Michelle Tan - Psiiss.net

Japan’s Initiatives Towards Enhancing Consumer
Protection and Safety Incidents—
Compulsory Safety Incident Reporting for Industries
Michelle Tan
Professor of Law,
Tezukayama University,
Nara, Japan
APEC Product Safety Incidents Information
Sharing System Workshop
Kuala Lumpur, 23 rd -26 th April, 2012

What I will talk about……
1. Japan’s PS law/policy
2. Types of PS incident reporting
3. Mandatory reporting of product incidents
4. Incident/Injury Databank
**The info/ views expressed herein are based on my research. Responsibility for any errors is mine.

Overview of PS law/policy
• Overall framework: Consumer Fundamental
Act (1968), and Consumer Safety Act (2009)
• PS law is mixture of administrative law, private law,
and self-regulation
‣ traditionally, emphasis on admin. law and self-reg
• Administrative law
PS law for consumer products and food:
Consumer Products Safety Act, Food Sanitation Act
• Private law: PL Act (1994) based on EU Directive
• Self-reg: eg. SG mark, ST mark, JIS

Administrative framework for PS
• Since Sept 1, 2009 Consumer Affairs Agency(CAA)
‣ collects/analyzes/ makes public incident information
‣ can request related ministries to take action
‣ can take action where there is an administrative “gap”
• Co-operates with other gov’t ministries/agencies
regarding policy, product incident reporting,
collecting/ exchanging/ disseminating information

Source: http://www.caa.go.jp/en/pdf/110204framework.pdf

• 2 types
Types of incident reporting
1. Mandatory reporting of “consumer product incidents” by
mfgers/ importers (Consumer Products Safety Act, s.35(1)
‣ most consumer products covered
‣ food, medicines/ pharmaceuticals, cosmetics, road transport
vehicles not included
2. National/ local gov’t admin. agencies required to report info
to the PM(delegated to CAA) regarding actual and likely
“serious incidents” (Consumer Safety Act, s.12(1))
‣ information from the consumer centres via the National
Consumer Affairs Centre of Japan &other relevant admin
agencies
‣ applies to products AND services

Mandatory reporting by industry
• Required under the Consumer Products Safety Act
s. 35(1) (since May 14, 2007)
• Who? manufacturers/ importers
• What? “serious product incidents” relating to
consumer products (no duty if clearly not productrelated)
• Where ? to CAA
• When? within 10 days from date became aware of
the incident
• How ? online (via METI website), downloadable
report form(Word document) on the CAA website

What is a “serious product incident?”
1. Harm to a consumer’s life/person has occurred, i.e
‣ death
‣ injury/illness
requiring treatment for 30 days or more
‣ a prescribed aftereffect of an injury/illness
‣ carbon monoxide poisoning
2. Destruction/damage to product and potential harm to
consumers i.e
‣ A fire occurred (determined by Fire Dep’t)

No. of serious incident reports to date
Year No. of reports
2007 1190
2008 1412
2009 1172
2010 1141
2011 155 (until May, 2011)
1169 (approx. final tot.)
Source:
http://www.meti.go.jp/committee/materials2/downloadfiles/g100420c03j.pdf
http://www.meti.go.jp/committee/summary/0004589/2301_03_00.pdf

What info must be reported
• Date of incident
• Details of injury/damage
• Details of incident
• Name of product
• Model/type
• Amount mfg’d/imported/ sold & period
• Date became aware of incident and method
• Cause (where known)
• Measures taken (e.g. recall)

Disclosing details of product incidents
to the public (mandatory reporting)
• Name of m’fgr, model, incident details made public where:
‣ serious incident involves product that uses gas/oil(kerosene)
(unless the product is clearly not the cause)
‣ serious incidents involving other products, and the product is
the likely cause
• If the cause is not clear/clearly not the product a summary of
the incident, not including the name of m’fgr/model, is made
public
• Later on, the withheld details may be made public in certain
cases, such as where it is later determined after investigation
that the product was the cause
• Timeframe for public disclosure is approx. 5 days

How info is made public
• Initially, press release (available online)
• Info then made available via the Incident/Injury
Databank
• NITE (which investigates product incidents) also
maintains its own database

Voluntary reporting by industry
• M’fgrs etc. encouraged to report to the CAA (or
METI) even if not sure if it is a reportable
incident
• Also, encouraged to report other non-serious
incidents to the National Institute of Technology
and Evaluation (NITE)
• Retailers etc may also report incidents

Making a report on line (1)
• Mft’r/Importer’s name
• Type of business: □ Mft’r □ Importer
• Registered mft’r □ yes □ no
– If yes, name of relevant Act
• Mft’r/Importer’s place of business
• Mft’r/Importer’s tel. no.
• Relevant dep’t name
• Relevant dep’t tel. no.
• Contact person’s name
• Contact person’s e-mail
• Industry body name(if member)
• Industry body address(if member)
• Industry body tel. no (if member)

Making a report online (2)
• Product name (generic name e.g. “television”,
“ microwave”)
• Product name (brand name)
• Type/make
• Country of manuf.
• Date of incident
• Time of incident
• Was there a fire? “yes” or “no”
• Was there carbon monoxide involved? “yes” or “no”
• Was there damage to the product? “yes” or “no”

Making a report online (3)
• Injury to persons
Death □ person/s
Injury or illness (requiring treatment 30 days & over)
□ person/s
Where there are aftereffects enter no. of persons according
to type: sense of visual , smell, hearing; disability of limbs;
impairment of respiratory organs: urinary impairment;
impairment of voice, speech, chewing; circulatory
impairment; digestive impairment
Injury or illness (requiring treatment < 30 days)
(Below is same as for injuries above 30 days)
No physical injury

Making a report online (4)
• Description of incident
‣ Description of circumstances (600 characters or less)
• No of similar incidents occurring with same kind of
product
□ cases
• Cause of incident
□ Poor design □ Poor mf’ture □ Poor part/ ingredient
□ Fatigue due to age □ Insufficient labelling
□ Insufficient instructions □ Poor installation
□ Other (give details in 600 characters or less)

Making a report online (5)
• Measures taken to prevent reoccurrence:
□stop mfg □ improve prod □ recall □ improve labels,
□ cease importing □ improve mfg process
□ inspection of/alteration to product □ improve
instructions □ cease selling □ strengthen quality
control □ warnings etc to consumers
□ no action taken □ other
• Preventative measures for the future
(write freely, up to 400 characters)
• Name and contact details of organization etc.
investigating this incident
• Name and address of organization in possession of the
product involved

Incident/Injury Information Databank
• Jointly operated by CAA and the NCAC
• Covers products/services/food
‣ Includes serious and non-serious incident/injury and related info
• What kind of info goes into the database?
‣ mandatory reporting info (see previous slides)
‣ incident/ injury information from consumer centres throughout Japan
(via the NCAC database)
• reports from consumers about injuries/ possible injuries
‣ incident/injury information comes in from relevant gov’t
dep’ts/agencies/quasi-gov’t agencies
• e.g. Non-serious injuries/incidents, food poisoning, car issues
(malfunction etc)
• No hospital injury data included at present
• 58,277 incidents(includes injury) recorded to date (2009.9-2012.4.19)

Access to the
Injury/Incident databank
• Searchable database available to general public
• But, at present, general public can not send in
reports

Info available
• Extent of disclosure to the public determined according
to relevant law/policies covering the product/service
• Info available (not all is avail., see note above):
‣ Manufacturer/product, service name/details (esp. if cause
known); date/place incident occurred; incident details/
summary; injury details (extent, no. of injured persons);
age/sex of injured; status of any investigation into cause;
status of measures initiated(e.g. recall); source of info, date of
registration of info, date info received, photos of product etc.

Ministries/ Agencies sending
information
• Consumer Agency
• National Consumer Affairs Centre of Japan (NCAC)
• Regional government consumer centres
• Ministry of Health, Labour and Welfare
• Ministry of Agriculture, Forestry and Fisheries
• Ministry of Land, Infrastructure, Transport and Tourism
• Ministry of Economy, Trade and Industry (METI)
• National Institute of Technology and Evaluation (NITE)
• Japan Legal Support Center
• National Agency for the Advancement of Sports and Health

Consumer Affairs Agency and the Incident/Injury Information Data Bank
Source: http://www.caa.go.jp/en/pdf/100215information.pdf

Thank you!