Thursday, December 27, 2012

Quick thoughts as Lisa Jackson prepares to step down from EPA

The news has broken today that EPA Administrator Lisa Jackson will be stepping down.

This has long been expected, so, in that sense, it isn’t a shock.

Health and environmental advocates will definitely miss her.  She has been a real champion for clean air.  She is going to be a tough act to follow.

Jackson had some very significant wins during her tenure.  High among them were strong standards to clean up mercury and other toxic emissions from coal power plants, new fuel economy and greenhouse gas standards for motor vehicles and new standards to limit fine particle soot in the air.  Very significantly, she also reversed the findings of the Bush administration and declared that climate change poses a real threat to health and the environment.  (This so-called endangerment finding was a necessary first step before the EPA could limit vehicle greenhouse gas emissions, power plant emissions, etc.) She also reversed the Bush policy and permitted California to move ahead with its own ghg vehicle standards, which then became the model for national standards.

Jackson also had some real setbacks, including the 2011 decision by the White House to block EPA from updating national clean air standards for smog, or ozone.  It was an ugly episode as political science trumped real science.

And the courts have, at least temporarily, stalled her efforts to limit power plant pollution that blows across state lines.

The cross-state pollution issue, the still-controversial ozone question, and the need for cleaner, low-sulfur gas will be among the priorities facing her successor.

Friday, December 21, 2012

Health and environmental groups less than thrilled with new EPA mercury/toxic standards for industry boilers, cement kilns

At long last, the US EPA has set new standards to limit mercury and other toxic emissions from industrial boilers and cement kilns.  Here is a link to the official material: and

Health and environmental groups are less than thrilled with the results (particularly the cement rules to quote one of our correspondents: "They still s*&k.") since these are weaker standards than EPA had previously put forth.  Can you hear the sound of one hand clapping?

The Washington Post reports that a White House aide brokered a deal with industry and then leaned on EPA to soften some requirements to make them more politically palatable. To cite the old cliche, is the perfect the enemy of the good?  [The EPA fact sheet on this at
does note that the new version of the boiler standards would make bigger cuts in mercury and sulfur dioxide emissions than an earlier March 2011 rule would have, though the new version would allow higher emissions of non-mercury metals, direct particulate matter and volatile organic compounds.]

It is clear that maximum health protection lost out to political considerations.  And this suggests that the Obama administration may take more of a conciliatory approach to industry in its second term.

Friday, December 14, 2012

Some Thoughts As EPA Sets Tougher National Soot Standard

This is the best holiday gift EPA could give breathers – the gift of cleaner air and better health.

Today’s decision is nothing short of historic.  It is the first time EPA has ever tightened the critical long-term soot standard first set 15 years ago.  

There’s a lot more we could say, but our friends at the American Lung Association have already done that.

Tuesday, December 11, 2012

Oil Industry Readies Media Blast Against New EPA Particle Soot Air Standards

... reporters please note below.  If Big Oil is against this move, it sounds pretty positive!

API calls on White House to

Avoid Unnecessary New Particulate Matter Standards


Press conference call on Wednesday, December 12, 2012 at 1:30 pm ET


Please join API’s top scientific advisor Howard Feldman to discuss EPA’s proposed PM NAAQS rule, which is currently with the White House Office of Management and Budget and is scheduled to be finalized soon.  Feldman will discuss the proposed rule and its impact on job growth, our nation’s economic recovery, and air quality. 

 There will be a question and answer session for reporters. 

Please RSVP by replying to this email ( or by calling API media relations at 202-682-8114.

 What:   Press call on EPA’s proposed PM NAAQS rule


Who:    Howard Feldman, API director of regulatory and scientific affairs


When:  December 12, 2012


             1:30 pm ET


Phone: (800) 374-2418

Code:   808 23 393


Drug Makers Oppose Bailout for Banned, Ozone-Depleting Primatene Mist

The leadership of the U.S. House of Representatives has again scheduled a vote, tentatively tomorrow, on legislation to bail out the maker of the banned, ozone depleting Primatene Mist.

 For some quick background, see

Other drug makers now have written to Congress, urging defeat of what can only be described as a smelly, special-interest bailout bill.  Here is the letter:
December 10, 2012


Via Email

U.S. House of Representatives
Washington, D.C. 20515

 Dear Representative:

On behalf of the International Pharmaceutical Aerosol Consortium (IPAC)—an association of companies that manufacture medicines for the treatment of respiratory illnesses, such as asthma and chronic obstructive pulmonary disease (COPD)—I am writing to you today in opposition to H.R. 6190, the “Asthma Inhalers Relief Act of 2012,” which is currently on the Suspension Calendar for Wednesday.

 IPAC’s members are: AstraZeneca, Boehringer Ingelheim, Chiesi Farmaceutici, GlaxoSmithKline, Sunovion, and Teva.  For more than 20 years, IPAC has been firmly committed to the transition from chlorofluorocarbon (CFC) metered-dose inhalers (MDIs) to CFC-free alternatives, pursuant to the mandates of the Montreal Protocol, and actively engaged in the transition process in the United States.  IPAC’s member companies invested substantial resources to develop CFC-free alternatives in order to accomplish the phase-out of CFC-based MDIs. 

 IPAC strongly opposes efforts within the House of Representatives to lift the December 31, 2011 ban on the sale of CFC-based epinephrine (brand name: Primatene Mist) metered dose inhalers (MDIs) through H.R. 6190.  Such a drastic reversal in settled law would be (1) unnecessary to protect the health of asthma patients and (2) contrary to the United States’ important and longstanding commitment to international treaties. 

 As you may know, the phase-out of Primatene Mist and other ozone-depleting MDIs was initiated more than two decades ago in response to the mandates of the Montreal Protocol which was signed by President Ronald Reagan in 1987.  The “essential use” process under the Montreal Protocol and Clean Air Act provided the MDI industry ample time to reformulate and seek approvals of CFC-free alternatives.  MDI manufacturers long ago began working diligently to research and develop CFC-free products in order to meet Montreal Protocol requirements.  Most companies (including all IPAC members) invested hundreds of millions of dollars to accomplish this important objective.  The attached timeline summarizes the extensive history of the essential use process and the careful, deliberative steps undertaken to promote a smooth and seamless transition to CFC-free alternatives. 

The December 31, 2011 phase-out date for CFC-based Primatene Mist was established by FDA in 2008 (under the prior Administration), and was based upon an extensive administrative record that included input from key stakeholders, including patient and physician groups.  This deadline provided three full years to transition patients to one of the several CFC-free alternatives available.  It is noteworthy that the manufacturer of Primatene Mist specifically sought the December 31, 2011 deadline after an earlier deadline was initially proposed by FDA. 

More importantly, the stockpiled Primatene Mist is nearing the end of its shelf life (assumed to be 24 months based on public data) and would, therefore, expire quite soon after being sold to patients.  According to a recent Congressional letter to FDA, Armstrong ceased producing Primatene Mist in August 2011 – more than a year ago.  Any remaining units sitting in a warehouse somewhere are rapidly nearing the end of their useful life. 

It has been suggested that re-introducing Primatene Mist would be cost-effective for patients.  A group of respected patient advocates directly disputes this assertion and they note that “two inhalations of epinephrine provide breathing relief ... for 15-30 minutes, whereas two inhalations of prescription bronchodilators, which is the recommended medication by NIH, last 3-6 hours with less unwanted cardiac stimulation.  Primatene Mist is not a cheaper alternative.”  (Allergy & Asthma Network Mothers of Asthmatics, et al, letter to Senators Pat Roberts and Jim DeMint October 28, 2011).  In addition, patient assistance programs (and product samples) continue to be available to assist many users of Primatene Mist to successfully transition to safe and effective CFC-free alternatives.
The only possible beneficiary of a reversal of the ban on Primatene Mist would be its manufacturer, which stands to garner a financial windfall if its limited stocks are sold.  And, any patient buying these MDIs will be forced to switch therapy a second time once the stocks are depleted (which is likely to be within a matter of months).  Granting extraordinary, unwarranted and special treatment to a single company would send an extremely negative signal to the manufacturers that responded to the U.S. Government’s call many years ago to be a partner in meeting the Montreal Protocol commitments.  Similar, prior requests for deadline relief (including requests to sell small stockpiles of CFC MDIs) have been firmly denied by the relevant regulatory authorities. 
Finally, there is no evidence that patient health will benefit from briefly re-introducing Primatene Mist onto the market, now almost one year after the ban became effective.  Rather, as stated during the July 18th hearing on this bill, the clear consensus of the major physician and patient groups is that such an action would be extremely confusing and disruptive for patients and would not contribute to improved health outcomes.  Tens of millions of asthma and COPD patients in the U.S. have successfully transitioned to CFC-free MDIs over the past 15 years.   

IPAC respectfully urges you and your House colleagues not to support H.R. 6190, the “Asthma Inhalers Relief Act of 2012” and to ensure that the phase-out of CFC-based MDIs remains in effect so that patients and consumers are not subjected to unnecessary risks or uncertainty.  For your reference, I have also included an attachment that provides you and your staff with a timeline for the phase-out of CFC-based MDIs.  We appreciate the opportunity to share our views in this letter, and please be assured that IPAC stands ready to serve as a resource on this issue.  If you and your staff have any questions about our letter, please feel free to contact me at (202) 230-5133 or


Maureen Donahue Hardwick
IPAC Secretariat and Legal Counsel




Friday, December 07, 2012

State Attorneys General, Led by NY, Press for Tough Soot Standard

Many thanks to the attorneys general, led by New York, for pressing for tough, health-protective national air standards to limit fine particle soot in the air.  Here is their letter:

Attorneys General of New York, Connecticut, Delaware, Maryland, Massachusetts, New Mexico, Rhode Island, Vermont, and Washington
December 6, 2012 By electronic mail and first class mail
Boris Bershteyn Acting Administrator
Office oflnformation and Regulatory Affairs
The White House Office of Management and Budget 725 17th Street, NW
Washington, D.C. 20503
Re:       National Ambient Air Quality Standards for Particulate Matter
Dear Acting Administrator Bershteyn:
We understand that the Environmental Protection Agency has recently submitted for interagency review a final rulemaking package on the National Ambient Air Quality Standards for Particulate Matter to the Office of Information and Regulatory Affairs. Under a consent decree that EPA entered into with our States and several public health organizations, the agency is required to sign the final rule by December  14, 2012.  We urge you to support EPA's adoption of annual and daily standards for fine particulate matter that are fully protective of public health, including the health of over 100 million Americans who are most vulnerable to particulate matter pollution.  An annual standard

for fine particulate matter of no higher than 12 micrograms per cubic meter (ug/m3   is
necessary to protect public health with an adequate margin of safety. In addition, the scientific evidence supports a daily standard of 30 ug/m3 to protect the public against short-term exposures.
Because of the public health imperative for sufficiently protective standards, our States have been advocating for years -- in agency rulemakings and in court -- for EPA to fulfill its duty under the Clean Air Act to issue standards that protect public health with
an adequate margin of safety.  After EPA rejected the advice of its independent science advisors, the Clean Air Scientific Advisory Committee, in 2006 to strengthen the existing 15 Jlg/m3 annual standard for fine particulate matter, we successfully challenged that standard in American Farm Bureau Fed'n v. EPA, and in early 2009, the D.C. Circuit remanded the standard -- which it termed "contrary to law" -- to EPA for reconsideration.
After EPA missed several self-imposed deadlines to issue standards consistent with the D.C. Circuit's decision and then also failed to meet its obligation under the
Clean Air Act to timely complete its five-year review, our States filed suit in district court in February 2012 seeking to compel EPA to expeditiously issue particulate matter standards.  The case, State ofNew York, et al. v. Lisa P. Jackson (S.D.N.Y. No. 12- 1064), which was subsequently transferred to federal district court in the District of

Columbia, resulted in a court order requiring EPA to sign the proposed rule by June 14, 2012.  The parties subsequently negotiated a settlement resolving the case, memorialized in a consent decree that requires EPA to sign the final rule by December  14, 2012.
It is a central goal of the Clean Air Act "to protect and enhance the quality of the Nation's air resources so as to promote the public health and welfare and the productive capacity of its population." 42 U.S.C. § 7401(b)(l). A core element of achieving this goal is the Act's requirement that EPA adopt "primary'' standards for certain pollutants, such as particulate matter. Critically, the Act requires the standard to be set at a level that protects public health with an "adequate margin of safety."
Fine particulate matter, or particulate matter less than two and a half micrometers in diameter ("PM2 .5"), forms predominantly as a result of the combustion of fossil fuel by power plants, motor vehicles, industrial facilities, and residential heating.  Because of its microscopic size, fine particulate matter can penetrate deep into the lungs and trigger a wide range of adverse health effects.  EPA has linked exposure to fine particulate matter pollution with increased respiratory symptoms (asthma attacks) and disease (acute and chronic bronchitis), decreased lung function, and premature deaths in people with heart or lung disease.
EPA estimates that more than 100 million Americans_:. one-third of the nation's population -- have special susceptibility to harm from particulate matter, including children, seniors and people with lung diseases such as asthma.  EPA calculated in 2010 that exposure to fine particulate matter pollution at the levels allowed under the
15 jlg/m 3annual standard could result in roughly 10,000 premature deaths per year in just
15 urban areas in the country.  The agency also found that up to half of these premature deaths could be averted if an annual standard of 12 jlg/m 3 were adopted.
Although fine particulate matter pollution in the U.S. has decreased since EPA performed these calculations, areas of the country continue to experience fine particulate matter concentrations below the level of the current standards but above the levels that EPA staff and Clean Air Scientific Advisory Committee concluded pose a risk to human health.  As set forth in affidavits filed in the New York v. Jackson case, there are a number of areas in our States in which fine particulate matter levels are at or below the current annual standard of 15 jlg/m 3 and above annual levels in the range of 11-13 jlg/m 3
EPA has proposed to strengthen the annual primary standard for PM2.5 from 15 jlg/m 3 to within a range of 12 jlg/m 3 -13 jlg/m, 3 and proposed to leave the 24-hour primary standard unchanged at 35 jlg/m 3 .  The agency also solicited comments on
alternative annual standards down to 11 jlg/m 3, and on the combination of annual and 24- hour standards.                                                                   ·
As explained in detail in the comments of some of our States on the proposed rule (attached for your reference), the adoption of an annual standard of no higher than
12 jlg/m 3 is necessary to protect public health with an adequate margin of safety as required under the Clean Air Act.  A primary standard set at no higher than this level is

compelled both by the extensive and overwhelming public health evidence contained in the record and by EPA's own 2010 quantitative health risk assessment for particulate matter.  In the rulemaking, EPA staff concluded that there is now a "stronger and broader body of evidence" than in 2006 that exposure to fine particulate matter causes premature death, breathing problems, and heart disease.  The Clean Air Scientific Advisory Committee concurred with EPA staffs finding that the strongest evidence supports a
standard in the range of 11-12  In addition, as explained in our attached comments
on the proposed  rule, the record  also supports EPA setting the 24-hour  standard  for fine particulate matter at 30 3  given that adverse public health impacts can occur as a result of exposure at the current level of 35 3.
Although EPA did alternatively propose to set the annual standard at 13 J..tglm 3 , adopting  a standard  at this level would  not  satisfy the agency's  obligation  under  the statute to protect public health with an adequate margin  of safety.   As explained  in the attached  comments,  EPA  staff and  the  Clean Air  Scientific Advisory  Committee both cited  evidence  ofharm  associated  with  exposures  to  concentrations  below  this  level. Therefore, we believe it would be both contrary to the Clean Air Act and to the D.C.
Circuit's decision in American Farm Bureau to set the annual standard at 13 .
Finally, EPA's decision should not be delayed on the grounds that more cost­ benefit analysis on the particulate matter standards is warranted in light of the D.C. Circuit's decision vacating the Cross-State Air Pollution Rule, one of the tools EPA cited for attaining the new particulate matter standards.  EPA, our States, and several other parties have petitioned the D.C. Circuit for rehearing of that decision.  But more importantly, the Supreme Court has unanimously held that "EPA may not consider implementation costs in setting primary and secondary [standards]."  Whitman v. Am. Trucking Ass'ns, 531 U.S. 457,486 (2001).  Instead, EPA must make decisions on the standards solely based on the scientific evidence.  42 U.S.C. § 7409(b)(1).

* * *

Every day, particulate matter pollution threatens the health of more than one-third of our nation's population-- particularly our most vulnerable: children, the elderly and the sick.  For this reason, we urge you to support EPA's timely adoption of particulate matter standards that fully meet the requirements of the Clean Air Act.  Thank you for your attention to this critical matter.

Attorney General ofNew York LEMUEL  SROLOVIC
Chief, Environmental Protection Bureau
I                                                                    i
By:                                   .

Michael J Myers, Assistant Attorney General
Environmental Protection Bureau The Capitol
Albany, NY  12224
(518) 492-2594
Attorney General of Connecticut SCOTT N. KOSCHWITZ
Assistant Attorney General
Office of the Attorney General 55 Elm Street
Hartford, CT 06106
Attorney General of Delaware VALERIE M. SATTERFIELD
Deputy Attorney General Attorney General's Office
Third Floor, 102 W. Water Street Dover, Delaware  19904
Attorney General ofMaryland MARY E. RAIVEL
Assistant Attorney General Office of the Attorney General
Maryland Department of the Environment
1800 Washington Blvd., S. 6048
Baltimore, MD 21230
Attorney General of Massachusetts
Assistant Attorney General Environmental Protection Division 1 Ashburton Place, Room  1813
Boston, MA 02108

Attorney  General ofNew Mexico STEPHEN R. FARRIS
Assistant Attorneys General
Water, Environment, and Util. Divis.
P.O. Box Drawer 1508 Sante Fe, NM 87504
Attorney  General ofRhode Island MICHAEL RUBIN
Assistant Attorneys General Department of Attorney General 150 South Main
Providence, RI 02903
Attorney General of Vermont THEA SCHWARTZ
Assistant Attorney General
Office ofthe Attorney  General 109 State Street
Montpelier, VT 05609-1001
Attorney General of Washington LESLIE R. SEFFERN
Assistant Attorney General
Office ofthe Attorney General
P.O. Box 40117
Olympia, WA 98504


cc:        Lisa P. Jackson, EPA Administrator

Nancy Sutley;Chair of Council on Environmental  Quality