CFR Title 16 Commercial Practices
Volume 1   Chapter I     FTC        Parts     0-999      
Volume 2   Chapter II   CPSC      Parts  1000–1799

CFR Title 15 Commerce and Foreign Trade

CFR  Title 19 Customs Duties

19 CFR 102.23  Origin and

Manufacturer Identification

​​      “There comes a point where we need to stop just pulling people out of the river.  We need to go upstream and find out why they're falling in."   -Desmond Tutu 
                    ​“Shallow understanding from people of good will is more frustrating than absolute misunderstanding from people of ill will."  -MLK,  Jr.

                                                                              "Believe none of what you hear, and only half of what you see"             -Benjamin Franklin
                                                                                                   "Diligence is the mother of good luck"          

​                                                                                               "Ask 'Why'  five times about every matter."     -Taiichi  Ohno

Regulatory Affairs
Federal, State Regulations and Government Agencies



     Cost of Quality (COQ)

1) Prevention Cost:  $

  • Quality Training  and Workforce Development.
  • Quality Planning (QAP).   
  • Product-Design Verification.
  • Onboarding Standards and Procedures.
  • Systems Development and Management.
  • Timely Industry Intelligence.
  • Enforced CPSC Regulations.
  • Vendor Relationship Building       to Establish Trust.
  • CPSIA 16 CFR 1107.

2) Appraisal Cost:   $$

3) Internal Failure Cost:  $$$ 

  • Scrap
  • Rework and Air-Freight.
  • Wasted resources. 
  • Failure analysis.
  • Quarantine Defects.
  • Regulatory Ambiguity.
  • Rational Ignorance.

4) External Failure Cost: $$$$$$$$$  

                                    

Links to US Regulations:
US Federal Trade Commission (FTC)
Product Marketing Claims. Textile Products ID Act (15 U.S.C. 70).
US Consumer Product Safety Commission (CPSC)    (CPSC videos)
Product Safety, CPSIA, New Toy Testing Standard: ASTM F963-16 Effective April 30, 2017.
US Customs and Border Protection (CBP)
Regulatory Enforcement, Intellectual Property Rights, Supply Chain Security (C-TPAT).
US Foreign Corrupt Practices Act (FCPA)
Addresses transparency and anti-bribery provision.
US Environmental Protection Agency (EPA)
Noise Reduction Rating for earplugs.
US Federal Communications Commission (FCC)
Digital Devices.
US Food and Drug Administration (FDA)
Medical Devices, Radiation-Emitting Products, Cosmetics, Food Contact Materials, Sunglasses.
US Occupational Safety & Health Administration (OSHA)
Personal Protective Equipment. Memorandum of Understanding between OSHA and CPSC 1974.
US Nuclear Regulatory Commission (NRC)
Radioactive Waste (Monitor supply chain with MSDS to prevent NRC investigations).

US Department of Agriculture (USDA)   Lacey Act  illegal trafficking wildlife, fish, plants, woods.  

California Prop 65   Sourcing compliant materials.

California SB657   Transparency in Supply Chain Act.
California Composite Wood Product ATCM

United States Congressional Oversight Hearing CPSC Agency: 1987-2007-2010-2012-2015-2019-2021

Past GAO reports on CPSC

-FOIA.gov

-REGinfo.gov

-IPR Center.gov

-regulations.govs

​-oversight.gov

-gao.gov

-DOC OIG

-CPSC OIG

-DOL OIG


U.S.-China Product Safety Summit  Sept 11, 2007

Place holder for CPSC widget to list all new consumer product recalls.


Currently CPSC widget connection is nonfunctional.

Hearing on efforts to protect children and consumers from Hazardous Products & Consumer Safety

House Energy & Commerce Subcommittee June 13, 2019

Consumer Protection & Commerce Chair: IL (D) Rep. Jan Schakowsky

House E&C Subcommittee on Digital Commerce and Consumer Protection.



​Senate  Commerce Subcommittee on Manufacturing, Trade, and Consumer Protection.



U.S. Federal Inspectors General

https://www.foia.gov/data.html

https://www.c-span.org/

https://www.c-span.org/networks/

https://www.c-span.org/schedule/

US CBP  Reasonable Care Checklist on Compliance

15 USC 2068   Prohibited Acts

15 USC 2052 (2)  Children's product defintion.

15 USC 2063   Product certification & labeling.

19 USC 1595 (a)  Forfeiture and other penalties. 

19 USC 1592 Penalties for fraud, gross negligence, and negligence.

Manufacturer and Importer Duty to Report to CPSC: Rights and Responsibilities of Businesses.

http://www.gao.gov/products/HRD-78-48

http://www.gao.gov/products/HRD-78-122

http://www.gao.gov/products/HRD-78-171

http://www.gao.gov/products/HRD-79-98

http://www.gao.gov/products/HRD-87-47

http://www.gao.gov/products/GAO-09-803

http://www.gao.gov/products/GAO-09-512R

http://www.gao.gov/products/GAO-12-30

http://www.gao.gov/products/GAO-12-250R

http://www.gao.gov/products/GAO-13-150

http://www.gao.gov/products/GAO-15-17

Place holder for CPSC widget to list all new children's product recalls.


Currently CPSC widget connection is nonfunctional.

Rigorous toy supply chain oversight to enforce 16 CFR 1107 with a robust CPSIA compliance program can help protect all stakeholders.

Hidden hazards: Kids at risk

http://www.chicagotribune.com/news/watchdog/chi-safety-storygallery-storygallery.html

...The Lead Paint Recall
digitalstrategies.tuck.dartmouth.edu/wp-content/uploads/2016/10/MattelRecall6-...
Supplier "Quality Fade" & "Outwitting Third-Party Testers" with Imports

https://www.forbes.com/2007/07/26/china-manufacturing-quality-ent-manage-cx_kw_0726whartonchina.html

QA/QC Protocols

Product Specifications

Compliance Programs

http://www.gao.gov/multimedia/podcasts/666875

June 20, 2019 Senate Hearing with CPSC link to Video.

JUNE 7, 2021   House Hearing on Infant Product Safety.

Retailers: Product Safety and Your Responsibilities

Thomas Doyle  MSc.


                                          Global Regulations and Safety Standards
                                                                                 European Union Regulations


CPSIA  (H.R. 4040) Effective 2/8/13

16 CFR 1107  Testing and Labeling Pertaining to Product Certification

16 CFR 1109  Conditions and Requirements for Relying on Component Part Testing or Certification, or Another Party's Finished Product Testing or Certification, to Meet Testing and Certification Requirements.

16 CFR 1110  Certificates of Compliance.