Domestic Preferences

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On September 14, 2020, the Federal Acquisition Regulatory Council published the long anticipated proposed rule amending the Federal Acquisition Regulation (“FAR”) in accordance with President Trump’s Executive Order 13881, “Maximizing Use of American-Made Goods, Products, and Materials.” As previously discussed here, the Executive Order, signed on July 15, 2019, required significant changes to the implementing regulations of the Buy American Act, 41 U.S.C. §§ 8301-8305, changing policies dating back nearly 70 years. Accordingly, the proposed rule seeks to increase both the domestic content requirements and the evaluation preferences provided by the FAR for domestically manufactured goods, particularly with regard to domestic content requirements for steel or iron end products and products made predominantly from iron or steel. Most significantly, however, the proposed rule will revive heightened restrictions for commercially available-off-the-shelf (“COTS”) products that are made predominantly of iron or steel, requiring both the end product and 95 percent of the component parts be domestically sourced in order to qualify under the rule. The COTS exception remains available for other end products (that are not made predominantly of iron or steel), but the proposed rule still will impose heightened obligations and vendors now need to scrutinize their supply chains even more closely, even for COTS items. The FAR Council is accepting comments through November 13, 2020. A final rule is likely by early-2021.
Continue Reading Proposed Changes to the Buy American Act Regulations Implementing Trump Executive Orders

On August 6, 2020, President Trump signed the “Executive Order on Ensuring Essential Medicines, Medical Countermeasures, and Critical Inputs Are Made in the United States,” requiring, among other things, the U.S. government to purchase “essential” medicines and medical supplies produced domestically, rather than abroad. Citing a need to reduce U.S. dependence on foreign suppliers, the Order sets forth several new requirements aimed at establishing reliable, long-term domestic production of essential drugs and devices, including their component parts. To be clear, this is a tall order: the Food and Drug Administration (FDA) will need to assemble a list of critical supplies and medicines; agencies will need to assess ways to secure the supply chain for both equipment and medicines; the Environmental Protection Agency (EPA) will need to consider how it can accelerate domestic manufacturing requests; the U.S. Trade Representative (USTR) and the Department of Defense (DOD) will need to re-negotiate the terms of international agreements; the Department of Veterans Affairs (VA) may (or may not) be exempted; and – lest it go without saying – everyone will have to update their regulations. While this “Buy American” requirement seems to take effect as soon as the FDA issues its list of critical materials, the Order may leave intact (at least temporarily) some exceptions, which may allow companies time to examine and adjust their supply chains. Over the longer term, most required agency actions are ordered to be realized within 90-180 days, but the inevitable regulatory updates will lag (far?) behind. For now, we find ourselves in a bit of a Twilight Zone – “the middle ground between light and shadow, between science and superstition, and … between the pit of man’s fears and the summit of his knowledge” – forced to guess which parts of this new Order are real and immediate, and which will leave us stuck in a “darker dimension.”
Continue Reading “Buy American” in the Twilight Zone: Executive Order Strengthening the U.S. Public Health Industrial Base

On February 10, 2020, the U.S. Court of Appeals for the Federal Circuit issued its long-awaited decision in Acetris Health LLC v. United States, No. 2018-2399 (Feb. 10, 2020).
Continue Reading What Does it Mean to Manufacture? Federal Circuit’s Acetris Decision Fundamentally Alters Trade Agreements Act Compliance

Selling drugs to the Government just got a lot simpler.  In Acetris Health LLC v. United States, No. 2018-2399 (Feb. 10, 2020), the Federal Circuit opened the Government door…
Continue Reading Federal Circuit Changes the Game for Selling Single-API Drugs to the Government

On July 15, 2019, President Trump signed an Executive Order requiring regulations implementing the Buy American Act, 41 U.S.C. §§ 8301-8305, to be changed. While President Trump has previously issued two other policy-based “Buy American” Executive Orders, this new Order directs that specific changes be made, reversing government policies that have been in place for 65 years. These changes have the potential to significantly disrupt many government contractors’ supply chains and internal compliance programs. As such, companies should start planning now for the final regulations that are expected sometime in 2020.
Continue Reading “Buy American” (Again): New Executive Order Requires Changes (By 2020)

Few phrases sum up the Trump administration’s policy goals better than “Buy American.” We hear it in advertising; we hear it in the State of the Union; and we find it littered throughout government buying priorities. Here is a short primer on some recent developments out of the White House regarding the oft-invoked (and often misunderstood) requirement to “Buy American,” including a new Executive Order issued just last month.
Continue Reading “Buy American” Updates: Trump’s Executive Orders, Government Reports, and Other Updates

Every two years, the U.S. Trade Representative updates the dollar values at which certain international trade agreements apply to certain types of U.S. government contracts. This means that certain contracts over the dollar thresholds are subject to the trade agreements, in other words, foreign-made products are placed on equal footing with U.S.-made goods. On the other hand, contracts beneath the dollar thresholds remain subject to certain “Buy American” provisions, preferring U.S.-made goods over foreign-made alternatives. Because most of you reading this post probably sell the Government products and components sourced from the global marketplace (where “Made in China” and “Made in Taiwan” may seem much more common than “Made in America”), you might want to know where these thresholds will sit until 2018. And since the U.S. Trade Representative took the unusual step of reducing these thresholds for 2016, this may be one of those rare occasions where a change in the regulations actually works to your advantage.
Continue Reading Trade Agreements Act Updates for 2016 – New Year, Lower Thresholds

The US is generally pretty keen on international free trade agreements. And why shouldn’t it be? After all, free trade agreements have the ability to open up foreign markets to US goods and services, allowing new and expanding opportunities for US companies. But “free trade” does not always mean “free trade” – it usually means “free-er trade, subject to numerous exceptions,” with the exceptions proving a constant irritant to our free trade partners. Case in point: two recent events – one in the European Union and one in Canada – demonstrate that “free trade” (subject to numerous caveats) is still a bone of contention, even among long-established trading partners. While “free-est trade” may be too much to ask for, maybe “free-er trade” with fewer strings attached would at least be a step in the right direction.
Continue Reading Free(er?) Trade – US, EU and Canada Quibble Over Market Access and Domestic Preferences

By David Gallacher

Two months ago, we published a brief list of compliance tips to keep in mind when dealing with Buy American requirements. We got an awful lot of…

Continue Reading Buy American Redux – 15 Tips for Navigating the Buy American Maze

By David Gallacher

1. There is no single “Buy American” requirement – there are numerous statutes with differing requirements. Make sure you know which one applies.

2. Whether you are a prime or a subcontractor, certify only to the specific “Buy American” requirements in the RFP; do not make a broader certification than is required.Continue Reading “Buy American” Compliance Tips