The Cabinet Office, government of Japan ＞ Top page of OTO ＞ Reorganization of the Office of the Trade and Investment Ombudsman
(Provisional Translation)
Further Follow-up on the Recommendations on Market Access Issues by the Market Access Ombudsman Council
May 12, 1997
Secretariat of the OTO
The following is a report on policy actions taken by the government in response to the "Recommendations on Market Access Issues Concerning Standards, Certifications and Others" by the Market Access Ombudsman Council, dated March 14, 1995.
Note: This report describes further follow-up on nine complaints discussed by the Market Access Ombudsman Council (May 27, 1996) on which action had not been completed (the Council made recommendations concerning 19 complaints in the March 1995 Recommendations).
1. Animals and plants, food
1-(1) Improvement of the plant quarantine system and others relating to the import cut flowers
2. Pharmaceuticals
2-(1) Simplification of approval procedures etc. for in-vitro diagnostics
3. Manufacturing and related areas
3-(2) Establishment of classification standards for X-ray film
3-(3) Changes to approval procedures for electric and electronic products
4. Transport and traffic
4-(2) Relaxation of weight restrictions when freight containers are transported by road
5. Construction
5-(2) Improvement of the certification system for wallpaper
6. Tertiary industries and related area
6-(2) Review of regulation on premium offers
6-(3) Deregulation of the restriction of the number of races open to foreign horses and horse owner registration of persons residing overseas by the Japan Racing Association
7. Import procedures
7-(1) Extension of work hours for Customs offices and other bodies relating to import processing procedures
1. Animals and plants, food
1-(1) Improvement of the plant quarantine system and others relating to the import cut flowers
1. Complainant:European Business Council (EBC)
2. Ministry concerned:Ministry of Agriculture, Forestry and Fisheries
3. Results of deliberation:
(1)
1) A study of risk assessment measures for pests including Pests Risk Analysis, for the purpose of clearly indicating pests which are not subject to quarantine in Japan, will be undertaken, to respond quickly to the international guidelines set out by the FAO.
2) The concerned ministry is currently working on developing methods to prove whether Plant pests are of the same biotype as those found in Japan. Regarding pests for which methods have already been developed, bilateral discussions will be held with the countries where the Plant pests inhabit, to obtain their understanding regarding the methods used.
3) To ensure that examination is carried out efficiently and to lighten the burden on applicants, a further study of sampling methods will be carried out, in consultation with experts.
(4) It will be necessary for experts from Japan and the Netherlands to clarify through discussion the reasons why infractions were committed on cut flowers examined under pre-inspection in the Netherlands, and being based on the results both countries will decide whether random basis checks are appropriate to be introduced.
(5)
1) Cargo Building No. 4 will be completed during FY1995. The parties concerned should give users opportunities to state their opinions, including improvement of refrigeration facilities requested by the complainant, so that the facilities can meet their specific needs. Based on the outcome of these meetings, the necessary improvements to warehousing and sorting areas should be made.
2) Cargo Building No. 4 will have covered areas.
3) Roofing of covering the areas where samples are left while awaiting inspections will be studied at an early date.
4. Actions taken:
(1)
1) In order to introduce quarantine measures consistent with international guidelines on Pest Risk Analysis (PRA) adopted by the FAO, partial amendments were made to the Plant Protection Law (June 1996). The revised law and related statutes were into force in April 1997. PRA has being done in accordance with international guidelines and pests which are not subject to quarantine were clearly indicate.
2) Bilateral consultations are being held with the concerned countries appropriate PRA methods to prove that pests are of the same biotype as those distributed in Japan or not.
All plants shall be subject to import inspection. Non quarantine pests which are exempted from quarantine measures shall be designated for those of biotype unknown abroad, even though they may be widespread in Japan. Information is currently being exchanged with the United States, Australia, the Netherlands and New Zealand.
3) As a result of studies on sampling methods, conclusion was reached that it would be worth introducing two-stage inspections for shipments with few pests, as a way of avoiding quarantine measures. This decision was approved by experts, under certain conditions. However, in view of viability such as the volume of imports to be processed and the needs of speedy inspection, further studies concluded that introduction of two-stage inspections on site would cause consuming more time for re-inspection and negative effects for re-sampling on the freshness of the cut flowers. It was also pointed out that loss of freshness due to re-inspection would be a burden on cut flower importers, and accordingly, introduction of two-stage inspection was deemed to be difficult.
(4) Through the discussions with experts from the Netherlands at the Japan-Netherlands Plant Quarantine Meeting in March 1996, the Netherlands expressed their understanding that it is impossible to introduce random testing, as infractions are continuing.
(5)
3) Roof installation to cover the passageway in front of the cargo inspection site where cut flowers during preparations for inspection are left is scheduled to be completed in May 1997.
2. Pharmaceuticals
2-(1) Simplification of approval procedures etc. for in-vitro diagnostics
1. Complainant:European Business Council, German Embassy
2. Ministry concerned:Ministry of Health and Welfare
3. Results of deliberation:
(1)
1) The ministry concerned is taking steps to simplify approval procedures while ensuring the function of in-vitro diagnostic drugs. Measures will be taken to reduce the clerical burden in connection with examination for approval to the same level as in the United States and Europe, by gradually adopting standards for in-vitro diagnostics, in consultation with the concerned parties including the complainants, and by establishing the range of in-vitro diagnostics for which approval is not required, and so on, as early as possible.
2) Regarding whether there should be a classification for in-vitro diagnostics separate from drugs and medical instruments, this issue will be studied after research into the systems in use in the United States and Europe.
4. Actions taken:
(1)
1) To simplify approval procedures for in-vitro diagnostics while ensuring their function, based on specific requests made by the concerned parties, the ministry introduced a new category which does not require a change in approval if some changes are made in the preparation method for the reagent used, as long as there is no effect on the product's function.
Regarding the type of material to be measured, the issue of streamlining the documentation required for application for approval for products using ingredients for which there is a set international evaluation (standard products, etc.) will be studied and implemented in FY1997. Further, based on specific requests, study will be continued regarding reducing the clerical burden imposed in connection with application for approval to levels similar to those in the United States and Europe.
2) A delegated research committee consisting of experts in clinical testing will continue to study how the function of in-vitro diagnostics is ensured in the United States and Europe.
3. Manufacturing and related areas
3-(2) Establishment of classification standards for X-ray film
1. Complainant:German Embassy
2. Ministry concerned:Ministry of International Trade and Industry
3. Results of deliberation:
The ministry concerned will make earnest efforts to participate in the ISO/TC135 committee (sub-committee on non-destructive testing), and even before international standards are established, will begin work to harmonize JIS with the Draft International Standards (DIS) after these are established, based on the committee draft which is scheduled to be produced by October 1995. Once international classification standards are established, JIS classifications harmonizing with international standards will be set down.
(Note: In a policy action taken by the OTO Secretariat in March 1995, the establishment of JIS classifications was moved up to take place when DIS were established.)
4. Actions taken:
JIS K7627 (X-ray film for industrial use Part 1: classification of film systems for X-ray film for industrial use), harmonizing with Draft International Standards (DIS 1169-1) for X-ray film for industrial use, was established in February 1997. When international classification standards are established, JIS classification standards harmonizing with international standards will be established.
3-(3) Changes to approval procedures for electric and electronic products
1. Complainant:Taipei Economic and Cultural Representative Office in Japan
2. Ministry concerned:Ministry of International Trade and Industry
3. Results of deliberation:
(1) Translation into English of the technical standards for the remaining items in the Electrical Appliance and Material Control Law will be continued.
(4)
1) During FY 1995 117 items in Type A electrical products will be transferred to Type B during FY1995, and the reporting forms for Type B electrical products will be simplified. More products will continue to be transferred to the Type B classification as well.
2) Specifications of the Electrical Appliance and Material Control Law will be made compatible with those of the IEC (International Electrotechnical Commission) within the next five years. (Note: this period was shortened to three years in April 1995, as part of emergency economic measures in response to yen appreciation.)
4. Actions taken:
(1) JETRO is cooperating in the English translation of the technical standards (ordinance determining technical standards for electrical products - MITI Ordinance #85, 1962) of the Electrical Appliance and Material Control Law. In addition to the 450 items for which an English translation of technical standards was published in FY1995, Attached List 3 (for 9 fuse products) and Attached List 5 (for 3 voltage regulators) of the same ordinance were translated in FY1996 and are scheduled to be published in FY1997.
(4)
1) The remaining items classified as Type A electrical products are wiring and wiring devices which are relatively hazardous (used in direct contact with the human body), but the Issue of transferring the remaining Type A items to Type B will continue to be studied considering the spread of the private sector third-party certification.
2) Technical studies will be undertaken to explore the feasibility of adopting some 300 IEC standards for electrical wiring, light bulbs and other electrical goods as technical regulations of Electrical Appliance and Material Control Law. And work will be undertaken to align technical regulations in some 500 items with international standards (IEC standards) more closely by the end of FY 1997.
4. Transport and traffic
4-(2) Relaxation of weight restrictions when freight containers are transported by road
1. Complainant:Australian Embassy, French Embassy, American Chamber of Commerce in Japan
2. Ministry concerned:Ministry of Transport, Ministry of Construction
3. Results of deliberation:
(1) Roads will be improved by the end of FY1997 to permit the creation of a road network of important distribution routes capable of handling semi-trailers carrying fully loaded 40-ft containers, which will be allowed to transit with transit permits issued by road authorities.
When axle weight restrictions, etc. are met, on the road networks capable of handling fully loaded 40-ft containers, transport of fully loaded 20-ft containers on vehicles with the distance between outer axles 10 meters will be allowed. Transit of fully loaded containers will be allowed if certain road networks can be established by securing detour roads and so on, even before the end of the 11th 5-Year Road Improvement Program. Information on road networks where weight restrictions will be relaxed will be provided as soon as possible.
(2)
1) For the convenience of vehicle manufacturers and vehicle transport operations, the conditions which vehicles must meet to be allowed to transit carrying fully loaded containers should be clarified well in advance through coordination by the concerned ministries and agencies, and notification given of when transit by vehicles carrying fully loaded containers will be allowed. At that time, the opinions of the complainants and of the businesses concerned regarding maneuverability and so on should be adequately considered.
2) The concerned ministry will also allow weight load limits for vehicles with the distance between outer axle 10 meters in current use to be amended by appropriate modifications, if they meet the safety standards for road transport vehicles.
(3) The concerned ministry will carry out improvements to important distribution routes, such as roads linking national expressways and main container yards, within the 11th 5-Year Road Improvement Program. Regarding the decision on the specific roads to be improved, priority should be given to roads with major demand for transport of freight containers. When deciding which roads will be improved, the ministry will take into consideration roads where there is currently heavy transport of freight containers under transit permits.
4. Actions taken:
(1) Bridges on roads which play a vital role in distribution, linking major ports, industrial parks and other distribution centers, are being improved and reinforced to allow them to bear passage of semi-trailers carrying fully-loaded 40-ft containers. Of the 460 bridges scheduled for improvements and reinforcing, work on 400 bridges was completed by the end of FY 1996, and work on the remaining locations will be completed by the end of FY1997.
Where further improvement and reinforcement work is concerned, if detours can be secured and a road network is established even before the end of FY1997, it will be possible for special vehicles carrying 40-ft containers to travel on the roads in question with transit permits.
Transport of fully-loaded 20-ft containers on vehicles with the distance between outer axles 10 meters will be allowed, when axle weight restrictions, etc. are met, on road networks capable of handling vehicles carrying fully-loaded 40-ft containers. Businesses will be advised as soon as possible concerning networks where weight restrictions have been eased.
(2)
1) The opinions of concerned organizations (organizations of vehicle manufacturers and transport operators, the Ministry of Transport, and the Ministry of Construction) were heard and the Ministry of Construction showed them a linked semi-trailer prototype in December 1996.
Based on the prototype shown, the concerned organizations and the Ministry of Construction will continue to study the vehicles which require modification in order to meet legal requirements and reach a conclusion during FY1997. The opinions of the complainants will also continue to be considered.
2) Regarding full loading of vehicles with the distance between outer axles 10 meters which have been suitably modified, these meet the axle weight restrictions, etc. which are the requirement of the vehicle prototype specified by the safety regulations for road transport vehicles, they will be permitted to transit when the road network is constructed.
(3) Improvement of roads where there is strong demand for transport of freight containers will be carried out during the 11th 5-Year Road Improvement Program, using examples of transit routes for tall containers as reference.
5. Construction
5-(2) Improvement of the certification system for wallpaper
1. Complainant:French Embassy
2. Ministry concerned:Ministry of Construction
3. Results of deliberation:
(1)
1) Since April 1, 1995, testing facilities already certified under the Guidelines for Designating Testing Laboratories began accepting test data for certification of fireproof materials.
2) In order to conduct designation of testing organizations smoothly, active efforts will be made to publicize the changes in the system concerning acceptance of foreign test data.
(2) The concerned ministry will hold discussions with France, the U.S., Canada and the EU concerning the introduction of a mutual certification system accepting performance evaluation by the counterpart country's certification organization and will actively promote the introduction of this system.
(3)
1) The ministry is consulting with the bodies and organizations involved in General Certification to further streamline procedures for this by the end of FY1994.
2) Pamphlets will be produced in English describing Japanese building standards concerning wallpaper, and certification procedures, for the information of foreign wallpaper manufacturers and importers.
4. Actions taken:
(2) The ministry has proposed holding discussions with France, which will take place after preparations by the French side are completed.
6. Tertiary industries and related area
6-(2) Review of regulation on premium offers
1. Complainant:American Chamber of Commerce in Japan
2. Ministry concerned:Fair Trade Commission
3. Results of deliberation:
The fair trade commission will review by the end of fiscal 1995 the maximum limit on values of premiums within the scope of general regulations according to conclusions that will be presented by a study group of academic experts at the end of March 1995. Taking into consideration the changes in socioeconomic conditions since premium regulations were established, a basic reevaluation of the need for regulation should be undertaken with the aim of promoting fair competition. Specific contents of the review should be indicated, with a view to making regulation clear and keeping restrictions to the minimum, within the scope of necessity, and should be implemented as soon as possible in FY1995.
(1) The definition and interpretation of premiums, including the distinction between open and closed lotteries, should be clarified and regulations made more transparent.
(2) The maximum limits to premiums should be reviewed, taking into consideration changes in socioeconomic conditions.
(3) In addition to clarifying that industry associations cannot extend the fair competition codes to companies which do not participate in the codes, the content and application of fair competition codes should be reviewed.
(4) Sales campaigns with premium by department stores should be liberalized and the offering of premium within the scope of general regulations should be allowed.
The issue of reviewing the other items mentioned in this complaint should also be studied.
4. Actions taken:
The Fair Trade Commission made the following changes to the notification and application standards for the general regulations concerning premiums from April 1, 1996: the maximum limit on amounts of lotteries or prize competition was raised; the limit on the value of premiums offered to general consumers was eliminated; Notification on premium offers to entrepreneur was abolished; Clause 8 of the Special Designation on Department Stores was removed; the upper limit on premiums for open lotteries was raised and restrictions on the scope of such premiums was reduced and clarified. Following this review and clarification of the general regulations, industry-specific notifications on restrictions on premiums were abolished in 27 industries' of 29 industries. In addition, together with elimination of Notifications by industry, 24 of 51 fair competition codes concerning premium offers were reviewed to conform to the general regulations.
6-(3) Deregulation of the restriction of the number of races open to foreign horses and horse owner registration of persons residing overseas by the Japan Racing Association
1. Complainant:Australia/New Zealand Chamber of Commerce
2. Ministry concerned:Ministry of Agriculture, Forestry and Fisheries
3. Results of deliberation:
The JRA should hold discussions with the complainant concerning racing restrictions on foreign-bred horses and make efforts to gain their understanding regarding internationalization measures. Regarding registration of horse owners, the JRA should solicit opinions from various related foreign organizations, etc., including the complainant, study the systems in use in various other countries, and consider at an early date a method of examining persons residing abroad equally appropriate to that used for persons residing in Japan. The JRA should discuss this matter with the complainant and endeavor to obtain their understanding.
From the perspective of measures taken to internationalize horse racing, the Ministry should encourage the JRA to hold talks with the complainant and to study the issue of horse owner registration of persons residing abroad in the immediate future.
4. Actions taken:
On April 13, 1995, the government urged the JRA to study the horse owner registration of persons residing abroad in the immediate future and to make efforts to obtain the understanding of related organizations abroad.
As a result, the JRA established a study group (project team) on April 20, 1995, charged with studying equally appropriate measures for examining persons residing abroad as those for persons residing in Japan. Until now, the project team has studied the horse owner registration systems of the principal horseracing countries (the U.S., France, the U.K., Australia, New Zealand). Based on the results of this study, and to ensure fairness in horse-racing, further research and study will be undertaken, on the premise that equally appropriate measures will be used for examining persons residing abroad as those for persons residing in Japan, and a conclusion will be reached during FY1997. Since 1995, the JRA has dispatched its directors and other members to Australia and New Zealand to describe its internationalization measures to breeder's organizations there. The latest such mission took place in March 1997.
7. Import procedures
7-(1) Extension of work hours for Customs offices and other bodies relating to import processing procedures
1. Complainant:Keidanren
2. Ministry concerned:Ministry of Agriculture, Forestry and Fisheries, Ministry of Health and Welfare
3. Results of deliberation:
(1) The concerned ministry is studying extending the working hours of Customs staff at Nagoya and Fukuoka airports, based on demand for after-hours processing and staff availability. This will increase convenience for users, including making it possible to present applications for after-hours processing in over time working hours, and the necessary measures should be taken soon.
(2) Overtime Customs service fees should be reviewed as necessary, taking the clerical processing situation into consideration.
(3) Regarding inspection procedures by other agencies, increased number of inspectors and extended service hours to permit taking inspection of goods carried by the last international cargo flight of the day should be considered to apply at Narita, Nagoya, Fukuoka and other major airports bearing administrative efficiency in mind.
4. Actions taken:
(3) Regarding inspection procedures prescribed by other laws, extension of work hours of the quarantine station was studied in the light of the actual volume of food imports. As a result, weekday work hours at Nagoya and Fukuoka airports were extended by three hours in FY1995, and since February 1997, the quarantine station at Nagoya Airport has been operating an additional three hours, until 8 p.m., on weekends and holidays. Additional 54 staff (see Note) was assigned to duty in FY1996.
Plant quarantine station hours were extended as from October 1996 at Narita, Nagoya and Fukuoka airports to handle the last international cargo flight of the day, in order to facilitate import procedures. Four plant quarantine stationers (see Note) were added in FY1996 for flexible staff assignment to handle the increased workload.
Animal quarantine station hours have already been extended, and one additional staff member was assigned to duty at main airports in FY1996.
Note: No. of officials shows those assigned in import section in food sanitation and plant quarantine duties respectively.
Business Hours of Import-related Offices
Regular hours, ordinary airports and ports
Customs
Mon-Fri 8:30-17:00. Open at other times under extended hours.
Quarantine
Mon-Fri 8:30-17:00
Plant Quarantine
Mon-Fri 8:30-17:00. Open on holidays or at other hours upon prior request.
Animal Quarantine
Mon-Fri 8:30-17:00. Open on holidays or at other hours upon prior request.
Narita Airport
Customs
24 hours a day, year-round (duty officer available).
Quarantine (Imported Food Inspection)
Year-round, 8:30-21:00
Plant Quarantine
24 hours a day, year-round (duty officer available).
Animal Quarantine
24 hours a day, year-round (duty officer available).
Kansai International Airport
Customs
24 hours a day, year-round (duty officer available).
Quarantine (Imported Food Inspection)
Year-round
Import declarations: 8:30-23:00.
Fresh food inspections handled 24 hours a day upon prior request.
Plant Quarantine
24 hours a day, year-round (duty officer available).
Animal Quarantine
24 hours a day, year-round (duty officer available).
Nagoya Airport
Customs
Year-round 8:30-21:30. Duty officer available.
Quarantine (Imported Food Inspection)
Year-round 8:30-20:00. 13:30-20:00 on Saturdays and holidays.
Plant Quarantine
Year-round 7:30-22:00 (duty officer available).
Animal Quarantine
Year-round 7:30-22:30 (duty officer available).
Chitose Airport
Customs
Regular hours
Quarantine (Imported Food Inspection)
8:30-19:00, Tuesdays, Thursdays in winter. Regular hours otherwise.
Plant Quarantine
Regular hours. Open on holidays or at other hours upon prior request.
Animal Quarantine
Year-round (duty officer available). 8:30-20:00. 10:00-20:00 on Saturdays and holidays.
Fukuoka Airport
Customs
Year-round 8:00-21:30 (duty officer available).
Quarantine (Imported Food Inspection)
Year-round 8:30-20:00. 8:30-17:00 on Saturdays and holidays.
Plant Quarantine
Year-round 7:45-21:30 (duty officer available).
Animal Quarantine (Imported Food Inspection)
Year-round 7:30-22:00 (duty officer available).