Tag Archives: asthmatics

EPA’s New Ozone Rule: Part 24

This last post about EPA’s new ozone rule will summarize the topic and will draw some conclusions. We begun with a September 2011 news item that the Obama administration had requested the EPA to withdraw a new proposal to reduce the maximum amount of ground-level ozone in the air:    from 75 ppb to 70 ppb (.075 ppm to .070 ppm)1. This decision stirred controversy with many in the business community praising the President for keeping economic concerns front and center against many in the environmental community claiming that the President had missed an important opportunity to improve air quality2. Our purpose was to determine which side held more weight.

The answer to that question depends a great deal on one’s sense of priorities: is a robust economy more important or is reducing sickness and death from air pollution to a minimum more important? We know that ozone is a respiratory irritant, lethal in high concentrations but damaging even in very low concentrations3. We have ample research that shows higher ground-level ozone concentrations causes more deaths and results in more visits to hospital emergency rooms and missed days from work4. On the other hand, minimizing ozone creation is an expensive proposition. Requiring industry, responsible for most ground-level ozone production, to reduce its ozone contribution is laying on it a heavy regulatory burden that hampers business activity and reduces employment5.

We discussed the origins and chemistry of ground-level ozone and saw why industry would need to bear most of the burden of lowering the standard6. We noted that the new rule actually imposed two standards, a primary standard based on highest averages to protect human health, and a secondary standard based on cumulative exposure to protect property and economic interests, particularly plant life7.

We talked about the damage that ozone does to people and property8, then went on to discuss the history of ozone regulation since 20089. We went into some detail into EPA’s thinking as recorded in government documents, trying to understand why they set the primary standard as .075 ppm in 2008 but .070 only two years later10, and why they originally did not really set a secondary standard but later formulated one on the insistence of CASAC (Clean Air Scientific Advisory Committee)11. We saw that the two administrators, Stephen Johnson under President Bush and Lisa Jackson under President Obama, had access to about the same evidence but came to very difficult conclusions about what was needed to protect the public health and leave an adequate margin for error12. We saw how CASAC strongly objected to not having a separate secondary standard and how they influenced the EPA to adopt such a standard in 201013. We discussed the burden of implementation and touched on the many industries that are effected by tougher ozone rules14. We did a very rough cost-benefit analysis weighing the financial benefits of stricter ozone regulation against its economic costs to society15.

Finally, we discussed how well current ozone rules are being implemented, what areas of the country are not in compliance with the current standard of 75 ppb, and by how much16. We saw that non-attainment of the current EPA standard is confined largely to the East and West Coasts and to major metropolitan areas. Only California has severe problems with ozone, and it has those problem in a large swath through the state. Baltimore and Dallas have moderate problems, and the rest of the country have at most marginal problems with ozone.

So where does that leave us? Should the EPA try to implement a stricter standard at a later date? President Obama himself stated in his September 2011 statement that the ozone standard would be reconsidered in 2013, so perhaps this year we will see a second attempt. But maybe not: Lisa Jackson left the EPA last February, and until the Senate confirms a successor, the EPA will be headed by an acting administrator (Bob Perciasepe). I understand that an acting director does not have the same authority as an administrator confirmed by the Senate, so I doubt that the EPA will adopt a stricter standard until a new Administrator is confirmed (Obama’s current nominee is Gina McCarthy).

I don’t disagree with Obama’s decision to request a retraction. Business opposition to the new rule was strong. He was facing a difficult election and he didn’t need to stir up more opposition than he had to. As we discussed earlier, deciding whether the ozone standard should be at 75 ppb or 70 ppb is largely a judgement call. The lower standard will save lives, increase life expectancy, and relieve illness, but will likely be an economic burden and an impediment to job creation. Reasonable people could take either side of the argument.

I tend to fall on the side of environmentalists. While the regulatory burden is a concern, people and economies adjust over time, as long as burden is reasonable. If a tougher standard was enforced, I think we would see some loss of economic activity and employment. But when regulations are enforced in an intelligent way, people eventually get used to them and learn to work within them. For example, take EPA’s Acid Rain Program, legislated in 1990 as part of the Clean Air Act and put into effect in 199517. The Acid Rain Program is a cap-and-trade program, enabling industries that are able to cut their sulfur dioxide emissions beneath a certain limit to sell the rights to emit the saved sulfur dioxide to other industries. This program may have played a major role in sharply reducing emissions in the U.S.18 People seem to have adjusted to it, with very little vocal opposition that I am aware of. Nobody has blamed the Acid Rain Program for the poor state of the economy.

But the key is that stricter standards must be intelligently enforced with sensitivity to the needs of business; heavy-handed regulation blindly administered with no regards to business can really be a drag on the economy. Not being an expert, I’m not sure how to do intelligent enforcement. However, I understand that Obama’s current nominee for EPA Administrator, Gina McCarthy, is a strong believer in working with business to find the best solutions to environmental problems. If so, she’d be perfect for the job, and I strongly urge the Senate to confirm her as soon as possible.

Yet the stricter standard was scuttled. I think part of the problem is that EPA’s manner can be rather imperious and somewhat patronizing, laying down new regulations without any serious input from other stakeholders. There was a period of public comment to which the agency responded19, but my impression is that the agency merely rebutted criticism rather than try to incorporate people’s concerns into the decision process. Naturally, affected stakeholders are resentful. As it writes a new standard into law, the EPA needs to build cooperation with stakeholders, and that was what was sorely lacking in the process. Everybody’s concerns need to be addressed and it’s important they feel their needs are being addressed.

Moreover, EPA tried to enact the new standard without garnering public support first. When I first learned of Obama’s retraction, I had never heard of the new ozone rule, and I doubt many people did, either. Many people were wondering, what is this bothersome new regulation all about and why is it important? EPA can still win a stricter ozone standard, but to accomplish that it must first raise awareness about the problems of ground-level ozone among the public. It can do this by working with environmental advocacy organizations and patient advocacy organizations (such as the American Lung Association) to build public awareness of ground-level ozone and its effects. Either it or a surrogate can build a major ad campaign to push ozone to the forefront of the national consciousness (how about the slogan “Ozone Kills!”). It can devise educational presentations that schools can use in their classrooms. It can put scientists and researchers on news programs and talk shows. It can have them write articles and op-ed pieces in newspapers and popular magazines. If there is a popular demand for stricter ozone standards, there will be a much better chance that the standards will make it into law.

I’ve wondered how ozone levels affect the performance of players in major league sports, particularly those played out-of-doors (baseball and football especially). If a negative correlation could be proved, we might have major league sports as allies. Players are occasionally accused of taking performance-enhancing drug. What if it could be proved that low-ozone air is a performance-enhancing drug that is perfectly legal?

Also, we need more research into ozone. I mentioned before that very few scientific studies have looked at the effects of 40 — 60 ppb ozone on subjects in the laboratory20. It also seems that there is a dearth of laboratory studies that have had asthmatics and other COPD (chronic obstructive pulmonary disease) sufferers as subjects21. We need more of these studies. We need to publicize epidemiological studies that compare the effects of living in areas of the country with high ozone concentrations with those of lower concentrations to convince people there is a difference, and that it affects them personally.

As for the secondary standard, I’d hold off on that. If the purpose of the secondary standard was to shore up struggling ecosystems and prevent species extinction, it would be worth fighting for. But if its main purpose is to protect property, then why should we be fighting for the concerns of property owners? We ought to educate people as to what a secondary standard can accomplish, but it shouldn’t be our responsibility to try to impose it. That should be for the beneficiaries, home owners, property owners, and farmers to demand. If they lobby EPA for it or if Congress pushes for it, the EPA should consider it. But if no stakeholders think they need such a standard, then we really don’t need it and we shouldn’t be pursuing it. With a world full of environmental threats, we need to choose our battles carefully, and this is a battle not worth fighting. We need to save our time, energy, and effort for where it is more needed.

So those are my conclusions and recommendations, which you can accept or reject as you see fit. Thank you for taking the time to read this topic, and I hope you found it helpful to understand an important public health issue.


Footnotes:

  1. Statement by the President on the Ozone National Ambient Air Qualities Standards. White House website. To view, click here.
  2. See my post The EPA’s New Ozone Rule: Part 1. To view it, click here.
  3. See my post The EPA’s New Ozone Rule: Part 7. To view it, click here. See also my blog pages Ozone Excerpts 1, which you can view here, and Ozone Excerpts 2, which you can view here.
  4. For example, see the six papers listed in my post The EPA’S New Ozone Rule: Part 22, which you can view by clicking here.
  5. I admit I’m on very shaky ground here: I haven’t actually seen a scientific study on the economic effects of regulation. Perhaps I’ve bought too deeply into the arguments of conservative Republicans and the Tea Party. But it makes sense that if companies are forced to spend large amounts of money, time, and effort on government regulations, they will have less resources to spend on their business and less money to pay employees. The regulations may be necessary or even vital, but there’s always a cost. Of course, the net cost to the world economy is lessened because money spent on regulation benefits other businesses. The net cost to the U.S. economy is lessened, too, if money spent on conforming to regulations is spent on U.S. businesses.
  6. See my post The EPA’s New Ozone Rule: Part 4, which you can view by clicking here.
  7. See my posts The EPA’s New Ozone Rule: Part 6, which you can view by clicking here, and The EPA’s New Ozone Rule: Part 15, which you can view by clicking here.
  8. See my post The EPA’s New Ozone Rule: Part 7. To view it, click here. See also my blog pages Ozone Excerpts 1, which you can view here, and Ozone Excerpts 2, which you can view here. As for the damage that ozone causes property, I haven’t really discussed that in any depth. However, in Ozone Excerpts 1, see Table 1-2: Summary of ozone causal determination for welfare effects, vegetation, and ecosystem effects. In Ozone Excerpts 2, see Table 2-2: Summary of ozone causal determinations for vegetation and ecosystem effects.
  9. See my post The EPA’s New Ozone Rule: Part 8. To view it, click here.
  10. See my posts The EPA’s New Ozone Rule: Part 10 through Part 14. You can view any of these posts by clicking on the following:     Part 10,     Part 11,     Part 12,     Part 13,     Part 14.
  11. See my posts The EPA’s New Ozone Rule: Part 15 through Part 18. You can view any of these posts by clicking on the following:     Part 15,     Part 16,     Part 17,    Part 18.
  12. For Administrator Stephen Johnson’s view, see my post The EPA’s New Ozone Rule: Part 10 which you can view by clicking here. For Administrator Lisa Jackson’s view, see my posts The EPA’s New Ozone Rule: Part 11, click here to view, and The EPA’s New Ozone Rule: Part 12, click here to view.
  13. See my posts The EPA’s New Ozone Rule: Part 17. To view it, click here.
  14. See my posts The EPA’s New Ozone Rule: Part 20 and Part 21. To view Part 20, click here. To view Part 21, click here.
  15. See my post The EPA’s New Ozone Rule: Part 22. To view it, click here.
  16. See my post The EPA’s New Ozone Rule: Part 23. To view it, click here.
  17. U.S. Environmental Protection Agency website, Clean Air Markets Acid Rain Program. To view, click here.
  18. For example, U.S. Environmental Protection Agency, Acid Rain and Related Programs: 2009 Highlights, 15 Years of Results 1995 to 2009. To review the report, click here.
  19. For example, U.S. Environmental Protection Agency, National Ambient Air Quality Standards for Ozone, July 2011, Section II.C.2. “Comments on the Proposed Decision”, pp. 77 – 163.
  20. See my post The EPA’s New Ozone Rule: Part 9. To view it, click here.
  21. This observation was made from inference. The U.S. Envronmental Protection Agency’s document National Ambient Air Quality Standards for Ozone, July 2011, states (p.38) “The most certain evidence of adverse health effects from exposure to O3 comes from the controlled human exposure studies, as discussed in the 2010 proposal in section II.A.2, and the large bulk of this evidence derives from studies of exposures at levels of 0.080 ppm and above. At those levels, there is consistent evidence of lung function decrements and respiratory symptoms in healthy young adults, as well as evidence of inflammation and other medically significant airway responses.” Later on, the document mentions the Adams studies at the only controlled studies “that examine respiratory effects associated with prolonged O3 exposures at levels below 0.080 ppm.” But the Adams studies only used healthy subjects. Thus, the number of controlled studies using subjects with COPD and other respiratory ailments must be few and far between.

EPA’s New Ozone Rule: Part 12

In my last post, we quoted the document National Ambient Air Quality Standards for Ozone, Final Preamble, 2011, where the current Administrator of the EPA, Lisa Jackson (who recently announced she is leaving the agency) discusses why she decided to lower the maximimum ozone concentration limit from 0.075 ppm to between 0.060 and 0.070 ppm. Now she will explain to us how she chose the exact limit. Note that she tacitly acknowledges that she can’t demand more than is necessary. Choosing the optimal number won’t be easy, because the evidence doesn’t point to any such number (p. 174):

The Administrator next considered what standard level within the proposed range of 0.060 to 0.070 ppm would be requisite to protect public health, including the health of susceptible populations, with an adequate margin of safety — i.e., a level that is sufficient but not more than necessary to achieve that result. She recognizes that neither the health evidence nor the human exposure and health risk assessments provide any “bright line” for selecting a specific level within the proposed range.

She explains the difficulties: no laboratory studies in the range of .060 to .070 ppm, studies of people in the street indicate no particular threshold within this range, difficulty in extrapolating what we know about healthy people to people with asthma, and risk assessments made at only two levels: 0.070 ppm and 0.064 ppm. In short, no easy method of determining the best limit. Instead, she will need to base her judgement on many factors taken together (Note: The paragraph sign in brackets [¶] indicates a paragraph break that I introduced that isn’t in the original document. P. 174):

[¶]No controlled human exposure studies were conducted at intermediate levels between 0.070 and 0.060 ppm. Associations reported in epidemiological studies generally ranged from well above to well below this range, with no suggestion of a possible threshold within this range. While there is substantial evidence that asthmatics have greater responses than healthy, non-asthmatic people, there is uncertainty about the magnitude of the differences in their responses within this range. Moreover, within this range, exposure and health risk assessments estimated the exposures of concern and health risks only for standard levels of 0.070 and 0.064 ppm. Thus, there is a combination of scientific evidence and other information that the Administrator needs to consider as a whole in making the public health policy judgment to select a standard level from within the proposed range.

The Administrator declares the limit she selected (p. 175):

After weighing the strengths and the inherent uncertainties and limitations in the evidence and assessments, and taking into account the range of views and judgments expressed by the CASAC Panel, including CASAC’s most recent advice, and in the public comments, as discussed above, the Administrator finds the evidence and other information on the public health impacts from exposure to O3 warrant an 8-hour primary standard set at 0.070 ppm [emphasis mine — MHK]…

Jackson notes that the surest source of evidence, laboratory studies, offer scant evidence below the 0.080 ppm level other than the studies of Adams. In the interest of brevity I’m omitting that section. She goes on to discuss epidemiological studies, studies of people in the street. While they may not be as robust as laboratory studies, the large number of studies do offer enough evidence of a link between levels of ozone and bad health outcomes to make a judgement (p. 177):

With regard to epidemiological studies, the Administrator observes that statistically significant associations between ambient O3 levels and a wide array of respiratory symptoms and other morbidity outcomes, including school absences, emergency department visits, and hospital admissions, have been reported in a large number of studies. These associations occur across distributions of ambient O3 concentrations that generally extend from above to well below the proposed range, although the Administrator recognizes that there are questions of biological plausibility in attributing the observed effects to O3 alone at the lower end of the concentration ranges extending down to background levels.

However, Jackson does recognize that epidemiological studies have their drawbacks, as she discusses here. Samet assures her that although these studies are less reliable at concentrations that approach the natural ambient level, they are not less reliable at the 0.060 to 0.070 ppm range (p. 177):

[¶] The Administrator also recognizes the uncertainty inherent in translating information from such studies into the basis for selecting a specific level from within the proposed range. The Administrator notes that in its most recent advice, CASAC concluded that epidemiological studies are inherently more uncertain as ambient O3 concentrations decrease and effect estimates become smaller, although CASAC’s confidence in attributing reported effects on health outcomes to O3 did not change over the range of 0.060 to 0.070 ppm (Samet, 2011. p.10-11).

Now Jackson must make a value judgement. At what level concentration is the epidemiological evidence pointing to? (p. 178)

[¶]In weighing this evidence and the related uncertainties, the Administrator concludes that while the epidemiological evidence provides support for a standard set no higher than 0.070 ppm, it does not warrant selecting a lower standard level within the proposed range.

But what about people with respiratory problems? Perhaps they need a standard below 0.070 ppm. but she concludes that there is not enough information to choose a lower limit for that reason (p. 178).

The Administrator has also considered the evidence from controlled human exposure and epidemiological studies that children and adults with asthma and other lung diseases are likely to experience larger and more serious responses to O3 exposures than healthy, non-asthmatic people. … the Administrator recognizes that controlled human exposure studies conducted using healthy subjects likely underestimate effects in this susceptible population. The Administrator also recognizes, however, that there is uncertainty about the magnitude of any such differences in responses. Thus, the Administrator concludes that while this evidence supports taking into consideration the extent to which a standard would limit exposures of susceptible populations to concentrations at and above the 0.070 and 0.060 ppm benchmark levels, it does not further inform the translation of the available evidence of O3– related effects in healthy subjects into the basis for selecting any specific standard level from within the proposed range.

Perhaps some quantifiable data can shed some light on an appropriate level that will assist people with respiratory problems. That is the subject of my next post.