October 9, 2020

ISEA Needs Volunteers for Position Papers

ISEA’s Government Relations Committee met on October 7 to address two key issues: combating fake, fraudulent and counterfeit PPE (primarily with a focus on COVID), and domestic sourcing of PPE (mainly for government procurement). The group formed two ad hoc subcommittees to write position statements on each topic.

Committee members volunteered to help write these position statements. However, they are seeking two volunteers for each committee. If you would like to help craft position statements on (1) anti-counterfeiting and (2) domestic sourcing of PPE, please contact Dan Glucksman at [email protected]

Anti-Counterfeiting

There’s no shortage of bills in the House and Senate. Each takes a slightly different approach to curbing counterfeits and provides the federal government with enforcement tools. In the summer, it appeared fortitude to tackle this topic was in short supply. But now, the increased awareness of the money lost to fraudsters and rip-off artists and the potential harm to those who may have been exposed to COVID from ineffective, unprotective products is pointing to possible action as part of a larger COVID bill – which is still a possibility.

A clear position statement backed up with examples of knockoffs, untrue federal certifications, and other scams will help keep ISEA in the mix as the true voice of the PPE industry.

Taking Action

The group reviewed federal resources that can aid in stopping scammers and starting the law enforcement process. A key resource is the Homeland Security Investigations’ Intellectual Property Coordination Center (IPRCC). IPRCC coordinates across US and international enforcement agencies.

Other opportunities for company and association engagements include the Federal Trade Commission’s Consumer Protection Bureau and the FDA’s task force on Regulatory Misconduct Allegations. This group at FDA reviews claims “that a medical device manufacturer or individuals marketing medical devices may be doing so in a manner that violates the law.”

A late-October webinar for ISEA members from HSI’s IPRCC leaders, who will speak about how to connect with this center, has been requested. Stay tuned!

Domestic Sourcing

Domestic sourcing requirements for PPE have raced to the top tier of policy discussions. If there are 15 active anti-counterfeiting bills, there 100 on domestic sourcing. The general theme of most bills is that state and federally stockpiled PPE should be made in the US with domestically sourced components. Most bills also have exemption clauses when items are not available in the quantities needed, when needed, and at the quality and price levels federal purchasers are seeking.

Similar to the anti-counterfeiting ad hoc committee this committee also seeks two additional volunteers to help craft a position statement along with an expanded background.

The issue is timely. An August 6 Executive Order allows the FDA and the US Trade Representative (USTR) to work cooperatively to identify essential medical PPE and remove those items from current US Trade Agreements. Some on Capitol Hill are recommending the same, as does Public Citizen.

ISEA involvement in domestic sourcing policy to date

ISEA President Chuck Johnson talked about this topic at a July 28 hearing of the Senate Finance Committee, and the association discussed it in a recent submission to the International Trade Committee. In both, ISEA stated there are multiple reasons to keep PPE in the nation’s many trade agreements.

ISEA’s Government Relations Committee has already had legislative forays in this area. Rep. Matt Cartwright (D-PA) reached out to ISEA for comment and discussion on The MAKE PPE Act. To be introduced, this legislation aims to help solve the current PPE supply and demand issue, while seeking a solution for PPE for future pandemics. The Committee provided useful input.

Two main provisions ISEA presented were (1) giving FEMA the ability to collect 30, 60 and 90 projections of PPE needs assessments, which would be shared with the manufacturing community; and (2) ISEA recommended legislative language recognizing companies with non-China based diverse supply chains to meet the bill’s intention of reducing reliance on supply chains based in China.

Domestic Procurement Law and Regulation Review

The group also reviewed the laws and regulations covering federal procurement. ISEA will work to arrange a webinar reviewing laws such as the Buy American Act, the Berry Amendment, and the Trade Agreement Act.

Here are summaries of the federal procurement laws common in contemporary political discourse:

Buy American Act (BAA)

This program covers specified products and requires the US government to purchase domestic construction materials. The Buy American Act created a national preference for the government to procure only domestic materials used for public construction unless a waiver had been granted. The 1933 Act applies to direct purchases by the federal government, but not third parties, such as private contractors given procurement funding through government endowments.

Trade Agreements Act of 1979

Under the TAA, the United States has committed to open its government procurement to 57 countries or economies on a non-discriminatory basis. With respect to the goods and services covered by these agreements, the US must treat the goods, services, and suppliers from the 57 parties in a manner comparable to US goods, services, and suppliers.

Berry Amendment

The Berry Amendment was originally passed by Congress in 1941 to promote the purchase of certain US goods. The Amendment was included in subsequent defense appropriations act until it was made permanent in Fiscal Year 1994 by Section 8005 of Pub. L. 103-139. It was subsequently codified as 10 U.S.C. 2533a in 2002 by section 832 of Public Law 107-107

NOTE: Buy America Act

This is a DOT funding/procurement law. The Buy America Act was established within Section 165 of The Surface Transportation Assistance Act of 1982, which was a transportation funding and policy act created under the Reagan administration. This provision was created to address concerns over the surface transportation of highways and bridges. The Buy America Act was intended to give preference for the use of domestically produced materials on any procurements funded at least in part by the federal government.