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Challenge to special zones for structural reform 2007-2008

“Special zones” are areas where businesses that are not possible under traditional laws and regulations have been allowed to operate. Special Zones for Structural Reform were instituted from 2002 onward, and over 2007 - 2008, we applied for one for industrial hemp.

By the appeal of Hemp Project of Industrial Cluster Okhotsk in Hokkaido, 21 regions and organizations performed the special hemp zone proposal.

The 12th proposal recruitment (October 15, 2007 to March 7, 2008)
About operation of the examination request about special zones for structural reform and a local revival (Information) July 12, 2007

※The Cabinet Office invited the proposal of the special zone and it asked the regulation government office for the answer.

October 15, 2007 Proposal

Requirements: Import deregulation of industrial hemp seeds

Competent governmental authority:
Ministry of Health, Labour and Welfare(MHLW)
Ministry of Economy, Trade and Industry(MITI)

-Legal grounds
Public Announcement on the Items of Goods Subject to Import Quotas, the Places of Origin or Places of Shipment of Goods Requiring Approval for Import, and Other Necessary Matters Concerning Import of Goods. Public Notice No. 170 of the Ministry of International Trade and Industry of April 30, 1966

About the handling of imports, hemp seeds
The Notification No. 238 of the first Narcotics Division chief, Pharmaceutical Affairs Bureau issued on September 15, 1965 from the Director General, Pharmaceutical Affairs Bureau, Ministry of Health and Welfare of Japan 

<The current state of regulation>
With regard to hemp seeds, submit a document certifying that heat treatment, etc. has been implemented so as to avoid germination (limited to those issued by the Narcotics Control Department of the Regional Bureau of Health and Welfare), submit to customs.

<Specific Details of Desired Measures>
Make permissible the import of hemp seeds without anti-germination processing for hemp varieties within the scientific classification of hemp (Cannabis sativa L.) that do not have tetrahydrocannabinol (THC below) content.

<Specifics of Industry Implementation and Reasons for Proposal>
The domestic cultivation of industrial hemp does not exceed 10ha, and when cultivators are interested in growing on a large scale to suit the needs of a new industrial product, they have no choice but to rely on seed import. However, as heat-activated anti-germination processing is mandated for seed imports, even those with cultivation licenses find themselves in a position where business-oriented cultivation is effectively impossible. If this restriction is lifted on those varieties that do not have THC content, it becomes possible to plan certain strategies for environmental conservation and agricultural promotion.

[Post-Approval Business Concept]
1. European nations have found success in the utilization of the fibers and stems of hemp as a substitute for lumber and plastics as a building and insulation material and textile, and such results should be achievable domestically as well. Biodegradable plastics made from hemp have also been adopted by automotive manufacturers in Europe for interior upholstery. As such applications contribute to the reduction of waste and fossil fuel emissions, we believe the use of hemp offers an effective method of solving a number of domestic challenges.

2. The extreme speed at which hemp grows makes it well-suited to fixing the greenhouse gas carbon dioxide, and can be expected to aid the shift towards biomass fuels. Further, it is an excellent crop to aid in the purification of underground water channels as a nitrate nitrogen "cleaning crop." Furthermore, it is an ideal next-generation crop in terms of establishing farmland preservation programs for fields and paddies that have been abandoned as a result of giving up farming or acreage reduction and other fallow land. Not only agricultural promotion, but general regional economic revitalization is possible with the establishment of nearby factories for the processing and manufacture of a wide variety of industrial products.

November 6, 2007: First response from MHLW*

*HHLW= the Ministry of Health, Labour and Welfare

Response to the proposals from each Ministry
Response to the Proposal - Measure Classification “C”: Cannot be supported
Details of the Measure - III

Regarding "Classification of the Measure"

 Classification  Details
 A  Can be supported “Special zones”
 B  Can be supported nationwide
 C  Cannot be supported
>>> This is what applies in this case!
 D  Can be supported current regulations
 E  Mistake of fact
 F  Consider measures

Regarding "Details of the Measure"

 Classification  Details
 Ⅰ  Requires changes to law
 Ⅱ  Requires changes to government ordinance
 Ⅲ  Requires changes to ministerial ordinance or notice >>> This is what applies in this case!
 Ⅳ  Requires directive or official notice preparation

(Ministry of Health, Labour, and Welfare's response)
It is well understood that as the psychoactive component of hemp, THC, is effective even at very low doses, there is a straightforward potential for abuse by utilizing distillation or extraction methods on hemp that even has low amounts of THC.
Consequently, the Cannabis Control Act operates on all hemp regardless of its THC content. Furthermore, it is extremely difficult to appreciate the final THC content of a hemp plant at the seed stage. Therefore, it is necessary to maintain the current import regulations as regards the import of hemp seeds, regardless of THC content. In addition, in the international treaty (Single Convention on Narcotic Drugs treaty in 1961), it is considered as the control target regardless of the quantity about the hemp containing THC. In light of this fact, there is a need to deal strictly with the import of hemp seeds.

November 13, 2007: First rebuttal submitted by the Hemp Project

Appeal and response to appeal

Appeal for reconsideration (Cabinet Office opinion)
1. As the regulatory authority, are you aware of the presence of hemp varieties that do not contain THC? Presuming they exist, would it be possible to differentiate such a hemp variety at the seed stage from the native species? 2. The proposing body has introduced to us case studies in the EU and Canada; is the Ministry aware of these? Hypothetically speaking, if all of the facts were different, please explain how this could come to be. 3. The proposing body has claimed that the French government has authorized a certification for THC-free hemp seeds; is the Ministry aware of this? Hypothetically speaking, if all of the facts were different, please explain how this could come to be.

<Opinion from the proposing body>
The current Cannabis Control Act and related provisions have no regulation with regards to THC concentration. This is even pointed out in the handbook for the law. Given the meaning and purpose of special deregulation zones, even if there was no legal basis (in this case, if the ministerial ordinance was not changed), surely it would be possible to establish a trial special economic zone to develop a progress-oriented case study? What would be the best way to establish seed certification, a system for importation, and a management structure like that in Tochigi Prefecture? The Single Convention on Narcotic Drugs is very clear in stating that beyond dealing with drug prevention, it does not apply to cultivation for industrial purposes. In the EU and Canada, drug prevention and industrial use are kept distinct, with THC concentration regulation. There is no reason why such a system could not be adopted in Japan, at least experimentally. If for some reason it's not possible, perhaps it should be concluded that the administrative prowess of this country is flagging in comparison with other nations.

December 21, 2007: Second response from MHLW  

Response to the appeal for reconsideration (Ministry of Health, Labour and Welfare's response)
"Measure Classification" Revision – “C”: Cannot be supported
"Details of the Measure" Revision - III

1. We are unaware of hemp varieties without THC content. Regarding hemp seeds, it is extremely difficult to differentiate hemp based on grown plant THC content at the seed stage.

2. Regarding the EU, etc., while there are countries that are cultivating industrial hemp while having ratified the Single Convention on Narcotic Drugs, according to the 1999 annual report of the International Narcotics Control Board (INCB), an estimated 100 tons or more of illegal marijuana cultivated and harvested under a claim of legal use had circulated throughout Europe.

3. We are not aware of the French government's approval of THC-free hemp seed certification.

4. Article 39 of the Single Convention on Narcotic Drugs states, "Notwithstanding anything contained in this Convention, a Party shall not be, or be deemed to be, precluded from adopting measures of control more strict or severe than those provided by this Convention...as in its opinion is necessary or desirable for the protection of the public health or welfare."In light of the above, with regards to the import of hemp seeds, it is necessary to maintain the current import regulations and treat them strictly, regardless of THC content.

January 7, 2008: Rebuttal from Hemp Project

1. Industrial hemp varieties are based on EU regulations with priority given to EU member state domestic law.

These varieties are controlled mainly by a seed company that has been recognized by the French government, and the company is able to issue certificates. Attachment 3. Even without distinguishing at the seed stage, THC content can be verified via certificates issued by the seed company, with commercial cultivation taking places throughout the EU region. Consequently, it is possible to ascertain THC with a certificate provided by the seed management company. There should be no problems if the post-import administrative structure adopts the Tochigi Prefecture model.

2. Regarding the distinction made in the EU and Canada between drug prevention and industrial use, please let us know if you have any thoughts on that.

<Second appeal for reconsideration> (Cabinet Office opinion)
Given the afore-mentioned proposing body's thoughts, please reconsider and provide an answer.

<Second opinion from the proposing body>
The Ministry has said they are "not aware" of varieties without THC content or the fact that the French government has recognized them. Please provide an answer in consideration of these facts.
Assuming that the above is true, it is possible to distinguish varieties that have no THC content. At the time of import, official bodies could conduct sequential sampling inspections (DNA tests, etc.), and combined with the construction of a seed oversight system led by the government, we believe it should be possible to halt circulation entirely.
In addition, we believe the non-proliferation of hemp seeds and the prevention of illegal cultivation can be guaranteed by requiring an application describing hemp cultivation goals and varieties, as well as a gubernatorial cultivation licensing system.

March 7, 2008: Response from MHLW

<Response to Second Appeal for Reconsideration>
"Measure Classification" Revision – “C”: Cannot be supported
"Details of the Measure" Revision - III

In a drug climate of increasing marijuana crime, as shown in the International Narcotics Control Board (INCB) 1999 report, an estimated 100 tons or more of illegal marijuana cultivated and harvested under a claim of legal use had circulated throughout Europe. Given such an international state of affairs, allowance of germination seeds cannot be dismissed as a potential promoter of illegal hemp cultivation. In keeping, it is necessary to maintain the current regulation on import and adhere to them strictly (we see no need for Japan to recognize imports of seeds with certifications issued by foreign governments, nor a need for the "construction of a seed oversight system led by the government," and there are currently no plans to do so).

<Commentary on HIHA>
Interaction as a special zone is the end here.
The proposer was not directly engaged with the Ministry of Health, Labor and Welfare, but was a proposal, refutation, answer through the Cabinet Office.
It was a big achievement that pulled out the official opinion of the Ministry of Health, Labor and Welfare as of 2007. However, the object of deregulation could not be attained at all and the next was to lead to Hokkaido 's unique industrial hemp special zone.