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Regulatory guidance documents are written by committees, resulting in statements that are both exact and generic. Meeting regulatory requirements involves not only interpreting these documents correctly but also addressing their omissions. This article provides practical guidance on issues that are not thoroughly covered by current guidance documents regarding validation of analytical methods for biopharmaceuticals.
We can generate evidence for the validity of analytical data in the formal method-validation program where all critical parameters are extensively tested under a detailed protocol that includes scientifically justified and logical step-by-step experimental approaches. All planned data sets must fall within pre-established protocol acceptance criteria (limits). These criteria should be derived from and justified in relation to historical data and product specifications. Once evidence for all critical elements is provided, the validated method will become the official, licensed procedure for that particular product and process step, and it will then support production and product release. The relationship between "valid" or "suitable and validated" is often overlooked, but there is a high price when "validated" test systems are simply inappropriate.Incentives to replace existing licensed test procedures may come from regulatory agencies, or they could be motivated by potential cost savings, ease of use (automation), and the opportunity to generate more accurate and reliable results.
The International Conference on Harmonisation (ICH)'s Q2A and Q2B1,2 and the United States Pharmacopoeia's USP 27 <1225>6 should be used for basic guidance. However, following just these guidelines will not necessarily produce a "valid" method and may not provide sufficient evidence that this method is suitable for product release. FDA provides guidance on some of the scientific issues that are not covered by Q2A and Q2B or USP 27.3,4,6
Process Map. A process map showing the recommended steps for the selection, development, validation, and potential transfer of analytical methods, illustrating all functional responsibilities was developed. Frequently, larger companies have separate functional units for method development, validation, and testing. The process flow in Figure 1 describes an ideal sequence of steps for better analytical method validation (AMV).
The rigorous standards suggested here are ideal, but they are not necessarily required or followed during method development. Methods can be developed without strict adherence to GMP regulations if adequate documentation systems are used.


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WARWICK � Two airlines may be offering flights from Rhode Island�s T.F. Green Airport to Europe next spring, airport chief Kelly J. Fredericks announced Tuesday morning at a briefing for elected officials, business leaders and other airport �stakeholders.�
Fredericks, who is president of the Rhode Island Airport Corporation, the state agency that runs Green, was tight-lipped with details, saying that he was in �final negotiations� with two airlines that would be new to Green.
He said the airlines would offer service four days a week � one of them on Mondays and Wednesdays, the other on Tuesdays and Thursdays.
Fredericks said that announcements for the flights could come as early as this month.
In December, the last time the airport held a stakeholders meeting, Fredericks also dangled the possibility that international service could announced near the beginning of 2014, but that didn�t happen, at least not on the schedule he had hoped. He said Tuesday that one of the two airlines that may announce European service this month is the same one he was talking about in December.
Location, ST | website.com

subset: commoncrawl


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A letter from the founder of BEYONDgear, Asa Firestone
BEYONDgear was founded on the simple principle that adventure can be used for good. In 2003, while living in Brazil, I traveled to Rio de Janeiro to climb on the wild granite peaks that erupt right out of the city. On the slopes of these cliffs, massive favelas (slums) have spawned from decades of Brazilian social inequalities. While visiting Rio, I was inspired to climb the wild 'Two Brothers' peak that soars 1,000 feet above the famous Ipanema Beach. Talking with local climbers, I was told it was too dangerous due to heavily armed drug militias that make their headquarters in the nearby favelas. I was frustrated that a peak could not be climbed because of crime. I decided to do my part to change that by sharing my positive experiences of climbing with the favela community. By providing outdoor education and enabling access to the climbing resources just above the favelas, the power of adventure can be harnessed to change lives.
In 2011, I teamed up with Andrew Lenz, a brilliant local climbing guide, to form the CEU Urban Climbing School in the Rocinha Favela. Rocinha is one of the largest slums in Brazil and located just below the Two Brothers Peak. CEU currently has 15 local students that participate in climbing trips, skills training, and environmental stewardship. CEU believes that the skills learned through climbing can create confidence and leadership skills in youth as well as teach risk management to the youth of the favelas. To further facilitate this mission, CEU obtained permission from the Brazilian Bureau of Sports to build a professional climbing wall in the government managed Rocinha sports complex.
In order to help fund this project, BEYONDgear was created. BEYONDgear is an outdoor lifestyle brand that utilizes the power of adventure to create positive impact in at-risk communities. Every purchase of BEYONDgear jewelry and apparel gives an adventure experience to an at-risk youth. BEYONDgear aims to enable outdoor enthusiasts to share their positive experiences in the outdoors with kids who would never have that opportunity otherwise. Together, we can generate an entire movement to use #adventure4good.


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Bypass the box office line at many theaters with guaranteed advance tickets. If something comes up, you can return or exchange them up until the posted showtime.
Earn rewards points from our partners, including AMC Stubs, Regal Crown Club and more.
Save your favorite theaters and movies to experience a customized Fandango just for you.
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Looking for movie tickets? Enter your location to see which movie theaters are playing The Adventures of Huckleberry Finn near you.
Mickey Rooney may have been born to play Mark Twain's legendary hellraiser Huck Finn, but 1939's The Adventures of Huckleberry Finn is so MGM-ized that Rooney seems to be sedated. Otherwise, this is a slick retelling of the Twain classic, with Huck escaping both the oppressive kindliness of the widow Douglas (Elizabeth Risdon) and the brutality of his drink-sodden Pap (Victor Kilian) by faking his own death. He heads down the Mississippi River in the company of fugitive slave Jim (Rex Ingram), who hopes to be reunited with his wife and child. Along the way, they get mixed up in the larcenous schemes of the "King" (Walter Connolly) and the "Duke" (William Frawley.) When Jim stops in his flight to save Huck's life after the latter is bitten by a rattler, the slave is captured and sentenced to be hanged for the "murder" of the still-missing Huck. The boy returns the favor by revealing that he's still alive (completely bypassing the hilarious episode in the book wherein Huck and Tom Sawyer--who has been written out of this filmization--map an elaborate jail breakout scheme). The Adventures of Huckleberry Finn is most familiar to baby-boomers via the 30-minute abridged version made available for school showings in the 1960s. ~ Hal Erickson, Rovi


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Can someone help me understand a row?
I am trying to begin this pretty cardigan...when you see it you need to know it starts out with knitting the cable bands that form around the neck and down the front...take a look...
Here is what the directions say: 18-Stitch Cable Braid--panel of 22 sts.
Row 1 and all WS rows - k2,p18,k2
Rows 2 and 4 - p2, k18, p2.
This is what I can't figure out...
Row 6-k6, C12F (which means to sl6 to cn and hold in front, k6, k6 from cn)..but that leaves me with stitches left over and the fold over is UGLY that this stitch makes.
Since it is an "18 stitch cable braid" I must still do the p2 at the beginning and end of that row which would leave me with the 18 for the cable. But the C12F only uses up 12 stitches...so what do I do with the 6 stitches that are left on the needle? So what am I "not getting" here?
Thanks SO much for any help you can give me.:hug:
Thank you!!
Thanks again!:muah:
Cable crosses look really awful until you've knit to the next one, then they don't look so bad. And with 6 and 12 sts to work with, it's harder. But after you're done, pull a little on it lengthwise, and when you wash and block it, the stretching will even out. And a tip - the tighter you knit them, the worse the sts stretch, so keep them loose, even knit with a larger needle on the row before and the crossover row and that helps.
|All times are GMT -4. The time now is 07:59 PM.
copyright knittinghelp.com


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We couldn't find any jobs that match your search for "engineering manufacturing other cleaning validation steam sterilization engineer direct hire or long term contract"
But don't give up – try one of these search tips:
- Use a more general job title or description. For example, "Sales" instead of "Sales Lead"
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- Check your spelling!


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The Daily Start-Up: Portola Teams Up With Biogen On Drug Development
Top stories in today's VentureWire:
Striking a deal with Biogen Idec potentially worth $554 million, Portola Pharmaceuticals gains $45 million up front, including $9 million in equity that adds to its $218 million in venture funding. The company, which is pushing its lead anticoagulant drug into a Phase III study, expects to finish 2011 with over $100 million in the bank, and is thinking about an IPO next year.
Mobile advertising company 4INFO has created a new unit to help advertisers target specific audiences across diverse platforms and networks. The company picked up $14 million in new financing to support the effort, led by Vulcan Capital, which invests on behalf of Microsoft co-founder Paul Allen.
Also in today's VentureWire: less than a year after closing its debut fund at $50 million, IA Ventures is well on its way to reaching its $110 million target for fund two…Navigating Cancer raised $3 million for its branded Web portals to help doctors digitize records and treatment plans…and online real estate brokerage Redfin plans to add new services and expand into new cities with it $14.8 million Series E financing.
(VentureWire is a daily newsletter with comprehensive analysis of all the investments, deals and personnel moves involving start-ups and their venture backers. For a two-week trial, click here.)
Elsewhere around the Web:
Dropbox has introduced a version of its file-sharing service aimed at corporations, another example of how consumer-facing Web companies are tailoring their offerings for enterprises, says the New York Times. The hot company recently raised a $250 million round.
A federal judge dismissed two lawsuits against Yelp by businesses alleging that the local reviews company threatened to downgrade their ratings if they didn't advertise on the site. The judge said the plaintiffs offered nothing more than "the mere possibility" that Yelp manipulated content.
The Wisconsin legislature is battling over a venture capital bill. The controversy centers on certified capital companies, or CAPCOs, which other states have used to encourage investment in start-ups. John Neis, a managing director at Venture Investors, suggested splitting off the provision to get the bill passed, the Milwaukee Journal Sentinel reports.


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Boat blessings start Sunday
Published: Thursday, April 11, 2013 at 10:45 a.m.
Last Modified: Thursday, April 11, 2013 at 10:45 a.m.
You can check out two of the area's biggest boat blessings coming up in Dulac and Chauvin.
Holy Family Catholic Church's boat blessing is scheduled from 10 a.m. to 5 p.m. Sunday at the church, 6641 Grand Caillou Road, Dulac. The day begins with a fishermen's Mass at 10 a.m., followed by a lunch at 11:30 a.m., then the blessing of the boats. For information, call the rectory at 563-2325.
In Chauvin, the boat blessing will be paired with the 2012 Chauvin Folk Art Festival. The festival runs from 11 a.m. to 5 p.m. April 21 at the Chauvin Sculpture Garden, 5337 Bayouside Drive.
You can watch the annual boat parade, sponsored by St. Joseph Catholic Church, from the bayouside. It starts in front of the church and proceeds down Bayou Little Caillou to Boudreaux Canal.
Reader comments posted to this article may be published in our print edition. All rights reserved. This copyrighted material may not be re-published without permission. Links are encouraged.


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Liberty man charged with possessing gun, drugs
LIBERTY — A raid on an apartment Friday led to the arrest of a Liberty man on suspicion of felony drug possession, village police said.
Detectives investigating drug-dealing at a North Main Street apartment arrested Ramon Gilliam, 37, and seized cocaine, scales, a loaded 20-gauge shotgun and over $500 in cash, police said.
Gilliam was charged with third- and fifth-degree criminal possession of a controlled substance, both felonies, and faces misdemeanor drug and weapons charges.
He was sent to Sullivan County Jail on $50,000 bail and is due back in court on July 24.


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Take a sneak peek at the new NIST.gov and let us know what you think!
(Please note: some content may not be complete on the beta site.).
Computational Science in Biological Metrology (CS in Bio Metrology) project is about Computational Science and Biology Delivering Measurements with Statistical Significance and Repeatability. The goal of the project is to ensure quality in biomedical research and clinical applications by evolving biology into a quantitative and information science. These activities will support applications such as: biomanufacturing, drug discovery, basic bio-medical research, medical intervention, diagnostics, and regenerative medicine.
With the increasing reliance of system biology researchers on microscopy imaging and the growing volumes of images generated during each experiment, there is a need to intertwine computational science and biological metrology. The motivation lies not only in saving human labor and time needed to achieve a biological discovery but also in understanding the accuracy and uncertainty introduced by computational steps of a discovery process. The overall objective is to ensure quality of outcomes obtained from collaborative research using microscopy imaging, and scalability of data-driven biological discovery with the increasing data volumes. This objective has to be achieved by bringing together multi-disciplinary expertise working on:
The following are key activities being addressed in this work(link to activity pages):
Major Accomplishments:
End Date:on-going
Lead Organizational Unit:itl
Carole Parent, NIH, NCI
Christina Stuelten, NIH, NCI
Michael Weiger, NIH, NCI
Wolfgang Losert, University of Maryland at College Park
Marcin Kociolek, Medical Electronics Division, Technical University of Lodz Poland
Anne Plant, Biosystems and Biomaterials Division
TN. Bhat, Cell Systems Science Group
John Elliott, Cell Systems Science Group
Michael Halter, Cell Systems Science Group
Subhash Sista, Cell Systems Science Group
Mary Brady, Information Systems Group


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GE Security 1015 Titanium KeySafe Original 5-Key Permanent Key Box with Pushbutton Combination Entry
Offer Ends
Product Features:
- Easy-to-use pushbutton combination
- Over 1,000 possible combinations available
- Holds up to five keys
- Mounting hardware included
- Solid, weather-resistant metal
Product Specifications:
- Height: 7"
- Width: 3-1/4"
- Depth: 2-3/4"
KeySafe Original 5-Key Permanent lockbox holds up to five keys and attaches securely to any wall or flat surface with the mounting hardware included. The StongBox design has a solid track record for unmatched quality and security. The pushbutton lock is convenient and easy-to-use. You set the combination; it can be changed at any time, as often as you want. There are over 1,000 combinations available. Easy access for family and friends. Never be locked out again!
Additional GE Security Links
Our SKU: 001015
This product is listed under the following manufacturer number(s):
- Titanium
*Denotes a finish or option that has been discontinued
GE Security KeySafe Original Collection
Warranty Info
GE Security Return and Warranty Policy
The Return and Warranty Policy (updated, effective Feb. 11, 2010) explains GE Security's policy on product returns, warranty repair/replacements, nonwarranty repairs, credit returns, advance replacements, and other matters. It also lists contact information for GE Security customer service centers, packaging and shipping requirements, and warranty periods by product category.
As stated in the Return and Warranty Policy, an RMA (return material authorization) is required for all product returns. To request an RMA, contact the appropriate customer service center listed in the Return and Warranty Policy or use the link below. You will need the following information:
- Original PO number
- SKU/part number
- Serial number
See the Terms and Conditions of Sale Policy for related information.


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Summit Tool Design uses Solid Edge and other advanced software tools to completely model a progressive die and the stamping process. The enhanced capabilities that 3D modeling provides make it easier to optimize a progressive die design and analyze potential problems before the design is released to the shop. It is very time-consuming and costly to recover from an error in the shop. With 3D design it is easier to make sure those errors don't happen.
|Click Here for Design Samples
Benefits of using Summit Tool Design for your sheet metal stamping dies:
Summit Tool Design provides premium quality service and tool designs in a timely fashion for a broad spectrum of products across a range of industries including automotive, off-road machinery & equipment, heavy truck, hardware, furniture, electrical, electronics and power tool.
Summit Tool Design's specialty is Progressive Dies. We also have extensive experience with transfer dies, draw dies, line dies, secondary dies, fixtures and 3D part modeling.
Scott Christensen founded Summit Tool Design in 1991. Christensen has more than 30 years of experience as a certified journeyman tool and diemaker and designer, providing a solid background for understanding and meeting the design and manufacturing requirements of each client.
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12 Station Die Shows Benefits of 3D
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If you would like to contact Summit Tool Design please click here.


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Canadian National Railway CEO Warns Against More Regulation
Tensions over Canada's recent move to ease grain-shipment bottlenecks haven't gone away.
Canadian National Railway Chief Executive Claude Mongeau Wednesday blasted the government's decision last month to impose minimum grain-shipment targets. Canada took that step to ease rail bottlenecks that were keeping grain farmers from moving last year's record crop.
Mr. Mongeau called the move a "slippery slope" that could lead to increased regulation of railways and other commodities that are shipped by rail.
"Railroads, and railroads alone, are going to be regulated in a way that is not going to be good for the country or the grain trade either," Mr. Mongeau said in a speech in Winnipeg. His remarks were webcast.
A rail car shortage in recent months caused shipments of Canadian grain to the U.S. to fall, with millions of tons of barley, wheat, canola and oats stuck at elevators and farms across the Canadian prairie provinces. Canada's two big rail companies – CN and rival Canadian Pacific Railway – said unusual harsh winter weather and a record grain crop were to blame. Mr. Mongeau reiterated that point Wednesday.
Farmers and grain elevator companies, though, said the railways' increasing crude shipments were a factor, a point Mr. Mongeau was quick to address in his speech.
"If you want railroads to be in the doghouse, you use crude," he said. "Crude is a perfect tool to designate the culprit … [But] we don't move more than 1.5% of our volume with crude," he said.
He also said railways learned late of the bumper crop of grain and that was a logistical challenge.
"No one can expect any supply chain in the world with no indications to prepare for such a surge to reasonably move this traffic in a matter of months," he said. "To set an expectation to do so is irresponsible, in my view."


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Frank Ohlhorst
Frank Ohlhorst is an award-winning technology journalist, professional speaker and IT business consultant with more than 25 years of experience in the technology market. He has written articles for a variety of technology and business publications, and he worked previously as executive technology editor at eWeek and director of the CRN Test Center.
The dirty little secrets that no one ever told you about storing data in the Cloud.
If you believe the hype, storing data in the Cloud is considered the "end all, be all" of data storage solutions. However, Cloud storage (aka hosted storage) is anything but perfect. When used incorrectly, it can cause more harm than good.
That is not to say that storing data in the Cloud is never appropriate. There are certain cases where a Cloud-based file and data repository makes perfect sense–it is just a matter of knowing when to use the Cloud instead of local storage.
First, let's take a look at the negatives of Cloud storage. This will give you an idea of when and where not to use the Cloud as a storage platform.


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[Page: H6918]
Mr. GILMAN. Mr. Speaker, I move to suspend the rules and pass the bill (H.R. 3743) to withhold voluntary proportional assistance for programs and projects of the International Atomic Energy Agency relating to the development and completion of the Bushehr nuclear power plant in Iran, and for other purposes, as amended.
The Clerk read as follows:
This Act may be cited as the `Iran Nuclear Proliferation Prevention Act of 1998'.
The Congress makes the following findings:
(1) Iran remains the world's leading sponsor of international terrorism and is on the Department of State's list of countries that provide support for acts of international terrorism.
(2) Iran has repeatedly called for the destruction of Israel and Iran supports organizations, such as Hizballah, Hamas, and the Palestine Islamic Jihad, which are responsible for terrorist attacks against Israel.
(3) Iranian officials have stated their intent to complete at least 3 nuclear power plants by 2015 and are currently working to complete the Bushehr nuclear power plant located on the Persian Gulf coast.
(4) The United States has publicly opposed the completion of reactors at the Bushehr nuclear power plant because the transfer of civilian nuclear technology and training could help to advance Iran's nuclear weapons program.
(5) In an April 1997 hearing before the Subcommittee on Near Eastern and South Asian Affairs of the Committee on Foreign Relations of the Senate, the former Director of the Central Intelligence Agency, James Woolsey, stated that through the operation of the nuclear power reactor at the Bushehr nuclear power plant, Iran will develop substantial expertise relevant to the development of nuclear weapons.
(6) Construction of the Bushehr nuclear power plant was halted following the 1979 revolution in Iran because the former West Germany refused to assist in the completion the plant due to concerns that completion of the plant could provide Iran with expertise and technology which could advance Iran's nuclear weapons program.
(7) Iran is building up its offensive military capacity in other areas as evidenced by its recent testing of engines for ballistic missiles capable of carrying 2,200 pound warheads more than 800 miles, within range of strategic targets in Israel.
(8) In January 1995 Iran signed a $780,000,000 contract with the Russian Federation for Atomic Energy (MINATOM) to complete a VVER-1000 pressurized-light water reactor at the Bushehr nuclear power plant.
(9) In March of 1998, Russia confirmed its intention to complete work on the two reactors at the Bushehr nuclear power plant and agreed in principle to the construction of 2 more reactors at the Bushehr site.
(10) At least 1 reactor could be operational within a few years and it would subsequently provide Iran with substantial expertise to advance its nuclear weapons program.
(11) Iran ranks 10th among the 105 nations receiving assistance from the technical cooperation program of the International Atomic Energy Agency.
(12) Between 1995 and 1999, the International Atomic Energy Agency has provided and is expected to provide a total of $1,550,000 through its Technical Assistance and Cooperation Fund for the Iranian nuclear power program, including reactors at the Bushehr nuclear power plant.
(13) The United States provides annual contributions to the International Atomic Energy Agency which total more than 25 percent of the annual assessed budget of the Agency and the United States also
provides annual voluntary contributions to the Technical Assistance and Cooperation Fund of the Agency which total approximately 32 percent ($16,000,000 in 1996) of the annual budget of the program.
(14) The United States should not voluntarily provide funding for the completion of nuclear power reactors which could provide Iran with substantial expertise to advance its nuclear weapons program and potentially pose a threat to the United States or its allies.
(15) Iran has no need for nuclear energy because of its immense oil and natural gas reserves which are equivalent to 9.3 percent of the world's reserves and Iran has 73,000,000,000 cubic feet of natural gas, an amount second only to the natural gas reserves of Russia.
Section 307 of the Foreign Assistance Act of 1961 (22 U.S.C. 2227) is amended by adding at the end the following:
`(d) Notwithstanding subsection (c), the limitations of subsection (a) shall apply to programs and projects of the International Atomic Energy Agency in Iran.'.
(a) Annual Review:
(1) In general: The Secretary of State shall undertake a comprehensive annual review of all programs and projects of the International Atomic Energy Agency in the countries described in section 307(a) of the Foreign Assistance Act of 1961 (22 U.S.C. 2227(a)) and shall determine if such programs and projects are consistent with United States nuclear nonproliferation and safety goals.
(2) Report: Not later than 1 year after the date of the enactment of this Act and on an annual basis thereafter for 5 years, the Secretary shall prepare and submit to the Congress a report containing the results of the review under paragraph (1).
(b) Opposition to Certain Programs and Projects of International Atomic Energy Agency: The Secretary of State shall direct the United States representative to the International Atomic Energy Agency to oppose the following:
(1) Programs of the Agency that are determined by the Secretary under the review conducted under subsection (a)(1) to be inconsistent with nuclear nonproliferation and safety goals of the United States.
(2)(A) Technical assistance programs or projects of the Agency designed to develop or complete the Bushehr nuclear power plant in Iran.
(B) Subparagraph (A) shall not apply with respect to programs or projects of the Agency that provide for the discontinuation, dismantling, or safety inspection of nuclear facilities or related materials, or for inspections and similar activities designed to prevent the development of nuclear weapons by Iran.
(a) In General: Not later than 180 days after the date of the enactment of this Act and on an annual basis thereafter for 5 years, the Secretary of State, in consultation with the United States representative to the International Atomic Energy Agency, shall prepare and submit to the Congress a report that--
(1) describes the total amount of annual assistance to Iran from the International Atomic Energy Agency, a list of Iranian officials in leadership positions at the Agency, the expected timeframe for the completion of the nuclear power reactors at the Bushehr nuclear power plant, and a summary of the nuclear materials and technology transferred to Iran from the Agency in the preceding year which could assist in the development of Iran's nuclear weapons program; and
(2) contains a description of all programs and projects of the International Atomic Energy Agency in each country described in section 307(a) of the Foreign Assistance Act of 1961 (22 U.S.C. 2227(a)) and any inconsistencies between the technical cooperation and assistance programs and projects of the Agency and United States nuclear nonproliferation and safety goals in these countries.
(b) Additional Requirement: The report required to be submitted under subsection (a) shall be submitted in an unclassified form, to the extent appropriate, but may include a classified annex.
It is the sense of the Congress that the United States Government should pursue internal reforms at the International Atomic Energy Agency that will ensure that all programs and projects funded under the Technical Cooperation and Assistance Fund of the Agency are compatible with United States nuclear nonproliferation policy and international nuclear nonproliferation norms.
The SPEAKER pro tempore. Pursuant to the rule, the gentleman from New York (Mr. Gilman) and the gentleman from Indiana (Mr. Hamilton) each will control 20 minutes.
The Chair recognizes the gentleman from New York (Mr. Gilman).
(Mr. GILMAN asked and was given permission to revise and extend his remarks.)
[Page: H6919]
Mr. GILMAN. Mr. Speaker, I ask unanimous consent that all Members may have 5 legislative days within which to revise and extend their remarks on H.R. 3743.
The SPEAKER pro tempore. Is there objection to the request of the gentleman from New York?
There was no objection.
Mr. GILMAN. Mr. Speaker, I yield myself such time as I may consume.
Mr. Speaker, I would like to commend the gentleman from New Jersey (Mr. Menendez) for introducing this measure and moving it through the committee, and I thank the ranking minority member, the gentleman from Indiana (Mr. Hamilton) for his cooperation.
I am pleased to support the bill, which amends current law to ensure that the United States does not provide funding for the completion of nuclear power reactors in Iran. We all know that the Iranians have dedicated significant resources to completing at least three nuclear power plants by the year 2015, and are now at work, with Russian assistance, to complete the Bushehr nuclear power plant.
Our Nation is opposed to completion of the reactors of the Bushehr facility because the transfer of civilian nuclear technology and training would help to advance Iran's nuclear weapons program. Between 1995 and 1999 it is anticipated that the International Atomic Energy Agency, IAEA, will have provided over $1.5 million to the Iranian nuclear power program through its Technical Assistance and Cooperation Fund.
Our Nation provides annual voluntary contributions to that fund, totaling $16 million in 1996. This legislation does not halt our voluntary contributions to the IAEA, but it does require that none of our funds may be used to fund IAEA programs and projects in Iran.
That is exactly the right policy. Our Nation should not voluntarily provide any funding which would help Iran complete nuclear power reactors that could assist them in developing a nuclear weapons program which could pose a threat to our Nation or to our allies.
This measure also establishes two important reporting requirements. One would provide the Congress with a comprehensive report on IAEA assistance to Iran. The second requirement would direct the Secretary of State to review IAEA programs, and ensures that they are consistent with our United States nuclear nonproliferation and safety goals. Based on that review, the Secretary shall direct the U.S. representative to IAEA to oppose establishing any program that is not consistent with U.S. policy.
Accordingly, Mr. Speaker, I urge my colleagues to fully support this measure.
Mr. Speaker, I reserve the balance of my time.
Mr. HAMILTON. Mr. Speaker, I yield 6 minutes to the distinguished gentleman from New Jersey (Mr. Menendez), the chief deputy whip.
Mr. MENENDEZ. Mr. Speaker, I thank the ranking Democrat on the Committee on International Relations for yielding me time, even though I know he does not support my bill.
Mr. Speaker, I want to thank the gentleman from New York (Mr. Gilman), the distinguished chairman of the Committee on International Relations, for both calling the bill up for consideration as well as for his support here today.
First let me say that as the sponsor of the bill, I recognize the importance of the International Atomic Energy Agency and its role in ensuring the safety of nuclear sites around the world. In recent months we have witnessed their struggle to carry out inspections in Iraq.
This bill, however, will not affect the IAEA's safeguard program. The bill does not seek to withhold any funds to IAEA's safeguard programs in Iran or elsewhere. The only funds affected by this bill are voluntary, not assessed, contributions to the IAEA's Technical Assistance and Cooperation Fund for Iran.
Prior to 1994, U.S. law required the withholding of proportional IAEA voluntary funds to all countries on our list of terrorist states, and, despite the change in the law, the administration continued to withhold those funds for two more years, until 1996.
What this bill does is require the administration to reinstate proportional withholding of IAEA's voluntary funds for Iran. It also requires our Secretary of State to undertake a comprehensive review of all IAEA programs and projects in other states which sponsor international terrorism to determine if the IAEA is sponsoring any other projects which conflict with U.S. nuclear nonproliferation and safety goals.
As it is, since the IAEA's inception more than $52 million for the Technical Assistance and Cooperation Fund has gone to countries on the U.S. list of states which sponsor terrorism. The United States is the largest supporter of the IAEA. We provide them with more than 25 percent of their annual budget.
In the Technical Assistance and Cooperation Fund we contribute in addition 32 percent, or $16 million annually, in voluntary funds, and it is from those funds that the IAEA intends to provide $1.5 million to assist in the development of the Bushehr power plant between 1997 and 1999.
Now, the Clinton Administration has publicly stated its opposition to Iran's development of nuclear reactors and its concern about the development of the Bushehr nuclear power plant. In Senate testimony last year, Deputy Assistant Secretary Bob Einhorn explained,
In our view, this is a large reactor project. It will involve hundreds of Russians being in Iran, hundreds of Iranians or more being in Moscow being trained, and this large scale kind of project can provide a kind of commercial cover for a number of activities that we would not like to see, perhaps much more sensitive activities than pursuing this power reactor project. It also will inevitably provide additional training and expertise in the nuclear field for Iranian technicians. In our view, given Iran's intention to acquire nuclear weapons, we do not want to see them move up the nuclear learning curve at all, and we believe this project would contribute to them moving up that curve.
In essence, this technical cooperation assistance is in fact helping them move up that learning curve that the Assistant Secretary spoke about. Given Iran's historic support for terrorism, coupled with the fact that Iran boasts immense oil and natural gas reserves, and the seismic activity near Bushehr which just recently took place, we must question Tehran's motives for constructing expensive nuclear reactors.
Moreover, the development of the nuclear reactors has been an economic nightmare for the Iranians. Clearly Iran does not need additional energy sources, nor is nuclear energy an economic choice for Iran.
So we need to ask a few basic questions. Given Iran's test last week of a medium range ballistic missile and reports that Iran is seeking technology for a long range missile, is it responsible to take Iran's word that it is also not developing nuclear weapons?
Despite the IAEA's presence in Iraq, we were surprised to learn of that country's extensive chemical and biological warfare programs. Why do we trust Iran?
Given the recent trial and imprisonment of the Mayor of Tehran, a political ally of President Khatami, do we really think President Khatami can control extremist elements in Iran?
And, lastly, does it make sense for the United States and U.S. taxpayers to provide any kind of support for the construction of a nuclear reactor which we clearly and justifiably oppose, or any type of technical assistance in the operation of such a plant that we do not want to see? The answer clearly must be no.
This bill seeks to protect the U.S. taxpayers from assisting countries like Iran who sponsor international terrorism, denounce the United States, and seek to develop weapons of mass destruction which may be used against us or our allies. It is ludicrous for the United States to support in any way a plant, even indirectly, which could pose a threat to the United States and to stability in the Middle East.
I urge my colleagues to support this legislation.
[Page: H6920]
Mr. HAMILTON. Mr. Speaker, I yield 3 minutes to the distinguished gentleman from New Jersey (Mr. Rothman).
Mr. ROTHMAN. Mr. Speaker, I thank the gentleman from Indiana for yielding me time.
Mr. Speaker, I thank our chairman, the gentleman from New York (Mr. Gilman), and my very good friend, the sponsor of this bill, the gentleman from New Jersey (Mr. Menendez).
Mr. Speaker, I rise today in support of H.R. 3743, the Iran Nuclear Proliferation Prevention Act of 1998. It is emblematic of the serious need to pass this bill that on July 22 of this year, the same day that the bill was considered and passed by the Committee on International Relations, Iran tested a missile capable of striking American troops throughout the Middle East. I do not think I have to explain to any of my colleagues here in the House, or to any American, for that matter, the implications of an Iranian nuclear missile.
H.R. 3743 rightfully seeks to prevent U.S. tax dollars from being used to help Iran develop nuclear technology, specifically nuclear power plants. Helping Iran develop its nuclear technology through U.S. taxpayer dollars, or in any other way, is like training a known assassin how to use an AK-47 assault rifle and expecting him to only use it for defensive purposes.
The only reason that Iran, one of the most oil-rich countries on the planet, is developing nuclear power technology is to advance its offensive missile technology program. To think that Iran is developing nuclear technology for civilian power needs is naive and dangerous, dangerous to the United States of America.
The Iranian Shahab-3 missile, which was successfully tested only two weeks ago, will reportedly have a range of between 1,300 and 1,500 kilometers and be capable of carrying a 750 to 1,000 kilogram warhead.
According to various intelligence reports, Russia is now helping Iran develop its technology that will put Shahab missiles within range of U.S. troops throughout the Middle East. If Iran combines their nuclear technology with these Shahab missiles, like the one fired just 2 weeks ago, the threat to our troops and the region will be unthinkable. The lives of American soldiers, sailors, U.S. allies, and ultimately, American citizens, would be in needless and mortal peril.
Let us send a message to the Iranians: The United States Congress still has its eye on the ball. We are not fooled by their President's statements of moderation, as welcome as those statements may be; statements made, however, at the same time they are trying to build weapons of mass destruction.
If they want to be friends with the United States of America they should behave as a friend, and they should let their actions speak louder than their words of moderation, which contradict their efforts to develop nuclear technology.
Mr. Speaker, I urge the passage of H.R. 3743.
Mr. HAMILTON. Mr. Speaker, I yield myself such time as I may consume.
Mr. Speaker, I rise in opposition to H.R. 3743. I do so with some reluctance because of my admiration for the sponsor of this bill, the gentleman from New Jersey (Mr. Menendez), his very strong contributions over a period of time to the work of the Committee on International Relations, and his leadership on a variety of issues before this body.
I recognize the strong popular support for this bill, but I rise in opposition, because I really am not able to point to anything very positive about the bill that it will accomplish.
Mr. Speaker, this bill is not going to stop, it is not going to slow Iran's civilian nuclear power reactor program. It will not make Iran's nuclear facilities any safer. It will not prevent the troublesome Bushehr facility from being developed, and it will not bring any greater international consensus on curbing Iranian actions on the weapons of mass destruction programs which trouble all of us.
I do see several down sides to this bill. It will, I think, politicize and polarize the IAEA at the very time that the United States has fought off attempts in the IAEA to politicize technical assistance to Israel. It will be seen in the IAEA as an effort to punish Iran, just at the time that Iran has agreed to new anytime, anywhere, IAEA safeguards and inspections.
The bill will make it more difficult for the United States to get information about Iran's nuclear program. It will make Iran's nuclear program less safe if the IAEA is forced to curtail its safety and regulatory assistance.
It will make it more difficult for the United States to convince other countries to contribute to the IAEA technical assistance and cooperation fund, and it will make it more difficult to convince other countries of the merits of IAEA safeguards when the United States is trying to block safety and regulatory assistance to a country that is party to the nonproliferation treaty.
I think the bill directly harms the U.S. role in the IAEA. We are the single most influential member of the IAEA. We must remain the most influential member. When we introduce political issues into the IAEA, we undercut our own efforts to keep this institution focused on its technical responsibilities.
The IAEA has a critical mission to promote international peace, security, and safety. We rely on the IAEA to promote and improve nuclear safeguards, to expand the number of countries and activities subject to safeguard controls and inspections, to halt illicit trafficking in nuclear materials, to support the negotiation of international treaties on nuclear power safety and radioactive waste management, to provide technical assistance to developing countries on nuclear safety and handling nuclear waste, and to address problems that know no boundaries, such as environmental pollution and eradication of insect pests that can affect U.S. agriculture. This international agency, then, serves very important U.S. interests.
In a few minutes we will complete consideration of a joint resolution on Iraq. The IAEA, as everyone here knows, plays a very key role in investigating Iraq's nuclear program. This is the wrong time to undermine the IAEA's authority or U.S. support for that agency. By reducing U.S. support for this agency and by undermining U.S. leadership in it, the bill will make the IAEA less effective in meeting its responsibilities for international safety and security.
The chief argument put forward by the proponents of the bill is that it sends a message to Iran. We have sent a message to Iran a thousand times, for the past 20 years. There is not any doubt about that message. Everyone in the world knows what we do not like about Iran's policies.
This is a feel-good bill. We think we are doing something about a problem when in fact we are not. This bill will have zero impact on whether Iran builds a civilian nuclear reactor. It will mean less information for us about Iran's nuclear programs, and the bill hurts the one international organization that works to stop the spread of nuclear weapons.
Another argument put forward by proponents of the bill is that the IAEA should give no assistance whatever to help Iran operate civilian nuclear power reactors. When Iran builds those reactors, it is in the interests of the United States and in the interests of the entire world that those civilian power reactors operate safely. I do not understand why we are better off if Iran learns nuclear safety from the same people who brought us Chernobyl.
Every Member of this body shares exactly the same goals on Iran: stop terrorism, stop weapons of mass destruction, and stop Iran's opposition to the Middle East peace process. The problem is that the U.S. policy is not working. Twenty years of isolation have not changed Iran's objectionable policies. We need a better policy to protect and promote the American national interest. We have to get beyond a policy of just saying no to Iran.
There are forces in Iran today debating that country's future. That debate is heated. We have a decided interest in the outcome of that debate and the direction Iran's leaders choose. We certainly cannot determine that outcome, but our actions, our rhetoric, and our legislation on Iran do matter.
Secretary Albright was exactly right in her speech 6 weeks ago: The United States should move, step-by-step, on a reciprocal basis, to seek an improvement in relations in Iran, and move toward an authoritative dialogue. It will not be an easy or quick journey to settle the many differences we have with Iran, but we should not ignore the largest and most important state in the Gulf region.
As part of that dialogue, I believe that we should communicate to Iran that we will not block Iran's purchase of nuclear power reactors for civilian purposes, so long, of course, as all nuclear facilities in Iran are under safeguards, and as long as Iran responds to all special inspections and requests for information about its nuclear activities.
We should, of course, continue to oppose any effort to strengthen Iran's nuclear weapons program. And if we adopt the policy I have indicated, we would then have the support of our friends and allies, and we would have an effective program to block Iran's nuclear weapons program. Today no one can claim that we have an effective policy or program.
The administration strongly opposes this bill. I quote from the letter from the Department of State:
`We oppose H.R. 3743. . . . The Department strongly objects to a bill requiring that the U.S. withhold the portion of our IAEA contribution used to fund International Atomic Energy Agency activities in Iran. Enactment of this legislation would harm our bipartisan effort to put a halt to any Iranian nuclear weapons program.
`Enactment of this legislation would be counterproductive to the Administration's efforts to cut off nuclear projects that might provide cover for an Iranian nuclear weapons program. The IAEA monitors commercial nuclear projects to help ensure that such projects do not benefit a covert nuclear weapons program. The IAEA has not, nor will it, provide support for construction of nuclear power plants in Iran or any other Nation. The IAEA has been careful to design its technical cooperation programs so that no assistance in potentially sensitive areas occurs. Recently Iran has agreed to new IAEA `anytime, anywhere' verification measures that will provide one of our only windows on Iran's commercial nuclear programs. This bill would therefore deny us this important nonproliferation tool.'
Mr. Speaker, the bill before us provides no benefits to the United States. It does pose several risks. We will only succeed in stopping weapons programs in Iran with the close cooperation and support of our friends and allies. We will not succeed in stopping that program by acting unilaterally. We should not waste our time on punishing the IAEA and starting needless fights with the very same countries whose support we will need if we are going to have an effective policy to stop Iran's weapons program.
Mr. Speaker, I urge the bill's defeat, and I reserve the balance of my time.
[Page: H6921]
Mr. GILMAN. Mr. Speaker, I am pleased to yield 2 minutes to the gentleman from New Jersey (Mr. Menendez).
Mr. MENENDEZ. Mr. Speaker, I thank the gentleman for yielding time to me.
First of all, I respectfully clearly disagree with my distinguished colleague, the gentleman from Indiana (Mr. Hamilton), although I respect fully his thoughtful, as always, analysis of the issues from his perspective.
I do want to not let a few things go unbalanced. Number one is it has been said that the safeguards are at risk here. Our contributions, our mandatory contributions to the IAEA is about safeguards, and those go untouched, untouched by this bill. So whatever we are providing by way of safeguards we will continue to provide.
What we do not want to see, and I think even the administration would agree with my distinguished colleague, the gentleman from Indiana, in his analysis of maybe we should permit nuclear reactors for civilian use, we have the Deputy Assistant Secretary, Mr. Einhorn, saying that this is not a project that we want to see built. This is not a project that we want to see built. He talks about the learning curve.
In essence, this is more than about sending a message to Iran. This is about slowing down, in any possible way, that learning curve that gets them to the point to put this reactor project online.
Also, we cannot believe that when the United States provides over 25 percent of the IAEA's budget, and 32 percent in addition, of its funds, that $1.5 million is going to make a dramatic difference to the IAEA, and that the IAEA is going to collapse, or that the U.S. role in the IAEA is going to be significantly diminished. I do not believe that that is possible.
We cannot have it both ways. Either this assistance is of value to Iran, in which case we should be looking not to provide assistance that is of value, or it is of no value, in which case we should not be spending our money on it.
The fact of the matter is that President Hatemi may be the hope we have for an Iran that is democratic in the future. He may be the hope that we have for a democratic Iran in the future, but he does not have the power. Recent analysis, statements by the administration, in fact say that whether or not he continues in power, that the missiles that we talked about today and that were recently tested in Iran will be in fact consummated.
The question is, do we want those missiles, as dangerous as they already are, to carry a nuclear warhead, have the potential to carry a nuclear warhead? Do we in any way want to assist those countries that are on our list of terrorist states in helping them in that learning curve? I would suggest we clearly do not want to have U.S. taxpayer dollars for that purpose.
This is not about safety. Safety is part of our regular program. We will continue to provide safety.
This is still continuing to have a major U.S. role in the IAEA, but it is an attempt to slow down the learning curve, not have any U.S. assistance, involuntary assistance to what the administration witnesses before the committee, when I questioned them, said, yes, we are providing assistance that in fact helps in an operational nature.
Why would we provide assistance in an operational nature to something that we do not want to see operate, to something that the administration has testified against? If this is unsafe, then why did the administration after 1994, when it was no longer the law, continue to withhold funds for 2 years? Clearly, during that period of time, if the argument is true, it could be said that it was unsafe to withhold funds.
This is not about safety. It is about having the United States not participate with its taxpayer dollars to assist a terrorist state that we may have hopes for that will be democratic in the future but that is not now, and having a learning curve that permits a nuclear reactor to be developed.
Mr. HAMILTON. Mr. Speaker, I yield 2 minutes to the gentleman from Virginia, Mr. Moran.
Mr. MORAN of Virginia. Mr. Speaker, in 1953, the United States was already competing in an international arms race. Recognizing that the danger of a buildup of nuclear weapons posed considerable, risk to the United States, President Eisenhower proposed not merely eliminating the use of nuclear technology for military purposes, but a mechanism to remove nuclear technology from the hands of soldiers and place it in the hands of those who could adapt it to the art of peace. The entity formed to accomplish this task was the International Atomic Energy Agency.
Under the auspices of the IAEA, nuclear technology has made substantial contributions to sustainable development across many sectors, including energy, health, agriculture and hydrology. It has also provided a platform for nuclear states to verify and monitor each other's compliance with nonproliferation treaties. This is why I oppose H.R. 3743, the so-called Iran Nuclear Proliferation Prevention Act of 1998.
Cutting U.S. contributions to the IAEA will not advance any legitimate United States interest, but it will increase risk to the United States and to civilians living in the Middle East. Without IAEA supervision, Iran will certainly turn to the Russians for help in constructing nuclear reactors. Would we really prefer that Iran's reactors be constructed by those responsible for Chernobyl? No offense to the Russians, but that would not even be in their own security interests.
If the IAEA withdraws from assisting Iran, as the sponsors of this bill would have it do, there will be even fewer organizations interacting with Iran. I would suggest that this is precisely the wrong course of action. The past few months have brought tentative first steps toward a more engaging relationship with Iran. We should not now push them away. We should try to find whatever positive opportunities there exists. I know the difficulties, but we need to support the moderates in Iran and not to give support, unintentionally, but in reality, to the most extreme elements. This bill, in fact, will give ammunition to the most extreme elements just as these kinds of resolutions directed toward Cuba, only serve to strengthen Fidel Castro's hold.
Lastly, Mr. Speaker, we are undeniably subjecting the IAEA's actions to domestic politics. I suppose that we should not be surprised, because in the same way that U.N. dues are held hostage every year to family planning and abortion debates, IAEA funding is now fair game for those that may disagree with its programs in Iran or Cuba or other nations who are fair game to political sanctions.
This is an irresponsible and dangerous road to go down, Mr. Speaker. Nuclear safety is simply too important to be held hostage to the political whims of Congress. This Congress should vote against this resolution.
[Page: H6922]
Mr. HAMILTON. Mr. Speaker, I yield myself the balance of my time.
Let me simply observe that the whole purpose of this bill is to cut the U.S. funding to the International Atomic Energy Agency by an amount equal to that agency's funding of safety projects. Of course it affects the safety of that project. It is quite clear, I think, by the terms of the legislation that it does.
Finally, may I say that all of the arguments the gentleman makes are premised on the basis that the United States is the only country in the world that can furnish this technology. There are dozens of countries that can furnish it. Nuclear technology today is not the province of the United States, no matter what we do in this country.
The project is going to go forward with the assistance of many other countries. What we have today is a policy that is not effective and has not been effective for 20 years in stopping the development of nuclear weapons programs in Iran. Let us rethink the problem.
Mr. GILMAN. Mr. Speaker, I yield myself such time as I may consume.
I want to commend the gentleman from New Jersey (Mr. Menendez) again for pointing out some of the pertinent aspects of this measure. I would like to remind the ranking minority member, the gentleman from Indiana (Mr. Hamilton), that what we are doing is merely to restore the policy that we had prior to 1993 and up to 1993, to make certain that we withhold any funding based on any violation of the prior agreements.
I would also like to note for our colleagues that last year before the Subcommittee on Near Eastern and South Asian Affairs in the Senate Committee on Foreign Relations, the former Director of Central Intelligence, Mr. Woolsey, stated that through the operation of the nuclear power reactor at the Bushehr nuclear power Plant, Iran will develop substantial expertise relevant to the development of nuclear weapons.
I would also like to note that the construction of the Bushehr nuclear power plant had initially been halted back in 1979 because the former West Germany refused to assist in the completion of the plant, due to concerns that the completion of the plant would provide Iran with expertise and technology which could advance Iran's nuclear weapons program.
We are all aware of the recent testing by Iran of a long range missile, missiles that could reach more than 800 miles, an 800-mile range, and be able to hit strategic targets throughout the Middle East, particularly Israel, at a time when we are trying to bring peace to that region.
In closing my argument, I would just like to urge our colleagues to fully support the Menendez measure that is before us now, in the interest of peace throughout that part of the world and throughout the entire world, because they say that eventually long range missiles being developed by Iran could reach the entire European continent and possibly our own shoreline in the future.
I urge full support for this measure.
New York: Iran this week successfully tested a missile with a range of about 800 miles, meaning it could hit Israel or Saudi Arabia, The New York Times reported Thursday.
The test comes a month after Secretary of State Madeleine Albright praised Iranian President Mohammad Khatami, a moderate who took office last summer and who has confronted considerable resistance from religious and other conservatives.
A U.S. spy satellite detected Wednesday morning's test of the medium-range missile the Iranians call Shahab-3, the Times reported, citing unidentified Clinton administration officials.
`This weapon would allow Iran to strike all of Israel, all of Saudi Arabia, most of Turkey and a tip of Russia,' a senior administration official told the Times.
The officials, while sure of the test, could not provide immediate information on the location of the launch or landing, both inside Iran.
Intelligence experts investigating the launch believe Iran bought the missile from North Korea, which has said it would sell to any nation with hard currency.
Iran also has bought technology from Russia and China, and wants not to strike its enemies but to be seen as a political and military force in the Middle East, officials said.
Israel is the only nuclear power in the region, and its missiles are believed to be capable of striking any nation in the Middle East.
Iran is working on developing a nuclear warhead but is believed to be years away from building and testing a weapon, the Times said.
`This test shows Iran is bent on acquiring nuclear weapons, because no one builds an 800-mile missile to deliver conventional explosives,' Gary Milhollin, an expert on the spread of weaponry, told the newspaper.
Mr. GILMAN. Mr. Speaker, I yield back the balance of my time.
The SPEAKER pro tempore (Mr. Pease). The question is on the motion offered by the gentleman from New York (Mr. Gilman) that the House suspend the rules and pass the bill, H.R. 3743, as amended.
The question was taken.
Mr. MENENDEZ. Mr. Speaker, on that, I demand the yeas and nays.
The yeas and nays were ordered.
The SPEAKER pro tempore. Pursuant to clause 5 of rule I and the Chair's prior announcement, further proceedings on this motion will be postponed.
[Page: H6923]


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