GHY Tradelines

An updated list of recently published government memorandums, notices, regulations and decisions for the week ending September 9, 2011 is now available on our website here.
 

(World Trade Interactive)

The Food and Drug Administration issued this week a letter providing specific recommendations to facilitate the FDA import entry review process for medical and non-medical radiation-emitting electronic products. This letter describes the affirmation of compliance (AofC) codes that can be provided at the time of entry to help expedite the admissibility process. FDA states that appropriately-submitted AofC codes increase the likelihood that a shipment will not be held for further review during FDA’s import screening process.

According to FDA, the following radiation-emitting electronic products are subject to a federal performance standard: television receivers and video display monitors with cathode ray tubes only, diagnostic x-ray systems and their major components, cabinet x-ray systems, microwave ovens, laser products (includes laser pointers, laser light shows, industrial lasers, medical lasers, and surveying, leveling and alignment lasers), sunlamp products and ultraviolet lamps intended for use in sunlamp products, high-intensity mercury vapor discharge lamps, and ultrasonic therapy products.

Importers of these products must submit information on each product shipment to FDA and U.S. Customs and Border Protection. CBP regulations require importers to affirm that products they are importing comply or do not comply with federal performance standards. FDA works with CPB by providing form FDA-2877, Declaration for Imported Electronic Products Subject to Radiation Control Standards, which must be completed by the importer and can be found here.

FDA notes that there are medical radiation-emitting electronic products, such as radiation therapy devices, linear accelerators, diagnostic ultrasounds for imaging, microwave diathermy, shortwave diathermy, hearing aids, cardiac radiofrequency ablation devices and extracorporeal shock wave lithotripters, that may have reporting requirements in 21 CFR 1002 but are not subject to federal performance standards. In these cases, form FDA-2877 is not required.

To help expedite the FDA electronic screening process for medical devices that are also radiation-emitting electronic products, each entry line should contain AofC codes applicable to both medical devices and radiation-emitting electronic products.

MEDICAL DEVICE RELATED CODES
Device Foreign Manufacturer (DEV) or Device Foreign Exporter (DFE)
Device Listing (LST)
Device Initial Importer (DII)
Premarket Application (PMA) [can be a PMA, a Humanitarian Device Exemption (HDE) or a Product Development Protocol (PDP) number]
OR a Premarket Notification Number (PMN)
OR an Investigational Device Exemption (IDE)

AND

ELECTRONIC PRODUCT RADIATION CONTROL RELATED CODES
EPRC Accession Number (ACC)
Or EPRC Annual Report Number (ANC)
EPRC Model Number (MDL)
AND,
AofC code from form FDA-2877

To help expedite the FDA electronic screening process for non-medical radiation-emitting electronic products, each entry line that is subject to federal performance standards should contain an AofC code related to the appropriate form FDA-2877 declaration and, if appropriate, should contain AofC codes ACC or ANC.

[The September 6, 2011, Letter to Industry about Import Entry Review Process is available here.]
 

(Montreal Gazette – Jordan Press, Postmedia News)

Nine months after the U.S. State Department began probing how Canadian parts ended up in a Chinese attack helicopter, American officials were frustrated with Canada’s lack of co-operation in the investigation, a leaked cable shows.

That frustration extended beyond the perceived lack of help from Canadian security agencies, to a perception that Canada was ineffective in stopping weapons from being exported into the wrong hands.

At a meeting with the RCMP, CSIS and the Canada Border Services Agency, Frank Ruggiero, a senior State Department security strategist, stressed the need for Canada to do more to help with cracking down on weapons exporters, according to a cable posted on the website WikiLeaks.

“The (Immigration and Customs Enforcement) officers argued that until the price to be paid for export control violations is the same in Canada as it is in the U.S. – prison – adversaries will persist in abusing Canada as a venue from which they can illegally procure and export U.S. defence technologies,” said the cable, signed by former U.S. ambassador David Wilkins. Read more here.
 

(CTV News – The Canadian Press)

Finance Minister Jim Flaherty concedes that government policies regarding tariffs on imports may be one of the reasons consumer goods cost less in the United States than in Canada.

A day after calling for the Senate finance committee to investigate the price gap, which one survey puts at 20% on average, the minister said Thursday that high tariffs may be a problem.  But he stopped short of saying they would be removed or reduced. He said that’s what the Senate probe will help determine.

“I’m responsible for tariffs and sometimes people in the retail business blame tariffs and so on, so I want to see and I want to know what the facts are,” he told reporters after a meeting of the Conservative caucus.  “I’m looking forward to the Senate committee getting to the facts … and we’ll take whatever steps we need to take.” Read more here.

(International Freighting Weekly – Pete Goldin)

Pilot programme launches this month with a Winter 2012 target for adoption

US Customs and Border Protection (CBP) has unveiled its Automated Commercial Environment (ACE) e-Manifest Rail and Sea, also called M1.

The new system will allow users to transmit electronic manifest data to ACE and the agency will begin a multi-phase pilot programme later this month.

Jenny Burke, Field Branch Chief at the CBP’s Office of Public Affairs, said the system woul;d be trialled using a limited audience with the intent of “slowly expanding the number of users until we are satisfied that the system has the functionality and capability to meet our requirements”. Read more here.
 

(Luiza Ch. Savage — Macleans)

Deeper economic integration has been stalled by a risk-averse U.S. government

What was once proudly touted as the world’s “longest undefended border” is now monitored by Predator drones and radar. Neighbours who could casually cross the border for a dinner or a hockey game now show a passport to get across. Businesses fill out proliferating stacks of paperwork to move goods across the border. “Nobody would have expected it [before 9/11],” says Eddie Goldenberg, who was a top aide to Chrétien. “And my own view is they have gone overboard since 9/11. It clearly has negative consequences. I think U.S. tourism is down because a lot of Americans don’t have passports. It’s become very complicated with goods, for just-in-time delivery, particularly for the automotive industry.”

Meanwhile, the infrastructure hasn’t kept up. A second bridge between Detroit and Windsor—more trade passes through that border crossing than between the U.S. and all of Japan—has been talked about for years but remains unbuilt. “It’s pathetic,” says Tom Ridge, the former Pennsylvania governor who was appointed by president George W. Bush as homeland security adviser and then the first secretary of homeland security. The failure to build a new bridge and the failure to enact “pre-clearance” facilities at the land border have been examples of what he calls government “inertia.” “Overall I’ve been disappointed,” Ridge told Maclean’s. “There has been modest progress but there remains cultural and institutional resistance.”

Read the complete article here.

Related: Maine Residents Block Massive Border Building Plans (CBC News)
 

(Courtney Flynn — The Voice)

Prior to 9/11 the Department of Homeland Security did not exist. But in its aftermath this civilian-based federal agency has gained a strong presence at Selfridge Air National Guard Base with an umbrella of agencies that once never existed and enhancing the size of others.

“Right after 9/11 we had to quickly decide how we were going to operate,” U.S. Customs and Border Protection United States Border Patrol Chief Patrol Agent Randy Gallegos said.

Gallegos said the U.S. Border Patrol was fully mobilized within 36 hours of the attacks; but the Department of Homeland Security, established on Nov. 25, 2002, did not become fully developed until about two years later. [...]

With a vulnerable northern border, one that didn’t receive much attention until after 9/11, Gallegos said such a strategy was needed. To reinforce this strategy the number of Border Patrol agents in the agency increased from 10,000 to about 21,000 from 2002 to now, he said. At the Great Lakes sector of the agency, which now includes Selfridge, Marysville, Gibraltar, Sault Ste. Marie and Sandusky, Ohio locations, has seen its ranks swell from 125 to about 500 employees.

“We are the largest sector in the northern border,” Gallegos said. “The resourcing has been refocused up here to a certain degree. At least the mindset has changed since 9/11.” Read more here.