[NHCOLL-L:5413] Re: [PERMIT-L] Sending specimens to China

Mon May 9 04:41:10 EDT 2011

Hi all,

regarding the new EC-veterinary laws we (GfBS, CETAF, SPNHC, DNFS, VBio) 
are doing our best and are awaiting detailed answers from the SANCO in 
Brussels (authority in charge for the new amendments). Their last 
meeting was last Friday.

Since enforcement of EC implementation regulation EC No. 142/2011, we 
have 27 different national interpretations of the same new European 
Verterinary Guidelines (EC No. 1069/2009). This makes import to Europe 
so tiresome at the moment, but we are strongly pushing for exemption 
from this nonsense for preserved specimens.

As posted already before, I will post new information from a workshop 
held last Thursday & Friday in Bonn soon. FedEx & UPS joined the 
workshop, and there is a bundle of things which we could improve with 
little effort on our side to avoid import issues (I need to summarise 
the relevant points)

Further restrictions on the use of genetic resources are currently 
discussed for the Access Benefit Sharing of the Rio-Convention (CBD) 
opening a profitable permits market for the pharmaceutical industry.
The Nagoya-Protocol does not include any exemptions for non-profit 
biological research and likely bans the subsequent usage of "genetic 
resources" collected after 1992. Enforcement for border inspection 
controls is currently discussed which would allow only import of samples 
which have an agreement of transfer of possession ... Lobbying from our 
side against this stupidity should be coordinated for mutual support of 
petitions.

All the best
Dirk

Am 07.05.2011 00:44, schrieb Doug Yanega:
> Ellen Paul wrote:
>
>> So let's start with this simple premise:
>> The people to whom you are sending these items should be working as 
>> hard at their end to avert problems as you are at your end. They are 
>> responsible for knowing what the permit and biosafety requirements 
>> are for their countries and for conveying that information to you. 
>> You should always ask them to provide this information before you ship.
>
> One would hope so, but when the regulatory agencies themselves cannot 
> agree on simple questions like "Do these rules apply to dried insect 
> specimens?" then the situation devolves into a matter of the personal 
> interpretation of each individual inspector who comes across a 
> scientific shipment; some will understand that pinned insect specimens 
> are not a biosafety hazard, others will not. Some will believe that 
> insects are not *covered* by the regulations, others will think they 
> *are*. There are plenty of regulations *on the books* that are not or 
> cannot be treated as enforceable (or applicable in certain contexts), 
> including a few I dare not mention in public because zealous 
> enforcement could have serious repercussions. It's a serious question: 
> if there is a one-in-a-thousand chance that a shipment you are 
> expecting could be stopped and held up, even if the shipment is 
> technically in the clear (based on interpretation of the regs), are we 
> nonetheless expected to tell people NOT to ship us any specimens 
> unless they fulfill all of the requirements, even if those 
> requirements are inapplicable?
>
>> I strongly suggest you NOT boycott all countries that apply biosafety 
>> regulations to scientific specimens because guess what?
>
> I was not suggesting we should, either.
>
>> The United States does it. Canada does it. The European Union does 
>> it. Pretty much every country wants to exclude pathogens that do not 
>> already occur in their country. In the U.S. it is (for birds) - 
>> "Exotic" Newcastle (we have three of the four forms here but not 
>> Viscerotropic Velogenic Newcastle Disease) and HPAI H5N1. The USDA 
>> has proposed to include all HPAIs on the excluded/restricted list; 
>> the OC suggested that the science does not support this.
>
> I have never heard of the US or Canada intercepting shipments of dead 
> insects as biosafety violations. Some EU countries have, in fact, done so.
>
>> For mammals it is Swine Vesicular Disease, Hoof-and-Mouth Disease, 
>> rinderpest (which has been eradicated but I'm not sure if they have 
>> lifted restrictions yet), Bovine Spongiform Encephalitis, African 
>> Horse Fever, Classical Swine Fever, Contagious Equine Metritis, and 
>> Classical Swine Fever.
>> The CDC has authority over the pathogens that affect human health 
>> (including African rodents, civets, small turtles, and non-human 
>> primates).
>
> If dead insects (or pickled fish, etc.) cannot carry these diseases, 
> then why should such shipments require certification that they are 
> disease-free? That makes more work for everyone, with no benefit.
>
>> I think you have misconstrued my comments about the fees. No one is 
>> doing this because it generates revenue. They are doing it because 
>> they need to exclude these pathogens.* That they allow you to bring 
>> this stuff in at all is an exemption to a prohibition that applies to 
>> everyone else. There is an express provision in the regulations that 
>> says you can import it for scientific study under conditions that 
>> they deem will prevent the introduction of harmful pathogens.* And 
>> that whole system depends on your getting permits, because that is 
>> the manner in which they can assure themselves that the material is 
>> handled appropriately.
>>
>> My point about the permit fees is that once they have a system of 
>> permits, they need people to administer that system of permits and 
>> those people are employees who have to be paid, who work in buildings 
>> that have to be purchased or leased, lights that have to be paid for, 
>> phones and computers that have to be paid for, etc. Appropriations 
>> don't begin to cover the costs. U.S. law requires that agencies 
>> charge user fees when they provide services to recipients that are 
>> not provided to the general public 
>> [http://www.whitehouse.gov/omb/circulars_a025/].
>
> If, say, 90% of all scientific material exchanged between institutions 
> cannot possibly carry diseases, then these agencies could presumably 
> cut down on their labor, paperwork (and maybe even staffing) by as 
> much as 90% if they simply made things like pinned insects and pickled 
> fish exempt from all these biosafety permitting requirements in the 
> first place. It sounds like their costs are so high in part because 
> they are trying to apply their regulations far too broadly.
>
>> In the case of APHIS, user fees are also authorized by section 
>> 2509(c)(1) of the Food, Agriculture, Conservation, and Trade Act of 
>> 1990, as amended (21 U.S.C. 136a). APHIS is authorized to establish 
>> and collect fees that will cover the cost of providing import- and 
>> export-related services for animals, animal products, birds, germ 
>> plasm, organisms, and vectors. Since fiscal year (FY) 1992, APHIS has 
>> received no directly appropriated funds to provide import- and export 
>> related services for animals, animal products, birds, germ plasm, 
>> organisms, and vectors. Their ability to provide these services 
>> depends on user fees.
>>
>> So they have to charge fees by law and those fees, by design, are 
>> supposed to defray the cost of providing the service. However, the 
>> cost of providing the service outstrips the appropriated funds and 
>> the revenue from fees. So they are reluctant to reduce the revenue 
>> from fees by combining permits or issuing blanket permits.
>
> Then why not exclude as much as possible from *requiring* permits? If 
> they don't have to issue permits for dead arthropods, or fish, or 
> mollusks, etc., then that reduces the costs of their services, right?
>
> I do, honestly, understand the motivation and need for regulations 
> like these, and would not dispute the *intent* of the law. But, at the 
> same time, if the rules are written without careful attention to when 
> and where they should and should not be applied, then there can be a 
> severe disconnect between the *intent* of the law, and the *letter* of 
> the law. Maybe, as an entomologist, I am overly sensitive to this sort 
> of thing; after all, I've literally stood in the presence of a BLM 
> ranger harrassing a colleague for collecting 5 insect specimens along 
> a roadside, and noticing that the grill on his jeep had over 30 dead 
> insects visible on it (and every car driving past us, as well). In 
> some cases, the rules are ambiguous, and it's like playing roulette as 
> to whether you run afoul of someone who interprets them too strictly - 
> in some cases, the rules are not ambiguous (and in your favor), but 
> the agents responsible for their enforcement are actually unaware of 
> those rules (as in the case of the BLM ranger above, who earned a 
> reprimand when we contacted his superiors) - and the biggest problems 
> are rules that are unambiguous and inappropriately broad. The work 
> Andy Bentley has done regarding hazardous materials shipping regs has 
> been exemplary in this regard, getting exemptions written into the 
> laws that facilitate our scientific endeavors (a single vial 
> containing 3 ml of 95% ethanol and a dead wasp is NOT hazardous); one 
> would hope that these biosafety regulators would be open to similar 
> changes to their rules, for the same reasons.
>
> Sincerely,
> -- 
>    
>
> Doug Yanega        Dept. of Entomology         Entomology Research Museum
> Univ. of California, Riverside, CA 92521-0314        skype: dyanega
> phone: (951) 827-4315 (standard disclaimer: opinions are mine, not UCR's)
>              http://cache.ucr.edu/~heraty/yanega.html
>   "There are some enterprises in which a careful disorderliness
>         is the true method" - Herman Melville, Moby Dick, Chap. 82

-- 
Dirk Neumann

Tel: 089 / 8107-111
Fax: 089 / 8107-300
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email: Dirk.Neumann(a)zsm.mwn.de

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