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	<title>Comments on: Don&#8217;t Believe Everything You Read in the Newspaper. . .</title>
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	<description>Latest News on DDTC, BIS, OFAC, and other export law matters</description>
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		<title>By: RS</title>
		<link>http://www.exportlawblog.com/archives/215/comment-page-1#comment-3644</link>
		<dc:creator>RS</dc:creator>
		<pubDate>Fri, 24 Aug 2007 17:45:00 +0000</pubDate>
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		<description>Mike, I agree with you regarding the publication of the CCATS. A great parallel to this is the CROSS system that is maintained by Customs. I will argue that for the most part, the binding rulings contain more information than the CCATS rulings. When I submit classification requests to BIS, I will generally not include proprietary information in the application itself, but IF needed, send it as an attachment. I think publishing the CCATS data would be a great help in furthering the stated goals of BIS.</description>
		<content:encoded><![CDATA[<p>Mike, I agree with you regarding the publication of the CCATS. A great parallel to this is the CROSS system that is maintained by Customs. I will argue that for the most part, the binding rulings contain more information than the CCATS rulings. When I submit classification requests to BIS, I will generally not include proprietary information in the application itself, but IF needed, send it as an attachment. I think publishing the CCATS data would be a great help in furthering the stated goals of BIS.</p>
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		<title>By: Mike Deal</title>
		<link>http://www.exportlawblog.com/archives/215/comment-page-1#comment-3638</link>
		<dc:creator>Mike Deal</dc:creator>
		<pubDate>Fri, 24 Aug 2007 14:37:24 +0000</pubDate>
		<guid isPermaLink="false">http://www.exportlawblog.com/archives/215#comment-3638</guid>
		<description>The reason given by BIS is not the proprietary information exception to FOIA, but Section 12(c) of the long expired EAA, which applies to licenses and license applications.  Its easy to see why an exporter might not want to release information about a license and/or license application, since that would reveal the name of the customer and other parties, the price, and other propietary information.  The CCAT determination is a different critter.  While the application for a CCAT might actually contain proprietary information, which could be protected by the proprietary information exception to FOIA, the actual CCAT itself does little more than identify the item and give the ECCN and available license exceptions. Many companies actually post their CCATs on the web, or at least the ECCN with the CCAT number, and find that rather than hurt business that doing so actually is good for business because it helps their customers and reduces their costs. Anyone who has ever tried to get an ECCN out of a salesman for a vendor who doesn&#039;t have a clue as to what an ECCN is can appreciate that a lot of time and effort is wasted. And BIS frowns on, though does not expressly prohibit, persons other than the maker submitting CCATs for products, even if they are the principal exporter. Legislation that failed in the last Congress would have made both CCAT and CJ determinations public, but it was opposed by BIS and DDTC.

I don&#039;t think this is a &quot;stealth Big Brother&quot; issue as much as it is just the typical bureaucratic self- protection instinct, but in the Bush Administration with its well-publicized opposition to public disclosure in general and FOIA in particular, you just can&#039;t be sure.</description>
		<content:encoded><![CDATA[<p>The reason given by BIS is not the proprietary information exception to FOIA, but Section 12(c) of the long expired EAA, which applies to licenses and license applications.  Its easy to see why an exporter might not want to release information about a license and/or license application, since that would reveal the name of the customer and other parties, the price, and other propietary information.  The CCAT determination is a different critter.  While the application for a CCAT might actually contain proprietary information, which could be protected by the proprietary information exception to FOIA, the actual CCAT itself does little more than identify the item and give the ECCN and available license exceptions. Many companies actually post their CCATs on the web, or at least the ECCN with the CCAT number, and find that rather than hurt business that doing so actually is good for business because it helps their customers and reduces their costs. Anyone who has ever tried to get an ECCN out of a salesman for a vendor who doesn&#8217;t have a clue as to what an ECCN is can appreciate that a lot of time and effort is wasted. And BIS frowns on, though does not expressly prohibit, persons other than the maker submitting CCATs for products, even if they are the principal exporter. Legislation that failed in the last Congress would have made both CCAT and CJ determinations public, but it was opposed by BIS and DDTC.</p>
<p>I don&#8217;t think this is a &#8220;stealth Big Brother&#8221; issue as much as it is just the typical bureaucratic self- protection instinct, but in the Bush Administration with its well-publicized opposition to public disclosure in general and FOIA in particular, you just can&#8217;t be sure.</p>
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		<title>By: Matthew J. Lancaster</title>
		<link>http://www.exportlawblog.com/archives/215/comment-page-1#comment-3629</link>
		<dc:creator>Matthew J. Lancaster</dc:creator>
		<pubDate>Fri, 24 Aug 2007 03:37:16 +0000</pubDate>
		<guid isPermaLink="false">http://www.exportlawblog.com/archives/215#comment-3629</guid>
		<description>It is my understanding that it was private industry that pushed BIS to not publish CCATs.  The theory is that the CCAT is treated as information proprietary to the requestor, which makes it unreleasable under a FOIA request.  Isn&#039;t this why BIS refuses to publish or release CCATs as opposed to a stealth Big Brother motive?</description>
		<content:encoded><![CDATA[<p>It is my understanding that it was private industry that pushed BIS to not publish CCATs.  The theory is that the CCAT is treated as information proprietary to the requestor, which makes it unreleasable under a FOIA request.  Isn&#8217;t this why BIS refuses to publish or release CCATs as opposed to a stealth Big Brother motive?</p>
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		<title>By: Mike Deal</title>
		<link>http://www.exportlawblog.com/archives/215/comment-page-1#comment-3612</link>
		<dc:creator>Mike Deal</dc:creator>
		<pubDate>Thu, 23 Aug 2007 12:43:44 +0000</pubDate>
		<guid isPermaLink="false">http://www.exportlawblog.com/archives/215#comment-3612</guid>
		<description>The BIS regulations pertaining to the classification of medical devices that BIS ignores expressly provide that hardware and software designed for medical end-use shall not be classified under the information security provisions of Category 5, part 2 of the CCL:

N.B. to Note 1: Commodities and software
specially designed for medical end-use that
incorporate an item in Category 5, part 2 are not
classified in any ECCN in Category 5, part 2.

Any ambiguity in the nota bene is dispelled in the preamble of the Federal Register notice by which it was promulgated:

Consistent with the standing export control agreement among Wassenaar Arrangement member nations, this rule also adds a nota bene (‘‘NB’’)immediately following Note 1 in Category 5 part II that clarifies that
commodities and software specially designed for medical end-use that incorporate encryption items listed in Category 5 part II are not controlled by
Category 5, part II of the Commerce Control List. This rule thus clarifies that a commodity or software product that is specially designed for medical end-use
is classified as EAR99, even if the medical product incorporates another product, part or component that would otherwise be classified as 5A002, 5D002, 5A992 or 5D992.

Bureau of Industry and Security, Docket No. 030529136–3136–01, RIN 0694–AC78, “Export Administration Regulations: Encryption Clarifications and Revisions,” 68 Fed. Reg. 35783 (June 17, 2003) (emphasis added).

The language of the preamble is echoed in interpretation 13 set forth in EAR Section 770.2(m):

However, commodities and software specially designed for medical end-use that incorporate an item in Category 5, part 2 are not controlled in Category 5, part 2. 


Perhaps other folks have gotten CCATs that don&#039;t ignore the regs.  There&#039;s no way of knowing because BIS won&#039;t publish, even under FOIA, its CCATs; therefore, there&#039;s no way of knowing whether its playing favorites (which in the Bush Administration, can never be ruled out).</description>
		<content:encoded><![CDATA[<p>The BIS regulations pertaining to the classification of medical devices that BIS ignores expressly provide that hardware and software designed for medical end-use shall not be classified under the information security provisions of Category 5, part 2 of the CCL:</p>
<p>N.B. to Note 1: Commodities and software<br />
specially designed for medical end-use that<br />
incorporate an item in Category 5, part 2 are not<br />
classified in any ECCN in Category 5, part 2.</p>
<p>Any ambiguity in the nota bene is dispelled in the preamble of the Federal Register notice by which it was promulgated:</p>
<p>Consistent with the standing export control agreement among Wassenaar Arrangement member nations, this rule also adds a nota bene (‘‘NB’’)immediately following Note 1 in Category 5 part II that clarifies that<br />
commodities and software specially designed for medical end-use that incorporate encryption items listed in Category 5 part II are not controlled by<br />
Category 5, part II of the Commerce Control List. This rule thus clarifies that a commodity or software product that is specially designed for medical end-use<br />
is classified as EAR99, even if the medical product incorporates another product, part or component that would otherwise be classified as 5A002, 5D002, 5A992 or 5D992.</p>
<p>Bureau of Industry and Security, Docket No. 030529136–3136–01, RIN 0694–AC78, “Export Administration Regulations: Encryption Clarifications and Revisions,” 68 Fed. Reg. 35783 (June 17, 2003) (emphasis added).</p>
<p>The language of the preamble is echoed in interpretation 13 set forth in EAR Section 770.2(m):</p>
<p>However, commodities and software specially designed for medical end-use that incorporate an item in Category 5, part 2 are not controlled in Category 5, part 2. </p>
<p>Perhaps other folks have gotten CCATs that don&#8217;t ignore the regs.  There&#8217;s no way of knowing because BIS won&#8217;t publish, even under FOIA, its CCATs; therefore, there&#8217;s no way of knowing whether its playing favorites (which in the Bush Administration, can never be ruled out).</p>
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		<title>By: Mike Deal</title>
		<link>http://www.exportlawblog.com/archives/215/comment-page-1#comment-3608</link>
		<dc:creator>Mike Deal</dc:creator>
		<pubDate>Thu, 23 Aug 2007 10:55:05 +0000</pubDate>
		<guid isPermaLink="false">http://www.exportlawblog.com/archives/215#comment-3608</guid>
		<description>BIS has blatantly flouted TSRA,not to mention its own notes to Cat.5,part 2,and the interpretation in 770.2, by simply classifying medical devices approved as such by the FDA as other than EAR99 simply because they use an operating system with encryption, including but not limited to such publicly available open-source operating systems as Linux with an open-source  encryption kernel, and therefore ineligible for licenses from OFAC.  In this way, they keep very sick people in places like Cuba, Syria and Iran from getting the best available diagnostic and treatment tools.  Granma is right.  Its criminal. Its intended to hurt people who live in those counties by denying them the most modern medical technology.</description>
		<content:encoded><![CDATA[<p>BIS has blatantly flouted TSRA,not to mention its own notes to Cat.5,part 2,and the interpretation in 770.2, by simply classifying medical devices approved as such by the FDA as other than EAR99 simply because they use an operating system with encryption, including but not limited to such publicly available open-source operating systems as Linux with an open-source  encryption kernel, and therefore ineligible for licenses from OFAC.  In this way, they keep very sick people in places like Cuba, Syria and Iran from getting the best available diagnostic and treatment tools.  Granma is right.  Its criminal. Its intended to hurt people who live in those counties by denying them the most modern medical technology.</p>
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		<title>By: Clif Burns</title>
		<link>http://www.exportlawblog.com/archives/215/comment-page-1#comment-3605</link>
		<dc:creator>Clif Burns</dc:creator>
		<pubDate>Thu, 23 Aug 2007 05:14:13 +0000</pubDate>
		<guid isPermaLink="false">http://www.exportlawblog.com/archives/215#comment-3605</guid>
		<description>Luis, yes, licenses are required for shipments of  medical products to Cuba, just as licenses are required for export of certain other items to other countries.   But a license requirement isn&#039;t an embargo.  And licenses are granted for shipments of medicine and medical devices to Cuba.  So Granma&#039;s claim that these shipments are embargoed is patently false.

On the other hand, I have argued here against unilateral sanctions regimes, such as the Cuba embargo, because they are ineffective in accomplishing regime change and tend to hurt a country&#039;s population rather than its leaders. In that vein, I would agree that the license requirement should be eliminated, as should all of the other requirements relating to AgMed and other civilian and non-dual-use shipments to Cuba.  Still, these requirements don&#039;t constitute an embargo and Granma&#039;s claim that there is such an embargo, without any further qualification, is transparent propaganda.</description>
		<content:encoded><![CDATA[<p>Luis, yes, licenses are required for shipments of  medical products to Cuba, just as licenses are required for export of certain other items to other countries.   But a license requirement isn&#8217;t an embargo.  And licenses are granted for shipments of medicine and medical devices to Cuba.  So Granma&#8217;s claim that these shipments are embargoed is patently false.</p>
<p>On the other hand, I have argued here against unilateral sanctions regimes, such as the Cuba embargo, because they are ineffective in accomplishing regime change and tend to hurt a country&#8217;s population rather than its leaders. In that vein, I would agree that the license requirement should be eliminated, as should all of the other requirements relating to AgMed and other civilian and non-dual-use shipments to Cuba.  Still, these requirements don&#8217;t constitute an embargo and Granma&#8217;s claim that there is such an embargo, without any further qualification, is transparent propaganda.</p>
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		<title>By: Luis Rumbaut</title>
		<link>http://www.exportlawblog.com/archives/215/comment-page-1#comment-3604</link>
		<dc:creator>Luis Rumbaut</dc:creator>
		<pubDate>Thu, 23 Aug 2007 04:21:11 +0000</pubDate>
		<guid isPermaLink="false">http://www.exportlawblog.com/archives/215#comment-3604</guid>
		<description>Your faithful readers may not know that the theoretical permission to sell medicine and equipment does not mean that you just call up and negotiate a contract.  That permission goes back to the 1992 Torricelli Act, when the bill proposed to deny any and all trade, and some senators balked at including food and medicine.  The re-done bill allowed those, but imposed onerous requirements instead, meant to make the permission unusable. Those provisions in turn were silently adopted by inference under Helms-Burton in 1996. 

You have to get a specific license for each sale, and prove that the intended end user will be the real user, down to the particular locality.  It amounts to getting a on-site certificate from someone approved by the US, which can object on the grounds that anything may be diverted, for example, to military use.   And soldiers do use medical supplies from band-aids and aspirin to high-tech equipment. 

The Commerce Dept says at 
http://www.bis.doc.gov/Licensing/TSRAsFAQs122101.html#QFourteen

&quot;14. Why are medicines and medical devices ineligible for this program for Cuba?

&quot;The Trade Sanctions Reform and Export Enhancement Act did not clearly repeal or supersede the relevant Cuban Democracy Act (CDA) provisions on medical items so the latter&#039;s requirements still apply. The CDA requires a specific license for exports of medicines and medical items. In addition, there are certain criteria, such as on-site monitoring requirements, that have to be met.&quot;

If you know of medical sales being easy to carry out, please let us know.  I know a doctor who&#039;d like to sell medicines. 

BTW, a US non-profit used to be the main supplier world-wide of humanitarian aid to the Cuban NGO of handicapped people.  Under its people-to-people license its members took wheelchairs and similar equipment, and medicines sch as those for bedsores.  In 2004, its application for renewal was not acted upon--no denial, no approval, no response.  Along with most other p2p licenses, it just faded away.</description>
		<content:encoded><![CDATA[<p>Your faithful readers may not know that the theoretical permission to sell medicine and equipment does not mean that you just call up and negotiate a contract.  That permission goes back to the 1992 Torricelli Act, when the bill proposed to deny any and all trade, and some senators balked at including food and medicine.  The re-done bill allowed those, but imposed onerous requirements instead, meant to make the permission unusable. Those provisions in turn were silently adopted by inference under Helms-Burton in 1996. </p>
<p>You have to get a specific license for each sale, and prove that the intended end user will be the real user, down to the particular locality.  It amounts to getting a on-site certificate from someone approved by the US, which can object on the grounds that anything may be diverted, for example, to military use.   And soldiers do use medical supplies from band-aids and aspirin to high-tech equipment. </p>
<p>The Commerce Dept says at<br />
<a href="http://www.bis.doc.gov/Licensing/TSRAsFAQs122101.html#QFourteen" rel="nofollow">http://www.bis.doc.gov/Licensing/TSRAsFAQs122101.html#QFourteen</a></p>
<p>&#8220;14. Why are medicines and medical devices ineligible for this program for Cuba?</p>
<p>&#8220;The Trade Sanctions Reform and Export Enhancement Act did not clearly repeal or supersede the relevant Cuban Democracy Act (CDA) provisions on medical items so the latter&#8217;s requirements still apply. The CDA requires a specific license for exports of medicines and medical items. In addition, there are certain criteria, such as on-site monitoring requirements, that have to be met.&#8221;</p>
<p>If you know of medical sales being easy to carry out, please let us know.  I know a doctor who&#8217;d like to sell medicines. </p>
<p>BTW, a US non-profit used to be the main supplier world-wide of humanitarian aid to the Cuban NGO of handicapped people.  Under its people-to-people license its members took wheelchairs and similar equipment, and medicines sch as those for bedsores.  In 2004, its application for renewal was not acted upon&#8211;no denial, no approval, no response.  Along with most other p2p licenses, it just faded away.</p>
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		<title>By: Clif Burns</title>
		<link>http://www.exportlawblog.com/archives/215/comment-page-1#comment-3601</link>
		<dc:creator>Clif Burns</dc:creator>
		<pubDate>Thu, 23 Aug 2007 02:15:02 +0000</pubDate>
		<guid isPermaLink="false">http://www.exportlawblog.com/archives/215#comment-3601</guid>
		<description>Ha! That&#039;s interesting.  Even Granma thought that the claim of criminal brutality might be a bit much for English readers, even though they might be able to lie about medicine and medical devices.  Good catch, Scott.</description>
		<content:encoded><![CDATA[<p>Ha! That&#8217;s interesting.  Even Granma thought that the claim of criminal brutality might be a bit much for English readers, even though they might be able to lie about medicine and medical devices.  Good catch, Scott.</p>
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		<title>By: Scott Caplan</title>
		<link>http://www.exportlawblog.com/archives/215/comment-page-1#comment-3596</link>
		<dc:creator>Scott Caplan</dc:creator>
		<pubDate>Wed, 22 Aug 2007 23:35:29 +0000</pubDate>
		<guid isPermaLink="false">http://www.exportlawblog.com/archives/215#comment-3596</guid>
		<description>El Granma&#039;s own translation, keeping the error, was:

While the Bush administration has hardened application of the siege against Cuba, with special malice against the tourist industry, the blockade also extends to medicines and healthcare technology.

http://www.granma.cubaweb.cu/english/news/art13.html

I was using a dictionary until I noticed that &quot;ensañamiento criminal&quot; could loosely be translated as criminal malice, and I realized I have to head back to law school in a week and a half.</description>
		<content:encoded><![CDATA[<p>El Granma&#8217;s own translation, keeping the error, was:</p>
<p>While the Bush administration has hardened application of the siege against Cuba, with special malice against the tourist industry, the blockade also extends to medicines and healthcare technology.</p>
<p><a href="http://www.granma.cubaweb.cu/english/news/art13.html" rel="nofollow">http://www.granma.cubaweb.cu/english/news/art13.html</a></p>
<p>I was using a dictionary until I noticed that &#8220;ensañamiento criminal&#8221; could loosely be translated as criminal malice, and I realized I have to head back to law school in a week and a half.</p>
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