On April 29, 2018, Fitzgerald Glider Kits LLC hired me to prepare a straw man Regulatory Impact Analysis (RIA) for an EPA regulation that would repeal certain provisions of a 2016 EPA regulation that would have intentionally driven several companies (including FGK) out of business.

EPA’s 1,116 page RIA for its 2016 regulation includes no incremental analysis of the benefits and costs of these provisions. This omission violated both OMB guidance and EPA guidance, both of which require incremental analysis of key provisions. It is therefore impossible for a third-party to prepare a fully-informed RIA; only a strawman RIA is feasible.

​Nonetheless, the strawman RIA shows that the glider provisions in the 2016 EPA regulation may result in greater greenhouse gas and pollutant emissions. That’s because if gliders are driven off the market as EPA intended in 2016, truck buyers no longer able to buy them are likely to purchase used trucks or retain existing old trucks in service. Used and existing old trucks emit more greenhouse gases and pollutants than gliders. It’s not known how many would purchase new trucks instead of gliders, but because new trucks are 40% more expensive, that fraction is likely to be small.

Meanwhile, the adverse economic effects of the glider provisions in the 2016 EPA regulation are clear — hundreds of millions of dollars in forced early retirement of capital and thousands of American jobs lost. In its RIA, EPA did not acknowledge either of these predictable effects. 

This strawman RIA should be sufficient to justify repealing the glider provisions. EPA has separate authority under the Clean Air Act to regulate rebuilt heavy-duty truck engines if it wants to treat all rebuilt engines fairly instead of discriminating against gliders.

The strawman RIA is #2 on my publications list and is directly accessible here.

The U.S. Patent and Trademark Office (USPTO) requires patent applicants to provide substantial information on request pursuant to numerous regulations. The Paperwork Reduction Act (PRA) requires the USPTO to obtain prior approval from the Office of Management and Budget (OMB) before collecting this information. But the USPTO never sought and obtained OMB approval of the collections of information contained in Rules, 111, 115, and 116 (among others). That means patent applicants have no legal obligation to comply, as set forth in 44 U.S.C. 3512(a).

This is all routine, except that in July 2013 OMB exempted the collections of information contained in these rules from the definition of information in the PRA and in 5 C.F.R. 1320.3(h), OMB’s implementing regulation. 

In this working paper, I show that OMB’s action violates the PRA’s statutory purpose and its own implementing regulation. OMB has no authority to override the statute Congress delegated to it to implement. And it certainly cannot apply its own implementing regulation in a way that conflicts with the plain text.

OMB has invited patent applicants to challenge its action in Federal court. 44 U.S.C. 3507(d)(6) shields certain OMB actions from judicial review, but this  action is not covered by that exemption. For a court to rule otherwise, it must grant OMB absolute power, including the power to override Congress and make up law as it sees fit.

On April 25, I testified on the National Toxicology Program's Report on Carcinogens before a joint hearing of the Committee on Science, Space, & Technology, Subcommittee on Investigations & Oversight, and the Committee on Small Business, Subcommittee on Healthcare & Technology.

My written testimony is here.

My research shows that the Report on Carcinogens is not a high-quality scientific work product. There are two major reasons why.

First, although Congress might have wanted a scientific compendium of substances carcinogenic to humans it did not ask for this in scientific language. Instead, it asked for a list of substances "which either are known to be carcinogens or may reasonably be anticipated to be carcinogens." But this is highly subjective, legalistic language that is foreign to the disciplines of science: Science does not “know” or “reasonably anticipate” things. These are not scientific words. They are the words of lawyers.

Second, the NTP has implemented this language in highly nonscientific ways that maximize its flexibility to use (or reject) scientific information  however it sees fit. Among other things, the NTP's criteria for listing do not include any minimum scientific standard of causality. The NTP deems a substance a "known" human carcinogen if, in its sole and unreviewable judgment, "There is sufficient evidence of carcinogenicity from studies in humans.* 

There is another highly significant problem with the way the NTP produces the Report on Carcinogens. The law establishes a second condition that must be met before a substance is listed as a human carcinogen: "a significant number of persons residing in the United States [must be] exposed" to it. The NTP simply ignores this statutory requirement.

Fixing the Report on Carcinogens will require congressional action. 

First, despite the extent to which NTP listings violate federal law by failing to satisfy the exposure requirement, it appears that no one has standing to challenge a listing in federal court.

Second, until Congress revises the law to clearly direct the NTP to produce a strictly scientific compendium of human carcinogens, the NTP will continue to produce policy determinations based on undisclosed criteria. 

​My testimony identifies six specific ways Congress can improve the scientific quality and public value of the Report on Carcinogens. Until these (or similar) reforms are made, the Report on Carcinogens will continue to be highly controversial and largely useless.

On February 3, I testified before the Subcommittee on Energy and Environment on ways to improve the quality of risk assessment at EPA. My written testimony is here.