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. April 5 , 2015.



### ACCOUNTING FOR VULNERABILITY IN THE NAAQS REVIEW PROCESS

RECOMMENDATION : E

PA should expand its efforts to quantify the combined risks to health for populations exposed to multiple chemical and social exposures (due to, for example, residence in lower income neighb orhoods) , using clear and consistent population level criteria for risk

. [ 1 ]



### BACKGROUND

P opulations or groups that experience multiple social, physical and chemical environmental stressors

are at increased risk of disease. Residents of low to moderate income urban communities, who are disproportionately Non

- Hispanic Black (NHB ) and Latino, are more likely to be exposed to multiple air pollutants

. [ 2 ] Su ch communities also experience heightened vulnerability to adverse health effects of air pollut ants due to higher rates o f chronic conditions su ch as asthma, obesity, diabetes, and
cardiovascular disease. [ 3

- 5 ] These vulnerabilities coincide with social stressors, including poverty, poor housing, psychosocial stress, and r educed access to nutritious foods and health care , further exacerbating adverse effects

. [ 6 ]
The combined effects of these multiple social, physical and chemical exposures, along with reduced access to resources necessary to maintain he alth (e.g., healthy foods, health care) have important implications for population health. Pregnant women, infants and children through puberty may be particularly susceptible to the adverse effects of these multiple exposures, due to differential dose as
well as the disproportionate impacts of exposures during critical developmental windows

. [ 7 ]
Several reports have highlighted the importance of understanding the aggregation of risks from multiple

environmenta l stressors. These include the National Research Council's (NRC) 1994 report Science and Judgment in Risk Assessment, [ 8 ] the 1997 report by the Presidential/ Congressional Commission on Risk Assessment and Risk Management, [ 9 ] and the NRC’s 2009 report on Science and Decisions. [ 10 ]
Despite these recommendations, t h e EPA has not applied consistent criteria to assess the joint effects of multiple exposures in recent NAAQS review processes. The absence of a clear and consistent process for identifying the combined effects of multiple exposures and vulnerabilities contribute s to in adequate
efforts to capture the se joint effects. New, more encompassing processes for assessing vulnerability that
account fo r the combined effects of multiple exposures and vul nerabilities are needed. [ 2 ]

ACCOUNTING FOR VULNERABILITY IN POPULATIONS WITH MULTIPLE RISK FACTORS

The EPA should set clear and consistent criteria to account for the combined health effects of

exposures to multiple social, physical and chemical stressors, such as those in low income communities and communities of color

, in the Integrated Science Assessment (ISA)

. Evidence using these criteria for assessing cumulative risks should be explicitly taken into account when setting the NAAQS standards.
Different criteria for ide ntifying vulnerable populations were used in t he two most recent NAAQS review processes. Specifically, the Ozone HREA ( 2014 ) did not account for more adverse effects due to already compromised health, a criterion laid out in the PM2.5 decision ( 2012 )

. Previously, EPA has defined four ways to establish vulnerable populations: 1) Higher levels of exposure; 2) Higher dose at a given level of ambient exposure; 3) More adverse effects at a given level of ambient exposure; and 4) More adverse
ef fects due to already compromised health. T he most recent NAAQS review process for PM 2.5 a pplied allPage 2

Contact Amy Schulz ( ajschulz@umich.edu ) for additional information. Produced by the Detroit Reproductive Environmental Advocacy Matters Working Group: Donele Wilkins , Amy Schulz, Natalie Sampson, Kelly Ferguson, Chris Coombe, and Trish Koman

. April 5 , 2015. four of these ways to establish a margin of safety for at

- risk populations. [ 11

, 12 ] However, the EPA only
included criteria 1

- 3 above for the development of the revised Ozone standard. Although contained in
the American Thorac ic Society statement [ 13 ] , EPAs Ensuring Risk Reduction in Communities with Multiple Stressors: Environmental Justice and Cumulative Risks/Impact [1] and applied in previous
NAAQS r eviews, the fourth criteria was omitted from correspondence with Administrator Jackson in the February 2013 memo to CASAC. [ 1 4 ] The rationale for eliminating the fourth criteria of population consequence is not discussed.

The EPA should apply a clear and consistent methodology to account for the population effects due to already compromised health from multiple social and chemical exposures

. There is scientific

c onsensus that the effects of exposures to environmental contaminants differ based on vulnerabilities such as underlying health status and the presence of co

- pollutants. [ 10 ] Furthermore, there is increasing recognition that social conditions can amplify the adverse effects of enviro nmental agents on health, [ 10

, 15 ] contributing to excess risk and racial, ethnic and socioeconomic disparities in health. F ailure to include criteria that specifically assess the population effects of exposures, particularly in populations which experience already

- compromised health due to multiple exposures, underestimates these effects,
and is inconsistent with recent scient ific guidance. The EPA has developed such population risk cri teria, but has not applied them consistently in its review proces ses. Failure to e stablish and apply consistent methodologies for cumulativ e risk assessment contributes to an underestimate of the margin of safety , is a departure from previous considerations , and is inconsistent with scientific guidance

.

S pecifically, guidance from ATS states that “Exposure to air pollution that increases the risk of an adverse effect to the entire population is adverse, even though it may not increase the risk of any individual to an unacceptable level. For example, a population of asthmatics could have a distribution of lung function such that no individual has a level associated with clinically important impairment. Exposure to air pollution could shift the distribution to levels that still do not bring an y individuals to a level that is associated with clinically relevant effects. However this would be considered to be adverse because individuals within the population would have diminished reserve function, and therefore would
be at increased risk for furt her environmental insult” (Part II, Section B, Part 3). [ 11

, 16 ]

For example, a recent multicity time series study cited in the Federal Register followed four cohorts of
Medicare enrollees with chronic conditions that might predispose them to ozone related effects from

1985

- 2006. [ 17 ] This stud y reported an association between long term (warm season) exposure to ozone and elevated risk of mortality in the cohort that had previously experienced an emergency hospital admission due to chronic obstructive pulmonary disease. Given socioeconomic, raci al and ethnic disparities in risk factors for COPD, these findings suggest that failure to apply c onsistent population risk criteria for vulnerability may underestimate adverse health effects in communities where residents experiences the combined effects of mult iple exposures and vulnerabilities. [ 18

- 24 ]

The purpose of selecting primary standards that provide an adequate margin of safety is to both prevent pollution levels that have been demonstrated as harmful, and to prevent lower pollution levels that may

pose an un acceptable risk of harm, even if the risk is not precisely identified. The EPA’s current methods for identifying populations at risk are inconsistent between the PM and Ozone NAAQS . They do not adequately account for multiple amplifying risk factors, including physical, social, and chemical exposures, and their combined impact on health . Consequently, the standards set with these methods are inadequate to protect h ealth in communities with multiple risk factors.Page 3

Contact Amy Schulz ( ajschulz@umich.edu ) for additional information. Produced by the Detroit Reproductive Environmental Advocacy Matters Working Group: Donele Wilkins , Amy Schulz, Natalie Sampson, Kelly Ferguson, Chris Coombe, and Trish Koman

. April 5 , 2015. CONCLUSIONS
The failure to set clear and consistent criteria to account for the combined health effects of exposures to multiple social, physical and chemical stressors, such as those in low income communities and communities of color, can lead to an underestimate of risks , and makes the review process inconsistent and not transparent. T his failure may contribute to underestimates in the adverse health effects of criteria pollutants, particularly for populations with multiple exposures and vulnerabilities

. Under the Clean Air Act, EPA has a duty to protect at

- risk populations with an adequate margin of safety. To do so, EPA must fully assess the risk to p opulations experiencing the cumulative effects of multiple social and chemical exposures, an d, particularly, pregnant women, infants and children within those populations

. F

uture ISAs and HREAs should more adequately account for the vulnerabilities of pregnant women and populations exposed to multiple social, physical and chemical stressors , using for example, the population level criteria for risk described above.

1. Group, N.E.J.A.C.C.R.I.W. Ensuring Risk Reduction in Communities with Multiple Stressors: Environmental Justice and Cumulative Risks/Impact 2004; Available from: http://www.epa.gov/compliance/ej/resources/publications/nejac/nej ac

- cum

- risk

- rpt

- 122104.pdf.

2. Morello

- Frosch, R., et al., Understanding the cumulative impacts of inequalities in environmental health: implications for policy. Health Aff (Millwood), 2011. 30 (5): p. 879

- 87.

3. Wasilevich, E., et al., Detroit

- The epicen ter of asthma burden , in Epidemiology of Asthma in Michigan , M.D.o.C.

Health, Editor. 2008: Lansing, MI.

4. (MDCH), M.D.o.C.H. Heart Disease Deaths and Death Rates Three Year Moving Average 2005

- 2007 . 2007 [cited 2012

05/21/2012]; Available from: http://w ww.mdch.state.mi.us/pha/osr/CHI/CRI/frame.asp.

5. Kannan, S., et al., Exposure to fine particulate matter and acute effects on blood pressure: effect modification by measures of obesity and location. J Epidemiol Community Health, 2010. 64 (1): p. 68

- 74.

6. Zenk, S., et al., Neighborhood racial composition, neighborhood poverty, and supermarket accessibility in metropolitan

Detroit. American Journal of Public Health, 2005. 95 (4): p. 660

- 667.

7. Exposure to toxic environmental agents. Fertil Steril, 2013. 100 ( 4): p. 931

- 4.

8. Committee on Improving Risk Assessment of Hazardous Air Pollutants, C.o.L.S., National Research Council, Science and Judgement in Risk Assessment . 1994, The National Academies Press.

9. Omenn, G. Framework for Environmental Health Risk Man agement: Final Report by the Presidential/Congressional

Commission on Risk Assessment and Risk Management. . 1997.

10. Committee on Improving Risk Analysis Approaches Used by the US EPA, N.R.C., Science and Decisions: Advancing Risk

Assessment 2009, The Na tional Academies Press.

11. Agency, E.P. Federal Register. National Ambient Air Quality Standards for Ozone; Proposed Rule. 2014.

12. Koman, P. Public Comment on Ozone Risk and Exposure Assessment and Policy Assessment . Comment on the Federal Register, 201 4.

13. American Thoracic Society, What constitutes an adverse health effect of air pollution? Official statement of the American Thoracic Society. Am J Respir Crit Care Med, 2000. 161 : p. 665

- 73.

14. Jackson, L. Response to Ozone Integrated Science Assess ment (Third External Review Draft) for National Ambient Air Quality Standards Review . 2013.

15. Payne

- Sturgis, D. and L. Martin, The Cumulative Risk Assessment Webinar Series: What We Learned

, N.C.f.E.R.a.O.o.t.S.A. Office of Research and Development, Risk Assessment Forum Cumulative Risk Technical Panel, Environmental Protection Agency., Editor. 2014.

16. Mannino, D.M., What constitutes an adverse health effect of air pollution? American journal of respiratory and critical care medicine, 2000. 161 (2 pt 1): p. 665

- 673.

17. Zanobetti, A. and J. Schwartz, Ozone and survival in four cohorts with potentially predisposing diseases. American journal of respiratory and critical care medicine, 2011. 184 (7): p. 836

- 841.

18. Brulle, R.J. and D.N. Pellow, Environmental justice: human health and environmental inequalities. Annu Rev Public Health, 2006. 27 : p. 103

- 24.

19. EPA, U. Regulatory Impact Analysis of the Proposed Revisions to the National Ambient Air Quality Standards for
Ground

- Level Ozone . 2014.Page 4

Contact Amy Schulz ( ajschulz@umich.edu ) for additional information. Produced by the Detroit Reproductive Environmental Advocacy Matters Working Group: Donele Wilkins , Amy Schulz, Natalie Sampson, Kelly Ferguson, Chris Coombe, and Trish Koman

. April 5 , 2015. 20. Evans, G.W. and E. Kantrowitz, Socioeconomic status and health: the potential role of environmental risk exposure. Annu Rev Public Health, 2002. 23 : p. 303

- 31.

21. Farley, T.A., et al., The relationship between the neighbourhood environment and adverse bir th outcomes. Paediatric and perinatal epidemiology, 2006. 20 (3): p. 188

- 200.

22. O'Neill, M.S., et al., Air pollution, inflammation and preterm birth in Mexico City: study design and methods. Sci Total

Environ, 2013. 448 : p. 79

- 83.

23. Ritz, B. and M. Wilh elm, Ambient air pollution and adverse birth outcomes: methodologic issues in an emerging field.

Basic Clin Pharmacol Toxicol, 2008. 102 (2): p. 182

- 90.

24. Woodruff, T.J., et al., Disparities in exposure to air pollution during pregnancy. Environ Health Pe rspect, 2003. 111 (7):

p. 942

- 6.