exempting [43 FR 53712, Nov. 17, 1978] a substance or category of substances from special packaging requirements. PART 1702—PETITIONS FOR EXEMP- The purpose of these rules is to provide TIONS FROM POISON PREVEN- procedures and requirements for sub- TION PACKAGING ACT REQUIRE- mitting petitions for exemption from MENTS; PETITION PROCEDURES special packaging requirements. AND REQUIREMENTS § 1702.2 Procedural requirements and Sec. recommendations. 1702.1 Purpose and policy. (a) Requirements. To be considered a 1702.2 Procedural requirements and rec- petition for exemption from special ommendations. packaging requirements under this 1702.3 Substantive requirements. 1702.4 Petitions with insufficient or incom- part a document filed under this part plete information. must: 1702.5 Failure to supply adverse informa- (1) Be mailed to the Office of the Sec- tion. retary, Consumer Product Safety Com- 1702.6 Trade secrets and other confidential mission, Washington, D.C. 20207, or de- information. livered to the Office of the Secretary, 1702.7 Justification for the exemption. 1702.8 Human experience data. Consumer Product Safety Commission, 1702.9 Relevant experimental data. 4330 East West Highway, Bethesda, MD 1702.10 Human experimental data involving 20814, the testing of human subjects. (2) Be written in the English lan- 1702.11 Product specifications. guage, 1702.12 Packaging specifications. (3) Contain the name and address of 1702.13 Labeling and packaging samples. 1702.14 Marketing history. the petitioner, 1702.15 Petitions alleging the incompati- (4) Contain an explicit request for ex- bility of child resistant packaging with emption from special packaging re- the particular substance petitioned for quirements, exemption. (5) Identify the category of sub- 1702.16 Petitions requesting an exemption stances under § 1700.14(a) from which for a drug or a new drug. 1702.17 Granting petitions. the exemption is sought, and 1702.18 Denying petitions. (6) Identify the particular substance 1702.19 Effect of filing petition. for which the exemption is sought. 919 VerDate Sep<11>2014 14:34 Sep 15, 2021 Jkt 253055 PO 00000 Frm 00929 Fmt 8010 Sfmt 8010 Q:\16\16V2.TXT PC31 kpayne on VMOFRWIN702 with $$_JOB § 1702.3 16 CFR Ch. II (1–1–21 Edition) (b) Failure to meet requirements. Where § 1702.4 Petitions with insufficient or a submission fails to meet all of the re- incomplete information. quirements of paragraph (a) of this sec- If a petition is submitted that is not tion, the Office of the Secretary shall complete and does not explain the rea- notify the person submitting it, de- son for the absence of the information, scribe the deficiency, and explain that the Commission shall afford the peti- the petition may be resubmitted when tioner a reasonable opportunity to pro- the deficiency is corrected. vide additional information. If the re- (c) Procedural recommendations. The quired information is not submitted to following are procedural recommenda- the Commission, or if the petitioner tions to help the Commission in its does not satisfactorily explain the ab- consideration of petitions. The Com- sence of the information within a rea- mission requests, but does not require, sonable time, the petition shall be that petitions filed under this part: closed if insufficient or incomplete in- (1) Be typewritten, formation has been submitted to en- (2) Include the word ‘‘petition’’ in a able the Commission to evaluate the heading preceding the text, merits of the exemption request. (3) Include the telephone number of the petitioner, and § 1702.5 Failure to supply adverse in- formation. (4) Be accompanied by at least five (5) copies of the petition. Failure to obtain and provide the Commission with all reasonably avail- [45 FR 13064, Feb. 28, 1980, as amended at 62 able information that the petitioner FR 46668, Sept. 4, 1997] knows is unfavorable or could reason- ably expect to be unfavorable to the pe- § 1702.3 Substantive requirements. tition shall result in the denial of the (a) A petition filed under this part petition. shall include the information required by this part, or a satisfactory expla- § 1702.6 Trade secrets and other con- nation for the absence of the informa- fidential information. tion. As provided by § 1702.4, a petition Where a petition contains material which is not complete may be closed. that the petitioner believes should be To be considered complete, a petition exempt from public disclosure under shall include the following: the Freedom of Information Act, 5 (1) A statement of the justification U.S.C. 552, the petitioner shall comply for the exemption in accordance with with the requirements of 16 CFR part § 1702.7, 1015, the Commission’s regulation (2) All reasonably available human under the Freedom of Information Act experience data, reasonably available concerning requests for treatment as relevant experimental data (both exempt material. The Commission human and animal), product and pack- shall act upon any request for treat- aging specifications, labeling, and mar- ment as exempt material in accordance keting history, in accordance with with the provisions of 16 CFR part 1015. §§ 1702.8 through 1702.14, (b) As used in this regulation, ‘‘rea- § 1702.7 Justification for the exemp- sonably available’’ information is data tion. in the petitioner’s possession; data The justification for the exemption, that has previously been generated by required under § 1702.3, shall explain the petitioner, and data that is obtain- the reason for the exemption based on able from such sources as: Reports one or more of the following grounds: from Poison Control Centers; reports of (a) If the justification is based on a adverse reactions that have been sub- lack of need for special packaging to mitted to the petitioner; the medical, protect young children from serious in- pharmacological, and toxicological lit- jury or illness from the substance, the erature; and information required by justification shall state how the lack of the FDA for an Investigational Exemp- toxicity and lack of adverse human ex- tion for a New Drug (IND) or a New perience for the substance clearly sup- Drug Application (NDA). ports granting the exemption. 920 VerDate Sep<11>2014 14:34 Sep 15, 2021 Jkt 253055 PO 00000 Frm 00930 Fmt 8010 Sfmt 8010 Q:\16\16V2.TXT PC31 kpayne on VMOFRWIN702 with $$_JOB Consumer Product Safety Commission § 1702.9 (b) If the exemption is requested be- mal body. Therefore, the Commission cause special packaging is not techno- considers experimental data obtained logically feasible, practicable, or ap- in animal studies to be an important propriate for the substance, the jus- supplement to such data as may exist tification shall explain why. from any experimental studies con- (c) If the exemption is requested be- ducted in humans. The minimum toxi- cause special packaging is incompat- cological evaluation necessary for a ible with the particular substance, the particular household substance is pro- justification shall explain why. portional to the expected exposure of man to that substance. Household sub- § 1702.8 Human experience data. stances which are not expected, in nor- Human experience data constitutes mal use, to contact man are subject to the primary criterion used by the Com- less extensive studies than those sub- mission in evaluating petitions for ex- stances, such as drugs, which are de- emptions. Petitions shall therefore in- signed to be used in or on man. The clude a compilation of all reasonably Commission has, therefore, separated available reports pertaining to human the requirements of this section into use of the particular substance, includ- three subsections. Section 1702.9(a) ing the product brand as well as ge- lists minimum acute animal toxicity neric equivalents and involving adverse data which shall be submitted, if rea- reports of personal injury, illness, and sonably available, for all petitions; significant allergenicity. Such infor- § 1702.9(b) lists those additional data mation in children is of particular im- which shall be submitted, if reasonably portance in evaluating exemption re- available, for drug products and all quests.