Tag: mpl

June 6, 2004 'Awa (Kava Kava)

Fiji Times–New hope for kava industry

AS pressure mounts on European and other countries to lift the ban placed on kava imports, the experts and producers of kava around the Pacific are joining forces to publicise the benefits of this age-old root plant to offset any negativity. Holding the helm of this counter-publicity drive in Fiji are the University of South Pacific Professor of Organic Chemistry Subramaniam Sotheeswaran and Kadavu chief Ratu Josateki Nawalowalo.

“In a recent study in collaboration with the organic chemists at the USP, the Saitama Cancer Centre Research Institute in Japan, has shown that kava may have promising anti cancer activity paralleling the anti-cancer activity of green tea,” Prof Sotheeswaran told the Sunday Times.

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April 4, 2004 Legislative Snippets

Ethanol facility tax credit.

http://www.capitol.hawaii.gov/hrscurrent/Vol04_Ch0201-0257/
HRS0235/HRS_0235-0110_0003.htm

?235-110.3 Ethanol facility tax credit. (a) Each year during the credit period, there shall be allowed to each taxpayer subject to the taxes imposed by this chapter, an ethanol facility tax credit that shall be applied to the taxpayer’s net income tax liability, if any, imposed by this chapter for the taxable year in which the credit is properly claimed.

For each qualified ethanol production facility, the annual dollar amount of the ethanol facility tax credit during the eight-year period shall be equal to thirty per cent of its nameplate capacity if the nameplate capacity is greater than five hundred thousand but less than fifteen million gallons. A taxpayer may claim this credit for each qualifying ethanol facility; provided that:

(1) The claim for this credit by any taxpayer of a qualifying ethanol production facility shall not exceed one hundred per cent of the total of all investments made by the taxpayer in the qualifying ethanol production facility during the credit period;

(2) The qualifying ethanol production facility operated at a level of production of at least seventy-five per cent of its nameplate capacity on an annualized basis;

(3) The qualifying ethanol production facility is in production on or before January 1, 2012; and

(4) No taxpayer that claims the credit under this section shall claim any other tax credit under this chapter for the same taxable year.

(b) As used in this section:

“Credit period” means a maximum period of eight years beginning from the first taxable year in which the qualifying ethanol production facility begins production even if actual production is not at seventy-five per cent of nameplate capacity.

“Investment” means a nonrefundable capital expenditure related to the development and construction of any qualifying ethanol production facility, including processing equipment, waste treatment systems, pipelines, and liquid storage tanks at the facility or remote locations, including expansions or modifications. Capital expenditures shall be those direct and certain indirect costs determined in accordance with section 263A of the Internal Revenue Code, relating to uniform capitalization costs, but shall not include expenses for compensation paid to officers of the taxpayer, pension and other related costs, rent for land, the costs of repairing and maintaining the equipment or facilities, training of operating personnel, utility costs during construction, property taxes, costs relating to negotiation of commercial agreements not related to development or construction, or service costs that can be identified specifically with a service department or function or that directly benefit or are incurred by reason of a service department or function. For the purposes of determining a capital expenditure under this section, the provisions of section 263A of the Internal Revenue Code shall apply as it read on March 1, 2004. For purposes of this section, investment excludes land costs and includes any investment for which the taxpayer is at risk, as that term is used in section 465 of the Internal Revenue Code (with respect to deductions limited to amount at risk).

“Nameplate capacity” means the qualifying ethanol production facility’s production design capacity, in gallons of motor fuel grade ethanol per year.

“Net income tax liability” means net income tax liability reduced by all other credits allowed under this chapter.

“Qualifying ethanol production” means ethanol produced from renewable, organic feedstocks, or waste materials, including municipal solid waste. All qualifying production shall be fermented, distilled, gasified, or produced by physical chemical conversion methods such as reformation and catalytic conversion and dehydrated at the facility.

“Qualifying ethanol production facility” or “facility” means a facility located in Hawaii which produces motor fuel grade ethanol meeting the minimum specifications by the American Society of Testing and Materials standard D-4806, as amended.

(c) In the case of a taxable year in which the cumulative claims for the credit by the taxpayer of a qualifying ethanol production facility exceeds the cumulative investment made in the qualifying ethanol production facility by the taxpayer, only that portion that does not exceed the cumulative investment shall be claimed and allowed.

(d) The department of business, economic development, and tourism shall:

(1) Maintain records of the total amount of investment made by each taxpayer in a facility;

(2) Verify the amount of the qualifying investment;

(3) Total all qualifying and cumulative investments that the department of business, economic development, and tourism certifies; and

(4) Certify the total amount of the tax credit for each taxable year and the cumulative amount of the tax credit during the credit period.

Upon each determination, the department of business, economic development, and tourism shall issue a certificate to the taxpayer verifying the qualifying investment amounts, the credit amount certified for each taxable year, and the cumulative amount of the tax credit during the credit period. The taxpayer shall file the certificate with the taxpayer’s tax return with the department of taxation. Notwithstanding the department of business, economic development, and tourism’s certification authority under this section, the director of taxation may audit and adjust certification to conform to the facts.

If in any year, the annual amount of certified credits reaches $12,000,000 in the aggregate, the department of business, economic development, and tourism shall immediately discontinue certifying credits and notify the department of taxation. In no instance shall the total amount of certified credits exceed $12,000,000 per year. Notwithstanding any other law to the contrary, this information shall be available for public inspection and dissemination under chapter 92F.

(e) If the credit under this section exceeds the taxpayer’s income tax liability, the excess of credit over liability shall be refunded to the taxpayer; provided that no refunds or payments on account of the tax credit allowed by this section shall be made for amounts less than $1. All claims for a credit under this section must be properly filed on or before the end of the twelfth month following the close of the taxable year for which the credit may be claimed. Failure to comply with the foregoing provision shall constitute a waiver of the right to claim the credit.

(f) If a qualifying ethanol production facility or an interest therein is acquired by a taxpayer prior to the expiration of the credit period, the credit allowable under subsection (a) for any period after such acquisition shall be equal to the credit that would have been allowable under subsection (a) to the prior taxpayer had the taxpayer not disposed of the interest. If an interest is disposed of during any year for which the credit is allowable under subsection (a), the credit shall be allowable between the parties on the basis of the number of days during the year the interest was held by each taxpayer. In no case shall the credit allowed under subsection (a) be allowed after the expiration of the credit period.

(g) Once the total nameplate capacities of qualifying ethanol production facilities built within the State reaches or exceeds a level of forty million gallons per year, credits under this section shall not be allowed for new ethanol production facilities. If a new facility’s production capacity would cause the statewide ethanol production capacity to exceed forty million gallons per year, only the ethanol production capacity that does not exceed the statewide forty million gallon per year level shall be eligible for the credit.

(h) Prior to construction of any new qualifying ethanol production facility, the taxpayer shall provide written notice of the taxpayer’s intention to begin construction of a qualifying ethanol production facility. The information shall be provided to the department of taxation and the department of business, economic development, and tourism on forms provided by the department of business, economic development, and tourism, and shall include information on the taxpayer, facility location, facility production capacity, anticipated production start date, and the taxpayer’s contact information. Notwithstanding any other law to the contrary, this information shall be available for public inspection and dissemination under chapter 92F.

(i) The taxpayer shall provide written notice to the director of taxation and the director of business, economic development, and tourism within thirty days following the start of production. The notice shall include the production start date and expected ethanol fuel production for the next twenty-four months. Notwithstanding any other law to the contrary, this information shall be available for public inspection and dissemination under chapter 92F.

(j) If a qualifying ethanol production facility fails to achieve an average annual production of at least seventy-five per cent of its nameplate capacity for two consecutive years, the stated capacity of that facility may be revised by the director of business, economic development, and tourism to reflect actual production for the purposes of determining statewide production capacity under subsection (g) and allowable credits for that facility under subsection (a). Notwithstanding any other law to the contrary, this information shall be available for public inspection and dissemination under chapter 92F.

(k) Each calendar year during the credit period, the taxpayer shall provide information to the director of business, economic development, and tourism on the number of gallons of ethanol produced and sold during the previous calendar year, how much was sold in Hawaii versus overseas, feedstocks used for ethanol production, the number of employees of the facility, and the projected number of gallons of ethanol production for the succeeding year.

(l) In the case of a partnership, S corporation, estate, or trust, the tax credit allowable is for every qualifying ethanol production facility. The cost upon which the tax credit is computed shall be determined at the entity level. Distribution and share of credit shall be determined pursuant to section 235-110.7(a).

(m) Following each year in which a credit under this section has been claimed, the director of business, economic development, and tourism shall submit a written report to the governor and legislature regarding the production and sale of ethanol. The report shall include:

(1) The number, location, and nameplate capacities of qualifying ethanol production facilities in the State;

(2) The total number of gallons of ethanol produced and sold during the previous year; and

(3) The projected number of gallons of ethanol production for the succeeding year.

(n) The director of taxation shall prepare forms that may be necessary to claim a credit under this section. Notwithstanding the department of business, economic development, and tourism’s certification authority under this section, the director may audit and adjust certification to conform to the facts. The director may also require the taxpayer to furnish information to ascertain the validity of the claim for credit made under this section and may adopt rules necessary to effectuate the purposes of this section pursuant to chapter 91. [L 2000, c 289, ?2; am L 2004, c 140, ?2]

Note
The 2004 amendment applies to taxable years beginning after December 31, 2003. L 2004, c 140, ?4.

April 7, 2003 'Awa (Kava Kava)

UH scientists may have solved kava mystery

honadv
By Kevin Dayton
Advertiser Big Island Bureau
HILO, Hawai’i — A team of University of Hawai’i scientists may have solved the mystery of why some Europeans who used products containing kava extract suffered severe liver damage, prompting a number of nations to ban sales of the herbal supplement.

The culprit may be a compound found in the stem peelings and leaves of the kava plant — known in Hawai’i as ‘awa — but not in the roots that are used to make the traditional kava drink consumed by Pacific Islanders.

Just to be safe, people should avoid tea or anything else made from the leaves or stems of the plant, according to C.S. Tang, professor of molecular biosciences and biosystems engineering at UH-Manoa.

Bans in Singapore, Germany, Canada, the United Kingdom and elsewhere wiped out pharmaceutical sales of kava and virtually destroyed it as an export crop in Hawai’i. While kava supplements are not banned in the United States, the Food and Drug Administration issued an advisory in March 2002 warning of the potential risk of severe liver injury from dietary supplements containing kava.

The health alarms left farmers in Hamakua and elsewhere with crops that were hardly worth harvesting.

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December 31, 2001 'Awa (Kava Kava)

Analysis of Kava Side Effects Reports Concerning the Liver

Translation to English by Lindenmaier M and Brinckmann J
31. December 2001

Analysis of hepatotoxic reactions listed by the BfArM (German Federal Institute for Drugs and Medical Devices)

The BfArM has recently informed industry and media about reported side effects that may be associated with the ingestion of kava preparations (2;3). In this preliminary information, it is stated that the Institute proposes to revoke marketing authorization for kava -containing drugs including homeopathic preparations with a final concentration of D6. Henceforth, the manufacturers have been given the opportunity, within 4 weeks time of receipt of the letter, to respond with its position concerning the proposed measures.Even though the announcements are rather serious, the need for urgency comes as a surprise: with regard to the drug safety protocol developed in Switzerland in 2000, of which the German health authorities also had knowledge of, the information status has not fundamentally changed. Yet on October 19, 2000, theGerman health authorities stated in a 10 part report that the BfArM had no intentions of conducting a new risk evaluation for kava products in Germany (1). ???

The announcement of a drug safety protocol through the BfArM was based on a listing of 24 cases of side effects in connection with serious hepatotoxic effects ranging up to liver failure, (cholestatic) hepatitis or cirrhosis of the liver. In 18 of these cases, the BfArM classified an association with kava as probable or possible. In one case, the adverse effect on the liver was fatal. Five cases were without any concomitant medication. Two reports couldnot be evaluated due a lack of clinical data. Also, in the cases involvingco-medication, the BfArM considered kava to be responsible for the side effect. Serological investigations, as far as they were carried out, were negative in all cases.

Closer inspection of the presented cases provides, however, another outcome andraises considerable questions with regard to the BfArM accuracy or carefulness in association with sensible procedures. For example, the report regarding virus serology is misleading: such investigations were conducted in only the fewest of cases, and these were primarily the ones reported in Switzerland. The adverse event case reports from Switzerland are collectively characterized as being representative, while the evaluation of the listings bythe BfArM is far from compliance with the current standards required to fulfill relevant European guidelines.

When one examines the reactions in detail, it appears that the BfArM’s classification of causality linked to kava, is, to a large extent, incomprehensible, and arbitrary. Moreover, in its evaluation of cases, the BfArM had not taken into consideration various existing pieces of information, for example those with regard to other possible causes. One extreme example may be concerning the aforementioned lethal case: in this instance, it was known to the Institute that the cause of liver failure was several years of alcoholabuse, and that kava was not involved in the genesis of the liver symptoms. The autopsy had shown that the cirrhotic process had already started long before the adminstration of kava began!

The second, internal listing documented that this circumstance was known to the BfArM, but this listing has not been made accessible to the manufacturers for use in rebuttal statements regarding the notice of possible marketing revocation. This second listing contained a compilation of all known suspected cases (32 in all), including those reported in Switzerland and those published in the literature. This listing is indeed carefully conveyed as being an ?official? paper, however it still contains a range of obvious errors.

Because the ?non-official? second listing of the BfArM is complete in regard to the sources referred to in this evaluation, the 24 reports of side effects initially reported by BfArM are consequently not being used as the basis of discussion, but rather the 32 cases that were entered into the second listing. In addition to the BfArM’s two listings, other sources of information for the present case evaluation include the

Interkantonalen Kontrollstelle (IKS) der Schweiz (Swiss Intercantonal Agency for Control of Medicines), the pharmacovigilance databank of the WHO, as well as concerned product manufacturers.The listing of cases that are suspected to be kava-related by the Arzneimittelkomission der deutschen ?rzteschaft (AKD?) (Drug Commission of the German Physician’s Association) is not included. The AKD?’s listing of the most recent adverse event reports contains no indications of liver toxicity from kava products. Moreover, theAKD? does not release the product names publicly, which prevents a meaningful use of the data a priori.?

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December 31, 2001 'Awa (Kava Kava)

Analysis of Kava Side Effects Reports Concerning the Liver–Total Listed Cases

Translation to English by Lindenmaier M and Brinckmann J
31. December 2001
Analysis of hepatotoxic reactions listed by the BfArM (German Federal Institute for Drugs and Medical Devices)

1. Total Listed Cases
Referring to the non-official second listing of the BfArM as a foundation, there is a database of 32 side effect reports, including those reported by the Swiss health authorities (IKS), the WHO, as well as those cases described in the medical literature. The number of 32 reports is of course not synonymous to 32 cases of confirmed causality. The list contains duplicate reports and questionable classifications. When one collects all the available data for the individual cases, one arrives inevitably at another evaluation of the data.

2. Duplicate Entries
With a more accurate observation of the case reports listed by the BfArM, one finds a range of duplicate entries. Obviously, the duplicate entries were not reconciled against each other when the information was obtained from different sources. Therefore, the report of one and the same case can lead to a threefold entry, if, on the one hand, the event is reported directly from the patient, and on the other hand, the event is also reported via the manufacturer’s duty of notification, and finally, the treating phyisician also turns in a case report. These redundant data entries are not only difficult to recognize, but the inflated number of cases has led to a shift in the risk evaluation for a drug substance. In the case of the BfArM listings, mistakes in data transfer have exacerbated this situation.
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