Consumer Product Safety Commission § 1702.12

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 substances 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.

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(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 information. (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 reasonably 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.

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(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 submission 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. However, similar data in adults other household substances which are shall also be submitted if available. normally intended to be used in or on Human experience data may be ob- the human body; and § 1702.9(c) lists tained from such sources as: those additional data which shall be (a) Reports from Poison Control Cen- submitted, if reasonably available, by ters, petitioners requesting exemption for (b) Reports of adverse reactions rel- substances not intended for use in or ative to the product that have been on the human or animal body. The submitted to the company by physi- Commission emphasizes that, while not cians, hospitals, consumers, and other absolutely necessary, the types of data sources, outlined in § 1702.9(c) may greatly expe- (c) Extensive searches of the medical, dite the Commission’s evaluation of a pharmacological, and toxicological lit- particular exemption request. erature, and (a) General criteria applicable to all pe- (d) For drugs, where the human expe- titions. (1) Each petition for an exemp- rience data submitted is based on data tion under this part shall include all required by FDA to be compiled for an reasonably available relevant experi- Investigational Exemption for a New mental data relating to the petition re- Drug (IND), 21 CFR part 312, or a New gardless of whether such data are unfa- Drug Application (NDA), 21 CFR part vorable to the petitioner’s request. As 314, a summary of the relevant data used in this part, the term ‘‘relevant should be provided. The entire NDA experimental data’’ includes, but is not and IND material need not be sub- limited to, all data, including animal mitted. and human studies revealing the nature and degree of the hazard associ- § 1702.9 Relevant experimental data. ated with the particular substance. Experimental data are generated in Generally, the hazard associated with both animals and humans in controlled the particular substance involves the situations in order to evaluate the bio- risk of injury arising from the acute logical effects of a substance. Certain accidental ingestion of a product. toxicological effects cannot generally Where a hazard different from the risk be evaluated in human beings. This is of injury arising from accidental inges- especially true of those substances tion is known to exist (e.g., potential which are not normally intended to be for significant allergenicity, dermal or used in or on the human body or ani- opthalmic injury from handling or

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using the product), the petitioner shall terminations should, where an LD50 also submit all reasonably available value may be calculated, include: relevant experimental data evaluating (i) The LD50 value with 95 percent the nature and degree of any additional confidence limits; hazard(s). (ii) A slope determination for the (2) All animal studies submitted in dose response curve, including 95 per- support of exemption requests should cent confidence limits; and be performed in conformity with good (iii) A description of the statistical pharmacological and toxicological method employed in the analysis of practice which includes, as a min- such data (with proper citation) as well imum, complete descriptions of proto- as the statistical analysis itself. cols used in experimental animal stud- (5) The Commission shall disregard ies, and signed laboratory reports any data which do not fulfill the strict which include the following basic infor- requirements of the statistical method mation: used in their analyses. Modifications of (i) An exact description of materials accepted statistical methods which tested; have been published in the literature (ii) A description of test animals em- are acceptable to the Commission pro- ployed in studies, including number, vided that a copy of the published work age, weight, sex and nutritional state is submitted. (6) Acute toxicity studies submitted of animals; with petitions should have at least a (iii) Dosage level(s) and number of seven day observation period of test animals tested per dosage level; animals. Good pharmacological prac- (iv) Basis upon which dosage was ad- tice provides that test animals are ob- ministered (e.g., as salt or base); served closely for several hours fol- (v) Route of administration and dos- lowing test substance administration age volume; and and less frequently on subsequent test (vi) Appendices containing all raw days. Succumbing animals should be data and any additional data generated necropsied as soon as practicable fol- subsequent to the completion of the lowing death, while surviving animals original study (e.g., results of should be necropsied, and gross patho- histopathological examinations, if per- logical alterations noted, at the end of formed). the observation period. Documentation (3) Each petition shall include all of non-lethal effects occurring during reasonably available reports of Median these observation periods should be Lethal Dosage (LD50) studies and shall submitted in conjunction with acute include all raw data obtained in such toxicity laboratory reports. Docu- studies. These studies should normally mentation of any lethal effects occur- be conducted in both adult and ring at high dosage levels, including weanling animals of the same species. mode of death (e.g., cardiac arrest/res- The oral route of administration piratory arrest), and time of death should be followed for studies involving should be submitted in conjunction substances subject to regulations pro- with acute toxicity laboratory reports. mulgated under the Poison Prevention Reports of gross necropsies performed Packaging Act of 1970. Where a upon surviving animals should be sub- percutaneous toxicity hazard exists, mitted, as well as results of necropsies the petition shall include reasonably performed upon animals succumbing to available studies using the the test substance, provided that such percutaneous route of administration. animals are examined prior to the Sufficient dosage levels as well as ade- onset of autolysis. Results of micro- quate numbers of test animals per dos- scopic examinations, when indicated by age level should be used to give statis- the nature or results of an acute tox- tical reliability to determined LD50 icity study, shall also be submitted. values. (b) Additional data criteria for petitions (4) In view of the fact that LD50 val- involving substances normally used in or ues in themselves do not necessarily on the human or animal body. (1) Peti- reflect a true estimate of the overall tioners submitting exemption requests toxic potential of a substance, LD50 de- for substances normally used on or

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taken into the human body or animal types of data, although often not gen- body shall, in addition to the require- erated for household substances not ments of paragraph (a) of this section normally used in or on the human or submit the following data, where rea- animal body, may be available to a pe- sonably available: titioner and should, where reasonably (i) Summary laboratory reports of available, be submitted. data obtained in subacute and chronic (1) Summary laboratory reports of animal studies where the data pertain data obtained in subacute and chronic to the absorption, distribution, metab- animal studies where such data pertain olism and excretion of substances in to the absorption, distribution, metab- question; olism, and excretion of the substance (ii) A median lethal dosage (LD50) de- in question; termination conducted in one addi- (2) Results of median lethal dosage tional species. Of the two LD50 deter- (LD50) studies conducted in additional minations required for persons submit- species of animals; and ting exemption requests under this (3) Any additional experimental stud- part, one should be conducted in a non- ies relevant to the exemption request rodent species; which would provide the Commission (iii) Summary reports of data ob- with additional means of assessing the tained in human studies designed to hazards to children of the product for measure the absorption, distribution, which exemption is sought. metabolism, and excretion of substances in question; and § 1702.10 Human experimental data in- (iv) Data indicating, insofar as is volving the testing of human sub- known, the mechanism of action of the jects. substance in question and the mecha- Any human experimental data sub- nism by which expected toxicological mitted with a petition requesting an effects occur. If these mechanisms are exemption under this part shall include unknown, the petition should state a statement establishing that adequate this. measures have been taken to ensure (2) Petitioners submitting exemption against psychological or physical in- requests for substances normally used jury to the subject of the human stud- on or taken into the human or animal ies. The Commission considers its regu- body shall, in addition to the require- lations concerning the protection of ments of paragraphs (a) and (b)(1) of human subjects (16 CFR part 1028) to be this section, submit an evaluation of an example of measures that are ade- the pharmacology and toxicology of quate to ensure against psychological the substance in question based on rea- or physical injury to human subjects. sonably available medical and scientific literature. The evaluation § 1702.11 Product specifications. should be a comprehensive one, and Each petition for an exemption shall should include proper literature cita- include: tions. To the extent possible, informa- (a) A complete quantitative formula tion submitted by the petitioner justi- for the product, including inert ingre- fying an exemption based on the med- dients, diluents, and solvents. (Peti- ical and scientific literature will be tioners should refer to § 1702.6 for infor- evaluated under the criteria specified mation regarding trade secrets.) in § 1702.9(a) for evaluating experi- (b) A listing of all physical forms or mental data. In certain cases where the dosage forms (whichever is appro- experimental data specified by § 1702.9 priate) in which the product is avail- (a) and (b) are unavailable, the medical able. and scientific literature may justify granting an exemption, particularly § 1702.12 Packaging specifications. where the pharmacology and toxi- Each petition for an exemption shall cology of the substance is well docu- include the following information for mented in the literature. each form of the product for which an (c) Optional data criteria for petitions exemption is sought: involving substances not used in or on the (a) A description of the packaging human or animal body. The following currently in use including the name of

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the manufacturer of the package and ard is incompatible with the particular all specifications for the package, substance or would seriously and ad- (b) A complete packaging description versely compromise the utility or sta- including any carton or wrapping in bility of a substance, the petitioner which the product is offered to the con- shall submit adequate evidence to sup- sumer, port the allegation. (c) A description of each size in which (b) If the allegation of incompati- the product is offered, including phys- bility is based upon the fact that pack- ical form, color and flavoring, and age choice is limited by a new drug ap- (d) An empty sample of each type and plication filed with the FDA, the peti- size of package petitioned for exemption shall state the limitation of pack- tion and, in the case of drugs, a des- age choice and a description of a time ignation of those packages intended to schedule to revise the NDA in order to be used in dispensing the product to allow additional package choice. the consumer for household use. (c) If the allegation of incompati- bility is based upon the fact that the § 1702.13 Labeling and packaging sam- shelf life of the product limits package ples. choice, the petition shall outline the Each petition for an exemption under particular limitation and shall include this part shall include a sample of the a description of a time schedule to re- label and complete packaging for each establish shelf-life data. size in which each form of the product § 1702.16 Petitions requesting an ex- for which an exemption is sought is emption for a drug or a new drug. packaged. This shall include the imme- diate container labeling, any package (a) Where the petition requests an ex- inserts, and other carton or wrapping emption for a drug, as defined in sec- labeling in which the product is offered tion 201(g)(1) of the Federal Food, to the consumer. In the case of drugs, Drug, and Cosmetic Act (21 U.S.C. each petition shall be accompanied by 321(g)(1), the petitioner shall include labeling on the outer carton or wrap- those reports required to be filed under ping in which the product is offered to the Food and Drug Administration’s the retailer, as well as samples of the Adverse Reaction Reporting Program. promotional and advertising informa- (b) [Reserved] tion for the product. [45 FR 13064, Feb. 28, 1980, as amended at 66 FR 40115, Aug. 2, 2001] § 1702.14 Marketing history. Each petition for an exemption under § 1702.17 Granting petitions. this part shall include a statement of Where the Commission determines the marketing history of the substance that reasonable grounds for an exemp- for which an exemption is requested. tion are presented by the petition, the The marketing history dates from the Commission shall publish, in the FED- year in which each form of the product ERAL REGISTER, a proposed amendment was introduced onto the market. The to the listing of substances requiring marketing history shall include the special packaging under § 1700.14(a). total number of units of each form or ‘‘Reasonable grounds’’ for publishing a strength and package size of the prod- proposed exemption are information uct distributed since the product was and data sufficient to support the con- introduced onto the market. In the clusion that: case of prescription drugs, the average (a) The degree or nature of the haz- prescription size for the product should ard to children in the availability of also be indicated, if known. the substance, by reason of its packaging, is such that special packaging is § 1702.15 Petitions alleging the incom- not required to protect children from patibility of child resistant pack- serious personal injury or serious ill- aging with the particular substance ness resulting from handling, using, or petitioned for exemption. ingesting the substance, or (a) Where the petition for an exemp- (b) Special packaging is not tech- tion is based upon an allegation that nically feasible, practicable, or appro- the applicable special packaging stand- priate for the subject substance, or

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(c) Special packaging is incompatible § 1702.19 Effect of filing petition. with the particular substance. The filing of a petition for exemption § 1702.18 Denying petitions. under this part 1702 shall not have the effect of staying the regulation from Where the Commission determines which the exemption is sought. There- that reasonable grounds for an exemp- fore, substances subject to special tion are not presented by the petition, packaging standards shall be consid- the petition shall be denied, and the pe- ered in violation of the law unless titioner notified in writing of the de- packaged in special packaging during nial, including a brief statement of the the Commission’s consideration of a reasons therefor. petition.

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