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The U.S. Consumer Product Safety Commission



 CPSC AND THE POISON
     PREVENTION
   PACKAGING ACT
          John W. Boja, Ph.D.

These comments are those of the CPSC staff, have not been
reviewed or approved by, and may not necessarily reflect the
                views of, the Commission.
Poison Prevention
   Packaging Act
To protect children from
serious personal injury or
serious illness resulting from
handling, using or ingesting
hazardous household
substances.
Household Substances
 Customarily produced or
 distributed for sale for
 consumption or use, or
 customarily stored, by
 individuals in or about the
 household and which are-
Household Substances
                      (cont.)
A.   A hazardous substance as defined by the
     Federal Hazardous Substances Act (FHSA);
B.   Foods, Drugs, or Cosmetics as defined by
     the Federal Food, Drug, and Cosmetics Act
     (FD&CA); or
C.   Substances intended for use as a fuel when
     stored in a portable container and used in
     the heating, cooking, or refrigeration
     system of a house.
15 U.S.C. § 1471(2)
What Is a Package?
“The term “package” means the
immediate container or wrapping
in which any household substance
is contained for consumption, use,
or storage in or about the
household…”
15 U.S.C. § 1471(3)
PPPA Findings
“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…”
15 U.S.C.   1472(a)(1)
PPPA Findings
“the special packaging to be required
by such standard is technically
feasible, practicable, and appropriate
for such substance.”
15 U.S.C.   1472(a)(2)
Special Packaging
“Packaging that is designed or
constructed to be significantly
difficult for children under five 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..”
15 U.S.C.   1471(4)
Special Packaging
“Nothing in this Act shall authorize the
Commission to prescribe specific
packaging designs, product content,
package quantity, or, with the exception
of authority granted in section 4(a)(2) of
this Act [15 U.S.C. § 1473(a)(2)], labeling.”
15 U.S.C.   1472(d)
Drugs currently included in
            16 CFR § 1700.14
•   acetaminophen       • ketoprofen
•   aspirin             • lidocaine
•   controlled drugs    • loperamide
•   dibucaine           • methyl salicylate
•   diphenhydramine     • minoxidil
•   ibuprofen           • mouthwash
•   iron-containing     • naproxen
    drugs and dietary   • oral prescription
    supplements           drugs
                        • OTC switch drugs
Substances currently included in
            16 CFR § 1700.14
• ethylene glycol    • mouthwash containing
• fluoride             ethanol
• furniture polish   • permanent wave
• glue removers        neutralizer containing
  containing           sodium or potassium
  acetonitrile         bromate
• hydrocarbons       • sodium and potassium
• kindling and/or      hydroxide
  illuminating       • solvents for paint or other
  preparations         coating material
• methacrylic acid   • sulfuric acid
• methyl alcohol     • turpentine
Exceptions
• Not Used In/Around the
  Household
   Institutional   Use
    — Hospitals, Nursing Homes


   Professional    Use
Exceptions (cont.)
• Prescription
   BulkDrugs Repackaged by the
    Pharmacist
   Requested by Patient or Physician
    — Section 4 allows limited use of non-
      complying packaging 15 U.S.C. § 1473
   Exempted   (16 CFR § 1702)
    — 16 CFR §1700.14(a)(10)(i)-(xxi)
Exceptions (cont.)
• OTCs - Household Products
  One   size
  Labeled   (16 CFR §1700.5)
   — “This Package For Households Without
       Young Children”
   — “Package Not Child-Resistant”
  Other   popular sizes are CR
  Imposed      exclusive CR
   — Drain cleaners (16 CFR 1500.17(a)(4))
Packaging Test Methods
 • Child Test - 16 CFR § 1700.20(a)(2)
   – Panels of 50 children (42-51 months)
   – Tester restriction - 30% children
   – Site restriction - 20% children
   – 5 minutes - demo - Teeth - 5 minutes
   – Sequential Pass/Fail Table
     • 16 CFR § 1700.20(a)(2)(iii)
     • 80% after 200 children
SEQUENTIAL TEST
 Test   # Children     Package Openings
Panel      Tested       (Full 10 minutes)
                     Pass   Continue   Fail

 1         50          0-5 6-14        15+
 2        100         6-15 16-24       25+
 3        150        16-25 36-34       35+
 4        200        26-40  ---        41+
Unit Packaging Failure
“… 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 …”
16 C.F.R. §1700.20(a)(2)(ii)
Packaging Test Methods
Senior Test -16 CFR § 1700.20(a)(3)
  •   100 adults (50-70 years old)
  •   Site restriction (24%)
  •   Tester restriction (35%)
  •   5 minute/1 minute test period
  •   Screening
  •   90% effectiveness
Packaging Test Methods

Metal cans/metal closures and
 aerosols
    • Use 100 Adults aged 18-45 years
    • One 5 minute time period
    • 90% effectiveness
Physician’s Samples
• Oral prescription drugs
  require special packaging.
  16 CFR 1700.14(a)(10)
• Section 4(b) of the PPPA
  grants physicians the
  authority to order non-CR
  packaging for their patients in
  the written prescription.
Physician’s Samples
               (continued)
• The Commission’s policy is to not
  require manufacturers of regulated
  prescription drug samples to provide
  the samples in special packaging.
  – 49 Fed. Reg. 8008 (March 5, 1984)
• The decision to provide special
  packaging is up to the physician on a
  case by case basis.
Physician’s Samples
              (continued)
• Section 4(b) does not apply to
  regulated over-the-counter (OTC)
  drugs because they are not
  dispensed by the order of a licensed
  practitioner.
• Samples of regulated OTC drugs
  must be packaged in special
  packaging.
Consumer Product
     Safety Improvement
         Act (CPSIA)
Under Section 102 a general certification requirement
has been extended to products subject to any similar
rule, standard, ban, or regulation under any Act
enforced by the Commission. General conformity
certifications do not need to be based on testing done
by a third-party laboratory. Certification must be based
on a test of the product or a "reasonable testing
program.”
Does Required Special
Packaging Need Certification?
                       YES!
• The PPPA requires special packaging for certain
  substances.
• Special packaging must meet the performance
  specifications of 16 C.F.R. § 1700.15.
• The importer or the domestic party that packages any
  substance that requires special packaging must certify
  that the special packaging meets the performance
  specifications of 16 C.F.R. § 1700.15.
GENERAL CONFORMITY
   CERTIFICATION
 1. Identification of the product

 2. Citation to each CPSC product safety
    regulation applicable

 3. Identification of the U.S. importer or
    domestic manufacturer

 4. Contact information for the individual
    maintaining records of test results
GENERAL CONFORMITY
 CERTIFICATION (cont.)
5. Date and place where the product was
   manufactured
6. Date and place where the product was tested
   for compliance with the regulation(s) cited
   above
7. Identification of any laboratory on whose
   testing the certificate depends

For complete instructions and more information see:
    http://www.cpsc.gov/about/cpsia/faq/elecertfaq.pdf
Additional Information
• The PPPA Web Page -
  http://www.cpsc.gov/businfo/
  pppainfo.html
  – Poison Prevention Packaging Act Regulations

  – PPPA Guidance Documents

  – Further Information on the PPPA

  – General Information on Poison Prevention
Additional Information on
       the CPSIA

http://www.cpsc.gov/about/cpsia/
 faq/faq.html#sect102

Section 102 Certification and the
 Poison Prevention Packaging
 Act
If you have questions
     about PPPA:
• John Boja 301-504-7300
  – e-mail jboja@cpsc.gov

• Carol Afflerbach 301-504-7529
  – email cafflerbach@cpsc.gov

• Mary Toro 301-504-7586
  – e-mail mtoro@cpsc.gov
Questions?

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CPSC and The Poison Prevention Packaging Act

  • 1. The U.S. Consumer Product Safety Commission CPSC AND THE POISON PREVENTION PACKAGING ACT John W. Boja, Ph.D. These comments are those of the CPSC staff, have not been reviewed or approved by, and may not necessarily reflect the views of, the Commission.
  • 2. Poison Prevention Packaging Act To protect children from serious personal injury or serious illness resulting from handling, using or ingesting hazardous household substances.
  • 3. Household Substances Customarily produced or distributed for sale for consumption or use, or customarily stored, by individuals in or about the household and which are-
  • 4. Household Substances (cont.) A. A hazardous substance as defined by the Federal Hazardous Substances Act (FHSA); B. Foods, Drugs, or Cosmetics as defined by the Federal Food, Drug, and Cosmetics Act (FD&CA); or C. Substances intended for use as a fuel when stored in a portable container and used in the heating, cooking, or refrigeration system of a house. 15 U.S.C. § 1471(2)
  • 5. What Is a Package? “The term “package” means the immediate container or wrapping in which any household substance is contained for consumption, use, or storage in or about the household…” 15 U.S.C. § 1471(3)
  • 6. PPPA Findings “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…” 15 U.S.C. 1472(a)(1)
  • 7. PPPA Findings “the special packaging to be required by such standard is technically feasible, practicable, and appropriate for such substance.” 15 U.S.C. 1472(a)(2)
  • 8. Special Packaging “Packaging that is designed or constructed to be significantly difficult for children under five 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..” 15 U.S.C. 1471(4)
  • 9. Special Packaging “Nothing in this Act shall authorize the Commission to prescribe specific packaging designs, product content, package quantity, or, with the exception of authority granted in section 4(a)(2) of this Act [15 U.S.C. § 1473(a)(2)], labeling.” 15 U.S.C. 1472(d)
  • 10. Drugs currently included in 16 CFR § 1700.14 • acetaminophen • ketoprofen • aspirin • lidocaine • controlled drugs • loperamide • dibucaine • methyl salicylate • diphenhydramine • minoxidil • ibuprofen • mouthwash • iron-containing • naproxen drugs and dietary • oral prescription supplements drugs • OTC switch drugs
  • 11. Substances currently included in 16 CFR § 1700.14 • ethylene glycol • mouthwash containing • fluoride ethanol • furniture polish • permanent wave • glue removers neutralizer containing containing sodium or potassium acetonitrile bromate • hydrocarbons • sodium and potassium • kindling and/or hydroxide illuminating • solvents for paint or other preparations coating material • methacrylic acid • sulfuric acid • methyl alcohol • turpentine
  • 12. Exceptions • Not Used In/Around the Household  Institutional Use — Hospitals, Nursing Homes  Professional Use
  • 13. Exceptions (cont.) • Prescription  BulkDrugs Repackaged by the Pharmacist  Requested by Patient or Physician — Section 4 allows limited use of non- complying packaging 15 U.S.C. § 1473  Exempted (16 CFR § 1702) — 16 CFR §1700.14(a)(10)(i)-(xxi)
  • 14. Exceptions (cont.) • OTCs - Household Products  One size  Labeled (16 CFR §1700.5) — “This Package For Households Without Young Children” — “Package Not Child-Resistant”  Other popular sizes are CR  Imposed exclusive CR — Drain cleaners (16 CFR 1500.17(a)(4))
  • 15. Packaging Test Methods • Child Test - 16 CFR § 1700.20(a)(2) – Panels of 50 children (42-51 months) – Tester restriction - 30% children – Site restriction - 20% children – 5 minutes - demo - Teeth - 5 minutes – Sequential Pass/Fail Table • 16 CFR § 1700.20(a)(2)(iii) • 80% after 200 children
  • 16. SEQUENTIAL TEST Test # Children Package Openings Panel Tested (Full 10 minutes) Pass Continue Fail 1 50 0-5 6-14 15+ 2 100 6-15 16-24 25+ 3 150 16-25 36-34 35+ 4 200 26-40 --- 41+
  • 17. Unit Packaging Failure “… 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 …” 16 C.F.R. §1700.20(a)(2)(ii)
  • 18. Packaging Test Methods Senior Test -16 CFR § 1700.20(a)(3) • 100 adults (50-70 years old) • Site restriction (24%) • Tester restriction (35%) • 5 minute/1 minute test period • Screening • 90% effectiveness
  • 19. Packaging Test Methods Metal cans/metal closures and aerosols • Use 100 Adults aged 18-45 years • One 5 minute time period • 90% effectiveness
  • 20. Physician’s Samples • Oral prescription drugs require special packaging. 16 CFR 1700.14(a)(10) • Section 4(b) of the PPPA grants physicians the authority to order non-CR packaging for their patients in the written prescription.
  • 21. Physician’s Samples (continued) • The Commission’s policy is to not require manufacturers of regulated prescription drug samples to provide the samples in special packaging. – 49 Fed. Reg. 8008 (March 5, 1984) • The decision to provide special packaging is up to the physician on a case by case basis.
  • 22. Physician’s Samples (continued) • Section 4(b) does not apply to regulated over-the-counter (OTC) drugs because they are not dispensed by the order of a licensed practitioner. • Samples of regulated OTC drugs must be packaged in special packaging.
  • 23. Consumer Product Safety Improvement Act (CPSIA) Under Section 102 a general certification requirement has been extended to products subject to any similar rule, standard, ban, or regulation under any Act enforced by the Commission. General conformity certifications do not need to be based on testing done by a third-party laboratory. Certification must be based on a test of the product or a "reasonable testing program.”
  • 24. Does Required Special Packaging Need Certification? YES! • The PPPA requires special packaging for certain substances. • Special packaging must meet the performance specifications of 16 C.F.R. § 1700.15. • The importer or the domestic party that packages any substance that requires special packaging must certify that the special packaging meets the performance specifications of 16 C.F.R. § 1700.15.
  • 25. GENERAL CONFORMITY CERTIFICATION 1. Identification of the product 2. Citation to each CPSC product safety regulation applicable 3. Identification of the U.S. importer or domestic manufacturer 4. Contact information for the individual maintaining records of test results
  • 26. GENERAL CONFORMITY CERTIFICATION (cont.) 5. Date and place where the product was manufactured 6. Date and place where the product was tested for compliance with the regulation(s) cited above 7. Identification of any laboratory on whose testing the certificate depends For complete instructions and more information see: http://www.cpsc.gov/about/cpsia/faq/elecertfaq.pdf
  • 27. Additional Information • The PPPA Web Page - http://www.cpsc.gov/businfo/ pppainfo.html – Poison Prevention Packaging Act Regulations – PPPA Guidance Documents – Further Information on the PPPA – General Information on Poison Prevention
  • 28. Additional Information on the CPSIA http://www.cpsc.gov/about/cpsia/ faq/faq.html#sect102 Section 102 Certification and the Poison Prevention Packaging Act
  • 29. If you have questions about PPPA: • John Boja 301-504-7300 – e-mail jboja@cpsc.gov • Carol Afflerbach 301-504-7529 – email cafflerbach@cpsc.gov • Mary Toro 301-504-7586 – e-mail mtoro@cpsc.gov