Consumer Product Safety Commission (CPSC) Enforcement Practices

Similar documents
The FDA Food Safety Modernization Act of 2009 Section-by-Section Summary

Automated Commercial Environment (ACE) Program Status. Jon Veley, Steve Hilsen ACE Business Office June 2015

FSMA User Guide. Food Safety Modernization Act Guide

Complaints Investigation and Review. Dr. Ademola Daramola International Relations Specialist Drugs US FDA India Office New Delhi February 22nd 2018

May 12, 2016 MEMORANDUM. Certain provisions of FSMA are already in effect, namely: Mandatory recall authority (FSMA 206).

Center for Drug Evaluation and Research - Compliance Central with FDA Center Compliance Directors: Part 1

SENATE APPROPRIATIONS COMMITTEE FY16 HOMELAND SECURITY APPROPRIATIONS U.S. COAST GUARD As of June 22, 2015

(This document reflects all provisions in effect on October 1, 2017)

Food Safety Capacity Building: The role of public private partnerships

NEWS: Senate Committee Approves FY2019 Transportation, HUD Appropriations Bill 1 message

Post Market Surveillance Requirements. SAMED Regulatory Conference 2 December 2015

CHAPTER 111. (Senate Bill 103) Maryland Clean Cars Act of 2007

A Practical Dialogue on Concessions, Concessionaires, and Airport Security. November 1, 2006

WILKES-BARRE RIFLE & PISTOL CLUB APPLICATION FOR MEMBERSHIP INSTRUCTIONS

Summary of AV START Act (S.1885)

Food Safety: Agencies Need to Address Gaps in Enforcement and Collaboration to Enhance Safety of Imported Food

Guam Customs and Quarantine Agency

A Very Big Branch. We ve Got a Job to Do. Help From Many. Carrying Out Laws: Enforcement. Name: The Executive Branch

December 21, 2004 NATIONAL SECURITY PRESIDENTIAL DIRECTIVE NSPD-41 HOMELAND SECURITY PRESIDENTIAL DIRECTIVE HSPD-13

Agency Information Collection Activities; Submission for Office of Management and Budget

Case: 1:10-cv Document #: 74-1 Filed: 04/15/11 Page 1 of 7 PageID #:2403 EXHIBIT A

The Executive Branch

Guidelines for the Virginia Investment Partnership Grant Program

Sample Policy and Procedure on Prohibition on Distributing Medical Marijuana

SENATE APPROPRIATIONS COMMITTEE FISCAL NOTE

Authorized Personnel to Review

FDA. Office of Criminal Investigations

Intellectual Property Rights Seizure Statistics Fiscal Year 2016

CONTENTS. Follow us on

Questionnaire for State Department of Health and Family Welfare

FISHERIES SERVICES JAPAN

Northern California Area Maritime Security Committee

2017 API INTERNATIONAL TRADE AND CUSTOMS CONFERENCE

The Security War. AAPA Security Meeting Jul 18, Jay Grant, Director Port Security Council

Chesapeake Area Professional Captains Association

STATEMENT. JEFFREY SHUREN, M.D., J.D. Director, Center for Devices and Radiological Health Food and Drug Administration

Request for Proposals. Airport Management Services

APEC Subcommittee on Standards and Conformance

vessel prepares for and actively off-loads two new Post-Panamax gantry cranes to the

AMERICAN MEDICAL ASSOCIATION HOUSE OF DELEGATES. Firearm-Related Injury and Death: Adopt a Call to Action

Candidates willing to be considered for more than one section should fill in separate Application Forms.

GENERAL ASSEMBLY OF NORTH CAROLINA SESSION 2013 SESSION LAW HOUSE BILL 484

Determining and Reporting Adverse Events vs. Product Complaints

49 USC NB: This unofficial compilation of the U.S. Code is current as of Jan. 4, 2012 (see

AAPM Responds to Follow up Questions from Congress after Hearing on Radiation in Medicine

NEW BRIGHTON CARE CENTER

9/11/2015. Navigation in the Meeting Room. Counter-Proliferation Investigations & National Security

UAV s And Homeland Defense Now More Critical Than Ever. LCDR Troy Beshears UAV Platform Manager United States Coast Guard

Complaint Handling and Medical Device Reporting (MDRs)

Issuing Letters of Compliance (December 2016)

SJN DO CB Field Alert Reports. Edwin Ramos Director of Compliance Food and Drug Administration San Juan District Office

Forty-first Annual Conference of the Center for Oceans Law & Policy. Yogyakarta, Indonesia May 16-19, 2017

Our Terms of Use and other areas of our Sites provide guidelines ("Guidelines") and rules and regulations ("Rules") in connection with OUEBB.

12.01 Safety Management Plan UWHC Administrative Policies

FSMA Update. Samantha Shinbaum. October 3, 2017

FY16 Senate Armed Services National Defense Authorization Act (NDAA)

FDA Reportable Food Registry. David E. Gombas, Ph.D. United Fresh Produce Association September 21, 2009

Draft Version Presentation Draft

SECTION 1. SHORT TITLE; FINDINGS; REFERENCE.

MODEL OPERATING PROCEDURES GUIDE FOR COMBINED MARITIME COUNTER DRUG OPERATIONS

Food Safety Modernization Act (FSMA)

Amusement Device Mechanic Inflatable. In-School Curriculum Standard. June 2013

The Classification and Labelling Inventory. Cefic s viewpoint

Preventing the Disaster of Mass Evacuations

Food Safety Modernization Act

Guidelines for the Major Eligible Employer Grant Program

Guidance for Industry

Scott Vaughan, Commissioner of the Environment and Sustainable Development Jim McKenzie, Principal Office of the Auditor General

LOCAL GOVERNMENT COMPREHENSIVE PLAN AMENDMENTS HENDRY COUNTY

FDA s Office of Regulatory Affairs: Violation Trends & Medical Device Update

INTRODUCTION TO HACCP

Introduction. Oil and Hazardous Materials Incident Annex. Coordinating Agencies: Cooperating Agencies:

Administrative Policies and Procedures. Policy No.: N/A Title: Medical Equipment Management Plan

ZAMBIA MEDICINES REGULATORY AUTHORITY EMPLOYMENT OPPORTUNITY

NOAA FISHERIES (NATIONAL MARINE FISHERIES SERVICE)

Special Report - Senate FY 2013 Department of Homeland Security Appropriations and California Implications - June 2012

School Nutrition Association:

ASSEMBLY, No STATE OF NEW JERSEY. 214th LEGISLATURE PRE-FILED FOR INTRODUCTION IN THE 2010 SESSION

Compounded Sterile Preparations Pharmacy Content Outline May 2018

u.s. Department o~. COMDTPUB P NVIC FEBRUARY 2005 NAVIGATION AND VESSEL INSPECTION CIRCULAR NO

HEALTH LEGISLATIONS Indian Association of Preventive and Social Medicine Gujarat Chapter

Florida Job Growth Grant Fund Public Infrastructure Grant Proposal

Maritime Risk Symposium Public & Private Partnerships. Bethann Rooney The Port Authority of NY & NJ November 7, 2011

16 Department of the Air Force Department of Veterans Affairs Department of Homeland Security

STOCKTON POLICE DEPARTMENT GENERAL ORDER DOWNED AIRPLANES SUBJECT

ASSEMBLY 36TH SESSION

Introduction of Saudi Arabia Medical Device Regulatory System Ali Al Dalaan Executive Director, SFDA AHWP TC Chair

16 Department of the Air Force Department of Veterans Affairs Department of Homeland Security

Injury and Work-Related Illness Prevention Program

if YES, indicate relevant information (i.e. signing, accession, ratification, entering into force, etc)

Kelly Bubolz Compliance Assistance Specialist Appleton OSHA Office January 15, 2013

Child Care Center Licensing Manual (August 2016)

Part 150 Advisory Circular Update

TABLE OF CONTENTS Roles & Responsibilities

Alteration of Bridges

Medical Device Recall Report FY FY 2012

Department of Defense DIRECTIVE

2017 MCAFDO Annual Conference

COMPLIANCE WITH THIS PUBLICATION IS MANDATORY THIS DOCUMENT IS AVAILABLE AT THE FOLLOWING URL:

Environment & Energy

Transcription:

2009/SOM2/SCSC/WKSP3/018 Consumer Product Safety Commission (CPSC) Enforcement Practices Submitted by: United States APEC Regulator Dialogue on Toy Safety Singapore 1-2 August 2009

CPSC Enforcement Practices Marc J. Schoem Deputy Director Office of Compliance and Field Operations U.S. Consumer Product Safety Commission 1 Agenda CPSC Overview Office of Compliance and Field Operations Overview Market Surveillance Import Surveillance Recalls 2

CPSC Overview CPSC is an independent agency created to protect the public from unreasonable risks of injury associated with consumer products Three Commissioners appointed by the president for multi-year terms with confirmation by the Senate 3 Inez Tenenbaum Chairman Commissioners Thomas Moore Commissioner Nancy A. Nord Commissioner The President appoints one Commissioner as the Chairman, who acts as Principal Executive Officer 4

Field Investigative Staff Locations 5 What is a Consumer Product? Jurisdiction over some 15,000 different consumer products under the Consumer Product Safety Act Excludes some products covered by other federal agencies, such as: Cars and related equipment (NHTSA) Food, drugs, medical devices, cosmetics (FDA) Firearms (BATF) Airplanes (FAA) Boats (Coast Guard) Pesticides (EPA) 6

Office of Compliance and Field Operations Overview Enforce mandatory standards and reporting requirements Investigate product hazards and make preliminary determinations, seeking corrective actions as necessary Coordinate enforcement efforts with U.S. Customs and Border Protection and State/local governments Develop guidance and help firms comply with the law 7 Office of Compliance and Field Operations Defect Investigations Division Regulatory Enforcement Division Import Surveillance Division Field Investigations Division By Hazard By Hazard By Port By City/State 8

Compliance Investigation Overview Field investigation conducted Compliance initiates contact with the firm Epidemiology conducts data search Engineering performs testing (both failure mode testing and performance testing) Preliminary Determination Made (not Fast Track cases) Recall negotiated Consumers notified 9 Identifying Defect/Hazard Pattern of Defect Identification of defect, flaw, error, design, engineering, quality control, labeling, use, assembly, etc Number of Defective Products Distributed into commerce Severity of Risk Severity of injury Likelihood injury will occur Vulnerable population affected 10

Violations / Prohibited Acts The Consumer Product Safety Act (CPSA) and the Federal Hazardous Substances Act (FHSA) make it unlawful to: Manufacture, distribute or import any product that does not comply with a mandatory standard ( CPSA & FHSA) Fail to report information as required by section 15(b) (CPSA); Fail to report choking incidents (CPSA); and Fail to report under Section 37 of the CPSA 11 Market Surveillance Retail surveillance Filed enforcement programs State and local government partners Recall effectiveness checks 12

Import Surveillance Import Surveillance Division Established in 2008 Investigators stationed at major ports and airports 13 Imported Consumer Products: There are hundreds of ships arriving daily at U.S. ports. Live view, ship traffic 3/31/08 8:42PM CST 14

And thousands more flights, many carrying imported consumer goods. 15 Airborne flights 3/27/08 @3:12PM CST ITDS/ACE In 2007, CPSC became a participating agency in the International Trade Data System Automated Commercial Environment (ACE) This tool gives qualified CPSC staff access to much better information for targeting unsafe consumer products ACE grows more sophisticated over time 16

ITDS/ACE Status CPSC on Fast Track for full participation, likely in 2010 Concept of Operations (ConOps) submitted at the end of FY 2008 CPSC is working through CBP s comments on the ConOps 17 Coordination with Customs Joint programs targeting unsafe consumer products by class Follow backwards and forwards on specific cases Joint audits of importers Importer Self Assessment (ISA) Product Safety pilot 18

What Exactly is a Recall? Recall is a generic term, and can involve requirement for firm to: repair product replace product refund purchase price of product 19 CPSC Recalls Regulated vs. Defect (Unregulated) Cases Updated through 7/14/2009 400 300 200 100 0 FY 00 FY 01 FY 02 FY 03 FY 04 FY 05 FY 06 FY07 FY 08 FY09 Regulated Unregulated 20

Contact Information Marc J. Schoem (301) 504-7520 - office (240) 638-6955 cell Emergency mschoem@cpsc.gov www.cpsc.gov Views expressed in this presentation are those of the staff and do not necessarily represent the views of the Commission 21