(a) As used in this part:

(1) Act means the Poison Prevention Packaging Act of 1970 (Pub. L. 91-601, 84 Stat. 1670-74; 15 U.S.C. 1471-75), enacted December 30, 1970.

(2) Commission means the Consumer Product Safety Commission established by section 4 of the Consumer Product Safety Act (86 Stat. 1210; 15 U.S.C. 2053).

(3) Dietary supplement means any vitamin and/or mineral preparation offered in tablet, capsule, wafer, or other similar uniform unit form; in powder, granule, flake, or liquid form; or in the physical form of a conventional food but which is not a conventional food; and which purports or is represented to be for special dietary use by humans to supplement their diets by increasing the total dietary intake of one or more of the essential vitamins and/or minerals.

(b) Except for the definition of “Secretary,” which is obsolete, the definitions given in section 2 of the act are applicable to this part and are repeated herein for convenience as follows:

(1) [Reserved]

(2) Household substance means any substance which is customarily produced or distributed for sale for consumption or use, or customarily stored, by individuals in or about the household and which is:

(i) A hazardous substance as that term is defined in section 2(f) of the Federal Hazardous Substances Act (15 U.S.C. 1261(f));

(ii) A food, drug, or cosmetic as those terms are defined in section 201 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 321); or

(iii) A substance intended for use as fuel when stored in a portable container and used in the heating, cooking, or refrigeration system of a house.

(3) Package means the immediate container or wrapping in which any household substance is contained for consumption, use, or storage by individuals in or about the household and, for purposes of section 4(a)(2) of the act, also means any outer container or wrapping used in the retail display of any such substance to consumers. “Package” does not include:

(i) Any shipping container or wrapping used solely for the transportation of any household substance in bulk or in quantity to manufacturers, packers, or processors, or to wholesale or retail distributors thereof; or

(ii) Any shipping container or outer wrapping used by retailers to ship or deliver any household substance to consumers unless it is the only such container or wrapping.

(4) Special packaging means packaging that is designed or constructed to be significantly difficult for children under 5 years of age to open or obtain a toxic or harmful amount of the substance contained therein within a reasonable time and not difficult for normal adults to use properly, but does not mean packaging which all such children cannot open or obtain a toxic or harmful amount within a reasonable time.

(5) Labeling means all labels and other written, printed, or graphic matter upon any household substance or its package, or accompanying such substance.

Authority under the Poison Prevention Packaging Act of 1970 is vested in the Consumer Product Safety Commission by section 30(a) of the Consumer Product Safety Act (15 U.S.C. 2079(a)).

(a) Pursuant to section 3 of the act, the Commission, after consultation with the technical advisory committee provided for by section 6 of the act, may establish by regulation standards for the special packaging of any household substance if the Commission finds:

(1) That the degree or nature of the hazard to children in the availability of such substance, by reason of its packaging, is such that special packaging is required to protect children from serious personal injury or serious illness resulting from handling, using, or ingesting such substance; and

(2) That the special packaging to be required by such standard is technically feasible, practicable, and appropriate for such substance.

(b) In establishing such a standard, the Commission shall consider:

(1) The reasonableness of such standard;

(2) Available scientific, medical, and engineering data concerning special packaging and concerning childhood accidental ingestions, illness, and injury caused by household substances;

(3) The manufacturing practices of industries affected by the act; and

(4) The nature and use of the household substance.

(c) In the process of establishing such a standard, the Commission shall publish its findings and reasons therefor and shall cite the sections of the act that authorize its action.

(d) In establishing such standards, the Commission shall not prescribe specific packaging designs, product content, package quantity, or labeling except for labeling under section 4(a)(2) of the act. Regarding a household substance for which special packaging is required by regulation, the Commission can prohibit the packaging of such substance in a package which the Commission determines is unnecessarily attractive to children.

(e) Promulgations pursuant to section 3 of the act shall be in accordance with section 5 of the act as to procedure.

(a) The FR document promulgating a regulation establishing a child protection packaging standard shall indicate the standard's effective date. Section 9 of the act specifies that the effective date shall not be sooner than 180 days or later than 1 year from the date the standard is promulgated in the Federal Register unless the Commission, for good cause found, determines that an earlier effective date is in the public interest and publishes in the Federal Register the reason for such finding, in which case such earlier effective date shall apply.

(b) Upon becoming effective, a child protection packaging standard shall apply only to household substances packaged on and after its effective date.

To make household substances that are subject to requirements for special packaging readily available to elderly or handicapped persons who are unable to use those substances in special packaging, section 4(a) of the act authorizes manufacturers and packers to package such substances in noncomplying packaging of a single size provided that complying packaging is also supplied and the noncomplying packages are conspicuously labeled to indicate that they should not be used in households where young children are present. The purpose of this § 1700.5 is to implement section 4(a) of the act by prescribing requirements for the labeling of noncomplying packages.

(a) Labeling statement. (1) The statement “This Package for Households Without Young Children” shall appear conspicuously, and in accordance with all of the requirements of paragraph (a) of this section, on the package of any household substance subject to the special packaging requirements of this part 1700 that is supplied in noncomplying packaging under section 4(a) of the act, unless the package bears the substitute labeling statement in accordance with all of the requirements of paragraph (b) of this section.

(2) The statement required by paragraph (a)(1) of this section shall appear on the principal display panel of the immediate container as well as on the principal display panel of any outer container or wrapping used in the retail display of the substance. If a package bears more than one principal display panel, the required statement shall appear on each principal display panel of the immediate container as well as on each principal display panel of any outer container or wrapping used in the retail display of the substance. The principal display panel is the part of the labeling most likely to be displayed, presented, shown, or examined.

(3) The required labeling statement shall appear within the borderline of a square or rectangle on the principal display panel in conspicuous and easily legible capital letters, shall be in distinct contrast, by typography, layout, color, or embossing, to other matter on the package, and shall appear in lines generally parallel to the base on which the package rests as it is designed to be displayed.

(4) The declaration shall be in letters in type size established in relationship to the area of the principal display panel of the package and shall be uniform for all packages of substantially the same size by complying with the following type-size specifications:

(i) Not less than 1/16 inch in height on packages the principal display panel of which has an area of 7 square inches or less.

(ii) Not less than 3/32 inch in height on packages the principal display panel of which has an area of more than 7 but not more than 15 square inches.

(iii) Not less than 1/8 inch in height on packages the principal display panel of which has an area of more than 15 but not more than 25 square inches.

(iv) Not less than 3/16 inch in height on packages the principal display panel of which has an area of more than 25 but not more than 100 square inches.

(v) Not less than 1/4 inch in height on packages the principal display panel of which has an area of more than 100 square inches.

(5)(i) For the purpose of obtaining uniform type size for the required statement for all packages of substantially the same size, the area of the principal display panel is the area of the side or surface that bears the principal display panel, which shall be:

(A) In the case of a rectangular package where one entire side properly can be considered to be the principal display panel, the product of the height times the width of that side.

(B) In the case of a cylindrical or nearly cylindrical container, 40 percent of the product of the height of the container times the circumference.

(C) In the case of any other shape of container, 40 percent of the total surface of the container; however, if such container presents an obvious principal display (such as the top of a triangular or circular package), the area shall consist of the entire area of such obvious principal display panel.

(ii) In determining the area of the principal display panel exclude tops, bottoms, flanges at the tops and bottoms of cans, and shoulders and necks of bottles or jars. In the case of cylindrical or nearly cylindrical containers, the labeling statement required by this section to appear on the principal display panel shall appear within that 40 percent of the circumference most likely to be displayed, presented, shown, or examined.

(b) Substitute labeling statement. If the area of the principal display panel, as determined in accordance with paragraph (a)(5) of this section, is too small to accommodate the statement required by paragraph (a)(1) using the type size required by paragraph (a)(4), the substitute statement “Package Not Child-Resistant” may be used. This substitute statement must comply with all of the requirements for size, placement, and conspicuousness prescribed by paragraph (a) of this section.

To protect children from serious personal injury or serious illness resulting from handling, using, or ingesting household substances, the Commission has determined that packaging designed and constructed to meet the following standards shall be regarded as “special packaging” within the meaning of section 2(4) of the act. Specific application of these standards to substances requiring special packaging is in accordance with § 1700.14.

(a) General requirements. The special packaging must continue to function with the effectiveness specifications set forth in paragraph (b) of this section when in actual contact with the substance contained therein. This requirement may be satisfied by appropriate scientific evaluation of the compatibility of the substance with the special packaging to determine that the chemical and physical characteristics of the substance will not compromise or interfere with the proper functioning of the special packaging. The special packaging must also continue to function with the effectiveness specifications set forth in paragraph (b) of this section for the number of openings and closings customary for its size and contents. This requirement may be satisfied by appropriate technical evaluation based on physical wear and stress factors, force required for activation, and other such relevant factors which establish that, for the duration of normal use, the effectiveness specifications of the packaging would not be expected to lessen.

(b) Effectiveness specifications. Special packaging, tested by the method described in § 1700.20, shall meet the following specifications:

(1) Child-resistant effectiveness of not less than 85 percent without a demonstration and not less than 80 percent after a demonstration of the proper means of opening such special packaging. In the case of unit packaging, child-resistant effectiveness of not less than 80 percent.

(2) Ease of adult opening. (i) Senior-adult test. Except for products specified in paragraph (b)(2)(ii) of this section, special packaging shall have a senior adult use effectiveness (SAUE) of not less than 90% for the senior-adult panel test of § 1700.20(a)(3).

(ii) Younger-adult test. (A) When applicable. Products that must be in aerosol form and products that require metal containers, under the criteria specified below, shall have an effectiveness of not less than 90% for the younger-adult test of § 1700.20(a)(4). The senior-adult panel test of § 1700.20(a)(3) does not apply to these products. For the purposes of this paragraph, metal containers are those that have both a metal package and a recloseable metal closure, and aerosol products are self-contained pressurized products.

(B) Determination of need for metal or aerosol container.

(1) Criteria. A product will be deemed to require metal containers or aerosol form only if:

(i) No other packaging type would comply with other state or Federal regulations,

(ii) No other packaging can reasonably be used for the product's intended application,

(iii) No other packaging or closure material would be compatible with the substance,

(iv) No other suitable packaging type would provide adequate shelf-life for the product's intended use, or

(v) Any other reason clearly demonstrates that such packaging is required.

(2) Presumption. In the absence of convincing evidence to the contrary, a product shall be presumed not to require a metal container if the product, or another product of identical composition, has previously been marketed in packaging using either a nonmetal package or a nonmetal closure.

(3) Justification. A manufacturer or packager of a product that is in a metal container or aerosol form that the manufacturer or packager contends is not required to comply with the SAUE requirements of § 1700.20(a)(3) shall provide, if requested by the Commission's staff, a written explanation of why the product must have a metal container or be an aerosol. Manufacturers and packagers who wish to do so voluntarily may submit to the Commission's Office of Compliance a rationale for why their product must be in metal containers or be an aerosol. In such cases, the staff will reply to the manufacturer or packager, if requested, stating the staff's views on the adequacy of the rationale.

(c) Reuse of special packaging. Special packaging for substances subject to the provisions of this paragraph shall not be reused.

(d) Restricted flow. Special packaging subject to the provisions of this paragraph shall be special packaging from which the flow of liquid is so restricted that not more than 2 milliliters of the contents can be obtained when the inverted, opened container is taken or squeezed once or when the container is otherwise activated once.

(a) Test protocols—(1) General requirements—(i) Requirements for packaging. As specified in § 1700.15(b), special packaging is required to meet the child test requirements and the applicable adult test requirements of this § 1700.20.

(ii) Condition of packages to be tested. (A) Tamper-resistant feature. Any tamper-resistant feature of the package to be tested shall be removed prior to testing unless it is part of the package's child-resistant design. Where a package is supplied to the consumer in an outer package that is not part of the package's child-resistant design, one of the following situations applies:

(1) In the child test, the package is removed from the outer package, and the outer package is not given to the child.

(2) In both the adult tests, if the outer package bears instructions for how to open or properly resecure the package, the package shall be given to the test subject in the outer package. The time required to remove the package from the outer package is not counted in the times allowed for attempting to open and, if appropriate, reclose the package.

(3) In both the adult tests, if the outer package does not bear any instructions relevant to the test, the package will be removed from the outer package, and the outer package will not be given to the test subject.

(B) Reclosable packages—adult tests. In both the adult tests, reclosable packages, if assembled by the testing agency, shall be properly secured at least 72 hours prior to beginning the test to allow the materials (e.g., the closure liner) to “take a set.” If assembled by the testing agency, torque-dependent closures shall be secured at the same on-torque as applied on the packaging line. Application torques must be recorded in the test report. All packages shall be handled so that no damage or jarring will occur during storage or transportation. The packages shall not be exposed to extreme conditions of heat or cold. The packages shall be tested at room temperature.

(2) Child test. (i) Test subjects. (A) Selection criteria. Use from 1 to 4 groups of 50 children, as required under the sequential testing criteria in table 1. No more than 20% of the children in each group shall be tested at or obtained from any given site. Each group of children shall be randomly selected as to age, subject to the limitations set forth below. Thirty percent of the children in each group shall be of age 42-44 months, 40% of the children in each group shall be of age 45-48 months, and 30% of the children in each group shall be of age 49-51 months. The children's ages in months shall be calculated as follows:

(1) Arrange the birth date and test date by the numerical designations for month, day, and year (e.g., test date: 8/3/1990; birth date: 6/23/1986).

(2) Subtract the month, day, and year numbers for the birth date from the respective numbers for the test date. This may result in negative numbers for the months or days. (e.g.,

(3) Multiply the difference in years by 12 to obtain the number of months in the difference in years, and add this value to the number of months that was obtained when the birth date was subtracted from the test date (i.e., 4 × 12 = 48; 48 + 2 = 50). This figure either will remain the same or be adjusted up or down by 1 month, depending on the number of days obtained in the subtraction of the birth date from the test date.

(4) If the number of days obtained by subtracting the days in the birth date from the days in the test date is +16 or more, 1 month is added to the number of months obtained above. If the number of days is −16 or less, subtract 1 month. If the number of days is between −15 and +15 inclusive, no change is made in the number of months. Thus, for the example given above, the number of days is −20, and the number of months is therefore 50 − 1 = 49 months.

(B) Gender distribution. The difference between the number of boys and the number of girls in each age range shall not exceed 10% of the number of children in that range. The children selected should have no obvious or overt physical or mental handicap. A parent or guardian of each child shall read and sign a consent form prior to the child's participation. (The Commission staff will not disregard the results of tests performed by other parties simply because informed consent for children is not obtained.)

(ii) Test failures. A test failure shall be any child who opens the special packaging or gains access to its contents. In the case of unit packaging, however, a test failure shall be any child who opens or gains access to the number of individual units which constitute the amount that may produce serious personal injury or serious illness, or a child who opens or gains access to more than 8 individual units, whichever number is lower, during the full 10 minutes of testing. The number of units that a child opens or gains access to is interpreted as the individual units from which the product has been or can be removed in whole or in part. The determination of the amount of a substance that may produce serious personal injury or serious illness shall be based on a 25-pound (11.4 kg) child. Manufacturers or packagers intending to use unit packaging for a substance requiring special packaging are requested to submit such toxicological data to the Commission's Office of Compliance.

(iii) Sequential test. The sequential test is initially conducted using 50 children, and, depending on the results, the criteria in table 1 determine whether the package is either child-resistant or not child-resistant or whether further testing is required. Further testing is required if the results are inconclusive and involves the use of one or more additional groups of 50 children each, up to a maximum of 200 children. No individual shall administer the test to more than 30% of the children tested in each group. Table 1 gives the acceptance (pass), continue testing, and rejection (fail) criteria to be used for the first 5 minutes and the full 10 minutes of the children's test. If the test continues past the initial 50-child panel, the package openings shown in table 1 are cumulative.

(iv) Test procedures. The children shall be divided into groups of two. The testing shall be done in a location that is familiar to the children, for example, their customary nursery school or regular kindergarten. No child shall test more than two special packages. When more than one special package is being tested, each package shall be of a different ASTM type and they shall be presented to the paired children in random order. This order shall be recorded. The children shall be tested by the procedure incorporated in the following test instructions:

(3) Senior-adult panel. (i) Test subjects. Use a group of 100 senior adults. Not more than 24% of the senior adults tested shall be obtained from or tested at any one site. Each group of senior adults shall be randomly selected as to age, subject to the limitations set forth below. Twenty-five percent of the participants shall be 50-54 years of age, 25% of participants shall be 55-59 years of age, and 50% of the participants shall be 60-70 years old. Seventy percent of the participants of ages 50-59 and ages 60-70 shall be female (17 or 18 females shall be apportioned to the 50-54 year age group). No individual tester shall administer the test to more than 35% of the senior adults tested. The adults selected should have no obvious or overt physical or mental disability.

(ii) Screening procedures. Participants who are unable to open the packaging being tested in the first 5-minute time period, are given a screening test. The screening tests for this purpose shall use two packages with conventional (not child-resistant (CR) or “special”) closures. One closure shall be a plastic snap closure and the other a CT plastic closure. Each closure shall have a diameter of 28 mm ± 18%, and the CT closures shall have been resecured 72 hours before testing at 10 inch-pounds of torque. The containers for both the snap- and CT-type closures shall be round plastic containers, in sizes of 2 ounce ± 1/2 ounce for the CT-type closure and 8 drams ± 4 drams for the snap-type closure. Persons who cannot open and close both of the screening packages in 1-minute screening tests shall not be counted as participants in the senior-adult panel.

(iii) SAUE. The senior adult use effectiveness (SAUE) is the percentage of adults who both opened the package in the first (5-minute) test period and opened and (if appropriate) properly resecured the package in the 1-minute test period.

(iv) Test procedures. The senior adults shall be tested individually, rather than in groups of two or more. The senior adults shall receive only such printed instructions on how to open and properly secure the special packaging as will appear on or accompany the package as it is delivered to the consumer. The senior-adult panel is tested according to the procedure incorporated in the following senior-adult panel test instructions:

(4) Younger-adult panel. (i) One hundred adults, age 18 to 45 inclusive, with no overt physical or mental handicaps, and 70% of whom are female, shall comprise the test panel for younger adults. Not more than 35% of adults shall be obtained or tested at any one site. No individual tester shall administer the test to more than 35% of the adults tested. The adults shall be tested individually, rather than in groups of two or more. The adults shall receive only such printed instructions on how to open and properly resecure the special packaging as will appear on the package as it is delivered to the consumer. Five minutes shall be allowed to complete the opening and, if appropriate, the resecuring process.

(ii) Records shall be kept of the number of adults unable to open and of the number of the other adults tested who fail to properly resecure the special packaging. The number of adults who successfully open the special packaging and then properly resecure the special packaging (if resecuring is appropriate) is the percent of adult-use effectiveness of the special packaging. In the case of unit packaging, the percent of adult-use effectiveness shall be the number of adults who successfully open a single (unit) package.

(b) The standards published as regulations issued for the purpose of designating particular substances as being subject to the requirements for special packaging under the act will stipulate the percent of child-resistant effectiveness and adult-use effectiveness required for each and, where appropriate, will include any other conditions deemed necessary and provided for in the act.

(c) It is recommended that manufacturers of special packaging, or producers of substances subject to regulations issued pursuant to the act, submit to the Commission summaries of data resulting from tests conducted in accordance with this protocol.

(d) Recommendations. The following instructions and procedures, while not required, are used by the Commission's staff and are recommended for use where appropriate.

(1) Report format for child test.

(2) Standardized adult-resecuring test instructions. CPSC will use the adult-resecuring test where an objective determination (e.g., visual or mechanical) that a package is properly resecured cannot be made. The adult-resecuring test is performed as follows:

(3) Report format for adult-resecuring test.

(a) In order to assist manufacturers of prescription drugs in discharging their responsibilities under the act concerning such drugs that are distributed to pharmacies, the Consumer Product Safety Commission has codified this statement of its policy concerning which prescription drug packages supplied by manufacturers to pharmacies must comply with the “special” (child-resistant) packaging requirements contained in 16 CFR 1700.15.

(b) Manufacturers of prescription drugs may package such drugs for distribution to pharmacies in different types of packages, depending on whether the manufacturer intends that the package will be the one in which the drug is ultimately given to the consumer or whether it is intended that the pharmacist will repackage the drug before it is dispensed to the consumer. If the drug is supplied in a bulk package from which individual prescriptions are intended to be repackaged by the pharmacist, the manufacturer need not utilize special packaging. However, the Commission interprets the provision of the act as requiring that all prescription drugs subject to a special packaging standard that are distributed to pharmacies shall be in special packaging if the immediate package in which the drugs are distributed by the manufacturer is intended to be the package in which the drugs are dispensed to the consumer. Examples of such packages include mnemonic dispensing devices; dropper bottles; packages with “tear off” labels; packages which incorporate ancillary instructions for consumer handling, storage, or use on permanently affixed portions of their labels; and products intended to be reconstituted in their original containers. The Commission believes that this interpretation is necessary in order to insure that the pharmacist will actually dispense the drug in the proper package. If the pharmacist receives a request from the consumer or an order from the prescribing medical practitioner for conventional (noncomplying) packaging, section 4(b) of the act permits the pharmacist to convert the package to conventional packaging or repackage the drug in conventional packaging.

(c) Manufacturers should also note that section 4(a) of the act (which allows a product to be marketed in noncomplying packaging of a single size under certain circumstances) does not apply to prescription drugs subject to section 4(b) of the act. Thus, since the section 4(a) single-size exemption for over-the-counter drugs and other household substances does not apply to prescription drugs, every unit of a prescription drug subject to a special packaging standard which is distributed to a pharmacy in a package intended by the manufacturer to be dispensed to a consumer shall be in special packaging.

(d) Nothing in this statement of policy and interpretation should be interpreted as relieving the pharmacist of the responsibility of insuring that all prescription drugs subject to a special packaging standard are dispensed to the consumer in special packaging unless otherwise ordered by the prescribing practitioner or otherwise requested by the consumer.

The special packaging requirements of the PPPA apply to “household substances” for which the Commission has determined there is a need for special packaging, as provided in section 3 of the act (15 U.S.C. 1472). At section 2(2) of the act (15 U.S.C. 1471) (restated at 16 CFR 1700.1(b)(2)), the term household substance is defined as “any substance which is customarily produced or distributed for sale for consumption or use, or customarily stored, by individuals in or about the household * * *.” The Commission has issued requirements for special packaging for certain hazardous substances at 16 CFR 1700.14(a). Unless otherwise indicated in the requirements for specific hazardous substances, the Commission interprets the term “household substance” as only applying to these hazardous substances when packaged in containers with a capacity of less than 5 gallons. As a result, unless otherwise specified, the hazardous substances at 16 CFR 1700.14(a) are not required to be in special packaging when packaged in containers of 5 gallons or more.

(a) Section 1700.14(a) of part 1700 lists household substances the Consumer Product Safety Commission requires, under section 3(a)(1) of the Poison Prevention Packaging Act of 1970, 15 U.S.C. 1472, to be contained in special packaging to protect children from serious personal injury or serious illness resulting from handling, using, or ingesting such substances. There may be occasions, however, when the Commission determines that a particular substance should be exempt from special packaging requirements.

(b) The Commission may, either on its own initiative or upon the petition of any interested person, amend the regulation at § 1700.14(a) by exempting a substance or category of substances from special packaging requirements. The purpose of these rules is to provide procedures and requirements for submitting petitions for exemption from special packaging requirements.

(a) Requirements. To be considered a petition for exemption from special packaging requirements under this part a document filed under this part must:

(1) Be mailed to the Office of the Secretary, Consumer Product Safety Commission, Washington, D.C. 20207, or delivered to the Office of the Secretary, Consumer Product Safety Commission, 4330 East West Highway, Bethesda, MD 20814,

(2) Be written in the English language,

(3) Contain the name and address of the petitioner,

(4) Contain an explicit request for exemption from special packaging requirements,

(5) Identify the category of substances under § 1700.14(a) from which the exemption is sought, and

(6) Identify the particular substance for which the exemption is sought.

(b) Failure to meet requirements. Where a submission fails to meet all of the requirements of paragraph (a) of this section, the Office of the Secretary shall notify the person submitting it, describe the deficiency, and explain that the petition may be resubmitted when the deficiency is corrected.

(c) Procedural recommendations. The following are procedural recommendations to help the Commission in its consideration of petitions. The Commission requests, but does not require, that petitions filed under this part:

(1) Be typewritten,

(2) Include the word “petition” in a heading preceding the text,

(3) Include the telephone number of the petitioner, and

(4) Be accompanied by at least five (5) copies of the petition.

(a) A petition filed under this part shall include the information required by this part, or a satisfactory explanation for the absence of the information. As provided by § 1702.4, a petition which is not complete may be closed. To be considered complete, a petition shall include the following:

(1) A statement of the justification for the exemption in accordance with § 1702.7,

(2) All reasonably available human experience data, reasonably available relevant experimental data (both human and animal), product and packaging specifications, labeling, and marketing history, in accordance with §§ 1702.8 through 1702.14,

(b) As used in this regulation, “reasonably available” information is data in the petitioner's possession; data that has previously been generated by the petitioner, and data that is obtainable from such sources as: Reports from Poison Control Centers; reports of adverse reactions that have been submitted to the petitioner; the medical, pharmacological, and toxicological literature; and information required by the FDA for an Investigational Exemption for a New Drug (IND) or a New Drug Application (NDA).

If a petition is submitted that is not complete and does not explain the reason for the absence of the information, the Commission shall afford the petitioner a reasonable opportunity to provide additional information. If the required information is not submitted to the Commission, or if the petitioner does not satisfactorily explain the absence of the information within a reasonable time, the petition shall be closed if insufficient or incomplete information has been submitted to enable the Commission to evaluate the merits of the exemption request.

Failure to obtain and provide the Commission with all reasonably available information that the petitioner knows is unfavorable or could reasonably expect to be unfavorable to the petition shall result in the denial of the petition.

Where a petition contains material that the petitioner believes should be exempt from public disclosure under the Freedom of Information Act, 5 U.S.C. 552, the petitioner shall comply with the requirements of 16 CFR part 1015, the Commission's regulation under the Freedom of Information Act concerning requests for treatment as exempt material. The Commission shall act upon any request for treatment as exempt material in accordance with the provisions of 16 CFR part 1015.

The justification for the exemption, required under § 1702.3, shall explain the reason for the exemption based on one or more of the following grounds:

(a) If the justification is based on a lack of need for special packaging to protect young children from serious injury or illness from the substance, the justification shall state how the lack of toxicity and lack of adverse human experience for the substance clearly supports granting the exemption.

(b) If the exemption is requested because special packaging is not technologically feasible, practicable, or appropriate for the substance, the justification shall explain why.

(c) If the exemption is requested because special packaging is incompatible with the particular substance, the justification shall explain why.

Human experience data constitutes the primary criterion used by the Commission in evaluating petitions for exemptions. Petitions shall therefore include a compilation of all reasonably available reports pertaining to human use of the particular substance, including the product brand as well as generic equivalents and involving adverse reports of personal injury, illness, and significant allergenicity. Such information in children is of particular importance in evaluating exemption requests. However, similar data in adults shall also be submitted if available. Human experience data may be obtained from such sources as:

(a) Reports from Poison Control Centers,

(b) Reports of adverse reactions relative to the product that have been submitted to the company by physicians, hospitals, consumers, and other sources,

(c) Extensive searches of the medical, pharmacological, and toxicological literature, and

(d) For drugs, where the human experience data submitted is based on data required by FDA to be compiled for an Investigational Exemption for a New Drug (IND), 21 CFR part 312, or a New Drug Application (NDA), 21 CFR part 314, a summary of the relevant data should be provided. The entire NDA and IND material need not be submitted.

Experimental data are generated in both animals and humans in controlled situations in order to evaluate the biological effects of a substance. Certain toxicological effects cannot generally be evaluated in human beings. This is especially true of those substances which are not normally intended to be used in or on the human body or animal body. Therefore, the Commission considers experimental data obtained in animal studies to be an important supplement to such data as may exist from any experimental studies conducted in humans. The minimum toxicological evaluation necessary for a particular household substance is proportional to the expected exposure of man to that substance. Household substances which are not expected, in normal use, to contact man are subject to less extensive studies than those substances, such as drugs, which are designed to be used in or on man. The Commission has, therefore, separated the requirements of this section into three subsections. Section 1702.9(a) lists minimum acute animal toxicity data which shall be submitted, if reasonably available, for all petitions; § 1702.9(b) lists those additional data which shall be submitted, if reasonably available, for drug products and all other household substances which are normally intended to be used in or on the human body; and § 1702.9(c) lists those additional data which shall be submitted, if reasonably available, by petitioners requesting exemption for substances not intended for use in or on the human or animal body. The Commission emphasizes that, while not absolutely necessary, the types of data outlined in § 1702.9(c) may greatly expedite the Commission's evaluation of a particular exemption request.

(a) General criteria applicable to all petitions. (1) Each petition for an exemption under this part shall include all reasonably available relevant experimental data relating to the petition regardless of whether such data are unfavorable to the petitioner's request. As used in this part, the term “relevant experimental data” includes, but is not limited to, all data, including animal and human studies revealing the nature and degree of the hazard associated with the particular substance. Generally, the hazard associated with the particular substance involves the risk of injury arising from the acute accidental ingestion of a product. Where a hazard different from the risk of injury arising from accidental ingestion is known to exist (e.g., potential for significant allergenicity, dermal or opthalmic injury from handling or using the product), the petitioner shall also submit all reasonably available relevant experimental data evaluating the nature and degree of any additional hazard(s).

(2) All animal studies submitted in support of exemption requests should be performed in conformity with good pharmacological and toxicological practice which includes, as a minimum, complete descriptions of protocols used in experimental animal studies, and signed laboratory reports which include the following basic information:

(i) An exact description of materials tested;

(ii) A description of test animals employed in studies, including number, age, weight, sex and nutritional state of animals;

(iii) Dosage level(s) and number of animals tested per dosage level;

(iv) Basis upon which dosage was administered (e.g., as salt or base);

(v) Route of administration and dosage volume; and

(vi) Appendices containing all raw data and any additional data generated subsequent to the completion of the original study (e.g., results of histopathological examinations, if performed).

(3) Each petition shall include all reasonably available reports of Median Lethal Dosage (LD50) studies and shall include all raw data obtained in such studies. These studies should normally be conducted in both adult and weanling animals of the same species. The oral route of administration should be followed for studies involving substances subject to regulations promulgated under the Poison Prevention Packaging Act of 1970. Where a percutaneous toxicity hazard exists, the petition shall include reasonably available studies using the percutaneous route of administration. Sufficient dosage levels as well as adequate numbers of test animals per dosage level should be used to give statistical reliability to determined LD50 values.

(4) In view of the fact that LD50 values in themselves do not necessarily reflect a true estimate of the overall toxic potential of a substance, LD50 determinations should, where an LD50 value may be calculated, include:

(i) The LD50 value with 95 percent confidence limits;

(ii) A slope determination for the dose response curve, including 95 percent confidence limits; and

(iii) A description of the statistical method employed in the analysis of such data (with proper citation) as well as the statistical analysis itself.

(5) The Commission shall disregard any data which do not fulfill the strict requirements of the statistical method used in their analyses. Modifications of accepted statistical methods which have been published in the literature are acceptable to the Commission provided that a copy of the published work is submitted.

(6) Acute toxicity studies submitted with petitions should have at least a seven day observation period of test animals. Good pharmacological practice provides that test animals are observed closely for several hours following test substance administration and less frequently on subsequent test days. Succumbing animals should be necropsied as soon as practicable following death, while surviving animals should be necropsied, and gross pathological alterations noted, at the end of the observation period. Documentation of non-lethal effects occurring during these observation periods should be submitted in conjunction with acute toxicity laboratory reports. Documentation of any lethal effects occurring at high dosage levels, including mode of death (e.g., cardiac arrest/respiratory arrest), and time of death should be submitted in conjunction with acute toxicity laboratory reports. Reports of gross necropsies performed upon surviving animals should be submitted, as well as results of necropsies performed upon animals succumbing to the test substance, provided that such animals are examined prior to the onset of autolysis. Results of microscopic examinations, when indicated by the nature or results of an acute toxicity study, shall also be submitted.

(b) Additional data criteria for petitions involving substances normally used in or on the human or animal body. (1) Petitioners submitting exemption requests for substances normally used on or taken into the human body or animal body shall, in addition to the requirements of paragraph (a) of this section submit the following data, where reasonably available:

(i) Summary laboratory reports of data obtained in subacute and chronic animal studies where the data pertain to the absorption, distribution, metabolism and excretion of substances in question;

(ii) A median lethal dosage (LD50) determination conducted in one additional species. Of the two LD50 determinations required for persons submitting exemption requests under this part, one should be conducted in a nonrodent species;

(iii) Summary reports of data obtained in human studies designed to measure the absorption, distribution, metabolism, and excretion of substances in question; and

(iv) Data indicating, insofar as is known, the mechanism of action of the substance in question and the mechanism by which expected toxicological effects occur. If these mechanisms are unknown, the petition should state this.

(2) Petitioners submitting exemption requests for substances normally used on or taken into the human or animal body shall, in addition to the requirements of paragraphs (a) and (b)(1) of this section, submit an evaluation of the pharmacology and toxicology of the substance in question based on reasonably available medical and scientific literature. The evaluation should be a comprehensive one, and should include proper literature citations. To the extent possible, information submitted by the petitioner justifying an exemption based on the medical and scientific literature will be evaluated under the criteria specified in § 1702.9(a) for evaluating experimental data. In certain cases where the experimental data specified by § 1702.9 (a) and (b) are unavailable, the medical and scientific literature may justify granting an exemption, particularly where the pharmacology and toxicology of the substance is well documented in the literature.

(c) Optional data criteria for petitions involving substances not used in or on the human or animal body. The following types of data, although often not generated for household substances not normally used in or on the human or animal body, may be available to a petitioner and should, where reasonably available, be submitted.

(1) Summary laboratory reports of data obtained in subacute and chronic animal studies where such data pertain to the absorption, distribution, metabolism, and excretion of the substance in question;

(2) Results of median lethal dosage (LD50) studies conducted in additional species of animals; and

(3) Any additional experimental studies relevant to the exemption request which would provide the Commission with additional means of assessing the hazards to children of the product for which exemption is sought.

Any human experimental data submitted with a petition requesting an exemption under this part shall include a statement establishing that adequate measures have been taken to ensure against psychological or physical injury to the subject of the human studies. The Commission considers its regulations concerning the protection of human subjects (16 CFR part 1028) to be an example of measures that are adequate to ensure against psychological or physical injury to human subjects.

Each petition for an exemption shall include:

(a) A complete quantitative formula for the product, including inert ingredients, diluents, and solvents. (Petitioners should refer to § 1702.6 for information regarding trade secrets.)

(b) A listing of all physical forms or dosage forms (whichever is appropriate) in which the product is available.

Each petition for an exemption shall include the following information for each form of the product for which an exemption is sought:

(a) A description of the packaging currently in use including the name of the manufacturer of the package and all specifications for the package,

(b) A complete packaging description including any carton or wrapping in which the product is offered to the consumer,

(c) A description of each size in which the product is offered, including physical form, color and flavoring, and

(d) An empty sample of each type and size of package petitioned for exemption and, in the case of drugs, a designation of those packages intended to be used in dispensing the product to the consumer for household use.

Each petition for an exemption under this part shall include a sample of the label and complete packaging for each size in which each form of the product for which an exemption is sought is packaged. This shall include the immediate container labeling, any package inserts, and other carton or wrapping labeling in which the product is offered to the consumer. In the case of drugs, each petition shall be accompanied by labeling on the outer carton or wrapping in which the product is offered to the retailer, as well as samples of the promotional and advertising information for the product.

Each petition for an exemption under this part shall include a statement of the marketing history of the substance for which an exemption is requested. The marketing history dates from the year in which each form of the product was introduced onto the market. The marketing history shall include the total number of units of each form or strength and package size of the product distributed since the product was introduced onto the market. In the case of prescription drugs, the average prescription size for the product should also be indicated, if known.

(a) Where the petition for an exemption is based upon an allegation that the applicable special packaging standard is incompatible with the particular substance or would seriously and adversely compromise the utility or stability of a substance, the petitioner shall submit adequate evidence to support the allegation.

(b) If the allegation of incompatibility is based upon the fact that package choice is limited by a new drug application filed with the FDA, the petition shall state the limitation of package choice and a description of a time schedule to revise the NDA in order to allow additional package choice.

(c) If the allegation of incompatibility is based upon the fact that the shelf life of the product limits package choice, the petition shall outline the particular limitation and shall include a description of a time schedule to re-establish shelf-life data.

(a) Where the petition requests an exemption for a drug, as defined in section 201(g)(1) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 321(g)(1), the petitioner shall include those reports required to be filed under the Food and Drug Administration's Adverse Reaction Reporting Program.

(b) Where the petition requests an exemption for a new drug, as defined in section 201(p) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 321(p)) the Commission shall deny the petition if the Food and Drug Administration has not, where required by FDA, approved a new drug application.

Where the Commission determines that reasonable grounds for an exemption are presented by the petition, the Commission shall publish, in the Federal Register, a proposed amendment to the listing of substances requiring special packaging under § 1700.14(a). “Reasonable grounds” for publishing a proposed exemption are information and data sufficient to support the conclusion that:

(a) The degree or nature of the hazard to children in the availability of the substance, by reason of its packaging, is such that special packaging is not required to protect children from serious personal injury or serious illness resulting from handling, using, or ingesting the substance, or

(b) Special packaging is not technically feasible, practicable, or appropriate for the subject substance, or

(c) Special packaging is incompatible with the particular substance.

Where the Commission determines that reasonable grounds for an exemption are not presented by the petition, the petition shall be denied, and the petitioner notified in writing of the denial, including a brief statement of the reasons therefor.

The filing of a petition for exemption under this part 1702 shall not have the effect of staying the regulation from which the exemption is sought. Therefore, substances subject to special packaging standards shall be considered in violation of the law unless packaged in special packaging during the Commission's consideration of a petition.